Fluid mixing apparatus and method

Abstract

The medical device may comprise a first inlet for receiving a first fluid, a second inlet for receiving a second fluid, and a composite including a first body defining a first lumen and a second body positioned within the first lumen. The first lumen may be fluid-communicated with the first inlet so that the first lumen receives the first fluid from the first inlet. The second body may define a second lumen. The second lumen may be fluid-communicated with the second inlet so that the second lumen receives the second fluid from the second inlet. The radial outer surface of the second body may have a plurality of openings so that the first lumen and the second lumen are fluid-communicated through the plurality of openings.

Description

Technical Field

[0001] This disclosure generally relates to fluid mixing devices and methods. Specifically, aspects of the present disclosure relate to medical devices and / or methods that promote the delivery of a liquid to a target site within a subject's anatomical structure by mixing the liquid with a fluid to aerate the liquid. This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 500,008, filed May 4, 2023, which is hereby incorporated by reference in its entirety.

Background Art

[0002] In medical procedures, it may be possible to deliver a fluid such as a liquid to a site (e.g., a treatment site) within a subject's anatomical structure. For example, an endoscopic procedure may be performed within a body lumen of a subject. Such procedures may include endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) that may be used to remove a lesion (e.g., a polyp) from a body lumen (e.g., the colon) of a subject. Perforation or other bleeding sources may occur as complications of such procedures. Bleeding may occur during the procedure or may occur later. Low-viscosity agents may be used prophylactically or hemostatically. Some low-viscosity fluids may move away from the site during delivery due to their low viscosity. High-viscosity agents pose challenges for transportation due to the amount of force required to deliver a high-viscosity liquid. Therefore, there is a need to deliver a drug to a target site within a subject's anatomical structure.

Summary of the Invention

[0003] This disclosure is a fluid mixing device and a method of using the same, including, for example, a device and a method for promoting the flow of a fluid by mixing a high-viscosity fluid with air, carbon dioxide, or another fluid. Each aspect disclosed herein may include one or more of the features described with respect to any of the other disclosed aspects.

[0004] In some embodiments, a medical device may comprise a first inlet for receiving a first fluid, a second inlet for receiving a second fluid, and a mixture. The mixture includes a first body defining a first lumen and a second body positioned within the first lumen. The first lumen may be fluid-communicated with the first inlet so that the first lumen receives the first fluid from the first inlet. The second body may define a second lumen. The second lumen may be fluid-communicated with the second inlet so that the second lumen receives the second fluid from the second inlet. The radial outer surface of the second body may have a plurality of openings so that the first lumen and the second lumen are fluid-communicated through the plurality of openings.

[0005] Any of the multiple embodiments disclosed herein may include any combination of any of the following features: The first body may be tubular. The second body may be tubular. The first and second bodies may be monolithically formed from a single piece of material. The first lumen may be coaxial with the second lumen. The composite may have a size that is accommodated within the working channel of the scope. The first fluid may be a liquid and the second fluid may be a gas. The composite may be configured to form a mixture of the first and second fluids within the first lumen by the second fluid flowing into the first lumen through the multiple openings. The medical device may further include an outlet configured to receive the mixture of the first and second fluids from the first lumen. The first fluid may be a gas and the second fluid may be a liquid. The medical device may further comprise an outer sheath defining a first inlet and an inner sheath at least partially located within the outer sheath and defining a second inlet. The radial outer wall of the outer sheath may include a side opening. The inner sheath may be configured to receive the second fluid through the side opening. The proximal end of the first body may be coupled to the distal end of the outer sheath. The proximal end of the second body may be coupled to the distal end of the inner sheath. The composite may be configured to form a mixture of the first fluid and the second fluid in the second lumen by allowing the first fluid to flow into the second lumen through the plurality of openings. The composite may be configured to form a mixture of gas and liquid by allowing a gas to pass through the plurality of openings.

[0006] In another embodiment, the medical device may comprise a first body defining a first lumen and a second body positioned within the first lumen. The second body may define a second lumen. The radial outer surface of the second body may have a plurality of openings such that the first lumen and the second lumen are in fluid communication through the openings. The medical device may be configured such that a gas flows through the plurality of openings to form a mixture of gas and liquid, either (a) from the first lumen into the second lumen or (b) from the second lumen into the first lumen.

[0007] Any of the multiple embodiments disclosed herein may have any combination of the following features: The first lumen may be coaxial with the second lumen. The first body may be tubular. The second body may be tubular.

[0008] In one embodiment, a medical method may include receiving a gas in a first lumen of a medical device, receiving a liquid in a second lumen of the medical device, passing the gas through a plurality of openings in the wall between the first lumen and the second lumen so that the gas is mixed with the liquid to form a mixture of the gas and the liquid, and delivering the mixture of the gas and the liquid to a location within the body lumen of a subject.

[0009] Any of the multiple embodiments disclosed herein may include any of the following steps or features: The liquid can be dispersed by passing a gas through the plurality of openings.

[0010] Any of the multiple embodiments described herein may have any combination of any of these features. The accompanying drawings incorporated herein and forming part thereof are illustrative of the present disclosure and, together with this description, are helpful in illustrating the principles of the present disclosure. [Brief explanation of the drawing]

[0011] [Figure 1] Figure 1 shows a side view of the mixing apparatus. [Figure 2] Figure 2 shows a cross-sectional side view of the mixing apparatus shown in Figure 1. [Figure 3-4] Figures 3 and 4 show a cross-sectional perspective view of the mixing apparatus shown in Figure 1. [Figure 5] Figure 5 shows another mixing apparatus. [Modes for carrying out the invention]

[0012] Details of several embodiments of this disclosure are described below, and their embodiments are shown in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts.

[0013] Both the general description above and the detailed description below are illustrative and descriptive only and do not limit the claimed invention. The terms “equipped,” “containing,” “including,” or any other variations thereof as used herein are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements may include not only those elements but also other elements not expressly enumerated or specific to such process, method, article, or apparatus. The term “diameter” may refer to width if the element is not circular. The term “distal” refers to the direction away from the operator, and the term “proximal” refers to the direction toward the operator. In some figures, arrows labeled “P” and “D” indicate the proximal and distal directions, respectively. The term “exemplary” is used to mean “example” rather than “ideal.” The term “approximately” or similar terms (e.g., “substantially”) include values ​​within + / - 10% of the stated value.

[0014] A medical device may be a mixing device that receives a first fluid, such as a therapeutic agent (e.g., a viscous liquid), and a second fluid, such as a gas (e.g., air or carbon dioxide). The medical device may generate bubbles in the first fluid by slowly introducing the second fluid into the first fluid. The bubbles may expand, increasing the dispersion / atomization of the first fluid. Therefore, the pressure required to discharge the first fluid (mixed with the second fluid) from the medical device may be reduced. In at least some examples, the first fluid (after mixing with the second fluid) may be delivered to the treatment site via an introduction device (e.g., a scope). In some examples, the first fluid may be mixed with the second fluid near the distal end of the introduction device close to the treatment site. In other examples, the first fluid may be mixed with the second fluid near the proximal end of the introduction device (e.g., outside the body lumen where the introduction device is positioned). The mixed fluid may then be advanced to the distal end of the introduction device and discharged from the introduction device outside the treatment site. The apparatus described herein may be used to deliver drugs containing viscous agents, and relates to fluid mixing devices and methods such as medical devices, and / or methods for aerating a liquid (e.g., a high-viscosity liquid) by mixing a fluid with a liquid and delivering it, thereby facilitating the delivery of the liquid to a treatment site.

[0015] The mixed first and second fluids can be delivered to the treatment site (e.g., the site where a polyp was removed) via an introduction device, such as EMR or ESD. The first fluid without the second fluid may not be deliverable hydraulically via the introduction device, or may require a very high level of delivery pressure. In some examples, the mixed fluids can be sprayed or otherwise administered to the treatment site. The mixing device and the mixed fluids may be used in conjunction with a material that, upon contact with tissue, coagulates, adheres to the tissue, and covers the defect, thereby providing protection from delayed perforation and / or delayed bleeding.

[0016] Figures 1 to 4 show embodiments of a medical device 100, which may be a mixing device used to mix a first fluid (e.g., a liquid treatment agent) with a second fluid (e.g., a gas such as air or carbon dioxide). Figure 1 shows a side view of the medical device 100. Figures 2 to 4 show cross-sectional views of the medical device 100, which have a cross-section cut along / parallel to the longitudinal axis (proximal / distal axis) of the medical device 100. Figure 2 shows a side view, while Figures 3 and 4 show perspective views. Note that the planes along the cross-sections in Figures 2 to 4 may differ from each other (however, all may be parallel to the longitudinal axis of the medical device 100). Therefore, the visible features in Figures 2 to 4 may differ.

[0017] The medical device 100 may include a complex 110, an input body 120, and an output body 130. These complex 110, input body 120, and output body 130 may be separate components assembled together or may be a single, integrated structure. A first fluid and a second fluid may be mixed within the complex 110. The input body 120 may guide (i.e., move) the second fluid into the complex 110. The output body 130 may receive the mixed first and second fluids and may transport the mixed first and second fluids to other components (e.g., a catheter or distal tip as described below). The medical device 100 may also include a first fluid conduit 148 for transporting the first fluid into the complex 110. The fluid conduit 148 may be integrated with the complex 110.

[0018] The composite 110 may include a housing 140. The housing 140 may have a generally tubular body with a cylindrical outer surface, as shown in Figure 1. As shown in Figures 2 to 4, the walls of the housing 140 may define a lumen 142. The cross-section of the lumen 142 perpendicular to the longitudinal axis of the composite 110 may have a substantially circular shape. In particular, as shown in Figure 2, the lumen 142 may include a proximal portion 144 and a distal portion 146. The proximal portion 144 may have a larger width / diameter than the distal portion 146. However, such a configuration is illustrative, and the lumen 142 may have a uniform diameter / width or other configurations with a variable diameter / width.

[0019] The first fluid conduit 148 may extend from the side of the composite 110 and may function as an inlet for the first fluid. For example, as shown in Figures 1 to 4, the first fluid conduit 148 may extend from the composite 110 at an angle of 0 to 90 degrees with respect to the longitudinal axis of the composite 110. Alternatively, the first fluid conduit 148 may extend at an angle of about 90 degrees with respect to the longitudinal axis of the composite 110, or at any other suitable angle. The first fluid conduit 148 may be flexible or rigid. The first fluid conduit may be tubular and may define a lumen 149. The lumen 149 of the first fluid conduit 148 may be in fluid communication with the lumen 142 of the composite 110, for example, through an opening 141 in the side wall of the housing 140 (see Figure 3), so that the fluid is received into the lumen 142 through the first fluid conduit 148. In the cross-section shown in Figure 4, the first fluid conduit 148 is not visible.

[0020] The second fluid conduit 150 may be a body located within the housing 140. For example, the second fluid conduit 150 may extend within the lumen 142 substantially parallel to the longitudinal axis of the composite 110 (for example, substantially coaxial with the central longitudinal axis of the composite 110). The cross-section of the second fluid conduit 150, taken perpendicular to its longitudinal axis, may be substantially circular. Part or all of the second fluid conduit 150 may have a tubular / annular / cylindrical shape. The second fluid conduit 150 may have a proximal portion 152 and a distal portion 154. The distal portion 154 may have a larger width / diameter than the proximal portion 152. Alternatively, the proximal portion 152 and the distal portion 154 may have the same diameter / width, or the distal portion 154 may have a smaller diameter / width than the proximal portion 152. The support portion 156 can connect the second fluid conduit 150 to the housing 140 of the composite 110. For example, the support portion 156 may be an annular wall extending between the housing 140 and the distal portion 154 of the second fluid conduit 150.

[0021] Lumen 158 may extend longitudinally through a second fluid conduit 150. The side walls of the second fluid conduit 150 (walls facing radially outward with respect to the longitudinal axis of lumen 158) may have a plurality of openings 160 formed in the side walls. The second fluid conduit 150 may contain any suitable number of openings 160. The openings 160 may have any suitable size or shape (e.g., circular). The size of the openings 160 may be selected depending on the properties (e.g., viscosity) of the first fluid (e.g., liquid) and / or the second fluid (e.g., gas). For example, the diameter of the openings 160 may be about 0.5 mm to about 2.0 mm. The plurality of openings 160 may be arranged along the second fluid conduit 150 (e.g., along the distal portion 154) at regular or irregular intervals in the longitudinal direction. Furthermore, the multiple openings 160 may be arranged around the second fluid conduit 150 (for example, around the distal portion 154) at regular or irregular intervals in the circumferential direction. The second fluid conduit 150 may have an opening structure with any suitable arrangement of the openings 160. For example, as shown, the second fluid conduit 150 may include four rows of openings 160 parallel to the longitudinal axis of the second fluid conduit 150. The four rows may be evenly spaced (i.e., spaced at 90 degrees) around the outer circumference of the second fluid conduit 150. Each row may have six holes of the same size and shape. The walls of the opening structure of the second fluid conduit 150 may be positioned between lumens 158 and 142 / form a boundary between them. The openings 160 may fluidly couple the lumen 158 of the second fluid conduit 150 to the lumen 142 of the composite 110. The distal end of the second fluid conduit 150 may be closed so that the second fluid can flow out only from the opening 160. Alternatively, the distal end of the second fluid conduit 150 may be open. The distal end of the second fluid conduit 150 may be located proximal to the distal end of the housing 140. The distal end of the lumen 158 may be located proximal to the distal end of the lumen 142.

[0022] The input body 120 may be coupled (e.g., detachably or fixedly) to the proximal end of the composite 110. The input body 120 and / or adapter 180 may be an inlet for a second fluid. Alternatively, the input body 120 may be formed integrally with the housing 140 of the composite 110 (i.e., formed as a single piece). The input body 120 may include a threaded portion 170 (see Figure 2) for engaging with the corresponding threaded portion of the housing 140 to couple the input body 120 to the housing 140. As shown in Figure 1, the outer surface of the input body 120 may include a gripping portion 179 (e.g., a raised surface) for gripping the input body 120 and screwing it to the housing 140. The input body 120 may define a passage 172 having an outlet 174 and an inlet 176. The outlet 174 can be fluidically (and sealfully) coupled to the lumen 158 of the second fluid conduit 150 so that the passage 172 is in fluid communication with the lumen 158. The width / diameter of the outlet 174 may be substantially the same as the width / diameter of the lumen of the proximal portion 152 of the second fluid conduit 150.

[0023] As shown particularly in FIG. 2, an adapter 180 can be coupled to the input body 120. In some examples, the adapter 180 can be fixedly provided on the distal end of a tube (not shown) that conveys a second fluid from a second fluid source (e.g., a gas source such as air or carbon dioxide). In other examples, the adapter 180 can removably receive the distal end of a tube (not shown) that conveys a second fluid from a supply source of the second fluid. The adapter 180 can include one or more return portions 182. For example, the return portion 182 can extend circumferentially around the distal end of the adapter 180. Alternatively, a plurality of return portions 182 can be provided spaced apart from each other. The one or more return portions 182 can engage one or more protrusions 178 of the input body 120. The one or more protrusions 178 can extend radially inwardly from the outer wall of the input body 120. The return portion 182 can be deformable such that the return portion 182 is compressible when the adapter 180 is inserted into the input body 120 and moves distally through the protrusion 178. The one or more return portions 182 can have shape memory characteristics or be otherwise biased to expand radially outwardly when located distal to the one or more protrusions 178. The return portion 182 can hold the adapter 180 within the input body 120 by engaging the protrusion 178. In some examples, the adapter 180 can be removed from the input body 120 after being inserted into the input body 120. In other examples, the adapter 180 may not be removable after being inserted into the input body 120. The adapter 180 can have a push connection interface with the input body 120. Alternatively or additionally, a tube (not shown) can be push-connected to the adapter 180.

[0024] The adapter 180 can have a lumen 184 that extends longitudinally therein. The lumen 184 can be open at its proximal and distal ends. The distal end of the lumen 184 can be coupled to the inlet 176 of the passageway 172. The lumen 184 can have approximately the same diameter / width as the inlet 176. Thus, the lumen 184 can be in fluid communication with the passageway 172.

[0025] The output body 130 can be coupled (e.g., removably or fixedly coupled) to the distal end of the composite 110. Alternatively, the output body 130 can be integrally formed (i.e., formed as a single unitary part) with the housing 140 of the composite 110. For example, the housing 140 can include an annular wall 147 that projects distally beyond the distal end of the lumen 142. The output body 130 can include a threaded portion 190 on its outer surface for engaging and coupling with a threaded portion on the inner surface of the annular wall 147. As shown in FIG. 1, the outer surface of the output body 130 can include a gripping portion 198 to assist in coupling the output body 130 to the composite 110.

[0026] Alternatively, any other suitable mechanism can be used to couple the output body 130 to the composite 110. The distal end of the output body 130 can include an interface 192 for coupling the output body 130 to a catheter or other type of tube (e.g., a rigid or flexible tube). For example, the interface 192 can be a luer-type interface.

[0027] The output body 130 can have a distal outlet 194 that is in fluid communication with the passageway 196. Note that because the cross-sections of FIGS. 2 and 3 are different from the cross-section of FIG. 4, the fluid connection between the passageway 196 and the outlet 194 is visible in FIG. 4 but not in FIGS. 2 and 3. The passageway 196 can have a proximal portion 196a and a distal portion 196b (FIG. 4). The distal portion 196b can have a smaller width / diameter than the proximal portion 196a. The width / diameter of the proximal portion 196a can be approximately the same as the width / diameter of the distal portion 146 of the lumen 142. The proximal portion 196a can be coupled to the distal portion 146 of the lumen 142 such that the lumen 142 is in fluid communication with the passageway 196. The width / diameter of the distal portion 196b can be configured to conform to the requirements of the interface 192. For example, the distal portion 196b can be provided within a nozzle 193 (see FIG. 4) that fits within a catheter or other tube coupled to the interface 192.

[0028] As an alternative to the output body 130, any type of dispensing tip may be attached to the distal end of the complex 110. For example, the dispensing tip may include a threaded portion on the tip for connection to the threaded portion of the housing 140. The dispensing tip may include an outlet having any of the features of the outlet 194.

[0029] During operation, a source of a second fluid (e.g., air or a gas such as carbon dioxide) may be coupled to the input body 120 (e.g., via an adapter 180). For example, the second fluid source may be a pressurizing source (e.g., a carbon dioxide canister or a compressed air source). A regulator (not shown) may also be used to adjust the flow rate of the second fluid (e.g., based on the viscosity of the first fluid).

[0030] A first fluid source may be coupled to the first fluid conduit 148. For example, the first fluid source may be a syringe or other container of the first fluid. The first fluid source may be actuated to deliver the first fluid into the complex 110 via the first fluid conduit 148. The first and second fluids may be introduced into the complex 110 simultaneously. Alternatively, the first fluid source may be actuated before the inflow of the second fluid, or vice versa. The first and second fluid sources may provide a force / pressure such that the first and second fluids flow through the complex 110 and a mixture of the first and second fluids flows out of outlet 194, as described below.

[0031] The first fluid can be received by the lumen 142 of the composite 110 via the first fluid conduit 148, which is fluid-coupled to the lumen 142, as described above. The second fluid can move through the lumen 184 of the adapter 180 and through the passage 172 of the input body 120 into the lumen 158 of the second fluid conduit 150. The second fluid can pass through the opening 160 and / or the distal end opening of the second fluid conduit 150 and / or flow out from the distal end opening. The size of the opening 160 and the flow rate of the source of the second fluid can be used to control the velocity at which the second fluid flows through the opening 160. The second fluid can create bubbles in the first fluid by passing through the opening 160 relatively slowly. The bubbles, by expanding in the first fluid, can cause a large dispersion of the first fluid, even if the first fluid has high viscosity. As the first and second fluid sources continue to operate, a distal force / pressure is exerted on the mixed first and second fluids as they move through the passage 196 and exit through the outlet 194. As the mixed first and second fluids exit through the outlet 194, at least some of the bubbles formed by the second fluid may burst.

[0032] Since the first fluid is mixed with the second fluid, a given volume of the mixed first and second fluids will contain less of the first fluid than an equivalent volume containing only the first fluid (without the second fluid). In fact, the second fluid (e.g., air or carbon dioxide) decomposes the first fluid (e.g., a liquid therapeutic agent). The first fluid is dispersed / atomized by the second fluid. Therefore, the force / pressure required to discharge the mixed first and second fluids through the passage 196 to the outlet 194 is less than the force / pressure required to discharge only the first fluid. Similarly, the force / pressure required to move the mixed first and second fluids through any tube / catheter attached to the distal end of the mixing device 100 is also less than that required for only the first fluid.

[0033] In some examples, the complex 110 may be inserted into the working channel of a delivery device such as a scope (e.g., endoscope, colonoscope, duodenoscope, cystoscope), catheter, or sheath. The complex 110 may have a size and shape that can be received by such a working channel. Thus, the complex 110 is positioned within the body lumen of the subject. The conduit / tube coupled to the first fluid conduit 148 and adapter 180 may extend proximal through the delivery device. The first fluid (e.g., liquid therapeutic agent) may be prepared in a catheter attached to the input body 120 and / or adapter 180 and extending proximal through the working channel of the delivery device. In such examples, the first and second fluids may be mixed at or near the distal end of the delivery device, close to the location where the first fluid is desired to be delivered at a predetermined flow rate (e.g., the site where the lesion has been resected). In such examples, a dispensing tip may be used instead of the output body 130. Additionally or alternatively, a spray component may be attached to the medical device 100 to enable the spraying of a mixed fluid.

[0034] In other examples, the complex 110 may be positioned outside the body lumen of the subject, proximal to the handle of the delivery device. A conduit / tube (e.g., a catheter) coupled to the outlet 194 may be inserted into the working channel of the delivery device and advanced to the site where delivery of the first fluid is desired. The mixed first and second fluids can then be delivered to that site via the conduit / tube. Such an arrangement may be advantageous when it is difficult to deliver the first fluid to the distal end of the delivery device before mixing due to the viscosity of the first fluid.

[0035] Figure 5 shows an alternative medical device 200 that can be used as a mixing device for mixing a first fluid (e.g., a liquid treatment agent) with a second fluid (e.g., a gas such as air or carbon dioxide). Unless otherwise specified below, medical device 200 may have any of the features described above with respect to medical device 100 and may function in any of the same ways having any of the same advantages. Embodiments of medical device 100 and medical device 200 may be combined in any suitable way.

[0036] The medical device 200 includes a composite 210 and a proximal portion 220 coupled to the proximal end of the composite 210. The first fluid and the second fluid can move separately through the proximal portion 220 to the composite 210 and are mixed within the composite 210. The mixed first and second fluids have any of the mixed fluid properties / characteristics described above with respect to the medical device 100.

[0037] The proximal portion 220 of the medical device 200 may include an outer sheath 275 and an inner sheath 277. The inner sheath 277 may be at least partially located within the outer sheath 275. The outer sheath 275 and the inner sheath 277 may be bodies having any suitable properties. The outer sheath 275 and the inner sheath 277 may each be tubular. In some examples, the outer sheath 275 and the inner sheath 277 may each be flexible catheters. Alternatively, parts of the outer sheath 275 and / or the inner sheath 277 may be rigid. Alternatively, the outer sheath 275 and / or the inner sheath 277 may have flexibility that varies along the length of the sheath. The outer sheath 275 and the inner sheath 277 may be substantially coaxial (i.e., the central longitudinal axis of the outer sheath 275 may be substantially coaxial with the central longitudinal axis of the inner sheath 277).

[0038] Each of the outer sheath 275 and the inner sheath 277 may be hollow and may define a lumen, as will be described in more detail below. The gap between the inner wall of the outer sheath 275 and the outer wall of the inner sheath 277 may define a passage 273, which may be part of the lumen defined by the outer sheath. The passage 273 may have an annular cross-sectional shape. The passage 273 may be configured to transport a second fluid (e.g., a gas such as air or carbon dioxide). The inner sheath 277 may define a central lumen 272. The lumen 272 may be configured to transport a first fluid (e.g., a liquid therapeutic agent).

[0039] The first fluid inlet 248 may extend through the sidewall of the outer sheath 275 and deliver the first fluid. The first fluid inlet 248 may be sealedly coupled to the wall of the outer sheath 275. For example, the outer sheath 275 may include an opening through which the first fluid inlet 248 passes. The first fluid inlet 248 and the wall of the outer sheath 275 may be sealedly coupled to each other. As shown in Figure 5, the first fluid inlet 248 may extend from the outer sheath 275 at an angle of about 90 degrees. However, such arrangements are merely illustrative, and the first fluid inlet 248 may extend from the outer sheath 275 at any desired angle (e.g., 0 degrees to about 90 degrees). The lumen of the first fluid inlet 248 may communicate with the lumen 272 via the sidewall of the inner sheath 277 and a joint 276 (e.g., an opening) formed at the distal end of the first fluid inlet 248.

[0040] In some examples, the first fluid inlet 248, outer sheath 275, and inner sheath 277 may be formed from a single, integral piece of material (for example, they may be additively manufactured to form a single, integrated body). Alternatively, one or more of the elements of the first fluid inlet 248, outer sheath 275, and inner sheath 277 may be formed separately and joined together. In one example, the first fluid inlet 248 and inner sheath 277 may be formed from a single, integral piece of material and joined to the outer sheath 275, which may be a separate piece of material. Such configurations are merely illustrative, and any suitable structure may be utilized.

[0041] In some examples, the first fluid inlet 248 and the inner sheath 277 may form a single sheath (e.g., a single tubular structure). Such a combined sheath may bend at an angle (e.g., about 90 degrees or any other suitable angle) and extend through the wall of the outer sheath 275. In other examples, the inner sheath 277 may extend proximal to the first fluid inlet 248 within the outer sheath 275. In such examples, the lumen 272 may extend proximal to the first fluid inlet 248 or terminate at the proximal end of the first fluid inlet 248 (e.g., the portion of the inner sheath 277 proximal to the first fluid inlet 248 may have a solid cross-section and may not contain a lumen). The exemplary structures described herein are not limiting, and any suitable structure may be employed to introduce the first fluid into the lumen 272.

[0042] The distal end of the proximal portion 220 may be joined to the proximal end of the composite 210 at the joint 270. In some examples, the elements of the composite 210 may be formed from a single, unified (monolithic) piece of material. For example, the composite 210 may be molded or additively manufactured to include all of the elements described herein. Alternatively, the elements of the composite 210 may be formed separately from each other and joined together (fixed or removable).

[0043] The composite 210 may include a housing 240. In some examples, the proximal end of the housing 240 may be located within the distal end of the outer sheath 275 and coupled to the distal end. For example, the housing 240 may be bonded to the outer sheath 275. The housing 240 may include an outer wall 241 which may have an annular cross-section (i.e., cylindrical / tubular).

[0044] The inner wall 250 may be located inside the outer wall 241. The inner wall 250 may be a body having a substantially annular cross-section (i.e., cylindrical / tubular shape) that defines a lumen 258 having a central longitudinal axis (extending in the proximal / distal direction) that is substantially coaxial with the central longitudinal axis (extending in the proximal / distal direction) of the housing 240. The inner wall 250 may have a tubular shape and may be flexible or rigid. As shown in Figure 5, the inner wall 250 may be formed integrally with the outer wall 241, and both may be part of the housing 240. For example, the inner wall 250 and the outer wall 241 may be joined to each other at the distal wall 243. Alternatively, the inner wall 250 may be a separate element (e.g., a flexible or rigid tube). The lumen 258 may be in fluid communication with the central lumen 272 (e.g., fluidically and / or sealed to it). Lumen 272 may be an inlet for lumen 258 through which fluid is transferred, so that lumen 258 receives fluid from lumen 272. For example, the proximal end of the inner wall 250 may be coupled to the distal end of the inner sheath 277 (for example, fixed and sealed by adhesive or another mechanism). For example, the inner wall 250 may include a notch 256. The distal end of the inner sheath 277 may be received by and engage with the notch 256.

[0045] The space between the outer wall 241 and the inner wall 250 may define a cavity (or lumen / passage / compartment) 242. The cavity 242 may have a substantially annular shape. The proximal end of the distal wall 243 may define a closed distal end of the cavity 242. The cavity 242 may have an open proximal end (for example, located at the proximal end of the complex 210 / housing 240 and closed at the distal end as described above). The cavity 242 may be in fluid communication with passage 273 so that the cavity 242 receives fluid from passage 273. Passage 273 may be an inlet for the cavity 242 through which the fluid is delivered. Although the inner wall 250, housing 240, and distal wall 243 are described as separate elements, the composite 210 can be described as a tubular element (housing 240) having an annular cavity 242 formed in the outer wall of the housing 240, extending from the proximal end of the housing 240 and terminating proximal to the distal end of the housing 240.

[0046] The inner wall 250 may face radially outward. The inner wall 250 may have a plurality of openings 260 formed in the inner wall 250. The openings 260 may have any of the characteristics of the openings 160 described above. For example, the openings 260 may extend around the periphery of the inner wall 250 (e.g., the outer circumference) along the longitudinal length (proximal / distal) of the inner wall 250. The inner wall 250 may have opening structures of any suitable pattern, such as the pattern described above, with respect to the openings 160. The inner wall 250 may form a boundary between the cavity 242 and the lumen 272. Through the openings 260, the cavity 242 may be in fluid communication with the central lumen 272. The most distal end of the cavity 242 may be located proximal to the most distal end of the central lumen 272.

[0047] The distal end of the housing 240 may define a nozzle 296. The nozzle 296 may include an annular wall having a circumference smaller than the outer circumference of the outer wall 241. The nozzle 296 may define an outlet 294 having an open distal end. The outlet 294 may be in fluid communication with the lumen 258 (e.g., it may be located distal to the lumen 258). The outlet 294 may have a width / diameter smaller than the lumen 258. Additionally or alternatively, the medical device 200 may include an output body similar to the output body 130, or the housing 240 may be coupled to a dispensing tip (e.g., a commercially available dispensing tip). The nozzle 296 may be directly coupled to the complex 210, or it may be integrally formed with the complex 210. Thus, the outlet 294 may be directly adjacent to the distal end of the lumen 258. The outlet 294 may optionally be coupled to a catheter or other element extending distally from the outlet 294.

[0048] During use, the medical device 200 may be coupled to a source of a first fluid (e.g., a liquid therapeutic agent) and a second fluid (e.g., a gas such as air or carbon dioxide). Any of the first and second fluid sources described above may be used with respect to the medical device 100. The first and second fluids may be delivered according to any of the mechanisms described above. Through any suitable mechanism, the first fluid source may be coupled to the first fluid inlet 248, and the second fluid source may be coupled to the outer sheath 275. The medical device 200 may be inserted into the working channel of a delivery device (e.g., a scope) before or after the fluid sources are coupled to the medical device 200. The medical device 200, including the complex 210, may have dimensions (including size and shape) configured to be received within the working channel of the delivery device. The complex 210 (and nozzle 296) may be advanced to the distal end of the delivery device and to the treatment site within the body lumen of the subject. In some examples, the complex 210 may be located at or near the distal opening of the scope's working channel. The first fluid inlet 248 (and part of the device 200 coupled to the second fluid source) may remain outside the subject's body (e.g., proximal to the scope's handle).

[0049] A second fluid (e.g., a gas such as air or carbon dioxide) can be transferred / moved / flowed distally into the passage 273 and within the cavity 242. The first fluid can be transferred / moved / flowed within the lumen 258 through the lumen 272. The second fluid can pass through the lumen 258 by passing through the opening 260. The second fluid can be mixed with the first fluid as described above with respect to the medical device 100. The mixed first and second fluids are discharged through the outlet 294 (i.e., transferred by the outlet 294) and can be dispensed at the treatment site in the body lumen of the subject.

[0050] While the principles of this disclosure have been described herein with reference to exemplary examples of specific applications, this disclosure is not limited thereto. Furthermore, while aspects of this disclosure have been described in relation to the examples described herein, features of various examples can be combined in any suitable manner. Those skilled in the art and those with access to the teachings provided herein will recognize that all additional modifications, applications, and substitutions of equivalents fall within the scope of the examples described herein. Therefore, the present invention should not be considered limited by the foregoing description.

Claims

1. It is a medical device, A first inlet for receiving the first fluid, A second inlet for receiving the second fluid, It is a complex, A first body defining a first lumen, wherein the first lumen is in fluid communication with the first inlet such that the first lumen receives the first fluid from the first inlet, A second body disposed within the first lumen and defining a second lumen, wherein the second lumen is in fluid communication with the second inlet so as to receive the second fluid from the second inlet, and the radial outer surface of the second body has the plurality of openings so as to allow the first lumen and the second lumen to be in fluid communication through the plurality of openings, The composite comprising, A medical device equipped with the following features.

2. The medical device according to claim 1, wherein the first main body is tubular.

3. The medical device according to claim 1 or 2, wherein the second main body is tubular.

4. The medical device according to any one of claims 1 to 3, wherein the first body and the second body are formed monolithically from a single piece of material.

5. The medical device according to any one of claims 1 to 4, wherein the first lumen is coaxial with the second lumen.

6. The medical device according to any one of claims 1 to 5, wherein the composite is sized to be received within the working channel of the scope.

7. The medical device according to any one of claims 1 to 6, wherein the first fluid is a liquid and the second fluid is a gas.

8. The medical device according to any one of claims 1 to 7, wherein the composite is configured such that the second fluid flows into the first lumen through the plurality of openings, thereby forming a mixture of the first fluid and the second fluid within the first lumen.

9. The medical device according to claim 8, further comprising an outlet configured to receive a mixture of the first fluid and the second fluid from the first lumen.

10. The medical device according to any one of claims 1 to 6, wherein the first fluid is a gas and the second fluid is a liquid.

11. The outer sheath defining the first entrance, An inner sheath located at least partially within the outer sheath and defining the second entrance, A medical device according to any one of claims 1 to 6, 10, further comprising:

12. The medical device according to claim 11, wherein the radial outer wall of the outer sheath includes a side opening, and the inner sheath is configured to receive the second fluid through the side opening.

13. The medical device according to claim 11 or 12, wherein the proximal end of the first body is connected to the distal end of the outer sheath, and the proximal end of the second body is connected to the distal end of the inner sheath.

14. The medical device according to any one of claims 1 to 6, 11 to 13, wherein the composite is configured such that the first fluid flows into the second lumen through the plurality of openings, thereby forming a mixture of the first fluid and the second fluid in the second lumen.

15. The medical device according to any one of claims 1 to 14, wherein the composite is configured such that a gas passes through the plurality of openings to form a mixture of gas and liquid.

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