Drug delivery device and method of using same - Patents.com

Abstract

The medical device includes a body configured to store a first substance and a second substance, a shaft extending distally from the body and having a distal end, and a pressure source in fluid communication with the first substance, the second substance, and the shaft. A pressurized medium from the pressure source is configured to deliver the first substance through the shaft at the distal end, deliver the second substance through the shaft at the distal end separately from the first substance, and deliver the pressurized medium through the shaft at the distal end separately from the first substance and the second substance. The pressurized medium mixes the first substance and the second substance outside of the shaft as the first and second substances exit the distal end.

Description

[Technical field]

[0001] Various aspects of the present disclosure relate generally to medical delivery systems, devices, and related methods. For example, the present disclosure includes systems, devices, and related methods for delivering a fluid mixture to a target treatment site of a subject. This application claims the benefit of priority to U.S. Provisional Application No. 63 / 186,551, filed May 10, 2021, which is incorporated herein by reference in its entirety. [Background technology]

[0002] Tissues undergoing surgical procedures (e.g., incisions, resections, etc.) are susceptible to a variety of injuries, such as perforations, wounds, bruises, etc. Such injuries can cause a variety of health challenges to the patient, including delayed leakage, infections, lesions, or other post-procedure complications. Medical devices that can prevent, treat, or protect tissue are limited, particularly endoscopic devices that deliver protective coatings over areas of tissue that may be susceptible to injury in the patient's gastrointestinal tract. Devices and methods for separately delivering multiple substances that form protective coatings at the target treatment site during application of the substances may be even more limited. Summary of the Invention

[0003] Aspects of the present disclosure relate, inter alia, to systems, devices, and methods for treating a target treatment site using a delivery device that supplies multiple substances to create a protective coating at the target treatment site. For example, the device may include a first substance and a second substance that are isolated and separated from each other during delivery to the target treatment site. These may be applied simultaneously to the target treatment site to form a solution mixture of a protective coating within a subject (e.g., a patient). Aspects of the present disclosure may extend to devices that include three or more substances and / or drug portions for mixing and application to the target treatment site. Each of the embodiments disclosed herein may include one or more of the features described in connection with any of the other disclosed embodiments.

[0004] According to one example, a medical device includes a body configured to store a first substance and a second substance, a shaft extending distally from the body and having a distal end, and a pressure source in fluid communication with the first substance, the second substance, and the shaft, wherein a pressurized medium from the pressure source is configured to (i) deliver the first substance through the shaft at the distal end, (ii) deliver the second substance through the shaft at the distal end separately from the first substance, and (iii) deliver the pressurized medium through the shaft at the distal end separately from the first substance and the second substance such that the pressurized medium mixes the first substance and the second substance outside the shaft as the first and second substances exit the distal end.

[0005] Any of the medical devices described herein may include any of the following features: The first and second substances exit the distal end of the shaft in the form of a plurality of droplets. The pressurized medium is configured to exit the distal end of the shaft at a predetermined rate and break up polymer chains of the plurality of droplets of each of the first and second substances. The pressurized medium is configured to atomize the plurality of droplets of the first and second substances at a location distal to the distal end of the shaft. The pressurized medium is configured to generate a stream that is atomized from the distal end of the shaft. The pressurized medium is configured to generate a mist that is atomized from the distal end of the shaft. The shaft includes a first channel for receiving the first substance, a second channel for receiving the second substance, and a third channel for receiving the pressurized medium. The body includes a first container for storing the first substance and a second container for storing the second substance such that the first substance and the second substance are isolated from each other within the body. The first container is in fluid communication with the pressure source and the first channel of the shaft, and the second container is in fluid communication with the pressure source and the second channel of the shaft. The first container includes a first intake tube extending into a cavity of the first container, the first intake tube having an opening disposed below a surface level of the first substance in the cavity. The pressurized medium is configured to enter the first container and generate pressure in the cavity to transport the first substance through the opening to the first intake tube. The pressure source is configured to simultaneously deliver the pressurized medium to the first container, the second container, and a third lumen of the shaft. The pressure source is disposed within the body and includes a gas canister, the pressurized medium includes compressed gas stored within the canister in supercritical or liquid form at about 850 psi (about 5.86 MPa), and the first substance and the second substance each have a viscosity greater than 1 centipoise.

[0006] According to another example, a medical device includes a body, a first container disposed within the body and configured to store a first substance, a second container disposed within the body and configured to store a second substance, and a pressure source disposed within the body and storing a pressurized medium and in fluid communication with the first container and the second container, wherein a first portion and a second portion of the pressurized medium are delivered into the first container and the second container, respectively, to expel at least a portion of the first substance and at least a portion of the second substance from the device at a first rate and a second rate, respectively, and a third portion of the pressurized medium is expelled from the device at a third rate faster than the first rate and the second rate to mix the first substance and the second substance outside the device.

[0007] Any of the medical devices described herein may include any of the following features: At least a portion of the first substance and at least a portion of the second substance form a plurality of droplets as they exit the device, and the pressurized medium atomizes the plurality of droplets of the first substance and the plurality of droplets of the second substance at a location outside the device. The pressurized medium sprays a stream or mist of the first substance and the second substance from the device. The first container includes a first inlet tube extending into a cavity of the first container, the first inlet tube including an opening that is submerged within the first substance in the cavity. The pressurized medium enters the first container and increases pressure within the cavity to transport the first substance up the first inlet tube through the opening.

[0008] According to a further example, a method of treating a subject includes placing a medical device at a target tissue of a subject, the medical device comprising a first container storing a first substance, a second container storing a second substance, and a pressure source storing a pressurized medium and in fluid communication with the first container and the second container, the method includes transferring first and second portions of the pressurized medium from the pressure source to the first container and the second container, respectively, to deliver at least a portion of the first substance and at least a portion of the second substance from the medical device, and delivering a third portion of the pressurized medium from the pressure source to the medical device to mix the first substance and the second substance outside the medical device.

[0009] 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]

[0010] [Figure 1] FIG. 1 is a side view of an exemplary medical device including a first fluid container and a second fluid container, according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 is a schematic diagram of a portion of the medical device of FIG. 1 with a first fluid container and a second fluid container coupled to a pressure source, according to an embodiment of the present disclosure. [Diagram 3] 3 is a partial side view of one of the fluid containers of the medical device of FIG. 1 according to an embodiment of the present disclosure. [Figure 4] 4 is a partial perspective view of a distal end of the medical device of FIG. 1 according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and, together with the description, serve to explain the principles of the disclosure. Included herein are medical delivery devices that include features for facilitating mixing and application of multiple substances (e.g., two or more) to a target treatment site. The target treatment site for receiving a protective coating may include a tissue wall, such as the esophagus or other portion of the patient's gastrointestinal system. The devices herein may include features for delivering multiple substances to a target treatment site and mixing the substances at the target treatment site and outside the device during application to form a protective coating.

[0012] Examples of the present disclosure include systems, devices, and methods for delivering a substance to a target treatment site within a subject (e.g., a patient). In several examples, accessing the patient's esophagus includes intraluminal placement of a medical device to the target treatment site. Placement of the medical device may be via a catheter, a scope (such as an endoscope, bronchoscope, colonoscope, gastroscope, etc.), a tube, or a sheath, inserted into an anatomical passageway via a natural orifice or via laparoscopy. The orifice can be, for example, the nose, mouth, or anus. Placement can be in any part of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Placement can also be within the GI tract, other body lumens, or other organs or other body spaces accessible via an orifice within the body, including using laparoscopy. The present disclosure is not limited to any particular medical procedure or treatment site within the body.

[0013] Reference will now be made in detail to the aspects of the present disclosure. Examples of aspects of the present disclosure are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers are used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the portion of the device that is furthest from the user when the device is introduced into a patient. In contrast, the term "proximal" refers to the portion of the device that is closest to the user when the device is placed within a subject. As used herein, the terms "comprises," "comprising," or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or device that includes a list of elements does not necessarily include only those elements, but may include other elements not expressly listed, or other elements inherent to such process, method, article, or device. The term "exemplary" is used in the sense of "example" rather than "ideal." As used herein, the terms "about," "substantially," and "approximately" indicate a range of values ​​within + / - 5% of the stated value.

[0014]

[0013] Examples of the present disclosure relate to devices and methods for performing various medical procedures and / or treatments of the large intestine (colon), small intestine, cecum, esophagus, any other portion of the gastrointestinal tract, and / or any other suitable portion of a patient's anatomy (collectively referred to herein as "target treatment sites"). As noted above, the present disclosure is not limited to any particular medical device or method, and aspects of the present disclosure may be used in connection with any suitable medical tool and / or method at any suitable site within the body. Various examples described herein include single use or disposable medical devices.

[0015] FIG. 1 illustrates an exemplary medical device 100 according to one or more examples of the present disclosure. The medical device 100 may include a body 102 defined by a proximal portion 104 and a distal portion 106. In this example, the body 102 may have a size and shape in the form of a handheld device, such as a spray gun. In this case, the proximal portion 104 may define a handle of the body 102. The distal portion 106 may define a barrel of the body 102. The medical device 100 may include an actuator 108 movably coupled to the body 102 adjacent the proximal portion 104. The actuator 108 may be operably coupled to a pressurized medium source 130 (see FIG. 2 ) disposed within the body 102 and configured to actuate the pressurized medium source 130 in response to actuation (e.g., proximal movement) of the actuator 108 relative to the body 102.

[0016] The medical device 100 may further include a canister 110 coupled to the body 102 adjacent the distal portion 106. In this example, the canister 110 may be at least partially received within the body 102 along a bottom surface of the distal portion 106. In some embodiments, the canister 110 may be removably coupled to the body 102 such that the canister 110 may be selectively removed from the body 102. In this example, the medical device 100 may include a removal mechanism 107 for decoupling the canister 110 from the body 102. The removal mechanism 107 may include various suitable actuators, such as, for example, a depressible button. In another example, the canister 110 may be separated from the body 102 by applying a downward pulling force to the canister 110 to separate the canister 110 from the body 102. In this case, the removal mechanism 107 may be omitted entirely. In other embodiments, the canister 110 may be rigidly secured to the distal portion 106 such that it is not removable from the body 102 .

[0017] As further shown and described herein, the canister 110 may define an enclosure for housing a plurality of fluid containers, including, but not limited to, at least a first fluid container 120A and a second fluid container 120B. In other embodiments, the canister 110 may include one or more partitions instead of a plurality of fluid containers. In this case, the one or more partitions may define a plurality of (e.g., at least two) fluid chambers within the canister 110 for storing a plurality of fluid substances. In some embodiments, the canister 110 may include an opaque exterior such that the first fluid container 120A and the second fluid container 120B are not visible from the exterior of the medical device 100. In other embodiments, the canister 110 may include a transparent exterior such that the pair of fluid containers 120A, 120B, specifically the amount of contents within each fluid container 120A, 120B, are visible from the exterior of the medical device 100.

[0018] 1 , the medical device 100 may further include a nozzle 109 extending distally from the distal portion 106 and a shaft 112 extending distally from the nozzle 109. The nozzle 109 may be rotatably coupled to the body 102 at the distal portion 106 and may be fixed relative to the shaft 112. Thus, rotation of the nozzle 109 relative to the body 102 may provide a corresponding rotation of the shaft 112 relative to the body 102. As described in more detail below, the nozzle 109 may be configured to at least partially control the spray stream of the medical device 100 from the shaft 112.

[0019] The shaft 112 may have a longitudinal length defined between a proximal end 114 and a distal end 116. The shaft 112 may have a flexible structure such that the proximal end 114 and the distal end 116 may be configured to move (e.g., bend, twist, rotate, deflect, etc.) relative to one another and the body 102. The shaft 112 may define a lumen sized and shaped to receive a plurality of outlet lines (e.g., flexible tubing) from one or more components of the medical device 100, such as, for example, the pressurized media source 130 and the pair of fluid containers 120A, 120B (see FIG. 2). The shaft 112 may further include an opening 118 at the distal end 116, as best seen in FIG. 4.

[0020] 2, a schematic diagram of a fluid system of the medical device 100 is shown. The medical device 100 may include a pressurized medium source 130 (disposed within the body 102), such as, for example, a pneumatic gas canister. The pressurized medium source 130 may be in fluid communication with each of the fluid containers 120A, 120B via respective inlet lines 132A, 132B (e.g., flexible tubing). In this example, the medical device 100 may include at least a first fluid container 120A and a second fluid container 120B disposed within the canister 110. In one example, the fluid containers 120A, 120B may include coiled tubing that is flexibly deformable into various sizes, shapes, and / or configurations. The first fluid container 120A may be fluidly coupled to the pressurized medium source 130 via the first inlet line 132A. The second fluid container 120B may be fluidly coupled to the pressurized medium source 130 via the second inlet line 132B. In further embodiments, the pressurized medium source 130 may be located outside the body 102 and fluidly coupled to the medical device 100 via a connector, such as a port.

[0021] The pressurized medium source 130 may be configured to store a pressurized medium. In one embodiment, the pressurized medium may include a compressed gas (e.g., carbon dioxide) stored in a supercritical or liquid form, such as at about 850 PSI (about 5.86 MPa). The capacity of the pressurized medium source 130 may define the amount (weight) of pressurized medium that the pressurized medium source 130 can store. Furthermore, the available weight of pressurized medium stored within the pressurized medium source 130 may correspond to a predetermined dose of fluid that the medical device 100 may be able to deliver during a procedure. By way of example, the pressurized medium source 130 may store about 10 grams to 20 grams of carbon dioxide, such as 16 grams. In this example, the medical device 100 may be configured to store 16 grams of pressurized medium, which may correspond to outputting about 5 liters of pressurized medium through the fluid system of the medical device 100 to deliver the predetermined dose.

[0022] 2, each of the pair of fluid containers 120A, 120B may include an inlet port 122A, 122B to receive a respective inlet line 132A, 132B from the pressurized medium source 130. In this example, the first inlet line 132A and the second inlet line 132B may have an inner diameter in the range of about 0.25 inches to 0.5 inches, such as 0.375 inches. Each of the pair of fluid containers 120A, 120B may further include an outlet port 124A, 124B to receive a respective outlet line 134A, 134B (e.g., flexible tubing). The first outlet line 134A may fluidly couple the first fluid container 120A to the shaft 112. The second outlet line 134B may fluidly couple the second fluid container 120B to the shaft 112.

[0023] In this example, the first and second outlet lines 134A, 134B may have an area in the range of about 0.0005 to 0.0032 square inches, such as, for example, 0.0016 square inches. Each of the first and second outlet lines 134A, 134B may extend through the nozzle 109 and into the lumen of the shaft 112. As further described and illustrated herein, each of the pair of outlet lines 134A, 134C may terminate in an opening 118 at the distal end 116 of the shaft 112 (see FIG. 4).

[0024] The medical device 100 may further include a fluid line 132C providing fluid communication between the pressurized medium source 130 and the shaft 112. The pressurized medium source 130 may be configured to deliver the pressurized medium directly to the shaft 112 via the fluid line 132C. The fluid line 132C may terminate adjacent to a pair of outlet lines 134A, 134B at the opening 118 of the distal end 116 (see FIG. 4). Thus, the lumen of the shaft 112 may be sized, shaped, and configured to receive multiple tubes and / or lines, such as, for example, the first output line 134A, the second outlet line 134B, and the fluid line 132C. The shaft 112 may have a diameter in the range of about 0.02 inches to 0.08 inches, such as, for example, 0.04 inches. In other embodiments, the shaft 112 may define multiple channels formed within the lumen such that each of the lines 132C, 134A, 134B is fluidly coupled to at least one channel. In this case, the first output line 134A, the second output line 134B, and the fluid line 132C are coupled to respective channels of the shaft 112 at the proximal end 114 and thus do not extend through the shaft 112.

[0025] 3 illustrates a fluid container 120 that may represent the first fluid container 120A and the second fluid container 120B described above. The fluid container 120 may include an inlet port 122 and an outlet port 124 along a top wall of the fluid container 120. In other embodiments, one or more of the inlet port 122 and / or outlet port 124 may be disposed along various other walls of the fluid container 120, such as one or more of the side walls of the fluid container 120. The fluid container 120 may further include an interior cavity 121 for storing at least one fluidic substance 10. In one example, the first fluid container 120A may store a first fluidic substance. The second fluid container 120B may store a second fluidic substance that is different from the first fluidic substance. Each fluidic substance 10 may generally have a high viscosity, such as a viscosity greater than about 1 centipoise (0.001 Pa·s (Pascal seconds)), such as in the range of 30 centipoise to 11,000 centipoise. As described in further detail below, the first and second fluidic substances may form a solution mixture when combined with one another for use in treating a target site (e.g., tissue). The solution mixture may include an adhesive capable of providing a protective barrier over areas of tissue susceptible to puncture or other damage. In other embodiments, the resulting solution may include various other agents that are formed in response to the mixture of two or more substances.

[0026] The fluid container 120 may further include an intake tube 126 disposed within the internal cavity 121. The intake tube 126 may be fluidly coupled to the outlet port 124 and at least partially immersed in the fluidic material 10 stored in the internal cavity 121. The intake tube 126 may have a longitudinal length extending between a first (upper) end coupled to the outlet port 124 and a second (lower) end 127 disposed within the internal cavity 121. The longitudinal length of the intake tube 126 may be such that the second end 127 is disposed below a surface level of the fluidic material 10 stored within the internal cavity 121. In other words, the second end 127 may be immersed within the fluidic material 10 such that the intake tube 126 may be in fluid communication with the fluidic material 10 through an opening in the second end 127. In this embodiment, the intake tube 126 may be sized to have a diameter equal to or greater than a diameter of the outlet lines 134A, 134B.

[0027] 3, the predetermined dose of the fluidic material 10 stored in the fluid container 120 may be based at least in part on the volume of the fluidic material 10 in the internal cavity 121. In particular, the predetermined dose may be based on the distance between a surface height of the fluidic material 10 in the internal cavity 121 and a position of the second end 127 relative to the internal cavity 121. As described in detail below, the fluid container 120 may be configured to divert the fluidic material 10 from the internal cavity 121 to the outlet line 134 (via the outlet port 124) in response to receiving a pressurized medium from the inlet line 132 into the internal cavity 121. In this case, as pressure increases within the internal cavity 121, at least a portion of the fluidic material 10 moves into the intake tube 126 via the second end 127 and moves toward the outlet port 124 to be received within the outlet line 134.

[0028] In some embodiments, the diameter of the internal cavity 121 may at least partially determine the inlet pressure generated within the fluid enclosure 120. For example, decreasing the diameter of the internal cavity 121 may result in an increase in pressure when a pressurized medium is received within the fluid enclosure 120. The force exerted on the fluidic material 10 stored within the fluid enclosure 120 may be increased by decreasing the cross-sectional dimension of the internal cavity 121, thereby improving the deliverability of the fluidic material 10 from the fluid enclosure 120 to the shaft 112.

[0029] The fluid enclosure 120 may further include a rotatable joint 128 coupled between the outlet port 124 and the outlet line 134. The rotatable joint 128 may be configured to facilitate rotation of the outlet line 134 relative to the outlet port 124, for example, in response to rotation of the shaft 112 relative to the body 102. Thus, the fluid enclosure 120 may be configured to maintain fluid communication between the outlet line 134 and the outlet port 124 during rotation of the shaft 112 (and the outlet line 134 disposed therein).

[0030] 4, the distal end 116 of the shaft 112 is shown with the distal openings of each of the fluid lines 132C, the first outlet line 134A, and the second outlet line 134B disposed adjacent the opening 118 of the distal end 116. It should be noted that the lines 132C, 134A, and 134B may be disposed in various suitable orientations and / or locations relative to one another other than those shown. As briefly described above, instead of the fluid lines 132C, the first outlet line 134A, and the second outlet line 134B extending through the shaft 112, the shaft 112 may include one or more channels coupled to each of the lines 132C, 134A, and 134B. In this case, the first fluidic material 10, the second fluidic material 10 in a container different from the first fluidic material 10, and the pressurized medium may be received directly into the respective channels of the shaft 112. Thus, the first fluid material 10 , the second fluid material 10 and the pressurized medium remain separated from one another within the shaft 112 .

[0031] In an exemplary use of the medical device 100, the shaft 112 may first be positioned adjacent to a target treatment site within a subject, such as through a working channel of a medical instrument (e.g., endoscope, gastroscope, etc.). As briefly described above, the target treatment site may include an area (e.g., tissue) within a subject (e.g., patient) that may be susceptible to damage or delayed leakage, such as due to perforation, suturing, etc. Referring back to FIG. 1 , with the distal end 116 facing the target treatment site and the body 102 disposed outside the subject, the medical device 100 may be actuated to initiate application of the two fluid substances 10 to the target treatment site by applying a proximal force to the actuator 108.

[0032] 2, actuation of actuator 108 may control the release of pressurized medium stored in pressurized medium source 130 into each of first inlet line 132A, second inlet line 132B, and fluid line 132C. Pressurized medium source 130 may be configured to transfer a portion of pressurized medium (e.g., compressed gas) into each of first fluid container 120A and second fluid container 120B at a delivery rate of about 0.10 PSI to 80 PSI, such as 40 PSI to 60 PSI. Specifically, a first portion of the pressurized medium may be directed through first inlet line 132A to first fluid container 120A, a second portion of the pressurized medium may be directed through second inlet line 132B to second fluid container 120B, and a third portion of the pressurized medium may be directed to shaft 112 through fluid line 132C.

[0033] The portion of the pressurized medium traveling through the inlet lines 132A, 132B may enter the respective fluid containers 120A, 120B via the inlet ports 122A, 122B. In some embodiments, the portion of the pressurized medium flowing through each of the first inlet line 132A, the second inlet line 132B, and the fluid line 132C may vary relative to one another. For example, the pressurized release of medium may be selectively adjusted based on the inherent viscosity of the first and / or second fluidic substances 10 stored in each of the respective fluid containers 120A, 120B.

[0034] 3, when the pressurized medium enters the fluid containers 120A, 120B, it creates an increase in pressure within the atmosphere of the internal cavity 121, which causes the first and second fluidic substances 10 to be pushed downward (e.g., away from the inlet port 122) relative to the internal cavity 121. At least a portion of the first and second fluidic substances 10 may be diverted through the respective inlet tubes 126 via the openings in the second ends 127. In this case, each portion of the fluidic substance 10 may be forced through the inlet tubes 126 toward the respective outlet ports 124 until the fluidic substance 10 is directed outwardly from the fluid containers 120A, 120B and into the corresponding outlet lines 134A, 134B. As described in more detail herein, the medical device 100 may be configured so that the pressurized medium released from the pressurized medium source 130 and delivered to the fluid containers 120A, 120B may be at a similar or varying pressure (e.g., pounds per square inch) and so that the first and second fluid substances 10 may be delivered to the corresponding outlet lines 134A, 134B at similar or varying rates relative to each other.

[0035] The first fluidic substance 10 and the second fluidic substance 10 may be delivered separately from one another into the shaft 112 from their respective fluid containers 120A, 120B such that the fluidic substances 10 do not interact or mix with one another at any point within the medical device 100. In other words, the first fluidic substance 10 is isolated from the second fluidic substance 10 throughout the travel path defined by the fluid system of the medical device 100 such that mixing of the fluidic substances 10 can only occur outside of the body 102, the canister 110, and the shaft 112.

[0036] In some embodiments, one or more of the fluid containers 120A, 120B may include inlet and / or outlet valves (or other suitable mechanisms) for controlling the resulting delivery rate and / or volume of the fluidic material 10 sent to the corresponding outlet line 134A, 134B. In this case, a user of the medical device 100 may selectively control the delivery of one or more fluidic materials 10 in response to actuation of the valves. In other embodiments, the intracellular composition of each fluidic material 10 may at least partially determine the delivery rate and / or volume of the fluidic material 10 delivered to the outlet line 134A, 134B, even though each fluid container 120A, 120B receives a similar pressure of medium from the pressurized medium source 130.

[0037] 4, the first fluidic substance 10 may be discharged out of the first outlet line 134A at the distal end 116, and the second fluidic substance 10 may be discharged out of the second outlet line 134B at the distal end 116. Also, the pressurized medium discharged from the pressurized medium source 130 may be discharged out of the medical device 100 at the distal end 116 via the fluid line 132C. Due to the generally high viscosity of the first and second fluidic substances 10, the fluidic substances 10 may slowly exit the respective outlet lines 134A, 134B in the form of multiple droplets. Each of the first and second fluidic substances 10 may encounter a flow of pressurized medium exiting the distal end 116 (via the fluid line 132C) at the same time that the pair of fluidic substances 10 exits the distal end 116. The first and second fluid materials 10 may be ejected from the distal end 116 at a first velocity, and the pressurized medium may be ejected from the distal end 116 at a second velocity that is faster than the first velocity. In some embodiments, the first fluid material 10 may have a different viscosity than the second fluid material 10, causing the pair of fluid materials 10 to fall from the distal end 116 at different velocities.

[0038] The medical device 100 may be configured to contact a pressurized medium with multiple droplets of the first and second fluidic substances 10. For example, a pair of droplets of the fluidic substances 10 may be allowed to fall by gravity to align with a stream of pressurized medium emitted from the fluid line 132C. In this case, the pressurized medium may mix the first fluidic substance 10 with the second fluidic substance 10 at a location external to the shaft 112 (e.g., distal to the distal end 116).

[0039] Further, the pressurized medium may be configured to exit the distal end 116 at a predetermined rate capable of breaking down the polymer chains of the plurality of droplets of each of the first and second fluidic materials 10. In other words, the stream of medium from the fluid line 132C may be released at a relatively high rate such that the pressure applied to the plurality of droplets of the first and second fluidic materials 10 may break down the chemical bonds of the droplets. The predetermined rate may be determined at least in part based on the release pressure of the medium from the pressurized medium source 130, which may range from about 0 PSI to about 100 PSI, such as, for example, 0.1 PSI to about 80 PSI.

[0040] Thus, the pressurized medium may be configured to atomize multiple droplets of the first and second fluidic substances 10 at a location distal to the shaft 112. In other words, the pressurized medium may create an atomization effect by mixing the first and second fluidic substances 10 with each other and spraying the resulting solution mixture onto the target treatment site. For example, the first and second fluidic substances 10 may be mixed with each other in a 1:1 ratio. As discussed above, the first and second fluidic substances 10 may be mixed in various other ratios based on various parameters, including, but not limited to, varying pressures of the medium received in each fluid container 120A, 120B from the pressurized medium source 130, selective control of the inlet or outlet valves, varying intracellular composition of each fluidic substance 10 stored in each fluid container 120A, 120B, etc.

[0041] In some embodiments, the pressurized medium emitted from the pressurized medium source 130 may be configured to generate a targeted stream of the solution mixture sprayed outwardly from the distal end 116. In this case, the medical device 100 may be configured to control the direction of delivery of the solution mixture from the shaft 112, for example against gravity. Alternatively, the pressurized medium may break up droplets of the first and second fluidic substances 10 to generate a targeted mist of the solution mixture. The directional delivery of the stream and / or mist of the solution mixture may be further controlled to cause a corresponding rotation of the shaft 112 in response to actuation (e.g., rotation) of the nozzle 109. The solution resulting from the mixture of the first and second fluidic substances 10 may form an adhesive composition (e.g., glue) capable of providing a protective barrier to the target treatment site.

[0042] Each of the above-mentioned systems, devices, assemblies, and methods may be used to deliver and mix multiple different substances during application to a target tissue. By providing a medical device capable of delivering multiple substances in isolation from one another during application to a target tissue, delivery of compounds with inaccurate ratios of individual substances may be minimized, thereby increasing the effectiveness of treating a target site. In this case, a user may reduce overall treatment time, improve treatment efficiency, and / or avoid unnecessary harm to the subject's body caused by subsequent treatments that deliver additional substances to a target site due to an inaccurate initial application of the substances.

[0043] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed apparatus and methods without departing from the scope of the disclosure. Other aspects of the disclosure 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 specification and examples be considered as merely illustrative.

Claims

1. 1. A medical device, comprising: a body configured to store a first substance and a second substance; a shaft extending distally from the body and having a distal end; a pressure source in fluid communication with the first material, the second material, and the shaft; The pressurized medium from the pressure source is (i) delivering the first substance through the shaft at the distal end; (ii) delivering the second substance through the shaft and out of the distal end separately from the first substance; (iii) the pressurized medium is delivered through the shaft at the distal end separately from the first and second substances such that the pressurized medium mixes the first and second substances outside of the shaft as the first and second substances exit the distal end. The medical device is configured to:

2. The medical device of claim 1 , wherein the first substance and the second substance exit the distal end of the shaft in the form of a plurality of droplets.

3. 3. The medical device of claim 2, wherein the pressurized medium is configured to exit the distal end of the shaft at a predetermined rate to break down polymer chains of the plurality of droplets of each of the first and second substances.

4. The medical device of claim 2 or 3, wherein the pressurized medium is configured to atomize the plurality of droplets of the first substance and the second substance at a location distal to the distal end of the shaft.

5. The medical device of claim 2 or 3, wherein the pressurized medium is configured to generate a stream that is sprayed from the distal end of the shaft.

6. The medical device of claim 2 or 3, wherein the pressurized medium is configured to generate a mist that sprays from the distal end of the shaft.

7. The medical device of any one of claims 1 to 3, wherein the shaft includes a first channel for receiving the first substance, a second channel for receiving the second substance, and a third channel for receiving the pressurized medium.

8. 8. The medical device of claim 7, wherein the body includes a first container for storing the first substance and a second container for storing the second substance such that the first substance and the second substance are isolated from each other within the body.

9. 9. The medical device of claim 8, wherein the first container is in fluid communication with the pressure source and the first channel of the shaft, and the second container is in fluid communication with the pressure source and the second channel of the shaft.

10. 9. The medical device of claim 8, wherein the first container includes a first suction tube extending into a cavity of the first container, the first suction tube having an opening positioned below a surface level of the first substance in the cavity.

11. 11. The medical device of claim 10, wherein the pressurized medium is configured to enter the first container and generate pressure within the cavity to transport the first substance through the opening to the first intake tube.

12. The medical device of claim 8 , wherein the pressure source is configured to simultaneously deliver the pressurized medium to the first container, the second container, and a third lumen of the shaft.

13. The medical device of any one of claims 1 to 3, wherein the pressure source is disposed within the body and includes a gas canister.

14. 14. The medical device of claim 13, wherein the pressurized medium comprises compressed gas stored in the gas canister in supercritical or liquid form at approximately 850 psi.

15. The medical device of any one of claims 1 to 3, wherein the first substance and the second substance each have a viscosity greater than 1 centipoise.

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