Patent Description:
There exists a need to deliver agents during a treatment/operation, and/or preoperatively and postoperatively, to target treatment sites within the body to protect those sites from tissue degradation, especially during or after endoscopic and open surgical procedures of the gastrointestinal (GI) tract. Examples of endoscopic and open surgical procedures of the GI tract include colonic resection, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy, among others. Procedures may result in perforation, post-surgical leaks, or other wounds of the tract. It is with all of the above considerations in mind that the improvements of the present disclosure may be useful.

<CIT> discloses a method and a device for the atomization of a liquid. A liquid jet is directed through a plurality of nozzles onto a hot contact surface a deflecting surface, so that a part of the liquid is vaporized. The non-vaporized liquid is atomized into small droplets that form an aerosol.

<CIT> discloses an aerosol generation mechanism where a liquid mass is arranged to impinge a liquid-phobic surface. The liquid spreads across the liquid-phobic surface without wetting it and at some point breaks up into an aerosol cloud.

The present invention is defined by independent claim <NUM>. Optional embodiments are defined by the dependent claims. Aspects of the disclosure relate to, among other things, systems, devices, and methods for delivering an agent, including an agent having multiple parts/components, to a target treatment site. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

According to certain aspects of the disclosure, an agent delivery device comprises: one or more agent containers (according to the current invention: two or more) at a proximal end of the agent delivery device, wherein the one or more agent containers are configured to contain one or more fluids; an insertion section connected to the proximal end of the one or more agent containers, the insertion section comprising a tube defining one or more lumens (according to the current invention: two or more lumens), the insertion section coupled to the agent containers such that the one or more fluids may flow from the agent containers to the one or more lumens and out of one or more outlets of the one or more lumens; and a distal impingement structure at the distal end of the insertion section, the distal impingement structure comprising an impingement surface arranged relative to one or more outlets (according to the current invention: two or more outlets) to impinge the one or more fluids dispensed from the one or more outlets to cause mixing of the one or more fluids (according to the current invention: two or more fluids) for application of the fluids at a treatment site.

The agent delivery device may include one or more of the following features. The one or more agent containers may comprise two syringes, the one or more lumens may comprise two lumens, and each syringe is in fluid communication with a respective lumen of the two lumens, and actuation of the two syringes causes the one or more fluids to flow through the two lumens. The agent delivery device may further comprise a connector element fixing the two syringes to the insertion section, and wherein the tube is flexible. The one or more lumens may comprise two lumens each extending distally from a distal face of the tube, wherein longitudinal axes of the two lumens intersect in a manner that causes mixing of the one or more fluids dispensed from the outlets prior to the one or more fluids contacting the impingement surface. The one or more fluids may include two different components of an agent. The distal impingement structure may comprise a J-shaped wire. The tube may have a diameter of less than <NUM>.

The agent delivery device may also include one or more of the following features. The distal impingement structure of the agent delivery device may further comprise a bottom surface connecting the distal end of the tube to the impingement surface. The impingement surface and a longitudinal axis of each of the one or more lumens may form an angle between <NUM> degrees and <NUM> degrees. The distal impingement structure may comprise a top surface extending distally from the impingement surface, wherein the top surface is substantially parallel to the bottom surface; and a distally-facing surface extending from the top surface and substantially parallel to the impingement surface. The agent delivery device may further comprise a distally-facing surface extending from an edge of the impingement surface opposite from the bottom surface, wherein the distally-facing surface is substantially perpendicular to a plane of the bottom surface. The bottom surface may also comprise one or more cylindrical rods extending in a direction substantially parallel to a longitudinal axis of the one or more lumens. The one or more fluids dispensed from the one or more outlets may form a fluid flow over the impingement surface and the top surface.

According to another aspect of the disclosure, an agent delivery device comprises: one or more agent containers at a proximal end of the agent delivery device, wherein the one or more agent containers contain one or more fluids; a flexible insertion tube connected to the proximal end of the one or more agent containers, the insertion tube defining at least one delivery lumen and a second lumen, the insertion tube coupled to the agent containers such that the one or more fluids may flow from the agent containers to the at least one delivery lumen and out of one or more outlets of the at least one delivery lumen; and a first impingement wire, wherein a proximal end of the first impingement wire is mounted in the distal end of the second lumen, the first impingement wire defining an impingement surface at a distal end of the first impingement wire, the impingement surface positioned relative to the at least one delivery lumen to impinge the one or more fluids dispensed from the one or more outlets.

The agent delivery device may include one or more of the following features. The impingement surface may be transverse to a longitudinal axis of the at least one delivery lumen. The agent containers comprise two containers, and the at least one delivery lumen may comprise a pair of lumens each arranged in fluid communication with a respective one of the agent containers. The agent delivery device may include a second impingement wire, wherein the proximal end of the second impingement wire may be mounted in a distal end of a third lumen, wherein the second impingement wire may include a second impingement surface arranged on the distal end of the second impingement wire and positioned relative to one of the pair of lumens to impinge the one or more fluids dispensed from the one or more outlets.

According to another aspect of the disclosure, a method for delivering an agent to a treatment site (the method not separately claimed) comprises: receiving, at a distal tip of an agent delivery device, two or more fluid agent components disbursed from two or more lumens; impinging, at the distal tip, the two or more fluid agent components; combining, proximate the distal tip, the two or more fluid agent components after the agent components are disbursed from the two or more lumens; and depositing the combined agent components a treatment site.

The objects and advantages of the disclosed embodiments will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure, as claimed.

The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate exemplary aspects of the disclosure and, together with the description, explain the principles of the disclosure.

Aspects of this disclosure relate to application of a multi-part agent at a target tissue site, for example, to protect those sites from further tissue degradation. Some prophylactic agents include multiple parts to effectively adhere to the target tissue site. Current devices and methods for delivery of such multi-part agents are limited. With the lack of effective treatment option and tools, there is a need to apply agents to target treatment sites to protect those sites from further tissue degradation. Some agents -for example, certain prophylactic agents- may require multiple parts to be able to cure or stay adhered to a target tissue. Many agents that are delivered may also potentially cure in the catheter unless a secondary means of curing is implemented, such as photosensitive cure (i.e. light cure). Catheters for delivering agents may also have significant clogging issues due to agents curing with in them.

Aspects of the disclosure include devices and methods for delivering agents to a target tissue site within a subject (e.g., patient). Examples of the disclosure further include devices and methods for adhering a multi-part agent to a target tissue site. In some aspects, delivery includes mixing and applying a two-part agent at a target tissue site using a distal impingement structure. Delivery and placement of the agent may be via a catheter, scope (endoscope, bronchoscope, colonoscope, etc.), tube, or sheath, inserted into the GI tract via a natural orifice. The orifice can be, for example, the nose, mouth, or anus, and the placement can be in any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Delivery and placement also can be in other body lumens or organs reachable via the GI tract, any other natural opening or body tract, or bodily incision.

Reference will now be made in detail to aspects of the disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term "distal" refers to a portion farthest away from a user when introducing a device into a patient. By contrast, the term "proximal" refers to a portion closest to the user when placing the device into the subject. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises 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 "ideal. " As used herein, the terms "about," "substantially," and "approximately," indicate a range of values within +/- <NUM>% of a stated value.

Examples of the disclosure may relate to devices and methods for performing various medical procedures and/or treating portions of the large intestine (colon), small intestine, cecum, esophagus, any other portion of the gastrointestinal tract, and/or any other suitable patient anatomy (collectively referred to herein as a "target treatment site"). Various examples described herein include single-use or disposable medical devices. Reference will now be made in detail to examples of the disclosure described above and illustrated in the accompanying drawings.

<FIG> and <FIG> show a medical device <NUM> (e.g. agent delivery device) in accordance with an example of this disclosure. Medical device <NUM> includes a proximal end <NUM>, a flexible insertion section <NUM>, and a distal end <NUM>. Proximal end <NUM> may include one or more agent containers, for example, syringes <NUM>, wherein each syringe comprises a plunger flange <NUM>, a barrel flange <NUM>, a barrel <NUM>, a seal <NUM>, and a nozzle <NUM>. Each of the one or more agent containers contains an agent component 17A, 17B that is dispersible out of the nozzle <NUM> and into the flexible insertion section <NUM>. While syringes are disclosed as exemplary with respect to this embodiment, other agent containers with similar structures for containing and delivering agent components upon activation by a user are also contemplated as within the scope of this disclosure. In some embodiments, the agent component is one of two parts of a prophylactic agent, where each syringe <NUM> contains one of each part of the prophylactic agent. Although agent components 17A, 17B may be separate, individual compositions, in some embodiments, agent components 17A, 17B may be the same agent component. Further, fewer or additional agent components may be incorporated in the medical device <NUM>, e.g., to have agent components 17C, 17D, etc..

Flexible insertion section <NUM> comprises a flexible tube <NUM>, lumens <NUM> contained within the flexible insertion section <NUM> for transporting agent components 17A, 17B from a proximal end to a distal end of the flexible insertion section, and connectors <NUM> between the nozzles <NUM> and lumens <NUM> for maintaining fluid communication between the nozzles <NUM> and lumens <NUM>. The connector <NUM> may be configured to be fixed to the distal end of syringes <NUM> (agent containers) and the proximal end of flexible tube <NUM>, by, for example, an adhesive, a heat shrink, a snap-fit connection, a threaded coupling, a crimping connection, and the like. The lumens <NUM> may extend through the flexible tube <NUM> from the proximal end in fluid communication with nozzles <NUM> and a distal end of the flexible tube. While lumens are discussed throughout this disclosure, the flexible insertion section <NUM> may comprise any separate flexible chamber, such as independent catheters, needles, cannula, co-extrusion, and/or two or more lumen extrusions for transporting agent components. In some embodiments, at least two agent components are transported through the flexible insertion section <NUM>. In additional embodiments, the flexible insertion section <NUM> is of sufficient length to transport the agent components from the proximal end of the medical device, outside of the body, to a treatment site within the body during endoscopic procedures. The flexible insertion section <NUM> may be inserted into a GI tract via a natural orifice. The orifice can be, for example, the nose, mouth, or anus, and the placement can be in any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Delivery and placement also can be in other body lumens or organs reachable via the GI tract, any other natural opening or body tract, or bodily incision.

Still referring to <FIG> and <FIG>, at the distal tip end of the medical device <NUM> is a distal impingement structure <NUM>. The distal impingement structure <NUM> may comprise outlets <NUM> which are in fluid communication with the lumens <NUM>. The proximal end of the distal impingement structure <NUM> may be configured to be fixed to the distal end of flexible tube <NUM>, by, for example, an adhesive, a heat shrink, a snap-fit connection, a threaded coupling, a crimping connection, and the like. In some embodiments, the distal impingement structure may be connected to or an integral part of the lumens <NUM>, examples of which are provided in <FIG>, discussed further below.

Upon activation of the plungers <NUM> of syringes <NUM>, the seals <NUM> cause agent components 17A, 17B to dispense from nozzles <NUM> into the inlets <NUM> of lumens <NUM>. The syringes <NUM> may be actuated to dispense agent components 17A, 17B simultaneously and/or in succession. While syringes are discussed here, any agent container for holding and delivering agent components to lumens <NUM> are contemplated within this disclosure. The agent components 17A, 17B subsequently flow out of the lumens <NUM> via outlets <NUM>. The flow of the agent components 17A, 17B then contacts a distal impingement structure <NUM>. The flow of the agent components 17A, 17B and the structure of the distal impingement structure <NUM> causes the agent components to mix in the environment (for example, air), and the combined agent <NUM> is deposited at a treatment site <NUM>. In some embodiments, one or more additional lumens may be used to apply a compressed gas, liquid, or other agents to the surface. In some embodiments, a third lumen for carrying a compressed gas may be used, where the compressed gas could extend to the distal tip to add further velocity to the exiting parts of the agent components 17A, 17B. In some embodiments, the distal impingement structure <NUM> may be adapted to mix the agent parts including by merging distal lumens by angulation while having a thin wall of separation at the distal tip, whereas the two streams merge in air outside of the catheter. The adaptation additionally could include interrupters to further mix, mist, and/or atomize the agents.

The treatment site <NUM> may be, for example, a target tissue such as an ulcer, fistula, or mucosal, submucosal, or full thickness defect. In some embodiments, as shown in <FIG>, a third agent component 17C may be pre-applied to the treatment site, such that depositing the combined agent on the treatment site as explained above results in faster or more efficient curing or additional prophylactic effects. In additional embodiments, prior to applying agent component 17C, the treatment site <NUM> may be flushed of contaminants such as organics or chemical residue from other treatment means (such as lifting agents, dyes, mucosal slime, blood, and compromised tissue). To prepare the surface, one of lumens <NUM> or an additional lumen, or device, may be extended to the target site and adapted to prepare the mucosa, submucosa, or muscle layer. The additional lumen may include a nozzle, jet needle, and/or atomizer tip, and may emit a mist.

Agent components 17A, 17B may be any agent or component thereof that is applied to a tissue site in the body. For example, agent components 17A, 17B may form cohesive and bio adhesive substrates that provide a protective covering in the GI tract. Examples of agent components for this purpose may include polysaccharides (e.g. chitosan, cellulose, alginates, etc.), poly(ethylene oxide) ("PEO"), poly(ethylene glycol) ("PEG"), and Dextran. As another example, agent components 17A, 17B may provide a protective covering or seal for a perforation, sutures, clipped tissue, and the like. Examples of agent components for this purpose may include polyamidoamine ("PAMAM"), polylysine, oxidized polysaccharides, and polyurethanes.

<FIG> is a top view of the distal impingement structure <NUM> located at a distal tip of a medical device, like the device shown in <FIG>. In some embodiments, the distal impingement structure <NUM> comprises a bottom surface <NUM>, an impingement surface <NUM> facing a distal face <NUM> of flexible tube <NUM>, and a top surface <NUM>. The lumens <NUM> carry agent components 17A, 17B through the flexible tube <NUM>. The lumens <NUM> include outlets <NUM> in a distal face <NUM> of the flexible tube <NUM> for dispensing agent components 17A, 17B. Distal face <NUM> as shown in <FIG> is a flat, distally-facing, partial cross-section of the flexible tube <NUM>, but may be any suitable shape. Distal face <NUM> is configured to allow lumens, nozzles, outlets, or other similar structures to pass through in order for agent components to be delivered to the distal impingement structure <NUM>. The bottom surface <NUM> is rectangular in shape as shown in <FIG>, but may comprise any other suitable shapes or dimensions. The impingement surface <NUM> may be rectangular in shape with chamfered or curved edges as shown in <FIG>, or may comprise any other suitable shape for impinging the flow of agent components 17A, 17B. For example, a scallop cut or valley shaped impingement surface <NUM> generates a narrow spray plume, which further may be beneficial for directing the spray direction. The top surface <NUM> may be flat or curved and partially cylindrical as shown in <FIG>, or may comprise any suitable shape. In some embodiments, agent component 17A, 17B is dispensed from the outlets <NUM> with sufficient velocity such that portions of agent component 17A, 17B form one or more streams over the bottom surface <NUM>, impingement surface <NUM>, and/or top surface <NUM>. In some embodiments, a substantial portion of agent component 17A, 17B contacts only impingement surface <NUM> before application to the treatment site. In other embodiments, portions of agent component 17A, 17B flow across bottom surface <NUM>, impingement surface <NUM>, and top surface <NUM>. The lumens <NUM>, outlets <NUM>, bottom surface <NUM>, impingement surface <NUM>, and top surface <NUM> are configured such that agent components 17A, 17B mix together to create a combined agent <NUM> applied to the treatment site. The distal impingement structure <NUM> of this embodiment causes significant increase in mixing after the streams contact the impingement surface <NUM>. For example, as further shown in <FIG>, two distinct flows for agent components 17A, 17B exit the outlets <NUM> and contact impingement surface <NUM>. After contact, the streams are directed radially and distally, e.g. the streams have two velocity components, a first velocity component distally toward the target treatment site and a second velocity component radially away from the axis of lumens <NUM>. As the stream gets further away from the impingement structure, redirection and dissipation of energy causes the streams to spread. In addition to mixing the streams, as the streams spread, elements of agent component 17A, 17B mix together in the center, resulting in a convergence and mixing of the streams and ultimately a combined agent <NUM> applied to the treatment site.

<FIG> is a side view of the distal impingement structure <NUM> of <FIG>. The distal impingement structure <NUM> may comprise a bottom surface <NUM>, an impingement surface <NUM> facing a distal face <NUM> of flexible tube <NUM>, a top surface <NUM>, an outer surface <NUM>, and an impingement surface angle <NUM>. Similar to <FIG>, distal face <NUM> may be a flat, partial cross-section of the flexible tube <NUM> that is configured to allow lumens, nozzles, outlets, or other similar structures to pass through in order for agent components to be delivered to the distal impingement structure <NUM>. The bottom surface <NUM> may be substantially flat and rectangular in shape as shown in <FIG>, but may comprise any other suitable shapes or dimensions. The impingement surface <NUM> may be rectangular in shape with chamfered or curved edges as shown in <FIG>, or may comprise any other suitable shape for impinging the flow of agent components 17A, 17B. The top surface <NUM> may be partially cylindrical as shown in <FIG>, or may comprise any suitable shape. In some embodiments, the outer surface <NUM> may be parallel to the impingement surface <NUM>. Impingement surface <NUM> comprises an impingement surface angle <NUM>, where the impingement surface angle is the angle of the impingement surface relative to the plane defined by the bottom surface <NUM> of the distal impingement structure <NUM>. In some embodiments, the impingement surface angle may be the angle of the impingement surface <NUM> relative to longitudinal axes of lumens <NUM> taken at or near outlets <NUM>. Impingement surface angle <NUM> may be configured so that the flow of agent component 17A, 17B impinges on impingement surface <NUM> and combines the components 17A, 17B into a combined agent <NUM> that is applied to the target tissue. In some embodiments, the impingement surface angle <NUM> may be between <NUM> degrees and <NUM> degrees. In additional embodiments, the flexible tube diameter is less than <NUM>. In further embodiments, the distance between the outlets <NUM> and the impingement surface <NUM> is less than <NUM>. In other embodiments, the distance from distal face <NUM> to the closest portion of top surface <NUM> is less than <NUM>. In some embodiments, the distance between the centers of each of outlets <NUM> may be between <NUM> and <NUM>.

<FIG> is a side view of an alternate embodiment of the distal impingement structure <NUM> for use with a medical device like that shown in <FIG>. The distal impingement structure <NUM> may comprise a distal end of a flexible tube <NUM>, lumens <NUM>, outlets <NUM>, a bottom surface <NUM>, an impingement surface <NUM>, an outer surface <NUM>, and an outlet height <NUM>. The outlet height <NUM> may be the distance from the plane of the bottom surface <NUM> to the lumens <NUM> and/or outlet <NUM>. In some embodiments, the outlet height <NUM> is the approximate distance between the bottom surface <NUM> and the bottom of the outlets <NUM>. The outlet height <NUM> is configured to reduce residual puddling of materials on the bottom surface <NUM> which may be caused by surface tension. In some embodiments, the outlet height is selected in order to reduce the portion of agent component 17A, 17B that contacts bottom surface <NUM> while increasing the portion of agent component 17A, 17B that contacts the impingement surface <NUM>. In some embodiments, the outlet height is between <NUM> and <NUM>.

<FIG> is a side view of an alternate embodiment of a distal impingement structure <NUM> for use in a medical device like the one shown in <FIG>. The distal impingement structure <NUM> may comprise an impingement surface <NUM> facing a distal face <NUM> of flexible tube <NUM>, an outer surface <NUM>, and cylindrical rods <NUM>. The cylindrical rods <NUM> may connect the flexible tube <NUM> to the impingement surface <NUM>, and are configured to allow a portion of agent component 17A, 17B to flow between or around the cylindrical rods <NUM>. In some embodiments, the outlets <NUM> are located directly above the gap in between the cylindrical rods <NUM>, to reduce residual puddling of fluids on the cylindrical rods that may be caused by surface tension. In some embodiments, the cylindrical rods <NUM> may be parallel to each other and/or parallel to lumens <NUM>. The cylindrical rods <NUM> may further be rigid. The cylindrical rods <NUM> may also extend further from the distal face <NUM> than lumens <NUM> extends from distal face <NUM>. In some embodiments, cylindrical rods <NUM> may comprise a total of two cylindrical rods as shown in <FIG>. The cylindrical rods may further have a round cross-section.

<FIG> is a top view of an exemplary embodiment of another distal impingement structure <NUM> that may be used with a medical device like the one shown in <FIG>. The distal impingement structure <NUM> may comprise a flexible tube <NUM>, lumens <NUM>, outlets <NUM>, a bottom surface <NUM>, and an impingement surface <NUM>. The lumens <NUM> may further having intersecting longitudinal axes. The axes may interest at or near the impingement surface <NUM>. The lumens <NUM> are configured to promote mixing of agent components 17A, 17B as the agent is dispersed from the outlets <NUM> of lumens <NUM>, resulting in application of combined agent <NUM> to the treatment site. In some embodiments, the lumens are configured such that the streams do not substantially contact each other prior to contacting the impingement surface <NUM>.

<FIG> is a side view of an exemplary embodiment of a distal impingement structure <NUM> for use with a medical device like the one shown in <FIG>. The distal impingement structure <NUM> may comprise a distal end of flexible tube <NUM>, lumens <NUM>, outlets <NUM>, bottom surface <NUM>, impingement surface <NUM>, and outer surface <NUM>, and may further be configured to generate a spray angle <NUM>. Spray angle <NUM> is the angle at which a portion of agent component 17A, 17B flows relative to the plane of the bottom surface <NUM> (in this case, that plane being parallel to a longitudinal axis of each lumens <NUM> at or near the outlets <NUM>). In some embodiments, the spray angle <NUM> is the angle at which a substantial or majority portion of agent component 17A, 17B flows relative to the plane of the bottom surface <NUM>. The spray angle <NUM> is at least partly dictated by the impingement surface angle <NUM> (shown in <FIG>).

<FIG> are side views of additional examples of distal impingement structures <NUM>. For example, impingement surface <NUM>, top surface <NUM>, and outer surface <NUM> may be configured as shown in <FIG>. As further shown in <FIG>, the top surface <NUM> and outer surface <NUM> may be filleted or chamfered, having a rounded top edge, to facilitate flow of a portion of agent component 17A, 17B over the impingement surface <NUM>, top surface <NUM>, and outer surface <NUM>. Top surface <NUM> may be flat and substantially parallel to the axes of lumens <NUM> and/or the bottom surface <NUM>. This may or may not be desirable depending on the application/use. With respect to <FIG>, the top surface <NUM> and outer surface <NUM> may be configured such that the outer surface <NUM> is substantially parallel to the impingement surface <NUM> (and therefore faces distally and radially outward), resulting in a reduction in flow of agent component 17A, 17B around the outer surface <NUM>. The top surface <NUM> of <FIG> may be substantially shorter than the top surface of 9A, and further, there may be no chamfering between top surface <NUM> and outer surface <NUM> such that there is a defined edge between the two surfaces. With respect to <FIG>, the impingement surface <NUM> may be configured to directly interface with the outer surface <NUM>, e.g. not including a top surface <NUM>. Instead, impingement surface <NUM> and outer surface <NUM> meet at an edge that is transverse (e.g. perpendicular to) the axes of lumens <NUM>. In addition, the outer surface <NUM> in <FIG> is substantially perpendicular to the plane of the bottom surface <NUM> and the axes of lumens <NUM>, which further reduces the flow of agent component 17A, 17B over the outer surface <NUM>. In yet another embodiment reflected in <FIG>, the impingement surface <NUM> and the outer surface <NUM> may be configured at different angles relative to the plane of the bottom surface <NUM> (and or axes of lumens <NUM>), such that the flow of agent component 17A, 17B over the outer surface <NUM> is eliminated or nearly eliminated. For example, the top surface <NUM> may be omitted, and impingement surface <NUM> and the outer surface <NUM> may meet at an edge. The edge between impingement surface <NUM> and outer surface <NUM> is transverse to (and in some embodiments, perpendicular to) axes of lumens <NUM>. The angle of impingement surface <NUM> relative to the bottom surface <NUM> and the longitudinal axes of lumens <NUM> may be greater than the angle of outer surface <NUM> relative to bottom surface <NUM> and the longitudinal axes of lumens <NUM>. Outer surface <NUM> may further face distally and radially outward.

<FIG> depicts a perspective, partial cross-sectional view of another exemplary distal impingement structure in accordance with an example of this disclosure. The distal impingement structure <NUM> comprises a nozzle <NUM>, a flexible tube <NUM>, an outlet <NUM>, an impingement surface <NUM>, and an impingement wire <NUM>. Lumen <NUM> is configured to deliver a combined agent <NUM> through flexible tube <NUM> and disburses the combined agent <NUM> via an outlet <NUM> of a nozzle <NUM> fixed in the distal end of the lumen <NUM>. Lumen <NUM> may comprise any chamber within a catheter, needle, cannula, co-extrusion, and/or two or more lumen extrusion for transporting agent components. A source of combined agent <NUM> may be proximal of lumen <NUM>. That source could be any suitable source of delivering such agent, including elements of embodiments shown in <FIG>, such as a multi-lumen catheter carrying agent components 17A,17B, and syringes (or other agent containers) for providing agent components 17A, 17B. Lumen <NUM> is configured to hold, at its distal end, the proximal end of impingement wire <NUM>. In some embodiments, the impingement wire <NUM> is mounted or affixed in the distal end of lumen <NUM>. The impingement wire <NUM> may be a J-shaped wire with a circular cross-sectional shape as shown in <FIG>, or may have other shapes (U-shaped, L-shaped, etc.) and/or cross-sectional shapes (oval, square, rectangular, and so forth). The impingement wire <NUM> also comprises an impingement surface <NUM>. The impingement surface <NUM> may be configured to match the size and shape of outlet <NUM>, or may be configured to be larger or smaller in diameter than outlet <NUM>. In some embodiments, the impingement surface <NUM> may also be positioned to align with outlet <NUM>. Combined agent <NUM> disbursed at the outlet <NUM> impinges surface <NUM> for application of the combined agent <NUM> to the treatment surface <NUM>. In some embodiments, the impingement surface <NUM> is parallel to the plane of the outlet <NUM>, such that a donut (annular) shaped spray is generated for applying the combined agent <NUM> to the treatment site. The impingement wire <NUM> may consist of any suitable material including but not limited to metals, glass, plastics, polymers, and the like.

<FIG> depicts another perspective, partial cross-sectional view of a distal impingement structure <NUM> in accordance with an example of this disclosure. The distal impingement structure <NUM> is identical to the distal impingement structure <NUM> in <FIG>, except the impingement surface <NUM> is oval and provided at an angle relative to the plane of the outlet <NUM> in order to better direct spray away from the outlet <NUM>, in a radial direction.

<FIG> depicts an additional perspective, partial cross-sectional view of an exemplary embodiment of a distal impingement structure <NUM>. The distal impingement structure <NUM> comprises nozzles <NUM>, outlets <NUM>, impingement surfaces <NUM>, and impingement wires <NUM>. Lumens <NUM>, comprising a pair, are configured to deliver agent components 1217A, 1217B through flexible tube <NUM> and disburses the agent components 1217A, 1217B via outlets <NUM> of nozzles <NUM> fixed in the distal ends of the lumens <NUM>. Lumens <NUM> may comprise any chamber within a catheter, needle, cannula, co-extrusion, and/or two or more lumen extrusion for transporting agent components. Lumens <NUM> are configured to hold, at their distal ends, the proximal ends of impingement wires <NUM>. The impingement wires <NUM> may be J-shaped with a circular cross-sectional shape as shown in <FIG>, or may have other shapes (U-shaped, L-shaped, etc.) and/or cross-sectional shapes (oval, square, rectangular, and so forth). The impingement wire <NUM> also comprises an impingement surface <NUM>. The impingement surface <NUM> may be configured to match the size and shape of outlet <NUM>, or may be configured to be larger or smaller in diameter than outlet <NUM>. In some embodiments, the impingement surface <NUM> may also be configured to align with outlet <NUM>. Agent components 1217A, 1217B disbursed at the outlets <NUM> impinge impingement surface <NUM> to facilitate mixing in air, such that a combined agent <NUM> is applied to a treatment site <NUM>. In some embodiments, the impingement surfaces <NUM> are provided at an angle relative to the plane of the outlets <NUM>. In some embodiments, impingement surfaces <NUM> may be angled to direct agent component spray away from outlets <NUM>; in the case of adhesives, this reduces the possibility of clogging or obstructing flow through nozzles <NUM> and outlets <NUM>. In some embodiments, lumens <NUM>, nozzles <NUM>, and outlets <NUM> may be proximal and substantially parallel to each other to facilitate uniform mixing of streams of agent components 1217A, 1217B. In some embodiments, impingement wires <NUM> may mirror each other and have identical shapes, cross-sectional shapes, and impingement surfaces <NUM> for a substantial uniform circular application of materials at the treatment site <NUM>. In other embodiments, impingement wires <NUM> may have different shapes, cross-sectional shapes, and/or impingement surfaces <NUM> to achieve different application profiles at the treatment site.

<FIG> depicts a flowchart illustrating an exemplary method of delivering an agent to a treatment site, according to aspects of this disclosure. At step <NUM>, a distal tip of an agent delivery device, such as the distal tip discussed above with respect to <FIG>, receives two or more fluid agent components disbursed from two or more lumens. At step <NUM>, the distal tip impinges the two or more fluid agent components as discussed above with respect to <FIG>. At step <NUM>, proximate the distal tip, the two or more fluid agent components are combined after the agent components have been disbursed from the two or more lumens. At step <NUM>, the combined agent is deposited at a treatment site as discussed above with respect to <FIG>.

Each of the aforementioned systems, devices, assemblies, and methods may be used to protect and/or treat treatment sites by delivering one or more components of an agent to the treatment site. By providing a medical device with multiple lumens for delivering an agent in parts, and mixing the components after dispensing the agents from the lumens using a distal tip impingement structure, known problems associated with invasive surgical procedures and/or premature curing and clogging of catheters are avoided. Accordingly, physicians may reduce the overall procedure time, increase efficiency of procedures, and/or avoid unnecessary harm to a subject's body caused by limited ability of other tools/devices to treat perforations, post-surgical leaks, or other wounds that might result from endoscopic and open surgical procedures of the gastrointestinal (GI) tract.

Claim 1:
An agent (<NUM>, <NUM>, <NUM>) delivery device, comprising:
two or more agent containers at a proximal end (<NUM>) of the agent delivery device, wherein the two or more agent containers are configured to contain two or more fluids;
an insertion section (<NUM>) connected to the proximal end of the one or more agent containers, the insertion section comprising a tube defining two or more lumens (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>), and the insertion section being coupled to the agent containers such that the two or more fluids may flow from the agent containers to the two or more lumens and out of two or more outlets (<NUM>, <NUM>, <NUM>) of the two or more lumens; and
a distal impingement structure (<NUM>, <NUM>, <NUM>, <NUM>) at the distal end (<NUM>) of the insertion section, the distal impingement structure comprising an impingement surface (<NUM>, <NUM>, <NUM>, <NUM>) arranged relative to two or more outlets to impinge the two or more fluids dispensed from the two or more outlets to cause mixing of the two or more fluids for application of the fluids at a treatment site (<NUM>, <NUM>).