Multi-lumen catheter

Abstract

The delivery device may include a sheath configured to be inserted into a body lumen of a patient. The sheath may have a proximal end, a distal end, a first channel extending into the sheath from the proximal end to the distal end, and a second channel extending into the sheath from the proximal end to the distal end. A total cross-sectional area of ​​the first channel and the second channel may be greater than 50% of a total cross-sectional area of ​​the sheath. The device may also include a handle at a proximal end of the sheath, the handle configured to provide communication between the first port and the first channel and between the second port and the second channel.

Description

[Technical field]

[0001] Various aspects of the present disclosure relate generally to medical devices for delivery of therapeutic agents, fluids, or medical instruments. Examples of the present disclosure relate to medical devices for endoscopic delivery of multiple portions of pressurized fluids and therapeutic agents to a targeted treatment site. [Background technology]

[0002] During treatment / surgery and / or before and after surgery, it is necessary to deliver drugs to targeted 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 colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. The procedures may result in perforation, postoperative leakage, or other wounding of the tract. Summary of the Invention

[0003] Aspects of the present disclosure relate, inter alia, to devices and methods for delivering agents to target treatment sites within the body during treatment / surgery and / or pre- and post-surgery. Each of the aspects disclosed herein may include one or more of the features described in association with any of the other disclosed aspects.

[0004] According to certain aspects of the disclosure, the delivery device may include a sheath having a proximal end, a distal end, a first channel extending within the sheath from the proximal end to the distal end, and a second channel extending within the sheath from the proximal end to the distal end. A total cross-sectional area of ​​the first channel and the second channel is greater than 50% of a total cross-sectional area of ​​the sheath. The delivery device may also include a handle at the proximal end of the sheath. The handle may be configured to provide communication between the first port and the first channel and between the second port and the second channel.

[0005] The delivery device may include one or more of the following features: The first channel of the delivery device may be defined by (1) at least one first planar surface extending from a proximal end to a distal end of the second channel, and (2) a first side opening extending from a proximal end to a distal end of the second channel. The second channel may be similarly defined. The first and second channels may be separated by an interlumen wall. The side opening separates the first and second flanges. The first and second flanges may be configured to flex radially inward and outward. The delivery device may comprise a tube within the first channel, a space being defined between the first planar surface and an outer surface of the tube. The delivery device may include an inner sheath and an outer sheath surrounding the inner sheath, and an at least partially annular space is defined between the outer and inner sheaths. The outer sheath may be rotatable relative to the inner sheath. The outer sheath and the inner sheath may be connected to each other by one or more connectors that extend partially or entirely between the inner surface of the outer sheath and the outer surface of the inner sheath from the proximal end to the distal end of the sheath. The inner sheath may be centered within the outer sheath by one or more ribs between the inner surface of the outer sheath and the outer surface of the inner sheath such that an at least partially annular space can completely surround the inner sheath. The multiple ribs may alternately protrude from the inner surface of the outer sheath and the outer surface of the inner sheath such that rotation of the inner sheath is limited to a predetermined angle. The inner sheath may define at least two channels separated by an inter-lumen wall that may extend from the proximal end to the distal end of the sheath. The delivery device may also include a third port on the handle in communication with the at least partially annular channel. The handle may include a proximal handle portion and a distal handle portion, the inner sheath may be fixed to the proximal handle portion and the outer sheath may be fixed to the distal handle portion, and a locking mechanism may couple the proximal handle portion to the distal handle portion such that the proximal handle portion may rotate relative to the distal handle portion and the inner sheath may rotate relative to the outer sheath.The proximal handle portion may include a flange, and the distal portion may include one or more protrusions proximal to the flange for coupling the proximal handle portion to the distal handle portion, each protrusion may be integral with a corresponding flexible post, and each flexible post may be configured to bend to extend over the flange, allowing the protrusion to enter a space in the handle proximal to the flange. The delivery device may further comprise a third channel extending within the sheath from the proximal end to the distal end, and a total cross-sectional area of ​​the first channel, the second channel, and the third channel may be greater than 75% of a total cross-sectional area of ​​the sheath.

[0006] According to another aspect of the present disclosure, a delivery device may include an outer sheath coupled to a handle, an inner sheath surrounded by the outer sheath, the inner sheath defining an at least partially annular channel between the inner sheath and the outer sheath, the inner sheath coupled to the handle, and a port that may communicate with the at least partially annular lumen.

[0007] The delivery device may include one or more of the following features: An additional port may be attached to each of the two channels of the inner sheath such that the additional port may communicate with a respective channel of the inner sheath. The handle may comprise a proximal handle portion and a distal handle portion, the inner sheath may be fixed to the proximal handle portion and the outer sheath may be fixed to the distal handle portion, and a locking mechanism may couple the proximal handle portion to the distal handle portion such that the proximal handle portion may rotate relative to the distal handle portion and the inner sheath may rotate relative to the outer sheath. The proximal handle portion may include a flange, and the distal portion may include one or more protrusions proximal of the flange for coupling the proximal handle portion to the distal handle portion.

[0008] According to another aspect of the present disclosure, a delivery method may include positioning a distal end of a delivery device proximate to a treatment site and simultaneously delivering a first portion of a medicament through a first channel of a sheath proximate to the treatment site, delivering a second portion of a medicament through a second channel of the sheath proximate to the treatment site, and delivering a pressurized fluid through a third channel of the sheath proximate to the treatment site, where the pressurized fluid mixes the first and second portions of the medicament for delivery to the treatment site. A total cross-sectional area of ​​the first, second, and third channels may be greater than 25% of a total cross-sectional area of ​​the sheath.

[0009] Additional objects and advantages of the disclosed embodiments will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the disclosed embodiments. 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.

[0010] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure, as claimed. [Brief description of the drawings]

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the disclosure and, together with the description, explain the principles of the disclosure. [Figure 1] FIG. 1 is a perspective view of a medical device according to an aspect of the present disclosure. [Diagram 2] 2 is a perspective cross-sectional view of a portion of the length of a sheath of the medical device of FIG. 1 according to an embodiment of the present disclosure. [Figure 2A] 3 is a perspective cross-sectional view of a portion of the length of the sheath of FIG. 2 with a tube inserted therein, according to an embodiment of the present disclosure. [Diagram 3] FIG. 13 is a perspective cross-sectional view of a portion of the length of a sheath, according to an aspect of the present disclosure. [Figure 4] FIG. 13 is a perspective cross-sectional view of a portion of the length of a sheath, according to an aspect of the present disclosure. [Diagram 5]FIG. 13 is a perspective cross-sectional view of a portion of the length of a sheath, according to an aspect of the present disclosure. [Figure 6] FIG. 13 is a perspective cross-sectional view of a portion of the length of a sheath, according to an aspect of the present disclosure. [Figure 7] FIG. 1 is a perspective view of a medical device according to an aspect of the present disclosure. [Figure 7A] 8 is a perspective cross-sectional view of a portion of the medical device of FIG. 7 according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Aspects of the present disclosure include devices and methods for delivering agents, including multi-part agents, to target tissue sites in a subject (e.g., a patient). Application of a multi-part agent at a target tissue site can, for example, protect those sites from further tissue degradation. Current devices and methods for the delivery of such multi-part agents are limited. Due to a lack of effective treatment options and equipment, agents must be applied to target treatment sites to protect those sites from further tissue degradation. Certain prophylactic agents may require multiple parts to be able to harden or remain attached to the target tissue. Many agents delivered may also potentially harden within the catheter unless a secondary hardening measure, such as photocuring (i.e., light curing), is performed. Catheters for delivering agents may also have significant clogging issues due to agents hardening within them. In some aspects of the present disclosure, the delivery device includes a multi-lumen tube that delivers a first portion of the agent, a second portion of the agent, and a pressurized fluid into the first, second, and / or third lumen of the delivery device. The shape and / or cross-sectional area of ​​the drug delivery lumen allows a sufficient volume of the drug portion to be delivered to the site, for example, without hardening or clogging in the delivery lumen. Pressurized fluid, for example, gas, helps mix the drug at the treatment site distal to the delivery device. The delivery device may be a catheter, a scope (endoscope, bronchoscope, gastroscope, ureteroscope, duodenoscope, colonoscope, etc.), a tube, or a sheath, and is inserted into a body lumen or lumen, for example, the GI tract, through a natural orifice. The orifice may be, for example, the nose, mouth, or anus, and placement may be any part of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Delivery and placement into the GI tract, any other natural orifice or body tract, or other body lumen or organ accessible via a body incision is also possible.

[0013] Reference will now be made in detail to aspects of the present disclosure, examples of which 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 variation 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 + / - 10% of the stated value.

[0014] Examples of the present disclosure may relate to devices and methods for performing various medical procedures and / or treatment portions of the large intestine (colon), small intestine, cecum, esophagus, any other portion of the gastrointestinal tract, and / or any other suitable patient anatomical structure (collectively referred to herein as the "target treatment site"). Various examples described herein include single use or disposable medical devices. Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0015] 1 shows a medical device 10 (e.g., a drug delivery device) according to an example of the present disclosure. Medical device 10 includes a proximal end 11 and a distal end 13. Handle 16 and ports 18, 24, and 26 are at or adjacent to the proximal end 11. A sheath 12 extends from the distal end of the handle 16 to the distal end 13 of the device 10. Any of the structures of medical device 10 described herein may be made of biocompatible materials, including certain polymers, rubbers, plastics, and the like.

[0016] Still referring to FIG. 1 , the proximal ports 18, 24, and 26 allow access to the lumens (channels) of the sheath 12 (described further herein). The ports are configured to couple to sources of drugs, gases, fluids, and the like, and can further provide access for devices to enter the device 10 and insert into the sheath 12. Such sources of drugs, gases, or fluids can be any suitable source known in the art. Such sources can include one or more drug containers (e.g., syringes, canisters, etc.). Alternatively, one or more devices, such as catheters, snares, forceps, graspers, imaging devices, or any other endoscopic instruments known in the art, can be inserted through the ports and their respective sheath lumens. The coupling between the sources of drugs, gases, fluids, and the like and the ports 18, 24, and 26 can be, for example, adhesives, heat shrink, snap-fit ​​couplings, threaded connections, crimp couplings, luer couplings, etc. The couplings can be permanent or removable. Each of the one or more drug containers may contain a drug component dispersible from a respective lumen of the flexible sheath 12. The ports 18, 24, and 26 communicate with multiple lumens (not shown) in the handle 16 and multiple sheath lumens.

[0017] The handle 16 is the junction of the ports 18, 26, and 24 with the sheath 12. In embodiments, the handle 16 can include and / or surround multiple ports, allowing their access and coupling to various drug sources and devices known in the art. The handle 16 can be configured to be secured to the distal end of each port 18, 24, and 26. Multiple drug containers can be attached to the proximal end of one or more of the ports 18, 24, and 26. These couplings can be via, for example, adhesives, heat shrink, snap-fit ​​couplings, threaded couplings, crimp couplings, etc. The handle 16 provides communication between the ports 18, 24, and 26 and the multiple lumens of the sheath 12, and also provides access for multiple devices from the multiple ports to the multiple lumens of the sheath 12. The handle 16 can include any actuator known in the art to control the delivery of drugs, gases, fluids, etc. from the ports 18, 24, and 26 to the sheath 12. These actuators may include triggers, buttons, switches, pneumatic controls, or other methods known in the art. In an embodiment, device 10 does not include a handle, but instead has ports 18, 24, and 26 that lead to and communicate with the lumens of sheath 12 without any intervening structure.

[0018] The sheath 12 is a tube having sufficient length and flexibility to access internal body sites and traverse tortuous anatomical structures. The lumens 14, 20, and 22 extend through the sheath 12 from its proximal end to its distal end. The lumens 14, 20, and 22 open at the distal face of the sheath 12, as shown in FIG. 1. The lumens 14, 20, and 22 are substantially parallel to one another, such that the longitudinal axes of the lumens 14, 20, and 22 are substantially parallel. The sheath 12 is not limited to including three lumens 14, 20, and 22, but may include more or fewer lumens. The sheath 12 is coupled to a handle 16 at the proximal end of the sheath 12, allowing access to the lumens 14, 20, and 22 from ports 18, 24, and 26 through the handle 16. In particular, port 18 provides access to lumen 14 , port 26 provides access to lumen 22 , and port 24 provides access to lumen 20 .

[0019] The lumen 14 is a completely enclosed lumen (completely surrounded on all sides by some portion of the sheath 12) that extends from the proximal end to the distal end of the sheath 12. The lumen 14 has a circular cross-sectional shape, but is not limited to such a shape, and opens at the distal face of the sheath 12. A port 18 communicates with the handle 16 and the lumen 14. Multiple enclosed lumens 14 may be included in the cross-sectional area of ​​the sheath and may have corresponding ports. The inner wall of the lumen 14 may be lined with a biocompatible material, such as expanded polytetrafluoroethylene (ePTFE), to reduce friction against any agents or devices inserted through the lumen 14. In an embodiment, the lumen 14 is configured to have a pressurized fluid (e.g., carbon dioxide gas) passed therethrough.

[0020] 2 shows a cross-section of a portion of the length of the sheath 12 of FIG. 1. The sheath 12 may be the same or similar in cross-section along the entire length of the sheath 12. A lumen 20 extends from the proximal end to the distal end of the sheath 12. There is communication between the lumen 20 and a corresponding port 24. The lumen 20 is defined by flat surfaces 42, 46, curved surfaces 34, 36, 40, 44, and 48, and a side opening 28. The cross-sectional area of ​​the lumen 20 occupies approximately one-quarter (1 / 4) of the cross-sectional area of ​​the sheath 12, although this ratio is not limited and lumens may be added or reduced and / or the size of the lumens may be adjusted. The cross-sectional area of ​​lumen 20 is maximized to accommodate, for example, a tube 68 (described further herein) of sufficient inner diameter to allow for the passage of an agent without clogging the inside of tube 68, while leaving sufficient material of sheath 20 for sufficient structural integrity and traversability along tortuous body lumens. The combined cross-sectional area of ​​lumens 14, 20, and 22 is at least 50% of the combined cross-sectional area of ​​sheath 12, and in certain embodiments, is from about two-thirds to at least about three-quarters of the combined cross-sectional area of ​​sheath 12.

[0021] The surfaces 34 and 40, and the surfaces 36 and 48, together with a portion of the outer surface of the sheath 12, define two flanges 29 and 31. The flanges 29 and 31 are disposed at the edges of the opening 28. The flanges 29 and 31 are flexible such that they can bend radially inward into the lumen 28 and radially outward of the sheath 12. The side opening 28, in combination with the flexibility of the flanges 29 and 31, allows the cross-sectional area of ​​the lumen 20 to expand for insertion and placement of the tube 68. Additionally or alternatively, the inner wall of the lumen 20 can be lined with a biocompatible material, such as ePTFE, to reduce friction of a tube inserted along the longitudinal axis of the lumen 20. The side opening 28 is configured to allow a user to insert or remove the tube 68 as the flanges 29, 31 bend inward and outward, respectively. The flanges 29, 31 extend the entire length of the lumen 20. Surfaces 34 and 36 of flanges 29 and 31, respectively, may have a radius of curvature that matches the curvature of tube 68, as shown in FIG. 2A.

[0022] The lumen 20 is defined by, among other surfaces, two flat surfaces 42, 46 oriented at an angle to each other and separated by a curved surface 44. The flat surfaces 42, 46 form the inner wall of the lumen 20 and extend the entire length of the sheath 12. The planar configuration of the surfaces 42, 46 creates a space between a circular tube 68 and those surfaces 42, 46 when the tube 68 is inserted into the lumen 20, as shown in FIG. 2A. The curved surfaces 40, 48 also create a space between the tube 68 and the surfaces that define the lumen 20.

[0023] Lumen 22 is separated from lumen 20 by inter-lumen wall 32 and may be a mirror image of lumen 20. However, lumen 22 is not limited to having the same geometric shape. For example, lumen 22 may vary in size and shape. There may be more than two lumens 20, 22 by being separated by additional inter-lumen walls. The number of lumens depends, among other things, on the cross-sectional area and material of sheath 12. For example, the material and walls of sheath 12 should provide sufficient structural support to prevent the lumens and / or sheath from collapsing. In addition, inter-lumen wall 32 should have sufficient thickness and rigidity to prevent lumens 20, 22 from changing shape, although in other embodiments, at least one of lumens 20, 22 may have some flexibility to accommodate larger devices, including tubes.

[0024] As shown in FIG. 2A, the tubes 68, 70 may each have a circular cross-sectional shape and multiple thin walls to separate the space of the lumens 20, 22 from the lumen of the tube 68. The tubes 68, 70 may be alternative cross-sectional shapes, such as oval, triangular, or may be the exact cross-sectional shape as the lumen allowing additional space in the tubes 68, 70 to reduce clogging. Additionally, different tubes may be inserted into the lumens 20, 22. For example, a circular tube may be inserted into the lumen 20 and a triangular tube may be inserted into the lumen 22. The tubes 68, 70 may be inserted by the user at the corresponding ports 24, 26 through the handle 16 or may be inserted into the lumen through the side openings 28, 30. Alternatively, the medical device 10 may be manufactured to include one or both of the tubes 68, 70 preloaded into the lumens 20, 22, respectively. The tubes 68, 70 may provide a pathway for a drug or device to be delivered. Such devices may include catheters, snares, graspers, forceps, or other endoscopic instruments known in the art.

[0025] Aspects of the present disclosure include a method of using the device 10. To do so, a user may first attach a source of medication and / or pressurized fluid to one or more of the ports 18, 24, and 26. Alternatively, such a source may be included within the handle 16 and may already be in communication with the lumens 14, 20, and 22. The user may then insert the distal end of the sheath 12 into the GI tract through a natural orifice. The orifice may be, for example, the nose, mouth, or anus, and placement may be any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Delivery and placement into the GI tract, any other natural orifice or body tract, other body lumens or organs accessible through a body incision, or through a delivery device such as an endoscope or sheath, is also possible. Once the desired site is accessed, the user may actuate the handle to allow medication and / or pressurized fluid to flow through the lumen 14 and / or tubes 68, 70. In one embodiment, the pressurized fluid flows through lumen 14 and two separate portions of the drug flow through tubes 68 and 70, respectively. The fluid and drug portions exit the distal ends of lumen 14 and tubes 68, 70 to mix and adhere to tissue at the target treatment site. Alternatively, a user may use lumen 14, tubes 68, 70, or lumens 20, 22 to insert any other diagnostic and / or therapeutic instrument.

[0026] FIG. 3 shows a cross-sectional view of a portion of the length of an exemplary embodiment of sheath 112. Sheath 112 is identical to sheath 12 of FIGS. 1, 2, and 2A, except as described below. Sheath 112 is composed of three closed lumens 114, 120, and 122 (completely surrounded on all sides by portions of sheath 12). Lumen 114 is identical to lumen 14 of FIGS. 1, 2, and 2A. Lumen 120 is completely surrounded by curved surfaces 140, 144, 148, 150 and flat surfaces 142, 146. These surfaces extend the entire length of sheath 112. Multiple interior walls of sheath 112, including wall 132, provide support for tubes or devices inserted through lumens 114, 120, and 122. Planes 142, 146 and curved surface 144 are identical to planes 42, 46 and curved surface 44 of FIG. 1. Curved surface 150 completely surrounds lumen 120 instead of having side opening 28 of FIGS. 1-2A. The triangular shape of lumen 120 creates additional space to allow a physician to insert or utilize therapeutic or diagnostic instruments. The inner walls of lumen 120 may be lined with a biocompatible material, such as expanded polytetrafluoroethylene (ePTFE), to reduce friction for any agents or devices inserted through the lumen. The cross-sectional area of ​​lumen 120 occupies approximately one-quarter (1 / 4) of the cross-sectional area of ​​sheath 112, although that ratio is not limited and lumens may be added or reduced and / or the size of the lumens may be adjusted. The cross-sectional area of ​​lumen 120 is maximized to, for example, allow an agent to pass through lumen 120 without clogging, while leaving enough material of sheath 120 for sufficient structural integrity and traversability along tortuous body lumens. The combined cross-sectional area of ​​lumens 114, 120, and 122 is at least 50% of the combined cross-sectional area of ​​sheath 12, and in certain embodiments, is about two-thirds to at least about three-quarters of the combined cross-sectional area of ​​sheath 112.

[0027] 4 illustrates a cross-sectional view of a portion of the length of an exemplary sheath 212. The sheath 212 includes an outer sheath 203 and an inner sheath 204. Each of the outer sheath 203 and the inner sheath 204 can vary in size, shape, and material. For example, for use with an endoscope having a working channel between 2.8 mm and 4.2 mm, the outer diameter of sheath 203 may be between about 0.090 inches (2.29 mm) and 0.155 inches (3.94 mm), the inner diameter of sheath 203 may be between about 0.076 inches (1.93 mm) and 0.141 inches (3.58 mm), the outer diameter of inner sheath 204 may be between about 0.066 inches (1.68 mm) and 0.136 inches (3.45 mm), and the area of ​​each of lumen 208 and lumen 210 is between about 0.0017 inches (0.0432) and 0.0062 inches (0.157 mm), or any other dimensions suitable for use with a working channel between 2.8 mm and 4.2 mm. The cross-sectional area of ​​the lumen 208 occupies approximately one-third (1 / 3) of the cross-sectional area of ​​the sheath 212, although that ratio is not limited and lumens may be added or reduced and / or the size of the lumens may be adjusted. The total cross-sectional area of ​​the lumens 202, 208, and 210 is at least 50% of the total cross-sectional area of ​​the sheath 212, and in certain embodiments, is approximately two-thirds to at least approximately three-quarters of the total cross-sectional area of ​​the sheath 12. The total usable area of ​​the sheath 212 is at least approximately 25% of the cross-sectional area of ​​the endoscope working channel, although that ratio is not limited as the size of the lumens can be adjusted. In addition, each of the sheaths 203, 204 may have a circular outer periphery and a circular inner periphery (as shown), but may instead have other geometric shapes, including an oval, a triangle, a rectangle, etc. The outer sheath 203 is independent of the inner sheath 204 in that it does not have a structure that secures the outer surface of the sheath 204 to the inner surface of the sheath 203. Additionally, in at least some methods of their use, the sheaths 203 and 204 do not contact one another along some or all of the length of the sheaths 203, 204. The inner surface of the outer sheath 203 and the outer surface of the inner sheath 204 define an annular lumen 202 that separates the sheaths 203, 204.The surfaces of the sheaths 203 , 204 may be lined with a biocompatible material, such as ePTFE, to reduce friction against any agents or devices inserted through the annular lumen 202 .

[0028] The inner sheath 204 is comprised of two lumens 208, 210 separated by an interlumen wall 206. The number, size, and shape of the lumens and interlumen walls that comprise the inner sheath 204 may vary. For example, the sheath 204 may define two semicircular lumens (as shown), three triangular lumens separated by three interlumen walls, or more of the same lumens of various shapes separated by multiple interlumen walls. The number of lumens that comprise the inner sheath may depend on the material strength and cross-sectional area of ​​the inner sheath 204. For example, the material should provide sufficient structural support to prevent the sheath from collapsing. Additionally, the interlumen walls 206 must be thick enough to allow the lumens 208, 210 to retain their shape throughout the length of the inner sheath 204, although in some embodiments the interlumen walls 206 may be flexible to allow the shape of one or more lumens 208, 210 to accommodate the amount or size of agent(s) or device(s) extending therethrough. The multiple lumens in the inner sheath 204 can be lined with a biocompatible material, such as ePTFE, to reduce friction against any agent or device inserted therethrough.

[0029] 7 shows a perspective view of an exemplary handle 500 for use with the sheath 212. The handle 500 includes handle portions 502, 504, and a port 522. The handle portion 502 is at or adjacent to the handle proximal end 501. The handle portion 504 is attached to the distal end of the handle portion 502.

[0030] 7A provides a cross-sectional view of the handle 500. The inner sheath 204 extends from the distal end to the proximal end of the handle portion 502 through the handle portion lumen 532. The handle portion 502 may be configured to be secured to an outer surface of the inner sheath 204 by adhesive, wire fitting, an overmolding process, or the like. Multiple drug containers can be attached to additional ports attached to the proximal end of the inner sheath 204 by, for example, adhesive, heat shrink, a snap-fit ​​connection, a threaded connection, a luer connection, a crimp connection, or the like. Alternatively, multiple ports can be attached to the proximal end of the handle portion 502 and can communicate with multiple lumens of the inner sheath 204.

[0031] The port 522 on the handle portion 502 is configured to connect to a source of medication, gas, fluid, or the like, providing access to the annular lumen 202 via the port lumen 530. Such a source of medication, gas, or fluid may be any suitable source known in the art. The longitudinal axis of the port lumen 530 is perpendicular to the longitudinal axis of the handle portion lumen 532 and the inner sheath 204, but the angular relationship is not limited thereto. The handle portion lumen 532 extends from the proximal end to the distal end of the handle portion 502. The handle portion lumen 532 is open at the proximal and distal ends. The handle portion 502 may include any number of actuators known in the art for controlling the delivery of medication, gas, fluid, or the like from the port 522 to the annular lumen 202. These actuators may include triggers, buttons, switches, pneumatic controls, or other methods known in the art. Alternatively, the port 522 and the multiple actuators can be configured on the handle portion 504 (described further herein). The handle portion 502 further includes a collar 510, a flange 512, and a flat 520. These structures aid in coupling the handle portion 504 to the handle portion 502.

[0032] The collar 510 extends distally from the remainder of the handle portion 502 and can vary in size and shape. For example, the collar 510 can have a cross-sectional shape that is circular, rectangular, or any other desired shape. The collar 510 defines a portion of the handle portion lumen 532. The flange 512 is proximal to the collar 510 and also defines a portion of the handle portion lumen 532. The flange 512 facilitates attachment of the handle portion 504 to the handle portion 502. The flange 512 is annular and conical in shape with a width dimension that tapers distally. The extension 516 is proximal to the flange 512. The extension 516 also defines a portion of the handle portion lumen 532 and provides an annular space for the snap feature 524 of the handle portion 504 to lock between the flange 512 and the proximal portion of the handle portion 502. Flat surface 520 provides a stop for the proximal end of snap feature 524 .

[0033] The handle portion 504 is comprised of a distal curved surface 528, a handle portion lumen 534, a collar cavity 505, a seal cavity 506, and a plurality of snap features 524, each having a protrusion 526. The curved surface 528 defines the distal end of the handle portion 504. The curved surface 528 is not limited to a conical shape as shown, and can vary in size. For example, the outer surface can be rectangular or triangular. The handle portion lumen 534 extends through the center of the handle portion 504. The handle portion lumen 534 is open at the proximal and distal ends and communicates with the handle portion lumen 532 when the handle portion 502 is assembled. The outer sheath 203 is attached to the handle portion lumen 532 using, for example, an adhesive, an overmolding process, or the like. The collar cavity 505 receives the collar 510 of the handle portion 502. The size and shape of the collar cavity 505 can vary depending on the desired attachment method of the handle portion 502. For example, the collar cavity 505 can be rectangular and receive a circular collar 510. Alternatively, the collar cavity 505 can be the same geometric shape as the collar 510. These components can be assembled together using adhesives, a press fit, or the like.

[0034] The seal cavity 506 holds a seal 508, which may be an O-ring made of rubber or other suitable material. The seal 508 forms an airtight seal between the collar 510 and the collar cavity 505 such that pressurized fluid entering the handle portion lumen 534 through the port lumen 530 does not leak out of the handle 502. The seal 508 and the seal cavity 506 can vary in size and shape.

[0035] The snap features 524 extend proximally from the proximally facing flat surface 536 of the handle portion 504. Each snap feature is comprised of a post 525 and a radially inward protrusion 526. The post 525 allows the protrusion to bend and flex radially outward on the flange 512. The protrusion 526 locks into place proximally of the flange 512, joining the handle portion 504 to the handle portion 502. The locking may be permanent or temporary. The size, shape, and number of the snap features 524 are not limited. For example, the handle 504 can have two or more snap features 524. The snap features 524 can also differ in size and shape relative to one another. The snap features 524 further allow the handle portions 502, 504 to rotate relative to one another but not translate relative to one another. For example, handle portion 502 can rotate clockwise while handle portion 504 is held stationary or rotated counterclockwise, or vice versa. Alternatively, handle portions 502, 504 can be attached using any other method known in the art, such as a press fit onto collar 510, a cork and screw design, etc.

[0036] The device of Figures 7-7A is used similarly to the device 10 of Figure 1. To do so, a user may first attach a pressurized fluid source to the port 522 leading to the annular lumen 202 and multiple drug sources to multiple ports leading to multiple lumens of the inner sheath 204. The user may then insert the distal end of the sheath 212 into the GI tract via a natural orifice. The orifice may be, for example, the nose, mouth, or anus, and placement may be any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Delivery and placement into the GI tract, any other natural orifice or body tract, other body lumens or organs accessible via a body incision, or through a delivery device such as an endoscope or sheath, is also possible. Once the desired site is accessed, the user can actuate handle 500 or other actuator (via any known suitable actuator) coupled to a source of drug and pressurized fluid to allow the drug portion and pressurized fluid to flow through the multiple lumens of sheath 204 and the annular space 202 between sheaths 203 and 204. The fluid and drug portion exit the distal end of sheath 212, mix at the target treatment site and adhere to tissue. The user can rotate handle portion 502 independently of handle portion 504 to manipulate the distal end of the sheath to a desired orientation during a procedure.

[0037] FIG. 6 shows a cross-sectional view of a portion of the length of an exemplary embodiment of a sheath 412 having an outer sheath 403 and an inner sheath 404. The inner sheath 404 is identical to the inner sheath 204 of FIG. 4. The outer sheath 403 is identical to the outer sheath 403 of FIG. 4 except as described below. The ribs 406, 408, 410 project radially inward from the inner surface of the outer sheath 403 and extend over a portion or the entire length of the outer sheath 403. Alternatively, the ribs 406, 408, and 410 can project from the outer surface of the inner sheath 404 and extend over a portion or the entire length of the inner sheath 404. The ribs 406, 408, and 410 provide support for the inner sheath 404. The ribs 406, 408, and 410 also keep the inner sheath 404 spaced from and concentric with the outer sheath 403. The ribs can also alternate the surface from which they protrude. For example, a rib can protrude from the inner surface of the outer sheath and a second rib can protrude from the outer surface of the inner sheath, such that when the inner sheath 404 and the outer sheath 403 are coupled together, the ribs can abut to act as a rotational stop at a predetermined angle, preventing the inner sheath from freely rotating along the longitudinal axis of the sheath. The embodiment of FIG. 6 can be used with handle 500 (described above).

[0038] FIG. 5 shows a cross-sectional view of a portion of the length of an exemplary embodiment of a sheath 312. The sheath 312 is identical to the sheath 212 of FIG. 4, except as described below. In the sheath 312, the annular lumen between the inner and outer sheaths is separated into two semi-annular lumens 302, 314 by two connectors 308, 310. There may be more than one such connector, and additional such lumens may be added. The multiple semi-annular lumens are separated from the lumen 316, 317 by the inner sheath 304. This embodiment may be used with the handle 500 described above. To do so, the proximal length of the outer sheath 312 may be scraped or otherwise removed and attached to the handle portion 502 using any of the methods described above. However, the handle portions 502, 504 are not independently movable relative to one another when the sheath 312 is used.

[0039] Each of the aforementioned systems, devices, assemblies, and methods may be used to protect and / or treat a treatment site by delivering one or more components of a medicament to the treatment site. By providing a medical device with multiple lumens for partially delivering the medicament and mixing the multiple components after dispensing the multiple medicaments from the lumens, known problems associated with invasive surgical procedures and / or premature hardening and clogging of catheters are avoided. Thus, physicians may reduce overall procedure time, improve efficiency of procedures, and / or avoid unnecessary harm to the subject's body caused by the limited ability of other instruments / devices to treat perforations, post-operative leakage, or other wounds that may result from endoscopic and open surgical procedures of the gastrointestinal (GI) tract.

[0040] It will be apparent to those skilled in the art that various modifications and changes can be made in the disclosed devices and methods without departing from the scope of the present disclosure. Other aspects of the present 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 exemplary only, with the true scope of the present disclosure being indicated by the following claims and equivalents thereof.

Claims

1. a sheath having a proximal end, a distal end, a first channel extending within the sheath from the proximal end to the distal end, and a second channel extending within the sheath from the proximal end to the distal end, wherein a total cross-sectional area of ​​the first channel and the second channel is greater than 50% of a total cross-sectional area of ​​the sheath; a handle at the proximal end of the sheath, the handle configured to provide communication between a first port and the first channel and between a second port and the second channel; A delivery device comprising:

2. 2. The delivery device of claim 1, wherein the first channel is defined by (1) at least one first plane extending from the proximal end to the distal end of the second channel and (2) a first side opening extending from the proximal end to the distal end of the second channel.

3. 3. The delivery device of claim 1 or 2, wherein the second channel is defined by (1) at least one second plane extending from the proximal end to the distal end of the second channel and (2) a second side opening extending from the proximal end to the distal end of the second channel, and the first channel and the second channel are separated by an inter-lumen wall.

4. The delivery device of claim 2 , wherein the first side opening separates first and second flanges, each configured to flex radially inward and outward.

5. The delivery device of claim 2 , further comprising a tube within the first channel, a space being defined between the first plane and an outer surface of the tube.

6. The sheath is an inner sheath, and the delivery device comprises: The delivery device of claim 1 , further comprising an outer sheath surrounding the inner sheath, wherein an at least partially annular space is defined between the outer sheath and the inner sheath.

7. The delivery device of claim 6 , wherein the outer sheath rotates relative to the inner sheath.

8. 7. The delivery device of claim 6, wherein the outer sheath and the inner sheath are coupled together by one or more connectors extending partially or entirely from the proximal end to the distal end of the sheath between an inner surface of the outer sheath and an outer surface of the inner sheath.

9. 8. The delivery device of claim 6 or 7, wherein the inner sheath is centered within the outer sheath by one or more ribs between the inner surface of the outer sheath and the outer surface of the inner sheath such that an at least partially annular space completely surrounds the inner sheath.

10. The delivery device of claim 9 , wherein a plurality of ribs protrude alternatingly from the inner surface of the outer sheath and the outer surface of the inner sheath such that rotation of the inner sheath is limited to a predetermined angle.

11. The delivery device of claim 6 , wherein the inner sheath defines at least two channels separated by an interlumen wall extending from the proximal end to the distal end of the sheath.

12. The delivery device of claim 6 , further comprising a third port in the handle in communication with the at least partially annular channel.

13. 7. The delivery device of claim 6, wherein the handle includes a proximal handle portion and a distal handle portion, the inner sheath is fixed to the proximal handle portion and the outer sheath is fixed to the distal handle portion, and a locking mechanism couples the proximal handle portion to the distal handle portion such that the proximal handle portion rotates relative to the distal handle portion and the inner sheath rotates relative to the outer sheath.

14. 14. The delivery device of claim 13, wherein the proximal handle portion includes a flange and the distal handle portion includes one or more protrusions proximal to the flange for coupling the proximal handle portion to the distal handle portion, each protrusion being integral with a corresponding flexible post, each flexible post being configured to flex to extend over the flange and allowing the protrusion to enter a space in the handle proximal to the flange.

15. 2. The delivery device of claim 1, further comprising a third channel extending within the sheath from the proximal end to the distal end, wherein a total cross-sectional area of ​​the first channel, the second channel, and the third channel is greater than 75% of a total cross-sectional area of ​​the sheath.

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