Endoluminal sealing devices and related methods of use

Abstract

To seal a target site of a body lumen of a subject.SOLUTION: A medical system comprises a porous body configured to be placed at a target site. The medical system comprises a tube including a lumen. The porous body is connected to a first end of the tube, and, in a state in which the porous body is positioned at the target site, the tube is configured to extend from the porous body into the body lumen. The medical system comprises a stent including a channel. In a state in which the porous body is positioned at the target site, the tube is configured to extend into the channel of the stent in order to seal the target site from the body lumen together with the stent.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present disclosure relates to minimally invasive (e.g., endoscopic and / or laparoscopic) medical devices and related methods of use. In embodiments, the present disclosure relates to one or more devices for sealing perforations, leaks, or wounds in the gastrointestinal tract, devices for advancing these sealing devices, and related methods of use and other aspects. [Background technology]

[0002] Endoscopic and open gastrointestinal (GI) tract surgeries include, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can result in perforations, postoperative leaks, or other wounds in the GI tract. Limited treatment options exist for the management of such wounds, resulting in significant morbidity and mortality. Options include reoperation and endoscopic placement of stents or clips. Surgery is relatively invasive and carries high morbidity and mortality rates. Endoscopic stent placement is a minimally invasive option. However, placed stents can migrate from their intended location and / or trap infection at the target site, inhibiting drainage. Summary of the Invention

[0003] According to one aspect, a medical system includes a porous body configured to be placed at a target site within a subject's body, a tube including a wall defining a tube lumen, the tube connected to the porous body at a first end of the tube, and a sealing device configured to seal the target site from the body lumen, wherein the tube is configured to extend from the target site into the body lumen when the sealing device seals the target site from the body lumen.

[0004] The sealing device can be a stent that can be configured to contact (1) the sidewall of the body lumen and (2) the vessel when the vessel and stent are implanted. The stent may include a wall defining a stent lumen, and the attachment device may extend from the wall into the stent lumen.

[0005] The wall of the stent may define channels that extend along the exterior surface of the stent. The wall of the stent may include a radially outwardly concave surface and a radially inwardly convex surface along the length of the channel.

[0006] The channel may be configured to align with the tube when the tube and stent are implanted, and the tube may be configured to extend into the channel to seal the target site from the body lumen. The channel may include a sloped surface oblique to a central longitudinal axis of the stent lumen, the sloped surface being configured to accommodate a tube.

[0007] The sealing device may be a valve defining a valve lumen, the valve may be configured to be positioned in an opening in a wall defining the body lumen between the target site and the body lumen, and a tube may be configured to extend from the target site through the valve lumen and into the body lumen.

[0008] The valve may have (1) a closed state in which the valve is in contact with the tubing, and (2) an open state in which the valve is not in contact with the tubing. The valve may be configured such that the size of the valve lumen changes due to peristaltic movement of a wall defining the body lumen.

[0009] The exterior surface of the valve may be U-shaped. Fluid from the target site can be configured to be evacuated from the target site through the tube lumen and the valve lumen.

[0010] The first end of the tube may include multiple branches embedded in the sponge. The tube may include a plurality of corrugations, and the tube may be configured to bend through the plurality of corrugations.

[0011] The tube may include a plurality of one-way valves, which may be configured to allow fluid to pass from the target site to the body lumen and may not allow fluid to pass from the body lumen to the target site.

[0012] According to another aspect, a medical device includes a porous body and a tube, the tube extending from a first end of the tube to a second end of the tube and including a tube lumen connected to the porous body at the first end of the tube, the tube including at least one one-way valve configured to allow fluid to pass from the first end of the tube to the second end of the tube and to prevent fluid from passing from the second end of the tube to the first end of the tube, and the tube lumen fluidly connected to the porous body at the first end of the tube.

[0013] The first end of the tube may include a plurality of branches embedded in the porous body, the tube lumen may extend through each branch of the plurality of branches, and each branch of the plurality of branches may include an opening fluidly connecting the tube lumen to the porous body.

[0014] The tube may include a plurality of corrugations, and the tube may be configured to bend through the plurality of corrugations. According to another aspect, a method for removing fluid from a target site adjacent the gastrointestinal tract comprises deploying a porous body at the target site, wherein a tube extends from the porous body into the gastrointestinal tract, and deploying a stent within the gastrointestinal tract to seal the target site from the gastrointestinal tract.

[0015] The method further includes moving one end of the stent into the stent lumen, withdrawing the porous body from the gastrointestinal tract, deploying a second porous body at the target site, and extending the end of the stent from the stent lumen to seal the target site from the gastrointestinal tract.

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Brief explanation of the drawings]

[0017] [Figure 1A] 1 is a cross-sectional view of an intraluminal negative pressure therapy (EVAC) system according to an embodiment. [Figure 1B]1B is a cross-sectional view of the EVAC system of FIG. 1A along line AA according to an embodiment. [Figure 2] 1B is a diagram of the EVAC system of FIG. 1A with a folded stent, according to an embodiment. [Figure 3] 1 is a cross-sectional view of an EVAC system according to another embodiment. [Figure 4A] 4 is a cross-sectional view of the EVAC system of FIG. 3 taken along line AA in accordance with an embodiment. [Figure 4B] 4 is a cross-sectional view of the EVAC system of FIG. 3 taken along line BB in accordance with an embodiment. [Figure 5A] 1 is a cross-sectional view of an EVAC system according to another embodiment. [Figure 5B] 5B is a cross-sectional view of a valve of the EVAC system of FIG. 5A along line DD according to an embodiment. [Figure 5C] 5B is a cross-sectional view of a valve of the EVAC system of FIG. 5A along line DD according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0018] For ease of description, portions of the disclosed devices and / or their components are referred to as proximal and distal portions. It should be noted that, in this specification, the term "proximal" is intended to refer to the portion of the device closer to the user, and the term "distal" is used to refer to the portion farther from the user. Similarly, "distally extending" indicates that a component extends in the distal direction, and "proximally extending" indicates that a component extends in the proximal direction. Furthermore, as used herein, the terms "about," "approximately," and "substantially" indicate a range of values ​​within + / - 10% of the stated or implied value. Terms indicating component / surface geometry refer to exact and approximate shapes. The present disclosure may be understood with reference to the following description and the accompanying drawings, in which like elements are designated with the same reference numerals.

[0019] Intraluminal negative pressure therapy (EVAC) has been proposed. EVAC delivers negative pressure to a wound site, for example, in the GI tract, through a nasogastric tube with a sponge at its end. The sponge is placed endoscopically into the perforation, leak, or other wound. Negative pressure is then applied. However, devices and systems suitable for EVAC are limited.

[0020] Embodiments of the present disclosure include devices, systems, and methods for intraluminal negative pressure therapy (EVAC). For example, EVAC involves the intraluminal placement of a sponge or other similar material at a wound (e.g., target) site, including a perforation, leak, cyst, anastomosis, etc. Placement of the material can occur via a catheter, scope (e.g., endoscope, bronchoscope, colonoscope, duodenoscope, gastroscope, etc.), tube, or sheath inserted into the GI tract through a natural orifice. The orifice can be, for example, the nose, mouth, or anus, and placement can be in any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Placement of the material can also occur within other organs accessible via the GI tract.

[0021] 1A illustrates an EVAC system 10 according to one example of the present disclosure. System 10 may be inserted into a patient's body, for example, to a target site 70 in a GI tract 80, for the treatment of a chronic wound. However, as discussed herein, the location of system 10 within the body is not limited. System 10 generally includes an EVAC device 20 and a stent 60. While this example relates to a GI tract 80, system 10 may be used in any body lumen.

[0022] The EVAC device 20 may include a sponge 30 (or other mesh-like or porous material) and a vacuum tube 40. The sponge 30 may be attached to the distal end of the vacuum tube 40. The sponge 30 may include openings 32 on its outer surface. The openings 32 may be any holes or pores. The openings 32 provide access to interconnected channels and pores (not shown) throughout the sponge 30 (for ease of reference, only the openings 32 are shown). The openings 32 may have different sizes and / or shapes, and the size and shape of the openings 32 may be selected based on the treatment location within the body. Fluid and / or other substances may be removed from the target site 70. For ease of understanding, fluid includes any fluid, substance, or other debris that is within and / or removed from the target site 70.

[0023] While sponge 30 is shown as having a spherical shape, it can be any shape, including cylindrical, cubic, irregular, etc. As described herein, sponge 30 can be compressed to a lower profile during insertion into the target site and can expand during deployment at the target site. Sponge 30 can initially have a first shape and size and can be trimmed, for example, with medical scissors, during a medical procedure to change the size and / or shape of sponge 30 depending on the size and shape of target site 70.

[0024] In embodiments of the present disclosure, the sponge can be any suitable biocompatible material capable of absorbing liquid and / or allowing liquid to pass through it under negative pressure. The material can be flexible, compressible, porous, hydrophilic, sterile, and / or disposable. The sponge material can be an open-cell foam. Suitable materials include polyurethanes, esters, ethers, composite materials, and any medical-grade material.

[0025] 1A , the tube 40 may be a nasogastric tube and include an outer wall 42 defining one or more lumens 44. The lumens 44 may include an opening at the distal end of the tube 40, or may include a single opening at the distal end. Alternatively, the tube 40 may include one or more branches (see, e.g., branch 40a′ in FIG. 3 ) within the sponge 30 at the end of the tube 40. The outer wall 42 may include multiple holes (not shown) along the circumference of the distal end of the vacuum tube 40 that are in fluid communication with the lumens 44. These holes may enhance fluid flow into the lumens 44. The distal end of the vacuum tube 40 may be attached to the sponge 30 via sutures, adhesive, or otherwise. In one example, the sponge 30 may be cut to expose the interior of the sponge 30, such as by cutting the sponge 30 into two halves of approximately equal size. A channel corresponding to the general shape and size of the distal end of the tube 40 may be formed in each half of the sponge 30. The tube 40 may be placed and / or attached within the channel of the sponge 30, and the halves of the sponge 30 may be rejoined using adhesives, sutures, or otherwise. This may provide additional structural support between the sponge 30 and the tube 40, and / or may allow the sponge 30 to be formed around the tube 40. For example, in instances where the tube 40 is irregularly shaped and / or where the tube 40 includes branches 40a', the sponge 30 may be formed around the tube 40. Alternatively, the sponge 30 may be formed around the distal end of the tube 40 by electrospinning, three-dimensional (3D) printing, or otherwise.

[0026] Once placed within the body, the proximal end of the tube 40 may extend proximally, i.e., in the opposite direction from the direction indicated by arrow P in FIG. 1A , which may be toward the insertion opening. Arrow P indicates the direction of peristaltic action through the GI tract 80, which will be described in more detail below. The extension direction of the proximal end of the tube 40 may allow fluid to be drawn from the target site 70 toward the insertion opening, for example, by a suction device attached to the proximal end of the tube 40. The tube 40 may bend, allowing the tube 40 to extend in the correct direction within the GI tract 80. For example, the diameter or thickness of the outer wall 42 of the tube 40 may be reduced and / or a different material may be used to make the tube 40 more flexible.

[0027] Continuing with reference to FIG. 1A, stent 60 may include an outer wall 62 defining a lumen 64. Stent 60 may create a seal between target site 70 and GI tract 80. This seal may prevent fluid from entering target site 70 from GI tract 80 while allowing fluids and nutrients to pass through lumen 64 of stent 60. The fluids and nutrients may be ingested or absorbed by GI tract 80 through the normal process by which the body absorbs these substances. Stent 60 may include a channel 66 extending distally from the proximal end of stent 60, and channel 66 may terminate proximal to the distal end of stent 60. FIG. 1B is a cross-sectional view of system 10 taken along line AA in FIG. 1A. Channel 66 may be defined by a U-shaped cross-sectional portion 61 of stent 60. U-shaped portion 61 defines a radially inwardly facing convex surface 61a and a radially outwardly facing concave surface 61b. The portion of the stent 60 having the channel 66 has a smaller cross-sectional area of ​​the lumen 64 than the portion of the stent 60 without the channel 66. The channel 66 may also include a sloped surface 66a of the wall 62 that is oblique with respect to the longitudinal axis of the stent 60 and that faces the U-shaped portion 61 of the channel 66 at its end. The channel 66 may be sized and shaped to receive the vessel 40 when the EVAC device 20 and stent 60 are deployed in the body, which may provide a better seal between the target site 70 and the GI tract 80. For example, the channel 66 may seal the vessel 40 against the inner wall of the GI tract 80, preventing kinks or bends that could allow substances and / or fluids to pass therethrough and into the target site 70. The stent 60 may be made of any material, including, but not limited to, chitosan. The stent 60 may also include any coated, braided, or mesh stent made of any suitable material.(Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic Nitinol, nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10 such as HASTELLOY® C276®), and the like. 276, other HASTELLOY® alloys and others), nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and others), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N® and others), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY Examples of suitable materials for the stent 60 include nickel-chromium alloys, nickel-molybdenum alloys, nickel-cobalt alloys, nickel-iron alloys, nickel-cobalt alloys, nickel-tungsten or tungsten alloys and nickel alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, and others), platinum-rich stainless steel, titanium, platinum, palladium, gold, combinations thereof, or any other suitable material. The covering can include, for example, any suitable polymer, plastic, or elastomer, and the braid or mesh can be any suitable plastic, metal, or alloy. The stent 60 can be flexible, bendable, and / or contractible to a smaller diameter and expandable to a larger diameter. In some instances, the stent 60 may be formed of a self-expanding material (e.g., nitinol) and may include a coating (e.g., chitosan, silicone, urethane, Chronoflex, polytetrafluoroethylene (PTFE)) on at least a portion of the self-expanding material. For example, the proximal and distal ends of the stent 60 may include a different material than the material spanning the opening in the target site 70.Additionally or alternatively, the proximal and distal ends of stent 60 may be left uncoated to promote tissue in-growth to prevent migration.

[0028] Stent 60 may also include loops 68a (e.g., hooks, sutures, or other grasping mechanisms) on the interior surface of lumen 64. Loops 68a may be connected, for example, to a portion of the coated mesh of stent 60. Loops 68a may be grasped by tool 90 (FIG. 2) to invert or flip stent 60. Tool 90 may be any medical instrument advanced to target site 70 configured to engage loops 68a and move stent 60. Suitable instruments include graspers, forceps, and others. Flip-over stent 60 may allow removal and / or replacement of EVAC device 20 without removing stent 60, which may shorten procedure time and / or reduce trauma. For example, FIG. 2 shows the proximal end of stent 60 being moved distally by loop 68a, causing the proximal portion of stent 60 to be moved distally and everted onto the distal portion of stent 60.

[0029] Although stent 60 is shown with channel 66 extending distally from the proximal end of stent 60, stent 60 may be deployed in the body with channel 66 extending proximally from the distal end of stent 60 (see, e.g., FIG. 3).

[0030] A method of insertion of the system 10 will now be described. The EVAC device 20 may be introduced through an opening (e.g., a natural body opening) and advanced to the target site 70, for example, using a catheter. The sponge 30 may be placed at the target site 70 and positioned so that the tube 40 extends proximally, for example, in a direction opposite to the direction indicated by arrow P in FIG. 2 . In some instances, a fluid is introduced to expand the sponge 30 from a contracted configuration to an expanded configuration. The fluid may be introduced via a catheter or associated tool. The stent 60 may then be introduced through the opening and advanced to the target site 70, for example, using a stent delivery catheter and / or any other suitable medical stent delivery device known in the art. The stent 60 may be deployed in an expanded state. Alternatively, the stent 60 may be contracted, rolled, or folded to reduce its profile, and then moved to the expanded state once positioned adjacent the target site 70, for example, using a stent delivery mechanism. After positioning stent 60 adjacent target site 70, stent 60 may be repositioned so that channel 66 is aligned with vessel 40. For example, before or after initial deployment, stent 60 may be rotated about its axis to align channel 66 with vessel 40 and / or translated axially to align with target site 70. The catheter and any other associated tools may then be withdrawn from the body through the opening.

[0031] In some instances, the EVAC device 20 may be replaced after a predetermined period of time, and a new, smaller sponge 30 (or a sponge with different mechanical and / or chemical properties) may be inserted as the tissue at the target site 70 heals. According to one example, a tool 90 may be advanced through the opening and engage with the loop 68a. For example, in FIG. 2 , the tool 90 may engage the loop 68a at the proximal end of the stent 60. The tool 90 may be moved distally, folding back the stent 60 (turning the stent 60 inside out) to expose the sponge 30 and tube 40. A catheter and / or grasping tool may grasp the EVAC device 20, and the EVAC device 20 may be withdrawn from the body. Alternatively, the tube 40 may be pulled proximally, thereby moving the sponge 30 and tube 40 toward the insertion opening. A different EVAC device 20 may then be advanced to the target site 70, and the sponge 30 may be placed at the target site 70. Tube 40 may be positioned within GI tract 80 to extend proximally toward the insertion opening. Tool 90 may then be pulled proximally, causing stent 60 to retract and cover target site 70. As stent 60 retracts, tube 40 enters channel 66, sealing sponge 30 and target site 70 from GI tract 80.

[0032] Another example system 10' is shown in Figure 3. System 10' includes an EVAC device 20' and a stent 60'. System 10' may be inserted into a target site 70 within a GI tract 80.

[0033] The EVAC device 20' may be similar to the EVAC device 20. For example, the EVAC device 20' may include a sponge 30' and a tube 40' extending from the sponge 30'. The sponge 30' may include openings 32' connected to channels or pores that may be fluidly connected to the proximal end of the tube 40'. As described herein, the proximal end of the tube 40' may include branches 40a' that may be embedded within the sponge 30' to increase the number and / or area of ​​the tube 40' in fluid communication with the sponge 30'. This increased number of openings may increase the fluid intake capacity of the tube 40'. The tube 40' may be shorter than the tube 40. For example, the length of the tube 40' may be approximately 200 mm. The length of the tube 40' may depend on the length of the stent 60'. For example, the length of the stent 60' may be approximately 40 mm to approximately 160 mm, and the length of the tube 40' may be longer than the stent 60'. In some instances, multiple stents 60' may be used in an overlapping manner to hold the device 20' in place. In this instance, the tube 40' may be longer than the combined length of the overlapping stents 60'. The length of the tube 40' may also be based on the patient's anatomy, such as a distended stomach or rectal bladder. The length of the tube 40' may be adjusted during the procedure, for example, by cutting the tube 40' to obtain the appropriate length depending on the device and / or anatomy involved.

[0034] Once placed within the body, the distal end of the tube 40' may extend distally, i.e., in the direction indicated by arrow P in FIG. 3 , which may be opposite the insertion opening. The extension direction of the distal end of the tube 40' may allow fluid to flow out of the target site 70 toward a natural exit opening, such as the stomach and / or anus. The tube 40' may also include a corrugated section 46', which may make the tube 40' more flexible near the connection point between the tube 40' and the sponge 30' and allow the tube 40' to extend in the proper direction within the GI tract 80. Alternatively, or additionally, the thickness or diameter of the outer wall 42' of the tube 40' may be reduced and / or a different material may be used near the corrugated section 46' to make the tube 40' more flexible.

[0035] The tube 40' may also include one or more one-way valves 48', which may close in the absence of peristaltic fluid flow and open in the presence of peristaltic fluid flow along the direction indicated by arrow P. For example, peristaltic movement in the direction of arrow P may cause the sponge 30' to squeeze against the walls of the GI tract 80, including the walls of the target site 70, thereby creating pressure on the sponge 30', causing the sponge 30' to take up fluid from the target site 70 and / or the sponge 30' to expel fluid into the tube 40'. Fluid may travel from the target site 70' through the tube 40' and be expelled into the GI tract 80 at the distal end of the tube 40'. Pressure exerted by fluid expelled from the sponge 30' during peristaltic movement may be sufficient to open the valve 48', thereby allowing fluid to flow from the sponge 30' toward the distal end of the tube 40'. Valve 48' may prevent fluids, substances, etc. captured by sponge 30' at target site 70 from flowing back into tube 40' and / or to target site 70 in the absence of peristaltic action.

[0036] 1A and 2 and may include a lumen 64' defined by an outer wall 62'. The stent 60' may create a seal between the target site 70 and the GI tract 80. Unlike the stent 60, the channel 66' of the stent 60' extends proximally from the distal end of the stent 60' and terminates distally of the proximal end of the stent 60'. Although shown with a channel 66', the stent 60' need not include a channel 66'. In this example, the stent 60' is sufficiently flexible to allow space for the vessel 40' between the stent 60' and the wall of the GI tract 80. Additionally, although not shown, the stent 60' may include attachment or gripping elements that may be useful during insertion of the stent 60' into the body and / or when everting (everting) or undoing the stent 60'.

[0037] 4A and 4B are cross-sectional views of the system 10' taken along lines BB and CC, respectively. The channel 66' may be defined by a U-shaped cross-sectional portion 61' of the stent 60'. The U-shaped portion 61' defines a radially inward convex surface 61a' and a radially outward concave surface 61b'. The cross-sectional area of ​​the lumen 64' in the portion of the stent 60' having the channel 66' is smaller than that in the portion of the stent 60' without the channel 66'. The channel 66' may also include a sloped surface 66a' of the wall 62' that is angled at its end toward the U-shaped portion 61' of the channel 66' with respect to the longitudinal axis of the stent 60'. The channel 66' may be sized and shaped to receive the vessel 40' when the EVAC device 20' and stent 60' are deployed in the body, which may provide a better seal between the target site 70 and the GI tract 80. For example, the channel 66 ′ may seal the tube 40 ′ against the inner wall of the GI tract 80 , preventing kinks or bends through which substances and / or fluids may enter into the target site 70 .

[0038] System 10' may be inserted into target site 70 in GI tract 80 in a manner similar to that described with respect to system 10. For example, EVAC device 20' may be advanced to target site 70. Sponge 30' may be inserted into target site 70 and tube 40' may extend into GI tract 80 and distal to target site 70. Stent 60' may be inserted into GI tract 80 and deployed to seal target site 70 from GI tract 80.

[0039] Another example system 10'' is shown in FIG. 5A. System 10'' includes an EVAC device 20' and a valve 100. Valve 100 may be biased to seal target site 70 from GI tract 80 and may also remain "open" to allow more fluid to escape from site 70 during peristalsis. Similar to system 10' of FIG. 3, sponge 30' may be placed at target site 70, and tube 40' may extend from sponge 30' to GI tract 80. Valve 100 may be provided within target site 70 between sponge 30' and GI tract 80 to prevent fluid from migrating from GI tract 80 to target site 70.

[0040] The valve 100 may include first ring(s) 106, the outer diameter of which is larger than the outer diameter of the second ring(s) 108. The second ring(s) 108 may be disposed between the first ring(s) 106, such that the first and second ring(s) 106, 108 form the outer side of the U-shaped (hourglass) of the valve 100. The first and second ring(s) 106, 108 may hold the position of the valve 100 between the GI tract 80 and the target site 70. For example, tissue of the outer wall of the GI tract 80 may extend between the first ring(s) 106 (e.g., be sandwiched between the outer lips of the first ring(s) 106). Also, tissue of the outer wall of the GI tract 80 may contact the second ring(s) 108 during deployment such that one of the first ring(s) 106 is inside the GI tract 80 and another of the first ring(s) 106 is outside the GI tract 80. First ring 106 may contact the wall of GI tract 80 and prevent valve 100 from moving during use. In other words, the portion of valve 100 facing sponge 30' and the portion of valve 100 facing GI tract 80 have a relatively larger diameter than the portion of valve 100 therebetween.

[0041] The valve 100 may be a solid, unitary structure, with a generally flat surface facing the sponge 30' and the GI tract 80, and may have any suitable shape. For example, the valve 100 may be a single piece of material. The valve 100 may also be circular, polygonal, rectangular, or irregularly shaped, depending on the shape of the opening. In certain instances, a particular shape of the valve 100 may be more suitable for maintaining the position of the valve 100 within the opening, sandwiched between the tissues of the GI tract 80. The valve 100 may also be larger than the opening between the GI tract 80 and the target tissue 70, maintaining the position of the valve 100 during deployment.

[0042] As shown in FIGS. 5B and 5C, which show a cross-section of the valve 100 along line DD, the valve 100 can include a central lumen 104 extending through the rings 106, 108. The tube 40' can pass through the lumen 104 to allow fluids and substances to pass from the target site 70 to the GI tract 80. FIG. 5B shows the valve 100 in an open state, and FIG. 5C shows the valve 100 in a closed, or semi-closed, state. In the absence of peristaltic movement, the wall of the GI tract 80 can press against the outer surface of the second ring 108, causing the valve 100 to collapse. In this example, portions of the rings 106, 108 can collapse into the lumen 104 due to the soft material forming the rings. In this collapsed state, the valve 100 can approach and / or contact the tube 40' along the circumference of the tube 40', as shown in FIG. 5C. In this state, the valve 100 prevents fluids and substances from entering the target site 70. Although in FIG. 5C the valve 100 has a generally circular outer surface, depending on the tissue, the valve 100 may have any shape, including an irregular shape, in its collapsed state based on the various forces exerted on the valve 100 by the tissue of the GI tract 80.

[0043] As peristalsis occurs, the target site 70 may constrict, increasing pressure within the target site 70. As described herein, peristaltic movement may force materials and fluids from the sponge 30' through the tube 40'. Additionally, the increased pressure on the fluids and substances within the target site 70 may overcome the force of the walls of the GI tract 80 on the valve 100, allowing the valve 100 to remain in an expanded state as shown in FIG. 5B. The expanded lumen 104 allows materials and fluids to flow from the target site 70 into the GI tract 80. Once peristalsis has ended, the valve 100 may collapse around the tube 40', closing the lumen 104. In this manner, the system 10'' increases its ability to expel more materials and fluids from the target site 70 with the peristaltic surge. The valve 100 may be made of any material suitable for medical use, including, but not limited to, rubber, polymer, or other materials.

[0044] A method of inserting system 10'' will now be described. EVAC device 20' may be inserted in a manner similar to that described with respect to systems 10 and 10'. Once sponge 30' is positioned at target site 70, valve 100 may be advanced to target site 70', for example, using a catheter and / or associated delivery tool. Tube 40' may be passed through lumen 104 of valve 100, and valve 100 may be placed between target site 70 and GI tract 80. The wall of GI tract 80 may be manipulated to fit within the U-shaped space defined by first and second rings 106, 108. The catheter and / or any associated tool may then be removed from the body through the opening. Alternatively, tube 40' may extend through lumen 104 of valve 100 prior to insertion. Thus, EVAC device 20' and valve 100 may be advanced to target site 70 simultaneously. Sponge 30' may be placed at target site 70. The wall of the GI tract 80 may be located within the U-shaped space and between the first rings 106 of the valve 100 .

[0045] It should be understood that any EVAC device, including a sponge or mesh device and a tube configured to remove fluid or other substances from a target site, may be used alone or in combination with one or more sealing devices described herein.

[0046] While different medical systems are described, it should be understood that the specific arrangement of the elements of these EVAC systems is not limited. Furthermore, the size, shape, and / or materials of the EVAC systems are not limited. As described herein, these include sponges and patches or sealing devices for sealing a target site from a body lumen. For example, the performance of various medical procedures can be improved by ensuring a proper seal between the target site and any debris or material within the body lumen. This seal can prevent these materials (e.g., bodily waste) from entering the target site, for example, through a post-operative leak, and invading other organs, where they could cause infection or other medical problems.

[0047] (Addendum) As a preferred embodiment, the technical concept that can be grasped from the above embodiment will be described below. [Item 1] 1. A medical system for sealing a target site in a body lumen of a subject, comprising: The medical system includes a porous body configured to be placed at the target site; The medical system includes a tube including an outer wall defining a tube lumen, the tube connected to the porous body at a first end of the tube; The medical system includes a sealing device configured to seal the target site from the body lumen together with the tube; the tube is configured to extend from the target site into the body lumen when the sealing device seals the target site from the body lumen; the sealing device is a stent, the stent being configured to contact (1) a sidewall of the body lumen and (2) the vessel when the vessel and the stent are implanted; The medical system wherein the wall of the stent defines a channel extending along an exterior surface of the stent. [Item 2] Item 1, the medical system of item 1, wherein the wall of the stent defines a stent lumen, and a grasping device extends from the wall into the stent lumen, the grasping device forming a loop. [Item 3] Item 10. The medical system of item 1, wherein the wall of the stent includes an outer concave surface and an inner convex surface recessed radially inward of the stent along the length of the channel. [Item 4] 3. The medical system of claim 2, wherein the channel is configured to align with the vessel when the vessel and the stent are implanted. [Item 5] Item 3. The medical system of item 2, wherein the channel includes an inclined surface oblique to a central longitudinal axis of the stent lumen, the inclined surface configured to accommodate a tube. [Item 6] 1. A medical system for sealing a target site in a body lumen of a subject, comprising: The medical system includes a porous body configured to be placed at the target site; The medical system includes a tube including a wall defining a tube lumen, the tube connected to the porous body at a first end of the tube; The medical system includes a sealing device configured to seal the target site from the body lumen; the tube is configured to extend from the target site into the body lumen when the sealing device seals the target site from the body lumen; the sealing device is a valve defining a valve lumen, the valve configured to be positioned at an opening in a wall defining the body lumen between the target site and the body lumen, and the tube configured to extend from the target site through the valve lumen and into the body lumen; The medical system, wherein the valve has (1) a closed state in which the valve contacts the tubing, and (2) an open state in which the valve does not contact the tubing. [Item 7] 7. The medical system of claim 6, wherein the valve is configured such that the size of the valve lumen changes due to peristaltic movement of the wall defining the body lumen. [Item 8] 8. The medical system of claim 6 or 7, wherein the outer surface of the valve is U-shaped. [Item 9] 9. The medical system according to any one of items 6 to 8, wherein the fluid from the target site is configured to be discharged from the target site via the tube lumen and the valve lumen. [Item 10] 10. The medical system according to any one of items 1 to 9, wherein the first end of the tube includes a plurality of branches embedded in the porous body. [Item 11] 1. A medical system for sealing a target site in a body lumen of a subject, comprising: The medical system includes a porous body configured to be placed at the target site; The medical system includes a tube including a wall defining a tube lumen, the tube connected to the porous body at a first end of the tube; The medical system includes a sealing device configured to seal the target site from the body lumen together with the tube; the tube is configured to extend from the target site into the body lumen when the sealing device seals the target site from the body lumen; The medical system, wherein the tube includes a plurality of corrugations, and the tube is configured to bend via the plurality of corrugations. [Item 12] 1. A medical system for sealing a target site in a body lumen of a subject, comprising: The medical system includes a porous body configured to be placed at the target site; The medical system includes a tube including a wall defining a tube lumen, the tube connected to the porous body at a first end of the tube; The medical system includes a sealing device configured to seal the target site from the body lumen together with the tube; the tube is configured to extend from the target site into the body lumen when the sealing device seals the target site from the body lumen; The medical system, wherein the tube includes a plurality of one-way valves configured to allow fluid to pass from the target site to the body lumen and to prevent fluid from passing from the body lumen to the target site. It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed apparatus without departing from the scope of the disclosure. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered exemplary, with the true scope and spirit of the invention being indicated by the following claims.

Claims

1. 1. A medical system for sealing a target site in a body lumen of a subject, comprising: The medical system includes a porous body configured to be placed at the target site; The medical system includes a tube including a lumen, the porous body connected to a first end of the tube, and the tube configured to extend from the porous body into the body lumen when the porous body is located at a target site; The medical system includes a stent including a channel; In the embodiment where the porous body is positioned at a target site, the tube is configured to extend into the channel of the stent to seal the target site from the body lumen together with the stent.

2. The medical system of claim 1 , wherein the stent includes a grasping device, the grasping device comprising a loop.

3. The medical system of claim 1 , wherein the channel of the stent is defined by a U-shaped cross-sectional portion of the stent.

4. The medical system of claim 1 , wherein the channels of the stent include sloped surfaces that are inclined relative to a central longitudinal axis of the stent.

5. The medical system of claim 1 , wherein the channel of the stent extends proximally from a distal end of the stent and terminates distal to the proximal end of the stent.

6. The medical system of claim 1 , wherein the tube is configured such that fluid from a target site can be released from a second end of the tube into the body lumen.

7. 1. A medical system for sealing a target site in a body lumen of a subject, comprising: The medical system includes a porous body configured to be placed at the target site; The medical system includes a tube including a lumen, the porous body connected to a first end of the tube, The medical system includes a valve configured to seal the target site from the body lumen; the valve defines a lumen, the valve is configured to be disposed between the target site and the body lumen, and the tube is configured to extend from the target site through the lumen of the valve and into the body lumen; The medical system wherein the lumen of the valve opens and closes around the tube.

8. The medical system of claim 7 , wherein the tube is configured to extend from the target site and distally into the body lumen.

9. 9. The medical system of claim 7 or 8, wherein the lumen of the valve is configured to open in response to peristaltic movement of a wall defining the body lumen.

10. The medical system of any one of claims 7 to 9, wherein the system is configured to release fluid from the target site into the body lumen through the lumen of the tube and the lumen of the valve.

11. The medical system according to any one of claims 7 to 10, wherein the valve includes a pair of first rings and a second ring disposed between the pair of first rings, and an outer diameter of each of the first rings is larger than an outer diameter of the second ring.

12. 1. A medical system for sealing a target site in a body lumen of a subject, comprising: The medical system comprises a porous body configured to be placed at the target site; The medical system includes a tube including a lumen, the porous body connected to a first end of the tube, the tube configured to extend from the target site into the body lumen, and the tube further includes a corrugated section; The medical system includes a sealing device configured to seal the target site from the body lumen together with the tube.

13. 1. A medical system for sealing a target site in a body lumen of a subject, comprising: The medical system includes a porous body configured to be placed at the target site; The medical system includes a tube including a lumen, the porous body connected to a first end of the tube, and the tube configured to extend from the target site into the body lumen; The medical system includes a sealing device configured to seal the target site from the body lumen together with the tube; The medical system, wherein the tube includes one or more one-way valves, each configured to allow fluid to pass from the target site to the body lumen and to prevent fluid from passing from the body lumen to the target site.

14. 14. The medical system of claim 12 or 13, wherein the sealing device is a stent or a valve.

15. The medical system of any one of claims 1 to 14, wherein the first end of the tube includes one or more branches within the porous body.

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