Endoluminal sealing device and related methods of use

Abstract

A medical system comprising: a porous body positioned at a target site in a body of a subject; a tube having a wall defining a lumen of the tube, wherein the tube is connected to the porous body at a first end of the tube; and a sealing device for isolating the target site from a body lumen. The tube extends from the target site into the body lumen when the sealing device isolates the target site from the body lumen.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 981,733, filed February 26, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to minimally invasive (e.g., endoscopic and / or laparoscopic) medical devices and related methods of use. In embodiments, this disclosure relates to one or more devices for sealing perforations, leaks, or wounds in the gastrointestinal tract, means for advancing these sealing devices, and related methods of use. Background Technology

[0004] Endoscopic and open surgical procedures of the gastrointestinal tract (GI) include, for example, colectomy, bariatric surgery, esophagectomy, gastric bypass, and sleeve gastrectomy. These procedures can result in duct perforation, postoperative leakage, or other wounds. Treatment options for managing such wounds are limited, and these wounds have significant morbidity and mortality rates. Options include surgical reoperation and endoscopic placement of stents or clips. Surgery is relatively invasive and also has high morbidity and mortality rates. Endoscopic stent placement is a less invasive option. However, the placed stent can migrate from the intended location and / or isolate infection at the target site, thereby inhibiting drainage. Summary of the Invention

[0005] According to one aspect, the medical system includes: a porous body configured to be positioned at a target site within a subject's body; a tube having a wall defining an inner lumen, wherein the tube is connected to the porous body at a first end; and a sealing device configured to isolate the target site from a body cavity, wherein the tube is configured to extend from the target site into the body cavity when the sealing device isolates the target site from the body cavity.

[0006] The sealing device may be a stent, and the stent may be configured to contact: (1) the sidewall of the body cavity, and (2) the tube, during tube and stent implantation.

[0007] The stent may include a wall defining a stent cavity, and an attachment means may extend from the wall into the stent cavity.

[0008] The walls of the support can define a channel that extends along the outer surface of the support.

[0009] The wall of the support may include a concave surface that faces outward radially along the length of the channel and a convex surface that faces inward radially.

[0010] When the cannula and stent are implanted, the channel can be configured to align with the cannula, and the cannula can be configured to extend within the channel to isolate the target site from the body cavity.

[0011] The channel may include an inclined surface angled relative to the central longitudinal axis of the support cavity, and the inclined surface may be configured to receive a tube.

[0012] The sealing device may be a valve that defines a valve cavity passing through it, wherein the valve may be configured to be located within an opening in the wall of the body cavity defining the target site and the body cavity, and wherein a tube may be configured to extend from the target site through the valve cavity into the body cavity.

[0013] The valve may have: (1) a closed configuration in which the valve contacts the tube, and (2) an open configuration in which the valve does not contact the tube.

[0014] The valve can be configured such that the dimensions of the valve cavity vary due to the peristaltic action of the walls defining the cavity.

[0015] The outer surface of the valve can be U-shaped.

[0016] Fluid from the target location can be configured to be discharged from the target location via the pipe lumen and valve lumen.

[0017] The first end of the tube may include multiple branches embedded in a sponge.

[0018] The tube may include multiple corrugations, and the tube may be configured to bend through the multiple corrugations.

[0019] The tube may include multiple check valves, which can be configured to allow fluid to flow from the target site into the body cavity, but to inhibit fluid from flowing from the body cavity into the target site.

[0020] According to another aspect, the medical device includes a porous body and a tube, the tube including a lumen extending from a first end of the tube to a second end of the tube and connected to the porous body at the first end of the tube, wherein the tube includes at least one one-way valve configured to allow fluid to flow from the first end of the tube to the second end of the tube, but inhibit fluid from flowing from the second end of the tube to the first end of the tube, and wherein the lumen is fluidly connected to the porous body at the first end of the tube.

[0021] The first end of the tube may include multiple branches embedded in the porous body, wherein the tube lumen may extend through each of the multiple branches, and each of the multiple branches may include an opening that fluidly connects the tube lumen to the porous body.

[0022] The tube may include multiple corrugations, and the tube may be configured to bend through the multiple corrugations.

[0023] According to another aspect, a method for removing fluid from a target site adjacent to the gastrointestinal tract includes 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 isolate the target site from the gastrointestinal tract.

[0024] The method may also include moving one end of the stent into the stent lumen, removing the porous body from the gastrointestinal tract, deploying a second porous body at the target site, and moving the end of the stent from the stent lumen to isolate the target site from the gastrointestinal tract. Attached Figure Description

[0025] 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.

[0026] Figure 1A This is a cross-sectional view of an intracavitary vacuum therapy (EVAC) system according to one embodiment;

[0027] Figure 1B According to an embodiment, Figure 1A Cross-sectional view of AA along the EVAC system in China;

[0028] Figure 2 According to an embodiment, Figure 1A A view of an EVAC system with an inward-turning bracket;

[0029] Figure 3 This is a cross-sectional view of an EVAC system according to another embodiment;

[0030] Figure 4A and 4B According to an embodiment, Figure 3 Cross-sectional views of the EVAC system along lines BB and CC respectively;

[0031] Figure 5A This is a cross-sectional view of an EVAC system according to another embodiment; and

[0032] Figure 5B and 5C According to an embodiment, Figure 5A A cross-sectional view of the valve along line DD in the EVAC system. Detailed Implementation

[0033] For ease of description, certain portions and / or components of the disclosed devices are referred to as proximal portions and distal portions. It should be noted that the term "proximal" is intended to refer to the portion closer to the user of the device, while the term "distal" is used herein to refer to the portion further away from the user. Similarly, "extending distally" indicates that a component extends in a distal direction, and "extending proximally" indicates that a component extends in a proximal direction. Furthermore, as used herein, the terms "about," "approximately," and "substantially" indicate a range of values ​​within ±10% of a specified or implied value. Terms indicating the geometry of components / surfaces refer to precise and approximate shapes. This disclosure can be understood with reference to the following description and accompanying drawings, wherein like elements are indicated by like reference numerals.

[0034] Endocavitary vacuum therapy (EVAC) has been proposed. In EVAC, negative pressure is applied to the wound site in the gastrointestinal tract, for example, via a nasogastric tube with a sponge at its end. The sponge is placed into the perforation, leakage, or other wound through an endoscope. Negative pressure is then applied. However, the devices and systems suitable for EVAC are limited.

[0035] Embodiments of this disclosure include apparatus, systems, and methods for endocavitary vacuum therapy (EVAC). In examples, EVAC involves placing a sponge or other similar material endocavitarily into a wound (e.g., a target) site, including perforations, leaks, cysts, anastomoses, etc. The material can be placed via a catheter, endoscope (endoscope, bronchoscope, colonoscope, duodenoscope, gastroscope, etc.), tube, or sheath inserted into the gastrointestinal tract through a natural orifice. The orifice can be, for example, the nose, mouth, or anus, and placement can occur in any part of the gastrointestinal tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. The material can also be placed in other organs reached via the gastrointestinal tract.

[0036] Figure 1A An example of an EVAC system 10 according to this disclosure is shown. System 10 can be inserted into a patient's body, for example, at a target site 70 in the gastrointestinal tract 80, for the treatment of chronic wounds. However, as discussed herein, the location of system 10 within the body is not limited. System 10 typically includes an EVAC device 20 and a support 60. Although the example relates to the gastrointestinal tract 80, system 10 can be used in any internal body cavity.

[0037] EVAC device 20 may include a sponge 30 (or other mesh material or porous body) 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. Openings 32 may be any holes or openings (only openings 32 are shown for reference) that provide access to interconnecting channels and orifices (not shown) throughout the sponge 30. Openings 32 may have different sizes and / or shapes, and the size and shape of openings 32 may be selected based on the location of the treatment within the body. Fluid and / or other materials may be removed from the target site 70. For ease of understanding, fluid will include any fluid, material, or other debris contained within and / or removed from the target site 70.

[0038] The sponge 30 is illustrated as having a spherical shape, but can be any shape, including cylinders, cuboids, irregular shapes, etc. As will be discussed herein, the sponge 30 can be compressed into a lower profile during insertion into the target site and can expand during deployment at the target site. The sponge 30 may initially have a first shape and size and can be trimmed during medical procedures using, for example, medical scissors, to change the size and / or shape of the sponge 30 according to the size and shape of the target site 70.

[0039] In embodiments of this disclosure, the sponge can be any suitable biocompatible material that absorbs liquids and / or allows liquids to pass through via 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 polyurethane, esters, ethers, composites, and any medical-grade material.

[0040] Continue to refer to Figure 1A The tube 40 may be a nasogastric tube, which includes an outer wall 42 defining one or more lumens 44. The lumen 44 includes an opening at the distal end of the tube 40 and may include a single opening at the distal end. Alternatively, the tube 40 may include one or more branches at the end of the tube 40 within the sponge 30 (see, for example...). Figure 3 (Branch 40a' in the tube 40). The outer wall 42 may include a plurality of holes (not shown) surrounding the circumference of the distal end of the vacuum tube 40 and in fluid communication with the inner cavity 44. These holes may increase the flow of fluid into the inner cavity 44. The distal end of the vacuum tube 40 may be attached to the sponge 30 by stitches, adhesives, etc. In one example, the sponge 30 may be cut to expose its interior by, for example, cutting it into two roughly equal halves. Channels corresponding to the approximate 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 channels of the sponge 30, and the two halves of the sponge 30 may be rejoined using adhesives, stitches, etc. This may provide additional structural support between the sponge 30 and the tube 40 and / or allow the sponge 30 to form around the tube 40. For example, in cases where the tube 40 is irregularly shaped and / or the tube 40 includes branches 40a', the sponge 30 may be formed around the tube 40. Alternatively, the sponge 30 can be formed around the distal end of the tube 40 by electrospinning, three-dimensional (3D) printing, or other methods.

[0041] When placed inside the body, the proximal end of tube 40 can extend proximally, that is, along with... Figure 1A The middle arrow P indicates the opposite direction, which can be towards the insertion hole. Arrow P indicates the direction of peristalsis in the gastrointestinal tract 80, which will be described in more detail below. The extension direction of the proximal end of tube 40 allows fluid to flow out of the target site 70 and, for example, to the insertion hole via a suction device attached to the proximal end of tube 40. Tube 40 can be bent to allow tube 40 to extend in the correct direction within the gastrointestinal tract 80. For example, the diameter or thickness of the outer wall 42 of tube 40 can be reduced and / or different materials can be used to aid in bending tube 40.

[0042] Continue to refer to Figure 1AThe stent 60 may include an outer wall 62 defining an inner lumen 64. The stent 60 may form a seal between the target site 70 and the gastrointestinal tract 80. This seal may allow fluids and nutrients to pass through the lumen 64 of the stent 60 while preventing fluids from entering the target site 70 from the gastrointestinal tract 80. During the normal process of bodily absorption of these substances, fluids and nutrients may be absorbed or aspirated by the gastrointestinal tract 80. The stent 60 may include a channel 66 extending distally from the proximal end of the stent 60, the channel 66 terminating proximally at the distal end of the stent 60. Figure 1B It is system 10 along Figure 1A A cross-sectional view taken along the midline AA. 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 inwardly facing convex surface 61a and a radially outwardly facing concave surface 61b. The portion of the stent 60 with channel 66 has a reduced cross-sectional area of ​​the lumen 64 compared to the portion of the stent 60 without channel 66. Channel 66 may also include an inclined surface 66a of wall 62, which is angled toward the end of the U-shaped portion 61 of channel 66 relative to the longitudinal axis of the stent 60. The size and shape of channel 66 may be designed to receive tube 40 when the EVAC device 20 and stent 60 are deployed in the body, which can provide an improved seal between the target site 70 and the gastrointestinal tract 80. For example, channel 66 may abut against the inner wall of the gastrointestinal tract 80 to seal tube 40 without creating any kinks or folds through which material and / or fluid can flow into the target site 70. Stent 60 may be made of any material, including but not limited to chitosan. The support 60 may also include any covered, woven, or mesh support made of any suitable material. (Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; low-carbon steel; nickel-titanium alloys, such as linearly elastic and / or superelastic nickel-titanium; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, for example...) 625; UNS: N06022, for example C- UNS:N10276, for example other Alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, for example). 400 400 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, e.g., MP35- (etc.), nickel-molybdenum alloys (e.g., UNS:N10665, for example) Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, for example). (etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material). The covering may include, for example, any suitable polymer, plastic, or elastomer, and the braid or mesh may be any suitable plastic, metal, or alloy. The scaffold 60 may be flexible, bendable, and / or compressible to a reduced diameter and expandable to an increased diameter. In some cases, the scaffold 60 may be formed of a self-expanding material (e.g., nitinol) and may include a coating (e.g., chitosan, silicone, polyurethane, Chronoflex, polytetrafluoroethylene (PTFE)) on at least a portion of the self-expanding material. For example, the proximal and distal ends of the scaffold 60 may include a material different from the material used for the opening across the target site 70. Alternatively or additionally, the proximal and distal ends of the scaffold 60 may be uncoated to promote tissue growth for anti-migration purposes.

[0043] The support 60 may also include a ring 68a (e.g., a hook, thread, or other gripping mechanism) on the inner surface of the cavity 64. For example, the ring 68a may be attached to a portion of the overlay fabric of the support 60. The ring 68a may be attached to a tool 90 ( Figure 2 The tool 90 is grasped to invert or fold the stent 60 onto itself. The tool 90 can be any medical instrument that is advanced to the target site 70 and configured to engage the ring 68a to move the stent 60. Suitable instruments include grippers, forceps, etc. Folding the stent 60 onto itself allows for the removal and / or replacement of the EVAC device 20 without removing the stent 60, which can reduce procedure time and / or trauma. For example, Figure 2 The proximal end of the stent 60 is shown to be moving distally via the ring 68a so that the proximal portion of the stent 60 moves distally and folds inward into the distal portion of the stent 60.

[0044] Although the stent 60 is shown to have a channel 66 extending distally from the proximal end of the stent 60, the stent 60 may be deployed in the body such that the channel 66 extends proximally from the distal end of the stent 60 (see, for example, Figure 3 ).

[0045] The method of inserting the system 10 will now be described. The EVAC device 20 can be introduced through an orifice (e.g., a natural bodily orifice) and advanced to the target site 70 using, for example, a conduit. A sponge 30 can be placed at the target site 70 and positioned such that the tube 40 can extend proximally, for example along... Figure 2The middle arrow P indicates the opposite direction. In some examples, fluid is introduced to expand the sponge 30 from a reduced profile to an expanded profile. The fluid can be introduced via a catheter or associated tool. Subsequently, the stent 60 can be introduced through an orifice and advanced to the target site 70 using, for example, a stent delivery catheter and / or any other suitable medical stent delivery device known in the art. The stent 60 may be in an expanded configuration during deployment. Alternatively, the stent 60 may be compressed, rolled up, or folded on itself to reduce its profile and, once positioned near the target site 70, can be moved to an expanded configuration using, for example, a stent delivery mechanism. After the stent 60 has been positioned near the target site 70, the stent 60 can be repositioned such that the channel 66 is aligned with the tube 40. For example, the stent 60 may be rotated about its axis to align the channel 66 and the tube 40, and / or translated axially before or after initial deployment to align with the target site 70. Subsequently, the catheter and any other associated tools can be removed from the body through the orifice.

[0046] In some examples, as the tissue at the target site 70 heals, the EVAC device 20 can be replaced after a predetermined time period to insert a new, smaller sponge 30 (or a sponge with different mechanical and / or chemical properties). According to examples, the tool 90 can be advanced from the orifice and engage the ring 68a. For example, the tool 90 can engage... Figure 2 A ring 68a is located proximally to the stent 60. The tool 90 can be moved distally to fold the stent 60 over itself (causing the stent 60 to invert) to expose the sponge 30 and tube 40. The catheter and / or gripping tool can grip the EVAC device 20, thus allowing the EVAC device 20 to be removed from the body. Alternatively, the tube 40 can be pulled proximally to move the sponge 30 and tube 40 toward the insertion port. The different EVAC devices 20 can then be advanced to the target site 70 and the sponge 30 can be placed at the target site 70. The tube 40 can be positioned in the gastrointestinal tract 80 to extend proximally toward the insertion port. The tool 90 can then be pulled proximally to unfold the stent 60 to cover the target site 70. When the stent 60 is unfolded, the tube 40 rests in the channel 66, isolating the sponge 30 and the target site 70 from the gastrointestinal tract 80.

[0047] According to another example, system 10' is shown Figure 3 The system 10' includes an EVAC device 20' and a support 60'. The system 10' can be inserted into the gastrointestinal tract 80 at the target site 70.

[0048] EVAC device 20' may be similar to EVAC device 20. For example, EVAC device 20' may include a sponge 30' and a tube 40' extending from the sponge 30'. The sponge 30' may include an opening 32' connected to a channel or orifice, which may be fluidly connected to the proximal end of the tube 40'. As described herein, the proximal end of the tube 40' may include a branch 40a', which may be embedded in the sponge 30' and may increase the number and / or area of ​​openings in fluid communication between the tube 40' and the sponge 30'. This increased number of openings may increase the fluid absorption of the tube 40'. The tube 40' may be shorter than the sponge 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 support 60'. For example, the length of the support 60' may be from approximately 40 mm to approximately 160 mm, and the length of the tube 40' may be longer than the support 60'. In some cases, multiple supports 60' may be used in an overlapping manner to hold the device 20' in place. In this case, the tube 40' may be longer than the combined length of the overlapping supports 60'. The length of the tube 40' can also be based on the patient's anatomy, such as an expanded stomach or rectal reservoir. The length of the tube 40' can be modified during surgery, for example, by cutting the tube 40', to obtain an appropriate length depending on the relevant device and / or anatomy.

[0049] When placed inside the body, the distal end of tube 40' can extend distally, that is, along... Figure 3 The direction indicated by the middle arrow P can be away from the insertion orifice. The extension direction of the distal end of tube 40' allows fluid to flow out of the target site 70 and toward, for example, the stomach and / or a natural outlet orifice such as the anus. Tube 40' may also include a corrugated portion 46', which allows tube 40' to be more easily bent near the junction between tube 40' and sponge 30', allowing tube 40' to extend in the correct direction within the gastrointestinal tract 80. Alternatively or additionally, the thickness or diameter of the outer wall 42' of tube 40' may be reduced and / or a different material may be used near the corrugated portion 46' to aid in bending tube 40'.

[0050] The tube 40' may also include one or more one-way valves 48' that can close in the absence of fluid flow caused by peristalsis and open in the presence of fluid flow caused by peristalsis in the direction indicated by arrow P. For example, peristalsis in the direction of arrow P may cause the sponge 30' to be squeezed by the walls of the gastrointestinal tract 80 (including the wall at the target site 70), which may result in pressure at the sponge 30' causing the sponge 30' to absorb fluid from the target site 70 and / or cause the sponge 30' to release fluid into the tube 40'. Fluid may travel from the target site 70' through the tube 40' and may be discharged into the gastrointestinal tract 80 at the distal end of the tube 40'. The pressure exerted by the fluid discharged from the sponge 30' during peristalsis may be sufficient to open the valve 48' and allow fluid to flow from the sponge 30' to the distal end of the tube 40'. In the absence of peristalsis, the valve 48' may prevent fluid, material, etc., absorbed by the sponge 30' at the target site 70 from being drawn back into the tube 40' and / or the target site 70.

[0051] The 60' bracket can be similar to Figure 1A and 2 The stent 60 shown may include an inner lumen 64' defined by an outer wall 62'. The stent 60' may form a seal between the target site 70 and the gastrointestinal 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 distal to the proximal end of the stent 60'. Although the channel 66' is shown, the stent 60' may not include the channel 66'. In this case, the stent 60' has sufficient flexibility to provide space for the tube 40' between the stent 60' and the wall of the gastrointestinal tract 80. Furthermore, although not shown, the stent 60' may include attachment or gripping elements that may assist in inserting the stent 60' into the body and / or folding (inverting) or unfolding the stent 60'.

[0052] Figure 4A and 4BThese are cross-sectional views taken along lines BB and CC of system 10', respectively. Channel 66' may be defined by a U-shaped cross-sectional portion 61' of the support 60'. The U-shaped portion 61' defines a radially inwardly facing convex surface 61a' and a radially outwardly facing concave surface 61b'. Compared to the portion of the support 60' without channel 66', the portion of the support 60' with channel 66' has a reduced internal cavity cross-sectional area 64'. Channel 66' may also include an inclined surface 66a' of wall 62' at the end of the U-shaped portion 61' of channel 66' and inclined relative to the longitudinal axis of the support 60' toward the U-shaped portion 61' of channel 66'. The size and shape of channel 66' may be designed to receive tube 40' when the EVAC device 20' and support 60' are deployed in the body, which can provide an improved seal between the target site 70 and the gastrointestinal tract 80. For example, the channel 66' may abut against the inner wall of the gastrointestinal tract 80 and seal the tube 40' without creating any kinks or folds through which material and / or fluid can flow into the target site 70.

[0053] System 10' can be inserted into the gastrointestinal tract 80 at the target site 70 in a manner similar to that described with reference to System 10. For example, EVAC device 20' can be advanced to the target site 70. Sponge 30' can be inserted into the target site 70, and tube 40' can extend into the gastrointestinal tract 80 and extend distal to the target site 70. Stent 60' can be inserted into the gastrointestinal tract 80 and deployed to isolate the target site 70 from the gastrointestinal tract 80.

[0054] According to another example, System 10” is shown Figure 5A In the middle. System 10” includes an EVAC device 20' and a valve 100. Valve 100 can be biased to isolate target site 70 from gastrointestinal tract 80, but is capable of being configured to “open” to release additional fluid from site 70 during peristalsis. Similar to Figure 3 In the system 10', a sponge 30' is disposed at the target site 70 and a tube 40' extends from the sponge 30' into the gastrointestinal tract 80. A valve 100 is disposed between the sponge 30' in the target site 70 and the gastrointestinal tract 80, which prevents fluid from flowing from the gastrointestinal tract 80 into the target site 70.

[0055] Valve 100 may include a first ring 106 with an outer diameter larger than that of a second ring 108. A second ring 108 may be disposed between the first rings 106 such that the first and second rings 106 form a U-shaped (hourglass) outer surface of valve 100. The first and second rings 106, 108 may hold valve 100 between the gastrointestinal tract 80 and the target site 70. For example, tissue from the outer wall of the gastrointestinal tract 80 may extend between the first rings 106 (e.g., between the outer lips of the first rings 106) and may contact the second ring 108 during deployment, such that one of the first rings 106 is inside the gastrointestinal tract 80 and the other is outside the gastrointestinal tract 80. The first ring 106 may contact the wall of the gastrointestinal tract 80 and may prevent valve 100 from moving during use. In other words, the portion of valve 100 facing the sponge 30' and the portion of valve 100 facing the gastrointestinal tract 80 have a relatively larger diameter than the portion of valve 100 between them.

[0056] Valve 100 can be a solid, single structure with a substantially flat surface facing the sponge 30' and the gastrointestinal tract 80 and having any suitable shape. For example, valve 100 can be a single piece of material. Depending on the shape of the opening, valve 100 can also be circular, polygonal, rectangular, or irregular. In one example, a particular shape of valve 100 may be more suitable for maintaining valve 100 in position within the opening and sandwiched between the tissues of the gastrointestinal tract 80. Valve 100 may also be larger than the opening between the gastrointestinal tract 80 and the target tissue 70 to maintain the position of valve 100 during deployment.

[0057] like Figure 5B and 5C As shown, this diagram illustrates a cross-section of valve 100 along line DD. Valve 100 may include a central lumen 104 extending through rings 106, 108. A tube 40' may pass through the lumen 104 to allow fluid and material to flow from target site 70 to gastrointestinal tract 80. Figure 5B The diagram shows the open configuration of valve 100, while Figure 5C The diagram illustrates a closed or semi-closed configuration of valve 100. When peristalsis is absent, the wall of the gastrointestinal tract 80 can press against the outer surface of the second ring 108, causing valve 100 to collapse. In this example, due to the low-hardness material forming these rings, portions of rings 106, 108 can collapse into the lumen 104. In this collapsed configuration, valve 100 can approach and / or contact tube 40' around its circumference, such as... Figure 5C As shown. In this configuration, valve 100 prevents fluid and material from entering the target area 70. Although valve 100... Figure 5C It has a generally circular outer surface, and based on the various forces exerted on the valve 100 by the tissue of the gastrointestinal tract 80, the tissue can make the valve 100 have any shape in the collapsed configuration, such as an irregular shape.

[0058] When peristalsis occurs, it compresses the target site 70, thereby increasing the pressure within the target site 70. As discussed herein, peristalsis forces material and fluid from the sponge 30' through the tube 40'. Furthermore, the increased pressure on the fluid and material in the target site 70 overcomes the force of the gastrointestinal tract wall on the valve 100, and allows the valve 100 to achieve the desired pressure. Figure 5B The expansion configuration is shown. The expanded lumen 104 allows material and fluid to flow from the target site 70 into the gastrointestinal tract 80. As peristalsis ends, the valve 100 may collapse around the tube 40' to close the lumen 104. In this way, the system 10's ability to expel additional material and fluid from the target site 70 with each wave of peristalsis increases. The valve 100 can be any material suitable for medical use, including but not limited to rubber, polymers, etc.

[0059] The method of inserting system 10” will now be described. The EVAC device 20’ can be inserted in a manner similar to that discussed with respect to systems 10 and 10’. Once the sponge 30’ is positioned at the target site 70’, the valve 100 can be advanced to the target site 70’ using, for example, a catheter and / or an associated delivery tool. A tube 40’ can be placed through the lumen 104 of the valve 100, and the valve 100 can be positioned between the target site 70 and the gastrointestinal tract 80. The walls of the gastrointestinal tract 80 can be manipulated to fit into a U-shaped space defined by the first and second rings 106, 108. The catheter and / or any associated tool can then be removed from the body through an orifice. Alternatively, the tube 40’ can be extended through the lumen 104 of the valve 100 prior to insertion. Thus, the EVAC device 20’ and the valve 100 can be advanced to the target site 70 simultaneously. The sponge 30’ can be placed at the target site 70. The walls of the gastrointestinal tract 80 can be positioned within the U-shaped space and between the first rings 106 of the valve 100.

[0060] It should be understood that any EVAC device, including sponge or mesh devices and tubes configured to remove fluid or other materials from a target site, can be used alone or in combination with one or more of the sealing devices described herein.

[0061] While different medical systems have been described, it should be understood that the specific arrangement of components within these EVAC systems is not limited. Furthermore, the size, shape, and / or materials of EVAC systems are not limited. As described herein, patches or sealing devices are included for isolating sponges and target sites from body cavities. For example, various medical procedures can be improved by ensuring a proper seal between the target site and any debris or materials in the body cavity. This seal prevents these materials (e.g., feces) from entering the target site and, for example, from entering another body organ via postoperative leakage, potentially leading to infection or other medical problems.

[0062] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus without departing from the scope of this disclosure. Other embodiments of this disclosure will be apparent to those skilled in the art upon consideration of the specification and the practice of the invention disclosed herein. The specification and embodiments are intended to be illustrative only, and the true scope and spirit of the invention are indicated by the appended claims.

Claims

1. A medical system comprising: A porous body configured to be positioned at a target site within the subject's body; A tube having a wall defining an inner lumen, wherein the tube is connected to the porous body at its first end; and A sealing device configured to isolate the target area from the body cavity. The sealing device includes an outer wall surrounding the cavity of the sealing device within the sealing device; Wherein, when the sealing device isolates the target portion from the body cavity, the tube is configured to extend from the target portion into the body cavity entirely outside the outer wall of the sealing device; The outer wall of the sealing device defines a channel, and the tube is configured to extend within the channel and contact the sidewall of the body cavity when the sealing device isolates the target site from the body cavity.

2. The medical system of claim 1, wherein the sealing device is a stent, and wherein the stent is configured to contact: (1) the sidewall of the body cavity and (2) the tube when the tube and the stent are implanted.

3. The medical system of claim 1, wherein the attachment device extends from the outer wall into the cavity of the sealing device.

4. The medical system of claim 1, wherein the channel extends along the outer surface of the sealing device.

5. The medical system of claim 4, wherein the outer wall of the sealing device comprises a concave surface radially outward along the length of the channel and a convex surface radially inward.

6. The medical system of claim 4 or 5, wherein the channel is configured to align with the tube when the tube and the sealing device are implanted, and the tube is configured to extend within the channel to isolate the target site from the body cavity.

7. The medical system of claim 4, wherein the channel includes an inclined surface angled relative to the central longitudinal axis of the sealing device cavity, the inclined surface being configured to receive the tube.

8. The medical system of claim 1, wherein the first end of the tube comprises a plurality of branches embedded in the porous body.

9. The medical system of claim 1, wherein the tube comprises a plurality of corrugations, and wherein the tube is configured to bend through the plurality of corrugations.

10. The medical system of claim 1, wherein the tube includes a plurality of one-way valves, wherein the plurality of one-way valves are configured to allow fluid to flow from the target site to the body cavity, but to inhibit fluid from flowing from the body cavity to the target site.

11. The medical system of claim 4, wherein the channel extends distally from the proximal end of the sealing device and terminates proximal to the distal end of the sealing device.

12. The medical system of claim 4, wherein the channel extends proximally from the distal end of the sealing device and terminates distally at the proximal end of the sealing device.

13. The medical system of claim 3, wherein the attachment device comprises a ring.

14. The medical system of claim 7, wherein the inclined surface of the channel contacts the tube along the length of the curved surface of the tube.

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