Device and method for anchoring a sleeve to a tissue cavity - Patents.com

Abstract

The objective is to improve medical device anchoring in tissue cavities and / or luminal tissue spaces. According to an embodiment of the invention, an anchoring system includes a sleeve having an inner surface defining a lumen, a first expandable sealing mechanism disposed along a proximal end of the sleeve, and a second expandable sealing mechanism disposed along the proximal end of the sleeve. The anchoring system further includes an open cell foam disposed on an outer surface of the sleeve. Expansion of the first and second expandable sealing mechanisms and application of a negative pressure to the anchoring system causes a seal to form between the first and second expandable sealing mechanisms, the outer surface of the sleeve, and the inner surface of the tissue cavity. According to some embodiments, a sleeve body is included with the sleeve, the first expandable sealing mechanism is disposed at a proximal end of the sleeve body, and the second expandable sealing mechanism is disposed at a distal end of the sleeve body.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 332,166, filed April 18, 2022, the entire contents of which are hereby incorporated by reference.

[0002] The field of the presently claimed embodiments of this invention relates to medical devices, and more particularly, to the delivery and anchoring of medical devices into tissue cavities and / or luminal tissue spaces using specialized delivery systems and endoscopes. [Background technology]

[0003] Delivery and anchoring devices for medical devices exist. However, delivery and anchoring of medical devices within tissue cavities and / or luminal tissue spaces can be difficult. There is a need for improvements in existing medical device anchoring, especially in tissue cavities and / or luminal tissue spaces. [Prior art documents] [Non-patent literature]

[0004] [Non-Patent Document 1] Morks, A. N., Havenga, K., Ploeg, R. J., "Can intraluminal devices prevent or reduce colorectal anastomotic leakage: A review," World J. Gastroenterol., 2011, 17(40), pp. 4461-4469. [Non-Patent Document 2] D'Urso, A., Komen, N., Lefevre, JH, "Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a First-In-Human trial on 15 patients", Surg. Endosc., 2019 [Non-Patent Document 3] Kim, JH, Kim, S., Jung, SH, "Fecal diverting device for the substitution of defunctioning stoma: preliminary clinical study", Surg. Endosc., 2019, 33(1), pp. 333-340 [Non-Patent Document 4] Reshef, A., Ben-Arie, G., Pinsk, I. "Protection of colorectal anastomosis with an intraluminal bypass device for patients undergoing an elective anterior resection: a pilot study", Tech. in Coloproctology, 2019, 23(6), pp. 565-571 [Non-Patent Document 5] Kang, SI, Kim, SH, Jung, SH, Kim, JH, "The effectiveness of a fecal diverting device for prevention of septic complications in a dog model of ischemic bowel anastomosis," Asian J.Surg., 2020, 43, pp. 251-256. [Non-Patent Document 6] Bakker, IS, Morks, AN, Ten Cate Hoedemaker, HO et al., "Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis," BJS Society Ltd., 2017 Summary of the Invention [Means for solving the problem]

[0005] According to some embodiments of the invention, the anchoring system includes a sleeve having an inner surface defining a lumen, a first expandable sealing mechanism disposed along a proximal end of the sleeve, and a second expandable sealing mechanism disposed along the proximal end of the sleeve. The anchoring system further includes an open cell foam disposed on an outer surface of the sleeve. Expansion of the first and second expandable sealing mechanisms and application of negative pressure to the anchoring system causes a seal to be formed between the first and second expandable sealing mechanisms, the outer surface of the sleeve, and the inner surface of the tissue cavity.

[0006] According to one embodiment, the anchoring system further includes a sleeve body. According to an embodiment, the first expandable sealing mechanism is disposed at a proximal end of the sleeve body and the second expandable sealing mechanism is disposed at a distal end of the sleeve body. According to some embodiments, the sleeve body and the sleeve are constructed from the same extruded polymer piece. According to other embodiments, the sleeve body is a separate tubular structure bonded to the tubular structure of the sleeve. According to some embodiments, the sleeve body of the anchoring system has a thicker wall thickness than the sleeve of the system. According to some embodiments, the sleeve body of the anchoring system has a higher durometer hardness than the sleeve of the system. According to some embodiments, the sleeve body of the anchoring system is configured such that the lumen does not collapse closed when the expandable sealing mechanism is expanded within the tissue cavity and a negative pressure is applied to the anchoring system. According to some embodiments, the sleeve body of the anchoring system is configured such that the expandable sealing mechanism remains in a substantially perpendicular orientation relative to the sleeve body when the sealing element is expanded within the tissue cavity and a negative pressure is applied to the anchoring system.

[0007] According to some embodiments, the distal end of the sleeve body is connected to the proximal end of the sleeve. According to other embodiments, the sleeve body is coextensive with the sleeve. According to some embodiments, the sleeve body is disposed on the proximal end of the sleeve.

[0008] According to embodiments, the sleeve includes multiple fluid lumens. According to some embodiments, the multiple fluid lumens include one or more of: (i) a distal fluid lumen for providing fluid to a first expandable sealing mechanism, (ii) a proximal fluid lumen for providing fluid to a second expandable sealing mechanism, (iii) an irrigation lumen, (iv) a contrast lumen, and (v) a negative pressure lumen.

[0009] According to some embodiments of the invention, application of negative pressure creates a frictional force that resists displacement of the sleeve and / or sleeve body. According to some embodiments of the invention, application of negative pressure brings open cell foam disposed on an outer surface of the sleeve into contact with an inner surface of the tissue cavity, thereby creating a frictional force that resists displacement of the sleeve.

[0010] According to some embodiments of the invention, the first and second expandable sealing mechanisms are expanded by providing a non-compressible fluid (e.g., saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution) to inflate or expand the first and second expandable sealing mechanisms. According to some embodiments of the invention, the first and second expandable sealing mechanisms are expanded by a radiopaque liquid. According to some embodiments of the invention, the first and second expandable sealing mechanisms are expanded by filling with a non-compressible liquid. According to some embodiments, the expandable sealing mechanisms are expanded by filling with air. According to embodiments, in the expanded state, the first and second expandable sealing mechanisms form a substantially air-tight and liquid-tight seal with the inner surface of the tissue cavity. According to some embodiments of the invention, the first and second expandable sealing elements are collapsible.

[0011] According to some embodiments of the invention, the sleeve protects the inner surface of the tissue cavity distal to the sleeve body from fecal flow. According to some embodiments, the lumen has a diameter between about 1 cm and about 6 cm. According to some embodiments, the outer surface of the sleeve and / or sleeve body has a diameter between about 1.1 cm and about 6.1 cm. According to some embodiments, the sleeve and / or sleeve body comprises a flexible material having a Shore A hardness between about 20A and about 70A. According to some embodiments, the sleeve and / or sleeve body has a length between about 3 cm and about 25 cm. According to some embodiments, the sleeve and / or sleeve body has a tubular wall thickness between about 0.1 mm and about 8 mm. According to some embodiments, the sleeve and / or sleeve body has a tubular wall thickness between about 0.2 mm and about 5 mm.

[0012] According to some embodiments of the present invention, the open cell foam comprises a material having an average pore size between about 50 microns and about 1000 microns. According to some embodiments, the open cell foam comprises a material having an average pore size between about 300 microns and about 600 microns. According to some embodiments, the open cell foam comprises a material having an average pore size between about 200 microns and about 400 microns. According to some embodiments, the open cell foam comprises a material having an average pore size between about 100 microns and about 300 microns. According to some embodiments, the open cell foam is compressible by peristaltic contractions of the patient's intestine. According to some embodiments, the open cell foam is compressible by negative pressure between the sealing element, the sleeve, and the tissue cavity. According to some embodiments, the open cell foam comprises polyvinyl alcohol, polyurethane foam, or other synthetic polymers. According to some embodiments, the open cell foam has a tensile strength of at least 50 kpa. According to some embodiments, the open cell foam has a thickness between 2 mm and 150 mm. According to some embodiments, the open cell foam comprises a single tubular foam piece. According to some embodiments, the open cell foam comprises a plurality of foam pieces. According to some embodiments, the open cell foam is bonded to the sleeve and / or sleeve body. According to some embodiments, the open cell foam has a higher coefficient of friction than the sleeve and / or sleeve body.

[0013] According to some embodiments, each of the first and second expandable sealing mechanisms comprises an inflatable or expandable elastomeric balloon. According to some embodiments, each of the first and second expandable sealing mechanisms comprises a plurality of expandable elastomeric balloons. According to some embodiments, the first expandable sealing mechanism comprises a single inflatable or expandable elastomeric balloon, while the second expandable sealing mechanism comprises a number or a plurality of expandable elastomeric balloons. According to embodiments, the first and second expandable sealing mechanisms have a ring diameter that is greater than a ring diameter of the open cell foam dispersed about the sleeve and / or sleeve body.

[0014] According to some embodiments of the present invention, the sleeve has a column strength of about 3.0 lbs. to 6.0 lbs. According to some embodiments of the present invention, the sleeve has a column strength of about 3.0 lbs. to 6.0 lbs. According to some embodiments, the combination of the sleeve body and sleeve has a column strength of 3.0 lbs. to 6.0 lbs.

[0015] According to some embodiments of the present invention, the anchoring system further comprises a retrieval bag disposed at a distal end of the sleeve and configured to manage bowel contents delivered from the anchoring system. According to embodiments, the anchoring system further comprises a retention dressing for attaching the anchoring system to the skin. According to embodiments, the anchoring system further comprises extension tubing connected to the distal end of the sleeve, the extension tubing configured to extend the anchoring system outside the patient's body. According to some embodiments, the extension tubing is between 1 foot and 6 feet. In some embodiments, the extension tubing is connected to a waste bag.

[0016] According to some embodiments of the present invention, the anchoring system further comprises a scope adapter configured to connect the sleeve to at least one of an endoscope, a sigmoidoscope, or a colonoscope. According to embodiments, the scope adapter comprises a main body, a compression nut, a compression sleeve, and a compression washer. According to embodiments, the main body comprises a plurality of threads configured to engage a plurality of grooves provided along an inner surface of the compression nut. According to some embodiments, the anchoring system further comprises a connector latch point configured to connect the sleeve to at least one of an endoscope, a sigmoidoscope, or a colonoscope through the scope adapter. According to some embodiments of the present invention, the scope adapter holds the extracorporeal end portion of the anchoring system in a fixed position on the length of the scope. According to some embodiments, the scope adapter is configured to allow the extracorporeal end portion of the anchoring system to be anchored in different positions along the length of the scope. In some embodiments, the scope adapter is configured to hold the extracorporeal end portion of the anchoring system with at least 3 pounds of longitudinal pulling or pushing force. In some embodiments, the scope adapter is configured to be quickly released from the extracorporeal end portion of the anchoring system to allow withdrawal of the scope from within the body while leaving the anchoring system in place.

[0017] According to some embodiments of the present invention, the anchoring system further comprises a negative pressure source, whereby negative pressure is applied to the anchoring system by the negative pressure source to maintain one of a constant negative pressure or a variable negative pressure at a level between −50 mmHg and −200 mmHg. According to embodiments, the anchoring system comprises a negative pressure lumen configured to provide negative pressure to the sleeve and / or sleeve body. According to some embodiments of the present invention, the anchoring system further comprises an irrigation lumen in fluid communication with an outer surface of the sleeve and / or sleeve body. According to some embodiments of the present invention, the anchoring system further comprises an irrigation system in fluid communication with the sleeve and / or sleeve body, where the irrigation system introduces fluid into the sleeve and / or sleeve body for irrigation. In some embodiments, the irrigation tube in fluid communication with the outer surface of the sleeve is the same plumbing as the pressure tube.

[0018] According to some embodiments of the present invention, the sleeve has a length that allows it to extend outside the tissue cavity. According to some embodiments, the lumen and the first and second expandable sealing mechanisms are compressible by normal peristaltic forces of the patient's intestines. According to some embodiments, the diameter of the first and second expandable sealing mechanisms is less than or equal to the diameter of the tissue cavity to which the sleeve is to be secured. According to some embodiments, the anchoring system is configured such that traction on the sleeve can be used to remove the anchoring system from the body cavity. According to some embodiments, the sleeve has a wall thickness that is between about 50 microns and about 5 mm. According to some embodiments, the sleeve has a length that is between about 8 inches and about 72 inches. According to some embodiments, the sleeve has a length that is between about 3 cm and about 25 cm. According to some embodiments, the sleeve has markings along its length that indicate the length of the sleeve within the tissue cavity after deployment. According to some embodiments, the sleeve body and / or sleeve is comprised of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, or other polymers. In some embodiments, the sleeve and sleeve body are constructed from a single continuous tubular extrusion.

[0019] According to some embodiments of the invention, the pressure tube is attached to the sleeve along its length. According to some embodiments, the pressure tube is disposed within the wall of the sleeve. According to some embodiments, the pressure tube is integrated into the sleeve and comprises the same material as the sleeve. According to some embodiments, the pressure tube is disposed within an additional lumen along the length of the sleeve.

[0020] According to some embodiments of the present invention, the sleeve body and / or sleeve are constructed from one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymers.

[0021] According to some embodiments of the present invention, the anchoring system further comprises a plurality of pressure tubes in fluid communication with the outer surface of the sleeve and / or the sleeve body.

[0022] According to some embodiments of the present invention, the anchoring system further includes a waste bag in fluid communication with the sleeve, the waste bag configured to receive contents of the sleeve. According to some embodiments, the waste bag is detachable. In some embodiments, the waste bag can be emptied of its contents without being detached from the sleeve.

[0023] According to some embodiments of the invention, the sleeve has a proximal end in sealing fluid communication with and extending distally relative to the distal end of the sleeve body and the second expandable sealing mechanism, the proximal end of the sleeve extending distally relative to the distal end of the sleeve body configured to cover the damaged area of ​​tissue of the tissue cavity to protect it from contents flowing through the lumen of the sleeve and the sleeve body. According to some embodiments of the invention, the sleeve body is bonded around the sleeve. According to some embodiments, the sleeve body and the sleeve of the anchoring system are a single continuous piece of polymer such that the sleeve body and the sleeve share the same lumen.

[0024] According to some embodiments of the invention, the sleeve and / or sleeve body and the first and second expandable sealing elements are fabricated from a single injection molding using a single material. According to some embodiments, the sleeve includes a releasable liquid tight connector between 8 inches and 36 inches from the second expandable sealing feature. According to some embodiments, the sleeve includes a breakaway joint between 8 inches and 36 inches from the second expandable sealing feature. According to some embodiments, the anchoring system is configured to be positioned in the tissue cavity using an endoscope.

[0025] According to some embodiments, the tissue cavity is an intestine including an anastomosis, and the anchoring system is positioned within the intestine such that the anastomosis is positioned within the intestine distal to the second expandable sealing mechanism. According to some embodiments, the anchoring system further includes an irrigation system in fluid communication with the sleeve and / or sleeve body, the irrigation system introducing fluid into the sleeve and / or sleeve body for irrigation.

[0026] According to some embodiments, there is irrigation tubing that extends from outside the body into the intestine proximal to the first expandable sealing mechanism, hi some embodiments, this irrigation tubing is used to dilute stool that is loaded into the proximal end of the anchoring system within the intestine.

[0027] According to some embodiments, there is additional irrigation tubing that extends from outside the body into the intestine distal to the second expandable sealing mechanism. In some embodiments, this additional irrigation tubing is used to irrigate the anastomosis. In some embodiments, this additional irrigation tubing is used to inject contrast to check for anastomotic leakage with x-ray imaging studies.

[0028] According to some embodiments of the invention, the delivery system includes an outer protective sheath that encases the anchoring system according to embodiments of the invention, a handle, a guide shaft, and a sheath puller handle. The anchoring system is configured to be pushed into place by advancing the guide shaft into the patient's intestine. According to some embodiments, the delivery system outer protective sheath is retracted through the center of the guide shaft to expose the expandable seal and the air conducting rough surface material (or open cell foam) disposed on the outer surface of the sleeve body. In some embodiments, the outer protective sheath extends simply to cover the sleeve body of the anchoring system enclosing the sealing element and the foam.

[0029] According to some embodiments, a delivery system is provided that includes a handle, a guide shaft connected to the handle, an outer protective sheath, and a sheath puller handle attached to the outer protective sheath. According to embodiments, the outer protective sheath is disposed within a central lumen of the guide shaft and is configured to extend from the central lumen to cover and protect a proximal end of an anchoring system having at least one expandable sealing mechanism. According to embodiments, the delivery system is used in conjunction with an anchoring system according to an embodiment of the invention having a sleeve with a column strength high enough to prevent collapse of the system during insertion through the delivery system.

[0030] According to some embodiments of the invention, an air conducting roughened surface material is disposed on an exterior surface of the sleeve body or proximally within the body portion of the sleeve. According to some embodiments, the air conducting roughened surface material is a stacked mesh matrix, a honeycomb lattice of interconnected channels, gauze, fabric, or a three-dimensional woven material that can be oriented in a radial manner around the sleeve, for example.

[0031] According to some embodiments of the present invention, a method of securing a sleeve to a tissue cavity, the sleeve having an outer surface including a foam for contacting an inner wall of the tissue cavity and an expandable sealing mechanism for isolating a portion of the tissue cavity adjacent the sleeve from a remainder of the tissue cavity, includes inserting the sleeve into the tissue cavity. The method further includes inflating or expanding the expandable sealing mechanism to create a seal between the expandable mechanism and the inner surface of the tissue cavity, and applying a negative pressure to an area between the outer surface of the sleeve and the inner surface of the isolated portion of the tissue cavity to create a frictional force between the foam of the sleeve and the inner surface of the tissue cavity. According to one embodiment, the sleeve further includes a sleeve body.

[0032] According to some embodiments of the present invention, inflating or expanding the expandable sealing mechanism is performed by injecting a non-compressible liquid into the expandable sealing mechanism. According to some embodiments of the present invention, inflating or expanding the expandable sealing mechanism is performed by injecting an inflation medium (e.g., saline, mineral oil, and / or a dye-based (e.g., iodine-based) contrast solution) into the expandable sealing mechanism. According to some embodiments, inflating or expanding the expandable sealing mechanism is performed by injecting a radiopaque contrast agent into the expandable sealing mechanism.

[0033] According to some embodiments of the invention, inserting the sleeve into the tissue cavity is performed using a delivery system including a handle and a guide shaft, According to some embodiments, the method further includes withdrawing the handle and guide shaft of the delivery system from the sleeve.

[0034] According to some embodiments of the invention, the method further includes removing the sleeve from the tissue cavity by (i) releasing the negative pressure, (ii) collapsing the expandable sealing mechanism, and (iii) injecting a volume of saline through the irrigation tubing to disrupt the seal.

[0035] According to some embodiments of the present invention, there is provided an anchoring device that utilizes two redundant anchoring methods for anchoring in the intestine, a first method is to utilize a negative pressure based friction anchor as described herein, and a second method is to secure the extracorporeal portion of the device to the skin using column strength against a sleeve, the column strength being high enough to hold the anchor portion of the device in place even if the first anchoring method fails, and the first anchoring method being sufficient to hold the anchor portion of the device in place if the second method fails. According to embodiments of the present invention, there is provided a method of inserting an anchoring system according to embodiments of the present invention, the method using an endoscope connected to the anchoring system. According to some embodiments, the anchoring system is inserted using direct visualization through the endoscope.

[0036] According to some embodiments of the invention, the anchoring system includes a sleeve having an inner surface defining a lumen, a first expandable sealing mechanism disposed along a proximal end of the sleeve, and a second expandable sealing mechanism disposed along the proximal end of the sleeve. The anchoring system further includes an air-conducting roughened surface material disposed on an outer surface of the sleeve. Expansion of the first and second expandable sealing mechanisms and application of a negative pressure to the anchoring system causes a seal to form between the first and second expandable sealing mechanisms, the outer surface of the sleeve, and the inner surface of the tissue cavity. According to some embodiments, the system further includes a sleeve body, the first expandable sealing mechanism disposed at a proximal end of the sleeve body, and the second expandable sealing mechanism disposed at a distal end of the sleeve body. According to some embodiments of the invention, the air-conducting roughened surface material is at least one of a stacked mesh matrix, a honeycomb lattice of interconnected channels, gauze, fabric, or a three-dimensional woven material.

[0037] Some embodiments of the present invention provide an anchoring device configured to be anchored in a patient's intestine, the anchoring device including a sleeve configured to be positioned in the patient's intestine, an extracorporeal portion configured to extend outside the body from the patient's intestine, and two redundant methods of anchoring the device in the intestine, where a first method of anchoring the device utilizes a negative pressure based system that applies negative pressure to the device to generate a frictional force that resists displacement of the sleeve of the device from the intestine, and a second method of anchoring the device secures the extracorporeal portion of the device to the patient's skin, and at least one of: (i) the column strength of the sleeve is high enough to hold the device in place even if the first anchoring method fails, or (ii) the first anchoring method is sufficient to hold the device in place even if the second anchoring method fails.

[0038] According to one embodiment, the fixation device further includes a third redundant method of fixation of the device, the third fixation method utilizing first and second expandable sealing mechanisms, expansion of the first and second expandable sealing mechanisms causing a seal to be formed between the first and second expandable sealing mechanisms and an inner surface of the tissue cavity, the third fixation method being sufficient to hold the device in place even if the first and / or second fixation methods fail.

[0039] Further objects and advantages will become apparent from a consideration of the description, drawings, and examples. [Brief description of the drawings]

[0040] [Figure 1A] 1 is a diagram of an anchoring system according to some embodiments of the present invention. [Figure 1B] FIG. 13 is an end view of an expandable sealing mechanism of the anchoring system according to an embodiment of the present invention. [Figure 1C] 1 is a schematic end view of an expandable sealing mechanism of an anchoring system according to an embodiment of the present invention. FIG. [Figure 1D] 1 is a schematic end view of an expandable sealing mechanism of an anchoring system according to an embodiment of the present invention. FIG. [Figure 2A] 1 is a schematic diagram of an anchoring system in a collapsed position according to some embodiments of the present invention. [Figure 2B] FIG. 2B is a schematic end view of the fastening system shown in FIG. 2A in accordance with an embodiment of the present invention. [Figure 2C] 1 is a schematic end view of a sleeve lumen of an anchoring system according to some embodiments of the present invention. [Diagram 3] 1 is a schematic diagram of an anchoring system according to some embodiments of the present invention. [Figure 4A] FIG. 2 is a schematic diagram of an anchoring system in a collapsed position according to an embodiment of the present invention. [Figure 4B] FIG. 1 is a schematic diagram of an anchoring system in an extended position according to an embodiment of the present invention. [Diagram 5] 1 is a schematic exploded view of each of the components of the fastening system according to some embodiments of the present invention. FIG. [Figures 6A-6C] FIG. 6A illustrates a method of insertion of the anchoring system into a tissue cavity using a flexible member and semi-rigid tube pusher, FIG. 6B illustrates the anchoring system in a desired position disconnected from the delivery system (flexible member and pushing member removed), and FIG. 6C illustrates the anchoring system with negative pressure applied through the pressure tube causing the intestinal wall to collapse around the sealing member and anchor sleeve body. [Figure 7A] 13 is a schematic diagram of a distal flow channel of the fixation system in an extended position in accordance with an embodiment of the present invention. [Figure 7B] 13 is a schematic diagram of a proximal flow channel of the fixation system in an extended position in accordance with an embodiment of the present invention. [Figure 8] 1 is a schematic diagram of a contrast lumen of an anchoring system in an extended position in accordance with an embodiment of the present invention. [Figure 9] FIG. 13 is a schematic diagram of a negative pressure path of the fixation system in an extended position according to an embodiment of the present invention. [Figure 10A] 1 illustrates a delivery system for an anchoring system according to some embodiments of the present invention. [Figure 10B] 1 is a schematic diagram of a delivery system in combination with an anchoring system according to an embodiment of the present invention. [Figure 10C] FIG. 10C is a cross-sectional view of a delivery system in combination with the anchoring system shown in FIG. 10B according to an embodiment of the present invention. [Figure 10D] FIG. 1C is a partial enlarged cross-sectional view of a handle of a delivery system combined with the anchoring system shown in FIGS. 10B and 10C in accordance with an embodiment of the present invention. [Figure 10E] 10B and 10C according to an embodiment of the present invention. FIG. [Figure 10F] 10E is a cross-sectional view of a fixation system having the delivery system shown in FIG. 10E according to an embodiment of the present invention. [Figure 10G] 10E along line BB of FIG. 10E, showing a cross-sectional view of a fixation system having a delivery system as shown in FIG. 10E in accordance with an embodiment of the present invention. [Figure 10H] 10E along line CC of FIG. 10E, showing a cross-sectional view of a fixation system having the delivery system shown in FIG. 10E in accordance with an embodiment of the present invention. [Figure 10I] 10E is a cross-sectional view of a fixation system having the delivery system shown in FIG. 10E according to an embodiment of the present invention. [Figure 10J] 10E is a cross-sectional view of a fixation system having the delivery system shown in FIG. 10E according to an embodiment of the present invention. [Figure 11A] FIG. 13 is a schematic diagram of a delivery system for use with an anchoring system according to another embodiment of the present invention. [Figure 11B] 11B is a cross-sectional view of a delivery system for use with the anchoring system shown in FIG. 11A in accordance with an embodiment of the present invention. [Figure 11C] 11C is a partial enlarged cross-sectional view of the end of the delivery system shown in FIGS. 11A and 11B in accordance with an embodiment of the present invention. [Figure 11D] FIG. 11C is a partial enlarged cross-sectional view of a handle of the delivery system shown in FIGS. 11A and 11B in accordance with an embodiment of the present invention. [Figure 12]13A-13D illustrate extension tubing for an anchoring system according to some embodiments of the present invention. [Figure 13] FIG. 1 illustrates an embodiment of an anchoring system including two anchorer elements for delivering a therapeutic agent to an isolated intestinal segment. [Figure 14] FIG. 1 is a side view of an embodiment of an anchoring system including two anchorer elements for delivering a therapeutic agent to an isolated intestinal segment. [Figure 15A] 1 is a schematic diagram of an endoscope adaptor according to some embodiments of the present invention. [Figure 15B] 1 is a schematic diagram of an endoscopic adapter according to some embodiments of the present invention. [Figure 16] 16 is a cross-sectional view of the endoscopic adapter shown in FIGS. 15A and 15B taken along line 16-16 in FIG. 15A in accordance with an embodiment of the present invention. [Figure 17] 1 is a schematic diagram of an anchoring system attached to an endoscope through an endoscope adapter according to some embodiments of the present invention. [Figure 18] 18 is a cross-sectional view of the endoscopic adapter shown in FIG. 17 taken along line 18-18 in FIG. 17 in accordance with an embodiment of the present invention. [Figure 19A] 1 is a schematic illustration of a retention bandage for securing an anchoring system to a patient, according to some embodiments of the present invention. [Figure 19B] 19B is a schematic diagram of a method of attaching the retention bandage shown in FIG. 19A to an anchoring system according to an embodiment of the present invention. [Figure 19C] 19B is a schematic diagram of a method of attaching the retention bandage shown in FIG. 19A to an anchoring system according to an embodiment of the present invention. [Figure 19D] 19B is a schematic diagram of a method of attaching the retention bandage shown in FIG. 19A to an anchoring system according to an embodiment of the present invention. [Figure 19E] 19B is a schematic diagram of a method of attaching the retention bandage shown in FIG. 19A to an anchoring system according to an embodiment of the present invention. [Figure 19F] 19B is a schematic diagram of a method of attaching the retention bandage shown in FIG. 19A to an anchoring system according to an embodiment of the present invention. [Figure 19G]19B is a schematic diagram of a method of attaching the retention bandage shown in FIG. 19A to an anchoring system according to an embodiment of the present invention. [Figure 19H] 19B is a schematic diagram of a method of attaching the retention bandage shown in FIG. 19A to an anchoring system according to an embodiment of the present invention. [Figure 20A] 1 is a schematic diagram of a retrieval bag according to some embodiments of the present invention. [Figure 20B] FIG. 20B is a schematic diagram of a pair of attachment straps for attaching the retrieval bag of FIG. 20A to a patient in accordance with an embodiment of the present invention. [Figure 21A] 1 is a schematic diagram of a retrieval bag according to some embodiments of the present invention. [Figure 21B] FIG. 21B is a side view of the retrieval bag of FIG. 21A in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] Among the benefits and improvements disclosed, other objects and advantages of the present disclosure will become apparent from the following description taken in conjunction with the accompanying drawings. Although detailed embodiments of the present disclosure are disclosed herein, it is to be understood that the embodiments of the present disclosure are merely exemplary of the present disclosure, which may be embodied in various forms. In addition, each of the examples provided with respect to the various embodiments of the present disclosure are intended to be illustrative and not limiting.

[0042] Throughout this specification and the claims, the following terms take the meanings expressly associated therewith herein, unless the context clearly dictates otherwise. As used herein, the phrases "in one embodiment," "in an embodiment," and "in some embodiments" do not necessarily refer to the same embodiment, although they may. Additionally, as used herein, the phrases "in another embodiment" and "in some other embodiments" do not necessarily refer to different embodiments, although they may. It is intended that all embodiments of the present disclosure can be combined without departing from the scope or spirit of the present disclosure.

[0043] As used herein, the term "based on" is not limiting and may be based on additional factors not described unless the context clearly dictates otherwise. In addition, throughout this specification, the meanings of "a," "an," and "the" include plural referents. The meaning of "in" includes "in" and "on."

[0044] When used herein, terms such as "comprising," "including," and "having" do not limit the scope of a claim to the materials or steps recited in that claim.

[0045] As used herein, terms such as "consisting of" and "consisting of" limit the scope of a particular claim to the materials or steps recited by that claim.

[0046] All prior patents, publications, and testing methods cited herein are incorporated by reference in their entirety.

[0047] In modern medical treatment, the need for temporary protection of the intestinal lumen and / or a segment of intestine from intestinal fecal flow is a common problem after bowel resection and anastomosis or when the intestinal wall is damaged (e.g., tissue injury). Examples include protection of newly formed surgical anastomoses, anatomical leaks, inflamed or irritable bowel, partial thickness damage to the intestinal wall, and full thickness intestinal perforation. The traditional means of temporarily protecting the intestine from intestinal flow is by creating an extracorporeal diversion channel of the intestine by the creation of an artificial fistula or stoma. A fistula is an intentional anastomosis between a segment of the gastrointestinal (GI) tract and the skin of the anterior abdominal wall. Essentially, the surgeon diverts the segment of intestine proximal to the area to be protected to the skin, diverting the fecal flow away from the vulnerable intestinal segment. An artificial fistula can be created virtually anywhere along the GI tract. In fecal diversion, the most common fistulas involve the distal small intestine (e.g., ileostomy) and the large intestine (e.g., colostomy). Fistulas are performed annually in approximately 300,000 patients in the United States and over 2 million patients worldwide, but the procedure is complicated by high morbidity, mortality, and significant impact on the patient's quality of life. Complications such as peristomal hernia, infection / sepsis, dermatitis and skin erosion, electrolyte depletion, dehydration, and prolapse are common. Up to 50% of patients who undergo a fistula will have some type of fistula-related complication, and many will require rehospitalization and additional surgery. Although many colostomies are intended to be temporary, as many as one-third of temporary colostomies are never closed due to, for example, the patient's fear of undergoing yet another surgery or risk factors associated with complications from the initial surgery. Furthermore, the atresia procedure itself has a high morbidity (17%) and significant mortality rate (1.2-7%). Thus, a need exists for improved methods and devices for fecal diversion with colon protection.

[0048] One of the main medical indications for temporary fistula creation is to protect the intestinal anastomosis after bowel resection. A protective fistula or stoma is performed to both protect the newly formed anastomosis from fecal flow and to prevent the development of severe sepsis if anastomotic leakage occurs. Anastomotic leakage is defined as a defect in the intestinal wall at the anastomosis that results in communication between the intraluminal and extraluminal compartments. The overall incidence of colorectal anastomotic leakage varies widely in the literature, from 1% to 24%. Leaks may result in severe complications such as anastomotic failure, sepsis, and death. Even if the anastomosis heals, poor compliance at the neorectum may lead to poor functional outcomes. Many large studies have shown that anastomotic leakage has a 50% incidence of pelvic sepsis. Protecting the anastomosis from fecal flow may prevent anastomotic leakage or, more importantly, reduce the complications of anastomotic leakage, such as severe sepsis, and mortality. For this reason, colon surgeons perform temporary fistulas after bowel resections, even when the majority of patients are likely to heal uneventfully. Even after anastomotic leakage has occurred, protection from fecal flow can make it less severe and aid in the healing of the leak. There are several risk factors for the development of anastomotic leakage. The most significant risk factor is the level of the anastomosis, with the incidence of leakage increasing the shorter the distance from the anastomosis to the anus. Besides meticulous technique in creating the anastomosis, the main approach to prevent and treat anastomotic leakage during complicated or high-risk cases with bowel resection is to redirect the flow of fecal flow by a protective fistula. This redirection is achieved by redirecting the flow of intestinal contents using an artificial fistula created in the bowel proximal to the anastomosis or anastomotic leakage. Proximal intestine is defined as where the GI tract goes up to the mouth and distal intestine is defined as where the GI tract goes down to the anus. The fistula can be either a single-hole fistula, such as a single-hole colostomy or a single-hole ileostomy, or a redirected loop ileostomy, which does not completely interrupt the continuity of the intestine.

[0049] Temporary diversion ostomy and its closure have a unique combination of complications and morbidities, including dehydration due to high output, difficulty in care of the stoma, stricture at the closure site, wound infection, and incisional hernia. The incidence of complications of stoma placement ranges between 5% and 100%. These complications can be divided into minor complications that do not require surgical intervention and severe complications that do. Severe complications include stricture, small bowel obstruction, atrophy, necrosis, prolapse, stricture, fistula, and peristomal hernia. In some cases, such as partial small bowel obstruction, the patient is initially offered conservative treatment and surgical intervention can be avoided. In severe complications, such as stoma necrosis extending longer than a few millimeters, surgical intervention is mandatory. Minor complications include dermatitis, electrolyte imbalance, and dehydration due to high stoma output, but dehydration often necessitates early closure of the stoma. In severe complications, the extra costs and morbidity associated with additional surgery or hospitalization can be significant. Even in the case of minor complications, treating the complications and providing ostomy education can be a burden to both the healthcare provider and the patient. Some complications, such as hernias, prolapse, and strictures, can become chronic and often require multiple corrective surgeries and associated costs. A stoma also significantly reduces the patient's quality of life. Fecal output from the stoma is collected in a stoma bag attached to the patient's abdomen. These bags must be emptied and changed frequently to properly care for the stoma and prevent accidental release of fecal material. Stoma devices can malfunction and lead to leakage. The burden of living with a stoma can negatively impact the patient's social life and limit physical activity.

[0050] Furthermore, closure of the colostomy is a surgical procedure that presents potential complications, since in many cases the abdominal compartment has dense adhesions that make the restoration of normal intestinal continuity technically difficult and sometimes morbid. Similarly, in the case of loop ileostomy or single-hole colostomy reattachment, respectively, the repaired intestine may develop leaks at the repair site or anastomosis after removal of the colostomy. Due to the possibility of intestinal injury and the development of leaks due to the colostomy closure procedure, the procedure is also associated with a significant mortality rate. In addition to the costs associated with operating on the patient, the patient generally requires hospitalization for 2-4 days after surgery until bowel function is restored. Furthermore, closure of the colostomy is unduly risky or impossible in some patients, requiring these patients to live the rest of their lives with the colostomy attached.

[0051] In addition to anastomosis protection, there are other possible medical indications for temporary fecal diversion. These indications include: 1) the procedure after anastomotic leakage has occurred, 2) diverticulitis, 3) inflammatory bowel disease such as colonic Crohn's disease or ulcerative colitis, 4) intestinal perforation, and 5) other less common cases of intestinal injury where fecal diversion may be beneficial, such as in cases of ischemic bowel disease, traumatic intestinal contusion, or non-healing perineal / perianal wounds. When leakage or intestinal perforation occurs, such as in cases of anastomotic leakage and diverticulitis, treatment with fecal diversion can reduce the severity and spread of the condition. Thus, these patients may be able to heal the leakage / perforation faster and may not develop serious complications when persistent fecal stream contamination of the affected area is reduced. Inflammatory conditions of the intestinal wall, such as Crohn's disease or ulcerative colitis, may render the intestinal lining more susceptible to injury from fecal stream. Continued fecal flow may further inflame and contaminate the intestinal wall, leading to systemic disease in the patient, infection / sepsis, or even worsening perforation of the intestinal wall. Protection from fecal flow would allow the inflamed intestinal segment to heal, and potentially fecal diversion could reduce recovery time, hospital stay, and limit serious complications such as perforation or fistula formation. Patients with these conditions may not be good candidates for surgery due to associated pathology or sepsis, and therefore, in these cases, major surgery to create an artificial fistula may cause further morbidity. Thus, there is a need for improved methods and devices to provide a less morbid alternative suitable for temporary fecal diversion.

[0052] More recently, intraluminal diversion using a protective sleeve / sheath within the intestine has been attempted as an alternative to temporary fistula formation. Instead of diverting the stool flow path outside the body using a fistula / stoma, the stool flow path is redirected through the lumen of the intestine inside a protective sleeve / sheath that substantially protects the intestinal wall from fecal contamination. However, reliable and secure anchoring of the sleeve / sheath within the intestinal lumen has historically proven difficult. All previous attempts at anchoring within the intestine have resulted in either potentially catastrophic complications (erosion or ischemic damage of the intestinal wall, high incidence of anastomotic leakage) or insecure anchoring and protection (premature extrusion, device migration, incomplete fecal diversion). Historically, these sleeves have been inserted blindly with or without direct visualization during laparoscopy or laparotomy. However, avoiding inadvertently causing damage to the intestine during blind insertion of the protective sleeve / sheath may be risky in situations where there is bowel wall injury or other bowel pathology such as inflammation that may make the bowel wall more prone to iatrogenic injury. However, there are many clinical scenarios that require placement of the anchoring device and its attached sleeve without an accompanying surgical laparoscopy or laparotomy. In these cases, performing laparoscopy or laparotomy to assist in the placement of the device would expose the patient to additional risks and potential complications of surgery, which may limit medical indications for use to only the most severe cases where the benefits of colon protection outweigh the potential morbidity of abdominal surgery. The ability to safely anchor the protective sleeve / sheath without performing laparoscopy or laparotomy would improve the medical indications for use of the protective device and minimize morbidity from its use. Thus, there is a need for a device for bowel segment protection that can be safely placed by a completely endoluminal approach without laparoscopy or laparotomy. There are many clinical examples where this technology may be advantageous. For example, conditions requiring temporary colon protection could include, for example, the high risks associated with colonoscopy, inflammatory bowel disease, or diverticulitis.

[0053] Systems and methods are disclosed for anchoring a protective sleeve proximal to an area of ​​the intestine requiring protection from fecal flow within the intestine, such as an intestinal anastomosis or intestinal injury site. These systems and methods can obviate the need for a temporary fecal diversion stomy in most patients, as they provide the same overall purpose as a temporary stomy by allowing for internal fecal diversion and protecting the distal intestinal segment from fecal flow. Additionally, additional configurations of the systems of the present invention are disclosed that allow for drug delivery to the intestinal lumen.

[0054] According to an embodiment, an anchoring system or intraluminal colonic diversion (ICD) system is provided, which is a medical device designed to temporarily protect a colon segment from fecal flow. The system and product are intended to improve patient care by reducing the need for temporary fistula creation following intestinal wall injury. The ICD system is a two-part system including (i) a patient-specific sterile ICD device and (ii) a patient-specific sterile ICD delivery device. The ICD device and ICD delivery system are assembled ready-to-use in a pouch, e.g., a Tyvek-PET / LDPE pouch, and the sealed pouch is packaged as a complete ICD system in a single chipboard box.

[0055] In some embodiments, the system (i.e., the ICD system) allows for atraumatic and recoverable anchoring of the sleeve in the GI tract, which redirects the flow path of fecal contents away from the anastomosis or damaged intestinal site. The device is designed to be left in place for a period of days to weeks (e.g., including 10 to 14 days, up to 21 days, and / or at least 4 weeks) and then completely removed after healing is complete or redirection is no longer required. Although the devices and methods are described herein in the context of securely anchoring a sleeve in the GI tract for therapeutic effects such as redirecting the flow path of intestinal contents, the anchoring devices and methods may also have application in other body areas where secure anchoring in a tissue cavity is desired. It is important to emphasize that the device of the present invention is a device designed to be sufficiently and securely anchored in place in the intestine, preventing substantial device migration until the device is actively discontinued and removed by the clinician. This is in contrast to other non-surgically applied sheath or sleeve based protective devices that over time gradually protrude from the intestine because they cannot be reliably anchored and cannot maintain the same high level of anchoring strength required to resist the evacuation forces of the intestine. The unique design of the devices disclosed herein allows them to be anchored in place without detachment, without damaging the intestinal wall, without requiring surgical fixation such as suturing, stapling or external intestinal retention rings, and without requiring permanent implantation. Each of these features is described in more detail below.

[0056] According to embodiments, the ICD device includes a specialized negative pressure anchoring device and associated protective sleeve designed to securely, reversibly, and safely protect the distal intestine (i.e., the intestine downstream from the anchoring device in the gastrointestinal (GI) tract) from fecal intestinal flow. The specialized negative pressure anchoring device utilizes a unique foam interface (or air-permeable roughened material) to create an atraumatic yet strong bond to the intestinal wall to hold the ICD device in place and prevent migration. According to some embodiments, the anchoring device portion of the ICD device has an expandable sealing mechanism in the form of, for example, two soft, inflatable elastomeric balloons that provide an atraumatic sealing surface to facilitate negative pressure anchoring while providing a liquid / air tight seal to prevent fecal contamination in the intestine distal to the anchoring device portion. These seals are also collapsible to allow withdrawal of the anchoring system without fatigue of the intestinal wall. Negative pressure is applied to the sealing area between the expandable or expanded sealing mechanism (e.g., inflated balloons) and the intestinal lumen to facilitate anchoring. A biocompatible elastomeric open cell foam material is spaced between the expandable sealing features (e.g., balloons) to provide a large contact surface and a means for evenly distributing negative pressure around the exterior surface of the anchor sleeve and / or anchor sleeve body and to the intestinal wall. Additionally, this interface creates a unique frictional bond to the intestinal wall that is stronger than previously achieved without the use of more invasive fixation techniques. The ICD device is designed to be placed in the operating / procedure room and can be removed in the patient's room or clinic. The ICD device does not require surgical fixation, such as, for example, stapling, extraluminal flow limiting rings, or expandable wire stent insertion, which can damage the delicate intestinal wall. The ICD device can be left in place for periods typically ranging from 10 to 14 days to provide long-term protection against surgical intestinal anastomosis or damaged intestinal segments, such as anastomotic leakage and / or intestinal inflammation, but can be left in place for up to 21 days or longer if necessary.

[0057] According to some embodiments, the device includes a negative pressure based anchoring device that prevents the sleeve and / or sleeve body from becoming detached from the inner surface of the intestine. According to some embodiments, the sleeve includes and / or is connected to the sleeve body, which in combination serves as a protective barrier between the GI tract and the GI contents flowing through the sleeve and sleeve body. In some embodiments, the sleeve body is affixed onto the proximal end of the sleeve. In some embodiments, the sleeve and sleeve body are manufactured as one continuous tubular structure. In some embodiments, the sleeve and sleeve body are separate tubular components that are bonded together. According to one embodiment, the sleeve body is a reinforcing member designed to support the sleeve and / or the proximal end of the device, more specifically the anchoring device element. The sleeve body is a critical component to the function of the device, (1) providing additional support to allow expansion of the expandable sealing member (e.g., balloon) without collapse of the sleeve lumen, (2) helping to maintain the expandable sealing member (e.g., balloon) at a perpendicular angle to the sleeve as it expands and providing support to prevent the expandable sealing member from twisting laterally, and (3) providing the additional support / strength needed for the sleeve to maintain an open and patent central lumen at the proximal end. This provides a thinner walled, softer, more flexible sleeve conduit along the length of the device.

[0058] In some embodiments, the device includes a pneumatic system for applying negative pressure to the anchorage system. In some embodiments, the device includes an external waste bag for collecting GI contents that have passed through the sleeve. However, an external waste bag is not required for the device to function. In some embodiments, the device has a sleeve that opens just outside the anal sphincter, allowing feces to pass through this opening. In this embodiment, the anal sphincter tightens around the sleeve to provide some continence, eliminating the need for a collection bag.

[0059] According to some embodiments, the anchoring portion of the device is placed in the GI tract proximal to the anastomosis or proximal to the damaged intestinal site. The anchoring portion of the device is defined as the portion including the expandable sealing element and the foam interface. Proximal is the "upstream" side with respect to the flow of GI contents through the GI tract. The above definition is in contrast to an anastomosis or wound treatment system configured to be applied directly to the anastomosis or wound site. The device is configured to be anchored in healthy, undamaged intestine. A constant and / or variable negative pressure is maintained by a pneumatic interface connected to the anchoring system and distributed through the open cell reticulated foam interface (or air-conducting roughened material). The expandable sealing element at the end of the sleeve and / or sleeve body creates a negative pressure space between the outer surface of the sleeve and / or sleeve body, including the foam interface, and the intestinal wall. When negative pressure is applied, a pressure gradient through the foam acts to create adhesive and frictional forces between the GI tract and the anchoring system. These adhesive and frictional forces, generated by the negative pressure sponge interface and significantly stronger than other non-surgically secured sleeve anchoring systems described above, allow the anchoring system to maintain a relatively immobile position within the intestine. This anchoring is also substantially safer with respect to intestinal damage compared to other forms of anchoring such as stapling, suturing, expandable stent insertion, or external anchoring rings. When the user is ready to remove the device, normal atmospheric pressure can be restored between the anchoring device and the intestine, allowing the device to move through the GI tract with minimal friction. This anchoring device and method does not require suturing, stapling, biodegradable implants, external anchoring rings, or other invasive anchoring techniques, and generates minimal trauma to the intestine. Thus, disclosed herein are methods and devices for securely anchoring a sleeve and / or sleeve body within the intestinal lumen in a manner that does not substantially damage the intestinal wall and allows for easy restoration of anchoring for removal of the device.

[0060] In accordance with an aspect of an embodiment of the present invention, a device for anchoring a sleeve and / or sleeve body in the intestine can be described as having a hollow body with one or more expandable sealing elements at one or both ends and a porous material on an exterior surface of the hollow body such that upon application of negative pressure to the exterior surface of the hollow body and expansion of the one or more expandable sealing elements, an adhesive force is formed between the intestinal wall and the hollow body. At least one lumen can deliver negative pressure (e.g., vacuum) to the sealing elements while one or more other lumens can deliver fluid (e.g., saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution) to inflate the one or more expandable sealing elements. A protective sleeve can be attached to the sealing members and a recovery system can recover contents through the sealing members.

[0061] Some embodiments of the present invention provide an ICD delivery device that includes a handle, a guide shaft, an outer protective sheath, and a sheath puller handle that allows a physician or surgeon to place the ICD device during a procedure, e.g., a colectomy. The ICD delivery system facilitates placement of the ICD device by maintaining a small anchor profile during insertion and protecting the expandable sealing mechanism (i.e., an expandable elastomeric balloon) from potential damage when inserting the device past a stapled anastomosis. In some embodiments, the ICD device is inserted, advanced, and positioned transanally using the ICD delivery system. For example, a water-based lubricant such as KY Jelly is used to facilitate placement. The anchorer portion of the ICD device is positioned 5 to 10 cm above (proximal in the GI tract) a site that requires protection from fecal flow (such as an anastomosis after rectal cancer surgery). Importantly, the anchorer portion of the ICD device is designed to be placed in healthy intestine and not in damaged intestinal areas that require protection. After positioning of the anchoring portion, the outer sheath is removed by withdrawing the outer sheath using the sheath puller handle. In some embodiments, retraction of the outer sheath of the delivery system is performed through the center of the guide shaft. After the outer sheath of the delivery system is removed, the device is ready for deployment.

[0062] According to an embodiment of the present invention, the deployment procedure of the ICD device is accomplished by (i) inflating the distal and proximal expandable sealing mechanisms (e.g., balloons) by injecting a non-compressible fluid (e.g., normal saline, mineral oil, or dye-based contrast agent or radiopaque contrast agent) through syringes connected to the distal and proximal fill ports of the ICD device, respectively; (ii) connecting a negative pressure source (e.g., vacuum source) to the vacuum port to secure the ICD device and / or activate the negative pressure; and (iii) withdrawing the handle and guide shaft of the ICD delivery system from the ICD device. According to another embodiment, the external portion of the ICD device is further secured to the patient's skin using an adhesive dressing. In some embodiments, the optional extension tubing can extend the tubing length to a gravity-assisted waste bag in the hospital room. The ICD device is designed to be easily removed in the hospital room or outpatient clinic without the need for additional invasive procedures. According to some embodiments, removal of the ICD device is accomplished by (i) turning off and distancing the negative pressure source (e.g., vacuum source) to release the vacuum, (ii) deflating the distal and proximal expandable sealing mechanisms (e.g., balloons) by completely removing fluid through syringes connected to the distal and proximal ports of the ICD device, respectively, and (iii) injecting a small amount of normal saline through the vacuum ports to break the sticky seal, and (iv) removing the external dressing and gently pulling on the sleeve of the ICD device until the ICD device is fully removed from the anal verge.

[0063] According to some embodiments, the ICD device includes at least two additional features. According to one embodiment, an irrigation lumen is provided that is used to instill normal saline proximal to the anchor portion of the device (if necessary) to liquefy formed stool and maintain patency of the redirection sleeve and / or sleeve body. In some embodiments, this irrigation lumen is in communication with an opening in the sleeve and / or sleeve body proximally in the intestine. According to another embodiment, a contrast lumen is provided that can be used to inject radiopaque dye distal to the anchor portion of the device in the intestine to perform radiographic leak testing.

[0064] In some embodiments, the ICD system is used in conjunction with a specialized adhesive dressing, a negative pressure source, and a retrieval bag. These features can be accessory products to the main system. Additionally, in one embodiment, the ICD system includes an endoscopic adapter that allows placement of the ICD device within the intestinal tract by using an endoscope or colonoscope to achieve direct visualization for insertion guidance.

[0065] According to a feature of an embodiment of the present invention, the ability of the anchoring section of the ICD device to advance against external resistance when the ICD device is mounted on a delivery system or on an endoscope, sigmoidoscope, or colonoscope is due to the combined effect of (i) the column strength associated with the size, shape, and material type of the outer sleeve body and / or sleeve of the anchoring device, and (ii) the internal support provided by the size, shape, and material type of the internal support member (e.g., the guide shaft of the delivery system). It is contemplated that the internal support member may include the shaft of a colonoscope or other endoscope or the guide shaft of the ICD delivery system. The unique properties of the sleeve and / or sleeve body provide the column strength to support the anchoring system during advancement into the intestine, thereby allowing the delivery system to function. The column strength of the sleeve body and / or sleeve allows for the external fixation of the ICD device in place. According to one embodiment, the yield strength for columnar buckling is the compressive yield strength of the selected material. With proper selection of material type and material properties, the column strength of the outer sleeve can be calculated and tailored to the application. In addition to the column strength of the outer sleeve, the internal support (e.g., the guide shaft of the delivery system) prevents both axial and lateral collapse and buckling. The additional support allows for the use of softer and / or thinner wall materials while providing the strength needed to overcome the anterior resistance and insert the device.

[0066] FIG. 1A illustrates a diagram of an anchoring system for an ICD device according to some embodiments of the present invention. The anchoring system 100 includes a sleeve body 102 having an inner surface (not shown) that defines a lumen (not shown). A first expandable sealing mechanism 108 is disposed at a proximal end of the sleeve body 102, and a second expandable sealing mechanism 110 is disposed at a distal end of the sleeve body 102. With respect to this device, proximal is defined as the portion of the device furthest from where fecal material exits the sleeve body and / or sleeve (defined in more detail below) (e.g., for a waste bag), and distal is defined as the portion of the device closer to where fecal material exits the sleeve body and / or sleeve during steady fecal flow. This orientation designation is used because it is in the context of flow through the device (proximal to distal) and corresponds to the orientation of the device in the intestine. A sleeve 116 is in fluid communication with the sleeve body 102 and forms a second lumen (not shown) that is continuous with the first lumen. An open cell foam 120 is disposed on the exterior surface of the sleeve body 102. Application of negative pressure to the sleeve 116 and / or sleeve body 102 and expansion of the first and second expandable sealing mechanisms 108, 110 causes a seal to form between the first and second expandable sealing mechanisms 108, 110 and the interior surface of the tissue cavity, creating a frictional force that resists displacement of the sleeve body 102. In some examples, the sleeve 116 extends through the sleeve body 102 so as to be coextensive with the sleeve body 102. In another embodiment, the sleeve body 102 is absent and the expandable sealing mechanisms 108, 110 and foam 120 are attached directly to the proximal end of the sleeve 116. In other examples, the distal end of the sleeve body 102 is connected to the proximal end of the sleeve 116.

[0067] 1A also shows a series of flexible (or fluid) tubes 125, 127, and 129 with respective associated connectors or ports 124, 126, 128. According to some embodiments, one of the flexible tubes 125 provides a fluid or inflation medium to each of the first and second expandable sealing mechanisms 108, 110, for example, through an associated connector or port 124, to inflate the first and second expandable sealing mechanisms 108, 110 with a fluid or inflation medium (e.g., saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution) to create a seal between the first and second expandable sealing mechanisms 108, 110 and the inner surface of the tissue cavity. Alternatively, the system 100 can include two flexible tubes 125A and 125B (see, e.g., FIG. 2B), one for each of the first and second expandable sealing mechanisms 108 and 110, to provide fluid or inflation media (e.g., saline, mineral oil, and / or contrast) for inflation. According to one embodiment, a flexible tube or flexible tubing 127 in communication with a connector or port 126 can be used to introduce fluid from an infiltration fluid source, such as a syringe. The port 126 is accessible through the flexible tubing 127 from outside the patient's body. This configuration of the anchoring system 100 allows for irrigation, delivery and removal of drugs (antibiotics, anti-inflammatory drugs, or chemotherapeutic agents), and radiological contrast agents between the exterior surface of the sleeve 116 and the intestinal wall and between the two expandable sealing mechanisms 108, 110. For example, one embodiment provides a flexible tube 127 and port 126 that can be used to inject a contrast agent or radiopaque dye distal to the anchored portion of the device in the intestine to perform an X-ray imaging leak test. Some embodiments provide another flexible tube, e.g., irrigation tubing, or flexible tubing 129 that is used (if necessary) to instill a fluid, e.g., normal saline, proximal to the anchored portion of the device to liquefy formed stool and maintain patency of the sleeve body 102 and / or sleeve 116.For example, according to one embodiment, a fluid, such as, for example, saline, can be introduced from an infiltration fluid source, such as, for example, a syringe, between the exterior surface of the sleeve 116 and the intestinal wall between the two expandable sealing mechanisms 108, 110 through a flexible tube or flexible tubing 129 in communication with a connector or port 128. Alternatively, the flexible tube or tubing 129 can be used to introduce a negative pressure source (i.e., vacuum) to the sleeve 116 and / or sleeve body 102 to form a seal between the first and second expandable sealing mechanisms 108, 110 and the interior surface of the tissue cavity.

[0068] FIG. 1B is an end view of one of the expandable sealing mechanisms according to an embodiment of the present invention. As shown in FIG. 1B, the first expandable sealing mechanism 108 includes an outer surface 130, an inner surface 132, and an opening that coincides with the lumen 106 of the sleeve body 102 and the sleeve 116. Although not shown in FIG. 1B, the second expandable sealing mechanism 110 includes the same configuration. When the first expandable sealing mechanism 108 (as well as the second expanded sealing mechanism 110) is expanded using a fluid or expansion medium, such as saline, mineral oil, and / or a dye-based (e.g., iodine-based) contrast solution to create a seal between the first expanded sealing mechanism 108 (as well as the second expanded sealing mechanism 110) and the inner surface of the tissue cavity, the outer surface 130 becomes further spaced from the inner surface 132.

[0069] FIG. 1C is another end view of one of the expandable sealing mechanisms according to an embodiment of the present invention. As shown in FIG. 1C, the first expandable sealing mechanism 108 includes an outer surface 130, an inner surface 132, and an opening that coincides with the lumen 106 of the sleeve body 102 and the sleeve 116. As further shown in FIG. 1C, the sleeve body 102 extends radially around the inner surface 132 of the first expandable sealing mechanism 108, and the sleeve 116 extends radially around the inner surface of the sleeve body 102. Additionally, the sleeve 116 contains various fluid lumens (as discussed in more detail below). Although not shown in FIG. 1C, the second expandable sealing mechanism 110 also includes the same configuration.

[0070] FIG. 1D is another end view of one of the expandable sealing mechanisms according to an embodiment of the present invention. As shown in FIG. 1D, the first expandable sealing mechanism 108 includes an outer surface 130, an inner surface 132, and an opening that coincides with the lumen 106 of the sleeve body 102 and the sleeve 116. As further shown in FIG. 1D, the sleeve body 102 and the sleeve 116 are provided within the inner surface 132 of the first expandable sealing mechanism 108. The sleeve 116 contains various fluid lumens (as will be discussed in more detail below). Additionally, the end view of FIG. 1D illustrates a foam 120, which is disposed between the inner surface 132 of the first expandable sealing mechanism 108 and the sleeve body 102. Although not shown in FIG. 1D, the second expandable sealing mechanism 110 also includes the same configuration.

[0071] FIG. 2A illustrates another view of the anchoring system 100 of FIG. 1A in accordance with an embodiment of the present invention. As shown in FIG. 2A, the anchoring system 100 includes a sleeve body 102. A first expandable sealing mechanism 108 is disposed at a proximal end of the sleeve body 102, and a second expandable sealing mechanism 110 is disposed at a distal end of the sleeve body 102. A sleeve 116 is in fluid communication with the sleeve body 102 by being connected to, coextensive with, and / or disposed within the sleeve body 102, and each of the sleeve 116 and the sleeve body 102 is in fluid communication with the lumen 106 (see, e.g., FIGS. 1B-1D, 2B, and 3). An open cell foam 120 is disposed on an exterior surface of the sleeve body 102. As discussed above, application of negative pressure to the anchoring system 100 and expansion of the first and second expandable sealing mechanisms 108, 110 causes a seal to form between the first and second expandable sealing mechanisms 108, 110 and the inner surface of the tissue cavity, generating a frictional force that resists displacement of the sleeve body 102. Also shown in Figure 2A is a series of flexible (or fluid) tubes 125, 127, and 129, and their respective associated connectors or ports 124, 126, 128, that are provided for introducing a fluid or expansion medium, such as, for example, saline, mineral oil, contrast media, etc., into the sleeve 116 and / or sleeve body 102 through flexible tubing or tubing 125, 127, 129 that are in communication with the respective connectors or ports 124, 126, 128.

[0072] Figure 2B shows an end view of the proximal end of the anchoring system 100 shown in Figure 2A. As shown in Figure 2B, the anchoring system includes a first expandable sealing mechanism 108 disposed at the proximal end of the sleeve body 102 (or sleeve 116), the sleeve body 102, the lumen 106, and the sleeve 116 containing various fluid lumens (discussed in more detail below). Additionally, Figure 2B shows a series of flexible (or fluid) tubes 123, 125A, 125B, 127, and 129, and their associated connectors or ports 122, 124A, 124B, 126, and 128, respectively. This embodiment provides two flexible tubes 125A and 125B, one for each of the first and second expandable sealing mechanisms 108, 110, for providing fluid or inflation media (e.g., saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution) for inflation through associated connectors or ports 124A, 124B. Some embodiments provide a flexible tube or flexible tubing 127, such as irrigation tubing (if required), that is used to instill a fluid, such as normal saline, proximal to the anchoring portion of the device to liquefy formed stool and maintain patency of the sleeve body 102 and / or sleeve 116. For example, according to one embodiment, a fluid, such as saline, can be introduced between the outer surface of the sleeve 116 and the intestinal wall between the two expandable sealing mechanisms 108, 110 from an infiltration fluid source, such as a syringe, through a flexible tube or flexible tubing 127 in communication with a connector or port 126. According to one embodiment, a flexible tube or flexible tubing 123 in communication with a connector or port 122 can be used to introduce the fluid from an infiltration fluid source, such as a syringe. This port 122 is accessible through the flexible tubing 123 from outside the patient's body. According to one embodiment, a flexible tube 123 and port 122 are provided for injecting a contrast agent or radiopaque dye distal to the anchored portion of the device in the intestine to perform an X-ray imaging leak test.According to one embodiment, another flexible tube 129 is provided for delivering a negative pressure source (or vacuum source) through its associated port 128 to the sleeve body 102 and / or sleeve 116. As discussed above, application of negative pressure to the sleeve body 102 and / or sleeve and expansion of the first and second expandable sealing mechanisms 108, 110 causes a seal to form between the first and second expandable sealing mechanisms 108, 110 and the inner surface of the tissue cavity, creating a frictional force that resists displacement of the sleeve body 102.

[0073] FIG. 2C shows an end view of sleeve 116 including various sleeve lumens according to an embodiment of the present invention. As shown in FIG. 2C , the sleeve 116 includes (i) a proximal fluid lumen 140 for providing a fluid or inflation medium, such as, for example, saline, mineral oil, and / or a dye-based (e.g., iodine-based) contrast solution, to the first expandable sealing mechanism 108 for inflation of the first sealing mechanism; (ii) a distal fluid lumen 142 for providing a fluid or inflation medium, such as, for example, saline, mineral oil, and / or a dye-based (e.g., iodine-based) contrast solution, to the second expandable sealing mechanism 110 for inflation of the second sealing mechanism; (iii) an irrigation lumen 144 for providing a fluid, such as, for example, normal saline, for flushing or liquefying stool that has accumulated within the lumen 106 of the sleeve 116 and / or sleeve body 102; (iv) a negative pressure lumen 145 for providing a source of negative pressure to the anchoring system; and (v) a contrast lumen 146 for providing a contrast dye to the anchoring portion of the device. According to one embodiment, (i) proximal fluid lumen 140 is in fluid communication with flexible tube 125A and its associated port 124A, (ii) distal fluid lumen 142 is in fluid communication with flexible tube 125B and its associated port 124B, (iii) irrigation lumen 144 is in fluid communication with flexible tube 127 and its associated port 126, (v) negative pressure lumen 145 is in fluid communication with flexible tube 129 and its associated port 128, and (v) contrast lumen 146 is in fluid communication with flexible tube 123 and its associated port 122. According to one embodiment, the fluid lumens (140, 142, 144, 145, 146) extend the length of sleeve 116 and are sealed at each end depending on their function. For example, according to one embodiment, the proximal and distal fluid lumens (140, 142), the contrast lumen (146), the negative pressure lumen (145), and the irrigation lumen 144 are sealed at their distal ends by sealing ends on a Y-fitting. According to some embodiments, the proximal and distal fluid lumens (140, 142), the contrast lumen (146), and the negative pressure lumen (145) are sealed at their proximal ends by silicone adhesive embedded within the ends of each lumen.Typically, the irrigation lumen (144) is not sealed at the proximal end to allow fluid to escape.

[0074] 3 illustrates another view of the anchoring system 100 of FIG. 1A in accordance with an embodiment of the present invention. As shown in FIG. 3, the anchoring system 100 includes a sleeve body 102. A first expandable sealing mechanism 108 is disposed at a proximal end of the sleeve body 102 and a second expandable sealing mechanism 110 is disposed at a distal end of the sleeve body 102. A sleeve 116 is in fluid communication with the sleeve body 102 by being connected to, coextensive with, and / or disposed within the sleeve body 102, and each of the sleeve 116 and the sleeve body 102 is in fluid communication with the lumen 106. An open cell foam 120 is disposed on an exterior surface of the sleeve body 102. As discussed above, the application of negative pressure to the fixation system 100 and the expansion of the first and second expandable sealing mechanisms 108, 110 causes a seal to be formed between the first and second expandable sealing mechanisms 108, 110 and the inner surface of the tissue cavity, generating a frictional force that resists displacement of the sleeve body 102.

[0075] 4A illustrates a view of the anchoring system 100 of FIG. 1A when the expandable sealing mechanism is in a collapsed position according to an embodiment of the present invention. As shown in FIG. 4A, the anchoring system 100 includes a sleeve body 102. A first expandable sealing mechanism 108 in a collapsed position is disposed at a proximal end of the sleeve body 102, and a second expandable sealing mechanism 110 also in a collapsed position is disposed at a distal end of the sleeve body 102. A sleeve 116 is in fluid communication with the sleeve body 102 by being connected to, coextensive with, and / or disposed within the sleeve body 102, and each of the sleeve 116 and the sleeve body 102 is in fluid communication with the lumen 106. An open cell foam 120 is disposed on an exterior surface of the sleeve body 102.

[0076] 1A and 4A when the expandable sealing mechanism is in an expanded position according to an embodiment of the present invention. As shown in FIG. 4B, the anchoring system 100 includes a sleeve body 102. A first expandable sealing mechanism 108 in an expanded position is disposed at a proximal end of the sleeve body 102, and a second expandable sealing mechanism 110 also in an expanded position is disposed at a distal end of the sleeve body 102. A sleeve 116 is in fluid communication with the sleeve body 102 by being connected to, coextensive with, and / or disposed within the sleeve body 102, and each of the sleeve 116 and the sleeve body 102 is in fluid communication with the lumen 106. An open cell foam 120 is disposed on an exterior surface of the sleeve body 102. In the embodiment of FIG. 4B, the first and second expandable sealing mechanisms 108, 110 are expanded by filling the sealing mechanisms with a fluid or inflation medium, such as, for example, saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution, delivered by the proximal and distal fluid lumens, respectively (see, e.g., proximal and distal fluid lumens 140 and 142 in FIG. 2C ).

[0077] 5 shows an exploded view of each of the components of the anchoring system 100 of FIG. 1A according to an embodiment of the present invention. As shown in FIG. 5, the anchoring system 100 includes a sleeve body 102 that is either (i) attached to the proximal end of the sleeve 116 through its distal end or (ii) disposed over the proximal end of the sleeve 116. As also shown in FIG. 5, the anchoring system 100 further includes a first (or proximal) expandable sealing mechanism 108 (e.g., a balloon) and a second (or distal) expandable sealing mechanism 110 (e.g., a balloon), and further includes a foam 120. According to some embodiments, the first expandable sealing mechanism 108 is disposed at the proximal end of the sleeve body 102, and the second expandable sealing mechanism 110 is disposed at the distal end of the sleeve body 102. The open cell foam 120 is disposed on an outer surface of the sleeve body 102. In some embodiments, as discussed above, the sleeve body 102 is absent and the expandable sealing mechanisms 108, 110 and foam 120 are attached directly to the proximal end of the sleeve 116.

[0078] 6A-6C show a method for insertion and anchoring of the anchoring system 200. The anchoring portion of the anchoring system 200, including the sleeve 220, the expandable sealing mechanism 212, 214, and the foam dispersed around the sleeve body, is delivered through the tissue cavity 202 to the anchoring site. In the case of an anastomosis, the device is delivered to a location proximal to the anastomosis such that the sleeve and the sealing mechanism are all proximal to the anastomosis. A semi-rigid tube pusher 203 is used to place the device in the proper position. A flexible membrane or protective sheath 204 covers the device, providing coverage and protection for the expandable sealing mechanism 212, 214, reducing friction during deployment and preventing damage to the sealing mechanism. The flexible membrane 204 also reduces friction further by covering the foam dispersed on the sleeve body. The device can be delivered using an endoscope or other delivery system without the flexible membrane cover. Exemplary delivery systems are discussed in detail below.

[0079] Once the device is positioned at a desired location above the area requiring isolation from the fecal stream by the sleeve 220, it is disconnected from the delivery system and the components of the delivery system, including the semi-rigid tube pusher 203 and the flexible membrane 204, are removed from the patient. In this regard, according to an embodiment, the flexible membrane 204 is positioned through a central lumen of the device 206 and emerges from a distal or tip end of the device 206 to cover and protect the expandable sealing mechanism 212, 214 and the foam dispersed around the sleeve body. The opposite end of the flexible membrane 204 is attached to a pulling handle (see, e.g., Figures 10A-10D), which allows for removal of the flexible membrane 204 by pulling it through the central lumen, thereby removing and exposing the expandable sealing mechanism 212, 214 and the foam dispersed around the sleeve body (see also, e.g., the discussion below with respect to Figures 10A-10J).

[0080] FIG. 6B shows the device 206 with the flexible membrane or protective sheath 204 removed and the expandable sealing mechanisms 212, 214 inflated by filling with a fluid or inflation medium (e.g., saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution). In some embodiments, the flexible membrane 204 is removed through the center of the semi-rigid tube pusher 203. FIG. 6C shows the device 208 after negative pressure is applied through the pressure lumen 210 and the expandable sealing mechanisms 212, 214 are filled with a fluid or inflation medium (e.g., saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution). As air is removed from the space on the outer surface of the sleeve body between the expandable sealing mechanisms 212 and 214, the inner wall of the tissue cavity is drawn in against the sleeve body. As shown in FIG. 6B, the device 206 can have an outer diameter of some or all of its components that is smaller than the inner diameter of the inner wall 215, 217 of the completely closed tissue cavity to which the device 206 is to be secured. In an expanded state, the expandable sealing mechanism 212, 214 further creates a seal with the tissue cavity wall at either end of the sleeve body. As shown in FIG. 6B and FIG. 6C, in an expanded state, the expandable sealing mechanism 212, 214 includes expanded sealing elements 222, 224 that are structured to conform with the inner wall 216, 218 of the tissue cavity when negative pressure is applied, thereby creating a liquid-tight and air-tight seal. The flexibility of the expanded sealing elements 222, 224 and the angle at which they protrude allows them to conform when negative pressure is applied to avoid causing compression ischemia of the intestinal wall. This allows the expanded sealing elements 222, 224 to lie flat against the tissue surface and create a seal with low pressure against the tissue at the interface between the expandable sealing mechanism 212, 214 (or the expanded sealing elements 222, 224) and the tissue cavity walls 216, 218. The expansion of the expandable sealing mechanism 212, 214 also provides the ability to accommodate contour irregularities in the tissue cavity inner walls 216, 218. Additionally, the expandable sealing mechanism 212, 214 has an outer diameter that is larger than the outer diameter of the foam. This allows for a more reliable seal to be created with the intestine when the intestinal wall is adsorbed during negative pressure activation.

[0081] The seals at both ends of the sleeve and / or sleeve body prevent air from entering the space between the sleeve and / or sleeve body and the cavity wall. The expandable sealing mechanism 212 at the proximal end of the sleeve body (or sleeve) also redirects the flow of fluids and other GI contents traveling through the tissue cavity into the central lumen of the sleeve when the tissue cavity is the intestine. The GI contents enter the sleeve 220 through the central lumen. Thus, the GI contents are isolated from the anastomosis more distal in the GI tract. This prevents contamination of the anastomosis by fecal flow. The expandable sealing mechanism 212, 214 in combination with the negative pressure creates an air-tight and liquid-tight GI contents bypass path that is superior to other methods that have been used to attempt to create an effective seal at the proximal end of the intraluminal bypass sleeve.

[0082] 1A and 4A when the expandable sealing mechanism is in an expanded position according to an embodiment of the present invention. As shown in FIG. 7A, the anchoring system 100 includes a sleeve body 102. A first expandable sealing mechanism 108 in an expanded position is disposed at a proximal end of the sleeve body 102, and a second expandable sealing mechanism 110 also in an expanded position is disposed at a distal end of the sleeve body 102. A sleeve 116 is in fluid communication with the sleeve body 102 by being connected to, coextensive with, and / or disposed within the sleeve body 102, and each of the sleeve 116 and the sleeve body 102 is in fluid communication with the lumen 106. An open cell foam 120 is disposed on an exterior surface of the sleeve body 102. In the embodiment of FIG. 7A, the first expandable sealing mechanism 108 is expanded (or inflated) by filling the sealing mechanism with a fluid or inflation medium, such as saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution, delivered to the first expandable sealing mechanism 108 through a proximal fluid lumen 140 in fluid communication therewith and via a proximal inlet 150.

[0083] 1A, 4A, and 7A when the expandable sealing mechanism is in an expanded position according to an embodiment of the present invention. As shown in FIG. 7B, the anchoring system 100 includes a sleeve body 102. A first expandable sealing mechanism 108 in an expanded position is disposed at a proximal end of the sleeve body 102, and a second expandable sealing mechanism 110 also in an expanded position is disposed at a distal end of the sleeve body 102. A sleeve 116 is in fluid communication with the sleeve body 102 by being connected to, coextensive with, and / or disposed within the sleeve body 102, and each of the sleeve 116 and the sleeve body 102 is in fluid communication with the lumen 106. An open cell foam 120 is disposed on an exterior surface of the sleeve body 102. In the embodiment of FIG. 7B, the second expandable sealing mechanism 110 is expanded (or inflated) by filling the sealing mechanism with a fluid, such as saline, mineral oil, and / or a dye-based (e.g., iodine-based) contrast solution, delivered to the second expandable sealing mechanism 110 through the distal inlet 152 via the distal fluid lumen 142, which is in fluid communication with the second expandable sealing mechanism 110.

[0084] FIG. 8 illustrates a view of the anchoring system 100 of FIGS. 1A and 4A when the expandable sealing mechanism is in an expanded position and a contrast lumen is provided according to an embodiment of the present invention. As shown in FIG. 8, the anchoring system 100 includes a sleeve body 102. A first expandable sealing mechanism 108 in an expanded position is disposed at a proximal end of the sleeve body 102, and a second expandable sealing mechanism 110 also in an expanded position is disposed at a distal end of the sleeve body 102. A sleeve 116 is in fluid communication with the sleeve body 102 by being connected to, coextensive with, and / or disposed within the sleeve body 102, and each of the sleeve 116 and the sleeve body 102 is in fluid communication with the lumen 106. An open cell foam 120 is disposed on an exterior surface of the sleeve body 102. In the embodiment of FIG. 8, a contrast lumen 146 is provided for injecting a contrast agent or radiopaque dye to perform an X-ray imaging leak test. For example, with the embodiment of FIG. 8, a contrast lumen 146 is provided for injecting a contrast agent or radiopaque dye through exit port 154 distal to the anchoring portion of the sleeve body 102 of the device within the intestine to perform an X-ray imaging leak test.

[0085] FIG. 9 illustrates a view of the anchoring system 100 of FIGS. 1A and 4A with the expandable sealing mechanism in an expanded position and negative pressure applied, according to an embodiment of the present invention. As shown in FIG. 9, the anchoring system 100 includes a sleeve body 102. A first expandable sealing mechanism 108 in an expanded position is disposed at a proximal end of the sleeve body 102, and a second expandable sealing mechanism 110 also in an expanded position is disposed at a distal end of the sleeve body 102. A sleeve 116 is in fluid communication with the sleeve body 102 by being connected to, coextensive with, and / or disposed within the sleeve body 102, and each of the sleeve 116 and the sleeve body 102 is in fluid communication with the lumen 106. An open cell foam 120 is disposed on an outer surface of the sleeve body 102. In the embodiment of FIG. 9, a negative pressure lumen 145 is provided for applying a negative pressure (e.g., a vacuum) to the anchoring system 100. 9, a negative pressure lumen 145 is provided to provide negative pressure to the anchor portion or sleeve body 102 of the device through exit ports 155, 156, and 157. The application of negative pressure to the anchor portion or sleeve body 102 and the expansion of the first and second expandable sealing mechanisms 108, 110 causes a seal to form between the first and second expandable sealing mechanisms 108, 110 and the inner surface of the tissue cavity, creating a frictional force that resists displacement of the sleeve body 102 and / or sleeve 116.

[0086] 13 and 14 illustrate an anchoring system for the treatment of the intestinal wall. In this embodiment, the anchoring system 600 has a first anchoring element 601 at the proximal end of the system located proximal to the intestinal site to be treated in the intestine, and a second distal anchoring element 602 that seals distally beyond the site to be treated in the intestine. There is a port 609 in fluid communication with the integrally sealed space between the two anchoring elements and between the intestinal wall and the outer surface of the sleeve, to allow for the introduction or removal of fluids or inflation media, such as, for example, saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solutions, for example, to inflate and deflate the expandable sealing mechanism. Fluid tubing 603 in communication with the port 609 can be used to introduce fluid (e.g., saline) from an infiltration fluid source 605, such as a syringe. This port is accessible from outside the patient's body through flexible tubing 603. This configuration of the device allows for inflation and / or deflation of the expandable sealing mechanism, irrigation, medication (such as antibiotics, anti-inflammatory drugs, or chemotherapy), and / or delivery and removal of fluids or distension media (e.g., saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solutions) for radiographic purposes between the outer surface of the sleeve 611 and the intestinal wall between the two anchoring elements 601, 602. In some embodiments, the second distal anchoring element 602 is shorter than the first proximal anchoring element 601 because the anchoring strength of the second anchoring element 602 may be less strong and a longer anchoring element 602 would not fit within the intestine in cases that may require treatment near the anal verge. The system 600 further includes a pressure tube 612. As shown in FIG. 13, the pressure tube 612 can be in fluid communication with the outer surface of the sleeve of the first anchoring element 601 and the sleeve of the second anchoring element 602. Alternatively, the system 600 can include two pressure tubes, one for each of the sleeves of the first anchor element 601 and the second anchor element 602. The pressure tube 612 is connected to a pneumatic system 607 configured to apply negative pressure to the pressure tubes to anchor the anchor elements 601, 602.

[0087] FIG. 14 is a side view of an embodiment of a dual anchoring element system, in which like reference numbers indicate like features as in FIG. 13. This configuration is clinically important for several scenarios in which it is believed that treatment of isolated bowel segments may be beneficial. Since this configuration allows for controlled containment of therapeutic agents to individual bowel segments within the bowel lumen, this embodiment offers the unique ability to provide robust localized treatment of the bowel wall. For example, after endoscopic polypectomy, the cut site could be isolated by an embodiment of the present disclosure and treated using local chemotherapy. Another example could be inflammatory bowel disease, in which case the diseased bowel segment could have an anti-inflammatory agent delivered and maintained at the disease site. In the event of injury or perforation of the bowel wall, an antimicrobial agent could be introduced to reduce the bacterial load during healing and reduce the risk of worsening infection. The two anchoring elements can be spaced anywhere from about 1 cm to 6 feet apart depending on the medical indication and the desired length of the bowel to be treated. In some cases, it is believed that the surgeon may be able to manually advance the device from outside the intestinal wall during open surgery, thus allowing for very long intestinal segments to be treated, with the upper limit on this length being the total length of the intestine. This also applies to the one anchoring element variant of the device, as it is believed that the device may be able to have a sleeve length that would be able to protect the entire intestine.

[0088] There are several key differences that distinguish this intestinal protection device from negative pressure wound therapy treatment devices that can be used within the intestinal tract. The anchoring portion of the device of the present disclosure is not configured to directly treat the site of an intestinal injury, wound, or anastomosis. The anchoring portion is configured to be suitable for anchoring a sleeve portion of the device that protects the site of an intestinal injury, wound, or anastomosis. Importantly, the anchoring portion of the device is designed to be placed in the intestine to healthy, uninjured intestine above or proximal to the site of an intestinal injury. This method dramatically increases the safety potential of the present device as negative pressure is not delivered to the site of anastomosis, injury, or injury and therefore this portion of the protected intestine is not rendered ischemic or exposed to significant shear or traction forces from the device.

[0089] Negative pressure, when delivered through a sponge interface, has been shown to reduce blood flow to the delivery site. Thus, delivering negative pressure to an injured site of the intestine may itself cause further injury to the intestine or impede healing as the intestine's blood supply is not as robust as that of other tissues (especially at the anastomosis). Additionally, the described method and device has a flexible sleeve that covers the anastomosis or injury site of the intestine, and therefore anchoring of the device occurs at a location separate from the site of the injured tissue. Because the flexible sleeve is not as mechanically stiff as negative pressure wound therapy dressings that use wire stent-based internal structures to maintain luminal patency and facilitate anchoring, less mechanical force is exerted on the intestine as the intestine squeezes around the device during intestinal contraction at the injured intestine site. Additionally, by locating the anchor away from the injured intestine site, the device does not exert mechanical force on the anastomosis or injured tissue when subjected to traction or pulling from pressure tubing or other parts of the device that are external to the patient's body. No part of the device is anchored distally to the damaged intestine, therefore traction is only exerted on the proximal healthy intestinal tissue, reducing the risk of dislodging the anastomotic repair or further damaging the damaged intestinal site.

[0090] Another difference is that the anchoring devices described herein should have a significantly higher pull-out strength because they must be anchored strongly enough to maintain the entire sleeve and anchor element in place in a normally functioning, intact intestine. To achieve this high pull-out strength, the anchor must be long and wide enough to allow a sufficient area of ​​sponge contact to prevent extrusion, the anchor and sleeve must be configured to fit to resist displacement due to peristalsis, and the expandable sealing mechanism must be more robust to prevent potential air leaks.

[0091] Unlike devices that are only designed to mechanically detach over time due to intestinal function and peristalsis, the devices described herein are designed to remain in place for extended periods of time until removed by the treating clinician. The higher anchoring strength and more secure fixation of the anchoring system 100 is important because it allows for placement of the device closer to the intestinal site being treated. In the case of intestinal anastomosis in the colon, placement of the device high in the intestine from the anus is difficult due to the curvature of the intestine. Thus, unlike devices that must be positioned quite high in the intestine (>40 cm above the site being treated) due to device migration during the treatment period, the immovable anchoring provided by the anchoring system of the present disclosure allows for placement of the anchoring elements (sleeve, expandable sealing mechanism, and foam) only a few centimeters above the site being treated. However, it may be preferable to place the anchoring elements at least 10 cm above the site being treated to avoid any potential further damage to the fragile intestinal segment.

[0092] This ability to deliver a controlled fixation is achieved through design elements of the present description detailed below.

[0093] In the following, components of an anchoring system according to some embodiments of the present invention are described in detail, with reference to Figures 1A, 2A, 3, 4A and 4B unless otherwise indicated.

[0094] Sleeve body According to some embodiments of the present invention, the sleeve body 102 is a flexible concentric tube. In some embodiments, the sleeve body 102 is attached and / or bonded to the outer surface of the sleeve 116 to provide local support within the anchor section while providing greater flexibility and suppleness along the entire length of the sleeve 116. In some embodiments, the sleeve body 102 provides additional local support to prevent collapse of the sleeve 116 and lumen 106 under expansion of the expandable sealing mechanisms 108 and 110, and additional support to prevent angular displacement of the expandable sealing mechanisms 108 and 110 after expansion. The sleeve body 102 can be tuned to provide greater or lesser strength by altering the wall thickness and material hardness as described below.

[0095] The outer diameter and profile can be configured to move without significant resistance within the intestine when negative pressure is not applied to the outer surface of the sleeve body 102. In some embodiments, the outer diameter of the sleeve body 102 is between 11 mm and 61 mm in cross-sectional outer diameter. The inner diameter of the sleeve body 102 determines the diameter of the lumen 106, and in some embodiments, the sleeve body 102 has an inner lumen diameter between 10 mm and 60 mm in cross-sectional inner diameter. For anchoring within tissue cavities other than the intestine, these parameters will differ based on the hollow organ to which anchoring is to be achieved. In some embodiments, the sleeve body 102 can have a diameter greater than or equal to the diameter of the tissue cavity. In some embodiments, the sleeve 116 can have a diameter less than the diameter of the tissue cavity. In some examples, the sleeve 116 can have a diameter less than 95% of the diameter of the tissue cavity. In some examples, the sleeve 116 can have a diameter less than 50% of the diameter of the tissue cavity. In some examples, the sleeve 116 can have a diameter that is less than 25% of the diameter of the tissue cavity.

[0096] In some embodiments, the sleeve body 102 is configured to be flexible enough to be easily removed by pulling on the sleeve 116 to slide it out through the intestine and anus, yet rigid enough that when negative pressure is applied, the sleeve body 102 retains a concentric shape to form the lumen 106. This allows for easy placement and removal of the device 100. When negative pressure is applied to the exterior surface of the sleeve body 102, the sleeve body 102 and the surrounding foam 120 conform to the contours of the GI tract.

[0097] The sleeve body 102 is configured to be flexible and malleable so as not to cause erosion in the intestine. The sleeve body 102 is sufficiently flexible and malleable to allow its proximal and distal ends to conform to the contours of the intestine, thereby maintaining foam-to-intestinal wall contact during peristalsis, and the expandable sealing mechanisms 108, 110 can create and maintain a seal, but keep the concentric tubular shape of the lumen 106 open to allow GI contents to pass. According to some embodiments, the sleeve body 102 comprises medical grade silicone, polyurethane, thermoplastic elastomer, rubber, or other polymers that provide the flexibility and rigidity properties described herein. The flexibility of the sleeve body 102 reduces pressure points caused by the contractile forces of the intestine, allowing the sleeve body 102 to be securely anchored within the patient's body. The sleeve body 102 according to some embodiments has a Shore A hardness between about 20A and about 70A, providing maximum flexibility while maintaining a concentric shape and a patent lumen. The flexibility of the sleeve body is also determined by the main body wall thickness. The sleeve body 102 has a thin wall, again allowing the deformation forces from intestinal peristalsis to act on the sleeve body 102. In some embodiments, the sleeve body 102 has a body thickness between 0.1 mm and 8 mm. This thickness allows for the utilization of more durable materials while still accommodating the peristaltic movements of the intestinal wall.

[0098] The flexibility of the sleeve body 102 allows it to deform with the intestine during peristalsis, which moves the contents in the intestine by sequentially compressing the proximal segments of the intestine. Because the device is flexible, it maintains a seal between the expandable sealing mechanisms 108 and 110 even when deformed by peristalsis or the passage of intestinal material. This seal is achieved without the intestine compressing the device by exerting a potentially damaging force on the intestinal wall as a counter force, maintaining a constant negative pressure between the expandable sealing mechanisms 108 and 110, which creates a near constant normal force along the length of the anchoring element that prevents migration by maintaining the foam-to-intestinal wall relationship during peristalsis. Thus, the device conforms and moves in concert with the intestinal wall, in part, due to the distribution of adhesive forces over the entire surface of the sleeve body 102 covered by the foam interface.

[0099] Additionally, the flexibility allows the sleeve body 102 to maintain the position of the foam 120 on the intestinal wall during intestinal contractions without generating shear forces between the foam 120 and the intestinal wall. As the intestine contracts, the flexible sleeve body 102 deforms due to forces exerted through the attached foam 120, and thus the foam 120 can easily deform with the intestinal wall instead of the intestinal wall peeling away, resulting in device migration.

[0100] Furthermore, with more flexible anchoring elements, the peristaltic waves have less ability to push against the anchoring element due to its flexibility and compliance to contraction, whereas with a stiffer, less compliant body, such as a wire-based stent, the peristaltic waves are resisted by the less deformable body to push, resulting in displacement of the device.

[0101] Additionally, the flexibility, compressibility, and malleability of the devices of the present disclosure aid in the placement and removal of the device through the curves of the intestinal lumen. As the intestine becomes more tortuous and curved the higher it gets in the digestive tract, flexibility allows for the delivery of the device therein and easier removal. This flexibility also allows for the longer sleeve body 102, with its larger area of ​​foam 120 and resulting higher anchoring strength, to be manipulated into the intestine. This flexibility is important for the anchoring system 100 because the foam 120 itself has a higher coefficient of friction than that of a device without the foam.

[0102] In contrast to the inventions of the present disclosure, the stent-like devices have a stiffness that resists compression. This stiffness increases the normal forces on the stent and intestine as the intestine contracts, causing the stent to slide along the intestinal surface with the peristaltic waves of normal intestinal contractions. Some stent-based designs do have some compressibility and flexibility, but much less than that of the devices of the present disclosure. Due to the low durometer structure, thickness, compressibility, and conformability of the sleeve body 102 of the device according to some embodiments, the anchoring element has a significant resistance to displacement due to peristaltic activity. The flexibility of the sleeve body 102 and the expandable sealing mechanism 108, 110 has the further advantage of facilitating steering along the normal longitudinal curvature of the intestinal lumen for placement within the intestine, as compared to stiffer devices. Furthermore, the devices of the present disclosure can more easily conform to accommodate longitudinal curvature when placed in intestinal regions having this curvature, and can maintain foam-to-intestinal surface contact when negative pressure is applied, preventing pressure points that can potentially damage the intestinal wall. Additionally, the elimination of wire stent-based construction significantly improves manufacturability in terms of both ease and cost.

[0103] The sleeve body length determines the length of the anchoring element, and the length of the anchoring portion of the device is also an important characteristic of the device. The anchoring strength of the anchoring portion of the device is directly dependent on the length of the sleeve body 102 and the area of ​​foam 120 in contact with the intestinal wall over this length. Just as the diameter affects the foam contact area, so does the length of the active portion. Unlike a stent, negative pressure dressing, or sheath that can be positioned over an anastomosis or damaged intestinal site distal in the colon near the anal verge and supported in place by the stiffness of the device, without having to conform significantly to bowel bends proximal in the intestine, the anchoring portion of the system according to some embodiments comprises a length window of over 3 cm to just under 25 cm in length. Testing in a porcine model conducted by the inventors has shown that if the anchoring device is less than 3 cm long and has a diameter of 33 mm, the device will not have the area to maintain a pullout strength of more than 5 pounds and may be susceptible to seal loss and device displacement with low forces (<5 pounds of force). Furthermore, if the length of the anchor portion of the device is longer than 25 cm, the device cannot be easily placed near anatomical bends in the intestine and cannot be placed at the intended anchoring site above the level of the intestinal section to be protected (proximal in the intestine). For applications in other tissue cavities that do not require as much pull-out strength, such as in ducts or the esophagus, the device length can be shorter than 3 cm. Furthermore, embodiments of the present invention are not limited to flexible sleeves, but rather a stent-like sleeve surrounded by foam can be used.

[0104] Expandable sealing mechanism The device 100 includes expandable sealing mechanisms 108, 110 disposed at each end of the sleeve body 102 and / or along the proximal end of the sleeve 116. According to some embodiments, the expandable sealing mechanisms 108, 110 include two soft, inflatable elastomeric balloons that provide an atraumatic sealing surface to facilitate negative pressure anchoring while providing a liquid / air tight seal that prevents fecal contamination distal to the anchoring system 100. According to one embodiment, the expandable sealing mechanisms 108, 110 are expanded by injecting a fluid or inflation medium (e.g., normal saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution) through a syringe connected to the distal and / or proximal ports of the anchoring system 100. The expandable sealing mechanisms 108, 110 contact the inner surface of the tissue cavity into which the sleeve body 102 and / or sleeve 116 are inserted. The expandable sealing mechanisms 108, 110 provide at least one function. First, the expandable sealing mechanisms 108, 110, in their expanded state, create a seal between the proximal and distal ends of the exterior surface of the sleeve body 102 and the intestinal wall, creating a negative pressure space that can draw the foam 120 to the intestinal wall and create an anchoring force. Second, these seals create a fluid-tight and air-tight seal with the interior surface of the tissue cavity at both ends of the sleeve body 102 when the expandable sealing mechanisms 108, 110 are expanded and a negative pressure is applied to the exterior surface of the sleeve body 102, thereby redirecting the flow path of the GI contents through the lumen 106 of the sleeve body 102 and into the same lumen 106 of the sleeve 116 attached to the sleeve body 102. Because the fecal flow is directed by the expandable sealing mechanisms 108, 110 to the central lumen 106 of the sleeve body 102, the expansion of the expandable sealing mechanisms 108, 110 minimizes the risk that forward or reverse flow of feces will result in destruction of the seal.

[0105] The exact height of each expandable sealing feature 108, 110 is not as important as the relationship of the sealing feature to the outer diameter of the foam 120 covering. The expandable sealing features 108, 110 of the system in some embodiments extend beyond the height of the foam 120 at rest, which facilitates the formation of a seal between the expandable sealing features 108, 110 and the intestinal wall without interference from the foam 120 when expansion and / or negative pressure is applied to collapse the intestinal wall. Thus, the annular diameter of the expandable sealing elements 108, 110 at rest, when no expansion and / or negative pressure is applied, is greater than the annular diameter of the foam 120 distributed on the sleeve body 102. In some embodiments, the expandable sealing features 108, 110 extend beyond the height of the foam 120 by at least 1 mm at rest.

[0106] The expandable sealing mechanisms 108, 110 are fabricated from soft, inflatable, flexible materials that allow them to expand and conform to the surface of the intestine. This flexibility is important because otherwise the peristaltic forces of intestinal contractions can result in potentially harmful pressure points. For example, the expandable sealing mechanisms 108, 110 can include thermoplastic elastomers, silicones, polyurethanes, rubber, or other rubber-like materials or polymers. The Shore A hardness of the material can range between about 20A and about 70A. Similar to the low durometer hardness of the sleeve body 102, the low durometer hardness of the expandable sealing mechanisms 108, 110 allows for compression and conformance with the intestinal lumen during the sealing process when expansion and negative pressure are applied and during intestinal peristalsis. The conformability, flexibility, and compressibility of the expandable sealing mechanisms 108, 110 in a manner similar to the flexibility of the sleeve body allows for smaller displacements during peristalsis and easier placement and removal of the device.

[0107] The expandable sealing features 108, 110 extend radially beyond the outer diameter of the sleeve body 102 and / or sleeve 116 to form a seal at each end of the sleeve body 102 and / or along the proximal end of the sleeve 116. The expandable sealing elements 108, 110 extend radially for the inner surface of the tissue cavity. In some embodiments, the expandable sealing elements 108, 110 extend radially beyond the foam 120 before and / or after expansion to allow a seal to be created at the end of the sleeve body 102 and / or sleeve 116 without interference from the foam 120. Each expandable sealing feature 108, 110 can be a single sealing element or multiple sealing elements. The expandable sealing elements allow for both air-tight and liquid-tight sealing and are configured to conform with GI tissue to create one or more air-tight and liquid-tight seals.

[0108] The expandable sealing mechanism 108, 110 can be configured to be concentrically mounted around the outer surface of the sleeve body 102 and / or sleeve 116, or can be incorporated into the walls of the sleeve body 102 and / or sleeve 116. In particular, the above relates to the manufacturing process used to make the anchor portion, as the expandable sealing element can be manufactured in one mold with the sleeve body 102 and / or sleeve 116, or can be molded separately from and bonded to the sleeve body 102 and / or sleeve 116. According to some embodiments, the expandable sealing element 108, 110 and the sleeve body 102 and / or sleeve 116 are manufactured as a single molded part, as both elements of the device have similar material property requirements for strength, flexibility, and compatibility. In some embodiments, the sleeve body 102 and / or sleeve 116 and the expandable sealing mechanism 108, 110 are made from a single mold using the same material.

[0109] In some embodiments, the sleeve body 102 and / or sleeve 116 are divided into multiple anchoring portion segments with independent negative pressure sources. An anchoring portion segment is a section along the sleeve that independently anchors the sleeve. In some embodiments, the sleeve body 102 and / or sleeve 116 are divided into one or more additional anchoring portion elements to create two or more complete sealing areas along the sleeve that independently anchor to the intestinal wall. Foam is placed in each complete sealing section to distribute pressure and interface with the intestinal wall. Negative pressure is applied to the space between the seals to create redundant anchoring sites along the length of the sleeve body and / or sleeve while each expandable sealing feature is expanded. In some configurations, negative pressure is applied to each segment from an independent negative pressure source while each sealing feature is expanded from one or more expansion and / or inflation sources. In some configurations, the segments share the same negative pressure source and / or the same inflation source. This embodiment provides redundancy in the anchoring system, similar to having multiple anchoring elements. The advantage of this design is that if the seal is broken in one segment, the adhesive / cohesive forces of the other segment or segments continue to exist.

[0110] Sleeves, extension tubing, and collection bags The device 100 includes a sleeve 116 that, in some embodiments, is in fluid communication with the sleeve body 102 by being connected to, coextensive with, and / or disposed within the sleeve body 102. According to some embodiments, the sleeve 116 is directly connected to the sleeve body 102. According to some embodiments, the sleeve 116 is indirectly connected to the sleeve body 102. For example, the sleeve 116 can be connected to a second expandable sealing mechanism 110 at the distal end of the sleeve body 102. In some embodiments, the sleeve and the sleeve body are a single tubular structure. For example, the sleeve 116 can be the sleeve body 102 by having two expandable sealing elements 108, 110 and a foam 120 distributed on the proximal end of the sleeve 116 without a separate sleeve body. The sleeve 116 shares the same lumen 106 as the sleeve body 102. The expandable sealing mechanisms 108, 110 redirect the flow path of GI contents into the sleeve body 102. Once the GI contents reach the distal end of the sleeve body 102, they continue through the lumen 106 of the sleeve 116. The sleeve 116 can be of sufficient length to extend from the distal end of the sleeve body 102 into the patient's anal canal and further outside the patient's body. Thus, as the GI contents enter the sleeve body 102, they are directed into the sleeve 116 and completely isolated from the inner surface of the patient's intestine distal to the sleeve body 102. The sleeve 116 forms a barrier between the fecal stream contents and the intestinal wall, thereby protecting this portion of the intestine. To isolate the intestinal wall from the fecal stream contents, the sleeve 116 should be substantially fluid impermeable. Secondarily, the sleeve 116 also mechanically protects the intestinal wall from the mechanical distension forces of the GI stream contents.

[0111] According to some embodiments, the sleeve 116 is coupled to the sleeve body 102 or the distal (second) expandable sealing mechanism 110. The sleeve 116 can have a molded in fastening fitting configured to lock into the sleeve body 102 or the distal sealing mechanism 110. According to some embodiments, the sleeve 116 is made of a non-degradable biocompatible material. For example, the sleeve 116 can be made of silicone, polyurethane, thermoplastic elastomer, rubber, or other polymers, although embodiments of the present invention are not limited to these materials. The sleeve 116 should be substantially impermeable to fluids and bacteria.

[0112] The sleeve 116 is configured to have a diameter that allows the sleeve 116 to reside in the GI tract without impeding the flow of GI flow material therethrough. In some embodiments, the sleeve 116 has a cross-sectional diameter between about 10 mm and about 60 mm. The sleeve 116 is made of a suitable material and is thin and malleable enough to be compressible by the intestinal wall and not eliminate the effects of peristalsis on fecal flow. Unlike semi-rigid drainage tubes that are primarily designed to remain patent and rely on gravity and gastrointestinal flow pressures to move GI contents down the tube, the sleeve according to some embodiments is deformable during peristalsis such that successive compressions allow the contents to move down the tube. This deformability allows for placement of the device in more proximal locations in the intestine, as gravity and GI flow pressures are insufficient to move material through the longer lengths of the sleeve due to flow resistance that increases with sleeve length. Additionally, this adaptability and associated flexibility allows for navigation around bowel bends, improving patient comfort and reducing the chance of bowel wall damage / erosion and clogging of the sleeve. Some embodiments of the sleeve 116 have a wall thickness between about 50 microns and 5 mm. In some embodiments, the length of the sleeve 116 is sufficient for the sleeve 116 to extend beyond the GI tract and out of the anal canal after device placement. In some instances, the sleeve 116 is between about 8 inches and 72 inches in length. In some embodiments, the device is configured such that the device can be removed from the body cavity using extracorporeal traction on the sleeve 116. The sleeve 116 should be strong enough to withstand a longitudinal traction force of at least 10 pounds of force without tearing so that the sleeve can be used to retrieve the device after treatment is complete. The sleeve 116 in some embodiments is marked with an indicator along its length to indicate the length of the sleeve 116 present in the GI tract or tissue cavity after placement in the bowel or other tissue cavity. A user can use the indicator to determine if the anchor section is moving or not.The sleeve 116 according to some embodiments has a fixed length.According to some embodiments, the length of the sleeve 116 can be adjusted by cutting the sleeve 116 .

[0113] According to an embodiment, the sleeve 116 is connected or clipped to optional extension tubing that can be attached for in-room use. FIG. 12 illustrates extension tubing 500 according to an embodiment of the present invention. As shown in FIG. 12, the extension tubing 500 includes an inlet or proximal end 502 having an inlet connection 512 that can be used to connect to the distal end of the sleeve 116. The extension tubing 500 further includes a tube 510 that extends from the inlet or proximal end 502 to an outlet or distal end 504. The outlet or distal end 504 includes an outlet connection 514 and one or more connection members 516 for attaching the extension tubing 500 to another member and / or a retrieval bag. According to one embodiment, the extension tubing 500 extends the length of the device sleeve 116 to a retrieval bag (discussed below) for in-room use. According to one embodiment, the extension tubing 500 allows for easy removal of the ICD device in the hospital room or outpatient clinic without the need for an additional invasive procedure.

[0114] According to some embodiments of the invention, a retrieval bag is placed at the distal end of the sleeve 116 and / or extension tubing 500 to manage the intestinal (or GI) contents delivered from the sleeve 116. The retrieval bag is airtight and leak-proof, with sufficient volume to accommodate at least one day of use and provisions for emptying the contents. The retrieval bag is attached to the sleeve 116 and / or extension tubing (see, e.g., extension tubing 500 in FIG. 12) and is easily replaced using quick connect fittings. The retrieval bag can be concealed and worn on the leg, for example in conjunction with an elastic leg strap, in mobile patients, or attached to the bedside when used with bedridden patients. The retrieval bag is resistant to GI contents, provides an odor barrier, and is biocompatible for use in direct contact with the skin. The retrieval bag is provided non-sterile in a single-use peel-open pouch.

[0115] 20A-20B and 21A-21B, according to one embodiment, a collection bag 1300, 1400, which may be attached to the end of the sleeve 116 and / or the distal end 504 of the extension tubing 500, includes an inlet end or connection 1302, 1402 attached to the end of the sleeve 116 and / or the distal end 504 of the extension tubing 500. The inlet end or connection 1302, 1402 of the collection bag 1300, 1400 is connected to a neck portion 1304, 1404 which is further attached to a bag portion 1305, 1405 of the collection bag 1300, 1400 which collects the GI contents that have flowed through the sleeve body 102 and the sleeve 116. The bag portion 1305, 1405 transitions to an outlet end 1310, 1410 where the collected GI contents can be emptied from the collection bag 1300, 1400. As shown in the embodiment of Figures 20A-20B and 21A-21B, the bag portion 1305, 1405 tapers to the outlet end 1310, 1410. The collection bag 1300, 400 can further include a number of markings 1306, 1406 for measuring the amount of collected GI contents. Additionally, the collection bag 1300, 1400 can include one or more openings 1308, 1408 that allow it to be attached to a patient and / or a hospital bed.

[0116] Figure 20A further illustrates a drainage clamp 1320 that can be used to fasten or seal the outlet end 1310 of the collection bag 1300 until the collected GI contents are to be emptied from the collection bag 1300 through the outlet end 1310. Figure 20B illustrates a pair of attachment straps 1330, 1340 that can be positioned within one or more openings 1308, 1408 in the bag portion 1305, 1405 of the collection bag 1300, 1400 to attach the collection bag 1300, 1400 to a patient and / or hospital bed.

[0117] The retrieval bag 1300, 1400 should be substantially impermeable to air and fluids. The retrieval bag 1300, 1400 retrieves GI contents that have flowed through the sleeve body 102 and the sleeve 116. In some configurations, the sleeve 116 terminates in a port that can be kept closed for continence and opened to be emptied. In other configurations, the sleeve 116 is flexible enough to allow the anal sphincter to compress the sleeve and provide continence. In this configuration, a retrieval bag may not be used. According to some embodiments, the retrieval bag can be disconnected and replaced as needed. In some embodiments, the retrieval bag can be configured with a connection fitting that allows the sleeve to be trimmed in length and a seal to the bag to be re-established. In some embodiments, the retrieval bag has markings (see, e.g., markings 1306, 1406) so that the volume of effluent can be determined. In some embodiments, the retrieval bag has leg straps (see, e.g., attachment straps 1330, 1340) for attaching it to the patient's body. In some embodiments, the retrieval bag can include a port to prevent any excess gas buildup. According to some embodiments, the extracorporeal retrieval bag includes a one-way valve to prevent the retrieved GI contents from flowing back into the sleeve. In some embodiments, the retrieval bag includes elastic leg straps (see, e.g., attachment straps 1330, 1340) that fasten the retrieval bag to the patient's body.

[0118] Foam and / or air-permeable roughened materials The device 100 includes foam 120 disposed on the exterior surface of the sleeve body 102. The foam 120 or foam-like material (e.g., an air-permeable roughened material) functions importantly in both enhancing adhesion strength and preventing damage to the intestine. The foam 120 provides important friction to hold the sleeve body 102 in place when suction is applied to the exterior surface of the sleeve body 102. Additionally, the foam 120 distributes negative pressure and forces to minimize pressure points that could potentially cause damage to the intestine.

[0119] The foam 120 distributed on the sleeve body 102 and / or sleeve 116 provides a high coefficient of friction material with the maximum area where adhesion occurs due to the normal force generated by the negative pressure. Foam and / or air-conducting rough surface materials are the best materials for distributing the negative pressure in the present application and for providing an effective coefficient of friction when negative pressure is applied. It is conceivable that a device could be envisioned using a membrane with a series of holes arranged in close proximity to distribute the negative pressure to form a porous membrane. However, the normal force that a membrane-based device generates is limited by the exposed area provided by the holes. Furthermore, a porous membrane has a much lower coefficient of friction than that of the foam and / or the rough surface of the air-conducting rough surface material. The foam and / or the air-conducting rough surface material also has a larger effective contact area with the intestine due to its open cell structure and multiple pores for distributing the negative pressure through the substance of the material. It is believed that the magnitude of the negative pressure required would have to be increased to maintain the same pull-out strength without the foam (or air-conducting rough surface material), imposing significant point stresses on the intestine.

[0120] The foam 120 and / or air-conducting rough surface material include materials selected to provide specific compression characteristics and coefficients of friction to prevent movement of the sleeve body 102 and / or sleeve 116. The foam 120 and / or air-conducting rough surface material can include materials with pore sizes that allow negative pressure to be dispersed through the foam while preventing tissue ingrowth into the foam. This allows the foam 120 and / or air-conducting rough surface material to easily detach from the inner surface of the tissue cavity when normal pressure is restored. To have the properties required to disperse negative pressure and generate high frictional forces, some embodiments of the foam 120 and / or air-conducting rough surface material have an average foam pore size that is between about 50 microns and about 1000 microns in diameter. The average pore size of the foam 120 and / or air-conducting rough surface material in some embodiments is between about 100 microns and 300 microns. The average pore size of the foam 120 and / or air-conducting rough surface material in some embodiments is between about 200 and 400 microns. The average pore size of the foam 120 and / or air-conducting rough surface material in some embodiments is between about 300 and 600 microns. Excessively small pore sizes and foam 120 and / or air-conducting rough surface material will lose some of their frictional function, and excessively large pore sizes and materials may have tissue ingrowth and have lower tear strength. In some embodiments, the density and material composition of the foam 120 and / or air-conducting rough surface material should allow the overall tensile strength of the foam to be at least about 50 Kpa. This allows deformation and traction forces on the sleeve body 102 not to shear or tear the foam 120 and / or air-conducting rough surface material. Because the foam 120 and / or air-conducting roughened surface material must withstand the shear forces applied to the fastening system 100, the foam must have a high tear strength capable of withstanding a shear force of 50 Kpa and must be secured to the sleeve body 102 such that it can withstand a pull-away force of approximately 50 Kpa without separating.The force levels acting on the device from both peristaltic and evacuation forces on the sleeve body 102 and sleeve 116 are significantly higher than the force levels required to hold a foam piece in place to treat small wound sites that could be achieved using negative pressure wound therapy.

[0121] The foam 120 and / or air-conducting rough surface material in some embodiments is comprised of a hydrophilic material that can prevent it from stripping moisture from surface tissue with which it comes in contact, although in some embodiments a hydrophobic material can be used. According to some embodiments, the foam 120 and / or air-conducting rough surface material comprises polyvinyl alcohol. In some embodiments, the foam 120 and / or air-conducting rough surface material is made of polyurethane, another polymer, or an organic fiber mesh. In some embodiments, the open cell foam 120 comprises a single tubular foam piece.

[0122] The foam 120 and / or air-conducting roughened material covers the outer surface of the sleeve body 102 and / or sleeve 116 and creates a frictional force that resists movement of the sleeve body 102 and sleeve 116 against the intestine when negative pressure is applied to the outer surface. The porosity of the foam 120 and / or air-conducting roughened material allows air to be evacuated from the area between the outer surface of the sleeve body 102 and the inner surface of the tissue without applying a strong suction force at any single point. This creates a frictional force that is evenly distributed throughout the outer surface of the foam 120 and / or air-conducting roughened material. The foam 120 and / or air-conducting roughened material under negative pressure provides a large area over which frictional forces that resist detachment are generated. The foam 120 and / or air-conducting roughened material is designed to be compressible to minimize the amount of force that is applied to any single point of the intestine when negative pressure is applied and to maximize the area of ​​contact with the intestine wall by conforming to the shape of the intestine wall.

[0123] In some embodiments, the foam 120 and / or air conducting rough surface material distributed throughout the sleeve body 102 and / or sleeve 116 should have a thickness or height that allows for the distribution of negative pressure throughout the sleeve body 102 and / or sleeve 116, but does not extend beyond the height of the radial edges of the expandable sealing mechanism 108, 110 at rest and / or after expansion, or cause narrowing of the sleeve lumen 106 to the point of impeding GI content flow. If the foam 120 and / or air conducting rough surface material is too thin, it will collapse or clog and will not have enough open porosity to distribute the negative pressure evenly around the sleeve body 102 and / or sleeve 116. If the foam and / or air conducting rough surface material is too thick, it will prevent an airtight seal from occurring at the expandable sealing mechanism 108, 110 and will constrain the diameter of the sleeve lumen 106. In some embodiments, the thickness of the foam 120 and / or air conducting roughened material disposed around the sleeve body 102 and / or sleeve 116 is between 2 mm and 1.5 cm.

[0124] According to some embodiments, the foam 120 and / or the air conducting rough surface material can be segmented into individual sub-units. In some embodiments, multiple pieces of foam are distributed around each bonded segment. As mentioned above, these segments can be separated by multiple in-line sealing elements. In these embodiments, negative pressure can be applied to all of the sub-units in parallel or individually by multiple independent negative pressure sources.

[0125] In some embodiments of the invention of the present disclosure, foam alternatives can be used to form an interface with the intestinal wall. For example, these foam-like alternatives, including air-conducting roughened materials, should distribute negative pressure evenly across the material, generate significant frictional forces to resist displacement when negative pressure is applied, be biocompatible with the tissues of the GI tract, and have compressibility and deformability to prevent excretion-induced and pressure-induced tissue damage. Some possible polymer-based alternatives or air-conducting roughened materials are stacked mesh matrices wrapped around the sleeve or sleeve body, honeycomb lattices of interconnected channels oriented radially around the sleeve or sleeve body, or 3D woven synthetic fiber materials. Natural fiber alternatives include gauze, naturally derived sponges, or woven fabrics. However, some embodiments of the device of the present invention utilize open-cell reticulated foams. According to one embodiment, the air-conducting roughened material has an average pore size between about 200 and 400 microns. According to some embodiments, the air conducting rough surface material has a higher coefficient of friction than that of the sleeve 116 and / or sleeve body 102 .

[0126] Pneumatic System According to one embodiment, the device 100 includes a pressure tube (not shown) in fluid communication with the exterior surface of the sleeve body 102 and / or sleeve 116. The pressure tube is connected to a negative pressure source, such as an air pump or vacuum, that draws air therefrom in a controlled manner. The pump maintains the negative pressure, either constant or variable, at a pressure level that allows sufficient anchoring without the anchoring portion becoming detached and harming the intestine. This device configuration allows for physiologically safe pressures up to -200 mmHg, although pressures from -50 mmHg to -150 mmHg can be a preferred range for negative pressure delivery. Negative pressure is applied to the tube after seals are formed at both ends of the sleeve body 102 by expansion of the expandable sealing mechanisms 108, 110. As the pressure tube connected to the negative pressure source continues to apply negative pressure, the inner walls of the tissue cavity are pulled against the exterior surface of the sleeve body 102 and / or sleeve 116, forcing the tissue into contact with the foam 120. The normal force generated by the negative pressure sucking the tissue to the foam 120 creates a frictional force that resists movement of the sleeve body 102. The pressure tubes are configured to prevent blockage due to wall collapse when negative pressure is applied. In some embodiments, there is more than one pressure tube, thereby providing redundancy in case of any one pressure tube kinking or clogging. In some embodiments with multiple pressure tubes, more flexible and adaptable tubing can be utilized due to the redundancy of negative pressure delivery. Each of these pressure tubes is individually in fluid communication with the foam 120 to enable negative pressure delivery. In some embodiments where there are multiple anchoring portion elements or where there are multiple anchoring portion segments, a separate pressure tube connected to each anchoring portion element or anchoring portion segment can be provided. The multiple pressure tubes can be connected to a single negative pressure source, such as a single pump, or individually connected to multiple pressure sources, such as multiple pumps.

[0127] In some embodiments, a pressure tube (not shown) extends from the sleeve body 102 beyond the anus. The pressure tube can be disposed within the wall of the sleeve 116 or can be separate. In some embodiments, the sleeve 116 defines an additional lumen in which the pressure tube is disposed, thereby isolating the pressure tube from the GI contents traveling through the sleeve 116. Alternatively, the pressure tube can be side-by-side with the sleeve 116, either attached to the outside of the sleeve 116, attached to the inside of the sleeve 116, or disconnected from the sleeve 116. In another embodiment, the additional lumen within the sleeve 116 is the pressure tube (see, e.g., negative pressure lumen 145 in FIG. 2C).

[0128] The proximal end of the pressure tube may connect to the distal end of the sleeve body 102 or may connect to a second expandable sealing mechanism 110 disposed at the distal end of the sleeve body 102 .

[0129] According to some embodiments, the pressure tube is part of a pneumatic system that controls the pressure on the exterior surface of the sleeve body 102 and / or sleeve 116. The pneumatic system includes a pump that draws air from the pressure tube and maintains a substantially constant and / or variable negative pressure at a set pressure level ranging from -50 mmHg to -200 mhg. Applicant's benchtop testing has demonstrated that a negative pressure of -50 mmHg into the system can result in a longitudinal pull-out force of >10 pounds. The pneumatic pump can be capable of applying positive pressure in some configurations to aid in removal of the device from the patient's intestine. The pneumatic pump can maintain the negative pressure by an electrical or mechanical pump mechanism. The pneumatic system can include an indicator that allows the user to determine whether sufficient negative pressure has been reached and maintained. For example, the pressure gauge can be an indicator that reveals that a seal is maintained when suction is measured within the pneumatic system.

[0130] In some embodiments, the pressure tube has an adapter that can be used to attach a syringe so that it can be flushed and the foam 120 can be irrigated with fluid. This flushing and irrigation can be advantageous upon removal of the device from the intestinal wall during a removal procedure or to wash GI contents from the foam interface that may clog the pneumatic system.

[0131] Insertion and Removal During insertion into the patient's intestine, the device 100 is introduced into the anal canal and moved past the anastomosis such that the second expandable sealing mechanism 110 located at the distal end of the sleeve body 102 is proximal to the anastomosis. The method of deployment depends on the height of the anastomosis. For low anastomoses, the device can be deployed by a manually placed capsule sheath system. For high anastomoses, an endoscope can be used to assist in deployment. The device can be positioned and secured on the outside of the endoscope to allow the user to position and deploy the device at the desired location.

[0132] According to some embodiments, the anchoring system 100 is configured to be placed in place by an endoscope. The device 100 can have sutures or tabs that can be grasped by an endoscopic grasper to pull the sleeve body 102 into place using an endoscope. In some embodiments, the device is attached to a releasable clip on the end of the endoscope that allows the device to be released from the endoscope end from outside the body. Alternatively, a flexible material such as a wire or string attached to the anchor and looped outside the patient's body can be held using an endoscope and pulled around the fixed end of the endoscope in the intestine to pull the device to a desired location in the intestine. As discussed in more detail below, the device 100 can be connected to an endoscope through an endoscope adaptor (see, e.g., Figs. 15A-18).

[0133] In some embodiments, the sleeve 116 can be attached to the endoscope using a releasable mechanism from outside the body clamping mechanism. In some embodiments, the sleeve 116 can be attached to semi-rigid tubing that fits over the endoscope. The tubing is configured to push the anchoring system 100 into place over the endoscope and then release from the anchoring system 100. In other embodiments, the introduction member is a first semi-rigid tube that includes the proximal portion of the device. The first semi-rigid tube is advanced into the intestine through the anus, and the device is held in place using a second semi-rigid pushing tube that encircles the sleeve and has a diameter smaller than that of the first semi-rigid tube while the first semi-rigid tube is removed after reaching the desired location. The second semi-rigid pushing tube is then removed after negative pressure anchoring of the anchoring system 100 is initiated.

[0134] 10A-10E show an ICD delivery system 300 according to one embodiment of the present invention. As shown in FIG. 10A, the ICD delivery system 300 includes a handle 306, a guide shaft 303, an outer protective sheath (see, e.g., sheath 320 in FIG. 10B), and a sheath puller handle 307 that allows a physician or surgeon to place the ICD device during, for example, a colectomy. The ICD delivery system 300 facilitates placement of the ICD device by maintaining a low anchor profile during insertion and protecting the expandable sealing mechanism (i.e., an expandable elastomeric balloon) from potential damage when inserting the device past a stapled anastomosis. To facilitate placement past the pelvic bend, the guide shaft 303 can have a slight curvature at the insertion tip in some embodiments. The ICD device is inserted, advanced, and placed transanally using the ICD delivery system 300. For example, a water-based lubricant such as KY Jelly can be used to facilitate placement. The anchorage portion is placed 5 to 10 cm above (proximal in the GI tract) a site requiring protection from fecal flow (such as an anastomosis following rectal cancer surgery). Importantly, the anchorage portion of the device is designed to be placed in healthy bowel and not a damaged bowel area requiring protection. After positioning of the anchorage, the outer sheath is removed by withdrawing it using the sheath puller handle 307. At this point the device is ready for deployment.

[0135] 10B and 10C show the ICD delivery system 300 of FIG. 10A combined with the anchoring system 100 described above. As shown in FIG. 10B and 10C, the anchoring system 100 includes a sleeve body 102, first and second expandable sealing mechanisms 108, 110 disposed on the sleeve body 102, a foam 120 dispersed on the sleeve body 102, and a sleeve 116 connected to the sleeve body 102, and a sheath 320 of the ICD delivery system 300 is disposed on the proximal end of the anchoring system 100 or over the sleeve body 102 to protect the sleeve body 102 during insertion of the anchoring system 100 into the patient's body. A guide shaft 303 attached to a handle 306 is positioned inside the sleeve 116 and the sleeve body 102 to push the anchoring system 100 into position in the anal canal.

[0136] Figure 10D shows a partial enlarged cross-sectional view of the distal end or handle portion of the ICD delivery system 300 of Figures 10A-10C. As shown in Figure 10D, the guide shaft 303 is attached to a handle 306 having a number of ridges 316 to assist a user or physician in gripping the handle 306. A sheath puller handle 307 interacts with the handle 306 to remove the sheath 320 from the proximal end or sleeve body 102 of the anchoring system 100 by pulling it distally, and is further attached to an inner portion 322 of the sheath 320 (see, e.g., Figures 10B and 10C).

[0137] FIG 10E shows a partial enlarged cross-sectional view of the proximal end of the ICD delivery system 300 of FIGS. 10A-10C. As shown in FIG 10E, a sheath 320 is placed over the proximal end or sleeve body 102 of the anchoring system 100, which includes the first and second expandable sealing mechanisms 108, 110 and the foam 120. A guide shaft 303 attached to a handle 306 is positioned inside the sleeve 116 and sleeve body 102 to push the anchoring system 100 into position within the anal canal. As shown in more detail in FIG 10E, the sheath 320 extends to an attachment portion 325 and an inner portion 322 attached to the sheath pulling handle 307 for removing the sheath 320 from the proximal end or sleeve body 102 of the anchoring system 100 by pulling the sheath pulling handle 307 distally, as discussed above. As the sheath puller handle 307 is pulled distally, the sheath 320 is removed from the exterior surface of the sleeve body 102, including the first and second expandable sealing mechanisms 108, 110 and the foam 120, and pulled through the sleeve body 102 and the lumen 106 of the sleeve 116, and then released from the device. Typically, this removal of the sheath 320 occurs after the anchoring system 100 has been positioned in its position within the anal canal by the guide shaft 303.

[0138] 10F-10J show cross-sectional views taken along various lines in FIG. 10E of an anchoring system having a delivery system as shown in FIG. 10E according to an embodiment of the present invention. For example, FIG. 10F shows a cross-sectional view taken along line AA in FIG. 10E of an anchoring system having a delivery system as shown in FIG. 10E. As shown in the embodiment of FIG. 10F, this end of the anchoring system 100 having a delivery system 300 includes a sheath 320 disposed about the first expandable sealing mechanism 108, a sleeve body 102, a mounting portion 325 of the sheath 320, and a guide shaft 303.

[0139] Figure 10G is a cross-sectional view taken along line BB of Figure 10E of the anchoring system with the delivery system shown in Figure 10E. In the embodiment of Figure 10G, a portion of the anchoring system 100 with the delivery system 300 includes a sheath 320 disposed about the first expandable sealing mechanism 108, the sleeve body 102, the sleeve 116, a mounting portion 325 of the sheath 320, and a guide shaft 303.

[0140] Figure 10H is a cross-sectional view taken along line CC of Figure 10E of an anchoring system having the delivery system shown in Figure 10E. In the embodiment of Figure 10H, a portion of an anchoring system 100 is illustrated having a delivery system 300 including a sheath 320 disposed about the foam 120, a sleeve body 102, a sleeve 116 including an outlet 330 in one of the sleeve lumens, one of the fluid lumens 345, an inner portion 322 of the sheath 320, and a guide shaft 303.

[0141] 10I is a cross-sectional view taken along line DD of Fig. 10E of an anchoring system having a delivery system as shown in Fig. 10E. In the embodiment of Fig. 10I, a portion of an anchoring system 100 is illustrated having a delivery system 300 including a sheath 320 disposed about the second expandable sealing mechanism 110, a sleeve body 102, a sleeve 116, one of the fluid lumens 345, an inner portion 322 of the sheath 320, and a guide shaft 303.

[0142] 10J is a cross-sectional view taken along line EE of Fig. 10E of an anchoring system having a delivery system as shown in Fig. 10E in accordance with an embodiment of the present invention. In the embodiment of Fig. 10J, a portion of an anchoring system 100 is illustrated having a delivery system 300 that includes a sleeve 116, one of the fluid lumens 345, an inner portion 322 of a sheath 320, and a guide shaft 303.

[0143] 11A-11D show an ICD delivery system 400 according to another embodiment of the present invention. As shown in FIGS. 11A and 11B, the ICD delivery system 400 includes a handle portion 404, a guide shaft 405, an outer protective sheath (not shown) that extends the length of the anchoring system and / or ICD delivery system 400 (see, e.g., sheath 420 in FIG. 11C), a connector member 406 at the distal end of the ICD delivery system 400, and a sheath puller handle 412 that is connected to the guide shaft 405 and allows a physician or surgeon to place the ICD device during, for example, a colectomy. The ICD delivery system 400 facilitates placement of the ICD device by maintaining a low anchor profile during insertion and protecting the expandable sealing mechanism (i.e., an expandable elastomeric balloon) from potential damage when inserting the device past a stapled anastomosis. This embodiment secures the open end of the outer sheath to the delivery handle to stretch the outer sheath and compress the anchoring portion of the device. Traction on the connecting member 406 stretches the attached outer sheath and compresses the anchoring portion of the device. After the device is positioned, the outer sheath is released from the connecting member 406 and withdrawn through the central lumen of the guide shaft 405. The ICD device is inserted, advanced, and positioned transanally using the ICD delivery system 400. A water-based lubricant, such as KY Jelly, is used to facilitate positioning. The anchoring portion is positioned 5 to 10 cm above (proximal in the GI tract) a site that requires protection from fecal flow (such as an anastomosis after rectal cancer surgery). Importantly, the anchoring portion of the device is designed to be placed in healthy intestine and not in damaged intestinal areas that require protection. After anchoring positioning, the outer sheath is removed by withdrawing it using the sheath pulling handle 412. At this point, the device is ready for deployment.

[0144] 11A and 11B further illustrate portions of the anchoring system that engage the ICD delivery system 400. For example, as shown in FIGS. 11A and 11B, the anchoring system includes a sleeve body 402 and a sleeve 410 connected to the sleeve body 402, which is further connected to a handle portion 404 of the ICD delivery system 400. According to one embodiment, a sheath (see, e.g., sheath 420 in FIG. 11C) of the ICD delivery system 400 is disposed over the proximal end and the entire length or the sleeve body 402 and sleeve 410 of the anchoring system to protect the sleeve body 402 and sleeve 410, as well as first and second expandable sealing mechanisms (not shown) disposed on the sleeve body 402 and foam (not shown) dispersed on the sleeve body 402 during insertion of the anchoring system into the patient's body. A guide shaft 405 attached to a sheath puller handle 412 is positioned inside the sleeve 410 and sleeve body 402 to push the anchoring system into position within the anal canal.

[0145] FIG 11C shows a partial enlarged cross-sectional view of the proximal end of the ICD delivery system 400 of FIG 11A and FIG 11B. As shown in FIG 11C, a sheath 420 is disposed over at least the proximal end of the anchoring system or sleeve body 402 and sleeve 410, which includes first and second expandable sealing mechanisms (not shown) and foam (not shown). A guide shaft 405 attached to a sheath pulling handle 412 is positioned inside the sleeve 410 and sleeve body 402 to push the anchoring system into position in the anal canal. As shown in more detail in FIG 11C, the sheath 420 extends to upper and lower portions 422A and 422B attached to the sheath pulling handle 412 for removing the sheath 420 from the anchoring system or sleeve body 402 and sleeve 410 by pulling the sheath pulling handle 412 distally. As the sheath puller handle 412 is pulled distally, the sheath 420 is removed from the exterior of the sleeve body 402 and sleeve 410, which contain the first and second expandable sealing mechanisms (not shown) and the foam (not shown), and pulled through the internal lumen of the sleeve body 402 and sleeve 410, and then released from the device. Typically, this removal of the sheath 420 occurs after the anchoring system has been positioned in its position within the anal canal by the guide shaft 405.

[0146] Figure 11D shows a partial enlarged cross-sectional view of the distal end or handle portion of the ICD delivery system 400 of Figures 11A and 11B. As shown in Figure 11D, the guide shaft 405 is attached to the sheath puller handle 412, and the guide shaft 405 is configured to slide in and out of the sleeve 410 of the anchoring system and the handle portion 404 and connector member 406 at the distal end of the ICD delivery system 400. As further shown in Figure 11D, the handle portion 404 is configured to (i) be attached to the sleeve 410 of the anchoring system at a proximal end of the handle portion 404, and (ii) be attached to the connector member 406 at a distal end of the handle portion 404.

[0147] In some embodiments, the ICD device is deployed by (i) expanding the expandable sealing mechanism 108, 110 (e.g., an expandable balloon) by injecting a fluid or inflation medium (e.g., normal saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solution) with syringes connected to the distal and proximal ports of the device, respectively, (ii) connecting a negative pressure source (e.g., a vacuum source) to a port (e.g., a vacuum port) to anchor the device and / or activate negative pressure, and (iii) withdrawing the handles 306, 412 and guide shafts 303, 405 of the ICD delivery system 300, 400 from the ICD device. According to one embodiment, a dye-based (e.g., iodine-based) contrast solution is used to fill the expandable sealing mechanism 108, 110 (e.g., expandable balloon) because the osmotic gradient of the contrast solution helps ensure that the expandable sealing mechanism 108, 110 (e.g., expandable balloon) remains in the expanded configuration and also allows radiographic analysis of the anchoring device location within the body. According to some embodiments, removal of the ICD device is accomplished by (i) releasing the negative pressure or vacuum by disconnecting the negative pressure source (e.g., vacuum source), (ii) collapsing the expandable sealing mechanism 108, 110 (e.g., expandable balloon) by completely removing the fluid through syringes connected to the distal and proximal ports of the device, respectively, (iii) injecting a small amount of normal saline through a port (e.g., vacuum port) to break the anchoring seal, and (iv) removing the external dressing (discussed in more detail below) and gently pulling on the sleeve of the ICD device until the ICD device is completely removed from the anal verge.

[0148] In some embodiments, there is a releasable, liquid-tight, disconnectable connector that allows for removal of a length of the sleeve outside the body to allow for easier device delivery. In some embodiments, the connector is located 8 inches to 36 inches from the proximal sealing mechanism. In other embodiments, the sleeve is connected directly to a waste bag or left open 8 inches to 36 inches from the proximal sealing mechanism 10.

[0149] According to some embodiments, the device 100 has a removal system to allow removal if necessary. Fluid (e.g., saline) or positive pressure can be delivered along the pressure tube (not shown) and / or negative pressure lumen 145 to reduce the adhesive forces generated to stick the device 100. The device 100 can then be safely removed from the patient. In some embodiments, the device 100 is configured with a port to allow the use of fluid (e.g., saline) to wet the tubing in communication with the foam to detach the sleeve body 102 from the intestinal wall. Fluid can be introduced into the pressure tube (not shown) or the device 100 can have a separate tube (see also, e.g., irrigation lumen 144 in FIG. 2C) that runs outside the patient's body to provide irrigation. It can be preferable to use pressure tubing for both negative pressure delivery and irrigation purposes. In some embodiments, an irrigation system is in fluid communication with the pressure tube, and the irrigation system introduces fluid into the pressure tube for irrigation. Irrigation through the tube can be used to wash away any abdominal contents that may have leaked around the proximal expandable sealing mechanism 108 and to detach the device 100 from the patient's intestinal wall. By using one or more of these removal methods, the pulling forces become negligible and the device 100 can be removed without damage to the surrounding tissue.

[0150] Endoscope Adapter In some embodiments, the system includes an ICD scope adapter that can be used with the ICD device to allow insertion and deployment of the ICD device using a sigmoidoscopy, endoscope, or scope for colonoscopy.

[0151] Figures 15A and 15B show an ICD endoscopic adapter according to one embodiment of the present invention. As shown in Figures 15A and 15B, endoscopic adapter 800 includes a main body 802, a compression nut 804, a compression sleeve 805, and a compression washer 806. As further shown in Figure 15B, main body 802 includes a plurality of threads 812 configured to engage a plurality of grooves 814 provided along an inner surface of compression nut 804.

[0152] FIG. 16 illustrates a cross-sectional view taken along line 16-16 in FIG. 15A of the endoscopic adapter shown in FIG. 15A and FIG. 15B in accordance with an embodiment of the present invention. As shown in FIG. 16, the main body 802 of the endoscopic adapter 800 engages the compression nut 804 by a plurality of threads 812 provided thereon engaging a plurality of grooves 814 provided on the compression nut 804. As further shown in FIG. 16, the compression sleeve 805 has a sliding tapered portion 810 that allows it to easily fit inside the main body 802. A compression washer 806 is disposed within the compression nut 804 and presses against the compression sleeve 805. In the embodiment of FIG. 16, the main body 802 further includes a recess 820 on each side thereof that allows for connection with a sigmoidoscope, endoscope, or scope for colonoscopy, as discussed in more detail below.

[0153] 17 is a schematic diagram of an anchoring system attached to an endoscope through an endoscopic adapter according to some embodiments of the present invention. As shown in the embodiment of FIG. 17, an anchoring system 1000 is shown including a first expandable sealing mechanism 1008 disposed at a proximal end of a sleeve body 1002, a second expandable sealing mechanism 1010 disposed at a distal end of the sleeve body 1002, an open cell foam 1020 disposed on an outer surface of the sleeve body 1002, and a sleeve 1016 in fluid communication with the distal end of the sleeve body 1002. The anchoring system 1000 further includes a number of connectors or ports 1024, 1026, and 1028 for providing fluid or inflation media for expansion of the first and second expandable sealing mechanisms 1008, 1010, such as saline, mineral oil, and / or dye-based (e.g., iodine-based) contrast solutions, irrigation, medications (such as antibiotics, anti-inflammatories, or chemotherapeutic agents), and / or radiological contrast agents, as discussed above with respect to FIG 1A. As further shown in FIG 17, an endoscope adapter 800 of the embodiment of FIGs 15A, 15B, and 16 is provided for connecting an end (i.e., distal end) of the anchoring system 1000 to an endoscope 1200.

[0154] Figure 18 is a cross-sectional view taken along line 18-18 of Figure 17 of the endoscopic adapter shown in Figure 17 according to an embodiment of the present invention. As shown in Figure 18, the sleeve 1016 of the anchoring system 1000 of Figure 17 is attached to the endoscopic adapter 800 by a quick connector latch point or fitting including an extension member 1100 having a latch member 1102 provided on the sleeve 1016 that latches with a recess 820 provided on each side of the main body 802 of the endoscopic adapter 800. According to one embodiment, the ICD endoscopic adapter 800 is attached to a quick connector latch point or fitting of an ICD device (e.g., the anchoring system 1000) such that the ICD device is attached to the ICD endoscopic adapter 800 by sliding (see, e.g., the scope shaft interface 1120 of Figure 18) over the shaft of an endoscope 1200 (or scope for sigmoidoscope or colonoscopy). When in the desired location, the main body 802 of the ICD scope adapter 800 is held securely in one hand while the compression nut 804 is turned in a clockwise direction with the other hand. The compression nut 804 of the ICD scope adapter 800 is turned until the compression sleeve 805 grips the outside of the shaft of the endoscope 1200 (or scope for sigmoidoscope or colonoscopy) to provide a non-sliding attachment (see, e.g., scope shaft interface 1120 in FIG. 18).

[0155] According to an embodiment, an ICD device (e.g., anchoring system 1000 of FIG. 17) is prepared for placement within a patient's body. If it is desired to advance the end of endoscope 1200 more distally or retract more proximally, the healthcare provider can simply loosen compression nut 804 of ICD endoscopic adapter 800 and adjust the position of compression sleeve 805 of ICD endoscopic adapter 800 to the desired position along endoscope 1200 before retightening.

[0156] ICD bandage In some embodiments, the system includes an ICD retention bandage that provides an aid for securing the ICD device to the patient and minimizing migration. The ICD retention bandage may be provided in an easy-to-open, cryo-sealed pouch.

[0157] 19A-19H show an ICD retention bandage according to one embodiment of the present invention. As shown in FIG. 19A, the ICD retention bandage 1200 includes a retention bandage 1204 and two retention bandage straps 1206A, 1206B. The retention bandage 1204 and retention bandage straps 1206A, 1206B are precut on a carrier sheet 1202, which can be prepared, for example, from Mylar, and can further include a precut removable liner paper (discussed in more detail below) to aid in attachment. As further shown in FIG. 19A, the retention bandage 1204 includes a body portion 1205, a midsection 1212 having a circular opening 1215, a first leg member 1208, and a second leg member 1210.

[0158] 19B-19H illustrate a method of attaching the ICD retention bandage shown in FIG. 19A to an anchoring system according to an embodiment of the present invention. In a first step shown in FIG. 19B, the ICD retention bandage 1200 including the retention bandage 1204 and the two retention bandage straps 1206A, 1206B is removed from the carrier sheet 1202. In a second step shown in FIG. 19C, the first precut removable liner 1220 is removed from the mid-section 1212 of the retention bandage 1204 including the circular opening 1215. In a third step shown in FIG. 19D, the two retention bandage straps 1206A, 1206B are placed within the circular opening 1215 of the mid-section 1212 of the retention bandage 1204. In a fourth step, shown in Figure 19E, the second and third precut removable liners 1216A, 1216B are removed from the ends of the two retention bandage straps 1206A, 1206B, respectively, in order to attach the two retention bandage straps 1206A, 1206B to the circular opening 1215 in the mid-section 1212. In a fifth step, shown in Figure 19F, the fourth and fifth precut removable liners 1226A, 1226B are removed from the sides of the two retention bandage straps 1206A, 1206B, respectively. Further, in a fifth step shown in Fig. 19F, the anchoring device or ICD device 1260 is inserted into the circular opening 1215 of the middle section 1212 of the retention bandage 1204 such that the end 1250 of the anchoring device or ICD device 1260 is disposed between the two retention bandage straps 1206A, 1206B. In a sixth step shown in Fig. 19G, the two retention bandage straps 1206A, 1206B are wrapped (e.g., spirally wrapped) around the anchoring device or ICD device 1260. The two opposing retention bandage straps 1206A, 1206B spirally wrap and adhere to the anchoring device or ICD device 1260, particularly its sleeve body, to secure the anchoring device or ICD device 1260 to the ICD retention bandage 1200.Finally, in the final step shown in FIGURE 19H, the sixth and seventh precut removable liners 1208A, 1210B are removed from the first and second leg members 1208, 1210 of the retention bandage 1204, respectively, and the eighth precut removable liner 1205A is removed from the body portion 1205 of the retention bandage 1204. At this point, the ICD retention bandage 1200 is affixed to the inside of the patient's hips through the body portion 1205 of the retention bandage 1204 and wrapped around the lower back and groin. According to one embodiment, the first and second leg members 1208, 1210 of the retention bandage 1204 are attached to the front of the patient and positioned on either side of the groin, while the middle section 1212 of the retention bandage 1204, including the circular opening 1215, is positioned around the patient's anus.

[0159] In some embodiments, the ICD retention bandage material is a biocompatible transparent polyurethane film laminated to a polyester spunlace nonwoven fabric, with the inner surface of the bandage coated with a medical grade pressure sensitive acrylic adhesive and supplied on a removable paper liner. The medical grade adhesive can be designed for extended wear skin contact applications. Additionally, the outer polyester spunlace surface can have a thin non-absorbent coating.

[0160] According to another embodiment, the ICD retention bandage is designed to be attached to the skin and worn by the patient for at least up to 14 days.

[0161] ICD device buckling strength According to some embodiments of the present invention, the ability of the anchoring section of the ICD device to advance against external resistance is due to the combined effect of (i) the column strength, which is related to the diameter, wall thickness, shape, and material type of the outer sleeve, and (ii) the internal support provided by the diameter, wall thickness, shape, and material type of the internal support member (i.e., guide shaft). In this case, the yield strength for columnar buckling is the compressive yield strength of the selected material. With proper selection of material type and material properties, the column strength of the outer sleeve can be calculated and adapted to the application. In addition to the column strength of the outer sleeve, the internal support (guide shaft) prevents both axial and lateral collapse and buckling. The additional support allows the use of softer and / or thinner wall materials while providing the strength required to overcome the forward resistance and insert the device.

[0162] According to some embodiments, the outer sleeve (e.g., sleeve 116) has a column strength of 4.0 lbs when supported by the internal support member. According to other embodiments, the column strength can range from 3.0 lbs to 6.0 lbs.

[0163] According to some embodiments, the outer sleeve (e.g., sleeve 116) has a wall thickness of 0.035 inches, although the wall thickness can range from 0.020 inches to 0.080 inches thick. According to one embodiment, the outer sleeve has a Shore 60A durometer hardness, although the hardness can range from Shore 40A to Shore 90A.

[0164] According to some embodiments, the internal support member (guide shaft) has a diameter of 0.500 inches, but the diameter can range from 0.375 inches to 0.625 inches. According to some embodiments, the internal support member has a wall thickness of 0.06 inches, but the wall thickness can range from 0.020 inches to 0.080 inches. According to some embodiments, the internal support member material has a tensile E modulus of 1,600 MPa, but the hardness can range from a tensile E modulus of 220 MPa to 2,500 MPa.

[0165] The embodiments of the invention described herein provide an anchoring device designed to have a redundant fecal bypass, since even if negative pressure fails, the expandable sealing mechanism (e.g., balloon) will still block most fecal flow, and the device will remain in place by the external fixator due to the column strength of the sleeve and / or sleeve body. Furthermore, use of the device on an endoscope requires that the sleeve and / or sleeve body not collapse as the device is pushed into the patient's body. Therefore, a certain column strength is necessary to ensure that a delivery system using an endoscopic adapter will function.

[0166] Other uses The embodiments of the invention described herein may have applications other than protection of damaged bowel or anastomosis protection. For example, the devices and methods of the present disclosure may be used for continence control in environments such as intensive care units. In these environments, fecal contamination of the perineum may result in significant skin irritation and skin damage. Existing continence control devices for redirecting the flow path of fecal flow into a collection bag often result in adverse effects such as fecal leakage, displacement of the fecal tube, and erosion of the bowel wall. In contrast, the devices and methods described herein may anchor a fecal collection sheath / sleeve in a patient's rectum using an anchoring mechanism that is atraumatic, completely sealed against leakage, does not easily detach, and is easily recoverable. The anchoring methods described herein may be used to anchor other sheaths / sleeves or drug delivery devices in the intestine. For example, sheaths / sleeves for absorption restriction used to treat metabolic disorders, diabetes, or obesity may be anchored using the techniques described herein. Specialized sheaths / sleeves designed to elute drugs may be anchored using the techniques described herein. For example, the sheath / sleeve attached to the anchoring device described herein can contain a controlled release anti-inflammatory drug to treat inflammatory bowel disease. Additionally, as described above, a second anchoring element can be placed distally to create a sealed space between the treated intestinal segment and the two anchoring elements and sleeve. This space can be filled with a therapeutic solution such as an antibiotic, an anti-inflammatory drug, or a chemotherapy agent for cancer. This allows for localized controlled delivery to the intestinal wall segment isolated between the two anchoring elements. Similarly, as described above, a sleeve can be anchored that can help redirect flow away from a damaged intestinal segment such as an inflamed or dilated intestine in cases such as perforation in the intestine, ischemic bowel, intestinal contusion due to blunt trauma, or inflammatory bowel disease.

[0167] Further aspects of the present disclosure are provided by the subject matter of the following clauses.

[0168] 1. An anchoring system comprising: a sleeve having an inner surface defining a lumen; a first expandable sealing mechanism disposed along a proximal end of the sleeve; a second expandable sealing mechanism disposed along the proximal end of the sleeve; and an open cell foam disposed on an outer surface of the sleeve, wherein expansion of the first and second expandable sealing mechanisms and application of a negative pressure to the anchoring system causes a seal to be formed between the first and second expandable sealing mechanisms, the outer surface of the sleeve, and an inner surface of a tissue cavity.

[0169] The fixation system of any preceding clause, further comprising a sleeve body, (i) a first expandable sealing mechanism disposed at a proximal end of the sleeve body, and (ii) a second expandable sealing mechanism disposed at a distal end of the sleeve body.

[0170] The fastening system of any preceding clause, wherein a distal end of the sleeve body is connected to a proximal end of the sleeve.

[0171] The fastening system of any preceding clause, wherein the sleeve body is coextensive with the sleeve.

[0172] The fastening system of any preceding clause, wherein the sleeve body is disposed on a proximal end of the sleeve.

[0173] The fastening system of any preceding clause, wherein the sleeve includes a plurality of fluid lumens.

[0174] The fixation system of any preceding clause, wherein the plurality of fluid lumens includes one or more of: (i) a distal fluid lumen for providing fluid to a first expandable sealing mechanism, (ii) a proximal fluid lumen for providing fluid to a second expandable sealing mechanism, (iii) an irrigation lumen, (iv) a contrast lumen, and (v) a negative pressure lumen.

[0175] A fastening system according to any of the preceding clauses, wherein application of negative pressure creates a frictional force which resists displacement of the sleeve.

[0176] The fixation system of any preceding clause, wherein application of negative pressure brings open cell foam disposed on an outer surface of the sleeve into contact with an inner surface of the tissue cavity, thereby generating a frictional force resisting displacement of the sleeve.

[0177] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms are expanded by providing a non-compressible fluid to expand the first and second expandable sealing mechanisms.

[0178] The fixation system of any preceding clause, wherein the incompressible fluid is at least one of saline, mineral oil, and a dye-based contrast solution.

[0179] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms, in the expanded state, form a substantially air-tight and liquid-tight seal with the inner surface of the tissue cavity.

[0180] The fastening system of any preceding clause, wherein the sleeve protects the inner surface of the tissue cavity from fecal flow.

[0181] The fixation system of any preceding clause, wherein the lumen has a diameter between about 1 cm and about 6 cm.

[0182] The fastening system of any preceding clause, wherein the sleeve comprises a flexible material having a Shore A hardness of between about 20A and about 70A.

[0183] The fastening system of any preceding clause, wherein the open cell foam comprises polyvinyl alcohol, polyurethane foam, or other synthetic polymer.

[0184] 13. The fastening system of any preceding clause, wherein the open cell foam has a tensile strength of at least 50 kpa.

[0185] 2. The fastening system of any preceding clause, wherein the open cell foam has a thickness between 2mm and 150mm.

[0186] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms each include an expandable elastomeric balloon.

[0187] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms comprise a plurality of expandable elastomeric balloons.

[0188] The anchoring system of any preceding clause, wherein (i) the first expandable sealing mechanism includes a single expandable elastomeric balloon; and (ii) the second expandable sealing mechanism includes a plurality of expandable elastomeric balloons.

[0189] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms have an annular diameter greater than an annular diameter of the open cell foam dispersed about the sleeve.

[0190] The fastening system of any preceding clause, wherein the sleeve has a column strength of about 3.0 lbs. to 6.0 lbs.

[0191] The anchoring system of any preceding clause, further comprising a retrieval bag disposed at a distal end of the sleeve and configured to manage intestinal contents delivered from the anchoring system.

[0192] The fastening system of any preceding clause, further comprising a retention dressing for attaching the fastening system to the skin.

[0193] The anchoring system of any preceding clause, further comprising an extension tubing connected to a distal end of the sleeve and configured to extend the anchoring system outside the patient's body.

[0194] The anchoring system of any preceding clause, further comprising an endoscope adapter configured to connect the sleeve to at least one of an endoscope, a sigmoidoscope, or a colonoscope.

[0195] The fastening system of any preceding clause, wherein the endoscopic adapter includes a main body, a compression nut, a compression sleeve, and a compression washer.

[0196] The fastening system of any preceding clause, wherein the main body includes a plurality of threads configured to engage a plurality of grooves provided along an inner surface of the compression nut.

[0197] The anchoring system of any preceding clause, further comprising a connector latch point configured to connect the sleeve to at least one of an endoscope, a sigmoidoscope, or a colonoscope through an endoscope adapter.

[0198] The fixation system of any preceding clause, further comprising a negative pressure source, wherein negative pressure is applied by the negative pressure source to the fixation system to maintain one of a constant negative pressure or a variable negative pressure at a level between -50mmHg and -200mmHg.

[0199] The fixation system of any preceding clause, further comprising a negative pressure lumen configured to provide a negative pressure to the sleeve.

[0200] The anchoring system of any preceding clause, wherein the sleeve has a length that enables it to extend outside the tissue cavity.

[0201] The anchoring system of any preceding clause, wherein the lumen and the first and second expandable sealing mechanisms are compressible by normal peristaltic forces of the patient's intestine.

[0202] The fastening system of any preceding clause, wherein the sleeve has a length between about 3 cm and about 25 cm.

[0203] The fastening system of any preceding clause, wherein the sleeve and / or sleeve body are comprised of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymer.

[0204] The fastening system of any preceding clause, wherein the sleeve and sleeve body are comprised of a single continuous tubular extrusion.

[0205] The fixation system of any preceding clause, wherein the proximal end of the sleeve is in sealing fluid communication with and extends distally to the distal end of the sleeve body and the second expandable sealing mechanism, and the proximal end of the sleeve extending distally to the distal end of the sleeve body is configured to cover and protect damaged areas of tissue of the tissue cavity from contents flowing through the lumen of the sleeve and the sleeve body.

[0206] 11. A delivery system comprising an outer protective sheath encasing the anchoring system of any preceding clause, a handle, a guide shaft, and a sheath puller handle, wherein the anchoring system is configured to be pushed into place by advancing the guide shaft into the patient's intestine.

[0207] A delivery system including a handle, a guide shaft connected to the handle, an outer protective sheath configured to cover and protect a proximal end of an anchoring system having at least one expandable sealing mechanism, and a sheath pulling handle attached to the outer protective sheath.

[0208] The delivery system of any preceding clause, wherein an outer protective sheath is disposed within a central lumen of the guide shaft and is configured to extend from the central lumen to cover and protect a proximal end of the fixation system having at least one expandable sealing mechanism.

[0209] The delivery system of any preceding clause used in conjunction with a fastening system having a sleeve with a column strength high enough to prevent collapse of the fastening system during insertion through the delivery system.

[0210] A method for securing a sleeve to a tissue cavity, the sleeve having an outer surface including foam for contacting the inner wall of the tissue cavity and an expandable sealing mechanism for isolating a portion of the tissue cavity adjacent the sleeve from a remainder of the tissue cavity, the method comprising the steps of inserting the sleeve into the tissue cavity, expanding the expandable sealing mechanism to create a seal between the expandable sealing mechanism and the inner wall of the tissue cavity, and applying a negative pressure to the area between the outer surface of the sleeve and the inner surface of the isolated portion of the tissue cavity to create a frictional force between the foam of the sleeve and the inner surface of the tissue cavity.

[0211] The method of any preceding clause, wherein the step of expanding the expandable sealing mechanism is performed by injecting an inflation medium into the expandable sealing mechanism.

[0212] The method of any preceding clause, wherein the inflation medium comprises at least one of saline, mineral oil, and / or a dye-based contrast solution.

[0213] The method of any preceding clause, wherein the step of inserting the sleeve into the tissue cavity is performed using a delivery system including a handle and a guide shaft.

[0214] The method of any preceding clause, further comprising withdrawing the handle and guide shaft of the delivery system from the sleeve.

[0215] The method of any preceding clause, further comprising removing the sleeve from the tissue cavity by releasing the negative pressure, collapsing the expandable sealing mechanism, and injecting a volume of saline through the port to disrupt the seal.

[0216] The device of any preceding clause utilizing two redundant anchoring methods for anchoring in the intestine, where (i) a first method utilizes a negative pressure based friction anchor as described in any preceding clause, and (ii) a second method anchors an extracorporeal portion of the device to use column strength against a sleeve, where the column strength is high enough to hold the anchor portion of the device in place even if the first anchoring method fails, and thus the first anchoring method is sufficient to hold the device in place even if the second method fails.

[0217] 20. A method of inserting a fixation system according to any preceding clause using an endoscope connected to the fixation system.

[0218] The method of any preceding clause, wherein the fixation system is inserted using direct visualization through an endoscope.

[0219] 1. An anchoring system comprising: a sleeve having an inner surface defining a lumen; a first expandable sealing mechanism disposed along a proximal end of the sleeve; a second expandable sealing mechanism disposed along the proximal end of the sleeve; and an air-conducting roughened material disposed on an outer surface of the sleeve, wherein (i) expansion of the first and second expandable sealing mechanisms and (ii) application of negative pressure to the anchoring system causes a seal to be formed between the first and second expandable sealing mechanisms, the outer surface of the sleeve, and an inner surface of a tissue cavity.

[0220] The fixation system of any preceding clause, further comprising a sleeve body, (i) a first expandable sealing mechanism disposed at a proximal end of the sleeve body, and (ii) a second expandable sealing mechanism disposed at a distal end of the sleeve body.

[0221] The fastening system of any preceding clause, wherein the air conducting rough surface material is at least one of a stacked mesh matrix, a honeycomb lattice of interconnected channels, gauze, fabric, or a three dimensional woven material.

[0222] The fastening system of any preceding clause, wherein a distal end of the sleeve body is connected to a proximal end of the sleeve.

[0223] The fastening system of any preceding clause, wherein the sleeve body is coextensive with the sleeve.

[0224] The fastening system of any preceding clause, wherein the sleeve body is disposed on a proximal end of the sleeve.

[0225] The fastening system of any preceding clause, wherein the sleeve includes a plurality of fluid lumens.

[0226] The fixation system of any preceding clause, wherein the plurality of fluid lumens includes one or more of: (i) a distal fluid lumen for providing fluid to a first expandable sealing mechanism, (ii) a proximal fluid lumen for providing fluid to a second expandable sealing mechanism, (iii) an irrigation lumen, (iv) a contrast lumen, and (v) a negative pressure lumen.

[0227] A fastening system according to any of the preceding clauses, wherein application of negative pressure creates a frictional force which resists displacement of the sleeve.

[0228] The fixation system of any preceding clause, wherein application of negative pressure brings an air-conducting roughened material disposed on an outer surface of the sleeve into contact with an inner surface of the tissue cavity, thereby generating a frictional force resisting displacement of the sleeve.

[0229] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms are expanded by providing a non-compressible fluid to expand the first and second expandable sealing mechanisms.

[0230] The fixation system of any preceding clause, wherein the incompressible fluid is at least one of saline, mineral oil, and a dye-based contrast solution.

[0231] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms, in the expanded state, form a substantially air-tight and liquid-tight seal with the inner surface of the tissue cavity.

[0232] The fastening system of any preceding clause, wherein the sleeve protects the inner surface of the tissue cavity from fecal flow.

[0233] The fixation system of any preceding clause, wherein the lumen has a diameter between about 1 cm and about 6 cm.

[0234] The fastening system of any preceding clause, wherein the sleeve comprises a flexible material having a Shore A hardness of between about 20A and about 70A.

[0235] 2. The fastening system of any preceding clause, wherein the air-conducting rough surface material has a tensile strength of at least 50 kpa.

[0236] 2. A fastening system according to any preceding clause, wherein the air-conducting rough surface material has a thickness between 2mm and 150mm.

[0237] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms each include an expandable elastomeric balloon.

[0238] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms comprise a plurality of expandable elastomeric balloons.

[0239] The anchoring system of any preceding clause, wherein (i) the first expandable sealing mechanism includes a single expandable elastomeric balloon; and (ii) the second expandable sealing mechanism includes a plurality of expandable elastomeric balloons.

[0240] The anchoring system of any preceding clause, wherein the first and second expandable sealing mechanisms have an annular diameter greater than an annular diameter of the air conducting rough surface material dispersed about the sleeve.

[0241] The fastening system of any preceding clause, wherein the sleeve has a column strength of about 3.0 lbs. to 6.0 lbs.

[0242] The anchoring system of any preceding clause, further comprising a retrieval bag disposed at a distal end of the sleeve and configured to manage intestinal contents delivered from the anchoring system.

[0243] The fastening system of any preceding clause, further comprising a retention dressing for attaching the fastening system to the skin.

[0244] The anchoring system of any preceding clause, further comprising an extension tubing connected to a distal end of the sleeve and configured to extend the anchoring system outside the patient's body.

[0245] The anchoring system of any preceding clause, further comprising an endoscope adapter configured to connect the sleeve to at least one of an endoscope, a sigmoidoscope, or a colonoscope.

[0246] The fastening system of any preceding clause, wherein the endoscopic adapter includes a main body, a compression nut, a compression sleeve, and a compression washer.

[0247] The fastening system of any preceding clause, wherein the main body includes a plurality of threads configured to engage a plurality of grooves provided along an inner surface of the compression nut.

[0248] The anchoring system of any preceding clause, further comprising a connector latch point configured to connect the sleeve to at least one of an endoscope, a sigmoidoscope, or a colonoscope through an endoscope adapter.

[0249] The fixation system of any preceding clause, further comprising a negative pressure source, wherein negative pressure is applied by the negative pressure source to the fixation system to maintain one of a constant negative pressure or a variable negative pressure at a level between -50mmHg and -200mmHg.

[0250] The fixation system of any preceding clause, further comprising a negative pressure lumen configured to provide a negative pressure to the sleeve.

[0251] The anchoring system of any preceding clause, wherein the sleeve has a length that enables it to extend outside the tissue cavity.

[0252] The anchoring system of any preceding clause, wherein the lumen and the first and second expandable sealing mechanisms are compressible by normal peristaltic forces of the patient's intestine.

[0253] The fastening system of any preceding clause, wherein the sleeve has a length between about 3 cm and about 25 cm.

[0254] The fastening system of any preceding clause, wherein the sleeve and / or sleeve body are comprised of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymer.

[0255] The fastening system of any preceding clause, wherein the sleeve and sleeve body are comprised of a single continuous tubular extrusion.

[0256] The fixation system of any preceding clause, wherein the proximal end of the sleeve is in sealing fluid communication with and extends distally to the distal end of the sleeve body and the second expandable sealing mechanism, and the proximal end of the sleeve extending distally to the distal end of the sleeve body is configured to cover and protect damaged areas of tissue of the tissue cavity from contents flowing through the lumen of the sleeve and the sleeve body.

[0257] 1. An anchoring system configured to be anchored within a patient's intestine, the anchoring device comprising: a sleeve configured to be positioned within the patient's intestine; an extracorporeal portion configured to extend outside the body from the patient's intestine; and two redundant methods of anchoring the device within the intestine, wherein a first method of anchoring the device utilizes a negative pressure based system that applies negative pressure to the device to generate a frictional force that resists displacement of the sleeve of the device from the intestine, and a second method of anchoring the device secures the extracorporeal portion of the device to the patient's skin, and wherein at least one of (i) the column strength of the sleeve is high enough to hold the device in place even if the first anchoring method fails, or (ii) the first anchoring method is sufficient to hold the device in place even if the second anchoring method fails.

[0258] The anchoring system of any preceding clause, further comprising a third redundant method of anchoring the device, wherein the third anchoring method utilizes first and second expandable sealing mechanisms, expansion of the first and second expandable sealing mechanisms causing a seal to form between the first and second expandable sealing mechanisms and an inner surface of the tissue cavity, and wherein the third anchoring method is sufficient to hold the device in place even if the first and / or second anchoring methods fail.

[0259] The following documents are incorporated herein by reference:

[0260] Morks, A. N., Havenga, K., Ploeg, R. J., "Can intraluminal devices prevent or reduce colorectal anastomotic leakage: A review," World J. Gastroenterol., 2011, 17(40), pp. 4461-4469.

[0261] D'Urso, A., Komen, N., Lefevre, JH, "Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: results from a First-In-Human trial on 15 patients", Surg. Endosc., 2019

[0262] Kim, JH, Kim, S., Jung, SH, "Fecal diverting device for the substitution of defunctioning stoma: preliminary clinical study", Surg. Endosc., 2019, 33(1), pp. 333-340

[0263] Reshef, A., Ben-Arie, G., Pinsk, I. "Protection of colorectal anastomosis with an intraluminal bypass device for patients undergoing an elective anterior resection: a pilot study", Tech. in Coloproctology, 2019, 23(6), pp. 565-571

[0264] Kang, SI, Kim, SH, Jung, SH, Kim, JH, "The effectiveness of a fecal diverting device for prevention of septic complications in a dog model of ischemic bowel anastomosis," Asian J.Surg., 2020, 43, pp. 251-256.

[0265] Bakker, IS, Morks, AN, Ten Cate Hoedemaker, HO et al., "Randomized clinical trial of biodegradeable intraluminal sheath to prevent anastomotic leak after stapled colorectal anastomosis," BJS Society Ltd., 2017

[0266] The embodiments illustrated and discussed herein are intended only to teach one of ordinary skill in the art how to make and use the present invention. In describing the embodiments of the present invention, specific terminology has been used for the purposes of clarity. However, the present invention is not limited to the specific terminology so selected. Those skilled in the art will recognize in light of the above teachings that the above-described embodiments of the present invention can be modified or altered without departing from the invention. It is therefore to be understood that the present invention may be practiced otherwise than as specifically described within the scope of the appended claims and their equivalents. [Explanation of symbols]

[0267] 100 Fastening System 102 Sleeve body 108 First expandable sealing mechanism 116 Sleeve 120 Foam

Claims

1. A fixing system, A sleeve having an inner surface that defines the lumen, A first expandable sealing mechanism is positioned along the proximal end of the sleeve, A second expandable sealing mechanism is positioned along the proximal end of the sleeve, An open-cell foam disposed on the outer surface of the sleeve, Includes, (i) expansion of the first and second expandable sealing mechanisms and (ii) application of negative pressure to the fixing system cause a seal to form between the first and second expandable sealing mechanisms and the outer surface of the sleeve and the inner surface of the tissue cavity. Fixing system.

2. The sleeve itself is also included. (i) The first expandable sealing mechanism is located at the proximal end of the sleeve body, and (ii) The second expandable sealing mechanism is located at the distal end of the sleeve body. The fastening system according to claim 1.

3. The fastening system according to claim 2, wherein the distal end of the sleeve body is connected to the proximal end of the sleeve.

4. The fastening system according to claim 2, wherein the sleeve body is in the same extension as the sleeve.

5. The fastening system according to claim 2, wherein the sleeve body is positioned on the proximal end of the sleeve.

6. The fixing system according to claim 1, wherein the sleeve includes a plurality of fluid lumens.

7. The fixing system according to claim 6, wherein the plurality of fluid lumens include one or more of the following: (i) a distal fluid lumen for supplying fluid to the first expandable sealing mechanism, (ii) a proximal fluid lumen for supplying fluid to the second expandable sealing mechanism, (iii) a lavage lumen, (iv) a contrast agent lumen, and (v) a negative pressure lumen.

8. The fixing system according to claim 1, wherein the application of negative pressure generates a frictional force that resists the displacement of the sleeve.

9. The fixing system according to claim 8, wherein the application of negative pressure brings the open-cell foam disposed on the outer surface of the sleeve into contact with the inner surface of the tissue cavity, thereby generating the frictional force that resists the displacement of the sleeve.

10. The fastening system according to claim 1, wherein the first and second expandable sealing mechanisms are expanded by providing an incompressible fluid for expanding the first and second expandable sealing mechanisms.

11. The fixing system according to claim 10, wherein the incompressible fluid is at least one of physiological saline, mineral oil, and dye-based contrast solution.

12. The fastening system according to claim 10, wherein, in the expanded state, the first and second expandable sealing mechanisms form a substantially airtight and liquidtight seal with the inner surface of the tissue cavity.

13. The fastening system according to claim 1, wherein the sleeve protects the inner surface of the tissue cavity from fecal flow.

14. The fixing system according to claim 1, wherein the lumen has a diameter between approximately 1 cm and approximately 6 cm.

15. The fastening system according to claim 1, wherein the sleeve comprises a flexible material having a Shore A hardness between approximately 20A and approximately 70A.

16. The bonding system according to claim 1, wherein the open-cell foam comprises polyvinyl alcohol, polyurethane foam, or other synthetic polymer.

17. The fixing system according to claim 1, wherein the open-cell foam has a tensile strength of at least 50 kPa.

18. The fixing system according to claim 1, wherein the open-cell foam has a thickness between 2 mm and 150 mm.

19. The fastening system according to claim 1, wherein the first and second expandable sealing mechanisms each include an expandable elastomer balloon.

20. The fastening system according to claim 1, wherein each of the first and second expandable sealing mechanisms includes a plurality of expandable elastomer balloons.

21. (i) The first expandable sealing mechanism comprises a single expandable elastomer balloon, and (ii) The second expandable sealing mechanism comprises a plurality of expandable elastomer balloons, according to claim 1.

22. The fastening system according to claim 1, wherein the first and second expandable sealing mechanisms have an annular diameter larger than the annular diameter of the open-cell foam dispersed around the sleeve.

23. The fastening system according to claim 1, wherein the sleeve has a column strength of approximately 3.0 pounds to 6.0 pounds.

24. The fixation system according to claim 1, further comprising a collection bag positioned at the distal end of the sleeve and configured to manage intestinal contents transported from the fixation system.

25. The fixation system according to claim 1, further comprising a retaining bandage for attaching the fixation system to the skin.

26. The fixing system according to claim 1, further comprising an extension pipe connected to the distal end of the sleeve and configured to extend the fixing system outside the patient's body.

27. The fixing system according to claim 1, further comprising a spectroscopy adapter configured to connect the sleeve to at least one of an endoscope, a sigmoidoscope, or a colonoscope.

28. The fastening system according to claim 27, wherein the telescope adapter includes a main body, a compression nut, a compression sleeve, and a compression washer.

29. The fastening system according to claim 28, wherein the main body includes a plurality of threads configured to engage with a plurality of grooves provided along the inner surface of the compression nut.

30. The fastening system according to claim 27, further comprising a connector latch point configured to connect the sleeve to at least one of an endoscope, sigmoidoscope, or colonoscope via the endoscopic adapter.

31. Further including a negative pressure source, A negative pressure is applied to the fixing system by the negative pressure source to maintain a constant or variable negative pressure at a level between -50 mmHg and -200 mmHg. The fastening system according to claim 1.

32. The fastening system according to claim 1, further comprising a negative pressure lumen configured to provide negative pressure to the sleeve.

33. The fastening system according to claim 1, wherein the sleeve has a length that allows it to extend outside the tissue cavity.

34. The fixation system according to claim 1, wherein the lumen and the first and second expandable sealing mechanisms are compressible by the normal peristaltic force of the patient's intestines.

35. The fastening system according to claim 1, wherein the sleeve has a length between approximately 3 cm and approximately 25 cm.

36. The fastening system according to claim 1 or 2, wherein the sleeve and / or sleeve body is composed of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymers.

37. The fastening system according to claim 2, wherein the sleeve and the sleeve body are composed of a single continuous tubular extruded product.

38. The proximal end of the sleeve is in sealing fluid communication with the distal end of the sleeve body and the second expandable sealing mechanism, and extends distally thereto. The proximal end of the sleeve, which extends distally to the distal end of the sleeve body, is configured to cover and protect the damaged area of ​​the tissue cavity from contents flowing through the sleeve and the lumen of the sleeve body. The fastening system according to claim 2.

39. A transmission system, An outer protective sheath enclosing the fastening system according to claim 1, The handlebars and Guide shaft and Sheath pull handle, Includes, The fixing system is configured to be pushed into a fixed position by advancing the guide shaft into the patient's intestines. Transmission system.

40. The handlebars and A guide shaft connected to the handle, An outer protective sheath configured to cover and protect the proximal end of a fastening system having at least one expandable sealing mechanism, A sheath pulling handle attached to the outer protective sheath, A transmission system including this.

41. The delivery system according to claim 40, wherein the outer protective sheath is located within the central lumen of the guide shaft and is configured to extend from the central lumen to cover and protect the proximal end of the fixing system having at least one expandable sealing mechanism.

42. The delivery system according to claim 40, which is used in conjunction with a fastening system having a sleeve having column strength, wherein the column strength is sufficiently high to prevent the system from collapsing during insertion through the delivery system.

43. A method for securing a sleeve to a tissue cavity, wherein the sleeve has an outer surface containing foam for contacting the inner wall of the tissue cavity, and an expandable sealing mechanism for isolating a portion of the tissue cavity adjacent to the sleeve from the rest of the tissue cavity, The steps include inserting the sleeve into the tissue cavity, A step of expanding the expandable sealing mechanism to create a seal between the expandable sealing mechanism and the inner wall of the tissue cavity, The steps include: applying negative pressure to the region between the outer surface of the sleeve and the inner surface of the isolation portion of the tissue cavity to generate a frictional force between the foam of the sleeve and the inner surface of the tissue cavity; Methods that include...

44. The method according to claim 43, wherein the step of expanding the expandable sealing mechanism is performed by injecting an expansion medium into the expandable sealing mechanism.

45. The method according to claim 44, wherein the expanding medium comprises at least one of physiological saline, mineral oil, and / or a dye-based contrast solution.

46. The method according to claim 43, wherein the step of inserting the sleeve into the tissue cavity is performed using a delivery system including a handle and a guide shaft.

47. The method according to claim 46, further comprising the step of withdrawing the handle and the guide shaft of the delivery system from the sleeve.

48. The negative pressure is released, The expandable sealing mechanism is crushed, and In order to break the seal, a certain amount of saline solution is injected through the port. The method according to claim 43, further comprising the step of removing the sleeve from the tissue cavity.

49. The device according to claim 1, which utilizes two redundant methods for fixation within the intestine, (i) The first method is to utilize a negative pressure-based friction fastener as described in claim 1, and (ii) The second method is to fix the external portion of the device to the skin using a column strength to the sleeve that is high enough to hold the fastener portion of the device in place even if the first fastening method fails, so that the first fastening method is sufficient to hold the fastener portion of the device in place if the second method fails. device.

50. A method for inserting the fixing system described in claim 1 using an endoscope connected to the fixing system.

51. The method according to claim 50, wherein the fixation system is inserted using direct visualization through the endoscope.

52. A fixing system, A sleeve having an inner surface that defines the lumen, A first expandable sealing mechanism is positioned along the proximal end of the sleeve, A second expandable sealing mechanism is positioned along the proximal end of the sleeve, An air-conducting rough surface material disposed on the outer surface of the sleeve, Includes, (i) expansion of the first and second expandable sealing mechanisms and (ii) application of negative pressure to the fixing system cause a seal to form between the first and second expandable sealing mechanisms and the outer surface of the sleeve and the inner surface of the tissue cavity. Fixing system.

53. The sleeve itself is also included. (i) The first expandable sealing mechanism is located at the proximal end of the sleeve body, and (ii) The second expandable sealing mechanism is located at the distal end of the sleeve body. The fastening system according to claim 52.

54. The fixing system according to claim 52, wherein the air-conducting rough surface material is at least one of a stacked mesh base material, a honeycomb grid of interconnecting channels, gauze, cloth, or a three-dimensional woven material.

55. The fastening system according to claim 53, wherein the distal end of the sleeve body is connected to the proximal end of the sleeve.

56. The fastening system according to claim 53, wherein the sleeve body is in the same extension as the sleeve.

57. The fastening system according to claim 53, wherein the sleeve body is positioned on the proximal end of the sleeve.

58. The fastening system according to claim 52, wherein the sleeve includes a plurality of fluid lumens.

59. The fixing system according to claim 58, wherein the plurality of fluid lumens include one or more of the following: (i) a distal fluid lumen for supplying fluid to the first expandable sealing mechanism, (ii) a proximal fluid lumen for supplying fluid to the second expandable sealing mechanism, (iii) a lavage lumen, (iv) a contrast agent lumen, and (v) a negative pressure lumen.

60. The fixing system according to claim 52, wherein the application of negative pressure generates a frictional force that resists the displacement of the sleeve.

61. The fixing system according to claim 60, wherein the application of negative pressure brings the air-conductive rough surface material, which is positioned on the outer surface of the sleeve, into contact with the inner surface of the tissue cavity, thereby generating the frictional force that resists the displacement of the sleeve.

62. The fastening system according to claim 52, wherein the first and second expandable sealing mechanisms are expanded by providing an incompressible fluid for expanding the first and second expandable sealing mechanisms.

63. The fixing system according to claim 62, wherein the incompressible fluid is at least one of physiological saline, mineral oil, and a dye-based contrast solution.

64. The fastening system according to claim 62, wherein, in the expanded state, the first and second expandable sealing mechanisms form a substantially airtight and liquidtight seal with the inner surface of the tissue cavity.

65. The fastening system according to claim 52, wherein the sleeve protects the inner surface of the tissue cavity from fecal flow.

66. The fixing system according to claim 52, wherein the lumen has a diameter between approximately 1 cm and approximately 6 cm.

67. The fastening system according to claim 52, wherein the sleeve comprises a flexible material having a Shore A hardness between approximately 20A and approximately 70A.

68. The fixing system according to claim 52, wherein the air-conducting rough surface material has a tensile strength of at least 50 kPa.

69. The fixing system according to claim 52, wherein the air-conducting rough surface material has a thickness between 2 mm and 150 mm.

70. The fastening system according to claim 52, wherein the first and second expandable sealing mechanisms each include an expandable elastomer balloon.

71. The fastening system according to claim 52, wherein the first and second expandable sealing mechanisms each include a plurality of expandable elastomer balloons.

72. The fastening system according to claim 52, wherein the first and second expandable sealing mechanisms have an annular diameter larger than the annular diameter of the air-conducting rough surface material dispersed around the sleeve.

73. The fastening system according to claim 52, wherein the sleeve has a column strength of approximately 3.0 pounds to 6.0 pounds.

74. The fixation system according to claim 52, further comprising a collection bag positioned at the distal end of the sleeve and configured to manage intestinal contents transported from the fixation system.

75. The fixation system according to claim 52, further comprising a retaining bandage for attaching the fixation system to the skin.

76. The fixing system according to claim 52, further comprising an extension pipe connected to the distal end of the sleeve and configured to extend the fixing system outside the patient's body.

77. The fixing system according to claim 52, further comprising a spectroscopy adapter configured to connect the sleeve to at least one of an endoscope, a sigmoidoscope, or a colonoscope.

78. The fastening system according to claim 77, wherein the telescope adapter includes a main body, a compression nut, a compression sleeve, and a compression washer.

79. The fastening system according to claim 78, wherein the main body includes a plurality of threads configured to engage with a plurality of grooves provided along the inner surface of the compression nut.

80. The fastening system according to claim 77, further comprising a connector latch point configured to connect the sleeve to at least one of an endoscope, sigmoidoscope, or colonoscope via the endoscopic adapter.

81. Further including a negative pressure source, A negative pressure is applied to the fixing system by the negative pressure source to maintain a constant or variable negative pressure at a level between -50 mmHg and -200 mmHg. The fastening system according to claim 52.

82. The fastening system according to claim 52, further comprising a negative pressure lumen configured to provide negative pressure to the sleeve.

83. The fastening system according to claim 52, wherein the sleeve has a length that allows it to extend outside the tissue cavity.

84. The fixation system according to claim 52, wherein the lumen and the first and second expandable sealing mechanisms are compressible by the normal peristaltic force of the patient's intestines.

85. The fastening system according to claim 52, wherein the sleeve has a length between approximately 3 cm and approximately 25 cm.

86. The fastening system according to claim 52 or 53, wherein the sleeve and / or sleeve body is composed of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymers.

87. The fastening system according to claim 53, wherein the sleeve and the sleeve body are composed of a single continuous tubular extruded product.

88. The proximal end of the sleeve is in sealing fluid communication with the distal end of the sleeve body and the second expandable sealing mechanism, and extends distally thereto. The proximal end of the sleeve, which extends distally to the distal end of the sleeve body, is configured to cover and protect the damaged area of ​​the tissue cavity from contents flowing through the sleeve and the lumen of the sleeve body. The fastening system according to claim 53.

89. An attachment device configured to be fixed inside the patient's intestines, (a) A sleeve configured to be positioned within the intestine of the patient, (b) an external portion configured to extend outside the body from the patient's intestine, and (c) Two redundant methods for fixing the device in the intestine, Includes, A first method for fixing the device utilizes a negative pressure-based system that applies negative pressure to the device to generate a frictional force that resists the displacement of the sleeve of the device from the intestine, A second method for fixing the device involves fixing the external portion of the device to the patient's skin, and (i) the column strength of the sleeve is sufficiently high to hold the device in place even if the first fastening method fails, or (ii) the first fastening method is sufficient to hold the device in place even if the second fastening method fails, at least one of these. Fixing device.

90. Further including a third redundant method for securing the device, The third fixing method utilizes the first and second expandable sealing mechanisms, The expansion of the first and second expandable sealing mechanisms causes a seal to form between the first and second expandable sealing mechanisms and the inner surface of the tissue cavity. The third method of fastening is sufficient to hold the device in place even if the first and / or second method of fastening fails. The fixing device according to claim 89.

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