Devices and methods for anchoring sheath in tissue cavity

Abstract

To provide devices and methods for anchoring a sheath in a tissue cavity.SOLUTION: According to some embodiments of the invention, an anchoring system includes a sleeve having an inner surface defining a first lumen, a first annular sealing mechanism disposed at a proximal end of the sleeve, and a second annular sealing mechanism disposed at a distal end of the sleeve. The anchoring system further includes a pressure tube in fluid connection with an outer surface of the sleeve, a sheath in mechanical connection with the sleeve, the sheath forming a second lumen, the second lumen being in fluid connection with the first lumen, and open-cell foam disposed on the outer surface of the sleeve. Application of negative pressure to the pressure tube causes a seal to form between the first and second annular sealing mechanisms and an inner surface of a tissue cavity. Application of negative pressure to the pressure tube also creates a frictional force that resists displacement of the sleeve.SELECTED DRAWING: None

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Application No. 62 / 283,877, filed on September 15, 2015, the entire disclosure of which is hereby incorporated by reference herein.

[0002] (1. Technical Field) The field of the presently claimed embodiments of the invention relates to medical devices, and more particularly, to tethering a medical device within a tissue cavity.

Background Art

[0003] (2. Discussion of Related Art) The need for temporary protection of the bowel lumen from fecal stream after surgical bowel resection and anastomosis, or when the bowel wall is damaged, has conventionally been achieved by creating an external bypass of the bowel through creation of a stoma. A stoma is an intentional anastomosis between a segment of the gastrointestinal (GI) tract and the skin of the anterior abdominal wall. A stoma can be created virtually anywhere along the GI tract. With respect to diversion of fecal stream, the most common stomas involve the distal small intestine (e.g., ileostomy) and the large intestine (e.g., colostomy). Stomas are performed on 300,000 patients in the United States and over 2 million patients worldwide, but the procedure is complicated by high morbidity, mortality, and a significant impact on the quality of life of the patient. Many stomas are intended to be temporary, but 1 / 3 of the cases of temporary stomas never recover. Thus, there is a need for improved methods and devices that provide a lower morbidity alternative for fecal diversion.

[0004] One of the main indications for temporary stoma is to protect intestinal anastomosis from intestinal contents that can lead to anastomotic leakage. Anastomotic leakage is defined as a defect in the intestinal wall at the anastomotic site that leads to communication between the intraluminal compartment and the extraluminal compartment. Anastomotic leakage after intestinal surgery is a serious complication. The overall incidence of colorectal anastomotic leakage varies widely in the literature, ranging from 1% to 24%. Leakage can cause serious complications such as anastomosis, sepsis, and death. Even in these cases where the anastomosis is salvaged, poor compliance of the artificial rectum can lead to poor functional outcomes. In many large-scale studies, anastomotic leakage has been shown to be associated with pelvic sepsis in 50% of cases. By protecting the anastomosis from fecal flow, anastomotic leakage can be prevented or their morbidity can be reduced. In addition, even after anastomotic leakage has occurred, protection from fecal flow can mitigate anastomotic leakage and assist in the healing of the leakage. There are several risk factors for the occurrence of anastomotic leakage. The most significant risk factor is the level of the anastomosis, and the leakage rate increases as the distance from the anastomosis to the anus decreases. In addition to meticulous technique when creating the anastomosis, the main strategy for preventing and treating anastomotic leakage during complex or high-risk cases involving intestinal resection is to divert fecal flow. This is achieved by using a stoma created in the intestine proximal to the anastomosis to divert the gastric content flow. The proximal in the intestine is defined as the higher upper part of the GI tract towards the mouth, and the distal in the intestine is defined as the lower lower part of the GI tract towards the anus. This stoma can be an end stoma such as an end colostomy or an end ileostomy, or it can be a loop colostomy that does not completely disrupt the continuity of the intestine.

[0005] Temporary loop stomas and their closure have their own set of complications and morbidity, including dehydration due to high output, difficulty in stoma care, strictures at the closure site, wound infections, and incisional hernias. The complication rate of stomas ranges from 5% to 100%. Complications can be divided into mild complications that do not require surgical intervention and severe complications that do require surgical intervention. Severe complications include strictures, small bowel obstruction, retraction, necrosis, prolapse, stenosis, fistulas, and peristomal hernias. In cases such as partial small bowel obstruction, the patient can initially be treated conservatively and surgical intervention can be avoided. In severe complications such as stoma necrosis extending beyond a few millimeters, surgical intervention is essential. Mild complications include dermatitis, electrolyte imbalance, and dehydration from high stoma output, but ultimately often necessitate early closure of the stoma. With regard to severe complications, the additional costs and morbidity associated with additional surgery or hospitalization can be significant. Even with mild complications, treating the complication and providing stoma education can be burdensome for both healthcare providers and patients. Some complications such as hernias, prolapses, and strictures can become chronic and often require multiple corrective surgeries and associated costs. Stomas also significantly reduce the quality of life of the patient. Fecal output from the stoma is collected in a stoma bag attached to the patient's abdomen. These bags need to be emptied and replaced regularly to properly care for the stoma and prevent unintentional discharge of fecal matter.

[0006] Furthermore, stoma reversal is often a surgical procedure with potential complications because in many cases the abdominal compartment has dense adhesions that make reestablishing normal bowel continuity both costly and potentially morbid. In addition to the costs associated with transporting the patient to the operating room, the patient typically requires a 2 - to 4-day hospital stay after the procedure to enable support until bowel function returns. Furthermore, stoma reversal can be difficult or impossible in some patients, requiring the patient to live with the stoma for the rest of their life. The repaired bowel after stoma removal can also develop leaks at the repair site or anastomosis site, respectively, in the case of loop ileostomy or terminal stoma reattachment.

[0007] In addition to anastomosis protection, there are other indications for temporary fecal diversion. These include: 1) its treatment after anastomotic leakage has occurred, 2) diverticulitis, 3) inflammatory bowel diseases such as Crohn's disease or ulcerative colitis, 4) intestinal perforation, and 5) fecal diversion may be useful in less common cases of intestinal injury, such as in cases of ischemic bowel disease, intestinal contusion from trauma, or non-healing perineal / peri-anal wounds. As an example, in cases such as anastomotic leakage and diverticulitis when leakage or intestinal perforation occurs, treatment using fecal diversion can reduce the severity and degree of symptoms. Therefore, these patients may heal more quickly from the leakage / perforation and not develop more severe complications when the continuous fecal stream contamination of the affected site is reduced. Inflammatory conditions of the intestinal wall, such as Crohn's disease or ulcerative colitis, can make the inner layer of the intestine more susceptible to damage from fecal stream. Continuous fecal stream can further cause and contaminate inflammation of the intestinal wall, leading to deterioration of the patient's overall disease or even obvious perforation of the intestinal wall. Protection from fecal stream allows the inflamed segment of the intestine to rest and heal, and potentially, fecal diversion can shorten the recovery time and hospital stay and limit severe complications such as perforation or fistula formation. Patients with these symptoms may not be good candidates for surgery due to concomitant symptoms or sepsis. Therefore, performing major surgery to create a stoma can be disease-causing in these cases. Hence, there is a need for improved methods and devices that provide a low morbidity alternative for fecal diversion.

[0008] In the past, the concept of an intraluminal sheath for internal fecal diversion has been described (U.S. Patent No. 4,716,900, U.S. Patent No. 4,905,693, U.S. Patent Application Publication No. 2010 / 0010519). The main challenge has been to develop a device that can be firmly tethered within the intestine without damaging the intestinal wall itself and effectively achieve an airtight and liquidtight fecal flow diversion. Staple and suture-based techniques for devices such as those described by Ravo et al. (U.S. Patent No. 4,716,900), Ravo (U.S. Patent No. 4,905,693), and Stopek et al. (U.S. Patent Application Publication No. 2010 / 0010519) are potentially harmful to the area of intestinal damage from traction and cannot achieve effective sheath tethering without major surgery. Other methods of intestinal tethering that rely on scar formation to anchor an anchor in place, such as the device described by Baker (U.S. Patent Application Publication No. 2008 / 0215076), have also been described. However, this method is not easily reversible and depends on the body's scar-forming ability, which can be impaired in some patients, for robust tethering. There are also stent-based anchors such as the devices described by Khosrovaninejad (U.S. Patent Application Publication No. 2011 / 0295288), Levine et al. (U.S. Patent No. 7,267,694), Rockey (U.S. Patent No. 4,641,653), and Bessler et al. (U.S. Patent No. 7,211,114), but the stents do not provide sufficient tethering strength to firmly hold the sheath in place during intestinal peristalsis, as evidenced by their high early expulsion rates, and can further damage the intestinal wall due to the necessary rigidity and expansion force they exert to provide tethering. Others, such as Assaf et al. (U.S. Patent Application Publication No. 2013 / 0158463), have attempted to use fixed biodegradable rings placed outside and around the intestinal wall, but this approach also requires major surgery for placement and exposes the intestine to potential erosion and damage due to the pressure points exerted on the intestinal wall. In addition, the need to create a substantially airtight and liquidtight bypass of fecal contents has also been a technical challenge.Expansive balloon - type seals, such as those described by Assaf et al. (U.S. Patent Application Publication No. 2013 / 0158463) and Weig (U.S. Patent No. 8,388,586 and U.S. Patent Application Publication No. 2010 / 0022976), are described as attempting to achieve an airtight and liquid - tight seal within the intestine, but these again require potentially harmful expansive forces and pressures on the intestinal wall to form the seal and often cannot achieve a sufficient airtight and liquid - tight barrier against intestinal flow.

[0009] Negative pressure wound closure therapy has been used in the past to treat anastomotic leaks, and these dressings typically utilize a foam interface that covers the damaged area of the intestine covered by an occlusive barrier connected to a negative pressure source. Devices specifically designed to treat wounds and provide negative pressure therapy within the intestine or body cavity have been described (U.S. Patent Application Publication No. 2013 / 0190706, U.S. Patent No. 8,926,576, and U.S. Patent Application Publication No. 2015 / 0250979). Importantly, these devices are designed to be placed and deliver negative pressure at the site of the anastomosis or tissue injury, and as a result, additional damage to the area of the anastomosis or tissue injury can occur when longitudinal forces are applied to these devices or negative pressure ischemia is induced. These devices are not designed to protect the intestinal lumen distal to the site of placement. These types of dressing devices for negative pressure wound closure therapy are difficult to establish and maintain an airtight seal and are frequently removed due to the lack of a sufficient sealing mechanism. Additionally, these devices are not configured in a way to withstand the additional longitudinal forces that can displace the device with the addition of a protective sheath. Finally, these devices employ an inflatable wire-stent-based design to provide a semi-rigid structure (U.S. Patent Application Publication No. 2013 / 0190706, U.S. Patent No. 8,926,576, and U.S. Patent Application Publication No. 2015 / 0250979) that can create tissue damage and make evacuation from the intestine more likely due to peristaltic forces. Khosrovaninejad (U.S. Patent Application Publication No. 2014 / 0222039) uses negative pressure suction in an attempt to anchor a protective sleeve within the intestine. The main problem with this device is that the attachment and anchoring of the device rely on the adhesive force of the negative pressure delivered through the perforations and the radial expansion force of the stent-based design. The perforations do not allow sufficient friction to be generated to substantially fix the device in place and resist the evacuation forces of the intestine. Thus, this device is designed to be expelled from the body after a few days and must be placed very high above the area being treated. Additionally, the inflatable stent-based design suffers from the same problems as other stent-based designs, namely potential intestinal damage and evacuation.Therefore, there is a need for devices and methods that can be securely tethered within a body cavity in a controlled manner, having an improved safety profile and increased tethering strength and reliability.

Prior Art Documents

Patent Documents

[0010]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Means for Solving the Problems

[0011] According to some embodiments of the present invention, a tethering system includes a sleeve having an inner surface defining a first lumen, a first annular sealing mechanism disposed at a proximal end of the sleeve, and a second annular sealing mechanism disposed at a distal end of the sleeve. The tethering system further includes a pressure tube in fluid connection with an outer surface of the sleeve, and a sheath mechanically connected to the sleeve, the sheath forming a second lumen that is in fluid connection with the first lumen, and a continuous bubble foam disposed on the outer surface of the sleeve. Application of a negative pressure to the pressure tube forms a seal between the first and second annular sealing mechanisms and an inner surface of the tissue cavity. Application of a negative pressure to the pressure tube also generates a frictional force that resists displacement of the sleeve.

[0012] According to some embodiments of the present invention, application of a negative pressure to the pressure tube contacts a continuous bubble foam disposed on the outer surface of the sleeve with an inner surface of the tissue cavity, thereby generating a frictional force that resists displacement of the sleeve.

[0013] According to some embodiments of the present invention, the first and second annular sealing mechanisms form a substantially airtight and liquidtight seal with the inner surface of the tissue cavity. According to some embodiments, the first and second annular sealing mechanisms comprise rounded protrusions, or a plurality of protrusions serially disposed at each end of a compressible sleeve. According to some embodiments, the first and second sealing mechanisms each comprise a plurality of concentric fins that form a series of concentric seals. According to some embodiments, the first and second sealing mechanisms each comprise a plurality of concentric protrusions that form a series of concentric seals.

[0014] According to some embodiments of the present invention, the sheath protects the inner surface of the tissue cavity from fecal flow distal to the sleeve. According to some embodiments, the first lumen has a diameter of about 1 cm to about 6 cm. According to some embodiments, the outer surface of the sleeve has a diameter of about 1.1 cm to about 6.1 cm. According to some embodiments, the sleeve comprises a flexible material having a Shore A hardness of about 20A to about 70A. According to some embodiments, the sleeve has a length of about 3 cm to about 25 cm. According to some embodiments, the sleeve has a tubular wall thickness of about 0.1 mm to about 8 mm. According to some embodiments, the sleeve has a tubular wall thickness of about 0.2 mm to about 5 mm.

[0015] According to some embodiments of the present invention, the open-cell foam comprises a material having an average pore size of from about 50 microns to about 1,000 microns. According to some embodiments, the open-cell foam comprises a material having an average pore size of from about 300 microns to about 600 microns. According to some embodiments, the open-cell foam comprises a material having an average pore size of from about 100 microns to about 300 microns. According to some embodiments, the open-cell foam is compressible by peristaltic contractions of a patient's intestine. 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 of from 2 mm to 150 mm. According to some embodiments, the open-cell foam comprises a single tubular foam.

[0016] According to some embodiments of the present invention, the first and second annular sealing mechanisms comprise a flexible material having a Shore A hardness of from about 20A to about 70A. According to some embodiments, the first and second annular sealing mechanisms have an annular diameter that exceeds the annular diameter of the open-cell foam dispersed around the sleeve. According to some embodiments, the first and second annular sealing mechanisms are oriented away from the center of the sleeve such that when negative pressure is delivered through the pressure tube, one or more tapered fins contact the inner surface of the tissue cavity and flatten, and are serially disposed on each end of the sleeve. According to some embodiments, the first and second annular sealing mechanisms comprise a rounded protrusion, or a plurality of protrusions serially disposed at each end of the sleeve that are compressible.

[0017] According to some embodiments of the present invention, the anchoring system further includes a negative pressure source, and the negative pressure is applied to the pressure tube by the negative pressure source so as to maintain a constant negative pressure at a level of -50 mmHg to -200 mmHg. According to some embodiments of the present invention, the anchoring system further includes a cleaning tube that is in fluid connection with the outer surface of the sleeve. According to some embodiments of the present invention, the anchoring system further includes a cleaning system that is in fluid connection with the pressure tube, and the cleaning system introduces fluid into the pressure tube for cleaning.

[0018] According to some embodiments of the present invention, the sheath has a length that allows it to extend outside the tissue cavity. According to some embodiments, the first lumen, the second lumen, and the first and second annular sealing mechanisms are compressible by the normal peristaltic force of the patient's intestine. According to some embodiments, the diameters of the first annular sealing mechanism and the second annular sealing mechanism are less than or equal to the diameter of the tissue cavity to which the sheath is anchored. According to some embodiments, the anchoring system is configured such that the pulling force on the sheath can be used to remove the anchoring system from the body cavity. According to some embodiments, the sheath has a wall thickness that is from about 50 microns to about 5 mm. According to some embodiments, the sheath has a length that is from about 8 inches to about 72 inches. According to some embodiments, the sheath has markings along its length indicating the length of the sheath within the tissue cavity after placement. According to some embodiments, the sheath is made of silicone, polyurethane, thermoplastic elastomer, rubber, or other polymers.

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

[0020] According to some embodiments of the present invention, the sleeve, the first and second sealing mechanisms, and the sheath are made of 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 mooring system further includes a plurality of pressure tubes in fluid connection with the outer surface of the sleeve.

[0022] According to some embodiments of the present invention, the mooring system further includes an effluent bag in fluid connection with the sheath, the effluent bag being configured to receive the contents of the sheath. According to some embodiments, the effluent bag is removable.

[0023] According to some embodiments of the present invention, the sleeve, the first annular sealing mechanism, and the second annular sealing mechanism form a first mooring element, and the mooring system further includes a second mooring element mechanically connected to the sheath, the second mooring element being disposed away from and distal to the first mooring element, and a port disposed between the first mooring element and the second mooring element. The sheath, the first mooring element, and the second mooring element create a sealed space between the first and second mooring elements, the sheath, and the inner surface of the tissue cavity, and the port communicates with the sealed space to allow access from outside the patient's body for fluid delivery and collection. According to some embodiments, the sheath is divided into a plurality of mooring compartments having independent negative pressure supply units. According to some embodiments, the fluid to be administered is an anti-inflammatory agent, a chemotherapeutic agent, an antibacterial agent, a radiopaque agent, or a washing solution. According to some embodiments, the sleeve is divided by additional sealing mechanisms to create a plurality of mooring compartments. According to some embodiments, a plurality of foams are dispersed around each mooring compartment. According to some embodiments, each mooring compartment has an independent negative pressure supply unit.

[0024] According to some embodiments of the present invention, the sleeve and the first and second annular sealing elements are made from a single injection molding using a single material. According to some embodiments, the sheath comprises a liquid-tight sheath connector releasable at 8 inches to 36 inches from the second annular sealing mechanism. According to some embodiments, the sheath comprises a separable joint at 8 inches to 36 inches from the second annular sealing mechanism. According to some embodiments, the tethering system is configured to be positioned into a tissue cavity using an endoscope. According to some embodiments, the tethering system is configured to be attached to a releasable clip on the end of the endoscope such that the tethering system can be released from the endoscope from outside the patient's body. According to some embodiments, the tissue cavity is an intestine with an anastomosis, and the tethering system is positioned within the intestine such that the anastomosis is located distal to the second annular sealing mechanism within the intestine. According to some embodiments, the tethering system further includes a cleaning system fluidly connected to a pressure tube, and the cleaning system introduces fluid into the pressure tube for cleaning.

[0025] According to some embodiments of the present invention, the delivery system includes a flexible tubular membrane that encloses the tethering system according to an embodiment of the present invention, and a semi-rigid tube pusher having a proximal end, a distal end, and a center. The tethering system is configured to be pushed into place by advancing the semi-rigid tube pusher into the patient's intestine, and the flexible tubular membrane indents at the proximal end of the semi-rigid tube pusher and exits from the distal end.

[0026] According to some embodiments of the present invention, the delivery system compresses the tethering system and holds the tethering system to the semi-rigid tube pusher when a longitudinal pulling force is applied to the flexible tubular membrane. According to some embodiments, the delivery system further includes a flexible member that can be removed from the semi-rigid tube pusher and extracted from the patient's body through the center of the semi-rigid tube pusher after placement of the tethering system.

[0027] According to some embodiments of the present invention, a temporary anchoring device for diverting fecal flow through the intestinal lumen includes a sleeve having an inner surface defining a first lumen, a first annular sealing mechanism disposed at the proximal end of the sleeve, and a second annular sealing mechanism disposed at the distal end of the sleeve. The temporary anchoring device further includes a pressure tube in fluid connection with the outer surface of the sleeve, and a sheath mechanically connected to the sleeve, the sheath forming a second lumen, the second lumen being in fluid connection with the first lumen, and an air-conducting rough material disposed on the outer surface of the sleeve. Application of a negative pressure to the pressure tube forms a seal between the first and second annular sealing mechanisms and the inner surface of the intestinal lumen, and application of a negative pressure to the pressure tube generates a frictional force that resists displacement of the sleeve.

[0028] According to some embodiments, the air-conducting rough material is a laminated mesh array, a honeycomb lattice of interconnected channels oriented in a radial pattern around the sleeve, a gauze, a fabric, or a three-dimensional woven material.

[0029] According to some embodiments of the present invention, a method for anchoring a sheath within a tissue cavity, the sheath being mechanically connected to a sleeve, the sleeve having an outer surface with a foam for contacting the inner wall of the tissue cavity and a sealing mechanism for isolating a portion of the tissue cavity adjacent to the sleeve from the remainder of the tissue cavity, the method includes inserting the sleeve into the tissue cavity. The method further includes applying a negative pressure to the region between the outer surface of the sleeve and the inner surface of the isolated portion of the tissue cavity to generate a frictional force between the outer surface of the sleeve and the inner surface of the tissue cavity. The present invention provides, for example, the following. (Item 1) A sleeve having an inner surface defining a first lumen, and A first annular sealing mechanism disposed at the proximal end of the sleeve, and A second annular sealing mechanism disposed at the distal end of the sleeve, and A pressure tube in fluid connection with the outer surface of the sleeve, and A sheath that is mechanically connected to the sleeve, the sheath forming a second lumen, the second lumen being in fluid connection with the first lumen, the sheath, A continuous bubble foam disposed on the outer surface of the sleeve, Comprising, Applying a negative pressure to the pressure tube forms a seal between the first and second annular sealing mechanisms and the inner surface of the tissue cavity, Applying the negative pressure to the pressure tube generates a frictional force that resists displacement of the sleeve, An anchoring system. (Item 2) Applying the negative pressure to the pressure tube brings the continuous bubble 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 displacement of the sleeve, the anchoring system according to item 1. (Item 3) The first and second annular sealing mechanisms form a substantially airtight and liquidtight seal with the inner surface of the tissue cavity, the anchoring system according to item 1. (Item 4) The sheath protects the inner surface of the tissue cavity from fecal flow distal to the sleeve, the anchoring system according to item 1. (Item 5) The first lumen has a diameter of about 1 cm to about 6 cm, the anchoring system according to item 1. (Item 6) The outer surface of the sleeve has a diameter of about 1.1 cm to about 6.1 cm, the anchoring system according to item 1. (Item 7) The continuous bubble foam comprises a material having an average pore diameter of about 50 microns to about 1,000 microns, the anchoring system according to item 1. (Item 8) The continuous bubble foam is compressible by peristaltic contractions of the patient's intestine, the anchoring system according to item 1. (Item 9) The sleeve comprises a flexible material having a Shore A hardness of about 20A to about 70A, the anchoring system according to item 1. (Item 10) The continuous bubble foam comprises polyvinyl alcohol, polyurethane foam, or other synthetic polymers, and the mooring system according to Item 1. (Item 11) The continuous bubble foam has a tensile strength of at least 50 kPa, and the mooring system according to Item 1. (Item 12) The continuous bubble foam has a thickness of 2 mm to 150 mm, and the mooring system according to Item 1. (Item 13) The first and second annular sealing mechanisms comprise a flexible material having a Shore A hardness of about 20 A to about 70 A, and the mooring system according to Item 1. (Item 14) The first and second annular sealing mechanisms have an annular diameter that exceeds the annular diameter of the continuous bubble foam dispersed around the sleeve, and the mooring system according to Item 1. (Item 15) When negative pressure is delivered through the pressure tube, the first and second annular sealing mechanisms are serially placed on each end of the sleeve in an orientation directed away from the center of the sleeve so that one or more tapered fins contact and flatten against the inner surface of the tissue cavity. The mooring system according to Item 1 comprises the one or more tapered fins. (Item 16) The first and second annular sealing mechanisms comprise a rounded protrusion or a plurality of protrusions serially placed at each end of the compressible sleeve. The mooring system according to Item 1. (Item 17) The mooring system according to Item 1 further comprises a negative pressure source, and the negative pressure is applied to the pressure tube by the negative pressure source so as to maintain a constant negative pressure at a level of -50 mmHg to -200 mmHg. (Item 18) The sheath has a length that allows it to extend outside the tissue cavity, and the mooring system according to Item 1. (Item 19) The retention system according to item 1, wherein the first lumen, the second lumen, and the first and second annular sealing mechanisms are compressible by the normal peristaltic force of the patient's intestine. (Item 20) The retention system according to item 1, wherein the sleeve has a length of about 3 cm to about 25 cm. (Item 21) The retention system according to item 1, wherein the sleeve, the first and second sealing mechanisms, and the sheath are made of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymers. (Item 22) The retention system according to item 1, further comprising a plurality of pressure tubes in fluid connection with the outer surface of the sleeve. (Item 23) The sleeve, the first annular sealing mechanism, and the second annular sealing mechanism form a first retention element, and the retention system further comprises a second retention element mechanically connected to the sheath, the second retention element being disposed away from and distal to the first retention element, and a port disposed between the first retention element and the second retention element, and the sheath, the first retention element, and the second retention element create a sealed space between the first and second retention elements, the sheath, and the inner surface of the tissue cavity, the port communicating with the sealed space to allow access from outside the patient's body for fluid delivery and collection, The retention system according to item 1. (Item 24) The retention system according to item 1, wherein the diameters of the first annular sealing mechanism and the second annular sealing mechanism are less than or equal to the diameter of the tissue cavity to which the sheath is tethered. (Item 25) A flexible tubular membrane enclosing the retention system according to item 1, and a semi-rigid tube pusher with a proximal end, a distal end, and a center. comprising the mooring system is configured to be pushed to a fixed position by advancing the semi-rigid tube pusher into the patient's intestine the flexible tubular membrane is recessed at the proximal end of the semi-rigid tube pusher and exits from the distal end delivery system (Item 26) The delivery system according to item 25, wherein when a longitudinal pulling force is applied to the flexible tubular membrane, the mooring system is compressed and the mooring system is held to the semi-rigid tube pusher. (Item 27) The delivery system according to item 26, further comprising a flexible member that can be removed from the semi-rigid tube pusher and extracted from the patient's body through the center of the semi-rigid tube pusher after the mooring system is placed. (Item 28) A temporary mooring device for bypassing fecal flow through the intestinal lumen, a sleeve having an inner surface defining a first lumen, a first annular sealing mechanism disposed at the proximal end of the sleeve, a second annular sealing mechanism disposed at the distal end of the sleeve, a pressure tube in fluid connection with the outer surface of the sleeve, a sheath mechanically connected to the sleeve, the sheath forming a second lumen, the second lumen being in fluid connection with the first lumen, an air-conducting rough material disposed on the outer surface of the sleeve, comprising application of a negative pressure to the pressure tube forms a seal between the first and second annular sealing mechanisms and the inner surface of the intestinal lumen, the application of the negative pressure to the pressure tube generates a frictional force that resists displacement of the sleeve, temporary mooring device (Item 29) The air-conducting rough material of item 28, for temporarily tethering a fecal stream through an intestinal lumen, is a laminated mesh matrix, a honeycomb lattice of interconnected channels oriented in a radial pattern around the sleeve, a gauze, a fabric, or a three-dimensional woven material. (Item 30) A method for tethering a sheath within a tissue cavity, the sheath being mechanically connected to a sleeve, the sleeve having an outer surface with a foam for contacting the inner wall of the tissue cavity and a sealing mechanism for isolating a portion of the tissue cavity adjacent to the sleeve from the rest of the tissue cavity. Inserting the sleeve into the tissue cavity. Applying a negative pressure to a region between the outer surface of the sleeve and the inner surface of the isolated portion of the tissue cavity to generate a frictional force between the outer surface of the sleeve and the inner surface of the tissue cavity. A method comprising:

Brief Description of the Drawings

[0030] Further objects and advantages will become apparent from a consideration of the description, drawings, and examples.

[0031]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

[0032] Some embodiments of the present invention are discussed in detail below. Specific terms are employed in describing the embodiments for clarity. However, the present invention is not intended to be limited to the specific terms so selected. Those skilled in the art will recognize that other equivalent components may be employed and other methods may be developed without departing from the broad concepts of the present invention. All references cited anywhere in this specification, including the sections on Background Art and Detailed Description of the Invention, are incorporated by reference as if each were individually incorporated.

[0033] Disclosed herein are systems and methods for tethering a protective sheath in the proximal intestine of a region of the intestine that requires protection from fecal flow, such as the area of an intestinal anastomosis or intestinal injury. The systems and methods provide an internal fecal bypass and can obviate the need for a temporary fecal diversion stoma in most patients by protecting the distal compartment of the intestine from fecal flow, thereby achieving the same overall purpose as a temporary stoma. Additionally, an additional configuration of the system that enables drug delivery into the intestinal lumen is disclosed.

[0034] The system includes a tethering mechanism that enables non-invasive and reversible tethering of a sheath within the GI tract to divert fecal contents away from the anastomosis site or the area of damaged intestine. The device is designed to be left in place for periods ranging from several days to four weeks and then removed completely from the patient after healing has occurred or diversion is no longer required. The device and method are described herein in the context of firmly tethering a sleeve within the GI tract for therapeutic benefit purposes such as diverting intestinal contents, but the device and method for tethering may also have applications in other areas of the body where robust tethering within a tissue cavity is desired. It is important to emphasize that the device is designed to be substantially and firmly tethered in place within the intestine and to prevent substantial device movement until the device is actively untethered and removed by a clinician. This is in contrast to other non-surgically attached sheath-based protection devices that are slowly extruded from the intestine over time because they cannot be firmly tethered and cannot maintain the same high level of tethering strength required to resist intestinal expulsive forces. The unique design of the device disclosed herein enables it to be tethered in place within the intestine without removal, without damaging the intestinal wall, without requiring surgical fixation such as suturing or stapling, and without requiring a permanent implant. These features are each described in further detail below.

[0035] According to some embodiments, the device includes a negative-pressure based anchoring system that prevents the sleeve from being withdrawn from the inner surface of the intestine. The sleeve is connected to the sheath and, in combination with the sheath, acts as a protective barrier between the GI tract and the GI contents flowing through the sleeve and sheath. According to some embodiments, the device includes a pneumatic system for applying negative pressure to the anchor system. The device, in some embodiments, includes an external effluent bag for collecting GI contents flowing through the sleeve and sheath. However, the external effluent bag is not required for the device to function. In some embodiments, the device has a sheath that opens just outside the anal sphincter and feces can be passed through this opening. In this embodiment, the anal sphincter contracts around the sheath, providing some fecal continence control and eliminating the need for a collection bag.

[0036] According to some embodiments, the anchoring portion of the device is positioned within the GI tract proximal to the anastomosis or proximal to the area of damaged intestine. The proximal side is the side that is “upstream” with respect to the flow of GI contents through the GI tract. This is in contrast to anastomosis or wound treatment systems that are configured to be applied directly to the anastomosis or wound site. The device is configured to be anchored within healthy, non-damaged intestine. A certain negative pressure is maintained via a pneumatic interface connected to the anchoring system and dispersed through a continuous bubble reticulated foam interface. Special sealing elements at the ends of the sleeve create a negative pressure space between the outer surface of the sleeve containing the foam interface and the intestinal wall. When negative pressure is applied, the pressure gradient acts through the foam to create adhesion and frictional forces between the GI tract and the anchoring system. These adhesion and frictional forces generated by the negative pressure-sponge interface allow an anchoring system that is much larger than other previously described non-surgically fixed sheath anchoring systems to maintain a relatively fixed position within the intestine. When the user is ready to remove the device, normal atmospheric pressure between the anchoring device and the intestine can be re-established, allowing the device to move through the GI tract with minimal friction. The anchoring device and method do not require sutures, stapling, biodegradable implants, or other invasive anchoring techniques and create minimal trauma to the intestine. Thus, described herein are methods and devices for securely fixing a sleeve within the intestinal tract in a manner that substantially does not damage the intestinal wall and allows the fixation to be easily reversed for device removal.

[0037] According to the features of embodiments of the present invention, a device for anchoring a sleeve within the intestine can be described as having a hollow body with a plurality of seals on each end and a porous material on the outer surface of the hollow body such that adhesion is formed between the intestinal wall and the hollow body in response to the application of negative pressure to the outer surface of the hollow body. A tube can deliver the negative pressure to the sealing member. A protective sleeve can be attached to the sealing member and a collection system can collect the contents passing through the sealing member.

[0038] Figure 1 shows a cross-sectional view of an anchor portion of a tethering system according to some embodiments of the present invention. The tethering system 100 includes a sleeve 102 having an inner surface 104 that defines a lumen 106. A first annular sealing mechanism 108 is disposed at the proximal end of the sleeve 102, and a second annular sealing mechanism 110 is disposed at the distal end of the sleeve 102. With respect to the device, proximal is defined as the part of the device that is furthest from the location where fecal matter exits the sheath (e.g., in the effluent bag), and distal is defined as the part of the device that is closer to the location where fecal matter exits the sheath into the normal fecal stream. This orientation convention is used because it is the relationship of flow through the device (from proximal to distal) and matches the orientation of the device within the intestine. The pressure tube 112 is in fluid communication with the outer surface 114 of the sleeve 102. The sheath 116 is mechanically connected to the distal end of the sleeve 102 and forms a second lumen 118 that is in fluid communication with the first lumen 106. The continuous bubble foam 120 is disposed on the outer surface 114 of the sleeve 102. Application of negative pressure to the pressure tube 112 forms a seal between the first and second annular sealing mechanisms 108, 110 and the inner surface of the tissue cavity, generating a frictional force that resists displacement of the sleeve 102.

[0039] Figures 2A-2C illustrate a method for insertion and tethering of a tethering system. The anchor portion of the tethering system 200, comprising a sleeve, sealing mechanisms 212, 214, and foam dispersed around the sleeve, is transmitted through the tissue cavity 202 to the tethering site. In the case of an anastomosis, the device is delivered to a position proximal to the anastomosis such that the sleeve and sealing mechanisms are proximal to all anastomoses. A semi-rigid tube pusher 203 is used to position the device in the appropriate location. The flexible membrane 204 covers the device and provides flattening of the sealing mechanisms 212, 214 to reduce friction during placement. The flexible membrane 204 also further reduces friction by covering the foam dispersed over the sleeve. The device may also be delivered using an endoscope or other delivery system. Exemplary delivery systems are discussed in more detail below.

[0040] Once the device is positioned at a desired location above the area requiring isolation from fecal flow by the sheath 220, it is removed from the delivery system, and the delivery system components, including the semi-rigid tube pusher 203 and the flexible membrane 204, are removed from the patient.

[0041] Figure 2B illustrates the device 206 removed from the delivery system and in a desired position. Figure 2C illustrates the device 208 once negative pressure has been applied through the pressure tube 210. As air is removed from the space between the mooring mechanisms on the outer surface of the sleeve, the inner wall of the tissue cavity is drawn towards the sleeve. As shown in Figure 2B, unlike an anchor that relies on an inflation force to provide fixation such as a stent, the device 206 can have an outer diameter of some or all of its components that is smaller than the inner diameter of the sealed tissue cavity inner walls 215, 217 to which it is moored. The sealing mechanisms 212, 214 create a seal with the wall of the tissue cavity at either end of the sleeve. As shown in Figure 2C, the sealing mechanisms 212, 214 comprise sealing elements 222, 224 that are structured to conform to the inner walls 216, 218 of the tissue cavity as negative pressure is applied, thereby creating a liquid-tight and air-tight seal. The flexibility of the sealing elements and the angle at which they project allow them to bend when negative pressure is applied, avoiding creating compressive ischemia of the intestinal wall as illustrated in Figure 2C. This allows the sealing elements to lie flat in contact with the tissue surface and form a seal using the tissue decompression at the interface between the sealing mechanisms 212, 214 and the tissue cavity walls 216, 218. The diversity of the annular design of the sealing mechanism (i.e., having multiple circular fins or protrusions) allows the ability to adapt to the redundancy of the seal created and the irregularity of the contour of the inner tissue cavity walls 216, 218. Additionally, the sealing elements have an outer diameter that exceeds the outer diameter of the foam. This allows for a more secure creation of the seal with the intestine when the intestinal wall is suctioned during negative pressure activation.

[0042] The seals at both ends of the sleeve prevent air from entering the space between the sleeve and the cavity wall. The sealing mechanism 212 at the proximal end of the sleeve also deflects fluid and other GI contents that would otherwise proceed through the tissue cavity and into the central lumen of the sleeve when the tissue cavity is the intestine. The GI contents pass through the central lumen and into the sheath 220. The GI contents are thus isolated from more distal anastomoses within the GI tract. This prevents anastomotic contamination by fecal flow. The sealing element, in combination with negative pressure, creates a superior gastointestinal (GI) content gas-tight and liquid-tight bypass compared to other methods, such as an inflatable cuff, that attempt to create an effective seal at the proximal end of the intraluminal bypass sheath.

[0043] Figures 3A-3D illustrate, in cross-section, the forces applied to the tissue and the anchoring system according to an embodiment of the present invention, and contrast these forces with those generated by devices such as stents that rely on inflation to achieve fixation. FIG. 3A shows the outer perimeter of the foam 300 surrounding the sleeve within the tissue cavity 302 under normal pressure conditions. FIG. 3B shows the foam 304 and tissue 306 when a negative pressure is applied. The application of the negative pressure draws the tissue 306 towards the foam 304 until the tissue 306 and the foam 304 come into contact. The foam 304 and the remainder of the device are sufficiently flexible so that the tissue 306 can compress the foam 304 and the remainder of the device during normal peristalsis of the GI tract. As shown in FIG. 2C, this can enable the tissue to contact the foam along the entire surface of the foam from the proximal portion of the anchoring mechanism 212 to the distal portion of the anchoring mechanism 214. The contact between the tissue and the foam results in a frictional force that resists displacement of the device. The negative pressure draws the intestine towards the sleeve and minimizes the ring tension applied to the tissue. This is important because the inflation force can generate stretching forces on the intestinal wall that can cause stretch injury or reduce intestinal wall perfusion. These problems are avoided using the devices disclosed herein. The frictional force is proportional to the vertical force exerted on the device by the surface area of the tissue and foam interface. For devices according to some embodiments of the present invention, the vertical force is primarily determined by the negative pressure applied to the outer surface of the sleeve, and the frictional force is determined by the surface area of the sponge interface and the properties of its sponge interface. These features will be described in more detail below.

[0044] In contrast, FIGS. 3C and 3D illustrate in cross-section the forces for a stent-like anchoring device that relies on inflation to generate friction. FIG. 3C shows the stent 308 within the intestine 310 prior to deployment of the inflation mechanism. FIG. 3D shows the inflated stent 312. The vertical force in this case depends on the size of the intestine relative to the size of the stent and the spring constant of the intestine. The stent-like anchoring device uses an inflation force that is counteracted by the surrounding intestine. A high inflation force is required to achieve a much higher tension within the tissue ring such that the stent achieves a vertical force similar to that of the devices of the present invention and thus potentially a similar anchoring force. The anchoring stent-like anchoring device must have a diameter greater than the diameter of the tissue cavity to be treated. Thus, the devices according to some embodiments of the present invention are capable of anchoring the sheath within the intestine with less stress on the intestinal tissue and potentially less damage. Since the intestinal wall is suctioned to the anchor using negative pressure in the disclosed devices, the exact size of the intestine is not as critical when the anchoring force depends on the inflation force employed by the stent or other expandable anchor type. Further, the anchoring system can anchor within a quiescent tissue cavity having a diameter greater than or equal to the diameter of the anchoring system. However, the anchoring system can also anchor within a tissue cavity having a diameter less than the diameter of the annular sealing mechanism and / or the foam when the tissue cavity is stretchable.

[0045] FIG. 4 shows the pull-out force as a function of negative pressure for a device according to some embodiments of the present invention. The pull-out force is the force required to remove the device from a static state when negative pressure is applied. For the purposes of this disclosure, this occurs when the traction force mimicking the expulsion force of the intestine is large enough to interfere with the sealing element and cause a loss of anchoring or displacement of the device > 1 cm along the length of the intestine. FIG. 4 shows data for devices having an annular sealing mechanism with a 33 mm cross-sectional diameter and devices having an annular sealing mechanism with a 38 mm cross-sectional diameter.

[0046] The data in Figure 4 demonstrate that there is some loss of anchoring strength, along with the reduced diameter of the anchor portion of the device and the associated reduced foam surface area. However, even with devices of much smaller diameter, unlike stent devices that rely on inflation force for anchoring, smaller diameter anchors still maintain high anchoring forces within the same size intestinal lumen.

[0047] The pull-out force is directly proportional to the pressure level delivered to the surface area of the foam in contact with the device and the intestinal wall. Higher pressure will result in higher perpendicular forces and higher friction that resists the pull-out of the device. The data in Figure 4 demonstrate that large forces (>5 pounds) are required to remove the device even when relatively low levels of negative pressure are applied. Negative pressure levels less than -200 mmHg have been shown to be safe for use on human tissue, but perfusion decreases as the level of negative pressure increases and in the area where the negative pressure is delivered. The benefit of the devices described herein is that even at relatively low levels of negative pressure of about -100 mmHg, the anchoring system still resists significant pull-out force due to the friction generated by the foam interface.

[0048] In addition, the test data demonstrate that anchoring can be effectively achieved even when the outer diameter of the anchor device annular sealing mechanism is within the range of about 50 percent of the inner diameter of the intestinal compartment at rest. This is because when negative pressure is applied to the closed space of the intestine, the intestine can be suctioned in to the device diameter. After the negative pressure is applied in a tissue cavity much larger than the outer diameter of the device, the ability of the device to anchor due to its design allows the device to be easily placed within the lumen and achieve fixation within the cavity without the need for subsequent inflation. A 65 mm diameter section of porcine intestine was used in a bench test model, and high levels (> 5 pounds) of pull-out strength were achieved using a 33 mm diameter anchor at -75 mmHg and -150 mmHg. These data demonstrated average pull-out strengths similar to smaller sizes of intestine tested using forces of 6.38 pounds and 12.62 pounds on average, required for displacement for negative pressures of -75 mmHg and -150 mmHg, respectively. These data demonstrate that the sealing element forms a seal even when the intestine is suctioned in to the size of the anchor and the intestine is much larger in diameter than the anchor body. This is important because once the anchor element is positioned proximally within the intestine, it allows the anchor element with a small outer diameter to be placed within a section of the intestine without the need for inflation. The anchor element includes a sleeve, annular sealing mechanisms on both sides of the sleeve, an open-cell foam, and a pressure tube. This also allows for simplified delivery typically through intestinal narrowing such as stapled anastomosis that is significantly smaller than the natural resting intestinal diameter. The device eliminates the need for an inflation mechanism such as a wire metal stent to achieve delivery of the device within the body cavity because a smaller diameter device can be delivered through the intestine and still achieve the same or higher anchoring force. Using the foam interface, the forces on the intestine are distributed across the entire contact surface area of the open-cell foam 120, further reducing the likelihood of the device damaging the intestine.

[0049] Figure 5 shows the extraction force required to extract devices with three different configurations at various pressures. The three configurations include a sleeve without foam, a sleeve without foam with perforations, and a sleeve with foam. The configuration with only perforations and no foam interface significantly reduced the extraction strength (adhesion) as shown in Figure 5 compared to when the foam interface was utilized. This is because the foam provides a uniquely broad high-friction surface area for the vertical forces resulting from negative pressure. These data are discussed in more detail below. Therefore, having a foam interface or a foam-like interface as part of the anchor device is an important element of the disclosed invention. Without an open-cell foam, the device would not have the ability to firmly anchor within the intestinal lumen. For example, having multiple perforations or holes as tested and shown in Figure 5 does not provide approximately the same anchor strength as the foam. Further, perforations or holes without a foam interface can suck tissue into the perforations or holes, resulting in pressure damage, ischemia, and tissue damage. The foam prevents this type of damage from occurring because it evenly distributes pressure over a broad surface area.

[0050] The tethering system can be configured to have a series of tethering configurations. In some embodiments, there is a single anchor element that includes a sleeve, a sealing mechanism on both sides of the sleeve, a foam, and pressure tubes. In other embodiments, the sheath may be tethered by a plurality of anchor elements. Having two anchor elements is important for another embodiment of the device in addition to increasing the tethering strength. FIGS. 18 and 19 show a tethering system for the treatment of the intestinal wall. In this embodiment, the tethering system 1800 includes a first anchor element 1801 at the proximal end of the system that is placed into the intestine proximal to the area of the intestine to be treated, and a second, more distal anchor element 1802 that seals distally in the intestine beyond the area to be treated. There is a port 1809 that is in fluid communication with a sealed space between the two anchor elements and between the outer surface of the sheath through which fluid can be introduced or removed and the intestinal wall. Fluid tubing 1803 that communicates with port 1809 can be used to introduce fluid from a fluid penetration source 1805 such as a syringe. This port can be introduced from outside the patient's body via fluid tubing 1803. This configuration of the device allows for the cleaning, delivery, and removal of drugs (such as antibiotics, anti-inflammatory drugs, or chemotherapeutic drugs) and radiopaque agents between the outer surface of the sheath 1811 and the intestinal wall between the two anchor elements 1801, 1802. In some embodiments, the second anchor element does not need to be as strong, and the second, more distal anchor element 1802 may be shorter than the first, more proximal anchor element 1801 because treatment near the anal verge may be required if the longer anchor element 1802 will not fit into the intestine. The system 1800 further includes a pressure tube 1812. The pressure tube 1812 can be in fluid connection with the outer surface of the sleeve of the first anchor element 1801 and the sleeve of the second anchor element 1802 as shown in FIG. 18. Alternatively, the system 1800 may include two pressure tubes, one for each of the sleeves of the first anchor element 1801 and the second anchor element 1802. The pressure tube 1812 is connected to a pneumatic system 1807 that is configured to apply a negative pressure to the pressure tube and tether the anchor elements 1801, 1802.

[0051] FIG. 19 is a side view of an embodiment of a double anchor element system where like reference numerals identify like features as in FIG. 18. This configuration is clinically important for several scenarios where treatment of an isolated compartment of the intestine may be beneficial. Since this configuration allows for controlled containment of therapeutic agents within the intestinal lumen for discrete compartments of the intestine, this embodiment provides a unique ability to provide sustained and local treatment of the intestinal wall. For example, after endoscopic polypectomy, the resection site can be isolated using the disclosed embodiments and treated with local chemotherapy. Another example can be inflammatory bowel disease where the affected compartment of the intestine can have anti-inflammatory agents delivered and maintained at the site of the disease. In the case of intestinal wall injury or perforation, an antibacterial agent can be introduced to reduce the bacterial load during healing and mitigate the risk of exacerbating an infection. The two anchor elements can be spaced anywhere from about 1 cm to 6 feet depending on the desired length of intestine to be adapted and treated. In some cases, since the surgeon can manually advance the device from the outside of the intestinal wall during an open abdominal case, very long segments of the intestine can be treated, with the upper limit being the entire length of the intestine. This applies to the one-anchor element version of the device since the device can potentially have a sheath length that can protect the entire intestine.

[0052] There are several major distinctions of this intestinal protection device from treatment devices for negative pressure wound closure therapy that can be used within the intestine. The disclosed anchoring portion of the device is not configured to directly treat the area of intestinal injury, wound, or anastomosis. This is configured to anchor the sheath portion of the device that protects the area of intestinal injury, wound, or anastomosis. Importantly, the anchor portion of the device is designed to be positioned within healthy, uninjured intestine above or proximal in the intestine from the area of intestinal injury. Since negative pressure is not delivered to the area of anastomosis, injury, or wound, this dramatically increases the potential safety of this device, and thus the protected area of the intestine is never made ischemic or exposed to significant shear or traction forces from the device.

[0053] Negative pressure, when delivered to tissue through a sponge interface, has been shown to reduce blood flow to the area to which it is delivered. Thus, delivering negative pressure to the area of injury of the intestine itself can further damage or impede healing of the intestine because the blood supply to the intestine is less robust than other tissues (especially in the area of the anastomosis). Further, the methods and devices described have a flexible sheath that covers the area of intestinal anastomosis or injury, and thus, the tethering of the device is at a location separate from the area of damaged tissue. During intestinal contraction in the area of the damaged intestine, the flexible sheath is not as mechanically rigid as a bandage for negative pressure wound closure that employs an internal wire stent-based structure to maintain luminal patency and facilitate tethering, and thus, when contracting around the device, it exerts less mechanical force on the intestine. Additionally, by placing the anchor far from the area of damaged intestine, the device does not exert mechanical force on the anastomosed or damaged tissue due to traction or pulling of the device from the pressure tubing or other parts of the device that are external to the patient's body. No part of the device is tethered distal to the damaged intestine, and thus, the pulling force is exerted only on the proximal healthy intestinal tissue. This further reduces the risk of pulling apart the anastomotic repair or further damaging the area of damaged intestine.

[0054] Another difference is that the tethering devices described herein must have a much higher pull-out strength because they must be tethered strongly enough to maintain the entire sheath and anchor element in place within the non-damaged intestine that is functioning normally. To achieve this, the body needs to be made long enough and wide enough such that sufficient surface area of the sponge is in contact to prevent drainage, the anchor and sheath must be configured to conform and resist displacement by peristalsis, and the sealing mechanism must be made more robust to prevent potential air leakage.

[0055] Unlike devices designed to be mechanically removed over time by intestinal function and peristalsis, the devices described are designed to remain in a fixed position for an extended period until removed by the clinician performing the treatment. The higher tethering strength and more robust fixation of the present tethering system 100 are important to enable placement of the device near the site of the intestine being treated. In the case of intestinal anastomosis in the colon, placement of the device higher up into the intestine from the anus becomes more difficult due to the curvature of the intestine. Thus, unlike devices that must be placed much higher up in the intestine (more than 40 cm above the area being treated) due to device movement during the treatment period, the fixed tethering provided by the disclosed tethering system allows the tethering elements (sleeves, annular sealing mechanisms, and foams) to be placed only a few centimeters above the area being treated. However, it may be preferable to place the anchor element at least 10 cm above the area being treated so as to avoid local ischemia.

[0056] This ability to achieve controlled tethering is accomplished through the design elements described, which are detailed below.

[0057] The components of the tethering system according to some embodiments of the present invention are described in detail below. Unless otherwise indicated, reference is made to FIG. 1.

[0058] Sleeve

[0059] According to some embodiments of the present invention, the sleeve 102 is a flexible concentric tube. The outer diameter and outer shape can be configured to move through the intestine without significant resistance when negative pressure is not applied to the outer surface 114 of the sleeve 102. In some embodiments, the outer diameter of the sleeve is such that the cross-sectional outer diameter is between 11 mm and 61 mm. The inner diameter of the sleeve determines the diameter of the first lumen, and in some embodiments, the sleeve has an inner lumen diameter with a cross-sectional inner diameter between 10 mm and 60 mm. With respect to anchoring in tissue cavities other than the intestine, these parameters will vary based on the hollow organ in which the anchoring is achieved. In some embodiments, the sleeve may have a diameter greater than or equal to the diameter of the tissue cavity. In some embodiments, the sleeve may have a diameter less than the diameter of the tissue cavity. In some embodiments, the sleeve may have a diameter less than 95% of the diameter of the tissue cavity. In some embodiments, the sleeve may have a diameter less than 50% of the diameter of the tissue cavity. In some embodiments, the sleeve may have a diameter less than 25% of the diameter of the tissue cavity.

[0060] In some embodiments, the sleeve 102 is flexible enough to be easily removed by pulling on the sheath 116 to slide the sleeve 102 out through the intestine and anus, but is rigid enough to maintain its concentric shape to form the lumen 106 when negative pressure is applied. This allows for easy placement and removal of the device 100. When negative pressure is applied to the outer surface 114 of the sleeve 102, the sleeve 102 and the foam 120 surrounding the sleeve 102 conform to the contour of the GI tract.

[0061] The sleeve 102 is soft and flexible and is configured not to cause erosion into the intestine. The sleeve 102 has sufficient flexibility and softness to allow the proximal and distal ends of the sleeve to conform to the contour of the intestine so that contact between the foam and the intestinal wall can be maintained during peristalsis. The annular sealing mechanisms 108, 110 create and maintain a seal while keeping the concentric tubular shape of the inner lumen 106 open so that GI contents can pass through. According to some embodiments, the sleeve 102 comprises medical grade silicone, polyurethane, thermoplastic elastomer, rubber, or other polymers exhibiting the flexible and rigid properties described herein. The flexibility of the sleeve reduces the pressure points generated from intestinal contraction forces, enabling the sleeve 102 to be safely anchored within the patient's body. The sleeve 102 according to some embodiments has a Shore A hardness of about 20A to about 70A to allow for maximum flexibility while maintaining a concentric configuration and an open lumen. Sleeve flexibility is also determined by the body wall thickness. The sleeve 102 is thin-walled, again allowing the deforming forces to act on it from intestinal peristalsis. In some embodiments, the sleeve has a body thickness of 0.1 mm to 8 mm. This thinness allows for more durable materials to be utilized while continuing to accommodate the peristaltic movements of the intestinal wall.

[0062] The flexibility of the sleeve 102 allows the sleeve 102 to deform with the intestine during peristaltic motion. Peristaltic motion moves the contents within the intestine by continuously compressing the proximal portion of the intestine. FIG. 6A shows a tethering system according to some embodiments of the present invention tethered to the intestinal wall 607 when the intestine is at rest. FIG. 6B shows the tethering system during peristalsis. The arrows indicate relative vertical forces, with larger arrows indicating larger vertical forces and smaller arrows indicating smaller vertical forces. Because the device is flexible, it maintains a seal between the sealing mechanisms 608, 610 even with deformation due to peristalsis or passage of intestinal substances. This maintains surface contact between the foam 600 and the intestinal wall 607, allowing the intestine to compress the device without the device exerting large and potentially harmful forces on the intestinal wall 607 in return. By maintaining a constant negative pressure, the negative pressure between the sealing mechanisms 608, 610 generates a more constant vertical force during peristalsis along the length of the anchor element that prevents movement by maintaining the relationship between the foam 600 and the intestinal wall 607. Thus, the device conforms and moves with the intestinal wall 607 by the distribution of adhesive forces across the entire surface of the sleeve covered by the foam interface.

[0063] Flexibility allows the sleeve to maintain the position of the foam 600 on the intestinal wall 607 without generating shear forces between the foam 600 and the intestinal wall 607 during intestinal contraction. In the case of less flexible bodies such as the stent-based anchor 612 of FIGS. 6C and 6D, the intestine is stretched and pulled around the anchor body because the anchor body cannot conform sufficiently to adapt to contractions occurring at or near the anchor body. The resulting shear forces can disrupt the position of the device and cause device movement. When the intestine contracts, instead of shearing the intestinal wall and causing device movement, the flexible sleeve deforms by the forces exerted through the attached foam so that the foam can deform more easily with the intestinal wall.

[0064] Furthermore, with respect to more flexible tethering elements, peristaltic waves have less ability to press against the tethering element due to flexibility and conformability to contraction. In the case of a more rigid and less conformal body such as a wire-based stent, the peristaltic wave has the resistance of a body that is less deformable to pressing, resulting in device displacement.

[0065] Also, the flexibility, compressibility, and softness of the disclosed device assist in the placement and removal of the device through the curvature of the intestinal lumen. Flexibility allows for higher and more proximal delivery of the device within the digestive tract as the intestine becomes more serpentine and curvilinear, allowing for easy removal. This flexibility also allows for a longer sleeve 102 having a larger foam 120 surface area and a resulting higher tethering strength to be manipulated into the intestine. This flexibility is also important for the tethering system 100 because, as shown in FIG. 5, the foam 120 itself has a higher coefficient of friction than that of a device without foam, even when negative pressure is not being delivered during device removal and placement.

[0066] FIG. 5C shows the semi-rigid stent-like device 612 in the intestine at rest, and FIG. 5D shows the stent-like device 612 during peristalsis. In contrast to the disclosed invention, the stent-like device 612 has rigidity that resists compression. This rigidity increases the vertical force on the stent and the intestine as the intestine compresses, and causes the stent to slide along the surface of the intestine with the peristaltic waves of normal intestinal contractions. Some stent-based designs have some degree of compressibility and flexibility, but this is much lower than that of the disclosed device. Due to the low durometer structure, thinness, compressibility, and conformability of the device sleeve 102 according to some embodiments, the sleeve is more resistant to displacement due to peristaltic activity. The flexibility of the sleeve 102 and the sealing mechanisms 608, 610 has the further advantage of being more easily manipulated for placement within the intestine along the normal longitudinal curvature of the intestinal lumen as compared to more rigid devices. Also, when the device is placed in a region of the intestine with a longitudinal curvature, it can more easily conform to and adapt to this curvature, maintain contact between the foam 600 and the intestinal surface area when negative pressure is applied, and prevent pressure points that could potentially damage the intestinal wall 607. Additionally, the elimination of the wire stent-based structure greatly enhances manufacturability from both the perspectives of ease and cost.

[0067] The sleeve length determines the length of the anchoring element, and the length of the anchor portion of the device is also an important characteristic of the device. The anchoring strength of the anchor portion of the device depends directly on the sleeve length and the associated surface area of the foam in contact with the intestinal wall. The length of the device also affects the diameter such that it affects the surface area of foam contact. Unlike stents, negative pressure dressings, or sheaths, which can be supported in a fixed position by device rigidity and need not conform significantly to intestinal flexures proximally in the intestine, the anchor portion of the system according to some embodiments is constructed within a length range of >3 cm to <25 cm in length. Our tests in a porcine model show that when the anchor device is less than 3 cm in length with a 33 mm diameter, it loses the surface area to maintain a pull-out strength of >5 pounds and can be susceptible to seal loss and low force device displacement (<5 pound force). Further, when the anchor portion of the device is longer than 25 cm, the device cannot be positioned within the intended anchoring area that is above the height of the protected intestinal area (proximally in the intestine) around the anatomical flexures of the intestine. For applications in other tissue cavities that require less pull-out strength, such as catheters or the esophagus, the device can be shorter than 3 cm in length. Further, embodiments of the present invention are not limited to flexible sleeves, and stent-like sleeves surrounded by foam may also be used.

[0068] Sealing mechanism

[0069] Device 100 includes annular sealing mechanisms 108, 110 disposed at each end of sleeve 102. The sealing mechanisms 108, 110 contact the inner surface of the tissue cavity into which sleeve 102 is inserted. The sealing mechanisms 108, 110 perform at least two functions. First, they create a negative pressure space so that the foam 120 can be sucked into the intestinal wall to generate an anchoring force, creating a seal between the intestinal wall at the proximal and distal ends of the outer surface of sleeve 102. Second, the seal creates a liquid-tight and air-tight seal with the inner surface of the tissue cavity at both ends of sleeve 102 when a negative pressure that bypasses GI contents through lumen 106 of sleeve 102 into lumen 118 of sheath 116 attached to sleeve 102 is applied to the outer surface 114 of sleeve 102. The angle at which the sealing elements of the sealing mechanism are inclined minimizes the risk of forward and reverse flow of feces from causing interference with the seal as the fecal flow is directed towards the central lumen of the sleeve by the sealing elements. In some embodiments, the angle of inclination from perpendicular to the intestinal wall is 5 to 25 degrees. In some embodiments, the angle of inclination from perpendicular to the intestinal wall is 25 to 45 degrees. In some embodiments, the angle of inclination from perpendicular to the intestinal wall is 45 to 85 degrees. In some embodiments, there is no inclination and the angle of inclination from perpendicular to the intestinal wall is 0 degrees.

[0070] The exact height of each sealing mechanism 108, 110 is not as important as the relationship of the sealing mechanism to the outer diameter of the coating of foam 120. The sealing mechanisms 108, 110 of the present system extend beyond the height of the foam 120 at rest in some embodiments so that a seal can be easily formed between the sealing mechanisms 108, 110 and the intestinal wall without interference by the foam 120 when a negative pressure is applied and the intestinal wall is crushed. Thus, the annular diameter of the sealing element exceeds the annular diameter of the foam dispersed on the body of the sleeve at rest when no negative pressure is applied. In some embodiments, the sealing mechanisms 108, 110 extend at least 1 mm beyond the height of the foam 120 at rest.

[0071] The sealing mechanisms 108, 110 are made of a soft and flexible material that allows them to conform to the surface of the intestine. This is important because without this flexibility, the peristaltic forces of intestinal contractions could potentially cause harmful pressure points. For example, the sealing mechanisms 108, 110 can comprise a thermoplastic elastomer, silicone, polyurethane, rubber, or other rubber-like material or polymer. The Shore A hardness of the material can range from about 20A to about 70A. Similar to the low durometer of the sleeve, the low durometer of the sealing mechanism allows for compression and conformalization to the intestinal lumen during the sealing process and during intestinal peristalsis when negative pressure is applied. The conformability, flexibility, and compressibility of the sealing mechanisms 108, 110, like the flexibility of the sleeve, allow for reduced displacement during peristalsis and easier device placement and removal.

[0072] The sealing mechanisms 108, 110 can include a plurality of sealing elements, also referred to as fins or protrusions. The protrusions have a more rounded geometry and the fins have a more tapered geometry. Both the protrusions and the fins extend radially beyond the outer diameter of the sleeve so as to form a seal at each end of the sleeve. The sealing elements extend radially to varying degrees towards the inner surface of the tissue cavity. In some embodiments, the sealing elements extend radially beyond the foam and enable sealing to occur at the ends of the sleeve 102 without interference by the foam 120. The sealing mechanisms 108, 110 may have a plurality of diameters along their bodies. Each sealing mechanism 108, 110 can be a single sealing element or can be divided into a plurality of sealing elements. The sealing elements are single annular airtight and liquidtight sealing protrusions. In the case of a plurality of sealing elements, the sealing mechanism can be configured to conform to the GI tissue and create a plurality of local airtight and liquidtight seals. Some of the different sealing mechanism and sealing element embodiments are shown in FIGS. 1, 7A-7J, 8, 11, 12, and 14-16. According to some embodiments, the sealing mechanisms 108, 110 may be oriented in different directions and shapes so as to create a specific surface area to which a negative pressure can be applied as may be required for sealing in hollow organs other than the intestine with different anatomical geometries.

[0073] Figure 7 shows cross-sectional views with only the upper half shown and depicts several different configurations of the sealing mechanism and sealing elements. Figure 7A shows three series of sealing elements that are concentric protrusions oriented perpendicular to the sleeve. Figure 7B shows three series of sealing elements that are concentric curved fins oriented perpendicular to the sleeve. Figure 7C shows three series of sealing elements that are concentric protrusions oriented at approximately 25 degrees from the vertical. Figure 7D shows three series of sealing elements that are concentric curved fins oriented at approximately 25 degrees from the vertical. Figure 7E shows three series of sealing elements that are concentric protrusions oriented at approximately 45 degrees from the vertical with respect to the sleeve. Figure 7F shows three series of sealing elements that are concentric curved fins oriented at approximately 45 degrees from the vertical with respect to the sleeve. Figure 7G shows three series of sealing elements that are concentric protrusions with a wider base oriented perpendicular to the sleeve. Figure 7H shows six series of sealing elements that are concentric, straight, and narrow fins with a vertical orientation. Figure 7I shows a single concentric curved fin sealing element oriented at approximately 45 degrees from the vertical with respect to the sleeve. Figure 7J shows two series of sealing elements with concentric, straight, and narrow fins oriented at approximately 60 degrees from the vertical with respect to the sleeve. According to some embodiments, the sealing elements have a contoured, tapered shape that becomes thinner as the distance from the sleeve 102 increases. These tapered fin-shaped sealing elements, as shown in Figures 7B, 7D, 7H, 7I, 7J, have several advantages. They reduce the rigidity of the outer portion of the sealing element and thus reduce the likelihood of intestinal wall damage when negative pressure is applied. The combination of a low durometer material and a thin tapered design allows very little pressure to be applied to the intestinal wall when the negative pressure is activated. Also, the low durometer and thin tapered design allow for maximum flexibility to enable conformalization during intestinal peristalsis. This helps to maintain the seal during the deforming forces of intestinal contractions and resist device expulsion. In some embodiments, the fins bend to further relieve intestinal wall pressure points.Curvilinear (Figs. 7B, 7D, 7F, and 7I), angled geometries (Figs. 7C, 7D, 7E, 7F, 7I, and 7J), and asymmetric triangles (7H) all serve to orient the sealing elements so that they fold away from the central portion of sleeve 102 during negative pressure delivery and intestinal wall compression. The sealing elements shown in Figs. 7A - 7J are non-limiting examples, and embodiments of the present invention are not limited to these configurations. Further, the sealing mechanism may include two or more different types of sealing elements within a single sealing mechanism. Each sealing mechanism may have one or more sealing elements.

[0074] FIG. 8 shows a tethering system 800 according to some embodiments of the present invention, where like reference numerals identify like features as in FIG. 1. The tethering system 800 has sealing mechanisms 808, 810 having a plurality of fins 822, 824 according to some embodiments of the present invention. The depicted fins 822 and 824 have angles, although the angles of the fins are not required if the fins are constructed of a material soft enough to conform to the intestinal wall without significant pressure, but the angles of the fins can be beneficial. The angle of the fins from vertical as shown in FIG. 8 is less than the angle of the fin embodiments shown in FIG. 1. The forces of the intestine on the fins 822, 824 cause them to conform to the shape of the intestine. This establishes a seal with the surface of the intestine at each end of the sleeve 802 and creates a vacuum chamber. The sealing elements conform to the wall of the tissue cavity and reduce the pressure at any single point within the tissue cavity. Instead, the pressure is distributed over the length of the sealing element. The seal that creates the vacuum chamber also prevents intestinal substances from flowing around the outside of the sleeve 802. The tips of the sealing mechanisms 808, 810 direct fluid into the lumen 806 of the sleeve 802 as the outer surface 814 of the sleeve 802 and the inner surface of the tissue cavity are drawn closer together. In some embodiments, the sealing elements overlap and further constrict the pressure points when drawn into the intestinal wall.

[0075] The sealing mechanisms according to some embodiments each have a plurality of sealing elements that are utilized at the end of the mooring portion of the device. These sealing elements create individual seals and provide redundancy of the seals, increasing the force required to displace the anchor when negative pressure is delivered between the seals. When a traction force or physiological bowel evacuation force is applied to the anchor, the airtight seal formed between the device and the intestinal wall can be broken. When this occurs, the vertical force generated by negative pressure suction and the associated friction are dissipated, resulting in a decrease in the mooring strength of the device. Having more than one seal has the advantage of providing redundancy when disruptive contraction (compression) peristaltic forces of the intestine, displacement forces from intestinal contents, or traction forces are applied to the device.

[0076] Furthermore, this is demonstrated using our pull-out strength test in a cadaveric pig intestine model. A 33 mm anchoring device with foam was shaped with one, two, or three sealing elements per sealing mechanism 108, 110 on each side of the sleeve. Pull-out strength was measured by determining the force required to be applied to the device to achieve a 1 cm displacement at a negative pressure of -75 mmHg or -150 mmHg (always accompanied by loss of the suction seal). Figures 9 and 10 show the pull-outs required for negative pressures of -75 mmHg and -150 mmHg, respectively. Pull-out strength data at both levels of negative pressure of -75 mmHg and -150 mmHg demonstrated significantly (p-value ≤ 0.05) higher pull-out strength using three sealing elements versus one sealing element (p-value = 0.0480 and p-value = 0.0386). For example, with respect to a negative pressure of -75 mmHg, the force required to remove a device with one sealing element averaged 6.49 pounds, while the force required to remove a device with three sealing elements averaged 8.38 pounds. With respect to a negative pressure of -150 mmHg, the force required to remove a device with one sealing element averaged 9.73 pounds, while the force required to remove a device with three sealing elements averaged 15.21 pounds. These data provide support for the increased functionality by having multiple sealing elements (more than one per sealing mechanism) in suction-based intestinal anchoring systems such as those described herein.

[0077] Figures 11 and 12 illustrate several additional embodiments in which the sealing mechanism is configured as concentric sealing elements that form a series of concentric seals. Figures 11 and 12 show mooring systems 1100, 1200 according to several embodiments of the present invention, with like reference numerals as in Figure 8 identifying like features. The sealing elements 1122, 1124, 1222, 1224 of these systems provide a series of seals and are configured to maintain a tight seal to the bowel even in the case of a small amount of air leakage in a single seal. The sealing elements are configured to have a height and rigidity to form an effective seal without causing pressure necrosis or erosion of the bowel wall as discussed above. In some embodiments, the plurality of sealing elements flatten when sucked into the bowel wall so as not to cause additional pressure points. This allows for a significant pressure from the sealing elements only to the bowel, actively maintaining a negative pressure seal. The embodiment shown in Figure 11 is an embodiment configured with sealing elements 1122, 1124 as protrusions with rounded ends having a small angle from vertical. The embodiment shown in Figure 12 shows a device with sealing elements 1222, 1224 configured as thin-edged fins having a greater angle from vertical than the sealing elements 1122, 1124 of Figure 11.

[0078] The sealing mechanism may be configured to be mounted concentrically around the outer surface 114 of the sleeve 102 or may be integrated into the wall thickness of the sleeve 102. Specifically, this relates to the manufacturing process used to create the anchor as the sealing elements can be made in one mold with the sleeve or can be molded separately and adhered to the sleeve. According to some embodiments, the sealing elements and the sleeve are created as a single molded part as both elements of the device have similar material properties of strength, flexibility, and conformability. In some embodiments, the sleeve 102 and the sealing mechanisms 108, 110 are made from the same material from a single mold.

[0079] In some embodiments, the sleeve is divided into a plurality of mooring compartments having an independent negative pressure supply. A mooring compartment is a section along the sleeve that moors the sleeve independently. In one embodiment, the sleeve is divided by one or more additional sealing elements so as to create two or more sealing areas along the sleeve that moor independently to the intestinal wall. A foam is placed between each sealed section so as to distribute pressure and make interfacial contact with the intestinal wall. A negative pressure is applied to the space between the seals so as to create a redundant area of mooring along the length of the sleeve. In some configurations, the negative pressure is applied to each compartment from an independent negative pressure source. In some configurations, the compartments are supplied by the same negative pressure source. This embodiment provides redundancy in the mooring system, as well as having a plurality of mooring elements. The advantage of this design is that if a seal is broken in one compartment, there is still adhesion to another compartment or compartments.

[0080] Sheath and collection bag

[0081] Device 100 includes a sheath 116 that is mechanically connected to the distal end of the sleeve 102. According to some embodiments, the sheath 116 is directly connected to the sleeve 102. According to some embodiments, the sheath 116 is indirectly connected to the sleeve 102. For example, the sheath 116 may be connected to the sealing mechanism 110 at the distal end of the sleeve 102. The sheath 116 forms a second lumen 118 that is in fluid communication with the first lumen 106. The sealing mechanisms 108, 110 divert GI contents into the sleeve 102. When the GI contents reach the distal end of the sleeve 102, they enter the lumen 118 of the sheath 116. The sheath 116 can have a length sufficient to extend from the distal end of the sleeve 102 to the patient's anal canal and outside the patient's body. Thus, once the GI contents enter the sleeve 102, they are directed into the sheath 116 and are completely isolated from the inner surface of the patient's intestine distal to the sleeve 102. The sheath forms a barrier between the GI 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 sheath should be substantially fluid impermeable. Secondarily, the sheath also mechanically shields the intestinal wall from the mechanical expansion forces of the GI stream contents.

[0082] According to some embodiments, the sheath 116 is coupled to the sleeve 102 or the distal sealing mechanism 110. The sheath 116 can have a shaped fixation attachment configured to lock into the sleeve 102 or the distal sealing mechanism 110. According to some embodiments, the sheath 116 is made of a non-degradable biocompatible material. For example, the sheath 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 sheath should be substantially impermeable to fluids and bacteria.

[0083] The sheath 116 is configured such that its diameter allows it to remain within the GI tract without obstructing the flow of GI effluent passing through it. In some embodiments, the sleeve has a cross-sectional diameter of from about 10 mm to about 60 mm. The sheath is made of a suitable material and is thin and flexible enough so that the sheath can be compressed by the intestinal wall and does not eliminate the effect of peristaltic movement on fecal flow. Unlike semi-rigid drainage tubes, which are designed primarily to maintain patency and rely on gravity and gastrointestinal flow pressure for the movement of GI contents through the tube, the sheath according to some embodiments allows for continuous compression and is deformable during peristalsis to move GI contents along the sheath. This allows for placement of the device more proximally in the intestine because gravity and GI flow pressure are insufficient to move material through longer lengths of tubing as the resistance to flow increases with the length of the tubing. Further, this flexibility and associated compliance allows for navigation around intestinal curvatures, improves patient comfort, reduces the likelihood of intestinal wall injury / erosion, and prevents sheath occlusion. Some embodiments of the sheath 116 have a wall thickness of from about 50 microns to 5 mm. In some embodiments, the length of the sheath 116 is sufficient for it to extend out of the anal canal beyond the GI tract after device placement. In some embodiments, the sheath 116 is from about 8 inches to 72 inches in length. In some embodiments, the device is configured such that a pulling force from outside the body on the sheath 116 can be used to remove the device from the body cavity. The sheath 116 must be strong enough to withstand longitudinal pulling force without undergoing a break of at least 10 pounds so that the sheath can be used to extract the sleeve after treatment is complete. The sheath 116 is marked along its length in some embodiments with an indicator that shows the length of the sheath 116 present inside the GI tract or tissue cavity after placement within the intestine or other tissue cavity. The user can use the indicator to determine whether the sleeve 102 is moving. The sheath 116 according to some embodiments has a fixed length.According to some embodiments, the length of the sheath 116 can be adjusted by cutting the sheath 116.

[0084] According to some embodiments of the present invention, a collection bag is disposed at the end of the sheath 116. The collection bag should be substantially impermeable to air and fluids. The collection bag collects GI contents flowing through the sleeve 102 and the sheath 116. In some configurations, the sheath 116 terminates at a port that can be closed for fecal management and kept open to be emptied. In other configurations, the sheath 116 is flexible enough to allow the anal sphincter to compress the sleeve and provide fecal management. In this configuration, the collection bag may not be used. According to some embodiments, the collection bag can be removed and replaced as needed. In some embodiments, the collection bag can be configured with a sealed attachment that allows for cutting of the length of the sleeve and re - establishment of the seal to the bag. In some embodiments, the collection bag has markings so that the volume of the effluent can be determined. In some embodiments, the collection bag has leg straps for attaching the collection bag to the patient's body. In some embodiments, the collection bag can also contain ports to prevent any excessive accumulation of gas. According to some embodiments, the external collection bag contains a one - way valve that prevents the collected GI contents from flowing back into the sheath. In some embodiments, the collection bag has elastic leg straps for fastening the collection bag to the patient's body.

[0085] Foam

[0086] Device 100 includes a foam 120 disposed on the outer surface 114 of the sleeve 102. The foam 120 or foam-like material plays an important role in both increasing the anchoring strength and preventing damage to the intestine. The foam 120 provides a critical frictional force to hold the sleeve 102 in place when suction is applied to the outer surface 114 of the sleeve 102. In addition, the foam 120 distributes the negative pressure and forces to minimize pressure points that could damage the intestine.

[0087] The foam 120 dispersed on the sleeve provides a high coefficient of friction material with a maximum surface area generated by the vertical force where adhesion is generated using negative pressure. The foam is the optimal material for distributing negative pressure and providing an effective coefficient of friction when negative pressure is applied in this application. A device could be envisioned that uses a membrane with a series of pores placed in close proximity to form a porous membrane to distribute negative pressure. However, the vertical force generated by a membrane-based device is limited by the open surface area generated by the pores. In addition, the porous membrane has a much lower coefficient of friction than the rough surface of the foam. The foam also has a larger surface area of effective contact with the intestine due to its continuous bubble structure and multiple pores for distributing negative pressure throughout the mass of the material. To maintain equivalent pull-out strength without the foam, the magnitude of negative pressure required would increase and significant point stress would need to be applied to the intestine. This was demonstrated in a series of experiments conducted in a cadaveric porcine intestine model as shown in FIG. 5.

[0088] Figure 5 shows the results of tests of the anchor pullout strength for a 33 mm diameter mooring system 100 with various configurations. A 33 mm diameter mooring system 100 with a foam 120 interface (the disclosed mooring system), a 33 mm diameter anchor device without a foam 120 interface (the disclosed mooring system with the foam removed), and a 33 mm diameter device with multiple perforations (a 33 mm diameter anchor device with dozens of small 1 - 3 mm holes communicating with a negative pressure source via tubing) were inserted into a porcine cadaver intestinal model, and pullout force measurements were taken using various amounts of negative pressure delivered to the anchor. Pullout was defined as the amount of force required to remove the anchor using the traction force in the vector of the intestine. This force was measured as the maximum amount of applied force before the device lost its seal or was displaced by 1 cm. As the pullout force was reached, there was a decrease in the force required to pull the device out of the intestine as the suction seal was broken or destroyed, which also corresponded to the device being displaced within the intestine. Each condition for each experiment was repeated 3 times separately. The tests were completed using the same section of cadaver intestine for each anchor, although different sections of intestine with slightly different diameters were used for the repeated experiments. The data demonstrate that the anchor with foam had a pullout strength 4.5 - 14 times higher than the anchor without foam. The data further demonstrate that the anchor with foam had a pullout strength 5.6 - 12.2 times higher than the anchor with multiple small suction perforations / holes. These results are dramatic, and a statistical analysis of each pressure (one - sided unequal variance t - test) demonstrates a significantly higher pullout strength at all pressures tested for the foam anchor compared to either of the non - foam anchors. The p - values demonstrating a significant increase in the mooring strength using foam compared to the anchor with the foam removed were (175 mmHg) p - value = 0.0012, (150 mmHg) p - value = 0.0095, (125 mmHg) p - value = 0.0079, (100 mmHg) p - value = 0.0106, (75 mmHg) p - value = 0.0034, (50 mmHg) p - value = 0.0017, and (0 mmHg) p - value = 0.0010.Compared to anchors with multiple holes / perforated surfaces, the p-values demonstrating a significant increase in retention strength using the foam anchor were (175 mmHg) p-value = 0.0003, (150 mmHg) p-value = 0.0071, (125 mmHg) p-value = 0.0071, (100 mmHg) p-value = 0.0112, (75 mmHg) p-value = 0.0042, (50 mmHg) p-value = 0.0050, and (0 mmHg) p-value = 0.0004. Anchors with the foam removed and anchors with multiple holes did not show a statistically significant difference in the pressures tested (all p-values > 0.05). As these data demonstrate, the foam interface produces a significant increase in pull-out strength and retention force at a given negative pressure suction level that is not achievable without the foam 120 or foam-like material. Even with multiple small perforations, the pull-out strength only increased slightly when negative pressure was applied. Additionally, using higher pressures requires a continuous circumferential seal around each hole, so the area of tissue sucked into the holes can become ischemic, and the diversity of perforation / hole designs for intestinal suction can potentially be dangerous. In our cadaver tests, in the perforation model, even with the short duration of treatment used in these experiments, we confirmed markings on the inner surface of the intestine where tissue had been sucked into the holes of the anchor. In contrast, the foam interface showed no inner surface markings. The continuous bubble foam 120 distributes negative pressure more evenly across the tissue than individual holes or perforations and is much less affected by damage to the intestinal tissue. The foam 120 uniquely provides a distribution of negative pressure that is non-traumatic to the intestinal tissue and generates a high frictional force that prevents the anchor from displacing.

[0089] The foam 120 comprises a material selected to produce specific compression characteristics and a coefficient of friction that prevent movement of the sleeve 102. The foam 120 can comprise a material having a pore size that allows negative pressure to be distributed throughout the foam while preventing ingrowth of tissue into the foam. This allows the foam 120 to be easily removed from the inner surface of the tissue cavity when normal pressure is restored. To have the properties required to distribute negative pressure and generate a high frictional force, some embodiments of the foam 120 have an average foam pore size with a diameter of from about 50 microns to about 1,000 microns. The average pore size of the foam is, in some embodiments, from about 100 to 300 microns. The average pore size of the foam 120 is, in some embodiments, from about 300 to 600 microns. If the pore size is too small, the foam 120 loses some of its frictional ability, and if the pore size is too large, the material can have ingrowth into the tissue and have a lower tear strength. In some embodiments, the density and material composition of the foam 120 must allow the overall tensile strength of the foam to be at least about 50 Kpa. This allows the deformation and traction forces on the sleeve not to shear or tear the foam. Since the foam 120 withstands the shearing force exerted on the anchoring system 100, the foam must have a high tear force and be able to withstand a shearing force of about 50 Kpa and be fixed to the sleeve 102 in a manner that it can withstand a stretching force of about 50 Kpa without separation. The level of force exerted on the device from both creep and expulsion forces on the sleeve 102 and the sheath 116 is much higher than that required to hold one foam in place to treat a small wound area so that negative pressure wound closure therapy can be performed.

[0090] In some embodiments, the foam 120 is made of a hydrophilic material that can prevent the surface tissue it contacts from drying out, although hydrophobic materials can also be used in some embodiments. According to some embodiments, the foam 120 comprises polyvinyl alcohol. In some embodiments, the foam 120 is made of polyurethane, another polymer, or an organic fiber mesh. In some embodiments, the open-cell foam 120 comprises a single tubular foam.

[0091] The foam 120 covers the outer surface 114 of the sleeve 102 and generates a frictional force that withstands the movement of the sleeve 102 relative to the intestine when negative pressure is applied to the outer surface 114. The porosity of the foam 120 allows air to be discharged from the region between the outer surface 114 of the sleeve 102 and the inner surface of the tissue without strong suction being applied to any single point. This generates a frictional force that is evenly distributed across the outer surface of the foam 120. The foam 120 under negative pressure also generates a large surface area such that the frictional force resists removal. The foam 120 is designed to be compressible in order to minimize the amount of force exerted on any single point of the intestine when negative pressure is applied and to maximize surface area contact with the intestinal wall by conforming to the shape of the intestinal wall.

[0092] In some embodiments, the foam 120 dispersed over the sleeve allows for the dispersion of negative pressure around the sleeve but does not extend beyond the height of the radial edge of the resting seal mechanism or cause constriction of the sleeve lumen 106 to the point of interfering with GI content flow and must have a thickness or height. If the foam 120 is too thin, it will be crushed or clogged and will not have sufficient open pores to evenly distribute negative pressure around the sleeve 102. If the foam is too thick, it will prevent an airtight seal from occurring at the seal mechanisms 108, 110 and will contract the diameter of the sleeve lumen 106. In some embodiments, the thickness of the foam disposed around the sleeve is between 2 mm and 1.5 cm.

[0093] According to some embodiments, the foam 120 can be compartmentalized into separate subunits. In some embodiments, multiple foams are dispersed around each anchoring compartment. As described above, these compartments can be separated by a plurality of continuous sealing elements. In these embodiments, negative pressure can be supplied to all of the subunits through an independent negative pressure supply, in parallel, or separately.

[0094] Alternatives to the foam may be used in some embodiments of the disclosed invention to form an interface with the intestinal wall. These foam-like alternatives must evenly distribute negative pressure through the material, generate significant frictional forces to resist displacement when negative pressure is applied, and have biocompatibility with the tissue of the GI tract and compressibility and deformability properties that resist evacuation and pressure-induced tissue damage. Some potential polymer-based alternatives are laminated mesh arrays wound around a sleeve, honeycomb lattices of interconnected channels oriented in a radial pattern around the sleeve, or 3D woven synthetic fabric materials. Natural fiber alternatives include gauze, naturally occurring sponges, or woven fabrics. However, some embodiments of the present device utilize an open-cell reticulated foam.

[0095] Pneumatic system

[0096] Device 100 includes a pressure tube 112 that is in fluid communication with the outer surface 114 of the sleeve 102. The pressure tube 112 is connected to a negative pressure source, such as an air pump, that draws air out of the tube in a controlled manner. This pump maintains a constant negative pressure at a level of pressure that allows for sufficient tethering so that the sleeve is not removed, but does not damage the intestine. The configuration of the device allows for a physiologically safe pressure of up to -200 mmHg, although a pressure of -50 to -150 mmHg can be a preferred range for negative pressure delivery. When negative pressure is applied to the tube, a seal is formed by the sealing mechanisms 108, 110 at both ends of the sleeve 102. As the pressure tube 112 connected to the negative pressure source continues to apply negative pressure, the inner wall of the tissue cavity is drawn towards the outer surface 114 of the sleeve 102, bringing the tissue into contact with the sealing mechanisms 108, 110 and the foam 120. The vertical force generated by the negative pressure that sucks in the foam generates a frictional force that resists the movement of the sleeve 102. The pressure tube is configured to resist occlusion from wall collapse when negative pressure is applied. In some embodiments, there is more than one pressure tube to provide redundancy in the event of torsion or blockage of any one pressure tube. In some embodiments with multiple pressure tubes, a more flexible and pliable tubing material can be utilized due to the redundancy of negative pressure delivery. Each of these pressure tubes is individually in fluid communication with the foam to allow for negative pressure delivery. In some embodiments, where there are multiple tethering elements or multiple tethering compartments, there may be separate pressure tubes to each tethering element or tethering compartment. The multiple pressure tubes can be individually connected to a single negative pressure source, such as a single pump, or to multiple pressure sources, such as multiple pumps.

[0097] The pressure tube 112 extends from the sleeve 102 beyond the anus. The pressure tube 112 can be disposed within the wall of the sheath 116 or can be separate. According to some embodiments, the sheath 116 defines an additional lumen that is arranged such that the pressure tube 112 is isolated from GI contents traveling through the sheath. Alternatively, the pressure tube 112 can be attached outside the sheath 116 and positioned alongside the sheath 116, either inside the sheath 116 or removed from the sheath 116. In another embodiment, the additional lumen in the sheath is the pressure tube.

[0098] The proximal end of the pressure tube 112 can be connected to the distal end of the sleeve 102 or to an annular seal mechanism 110 disposed at the distal end of the sleeve 102. FIGS. 13A - 13C illustrate the configuration of a pressure tube 1324 and a sleeve 1333 according to some embodiments of the present invention. The foam is not shown in FIGS. 13A - 13C so that the relationship between the sleeve 1333 and the pressure tube 1324 can be more clearly shown. In some embodiments, the outer surface of the sleeve 1133, including an opening into or in the pressure tube, will be coated with a closed - cell foam.

[0099] FIG. 13A shows an embodiment having a tubular feature 1316 where the sleeve projects from the distal end of the sleeve 1333 and opens to the outer surface 1320 of the sleeve 1333. The end of the tubular feature 1316 is sized to connect to the proximal end of the pressure tube. The two parts are joined or welded together to create an airtight and liquid - tight seal.

[0100] FIG. 13B illustrates an embodiment in which the pressure tube 1324 extends through the secondary lumen of the sheath 1322. Holes are drilled through the side of the distal annular seal mechanism 1310 or the sleeve 1333, and the pressure tube 1324 is routed to the outer surface of the sleeve below a foam (not shown). A plurality of holes are drilled in the pressure tube to create redundant paths for negative pressure delivery and to prevent blockages from interfering with negative pressure delivery. A sealant / adhesive is used to join the pressure tube to the sleeve and to create an airtight seal around the pressure tube where the holes are drilled in the annular seal mechanism 1310 or the sleeve 1333.

[0101] FIG. 13C illustrates an embodiment in which the pressure tube 1324 is routed straight through the secondary lumen of the sheath 1322 and into the inner lumen of the sleeve 1333. According to some embodiments, the pressure tube 1324 extends to the proximal end of the sleeve 1333. An adhesive may be applied to hold the pressure tube 1324 in place in contact with the inner surface of the sleeve 1333. The proximal end of the pressure tube 1324 is sealed. Holes are drilled through the sleeve into the pressure tube 1324 along the length of the sleeve to create communication between the outer surface of the sleeve 1333 and the pressure tube 1324 and the negative pressure source. A foam (not shown) is placed on the outer surface of the sleeve 1333 such that pressure is distributed across the surface of the foam instead of concentrating in the holes within the sleeve 1333.

[0102] FIG. 14 shows a cross-sectional side view of an embodiment of a mooring system 1400 corresponding to the device shown in FIG. 13A, with like reference numerals identifying like features as in FIGS. 1 and 8. Tubular feature 1426 connects pressure tubing 1412 to the outer surface 1414 of sleeve 1402 through opening 1428. FIG. 15 shows an enlarged view of the integration of pressure tube 1512 with annular seal mechanism 1524 and sleeve 1502. As described above with reference to FIG. 13A, the sleeve has a tubular feature 1526 that projects from the distal end of the sleeve and connects to an opening 1528 on the outer surface of sleeve 1502. Tubular feature 1526 allows pressure tube 1512 to be coupled to the outer surface of sleeve 1502 without interfering with the sealing function of seal mechanism 1524. The proximal end of the tubular feature is open so that negative pressure can be delivered to the outer surfaces of sleeve 1502 and the foam (1420 in FIG. 14, not shown in FIG. 15).

[0103] FIG. 16 is an out-of-focus view of a mooring system having the tubular features shown in FIGS. 14 and 15. The mooring system is shown with a semi-rigid tube pusher 1601 disposed within the lumens of sleeve 1602 and sheath 1616. Tubular feature 1628 is connected to pressure tube 1612 having an opening 1626 to the outside of sleeve 1602. Foam 1620 is dispersed around sleeve 1620 between proximal and distal annular seal mechanisms 1622, 1624 and covers opening 1626 of tubular feature 1628.

[0104] According to some embodiments, the sleeve 102 and / or the second annular sealing member 110 are thin and have a nozzle connected to the pressure tube 112 that is continuous with the space occupied by the foam 120 and configured not to impede flow through the lumen of the sleeve 102. According to some embodiments, the pneumatic interface contains a one-way valve that maintains a pressure gradient during the momentary loss of negative pressure delivery from the pneumatic device. The one-way valve can be disposed within the tubular junctions shown in FIGS. 13A, 14, and 16, or within the interface between the pressure tube and the vacuum source. According to some embodiments, the additional lumen in the sheath 116 is the pressure tube 112, and the port connecting to the additional lumen may contain a one-way valve oriented to prevent loss of suction. In some embodiments, these are one-way duckbill valves.

[0105] According to some embodiments, the pressure tube 112 is part of a pneumatic system that controls the pressure on the outer surface 114 of the sleeve 102. The pneumatic system includes a pump that draws air from the pressure tube 112 and maintains a substantially constant negative pressure at a set pressure level within the range of -50 mmHg to -200 mmHg. The pneumatic pump may also be able to apply a positive pressure in some configurations, for example, to assist in the removal of the sleeve 102 from the patient's intestine. The pneumatic pump can maintain the negative pressure through an electric pump mechanism or a mechanical pump mechanism. The pneumatic system may include an indicator that enables the user to determine whether sufficient negative pressure has been achieved and maintained. For example, a pressure gauge can be an indicator that demonstrates that the seal is maintained as the suction force is measured within the pneumatic system.

[0106] In some embodiments, the pressure tube 112 has an adapter that can be used to attach a syringe so that the pressure tube can be flushed and the foam 120 can be washed with fluid. This can be useful in the removal of the device from the intestinal wall during the removal procedure or to flush GI contents that can clog the pneumatic system from the foam interface.

[0107] Insertion and Removal

[0108] During insertion into the patient's intestine, the device 100 is introduced into the anal canal and moved past the anastomosis site such that the annular sealing mechanism 110 disposed at the distal end of the sleeve 102 is proximal to the anastomosis. The method of deployment depends on the height of the anastomosis. For a low anastomosis, the device can be deployed through a manually positioned capsule sheath system. For a higher anastomosis, an endoscope can be used to assist with deployment. The device can be attached to cover the outside of the endoscope so that the user can position and deploy the device at the desired location.

[0109] According to some embodiments, the tethering system 100 is configured to be retained in a fixed position by an endoscope. The device 100 can have sutures or tabs such that the device can be grasped by an endoscope grasper to pull the sleeve 102 in a fixed position using the endoscope. In some embodiments, the device is attached to a releasable clip on the end of the endoscope that can release the device from the outside of the body. Alternatively, the endoscope can be looped out of the patient's body and used to hold a flexible member such as a wire or string attached to an anchor that is pulled around the fixed end of the endoscope within the intestine to pull the device into the intestine and to the desired position.

[0110] In some embodiments, the sleeve 102 can be attached to the endoscope using a crimping mechanism that can be released from the outside of the body. In some embodiments, the sleeve 102 can be attached to a semi-rigid tube-like structure that fits over and covers the endoscope. This tube-like structure is configured to push the anchoring system 100 into place over the endoscope and then release it from the anchoring system 100. In other embodiments, the introduction member is a first semi-rigid tube that contains the proximal portion of the device. This first semi-rigid tube is advanced through the anus and into the intestine, and after reaching the desired position, a second semi-rigid push tube, which surrounds the sheath and has a smaller diameter than the first semi-rigid tube, is used to hold the device in place while the first semi-rigid tube is removed. The second semi-rigid push tube is then removed after the negative pressure anchoring of the anchoring system 100 is initiated.

[0111] As shown in FIG. 17, in some embodiments, the delivery system comprises a flexible tubular membrane 1704 that is wound around the mooring system and that is inserted into a semi-rigid tube pusher 1703. The flexible tubular membrane 1704 wraps around the mooring system and inserts into an opening 1705 within the proximal end of the semi-rigid tube pusher 1703 and exits from the distal end of the semi-rigid tube pusher 1703. In some embodiments, an end 1709 of the flexible tubular membrane 1704 outside the semi-rigid tube pusher 1703 is attached to the semi-rigid tube pusher 1703 using a crimping mechanism 1714. An end 1711 of the flexible tubular membrane 1704 that exits from the distal end of the semi-rigid tube pusher 1703 is attached to a handle 1707 in some embodiments. A longitudinal pulling force in the distal direction on the handle 1707 or the end 1711 of the flexible tubular membrane 1704 provides compression of the sealing elements 1708, 1710 and the foam 1720. Alternatively, in some embodiments, the end of the flexible tubular membrane 1704 that exits from within the distal end of the semi-rigid tube pusher 1703 is fixed to the end of the semi-rigid tube pusher 1703. A longitudinal pulling force in the distal direction on the end 1709 of the flexible tubular membrane outside the semi-rigid tube pusher 1703 provides compression of the sealing elements and the foam to assist in the delivery of the device. In these embodiments of the delivery system, the flexible tubular membrane 1704 also holds the semi-rigid tube pusher 1703 to the mooring system and allows the mooring system to be advanced into the intestine as the semi-rigid tube pusher 1703 is advanced. Because the flexible tubular membraneIn some embodiments, the flexible tubular membrane end portion outside the device 100 and the semi-rigid tube pusher 1703 is fixed to the semi-rigid tube pusher 1703 such that only a longitudinal pulling force on the flexible tubular membrane end portion 1711 exiting from the distal end of the semi-rigid pusher is required to compress the mooring system and hold the mooring system to the semi-rigid tube pusher 1703. Once the device is positioned in place, the flexible tubular membrane 1704 is removed from the semi-rigid tube pusher 1703 by the pulling force of 1711 on the end of the flexible tubular membrane exiting from the distal end of the semi-rigid tube pusher 1703 and can be withdrawn from the patient's intestine through the center of the semi-rigid tube pusher 1703. The semi-rigid tube pusher 1703 can then be removed from the patient once the mooring device is activated at negative pressure.

[0112] In some embodiments, there is a releasable liquid-tight removable connector that allows removal of the length of the sheath outside the body to enable easier delivery of the device. In some embodiments, the connector is located 8 inches to 36 inches from the nearest sealing element. In other embodiments, the sheath is directly connected to the effluent bag or left open at 8 inches to 36 inches from the nearest sealing mechanism 110.

[0113] According to some embodiments, device 100 has a removal system that enables it to be removed as needed. Fluid or positive pressure can be delivered through pressure tube 112 to reduce the adhesive force generated to tether device 100. Device 100 can then be safely removed from the patient. In some embodiments, device 100 is configured with ports such that fluid (e.g., saline) can penetrate into tubing that communicates with the foam and be used to remove sleeve 102 from the intestinal wall. The fluid can be introduced into pressure tube 112, or device 100 can have a separate tube that extends outside the patient's body to provide irrigation. It may be preferable to use pressure tubing for both negative pressure delivery and irrigation. In some embodiments, the irrigation system fluidly connects to the pressure tube and the irrigation system introduces fluid into the pressure tube for irrigation. Irrigation through the tube can be used to flush out abdominal contents that may be leaking around the proximal seal mechanism 108 and to remove device 100 from the patient's intestinal wall. By using one or more than one of these removal methods, the withdrawal force is minimized and device 100 can be removed without damaging the surrounding tissue.

[0114] Other uses

[0115] The embodiments of the invention described herein may have uses other than the protection of damaged intestine or anastomosis protection. For example, the disclosed devices and methods may also be used for defecation regulation control in settings such as intensive care units. In these settings, perineal fecal contamination can result in significant dermatitis and damage. Existing defecation regulation control devices for diverting fecal flow into a collection bag often result in complications such as fecal leakage, displacement of the fecal tube, and erosion into the intestinal wall. In contrast, the devices and methods described herein are non-invasive, sealed against leakage, and can tether a fecal collection sheath within the patient's rectum using a tethering mechanism that is not easily removed and is easily reversible. The tethering methods described herein may also be used to secure other sheaths or drug delivery devices within the intestine. For example, a sheath for limiting absorption, used to treat metabolic disorders, diabetes, or obesity, may be tethered using the described techniques. A specialized sheath designed to elute drugs may also be tethered using the described techniques. For example, a sheath attached to the anchor device described herein can contain a controlled-release anti-inflammatory drug to treat inflammatory bowel disease. Also, as described above and shown in FIGS. 18 and 19, a second anchor element can be distally positioned to create a sealed space between the treated section of the intestine, the two anchor elements, and the sheath. This space can be filled with a therapeutic solution such as an antibiotic, an anti-inflammatory drug, or a chemotherapeutic drug for cancer. This allows for controlled local delivery to a section of the intestinal wall isolated between the two anchor elements. Also, as previously mentioned, a sheath that can help divert flow from a damaged section of the intestine, such as in cases of intestinal perforation, ischemic bowel, intestine bruised by blunt trauma, or inflamed or dilated intestine in cases of inflammatory bowel disease, may be tethered.

[0116] The embodiments illustrated and discussed in this specification are intended only to teach those skilled in the art how to make and use the invention. Specific terms are employed in describing the embodiments of the invention for the purpose of clarity. However, the invention is not intended to be limited to the specific terms so selected. The above embodiments of the invention may be modified or varied without departing from the invention, as will be understood by those skilled in the art in light of the above teachings. Accordingly, it is to be understood that the invention may be practiced otherwise than as specifically described within the scope of the claims and their equivalents.

Claims

Claim 1: A tethering system, wherein the tethering system comprises a sleeve having an inner surface defining a first lumen, the sleeve being configured to be disposed within the tissue cavity proximal to a damaged area of tissue of the tissue cavity; a pressure tube in fluid connection with an outer surface of the sleeve; a sheath connected to the sleeve, the sheath forming a second lumen, the second lumen being in fluid connection with the first lumen of the sleeve, the sheath having a distal end in sealed fluid communication with the distal end of the sleeve and an end extending distally beyond the distal end of the sleeve, the end of the sheath extending distally beyond the distal end of the sleeve being configured to cover the damaged area of the tissue of the tissue cavity and protect the damaged area from contents flowing through the second lumen of the sheath and the first lumen of the sleeve; a negative pressure system having a source of negative pressure coupled to the sleeve via the pressure tube, the negative pressure system being configured to create a vacuum to leave the sleeve in a fixed position within the tissue cavity at a tethering site proximal to the damaged area of the tissue of the tissue cavity; and the sleeve being configured to remain in a fixed position at the tethering site proximal to the damaged area of the tissue of the tissue cavity during peristalsis of the patient's intestine. A tethering system. Claim 2: The tethering system according to claim 1, further comprising an indicator configured to indicate when a sufficient negative pressure has been achieved and / or maintained by the negative pressure system. Claim 3: The tethering system according to claim 2, wherein the indicator is a pressure gauge. Claim 4: The tethering system according to claim 1, wherein the negative pressure system comprises one of an electric pump mechanism or a mechanical pump mechanism. Claim 5: The tethering system according to claim 1, wherein the negative pressure system is further configured to apply a positive pressure to cause the sleeve to be released from the tethering site proximal to the damaged area of the tissue of the tissue cavity. Claim 6: The tethering system according to claim 1, wherein the negative pressure system is configured to apply a negative pressure to the pressure tube to maintain the negative pressure at a level between -50 mmHg and -200 mmHg. Claim 7: The sleeve is (a)a first sealing mechanism disposed at the proximal end of the sleeve; (b)a second sealing mechanism disposed at the distal end of the sleeve; The mooring system according to claim 1, further comprising: **Claim 8**: The first sealing mechanism and the second sealing mechanism each comprise one or more tapered fins, and the one or more tapered fins are serially disposed on each end of the sleeve in an orientation directed away from the center of the sleeve such that when negative pressure is applied to the pressure tube, the one or more tapered fins contact and flatten against the non-damaged area of the tissue in the tissue cavity. The mooring system according to claim 7. **Claim 9**: The diameter of each of the first sealing mechanism and the second sealing mechanism is less than or equal to the diameter of the tissue cavity in the non-damaged area of the tissue of the tissue cavity. The mooring system according to claim 7. **Claim 10**: The mooring system according to claim 7, further comprising a connector tube coupling the pressure tube to the sleeve, the connector tube extending through one of the first sealing mechanism and the second sealing mechanism and having an opening on the outer surface of the sleeve. **Claim 11**: The connector tube includes a one-way valve therein. The mooring system according to claim 10. **Claim 12**: The sleeve, the first sealing mechanism, the second sealing mechanism, and the sheath are made of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymers. The mooring system according to claim 7. **Claim 13**: The mooring system according to claim 1, further comprising a cleaning system in fluid connection with the pressure tube, the cleaning system configured to introduce fluid into the pressure tube for cleaning. **Claim 14**: The mooring system according to claim 1, further comprising a plurality of pressure tubes in fluid connection with the outer surface of the sleeve. **Claim 15**: The mooring system according to claim 1, further comprising a flexible membrane enclosing at least the sleeve of the mooring system. **Claim 16**: The mooring system according to claim 1, further comprising a surface material disposed on the outer surface of the sleeve. The retention system according to claim 1, wherein the surface material is a laminated mesh matrix, a honeycomb lattice of interconnected channels oriented in a radial pattern around the sleeve, a gauze, a fabric, a three-dimensional woven material, or an open-cell foam.

17. The retention system according to claim 1, wherein the sheath has a length that allows it to extend outside the tissue cavity.

18. The retention system according to claim 1, wherein the sleeve has a length between 3 cm and 25 cm.

19. The retention system according to claim 1, further comprising a collection bag in fluid connection with the sheath, the collection bag being configured to receive GI contents flowing through the sheath.

20. The retention system according to claim 1, wherein the sleeve is configured to be introduced into the tissue cavity through the patient's anal canal using an endoscope.

21. The retention system according to claim 20, wherein the retention system is releasably attached to the endoscope.

22. The retention system according to claim 21, wherein the retention system is attached to the end of the endoscope via a releasable clip.

23. The retention system according to claim 1, wherein the sleeve is configured to remain in place within the tissue cavity at the retention site proximal to the damaged area of the tissue for an extended period of time until the sleeve is removed.

24. A system for protecting an intestinal anastomosis, the system comprising a device configured to be introduced into the intestine through the anal canal of a subject, the device comprising a negative pressure anchor having a sleeve attached to a sheath wherein the negative pressure anchor is configured to be deployed at a retention site within the intestine upstream of the anastomosis, negative pressure is applied to the negative pressure anchor to suck the intestinal wall against the outer surface of the sleeve of the negative pressure anchor, whereby the device is tethered to the intestinal wall, and the sheath extends downstream from the negative pressure anchor across the anastomosis, thereby protecting the anastomosis, wherein the sleeve is configured to remain in place at the retention site within the intestine upstream of the anastomosis during peristalsis of the patient's intestine.

25. The negative pressure anchor is a first sealing mechanism disposed at the proximal end of the sleeve; a second sealing mechanism disposed at the distal end of the sleeve; The system according to claim 24, further comprising: **Claim 26** The first sealing mechanism and the second sealing mechanism each comprise one or more tapered fins, and the one or more tapered fins are arranged in series on each end of the sleeve in an orientation directed away from the center of the sleeve such that when negative pressure is applied to the negative pressure anchor, the one or more tapered fins contact and flatten against the non-damaged area of the tissue in the tissue cavity. The system according to claim 25. **Claim 27** The diameter of each of the first sealing mechanism and the second sealing mechanism is not greater than the diameter of the intestine at the anchoring site in the intestine upstream of the anastomosis. The system according to claim 25. **Claim 28** The negative pressure anchor further comprises a connector tube coupling a pressure tube to the sleeve, the connector tube extending through one of the first sealing mechanism and the second sealing mechanism and having an opening on the outer surface of the sleeve. The system according to claim 25. **Claim 29** The connector tube includes a one-way valve therein. The system according to claim 28. **Claim 30** The sleeve, the first sealing mechanism, the second sealing mechanism, and the sheath are made of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymers. The system according to claim 25. **Claim 31** The negative pressure anchor further comprises a pressure tube in fluid connection with the outer surface of the sleeve. The system according to claim 24. **Claim 32** The device further includes a cleaning system in fluid connection with the pressure tube, the cleaning system introducing fluid into the pressure tube for cleaning. The system according to claim 31. **Claim 33** The negative pressure anchor further comprises a plurality of pressure tubes in fluid connection with the outer surface of the sleeve. The system according to claim 24. **Claim 34**: The device is configured to be introduced into the intestine through the anal canal of a subject using a delivery system, the delivery system comprising a semi-rigid tube pusher configured to push the negative pressure anchor to the anchoring site within the intestine upstream of the anastomosis. The system according to claim 24. **Claim 35**: The device further includes a flexible membrane that encloses the negative pressure anchor, the flexible membrane configured to recess into the proximal end of the semi-rigid tube pusher and exit from the distal end of the semi-rigid tube pusher. The system according to claim 34. **Claim 36**: Further, the semi-rigid tube pusher and the flexible membrane are configured to be removed from the anal canal. The system according to claim 35. **Claim 37**: The negative pressure anchor further comprises a surface material disposed on the outer surface of the sleeve. The surface material is a laminated mesh array, a honeycomb lattice of interconnected channels oriented in a radial pattern around the sleeve, a gauze, a fabric, a three-dimensional woven material, or an open-cell foam. The system according to claim 24. **Claim 38**: Protecting the anastomosis includes temporarily protecting the anastomosis. The device is configured to be removed from the intestine through the anal canal in response to healing of the anastomosis. The system according to claim 24. **Claim 39**: The sheath has a length that allows it to extend outside the anal canal. The system according to claim 24. **Claim 40**: The sleeve has a length between 3 cm and 25 cm. The system according to claim 24. **Claim 41**: The device further comprises a collection bag in fluid connection with the sheath, the collection bag configured to receive GI contents flowing through the sheath. The system according to claim 24. **Claim 42**: The device is configured to be introduced into the intestine through the anal canal of a subject using an endoscope. The system according to claim 24. **Claim 43**: The negative pressure anchor is configured to remain in place at the anchoring site within the intestine upstream of the anastomosis for an extended period until the negative pressure anchor is removed through the anal canal. The system according to claim 24.

44. The system according to claim 24, further configured such that one of positive pressure or fluid to the negative pressure anchor is delivered to reduce the negative pressure used to anchor the device to the intestinal wall.

45. The system according to claim 44, wherein the negative pressure anchor is configured to be removed from the intestine through the anal canal.

46. An anchoring device, a sleeve having an inner surface defining a first lumen, the sleeve being configured to be disposed within the tissue cavity proximal to the damaged area of the tissue of the tissue cavity; and a porous material disposed on the outer surface of the sleeve, the porous material being configured to distribute negative pressure along the outer surface of the sleeve through a negative pressure tube in fluid connection with the porous material. The anchoring device, wherein the sleeve is configured to remain in place within the tissue cavity at an anchoring site proximal to the damaged area of the tissue of the tissue cavity during peristalsis of the patient's intestine.

47. The anchoring device according to claim 46, wherein the porous material includes at least one of a laminated mesh array, a honeycomb lattice of interconnected channels oriented in a radial pattern around the sleeve, a gauze, a fabric, a natural sponge, a three-dimensional woven material, or an open-cell foam.

48. The anchoring device according to claim 46, wherein the porous material includes an open-cell foam.

49. The anchoring device according to claim 48, wherein the open-cell foam includes polyvinyl alcohol, a polymer, polyurethane, an organic fiber mesh, or a combination thereof.

50. The anchoring device according to claim 48, wherein the open-cell foam includes a tubular foam.

51. The anchoring device according to claim 46, wherein the porous material has an average pore diameter of 50 microns to 1,000 microns. **Claim 52**: The device further comprises a sheath connected to the sleeve, the sheath forming a second lumen, the second lumen being in fluid communication with the first lumen of the sleeve, the sheath having an end in sealed fluid communication with the distal end of the sleeve and extending distally beyond the distal end of the sleeve, the end of the sheath extending distally beyond the distal end of the sleeve being configured to cover the damaged area of the tissue of the tissue cavity and protect the damaged area from contents flowing through the second lumen of the sheath and the first lumen of the sleeve. The anchoring device according to claim 46. **Claim 53**: The sheath has a length that allows it to extend outside the tissue cavity. The anchoring device according to claim 52. **Claim 54**: The device further comprises a negative pressure system having a source of negative pressure coupled to the sleeve via the negative pressure tube, the negative pressure system being configured to create a vacuum to leave the sleeve in a fixed position within the tissue cavity at the anchoring site proximal to the damaged area of the tissue of the tissue cavity. The anchoring device according to claim 46. **Claim 55**: The negative pressure system comprises one of an electric pump mechanism or a mechanical pump mechanism. The anchoring device according to claim 54. **Claim 56**: The negative pressure system is configured to apply the negative pressure to the negative pressure tube so as to maintain the negative pressure at a level between -50 mmHg and -200 mmHg. The anchoring device according to claim 54. **Claim 57**: The sleeve further comprises a first sealing mechanism disposed at the proximal end of the sleeve, and a second sealing mechanism disposed at the distal end of the sleeve. The anchoring device according to claim 46. **Claim 58**: The diameter of each of the first sealing mechanism and the second sealing mechanism is not greater than the diameter of the tissue cavity in the non-damaged area of the tissue of the tissue cavity. The anchoring device according to claim 57. **Claim 59**: The device further comprises a connector tube having an opening on the outer surface of the sleeve and coupling the negative pressure tube to the sleeve. The anchoring device according to claim 46. **Claim 60**: The sleeve is made of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymers. The anchoring device according to claim 46. The mooring device according to claim 46, further comprising a flexible membrane that at least wraps the sleeve. The mooring device according to claim 46, further comprising a collection bag that is in fluid connection with the sleeve, the collection bag being configured to receive GI contents flowing through the sleeve. The mooring device according to claim 46, wherein the sleeve is configured to be introduced into the tissue cavity through the anal canal of a patient using an endoscope. The mooring device according to claim 63, wherein the mooring device is releasably attached to the endoscope. The mooring device according to claim 46, wherein the sleeve is configured to remain in a fixed position within the tissue cavity at the mooring site proximal to the damaged area of the tissue for a long period of time until the sleeve is removed. A system for protecting an anastomosis in the intestine, the system comprising a device configured to be introduced into the intestine through the anal canal of a subject, the device comprising a negative pressure anchor with a sleeve, the sleeve having a porous material disposed on an outer surface of the sleeve and the negative pressure anchor is configured to be deployed at a mooring site within the intestine upstream of the anastomosis, negative pressure is configured to be applied to the negative pressure anchor via a negative pressure tube in fluid connection with the porous material to suck the intestinal wall against the outer surface of the sleeve of the negative pressure anchor, the porous material being configured to distribute the negative pressure along the outer surface of the sleeve such that the device is tethered to the wall of the intestine, the sleeve is configured to remain at the mooring site during peristalsis. The system according to claim 66, wherein the negative pressure anchor further comprises a sheath attached to the sleeve, the sheath extending downstream from the negative pressure anchor across the anastomosis, thereby protecting the anastomosis. The system according to claim 66, wherein the porous material comprises at least one of a laminated mesh array, a honeycomb lattice of interconnected channels oriented in a radial pattern around the sleeve, a gauze, a fabric, a naturally occurring sponge, a three-dimensional woven material, or an open-cell foam.

69. The system according to claim 66, wherein the porous material includes an open-cell foam.

70. The negative pressure anchor further comprises a first sealing mechanism disposed at the proximal end of the sleeve, and a second sealing mechanism disposed at the distal end of the sleeve. The system according to claim 66.

71. The device is configured to be introduced into the intestine through the anal canal of a subject using a delivery system, the delivery system comprising a semi-rigid tube pusher configured to push the negative pressure anchor to the anchoring site in the intestine upstream of the anastomosis. The system according to claim 66.

72. The device further includes a flexible membrane that wraps around the negative pressure anchor and is configured to recess into the proximal end of the semi-rigid tube pusher and exit from the distal end of the semi-rigid tube pusher, and the semi-rigid tube pusher and the flexible membrane are configured to be removed from the anal canal. The system according to claim 71.

73. Protecting the anastomosis includes temporarily protecting the anastomosis, and the device is configured to be removed from the intestine through the anal canal in response to healing of the anastomosis. The system according to claim 66.

74. The device is configured to be introduced into the intestine through the anal canal of a subject using an endoscope. The system according to claim 66.

75. Either fluid or positive pressure is configured to be delivered to the negative pressure anchor to reduce the negative pressure used to anchor the device to the wall of the intestine, and the negative pressure anchor is configured to be removed from the intestine through the anal canal. The system according to claim 66.

Images