System and method for introducing and monitoring a negative pressure device to protect the intestinal anastomosis.

Abstract

A system and method are provided for monitoring a bypass device for protecting a bowel anastomosis. The system includes a pump, one or more fluid inlet lines fluidically coupled to a negative pressure chamber of the pump and the bypass device, and one or more sensors configured to measure data indicating the pressure in the negative pressure chamber. A controller operably coupled to the pump and one or more sensors may be programmed to operate the pump to generate a vacuum in the negative pressure chamber, thereby pulling bowel tissue toward the bypass device and anchoring the bypass device to a target location upstream of the bowel anastomosis. The controller may further compare the pressure in the negative pressure chamber to a predetermined pressure range and, if the pressure is outside the predetermined pressure range, adjust the pump to maintain the vacuum within the predetermined pressure range.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 589,965, filed on October 12, 2023; U.S. Provisional Patent Application No. 63 / 589,973, filed on October 12, 2023; U.S. Provisional Patent Application No. 63 / 490,847, filed on March 17, 2023; and European Patent Application No. 23305367.7, filed on March 17, 2023, each of which is incorporated herein by reference in its entirety.

[0002] This technology relates to a system and method for introducing and monitoring an internal bypass device having a negative pressure system for protecting against leakage at the anastomosis site following bowel resection procedures.

Background Art

[0003] In some cases, a section of a patient's intestine must be removed to treat certain obstructions and diseases such as colorectal cancer, diverticulitis, severe bleeding, obstructions, and the like. In these bowel resection procedures, the physician dissociates and removes the diseased or embolized portion of the large intestine and then reconnects the healthy ends of the intestine using small staples or sutures, which is often referred to as the intestinal anastomosis. The most severe complication that occurs with bowel resection procedures is anastomotic leakage, which can occur when the healing process is delayed or incomplete. Anastomotic leakage allows feces and other excretory substances to leak into the abdominal cavity, which can lead to dangerous infections or sepsis. To prevent this from occurring, the anastomosis site must be protected immediately after surgery.

[0004] Traditionally, to prevent leakage at the anastomosis site, surgeons create an external bypass of the anastomosis site, a procedure called circumferential fistula creation. In this procedure, the surgeon creates a temporary opening or fistula (e.g., an artificial anus) and diverts the intestine to this opening. The surgeon then places a fistula bag into the opening in the abdomen to collect the patient's feces and other excretions during the healing period. Unfortunately, fistula creation is debilitating for the patient, prone to complications, costly and inefficient from a patient management perspective. In addition, fistula creation requires a second surgical procedure to reverse.

[0005] To overcome the limitations of bypass fistula formation procedures, internal temporary bypass devices have been developed. These bypass devices typically include a flexible sheath that is introduced into the colon and positioned against the inner wall of the colon at the anastomosis site. The bypass device eliminates any contact between the tissue and feces or other excretions progressing through the intestine, thereby ensuring cleanliness of the anastomosis site. After healing is complete, the sheath can be removed from the patient through a standard endoscopic procedure without requiring a second surgical procedure.

[0006] One of the challenges with internal bypass devices is ensuring they remain in close contact with the intestinal tissue surrounding the anastomosis site, preventing sheath migration or any leakage of intestinal contents into the area surrounding the sheath and into the patient's abdomen. To overcome this challenge, bypass devices may include a negative suction or vacuum pressure system that provides sustained negative pressure to the outer wall of the sheath, ensuring the sheath remains in close contact with the inner wall of the intestine surrounding the anastomosis site. This negative suction pressure is typically supplied to the peripheral wall of the sheath using one or more fluid lines or catheters. The fluid lines are coupled to an external negative pressure source, such as a suction canister or equivalent.

[0007] While these new bypass devices are highly effective, they suffer from certain drawbacks. For example, continuous suction pressure must be applied to the bypass sheath throughout the entire healing period. If any part of the pressure system suffers a loss of negative pressure, the outer wall of the sheath loses contact with the intestine, which can allow the sheath to migrate and / or leak fecal or excretory material through the anastomosis. Therefore, the pressure of the suction system must be constantly monitored. In the event of a loss of negative pressure, healthcare professionals must be immediately alerted so that the system can be replaced before the sheath ceases to function as intended.

[0008] Another drawback of existing negative pressure systems, designed for use with internal bypass devices, is that the suction canister is typically supplied with negative pressure by a separate vacuum device. Therefore, to provide patient mobility during the healing period in the hospital, the storage canister must either be completely disconnected from the vacuum device, or the patient must carry the entire system with them. This not only requires the patient to carry more devices, but also excess tubing that must be clipped and secured to prevent falls. These problematic systems are inconvenient for patients or the physical therapists assisting them with their movement.

[0009] To further improve patient mobility, suction canisters are designed to be pre-supplied with negative pressure prior to patient use. Since these suction canisters already have negative or vacuum pressure, they do not require attachment to a separate tube for connection to a vacuum source. While this provides some improvement in patient mobility, suction canisters alone are typically difficult for patients to easily grasp and transport. An improved system for monitoring negative pressure devices is described in DePierro U.S. Patent Application Publication No. 2022 / 0355017 (the full contents of which are incorporated herein by reference).

[0010] In light of the aforementioned shortcomings of existing systems and methods, there is a need for improved systems and methods for protecting the anastomosis site and monitoring the system after bowel resection surgery. Furthermore, it would be desirable to provide a portable system that allows patients to move around during the recovery period, improves GI mobility during this period, and improves the patient's overall quality of life. [Prior art documents] [Patent Documents]

[0011] [Patent Document 1] U.S. Patent Application Publication No. 2022 / 0355017 [Overview of the Initiative] [Means for solving the problem]

[0012] This disclosure overcomes the shortcomings of previously known systems and methods by providing a system for monitoring a bypass device for protecting a bowel anastomosis, wherein the bypass device comprises a negative pressure chamber and is configured to be implanted at a target location upstream of the bowel anastomosis. For example, the system may include a pump, one or more fluid inlet tubes each coupled to the pump, having a downstream end and an upstream end having one or more pores that fluidly communicate with the negative pressure chamber of the bypass device, one or more sensors configured to measure data indicating the pressure in the negative pressure chamber, and a controller operably coupled to the pump and one or more sensors. The controller may be programmed with instructions to operate a pump with pump parameters to discharge fluid from a negative pressure chamber through one or more fluid inlet tubes, thereby generating a vacuum within the negative pressure chamber having a pressure within a predetermined pressure range, the vacuum being sufficient to pull intestinal tissue toward a bypass device and anchor the bypass device to a target location upstream of the intestinal anastomosis; to compare data indicating the pressure within the negative pressure chamber, received over time from one or more sensors, with a predetermined pressure range; and, if the pressure within the negative pressure chamber is outside the predetermined pressure range, to adjust the pump parameters of the pump so that the pump applies a vacuum within the negative pressure chamber and maintains it within the predetermined pressure range.

[0013] For example, the controller may be programmed to generate an alert if the pressure in the vacuum chamber is outside a predetermined pressure range. In addition, or alternatively, the controller may be programmed to generate an alert if the pressure in the vacuum chamber is not within a predetermined pressure range within a predetermined period of time. The alert may be, for example, at least one of an audible or visual alert. The controller may further be programmed to adjust the predetermined pressure range of the vacuum over time. In addition, the controller may further be programmed to stop the pump from operating when the pressure in the vacuum chamber is within a predetermined pressure range. For example, the system may further include one or more check valves in fluid communication with the pump, one or more of which are configured to transition between a closed state and an open state to bring the pump to ambient pressure.

[0014] The controller may further calculate the actual pumping time required to achieve a predetermined total volume of the system and determine the presence of an obstruction in the system if the actual pumping time deviates from the expected pumping time. Furthermore, the controller may be configured to calculate the volume of the system in real time based on data measured by one or more sensors, so that the controller may be configured to calculate the expected pumping time based on the real-time volume of the system. The controller may be configured to generate an alert in response to the determination of the presence of an obstruction in the system. The system may further include a fluid reservoir chamber in fluid communication with one or more fluid inlet pipes. The fluid reservoir chamber may be sized and molded to collect at least one of liquid or solid waste from the fluid discharged from the negative pressure chamber. For example, one or more sensors may include pressure transducers operably coupled to the fluid reservoir chamber.

[0015] In some embodiments, the system may include sensors configured to measure data indicating the level of at least one of the liquid or solid waste in a fluid reservoir chamber, such that the controller may be programmed to generate an alert if the level of at least one of the liquid or solid waste exceeds a predetermined threshold. One or more fluid inlet tubes may be operably coupled to pressure transducers, which are operably coupled to the controller, and the pressure transducers are configured to measure data indicating the pressure in the fluid reservoir chamber. Thus, the controller may be configured to compare data indicating the pressure in the negative pressure chamber, received from one or more sensors, with data indicating the pressure in the fluid reservoir chamber, received from the pressure transducers, and to determine the presence of a blockage in one or more fluid inlet tubes if the pressure difference between the pressures in the negative pressure chamber and the fluid reservoir chamber falls below a predetermined pressure threshold. The controller may further be programmed to generate an alert in response to the determination of the presence of a blockage in one or more fluid inlet tubes.

[0016] One or more fluid inlet tubes may be operably coupled to a pressure transducer, which is operably coupled to a controller, and the pressure transducer is configured to measure data indicating the pressure in the fluid reservoir chamber. Thus, the controller may be configured to compare data indicating the pressure in the negative pressure chamber, received from one or more sensors, with data indicating the pressure in the fluid reservoir chamber, received from the pressure transducer, and to determine the presence of a blockage in one or more fluid inlet tubes if the pressure difference between the pressure in the negative pressure chamber and the pressure in the fluid reservoir chamber falls below a predetermined pressure threshold. The controller may further be programmed to generate an alert in response to the determination of the presence of a blockage in one or more fluid inlet tubes.

[0017] Furthermore, the system may include a pressure normalization chamber fluidly coupled to the pump, and a valve fluidly coupled to the fluid reservoir chamber and the pressure normalization chamber, the valve being operably coupled to a controller and transitionable between a closed state and an open state. In addition, the system may include a check valve fluidly coupled to the pressure normalization chamber, the check valve being operably coupled to a controller and transitionable between a closed configuration and an open configuration, bringing the pressure normalization chamber to atmospheric pressure. Thus, one or more sensors may be fluidly coupled to at least one of the fluid reservoir chamber or the pressure normalization chamber. In addition, or alternatively, one or more sensors may be located on a bypass device.

[0018] The system may further include a housing configured to contain at least a pump and a controller. For example, the housing may be sized and molded to be worn by a patient, and / or the housing may be configured to be mounted at the bedside or on an IV pole. The housing may include a user interface operably coupled to the controller. For example, the user interface may be configured to allow the user to select pump parameters from a set of pump parameters. In addition, the user interface may include a display to show information associated with the bypass device. Furthermore, the negative pressure chamber may be defined by a mesh anchor that is sealed to an inner sheath via a downstream seal and an upstream seal. The mesh anchor may be configured to engage with intestinal tissue in an extended and deployed state, and one or more fluid inlet tubes may extend across the downstream seal such that one or more pores are located within the negative pressure chamber. In addition, the inner sheath may have a length such that it extends from the mesh anchor at the target site, across the intestinal anastomosis, and outward from the external anal opening, and may have a lumen that is sized and shaped to allow feces to pass through the intestinal anastomosis without contact with it.

[0019] In some embodiments, the mesh anchor may comprise a downstream region, an upstream region, and a central region extending between the downstream and upstream regions, the central region having an outer diameter less than the outer diameters of the downstream and upstream regions. Furthermore, the system may further include a central seal that seals an inner sheath to the central region of the mesh anchor, thereby defining a first negative pressure chamber between the inner sheath, the downstream seal, the central seal, and a portion of the mesh anchor between the downstream and central seals, and a second negative pressure chamber between the inner sheath, the upstream seal, the central seal, and a portion of the mesh anchor between the upstream and central seals. Thus, a first set of one or more fluid inlet tubes may extend across the downstream seal such that one or more pores of the first set of one or more fluid inlet tubes are located in the first negative pressure chamber, and a second set of one or more fluid inlet tubes may extend across the downstream seal and the central seal such that one or more pores of the second set of one or more fluid inlet tubes are located in the second negative pressure chamber.

[0020] The central seal may comprise a seal ring having multiple inlet ports configured to be fluidly coupled to the pump via one or more suction tubes. Furthermore, the downstream seal may comprise a seal ring having multiple inlet ports configured to be fluidly coupled to the pump via one or more suction tubes. In some embodiments, the upstream seal may extend along the upstream region of the mesh anchor and cover the upstream end of the mesh anchor. Thus, the upstream seal may be configured to prevent inward growth of mucosa on the bypass device and prevent damage to intestinal tissue. Similarly, the downstream seal may extend along the downstream region of the mesh anchor and cover the downstream end of the mesh anchor. Thus, the downstream seal may be configured to prevent inward growth of mucosa on the bypass device and prevent damage to intestinal tissue.

[0021] The mesh may comprise an inner mesh anchor comprising a downstream region, an upstream region, and a central region extending between the downstream and upstream regions, having an outer diameter less than the outer diameters of the downstream and upstream regions, and an outer mesh anchor positioned across the inner mesh anchor. The outer mesh anchor may be configured to transition from a cylindrical configuration to a shape corresponding to the geometry of the inner mesh anchor when a vacuum is generated in the negative pressure chamber. The system may further include one or more additional sensors configured to measure data indicating the presence of at least one of blood, feces, or a predefined gas between the bypass device and the intestinal tissue surrounding the bypass device. Thus, the controller may be programmed to generate an alert if the level of at least one of blood, feces, or a predefined gas exceeds a predetermined threshold. In addition, the system may include one or more additional sensors configured to measure data indicating the position of the bypass device relative to the intestinal anastomosis. Thus, the controller may be programmed to generate an alert if the position of the bypass device relative to the intestinal anastomosis indicates that the bypass device is sliding away from its target location.

[0022] Furthermore, one or more fluid inlet tubes may include a first fluid inlet tube having a first downstream end coupled to a pump and a first upstream end having a first set of one or more pores that fluidly communicate with the negative pressure chamber of the bypass device, and a second fluid inlet tube having a second downstream end coupled to a pump and a second upstream end having a second set of one or more pores that fluidly communicate with the negative pressure chamber of the bypass device. The first and second upstream ends of the first and second fluid inlet tubes may be equally spaced and circumferentially spaced within the negative pressure chamber. In addition, one or more sensors may include a sensing tube having a third downstream end coupled to a vacuum transducer and a third upstream end that fluidly communicates with the negative pressure chamber of the bypass device. The first, second, and third upstream ends of the first fluid inlet tube, the second fluid inlet tube, and the sensing tube may each be equally spaced and circumferentially spaced within the negative pressure chamber.

[0023] The system may further include a manifold configured to fluidly couple the first and second fluid inlet pipes and the sensing pipe to a pump and a vacuum transducer, respectively. The manifold may include a first inlet port and a first outlet port configured to receive the first fluid inlet pipe through it, a second inlet port and a second outlet port configured to receive the second fluid inlet pipe through it, a third inlet port configured to receive the downstream end of the distal portion of the sensing pipe, a third outlet port configured to receive the upstream end of the proximal portion of the sensing pipe through it, and a flush port that is in fluid communication with the downstream end of the distal portion of the sensing pipe and the upstream end of the proximal portion of the sensing pipe. The flush port may be configured to receive fluid for flushing the pipe. In addition, the manifold may include a clamp positioned on the proximal portion of the sensing pipe. The clamp may be configured to transition between an open state, in which fluid flow is permitted throughout the entire length of the sensing tube, and a closed state, in which fluid flow is blocked within the sensing tube downstream of the clamp.

[0024] According to another aspect of the present disclosure, a method for protecting an intestinal anastomosis is provided. The method includes introducing a bypass device into the intestine through the anal opening, positioning the bypass device at a target location upstream of the intestinal anastomosis, deploying the bypass device at the target location, coupling the downstream ends of one or more fluid inlet lines extending from the negative pressure chamber of the bypass device to a pump outside the anal opening, operating the pump with pump parameters to discharge fluid from the negative pressure chamber through the one or more fluid inlet tubes, generating a vacuum having a pressure within a predetermined pressure range in the negative pressure chamber, the vacuum being sufficient to draw the intestinal tissue into the negative pressure chamber and anchor the bypass device at the target location, measuring the pressure in the negative pressure chamber over time via one or more pressure sensors, and adjusting the pump parameters of the pump to apply a vacuum and maintain it within the predetermined pressure range in the negative pressure chamber when the pressure in the negative pressure chamber is outside the predetermined pressure range.

[0025] For example, introducing the bypass device into the intestine through the anal opening may include introducing a first tubular portion of a guide tube of an introducer device through the anal opening. The first tubular portion may house the bypass device in a collapsed delivery state therein. Further, deploying the bypass device at the target location may include rotating an actuator of a handle operatively coupled to a second tubular portion of the guide tube downstream of the first tubular portion such that a slidable engagement between one or more notches of the handle and one or more grooves extending along an outer surface of the second tubular portion causes an axial translation of the guide tube with respect to the handle, thereby exposing the bypass device beyond the upstream tip of the first tubular portion.

[0026] The method may further include generating an alert via a controller operably coupled to one or more sensors when the pressure in the negative pressure chamber is outside a predetermined pressure range. Additionally or alternatively, the method may include generating an alert via a controller operably coupled to one or more sensors when the pressure in the negative pressure chamber is not within a predetermined pressure range within a predetermined period. Additionally, the method may include stopping the operation of the pump when the pressure in the negative pressure chamber is within a predetermined pressure range. Further, the method may include collecting at least one of liquid or solid excrement from the fluid discharged from the negative pressure chamber in a reservoir that is in fluid communication with one or more fluid inlet lines, monitoring the level of at least one of the liquid or solid excrement in the reservoir, and generating an alert when the level of at least one of the liquid or solid excrement in the reservoir exceeds a predetermined threshold.

[0027] Additionally, the negative pressure chamber may be defined by a mesh anchor that is sealed to the inner sheath via a downstream seal and an upstream seal, the downstream seal extending along a downstream region of the mesh anchor and covering the downstream end of the mesh anchor, and the upstream seal extending along an upstream region of the mesh anchor and covering the upstream end of the mesh anchor. Thus, deploying the bypass device at the target location may include expanding the mesh anchor to an expanded deployment state such that the upstream and downstream seals are formed against the intestinal tissue. The upstream and downstream seals may prevent ingrowth of mucosa on the bypass device and prevent damage to the intestinal tissue.

[0028] The mesh anchor may comprise an inner mesh anchor having a downstream region, an upstream region, and a central region extending between the downstream and upstream regions, having an outer diameter less than the outer diameters of the downstream and upstream regions, and an outer mesh anchor positioned across the inner mesh anchor. The outer mesh anchor may be configured to transition from a cylindrical configuration to a shape corresponding to the geometry of the inner mesh anchor when a vacuum is generated in the negative pressure chamber, in response to the operation of a pump to generate a vacuum in the negative pressure chamber. The method may further include calculating the actual pump operating time of the pump to achieve a predetermined total volume of the system, and determining the presence of blockages in the system if the actual pump operating time deviates from the expected pump operating time. Adjusting the pump parameters of a pump when the pressure in the negative pressure chamber is outside a predetermined pressure range may include automatically adjusting the pump parameters of a pump via a controller operably coupled to one or more sensors and the pump when the pressure in the negative pressure chamber is outside a predetermined pressure range.

[0029] The method may further include measuring the pressure in a fluid reservoir chamber that is in fluid communication with one or more fluid inlet pipes via a pressure transducer, comparing the pressure in a negative pressure chamber with the pressure in the fluid reservoir chamber, and determining the presence of a blockage in one or more fluid inlet pipes if the pressure difference between the pressure in the negative pressure chamber and the pressure in the fluid reservoir chamber falls below a predetermined pressure threshold. Therefore, the method may also include generating an alert via a controller in response to the determination of the presence of a blockage in one or more fluid inlet pipes. In addition, the method may also include flushing one or more fluid inlet pipes and removing the blockage via a manifold that fluidly connects one or more fluid inlet pipes to the negative pressure chamber and the pump. In some embodiments, one or more fluid inlet pipes may include first and second fluid inlet pipes extending from the negative pressure chamber of a bypass device to the pump. Furthermore, measuring the pressure in the negative pressure chamber over time via one or more pressure sensors may include measuring the pressure in the negative pressure chamber over time via a sensing tube extending from the negative pressure chamber to the vacuum transducer via a vacuum transducer.

[0030] According to yet another aspect of the present disclosure, a bypass device is provided which is configured to be implanted at a target location upstream of an intestinal anastomosis in order to protect the intestinal anastomosis. The bypass device may include an inner mesh anchor comprising a downstream region, an upstream region, and a central region extending between the downstream and upstream regions, having an outer diameter less than the outer diameters of the downstream and upstream regions; an outer mesh anchor positioned across the inner mesh anchor, configured to transition between a cylindrical configuration configured to engage with the inner wall of the intestine and a shape corresponding to the geometry of the inner mesh anchor; and a sheath which is at least partially positioned within the inner mesh anchor and coupled to the inner and outer mesh anchors, defining a negative pressure chamber between the outer surface of the sheath and the inner wall of the intestine. The sheath may have a lumen which is sized and shaped to allow feces to pass through the intestinal anastomosis without contact with it. Therefore, in response to the application of negative pressure into the negative pressure chamber, the outer mesh anchor may be configured to transition from a cylindrical shape to a shape corresponding to the geometry of the inner mesh anchor. The geometry of the inner mesh anchor may include an hourglass shape.

[0031] In addition, the sheath may have a length such that it extends from the internal and external mesh anchors at the target site, across the intestinal anastomosis, and outward from the external orifice of the anus. Furthermore, the sheath may be sealed to the upstream and downstream regions of the internal and external mesh anchors via an upstream seal and a downstream seal, respectively, thereby defining a negative pressure chamber between the outer surface of the sheath, the upstream and downstream seals, and the inner wall of the intestine. In some embodiments, the upstream region of the sheath may extend through the lumen of the internal mesh anchor and wrap around the upstream ends of the internal and external mesh anchors so that the upstream region of the sheath encloses the upstream regions of the internal and external mesh anchors. Thus, the upstream seal may be thermally bonded to the upstream region of the sheath, the internal mesh anchor, and the external mesh anchor. Furthermore, the upstream seal may be configured to prevent inward growth of the mucosa in the upstream regions of the internal and external mesh anchors and to prevent damage to the intestinal tissue surrounding the bypass device. The bypass device may further include sheath material, with the downstream seal positioned across the downstream region of the outer mesh anchor so that it can be thermally bonded to the sheath material and the downstream region of the sheath, the inner mesh anchor, and the outer mesh anchor. In addition, the downstream seal may be configured to prevent inward growth of mucosa in the downstream regions of the inner and outer mesh anchors, thereby preventing damage to the intestinal tissue surrounding the bypass device.

[0032] In addition, the bypass device may include one or more fluid inlet tubes, each having a downstream end coupled to the pump and an upstream end having one or more pores that fluidly communicate with the negative pressure chamber. For example, one or more fluid inlet tubes may extend across the downstream seal so that one or more pores are located within the negative pressure chamber. The bypass device may further include one or more check valves that fluidly communicate with the pump. One or more check valves may be configured to transition between a closed state and an open state to bring the pump to ambient pressure. Furthermore, a first set of one or more fluid inlet tubes may extend across the downstream seal so that one or more pores of the first set of one or more fluid inlet tubes are located within a first negative pressure chamber, and a second set of one or more fluid inlet tubes may extend across the downstream seal and the central seal so that one or more pores of the second set of one or more fluid inlet tubes are located within a second negative pressure chamber. The upstream ends of one or more fluid inlet tubes may be equally spaced and circumferentially spaced within the negative pressure chamber.

[0033] The bypass device may further include a housing configured to contain at least a pump. For example, the housing may be sized and molded to fit a patient. The housing may have a user interface configured to allow the user to select the pump parameters of the pump from a set of predetermined pump parameters. The user interface may further include a display for displaying information associated with the bypass device. The bypass device may further include one or more sensors configured to measure data indicating the pressure in a negative pressure chamber. The bypass device may further include a controller operably coupled to the pump and one or more sensors. The controller may be programmed with commands that cause the pump to operate with predetermined pump parameters, to discharge fluid from the negative pressure chamber through one or more fluid inlet tubes, and to generate a vacuum in the negative pressure chamber having a pressure within a predetermined pressure range, which is sufficient to pull the intestinal tissue toward the bypass device and to anchor the bypass device to a target location upstream of the intestinal anastomosis; to compare data indicating the pressure in the negative pressure chamber received over time from one or more sensors with a predetermined pressure range; and, if the pressure in the negative pressure chamber is outside the predetermined pressure range, to adjust the pump's predetermined pump parameters so that the pump applies a vacuum in the negative pressure chamber and maintains it within the predetermined pressure range.

[0034] In addition, the controller may be configured to calculate the actual pump operating time required to achieve a predetermined total volume of the system, and to determine the presence of an obstruction in the system if the actual pump operating time deviates from the expected pump operating time. For example, the controller may be configured to calculate the volume of the system in real time based on data measured by one or more sensors, so that the controller can be configured to calculate the expected pump operating time of the pump based on the real-time volume of the system. Alternatively, the expected pump operating time may be predetermined. The controller may be configured to generate an alert in response to the determination of the presence of an obstruction in the system. In addition, the controller may be configured to generate an alert if the pressure in the negative pressure chamber is outside a predetermined pressure range.

[0035] The bypass device may further include one or more additional sensors configured to measure data indicating the presence of at least one of blood, feces, or a predefined gas between the bypass device and the intestinal tissue surrounding the bypass device. Thus, the controller may be configured to generate an alert if the level of at least one of blood, feces, or a predefined gas exceeds a predetermined threshold. In addition, the bypass device may further include one or more additional sensors configured to measure data indicating the position of the bypass device relative to the intestinal anastomosis. Thus, the controller may be configured to generate an alert if the position of the bypass device relative to the intestinal anastomosis indicates that the bypass device is sliding away from its target location. Furthermore, prior to the application of negative pressure into the negative pressure chamber, the inner mesh anchor may exhibit an hourglass configuration, and the outer mesh anchor may exhibit a cylindrical configuration. In response to the application of negative pressure into the negative pressure chamber, both the outer and inner mesh anchors may exhibit an hourglass configuration while at the target location in the intestine.

[0036] According to another aspect of the present disclosure, a method for protecting an intestinal anastomosis is provided. The method involves positioning a bypass device at a target location upstream of a patient's intestinal anastomosis, the bypass device comprising an inner mesh anchor, an outer mesh anchor positioned across the inner mesh anchor, and a sheath, at least partially positioned within the inner mesh anchor and coupled to the inner and outer mesh anchors, defining a negative pressure chamber between the outer surface of the sheath and the inner wall of the intestine, wherein the inner mesh anchor comprises a downstream region, an upstream region, and a central region extending between the downstream and upstream regions, having an outer diameter less than the outer diameters of the downstream and upstream regions, and may also include applying negative pressure into the negative pressure chamber, wherein in response to the application of negative pressure into the negative pressure chamber, the outer mesh anchor transitions from a cylindrical configuration to a shape corresponding to the geometric shape of the inner mesh anchor.

[0037] Prior to the application of negative pressure into the negative pressure chamber, the inner mesh anchor may have an hourglass configuration, and the outer mesh anchor may have a cylindrical configuration. In response to the application of negative pressure into the negative pressure chamber, both the outer and inner mesh anchors may have an hourglass configuration while at the target location in the intestine. Furthermore, the method may include connecting the downstream end of one or more fluid inlet tubes extending from the negative pressure chamber of the bypass device to a pump outside the patient's anal os. Thus, applying negative pressure into the negative pressure chamber may include operating the pump at pump parameters to discharge fluid from the negative pressure chamber through one or more fluid inlet tubes, thereby creating a vacuum within the negative pressure chamber with a pressure within a predetermined pressure range, which is sufficient to pull intestinal tissue within the negative pressure chamber and anchor the bypass device at the target location. In addition, this method may include measuring the pressure in a negative pressure chamber over time via one or more pressure sensors, and adjusting the pump parameters of the pump so that, if the pressure in the negative pressure chamber is outside a predetermined pressure range, the pump applies a vacuum in the negative pressure chamber to maintain it within the predetermined pressure range.

[0038] According to yet another aspect of this disclosure, a system for protecting an anastomosis in the intestine is provided. The system may include an anchor (e.g., a mesh stent) configured to be embedded at a target site in the intestine upstream of the anastomosis. The anchor may be configured to transition from a compressed state to an expanded state, and the outer surface of the anchor is in contact with the inner wall of the intestine at the target site. The system may further include a sheath positioned within and coupled to the anchor, defining a negative pressure chamber between the outer surface of the sheath and the inner wall of the intestine. The outer surface of the sheath may have a microstructured micropattern configured to maintain a vacuum throughout the negative pressure chamber so that when negative pressure is applied into the negative pressure chamber, the anchor remains anchored at the target site.

[0039] The anchor may comprise an inner mesh anchor having a downstream region, an upstream region, and a central region extending between the downstream and upstream regions, having an outer diameter less than the outer diameters of the downstream and upstream regions, and an outer mesh anchor positioned across the inner mesh anchor. The outer mesh anchor may be configured to transition from a cylindrical configuration to a shape corresponding to the geometry of the inner mesh anchor when negative pressure is applied into the negative pressure chamber. For example, a sheath may be sealed to the upstream and downstream regions of the inner and outer mesh anchors via an upstream seal and a downstream seal, respectively, thereby defining the negative pressure chamber between the outer surface of the sheath, the upstream and downstream seals, and the inner wall of the intestine. Prior to the application of negative pressure into the negative pressure chamber, the inner mesh anchor may exhibit an hourglass configuration, and the outer mesh anchor may exhibit a cylindrical configuration. In response to the application of negative pressure into the negative pressure chamber, both the outer and inner mesh anchors may exhibit an hourglass configuration while at the target location in the intestine.

[0040] Furthermore, each microstructure in the microstructure micropattern may have a shape, such as a cylindrical column, rectangle, triangle, square, sinusoidal, or hemispherical shape. The microstructure micropattern may extend radially around the entire circumference of the outer surface of the sheath and longitudinally along the entire length of the outer surface of the sheath within the negative pressure chamber. In addition, the sheath may extend downstream of the anchor, across the anastomosis, and outward from the anus. In some embodiments, the microstructure micropattern is located only on the outer surface of the sheath within the negative pressure chamber. Furthermore, the microstructure micropattern may be configured to, in response to the vacuum, prevent the inner wall of the intestine from sealing against the outer surface of the sheath, thereby promoting 360° fluid communication within the negative pressure chamber.

[0041] The microstructure micropattern may comprise multiple rows and columns of microstructures throughout the negative pressure chamber. In some embodiments, the microstructure micropattern may be arranged in a triangular or rectangular shape on the outer surface of the sheath within the negative pressure chamber. In addition, the outer surface of the sheath may comprise at least one of ribs or channels configured to guide fluid flow within the negative pressure chamber. Furthermore, each microstructure in the microstructure micropattern may have a cross-sectional width of 50 to 500 microns and a height of 50 to 1,000 microns. For example, each microstructure in the microstructure micropattern may have a cross-sectional width of about 300 microns and a height of about 600 microns. Moreover, each microstructure in the microstructure micropattern may be a projection configured to extend outward from the outer surface of the sheath toward the inner wall of the intestine.

[0042] The system may further include one or more fluid inlet pipes, each having a downstream end coupled to a pump and an upstream end having one or more pores that fluidly communicate with the negative pressure chamber. For example, the upstream ends of one or more fluid inlet pipes may be equally spaced and circumferentially spaced apart within the negative pressure chamber. In addition, the system may include one or more sensors configured to measure data indicating the pressure within the negative pressure chamber. Furthermore, the system may include a controller operably coupled to the pump and one or more sensors. The controller may be programmed with commands that cause the pump to operate with predetermined pump parameters, to discharge fluid from the negative pressure chamber through one or more fluid inlet tubes, and to generate a vacuum in the negative pressure chamber having a pressure within a predetermined pressure range, which is sufficient to pull the intestinal tissue toward the anchor and to maintain the anchor in the target location; to compare data indicating the pressure in the negative pressure chamber received over time from one or more sensors with a predetermined pressure range; and, if the pressure in the negative pressure chamber is outside the predetermined pressure range, to adjust the pump's predetermined pump parameters so that the pump applies a vacuum in the negative pressure chamber and maintains it within the predetermined pressure range.

[0043] Furthermore, the controller may be configured to generate an alert if the pressure in the negative pressure chamber is outside a predetermined pressure range. The controller may also be configured to calculate the actual pump operating time required to achieve a predetermined total volume of the system and to determine the presence of an obstruction in the system if the actual pump operating time deviates from the expected operating time. Therefore, the controller may be configured to generate an alert in response to the determination of the presence of an obstruction in the system.

[0044] According to another aspect of the present disclosure, a method for protecting an intestinal anastomosis is provided. The method includes positioning an anchor at a target location in the intestine upstream of the anastomosis, the anchor being coupled to a sheath positioned within the anchor and defining a negative pressure chamber between the outer surface of the sheath and the inner wall of the intestine; transitioning the anchor from a compressed state to an expanded state, the outer surface of the anchor being in contact with the inner wall of the intestine at the target location; and applying negative pressure into the negative pressure chamber, the outer surface of the sheath being provided with a microstructured micropattern configured to maintain a vacuum throughout the negative pressure chamber when the negative pressure is applied, so that the anchor remains anchored at the target location.

[0045] For example, the anchor may comprise an inner mesh anchor and an outer mesh anchor positioned across the inner mesh anchor, the inner mesh anchor comprising a downstream region, an upstream region, and a central region extending between the downstream and upstream regions, having an outer diameter less than the outer diameters of the downstream and upstream regions. Furthermore, in response to the application of negative pressure into the negative pressure chamber, the outer mesh anchor may transition from a cylindrical configuration to a shape corresponding to the geometry of the inner mesh anchor. In addition, the sheath may be sealed to the upstream and downstream regions of the inner and outer mesh anchors via an upstream seal and a downstream seal, respectively, thereby defining the negative pressure chamber between the outer surface of the sheath, the upstream and downstream seals, and the inner wall of the intestine. In some embodiments, the microstructure micropattern may be present only on the outer surface of the sheath between the upstream and downstream seals within the negative pressure chamber.

[0046] In another aspect of this disclosure, an introducer device is provided for delivering a bypass device for protecting a bowel anastomosis into the bowel. The introducer device may include a guide tube having a lumen such that the guide tube comprises a first tubular portion configured to hold a bypass device therein in a collapsed delivery state, and a second tubular portion downstream of the first tubular portion. The first tubular portion may include an upstream end configured to be introduced into the bowel through the external os of the anus, and a length such that the upstream end can be positioned at a target location upstream of the bowel anastomosis. Furthermore, the outer surface of the second tubular portion may include one or more grooves. The introducer device may further include a handle operably coupled to the second tubular portion via one or more features configured to slidably engage with one or more grooves. In addition, the handle may include an actuator configured to rotate via a slidable engagement between one or more features and one or more grooves, thereby causing axial translation of the guide tube relative to the handle.

[0047] For example, the upstream end of the first tubular portion may include a plurality of flexible cutout tabs configured to transition between a closed tulip configuration and an open configuration. Furthermore, one or more grooves may extend along the outer surface of the second tubular portion in a circumferential and axial pattern such that rotation of the actuator causes rotation of one or more features relative to the second tubular portion, and movement of one or more features along one or more grooves causes axial translation of the guide tube relative to the handle. The outer surface of the second tubular portion may further include a linear track, and the handle may further include an engager configured to slidably engage with the linear track such that the engagement between the engager and the linear track prevents rotation of the guide tube relative to the handle as the guide tube moves axially parallel to the handle.

[0048] The handle may further include one or more flexible tabs extending circumferentially along at least a portion of the outer surface of the handle. One or more flexible tabs may be configured to transition between a radially compressed state and a radially expanded state. One or more flexible tabs may be biased toward the radially expanded state. Furthermore, the inner surface of the actuator may include one or more grooves configured to slidably engage with one or more flexible tabs. One or more grooves may have a shape that allows rotation of the actuator in a first direction relative to the handle, while rotation of the actuator in a second direction opposite to the first direction relative to the handle is prevented in the radially expanded state in response to the engagement of one or more flexible tabs and the stop feature.

[0049] The injector device may further include a stopper positioned between a first tubular portion and a second tubular portion. For example, the stopper may have an outer diameter larger than the outer diameter of the first tubular portion. In addition, the injector device may include a pusher having a downstream end coupled to the handle and an upstream end slidably positioned within the lumen of the guide tube at a position downstream of the bypass device in a collapsed delivery state, such that axial parallel movement of the guide tube downstream of the handle engages the upstream end of the pusher with the bypass device, maintaining the bypass device at a target position upstream of the intestinal anastomosis until the bypass device is exposed beyond the upstream end of the guide tube and transitions to an expanded deployed state. [Brief explanation of the drawing]

[0050] [Figure 1] Figure 1 illustrates an exemplary negative pressure bypass system implanted within a patient biostructure, constructed according to the principles of this disclosure.

[0051] [Figure 2A] Figure 2A illustrates the embeddable portion of the negative pressure bypass system of Figure 1, which has a microstructure micropattern.

[0052] [Figure 2B] Figure 2B is a cross-sectional view of the embeddable portion of the negative pressure bypass system shown in Figure 2A.

[0053] [Figure 2C] Figure 2C illustrates the embeddable portion of the negative pressure bypass system of Figure 2A under vacuum, according to the principle of this disclosure.

[0054] [Figure 3A] Figures 3A and 3B illustrate exemplary pump devices for a negative pressure bypass system constructed in accordance with the principles of this disclosure. [Figure 3B] Figures 3A and 3B illustrate exemplary pump devices for a negative pressure bypass system constructed in accordance with the principles of this disclosure.

[0055] [Figure 3C] Figure 3C is a schematic diagram illustrating various components of a pump device based on the principle of this disclosure.

[0056] [Figure 4] Figure 4 illustrates exemplary components of a controller for a pump device based on the principles of this disclosure.

[0057] [Figure 5] Figure 5 is a flowchart illustrating exemplary method steps for monitoring and controlling the pressure in a negative pressure bypass system.

[0058] [Figure 6A] Figure 6A illustrates the colon with a single braided anchor placed inside, and Figure 6B illustrates the colon under vacuum generated via the single braided anchor. [Figure 6B] Figure 6A illustrates the colon with a single braided anchor placed inside, and Figure 6B illustrates the colon under vacuum generated via the single braided anchor.

[0059] [Figure 6C]Figure 6C illustrates the colon with a double braided anchor placed inside it, and Figure 6D illustrates the colon under vacuum generated via the double braided anchor. [Figure 6D] Figure 6C illustrates the colon with a double braided anchor placed inside it, and Figure 6D illustrates the colon under vacuum generated via the double braided anchor.

[0060] [Figure 7A] Figures 7A–7G illustrate exemplary introducer devices for delivering a negative pressure bypass system, constructed according to the principles of this disclosure. [Figure 7B] Figures 7A–7G illustrate exemplary introducer devices for delivering a negative pressure bypass system, constructed according to the principles of this disclosure. [Figure 7C] Figures 7A–7G illustrate exemplary introducer devices for delivering a negative pressure bypass system, constructed according to the principles of this disclosure. [Figure 7D] Figures 7A–7G illustrate exemplary introducer devices for delivering a negative pressure bypass system, constructed according to the principles of this disclosure. [Figure 7E] Figures 7A–7G illustrate exemplary introducer devices for delivering a negative pressure bypass system, constructed according to the principles of this disclosure. [Figure 7F] Figures 7A–7G illustrate exemplary introducer devices for delivering a negative pressure bypass system, constructed according to the principles of this disclosure. [Figure 7G] Figures 7A–7G illustrate exemplary introducer devices for delivering a negative pressure bypass system, constructed according to the principles of this disclosure.

[0061] [Figure 8A] Figures 8A and 8B illustrate the delivery of a negative pressure bypass system using the introducer device shown in Figures 7A-7G. [Figure 8B] Figures 8A and 8B illustrate the delivery of a negative pressure bypass system using the introducer device shown in Figures 7A-7G.

[0062] [Figure 9] Figure 9 illustrates an alternative, exemplary negative pressure bypass system implanted within a patient biostructure, constructed according to the principles of this disclosure.

[0063] [Figure 10A] Figure 10-15A illustrates an exemplary embeddable portion of an alternative negative pressure bypass system constructed in accordance with the principles of this disclosure. [Figure 10B] Figure 10-15A illustrates an exemplary embeddable portion of an alternative negative pressure bypass system constructed in accordance with the principles of this disclosure. [Figure 11] Figure 10-15A illustrates an exemplary embeddable portion of an alternative negative pressure bypass system constructed in accordance with the principles of this disclosure. [Figure 12] Figure 10-15A illustrates an exemplary embeddable portion of an alternative negative pressure bypass system constructed in accordance with the principles of this disclosure. [Figure 13] Figure 10-15A illustrates an exemplary embeddable portion of an alternative negative pressure bypass system constructed in accordance with the principles of this disclosure. [Figure 14] Figure 10-15A illustrates an exemplary embeddable portion of an alternative negative pressure bypass system constructed in accordance with the principles of this disclosure. [Figure 15A] Figure 10-15A illustrates an exemplary embeddable portion of an alternative negative pressure bypass system constructed in accordance with the principles of this disclosure.

[0064] [Figure 15B] Figure 15B is a perspective view of the central seal ring of the embeddable portion shown in Figure 15A.

[0065] [Figure 16A] Figures 16A and 16B illustrate alternative exemplary sealing rings constructed in accordance with the principles of this disclosure. [Figure 16B] Figures 16A and 16B illustrate alternative exemplary sealing rings constructed in accordance with the principles of this disclosure.

[0066] [Figure 17] Figure 17 illustrates an alternative exemplary embeddable portion of a negative pressure bypass system constructed in accordance with the principles of this disclosure.

[0067] [Figure 18A] Figures 18A and 18B illustrate alternative exemplary embeddable portions of a negative pressure bypass system having a microstructure micropattern, constructed according to the principles of this disclosure. [Figure 18B] Figures 18A and 18B illustrate alternative exemplary embeddable portions of a negative pressure bypass system having a microstructure micropattern, constructed according to the principles of this disclosure.

[0068] [Figure 18C] Figure 18C is a cross-sectional view of the central region of the embeddable portion of the negative pressure bypass system shown in Figure 18B.

[0069] [Figure 19A] Figure 19A illustrates an exemplary manifold of the negative pressure bypass system of Figure 18A, constructed in accordance with the principles of this disclosure.

[0070] [Figure 19B] Figure 19B illustrates the manifold of Figure 19A with a closed clamp, and Figure 19C illustrates the manifold of Figure 19A with an open clamp during flushing. [Figure 19C] Figure 19B illustrates the manifold of Figure 19A with a closed clamp, and Figure 19C illustrates the manifold of Figure 19A with an open clamp during flushing.

[0071] [Figure 20] Figure 20 is a schematic diagram illustrating various components of an exemplary pump device for the negative pressure bypass system of Figures 18A-18C, constructed in accordance with the principles of this disclosure.

[0072] [Figure 21A]Figures 21A and 21B are schematic diagrams illustrating various components of an alternative embodiment of a pump device for a negative pressure bypass system constructed according to the principles of this disclosure. [Figure 21B] Figures 21A and 21B are schematic diagrams illustrating various components of an alternative embodiment of a pump device for a negative pressure bypass system constructed according to the principles of this disclosure. [Modes for carrying out the invention]

[0073] Detailed explanation This disclosure provides systems and devices for creating an internal bypass within a target area of ​​a patient's gastrointestinal (GI) tract, allowing feces and other excretory materials to pass through the target area without contacting the walls of the GI tract in the target area. The target area may be an anastomotic site in the colon, rectum, or anal passage, created after bowel resection surgery to treat obstructions and diseases such as colorectal cancer, diverticulitis, severe bleeding, obstructions, and equivalents. The bypass device may be fixed to the target site upstream of the anastomotic site via a negative pressure system including an external pump, which is fluidically coupled to the negative pressure chamber of the bypass device, for example, via a suitable medical tube or equivalent. The external pump may further include a “smart” vacuum monitoring system that monitors the pressure in the negative pressure chamber and automatically responds if the pressure in the negative pressure chamber is outside a predetermined range. For example, the smart vacuum monitoring system may automatically adjust the pump parameters and / or turn on the pump to maintain the pressure in the negative pressure chamber within a predetermined range. In addition, the smart vacuum monitoring system may generate an alert and notify the user if the pressure in the negative pressure chamber is outside a predetermined range. Thus, the systems described herein provide continuous sensing and the ability to maintain a specific vacuum threshold more rapidly and continuously. The disclosure further provides a delivery system for introducing a bypass device into a target area of ​​a GI tube.

[0074] Referring here to Figure 1, a system 100 for monitoring a bypass device for protecting the intestinal anastomosis is provided. As shown in Figure 1, the system 100 may include a bypass device 200 configured to be anchored in the patient's GI canal, for example, upstream of the intestinal anastomosis AS, to allow feces and other excretory material to pass through the anastomosis AS without contacting the wall of the GI canal at the anastomosis AS. For example, as will be described in more detail below, the bypass device 200 may include, as shown in Figure 1, an anchor for fixing to the bypass device 200 at a location upstream of the anastomosis AS via a negative pressure system, for example, a negative pressure system 300, which is fluidically coupled to the bypass device 200 outside the patient, and a sheath coupled to the anchor, extending through the GI canal across the anastomosis AS and through the patient's anus. The sheath may have a lumen, which is sized and shaped to allow feces and other excretory material to pass through it.

[0075] Referring here to Figures 2A-2C, a bypass device 200 is provided for providing an internal bypass to a target site within the patient's GI canal. As shown in Figure 2A, the bypass device 200 has an expanded downstream region 202, an expanded upstream region 204, and a recessed central region 206 extending between the downstream region 202 and the upstream region 204. The bypass device 200 may also include an internal anchor 201, an external anchor 220 circumferentially positioned around the internal anchor 201, and an elongated flexible sheath 203 coupled to the internal and external anchors 201, 220 and extending downstream therefrom. The internal and external anchors 201, 220 may each be formed of a stent / scaffold, e.g., a self-expandable braided wire mesh. As shown in Figure 2B, the internal anchor 201 may have a pre-formed shape, e.g., an hourglass / bone shape, defining the recessed central region 206 of the bypass device 200. For example, the central region 206, defined by the inner anchor 201, may have an outer diameter less than the outer diameters of the downstream region 202 and the upstream region 204, thereby providing a larger volume between the outer surface of the central region 206 and the intestinal wall, and improving negative pressure chamber engagement with the intestinal tissue during the application of vacuum. Preferably, the inner anchor 201 may be symmetrical such that the downstream region 202 may have an outer diameter equal to the outer diameter of the upstream region 204. The outer anchor 220 may be configured to transition from a natural cylindrical configuration to a shape corresponding to the inner anchor 201 when the system 100 is under vacuum, as shown in Figure 2C.

[0076] The inner and outer anchors 201 and 220 may be coupled together at their respective upstream and downstream ends, as well as to the distal region of the sheath 203. For example, as shown in Figure 2B, the upstream region of the sheath 203 may extend through the lumen of anchor 201 and wrap around the upstream ends of the inner and outer anchors 201 and 220, such that the upstream region of the sheath 203 contacts the outer surface of the upstream region of the outer anchor 220 and the inner surface of the upstream region of the inner stent 201. Furthermore, the upstream region of the sheath 203 may extend along the periphery of the upstream ends of the inner and outer anchors 201 and 220 and be coupled to the upstream regions of the inner and outer anchors 201 and 220 via an upstream seal ring 210, which can thereby securely fasten the sheath 203 to the upstream regions of the inner and outer anchors 201 and 220. In addition, the sheath material 218 may be circumferentially positioned over the downstream region of the outer anchor 220 so that a portion of the sheath 203 extends along the periphery of the downstream ends of the inner and outer anchors 201, 220, thereby enabling coupling of the sheath material 218 and the downstream region of the inner and outer anchors 201 via a downstream seal ring 204, which can securely fasten the sheath 203 to the downstream region of the inner and outer anchors 201, 220.

[0077] For example, the upstream seal ring 210 and the downstream seal ring 208 may be thermally or solvent-bonded to the upstream and downstream regions of the inner and outer anchors 201, 220, the sheath 203, and the sheath material 218, for example, via a reflow process. Alternatively, the upstream seal ring 210 and the downstream seal ring 208 may be compression-molded onto or directly overmolded over the upstream and downstream regions of the inner and outer anchors 201, 220. For example, the upstream seal ring 210 and the downstream seal ring 208 may be formed from a moldable thermoplastic material such as thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and / or thermoplastic vulcanized material (TPV). Thus, the negative pressure chamber 212 may be defined by the outer surface of the sheath 203, the upstream seal ring 210, the downstream seal ring 208, and a portion of the outer anchor 220 between the upstream seal ring 210 and the downstream seal ring 208. Both the internal and external anchors 201 and 220 may be configured to provide outward radial forces to the intestinal wall at the target site. Thus, the internal and external anchors 201 and 220 work in cooperation with the negative pressure system to fix the bypass device 200 to the target site and keep the target area within the GI tube open so that feces and other excretory material can pass through the sheath 203 without contacting the wall surrounding the anastomosis site. As described above, under vacuum, the intestinal tissue may be pulled into the negative pressure chamber 212, as shown in Figure 2C, thereby applying a radially inward force to the external anchor 220, causing the external anchor 220 to transition from its own natural cylindrical configuration and conform to the pre-formed shape of the internal anchor 201.

[0078] As described above, the upstream seal ring 210 and the downstream seal ring 208 may extend along the periphery of the upstream and downstream ends of the inner and outer anchors 201 and 220, respectively, thereby forming the soft, flexible upstream leading edge and the soft, flexible downstream leading edge of the inner and outer anchors 201 and 220. Thus, the upstream seal ring 210 and the downstream seal ring 208 can prevent damage to intestinal tissue adjacent to the upstream and downstream ends of the inner and outer anchors 201 and 220. In addition, the upstream seal ring 210 and the downstream seal ring 208 may provide a longer sealing surface and flexibility to assist in the retrieval of the bypass device 200 along the upstream region 204 and the downstream region 202, respectively. Furthermore, the upstream seal ring 210 and the downstream seal ring 208 can prevent inward growth of mucosa over at least the upstream region 204 and the downstream region 202 of the bypass device 200, for example, the area covered by the seal rings.

[0079] The sheath 203 has an outer surface and an internal channel to allow the passage of feces and other excretions through it. The sheath 203 has a length selected to extend from a target site in the GI tube, through the patient's intestines and anus, to a location outside the patient, as shown in Figure 1. In some embodiments, the downstream end of the sheath 203 may be coupled to an external collection container (not shown) outside the patient's body for collecting feces and other excretions therein. The sheath 203 may be formed from a biocompatible elastomer material such as silicone or polyurethane.

[0080] As shown in Figure 2B, one or more suction / fluid inlet tubes, e.g., suction tubes 214, 216, may extend along the outer surface of the sheath 203, away from the patient, toward the negative pressure chamber 212. The upstream regions of the suction tubes 214, 216 may include a plurality of inlet ports 215, 217, each sized and molded to allow fluid to be discharged through it, sufficient to create a vacuum within the negative pressure chamber 212. For example, the upstream regions of the suction tubes 214, 216 may be positioned across the downstream seal ring 208 so that one or more inlet ports 215 of the suction tube 214 and one or more inlet ports 217 of the suction tube 216 are located within the negative pressure chamber 212 and can communicate with it. The inlet ports 215, 217 may be spatially uniformly distributed along the length of the upstream regions of the suction tubes 214, 216. Alternatively, the spatial distribution of the inlet ports 215, 217 may be selected to create a desired vacuum within the negative pressure chamber 212. Preferably, the upstream regions of the suction tubes 214, 216 may be equally spaced within the negative pressure chamber 212 along the circumference of the outer surface of the sheath 203, thereby providing a symmetrical application of vacuum within the negative pressure chamber 212. The suction tubes 214, 216 may extend outward from within the negative pressure chamber 212, through the downstream seal ring 208, along the outer surface of the sheath 203, from the patient's anus, so that the downstream ends of the suction tubes 214, 216 can be fluidly coupled to an external pump of the negative pressure system 300 to create a vacuum within the negative pressure chamber 212. In some embodiments, at least portions of the suction tubes 214, 216 may extend within the wall of the sheath 203, for example, within the membrane forming the sheath 203.

[0081] As will be described in more detail below, the inner and outer anchors 201, 220 may be used in conjunction with an external pump, which is fluidically coupled to a negative pressure system, e.g., one or more suction / fluid inlet tubes, e.g., suction tubes 214, 216, to discharge fluid from the negative pressure chamber 212 through one or more suction / fluid inlet tubes, thereby creating a vacuum within the negative pressure chamber 212. Figures 2A-2C illustrate two suction tubes, but as will be understood by those skilled in the art, the system 100 may include more or fewer suction tubes than two to generate a desired vacuum within the negative pressure chamber 212, and / or the suction tubes may not be equally spaced circumferentially along the outer circumference of the sheath 203.

[0082] The bypass device 200 may include, for example, one or more downstream retrieval loops 205 extending from the downstream ends of the internal and external anchors 201, 220 to facilitate the removal of the bypass device 200 after the anastomosis has completely healed. For example, a retrieval device, such as an endoscopic grappler, may be introduced along the outer surface of the sheath 203 toward the downstream retrieval loop 205, thereby applying force to the downstream portion of the retrieval device, pulling the downstream retrieval loop 205 downstream, thereby contracting the downstream retrieval loop 205 radially inward, and engaging with the downstream retrieval loop 205 so as to be able to detach at least the downstream region of the internal and external anchors 201, 220, such as the downstream seal ring 208, from the intestinal tissue surrounding the internal and external anchors 201, 220, such as the inward growth of the mucosa that may form on the internal and external anchors 201, 220. The retrieval device may then be further retracted, applying a pulling force to the downstream retrieval loop 205 in the downstream direction, thereby removing the bypass device 200 from the patient's body.

[0083] As shown in Figure 2A, at least a portion of the outer surface of the sheath 203 within the negative pressure chamber 212 includes a plurality of microstructures, for example, a micropattern of microstructure 224, which are arranged thereon. For example, the micropattern of microstructure 224 may include a micropattern of protruding portions that extend outward from the outer surface of the sheath 203. Preferably, the micropattern of microstructure 224 is arranged only on the outer surface of the sheath 203, which is located within the negative pressure chamber 212. In addition, the micropattern 224 is preferably formed integrally with a portion of the sheath 203 within the negative pressure chamber 212. Alternatively, the micropattern 224 may be attached to a portion of the sheath 203 within the negative pressure chamber 212 during manufacturing. As shown in Figure 2A, each microstructure of the micropattern of microstructure 224 may have a hemispherical shape. For example, each microstructure in the micropattern of the microstructure 224 may have a cross-sectional width of 50 to 500 microns, for example, about 300 microns, and a height of 50 to 1000 microns, for example, about 600 microns. In some embodiments, each microstructure in the micropattern of the microstructure 224 may have a pitch of 800 to 1200 microns, for example, about 1000 microns. As will be understood by those skilled in the art, the microstructures may have other shapes, such as cylinders, cubes, cones, pyramids, cylindrical columns, rectangles, triangles, squares, sine waves, etc.

[0084] The micropattern of the microstructure 224 may include multiple rows and multiple columns of microstructure throughout the entire negative pressure chamber 212. For example, the micropattern of the microstructure 224 may extend radially around the entire circumference of the outer surface of the sheath 203 and longitudinally along the entire length of the outer surface of the sheath 203 within the negative pressure chamber 212. In some embodiments, the micropattern of the microstructure 224 may be arranged in a triangular or rectangular shape on the outer surface of the sheath 203 within the negative pressure chamber 212. Furthermore, the outer surface of the sheath 203 may further include one or more ribs and / or one or more channels that are sized and shaped to guide fluid flow within the negative pressure chamber 212 toward, for example, fluid inlet pipes 214, 216.

[0085] In response to the operation of the negative pressure system, a vacuum with a predetermined pressure is created within the negative pressure chamber 212, thereby drawing intestinal tissue toward the inner and outer anchors 201, 220 and fixing the bypass device 200 to the target site. At least some of the intestinal tissue may be drawn through at least some openings 221 in the outer anchor 220 and at least some openings 207 in the inner anchor 201 in the central region 206, and further, may come into contact with the micropattern of the microstructure 224. The micropattern of the microstructure 224 is configured to prevent the inner wall of the intestine from sealing against the outer surface of the sheath 203 in response to the vacuum, thereby promoting 360° fluid communication within the negative pressure chamber 212. Thus, the micropattern of the microstructure 224 prevents the intestinal tissue from closing against the outer surface of the sheath 203 and creating a sub-chamber of vacuum within the negative pressure chamber 212. Therefore, the micropattern of the microstructure 224 maintains a vacuum throughout the vacuum chamber 212 so that when negative pressure is applied into the vacuum chamber 212, the bypass device 200 remains anchored in its target location. As will be understood by those skilled in the art, the micropattern of the microstructure may be incorporated with any of the device bypasses described herein, e.g., bypass devices 1000, 1100, 1200, 1300, 1400, 1500, 1700, thereby promoting 360° fluid communication within individual vacuum chambers so that when negative pressure is applied into the vacuum chamber, a vacuum is maintained throughout the vacuum chamber and individual anchors remain anchored in their target locations. By implementing a micro-pattern of microstructures on the outer surface of the sheath within the negative pressure chamber to promote 360° fluid communication within the negative pressure chamber, as well as a recessed central region under vacuum to improve mechanical anchoring, such as a double anchor with a dogbone shape similar to an hourglass, and automated pump parameter adjustment to improve vacuum maintenance, the total length of the stent / scaffold of the inner and outer anchors 201, 220 can be reduced to, for example, 80-90 mm or 70 mm.

[0086] Referring here to Figures 3A and 3B, an exemplary negative pressure system is provided for generating a vacuum in the negative pressure chamber 212 of the bypass device 200 and monitoring the pressure therein. The system 300 may include an external pump, for example, located in a housing 301 and fluidically coupled to the negative pressure chamber 212 via suction tubes 214, 216. For example, the external pump may be fluidically coupled to the downstream end of the suction / fluid inlet tubes 214, 216. Thus, the pump may be operated to discharge fluid from the negative pressure chamber 212 via the suction tubes 214, 216, thereby creating a vacuum in the negative pressure chamber 212. As shown in Figures 3A and 3B, the housing 301 may have a handle 303, which is sized and molded to facilitate the transport and handling of the system 300 by the user. The housing 301 may be sized and molded to be worn by a patient, for example, via a patient-wearable shoulder bag or belt. In addition, or alternatively, the housing 301 may be sized and molded to be mounted, for example, bedside, on an IV pole, etc. Furthermore, the system 300 may further include a removable fluid reservoir chamber 302, configured to be removably coupled to the housing 301 to facilitate the removal of excrement from the fluid reservoir chamber 302 and / or the cleaning of the fluid reservoir chamber 302. Thus, the fluid reservoir chamber 302 may be fluidically coupled to a negative pressure chamber of a separate anchor via a fluid inlet pipe coupled thereto, and may be sized and molded to collect excrement in the fluid discharged from the negative pressure chamber when negative pressure is applied.

[0087] As shown in Figure 3B, the fluid reservoir chamber 302 may be made of a transparent material to facilitate manual inspection of the contents of the fluid reservoir chamber 302 by the user, thereby informing the user when the fluid reservoir chamber 302 needs to be emptied, cleaned, and / or replaced. The system 300 may include one or more sensors fluidically coupled to the fluid reservoir chamber 302 so that a controller of the system 300, e.g., controller 400, e.g., described in more detail below with respect to Figure 4, can generate an alert and notify the user when the amount of excrement in the fluid reservoir chamber 302 exceeds a predetermined threshold. For example, the alert may be an audible or visual alert emitted / displayed on a user interface on the housing 301, e.g., a graphical user interface. In addition, or alternatively, the alert may be emitted / displayed via a remote computer operably coupled to the system 300. The user interface of system 300 may include one or more actuators, such as buttons and switches, configured for user operation to turn one or more operating parameters of system 300 on / off and / or adjust / control them. The user interface may also display information associated with system 300, such as pressure measurements in the negative pressure chamber 212.

[0088] Figure 3C is a schematic diagram illustrating the internal components of an exemplary negative pressure system for generating a vacuum within a negative pressure chamber. System 300 may be used in conjunction with any of the bypass devices described herein, for example, bypass devices 200, 1000, 1100, 1200, 1300, 1400, 1500, and 1700. As described above, the fluid reservoir chamber 302 may be sized and molded to collect fluid and excrement in the fluid discharged from the negative pressure chamber of the anchor, for example, via suction tubes 214, 216, and may be fluidically coupled to the pump 316. For example, fluid discharged from the negative pressure chamber 212 may proceed through suction tubes 214, 216 and enter the fluid reservoir chamber 302 via the inlet 306. As shown in Figure 3C, the system 300 may also include a controller, for example, a controller 400, which is in electrical communication with the electrical components of the system 300, such as the pump 316 and the pressure transducer 312, which are described in more detail below.

[0089] As shown in Figure 3C, the system 300 may include a vacuum / pressure transducer 312, which is fluidically coupled to a negative pressure chamber 212 via a fluid reservoir chamber 302 and suction / fluid inlet tubes coupled thereto, e.g., suction tubes 214, 216. The pressure transducer 312 may be configured to measure the pressure in the fluid reservoir chamber 302, which indicates the pressure in the negative pressure chamber 212, and to generate one or more signals indicating the measured pressure for transmission to a controller 400. The controller 400 may be operably coupled to a pump 316, thereby causing the pump 316 to generate a vacuum with a predetermined pressure in the negative pressure chamber 212 via the suction tubes 214, 216. In some embodiments, each suction tube may be fluidically coupled to a dedicated pressure transducer to measure the pressure in an individual fluid inlet tube. Furthermore, the suction tubes 214 and 216 may be fluidically coupled together via a coupler 304 such that a single fluid inlet line, which is in fluid communication with both suction tubes 214 and 216, is fluidically coupled to the fluid reservoir chamber 302 via an inlet 306 of the fluid reservoir chamber 302. In addition, the system 300 may include a filter 310 positioned between the fluid reservoir chamber 302 and the pump 316 to prevent waste from entering the pump 316. For example, waste and other fluids in the fluid discharged from the negative pressure chamber 212 may be collected in the fluid reservoir chamber 302 so that the remaining fluid, such as gas, can exit the fluid reservoir chamber 302 via an outlet 308, travel across the filter 310, and exit the system 300 via the pump 316.

[0090] The system 300 may further include one or more check valves 314, fluidly coupled to suction tubes 214, 216 between the filter 310 and the pump 316, configured to allow the pump 316 to return to ambient pressure, e.g., atmospheric pressure, without affecting the pressure of the system 300. For example, prior to turning on the pump 316, the check valve 314 may be operated to the open position until the pressure in the pump 316 reaches atmospheric pressure. The check valve 314 may then be operated to the closed position during the operation of the pump 316, so that the pump 316 can generate a vacuum with a predetermined pressure in the negative pressure chamber 212. In some embodiments, instead of the check valve 314, the system 300 may include a small controlled leak, configured to allow the pump 316 to reach atmospheric pressure, for example, when the system 300 is under steady-state conditions. In some embodiments, the system 300 may include one or more sensors that are fluidically coupled to the fluid reservoir chamber 302 and configured to measure the amount of excrement in the fluid reservoir chamber 302. One or more additional sensors may generate one or more signals indicating the level of excrement in the fluid reservoir chamber 302 for transmission to the controller 400.

[0091] Referring here to Figure 4, components are provided that may be included within a controller 400 for controlling the negative pressure system described herein. The controller 400 may include one or more processors 402, a communication network 404, a power source 406, a user interface 408, and / or memory 410. One or more electrical components and / or circuits may perform some or all of the roles of the various components described herein. It should be understood that, although described separately, electrical components do not have to be separate structural elements. For example, the controller 400 and the communication network 404 may be embodied in a single chip. In addition, although the controller 400 is described as having memory 410, the memory chip may be provided separately.

[0092] The controller 400 includes and / or is coupled to the memory via one or more buses, and may read information from or write information to the memory. The memory 410 may also include a processor cache, which includes a multi-level hierarchical cache, where different levels have different capacities and access speeds. The memory may also include random access memory (RAM), other volatile storage devices, or non-volatile storage devices. The memory 410 may include RAM, ROM, Flash®, other volatile storage devices or non-volatile storage devices, or other known memories, or any combination thereof, preferably including a storage device in which data can be selectively stored. For example, the storage device may include, for example, a hard drive, an optical disk, flash memory, and a Zip drive. Programmable instructions may be stored on the memory 410 and execute an algorithm to, for example, determine whether the pressure measured in the negative pressure chamber 212 is outside a predetermined range, adjust one or more parameters of the pump 316, and maintain the pressure in the negative pressure chamber 212 within a predetermined range.

[0093] The controller 400 may incorporate a processor 402, which may consist of one or more processors, and may be other programmable logic devices such as general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or programmable logic controllers (PLCs), discrete gate or transistor logic, discrete hardware components, or any suitable combination thereof designed to perform the functions described herein. The controller 400 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in combination with a DSP core, or any other such configuration. The controller 400 may run an operating system (e.g., operating system 418), such as Windows®, Mac OS, QNX, Unix®, or Solaris® 5.10, together with firmware / software stored in memory 410. The controller 400 also runs software applications, which are stored in memory. For example, the software may be a program in any suitable programming language known to those skilled in the art, including, for example, C++, PHP, or Java®.

[0094] The communication network 404 may include a network that enables the controller 400 to communicate with the pump 316 and the pressure transducer 312, and optionally one or more additional sensors associated with the system 100, as will be described in more detail below. The communication network 404 may be configured for wired and / or wireless communication via a network such as the Internet, a telephone network, a Bluetooth® network, and / or a Wi-Fi network, using techniques known in the art. The communication network 404 may also include communication chips known in the art, such as a Bluetooth® chip and / or a Wi-Fi chip. The communication network 404 enables the controller 400 to transfer information such as pressure measurements in the negative pressure chamber 212 locally and / or to a remote location such as a server.

[0095] The power source 406 may supply alternating current or direct current. The power source 406 may also be a port that allows the controller 400 to be plugged into a conventional wall socket via a cord, which includes an AC / DC power converter and / or a USB port, for example, to power components within the controller 400. In the direct current embodiment, the power source 406 may include a suitable battery, such as a replaceable battery or a rechargeable battery, and may include a circuit network for charging the rechargeable battery.

[0096] The user interface 408 may be used to receive input from the user and / or provide output thereto. For example, the user interface 408 may include a touchscreen display, switches, dials, lights, etc. Thus, the user interface 408 may display information such as a pressure measurement of the negative pressure chamber 212 and / or a visual alert when the pressure in the negative pressure chamber 212 is outside a predetermined range. In some embodiments, the user interface 408 may receive user input, including adjustment to one or more operating parameters of the pump 316. In some embodiments, the user interface 408 is not located on the controller 400, but is instead provided on a remote external computing device that is communicably connected to the controller 400 via a communication network 404.

[0097] A memory 410, which is an embodiment of a non-transient computer-readable medium, may be used to store an operating system (OS) 418, a system parameter determination module 412, a pump interface module 414, and an alert generation module 416. The modules are provided in the form of computer-executable instructions / algorithms that can be executed by a processor 402 to perform the various operations according to this disclosure.

[0098] The system parameter determination module 412 may be run by the processor 402 to receive one or more signals from the pressure transducer 312 indicating the pressure in the negative pressure chamber 212 in real time. Furthermore, the system parameter determination module 412 may be configured to process and analyze the pressure measurement signals and determine whether the pressure in the negative pressure chamber 212 is outside a predetermined range stored in memory 410. The system parameter determination module 412 may also be configured to determine the volume of system 300 in real time based on the measured pressure of system 300, as will be understood by those skilled in the art. Thus, based on the measured volume of system 300, the known target volume of system 300 stored in memory 410, and the known pump flow rate of pump 312, the system parameter determination module 412 may calculate the expected pump uptime, for example, the amount of time required by pump 316 to achieve the known target volume of system 300 under normal conditions. In addition, or alternatively, the expected pump uptime may be predetermined and stored in memory 410.

[0099] Furthermore, the actual pump operating time, for example, the amount of time actually required by the pump 316 to achieve a known target volume of system 300, may be recorded. Thus, the system parameter determination module 412 may detect the presence of an obstruction in system 100 if the actual pump operating time deviates from the expected pump operating time, for example, by exceeding a predetermined threshold. For example, for a negative pressure system having a total system volume of 500 mL and a pump flow rate of 10,000 mL / min, the expected pump operating time for the operating vacuum range of 0 to -50 kPa may be about 6.5 seconds, and the expected pump operating time for the operating vacuum range of -30 to -50 kPa may be about 1.5 seconds. Therefore, the system parameter determination module 412 may determine that an obstruction exists in the system if the pump operating time is less than 1 second. For example, the total system volume may be 250 to 2,000 mL, the pump flow rate may be 1,000 to 50,000 mL / min, the operating vacuum range may be 0 to -80 kPa, and blockage may be detected when the actual pump operating time deviates from the expected pump operating time by, for example, 0.25 to 10 seconds.

[0100] As described above, the system 300 may include one or more additional sensors configured to generate one or more signals indicating the amount of excrement in the fluid reservoir chamber 302. Thus, the system parameter determination module 412 may be configured to receive one or more signals indicating the amount of excrement in the fluid reservoir chamber 302, process and analyze one or more signals, and determine whether the amount of excrement in the fluid reservoir chamber 302 exceeds a predetermined threshold. In some embodiments, as will be described in more detail below, the system 100 may include one or more additional sensors configured to measure data indicating, for example, the presence of at least one of blood, feces, or a predefined gas between the bypass device and the intestinal tissue surrounding the bypass device 200, and / or data indicating the position of the bypass device 200 relative to the intestinal anastomosis. Thus, the system parameter determination module 412 may be configured to process and analyze the data measured by one or more additional sensors and determine whether the measured data is outside one or more separate predetermined ranges.

[0101] The pump interface module 414 may be executed by the processor 402 to control the operation of the pump 316. For example, in response to the operation of the pump 316 via the user interface 408, the pump interface module 414 may instruct the pump 316 to turn on. Furthermore, if the system parameter determination module 412 determines that the pressure in the negative pressure chamber 212 is outside a predetermined range, the pump interface module 414 may automatically adjust one or more operating parameters of the pump 316 and instruct the pump 316 to operate according to the adjusted parameters, thereby maintaining the pressure in the negative pressure chamber 212 within a predetermined range. Preferably, the pump interface module 414 may be configured to instruct the pump 316 to turn off when the pressure in the negative pressure chamber 212, as measured by the pressure transducer 312, is within a predetermined range. Therefore, the system 100 may include one or more valves fluidly coupled to suction tubes 214, 216, configured to prevent fluid from entering the negative pressure chamber 212 and thereby maintain the pressure inside the negative pressure chamber 212. Thus, the pump interface module 414 may instruct the pump 316 to turn back on when the pressure inside the negative pressure chamber 212 is outside a predetermined range.

[0102] In some embodiments, the pump interface module 414 may be configured to adjust one or more parameters of the pump 316 over time. For example, as inward growth of intestinal tissue / mucosa forms over time on the inner and outer anchors 201, 220, a lower vacuum may be required to anchor the bypass device 200 to the target site upstream of the anastomosis site. Therefore, the pump interface module 414 may reduce the operation of the pump 316 and generate a lower vacuum in the negative pressure chamber 212 over time. Alternatively, in some embodiments, the pump interface module 414 may be configured to operate continuously and, for example, instruct the pump 316 to continuously drain fluid from the negative pressure chamber 212 and continuously create a vacuum with a pressure within a predetermined range.

[0103] The alert generation module 416 may be executed by the processor 402 to generate an alert when the system parameter determination module 412 determines that the pressure in the negative pressure chamber 212 is outside a predetermined range. For example, the alert may be an audible alert and / or a visual alert, which may be displayed via the user interface 408. In addition, or alternatively, the alert generation module 416 may be configured to generate alerts periodically to encourage the user to perform routine manual checks of the system 300. For example, the alert generation module 416 may be configured to generate alerts once or multiple times a day to remind the user to manually monitor the operation of the system 300. In addition, the alert generation module 416 may be configured to generate an alert when an obstruction in the system 100 is detected, for example, when the system parameter determination module 412 determines that the actual pump uptime exceeds a predetermined threshold and deviates from the expected pump uptime, as described above.

[0104] Furthermore, the alert generation module 416 may be configured to generate an alert when the measured amount of excretory material in the fluid reservoir chamber 302 exceeds a predetermined threshold, thereby informing the user that the fluid reservoir chamber 302 should be emptied or replaced. As described above, the system 100 may measure data indicating, for example, the presence of at least one of blood, feces, or a predefined gas between the bypass device and the intestinal tissue surrounding the bypass device 200, and / or data indicating the position of the bypass device 200 relative to the intestinal anastomosis. Thus, the alert generation module 416 may be configured to generate an alert indicating when the presence of at least one of blood, feces, or a predefined gas between the bypass device and the intestinal tissue surrounding the bypass device 200 exceeds a predetermined threshold, and / or when the position of the bypass device 200 relative to the intestinal anastomosis exceeds a predetermined threshold, so that corrective measures can be taken.

[0105] Referring here to Figure 5, exemplary method steps for automated monitoring of the bypass device 200 are provided. In step 502, the controller 400 may monitor the vacuum in the system 100, for example, the pressure in the negative pressure chamber 212. For example, a system parameter determination module 412 may process and analyze a pressure measurement signal received from a pressure transducer 312 indicating the pressure in the negative pressure chamber 212. In step 504, the controller 400 may determine whether the pressure in the negative pressure chamber 212, as indicated by the pressure measurement by the pressure transducer 312, is outside a predetermined range. If in step 504 it is determined that the pressure in the negative pressure chamber 212 is not outside a predetermined range, the method 500 may return to step 502. If it is determined that the pressure in the negative pressure chamber 212 is outside a predetermined range, in step 504 the method 500 may proceed to step 506.

[0106] In step 506, the controller 400 may automatically modify the pump settings of the pump 316, for example, one or more operating parameters of the pump 316, to maintain the pressure in the vacuum chamber 212 within a predetermined range. For example, the controller 400 may command the pump 316 to turn on if the pump 316 is currently off, or command the pump 316 to turn off if the pump 316 is currently on, and / or the controller 400 may command the pump 316 to discharge the fluid in the vacuum chamber 212 at a higher rate / force, thereby increasing the pressure in the vacuum chamber 212, or to discharge it at a lower rate / force, thereby decreasing the pressure in the vacuum chamber 212. Thus, method 500 may return to step 502 and continuously monitor the vacuum of the system 300. Optionally, in step 508, the controller 400 may generate an alert and notify the user if it detects that the pressure in the vacuum chamber 212 is outside a predetermined range. In addition, or alternatively, as described above, the controller 400 may periodically generate alerts to remind the user to manually monitor the operation of the system 300.

[0107] Figure 6A illustrates colon C with a bypass device having a single braided anchor positioned within the lumen of the colon, and Figure 6B illustrates colon C under vacuum generated via the single braided anchor bypass device. Figure 6C illustrates colon C with a bypass device having a double braided anchor, for example, a bypass device 200 having inner and outer anchors 201, 220, positioned within the lumen of the colon, and Figure 6D illustrates colon C under vacuum generated via the bypass device 200. A comparison of Figures 6B and 6D shows that the bypass device 200 generates a stronger and more consistent vacuum within the system, as supported by colon C, which is tightly wrapped around the double braided anchor bypass system in Figure 6D, compared to the single braided anchor bypass system in Figure 6B.

[0108] Referring here to Figures 7A-7G, an exemplary introducer device for delivering the bypass device 200 to a target site in the patient's GI duct is provided. The introducer 700 may include a guide tube having a first tubular portion 708 configured for insertion into the patient's GI duct and a second tubular portion 714 coupled to the downstream end of the first tubular portion 708. In addition, the introducer 700 may include a handle portion 702 operably coupled to the second tubular portion 714 and configured to actuate the introducer 700. As shown in Figures 7A and 7B, the upstream end of the second tubular portion 714 may be fixedly coupled to the downstream end of the first tubular portion 708, for example, via a stopper 716. The stopper 716 may have a disc-shaped outer form having a diameter larger than the diameter of the first tubular portion 708. For example, the stopper 716 may be sized and molded to prevent further insertion of the inlet 700 into the GI tube through the patient's anus by contacting the patient's anus.

[0109] The first tubular portion 708 may have a length such that its upstream end 710 is positioned at a target site in the patient's GI canal upstream of the anastomosis site, while the stop 716, the second tubular portion 714, and the handle portion 702 are selected to remain outside the patient's body. Therefore, the first tubular portion 708 may be formed from a flexible material to facilitate the maneuvering of the first tubular portion 708 through the patient's GI canal. As shown in Figure 7A, the outer surface of the first tubular portion 708 may include a marking 712 to visually indicate the depth in which the first tubular portion 708 is inserted into the patient's GI canal through the anus. Furthermore, as shown in Figure 7B, the first tubular portion 708 may have a lumen 709 extending through it, which, in its collapsed delivery state, is sized and molded to receive the bypass device 200 therein.

[0110] The upstream tip 710 may be constructed as described in U.S. Patent No. 11,589,869 of Khosrovaninejad (the full contents of which are incorporated herein by reference). For example, the upstream tip 710 may be configured to transition between a closed configuration and an open configuration to expose the lumen 709 and allow delivery of the bypass device 200 through it. In addition, the upstream tip 710 may have a tulip configuration formed from a plurality of elastically deformable cutout tabs biased toward a closed configuration, the plurality of tabs forming a sealed closure that isolates the lumen 709 from the environment surrounding the introducer 700, e.g., the GI tube. The plurality of tabs may overlap each other to form a sealed closure, and in the closed configuration may have sufficient rigidity to be inserted into the GI tube through the patient's anus. Furthermore, the plurality of tabs may transition to an open configuration in response to the application of force to the plurality of tabs from within the lumen 709, for example. For example, as described in more detail below, as the first tubular portion 708 is retracted downstream relative to the bypass device 200 in the lumen 709, the bypass device 200 may apply force to a plurality of tabs on the upstream end 710, thereby causing the upstream end 710 to transition to its open configuration, allowing the bypass device 100 to pass through it into the GI tube at the target site.

[0111] As shown in Figures 7A and 7B, the handle portion 702 may include a handle housing 704, which is sized and molded to be held by the user as the introducer 700 is inserted into the patient's GI tube. The handle housing 704 may be operably coupled to an actuator 706, for example, a rotatable knob, which is rotatable relative to the handle housing 704 and configured to actuate a second tubular portion 714, as will be described in more detail below. For example, as shown in Figures 7C and 7D, the knob 706 may be fixedly coupled to the inner tube 720, which is located within the handle housing 704, via a connector 707, such that rotation of the knob 706 causes rotation of the inner tube 720 relative to the handle housing 704, while preventing axial movement of the inner tube 720 relative to the handle housing 704.

[0112] As shown in Figure 7D, the downstream end of the second tubular portion 714 may be located within the lumen of the inner tube 720. Furthermore, the upstream end of the inner tube 720 may include one or more features 721 that extend radially inward and are sized and molded to slidably engage with one or more grooves 718 that extend along the outer surface of the second tubular portion 714. For example, the threaded surface of the second tubular portion 714 may be such that, as the inner tube 720 rotates via the rotation of the knob 706, the slidable engagement between the one or more features 721 and the one or more grooves 718 causes the one or more grooves 718 to slide along the one or more grooves 718, thereby moving the second tubular portion 714, and thus the first tubular portion 708 fixed thereto, axially relative to the inner tube 720 and the handle housing 704. Therefore, one or more grooves 718 may extend along the outer surface of the second tubular portion 714, for example in a helical pattern, in a circumferential and axial pattern. Furthermore, as shown in Figure 7C, the second tubular portion 714 may have a linear track 719 that extends longitudinally along the outer surface of the second tubular portion 714 and is slidably engaged with a rail (not shown) of the handle housing 704, thereby preventing rotation of the second tubular portion 714 relative to the handle housing 704 as the engagement between one or more features 721 and one or more grooves 718 causes axial translation of the second tubular portion 714 relative to the handle housing 704 during rotation of the knob 706. Specifically, the engagement between the rail of the handle housing 704 and the linear track 719, together with the engagement between one or more features 721 and one or more grooves 718, causes an axial translation of the second tubular portion 714 relative to the handle housing 704 as the inner tube 720 rotates.

[0113] As shown in Figures 7B and 7D, the introducer 700 may further include a pusher 724, the upstream end 728 of which is fixedly coupled to the handle housing 704 such that it is positioned upstream of the lumen 709 of the first tubular portion 708, for example downstream of the bypass device 200 in the lumen 709 in its crushed delivery state, and extending through at least a portion of the lumen 714 of the second tubular portion 708 and the lumen 709 of the first tubular portion 708. For example, as shown in Figure 7D, the downstream end 726 of the pusher 724 may be fixedly coupled to a holder 722 located within the handle housing 704. For example, the holder 722 may include an inner portion located within the lumen of the second tubular portion 714 such that the inner portion is fixedly coupled to the pusher 724, and an outer portion fixedly coupled to the handle housing 704. Furthermore, the holder 722 may include a rail that is slidably received within a linear track 719 and is configured to prevent rotation of the second tubular portion 714 as it moves axially relative to the handle housing 704, which extends between the inner and outer portions of the holder 722.

[0114] Furthermore, the pusher 724 may be formed from a flexible material to facilitate the navigation of the introducer 700 through the patient's GI tube. Additionally, the pusher 724 may be slidably positioned within the lumen 709 of the first tubular portion 708 and the lumen 714 of the second tubular portion 714, so that the first tubular portion 708 and the second tubular portion 714 can move axially relative to the pusher 724, for example, via the rotation of the knob 706, and the pusher 724 and handle portion 702 are stationary relative to the patient and the target site in the GI tube. The upstream end 728 may be sized and molded to engage with the bypass device 200 and maintain in position relative to the target site as the first tubular portion 708 moves axially downstream relative to the bypass device 200 and the pusher 724, as shown in Figure 8A (the bypass device 200 is omitted for brevity). Therefore, as the first tubular portion 708 is moved axially downstream, the pusher 724 causes the bypass device 200 to apply force to the multiple tabs of the upstream end 710 of the first tubular portion 708, thereby transitioning the upstream end 710 from a closed configuration to an open configuration, allowing the bypass device 200 to pass through it. As shown in Figure 8B, once the bypass device 200 is fully exposed from the lumen 709 of the first tubular portion 708, the bypass device 200 may transition from its compressed delivery state to its expanded deployment state at the target site in the GI tube, for example, via self-expansion.

[0115] Referring again to Figure 7A, the introducer 700 may further include a safety clip 715 configured to prevent premature deployment of the bypass device 200. As shown in Figure 7A, the safety clip 715 may be sized and molded to engage with a second tubular portion 714 between the stopper 716 and the handle housing 704. For example, the safety clip 715 may include a rail (not shown) that is received by a linear track 719 of the second tubular portion 714, and is sized and molded to removeably secure the safety clip 715 to the second tubular portion 714. Once the safety clip 715 is engaged with the second tubular portion 714, as shown in Figure 7A, axial translation of the second tubular portion 714 relative to the handle housing 704 is prevented because the rail of the handle housing 704 may not move axially along the linear track 719, as described above. Therefore, during the delivery of the bypass device 200 via the introducer 700, the first tubular portion 708 can be inserted into the GI tube through the patient's anus, while the safety clip 715 engages with the second tubular portion 714. Once the user confirms that the upstream tip 710 is in the desired position relative to the target site so that the bypass device 200 can be deployed to the target site in the GI tube, the safety clip 715 may be removed from the second tubular portion 714, thereby allowing the handle portion 702 to be operated when the bypass device 200 is ready for deployment.

[0116] Referring here to Figures 7E-7G, the operation of the knob 706 may be restricted to one direction during the deployment of the bypass device 200 at the target site. For example, as shown in Figure 7E, the downstream portion 705 of the handle housing 704 may be configured to rotatably engage with the knob 706. Specifically, the downstream portion 705 may be sized and molded to receive an internal channel extending through at least a portion of the knob 706 so that the knob 706 can be rotated relative to the downstream portion 705. As shown in Figure 7E, the downstream portion 728 may include one or more flexible tabs 728 extending circumferentially along at least a portion of the downstream portion 705. Each flexible tab 728 may be configured to transition between a radially compressed state, in which they extend radially inward, and a radially expanded state, in which they extend radially outward. Furthermore, the flexible tabs 728 may be biased toward the radially expanded state so that a force is required to transition the flexible tab 728 toward the radially compressed state.

[0117] As shown in Figure 7F, the inner surface of the knob 706 defining the internal channel of the knob 706 may include one or more grooves 730 configured to slidably engage with one or more flexible tabs 728 as the knob 706 is rotated relative to the handle housing 704. Each groove 730 may have an outer shape such that, in the radially expanded state, the engagement of one or more flexible tabs 728 with the stopping features 732 of one or more grooves 730 allows the knob 706 to rotate in a first direction relative to the handle housing 704, while preventing the knob 706 from rotating in a second direction opposite to the first direction relative to the handle housing 704, as shown in Figure 7G. Figure 7G illustrates two flexible tabs 728 and four grooves 730, but as will be understood by those skilled in the art, the handle portion 702 may include more or fewer flexible tabs and grooves. As will be understood by those skilled in the art, the introducer 700 may be used to deliver any of the bypass device anchors described herein, for example, bypass devices 1000, 1100, 1200, 1300, 1400, 1500, 1700, and 1800.

[0118] Referring here to Figure 9, another exemplary system for monitoring a bypass device 200 for protecting a bowel anastomosis AS using system 100 and one or more additional sensors is provided. As shown in Figure 9, internal and external anchors 201, 220 may be deployed and fixed to a target site in the intestine I upstream of the bowel anastomosis AS, thereby fixing the bypass device 200 within the patient's GI tubule such that the sheath 203 extends from the internal and external anchors 201, 220 through the intestine I across the bowel anastomosis AS and out of the patient's anus A. Furthermore, one or more suction tubes, e.g., suction tubes 214, 216, may extend from the negative pressure chamber of the bypass device 200 through the intestine I and out of the patient's anus A, as described above, and be fluidly coupled to the negative pressure system 300.

[0119] As shown in Figure 9, one or more additional sensors may be operably coupled to the system 300 to monitor the bypass device 200. For example, sensor S1 may be positioned on at least one of the internal or external anchors 201, 220 and configured to generate one or more signals indicating the pressure between the internal and external anchors 201, 220 and the intestine I. In addition, or alternatively, sensor S1 may be configured to generate one or more signals indicating the location of S1 within the intestine I. Furthermore, sensors S2 and / or S3 may be positioned along the length of the sheath 203 and configured to generate one or more signals indicating the locations of S2 and S3 within the intestine I, respectively. Therefore, based on the positional measurements of S1, S2, and S3, the controller of system 300 may determine the relative positions between sensors S1, S2, and S3, and further, based on the positional data, may determine whether the sheath 203 is, for example, bunching, and / or whether the internal and external anchors 201 and 220 are, for example, sliding within the intestine I. In addition, sensors S4 and / or S5 may be positioned along the length of the sheath 203 on the outer surface of the sheath 203 and may be configured to generate one or more signals indicating the presence of one or more substances, such as gases such as methane or hydrogen sulfide, that may indicate anastomotic leakage. Therefore, based on the positional measurements of sensors S4 and S5, the controller of system 300 may determine whether a particular substance is detected within the intestine I, and further, based on the presence of the substance, may determine whether anastomotic leakage is present. As described above, the system 300 may generate an alert in response to a decision based on one or more parameters measured by one or more additional sensors, for example, sensors S1, S2, S3, S4, S5. For example, based on the sensed data, the system 300 may generate an alert and notify the user when the sheath 203 is bunching, the inner and outer anchors 201, 220 are sliding, and / or there is anastomosis leakage.

[0120] Referring here to Figures 10A–18C, alternative exemplary anchors for anchoring a bypass device to a target site within the GI duct are provided. For example, referring here to Figures 10A and 10B, a bypass device 1000 is provided for providing an internal bypass to a target site within a patient's GI duct. As shown in Figure 10A, the bypass device 1000 includes an anchor 1001 and an elongated flexible sheath 1002 coupled to the anchor 1001 and extending downstream therefrom. Like sheath 203, the sheath 1002 has an outer surface and an internal channel for allowing the passage of feces and other excretions through it. The sheath 1002 has a length selected to extend from the target site within the GI duct through the patient's intestines and anus to a location outside the patient. In some embodiments, the downstream end of the sheath 1002 may be coupled to an external collection container (not shown) outside the patient's body for collecting feces and other excretions therein. The sheath 1002 may be formed from a biocompatible elastomer material such as silicone or polyurethane.

[0121] Unlike the bypass device 200, the bypass device 1000 may include a single anchor, for example, anchor 1001. Like the anchor of the bypass device 200, anchor 1001 may be formed of a stent / scaffold, for example, a self-expandable braided wire mesh, which is coupled to the sheath 1002 and configured to provide outward radial force against the intestinal wall at the target site. Thus, anchor 1001, in conjunction with a negative pressure system, functions to fix the bypass device to the target site and keep the target area within the GI tube open, allowing feces and other excretory material to pass through anchor 1001 and the sheath 1002 without contacting the wall surrounding the anastomosis site. For example, as shown in Figure 10B, the upstream region of the sheath 1002 may extend through the lumen of the anchor 1001 and be coupled to the inner surface of the stent 1001 via the upstream seal ring 1006 and the downstream seal ring 1004, thereby forming a negative pressure chamber 1008 defined by the outer surface of the sheath 1002, the upstream seal ring 1006, the downstream seal ring 1004, and the portion of the anchor 1001 between the upstream seal ring 1006 and the downstream seal ring 1004. The anchor 1001 and sheath 1002 for use with the bypass device 1000 may be constructed as described in Khosrovaninejad's U.S. Patents 9,339,272 and 9,980,727 (their respective full contents incorporated herein by reference).

[0122] As described above, the anchor 1001 may be used in conjunction with the negative pressure system described herein and fluidically coupled to an external pump, thereby drawing intestinal tissue toward and at least partially through the multiple openings 1003 of the anchor 1001, thereby fixing the anchor 1001 to the target site, and the fluid may be discharged from the negative pressure chamber 1008 via one or more suction / fluid inlet tubes, e.g., suction tubes 1012, 1014, which create a vacuum within the negative pressure chamber 1008. Figures 10A and 10B illustrate two suction tubes, but as will be understood by those skilled in the art, the bypass device 1000 may include more or fewer suction tubes to generate the desired vacuum within the negative pressure chamber 1008. As shown in Figure 10B, the upstream regions of the suction tubes 1012, 1014 may extend through the downstream seal ring 1004 and may be located within the negative pressure chamber 1008.

[0123] Furthermore, the upstream regions of the suction tubes 1012 and 1014 may include a number of inlet ports 1013 and 1015, each sized and shaped to allow fluid to be discharged through them, sufficient to create a vacuum within the negative pressure chamber 1008. The inlet ports 1013 and 1015 may be spatially uniformly distributed along the length of the upstream regions of the suction tubes 1012 and 1014. Alternatively, the spatial distribution of the inlet ports 1013 and 1015 may be selected to create a desired vacuum within the negative pressure chamber 1008. Preferably, the upstream regions of the suction tubes 1012 and 1014 may be equally spaced within the negative pressure chamber 1008 along the circumference of the sheath 1002. The suction tubes 1012 and 1014 may extend from within the negative pressure chamber 1008 through the downstream seal ring 1004 along the outer surface of the sheath 1002 out from the patient's anus, so that the downstream ends of the suction tubes 1012 and 1014 can be fluidly coupled to an external pump of the negative pressure system for creating a vacuum within the negative pressure chamber 1008. In some embodiments, at least portions of the suction tubes 1012 and 1014 may extend within the wall of the sheath 1002, for example, within a membrane forming the sheath 1002.

[0124] In some embodiments, the upstream end of the sheath 1002 may extend toward the upstream end of the anchor 1001, as shown in Figure 10A, or it may extend along the periphery of the upstream end of the anchor 1001 and be coupled to the upstream end of the anchor 1001 via an upstream covering ring 1010 that secures and fastens the sheath 1002 to the anchor 1001. Furthermore, the anchor 1001 may include, for example, one or more downstream retrieval loops 1016 extending from the downstream end of the anchor 1001 and / or one or more upstream retrieval loops 1018 extending from the upstream end of the anchor 1001 to facilitate the removal of the bypass device 1000 after the anastomosis has completely healed. For example, a retrieval device, such as an endoscopic grappler, may be introduced through the lumen of the sheath 1002 toward the lumen of the anchor 1001 so that a force can be applied to the downstream portion of the retrieval device, pulling the upstream retrieval loop 1018 downstream, thereby engaging with the upstream retrieval loop 1018. Thus, the upstream end of the anchor 1001 may be inverted toward the lumen of the sheath 1002 into the lumen of the anchor 1001 via a pulling force toward the upstream retrieval loop 1018, thereby detaching the anchor 1001 from the intestinal tissue surrounding the anchor 1001, such as the inward growth of the mucosa that may form on the anchor 1001. The retrieval device may then be disengaged from the upstream retrieval loop 1018 and subsequently engaged with the downstream retrieval loop 1016, thereby applying a pulling force downstream to the downstream retrieval loop 1016 and removing the bypass device 1000 from the patient's body.

[0125] Anchor 1101 in Figure 11, anchor 1201 in Figure 12, anchor 1301 in Figure 13, anchor 1401 in Figure 14, anchor 1501 in Figure 15A, anchor 1701 in Figure 17, and anchor 1801 in Figure 18A may be constructed similarly to anchor 1001, in that they may be formed from a self-expandable braided wire mesh stent / scaffolding that can define one or more negative pressure chambers for creating a vacuum and draining fluid, via one or more suction tubes which are fluidly coupled to one or more negative pressure chambers, respectively, via at least upstream and downstream seal rings, and thereby fluidly coupled to one or more negative pressure chambers. Unlike anchor 1001, but similar to inner anchor 201, the stents / scaffolds forming anchors 1101, 1201, 1301, 1401, 1501, 1701, and 1801 may have a bone-shaped outer shape, creating a recessed central region between the expanded upstream and downstream regions, for example, an hourglass, thereby improving negative pressure chamber engagement with the intestinal tissue. For example, the recessed central region may have an outer diameter less than the outer diameter of the upstream and downstream regions, thereby providing a larger volume between the outer surface of the individual anchors and the intestinal wall.

[0126] Referring here to Figure 11, the anchor 1101 of the bypass device 1100 may include a downstream region 1102, an upstream region 1104, and a recessed central region 1106 extending between the downstream region 1102 and the upstream region 1104. The central region 1106 may have an outer diameter less than the outer diameters of the downstream region 1102 and the upstream region 1104, thereby providing a larger volume between the outer surface of the central region 1106 and the intestinal wall, improving negative pressure chamber engagement with the intestinal tissue during vacuum application. In some embodiments, the anchor 1101 may be symmetrical such that the downstream region 1102 may have an outer diameter equal to the outer diameter of the upstream region 1104. Furthermore, the sheath 1103 of the bypass device 1100 may be coupled to the anchor 1101 via a downstream seal ring 1108 and an integrated upstream seal ring 1110, thereby defining the negative pressure chamber 1112 between the outer surface of the sheath 1103, the downstream seal ring 1108, the upstream seal ring 1110, and the central region 1106 of the anchor 1101.

[0127] As shown in Figure 11, the integrated upstream seal ring 1110 may include an integrated upstream seal ring portion 1111, which is positioned along the upstream edge of the anchor 1101 and configured to form a soft, flexible upstream anterior edge of the anchor 1101. For example, the integrated upstream seal ring portion 1111 can prevent damage to intestinal tissue adjacent to the upstream end of the anchor 1101. In addition, the integrated upstream seal ring portion 1111 provides a longer sealing surface along the upstream region 1104 and flexibility to assist in the retrieval of the bypass device 1100. Furthermore, the integrated upstream seal ring portion 1111 prevents inward growth of mucosa onto at least the upstream region 1104 of the anchor 1101. The downstream seal ring 1108 and the integrated upstream seal rings 1110, 1111 may be compression molded onto the stent / scaffold of the anchor 1101 and sheath 1103, or directly overmolded over them, or alternatively, thermally bonded or solvent-bonded thereto. For example, the downstream seal ring 1108 and the integrated upstream seal rings 1110, 1111 may be formed from a moldable thermoplastic material such as thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and / or thermoplastic vulcanized material (TPV). One or more suction tubes (not shown) may be positioned across the downstream seal ring 1108 such that one or more inlet ports of one or more suction tubes may be positioned within the negative pressure chamber 1112. A vacuum having a predetermined pressure may be created within the negative pressure chamber 1112 in response to the operation of an external pump, for example, fluidly coupled to one or more suction tubes, thereby pulling the intestinal tissue toward the anchor 1101 and fixing the bypass device 1100 to the target site. At least some of the intestinal tissue may be pulled through at least some openings in the stent / scaffold in the central region 1106.

[0128] Referring here to Figure 12, the anchor 1201 of the bypass device 1200 may include a downstream region 1202, an upstream region 1204, and a recessed central region 1206 extending between the downstream region 1202 and the upstream region 1204. The central region 1206 may have an outer diameter less than the outer diameters of the downstream region 1202 and the upstream region 1204, thereby providing a larger volume between the outer surface of the central region 1206 and the intestinal wall, improving negative pressure chamber engagement with the intestinal tissue during vacuum application. In some embodiments, the anchor 1201 may be symmetrical such that the downstream region 1202 may have an outer diameter equal to the outer diameter of the upstream region 1204. Furthermore, the sheath 1203 of the bypass device 1200 may be coupled to the anchor 1201 via an integrated downstream seal ring 1208 and an integrated upstream seal ring 1210, thereby defining the negative pressure chamber 1212 between the outer surface of the sheath 1203, the downstream seal ring 1208, the upstream seal ring 1210, and the central region 1206 of the anchor 1201.

[0129] As shown in Figure 12, the integrated downstream seal ring 1208 may include an integrated downstream edge seal ring portion 1209, which is positioned along the downstream edge of the anchor 1201 and is configured to form a soft, flexible downstream rear edge of the anchor 1201. For example, the integrated downstream edge seal ring portion 1209 can prevent damage to the intestinal tissue and the outer surface of the sheath 1203 adjacent to the downstream end of the anchor 1201. In addition, the integrated upstream seal ring 1210 may include an integrated upstream edge seal ring portion 1211, which is positioned along the upstream edge of the anchor 1201 and is configured to form a soft, flexible upstream front edge of the anchor 1201. For example, the integrated upstream edge seal ring portion 1211 can prevent damage to the intestinal tissue adjacent to the upstream end of the anchor 1201. Furthermore, the integrated downstream edge seal ring portion 1209 and the integrated upstream edge seal ring portion 1211 provide a longer sealing surface along the downstream region 1202 and the upstream region 1204, respectively, and flexibility to assist in the retrieval of the bypass device 1200. In addition, the integrated downstream edge seal ring portion 1209 and the integrated upstream edge seal ring portion 1211 prevent inward growth of mucosa onto at least the downstream region 1202 and the upstream region 1204 of the anchor 1201.

[0130] The integrated downstream seal rings 1208, 1209 and the integrated upstream seal rings 1210, 1211 may be compression-molded onto the stent / scaffold of the anchor 1201 and sheath 1203, or directly overmolded over them, or alternatively, thermally bonded or solvent-bonded thereto. For example, the integrated downstream seal rings 1208, 1209 and the integrated upstream seal rings 1210, 1211 may be formed from a moldable thermoplastic material such as thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and / or thermoplastic vulcanized material (TPV). One or more suction tubes (not shown) may be positioned across the integrated downstream seal rings 1208, 1209 such that one or more inlet ports of one or more suction tubes may be positioned within the negative pressure chamber 1212. A vacuum with a predetermined pressure may be created within the negative pressure chamber 1212 in response to the operation of an external pump, for example, fluidly coupled to one or more suction tubes, thereby pulling the intestinal tissue toward the anchor 1201 and fixing the bypass device 1200 to the target site. At least some of the intestinal tissue may be pulled through at least some openings in the stent / scaffold in the central region 1206.

[0131] Referring here to Figure 13, the anchor 1301 of the bypass device 1300 may include a downstream region 1302, an upstream region 1304, and a recessed central region 1306 extending between the downstream region 1302 and the upstream region 1304. The central region 1306 may have an outer diameter less than the outer diameters of the downstream region 1302 and the upstream region 1304, thereby providing a larger volume between the outer surface of the central region 1306 and the intestinal wall, improving negative pressure chamber engagement with the intestinal tissue during vacuum application. In some embodiments, the anchor 1301 may be symmetrical such that the downstream region 1302 may have an outer diameter equal to the outer diameter of the upstream region 1304.

[0132] Furthermore, the sheath 1303 of the bypass device 1300 may be coupled to the anchor 1301 via a first downstream seal ring 1308 and a first upstream seal ring 1310, thereby defining the negative pressure chamber 1312 between the outer surface of the sheath 1303, the first downstream seal ring 1308, the first upstream seal ring 1310, and the central region 1306 of the anchor 1301. In some embodiments, the first downstream seal ring 1308 may be positioned along the downstream edge of the anchor 1301, and / or the first upstream seal ring 1310 may be positioned along the upstream edge of the anchor 1301, thereby forming a soft, flexible downstream trailing edge and / or a soft, flexible upstream trailing edge of the anchor 1301, respectively. For example, the first downstream seal ring 1308 can prevent damage to the intestinal tissue and the outer surface of the sheath 1303 adjacent to the downstream end of the anchor 1301, and the first upstream seal ring 1310 can prevent damage to the intestinal tissue adjacent to the upstream end of the anchor 1301. The first downstream seal ring 1308 and the first upstream seal ring 1310 may be compression molded onto the stent / scaffold of the anchor 1301 and the sheath 1303, or directly overmolded over them, or alternatively, thermally bonded or solvent-bonded thereto. For example, the first downstream seal ring 1308 and the first upstream seal ring 1310 may be formed from a moldable thermoplastic material such as thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and / or thermoplastic vulcanized material (TPV).

[0133] As shown in Figure 13, the bypass device 1300 may further include a second downstream seal ring 1309 positioned on the anchor 1301 upstream of the first downstream seal ring 1308, and a second upstream seal ring 1311 positioned on the anchor 1301 downstream of the first upstream seal ring 1310. Neither the second downstream seal ring 1309 nor the second upstream seal ring 1311 is coupled to the sheath 1303. Therefore, the second downstream seal ring 1309 and the second upstream seal ring 1311 may be compression molded onto the stent / scaffold of the anchor 1301, or directly overmolded over it, or alternatively, thermally bonded or solvent-bonded thereto. For example, the second downstream seal ring 1309 and the second upstream seal ring 1311 may be formed from a moldable thermoplastic material such as thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and / or thermoplastic vulcanized material (TPV).

[0134] One or more suction tubes (not shown) may be positioned across the first downstream seal ring 1308 such that one or more inlet ports of one or more suction tubes may be positioned within the negative pressure chamber 1312. A vacuum with a predetermined pressure may be created within the negative pressure chamber 1312 in response to the operation of an external pump, for example, fluidly coupled to one or more suction tubes, thereby pulling the intestinal tissue toward the anchor 1301 and fixing the bypass device 1300 to the target site. At least some of the intestinal tissue may be pulled through at least some openings in the stent / scaffold in the central region 1306. Furthermore, as the vacuum created within the negative pressure chamber 1312 pulls the intestinal tissue toward the anchor 1301, the intestinal tissue may come into contact with the outer surfaces of the second downstream seal ring 1309 and the second upstream seal ring 1311, thereby creating a downstream suction chamber 1313 defined by the sheath 1303, the first and second downstream seal rings 1308, 1309, and the intestinal tissue surrounding the anchor 1301 between the first and second downstream seal rings 1308, 1309, and an upstream suction chamber 1315 defined by the sheath 1303, the first and second upstream seal rings 1310, 1311, and the intestinal tissue surrounding the anchor 1301 between the first and second upstream seal rings 1310, 1311. Therefore, the vacuum created in the downstream suction chamber 1313 and the upstream suction chamber 1315 can facilitate engagement between the bypass device 1300 and the intestinal wall.

[0135] Referring here to Figure 14, a bypass device 1400 is provided. The bypass device 1400 may be constructed similarly to the bypass device 1300. For example, the bypass device 1400 may include an anchor 1401 having upstream, downstream, and central regions 1402, 1404, and 1406, first and second downstream seal rings 1408, 1409 for generating a downstream suction chamber 1413, and first and second upstream seal rings 1410, 1411 for generating an upstream suction chamber 1415, which corresponds to the bypass device 1300 having an anchor 1301 having upstream, downstream, and central regions 1302, 1304, and 1306, first and second downstream seal rings 1308, 1309 for generating a downstream suction chamber 1313, and first and second upstream seal rings 1310, 1311 for generating an upstream suction chamber 1315. Bypass device 1400 differs from bypass device 1300 in that bypass device 1400 may include a central seal ring 1414 configured to connect a sheath 1403 to an anchor 1401 in a central region 1406, thereby defining a first negative pressure chamber 1412a defined by a first downstream seal ring 1408, a central seal ring 1414, the upper surface of the sheath 1403, and a portion of the anchor 1401 between the first downstream seal ring 1408 and the central seal ring 1414, and a second negative pressure chamber 1412b defined by a first upstream seal ring 1410, a central seal ring 1414, the upper surface of the sheath 1403, and a portion of the anchor 1401 between the first upstream seal ring 1410 and the central seal ring 1414.

[0136] Therefore, one or more suction tubes (not shown) may be positioned across the first downstream seal ring 1408 such that one or more inlet ports of one or more suction tubes may be positioned within the negative pressure chamber 1412a. In addition, one or more additional suction tubes (not shown) may be positioned across the first downstream seal ring 1408 and the central seal ring 1414 such that one or more inlet ports of one or more additional suction tubes may be positioned within the negative pressure chamber 1412b. Alternatively, the same one or more suction tubes may be positioned across the first downstream seal ring 1408 and the central seal ring 1414 such that a first set of one or more inlet ports of one or more suction tubes may be positioned within the negative pressure chamber 1412a, and a second set of one or more inlet ports of one or more suction tubes may be positioned within the negative pressure chamber 1412b. A vacuum with a predetermined pressure may be created within the negative pressure chambers 1412a, 1412b in response to the operation of an external pump, for example, which is fluidly coupled to the suction tube, thereby pulling the intestinal tissue toward the anchor 1401 and fixing the bypass device 1400 to the target site. At least some of the intestinal tissue may be pulled through at least some openings in the stent / scaffold in the central region 1406.

[0137] Furthermore, as the vacuum created within the negative pressure chamber 1412a pulls the intestinal tissue toward the anchor 1401, the intestinal tissue may come into contact with the outer surface of the second downstream seal ring 1409, thereby creating a downstream suction chamber 1413 defined by the sheath 1403, the first and second downstream seal rings 1408, 1409, and the intestinal tissue surrounding the anchor 1401 between the first and second downstream seal rings 1408, 1409. Similarly, as the vacuum created in the negative pressure chamber 1412b pulls the intestinal tissue toward the anchor 1401, the intestinal tissue may come into contact with the outer surface of the second upstream seal ring 1411, thereby creating an upstream suction chamber 1415 defined by the sheath 1403, the first and second upstream seal rings 1410, 1411, and the intestinal tissue surrounding the anchor 1401 between the first and second upstream seal rings 1410, 1411. Thus, the vacuums created in the downstream suction chamber 1413 and the upstream suction chamber 1415 can facilitate engagement between the bypass device 1400 and the intestinal wall. In some embodiments, a suction tube, fluidically coupled to the negative pressure chamber 1412a, may operate independently of the suction tube, fluidly coupled to the negative pressure chamber 1412b, thereby creating a vacuum in the negative pressure chamber 1412a having a different pressure than the vacuum created in the negative pressure chamber 1412b.

[0138] Referring here to Figure 15A, a bypass device 1500 is provided. The bypass device 1500 may be constructed similarly to the bypass device 1400, except that it does not include second downstream and upstream seal rings. For example, the bypass device 1500 may include an anchor 1501 having upstream, downstream, and central regions 1502, 1504, and 1506, a downstream seal ring 1508, and an upstream seal ring 1510, which corresponds to the anchor 1401 having upstream, downstream, and central regions 1402, 1404, and 1406, a downstream seal ring 1408, and an upstream seal ring 1410 of the bypass device 1400. Like the bypass device 1400, the bypass device 1500 may also include a central seal ring, for example, a central seal ring 1514, thereby defining a first negative pressure chamber 1512a defined by a downstream seal ring 1508, the central seal ring 1514, the upper surface of the sheath 1503, and a portion of the anchor 1501 between the downstream seal ring 1508 and the central seal ring 1514, and a second negative pressure chamber 1512b defined by an upstream seal ring 1510, the central seal ring 1514, the upper surface of the sheath 1503, and a portion of the anchor 1501 between the first upstream seal ring 1510 and the central seal ring 1514.

[0139] However, the central seal ring 1514 differs from the central seal ring 1414 in that it may include a plurality of inlet ports 1515 configured to fluidly connect to one or more suction tubes of the negative pressure system and sized and molded to discharge fluid through it. For example, the central seal ring 1514 may include a plurality of inlet ports 1515 and a chamber configured to fluidly connect to one or more suction tubes. As shown in Figure 15B, the plurality of inlet ports 1515 may be spatially uniformly distributed along the outer surface of the central seal ring 1514. In some embodiments, the plurality of inlet ports 1515 may be distributed only along the upstream side of the central seal ring 1514, or alternatively, the plurality of inlet ports 1515 may point only upstream so that the suction is directed upstream, thereby creating resistance to downstream tension and resisting the primary direction of peristaltic force during operation.

[0140] A first set of one or more additional suction tubes (not shown) may be positioned across the downstream seal ring 1508 such that one or more inlet ports of the first set of one or more additional suction tubes may be positioned within the negative pressure chamber 1512a, and a second set of one or more additional suction tubes (not shown) may be positioned across the downstream seal ring 1508 and the central seal ring 1514 such that one or more inlet ports of the second set of one or more additional suction tubes may be positioned within the negative pressure chamber 1512b. Alternatively, the same one or more additional suction tubes may be positioned across the downstream seal ring 1508 and the central seal ring 1514 such that a first set of one or more inlet ports of the one or more additional suction tubes may be positioned within the negative pressure chamber 1512a, and a second set of one or more inlet ports of the one or more additional suction tubes may be positioned within the negative pressure chamber 1512b.

[0141] A vacuum with a predetermined pressure may be created within the negative pressure chambers 1512a, 1512b in response to the operation of an external pump, for example, fluidically coupled to the suction tube, thereby pulling the intestinal tissue toward the anchor 1501 and fixing the bypass device 1500 to the target site. At least some of the intestinal tissue may be pulled through at least some openings in the stent / scaffold of the central region 1506. Furthermore, the operation of the negative pressure system may cause the discharge of fluid through the inlet port 1515 of the central seal ring 1514, thereby creating a vacuum in the space between the anchor 1501 and the inner wall of the intestine surrounding the central region 1506, which pulls the intestinal tissue toward the central seal ring 1514. For example, the intestinal tissue may be pulled and come into contact with the sealing surface of the central seal ring 1514, thereby creating a localized vacuum ring and protecting against vacuum leakage resulting from seal failure. In some embodiments, the suction tubes, which are fluidically coupled to the negative pressure chamber 1512a, the negative pressure chamber 1512b, and the central seal ring 1514, may each be independently operable.

[0142] Referring here to Figures 16A and 16B, an exemplary downstream seal ring is provided as an alternative. As shown in Figure 16A, the downstream seal ring 1602 may include a plurality of inlet ports 1604 configured to be fluidly coupled to one or more suction tubes of a negative pressure system, e.g., negative pressure system 300, and sized and molded to discharge fluid through it. For example, the downstream seal ring 1602 may include a chamber configured to be fluidly coupled to the plurality of inlet ports 1604 and one or more suction tubes. As shown in Figure 16A, the plurality of inlet ports 1604 may be spatially uniformly distributed along the upstream outer surface of the downstream seal ring 1602 so that suction is directed upstream, thereby creating resistance to downstream tension and resisting the primary direction of peristaltic force during operation. Alternatively, the distribution of the plurality of inlet ports 1602 along the downstream seal ring 1602 is not limited to the upstream side of the downstream seal ring 1602. As shown in Figure 16A, each of the multiple inlet ports 1604 may have an oval shape. Alternatively, as shown in Figure 16B, each of the multiple inlet ports 1604' of the downstream seal ring 1602', which can be constructed similarly to the downstream seal ring 1602, may have a circular shape.

[0143] As will be understood by those skilled in the art, a seal ring (e.g., downstream seal ring 1602) having multiple inlet ports for discharging fluid through it may be incorporated into any of the bypass devices described herein to facilitate the adhesion of individual bypass devices to a target site in the patient's GI duct. Furthermore, such a seal ring is not limited to use as a downstream seal ring and may also be incorporated into an upstream seal ring as described herein. Such an upstream seal ring may have an inlet port facing downstream.

[0144] Referring here to Figure 17, a bypass device 1700 is provided. The bypass device 1700 may be constructed similarly to the bypass device 1200. For example, the bypass device 1700 may include an anchor 1701 having upstream, downstream, and central regions 1702, 1704, 1706, first and second downstream seal rings 1708, 1709 for generating a downstream suction chamber 1713, and first and second upstream seal rings 1710, 1711 for generating an upstream suction chamber 1715. The bypass device 1700 differs from the bypass device 1200 in that, like the bypass device 1200, it may include an integrated downstream edge seal ring portion in which the downstream seal ring 1708 is positioned along the downstream edge of the anchor 1701 and is configured to form a soft, flexible downstream rear edge of the anchor 1701, and the upstream seal ring 1710 may include an integrated upstream edge seal ring portion in which the upstream seal ring 1710 is positioned along the upstream edge of the anchor 1701 and is configured to form a soft, flexible upstream front edge of the anchor 1701. Therefore, the integrated downstream and upstream edge seal ring portions of the downstream seal ring 1708 and the upstream seal ring 1710 can prevent damage to intestinal tissue adjacent to the downstream and upstream ends of the anchor 1701. Furthermore, the downstream seal ring 1708 and the upstream seal ring 1710 provide longer sealing surfaces along the downstream region 1702 and the upstream region 1704, respectively, and flexibility to assist in the retrieval of the bypass device 1700. In addition, the downstream seal ring 1708 and the upstream seal ring 1710 prevent inward growth of the mucosa onto at least the downstream region 1702 and the upstream region 1704 of the anchor 1701.

[0145] One or more suction tubes (not shown) may be positioned across the first downstream seal ring 1708 such that one or more inlet ports of one or more suction tubes may be positioned within the negative pressure chamber 1712. A vacuum with a predetermined pressure may be created within the negative pressure chamber 1712 in response to the operation of an external pump, for example, fluidly coupled to one or more suction tubes, thereby pulling the intestinal tissue toward the anchor 1701 and fixing the bypass device 1700 to the target site. At least some of the intestinal tissue may be pulled through at least some openings in the stent / scaffold in the central region 1706. Furthermore, as the vacuum created within the negative pressure chamber 1712 pulls the intestinal tissue toward the anchor 1701, the intestinal tissue may come into contact with the outer surfaces of the second downstream seal ring 1709 and the second upstream seal ring 1711, thereby creating a downstream suction chamber 1713 defined by the sheath 1703, the first and second downstream seal rings 1708, 1709, and the intestinal tissue surrounding the anchor 1701 between the first and second downstream seal rings 1708, 1709, and an upstream suction chamber 1715 defined by the sheath 1703, the first and second upstream seal rings 1710, 1711, and the intestinal tissue surrounding the anchor 1701 between the first and second upstream seal rings 1710, 1711. Therefore, the vacuum created in the downstream suction chamber 1713 and the upstream suction chamber 1715 can facilitate engagement between the bypass device 1700 and the intestinal wall.

[0146] Referring here to Figures 18A-18C, a bypass device 1800 is provided. The bypass device 1800 may be constructed similarly to the bypass device 1200. For example, the bypass device 1800 may include, as shown in Figure 18B, an anchor 1801 having downstream, upstream, and central regions 1802, 1804, and 1806; an integrated downstream seal ring 1808 including an integrated downstream seal ring portion configured to be positioned along the downstream edge of the anchor 1801; and an integrated upstream seal ring 1810 including an integrated upstream seal ring portion configured to be positioned along the upstream edge of the anchor 1801, thereby forming a soft, flexible downstream trailing edge and a soft, flexible upstream trailing edge of the anchor 1801. Furthermore, the sheath 1803 may be positioned within the lumen of the anchor 1801 and coupled to the integrated downstream seal ring 1808 and the integrated upstream seal ring 1810, thereby defining the negative pressure chamber 1812 between the outer surface of the sheath 1803, the integrated downstream seal ring 1808, the integrated upstream seal ring 1810, and the anchor 1801. As shown in Figure 18A, the sheath 1803 may extend downstream of the anchor 1801.

[0147] As shown in Figure 18A, the anchor 1801 may include one or more downstream retrieval loops 1805 extending from the downstream end of the anchor 1801 and / or one or more upstream retrieval loops 1807 extending from the upstream end of the anchor 1801, for example, to facilitate the removal of the bypass device 1800 after the anastomosis has completely healed. The retrieval loops 1805, 1807 may be constructed similarly to the retrieval loops 1016, 1018 described above with respect to Figure 10A. Furthermore, as shown in Figure 18A, the outer surface of the downstream region of the sheath 1803 may include a marking 1809 to visually indicate the depth to which the sheath 1803 is inserted into the patient's GI duct through the anus. In addition, as shown in Figure 18A, the bypass device 1800 may include first and second suction / fluid inlet tubes 1814, 1816, which may be constructed similarly to the suction tubes 214, 216 described above. For example, each of the fluid inlet tubes 1814 and 1816 may have a distal region having a set of inlet ports that are located within and fluidly communicate with the negative pressure chamber 1812, and a proximal end that is fluidically coupled to a pump configured to apply negative pressure into the negative pressure chamber 1812. The proximal ends of the fluid inlet tubes 1814 and 1816 may also be fluidically coupled via the fluid inlet tubes 1814 and 1816 to one or more vacuum / pressure transducers configured to measure the pressure within the negative pressure chamber 1812, as will be described in more detail below.

[0148] As shown in Figures 18A and 18C, the bypass device 1800 may further include a sensing tube 1818 having a distal region that is located within and fluidly communicates with the negative pressure chamber 1812, and a proximal end that is fluidly coupled to a vacuum / pressure transducer configured to measure the pressure within the negative pressure chamber 1812 via the sensing tube 1818. Preferably, the distal regions of the fluid inlet tubes 1814, 1816 and the sensing tube 1818 are equally and circumferentially spaced apart within the negative pressure chamber 1812, as shown in Figure 18C. As will be understood by those skilled in the art, the distal regions of the fluid inlet tubes 1814, 1816 and the sensing tube 1818 may be arranged in a manner different from that illustrated in Figure 18C. In addition, there may be more or fewer fluid inlet tubes and / or more or fewer sensing tubes than two, as shown in Figure 18C. Furthermore, the number and arrangement of fluid inlet pipes and sensing pipes may be incorporated with any of the bypass devices described above, such as bypass devices 200, 1000, 1100, 1200, 1300, 1400, 1500, and 1700.

[0149] Like the bypass device 200, at least a portion of the outer surface of the sheath 1803 within the negative pressure chamber 1812 may include a plurality of microstructures, for example, a micropattern of microstructure 1820, which are disposed on it. For example, the micropattern of microstructure 1820 may include a micropattern of protruding portions that extend outward from the outer surface of the sheath 1803. Preferably, the micropattern of microstructure 1820 is disposed only on the outer surface of the sheath 1803 which is disposed within the negative pressure chamber 1812. In addition, the microstructure 1820 is preferably formed integrally with a portion of the sheath 1803 within the negative pressure chamber 1812. Alternatively, the microstructure 1820 may be attached to a portion of the sheath 1803 within the negative pressure chamber 1812 during manufacturing.

[0150] As shown in Figure 18B, each microstructure in the micropattern of the microstructure 1820 may have a hemispherical shape. For example, each microstructure in the micropattern of the microstructure 1820 may have a cross-sectional width of 50 to 500 microns, for example, about 300 microns, and a height of 50 to 1,000 microns, for example, about 600 microns. In some embodiments, each microstructure in the micropattern of the microstructure 1820 may have a pitch of 800 to 1,200 microns, for example, about 1,000 microns. As will be understood by those skilled in the art, the microstructures may have other shapes, such as rows, cubes, cones, pyramids, cylindrical columns, rectangles, triangles, squares, sine waves, etc.

[0151] The micropattern of the microstructure 1820 may include multiple rows and multiple columns of microstructure throughout the entire negative pressure chamber 1812. For example, the micropattern of the microstructure 1820 may extend radially around the entire circumference of the outer surface of the sheath 1803 and longitudinally along the entire length of the outer surface of the sheath 1803 within the negative pressure chamber 1812. In some embodiments, the micropattern of the microstructure 1820 may be arranged in a triangular or rectangular shape on the outer surface of the sheath 1803 within the negative pressure chamber 1812. In some embodiments, the outer surface of the sheath 1803 may further include one or more ribs and / or one or more channels that are sized and shaped to guide fluid flow within the negative pressure chamber 1812 toward, for example, fluid inlet pipes 1814, 1816.

[0152] A vacuum with a predetermined pressure may be created in the internal negative pressure chamber 1812 in response to the operation of an external pump, for example, fluidly coupled to one or more suction tubes, thereby pulling the intestinal tissue toward the anchor 1801 and fixing the bypass device 1800 to the target site. At least some of the intestinal tissue may be pulled through at least some openings in the stent / scaffold of the central region 1806 and may also come into contact with the micropattern of the microstructure 1820. The micropattern of the microstructure 1820 is configured to prevent the inner wall of the intestine from sealing against the outer surface of the sheath 1803 in response to the vacuum, thereby promoting 360° fluid communication within the negative pressure chamber 1812. Thus, the micropattern of the microstructure 1820 prevents the intestinal tissue from closing against the outer surface of the sheath 1803 and creating a sub-chamber of vacuum within the negative pressure chamber 1812. Therefore, the micropattern of the microstructure 1820 maintains a vacuum throughout the vacuum chamber 1812 so that when negative pressure is applied to the vacuum chamber 1812, the anchor 1801 remains anchored in the target location. By implementing a micropattern of microstructures on the outer surface of the sheath inside the vacuum chamber to promote 360° fluid communication within the vacuum chamber, as well as a recessed central region to improve mechanical anchoring, for example, an anchor having a dogbone shape similar to an hourglass, and automated pump parameter adjustment to improve vacuum maintenance, the overall length of the anchor stent / scaffold can be reduced to, for example, 80-90 mm or even 70 mm.

[0153] Referring here to Figures 19A-19C, an exemplary manifold for fluidly coupling fluid inlet and sensing pipes to a negative pressure chamber and individual pumps and pressure / vacuum transducers is provided. As shown in Figure 19A, the manifold 1900 may include a first inlet port 1904 and a first outlet port 1905, through which a first inlet pipe 1814 is sized and molded to receive a first inlet pipe 1814 so that it extends into the manifold 1900 through a first inlet port 1904 and out of the manifold 1900 through a first outlet port 1905; and a second inlet port 1906 and a second outlet port 1907, through which a second inlet pipe 1816 is sized and molded to receive a second inlet pipe 1816 so that it extends into the manifold 1900 through a second inlet port 1906 and out of the manifold 1900 through a second outlet port 1907. In addition, the manifold 1900 may include a third inlet port 1908, which is sized and molded to receive the downstream end of the distal portion of the sensing pipe 1818 through it, so that the sensing pipe 1818 extends into the manifold 1900 through a third inlet port 1908 and out from the manifold 1900 through a third outlet port 1909, and a third outlet port 1909, which is sized and molded to receive the upstream end of the proximal portion of the sensing pipe 1818 through it.

[0154] As described above, the distal / upstream regions of the fluid inlet pipes 1814, 1816 and the sensing pipe 1818 may extend toward and be located within the negative pressure chamber of the anchor, and the proximal / downstream ends of the fluid inlet pipes 1814, 1816 and the sensing pipe 1818 may extend toward and be fluidically coupled to individual pumps and pressure / vacuum transducers. As shown in Figures 19B and 19C, the manifold 1900 may further include a clamp 1910 configured to transition between an open state, as shown in Figure 19B, which allows fluid to flow out through the sensing pipe 1818, and a closed state, as shown in Figure 19C, which prevents fluid flow through at least a portion of the sensing pipe 1818 beyond, for example, the clamp 1910. As shown in Figure 19C, the clamp 1910 may be coupled to the proximal portion of the sensing pipe 1818 downstream of the joint between the fluid port 1902 and the sensing pipe 1818. Furthermore, the clamp 1901 may be removably coupled to the sensing tube 1818, or alternatively, it may be permanently fixed to / integrated with the sensing tube 1818.

[0155] The manifold 1900 may further include a flush port 1902 that is in fluid communication with the sensing pipe 1818. For example, the flush port 1902 may be fluidly coupled to the downstream end of the distal portion of the sensing pipe 1818 and the upstream end of the proximal portion of the sensing pipe 1818, as shown in Figure 19C. The flush port 1902 may be configured to receive fluid from a fluid source to flush the fluid inlet pipes 1814, 1816 and the sensing pipe 1818, for example, for normal cleaning / maintenance and / or to remove blockages therein. For example, clamp 1910 may be transitioned to its closed state, and fluid may be introduced through the fluid port 1902 so that clamp 1901 pushes the fluid forward and it flows upstream through the sensing pipe 1818 toward the negative pressure of the anchor. As negative pressure is applied to the negative pressure chamber through the fluid inlet pipes 1814 and 1816, the fluid in the negative pressure chamber will flow downstream through the fluid inlet pipes 1814 and 1816 toward the fluid reservoir chamber of the external pump, as shown in Figure 19C.

[0156] Figure 20 is a schematic diagram illustrating the internal components of an alternative negative pressure system for generating a vacuum within a negative pressure chamber. System 2000 may be constructed similarly to system 300 in Figures 3A and 3B and may be used in conjunction with any of the bypass devices described herein, for example, bypass device 1800 having a sensing line 1818, when a sensing line is utilized. For example, system 2000 may include a housing sized and molded to accommodate an external pump and may be fluidically coupled to the downstream ends of suction / fluid inlet pipes, for example, pipes 242, 216, 1814, and 1816. As shown in Figure 20, system 2000 may include a controller, for example, controller 400, which is in electrical communication with the electrical components of system 2000, for example, pump 2016 and pressure transducers 2004 and 2012, which are described in more detail below. System 2000 may include a fluid reservoir chamber 2002 which is fluidically coupled to pump 2016. The fluid reservoir chamber 2002 may be sized and molded to collect the fluid and waste products in the fluid discharged from the negative pressure chamber of the anchor. The controller 400 may be operably coupled to the pump 2016, for example, via a pump interface 414, as described above with respect to Figure 4. Thus, the pump interface 414 may cause the pump 2016 to generate a vacuum with a predetermined pressure in the negative pressure chamber via a fluid inlet pipe. For example, the fluid discharged from the negative pressure chamber may proceed through fluid inlet pipes 1814, 1816 and enter the fluid reservoir chamber 2002 via inlet 2006.

[0157] In addition, a vacuum / pressure transducer 2012 may be included, which is fluidically coupled to the negative pressure chamber of the anchor via a fluid reservoir chamber 2002 and suction / fluid inlet tubes coupled thereto, for example, fluid inlet tubes 1814, 1816. In some embodiments, each fluid inlet tube may be fluidically coupled to a dedicated pressure transducer to measure the pressure within the individual fluid inlet tube. The pressure transducer 2012 may be configured to measure the pressure in the negative pressure chamber via the fluid inlet tubes 1814, 1816 and generate one or more signals indicating the measured pressure for transmission to a controller 400, for example, a system parameter determination module 412. Thus, the system parameter determination module 412 may be configured to receive, process, and analyze the pressure data received from the pressure transducer 2012 and calculate the pressure in the negative pressure chamber via the fluid inlet tubes 1814, 1816.

[0158] As shown in Figure 20, the fluid inlet pipes 1814 and 1816 may be fluidically coupled together via a coupler 2005 so that a single fluid inlet line, which is in fluid communication with both fluid inlet pipes 1814 and 1816, is fluidically coupled to the fluid reservoir chamber 2002 via an inlet 2006 of the fluid reservoir chamber 2002. Excrement and other fluids in the fluid discharged from the negative pressure chamber may be collected within the fluid reservoir chamber 2002 so that the remaining fluid, e.g., gas, can exit the fluid reservoir chamber 2002 via an outlet 2008, proceed across a filter 2009, and exit the system 2000 via a pump 2016. In addition, the system 2000 may include a filter 2009 positioned between the fluid reservoir chamber 2002 and the pump 2016 to prevent excrement from entering the pump 2016. The fluid reservoir chamber 2002 may be removably coupled to the housing to facilitate the removal of waste matter from the fluid reservoir chamber 2002 and / or the cleaning of the fluid reservoir chamber 2002. Like system 300, system 2000 may further include one or more check valves, for example, fluidically coupled to suction tubes 1814, 1816 between the filter 2009 and the pump 2016, configured to allow the pump 2016 to return to ambient pressure, e.g., atmospheric pressure, without affecting the pressure of system 2000.

[0159] As shown in Figure 20, the system 2000 may include a vacuum / pressure transducer 2004 that is fluidly coupled to the negative pressure chamber of the anchor via a dedicated sensing tube 1818, which has a direct route to the negative pressure chamber and should at all times be free from potential blockages, such as excrement. The pressure transducer 2004 may be configured to measure the pressure in the negative pressure chamber via the sensing tube 1818 and generate one or more signals indicating the measured pressure for transmission to a controller 400, for example, a system parameter determination module 412, as described above with respect to Figure 4. Thus, the system parameter determination module 412 may be configured to receive, process, and analyze the pressure data received from the pressure transducer 2004 and calculate the pressure in the negative pressure chamber as measured by the sensing tube 1818. For example, if the system parameter determination module 412 determines that the pressure in the negative pressure chamber is outside a predetermined range, the controller 400 may automatically adjust one or more operating parameters of the pump 2016 and instruct the pump 2016 to operate according to the adjusted parameters, thereby maintaining the pressure in the negative pressure chamber within the predetermined range.

[0160] The system parameter determination module 412 may be configured to detect a vacuum pressure difference between the sensing tube 1818 and the fluid inlet tubes 1814, 1816 by comparing pressure measurement data received from pressure transducers 2004, 2012, for example, the pressure in the negative pressure chamber of the anchor, with the pressure in the fluid reservoir chamber 2002, and may determine the presence of blockage / deadheading / clogging in at least one of the fluid inlet tubes 1814, 1816, and / or when the fluid reservoir chamber 2002 is full and needs to be emptied / changed, for example, when the detected pressure difference exceeds a predetermined pressure threshold. In some embodiments, the system 2000 may include one or more additional sensors that are fluidically coupled to the fluid reservoir chamber 2002 and configured to measure the amount of excrement in the fluid reservoir chamber 2002. One or more additional sensors may generate one or more signals indicating the level of excrement in the fluid reservoir chamber 2002 for transmission to the controller 400.

[0161] In addition, the controller 400 of the system 2000 may generate one or more alerts, for example, via the alert generation module 416 of the controller 400, as described above with respect to Figure 4. For example, the alert generation module 416 may be configured to generate alerts when the pressure in the negative pressure chamber is outside a predetermined range, when the measured amount of excrement in the fluid reservoir chamber 2002 exceeds a predetermined threshold, or when the presence of a blockage is detected in the fluid inlet pipes 1814, 1816, in order to periodically encourage the user to perform routine manual inspections of the system 2000.

[0162] Referring here to Figures 21A and 21B, internal components of an alternative exemplary negative pressure system are provided. The negative pressure system 2100 may be constructed similarly to system 300. For example, a fluid reservoir chamber 2102 having an inlet 2106, a pump 2112, and a pressure transducer 2112, configured to be fluidly coupled to one or more suction tubes, e.g., suction tubes 214, 216, corresponds to a fluid reservoir chamber 302 having an inlet 306, a pump 316, and a pressure transducer 312. System 2100 differs from system 300 in that system 2100 may include a pressure normalization chamber 2104, fluidly coupled to the pump 2116. For example, the fluid reservoir chamber 2102 may be fluidly coupled to the pressure normalization chamber 2104 via a valve 2110, e.g., a solenoid valve, as shown in Figure 21A. The valve 2110 may be configured to operate to transition between a closed state in which the fluid reservoir chamber 2102 is fluidly isolated from the pressure normalization chamber 2104 and an open state in which the fluid reservoir chamber 2102 is fluidly coupled to the pressure normalization chamber 2104.

[0163] In addition, the pressure normalization chamber 2104 may include a check valve 2114 configured to actuate so that the pressure normalization chamber 2104 can reach atmospheric pressure. For example, the check valve 2114 may be actuated to the open position prior to turning on the pump 2116, thereby enabling the pressure normalization chamber 2104. When the pressure in the pressure normalization chamber 2104 is atmospheric pressure, the pump 2116 may be turned on, the check valve 2114 may be actuated to the closed position, and the valve 2110 may be actuated to the open position and fluidly coupled to the pump 2116, the fluid reservoir chamber 2102, and the pressure normalization chamber 2104. In some embodiments, instead of the check valve 2114, the system 2100 may include a small controlled leak configured to actuate so that the pressure normalization chamber 2104 can reach atmospheric pressure, for example, when the system 2100 is under steady-state conditions.

[0164] Furthermore, excrement and other fluids in the fluid discharged from the negative pressure chamber 212 may be collected in the fluid reservoir chamber 2102 so that the remaining fluid, for example, gas, can proceed across the valve 2110 in its open state to the pressure normalization chamber 2104 and exit the system 2100 via the pump 2116. For example, the fluid may exit the pressure normalization chamber 2104 via the outlet 2108. As shown in Figure 21B, the system 2100 may include a controller 400 that is in electrical communication with the electrical components of the system 2100, for example, the pump 2116 and the pressure transducer 2112. In some embodiments, the system 2100 may include one or more additional sensors that are fluidically coupled to the fluid reservoir chamber 2102 and configured to measure the amount of excrement in the fluid reservoir chamber 2102. One or more additional sensors may generate one or more signals indicating the level of excrete in the fluid reservoir chamber 2102 for transmission to the controller 400.

[0165] While various illustrative embodiments of the present invention are described above, it will be apparent to those skilled in the art that various changes and modifications can be made herein without departing from the present invention. For example, any of the bypass devices described above, e.g., bypass devices 200, 1000, 1100, 1200, 1300, 1400, 1500, 1700, 1800, may incorporate upstream and / or downstream retrieval loops and / or dual anchors as described above to facilitate the removal of individual anchors from the patient's GI tube. The appended claims are intended to cover all such changes and modifications that fall within the true scope of the invention.

Claims

1. A system for monitoring a bypass device for protecting a bowel anastomosis, wherein the bypass device comprises a negative pressure chamber and is configured to be implanted at a target location upstream of the bowel anastomosis, and the system, Pump and One or more fluid inlet pipes, each of which has a downstream end connected to the pump and an upstream end having one or more pores that communicate fluidly with the negative pressure chamber of the bypass device, One or more sensors configured to measure data indicating the pressure inside the negative pressure chamber, A controller operably coupled to the pump and one or more sensors, wherein the controller is The pump is operated with predetermined pump parameters to discharge fluid from the negative pressure chamber through one or more fluid inlet pipes, thereby generating a vacuum within the negative pressure chamber having a pressure within a predetermined pressure range, wherein the vacuum is sufficient to pull the intestinal tissue toward the bypass device and to anchor the bypass device to a target location upstream of the intestinal anastomosis. The data indicating the pressure in the negative pressure chamber, received over time from one or more sensors, is compared with the predetermined pressure range. If the pressure in the negative pressure chamber is outside the predetermined pressure range, the pump adjusts its predetermined pump parameters so that it applies the vacuum in the negative pressure chamber and maintains the pressure within the predetermined range. A controller and programmed with instructions configured to perform the following actions A system that includes these features.

2. The system according to claim 1, wherein the controller is configured to generate an alert when the pressure in the negative pressure chamber is outside the predetermined pressure range.

3. The system according to claim 2, wherein the alert comprises at least one of an audible or visual alert.

4. The system according to claim 1, wherein the controller is configured to generate an alert if the pressure in the negative pressure chamber is not within the predetermined pressure range within a predetermined period of time.

5. The system according to claim 1, wherein the controller is configured to adjust a predetermined pressure range of the vacuum over time.

6. The system according to claim 1, wherein the controller is configured to stop the operation of the pump when the pressure in the negative pressure chamber is within the predetermined pressure range.

7. The system according to claim 1, further comprising one or more check valves in fluid communication with the pump, wherein the one or more check valves are configured to transition between a closed state and an open state to bring the pump to ambient pressure.

8. The aforementioned controller, To calculate the actual pump operating time of the pump in order to achieve a predetermined total volume of the system, If the actual pump operating time deviates from the expected pump operating time, it is determined that there is an obstruction in the system. The system according to claim 1, configured to perform the following:

9. The system according to claim 8, wherein the controller is configured to calculate the volume of the system in real time based on data measured by the one or more sensors, and the controller is configured to calculate the expected pump operating time of the pump based on the real-time volume of the system.

10. The system according to claim 8, wherein the controller is configured to generate an alert in response to a determination of the presence of an obstruction in the system.

11. The system according to claim 1, further comprising a fluid reservoir chamber in fluid communication with one or more fluid inlet pipes, wherein the fluid reservoir chamber is configured to collect at least one of liquid or solid waste from the fluid discharged from the negative pressure chamber.

12. The system according to claim 11, wherein the one or more sensors include pressure transducers operably coupled to the fluid reservoir chamber.

13. The one or more fluid inlet tubes are operably coupled to pressure transducers which are operably coupled to the controller, and the pressure transducers are configured to measure data indicating the pressure in the fluid reservoir chamber, and the controller, The data indicating the pressure in the negative pressure chamber, received from one or more sensors, is compared with the data indicating the pressure in the fluid reservoir chamber, received from the pressure transducer. If the pressure difference between the pressure in the negative pressure chamber and the pressure in the fluid reservoir chamber falls below a predetermined pressure threshold, it is determined that there is an obstruction in one or more fluid inlet pipes. The system according to claim 11, configured to perform the following:

14. The system according to claim 1, further comprising a housing configured to include at least the pump and the controller therein.

15. The system according to claim 14, wherein the housing is sized and molded to fit the patient.

16. The system according to claim 14, wherein the housing is configured to be mounted on a bedside or on an IV pole.

17. The system according to claim 14, wherein the housing comprises a user interface operably coupled to the controller.

18. The system according to claim 17, wherein the user interface is configured to allow the user to select the predetermined pump parameter from a plurality of predetermined pump parameters.

19. The system according to claim 17, wherein the user interface includes a display for displaying information associated with the bypass device.

20. The system according to claim 1, wherein the one or more sensors are arranged on the bypass device.

21. The negative pressure chamber is defined by a mesh anchor that is sealed to the inner sheath via a downstream seal and an upstream seal, and the mesh anchor is configured to engage with the intestinal tissue when extended and deployed. The system according to claim 1, wherein the one or more fluid inlet pipes extend across the downstream seal such that the one or more pores are located within the negative pressure chamber.

22. The system according to claim 21, wherein the inner sheath has a length such that it extends from the mesh anchor at the target location across the intestinal anastomosis and outward from the anal opening, and the inner sheath has a lumen that is sized and shaped to allow feces to pass through the intestinal anastomosis without contacting it.

23. The system according to claim 21, wherein the mesh anchor comprises a downstream region, an upstream region, and a central region extending between the downstream region and the upstream region, the central region having an outer diameter less than the outer diameter of the downstream region and the upstream region.

24. The system according to claim 23, further comprising a central seal, the central seal sealing the inner sheath to the central region of the mesh anchor, thereby defining a first negative pressure chamber between the inner sheath, the downstream seal, the central seal, and a portion of the mesh anchor between the downstream seal and the central seal, and defining a second negative pressure chamber between the inner sheath, the upstream seal, the central seal, and a portion of the mesh anchor between the upstream seal and the central seal.

25. The first set of one or more fluid inlet tubes extends across the downstream seal such that one or more pores of the first set of one or more fluid inlet tubes are located within the first negative pressure chamber. The system according to claim 24, wherein the second set of one or more fluid inlet tubes extends across the downstream seal and the central seal such that one or more pores of the second set of one or more fluid inlet tubes are located within the second negative pressure chamber.

26. The system according to claim 24, wherein the central seal comprises a seal ring having a plurality of inlet ports configured to be fluidly coupled to the pump via one or more suction tubes.

27. The system according to claim 21, wherein the downstream seal comprises a seal ring having a plurality of inlet ports configured to be fluidly coupled to the pump via one or more suction tubes.

28. The upstream seal extends along the upstream region of the mesh anchor and covers the upstream end of the mesh anchor. The system according to claim 21, wherein the upstream seal is configured to prevent inward growth of mucosa on the bypass device and to prevent damage to the intestinal tissue.

29. The downstream seal extends along the downstream region of the mesh anchor and covers the downstream end of the mesh anchor. The system according to claim 28, wherein the downstream seal is configured to prevent inward growth of mucosa on the bypass device and to prevent damage to the intestinal tissue.

30. The aforementioned mesh anchor is, An inner mesh anchor comprising a downstream region, an upstream region, and a central region extending between the downstream region and the upstream region, wherein the central region has an outer diameter less than the outer diameter of the downstream region and the upstream region, An outer mesh anchor is positioned across the inner mesh anchor, wherein the outer mesh anchor is configured to transition from a cylindrical configuration to a shape corresponding to the geometric shape of the inner mesh anchor when the vacuum is generated in the negative pressure chamber. The system according to claim 21, comprising:

31. The system further comprises one or more additional sensors configured to measure data indicating the presence of at least one of blood, feces, or a predefined gas between the bypass device and the intestinal tissue surrounding the bypass device, The system according to claim 1, wherein the controller is configured to generate an alert if the level of at least one of blood, feces, or a predefined gas exceeds a predetermined threshold.

32. The system further comprises one or more additional sensors configured to measure data indicating the position of the bypass device relative to the intestinal anastomosis, The system according to claim 1, wherein the controller is configured to generate an alert if the position of the bypass device relative to the intestinal anastomosis indicates that the bypass device is sliding away from the target location.

33. The one or more fluid inlet pipes are, A first fluid inlet pipe having a first downstream end coupled to the pump and a first upstream end having a first set of one or more pores that are in fluid communication with the negative pressure chamber of the bypass device, A second fluid inlet pipe having a second downstream end coupled to the pump and a second upstream end having a second set of one or more pores that are in fluid communication with the negative pressure chamber of the bypass device. The system according to claim 1, comprising:

34. The system according to claim 33, wherein the first upstream end and the second upstream end of the first fluid inlet pipe and the second fluid inlet pipe are equally spaced apart in the circumferential direction within the negative pressure chamber.

35. The system according to claim 33, wherein the one or more sensors comprises a sensing tube having a third downstream end coupled to a vacuum transducer and a third upstream end in fluid communication with the negative pressure chamber of the bypass device.

36. The first fluid inlet pipe, the second fluid inlet pipe, and the sensing pipe are further configured to be fluidly coupled to the pump and the vacuum transducer, respectively, and the manifold is A first inlet port and a first outlet port configured to receive the first fluid inlet pipe through them, A second inlet port and a second outlet port configured to receive the second fluid inlet pipe through them, A third inlet port configured to receive the downstream end of the distal portion of the aforementioned sensing tube, A third outlet port is configured to receive the upstream end of the proximal portion of the aforementioned sensing tube through it, A flush port that is in fluid communication with the downstream end of the distal portion of the sensing pipe and the upstream end of the proximal portion of the sensing pipe, wherein the flush port is configured to receive fluid for flushing the pipe, and The system according to claim 35, comprising:

37. The system according to claim 36, wherein the manifold comprises a clamp positioned on the proximal portion of the sensing pipe, the clamp being configured to transition between an open state in which fluid flow is permitted throughout the entire length of the sensing pipe and a closed state in which fluid flow is blocked in the sensing pipe downstream of the clamp.

38. A bypass device configured to be implanted at a target location upstream of the intestinal anastomosis in order to protect the intestinal anastomosis, wherein the bypass device is An inner mesh anchor comprising a downstream region, an upstream region, and a central region extending between the downstream region and the upstream region, wherein the central region has an outer diameter less than the outer diameter of the downstream region and the upstream region, An outer mesh anchor is positioned across the inner mesh anchor, wherein the outer mesh anchor is configured to transition between a cylindrical configuration configured to engage with the inner wall of the intestine and a shape corresponding to the geometric shape of the inner mesh anchor. A sheath, the sheath being at least partially positioned within the inner mesh anchor and coupled to the inner mesh anchor and the outer mesh anchor, defining a negative pressure chamber between the outer surface of the sheath and the inner wall of the intestine, the sheath having a lumen that is sized and shaped to allow feces to pass through it without contacting the intestinal anastomosis, and Equipped with, A bypass device configured such that, in response to the application of negative pressure into the negative pressure chamber, the outer mesh anchor transitions from a cylindrical configuration to a shape corresponding to the geometric shape of the inner mesh anchor.

39. The bypass device according to claim 38, wherein the geometric shape of the inner mesh anchor is hourglass-shaped.

40. The bypass device according to claim 38, wherein the sheath has a length such that it extends from the inner mesh anchor and the outer mesh anchor at the target location across the intestinal anastomosis and outward from the anal opening.

41. The bypass device according to claim 38, wherein the sheath is sealed to the upstream and downstream regions of the inner mesh anchor and the outer mesh anchor via an upstream seal and a downstream seal, respectively, thereby defining the negative pressure chamber between the outer surface of the sheath, the upstream seal and the downstream seal and the inner wall of the intestine.

42. The bypass device according to claim 41, wherein the upstream region of the sheath extends through the lumen of the inner mesh anchor, and the upstream region of the sheath is wrapped around the upstream ends of the inner mesh anchor and the outer mesh anchor such that the upstream region of the sheath sandwiches the upstream regions of the inner mesh anchor and the outer mesh anchor, and the upstream seal is thermally bonded to the upstream region of the sheath, the inner mesh anchor and the outer mesh anchor.

43. The bypass device according to claim 41, wherein the upstream seal is configured to prevent inward growth of mucosa in the upstream regions of the inner mesh anchor and the outer mesh anchor, thereby preventing damage to the intestinal tissue surrounding the bypass device.

44. The outer mesh anchor further comprises a sheath material positioned over the downstream region of the outer mesh anchor, The bypass device according to claim 41, wherein the downstream seal is thermally bonded to the sheath material and the downstream region of the sheath, the inner mesh anchor, and the outer mesh anchor.

45. The bypass device according to claim 41, wherein the downstream seal is configured to prevent inward growth of mucosa in the downstream regions of the inner mesh anchor and the outer mesh anchor, thereby preventing damage to the intestinal tissue surrounding the bypass device.

46. One or more fluid inlet tubes, each of which has a downstream end connected to a pump and an upstream end having one or more pores that communicate fluidly with the negative pressure chamber. Furthermore, The bypass device according to claim 41, wherein the one or more fluid inlet tubes extend across the downstream seal such that the one or more pores are located within the negative pressure chamber.

47. The bypass device according to claim 46, further comprising one or more check valves in fluid communication with the pump, wherein the one or more check valves are configured to transition between a closed state and an open state to bring the pump to ambient pressure.

48. The first set of one or more fluid inlet tubes extends across the downstream seal such that one or more pores of the first set of one or more fluid inlet tubes are located within the first negative pressure chamber. The bypass device according to claim 46, wherein the second set of one or more fluid inlet tubes extends across the downstream seal and the central seal such that one or more pores of the second set of one or more fluid inlet tubes are located within the second negative pressure chamber.

49. The bypass device according to claim 46, wherein the upstream ends of one or more fluid inlet pipes are equally and circumferentially spaced apart within the negative pressure chamber.

50. The bypass device according to claim 46, further comprising a housing configured to include at least the pump therein.

51. The bypass device according to claim 50, wherein the housing is sized and molded to fit the patient.

52. The bypass device according to claim 50, wherein the housing includes a user interface configured to allow a user to select the pump parameters of the pump from a plurality of predetermined pump parameters.

53. The bypass device according to claim 52, wherein the user interface includes a display for displaying information associated with the bypass device.

54. The bypass device according to claim 46, further comprising one or more sensors configured to measure data indicating the pressure in the negative pressure chamber.

55. The pump and the one or more sensors are further operably coupled to a controller, the controller is The pump is operated with predetermined pump parameters to discharge fluid from the negative pressure chamber through one or more fluid inlet pipes, thereby generating a vacuum within the negative pressure chamber having a pressure within a predetermined pressure range, wherein the vacuum is sufficient to pull the intestinal tissue toward the bypass device and to anchor the bypass device to a target location upstream of the intestinal anastomosis. Comparing data indicating the pressure in the negative pressure chamber, received over time from one or more sensors, with the predetermined pressure range, If the pressure in the negative pressure chamber is outside the predetermined pressure range, the pump adjusts its predetermined pump parameters so that it applies the vacuum in the negative pressure chamber and maintains the pressure within the predetermined range. The bypass device according to claim 54, programmed with instructions configured to perform the following:

56. The aforementioned controller, To calculate the actual pump operating time of the pump in order to achieve a predetermined total volume of the system, If the actual pump operating time deviates from the expected pump operating time, it is determined that there is an obstruction in the system. The bypass device according to claim 55, configured to perform the following:

57. The bypass device according to claim 56, wherein the controller is configured to calculate the volume of the system in real time based on data measured by the one or more sensors, and the controller is configured to calculate the expected pump operating time of the pump based on the real-time volume of the system.

58. The bypass system according to claim 56, wherein the expected pump operating time is determined in advance.

59. The bypass device according to claim 56, wherein the controller is configured to generate an alert in response to a determination of the presence of an obstruction in the system.

60. The bypass device according to claim 55, wherein the controller is configured to generate an alert when the pressure in the negative pressure chamber is outside the predetermined pressure range.

61. One or more additional sensors configured to measure data indicating the presence of at least one of blood, feces, or a predefined gas between the bypass device and the intestinal tissue surrounding the bypass device. Furthermore, The bypass device according to claim 55, wherein the controller is configured to generate an alert if the level of at least one of blood, feces, or a predefined gas exceeds a predetermined threshold.

62. The system further comprises one or more additional sensors configured to measure data indicating the position of the bypass device relative to the intestinal anastomosis, The bypass device according to claim 55, wherein the controller is configured to generate an alert if the position of the bypass device relative to the intestinal anastomosis indicates that the bypass device is sliding away from the target location.

63. Prior to the application of the negative pressure into the negative pressure chamber, the inner mesh anchor has an hourglass configuration, and the outer mesh anchor has a cylindrical configuration. The bypass device according to claim 38, wherein, in response to the application of the negative pressure into the negative pressure chamber, both the outer mesh anchor and the inner mesh anchor exhibit the hourglass configuration while they are at the target location in the intestine.

64. A method for protecting the intestinal anastomosis, wherein the method is The bypass device is positioned at a target location upstream of the intestinal anastomosis in the patient, wherein the bypass device comprises an inner mesh anchor, an outer mesh anchor positioned across the inner mesh anchor, and a sheath, at least partially positioned within the inner mesh anchor and coupled to the inner and outer mesh anchors, defining a negative pressure chamber between the outer surface of the sheath and the inner wall of the intestine, wherein the inner mesh anchor comprises a downstream region, an upstream region, and a central region extending between the downstream and upstream regions, the central region having an outer diameter less than the outer diameters of the downstream and upstream regions. Applying negative pressure to the negative pressure chamber and Includes, A method wherein, in response to the application of negative pressure into the negative pressure chamber, the outer mesh anchor transitions from a cylindrical configuration to a shape corresponding to the geometric shape of the inner mesh anchor.

65. Prior to the application of the negative pressure into the negative pressure chamber, the inner mesh anchor has an hourglass configuration, and the outer mesh anchor has a cylindrical configuration. The method according to claim 64, wherein, in response to the application of the negative pressure into the negative pressure chamber, both the outer mesh anchor and the inner mesh anchor exhibit the hourglass configuration while they are in the target location in the intestine.

66. The further includes connecting the downstream end of one or more fluid inlet tubes extending from the negative pressure chamber of the bypass device to a pump outside the patient's anal opening, The method according to claim 64, wherein applying negative pressure into the negative pressure chamber is to operate the pump at pump parameters to discharge fluid from the negative pressure chamber through one or more fluid inlet pipes, thereby generating a vacuum within the negative pressure chamber having a pressure within a predetermined pressure range, the vacuum being sufficient to pull intestinal tissue within the negative pressure chamber and to anchor the bypass device at the target location.

67. The pressure inside the negative pressure chamber is measured over time via one or more pressure sensors, If the pressure in the negative pressure chamber is outside the predetermined pressure range, the pump parameters of the pump are adjusted so that the pump applies the vacuum in the negative pressure chamber and maintains the pressure within the predetermined range. The method according to claim 66, further comprising:

68. An introduction device for delivering a bypass device for protecting the intestinal anastomosis into the intestine, wherein the introduction device is A guide tube having a lumen, the guide tube is A first tubular portion configured to hold the bypass device in a crushed delivery state, the first tubular portion comprising an upstream end configured to be introduced into the intestine through the external anal opening, and a length such that the upstream end can be positioned at a target location upstream of the intestinal anastomosis, A second tubular portion downstream of the first tubular portion, wherein the outer surface of the second tubular portion is provided with one or more grooves, and A guide tube equipped with, A handle operably coupled to the second tubular portion via one or more features configured to slidably engage with one or more grooves, wherein the handle comprises an actuator configured to rotate via the slidable engagement between the one or more features and the one or more grooves, causing axial parallel movement of the guide tube relative to the handle. An introduction device equipped with the following features.

69. The introducer device according to claim 68, wherein the upstream end of the first tubular portion comprises a plurality of flexible cutout tabs configured to transition between a closed tulip configuration and an open configuration.

70. The introducer device according to claim 68, wherein the one or more grooves extend along the outer surface of the second tubular portion in a circumferential and axial pattern such that the rotation of the actuator causes the rotation of the one or more features to occur relative to the second tubular portion, and the movement of the one or more features along the one or more grooves causes the axial parallel movement of the guide tube to occur relative to the handle.

71. The introduction device according to claim 70, wherein the outer surface of the second tubular portion further comprises a linear track, and the handle further comprises an engager configured to slidably engage with the linear track such that the engagement between the engager and the linear track prevents the guide tube from rotating relative to the handle as the guide tube moves axially parallel to the handle.

72. The handle comprises one or more flexible tabs extending circumferentially along at least a portion of the outer surface of the handle, the one or more flexible tabs being configured to transition between a radially compressed state and a radially expanded state, and the one or more flexible tabs being biased toward the radially expanded state. The introducer device according to claim 68, wherein the inner surface of the actuator comprises one or more grooves configured to slidably engage with one or more flexible tabs, and the one or more grooves have an outer shape with a stopping feature such that rotation of the actuator in a first direction relative to the handle is permitted, while rotation of the actuator in a second direction opposite to the first direction relative to the handle is prevented in the radially extended state in accordance with the engagement of the one or more flexible tabs and the stopping feature.

73. The introduction device according to claim 68, further comprising a stopper positioned between the first tubular portion and the second tubular portion, wherein the stopper has an outer diameter larger than the outer diameter of the first tubular portion.

74. The introduction device according to claim 68, further comprising a pusher having a downstream end coupled to the handle and an upstream end slidably positioned within the lumen of the guide tube at a position downstream of the bypass device in the compressed delivery state, such that axial parallel movement of the guide tube downstream of the handle engages the upstream end of the pusher with the bypass device and maintains the bypass device at the target position upstream of the intestinal anastomosis until the bypass device is exposed beyond the upstream end of the guide tube and transitions to an expanded deployed state.

75. A method for protecting the intestinal anastomosis, wherein the method is The bypass device is introduced into the intestine through the external anal opening, and the bypass device is positioned at a target location upstream of the intestinal anastomosis. Deploying the bypass device at the target location, The downstream end of one or more fluid inlet pipes extending from the negative pressure chamber of the bypass device is connected to a pump outside the anal opening, The pump is operated according to the pump parameters to discharge fluid from the negative pressure chamber through one or more fluid inlet pipes, thereby generating a vacuum within the negative pressure chamber having a pressure within a predetermined pressure range, wherein the vacuum is sufficient to pull the intestinal tissue within the negative pressure chamber and anchor the bypass device at the target location. The pressure inside the negative pressure chamber is measured over time via one or more pressure sensors, If the pressure in the negative pressure chamber is outside the predetermined pressure range, the pump parameters of the pump are adjusted so that the pump applies the vacuum in the negative pressure chamber and maintains the pressure within the predetermined range. Methods that include...

76. Introducing the bypass device into the intestine through the anal ostia includes introducing a first tubular portion of the guide tube of the introduction device through the anal ostia, wherein the first tubular portion positions the bypass device therein in a compressed delivery state. The method according to claim 75, wherein deploying the bypass device at the target location involves a sliding engagement between one or more notches of the handle and one or more grooves extending along the outer surface of the second tubular portion causing an axial parallel movement of the guide tube relative to the handle, thereby rotating an actuator of the handle which is operably coupled to the second tubular portion of the guide tube downstream of the first tubular portion, so as to expose the bypass device beyond the upstream end of the first tubular portion.

77. The method according to claim 75, further comprising generating an alert via a controller operably coupled to one or more sensors if the pressure in the negative pressure chamber is outside the predetermined pressure range.

78. The method according to claim 75, further comprising generating an alert via a controller operably coupled to one or more sensors if the pressure in the negative pressure chamber is not within the predetermined pressure range for a predetermined period of time.

79. The method according to claim 75, further comprising stopping the operation of the pump when the pressure in the negative pressure chamber is within the predetermined pressure range.

80. Collecting at least one of liquid or solid waste from the fluid discharged from a negative pressure chamber in a reservoir that is in fluid communication with one or more fluid inlet pipes, Monitoring the level of at least one of the liquid or solid waste in the reservoir, When the level of at least one of the liquid or solid waste in the reservoir exceeds a predetermined threshold, an alert is generated. The method according to claim 75, further comprising:

81. The negative pressure chamber is defined by a mesh anchor sealed to an inner sheath via a downstream seal and an upstream seal, the downstream seal extending along the downstream region of the mesh anchor and covering the downstream end of the mesh anchor, and the upstream seal extending along the upstream region of the mesh anchor and covering the upstream end of the mesh anchor. Deploying the bypass device at the target location includes extending the mesh anchor to an expanded and deployed state such that the upstream seal and the downstream seal form a seal against the intestinal tissue, The method according to claim 75, wherein the upstream seal and the downstream seal prevent inward growth of mucosa on the bypass device and prevent damage to the intestinal tissue.

82. The aforementioned mesh anchor is, An inner mesh anchor comprising a downstream region, an upstream region, and a central region extending between the downstream region and the upstream region, wherein the central region has an outer diameter less than the outer diameter of the downstream region and the upstream region, An outer mesh anchor is positioned across the inner mesh anchor, wherein the outer mesh anchor is configured to transition from a cylindrical configuration to a shape corresponding to the geometric shape of the inner mesh anchor when the vacuum is generated in the negative pressure chamber. Equipped with, The method according to claim 81, wherein, in response to the operation of the pump for generating the vacuum in the negative pressure chamber, the outer mesh anchor transitions from a cylindrical configuration to a shape corresponding to the geometric shape of the inner mesh anchor.

83. The method according to claim 75, wherein adjusting the pump parameters of the pump when the pressure in the negative pressure chamber is outside the predetermined pressure range includes automatically adjusting the pump parameters of the pump via one or more sensors and a controller operably coupled to the pump when the pressure in the negative pressure chamber is outside the predetermined pressure range.

84. To calculate the actual pump operating time of the pump in order to achieve a predetermined total volume of the system, If the actual pump operating time deviates from the expected pump operating time, it is determined that there is an obstruction in the system. The method according to claim 75, further comprising:

85. The pressure in a fluid reservoir chamber that is in fluid communication with one or more fluid inlet pipes is measured via a pressure transducer, The pressure in the negative pressure chamber is compared with the pressure in the fluid reservoir chamber, If the pressure difference between the pressure in the negative pressure chamber and the pressure in the fluid reservoir chamber falls below a predetermined pressure threshold, it is determined that there is an obstruction in one or more fluid inlet pipes. The method according to claim 75, further comprising:

86. The method according to claim 75, further comprising generating an alert via one or more sensors and a controller operably coupled to the pressure transducer in response to a determination of the presence of an obstruction in one or more fluid inlet pipes.

87. The method according to claim 75, further comprising flushing the one or more fluid inlet pipes and removing the blockage via a manifold that fluidly connects the one or more fluid inlet pipes to the negative pressure chamber and the pump.

88. The method according to claim 75, wherein the one or more fluid inlet pipes comprises a first fluid inlet pipe and a second fluid inlet pipe extending from the negative pressure chamber of the bypass device to the pump.

89. The method according to claim 75, wherein measuring the pressure in the negative pressure chamber over time via one or more pressure sensors includes measuring the pressure in the negative pressure chamber over time via a vacuum transducer and a sensing tube extending from the negative pressure chamber to the vacuum transducer.

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