Patent ID: 12213673

DETAILED DESCRIPTION

The present disclosure provides systems and devices for creating an internal bypass within a target area of the gastrointestinal (GI) tract of a patient to allow feces and other waste matter to pass through the target area without contacting the walls of the GI tract at the target area. The target area may be, for example, an anastomosis site in the colon, rectum, or anal passage created after bowel resection surgery to treat certain blockages and diseases, such as colorectal cancer, diverticulitis, severe bleeding, obstructions, and the like. The bypass device may be secured to a target site upstream of the anastomosis site via a negative pressure system including, for example, an external pump fluidicly coupled to a negative pressure chamber of the bypass device via suitable medical tubing, or the like. The external pump further may include a “smart” vacuum monitoring system that monitors the pressure within the negative pressure chamber, and automatically responds when the pressure within the negative pressure chamber falls outside of a predetermined range. For example, the smart vacuum monitoring system may automatically adjust the pump parameters and/or turn the pump on to maintain the pressure within the negative pressure chamber within the predetermined range. In addition, the smart vacuum monitoring system may generate an alert to inform a user when the pressure within the negative pressure chamber falls outside of the predetermined range. Accordingly, the systems described herein provide constant sensing and the ability to more rapidly and continuously maintain a specific vacuum threshold. The present disclosure further provides a delivery system for introducing the bypass device at the target area of the GI tract.

Referring now toFIG.1, system100for monitoring a bypass device for protecting an intestinal anastomosis is provided. As shown inFIG.1, system100may include bypass device200configured to be anchored within a patient's GI tract, e.g., upstream of intestinal anastomosis AS, for allowing feces and other waste matter to pass through anastomosis AS without contacting the walls of the GI tract at anastomosis AS. For example, as described in further detail below, bypass device200may include an anchor for securing bypass device200at the location upstream of anastomosis AS via a negative pressure system, e.g., negative pressure system300, fluidicly coupled to bypass device200external to the patient, as well as a sheath coupled to the anchor and extending through the GI tract across anastomosis AS and extending through the patient's anus, as shown inFIG.1. The sheath may have a lumen sized and shaped to permit feces and other waste matter to pass therethrough.

Referring now toFIGS.2A to2C, bypass device200for providing an internal bypass at a target site within the GI tract of the patient is provided. As shown inFIG.2A, bypass device200having flared downstream region202, flared upstream region204, and recessed middle region206extending between downstream region202and upstream region204, may include inner anchor201, outer anchor220disposed circumferentially around inner anchor201, and elongated flexible sheath203coupled to inner and outer anchors201,220and extending therefrom in a downstream direction. Inner and outer anchors201,220may each be formed by a stent/scaffold, e.g., a self-expandable braided wire mesh. As shown inFIG.2B, inner anchor201may have a pre-formed shape, e.g., an hourglass/bone shape, defining recessed middle region206of bypass device200. For example, middle region206defined by inner anchor201may have an outer diameter that is less than the outer diameters of downstream region202and upstream region204, thereby providing a larger volume between the outer surface of middle region206and the wall of the intestine to improve negative pressure chamber engagement with the intestinal tissue during application of the vacuum. Preferably, inner anchor201may be symmetric such that downstream region202may have an outer diameter that is equal to the outer diameter of upstream region204. Outer anchor220may be configured to transition between a natural cylindrical configuration to a shape corresponding with inner anchor201when system100is under vacuum, as shown inFIG.2C.

Inner and outer anchors201,220may be coupled together at their respective upstream and downstream ends, as well as to a distal region of sheath203. For example, as shown inFIG.2B, an upstream region of sheath203may extend through the lumen of anchor201and wrap around the upstream ends of inner and outer anchors201,220, such that the upstream region of sheath203contacts the outer surface of an upstream region of outer anchor220and the inner surface of an upstream region of inner stent201. Moreover, the upstream region of sheath203may be coupled to the upstream regions of inner and outer anchors201,220via upstream sealing ring210, which may extend along the periphery of the upstream ends of inner and outer anchors201,220, to thereby securely fasten sheath203to the upstream regions of inner and outer anchors201,220. In addition, sheath material218may be disposed circumferentially over a downstream region of outer anchor220, such that a portion of sheath203may be coupled to sheath material218and the downstream regions of inner and outer anchors201via downstream sealing ring204, which may extend along the periphery of the downstream ends of inner and outer anchors201,220, to thereby securely fasten sheath203to the downstream regions of inner and outer anchors201,220.

For example, upstream scaling ring210and downstream sealing ring208may be thermally bonded or solvent bonded to the upstream and downstream regions of inner and outer anchors201,220, sheath203, and sheath material218, e.g., via a reflow process. Alternatively, upstream sealing ring210and downstream sealing ring208may be compression molded onto or overmolded directly over the upstream and downstream regions of inner and outer anchors201,220. For example, upstream sealing ring210and downstream sealing ring208may be formed of a moldable thermoplastic material such as, thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and/or thermoplastic vulcanizate (TPV). Accordingly, negative pressure chamber212may be defined by an outer surface of sheath203, upstream sealing ring210, downstream sealing ring208, and the portion of outer anchor220between upstream scaling ring210and downstream sealing ring208. Together, inner and outer anchors201,220may be configured to provide an outward radial force against the walls of the intestine at the target site. Accordingly, inner and outer anchors201,220function to secure bypass device200at the target site in conjunction with the negative pressure system, and to hold open the target area within the GI tract such that feces and other waste matter may pass through sheath203without contacting the walls surrounding the anastomosis site. As described above, under vacuum, intestinal tissue may be pulled into negative pressure chamber212, thereby applying a radially inward force to outer anchor220and causing outer anchor220to transition from itself natural cylindrical configuration and conform to the pre-formed shape of inner anchor201, as shown inFIG.2C.

As described above, upstream sealing ring210and downstream scaling ring208may extend along the periphery of the upstream and downstream ends of inner and outer anchors201,220, respectively, thereby forming a soft, flexible upstream leading edge of inner and outer anchors201,220, and a soft, flexible downstream edge of inner and outer anchors201,220. Accordingly, upstream sealing ring210and downstream sealing ring208may prevent damage to the intestinal tissue adjacent to the upstream and downstream ends of inner and outer anchors201,220. In addition, upstream sealing ring210and downstream sealing ring208may provide longer sealing surfaces along upstream region204and downstream region202, respectively, and flexibility to aid in retrieval of bypass device200. Moreover, upstream sealing ring210and downstream scaling ring208may inhibit mucosal ingrowth on at least upstream region204and downstream region202of bypass device200, e.g., the areas covered by the sealing rings.

Sheath203has an outer surface and an internal channel for allowing passage of feces and other waste matter therethrough. Sheath203has a length selected to extend from the target site in the GI tract through the patient's intestines and anus to a location external to the patient, as shown inFIG.1. In some embodiments, the downstream end of sheath203may be coupled to a collection vessel (not shown) external to the patient's body for collecting feces and other waste matter therein. Sheath203may be formed of a biocompatible elastomer material such as, e.g., silicone or polyurethane.

As shown inFIG.2B, one or more suction/fluid inlet tubes, e.g., suction tubes214,216may extend along the outer surface of sheath203from out of the patient towards negative pressure chamber212. The upstream regions of suction tubes214,216may include a plurality of inlet pores215,217, respectively, sized and shaped to evacuate fluid therethrough, sufficient to create the vacuum within negative pressure chamber212. For example, the upstream regions of suction tubes214,216may be disposed across downstream sealing ring208, such that one or more inlet pores215of suction tube214and one or more inlet pores217of suction tube216may be disposed within and in fluid communication with negative pressure chamber212. Inlet pores215,217may be distributed spatially evenly along the length of the upstream regions of suction tubes214,216. Alternatively, the spatial distribution of inlet pores215,217may be selected to create a desired vacuum within negative pressure chamber212. Preferably, the upstream regions of suction tubes214,216may be equally spaced apart within negative pressure chamber212along the circumference of the outer surface of sheath203to thereby provide a symmetric application of vacuum within negative pressure chamber212. Suction tubes214,216may extend from within negative pressure chamber212, through downstream sealing ring208, and along the outer surface of sheath203and out the patient's anus, such that the downstream ends of suction tubes214,216may be fluidicly coupled to the external pump of negative pressure system300for creating the vacuum within negative pressure chamber212. In some embodiments, at least a portion of suction tubes214,216may extend within the wall of sheath203, e.g., within the membrane forming sheath203.

As described in further detail below, inner and outer anchors201,220may be used in conjunction with a negative pressure system, e.g., an external pump fluidicly coupled to the one or more suction/fluid inlet tubes, e.g., suction tubes214,216, to evacuate fluid from negative pressure chamber212via the one or more suction/fluid inlet tubes, to thereby create a vacuum within negative pressure chamber212. AlthoughFIGS.2A to2Cillustrate two suction tubes, as will be understood by a person having ordinary skill in the art, system100may include more or less than two suction tubes for generating the desired vacuum within negative pressure chamber212, and/or the suction tubes may not be equally spaced circumferentially along the outer perimeter of sheath203.

Bypass device200may include one or more downstream retrieval loops205extending from a downstream end of inner and outer anchors201,220for facilitating removal of bypass device200, e.g., after the anastomosis has fully healed. For example, a retrieval device, e.g., an endoscopic grasper, may be introduced along the outer surface of sheath203toward downstream retrieval loop205, to thereby engage with downstream retrieval loop205, such that a force may be applied to the downstream portion of the retrieval device to pull on downstream retrieval loop205in the downstream direction, to thereby cause downstream retrieval loop205to contract radially inward and detach at least the downstream region of inner and outer anchors201,220, e.g., downstream sealing ring208, from the intestinal tissue surrounding inner and outer anchors201,220, e.g., mucosal ingrowth that may have formed on inner and outer anchors201,220. The retrieval device may then be further retracted to apply a pulling force to downstream retrieval loop205in the downstream direction and remove bypass device200from the patient's body.

As shown inFIG.2A, at least a portion of the outer surface of sheath203within negative pressure chamber212includes a plurality of microstructures, e.g., a micropattern of microstructures224, disposed thereon. For example, the micropattern of microstructures224may comprise a micropattern of protrusions extending outwardly from the outer surface of sheath203. Preferably, the micropattern of microstructures224is only disposed on the outer surface of sheath203that is disposed within negative pressure chamber212. In addition, microstructures224preferably are integrally formed with the portion of sheath203within negative pressure chamber212. Alternatively, microstructures224may be affixed to the portion of sheath203within negative pressure chamber212during manufacture. As shown inFIG.2A, each microstructure of the micropattern of microstructures224may have a semi-spherical shape. For example, each microstructure of the micropattern of microstructures224may have a cross-sectional width of between 50 and 500 microns, e.g., about 300 microns, and a height of between 50 to 1000 microns, e.g., about 600 microns. In some embodiments, each microstructure of the micropattern of microstructures224may have a pitch of between 800-1200 microns, e.g., about 1000 microns. As will be understood by a person having ordinary skill in the art, the microstructures may have other shapes, e.g., columns, cubes, cones, pyramidal, circular pillars, rectangles, triangles, squares, sinusoids, etc.

The micropattern of microstructures224may include a plurality of rows and a plurality of columns of microstructures throughout negative pressure chamber212. For example, the micropattern of microstructures224may extend radially around a full circumference of the outer surface of sheath203and longitudinally along an entire length of the outer surface of sheath203within negative pressure chamber212. In some embodiments, the micropattern of microstructures224may be arranged in a triangular or rectangular shape on the outer surface of sheath203within negative pressure chamber212. Moreover, the outer surface of sheath203further may include one or more ribs and/or one or more channels sized and shaped to guide fluid flow within negative pressure chamber212, e.g., towards fluid inlet tubes214,216.

Upon actuation of the negative pressure system, a vacuum having a predetermined pressure may be created within negative pressure chamber212to thereby pull intestinal tissue toward inner and outer anchors201,220and secure bypass device200at the target site. At least some intestinal tissue may be pulled through at least some openings221of outer anchor220and at least some openings207of inner anchor201at middle region206, and further may contact the micropattern of microstructures224. The micropattern of microstructures224is configured to inhibit the inner wall of the intestine from sealing against the outer surface of sheath203responsive to the vacuum to thereby encourage 360° fluidic communication within negative pressure chamber212. Thus, the micropattern of microstructures224prevents the intestinal tissue from shutting off on the outer surface of sheath203and creating a sub-chamber of vacuum within negative pressure chamber212. Accordingly, the micropattern of microstructures224maintains a vacuum throughout negative pressure chamber212such that bypass device200remains anchored at the target location when negative pressure is applied in negative pressure chamber212. As will be understood by a person having ordinary skill in the art, the micropattern of microstructures may be incorporated with any of the bypass devices described herein, e.g., bypass devices1000,1100,1200,1300,1400,1500,1700, to thereby encourage 360° fluidic communication within the respective negative pressure chamber such that a vacuum is maintained throughout the negative pressure chamber and the respective anchor remains anchored at the target location when negative pressure is applied in the negative pressure chamber. By implementing a micropattern of microstructures on the outer surface of a sheath within the negative pressure chamber to encourage 360° fluidic communication within the negative pressure chamber, as well as double anchor having a recessed middle region, e.g., dog bone shape resembling an hourglass, under vacuum to improve mechanical anchoring, and automated pump parameters adjustment to improve vacuum maintenance, the overall length of the stent/scaffold of inner and outer anchors201,220may be reduced, e.g., 80-90 mm, or 70 mm.

Referring now toFIGS.3A and3B, an exemplary negative pressure system for generating the vacuum within negative pressure chamber212of bypass device200, and monitoring the pressure therein is provided. System300may include an external pump, for example, disposed within housing301and fluidicly coupled to negative pressure chamber212via, e.g., suction tubes214,216. For example, the external pump may be fluidicly coupled to the downstream ends of suction/fluid inlet tubes214,216. Accordingly, the pump may be actuated to evacuate fluid from negative pressure chamber212via suction tubes214,216, to thereby create the vacuum within negative pressure chamber212. As shown inFIGS.3A and3B, housing301may have handle303sized and shaped to facilitate carrying and handling of system300by a user. Housing301may be sized and shaped to be worn by the patient, e.g., via a satchel or a belt wearable by the patient. Additionally, or alternatively, housing301may be sized and shaped to be mounted, e.g., bedside, on an IV pole, etc. Moreover, system300further may include detachable fluid reservoir chamber302configured to be removably coupled to housing301to facilitate removal of waste matter from fluid reservoir chamber302and/or cleaning of fluid reservoir chamber302. Accordingly, fluid reservoir chamber302may be fluidicly coupled to the negative pressure chamber of the respective anchor via the fluid inlet tubes coupled thereto, and sized and shaped to collect waste matter within fluid evacuated from the negative pressure chamber when negative pressure is applied.

As shown inFIG.3B, fluid reservoir chamber302may be made of a transparent material to facilitate manual inspection of the contents within fluid reservoir chamber302by a user, to thereby inform a user of when fluid reservoir chamber302needs to be emptied, cleaned, and/or replaced. System300may include one or more sensors fluidicly coupled to fluid reservoir chamber302, such that a controller of system300, e.g., controller400described in further detail below with regard toFIG.4, may generate an alert to inform a user when the waste matter within fluid reservoir chamber302exceeds a predetermined threshold. For example, the alert may be an audible or visual alert emitted/displayed on a user interface on housing301, e.g., a graphical user interface. Additionally, or alternatively, the alert may be emitted/displayed via a remote computer operatively coupled to system300. The user interface of system300may include one or more actuators, e.g., buttons, switches, etc., configured for actuation by a user to turn on/off and/or adjust/control one or more operating parameters of system300. The user interface may display information associated with system300, e.g., pressure measurements within negative pressure chamber212.

FIG.3Cis a schematic illustrating the internal components of an exemplary negative pressure system for generating the vacuum within the negative pressure chamber. System300may be used with any of the bypass devices described herein, e.g., bypass devices200,1000,1100,1200,1300,1400,1500,1700. As described above, fluid reservoir chamber302may be sized and shaped for collecting fluid and waste matter within the fluid evacuated from the negative pressure chamber of the anchor, e.g., via suction tubes214,216, and may be fluidicly coupled to pump316. For example, fluid evacuated from negative pressure chamber212may travel through suction tubes214,216, and enter fluid reservoir chamber302via inlet306. As shownFIG.3C, system300may include a controller, e.g., controller400, in electrical communication with the electrical components of system300, e.g., pump316and pressure transducers312, described in further detail below.

As shown inFIG.3C, system300may include vacuum/pressure transducer312fluidicly coupled to negative pressure chamber212via fluid reservoir chamber302and the suction/fluid inlet tubes coupled thereto, e.g., suction tubes214,216. Pressure transducer312may be configured to measure pressure within fluid reservoir chamber302, which is indicative of the pressure within negative pressure chamber212, and generate one or more signals indicative of the measured pressure for transmission to controller400. Controller400may be operatively coupled to pump316, to thereby cause pump316to generate a vacuum having a predetermined pressure within negative pressure chamber212via suction tubes214,216. In some embodiments, each suction tube may be fluidicly coupled to a dedicated pressure transducer for measuring pressure within the respective fluid inlet tube. Moreover, suction tubes214,216may be fluidicly coupled together via coupler304, such that a single fluid inlet line in fluid communication with both suction tubes214,216is fluidicly coupled to fluid reservoir chamber302via inlet306of fluid reservoir chamber302. In addition, system300may include filter310disposed between fluid reservoir chamber302and pump316to prevent waste matter from entering pump316. For example, waste matter within the fluid evacuated from negative pressure chamber212and other fluids may be collected within fluid reservoir chamber302, such that the remaining fluid, e.g., gas, may exit fluid reservoir chamber302via outlet308and travel across filter310and exit system300via pump316.

System300further may include one or more check valves314fluidicly coupled to suction tubes214,216, e.g., between filter310and pump316, configured to allow pump316to return to ambient pressure, e.g., atmospheric pressure, without impacting pressure of system300. For example, prior to turning on pump316, check valve314may be actuated to an open state until the pressure within pump316reaches atmospheric pressure. Check valve314may then be may be actuated to a closed state during operation of pump316, such that pump316may generate a vacuum having a predetermined pressure within negative pressure chamber212. In some embodiments, instead of check valve314, system300may include a small controlled leak configured to allow pump316to reach atmospheric pressure, e.g., when system300is in steady state conditions. In some embodiments, system300may include one or more sensors fluidicly coupled to fluid reservoir chamber302and configured to measure an amount of waste matter within fluid reservoir chamber302. The one or more additional sensors may generate one or more signals indicative of the level of waste matter within fluid reservoir chamber302for transmission to controller400.

Referring now toFIG.4, components that may be included in controller400for controlling the negative pressure systems described herein are provided. Controller400may include one or more processors402, communication circuitry404, power supply406, user interface408, and/or memory410. One or more electrical components and/or circuits may perform some of or all the roles of the various components described herein. Although described separately, it is to be appreciated that electrical components need not be separate structural elements. For example, controller400and communication circuitry404may be embodied in a single chip. In addition, while controller400is described as having memory410, a memory chip(s) may be separately provided.

Controller400may contain memory and/or be coupled, via one or more buses, to read information from, or write information to, memory. Memory410may include processor cache, including a multi-level hierarchical cache in which different levels have different capacities and access speeds. The memory also may include random access memory (RAM), other volatile storage devices, or non-volatile storage devices. Memory410may be RAM, ROM, Flash, other volatile storage devices or non-volatile storage devices, or other known memory, or some combination thereof, and preferably includes storage in which data may be selectively saved. For example, the storage devices can include, for example, hard drives, optical discs, flash memory, and Zip drives. Programmable instructions may be stored on memory410to execute algorithms for, e.g., determining whether the pressure measured within negative pressure chamber212falls outside of a predetermined range and adjusting one or more parameters of pump316to maintain the pressure within negative pressure chamber212within the predetermined range.

Controller400may incorporate processor402, which may consist of one or more processors and may be a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device such as a programmable logic controller (PLC), discrete gate or transistor logic, discrete hardware components, or any suitable combination thereof designed to perform the functions described herein. Controller400also may be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Controller400, in conjunction with firmware/software stored in memory410may execute an operating system (e.g., operating system418), such as, for example, Windows, Mac OS, QNX, Unix or Solaris 5.10. Controller400also executes software applications stored in the memory. For example, the software may be programs in any suitable programming language known to those skilled in the art, including, for example, C++, PHP, or Java.

Communication circuitry404may include circuitry that allows controller400to communicate with pump316and pressure transducer312, and optionally, one or more additional sensors associated with system100, as described in further detail below. Communication circuitry404may be configured for wired and/or wireless communication over a network such as the Internet, a telephone network, a Bluetooth network, and/or a WiFi network using techniques known in the art. Communication circuitry404may be a communication chip known in the art such as a Bluetooth chip and/or a WiFi chip. Communication circuitry404permits controller400to transfer information, such as pressure measurements within negative pressure chamber212locally and/or to a remote location such as a server.

Power supply406may supply alternating current or direct current. Power supply406may be a port to allow controller400to be plugged into a conventional wall socket, e.g., via a cord with an AC to DC power converter and/or a USB port, for powering components within controller400. In direct current embodiments, power supply406may include a suitable battery such as a replaceable battery or rechargeable battery and may include circuitry for charging the rechargeable battery.

User interface408may be used to receive inputs from, and/or provide outputs to, a user. For example, user interface408may include a touchscreen display, switches, dials, lights, etc. Accordingly, user interface408may display information such as pressure measurements of negative pressure chamber212and/or visual alerts, e.g., when the pressure within negative pressure chamber212falls outside the predetermined range. In some embodiments, user interface408may receive user input including adjustments to one or more operating parameters of pump316. In some embodiments, user interface408is not present on controller400, but is instead provided on a remote, external computing device communicatively connected to controller400via communication circuitry404.

Memory410, which is one example of a non-transitory computer-readable medium, may be used to store operating system (OS)418, system parameters determination module412, pump interface module414, and alert generation module416. The modules are provided in the form of computer-executable instructions/algorithms that may be executed by processor402for performing various operations in accordance with the disclosure.

System parameters determination module412may be executed by processor402for receiving one or more signals from pressure transducer312, indicative of pressure within negative pressure chamber212in real time. Moreover, system parameters determination module412may be configured to process and analyze the pressure measurement signals to determine whether the pressure within negative pressure chamber212falls outside of a predetermined range stored in memory410. System parameters determination module412further may be configured to determine the volume of system300in real time, e.g., based on the measured pressure of system300, as will be understood by a person having ordinary skill in the art. Accordingly, based on the measured volume of system300and the known target volume of system300stored in memory410, as well as the known pump flow rate of pump312, the expected pump run time, e.g., the amount of time required by pump316to achieve the known target volume of system300under normal conditions, may be calculated by system parameters determination module412. Additionally or alternatively, the expected pump run time may be predetermined and stored in memory410.

Further, the actual pump run time, e.g., the amount of time actually required by pump316to achieve the known target volume of system300, may be recorded. Accordingly, system parameters determination module412may detect the presence of an occlusion within system100if the actual pump run time deviates from the expected pump run time, e.g., by more than 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 run time for an operating vacuum range from 0 to −50 kPa may approximately be 6.5 seconds, and the expected pump run time for an operating vacuum range from −30 to −50 kPa may approximately be 1.5 seconds, such that system parameters determination module412may determine that there is an occlusion within the system if the pump run time is less than 1 second. For example, the total system volume may be 250 to 2000 mL, the pump flow rate may be 1,000 to 50,000 mL/min, the operating vacuum range may be from 0 to −80 kPa, and an occlusion may be detected if the actual pump run time deviates from the expected pump run time by, e.g., 0.25 to 10 seconds.

As described above, system300may include one or more additional sensors configured to generate one or more signals indicative of an amount of waste matter within fluid reservoir chamber302. Accordingly, system parameters determination module412may be configured to receive the one or more signals indicative of the amount of waste matter within fluid reservoir chamber302, and process and analyze the one or more signals to determine whether the amount of waste matter within fluid reservoir chamber302exceeds a predetermined threshold. In some embodiments, as described in further detail below, system100may include one or more additional sensors configured to measure, e.g., data indicative of a presence of at least one of blood, feces, or predefined gases between the bypass device and intestinal tissue surrounding bypass device200, and/or data indicative of a position of bypass device200relative to the intestinal anastomosis. Accordingly, system parameters determination module412may be configured to process and analyze the data measured by the one or more additional sensors to determine whether the measured data falls outside one or more respective predetermined ranges.

Pump interface module414may be executed by processor402for controlling operation of pump316. For example, upon actuation of pump316, e.g., via user interface408, pump interface module414may instruct pump316to turn on. Moreover, when system parameters determination module412determines that the pressure within negative pressure chamber212falls outside of the predetermined range, pump interface module414may automatically adjust one or more operating parameters of pump316, and instruct pump316to operate in accordance with the adjusted parameters, to thereby maintain the pressure within negative pressure chamber212within the predetermine range. Preferably, pump interface module414may be configured to instruct pump316to turn off when the pressure within negative pressure chamber212, as measured by pressure transducer312, falls within the predetermined range. Thus, system100may include one or more valves fluidicly coupled to suction tubes214,216configured to prevent fluid ingress towards negative pressure chamber212, to thereby maintain the pressure within negative pressure chamber212. Accordingly, pump interface module414may instruct pump316to turn back on when the pressure within negative pressure chamber212falls outside of the predetermined range.

In some embodiments, pump interface module414may be configured to adjust one or more parameters of pump316over time. For example, as intestinal tissue/mucosal ingrowth forms on inner and outer anchors201,220over time, a smaller vacuum may be required to secure bypass device200at the target site upstream of the anastomosis site. Accordingly, pump interface module414may reduce the operations of pump316to generate a smaller vacuum within negative pressure chamber212over time. Alternatively, in some embodiments, pump interface module414may be configured to instruct pump316to operate continuously, e.g., continuously evacuating fluid from negative pressure chamber212to continuously create a vacuum having a pressure within the predetermined range.

Alert generation module416may be executed by processor402for generating an alert when system parameters determination module412determines that the pressure within negative pressure chamber212falls outside of the predetermined range. For example, the alert may be an audible alert and/or a visual alert, which may be displayed via user interface408. Additionally, or alternatively, alert generation module416may be configured to periodically generate an alert to facilitate routine manual inspection of system300by a user. For example, alert generation module416may be configured to generate an alert once or multiple times a day to remind a user to manually monitor the operations of system300. In addition, alert generation module416may be configured to generate an alert indicative of when the presence of a occlusion of system100, e.g., a clog in one or more of suction tubes214,216, is detected, e.g., when system parameters determination module412determines that the actual pump run time deviates from the expected pump run time by more than a predetermined threshold, as described above.

Moreover, alert generation module416may be configured to generate an alert when the amount of waste matter within fluid reservoir chamber302measured exceeds the predetermined threshold, to thereby inform a user to empty or replace fluid reservoir chamber302. As described above, system100may measure, e.g., data indicative of a presence of at least one of blood, feces, or predefined gases between the bypass device and intestinal tissue surrounding bypass device200, and/or data indicative of a position of bypass device200relative to the intestinal anastomosis. Accordingly, alert generation module416may be configured to generate an alert indicative of when presence of at least one of blood, feces, or predefined gases between the bypass device and intestinal tissue surrounding bypass device200exceeds a predetermined threshold, and/or when the position of bypass device200relative to the intestinal anastomosis exceeds a predetermined threshold, such that corrective action may be taken.

Referring now toFIG.5, exemplary method steps for automated monitoring of bypass device200is provided. At step502, controller400may monitor the vacuum within system100, e.g., the pressure within negative pressure chamber212. For example, system parameters determination module412may process and analyze the pressure measurement signals received from pressure transducer312, indicative of pressure within negative pressure chamber212. At step504, controller400may determine whether the pressure within negative pressure chamber212, as indicated by the pressure measurements by pressure transducer312, falls outside of a predetermined range. If the pressure within negative pressure chamber212is determined not to fall outside the predetermined range at step504, method500may return to step502. If the pressure within negative pressure chamber212is determined to fall outside the predetermined range at step504, method500may proceed to step506.

At step506, controller400may automatically modify pump settings of pump316, e.g., one or more operational parameters of pump316, to maintain the pressure within negative pressure chamber212within the predetermined range. For example, controller400may instruct pump316to turn on if pump316is currently in an off state, controller400may instruct pump316to turn off if pump316is currently in an on state, and/or controller400may instruct pump316to evacuate fluid within negative pressure chamber212at a higher rate/force to thereby increase the pressure within negative pressure chamber212or at a lower rate/force to thereby decrease the pressure within negative pressure chamber212. Accordingly, method500may return to step502to continuously monitor the vacuum of system300. Optionally, at step508, controller400may generate an alert to inform a user when the pressure within negative pressure chamber212is detected to fall outside of the predetermined range. Additionally, or alternatively, as described above, controller400may periodically generate an alert to remind a user to manually monitor operations of system300.

FIG.6Aillustrates colon C with a bypass device having a single braided anchor disposed within the lumen of the colon, andFIG.6Billustrates colon C under vacuum generated via the single braided anchor bypass device.FIG.6Cillustrates colon C with a bypass device having a double braided anchor, e.g., bypass device200having inner and outer anchors201,220, disposed within the lumen of the colon, andFIG.6Dillustrates colon C under vacuum generated via bypass device200. From a comparison ofFIGS.6B and6D, bypass device200is shown to generate a stronger and more consistent vacuum within the system, e.g., as evidenced by colon C being more tightly wrapped around the double braided anchor bypass system inFIG.6Dthan the single braided anchor bypass system inFIG.6B.

Referring now toFIGS.7A to7G, an exemplary introducer device for delivering bypass device200to the target site within the patient's GI tract is provided. Introducer700may include a guide tube having first tubular portion708configured for insertion within the patient's GI tract, and second tubular portion714coupled to a downstream end of first tubular portion708. Additionally, introducer700may include handle portion702operatively coupled to second tubular portion714and configured to be actuated to actuate introducer700. As shown inFIGS.7A and7B, an upstream end of second tubular portion714may be fixedly coupled to the downstream end of first tubular portion708, e.g., via stop716. Stop716may have a disc-shaped profile, having a diameter larger than the diameter of first tubular portion708. For example, stop716may be sized and shaped to prevent further insertion of introducer700through a patient's anus into the GI tract, by contacting the patient's anus.

First tubular portion708may have a length selected such that upstream tip710of first tubular portion708may be disposed at the target site within the patient's GI tract upstream of an anastomosis site, while stop716, second tubular portion714, and handle portion702remain external to the patient's body. Accordingly, first tubular portion708may be formed of a flexible material to facilitate maneuvering of first tubular portion708through the patient's GI tract. As shown inFIG.7A, the outer surface of first tubular portion708may include markings712for visually indicating a depth first tubular portion708has been inserted within a patient's GI tract through the anus. Moreover, as shown inFIG.7B, first tubular portion708may have lumen709extending therethrough, and sized and shaped to receive bypass device200therein in its collapsed delivery state.

Upstream tip710may be constructed as described in U.S. Pat. No. 11,589,869 to Khosrovaninejad, the entire contents of which are incorporated herein by reference. For example, upstream tip710may be configured to transition between a closed configuration and an open configuration to expose lumen709and permit delivery of bypass device200therethrough. In addition, upstream tip710may have a tulip configuration formed of a plurality of elastically deformable cut-out tabs that are biased towards the closed configuration where the plurality of tabs form a sealed closure to isolate lumen709from the environment surrounding introducer700, e.g., the GI tract. The plurality of tabs may overlap with each other to form the scaled closure, and may have a stiffness in the closed configuration sufficient to be inserted through a patient's anus and into the GI tract. Moreover, the plurality of tabs may be transitioned to the open configuration upon application of a force against the plurality of tabs, e.g., from within lumen709. For example, as described in further detail below, as first tubular portion708is retracted in a downstream direction relative to bypass device200within lumen709, bypass device200may apply a force against the plurality of tabs of upstream tip710to thereby transition upstream tip710to its open configuration to permit bypass device100to pass therethrough into the GI tract at the target site.

As shown inFIGS.7A and7B, handle portion702may include handle housing704sized and shaped to be held by a user as introducer700is inserted within a patient's GI tract. Handle housing704may be operatively coupled to actuator706, e.g., a rotatable knob, configured to be rotated relative to handle housing704to actuate second tubular portion714, as described in further detail below. For example, as shown inFIGS.7C and7D, knob706may be fixedly coupled to inner tube720disposed within handle housing704via connection707, such that rotation of knob706causes rotation of inner tube720relative to handle housing704, while axial movement of inner tube720relative to handle housing704is prevented.

As shown inFIG.7D, a downstream end of second tubular portion714may be disposed within a lumen of inner tube720. Moreover, an upstream end of inner tube720may include one or more features721extending radially inwardly, and sized and shaped to slidably engage with one or more grooves718extending along an outer surface of second tubular portion714. For example, one or more grooves718may form a threaded surface of second tubular portion714, such that as inner tube720, which is fixed axially relative to handle housing704, rotates via rotation of knob706, the slidable engagement between one or more features721and one or more grooves718causes one or more grooves718to slide along one or more grooves718, thereby moving second tubular portion714, and accordingly first tubular portion708fixed thereto, axially relative to inner tube720and handle housing704. Accordingly, one or more grooves718may extend in a circumferential and axial pattern along the outer surface of second tubular portion714, e.g., in a helical pattern. Moreover, as shown inFIG.7C, second tubular portion714may have linear track719extending longitudinally along the outer surface of second tubular portion714, and sized and shaped to slidably engage with a rail (not shown) of handle housing704, to thereby prevent rotation of second tubular portion714relative to handle housing704as the engagement between one or more features721and one or more grooves718causes axial translation of second tubular portion714relative to handle housing704during rotation of knob706. Specifically, the engagement between the rail of handle housing704and linear track719in conjunction with the engagement between one or more features721and one or more grooves718as inner tube720is rotated causes axial translation of second tubular portion714relative to handle housing704.

As shown inFIGS.7B and7D, introducer700further may include pusher724fixedly coupled to handle housing704, and extending through a lumen of second tubular portion714and at least a portion of lumen709of first tubular portion708, such that upstream end728of pusher724is disposed within an upstream region of lumen709of first tubular portion708, e.g., downstream of bypass device200in its collapsed delivery state within lumen709. For example, as shown inFIG.7D, downstream end726of pusher724may be fixedly coupled to holder722disposed within handle housing704. For example, holder722may include an inner portion disposed within the lumen of second tubular portion714, such that the inner portion is fixedly coupled to pusher724, and an outer portion that is fixedly coupled to handle housing704. Moreover, holder722may include the rail configured to be slidably received within linear track719to prevent rotation of second tubular portion714as second tubular portion714axially moves relative to handle housing704, which extends between the inner portion and the outer portion of holder722.

Moreover, pusher724may be formed of a flexible material to facilitate navigation introducer700through the patient's GI tract. Moreover, pusher724may be slidably disposed within lumen709of first tubular portion708and the lumen of second tubular portion714, such that first tubular portion708and second tubular portion714may move axially relative to pusher724, e.g., via rotation of knob706as described above, which pusher724and handle portion702relative stationary relative to the patient and the target site within the GI tract. Upstream end728may be sized and shaped to engage with and maintain bypass device200in position relative to the target site as first tubular portion708is moved axially relative to bypass device200and pusher724in the downstream direction, as shown inFIG.8A(bypass device200omitted for brevity). Accordingly, as first tubular portion708is moved axially in the downstream direction, pusher724causes bypass device200to apply a force against the plurality of tabs of upstream tip710of first tubular portion708, to thereby cause upstream tip710to transition from the closed configuration to the open configuration and permit bypass device200to pass therethrough. As shown inFIG.8B, when bypass device200is fully exposed from lumen709of first tubular portion708, bypass device200may transition from its collapsed delivery state to its expanded deployed state at the target site within the GI tract, e.g., via self-expansion.

Referring again toFIG.7A, introducer700further may include safety clip715configured to prevent premature deployment of bypass device200. As shown inFIG.7A, safety clip715may be sized and shaped to engage with second tubular portion714, between stop716and handle housing704. For example, safety clip715may include a rail (not shown) sized and shaped to be received by linear track719of second tubular portion714, to thereby removably secure safety clip715to second tubular portion714. When safety clip715is engaged with second tubular portion714, as shown inFIG.7A, axial translation of second tubular portion714relative to handle housing704is prevented, as the rail of handle housing704may not move axially along linear track719, as described above. Accordingly, during delivery of bypass device200via introducer700, first tubular portion708may be inserted through the patient's anus and into the GI tract, while safety clip715is engaged with second tubular portion714. When the user confirms that upstream tip710is in the desired position relative to the target site, such that bypass device200may be deployed at the target site within the GI tract, safety clip715may be removed from second tubular portion714, to thereby permit actuation of handle portion702when bypass device200is ready for deployment.

Referring now toFIGS.7E to7G, actuation of knob706may be restricted in a single direction during deploying of bypass device200at the target site. For example, as shown inFIG.7E, downstream portion705of handle housing704may be configured to rotatably engage with knob706. Specifically, downstream portion705may be sized and shaped to be received by an interior channel extending through at least a portion of knob706, such that knob706may be rotated relative to downstream portion705. As shown inFIG.7E, downstream portion728may include one or more flexible tabs728extending circumferentially along at least a portion of downstream portion705. Flexible tabs728may each be configured to transition between a radially compressed state where they extend radially inward, and a radially expanded state where they extend radially outward. Moreover, flexible tabs728may be biased toward the radially expanded state, such that a force is required to transition flexible tabs728to the radially compressed state.

As shown inFIG.7F, an inner surface of knob706defining the interior channel of knob706may include one or more grooves730configured to slidably engage with one or more flexible tabs728as knob706is rotated relative to handle housing704. Grooves730each may have a profile having stop feature732such that rotation of knob706in a first direction relative to handle housing704is permitted, while rotation of knob706in a second direction opposite to the first direction relative to handle housing704is prevented upon engagement of one or more flexible tabs728and stop feature732of one or more grooves730in the radially expanded state, as shown inFIG.7G. AlthoughFIG.7Gillustrates two flexible tabs728, and four grooves730, as will be understood by a person having ordinary skill in the art, handle portion702may include more or less flexible tabs and grooves. As will be understood by a person having ordinary skill in the art, introducer700may be used to deliver any of the bypass device anchors described herein, e.g., bypass device1000,1100,1200,1300,1400,1500,1700,1800.

Referring now toFIG.9, another exemplary system for monitoring bypass device200for protecting intestinal anastomosis AS using system100and one or more additional sensors is provided. As shown inFIG.9, inner and outer anchors201,220may be deployed and secured at a target site within intestine I, upstream of intestinal anastomosis AS, to thereby secure bypass device200within the patient's GI tract, such that sheath203extends from inner and outer anchors201,220, through intestine I, across anastomosis AS, and out of the patient's anus A. Moreover, one or more suction tubes, e.g., suction tubes214,216, may extend from the negative pressure chamber of bypass device200, through intestine I and out of the patient's anus A, and fluidicly coupled to negative pressure system300, as described above.

As shown inFIG.9, one or more additional sensors may be operatively coupled to system300for monitoring bypass device200. For example, sensor S1may be disposed on at least one of inner or outer anchors201,220, and configured to generate one or more signals indicative of the pressure between inner and outer anchors201,220and intestine I. Additionally or alternatively, sensor S1may be configured to generate one or more signals indicative of the position of S1within intestine I. Moreover, sensors S2and/or S3may be disposed along a length sheath203, and may be configured to generate one or more signals indicative of the position of S2and S3, respectively, within intestine I. Accordingly, based on the position measurements of S1, S2, and S3, the controller of system300may determine the relative positions between sensors S1, S2, S3, and may further determine if sheath203is, e.g., bunching, and/or if inner and outer anchors201,220are, e.g., slipping within intestine I based on the position data. In addition, sensor S4and/or sensor S5may be disposed on the outer surface of sheath203along a length of sheath203, and may be configured to generate one or more signals indicative of the presence of one or more substances, e.g., gases such as methane or hydrogen sulfide, which may be indicative of an anastomotic leak. Accordingly, based on the position measurements of sensors S4, S5, the controller of system300may determine whether a particular substance is detected within intestine I, and further may determine if there is an anastomotic leak based on the presence of the substance. As described above, system300may generate an alert responsive to determinations based on one or more parameters measured by the one or more additional sensors, e.g., sensors S1, S2, S3, S4, S5. For example, based on the sensed data, system300may generate an alert to inform a user when sheath203is bunching, inner and outer anchors201,220are slipping, and/or there is an anastomotic leak.

Referring now toFIGS.10A to18C, alternative exemplary anchors for securing the bypass device at the target site within the GI tract are provided. For example, referring now toFIGS.10A and10B, bypass device1000for providing an internal bypass at a target site within the GI tract of the patient is provided. As shown inFIG.10A, bypass device1000includes anchor1001, and elongated flexible sheath1002coupled to anchor1001and extending therefrom in a downstream direction. Like sheath203, sheath1002has an outer surface and an internal channel for allowing passage of feces and other waste matter therethrough. Sheath1002has a length selected to extend from the target site in the GI tract through the patient's intestines and anus to a location external to the patient. In some embodiments, the downstream end of sheath1002may be coupled to a collection vessel (not shown) external to the patient's body for collecting feces and other waste matter therein. Sheath1002may be formed of a biocompatible elastomer material such as, e.g., silicone or polyurethane.

Unlike bypass device200, bypass device1000may include a single anchor, e.g., anchor1001. Like the anchors of bypass device200, anchor1001may be formed by a stent/scaffold, e.g., a self-expandable braided wire mesh, coupled to sheath1002and configured to provide an outward radial force against the walls of the intestine at the target site. Accordingly, anchor1001functions secure bypass device at the target site in conjunction with the negative pressure system, and to hold open the target area within the GI tract such that feces and other waste matter may pass through anchor1001and sheath1002without contacting the walls surrounding the anastomosis site. For example, as shown inFIG.10B, an upstream region of sheath1002may extend through the lumen of anchor1001, and may be coupled to an inner surface of stent1001via upstream sealing ring1006and downstream sealing ring1004, thereby forming negative pressure chamber1008defined by an outer surface of sheath1002, upstream scaling ring1006, downstream sealing ring1004, and the portion of anchor1001between upstream sealing ring1006and downstream sealing ring1004. Anchor1001and sheath1002for use with bypass device1000may be constructed as described in U.S. Pat. Nos. 9,339,272 and 9,980,727 to Khosrovaninejad, the entire contents of each of which are incorporated herein by reference.

As described above, anchor1001may be used in conjunction with the negative pressure systems described herein to evacuate fluid from negative pressure chamber1008via one or more suction/fluid inlet tubes, e.g., suction tubes1012,1014, fluidicly coupled to an external pump, to thereby create a vacuum within negative pressure chamber1008, which pulls intestinal tissue towards and at least partially through plurality of openings1003of anchor1001, to thereby secure anchor1001at the target site. AlthoughFIGS.10A and10Billustrate two suction tubes, as will be understood by a person having ordinary skill in the art, bypass device1000may include more or less than two suction tubes for generating the desired vacuum within negative pressure chamber1008. As shown inFIG.10B, the upstream regions of suction tubes1012,1014may extend through downstream sealing ring1004and may be disposed within negative pressure chamber1008.

Moreover, the upstream regions of suction tubes1012,1014may include a plurality of inlet pores1013,1015, respectively, sized and shaped to evacuate fluid therethrough, sufficient to create the vacuum within negative pressure chamber1008. Inlet pores1013,1015may be distributed spatially evenly along the length of the upstream regions of suction1012,1014. Alternatively, the spatial distribution of inlet pores1013,1015may be selected to create a desired vacuum within negative pressure chamber1008. Preferably, the upstream regions of suction tubes1012,1014may be equally spaced apart within negative pressure chamber1008along the circumference of sheath1002. Suction tubes1012,1014may extend from within negative pressure chamber1008, through downstream sealing ring1004, and along the outer surface of sheath1002and out the patient's anus, such that the downstream ends of suction tubes1012,1014may be fluidicly coupled to the external pump of the negative pressure system for creating the vacuum within negative pressure chamber1008. In some embodiments, at least a portion of suction tubes1012,1014may extend within the wall of sheath1002, e.g., within the membrane forming sheath1002.

In some embodiments, the upstream end of sheath1002may extend towards the upstream end of anchor1001, and may be coupled to the upstream end of anchor1001via upstream covering ring1010extending along the periphery of the upstream end of anchor1001, to thereby securely fasten sheath1002to anchor1001, as shown inFIG.10A. Moreover, anchor1001may include one or more downstream retrieval loops1016extending from a downstream end of anchor1001, and/or one or more upstream retrieval loops1018extending from an upstream end of anchor1001for facilitating removal of bypass device1000, e.g., after the anastomosis has fully healed. For example, a retrieval device, e.g., an endoscopic grasper, may be introduced through the lumen of sheath1002toward the lumen of anchor1001, to thereby engage with upstream retrieval loops1018, such that a force may be applied to the downstream portion of the retrieval device to pull on upstream retrieval loops1018in the downstream direction. Accordingly, the upstream end of anchor1001may be inverted into the lumen of anchor1001towards the lumen of sheath1002via the pulling force on upstream retrieval loops1018, to thereby detach anchor1001from the intestinal tissue surrounding anchor1001, e.g., mucosal ingrowth that may have formed on anchor1001. The retrieval device may then be disengaged from upstream retrieval loops1018, and subsequently engaged with downstream retrieval loops1016, to thereby apply a pulling force to downstream retrieval loops1016in the downstream direction and remove bypass device1000from the patient's body.

Anchor1101ofFIG.11, anchor1201ofFIG.12, anchor1301ofFIG.13, anchor1401ofFIG.14, anchor1501ofFIG.15A, anchor1701ofFIG.17, and anchor1801ofFIG.18Aeach may be constructed similar to anchor1001in that they each may be formed of a self-expandable braided wire mesh stent/scaffold that may be coupled to an outer surface of an inner sheath, e.g., sheaths1103,1203,1303,1403,1503,1703,1803respectively, via at least upstream and downstream sealing rings to thereby define one or more negative pressure chambers for creating a vacuum and evacuating fluid via one or more suction tubes fluidly coupled to the one or more negative pressure chambers. Unlike anchor1001, but like inner anchor201, the stent/scaffold forming anchors1101,1201,1301,1401,1501,1701,1801may have a recessed middle region between flared upstream and downstream regions, e.g., a bone-shaped profile that makes an hourglass, to thereby improve negative pressure chamber engagement with the intestinal tissue. For example, the recessed middle region may have an outer diameter that is less than the outer diameters of the upstream and downstream regions to thereby provide a larger volume between the outer surface of the respective anchors and the wall of the intestine.

Referring now toFIG.11, anchor1101of bypass device1100may include downstream region1102, upstream region1104, and recessed middle region1106extending between downstream region1102and upstream region1104. Middle region1106may have an outer diameter that is less than the outer diameters of downstream region1102and upstream region1104, thereby providing a larger volume between the outer surface of middle region1106and the wall of the intestine to improve negative pressure chamber engagement with the intestinal tissue during application of the vacuum. In some embodiments, anchor1101may be symmetric such that downstream region1102may have an outer diameter that is equal to the outer diameter of upstream region1104. Moreover, sheath1103of bypass device1100may be coupled to anchor1101via downstream sealing ring1108and integrated upstream scaling ring1110, to thereby define negative pressure chamber1112between the outer surface of sheath1103, downstream scaling ring1108, upstream sealing ring1110, and middle region1106of anchor1101.

As shown inFIG.11, integrated upstream sealing ring1110may include an integrated upstream edge sealing ring portion1111configured to be disposed along the upstream edge of anchor1101, thereby forming a soft, flexible upstream leading edge of anchor1101. For example, integrated upstream edge sealing ring portion1111may prevent damage to the intestinal tissue adjacent to the upstream end of anchor1101. In addition, integrated upstream edge sealing ring portion1111provides a longer sealing surface along the upstream region1104and flexibility to aid in retrieval of bypass device1100. Moreover, integrated upstream edge sealing ring portion1111inhibits mucosal ingrowth on at least upstream region1104of anchor1101. Downstream sealing ring1108and integrated upstream sealing ring1110,1111may be compression molded onto or overmolded directly over the stent/scaffold of anchor1101and sheath1103, or alternatively, may be thermally bonded or solvent bonded thereto. For example, downstream sealing ring1108and integrated upstream sealing ring1110,1111may be formed of a moldable thermoplastic material such as, thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and/or thermoplastic vulcanizate (TPV). One or more suction tubes (not shown) may be disposed across downstream sealing ring1108, such that one or more inlet pores of the one or more suction tubes may be disposed within negative pressure chamber1112. Upon actuation of the negative pressure system, e.g., an external pump fluidicly coupled to the one or more suction tubes, a vacuum having a predetermined pressure may be created within negative pressure chamber1112to thereby pull intestinal tissue toward anchor1101and secure bypass device1100at the target site. At least some intestinal tissue may be pulled through at least some openings of the stent/scaffold of middle region1106.

Referring now toFIG.12, anchor1201of bypass device1200may include downstream region1202, upstream region1204, and recessed middle region1206extending between downstream region1202and upstream region1204. Middle region1206may have an outer diameter that is less than the outer diameters of downstream region1202and upstream region1204, thereby providing a larger volume between the outer surface of middle region1206and the wall of the intestine to improve negative pressure chamber engagement with the intestinal tissue during application of the vacuum. In some embodiments, anchor1201may be symmetric such that downstream region1202may have an outer diameter that is equal to the outer diameter of upstream region1204. Moreover, sheath1203of bypass device1200may be coupled to anchor1201via integrated downstream sealing ring1208and integrated upstream sealing ring1210, to thereby define negative pressure chamber1212between the outer surface of sheath1203, downstream sealing ring1208, upstream sealing ring1210, and middle region1206of anchor1201.

As shown inFIG.12, integrated downstream sealing ring1208may include an integrated downstream edge sealing ring portion1209configured to be disposed along the downstream edge of anchor1201, thereby forming a soft, flexible downstream trailing edge of anchor1201. For example, integrated downstream edge scaling ring portion1209may prevent damage to the intestinal tissue and the outer surface of sheath1203adjacent to the downstream end of anchor1201. In addition, integrated upstream sealing ring1210may include an integrated upstream edge scaling ring portion1211configured to be disposed along the upstream edge of anchor1201, thereby forming a soft, flexible upstream leading edge of anchor1201. For example, integrated upstream edge scaling ring portion1211may prevent damage to the intestinal tissue adjacent to the upstream end of anchor1201. Moreover, integrated downstream edge scaling ring portion1209and integrated upstream edge scaling ring portion1211provide a longer sealing surface along the downstream region1202and upstream region1204, respectively, and flexibility to aid in retrieval of bypass device1200. In addition, integrated downstream edge sealing ring portion1209and integrated upstream edge scaling ring portion1211inhibit mucosal ingrowth on at least downstream region1202and upstream region1204of anchor1201.

Integrated downstream sealing ring1208,1209and integrated upstream sealing ring1210,1211may be compression molded onto or overmolded directly over the stent/scaffold of anchor1201and sheath1203, or alternatively, may be thermally bonded or solvent bonded thereto. For example, integrated downstream sealing ring1208,1209and integrated upstream sealing ring1210,1211may be formed of a moldable thermoplastic material such as, thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and/or thermoplastic vulcanizate (TPV). One or more suction tubes (not shown) may be disposed across integrated downstream sealing ring1208,1209such that one or more inlet pores of the one or more suction tubes may be disposed within negative pressure chamber1212. Upon actuation of the negative pressure system, e.g., an external pump fluidicly coupled to the one or more suction tubes, a vacuum having a predetermined pressure may be created within negative pressure chamber1212to thereby pull intestinal tissue toward anchor1201and secure bypass device1200at the target site. At least some intestinal tissue may be pulled through at least some openings of the stent/scaffold of middle region1206.

Referring now toFIG.13, anchor1301of bypass device1300may include downstream region1302, upstream region1304, and recessed middle region1306extending between downstream region1302and upstream region1304. Middle region1306may have an outer diameter that is less than the outer diameters of downstream region1302and upstream region1304, thereby providing a larger volume between the outer surface of middle region1306and the wall of the intestine to improve negative pressure chamber engagement with the intestinal tissue during application of the vacuum. In some embodiments, anchor1301may be symmetric such that downstream region1302may have an outer diameter that is equal to the outer diameter of upstream region1304.

Moreover, sheath1303of bypass device1300may be coupled to anchor1301via first downstream sealing ring1308and first upstream sealing ring1310, to thereby define negative pressure chamber1312between the outer surface of sheath1303, first downstream sealing ring1308, first upstream sealing ring1310, and middle region1306of anchor1301. In some embodiments, first downstream sealing ring1308may be disposed along the downstream edge of anchor1301and/or first upstream sealing ring1310may be disposed along the upstream edge of anchor1301, thereby forming a soft, flexible downstream trailing edge of anchor1301and/or a soft, flexible upstream trailing edge of anchor1301, respectively. For example, first downstream sealing ring1308may prevent damage to the intestinal tissue and the outer surface of sheath1303adjacent to the downstream end of anchor1301, and first upstream scaling ring1310may prevent damage to the intestinal tissue adjacent to the upstream end of anchor1301. First downstream sealing ring1308and first upstream sealing ring1310may be compression molded onto or overmolded directly over the stent/scaffold of anchor1301and sheath1303, or alternatively, may be thermally bonded or solvent bonded thereto. For example, first downstream sealing ring1308and first upstream sealing ring1310may be formed of a moldable thermoplastic material such as, thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and/or thermoplastic vulcanizate (TPV).

As shown inFIG.13, bypass device1300further may include second downstream scaling ring1309disposed on anchor1301upstream of first downstream sealing ring1308, as well as second upstream sealing ring1311disposed on anchor1301downstream of first upstream sealing ring1310. Neither second downstream sealing ring1309nor second upstream sealing ring1311are coupled to sheath1303. Accordingly, second downstream sealing ring1309and second upstream sealing ring1311may be compression molded onto or overmolded directly over the stent/scaffold of anchor1301, or alternatively, may be thermally bonded or solvent bonded thereto. For example, second downstream sealing ring1309and second upstream sealing ring1311may be formed of a moldable thermoplastic material such as, thermoplastic urethane (TPU), thermoplastic elastomer (TPE), and/or thermoplastic vulcanizate (TPV).

One or more suction tubes (not shown) may be disposed across first downstream sealing ring1308such that one or more inlet pores of the one or more suction tubes may be disposed within negative pressure chamber1312. Upon actuation of the negative pressure system, e.g., an external pump fluidicly coupled to the one or more suction tubes, a vacuum having a predetermined pressure may be created within negative pressure chamber1312to thereby pull intestinal tissue toward anchor1301and secure bypass device1300at the target site. At least some intestinal tissue may be pulled through at least some openings of the stent/scaffold of middle region1306. Moreover, as the vacuum created within negative pressure chamber1312causes intestinal tissue to be pulled toward anchor1301, the intestinal tissue may contact the outer surface of second downstream sealing ring1309and second upstream sealing ring1311, thereby creating downstream suction chamber1313defined by sheath1303, first and second downstream sealing rings1308,1309, and the intestinal tissue surrounding anchor1301between first and second downstream sealing rings1308,1309, and upstream suction chamber1315defined by sheath1303, first and second upstream sealing rings1310,1311, and the intestinal tissue surrounding anchor1301between first and second upstream sealing rings1310,1311. Accordingly, the vacuum created within downstream suction chamber1313and upstream suction chamber1315may facilitate engagement of bypass device1300to the intestinal wall.

Referring now toFIG.14, bypass device1400is provided. Bypass device1400may be constructed similar to bypass device1300. For example, bypass device1400may include anchor1401having upstream, downstream, and middle regions1402,1404,1406, first and second downstream scaling rings1408,1409for generating downstream suction chamber1413, and first and second upstream sealing rings1410,1411for generating upstream suction chamber1415, which corresponds to anchor1301having upstream, downstream, and middle regions1302,1304,1306, first and second downstream scaling rings1308,1309for generating downstream suction chamber1313, and first and second upstream sealing rings1310,1311for generating upstream suction chamber1315, of bypass device1300. Bypass device1400differs from bypass device1300in that bypass device1400may include middle scaling ring1414, as shown inFIG.14, configured to couple sheath1403to anchor1401within middle region1406, thereby defining first negative pressure chamber1412adefined by first downstream scaling ring1408, middle sealing ring1414, the upper surface of sheath1403, and the portion of anchor1401between first downstream sealing ring1408and middle sealing ring1414, and second negative pressure chamber1412bdefined by first upstream sealing ring1410, middle scaling ring1414, the upper surface of sheath1403, and the portion of anchor1401between first upstream scaling ring1410and middle sealing ring1414.

Accordingly, one or more suction tubes (not shown) may be disposed across first downstream sealing ring1408such that one or more inlet pores of the one or more suction tubes may be disposed within negative pressure chamber1412a. Additionally, one or more additional suction tubes (not shown) may be disposed across first downstream sealing ring1408and middle sealing ring1414such that one or more inlet pores of the one or more additional suction tubes may be disposed within negative pressure chamber1412b. Alternatively, the same one or more suction tubes may be disposed across first downstream sealing ring1408and middle sealing ring1414such that a first set of one or more inlet pores of the one or more suction tubes may be disposed within negative pressure chamber1412a, and a second set of one or more inlet pores of the one or more suction tubes may be disposed within negative pressure chamber1412b. Upon actuation of the negative pressure system, e.g., an external pump fluidicly coupled to the suction tubes, a vacuum having a predetermined pressure may be created within negative pressure chambers1412a,1412bto thereby pull intestinal tissue toward anchor1401and secure bypass device1400at the target site. At least some intestinal tissue may be pulled through at least some openings of the stent/scaffold of middle region1406.

Moreover, as the vacuum created within negative pressure chamber1412acauses intestinal tissue to be pulled toward anchor1401, the intestinal tissue may contact the outer surface of second downstream sealing ring1409, thereby creating downstream suction chamber1413defined by sheath1403, first and second downstream sealing rings1408,1409, and the intestinal tissue surrounding anchor1401between first and second downstream sealing rings1408,1409. Similarly, as the vacuum created within negative pressure chamber1412bcauses intestinal tissue to be pulled toward anchor1401, the intestinal tissue may contact the outer surface of second upstream sealing ring1411, thereby creating upstream suction chamber1415defined by sheath1403, first and second upstream sealing rings1410,1411, and the intestinal tissue surrounding anchor1401between first and second upstream sealing rings1410,1411. Accordingly, the vacuum created within downstream suction chamber1413and upstream suction chamber1415may facilitate engagement of bypass device1400to the intestinal wall. In some embodiments, the suction tubes fluidicly coupled to negative pressure chamber1412amay be actuated independently from the suction tubes fluidicly coupled to negative pressure chamber1412b, to thereby create a vacuum within negative pressure chamber1412ahaving a different pressure than the vacuum created within negative pressure chamber1412b.

Referring now toFIG.15A, bypass device1500is provided. Bypass device1500may be constructed similar to bypass device1400, except without second downstream and upstream sealing rings. For example, bypass device1500may include anchor1501having upstream, downstream, and middle regions1502,1504,1506, downstream sealing ring1508, and upstream sealing ring1510, which corresponds to anchor1401having upstream, downstream, and middle regions1402,1404,1406, downstream sealing ring1408, and upstream sealing ring1410of bypass device1400. Like bypass device1400, bypass device1500also may include a middle scaling ring, e.g., middle sealing ring1514, thereby defining first negative pressure chamber1512adefined by downstream sealing ring1508, middle sealing ring1514, the upper surface of sheath1503, and the portion of anchor1501between downstream sealing ring1508and middle sealing ring1514, and second negative pressure chamber1512bdefined by upstream sealing ring1510, middle sealing ring1514, the upper surface of sheath1503, and the portion of anchor1501between first upstream sealing ring1510and middle sealing ring1514.

However, middle sealing ring1514differs from middle sealing ring1414in that middle sealing ring1514may include a plurality of inlet ports1515configured to be fluidicly coupled to one or more suction tubes of the negative pressure system, and sized and shaped to evacuate fluid therethrough. For example, middle sealing ring1514may include a chamber configured to be fluidly coupled to plurality of inlet ports1515and to the one or more suction tubes. As shown inFIG.15B, plurality of inlet ports1515may be spatially evenly distributed along the outer surface of middle sealing ring1514. In some embodiments, plurality of inlet ports1515may only be distributed along an upstream side of middle sealing ring1514, or alternatively, plurality of inlet ports1515may only point in the upstream direction, such that the suction is directed upstream to thereby create resistance to tension downstream and resist the main direction of peristaltic forces during operation.

A first set of one or more additional suction tubes (not shown) may be disposed across downstream sealing ring1508, such that one or more inlet pores of the first set of one or more additional suction tubes may be disposed within negative pressure chamber1512a, and a second set of one or more additional suction tubes (not shown) may be disposed across downstream sealing ring1508and middle sealing ring1514such that one or more inlet pores of the second set of one or more additional suction tubes may be disposed within negative pressure chamber1512b. Alternatively, the same one or more additional suction tubes may be disposed across downstream sealing ring1508and middle sealing ring1514such that a first set of one or more inlet pores of the one or more additional suction tubes may be disposed within negative pressure chamber1512a, and a second set of one or more inlet pores of the one or more additional suction tubes may be disposed within negative pressure chamber1512b.

Upon actuation of the negative pressure system, e.g., an external pump fluidicly coupled to the suction tubes, a vacuum having a predetermined pressure may be created within negative pressure chambers1512a,1512b, to thereby pull intestinal tissue toward anchor1501and secure bypass device1500at the target site. At least some intestinal tissue may be pulled through at least some openings of the stent/scaffold of middle region1506. Moreover, actuation of the negative pressure system may cause evacuation of fluid through inlet ports1515of middle sealing ring1514, thereby creating a vacuum in the space between anchor1501and the inner wall of the intestine surrounding middle region1506, which pulls intestinal tissue toward middle sealing ring1514. For example, the intestinal tissue may be pulled to contact the sealing surface of middle sealing ring1514, thereby creating a localized vacuum ring and protecting against vacuum leaks due to seal breach. In some embodiments, the suction tubes fluidicly coupled to negative pressure chamber1512a, negative pressure chamber1512b, and middle sealing ring1514, each may be independently actuatable.

Referring now toFIGS.16A and16B, alternatively exemplary downstream scaling rings are provided. As shown inFIG.16A, downstream sealing ring1602may include a plurality of inlet ports1604configured to be fluidicly coupled to one or more suction tubes of the negative pressure system, e.g., negative pressure system300, and sized and shaped to evacuate fluid therethrough. For example, downstream sealing ring1602may include a chamber configured to be fluidly coupled to plurality of inlet ports1604and to the one or more suction tubes. As shown inFIG.16A, plurality of inlet ports1604may be spatially evenly distributed along the outer surface of the upstream side of downstream sealing ring1602, such that the suction is directed upstream to thereby create resistance to tension downstream and resist the main direction of peristaltic forces during operation. Alternatively, distribution of plurality of inlet ports1602along downstream sealing ring1602may not be limited to the upstream side of downstream sealing ring1602. As shown inFIG.16A, plurality of inlet ports1604may each have an oval-shaped profile. Alternatively, as shown inFIG.16B, plurality of inlet ports1604′ of downstream sealing ring1602′, which may be constructed similar to downstream sealing ring1602, may each have a circular-shaped profile.

As will be understood by a person having ordinary skill in the art, a scaling ring having a plurality of inlet ports for evacuating fluid therethrough (such as downstream sealing ring1602) may be incorporated in any of the bypass devices described herein to facilitate securement of the respective bypass device at the target site within the patient's GI tract. Moreover, such a sealing ring is not limited for use as a downstream sealing ring, but also may be incorporated within the upstream sealing rings described herein. Such upstream scaling rings may have downstream facing inlet ports.

Referring now toFIG.17, bypass device1700is provided. Bypass device1700may be constructed similar to bypass device1200. For example, bypass device1700may include anchor1701having upstream, downstream, and middle regions1702,1704,1706, first and second downstream sealing rings1708,1709for generating downstream suction chamber1713, and first and second upstream sealing rings1710,1711for generating upstream suction chamber1715. Bypass device1700differs from bypass device1200in that, like bypass device1200, downstream sealing ring1708may include an integrated downstream edge sealing ring portion configured to be disposed along the downstream edge of anchor1701, thereby forming a soft, flexible downstream trailing edge of anchor1701, and upstream sealing ring1710may include an integrated upstream edge sealing ring portion configured to be disposed along the upstream edge of anchor1701, thereby forming a soft, flexible upstream leading edge of anchor1701. Accordingly, the integrated downstream and upstream edge scaling ring portions of downstream scaling ring1708and upstream scaling ring1710may prevent damage to the intestinal tissue adjacent the downstream and upstream ends of anchor1701. Moreover, downstream scaling ring1708and upstream scaling ring1710provide a longer scaling surface along the downstream region1702and upstream region1704, respectively, and flexibility to aid in retrieval of bypass device1700. In addition, downstream sealing ring1708and upstream scaling ring1710inhibit mucosal ingrowth on at least downstream region1702and upstream region1704of anchor1701.

One or more suction tubes (not shown) may be disposed across first downstream sealing ring1708such that one or more inlet pores of the one or more suction tubes may be disposed within negative pressure chamber1712. Upon actuation of the negative pressure system, e.g., an external pump fluidicly coupled to the one or more suction tubes, a vacuum having a predetermined pressure may be created within negative pressure chamber1712to thereby pull intestinal tissue toward anchor1701and secure bypass device1700at the target site. At least some intestinal tissue may be pulled through at least some openings of the stent/scaffold of middle region1706. Moreover, as the vacuum created within negative pressure chamber1712causes intestinal tissue to be pulled toward anchor1701, the intestinal tissue may contact the outer surface of second downstream sealing ring1709and second upstream sealing ring1711, thereby creating downstream suction chamber1713defined by sheath1703, first and second downstream sealing rings1708,1709, and the intestinal tissue surrounding anchor1701between first and second downstream sealing rings1708,1709, and upstream suction chamber1715defined by sheath1703, first and second upstream sealing rings1710,1711, and the intestinal tissue surrounding anchor1701between first and second upstream sealing rings1710,1711. Accordingly, the vacuum created within downstream suction chamber1713and upstream suction chamber1715may facilitate engagement of bypass device1700to the intestinal wall.

Referring now toFIGS.18A to18C, bypass device1800is provided. Bypass device1800may be constructed similar to bypass device1200. For example, bypass device1800may include anchor1801having downstream, upstream, and middle regions1802,1804,1806, and integrated downstream sealing ring1808including an integrated downstream edge scaling ring portion configured to be disposed along the downstream edge of anchor1801and integrated upstream sealing ring1810including an integrated upstream edge scaling ring portion configured to be disposed along the upstream edge of anchor1801to thereby form a soft, flexible downstream trailing edge and a soft, flexible upstream leading edge of anchor1801, as shown inFIG.18B. Moreover, sheath1803may be disposed within the lumen of anchor1801, and coupled to integrated downstream sealing ring1808and integrated upstream sealing ring1810to thereby define negative pressure chamber1812between the outer surface of sheath1803, integrated downstream sealing ring1808, integrated upstream sealing ring1810, and anchor1801. As shown inFIG.18A, sheath1803may extend downstream from anchor1801.

As shown inFIG.18A, anchor1801may include one or more downstream retrieval loops1805extending from a downstream end of anchor1801, and/or one or more upstream retrieval loops1807extending from an upstream end of anchor1801for facilitating removal of bypass device1800, e.g., after the anastomosis has fully healed. Retrieval loops1805,1807may be constructed similar to retrieval loops1016,1018, described above with regard toFIG.10A. Moreover, as shown inFIG.18A, the outer surface of a downstream region of sheath1803may include markings1809for visually indicating a depth sheath1803has been inserted within a patient's GI tract through the anus. In addition, as shown inFIG.18A, bypass device1800may include first and second suction/fluid inlet tubes1814,1816, which may be constructed similar to suction tubes214,216described above. For example, fluid inlet tubes1814,1816may each have a distal region having a set of inlet pores disposed within and in fluid communication with negative pressure chamber1812, and a proximal end fluidicly coupled to a pump configured to apply negative pressure within negative pressure chamber1812. The proximal ends of fluid inlet tubes1814,1816also may be fluidicly coupled to one or more vacuum/pressure transducers configured to measure pressure within negative pressure chamber1812via fluid inlet tubes1814,1816, as described in further detail below.

As shown inFIGS.18A and18C, bypass device1800further may include sensing tube1818having a distal region disposed within and in fluid communication with negative pressure chamber1812and a proximal end fluidicly coupled to a vacuum/pressure transducer configured to measure pressure within negative pressure chamber1812via sensing tube1818. Preferably, the distal regions of fluid inlet tubes1814,1816and sensing tube1818are equally and circumferentially spaced apart within negative pressure chamber1812, as shown inFIG.18C. As will be understood by a person having ordinary skill in the art, the distal regions of fluid inlet tubes1814,1816and sensing tube1818may be disposed in a different manner than is illustrated inFIG.18C. In addition, there may be more or less than two fluid inlet tubes, and/or more or less than one sensing tube, as shown inFIG.18C. Moreover, the number and arrangement of fluid inlet tubes and sensing tube(s) may be incorporated with any of the bypass devices described above, e.g., bypass devices200,1000,1100,1200,1300,1400,1500,1700.

Like bypass device200, at least a portion of the outer surface of sheath1803within negative pressure chamber1812may include a plurality of microstructures, e.g., a micropattern of microstructures1820, disposed thereon. For example, the micropattern of microstructures1820may comprise a micropattern of protrusions extending outwardly from the outer surface of sheath1803. Preferably, the micropattern of microstructures1820is only disposed on the outer surface of sheath1803that is disposed within negative pressure chamber1812. In addition, microstructures1820preferably are integrally formed with the portion of sheath1803within negative pressure chamber1812. Alternatively, microstructures1820may be affixed to the portion of sheath1803within negative pressure chamber1812during manufacture.

As shown inFIG.18B, each microstructure of the micropattern of microstructures1820may have a semi-spherical shape. For example, each microstructure of the micropattern of microstructures1820may have a cross-sectional width of between 50 and 500 microns, e.g., about 300 microns, and a height of between 50 to 1000 microns, e.g., about 600 microns. In some embodiments, each microstructure of the micropattern of microstructures1820may have a pitch of between 800-1200 microns, e.g., about 1000 microns. As will be understood by a person having ordinary skill in the art, the microstructures may have other shapes, e.g., columns, cubes, cones, pyramidal, circular pillars, rectangles, triangles, squares, sinusoids, etc.

The micropattern of microstructures1820may include a plurality of rows and a plurality of columns of microstructures throughout negative pressure chamber1812. For example, the micropattern of microstructures1820may extend radially around a full circumference of the outer surface of sheath1803and longitudinally along an entire length of the outer surface of sheath1803within negative pressure chamber1812. In some embodiments, the micropattern of microstructures1820may be arranged in a triangular or rectangular shape on the outer surface of sheath1803within negative pressure chamber1812. In some embodiments, the outer surface of sheath1803further may include one or more ribs and/or one or more channels sized and shaped to guide fluid flow within negative pressure chamber1812, e.g., towards fluid inlet tubes1814,1816.

Upon actuation of the negative pressure system, e.g., an external pump fluidicly coupled to the one or more suction tubes, a vacuum having a predetermined pressure may be created within negative pressure chamber1812to thereby pull intestinal tissue toward anchor1801and secure bypass device1800at the target site. At least some intestinal tissue may be pulled through at least some openings of the stent/scaffold of middle region1806, and further may contact the micropattern of microstructures1820. The micropattern of microstructures1820is configured to inhibit the inner wall of the intestine from sealing against the outer surface of sheath1803responsive to the vacuum to thereby encourage 360° fluidic communication within negative pressure chamber1812. Thus, the micropattern of microstructures1820prevents the intestinal tissue from shutting off on the outer surface of sheath1803and creating a sub-chamber of vacuum within negative pressure chamber1812. Accordingly, the micropattern of microstructures1820maintains a vacuum throughout negative pressure chamber1812such that anchor1801remains anchored at the target location when negative pressure is applied in negative pressure chamber1812. By implementing a micropattern of microstructures on the outer surface of a sheath within the negative pressure chamber to encourage 360° fluidic communication within the negative pressure chamber, as well as an anchor having a recessed middle region, e.g., dog bone shape resembling an hourglass, to improve mechanical anchoring, and automated pump parameters adjustment to improve vacuum maintenance, the overall length of the stent/scaffold of the anchor may be reduced, e.g., 80-90 mm, or 70 mm.

Referring now toFIGS.19A to19C, an exemplary manifold for fluidicly coupling the fluid inlet tubes and the sensing tube to the negative pressure chamber and to the respective pump and pressure/vacuum transducers is provided. As shown inFIG.19A, manifold1900may include first inlet port1904and first outlet port1905sized and shaped to receive first inlet tube1814therethrough, such that first inlet tube1814extends into manifold1900through first inlet port1904and out of manifold1900through first outlet port1905, and second inlet port1906and second outlet port1907sized and shaped to receive second inlet tube1816therethrough, such that second inlet tube1816extends into manifold1900through second inlet port1906and out of manifold1900through second outlet port1907. In addition, manifold1900may include third inlet port1908sized and shaped to receive a downstream end of a distal portion of sensing tube1818therethrough, and third outlet port1909sized and shaped to receive an upstream end of a proximal portion of sensing tube1818therethrough, such that sensing tube1818extends into manifold1900through third inlet port1908and out of manifold1900through third outlet port1909.

As described above, the distal/upstream regions of fluid inlet tubes1814,1816and sensing tube1818may extend towards and be disposed within the negative pressure chamber of the anchor, and the proximal/downstream ends of fluid inlet tubes1814,1816and sensing tube1818may extend towards and be fluidicly coupled to the respective pump and pressure/vacuum transducers. As shown inFIGS.19B and19C, manifold1900further may include clamp1910configured to transition between an open state where fluid is permitted to flow throughout sensing tube1818, as shown inFIG.19B, and a closed state where fluid flow is prevented through at least a portion of sensing tube1818, e.g., beyond clamp1910, as shown inFIG.19C. As shown inFIG.19C, clamp1910may be coupled to the proximal portion of sensing tube1818, downstream of the junction of fluid port1902and sensing tube1818. Moreover, clamp1901may be removeably coupled to sensing tube1818, or alternatively, may be permanently fixed to/integral with sensing tube1818.

Manifold1900further may include flush port1902in fluid communication with sensing tube1818. For example, flush port1902may be fluidicly coupled to the downstream end of a distal portion of sensing tube1818and to the upstream end of a proximal portion of sensing tube1818, as shown inFIG.19C. Flush port1902may be configured to receive fluid from a fluid source for flushing fluid inlet tubes1814,1816and sensing tube1818, e.g., for routine cleaning/maintenance and/or to remove a clog therein. For example, clamp1910may be transitioned to its closed state and fluid may be introduced through fluid port1902, such that clamp1901forces the fluid to flow through sensing tube1818in an upstream direction towards the negative pressure of the anchor. As negative pressure is applied to the negative pressure chamber via fluid inlet tubes1814,1816, the fluid within the negative pressure chamber will flow through fluid inlet tubes1814,1816in a downstream direction towards the fluid reservoir chamber of the external pump, as shown inFIG.19C.

FIG.20is a schematic illustrating the internal components of an alternative negative pressure system for generating the vacuum within the negative pressure chamber. System2000may be constructed similar to system300ofFIGS.3A and3B, and may be used with any of the bypass devices described herein when a sensing line is utilized, e.g., bypass device1800having sensing line1818. For example, system2000may include a housing sized and shaped to house an external pump therein, and may be fluidicly coupled to the downstream ends of the suction/fluid inlet tubes, e.g., tubes242,216,1814,1816. As shownFIG.20, system2000may include a controller, e.g., controller400, in electrical communication with the electrical components of system2000, e.g., pump2016and pressure transducers2004,2012, described in further detail below. System2000may include fluid reservoir chamber2002fluidicly coupled to pump2016. Fluid reservoir chamber2002may be sized and shaped for collecting fluid and waste matter within the fluid evacuated from the negative pressure chamber of the anchor. Controller400may be operatively coupled to pump2016, e.g., via pump interface414, as described above with regard toFIG.4. Accordingly, pump interface414may cause pump2016to generate a vacuum having a predetermined pressure within the negative pressure chamber via the fluid inlet tubes. For example, fluid evacuated from the negative pressure chamber may travel through fluid inlet tubes1814,1816, and enter fluid reservoir chamber2002via inlet2006.

In addition, may include vacuum/pressure transducer2012fluidicly coupled to the negative pressure chamber of the anchor via fluid reservoir chamber2002and the suction/fluid inlet tubes coupled thereto, e.g., fluid inlet tubes1814,1816. In some embodiments, each fluid inlet tube may be fluidicly coupled to a dedicated pressure transducer for measuring pressure within the respective fluid inlet tube. Pressure transducer2012may be configured to measure pressure within the negative pressure chamber via fluid inlet tubes1814,1816, and generate one or more signals indicative of the measured pressure for transmission to controller400, e.g., system parameters determination module412. Accordingly, system parameters determination module412, may be configured to receive, process, and analyze pressure data received from pressure transducer2012to calculate the pressure within negative pressure chamber via fluid inlet tubes1814,1816.

As shown inFIG.20, fluid inlet tubes1814,1816may be fluidicly coupled together via coupler2005, such that a single fluid inlet line in fluid communication with both fluid inlet tubes1814,1816is fluidicly coupled to fluid reservoir chamber2002via inlet2006of fluid reservoir chamber2002. Waste matter within the fluid evacuated from the negative pressure chamber and other fluids may be collected within fluid reservoir chamber2002, such that the remaining fluid, e.g., gas, may exit fluid reservoir chamber2002via outlet2008and travel across filter2009and exit system2000via pump2016. In addition, system2000may include filter2009disposed between fluid reservoir chamber2002and pump2016to prevent waste matter from entering pump2016. Fluid reservoir chamber2002may be removably coupled to the housing to facilitate removal of waste matter from fluid reservoir chamber2002and/or cleaning of fluid reservoir chamber2002. Like system300, system2000further may include one or more check valves fluidicly coupled to suction tubes1814,1816, e.g., between filter2009and pump2016, configured to allow pump2016to return to ambient pressure, e.g., atmospheric pressure, without impacting pressure of system2000.

As shown inFIG.20, system2000may include vacuum/pressure transducer2004fluidicly coupled to the negative pressure chamber of the anchor via dedicated sensing tube1818, which has a direct path to the negative pressure chamber and should always be clear of potential occluders, e.g., waste matter. Pressure transducer2004may be configured to measure pressure within the negative pressure chamber via sensing tube1818, and generate one or more signals indicative of the measured pressure for transmission to controller400, e.g., system parameters determination module412, described above with regard toFIG.4. Accordingly, system parameters determination module412may be configured to receive, process, and analyze pressure data received from pressure transducer2004to calculate the pressure within the negative pressure chamber as measured by sensing tube1818. For example, when system parameters determination module412determines that the pressure within the negative pressure chamber falls outside of the predetermined range, controller400may automatically adjust one or more operating parameters of pump2016, and instruct pump2016to operate in accordance with the adjusted parameters, to thereby maintain the pressure within the negative pressure chamber within the predetermine range.

System parameters determination module412may be configured to detect vacuum pressure differences between sensing tube1818and fluid inlet tubes1814,1816by comparing pressure measurement data received from pressure transducers2004,2012, e.g., pressure within the negative pressure chamber of the anchor and pressure within fluid reservoir chamber2002, and may determine the presence of an occlusion/blockage/clog within at least one of fluid inlet tubes1814,1816, and/or when fluid reservoir chamber2002is full and needs to be emptied/changed, e.g., when the pressure differential detected exceeds a predetermined pressure threshold. In some embodiments, system2000may include one or more additional sensors fluidicly coupled to fluid reservoir chamber2002and configured to measure an amount of waste matter within fluid reservoir chamber2002. The one or more additional sensors may generate one or more signals indicative of the level of waste matter within fluid reservoir chamber2002for transmission to controller400.

In addition, controller400of system2000may generate one or more alerts, e.g., via alert generation module416of controller400, described above with regard toFIG.4. For example, alert generation module416may be configured to generate an alert when the pressure within the negative pressure chamber falls outside of the predetermined range, to periodically facilitate routine manual inspection of system2000by a user, when the amount of waste matter within fluid reservoir chamber2002measured exceeds the predetermined threshold, when the presences of a clog is detected within fluid inlet tubes1814,1816, etc.

Referring now toFIGS.21A and21B, internal components of an alternative exemplary negative pressure system is provided. Negative pressure system2100may be constructed similar to system300. For example, fluid reservoir chamber2102having inlet2106configured to be fluidicly coupled to one or more suction tubes, e.g., suction tubes214,216, pump2112, and pressure transducer2112correspond with fluid reservoir chamber302having inlet306, pump316, and pressure transducer312. System2100differs from system300in that system2100may include pressure normalization chamber2104fluidicly coupled to pump2116. For example, fluid reservoir chamber2102may be fluidicly coupled to pressure normalization chamber2104via valve2110, e.g., a solenoid valve, as shown inFIG.21A. Valve2110may be configured to be actuated to transition between a closed state where fluid reservoir chamber2102is fluidicly isolated from pressure normalization chamber2104, and an open state where fluid reservoir chamber2102is fluidicly coupled to pressure normalization chamber2104.

In addition, pressure normalization chamber2104may include check valve2114configured to be actuated to permit pressure normalization chamber2104to reach atmospheric pressure. For example, check valve2114may be actuated to an open state to allow pressure normalization chamber2104, prior to turning on pump2116. When the pressure within pressure normalization chamber2104is at atmospheric pressure, pump2116may be turned on, check valve2114may be actuated to a closed state, and valve2110may be actuated to the open state to fluidicly couple pump2116, fluid reservoir chamber2102, and pressure normalization chamber2104, such that pump2116may generate a vacuum having a predetermined pressure within negative pressure chamber212. In some embodiments, instead of check valve2114, system2100may include a small controlled leak configured to allow pressure normalization chamber2104to reach atmospheric pressure, e.g., when system2100is in steady state conditions.

Moreover, waste matter within the fluid evacuated from negative pressure chamber212and other fluids may be collected within fluid reservoir chamber2102, such that the remaining fluid, e.g., gas, may travel across valve2110in the open state to pressure normalization chamber2104and exit system2100via pump2116. For example, the fluid may exit pressure normalization chamber2104via outlet2108. As shown inFIG.21B, system2100may include controller400in electrical communication with the electrical components of system2100, e.g., pump2116and pressure transducer2112. In some embodiments, system2100may include one or more additional sensors fluidicly coupled to fluid reservoir chamber2102and configured to measure an amount of waste matter within fluid reservoir chamber2102. The one or more additional sensors may generate one or more signals indicative of the level of waste matter within fluid reservoir chamber2102for transmission to controller400.

While various illustrative embodiments of the invention are described above, it will be apparent to one skilled in the art that various changes and modifications may be made therein without departing from the invention. For example, any of the bypass devices described above, e.g., bypass devices200,1000,1100,1200,1300,1400,1500,1700,1800may incorporate upstream and/or downstream retrieval loops to facilitate removal of the respective anchor from the patient's GI tract, and/or a double anchor as described above. The appended claims are intended to cover all such changes and modifications that fall within the true scope of the invention.