# US 12,213,673 B2 · Systems and methods for introducing and monitoring a negative pressure device for protecting an intestinal anastomosis > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,213,673 B2 - Document ID: US12213673B2 - Status: Granted - Kind: B2 - Application number: 18/607,051 - Filed: 2024-03-15 - Published: 2024-09-19 - Granted: 2025-02-04 - Earliest claimed: 2023-03-17 - Assignees: SafeHeal SAS - Applicants: SafeHeal SAS - Inventors: Michael J. Augelli; Daniel Congdon - Web page: https://patentgrep.com/patent/US12213673B2 ## CPC - A61B 17/1114: {of the digestive tract, e.g. bowels or oesophagus} - A61M 1/74: {Suction control (underwater drainage A61M1/61)} - A61M 1/84: {Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32)} - A61M 1/98: {Containers specifically adapted for negative pressure wound therapy} - A61B 5/06: Devices, other than using radiation, for detecting or locating foreign bodies {; Determining position of diagnostic devices within or on the body of the patient} - A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06) - A61B 2017/00022: {Sensing or detecting at the treatment site} - A61B 2017/00119: {alarm; indicating an abnormal situation} - A61B 2017/00544: {pneumatically} - A61B 2017/00561: {creating a vacuum} - A61B 2017/00566: {fixation of form upon application of vacuum} - A61B 2017/00818: {Treatment of the gastro-intestinal system} - A61B 2017/00955: {thermoplastic} - A61B 2017/1132: {End-to-end connections} - A61F 2002/045: {Stomach, intestines} - A61M 2205/3351: Controlling upstream pump pressure - A61M 2210/1064: Large intestine - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract Systems and methods for monitoring a bypass device for protecting an intestinal anastomosis are provided. The system includes a pump, one or more fluid inlet lines fluidicly coupled to the pump and to a negative pressure chamber of the bypass device, and one or more sensors configured to measure data indicative of pressure within the negative pressure chamber. A controller operatively coupled to the pump and the one or more sensors may be programmed to actuate the pump to generate a vacuum within the negative pressure chamber to thereby pull intestinal tissue towards the bypass device to anchor the bypass device at a target location upstream of the intestinal anastomosis. The controller further may compare the pressure within the negative pressure chamber with a predetermined pressure range and, if the pressure falls outside the predetermined pressure range, adjust the pump to maintain the vacuum within the predetermined pressure range. ## Claims ### Claim 1 A system for monitoring a bypass device for protecting an intestinal anastomosis, the bypass device comprising a negative pressure chamber and configured to be implanted at a target location upstream of the intestinal anastomosis, the system comprising: a pump; one or more fluid inlet tubes each having a downstream end coupled to the pump and an upstream end having one or more pores in fluid communication with the negative pressure chamber of the bypass device; one or more sensors configured to measure data indicative of pressure within the negative pressure chamber; and a controller operatively coupled to the pump and the one or more sensors, the controller programmed with instructions configured to: actuate the pump at predetermined pump parameters to evacuate fluid from the negative pressure chamber via the one or more fluid inlet tubes to generate a vacuum within the negative pressure chamber having a pressure within a predetermined pressure range, the vacuum sufficient to pull intestinal tissue toward the bypass device to anchor the bypass device at the target location upstream of the intestinal anastomosis; compare the data indicative of the pressure within the negative pressure chamber received from the one or more sensors over time with the predetermined pressure range; and adjust, if the pressure within the negative pressure chamber falls outside the predetermined pressure range, the predetermined pump parameters of the pump, such that the pump applies and maintains the vacuum within the predetermined pressure range within the negative pressure chamber. ### Claim 2 (depends on 1) The system of claim 1, wherein the controller is configured to generate an alert if the pressure within the negative pressure chamber falls outside the predetermined pressure range, the alert comprising at least one of an audible or visual alert. ### Claim 3 (depends on 1) The system of claim 1, wherein the controller is configured to generate an alert if the pressure within the negative pressure chamber does not fall within the predetermined pressure range within a predetermined time period. ### Claim 4 (depends on 1) The system of claim 1, wherein the controller is configured to adjust the predetermined pressure range of the vacuum over time. ### Claim 5 (depends on 1) The system of claim 1, wherein the controller is configured to stop actuation of the pump when the pressure within the negative pressure chamber is within the predetermined pressure range. ### Claim 6 (depends on 1) The system of claim 1, further comprising one or more check valves in fluid communication with the pump, the one or more check valves configured to transition between a closed state and an open state to bring the pump to ambient pressure. ### Claim 7 (depends on 1) The system of claim 1, wherein the controller is configured to: calculate an actual pump run time of the pump to achieve a predetermined total volume of the system; and determine a presence of an occlusion in the system if the actual pump run time deviates from an expected pump run time. ### Claim 8 (depends on 7) The system of claim 7, wherein the controller is configured to calculate a volume of the system in real time based on the data measured by the one or more sensors, and wherein the controller is configured to calculate the expected pump run time of the pump based on the volume of the system in real time. ### Claim 9 (depends on 7) The system of claim 7, wherein the controller is configured to generate an alert upon determination of the presence of the occlusion in the system. ### Claim 10 (depends on 1) The system of claim 1, further comprising a fluid reservoir chamber in fluid communication with the one or more fluid inlet tubes, the fluid reservoir chamber configured to collect at least one of liquid or solid waste from the fluid evacuated from the negative pressure chamber. ### Claim 11 (depends on 1) The system of claim 1, further comprising a housing configured to contain at least the pump and the controller therein. ### Claim 12 (depends on 11) The system of claim 11, wherein the housing is sized and shaped to be worn by a patient. ### Claim 13 (depends on 11) The system of claim 11, wherein the housing is configured to be mounted bedside or on an IV pole. ### Claim 14 (depends on 11) The system of claim 11, wherein the housing comprises a user interface operatively coupled to the controller, the user interface configured to permit a user to select the predetermined pump parameters from a plurality of predetermined pump parameters. ### Claim 15 (depends on 14) The system of claim 14, wherein the user interface comprises a display for displaying information associated with the bypass device. ### Claim 16 (depends on 1) The system of claim 1, wherein the negative pressure chamber is defined by a mesh anchor sealed to an inner sheath via a downstream seal and an upstream seal, the mesh anchor configured to engage with the intestinal tissue in an expanded deployed state, and wherein the one or more fluid inlet tubes extend across the downstream seal such that the one or more pores are disposed within the negative pressure chamber. ### Claim 17 (depends on 16) The system of claim 16, wherein the inner sheath comprises a length such that the inner sheath extends from the mesh anchor at the target location across the intestinal anastomosis and out of an anal orifice, the inner sheath having a lumen sized and shaped to permit feces to pass therethrough without contacting the intestinal anastomosis. ### Claim 18 (depends on 16) The system of claim 16, wherein the mesh anchor comprises a downstream region, an upstream region, and a middle region extending between the downstream and upstream regions, the middle region having an outer diameter less than outer diameters of the downstream and upstream regions. ### Claim 19 (depends on 18) The system of claim 18, further comprising a middle seal configured to seal the inner sheath to the middle region of the mesh anchor to thereby define a first negative pressure chamber between the inner sheath, the downstream seal, the middle seal, and a portion of the mesh anchor between the downstream seal and the middle seal, and a second negative pressure chamber between the inner sheath, the upstream seal, the middle seal, and a portion of the mesh anchor between the upstream seal and the middle seal. ### Claim 20 (depends on 19) The system of claim 19, wherein a first set of the one or more fluid inlet tubes extend across the downstream seal such that one or more pores of the first set of the one or more fluid inlet tubes are disposed within the first negative pressure chamber, and wherein a second set of the one or more fluid inlet tubes extend across the downstream seal and the middle seal such that one or more pores of the second set of the one or more fluid inlet tubes are disposed within the second negative pressure chamber. ### Claim 21 (depends on 19) The system of claim 19, wherein the middle seal comprises a sealing ring having a plurality of inlet ports configured to be fluidicly coupled to the pump via one or more suction tubes. ### Claim 22 (depends on 16) The system of claim 16, wherein the downstream seal comprises a sealing ring having a plurality of inlet ports configured to be fluidicly coupled to the pump via one or more suction tubes. ### Claim 23 (depends on 16) The system of claim 16, wherein the upstream seal extends along an upstream region of the mesh anchor and covers an upstream end of the mesh anchor, and wherein the upstream seal is configured to inhibit mucosal ingrowth on the bypass device and inhibit damage to the intestinal tissue. ### Claim 24 (depends on 23) The system of claim 23, wherein the downstream seal extends along a downstream region of the mesh anchor and covers a downstream end of the mesh anchor, and wherein the downstream seal is configured to inhibit mucosal ingrowth on the bypass device and inhibit damage to the intestinal tissue. ### Claim 25 (depends on 16) The system of claim 16, wherein the mesh anchor comprises: an inner mesh anchor comprising a downstream region, an upstream region, and a middle region extending between the downstream and upstream regions, the middle region having an outer diameter less than outer diameters of the downstream and upstream regions; and an outer mesh anchor disposed over the inner mesh anchor, the outer mesh anchor configured to transition from a cylindrical configuration towards a shape corresponding to a geometry of the inner mesh anchor when the vacuum is generated within the negative pressure chamber. ### Claim 26 (depends on 1) The system of claim 1, further comprising: one or more additional sensors configured to measure data indicative of a presence of at least one of blood, feces, or predefined gases between the bypass device and intestinal tissue surrounding the bypass device, wherein the controller is configured to generate an alert if the level of the at least one of blood, feces, or predefined gases exceeds a predetermined threshold. ### Claim 27 (depends on 1) The system of claim 1, further comprising: one or more additional sensors configured to measure data indicative of a position of the bypass device relative to the intestinal anastomosis, wherein the controller is configured to generate an alert if the position of the bypass device relative to the intestinal anastomosis indicates that the bypass device is slipping from the target location. ### Claim 28 (depends on 1) The system of claim 1, wherein the one or more fluid inlet tubes comprise: a first fluid inlet tube having a first downstream end coupled to the pump and a first upstream end having a first set of one or more pores in fluid communication with the negative pressure chamber of the bypass device; and a second fluid inlet tube having a second downstream end coupled to the pump and a second upstream end having a second set of one or more pores in fluid communication with the negative pressure chamber of the bypass device. ### Claim 29 (depends on 28) The system of claim 28, wherein the first and second upstream ends of the first fluid and second fluid inlet tubes are equally and circumferentially spaced apart within the negative pressure chamber. ### Claim 30 A method for protecting an intestinal anastomosis, the method comprising: introducing a bypass device through an anal orifice into an intestine, and positioning the bypass device at a target location upstream of the intestinal anastomosis; deploying the bypass device at the target location; coupling a downstream end of one or more fluid inlet tubes extending from a negative pressure chamber of the bypass device to a pump external to the anal orifice, the one or more fluid inlet tubes each having an upstream end having one or more pores in fluid communication with the negative pressure chamber of the bypass device; actuating the pump at pump parameters to evacuate fluid from the negative pressure chamber via the one or more fluid inlet tubes to generate a vacuum having a pressure within a predetermined pressure range within the negative pressure chamber, the vacuum sufficient to pull intestinal tissue within the negative pressure chamber to anchor the bypass device at the target location; measuring pressure within the negative pressure chamber over time via one or more pressure sensors; and adjusting, when the pressure within the negative pressure chamber falls outside the predetermined pressure range, the pump parameters of the pump, such that the pump applies and maintains the vacuum within the predetermined pressure range within the negative pressure chamber.