# US 11,998,693 B2 · System and method for avoiding leakage in endotracheal tube with single or double cuff > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,693 B2 - Document ID: US11998693B2 - Status: Granted - Kind: B2 - Application number: 18/323,399 - Filed: 2023-05-24 - Published: 2023-09-21 - Granted: 2024-06-04 - Earliest claimed: 2021-12-22 - Assignees: Medical Technology for Life - Applicants: Medical Technology For Life - Inventors: Kristof Braem - Web page: https://patentgrep.com/patent/US11998693B2 ## CPC - A61M 16/0445: {Special cuff forms, e.g. undulated} - A61M 16/0447: {Bell, canopy or umbrella shaped} - A61M 16/024: {including calculation means, e.g. using a processor} - A61M 16/044: {External cuff pressure control or supply, e.g. synchronisation with respiration} - A61M 16/045: {with cuffs partially or completely inflated by the respiratory gas} - A61M 16/0459: {one cuff behind another} - A61M 16/0463: {combined with suction tubes, catheters or the like; Outside connections} - A61M 16/208: {Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves} - A61M 16/0051: {with alarm devices} - A61M 16/0443: {Special cuff-wall materials (A61M16/0481, A61M16/0422 take precedence)} - A61M 16/0479: {above the cuff, e.g. giving access to the upper trachea} - A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)} - A61M 25/1034: {Joining of shaft and balloon} - A61M 2205/07: having air pumping means - A61M 2205/15: Detection of leaks - A61M 2205/18: with alarm - A61M 2205/3331: Pressure; Flow - A61M 2205/3334: Measuring or controlling the flow rate - A61M 2205/3344: Measuring or controlling pressure at the body treatment site - A61M 2205/502: User interfaces, e.g. screens or keyboards - A61M 2205/8206: battery-operated - 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)} ## Abstract An inflatable cuff for an endotracheal tube system has a sealing component that is one or a combination of (a) a proximal one-directional valve configured to deflect with underpressure during the intubation procedure and contact the tracheal wall of a patient to provide sealing, (b) a distal one-directional valve configured to deflect with overpressure during the intubation procedure and contact the tracheal wall to provide sealing; and (c) a cloud shape of the inflatable portion. The cloud shape is defined by at least one sealing section of the inflatable portion having a primary maximum inflated diameter and at least one non-sealing section of the inflatable portion having a maximum inflated diameter less than the primary maximum inflated diameter. The inflatable cuff may be inflatable by a ventilation tube. The system may include a cuff controller that senses airflow parameters and provides regulated flows of air during an intubation procedure. ## Claims ### Claim 1 An inflatable cuff for an endotracheal tube system, the inflatable cuff comprising: an internal channel adapted for insertion of a ventilation tube of the endotracheal tube system through the internal channel from a proximal opening of the inflatable cuff to a distal opening of the inflatable cuff, the internal channel having a longitudinal axis of the inflatable cuff defined therethrough; a proximal one-directional valve at the proximal opening of the inflatable cuff, the proximal one-directional valve being double-walled and inflatable; a distal one-directional valve at the distal opening of the inflatable cuff, the distal one-directional valve being double-walled and inflatable; an inflatable portion between the proximal opening and the distal opening; wherein the proximal one-directional valve, the distal one-directional valve, and the inflatable portion are configured such that, during an intubation procedure on a patient in which the inflatable cuff is attached to the ventilation tube: the inflatable portion comprises: a sealing section having a primary maximum inflated diameter; and at least one non-sealing section joined to the sealing section at a joint, the at least one non-sealing section having a maximum inflated diameter less than the primary maximum inflated diameter of the sealing section, the joint defining a diameter less than the maximum inflated diameter of the at least one non-sealing section; the sealing section of the inflatable portion, each non-sealing section of the inflatable portion, the proximal one-directional valve, and the distal one-directional valve, are inflated; when the inflatable portion is inflated, the sealing section and each non-sealing section of the inflatable portion comprise outer surfaces each having a rounded convex contour bulging outwardly away from the internal channel; the sealing section of the inflatable portion provides sealing against a tracheal wall of the patient; the proximal one-directional valve deflects with underpressure and provides upon deflection a first sealing contact against the tracheal wall; and the distal one-directional valve deflects with overpressure and provides upon deflection a second sealing contact against the tracheal wall. ### Claim 2 (depends on 1) The inflatable cuff of claim 1, wherein: the proximal one-directional valve comprises a proximal surface that is concave as viewed from a superior position in an inferior direction and is configured to deflect in the inferior direction with underpressure during the intubation procedure and contact the tracheal wall around an outer periphery of the proximal one-directional valve; and/or the distal one-directional valve comprises a distal surface that is concave as viewed from an inferior position in a superior direction and is configured to deflect in the superior direction with overpressure during the intubation procedure and contact the tracheal wall around an outer periphery of the distal one-directional valve. ### Claim 3 (depends on 1) The inflatable cuff of claim 1, having a thickness from 0.05 mm to 0.2 mm and a thickness uniformity of ±5%. ### Claim 4 (depends on 1) The inflatable cuff of claim 1, wherein the inflatable portion is made from polyethylene terephthalate (PETP), low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, polypropylene, or polyurethane (PU). ### Claim 5 (depends on 1) An endotracheal tube system for ventilating a patient, the endotracheal tube system comprising: an inflatable cuff according to claim 1; a ventilation tube inserted through the internal channel of the inflatable cuff, the ventilation tube comprising a primary inflation outlet in fluidic communication with the inflatable portion of the at least one inflatable cuff and a primary cuff inflation lumen defined through the ventilation tube. ### Claim 6 (depends on 5) The endotracheal tube system of claim 5, wherein: the inflatable cuff comprises a primary inflatable portion, a secondary inflatable portion, and an inter-cuff region defined between the primary inflatable portion and the secondary inflatable portion; the primary inflatable portion is in fluidic communication with the primary inflation outlet of the ventilation tube; and the secondary inflatable portion is in fluidic communication either with the primary inflation outlet or with a secondary inflation outlet that is in fluidic communication either with the primary cuff inflation lumen or with a secondary cuff inflation lumen through the ventilation tube and separate from the primary cuff inflation lumen. ### Claim 7 (depends on 6) The endotracheal tube system of claim 6, further comprising: a sensor located in the inter-cuff region, the sensor being operative to sense or measure airflow parameters in the inter-cuff region; and a cuff controller comprising an electronic device that receives the airflow parameters, computes one or more regulated flows of air from the airflow parameters, and communicates with one or more first mechanical system or mechanical device that provides the regulated flows of air. ### Claim 8 (depends on 6) The endotracheal tube system of claim 6, further comprising a cuff controller, the cuff controller comprising: (i) an electronic device that receives sensed parameters from the inflatable cuff and computes one or more regulated flows of air from the sensed parameters; (ii) one or more first mechanical system or mechanical device that provides the regulated flows of air. ### Claim 9 (depends on 8) The endotracheal tube system of claim 8, wherein the cuff controller further comprises one or more second mechanical system or mechanical device that provides one or more suction actions, wherein the electronic device determines or computes the one or more suction actions. ### Claim 10 (depends on 9) The endotracheal tube system of claim 9, further comprising a non-transitory machine-readable storage medium storing a computer program product, operable on a processing engine, for executing any of the computing operations the electronic device. ### Claim 11 (depends on 1) The inflatable cuff of claim 1, wherein the at least one non-sealing section of the inflatable portion comprises at least one proximal non-sealing section between the sealing section and the proximal one-directional valve. ### Claim 12 (depends on 1) The inflatable cuff of claim 1, wherein the at least one non-sealing section of the inflatable portion comprises: at least one proximal non-sealing section between the sealing section and the proximal one-directional valve; and at least one distal non-sealing section between the sealing section and the distal one-directional valve. ### Claim 13 (depends on 1) The inflatable cuff of claim 1, wherein: the at least one non-sealing section comprises a first non-sealing section and a second non-sealing section; the first non-sealing section is interposed between the sealing section and the second non-sealing section; and the maximum inflated diameter of the second non-sealing section is less than the maximum inflated diameter of the first non-sealing section. ### Claim 14 (depends on 1) The inflatable cuff of claim 1, wherein: the at least one non-sealing section comprises a first proximal non-sealing section, a second proximal non-sealing section, a first distal non-sealing section, and a second distal non-sealing section; the first proximal non-sealing section is interposed between the sealing section and the second proximal non-sealing section; the first distal non-sealing section is interposed between the sealing section and the second distal non-sealing section; the maximum inflated diameter of the second proximal non-sealing section is less than the maximum inflated diameter of the first proximal non-sealing section; and the maximum inflated diameter of the second distal non-sealing section is less than the maximum inflated diameter of the first distal non-sealing section. ### Claim 15 (depends on 14) The inflatable cuff of claim 14, wherein: the proximal one-directional valve is attached to the inflatable cuff around a joint of the inflatable portion between the first proximal non-sealing section and the second proximal non-sealing section; and/or the distal one-directional valve is attached to the inflatable cuff around a joint of the inflatable portion between the first distal non-sealing section and the second distal non-sealing section. ### Claim 16 (depends on 1) The inflatable cuff of claim 1, wherein the sealing section and each non-sealing section of the inflatable portion comprise the outer surfaces each having the rounded convex contour bulging outwardly away from the internal channel when the inflatable portion is inflated to a cuff pressure from 5 cm H2O to 100 cm H2O.