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WO2023028052A1 - Dispositifs, systèmes et procédés de détection de fuite - Google Patents

Dispositifs, systèmes et procédés de détection de fuite Download PDF

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Publication number
WO2023028052A1
WO2023028052A1 PCT/US2022/041216 US2022041216W WO2023028052A1 WO 2023028052 A1 WO2023028052 A1 WO 2023028052A1 US 2022041216 W US2022041216 W US 2022041216W WO 2023028052 A1 WO2023028052 A1 WO 2023028052A1
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WO
WIPO (PCT)
Prior art keywords
sensor
implantable device
leak
infection
alert
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2022/041216
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English (en)
Other versions
WO2023028052A8 (fr
Inventor
Scott Schorer
Theodore Bertele
Chris Thompson
David Lautz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Elless LLC
Original Assignee
Elless LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Elless LLC filed Critical Elless LLC
Publication of WO2023028052A1 publication Critical patent/WO2023028052A1/fr
Publication of WO2023028052A8 publication Critical patent/WO2023028052A8/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—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
    • A61B5/14532—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 for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—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
    • A61B5/14539—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 for measuring pH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6873—Intestine

Definitions

  • TPN feeding is unpleasant for the patient, as it is uncomfortable, requires a peripherally inserted central catheter (PICC), and entails high expense. Often, exploratory surgery or procedures are conducted to determine the root cause of infection or other clinical issues which carries its own additional risk and is often inconclusive.
  • PICC peripherally inserted central catheter
  • What is needed is a more definitive and early means of diagnosis as opposed to analyzing indirect markers of a potential leak and/or infection after the clinical issues have manifested and become acute.
  • the early detection of a leak and/or infection may allow clinicians to act upon it before significant clinical issues manifest with often grave clinical consequences.
  • What is needed is a low-cost sensor that can combine a number of inputs into a custom algorithm and custom data presentation that provides realtime data and analysis to facilitate clinical decision-making and accelerate intervention for those patients diagnosed with a leak and/or infection.
  • the present disclosure provides devices, systems, and methods for leak and infection detection.
  • the present invention provides an implantable device including a deformable housing including at least one sensor, wherein said flexible housing is connected to an alert element.
  • the flexible housing includes a plurality of sensors.
  • the sensor is a temperature sensor, a pressure sensor, an ultrasonic sensor, an impedance sensor, a pH sensor, a viscosity sensor, or an optical sensor.
  • a conductor connects the flexible housing and the alert element.
  • the flexible housing has a shape selected from the group consisting of linear, curved, coiled, disc, or sheet.
  • the alert element is selected from the group consisting of a display, an indicator light, and vibration element. In some embodiments, the alert element is incorporated into an enclosure.
  • the enclosure further includes a battery.
  • the device further includes a control element.
  • the control element is a computer processing unit. In some embodiments, the control element is incorporated in the enclosure.
  • the flexible housing further includes at least one locator.
  • the locator is a radio-opaque identifier.
  • the shape of the radioopaque identifier is selected from the group consisting of a square, a diamond, a triangle, a cross, a circle, a horseshoe, and a star.
  • the device further includes a fluid collection reservoir.
  • the fluid collection reservoir includes at least one sensor.
  • the at least one sensor is a temperature sensor, a pressure sensor, an ultrasonic sensor, an impedance sensor, a pH sensor, a viscosity sensor, or an optical sensor.
  • the alert element includes a fixation element.
  • the implantable device further includes a wireless connection.
  • the implantable device further includes a closure element.
  • the present invention provides a wound closure system including an implantable device including a deformable housing including at least one sensor, wherein said flexible housing is connected to an alert element;
  • the present invention provides a method of sensing a leak and/or infection in the peritoneal cavity.
  • the method includes the steps of (a) providing the an implantable device including a deformable housing including at least one sensor, wherein said flexible housing is connected to an alert element; (b) placing the implantable device in the peritoneal cavity of a subject; (c) detecting a baseline condition with the sensor;( d) taking measurements of peritoneal cavity with the sensor and comparing against the measurements the baseline condition to detect a leak and/or infection; and (e) alerting the subject of a leak and/ or infection with the alert element.
  • the alert element : (a) vibrates to alert the subject of a leak and/or infection; (b) displays a status to alert the patient of a leak and/or infection; and/or (c) displays a light to alert the patient of a leak and/or infection.
  • the alert element displays the location of the leak and/or infection.
  • the flexible housing further includes at least one locator. In some embodiments, the method further includes visualizing the locator to locate the leak and/or infection.
  • the alert element includes a fixation element.
  • the method further includes the step of fixing the alert element to the skin of the patient using the fixation element.
  • the method further includes the step of removing the implantable device.
  • the implantable device is removed after 1 -3 weeks.
  • the implantable device is pulled out of the subject.
  • the implantable device is placed under the suture line in the peritoneal cavity of a subject.
  • a plurality of implantable devices is placed in the peritoneal cavity of a subject.
  • the plurality of implantable devices wirelessly connects to a central unit. In some embodiments, the plurality of implantable devices wirelessly sends sensor data to the central unit.
  • the term “leak” refers to the instances of substances, such as blood, bacteria, food, etc., seeping out of an internal organ following a procedure or surgery.
  • implant and “implantable device” are used interchangeable herein, and describe medical devices for placement inside a body.
  • FIG. 1 shows one embodiment of an implantable device having a housing and a control element.
  • FIG. 2A and FIG. 2B show embodiments an implantable device for detecting leaks and/or infection.
  • FIG. 2A shows a flat housing having indicators.
  • FIG. 2B shows a rounded housing having indicators.
  • FIG. 3 shows an enclosure having a control element and an alert element.
  • FIG. 4 shows an enclosure having an adhesive backing.
  • FIG. 5 shows an embodiment of an implantable device for detecting leaks and/or infection having temperature, impedance, and pH sensors.
  • FIG. 6 shows an embodiment of an implantable device for detecting leaks and/or infection having a plurality of different types of sensors in a flat tape-like shape.
  • FIG. 7 shows exemplary embodiments of an implantable device for detecting leaks and/or infection.
  • FIG. 8 shows exemplary embodiments of an implantable device for detecting leaks and/or infection having a fluid collection reservoir.
  • FIG. 9 shows exemplary embodiments of an implantable device for detecting leaks and/or infection having a fluid collection reservoir and a control element.
  • This invention relates generally to devices, systems, and methods for leak and/or infection detection.
  • Leaks are a particularly difficult clinical issue to diagnose and treat, are costly, and unnecessarily risk patient lives. Leaks are common in a number of procedures. Procedures having a substantial risk of leakage include colorectal, intra-abdominal, thoracic, urological, and gynecological procedures or surgeries. Staple lines, suture lines, and anastomoses are common locations of leaks. Revision procedures of the colon, gastric system, esophageal, colonic interposition, gastric polyp, gall bladder, bariatric system also represent high risk procedures for leaks. There are different stages of deterioration following leaks. Leaks tend to form in different groups and stages. Leaks are the most common of severe poor outcomes that can be detected early and acute issues prevented, for example, with the present leak detection methods, devices, and systems.
  • leaks are self-detected by patients. Shortcomings of patient self-detection are many. Patients are weakened following surgery and may not be able to distinguish post-operative symptoms from leak indicators. Other comorbidities and medications further confound the ability of the patient to self-detect malaise, right upper quadrant (RUQ) pain, fever, or arrythmia. Clinical issues associated with leaks may manifest in arrythmia, pH imbalance, pressure change, impedance changes, abnormal blood work and or abnormal imaging results. An initial signal of a leak or infection is the manifestation of slight arrythmia and or tachycardia. Patients generally are often unaware of and often cannot self-detect mild tachycardia (over 100BPM).
  • WBC White blood cell count
  • CRP C-reactive protein
  • Procedures to resolve a post-procedure leak have high complication rates and can carry substantial patient risk, such as dehiscence, as well drive excess cost to the healthcare.
  • Early detection of leaks leads to more immediate intervention, diagnosis is difficult, and often results in exploratory surgery to attempt to locate and diagnose the type of leak. For example, if clinical issues manifest after a procedure involving anastomoses such as various forms of gastric bypass, the gut is insufflated and during an exploratory procedure is visually inspected for bubbles which are indicative of a leak. Exploratory surgery is primitive and invasive, and often fails to fully diagnose leaks. If one leak is found is found during exploratory surgery that does not signify that all leaks have been found.
  • the present implantable device for detecting leaks and/or infection is an advantageous alternative to the above-described treatments.
  • the implantable device may be used in a variety of surgeries, and may lead to enhanced patient outcomes through more rapid and accurate diagnosis.
  • the implantable device, having at least one sensor is advantageous in that it may be in a small physical form, is easily manufactured at low cost, and has the ability to be used in a variety of procedures.
  • Consequences of late leak detection are severe infection, poor patient outcome, readmission, reoperation, high-cost and mortality.
  • Early detection of leaks is highly beneficial, as the leak may be treated earlier, including earlier consideration of “nothing by mouth” (NPO) orders, the conducting of upper Gl series tests, and administration of intravenous antibiotics. If the leak is detected early enough, the clinical issue may be able to be treated at home or in a hospital without advancing diet to NPO.
  • NPO nothing by mouth
  • the present invention relates to devices, systems, and methods for detecting leaks and/or infection, thus avoiding the negative consequences of delayed patient self-detection. More specifically, the present invention relates to implants or implantable devices, as well as methods of use, for sensing leaks and/or infection.
  • the present implantable device may include an enclosure having a control element and/or alert element connected to a housing having at least one sensor.
  • FIG. 1 shows an enclosure connected to a housing having at least one sensor.
  • FIG. 3 shows an exemplary embodiment of an enclosure.
  • the enclosure may be box, bulb, or bag.
  • the enclosure may be watertight, such as to protect internal components from bodily fluids.
  • the devices may include a housing, wherein the housing includes at least one sensor.
  • the housing may be straight, curved, coiled, contoured, circular, rectangular, spiral, net, etc.
  • the housing may be in a sheet form.
  • the housing is tubular.
  • the housing is a lead.
  • the device does not include an enclosure, and solely includes a housing having at least one sensor.
  • the device may rigid or deformable. In some embodiments, the device may be entirely or partially deformable, flexible, rigid, hard, soft, etc. In some embodiments, the enclosure is deformable. In some embodiments, the enclosure is rigid or hard. In some embodiments, the housing is deformable. In some embodiments, the housing is flexible. In some embodiments, the housing is soft. In some embodiments, the housing is rigid or hard.
  • the device may be formed from various materials.
  • the device is fabricated from biocompatible materials.
  • the device includes a polymer, e.g., the enclosure may include a polymer, such as a thermoplastic.
  • the device includes a metal.
  • the device may further include a balloon.
  • the devices may be placed at the site of surgery.
  • the device is placed at an anastomotic site.
  • An anastomotic site is a surgical connection between two structures, and is commonly the location of a leak following surgery.
  • the device may be placed partially into the body of the subject, such that there is at least one sensor both inside and outside the body.
  • the at least one sensor inside the body is a temperature, pressure, ultrasonic, impedance, pH, or photodetection sensor.
  • the at least one sensor outside the body is a temperature, heartrate, or glucose sensor.
  • the device may be placed at a wound closure. Placement of a device at a wound closure is advantageous in that a wound closure is often the site of a leak, and also offers ease of placement and removal.
  • the wound is closed following placement, e.g., with sutures.
  • the device is placed through a wound closure, such that at least one sensor is present on either side of the wound. For example, the sensor may be internal to the wound, while the indicator is external to the wound.
  • the device is integrated into a wound closure system, e.g., a suture, a staple, a compression, glue, etc.
  • the device is incorporated into a wound closure kit.
  • a wound closure kit may include the presently described implantable devices and a suture or staple.
  • a wound closure system is contemplated including the device and sutures or staples.
  • the device may be placed in the gut (e.g., the intestine). Leaks during intestinal surgery are common, and thus the device is advantageous for the use in intestinal surgeries.
  • a sensor may be inserted through the gut wall and anchored to the gut wall.
  • the device may be integrated into a drain. Surgical drains are implants that allow removal of fluid and/or gas from a wound or body cavity. Incorporation of the devices into drains may aid clinicians in identifying if the drain is working properly and facilitate the detection of a leak by analyzing the characteristics of fluid flowing through the drain.
  • the device includes a closure disk to prevent leaking out of the peritoneal cavity.
  • Fluid may be collected from the site of surgery. Collection of fluid may serve several purposes, including analysis of the fluid for infection, detecting leaks from one internal cavity to another, or removal of leaked fluid to prevent infection.
  • the device may include a fluid collection system, including a fluid collector, a channel, and a fluid collection reservoir.
  • the fluid collection system may be in the housing and/ or enclosure. Alternatively, the fluid collector may be in the housing, and the fluid collection reservoir in the enclosure, with the channel connecting the fluid collector and the fluid collection reservoir.
  • the device may include a fluid collector.
  • the fluid may be collected through a housing, such as through fluid ports, and transported through a fluid channel to a fluid collection reservoir.
  • the device may include a fluid collection reservoir.
  • the fluid collection reservoir may be in the form of a bulb, bag, or tube.
  • the at least one sensor may allow the present invention to provide data regarding severity, position, and anatomical location of the leak.
  • the at least one sensor may detect a clinical issue, such as a leak or an infection.
  • the at least one sensor may be present in the housing. Additionally, at least one sensor may be present in the fluid collection reservoir, such as a fluid collection reservoir of a drain integrated with a sensor
  • the senor may detect a baseline. Throughout implantation the at least one sensor may continue detecting. Data may be compared throughout the period of implantation of the device between current measurements and a previously collected baseline measurement to detect changes to clinical indications.
  • the device includes at least one temperature sensor. In some embodiments, the device includes a plurality of temperature sensors. Temperature sensors are advantageous due to size and may be incorporated into a miniaturized device. Temperature sensors may provide time history data. Using the circadian baseline, deviations from baseline may be identified. In addition, a change in temperature of fluid may indicate a clinical issue, e.g., an infection.
  • the device includes at least one pressure sensor.
  • Pressure sensors may include diaphragms, strain gauges, piezoresistive pressure sensors, capacitive pressure sensors, or electromagnetic sensors. Pressure sensors are advantageous in that they may detect inflammation (e.g., an increase in pressure), change in tissue response, monitor a heartbeat, establish a normal profile, and detect arrythmia.
  • the device includes at least one ultrasonic sensor.
  • Ultrasonic sensors may detect changes in tissue density.
  • the device includes at least one impedance sensor.
  • the impedance sensor includes electrodes. Impedance sensors are advantageous in that they may be used to conduct bioelectrical impedance analysis (BIA).
  • the present methods include the step of conducting bioelectrical impedance analysis (BIA).
  • the BIA is conducted with an external or internal impedance sensor. Consistent patterns of change in BIA variables are seen in various models of wound healing.
  • the device includes at least one pH sensor.
  • the pH sensor is an ion sensitive glass electrode. Ion sensitive glass electrodes are advantageous in that they may be configured to have small dimensions, and thus reduce the size of the present invention. It has been found that pH has a role in the wound healing process. The pH of the human body lies in a range between 7.35-7.45, and minor alterations from this range may have an impact on health and indicate a potential clinical issue. Pancreatic alpha-amylase is stable over a range of pH values (5.0- 10.5) with an optical pH for the enzymatic activity of 7.0. Blood pH is about 7.4. Bile is composed of bile acids and salts, phospholipids, cholesterol, pigments, water, and electrolyte chemical that keep the total solution slightly alkaline, with a pH of about 7 and 8.
  • the device includes at least one optical sensor.
  • the optical sensor may include a light source, e.g., an LED light source, and associated photodetector.
  • the light source in one example emits light at different wavelengths within the visible spectrum, including a violet light, a blue light, a green light, a yellow light, an orange light, and a red light.
  • the optical sensor includes a singular light source or a plurality of light sources, similarly the photodetector may include a single photodetector or a plurality of photodetectors.
  • Photodetection sensors are advantageous in that they may illuminate implanted optical components and read the intensity and wavelength that returns via a fiber optic cable.
  • the device includes at least one gas sensor.
  • the present invention relates to method in which a cavity is insufflated, the device administered to the cavity, and the gas in the cavity measured and/or identified by a gas sensor in the device.
  • the device includes at least one viscometer.
  • At least one sensor may be present in the fluid collection reservoir.
  • the fluid collection reservoir may include any of the sensors previously discussed, including, but not limited to, optical sensors, pH sensors, pressure sensors, viscosity sensors, or temperature sensors.
  • the at least one sensor may monitor the fluid for indications of clinical issue. For example, viscous and cloudy fluid is indicative of a clinical issue, e.g., an infection.
  • the optical sensor may sense the clarity of the fluid in the fluid collection reservoir.
  • the viscosity sensor may sense the viscosity of the fluid in the fluid collection reservoir. Alert
  • the device is advantageous in that it may alert the subject or clinician of a leak and/or infection in the subject such that corrective action may be taken.
  • the device may include at least one alert element.
  • the device includes a plurality of alert elements.
  • the alert element may be incorporated into the device in a variety of manners, including inclusion into the housing.
  • the housing includes a plurality of alert elements.
  • the alert element may include a display, an indicator light, or vibration element.
  • the device may include an indicator light.
  • FIG. 3, FIG. 7, FIG. 8, and FIG. 9 show exemplary embodiments of devices having indicator lights.
  • the indicator light is multi-colored.
  • the indicator light turns on to indicate a leak and/or infection and alert the subject and/or the clinician.
  • the device may include a buzzer or vibration element.
  • the buzzer or vibration element may vibrate to alert the user of a leak and/or infection.
  • a buzzer or vibration element may be advantageous if the enclosure is secured to the subject, such that the subject would rapidly be alerted to a leak following their procedure.
  • the device may include a display screen.
  • FIG. 7, FIG. 8, and FIG. 9 show exemplary embodiments of devices having display screens.
  • the display screen displays the status of a leak and/or infection.
  • the display screen displays a number or letter to alert the user of a leak and/or infection.
  • the number or letter corresponds to the location and/or severity of a leak and/or infection.
  • the number or letter corresponds to a zone of the implantable device.
  • the alert element may be fastened to the patient, such as with an adhesive, e.g., glue or a clip.
  • the present invention is wirelessly enabled, such as through WiFi or BLUETOOTH®, and alerts the subject or clinician through a digital device, a handheld device (e.g., a cellular phone), a digital application, a watch, a text message, or a call.
  • wirelessly enabled devices may be fully implanted. For example, if the device includes a flexible housing having at least one sensor without an enclosure having an indicator light or buzzer or vibration element, the subject or clinician may be alerted to a leak using a wirelessly enabled device.
  • the alert element may be capable of waking a sleeping patient.
  • the devices may be used in methods of identifying clinical issues, including leaks and infection.
  • the present invention relates to a method including the steps of (a) providing a leak detection device including at least one sensor, (b) implanting the leak detection device in a subject, (c) detecting a leak with the sensor, (d) alerting the subject and/or clinician of a leak, (e) administering imaging to the subject to determine the location of a leak, (f) removing the implant, and (g) treating the leak.
  • the present invention relates to a method including the steps of (a) providing a leak detection device including at least one sensor, (b) implanting the leak detection device in a subject, (c) detecting a leak with the at least one sensor, (d) alerting the subject and/or clinician of the leak, (e) removing the implant, and (f) treating the leak.
  • the present invention relates to a method including the steps of (a) providing a device including at least one sensor, (b) implanting the at least a portion of the device in a subject, (c) detecting an infection with the at least one sensor, (d) alerting the subject and/ or clinician of the infection, (e) removing the implant, and (f) treating the infection.
  • the subject and/or clinician is alerted to the location of the leak and/or infection.
  • the device further includes a flexible housing, wherein the at least one sensor is within the flexible housing.
  • the device further includes a fluid collection reservoir. In some embodiments, the device collections fluid from the subject in the fluid collection reservoir. In some embodiments, the at least one sensor is within the fluid collection reservoir. In some embodiments, at least one sensor is within the flexible housing and at least one sensor is within the fluid collection reservoir.
  • the at least one sensor includes a temperature sensor.
  • a change in temperature of at least 5% e.g., 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%, is indicative of a leak and/or infection.
  • the at least one sensor includes a pressure sensor.
  • a change in pressure of at least 5% e.g., 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%, is indicative of a leak and/or infection.
  • the at least one sensor includes a pH sensor.
  • a change in pH of at least 5% e.g., 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%, is indicative of a leak and/or infection.
  • the at least one sensor includes an optical sensor.
  • the optical sensor measures the clarity of fluid in the fluid collection reservoir.
  • a decrease in clarity of the fluid is indicative of an infection.
  • a decrease in clarity of at least 5% e.g., 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%, is indicative of a leak and/or infection.
  • the at least one sensor includes an impedance sensor.
  • the device includes indicators that may be seen by clinicians during imaging.
  • the indicators are radio-opaque markers. The indicators are advantageous in that the clinician can not only find the device during imaging, but also visualize where the clinical issue is, e.g., where a leak is.
  • the device is segmented or broken up into zones.
  • different sensors are in different segments or zones.
  • different indicators or radioopaque markers are in different segments or zones.
  • the radio-opaque markers are different shapes.
  • the shape of the radio-opaque markers is selected from the list consisting of square, circular, diamond, oval, star, horseshoe, and cross. Control
  • the device includes at least one conductor that transmits signals from the sensors to a control element and/or an alert element.
  • the conductor includes a wire.
  • a conductor may be shown in FIG. 7, FIG. 8, and FIG. 9.
  • the device includes at least one control element.
  • the control element is a central processing unit, as shown in FIG. 9.
  • the control element includes a circuit board or data storage unit.
  • the enclosure includes a control element.
  • the control element may be configured to send signals to and receive signals from an external computer, e.g., a mobile device, or a software application, such as an electronic health record (EHR).
  • EHR is a digital version of a patient’s paper chart. EHRs are real-time, patient records that make information available securely to authorized users. EHRs contain a patient’s medical history, diagnoses, medications, treatment plans, immunization dates, allergies, radiology images, and laboratory and test results. EHRs allow access to evidence-based tools that providers may use to make decisions about a patient’s care, including the present device. EHRs are able to share information with other health care providers and organizations - such as laboratories, specialists, medical imaging facilities, pharmacies, emergency facilities, and school and workplace clinics. In this way information collected from the present device may be shared with the patient’s healthcare team through their EHR.
  • the control element may include a transmission element, e.g., a wireless transmission element, and receiver element for wirelessly sending signal to and receiving signals from the external computer.
  • the transmission element is a BLUETOOTH® transmission element.
  • the external computer may include a processor and instructions, which when executed, cause the processor to actuate a sensor to take a measurement.
  • the external computer may also cause the processor to send the measurement to an external computer or alert the subject and/or clinician with an alert element described herein.
  • the measurement is indicative of a clinical indication, e.g., a leak and/or an infection.
  • the external computer may cause the processor to send the clinical indication to an external computer and/or alert element described herein.
  • the alerting is a message sent to an external computer.
  • the alerting is accomplished in the external computer through a software application, e.g., an EHR.
  • the sending of the measurement and/or clinical indication may be accomplished through the transmission element, e.g., a wireless transmission element, e.g., a BLUETOOTH® transmission element.
  • the device may be battery powered.
  • the enclosure includes a battery.
  • the external computer may include a processor and instructions, which when executed, cause the processor to one or more of monitor remaining battery power of the battery and output a warning when the battery reaches a predetermined low level of charge.
  • the device includes an enclosure external to the subject.
  • the control element and/or alert element is within the enclosure.
  • the enclosure is frosted or clear.
  • the enclosure may be clear, such that an alert element may be seen from outside of the enclosure.
  • the enclosure includes an adhesive element.
  • the adhesive element may be used to secure the enclosure external to the subject.
  • the adhesive element may include a glue.
  • the device may be removed by a clinician prior to treatment of a leak and/or infection.
  • the device is pulled out of the subject. In some embodiments, the removal is without requiring a secondary removal procedure.
  • the device is collapsible.
  • the device includes cords which may be pulled to collapse the device before it is removed from the subject.
  • the device may be in a sheet form including cords throughout, which upon pulling the cords both collapse the device and remove it from the subject.
  • the device may be removed without causing trauma.
  • a plurality of devices may be used in conjunction. In some embodiments, comparisons may be made across multiple sensors, wherein the sensors are present in a plurality of devices. At least a portion of or all of the plurality of devices may wirelessly connect to a control unit which combines the data collected from the plurality of sensors. The clinician may have access to the control unit, and uses the control unit to monitor the subject.
  • At least one sensor may be placed on either side of an anastomotic site.
  • At least one sensor is placed inside the body and at least one sensor is placed outside the body.
  • At least one sensor may be placed in the gut and at least one sensor in peritoneum. In some embodiments, at least one sensor may be inserted through the gut wall and anchored to the gut wall. In some embodiments, the at least one sensor anchored to the gut wall may be used with at least one sensor in the peritoneum.
  • a plurality of sensors may be placed in the peritoneum in multiple locations.
  • the type and severity of the clinical issue may be ascertained, as well as rate of change, and therefore potential clinical trajectory and severity of the bleed.
  • Multiple sensors assist in establishing a patient-specific baseline. For example, if one of the two or more sensors’ “drifts” from the group established baseline, that will be indicative of a clinical issue at that site. For example, all pH sensors in the peritoneal cavity should read the same pH. However, if one sensor’s pH drifts from group baseline or mean, then that is indicative of a clinical issue there.
  • the present invention may be used in conjunction with leak and/or infection identification algorithms and machine learning. Data collected by sensors may be combined and analyzed for risk indicators, etc., such that the present invention may be able to detect leaks and/or infection earlier through analysis of leading clinical indicators which may be combined with currently prevalent leak detection algorithms.
  • the algorithm utilizes the Glasgow-Blatchford Bleeding Score (GBS) system.
  • GBS helps identify which patients with upper Gl bleeding (UGIB) may be safely discharged from a medical facility. Any of the 9 variables, if present, increase the priority for admission (and likelihood of need for acute intervention).
  • the 9 variables are hemoglobin level, blood urea nitrogen (BUN) level, initial systolic blood pressure, patient sex, heart rate over 100 beats per minute (BPM), if melena is present, if there was recent syncope, if there is a history of hepatic disease, and if cardiac failure is present.
  • GBS scores range from 0-23, with higher scores corresponding to increasing acuity and mortality. A score of 0 suggests low risk of complications, e.g., 0.5% risk of complication.
  • the algorithm utilizes the Rockall Score for Upper Gl Bleeding.
  • the preendoscopy Rockall Score estimates mortality in patients with active upper Gl bleed who have not had endoscopy.
  • the pre-endoscopy Rockall Score can help stratify which patients need endoscopy and intensive care.
  • the complete Rockall Score estimates mortality in patients with active upper Gl bleed who have had endoscopy.
  • the algorithm utilizes the Cedars-Sinai Medical Center Predictive Index (CSMCPI) in predicting clinical outcomes in patients with upper gastrointestinal bleeding.
  • CSMCPI Cedars-Sinai Medical Center Predictive Index
  • leak identification algorithms and machine learning leads to higher monitoring levels, and better patient outcomes, such as at home treatment.

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Abstract

La présente invention concerne de manière générale des dispositifs, des systèmes et des procédés de détection de fuite et/ou d'infection. La présente invention fournit un dispositif implantable comprenant un boîtier déformable contenant au moins un capteur, ledit boîtier souple étant raccordé à un élément d'alerte. Le boîtier souple peut comprendre une pluralité de capteurs. La pluralité de capteurs peut comprendre un capteur de température, un capteur de pression, un capteur ultrasonique, un capteur d'impédance, un capteur de pH, un capteur de viscosité ou un capteur optique.
PCT/US2022/041216 2021-08-23 2022-08-23 Dispositifs, systèmes et procédés de détection de fuite Ceased WO2023028052A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070252713A1 (en) * 2006-04-28 2007-11-01 Medtronic, Inc. External voiding sensor system
US20090012372A1 (en) * 2006-06-12 2009-01-08 Novalert, Inc. External sensing for implant rupture
US20090076348A1 (en) * 2007-09-14 2009-03-19 Corventis, Inc. Injectable Device for Physiological Monitoring
US20170281025A9 (en) * 2011-10-28 2017-10-05 Three Rivers Cardiovascular Systems Inc. System and apparatus comprising a multi-sensor catheter for right heart and pulmonary artery catheterization
US20190290911A1 (en) * 2018-03-21 2019-09-26 Medtronic, Inc. Implantable medical device structures including recharge and/or telemetry coil
WO2021064686A1 (fr) * 2019-10-02 2021-04-08 Establishment Labs S.A. Procédés et systèmes pour détecter des procédés dans des dispositifs implantables

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070252713A1 (en) * 2006-04-28 2007-11-01 Medtronic, Inc. External voiding sensor system
US20090012372A1 (en) * 2006-06-12 2009-01-08 Novalert, Inc. External sensing for implant rupture
US20090076348A1 (en) * 2007-09-14 2009-03-19 Corventis, Inc. Injectable Device for Physiological Monitoring
US20170281025A9 (en) * 2011-10-28 2017-10-05 Three Rivers Cardiovascular Systems Inc. System and apparatus comprising a multi-sensor catheter for right heart and pulmonary artery catheterization
US20190290911A1 (en) * 2018-03-21 2019-09-26 Medtronic, Inc. Implantable medical device structures including recharge and/or telemetry coil
WO2021064686A1 (fr) * 2019-10-02 2021-04-08 Establishment Labs S.A. Procédés et systèmes pour détecter des procédés dans des dispositifs implantables

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