Patent Publication Number: US-2021169677-A1

Title: Ostomy collection status detector

Description:
RELATED APPLICATIONS 
     This patent application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent App. No. 62/943,426, filed Dec. 4, 2019, entitled “OSTOMY COLLECTION STATUS DETECTOR,” incorporated herein by reference in entirety. 
    
    
     BACKGROUND 
     Ostomy collection systems are post-surgical arrangements for collection of bodily wastes based on a surgically diverted biological stream. An ostomy pouching system is a prosthetic medical device that externally interfaces with a stoma, or surgically created exit, for retaining expelled material into a pouch or bag from which they may be disposed. Pouching systems are often associated with colostomies, ileostomies, and urostomies. A collection pouch interfaces with an engagement barrier that secured to a dermal surface of a patient by adhesive and/or belted means. Periodic collection prior to overflow prevents a breach of the collection system. 
     SUMMARY 
     A biomaterial collection system with overflow detection has a receptacle, pouch or bag for collection of biomaterial output from a stoma. and a status detection device for indicating excessive bag volume based on a distance between opposed sides or panels of the receptacle. The receptacle is a collection vessel defining a sealed containment defined by at least two opposed panels, and an interior volume defined by a distance between the opposed panels. The collection vessel may be employed in conjunction with or after procedures such as ileostomy, urostomy and colostomy for indication of a nearly full collection vessel that requires emptying. A sensor apparatus is disposed on at least one of the panels and is configured for identifying a fluidic occupancy of the interior volume based on detecting a distance between the opposed panels. The sensor apparatus includes a first component on a first panel of the opposed panel and a second component on a second panel of the opposed panels, such that the first component is configured for generating a value based on a distance to the second component. In one configuration, a detection circuit including a Hall effect sensor and rare-earth magnet provides a signal indicative of the distance. Due to the planar construction of the bag, this distance tends to be indicative of a quantity of gastric contents or other contained materials for collection or dispensing from the bag. 
     The collection vessel generally takes the form of a flexible container having generally coplanar flexible plastic sheets fused or joined around the perimeter to allow expansion between the panels for fluidic collection. An inlet or opening formed at a seam or orifice allows inflow of discharged patient fluids, resulting in expansion of the plastic bag as the panels separate to create a void for the incoming gastric contents. The collection vessel adheres or attaches to the patient using an engagement barrier to define a fluidic connection to a surgically defined exit point. The engagement barrier is typical an epidermal adhesion that attaches the collection vessel to the patient. Excessive pressure and/or volume in the collection vessel can cause failure of the collection system, often at the engagement barrier. As the collection vessel fills, a distance between the panels increases. In an example configuration, the sensor apparatus is a Hall effect sensor and the first component is in magnetic communication with the second component, thus providing a signal based on the distance between the panels, the distance being indicative of the volume. 
     In further detail, the disclosed ostomy collection and overflow detection system performs a method for detecting a volume in a flexible liquid containment by engaging a fluid receptacle with a medical or surgical conduit for receiving a volume into the fluid receptacle, in which the fluid receptacle has 2 or more flexible panels defining an enclosed interior for containing the volume. The detection system receives a distance signal from a distance sensor adhered to a panel of the fluid receptacle, such that the distance signal is indicative of a distance to another of the plurality of flexible panels, in which the distance results from a quantity of the contained volume. Capacity logic computes, based on the distance signal, a volume of the fluid contained in the receptacle approaching an overflow level. 
     In particular configurations, the receptacle may be any suitable fluidic containment with a need for volume monitoring. An ostomy receptacle or bag for collection of gastric contents may be monitored for a fluid volume approaching a full volume. In addition to ostomy based collection, any suitable medical collection apparatus, such as catheter collectors, surgical drains and blood collection, for example, may also be employed. Other configurations may attach to an IV bag for measurement of drained fluid to indicate a depleted volume with capacity logic for computing, based on the distance signal, a volume of the fluid contained in the receptacle approaching an empty level. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing and other objects, features and advantages of the invention will be apparent from the following description of particular embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. 
         FIG. 1  is a perspective, transparent view of the volume detector device installed on an ostomy collection bag; 
         FIG. 2  is a flowchart of volume detection in the device of  FIG. 1 ; 
         FIG. 3  is a block diagram of the detector device of  FIGS. 1 and 2 ; 
         FIGS. 4A-4D  are a schematic diagram of the detector device of  FIG. 1 ; 
         FIG. 5  shows deployed limits of the detection device of  FIGS. 1-4D ; 
         FIG. 6  shows a patient deployment in the ostomy configuration of  FIGS. 1-5 ; 
         FIG. 7  shows operation and detection logic of the device of  FIGS. 1-6 ; 
         FIGS. 8A-8C  show the detection device, receiver and magnet components; 
         FIGS. 9A-9B  show a locking engagement with the receiver of  FIGS. 8B-8C ; 
         FIGS. 10A-10C  show internal circuits in the device of  FIGS. 1-9B ; and 
         FIG. 11  shows example sensor outputs and corresponding magnetic field strength in operation of the device of  FIGS. 1-10C . 
     
    
    
     DETAILED DESCRIPTION 
     Depicted below is an example of various configurations of a collection receptacle volume measurement and alarm apparatus suitable for use with any fluid collection or supply measurement context. Configurations herein are based, in part, on the observation that collection systems are often employed in medical contexts for accommodating a temporary or permanent redirection of physiological fluid generation, often for collection of biological materials. Such systems are usually for buffering or containing a fluidic accumulation for facilitating mobility or sleep, and require periodic emptying, draining or replacement, often depending on the nature of the fluid contained therein. Unfortunately, conventional approaches to collection systems suffer from the shortcoming that an overfilled collection repository can present sanitary and comfort complications, as the contained fluids often present biohazard and/or infection concerns. Accordingly, configurations herein substantially overcome the shortcomings of conventional collection systems by providing a system, method and apparatus for determining a volume and fill status of a collection receptacle, bag or pouch and rendering an audio and/or visual and/or electronic (e.g. BLUETOOTH® or WiFi) alarm in response to an approaching overflow condition. 
     In a particular configuration, an ostomy collection system for gastric contents is beneficial for avoiding an overflow condition, particularly while sleeping or an ambulation situation where receptacle (bag) maintenance is sporadic.  FIG. 1  is a perspective, transparent view of the volume detector device installed on a fluid receptacle  100  such as an ostomy collection bag. Fluidic volume detection as disclosed herein includes a fluid receptacle such as the collection receptacle  100  (bag) having a plurality of flexible panels  102 - 1  . . .  102 - 2  ( 102  generally) defining an enclosed interior  108  for containing a volume of fluid. The detector device includes a detection module  110  including a distance sensor  150  attached to one of the flexible panels  120 - 1  and configured for detecting a distance to another of the plurality of flexible panels, such as panel  120 - 2 . The detection module  110  includes volume logic for computing a volume of the fluid receptacle based on the detected distance, discussed further below. 
     The generally ovaloid shape of the collection receptacle  100  results from the two panels  102 , each defined from a flexible material and oval shape such that upon filling, the ovaloid shape emerges as the fluid (typically liquid) fills the volume and disposes the panels  102  apart by a distance. The collection receptacle  100  generally includes at least two of the panels  102  arranged in an opposed manner, such that the distance sensor  150  is disposed on one of the opposed panels and configured for detecting the distance  112  to the opposed panel  102 - 2 . Any suitable arrangement and shape of panels may be employed, with the preference that the detected distance results from panels  102  disposed apart from a quantity of the contained liquid. 
     The orifice  106  or opening allows inflow of the fluid for measurement. An example configuration deploys an ostomy collection bag, and the orifice is fluidically coupled to the ostomy for receiving gastric contents. The collection bag is adhered or strapped to the patient&#39;s ostomy by any suitable approach. In particular configurations, the attachment may include an adapter such as that disclosed in U.S. patent application Ser. No. 16/744,256, filed Jan. 16, 2020, entitled “Ostomy Skin Barrier Adapter.” 
     The distance  112  is determined based on a marker  120  attached or adhered to the opposed panel  102 - 2 . In the example arrangement, the distance sensor  150  is a magnetic flux sensor and the marker  120  on the opposed flexible panel  102 - 2  has a magnetic source  130 , such that the detected distance is indicative of a distance from the magnetic flux sensor to the magnetic source  130 . One particular configuration employs a Hall effect sensor disposed for receiving magnetic flux from the opposed flexible panel  102 - 2 , and the magnetic source  130  includes a rare-earth magnet contained in the marker  120 . 
     The Hall effect sensor provides a voltage. The Hall voltage is a measure of the magnetic flux density, which can vary based on two kinds of Hall-effect sensors: linear, which means that the output of voltage linearly depends on magnetic flux density; and threshold, which means that there is a sharp decrease of output voltage at some magnetic flux density. Other suitable distance sensing mediums may be employed. For example, an ultrasound sensor and sonic emitting source, or an infrared (IR) medium and photodetector are operable if the contained liquid is sufficiently clear. An electromagnetic medium of any suitable wavelength may also be employed as long as power and range aspects are appropriate. 
       FIG. 2  is a flowchart  200  of volume detection in the apparatus and device of  FIG. 1 . At step  201 , the method for detecting a volume in a flexible liquid containment includes engaging the collection receptacle  100  with a conduit in fluid communication for filling the collection receptacle, such as the orifice  106  positioned at a surgical stoma. A distance computation circuit receives a distance signal from a distance sensor  150  adhered to a panel  102  of the fluid receptacle  100 , such that the distance signal is indicative of a distance to another of the plurality of flexible panels. The distance results from a quantity of the contained volume, as depicted at step  202 . In the above example, the distance signal is a voltage level indicating the magnetic flux sensed or measured from the opposed magnetic source  130  (magnet), which decreases inversely with the distance  112 . The distance computation circuit computes, based on the distance signal, a volume of the fluid contained in the receptacle, as disclosed at step  203 . 
       FIG. 3  is a block diagram of the detector device depicted in  FIGS. 1 and 2 . Referring to  FIGS. 1-3 , a detection circuit  300  is configured for mapping the detected distance  112  to a volume, such that the volume is based on a capacity of the fluid receptacle  100  when the panels  102  are separated by the detected distance. The detection circuit  300  includes a distance computation circuit  156  and capacity logic  168 . The distance sensor  150  receives a magnetic flux  152  from the magnetic source  130 , and sends a corresponding distance signal  154  to the distance computation circuit  156 . 
     In the example arrangement, the detection circuit has a mapping table  160  of distance values  164  and corresponding volume values  166 , such that the distance values define a sequence of incremental separation of the panels  102 . The distance computation circuit  156  is configured for identifying the volume mapped from one of the distance values in the sequence based on the mapping table  160 . The mapping table  160  relates voltage levels  162  to a distance field  164  calibrated for the distance  112 . The dimensions of the fluid receptacle  100  determine the capacity  166  at a particular distance. In general, basic geometry indicates that, for similar sized parallel panels  102 , the area multiplied by the distance gives an interior volume for containing fluid. While capacity may be computed somewhat accurately by this relation, the capacity  166  is stored for increments of distance to accommodate for curvature and flexures of the oval shape of the panels  102 , and for effects of gravity on a free flowing liquid volume contained in a resilient or flexible pouch. 
     An alternate configuration may employ a pressure sensor  178 , which detects a pressure of the repository  100  contents, which may occur if the bag is compressed (e.g. sat on, rolled on by a sleeping patient) prior to complete filling. The pressure sensor  178  is disposed in communication with the receptacle  100  or on a circumferential band for sensing a pressure of the fluid receptacle. The detection circuit  300  couples to the pressure sensor for rendering the alarm signal based on the pressure sensor. 
     Capacity logic  168  receives the current computed volume level  170  for comparison with an alarm threshold  172 . The capacity logic further comprises an alarm threshold  172  based on a volume, and the detection circuit is operable to render an alarm signal when the volume exceeds the alarm threshold. The threshold  172  indicates a fluid volume level  170  approaching an overflow level, such as 80% of maximum volume or capacity. The threshold may also have multiple tiers, such as 75% full, 90% full, and other levels as needed. If the received level  170  exceeds the threshold  172 , the capacity logic  168  sends an alarm signal  174  to an alarm  176 , which renders an audible and/or visual and/or electronic signal signaling needed attention for emptying or changing the fluid receptacle  100 . Other suitable annunciator actions may include, for example, a Bluetooth transmission, text message or email for directing remedial action. Other use cases may include a monitoring dashboard system in a healthcare facility (such as a nursing home or hospital) at a nurses station to monitor the ostomy displacement status. Oversight of multiple ostomy patients in the ward provides a centralized alarm station to monitor the cohort of ostomy collection systems with pending emptying needs. In a hospital environment, for example, the alarm system with similar configuration but modified detection threshold computations may be used to monitor the fullness status of fluid containing bags as they empty, such as IV bags. When combined with wireless communication technology, the alarm system could be deployed in the hospital wards to assist healthcare teams to remotely monitor the status of intravenous administration of medications to patients. 
       FIGS. 4A-4D  are a schematic diagram of the detector device of  FIG. 1 . Referring to  FIGS. 1-3 and 4A-4D , the panel  102 - 2  forms a back panel as shown in  FIG. 4A , and panel  102 - 1  forms a front panel, which are joined, glued or fused to form the enclosed interior  108 . The magnetic source  130  aligns with the distance sensor  150  in the detection module  110  when the collection receptacle  100  is empty, and remains generally aligned in an opposed manner, however slight angular deviations may occur as the bag fills, discussed further below. The magnet is disposed just below the orifice  106 , and a drain  105  allows emptying as with most conventional collection bags.  FIG. 4D  shows the alignment of the magnetic source  130  (magnet) and distance sensor  150  separated by a distance  112  across the interior  108 . It follows that as the interior expands to accommodate inflow, the distance  112  increases generally proportionally and based on the dimensions of the fused panels  102 . 
       FIG. 5  shows deployed limits of the detection device of  FIGS. 1-4D . Referring to  FIGS. 4A-5 , a maximally expanded (filled) collection receptacle is shown to have a distance of 3.11″ for a particular representative configuration. The detection module  110  and marker  120  may integrate with various common sizes and shapes of collection bags, which may vary somewhat in dimension, maximum capacity and filled distance  112 . The mapping table  160  may be calibrated for particular distance values  164  associated with a bag of a specific vendor, however a small deviation from size parameters will not impede operation, e.g. one vendor&#39;s 75% capacity may be another vendor&#39;s 80% capacity.  FIG. 5  also illustrates a curvature  103  that results from panel  102  shape and flexibility, which causes the interior  108  to deviate from a mathematical volume computation based on an ideal cube shape. While mathematical computations based on area and distance  112  would likely provide a close approximation, the mapping table  160  allows greater precision and granularity of filling increments. 
     In particular configurations, an array of Hall effect sensors, either individual units or a self-contained Hall array module can be used to detect the orientation of the magnet in cases where the magnet becomes oriented off-axis with the sensor unit. By using a Hall array, magnetic field strength and orientation are known, and combined with a known magnet strength, can be used to calculate the position of the magnet at differing orientations for mitigating deviation from a shortest-path distance that assumes purely parallel orientation of the opposed panels  102 . 
       FIG. 6  shows a patient deployment in the ostomy configuration of  FIGS. 1-5 . Referring to  FIGS. 4A and 6 , the location of the orifice  106  disposes the magnet just below the surgical stoma  180  of the patient  182 . The magnetic source  130  has a magnetic flux  152  magnitude based on a distance from a location of a stoma  180  defining an installed location of the fluid receptacle  100 . Magnetic strength imposed by the magnetic source  130  should be considered with respect to any other installed medical devices. For example, pacemakers are a common occurrence; the placement of the device should be distal from a location of a surgically installed cardiac appliance, in which the cardiac appliance may be sensitive to the magnetic flux  152 . As the stoma is generally disposed based on the lower gastrointestinal tract of the patient  182 , this placement ensures that the marker magnetic source  130  is sufficiently distal from placement of a typical pacemaker  184  for ensuring no adverse magnetic interference. 
       FIG. 7  shows operation and detection logic of the device of  FIGS. 1-6 . Referring to  FIGS. 3 and 7 , the detection module  110  has control electronics including the distance computation circuit  156 , the capacity logic  168  and other controls and user interfaces. Referring to  FIGS. 1, 3 and 7 , an operational state diagram  700  includes a device power up, transitioning from an off/sleep state  710  to a startup state  712 . This commences a device measuring state  714 , during which measurement operations  754  occur iteratively with the distance signal  154  processed at periodic intervals. A power saving feature may employ adaptive sampling such that the frequency of polling the Hall effect sensor is varied as a function of bag displacement, rate of change of bag displacement and/or acceleration of bag displacement. If the capacity logic  168  concludes a threshold  172  is attained, then a full bag alarm state  774  is triggered by the alarm signal  174 . 
     A low battery state  716  occurs if a power supply (typically a rechargeable lithium cell) degrades, commencing a battery cut-off and restart sequence  718 . A separate activation check state  720  can be initiated at any time to confirm that the measuring state  714  is engaged and monitoring bag contents. 
     A data recording feature may log or transmit a fill profile of the bag over time. A profile of data points may be recorded and can be made available to the user to gain a better understanding of their digestive output profile, and to monitor changes to the output profile. 
     A user interface or GUI (Graphical User Interface) may be provided, for example as an app on a mobile device or laptop, and coupled via a USB port. This GUI would allow the user to modify the detection/alarm system threshold to alarm at a variable displacement. The user may also increase the frequency of measurements taken such as in the case of large, sudden output into the ostomy collection system. 
       FIGS. 8A-8C  show the detection device, receiver and magnetic components. The detection module  110  encapsulates the distance sensor  150  and detection circuit  300  in a deployable package in conjunction with the collection receptacle  100 , and may take several forms which will now be discussed. Ostomy bags are consumable healthcare appliances, and the detection module  110  and marker  120  may be adhered, molded, attached and/or integrated with a suitable collection receptacle  100  by a variety of mechanical and manufacturing approaches. In the particular examples herein, referring to  FIGS. 1-3 and 8A-8C , the detection module  110  is adapted to engage a receiver  802  attached to one of the flexible panels  102  and adapted for slidable engagement with the detection module  110 . Selective engagement of the detection module allows product longevity when paired with a single or limited use collection receptacle; the receiver  802  is likewise a low-cost disposable element. The collection receptacle  100  may attach via an adhesive region  805  on the receiver  802 , such that the adhesive region  805  secures the receiver to the flexible panel  102 . The marker  120  has a similar adhesive region  807  for affixing the magnetic source  130  in alignment. Alternatively, the receiver  802  may be molded into the collection receptacle  100  as part of a manufacturing process, and the marker may be similarly attached. 
     To facilitate separation and reuse, the detection module  110  has a pair of elongated, parallel rails  810 - 1  . . .  810 - 2  ( 810  generally) and the receiver  802  has a pair of parallel channels  820 - 1  . . .  820 - 2  ( 820  generally). The parallel channels  820  define slots for slidably engaging the rails  810  and secure the module  110  with a lip  812  that underrides an upper edge of the channels  820 . 
       FIGS. 9A-9B  show a locking engagement with the receiver of  FIGS. 8B-8C . Referring to  FIGS. 1 and 8A-9B , the engaged receiver  802  and detection module  110  form a secured unit  900  affixed to the panel  102 , complemented by the magnet  130  on the opposite panel. The module  110  further includes a locking tab  902  for securing the detection module  110  from inadvertently sliding out of the receiver  802 . The locking tab  902  is adapted to be disposed into an interference fit in a slot  906  for preventing retraction of the parallel rails  810  from the parallel channels  820 . One fully inserted, the locking tab  902  is disposed in the direction of arrow  910  to position  902 ′ such that a protrusion  904  engages the slot  906  for preventing retraction of the module  110  unless the locking tab  902 ′ is disengaged. 
       FIGS. 10A-10C  show internal circuits in the device of  FIGS. 1-9B . Referring to  FIGS. 3, 7 and 10A -C, the detection module  110  packages the detection circuit  300 , distance sensor  150  and related components. The detection module  110  further encapsulates a memory  1008  for storing the volume logic, the detection circuit  300 , which is coupled to the distance sensor  150  for receiving the distance signal  154  and a power supply for powering the memory  1008  and the detection circuit  300 . Other components include a USB connector for optional I/O or remote activities, an optional multi-pin test port  1004 , switches  1020 ,  1022  for operational input as disclosed in  FIG. 7  and LEDs or visual indicators. The illustration is exemplary; a variety of suitable hardware and software components may be employed for implementing the disclosed device and operation. 
     In the particular configuration,  FIG. 10B  shows a portion of the sensor  150  circuit  1050 , and  FIG. 10C  shows a portion of the power control circuit  1060 . As discussed above, the disclosed configuration employs a Hall effect sensor  150 ′ as the distance sensor  150 . 
       FIG. 11  shows example sensor outputs and corresponding magnetic field strength in operation of the device of  FIGS. 1-10C . Referring to  FIGS. 3 and 11 , the data and readings in the table  1100  show differing rare-earth magnet configurations for the magnetic source  130 , and at different positions from the Hall effect sensor  150 ′, shown by position coordinates  1102 ,  1104 . The magnet configurations include a number of 15*1.7 mm neodymium magnets stacked in configurations of 1, 2, and 3 for columns  1106 - 1 ,  1106 - 2  and  1106 - 3 , respectively. The disclosed magnet size is exemplary; a variety of suitable magnet configurations may be employed to achieve the desired magnetic field strength and dimensions. 
     For each magnet configuration  1106 , the distance signal  154  at respective coordinates is shown along with a magnetic field strength mT as recorded with a Gaussmeter. Depending on the distance signal  154  for a specific receptacle configuration, the filled volume can be computed for population of the capacity  166 . 
     Those skilled in the art should readily appreciate that the programs and methods defined herein are deliverable to a user processing and rendering device in many forms, including but not limited to a) information permanently stored on non-writeable storage media such as ROM devices, b) information alterably stored on writeable non-transitory storage media such as solid state drives (SSDs) and media, flash drives, floppy disks, magnetic tapes, CDs, RAM devices, and other magnetic and optical media, or c) information conveyed to a computer through communication media, as in an electronic network such as the Internet or telephone modem lines. The operations and methods may be implemented in a software executable object or as a set of encoded instructions for execution by a processor responsive to the instructions, including virtual machines and hypervisor controlled execution environments. Alternatively, the operations and methods disclosed herein may be embodied in whole or in part using hardware components, such as Application Specific Integrated Circuits (ASICs), Field Programmable Gate Arrays (FPGAs), state machines, controllers or other hardware components or devices, or a combination of hardware, software, and firmware components. 
     While the system and methods defined herein have been particularly shown and described with references to embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.