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EP-3532006-B1 - DEVICE AND METHOD FOR MOBILE MONITORING OF DRAINAGE CATHETER

EP3532006B1EP 3532006 B1EP3532006 B1EP 3532006B1EP-3532006-B1

Inventors

  • DOSHI, PALAK
  • MASSI, SHAYNA
  • KRUEGER, JOHN, A.

Dates

Publication Date
20260513
Application Date
20171020

Claims (11)

  1. A non-transitory computer-readable medium storing instructions configured to be executed by a processor (300, 3001), wherein the instructions are configured to, when executed by the processor, cause the processor to perform operations of: rendering a user interface (301) configured to: provide an output interface (302) configured to prompt a user to input catheter use information, the catheter use information being information related to using the catheter (112) to drain fluid from the patient; and provide an input interface (303) for the user to input the catheter use information; receiving catheter use information input by the user through the user interface (301), wherein the received catheter use information comprises an image of the patient's catheter exit site; generating catheter management information based upon the received catheter use information; extracting a color signal from the image of the patient's catheter exit site; comparing the extracted color signal from the image with one or more color signals from one or more previous images associated with the patient; determining a percentage change in color signal from the previous image(s) to the image; determining whether the percentage change in color is greater than a predetermined percentage; and upon determining that the percentage change is greater than the predetermined percentage, automatically contacting medical personnel with a message informing the medical personnel that the patient is exhibiting the predetermined percentage change in color signal and may be exhibiting an infection.
  2. The non-transitory computer-readable medium of claim 1, wherein the instructions are configured to cause the processor to generate the catheter management information by providing, based upon the received catheter use information, a recommendation of a step to be taken by the user to use the catheter to drain fluid from the patient.
  3. The non-transitory computer-readable medium of claim 2, wherein the recommendation of the step to be taken by the user to use the catheter to drain fluid from the patient comprises at least one of: a page (1900) configured to request a new prescription for a component of using the catheter to drain fluid from the patient; a page (2800) configured to order a component of using the catheter to drain fluid from the patient; instructions (2301-2304) for how to use the catheter to drain fluid from the patient; instructions for when to next use the catheter to drain fluid from the patient; or a page (2500) configured to access a video file related to using the catheter to drain fluid from the patient.
  4. The non-transitory computer-readable medium of claim 1, wherein the instructions are further configured to cause the processor to encrypt the catheter management information and to provide the encrypted catheter management information to a server, the server being accessible to medical personnel through a secure portal associated with the medical personnel.
  5. The non-transitory computer-readable medium of claim 1, wherein the output interface (302) is configured to prompt the user to input catheter use information comprising at least one of: drainage volume from the patient; drainage frequency of the patient; catheter exit site infections of the patient; ambulatory ability of the patient; a date of a drainage of the patient; a time of a drainage of the patient; a discomfort level of the patient; a portion of body of the patient from which a drainage is obtained; or an image of a drainage bottle used in association with the catheter to drain fluid from the patient.
  6. The non-transitory computer-readable medium of claim 5, wherein the output interface (302) is configured to prompt the user to input, as catheter use information, an image of the drainage bottle used in association with the catheter to drain fluid from the patient, and wherein the instructions are configured to cause the processor to generate the catheter management information by performing image analysis of the image of the drainage bottle.
  7. The non-transitory computer-readable medium of claim 1, wherein the instructions are further configured to cause the processor to perform operations of: displaying a secure portal (400) that is associated with the patient, the secure portal requiring that the user enter credentials associated with the patient to access the secure portal; and in response to the user accessing the secure portal: allowing the output interface (302, 1000) to prompt the user to input catheter use information; and allowing the user to input catheter use information with the input interface.
  8. A method for mobile monitoring of a catheter to drain fluid from a patient, comprising: rendering, by a processor, a user interface configured to: provide an output interface configured to prompt a user to input catheter use information, the catheter use information being information related to using the catheter to drain fluid from the patient; and provide an input interface for the user to input the catheter use information; receiving, by a processor, catheter use information input by the user through the user interface, wherein the received catheter use information comprises an image of the patient's catheter exit site; generating, by a processor, catheter management information based upon the received catheter use information; extracting a color signal from the image of the patient's catheter exit site; comparing the extracted color signal from the image with one or more color signals from one or more previous images associated with the patient; determining a percentage change in color signal from the previous image(s) to the image; determining whether the percentage change in color is greater than a predetermined percentage; and upon determining that the percentage change is greater than the predetermined percentage, automatically contacting medical personnel with a message informing the medical personnel that the patient is exhibiting the predetermined percentage change in color signal.
  9. The method of claim 8, wherein generating the catheter management information comprises providing, by a processor, based upon the received catheter use information, a recommendation of a step to be taken by the user to use the catheter to drain fluid from the patient, wherein the recommendation of the step to be taken by the user to use the catheter to drain fluid from the patient comprises at least one of: a page configured to request a new prescription for a component of using the catheter to drain fluid from the patient; a page configured to order a component of using the catheter to drain fluid from the patient; instructions for how to use the catheter to drain fluid from the patient; instructions for when to next use the catheter to drain fluid from the patient; or a page configured to access a video file related to using the catheter to drain fluid from the patient.
  10. The method of claim 8, wherein the output interface is configured to prompt the user to input catheter use information comprising at least one of: drainage volume from the patient; drainage frequency of the patient; catheter exit site infections of the patient; ambulatory ability of the patient; a date of a drainage of the patient; a time of a drainage of the patient; a discomfort level of the patient; a portion of body of the patient from which a drainage is obtained; or an image of a drainage bottle used in association with the catheter to drain fluid from the patient.
  11. The method of claim 10, wherein the output interface (302) is configured to prompt the user to input, as catheter use information, an image of the drainage bottle used in association with the catheter to drain fluid from the patient, and further comprising generating, by a processor, the catheter management information by performing image analysis of the image of the drainage bottle.

Description

TECHNICAL FIELD The present invention relates to the mobile monitoring of a catheter to drain fluids from a patient. US 2012/0259265 describes a regulated gravity-based cerebral spinal fluid drainage device for drainage from the brain or spine. A sensor mechanism of a fluid-handling module of the device comprises a pair of electrodes used to sense a change in the amount of fluid in a flexible compartment or internal bag to detect when a cerebral spinal fluid tubing pathway is clogged and to detect if a change in the amount of fluid in the internal bag is lower than a predetermined value. BACKGROUND Fluid accumulation conditions can cause a patient a variety of unpleasant symptoms including pain, discomfort, bloating, shortness of breath, and coughing. For example, ascites describes an accumulation of fluid and other materials in the peritoneal or other body cavity. Pleural effusion refers to the effusion of fluid into the pleural space. Fluid accumulation conditions such as ascites and pleural effusion may be treated by draining the excess fluid from an affected body cavity. Some methods of draining excess fluid from a body cavity involve implanting a catheter so that the catheter's distal end extends into the body cavity, and aspirating the excess fluid through the distal end, by applying a negative pressure at the catheter's opposite proximal end. A suitable drainage apparatus 100 is shown partially disassembled in FIG. 1A. Apparatus 100 is shown in FIGS. 1B-1C as assembled and installed in a patient body (respectively, for pleural and peritoneal drainage) and includes a drainage container 114, typically a vacuum bottle. The drainage container 114 is removably attached by a proximal tube 110 at a valve 116 to a body-contacting distal catheter 112. The valve 116 may be configured in any number of ways known in the art for attaching catheters together in a fluid-patent manner, (which may include a two-part valve), and the proximal portion attached to the distal catheter 112 may be configured to be self-sealing when disconnected from the proximal tube 110. The distal end portion of the distal catheter 112 is shown indwelling the patient, disposed through the body wall 121 into an intra-body space 123b/123c, which may be - for example - a pleural cavity/space (e.g., FIG. 1B), peritoneal cavity/space (e.g., FIG. 1C), or other body cavity. That distal portion includes a sealing cuff 119 and a flexible fluid-intake length 115 including fenestrations 118 which - when the device is used - are located in the intra-body spaces 123b/123c. This structure may be better understood with reference to U.S. Pat. No. 5,484,401, and with reference to commercial products marketed under the name PleurX® by CareFusion® of San Diego, Calif. (a Becton Dickinson Company). Often, although the step of implanting the catheter is performed by a physician, the drainage procedure is performed at home by the patient or by a caretaker. Symptom relief and patient outcome is dependent on regular drainage and proper post-procedure monitoring of factors such as drainage volume, drainage frequency, and the condition of the catheter site. Conventionally, clinicians require patients to record drainage volume and frequency on a paper log and bring the paper log with them to the follow-up appointment, where the clinician may also examine the catheter site. This conventional monitoring technology presents various technical problems. For example, the patient may need to be physically transported, along with the paper log, to the clinician's office before the clinician can view the log or know the patient's treatment status. Accordingly, until the patient comes to the office, the clinician may not know, for example, whether the patient is maintaining a drainage log, whether the patient is complying with a prescribed drainage routine, whether the catheter site is in good condition, or whether the patient is exhibiting signs of developing a potentially harmful condition related to the drainage. It may be desirable to provide improved devices and methods for monitoring and/or managing the use of a catheter to drain fluids from a body, which would provide patients and/or clinicians with improved convenience, more timely communication of relevant information, and/or a higher likelihood of compliance with prescribed drainage routines. BRIEF SUMMARY In one aspect, the present invention includes a non-transitory computer-readable medium storing instructions configured to be executed by a processor. The instructions are configured to, when executed by the processor, cause the processor to perform an operation of rendering a user interface. The user interface is configured to provide an output interface configured to prompt a user to input catheter use information, the catheter use information being information related to using the catheter to drain fluid from the patient. The user interface is further configured to provide an input interface for the user to in