US20150066531A1 - System and method of monitoring and managing a remote infusion regimen - Google Patents

System and method of monitoring and managing a remote infusion regimen Download PDF

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Publication number
US20150066531A1
US20150066531A1 US14/472,549 US201414472549A US2015066531A1 US 20150066531 A1 US20150066531 A1 US 20150066531A1 US 201414472549 A US201414472549 A US 201414472549A US 2015066531 A1 US2015066531 A1 US 2015066531A1
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United States
Prior art keywords
infusion
event data
regimen
database
monitoring
Prior art date
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Abandoned
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US14/472,549
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English (en)
Inventor
James D. Jacobson
Shawn Mitchell Folkes
Anatoly S. Belkin
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ICU Medical Inc
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Individual
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Filing date
Publication date
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Priority to CA2922425A priority Critical patent/CA2922425C/en
Priority to US14/472,549 priority patent/US20150066531A1/en
Priority to PCT/US2014/053440 priority patent/WO2015031774A1/en
Priority to AU2014312122A priority patent/AU2014312122A1/en
Priority to JP2016537899A priority patent/JP6621748B2/ja
Assigned to HOSPIRA, INC. reassignment HOSPIRA, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FOLKES, SHAWN MITCHELL, MR., BELKIN, ANATOLY S., MR., JACOBSON, JAMES D., MR.
Publication of US20150066531A1 publication Critical patent/US20150066531A1/en
Assigned to ICU MEDICAL, INC. reassignment ICU MEDICAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HOSPIRA, INC.
Priority to US16/835,027 priority patent/US11571508B2/en
Priority to AU2020202334A priority patent/AU2020202334A1/en
Priority to AU2022201948A priority patent/AU2022201948A1/en
Priority to US18/102,047 priority patent/US11986623B2/en
Priority to US18/663,654 priority patent/US20240293610A1/en
Priority to AU2024203433A priority patent/AU2024203433A1/en
Abandoned legal-status Critical Current

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    • G06F19/3468
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • G06F19/3418
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q30/00Commerce
    • G06Q30/018Certifying business or products
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M2005/14208Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/18General characteristics of the apparatus with alarm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3553Range remote, e.g. between patient's home and doctor's office
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient

Definitions

  • This invention is directed to a system and method that automates compliance of use of an infusion pump and more particularly a system and method that increases the probability that a prescribed infusion regimen is followed.
  • Ambulatory pumps are used on patients that can actively ambulate, which presents unique challenges in the care and management of patients.
  • patients on ambulatory pumps remain under observation which limits non-compliance opportunities.
  • home or other alternate site locations it becomes difficult to monitor and enforce patient compliance with prescribed infusion protocols.
  • Home infusion patients generally prefer to be home versus the hospital in many cases, but can become non-compliant with infusion plans due to the technical challenges of managing infusions, a desire to skip or terminate treatments, or inadvertent misses.
  • Compliance with prescribed infusion plans is particularly important in the home setting as there is typically an expense associated with incorrectly followed infusion schedules.
  • Antibiotics the most ubiquitous home infusion medication class, are typically effective only if completed in a full protocol. The patient who feels better on day three or four and subsequently fails to complete a planned seven day infusion regimen will likely require a hospital re-admission, often through the Emergency Room, thereby negating the financial benefits and patient preference benefits of out-of-hospital infusion strategies.
  • Such non-compliance becomes noteworthy not only to the patient but to the hospital as well as the payer/insurer, who generally supports alternate care strategies in order to avoid or truncate hospitalizations.
  • TPN TPN
  • protein-derived therapeutics which are typically very expensive
  • oncolytics All of these medications' effectiveness are dictated by timely and complete compliance. Payers generally will continue to be very invested in paying for home infusions that are in fact correctly administered. Further, discharging hospitals are growing more invested in post-discharge patient outcomes through pay-for-performance incentives and re-admission metrics are growing in importance through accountable care evolution.
  • An objective of the present invention is to provide a system and method that fully automates compliance monitoring and management of an infusion pump regimen.
  • Another objective of the present invention is to provide a system and method to link a prescribed infusion regiment to what is actually carried out by the home patient.
  • a still further objective of the present invention is to provide a system and method that increases the probability that a patient follows a prescribed infusion regimen.
  • Yet another objective of the present invention is to provide a system and method that increases the probability that an incomplete or incorrect regimen is addressed early in the non-compliance cycle.
  • Another objective of the present invention is to provide a system and method that captures value for a patient, a payer, an alternate site caregiver, and a discharging hospital.
  • One more objective of the present invention is to provide a system and method that increases motivation to use pumps for home infusions, whereby pumps can generally provide a safer means of controlled medication infusion than gravity infusions and provide a means by which to electronically capture the medication delivery details.
  • a system and method for monitoring and managing remote compliance with an infusion regimen includes a healthcare provider having a controller with a processing unit, a database and a display.
  • the database includes a plurality of patient records that include prescribed infusion regimens and patient outcome data.
  • a patient is provided medication, an infusion pump, and one or more infusion sets in order to perform an infusion event at a remote location.
  • infusion event data is captured and transmitted to the healthcare provider where the data is stored in the patient outcome data and compared to the prescribed infusion regimen to determine if the data is within predetermined parameters. Notification is then provided to a monitoring technician and the patient.
  • the anticipated infusion schedule is automatically monitored in order to trigger messaging or notification to the healthcare provider and/or patient in the event that appropriate infusion confirmation is not provided to match the infusion schedule within an appropriate time window.
  • the prescribed infusion regimen is downloaded to the infusion pump.
  • the infusion event data from an infusion event is captured and compared with anticipatory infusion event data within the pump. If successful, the patient and/or supportive caregiver are provided with a code which is transmitted to the healthcare provider. If not within predetermined parameters an alarm or other notification is provided to the patient and/or supportive caregiver. This alarm or notification can be transmitted automatically through cellular communications, internet communications, or other means.
  • the prescribed infusion regimen is downloaded to the infusion pump.
  • the infusion event data from an infusion event is captured and compared with anticipatory infusion event data within the pump. If the infusion schedule is not followed, the patient and/or supportive caregiver are messaged to initiate the infusion or to facilitate communication between the patient and caregiver.
  • FIG. 1 is a schematic view of a system for managing and monitoring a remote infusion regimen
  • FIG. 2 is a flow diagram of a method for managing and monitoring a remote infusion regimen
  • FIG. 3 is a flow diagram of a method for managing and monitoring a remote infusion regimen.
  • a system and method of monitoring and managing a remote infusion regimen 10 includes a monitoring healthcare provider 12 such as a discharging hospital, having a controller 14 with a processing unit 16 , a database 18 , and a display 20 .
  • the database 18 includes a plurality of patient records 22 and therapeutic approaches 24 . Included in the patient record 22 is personal information 26 related to the patient 28 , an infusion regimen 30 that has been prescribed by the healthcare facility 12 , and patient outcome data 32 .
  • an infusion regimen 30 which may consist of one or many infusions
  • the patient 28 is discharged from the healthcare facility 12 .
  • Medications 34 an infusion pump 36 , and one or more pump tubing infusion sets 38 are provided to the patient 28 for remote use in the patient's home or other remote location 40 .
  • a monitoring clinician 41 such as a nurse, case manager or similar healthcare technician visits the remote location to train infusion techniques to the patient and/or a supportive caregiver 42 which includes a friend, a family member, or other individual who will initiate an infusion event 44 .
  • infusion event data 46 is captured by an electronic device 48 connected to the infusion pump 36 .
  • Infusion event data includes, but is not limited to, start time, end time, medication, flow rate events, alarms, and the like.
  • Infusion event data 46 may also include infusion set disconnections from the bag or patient.
  • the electronic device 48 includes a cellular telephone, Wi-Fi, cable, modem link or the like and any combination of the above.
  • the electronic device 48 includes a processing unit 50 , and a database 52 .
  • the electronic device may be separate from the infusion pumps or could be integrated within the infusion pump.
  • the data 46 is transmitted from the electronic device 48 , via an electronic network, to the controller 14 , where the data 46 is stored in the patient outcome data 32 in the patient record 22 .
  • the infusion event data 46 may also be stored on the database 52 of electronic device 48 or transferred to the patient record 22 in packets or through post infusion events.
  • the transmitted infusion event data 46 is compared by the processing unit 16 to the prescribed infusion regimen 30 to determine if the infusion event 44 is in compliance with the prescribed infusion regimen 30 .
  • the results of the comparison are stored in the patient record 22 and shown on display 20 .
  • the display 20 may show information related to a single patient record 22 , or may provide an on-screen triage of multiple home patients for a dashboard-type snapshot of infusion activity.
  • the monitoring technician 41 is notified automatically by the controller 14 either through the display 20 , or a communication to the monitoring technician's electronic device 53 such as by e-mail or text message.
  • the patient 28 and/or supportive caregiver 42 may also be notified by the controller 14 via the electronic network by a communication to the electronic device 48 .
  • the prescribed infusion regimen would be monitored automatically to identify missed infusions or incomplete infusions (i.e., those started but not successfully completed) or highly problematic infusions consisting of numerous alarms or inconsistencies. Upon notification, a skipped infusion or truncated regimen is immediately known, providing the opportunity to notify the patient 28 , send out a nurse 41 , or respond in another manner.
  • the controller automatically generates a report on patient compliance against an approved prescribed regimen or clinical pathway for the payer, hospital, caregiver, and physician.
  • the transmitted infusion event data 46 may also be tied to a billing system 54 for the healthcare provider 12 to ensure charge capture, and may be linked to the electronic device 55 of a manufacturer 56 to allow for development of improved pump usage statistics.
  • the patient record 22 has an interface 58 to capture orders from computerized physician order entry (CPOE) and/or pharmacy systems and an interface 60 for the electronic medical record (EMR) to log therapies.
  • CPOE computerized physician order entry
  • EMR electronic medical record
  • the prescribed infusion regimen 30 is downloaded and stored in an electronic device 59 that includes a communication engine, wireless card or the like that is within the infusion pump 36 and the monitoring technician 41 is provided remote access through an electronic network to the infusion event data 46 that is stored on a database 61 within pump 36 .
  • the pump would be provided with one or more predetermined codes 62 that are provided to the patient 28 and/or the supportive caregiver 42 upon completion of a successful infusion event 44 which is then provided to the monitoring technician 41 either through the electronic network such as by e-mail or through a telephone call.
  • the monitoring technician has access to the predetermined code 62 which is stored in the patient record 22 and can monitor the remote infusion event 44 when the code is received.
  • the infusion event data 46 is compared to anticipated infusion data 64 that is stored on the infusion pump 36 , with subsequent infusion event data 46 download or exception reporting to the patient record 22 or other caregiver-accessible database 52 .
  • an on-pump alarm 66 is activated.
  • patients 28 are notified immediately if they are not performing infusions within the allotted time, at appropriate start times, or the like.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Business, Economics & Management (AREA)
  • Biomedical Technology (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Accounting & Taxation (AREA)
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  • Entrepreneurship & Innovation (AREA)
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US14/472,549 2013-08-30 2014-08-29 System and method of monitoring and managing a remote infusion regimen Abandoned US20150066531A1 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
CA2922425A CA2922425C (en) 2013-08-30 2014-08-29 System and method of monitoring and managing a remote infusion regimen
US14/472,549 US20150066531A1 (en) 2013-08-30 2014-08-29 System and method of monitoring and managing a remote infusion regimen
PCT/US2014/053440 WO2015031774A1 (en) 2013-08-30 2014-08-29 System and method of monitoring and managing a remote infusion regimen
AU2014312122A AU2014312122A1 (en) 2013-08-30 2014-08-29 System and method of monitoring and managing a remote infusion regimen
JP2016537899A JP6621748B2 (ja) 2013-08-30 2014-08-29 遠隔輸液レジメンを監視および管理するシステムならびに方法
US16/835,027 US11571508B2 (en) 2013-08-30 2020-03-30 System and method of monitoring and managing a remote infusion regimen
AU2020202334A AU2020202334A1 (en) 2013-08-30 2020-04-02 System and method of monitoring and managing a remote infusion regimen
AU2022201948A AU2022201948A1 (en) 2013-08-30 2022-03-21 System and method of monitoring and managing a remote infusion regimen
US18/102,047 US11986623B2 (en) 2013-08-30 2023-01-26 System and method of monitoring and managing a remote infusion regimen
US18/663,654 US20240293610A1 (en) 2013-08-30 2024-05-14 System and method of monitoring and managing a remote infusion regimen
AU2024203433A AU2024203433A1 (en) 2013-08-30 2024-05-23 System and method of monitoring and managing a remote infusion regimen

Applications Claiming Priority (2)

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US201361872333P 2013-08-30 2013-08-30
US14/472,549 US20150066531A1 (en) 2013-08-30 2014-08-29 System and method of monitoring and managing a remote infusion regimen

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US16/835,027 Continuation US11571508B2 (en) 2013-08-30 2020-03-30 System and method of monitoring and managing a remote infusion regimen

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US14/472,549 Abandoned US20150066531A1 (en) 2013-08-30 2014-08-29 System and method of monitoring and managing a remote infusion regimen
US16/835,027 Active 2035-01-21 US11571508B2 (en) 2013-08-30 2020-03-30 System and method of monitoring and managing a remote infusion regimen
US18/102,047 Active US11986623B2 (en) 2013-08-30 2023-01-26 System and method of monitoring and managing a remote infusion regimen
US18/663,654 Pending US20240293610A1 (en) 2013-08-30 2024-05-14 System and method of monitoring and managing a remote infusion regimen

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US16/835,027 Active 2035-01-21 US11571508B2 (en) 2013-08-30 2020-03-30 System and method of monitoring and managing a remote infusion regimen
US18/102,047 Active US11986623B2 (en) 2013-08-30 2023-01-26 System and method of monitoring and managing a remote infusion regimen
US18/663,654 Pending US20240293610A1 (en) 2013-08-30 2024-05-14 System and method of monitoring and managing a remote infusion regimen

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US (4) US20150066531A1 (ja)
EP (1) EP3039596A4 (ja)
JP (1) JP6621748B2 (ja)
AU (4) AU2014312122A1 (ja)
CA (1) CA2922425C (ja)
WO (1) WO2015031774A1 (ja)

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US10238799B2 (en) 2014-09-15 2019-03-26 Icu Medical, Inc. Matching delayed infusion auto-programs with manually entered infusion programs
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US10311972B2 (en) 2013-11-11 2019-06-04 Icu Medical, Inc. Medical device system performance index
US10314974B2 (en) 2014-06-16 2019-06-11 Icu Medical, Inc. System for monitoring and delivering medication to a patient and method of using the same to minimize the risks associated with automated therapy
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US11369730B2 (en) 2016-09-29 2022-06-28 Smith & Nephew, Inc. Construction and protection of components in negative pressure wound therapy systems
US20220339355A1 (en) * 2018-06-19 2022-10-27 Jesse E. Ambrosina Fluid delivery event tracking and transaction management
US11484652B2 (en) 2017-08-02 2022-11-01 Diabeloop Closed-loop blood glucose control systems and methods
US11574737B2 (en) 2016-07-14 2023-02-07 Icu Medical, Inc. Multi-communication path selection and security system for a medical device
US11571508B2 (en) 2013-08-30 2023-02-07 Icu Medical, Inc. System and method of monitoring and managing a remote infusion regimen
US11587669B2 (en) 2018-07-17 2023-02-21 Icu Medical, Inc. Passing authentication token to authorize access to rest calls via web sockets
US20230053469A1 (en) * 2021-08-17 2023-02-23 Cerner Innovation, Inc. Automated Suggestions and Monitoring in a Longitudinal Care Plan
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US11712508B2 (en) 2017-07-10 2023-08-01 Smith & Nephew, Inc. Systems and methods for directly interacting with communications module of wound therapy apparatus
US11793924B2 (en) 2018-12-19 2023-10-24 T.J.Smith And Nephew, Limited Systems and methods for delivering prescribed wound therapy
US11974903B2 (en) 2017-03-07 2024-05-07 Smith & Nephew, Inc. Reduced pressure therapy systems and methods including an antenna
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US12130910B2 (en) 2020-05-07 2024-10-29 Icu Medical, Inc. Threshold signature based medical device management

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US10194938B2 (en) 2011-03-14 2019-02-05 UnoMedical, AS Inserter system with transport protection
WO2013050277A1 (en) 2011-10-05 2013-04-11 Unomedical A/S Inserter for simultaneous insertion of multiple transcutaneous parts
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JP2016529632A (ja) 2016-09-23
CA2922425A1 (en) 2015-03-05
CA2922425C (en) 2023-05-16
US20230166026A1 (en) 2023-06-01
WO2015031774A1 (en) 2015-03-05
AU2022201948A1 (en) 2022-04-14
AU2024203433A1 (en) 2024-06-13
AU2014312122A1 (en) 2016-04-07
EP3039596A4 (en) 2017-04-12
US20200335194A1 (en) 2020-10-22
AU2020202334A1 (en) 2020-04-23
US20240293610A1 (en) 2024-09-05
US11986623B2 (en) 2024-05-21
JP6621748B2 (ja) 2019-12-18

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