# US 12,112,849 B2 · Safety features for medical devices requiring assistance and supervision

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- Number: US 12,112,849 B2
- Document ID: US12112849B2
- Status: Granted
- Kind: B2
- Application number: 17/882,073
- Filed: 2022-08-05
- Published: 2022-11-24
- Granted: 2024-10-08
- Earliest claimed: 2005-10-25
- Assignees: NxStage Medical, Inc.
- Applicants: NxStage Medical, Inc.
- Inventors: Jeffrey H. Burbank; Dennis M. Treu; James M. Brugger
- Web page: https://patentgrep.com/patent/US12112849B2

## CPC

- G16H 40/63: for local operation
- A61B 5/0077: {Devices for viewing the surface of the body, e.g. camera, magnifying lens}
- A61B 5/015: {By temperature mapping of body part}
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/117: Identification of persons (methods or arrangements for recognising patterns, e.g. fingerprints, G06F18/00, G06V40/00; identification of persons by analysing their voice or speech G10L17/00)
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 5/7475: {User input or interface means, e.g. keyboard, pointing device, joystick}
- A61M 1/14: Dialysis systems; Artificial kidneys; Blood oxygenators (semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00){; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis}
- A61M 1/36: Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation {; Extra-corporeal blood circuits}
- A61M 1/367: {Circuit parts not covered by the preceding subgroups of group A61M1/3621}
- G05B 1/01: electric
- G05B 9/02: electric
- G08B 21/182: {Level alarms, e.g. alarms responsive to variables exceeding a threshold}
- G08B 21/22: responsive to presence or absence of persons
- G16H 30/40: for processing medical images, e.g. editing
- G16H 40/67: for remote operation
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61M 2205/18: with alarm
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/6009: for matching patient with his treatment, e.g. to improve transfusion security
- G16H 20/00: ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)
- G08B: SIGNALLING SYSTEMS, e.g. PERSONAL CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

A medical treatment device is configured to be used during a treatment session at a first location and includes a medical treatment component configured to perform at least one of hemodialysis, hemofiltration, and peritoneal dialysis on a patient during the treatment session at the first location. The device also includes a monitoring system configured to receive data from one or more sensors connected to the monitoring system, and to confirm a presence of an authorized helper at the first location. A user interface permits an operator to control functions of the medical treatment component and the monitoring system is configured to perform the presence confirmation automatically and at the predefined time intervals during the treatment session. The monitoring system is also configured to generate an alarm and to cause the medical treatment component to go into a failsafe operational mode.

## Claims

### Claim 1

A dialysis treatment device configured to be used during a treatment session at a first location, the dialysis treatment device comprising:
a medical treatment component configured to perform at least one of hemodialysis, hemofiltration, and peritoneal dialysis on a patient during the treatment session at the first location;
a monitoring system configured to receive data from one or more sensors connected to the monitoring system, and to confirm a presence of an authorized helper, different from the patient, at the first location; and
a user interface adapted for permitting an operator to control functions of the medical treatment component, wherein
the medical treatment component includes data storage for storing an internal representation of a prescription for a treatment of the patient,
the monitoring system is configured to confirm the presence by
generating repeatedly, at predefined time intervals during the treatment session, one or more verification requests requesting input of a verification response into the user interface of the monitoring system in response to the one or more verification requests, the verification response verifying that a helper is present at the first location, and identifying that the helper is the authorized helper, and
confirming a pattern of presences of the authorized helper over a plurality of the predefined time intervals during the treatment session in which the medical treatment component is operative to deliver therapy to the patient based on the verifying and identifying, and
the monitoring system is further configured to generate a signal indicative of an abnormal condition when the pattern of presences of the authorized helper is not confirmed and causing the medical treatment component to go into a failsafe operational mode to reduce risks to the patient during the treatment session.

### Claim 2 (depends on 1)

The dialysis treatment device of claim 1, wherein
the medical treatment component includes a controller connected to a network or the Internet and communicating with information servers and/or remote terminals, the controller being configured to obtain instructions from the information servers and/or the remote terminals, to report status, and/or notify of conditions of the medical treatment component, and
the controller is configured to report a use of the medical treatment component to a remote supervisor by the Internet or remote terminals, and send a message to the remote supervisor by the Internet or the remote terminals responsively to a failure to confirm the presence of the authorized helper at the first location.

### Claim 3 (depends on 1)

The dialysis treatment device of claim 1, wherein
the monitoring system includes a video camera and a video classification engine that monitors a scene that includes the patient and the helper to confirm that the helper is present at the first location and is the authorized helper.

### Claim 4 (depends on 1)

The dialysis treatment device of claim 1, wherein the one or more sensors include an authentication device including at least one of a key code receiver, an RFID reader, mechanical lock, a biometric reader, a magnetic stripe reader, a nonvolatile memory card reader, a smart card reader, a video camera, or a bar code reader.

### Claim 5 (depends on 1)

The dialysis treatment device of claim 1, wherein the monitoring system generates an alert signal and waits for a reception of an alert-cancel command after generating the alert signal, the monitoring system causing the medical treatment component to go into the failsafe operational mode in response to the abnormal condition and a failure of the alert-cancel command being received.

### Claim 6

A method for controlling an extracorporeal blood treatment machine at a first location to reduce a risk of continuing a blood treatment procedure of a patient in an absence of an authorized helper other than the patient in an immediate vicinity of the extracorporeal blood treatment machine, comprising:
providing the extracorporeal blood treatment machine at the first location;
receiving instructions at a user interface of the extracorporeal blood treatment machine from an operator to control medical treatment functions of the extracorporeal blood treatment machine;
performing repeatedly, by the extracorporeal blood treatment machine, presence confirmation at predetermined time intervals after starting the blood treatment procedure to confirm a presence of the authorized helper at the first location, wherein the performing of the presence confirmation comprises:
generating, by the extracorporeal blood treatment machine, automatically and at the predetermined time intervals after starting the blood treatment procedure, one or more verification request signals requesting a helper to manually input a verification response into the user interface of the extracorporeal blood treatment machine in response to the one or more verification request signals, the verification response verifying that the helper is present in the first location and identifying that the helper is the authorized helper; and
confirming a pattern of presences of the authorized helper over a plurality of the predetermined time intervals after starting the blood treatment procedure in which the extracorporeal blood treatment machine is operative to deliver therapy to the patient based on the verifying and identifying; and
responsively to the pattern of presences of the authorized helper not being confirmed, generating a signal indicative of an abnormal condition and implementing a failsafe operational mode of the extracorporeal blood treatment machine to reduce the risk of continuing the blood treatment procedure.

### Claim 7 (depends on 6)

The method according to claim 6, wherein
the extracorporeal blood treatment machine includes a controller connected to a network or the Internet and communicating with information servers and/or remote terminals at a second location remote from the first location, and
the method further comprises
obtaining the instructions by the controller from the information servers and/or the remote terminals, the instructions including at least prescription information specific to the patient at the first location; and
reporting a status and/or notifying of conditions of the extracorporeal blood treatment machine by the controller to the information servers and/or remote terminals at the second location.

### Claim 8 (depends on 7)

The method of claim 7, further comprising:
sending, by the information servers and/or the remote terminals, a message to a remote supervisor responsively to the presence confirmation failing to confirm the presence of the authorized helper at the first location.

### Claim 9 (depends on 7)

The method according to claim 7, wherein the status includes notifications requiring special or immediate attention and to transmit information and receive commands to/from the information servers and/or remote terminals.

### Claim 10 (depends on 6)

The method of claim 6, wherein the blood treatment procedure is a renal replacement therapy.

### Claim 11 (depends on 6)

The method of claim 6, wherein the implementing the failsafe operational mode includes clamping blood lines of the extracorporeal blood treatment machine.

### Claim 12 (depends on 6)

The method of claim 6, wherein the implementing the failsafe operational mode includes generating one of an automated cellular message and an automated telephonic message to an ambulance service.

### Claim 13 (depends on 6)

The method of claim 6, wherein the implementing the failsafe operational mode includes slowing a pumping rate through blood lines of the extracorporeal blood treatment machine or terminating the blood treatment procedure.

### Claim 14 (depends on 6)

The method of claim 6, wherein the confirming the pattern of presences of the authorized helper is performed at least three times being spaced apart such that a third time is more than half-way through the blood treatment procedure.