US 12,112,849 B2Granted

Safety features for medical devices requiring assistance and supervision

AssigneeNxStage Medical, Inc.

InventorsJeffrey H. Burbank, Dennis M. Treu, James M. Brugger

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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.

Claims14

Dependent claims

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.

6 more elements

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.

5 more elements

Dependencies are inferred from the claim text.

Facts

Application: 17/882,073Filed 5 Aug 2022 · continuation
Priority: 25 Oct 2005
Published: US 2022/0375592 A124 Nov 2022
Granted: 8 Oct 2024
Term ends: Not estimatedThe source records don’t support an estimate.

Classification27 codes

G16H 40/63
For the operation of medical equipment or devices: for local operation
A61B 5/0077
Using light, e.g. diagnosis by transillumination, diascopy, fluorescence: devices for viewing the surface of the body, e.g. camera, magnifying lens
A61B 5/015
Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue: by temperature mapping of body part
A61B 5/0816
Measuring devices for evaluating the respiratory organs: measuring devices for examining respiratory frequency

Family

Application60/596,840Us provisional application · filed 25 Oct 2005
PCT/US2006/060218Parent of this continuation · filed 25 Oct 2006
Application13/618,716Parent of this continuation · filed 14 Sep 2012
Application14/682,440Parent of this continuation · filed 9 Apr 2015
US 9,024,746 B2Parent of this continuation · filed 5 May 2015
Application15/189,532Parent of this continuation · filed 22 Jun 2016
US 9,375,527 B2Parent of this continuation · filed 28 Jun 2016
Application15/977,619Parent of this continuation · filed 11 May 2018
Application17/139,442Parent of this continuation · filed 31 Dec 2020
US 2022/0375592 A1Pre-grant publication · published 24 Nov 2022
Application12/091,728Parent of this continuation
US 11,783,939 B2Related patent
US 2009/0222671 A1Published application
US 2013/0069778 A1Published application
US 2015/0209501 A1Published application
US 2016/0306938 A1Published application
US 2018/0261323 A1Published application
US 2021/0125715 A1Published application
US 12,112,849 B2This patent

From the US filing history. Foreign family members aren’t listed.

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