Drug delivery system and method of use

Patent metadata

Field	Value
Publication number	US-2022395635-A1
Application number	US-202017770349-A
Country	US
Kind code	A1
Filing date	Oct 29, 2020
Priority date	Nov 7, 2019
Publication date	Dec 15, 2022
Grant date	—

Abstract

A drug delivery system includes a delivery container including a container body adapted to accommodate a drug therein, a supply line, a flow rate sensor, and a flow controller. The delivery container further includes an outlet port and is constructed from a resilient material. The container body is adapted to exert an urging force on the drug to expel the drug from the outlet port. The supply line is operably coupled to the outlet port to deliver the drug to a user. The flow sensor senses a flow rate of the drug within the supply line. The flow controller is configured to regulate a flow rate of the drug; the flow controller includes a supply line restrictor and a controller for adjusting the supply line restrictor between at least two settings.

First claim

1 . A drug delivery system comprising:
a delivery container including a container body adapted to accommodate a drug therein, an outlet port, and a hanging portion adjacent to a top of the delivery container, the delivery container configured to be supported by the hanging portion such that gravitational forces urge the drug from the outlet port; a supply line operably coupled to the outlet port to deliver the drug to a user; a flow rate sensor that senses a flow rate of the drug within the supply line; and a flow controller operatively coupled to at least the flow rate sensor, wherein the flow controller is configured to regulate a flow rate of the drug, the flow controller comprising: a supply line restrictor movable between at least a first setting and a second setting, where the supply line is more restricted when the supply line restrictor is in the second setting than in the first setting; and a controller for adjusting the supply line restrictor between at least the first setting and the second setting in response to input from the flow rate sensor.

2 . The drug delivery system of claim 1 , wherein the controller is adapted to receive the input from the flow rate sensor and compare the input to a desired flow rate to calculate a difference value, wherein upon the difference value exceeding a threshold value, the controller is adapted to adjust an operational parameter of the supply line restrictor.

3 . The drug delivery system of claim 1 , wherein the flow restrictor includes a ramped surface and a movable clamp, wherein a portion of the supply line is positioned between the ramped surface and the movable clamp, and wherein the flow controller includes a controller arm coupled with the movable clamp and configured to move the movable clamp between at least a first position and a second position, wherein the controller arm is optionally configured to move the movable clamp along at least a length of the ramped surface.

4 . (canceled)

5 . The drug delivery system of claim 1 , wherein the flow restrictor further includes:
a ramped surface; and a track extending adjacent to the ramped surface; wherein the supply line restrictor is a movable clamp operatively engaged with the track, wherein a portion of the supply line is positioned between the ramped surface and the movable clamp, and wherein the flow controller includes a motor configured to rotate the movable clamp and transversely move the movable clamp along the track.

6 . The drug delivery system of claim 1 , wherein the flow restrictor includes a rotary dial, wherein a portion of the supply line is positioned adjacent to the rotary dial, and wherein the flow controller includes an eccentric portion coupled with the rotary dial and configured to move the rotary dial between at least a first position and a second position.

7 . The drug delivery system of claim 6 , wherein the flow restrictor further includes a controller arm configured to rotate the rotary dial, wherein the controller arm is configured to rotate the rotary dial along at least a rotational profile of at least 30 degrees.

8 - 9 . (canceled)

10 . The drug delivery system of claim 2 , wherein the flow controller further comprises an alarm operably coupled to the controller, the controller being adapted to activate the alarm upon the difference value exceeding an alarm value.

11 . The drug delivery system of claim 1 , wherein the flow rate sensor further comprises: 1) an interface coupled to the controller to receive at least one input; and 2) a display coupled to the controller.

12 . The drug delivery device of claim 1 , wherein the supply line restrictor is at least one of (a) movable continuously between a plurality of non-discreet settings between the first setting and the second setting, or (b) movable from the first setting to the second setting, and from the second setting to the first setting.

13 . (canceled)

14 . A drug delivery system comprising:
a delivery container including a container body adapted to accommodate a drug therein and an outlet port, the container body being constructed from a resilient material such that the container body is adapted to exert an urging force on the drug to expel the drug from the outlet port; a supply line operably coupled to the outlet port to deliver the drug to a user; a flow rate sensor that senses a flow rate of the drug within the supply line; and a flow controller operatively coupled to at least the flow rate sensor, wherein the flow controller is configured to regulate a flow rate of the drug, the flow controller comprising: a supply line restrictor movable between at least a first setting and a second setting, where the supply line is more restricted when the supply line restrictor is in the second setting than in the first setting; and a controller for adjusting the supply line restrictor between at least the first setting and the second setting in response to input from the flow rate sensor.

15 . The drug delivery system of claim 14 , wherein the controller is adapted to receive the input from the flow rate sensor and compare the input to a desired flow rate to calculate a difference value, wherein upon the difference value exceeding a threshold value, the controller is adapted to adjust an operational parameter of the supply line restrictor.

16 . The drug delivery system of claim 14 , wherein the flow restrictor includes a ramped surface and a movable clamp, wherein a portion of the supply line is positioned between the ramped surface and the movable clamp, and wherein the flow controller includes a controller arm coupled with the movable clamp and configured to move the movable clamp between at least a first position and a second position, wherein the controller arm is optionally configured to move the movable clamp along at least a length of the ramped surface.

17 . (canceled)

18 . The drug delivery system of claim 14 , wherein the flow restrictor further includes:
a ramped surface; and a track extending adjacent to the ramped surface; wherein the supply line restrictor is a movable clamp operatively engaged with the track, wherein a portion of the supply line is positioned between the ramped surface and the movable clamp, and wherein the flow controller includes a motor configured to rotate the movable clamp and transversely move the movable clamp along the track.

19 . The drug delivery system of claim 14 , wherein the flow restrictor includes a rotary dial, wherein a portion of the supply line is positioned adjacent to the rotary dial, and wherein the flow controller includes an eccentric portion coupled with the rotary dial and configured to move the rotary dial between at least a first position and a second position.

20 . The drug delivery system of claim 19 , wherein the flow restrictor further includes a controller arm configured to rotate the rotary dial, wherein the controller arm is optionally configured to rotate the rotary dial along at least a rotational profile of 30 degrees or 45 degrees.

21 - 22 . (canceled)

23 . The drug delivery system of claim 15 , wherein the flow controller further comprises an alarm operably coupled to the controller, the controller being adapted to activate the alarm upon the difference value exceeding an alarm value.

24 . The drug delivery system of claim 23 , wherein the alarm value is at least partially based on a risk profile of the drug contained in the delivery container.

25 . The drug delivery

Assignees

• Amgen Inc

Inventors

• Malloy Shawn P

Classifications

• A61M5/16831

  Monitoring, detecting, signalling or eliminating infusion flow anomalies (low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066) · CPC title

• A61M2205/502

  User interfaces, e.g. screens or keyboards · CPC title

• A61M5/16813

  by controlling the degree of opening of the flow line · CPC title

• A61M5/1414

  Hanging-up devices · CPC title

• A61M39/285

  Cam clamps, e.g. roller clamps with eccentric axis · CPC title