Medicament preparation devices, methods, and systems

Patent metadata

Field	Value
Publication number	US-12263286-B2
Application number	US-202017612747-A
Country	US
Kind code	B2
Filing date	May 21, 2020
Priority date	May 23, 2019
Publication date	Apr 1, 2025
Grant date	Apr 1, 2025

Abstract

A system for mixing a batch of medicament has a pump actuator, control valve actuators, a source of concentrate, and a purified water source, all connected by a fluid circuit. A controller controls various control valves to open fluid channels from the source of concentrate and from the purified water source to connect a junction of the fluid circuit to the concentrate container and the purified water source. The controller also controls the pump actuator and a water pump to flow water and concentrate through the junction into a mixing container, such that the mixture of the concentrate and the water requires additional dilution to form a ready-to-use medicament. The controller samples the mixture and calculate an additional quantity of water to add based on the sampling.

First claim

What is claimed is:

1. A system for mixing a batch of medicament, comprising:
a pump actuator and control valve actuators controlled by a controller;
a fluid circuit fluidly connected to the pump actuator and the valve actuators;
the fluid circuit including a concentrate container filled with a concentrate or a concentrate connector for connection to the concentrate container;
the fluid circuit being connected to a mixing container by an inlet line and an outlet line of the mixing container at ends of a pumping tube segment that engages the pump actuator to form a peristaltic pump;
a water pump connected to the system and controlled by the controller, the water pump being configured to pump purified water from a purified water source;
the controller being configured to control the valve actuators to open fluid channels from the concentrate container or the concentrate connector and to open channels from the purified water source to connect a junction of the fluid circuit to the concentrate container and the purified water source;
the controller being further configured to control the pump actuator and the water pump to flow water and concentrate into said junction, the junction being connected to the inlet line of the mixing container, such that water and concentrate flow concurrently into the mixing container;
the controller being further configured to control the peristaltic pump and the water pump to flow concentrate in proportion such that a mixture of the concentrate and the purified water in the mixing container requires additional dilution to form a ready-to-use medicament;
the fluid circuit having a drain line connectable to a conductivity sensor and the controller being configured to collect a sample of contents of the mixing container through the drain line and to measure a conductivity of the sample with the conductivity sensor; and
the controller being further configured to calculate an additional quantity of water to add to the mixing container responsively to the conductivity measured.

2. The system of claim 1 , wherein the mixing container has an outlet connected to an inlet of the pumping tube segment and the controller is configured to mix the contents of the mixing container by recirculating the contents through the fluid circuit through the inlet to the mixing container.

3. The system of claim 1 , wherein the controller is connected to the conductivity sensor that connects to the drain line.

4. The system of claim 1 , wherein the fluid circuit has a check valve in said mixing container inlet line, the check valve having a predefined cracking pressure, the peristaltic pump pumping against a resistance of said check valve to generate a pumping head to force fluid through said drain line.

5. The system of claim 1 , wherein the fluid circuit has a water inlet line connected to the purified water source, the water inlet line has a sterile filter positioned to filter all water pumped to said junction.

6. A fluid circuit, comprising:
a valve network having a water line, a drain line, a concentrate line, and a product fluid line;
an empty mixing container;
a prefilled concentrate container;
the water line, the product fluid line, and the drain line being connected to the empty mixing container both directly and also through a pumping tube segment via respective mixing container inlet and outlet lines;
the mixing container inlet line having a check valve and the mixing container outlet line being configured mate with a control valve; and
the check valve having a predefined cracking pressure.

7. The fluid circuit of claim 6 , further comprising a sterile filter positioned to filter water flowing through the water line.

8. The fluid circuit of claim 7 , wherein the concentrate line is connected to the mixing container outlet line.

9. The fluid circuit of claim 6 , wherein the concentrate line is connected to the mixing container outlet line.

10. The fluid circuit of claim 8 , wherein the product fluid line has a set of terminal connectors that stem as branches from said product fluid line.

11. The fluid circuit of claim 6 , wherein the product fluid line has a set of terminal connectors that stem as branches from said product fluid line.

12. A method for mixing a batch of medicament, comprising:
providing a system that includes
a pump actuator and control valve actuators controlled by a controller;
a fluid circuit fluidly connected to the pump actuator and valve actuators;
the fluid circuit including a concentrate container filled with a concentrate or a concentrate connector for connection to the concentrate container;
the fluid circuit being connected to a mixing container by an inlet line and an outlet line of the mixing container at ends of a pumping tube segment that engages the pump actuator to form a peristaltic pump;
fluid circuit having a drain line connectable to a conductivity sensor;
a water pump connected to be controlled by the controller, the water pump being configured to pump purified water from a purified water source;

using the controller, controlling the valve actuators to open fluid channels from the concentrate container or the concentrate connector and to open channels from the purified water source to connect a junction of the fluid circuit to the concentrate and purified water source;
using the controller, controlling the pump actuator and the water pump to flow water and concentrate into said junction, the junction being connected to said mixing container inlet line, such that water and concentrate flow concurrently into the mixing container;
using the controller, controlling the peristaltic pump and the water pump to flow concentrate in proportion such that a mixture of the concentrate and the purified water in the mixing container requires additional dilution to form a ready-to-use medicament;
using the controller, collecting a sample of contents of the mixing container from the drain line and measuring a conductivity of the sample with the conductivity sensor; and
using the controller, calculating an additional quantity of water to add to the mixing container responsively to the conductivity measured.

13. The method of claim 12 , wherein the mixing container has an outlet connected to an inlet of the pumping tube segment, the method including, using the controller, mixing the contents of the mixing container by recirculating the contents through the fluid circuit through the inlet to the mixing container.

14. The method of claim 12 , wherein the controller is connected to the conductivity sensor that connects to the drain line.

15. The method of claim 14 , wherein the fluid circuit has a check valve in said mixing container inlet line, the check valve having a predefined cracking pressure, the peristaltic pump pumping against a resistance of said check valve to generate a pumping head to force fluid through said drain line.

16. The method of claim 12 , wherein the fluid circuit has a water inlet line connected to the purified water source, the water inlet line has a sterile filter positioned to filter all water pumped to said junction.

Assignees

• Nxstage Medical Inc

Inventors

• Friederichs Goetz
• Hughes Kevin

Classifications

• B01F2101/22

  Mixing of ingredients for pharmaceutical or medical compositions · CPC title

• B01F23/45

  using flow mixing · CPC title

• B01F35/831

  using one or more pump or other dispensing mechanisms for feeding the flows in predetermined proportion, e.g. one of the pumps being driven by one of the flows (B01F35/832 takes precedence) · CPC title

• B01F35/181

  Preventing generation of dust or dirt; Sieves; Filters (B01F35/145, B01F35/43 take precedence) · CPC title

• B01F35/71805

  using valves, gates, orifices or openings · CPC title