The objective of this project is to design a device to deliver 50 mL of immunoglobulin to the subcutaneous space with a volumetric flow rate of 50 mL per hour.
Sponsor
CSL Behring
Team Members
Nate Chamberlain Ben Song Sang Jun Han Marie Misener
Project Poster
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Project Video
Project Summary
Overview
CSL Behring is a biopharmaceutical company, which focuses on manufacturing plasma derived and recombinant therapeutic products. CSL Behring wants to create a device to treat primary immunodeficiency disease (PID). PID occurs in about 1 in every 1200 individuals with the most common treatment being immunoglobulin G (IgG or Ig) replacement therapy. This replacement therapy is required every 3 to 4 weeks. The typical injection volume required is 50ml. Patients will usually perform these injections at home.
Objectives
The overall goal of this project is to develop a device that should be comfortable and easy to use, allowing users to maintain their mobility. A pump mechanism must be developed such that immunoglobulin of 14cP viscosity may be delivered at a minimum flow rate of 25 ml/hour. However, a target flow rate of 50mL/hour is desired. To maintain patient comfort during the infusion, a maximum needle diameter of 24 gauge is required. The target needle size is 27 gauge. The product may be manufactured in such way that it is either reusable or disposable. Additionally, it is desirable that this device is low in cost and easy to manufacture.
Approach
Weekly group meetings to discuss important events and decisions
Contact sponsor on a biweekly basis to receive feedback and ask for any clarification if needed
Purchase necessary equipment needed to design pump mechanism
Test and analyze different pumps to determine which is bested suited for our purposes. One important test is figuring out the different flow rates each motor will produce
From the motor test calculate the delay for the motor in order to achieve the target flow rate
Create code to implement delay and make sure that the target flow rate of 50ml/hr is achieved
Create CAD models to test and figure out best design for the housing of the pump
Outcomes
The final prototype is capable of delivering a volumetric flow rate of 50ml/hr. The pump system selected is called a peristaltic pump. Peristaltic pumps have several advantages over the stepper motor, another motor we looked at. The main advantage is that the fluid never touches the pump, and it is always contained in the tubing. This means that the device has the potential to be reusable as the only item that needs to be changed out between injections is the tubing.
A 25-gauge needle was selected for the final prototype because this size was a good compromise between patient comfort and flow rate.
Overall patient comfort was increased due the small and lightweight design of the device. This device is easy to carry around and does not prevent patient mobility.
The device was also relatively cheap costing only 146 dollars. This low cost allows for easy manufacturing on a large scale.