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Research Papers

Design and Preliminary Testing of a Novel Dual-Chambered Syringe

[+] Author and Article Information
Karen May-Newman1

Department of Mechanical Engineering, Bioengineering Program, San Diego State University, San Diego, CA 92181-1323kmaynewm@mail.sdsu.edu

Maria T. Matyska

 San Jose State University, San Jose, CA 95192

Martin N. Lee

 Preventiv, Inc., Sacramento, CA

1

Corresponding author.

J. Med. Devices 5(2), 021003 (Jun 17, 2011) (5 pages) doi:10.1115/1.4003822 History: Received October 21, 2010; Revised February 18, 2011; Published June 17, 2011; Online June 17, 2011

Intravenous catheterization is the most common invasive medical procedure today and is designed to introduce medication directly into the blood stream. Common practice is to administer medicine with one syringe, followed by a saline flush to clear the line of any residual medication. The risk of infection due to the introduction of bacteria in the catheter hub is increased with the number of times the hub is accessed. In addition, the two-step process adds millions of nursing hours per year and is prone to error. The goal of this effort was to design and test a dual-chamber syringe that could be reliably used for both dispensing medicine and the saline flush, and be produced at a low cost. The syringe has a novel dual-chamber design with a proximal chamber for medicine and a distal chamber that contains saline. The saline chamber has a fixed volume when the handle is locked into position, which allows the handle to control the variable volume of the medicine chamber. Between the two chambers is a plunger that surrounds the small channel (which is an extension of the distal chamber) that separates the saline from the medicine. When the distal chamber is unlocked, the handle controls the volume of the saline chamber. By this mechanism, the syringe is able inject the medicine followed by the saline flush with a single access to the catheter hub. The smooth operation of the device relies on a locking mechanism to control the rear plunger and volume of the distal saline chamber, and a bubble plug residing in the small channel between the chambers that prevents mixing of the medicine and saline fluids. The bubble plug is held in place by a balance of forces that depend on geometric variables and fluid properties. The chosen design prevents mixing of the two fluids during the operation of the device, which was experimentally validated with mass spectrometry. The dual-chamber syringe has successfully achieved the design goal of a single syringe for the two-step catheter procedure of dispensing medicine and a saline flush. This novel design will reduce the potential for catheter-based infection, medical errors, medical waste, and clinician time. Preliminary test results indicate that this innovation can significantly improve the safety and efficiency of catheter-based administration of medicine.

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Copyright © 2011 by American Society of Mechanical Engineers
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Figures

Grahic Jump Location
Figure 1

The dual-chamber syringe has a variable volume proximal chamber and a fixed volume rear chamber, intended for saline flush

Grahic Jump Location
Figure 2

The bubble, shown in the upright position (left) and on its side (right), prevents mixing between the two chambers and is stabilized by a balance of pressure, surface tension, gravity, and buoyancy forces

Grahic Jump Location
Figure 3

Cross section of small channel showing the bubble dimensions: R, radius; h, length; H, half length

Grahic Jump Location
Figure 4

MS data for samples 1, 2 and control sample (marked 10 μL). For sample designation, see Table 3 and text.

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