How a Needle-Free Insulin Injection System Works

Tom Dougherty
Diabetes is a serious metabolic disease currently affecting nearly 26 million Americans, or roughly 10% of the entire United States population. Generally, this condition causes a person to have very high blood sugar due to a deficiency in the hormone responsible for absorbing glucose, insulin. There are 2 main forms of diabetes: Type 1 Diabetes-the pancreas fails to produce sufficient insulin (or any insulin at all) Type 2 Diabetes-the pancreas is capable of generating insulin; however, the bodys cells do not recognize the insulin that has been produced Regardless of which form of diabetes is present, a patient will often need insulin injections in order to live a healthy life. The traditional and long-accepted insulin injection method required a needle that would pierce through the skin and release the insulin content into the body. Due to the prevalence of needle phobia as well as the risk of cross contamination associated with this conventional method, needle-free insulin injection devices are increasingly becoming the norm for diabetes care. This new mechanism forces a stream of insulin at a very high speed through a small orifice at the tip of the device, and thus insulin enters the body through the skin in a faster period of time and without the need for a needle.

Figure 1- The image on the left depicts the entrance of insulin into the body using the traditional needle method, while the image on the right shows the entrance of insulin into the body using the needle-free device

Design of the Device

The needle-free insulin injection device is composed of 3 main components: the nozzle, the insulin reservoir, and the pressure source. Nozzle The overall performance of this device hinges upon this critical component. The nozzle is located at the very edge of the needle-free injection system and provides both a pathway for the insulin to leave the

device as well as an interface or flat contact surface for the skin. The first of these functions is especially important since diameter of the orifice directly affects both the diameter and speed of the insulin stream that leaves the device and flows through the skin. This component is only about 1 mm in length and, as will be discussed below, the diameter of the orifice can vary. Insulin Reservoir This component of the device is responsible for storing the insulin within the device prior to its insertion into the body, and it is on average about 40 mm in length. Pressure Source The final component of this injection device is the pressure source, which is responsible for providing the force that drives the insulin through the length of the device, out of the orifice, and into the body. This component transfers stored potential energy into kinetic energy by releasing a once-stationary mechanical spring attached to a plunger through the reservoir component. This creates a pressure which drives the insulin out of the device. Since the plunger must achieve a high velocity in order to provide the proper pressure gradient, this component is often the longest in length at around 96 mm.

Figure 2- A typical needle-free injection device composed of an injector-body (pressure source), ampoule (insulin reservoir), and a nozzle (located at left edge of device)

Figure 3- Schematic of nozzle from a perpendicular view of the nozzle plane (orifice is represented by solid black circle)

As an overall mechanism, these 3 components combine to produce a single dosage of insulin. After the triggering of an external switch by the user, the mechanical spring instantaneuously travels the length of the pressure source chamber. The spring then crosses into the reservoir and pushes the insulin through the 40 mm length of this segment. Upon reaching the nozzle of the device, the insulin travels through the orifice and through the persons skin.

Factors Affecting both the Device and its Performance

While the needle-free insulin injection system functions in an overall simple way, slight variations in certain parameters can largely impact both the design and performance of the device. These parameters include the orifice diameter, the insulin exit velocity, the jet power, and skin properties. Orifice Diameter The diameter of the orifice (located at the nozzle component of this device) directly affects both the penetration depth and dispersion of the insulin within the persons skin. Assuming constant insulin exit velocity, every increase in orifice diameter creates an accompanying increase in insulin penetration depth and dispersion. For example, insulin travelling through an orifice diameter of 31 m would only penetrate through the epidermis of the skin (upper skin layer), while a diameter 229 m would allow the insulin to reach all the way down to the bottom of the dermis (deepest portion of skin). Clearly, larger diameter orifices cause a more optimal device performance. Insulin Exit Velocity Just as the orifice diameter has a direct effect on how effectively insulin is released into the body, the velocity of the insulin stream when it exits this device is also very important. As insulin exit velocity increases (with constant orifice diameter), so does insulin penetration depth and dispersion in the body. Since the mechanical spring, or pressure source, is responsible for how fast the insulin jet is travelling, modifications must be made to either increase the strength of the spring or elongate the pressure source region of the device. Both of these changes would cause the spring to be able to place a greater force on the insulin, which would in turn cause the insulin exit velocity to increase. Jet Power Since it is often difficult to account for both orifice diameter and insulin exit velocity when making penetration depth and dispersion calculations, it is often useful to combine both into a single variable, jet power. The following equation makes it much simpler to grade the overall effectiveness of a given needle-free insulin injection system:

P0=jet power P=insulin density D0=orifice diameter U0=insulin exit velocity Skin Properties While general properties of a persons skin are not explicitly part of this device, they also have a large influence on the performance of the injection system and therefore must be discussed briefly. The main parameters affecting insulin penetration in the body are the skins elasticity and thickness. More elastic skin makes it more difficult for the insulin stream to make a hole and break through the skin, while

thicker skin simply increases the distance that the insulin must travel in order to reach the interior of the body.

Conclusion
Needle-free insulin injection systems are currently revolutionizing diabetes care by helping diabetics live more healthy and comfortable lives. While simple in construction and operation, this device can have its performance affected through many seemingly slight changes in design. Through continued research and implementation, this great device will continue to improve and will soon reach optimal levels of performance.

Sources
Figure 1- http://www.injex.com.au/applications/male-erectile-dysfunction/ Figure 2- http://www.ijppsjournal.com/Vol5Issue4/7464.pdf Figure 3-I developed this image myself

You may notice that Figure 1 was a device used for erectile dysfunction, not insulin delivery. Many of these needle-free devices are very similar in design regardless of which liquid is used in the reservoir, so I thought that this image was still a good representation.