Lancing device and method of sample collection

Abstract

A lancing device and method for self-collecting a sample of body fluid by penetrating a body tissue at a sampling site. The invention includes a housing geometry configured for ease of use at different sampling sites on the body, even by persons having reduced dexterity and / or poor vision. Depth of penetration is selectively controlled by adjusting the stroke range of a spring-driven lancet carrier. A pressure applicator is included for stimulating flow of the body fluid. A transparent portion permits observation of the sampling site.

Description

FIELD OF THE INVENTION[0001]The present invention relates generally to devices and methods for use in medical sampling and testing, and more particularly to a lancing device and a method for penetrating body tissue to obtain a sample of body fluid.BACKGROUND OF THE INVENTION[0002]Samples of blood, interstitial fluid, or other body fluids are commonly required for various medical purposes. For example, many diabetics must periodically monitor their blood glucose level to determine when an insulin injection is needed. Self-testing systems are available to enable a person to obtain a sample of his or her own blood, typically by penetrating the skin, and to subject the harvested blood sample to analysis of the blood glucose level. Often, a lancing device is used to penetrate the skin to obtain the required sample of blood. For example, U.S. Pat. Nos. 5,954,738; 5,879,311; 5,857,983; and 5,318,584 disclose particular forms of body fluid sampling devices.[0003]In order to encourage compli...

AI Technical Summary

Benefits of technology

[0010]Accordingly, depth of penetration is easily and accurately adjusted to suit the needs of the individual user, and to produce the required sample size with minimal pain to the user and promote quick healing. Additionally, by minimizing the size of the wound necessary to generate a desired sample size, the wound closes quickly after sampling to reduce the incidence of residual bleeding that may stain the user's clothing.

Problems solved by technology

Nerve density is high in the fingertips, however, and significant pain often results from fingertip sampling.

Moreover, repeated sampling can adversely result in callous formation on the fingertips.

This is of particular importance with lancing devices intended for use by diabetics, as many diabetics suffer from poor eyesight and neuropathy, often resulting in reduced manual dexterity.

Many previously known lancing devices have been found particularly difficult for such users to manipulate in carrying out certain sampling methods.

For example, pen-shaped lancing devices are often too narrow for some users to grasp easily, and their cylindrical shape may render them difficult for some users to hold without unintentional twisting of the barrel of the device.

Also, because such devices are typically relatively long compared to their width (or diameter) it is difficult for some users to apply sufficient pressure to maintain the device in a stable manner against the user's forearm during sampling.

Such devices are generally adapted for fingertip sampling, but are not well-suited for sampling at a site on the forearm.

In particular, due to their angular offset, many users find it difficult to press these lancing devices against the forearm while maintaining the device in an orientation for lancing perpendicularly to the skin.

Because of differences between individual users, such devices may generate a sample size larger or smaller than necessary.

Particular forms of previously known lancing devices have incorporated an eject feature that permits a lancet to be “launched” from the device, potentially resulting in injury.

Other known devices require the user to grasp the used lancet for removal, thereby presenting a risk of needle sticks.

The configuration of previously known stimulator members has been found to provide less than optimal sampling rates, to result in undesirable levels of user discomfort, and to result in bruising or marking of the skin with pressure indentations.

In addition, it is often difficult to monitor the sample size produced during use of such previously known devices.

Images