Many medical procedures require puncturing of the skin, and sometimes underlying tissues, of a human or animal subject. For example, a sharp lancet tip is commonly used to prick the subject's skin at a lancing site to obtain a sample of blood or other body fluid, as for example in blood glucose monitoring by diabetics and in blood typing and screening applications.
In order to obtain an adequate sample size with minimal or no pain to the subject, it is often desirable to provide for adjustment of the depth of penetration of the lancet tip into the subject's skin. For example, individuals with thicker skin or deeper capillaries may require lancing to a deeper penetration depth than individuals having thinner skin or shallower capillaries. Also, alternate site lancing, for example on the forearm or other body portion of the subject, rather than fingertip sampling, may require a deeper penetration depth.
Common mechanisms for accomplishing depth adjustment include movable stop members for limiting the stroke of a lancet or lancet carrier, and adjustable endcaps for varying the position of the sampling site relative to the forward extent of the lancet stroke. Some known depth adjustment mechanisms for lancing devices may contribute to the transmission of an unacceptable degree of vibration to the lancing site, which may increase the perception of pain from the lancing procedure. Also, in many instances it may be desirable to provide a more precise adjustment of penetration depth than some known depth adjust mechanisms provide. Accordingly, it can be seen that continued improvement to depth control in lancing devices is desirable.
Additionally, in the design of lancing devices it is often desirable to provide a distinctive and unique product configuration to a lancing device, for purposes of product differentiation in the marketplace, for aesthetic and/or functional compatibility with related products such as blood glucose meters, and/or for branding purposes. For example, a first supplier may wish for their model of lancing device to have one shape, color scheme, etc., whereas a second supplier may wish for their model of lancing device to have a different shape, color scheme, etc. The expense and time involved in designing and developing a commercially acceptable lancing device can be considerable. Accordingly, it can be seen that improvements to lancing devices and to design, development and manufacturing methods for lancing devices that permit differentiation of products more efficiently and economically is desirable.
It is to the provision of improved lancing devices, and to improved design, development and manufacturing methods for lancing devices meeting this and other needs that the present invention is primarily directed.
USPTO Backgrounds
USPTO Backgrounds