Method and apparatus for penetrating tissue

Abstract

A body fluid sampling system for use on a tissue site includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A cartridge houses the penetrating member. The cartridge has first and second seals coupled to the penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

Description

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is a divisional of U.S. Ser. No. 10 / 335,252, filed Dec. 31, 2002, which is a continuation-in-part of U.S. Ser. No. 10 / 127,395, filed Apr. 19, 2002, said Ser. No. 10 / 335,252 also claims the benefit U.S. Ser. No. 10 / 237,261, filed Sep. 5, 2002 U.S. Ser. No. 10 / 237,262 filed Sep. 5, 2005. All applications listed above are fully incorporated herein by reference for all purposes.BACKGROUND OF THE INVENTION [0002] Lancing devices are known in the medical health-care products industry for piercing the skin to produce blood for analysis. Typically, a drop of blood for this type of analysis is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin. [0003] Early methods of lancing included piercing or slicing the skin with a needle or razor. Current methods utilize lancing devices that contain a multitude of spring, cam and mass actuators to dr...

AI Technical Summary

Benefits of technology

[0006] Accordingly, an object of the present invention is to provide improved tissue penetrating systems, and their methods of use.

[0014] A further object of the present invention is to provide improved tissue penetrating systems, and their methods of use, that have user interfaces.

[0021] In another embodiment of the present invention, a body fluid sampling system for use on a tissue site includes a drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. The drive force generator is configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of the tissue. A cartridge houses the penetrating member. The cartridge has first and second seals coupled to the penetrating member to maintain a sterile environment around a portion of the penetration member prior to penetrating member actuation.

Problems solved by technology

Unfortunately, the pain associated with each lancing event using known technology discourages patients from testing.

In addition to vibratory stimulation of the skin as the driver impacts the end of a launcher stop, known spring based devices have the possibility of harmonically oscillating against the patient tissue, causing multiple strikes due to recoil.

This recoil and multiple strikes of the lancet against the patient is one major impediment to patient compliance with a structured glucose monitoring regime.

Another impediment to patient compliance is the lack of spontaneous blood flow generated by known lancing technology.

In addition to the pain as discussed above, a patient may need more than one lancing event to obtain a blood sample since spontaneous blood generation is unreliable using known lancing technology.

Known devices poorly account for these skin thickness variations.

A still further impediment to improved compliance with glucose monitoring are the many steps and hassle associated with each lancing event.

The large number of steps required in traditional methods of glucose testing, ranging from lancing, to milking of blood, applying blood to the test strip, and getting the measurements from the test strip, discourages many diabetic patients from testing their blood glucose levels as often as recommended.

Older patients and those with deteriorating motor skills encounter difficulty loading lancets into launcher devices, transferring blood onto a test strip, or inserting thin test strips into slots on glucose measurement meters.

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