Tissue penetration device
First Claim
1. A body fluid collection system, comprising:
- a housing with a body fluid sample chamber and a sample transport channel;
a penetrating member with a sharpened tip and positioned within the housing;
a tissue penetration depth selection device configured to provide a desired penetration depth of the penetrating member below a skin surface; and
a penetrating member driver configured to be coupled to the penetrating member, drive the penetrating member along a movement path to penetrate a skin surface in a first direction during a penetration phase, and withdraw the penetrating member in an opposing second direction during a retraction phase, wherein the penetrating member driver drives the penetrating member through the skin surface to a defined puncture depth and remain below the skin surface for a sufficient time for a body fluid sample to be collected during a collection phase at the body fluid sample chamber and a sample transport channel.
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Accused Products
Abstract
A tissue penetration device and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.
211 Citations
38 Claims
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1. A body fluid collection system, comprising:
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a housing with a body fluid sample chamber and a sample transport channel; a penetrating member with a sharpened tip and positioned within the housing; a tissue penetration depth selection device configured to provide a desired penetration depth of the penetrating member below a skin surface; and a penetrating member driver configured to be coupled to the penetrating member, drive the penetrating member along a movement path to penetrate a skin surface in a first direction during a penetration phase, and withdraw the penetrating member in an opposing second direction during a retraction phase, wherein the penetrating member driver drives the penetrating member through the skin surface to a defined puncture depth and remain below the skin surface for a sufficient time for a body fluid sample to be collected during a collection phase at the body fluid sample chamber and a sample transport channel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A body fluid collection system, comprising:
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a sample collection unit that includes body fluid sample chamber and a sample transport channel; a penetrating member holder for holding the sample collection unit; a drive for driving the lancet holder through a piercing and retraction movement; and a damping mechanism coupled to the lancet holder to damp deceleration of the lancet holder toward an end of the retraction movement. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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25. A method of obtaining a body fluid sample, comprising:
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(a) an introduction phase when a penetrating member is advanced from a stationary position towards a skin surface; (b) a tissue contact phase when the distal end of the penetrating member makes initial contact with the skin surface; (c) a tissue deformation phase when the skin surface bends depending on its elastic properties; (d) a tissue lancing phase when the penetrating member hits an inflection point on the skin and begins to cut the skin surface and advance through tissue adjacent to the skin surface; (e) a penetrating member rest phase that is a limit of penetration by the penetrating member into the skin; and (f) a penetrating member retraction phase, wherein an average velocity of the penetrating member during the tissue lancing phase is greater than an average velocity of the penetrating member during the penetrating member retraction phase. - View Dependent Claims (24, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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Specification