Tissue penetration device
First Claim
1. A method for creating a puncture wound in the epidermis of a body part to obtain a body fluid sample, comprising:
- creating a skin opening in the epidermis at a puncture site to a first depth without reaching blood carrying tissue during a skin-opening step;
allowing the epidermis at the puncture site to relax; and
inserting a penetrating member into the skin opening to a second depth that reaches blood carrying tissue to create a puncture wound for collecting the body fluid sample during a sample collection step.
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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.
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Citations
16 Claims
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1. A method for creating a puncture wound in the epidermis of a body part to obtain a body fluid sample, comprising:
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creating a skin opening in the epidermis at a puncture site to a first depth without reaching blood carrying tissue during a skin-opening step; allowing the epidermis at the puncture site to relax; and inserting a penetrating member into the skin opening to a second depth that reaches blood carrying tissue to create a puncture wound for collecting the body fluid sample during a sample collection step. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method of using a penetrating member apparatus to create a puncture wound in an epidermis of a body part to obtain a body fluid sample, the penetrating member apparatus including a penetrating member, a drive for reciprocating the penetrating member, and a housing having an opening from which the penetrating member is accessible for contacting a body part the method comprising:
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(a) contacting the apparatus with a body part from which a body fluid sample is to be obtained; (b) advancing the penetrating member to a first distance relative to the apparatus and create a skin opening in the epidermis with a first depth that does not reach blood carrying tissue; (c) allowing the epidermis around the skin opening to relax; and (d) advancing the penetrating member a second distance into the skin opening to a second depth that reaches blood carrying tissue and create a puncture wound for collecting the body fluid sample. - View Dependent Claims (9, 10, 11, 12, 13)
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14. A handheld apparatus for creating a puncture wound, comprising:
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a penetrating member; a drive for moving the penetrating member toward and away from a skin surface; a control device for controlling the movement of the penetrating member, the control device being operable to, (i) move the penetrating member in a skin opening step a first distance toward the skin to create a skin opening, slow or pause movement of the penetrating member for a sufficient time to allow the epidermis at a puncture site to relax, and (iii) move the penetrating member toward the skin a second distance and create a puncture wound for collecting a body fluid sample. - View Dependent Claims (15, 16)
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Specification