Tissue penetration device
First Claim
1. A method for creating a puncture wound in the epidermis of a patient'"'"'s body part to obtain a body fluid sample, comprising:
- providing a fluid sampling device with a housing and a cartridge positionable in the housing that includes a plurality of penetrating members;
creating a skin opening in the epidermis with one of said plurality of penetrating members at a puncture site to a depth below the puncture site during a skin-opening step;
using a processor to allow said one of said plurality of the penetrating members to settle at the depth of the puncture site for a sufficient amount of time at a body fluid sampling site below the epidermis;
using the processor to customize a penetrating member driver velocity profile by scaling or modifying the penetrating member driver velocity profile based on user input information and in response to said customizing, the processor modulating power from a power supply to the penetrating member driver through an amplifier;
withdrawing said one of said plurality of the penetrating members from the puncture site;
maintaining the patient'"'"'s skin in position at the body fluid sampling site until an adequate volume of blood has been collected; and
providing a signal to the patient from the fluid sampling device that the patient'"'"'s skin may be lifted from the sampling site after said one of said plurality of the penetrating members has been withdrawn, the signal being either a visual or audio signal.
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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.
2206 Citations
15 Claims
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1. A method for creating a puncture wound in the epidermis of a patient'"'"'s body part to obtain a body fluid sample, comprising:
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providing a fluid sampling device with a housing and a cartridge positionable in the housing that includes a plurality of penetrating members; creating a skin opening in the epidermis with one of said plurality of penetrating members at a puncture site to a depth below the puncture site during a skin-opening step; using a processor to allow said one of said plurality of the penetrating members to settle at the depth of the puncture site for a sufficient amount of time at a body fluid sampling site below the epidermis; using the processor to customize a penetrating member driver velocity profile by scaling or modifying the penetrating member driver velocity profile based on user input information and in response to said customizing, the processor modulating power from a power supply to the penetrating member driver through an amplifier; withdrawing said one of said plurality of the penetrating members from the puncture site; maintaining the patient'"'"'s skin in position at the body fluid sampling site until an adequate volume of blood has been collected; and providing a signal to the patient from the fluid sampling device that the patient'"'"'s skin may be lifted from the sampling site after said one of said plurality of the penetrating members has been withdrawn, the signal being either a visual or audio signal. - 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 patient'"'"'s skin at a sampling site to obtain a body fluid sample, the penetrating member apparatus including a cartridge with a plurality of penetrating members, a drive for advancing and retracting said plurality of penetrating members, and a housing having an opening from which said plurality of penetrating members are accessible for contacting a body part with the cartridge positionable in the housing, the method comprising:
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contacting the apparatus with a body part from which a body fluid sample is to be obtained; advancing one of said plurality of the penetrating members to create a skin opening in the epidermis; using a processor to allow said one of said plurality of the penetrating members to settle at the body fluid sampling site for a sufficient amount of time, the processor in operation providing an ability to accurately control depth of penetration, control penetrating member penetration and withdrawal velocity, and reduce pain perceived when cutting into the skin; using the processor to customize a penetrating member driver velocity profile by scaling or modifying the penetrating member driver velocity profile based on user input information and in response to said customizing, the processor modulating power from a power supply to the penetrating member driver through an amplifier; maintaining the patient'"'"'s skin in position at the sampling site until an adequate volume of body fluid has been collected, and; providing a signal from the penetrating member apparatus to the patient that a patient'"'"'s skin may be lifted from the sampling site after said one of said plurality of the penetrating members has been withdrawn, the signal being either a visual or audio signal. - View Dependent Claims (9, 10, 11, 12)
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13. A handheld apparatus for creating a puncture wound at a sampling site, comprising:
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a housing;
a cartridge positionable in the housing;a plurality of penetrating members positioned in the cartridge; a drive for moving the penetrating member toward and away from a patient'"'"'s skin; a processor coupled to the drive and to the plurality of penetrating members for controlling the movement of the plurality of penetrating members, the processor configured to provide that a penetrating member velocity through the patient'"'"'s skin is different from a withdrawal velocity of the penetrating member out of the puncture site, the processor configured to select a penetrating member driver velocity profile from a set of alternative driver velocity profiles that have been programmed in the processor based on desired tissue penetration, the processor customizing the selected penetrating member driver velocity profile by scaling or modifying said selected penetrating member driver velocity profile based on user input information and in response to said customizing, the processor modulating power from a power supply to the penetrating member driver through an amplifier; the processor providing the patient with a visual or audio signal that the patient'"'"'s skin may be lifted from the sampling site after the patient'"'"'s skin has been maintained in position at the sampling site until an adequate volume of blood has been collected and said one of said plurality of the penetrating members has been withdrawn. - View Dependent Claims (14, 15)
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Specification