BLOOD AND INTERSTITIAL FLUID SAMPLING DEVICE
First Claim
1. A sampling module, comprising:
- a module body portion comprising a lancet channel having at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel;
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel; and
a sample reservoir in fluid communication with a sample input port of the module body portion.
4 Assignments
0 Petitions
Accused Products
Abstract
A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle (16), drive mechanism (11), kneading or vibration mechanism (25), optional suction system (7), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component (83) for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.
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Citations
28 Claims
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1. A sampling module, comprising:
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a module body portion comprising a lancet channel having at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel; a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel; and a sample reservoir in fluid communication with a sample input port of the module body portion. - View Dependent Claims (2, 3, 4)
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5. A sampling module, comprising:
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a module body portion comprising a lancet channel; a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel of the module body portion; a sample reservoir having an input end and a terminal end, the sample reservoir being in fluid communication with a sample input port of the module body portion; and a vent disposed between and in fluid communication with the terminal end of the sample reservoir and the lancet channel. - View Dependent Claims (6, 7)
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8. A sampling module comprising:
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a module body portion having a sampling site adjacent a lancet exit port where the sharpened distal tip of the lancet exits a distal end of the module body portion that includes a sample cavity in a distal end surface of the module body portion; a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion and extendable from the lancet exit port; and a sample reservoir in fluid communication with a sample cavity of the module body portion. - View Dependent Claims (9, 10)
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11. A lancet module comprising
a module body portion configured to be mechanically registered and secured adjacent a lancet driver; - and
a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion. - View Dependent Claims (12, 13)
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- 14. A lancet module comprising a module body portion having a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel.
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17. A sampling module comprising:
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a module body portion configured to be mechanically registered and secured adjacent a lancet driver; a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion; and a sample reservoir in fluid communication with a sampling site of the module body portion. - View Dependent Claims (18, 19, 20)
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21. A sampling module comprising:
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a module body portion; a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within a lancet channel of the module body portion; and a sample reservoir which has an analytical region with sample sensors disposed within the analytical region the sample reservoir being in fluid communication with a sampling site of the module body portion.
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22. A tissue penetrating device, comprising:
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a housing; at least one penetrating member; a penetrating member driver coupled to the at least one penetrating member; a tissue stabilizer member coupled to the housing; and a human interface providing at least one output. - View Dependent Claims (23)
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24. A body fluid sampling system for use on a tissue site, the system comprising:
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a drive force generator; a penetrating member operatively coupled to said force generator, said force generator moving said member along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site; wherein said penetrating member is an elongate member without a molded attachment. a coupler on said force generator configured to engage at least a portion of said elongate portion of the penetrating member and drive said member along a path into a tissue site and withdrawn from a tissue site; a tissue stabilizing member associated with said housing and positioned to at least partially surround an impact location of the penetrating member on the tissue site.
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25. A method for sampling body fluids from a patient, the method comprising:
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using a human interface on a lancet driver to communicate information to the patient; actuating said lancet driver to drive a lancet into the patient in a manner sufficient to obtain said body fluid sample. - View Dependent Claims (26, 27, 28)
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Specification