US6332871B1 — Blood and interstitial fluid sampling device

Claim 1

Independent Claim 182 words

A device for obtaining a sample of body fluid through the skin comprising: a housing member suitable for use and adapted to contain a needle for piercing the skin; a spring member in the housing for urging the needle to protrude from the end of the housing sufficient to penetrate the skin; a plunger member for retracting the needle against the spring tension and a trigger member to engage the plunger to hold the needle retracted until released by the trigger; a stop member to limit the depth of needle penetration of the skin when released by the trigger; a sample container communicating with the needle for receiving the sample from the needle; a second spring for retracting the needle from the skin and a suction cam and plunger activated upon the retraction of the needle for drawing the sample of fluid which accumulates on the surface of the skin into the sample container; and a skin stimulation member constructed for contacting and stimulating the skin by at least one of mechanical action, piezoelectric action, ultrasonic action, electrical action, and thermal action.

Claim 2

Independent Claim 182 words

A device for obtaining a sample of body fluid through the skin comprising: a housing member suitable for use and adapted to contain a needle for piercing the skin; a spring member in the housing for urging the needle to protrude from the end of the housing sufficient to penetrate the skin; a plunger member for retracting the needle against the spring tension and a trigger member to engage the plunger to hold the needle retracted until released by the trigger; a stop member to limit the depth of needle penetration of the skin when released by the trigger; a sample container communicating with the needle for receiving the sample from the needle; a second spring for retracting the needle from the skin and a suction cam and plunger activated upon the retraction of the needle for drawing the sample of fluid which accumulates on the surface of the skin into the sample container; and a skin stimulation member constructed for contacting and stimulating the skin by at least one of mechanical action, piezoelectric action, ultrasonic action, electrical action, and thermal action.

Claim 3

Dependent Claim 41 words

A device according to claim 1 comprising: an actuator to deploy the stimulation member in the down position before needle penetration of the skin for holding the skin taut; and for a stop member providing accurate depth control of needle penetration.

Claim 4

Dependent Claim 17 words

A device according to claim 1 further comprising a system for injecting a material into the skin.

Claim 5

Dependent Claim 26 words

A device according to claim 2 wherein the skin stimulation member is adapted to stimulate the skin prior to or during the piercing of the skin.

Claim 6

Independent Claim 129 words

A device for obtaining a sample of body fluid through the skin comprising: a housing member adapted to contain a needle for piercing the skin; a drive means in the housing for urging the needle to protrude from the end of the housing sufficient to penetrate the skin; a stop member to limit the depth of needle penetration into the skin by the device means; a sample container communicating with the needle for retrieving the sample from the needle; means for retracting the needle from the skin; means for drawing the sample of fluid which accumulates on the surface of the skin into the sample container; and means for stimulating the surface of the skin by at least one of mechanical action, piezoelectric action, electrical action, and thermal action.

Claim 7

Independent Claim 129 words

A device for obtaining a sample of body fluid through the skin comprising: a housing member adapted to contain a needle for piercing the skin; a drive means in the housing for urging the needle to protrude from the end of the housing sufficient to penetrate the skin; a stop member to limit the depth of needle penetration into the skin by the device means; a sample container communicating with the needle for retrieving the sample from the needle; means for retracting the needle from the skin; means for drawing the sample of fluid which accumulates on the surface of the skin into the sample container; and means for stimulating the surface of the skin by at least one of mechanical action, piezoelectric action, electrical action, and thermal action.

Claim 8

Dependent Claim 25 words

A device according to claim 5 further comprising a skin stimulation member for contacting and massaging the skin adjacent to the point of needle penetration.

Claim 9

Dependent Claim 17 words

A device according to claim 6 further comprising a system for injecting a material into the skin.

Claim 10

Independent Claim 65 words

A device for obtaining a sample of body fluid through the skin comprising: a housing member suitable for hand held use; a system for piercing the skin comprising a laser system or a fluid under pressure; a sample collection tube positioned to collect a sample of fluid emerging from the pierced skin; and an actuator for causing the member or system to pierce the skin.

Claim 11

Independent Claim 65 words

A device for obtaining a sample of body fluid through the skin comprising: a housing member suitable for hand held use; a system for piercing the skin comprising a laser system or a fluid under pressure; a sample collection tube positioned to collect a sample of fluid emerging from the pierced skin; and an actuator for causing the member or system to pierce the skin.

Claim 12

Independent Claim 71 words

A device for collecting a sample of body fluid from a wound in the skin comprising: a housing member suitable for hand-held use containing a chamber for collecting a sample of fluid emerging from the wound; and a skin stimulation member movably positioned at the end of the housing member for contacting and massaging the skin near the wound to stimulate the flow of fluid to and out of the wound.

Claim 13

Independent Claim 71 words

A device for collecting a sample of body fluid from a wound in the skin comprising: a housing member suitable for hand-held use containing a chamber for collecting a sample of fluid emerging from the wound; and a skin stimulation member movably positioned at the end of the housing member for contacting and massaging the skin near the wound to stimulate the flow of fluid to and out of the wound.

Claim 14

Dependent Claim 39 words

A device according to claim 9 wherein a stimulation member is positioned between the chamber and the housing and is adapted to telescopically extend from the housing to contact the skin and pump the body fluid to the wound.

Claim 15

Dependent Claim 51 words

A device according to claim 9 wherein the stimulation member comprises a polygon, square, circular or annular shape, a paddle or squeegee member, a system for employing a fluid under pressure to contact and stimulate the skin, or a fluid contained in a flexible membrane for contacting and stimulating the skin.

Claim 16

Dependent Claim 43 words

A needle for piercing the skin comprising a hollow tube having a center line, and a pointed spade protrusion extending substantially longitudinally from a portion of one side of the end of the tube and angled toward the center line of the tube.

Claim 17

Dependent Claim 43 words

A needle for piercing the skin comprising a hollow tube having a center line, and a pointed spade protrusion extending substantially longitudinally from a portion of one side of the end of the tube and angled toward the center line of the tube.

Claim 18

Independent Claim 80 words

A device for use in a body fluid sampling device for obtaining a sample through the skin comprising: a standoff member adapted for contacting the skin; a sample collection tube positioned in the standoff member for receiving the fluid sample; a lancet member movably positioned in the standoff member adjacent to the tube for piercing the skin; and electrodes positioned in the standoff member adapted for connection to a sensor to sense the presence of fluid within the standoff member.

Claim 19

Independent Claim 80 words

A device for use in a body fluid sampling device for obtaining a sample through the skin comprising: a standoff member adapted for contacting the skin; a sample collection tube positioned in the standoff member for receiving the fluid sample; a lancet member movably positioned in the standoff member adjacent to the tube for piercing the skin; and electrodes positioned in the standoff member adapted for connection to a sensor to sense the presence of fluid within the standoff member.

Claim 20

Dependent Claim 16 words

A device according to claim 13 further comprising: an integral test unit for testing the sample.

Claim 21

Dependent Claim 20 words

A device of claim 13 adapted to receive a test device unit which absorbs the sample from the wound site.

Claim 22

Dependent Claim 27 words

A body fluid collection device comprising a capillary tube flared on one end for contacting the skin and having a suction member positioned on the opposite end.

Claim 23

Dependent Claim 27 words

A body fluid collection device comprising a capillary tube flared on one end for contacting the skin and having a suction member positioned on the opposite end.

Claim 24

Dependent Claim 22 words

A device according to claim 16 further comprising a test strip on which the fluid sample is deposited from the capillary tube.

Claim 25

Independent Claim 55 words

A device for use in a body fluid sampling device for obtaining a sample through the skin comprising: an elongated holder member having a plurality of passageways extending longitudinally through the member; and lancet members positioned in said passageways and adapted for creating a plurality of wounds in the skin when contacted with the skin.

Claim 26

Independent Claim 55 words

A device for use in a body fluid sampling device for obtaining a sample through the skin comprising: an elongated holder member having a plurality of passageways extending longitudinally through the member; and lancet members positioned in said passageways and adapted for creating a plurality of wounds in the skin when contacted with the skin.

Claim 27

Independent Claim 50 words

A device for use in a body fluid sampling device for obtaining a sample through the skin comprising: a plate member having a plurality of sharp protrusion extending from one side of the plate member adapted for creating a plurality of wounds in the skin when contacted with the skin.

Claim 28

Independent Claim 50 words

A device for use in a body fluid sampling device for obtaining a sample through the skin comprising: a plate member having a plurality of sharp protrusion extending from one side of the plate member adapted for creating a plurality of wounds in the skin when contacted with the skin.

Claim 29

Independent Claim 35 words

A method of collecting a sample of body fluid which includes piercing the skin; mechanically stimulating the wound created by piercing the skin; collecting the sample which results from the stimulating; and dispensing the sample.

Claim 30

Independent Claim 35 words

A method of collecting a sample of body fluid which includes piercing the skin; mechanically stimulating the wound created by piercing the skin; collecting the sample which results from the stimulating; and dispensing the sample.

Claim 31

Dependent Claim 35 words

A device according to claim 1 wherein the portion of the device which pierces the skin is adapted to oscillate while inserted into the skin which oscillation is by vertical, horizontal, rotation or cyclic movement.

Claim 32

Dependent Claim 77 words

A device according to claim 8 wherein the sample container or sample collection tube comprises a material having an affinity for the sample fluid sufficiently high to collect the fluid sample from the surface of the skin but sufficiently low to allow the fluid sample to wick from the container or tube when placed in contact with a test strip or device having an affinity for the fluid sample higher than that of the container or tube.

Claim 33

Independent Claim 45 words

A method of collecting a sample of body fluid comprising: piercing the skin with a hypodermic needle; withdrawing the needle from the skin; massaging an area adjacent the wound; and collecting a sample of fluid from the surface of the skin into the hypodermic needle.

Claim 34

Independent Claim 45 words

A method of collecting a sample of body fluid comprising: piercing the skin with a hypodermic needle; withdrawing the needle from the skin; massaging an area adjacent the wound; and collecting a sample of fluid from the surface of the skin into the hypodermic needle.

Claim 35

Independent Claim 44 words

A method for collecting a sample body fluid comprising: mechanically massaging a skin area; piercing the skin area to create a wound; mechanically massaging the skin area adjacent the wound; and collecting a fluid sample from the wound or the surface of the skin.

Claim 36

Independent Claim 44 words

A method for collecting a sample body fluid comprising: mechanically massaging a skin area; piercing the skin area to create a wound; mechanically massaging the skin area adjacent the wound; and collecting a fluid sample from the wound or the surface of the skin.

Claim 37

Dependent Claim 21 words

A method according to claim 23 comprising inserting a device to pierce the skin and oscillating the device in the wound.

Claim 38

Dependent Claim 16 words

The device according to claim 16 , further comprising a bulb-shaped member at the opposite end.

Claim 39

Dependent Claim 25 words

The device according to claim 16 , wherein the tube is modified with a surfactant to increase its ability to wick up the body fluid.

Claim 40

Independent Claim 39 words

A device for obtaining a sample of body fluid through the skin comprising: a housing member containing means for lancing the skin; a stop member; and a heated stimulation member adapted to contact the skin and stimulate blood flow.

Claim 41

Independent Claim 39 words

A device for obtaining a sample of body fluid through the skin comprising: a housing member containing means for lancing the skin; a stop member; and a heated stimulation member adapted to contact the skin and stimulate blood flow.

Claim 42

Dependent Claim 22 words

The device of claim 28 , wherein the stimulation member is in the form of a polygon, circle or annular shaped ring.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2004-12-24	2005-06-25	2005-12-25	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2008-12-24	2009-06-25	2009-12-25	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2012-12-24	2013-06-25	2013-12-25	$7700.00	Window Closed / Lapsed

Blood and interstitial fluid sampling device

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