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MALDI MS: A Practical Guide to Instrumentation, Methods and Applications
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Among these advantages are the following:. Ability to use parts of the body, other than the finger, as a site for the extraction of blood;. Increase in speed of collection of blood samples by means of pre-treatment comprising a combination of stretching of the skin in conjunction with heat or vacuum or both heat and vacuum;.

The following examples illustrate various features of the present invention but is not intended to in any way limit the scope of the invention as set forth in the claims. In the following examples, the term "pierce" and forms thereof and the term "puncture" and forms thereof are used interchangeably. Although the expression "glucose detector" is used herein, one of ordinary skill in the art will recognize that the apparatus and methods of the present invention can also be used to perform other diagnostic tests.

This example illustrates that greater volumes of blood can be extracted and collected by applying a vacuum, pulsed or continuous, after piercing than can be extracted and collected when no vacuum is applied. No vacuum was applied prior to piercing. Four control runs without a vacuum were also carried out one puncture per person. A total of 60 punctures per person were carried out.

Accordingly, it can be seen that a total of runs were carried out. The vacuum was applied for a duration of 30 seconds after puncturing. Blood was collected into capillary tubes.

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In the control runs, the samples were extracted and collected 30 seconds after puncturing. The amount of blood collected was determined by measuring the length of blood in the tubes. The percentage of collections in which the volume of blood collected exceeded 1.

business-unlimited.com/modules/mac/sonep-download-photoshop-gratuit.php Sensation of pain was also recorded. The following pain scores were used:. With no vacuum, average volume of blood collected was 0. The pain results were as follows:. The control runs no vacuum provided much lower volumes of blood collected than did the runs where vacuum was applied.

Increased vacuum resulted in higher volumes of blood extracted. This example illustrates that application of vacuum prior to piercing as well as after piercing results in a greater volume of blood extracted than does the application of vacuum only after piercing. The four levels of vacuum used were Four punctures per person were carried out at each of the four levels of continuous vacuum. Accordingly, it can be seen that a total of 64 runs were carried out. Prior to puncturing, the vacuum was applied for a period of 30 seconds; subsequent to puncturing, the vacuum was applied for a period of 30 seconds.

The skin was under vacuum at the time the lancet was triggered. After the lancet was triggered, the lancet assembly was removed, and the vacuum was used to apply the same level of vacuum that had been used for the vacuum prior to puncturing. The pipette tip of the vacuum device was held level to the plane of the skin. Blood was then collected into capillary tubes.

A nearly linear relationship between level of vacuum and volume of blood collected was observed. The average volume of blood collected with vacuum applied prior and after piercing was approximately twice that collected with vacuum applied only after piercing without vacuum applied prior to piercing.

See the results of Example 1 for this comparison 7. This example illustrates that localized heating of the area to be pierced followed by vacuum after piercing results in a greater volume of blood being extracted than does extraction with only vacuum after piercing.

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A total of 32 runs were carried out, 16 runs where the pre-heating duration was 15 seconds and 16 runs where the pre-heating duration was 60 seconds. Vacuum was applied after each puncturing for 30 seconds at Pain was also tracked. The average volume of blood collected using a pre-heating duration of 15 seconds was more than twice the average volume of blood collected at a post-puncturing vacuum level of See the results of Example 1 for this comparison 6.

The average volume of blood collected using a pre-heating duration of 60 seconds was approximately four times the average volume of blood collected at a post-puncturing vacuum level of See the results of Example 1 for this comparison This example illustrates the effect that stretching the skin upwardly with a vacuum has on the extraction of blood. Vacuum was applied for a period of 30 seconds prior to puncturing at The first fixture was a 15 mm diameter vacuum fixture i.

The second fixture was a 15 mm diameter vacuum fixture i. The net prevented skin from being raised up into the vacuum fixture. The same vacuum fixture used prior to puncturing was applied for a period of 30 seconds after puncturing. The fixture was held level with the plane of the skin.

Four punctures were carried out per person per condition without net, with net. Accordingly, it can be seen that a total of 32 runs were carried out. The magnitude of the difference in volume of blood collected and success rates i. The pain scores were low.

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This example demonstrates that the combination of skin stretching and applied vacuum significantly increased the volume of blood extracted. Vacuum was applied for less than five seconds prior to puncturing. The forearm was punctured under a vacuum of either The vacuum applied was maintained for 30 seconds after puncturing. The diameter of the pipette tip used to apply vacuum after puncturing was varied, with diameter of 4, 6, 8, and 10 mm being used.

Four punctures per condition diameter, vacuum level were carried out per person. The volume of blood collected and success rates i. A much greater volume of skin was raised up into the larger diameter pipette tip than into the smaller diameter pipette tips. This example illustrates that a plastic multiple point lancet can be used with heat and vacuum to collect a useful amount of blood. Four punctures were carried out per condition temperature, time per person.

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Heat was applied with a heating block, which comprised an aluminum block having one face covered with a "KAPTON" film heater element controlled by an "OMEGA" DP 41 temperature controller using a T-type thermocouple and the opposite face in contact with the larger base of a frustum of a cone made of copper. The larger base of the frustum had a diameter of 0. The height of the frustum was 0.

The smaller base of the frustum had a diameter of 0. The smaller base had a cylindrical opening having a diameter of 0. The cylindrical opening had a common axis with the frustum. The cylindrical opening reduced the heating surface of the copper frustum.

Description

Vacuum The vacuum in contact with the skin was formed by a pipette tip having a diameter of 8 mm. The pipette tip was held level with the plane of the skin. Design parameters of the prototype are listed below. The definitions of these parameters were previously set forth. This configuration resulted in good lancing results when tested on human subjects.

The measured lancet speed at the end of the stroke was 2. Glucose detectors in the form of multiple-layer elements comprising the following layers, from top to bottom, were prepared:.

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The arrangement of the layers is shown schematically in FIGS. P2, filed on evendate herewith, the entirety of which is incorporated herein by reference.

However, the overcoat layer is substantially coplanar with the blood-transporting layer as shown in FIG. The multiple-layer element was placed in an apparatus similar to that shown in FIG. A vacuum of The apparatus was placed in contact with the forearm of a volunteer. The skin of the forearm was stretched and it raised up into the nosepiece, where it came near to or into contact with the covering layer of the multiple-layer element.

After the vacuum had been applied for five seconds, the lancet was fired into the skin by means of a pneumatic lancet assembly of the type illustrated in FIGS. The lancet passed through the openings in the meter-contactable layer and in the covering layer.

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The lancet was retracted and blood began to emerge from the forearm of the volunteer. The vacuum aided in the extraction of blood until the blood reached the blood-transporting layer. The blood was then transported along the blood-transporting layer until it reached the detecting layer of the multiple-layer element. When the blood reached the detecting layer of the multiple-layer element, an electrical current was generated. This current was used to determine when to release the vacuum. Eight volunteers were tested as described in the previous paragraph.

The time required for the multiple-layer element to fill after the lancing operation was recorded. The type of multiple-layer element used in this example had one opening in the meter-contactable layer, as described in Example 8 and shown in FIGS. The multiple-layer element was considered to be filled when a current of 1.

The vacuum was then released and the integrated current i. The lancing procedure and data collection were repeated four times per volunteer. The average time required to fill the multiple-layer element was The skin of the forearm was stretched and it raised up into the nosepiece, where it came near or into contact with the covering layer of the multiple-layer element.

The lancet passed through openings in the meter-contactable layer and the covering layer of the multiple-layer element. As quickly as possible, the multiple-layer element was slid approximately 2 mm in the direction away from the electrical contacts. P4, filed on evendate herewith, the entirety of which is incorporated herein by reference. Nine non-diabetic volunteers were tested as described in the previous paragraph.

Each volunteer was tested with two types of multiple-layer element. One type of multiple-layer element had two openings in the meter-contactable layer, as described in Example 9 and shown in FIG. The other type of multiple-layer element had one opening in the meter-contactable layer, as described in Example 9 and shown in FIG.