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`
`PCT/US2006/000893
`
`23.
`
`· The platform as claimed in Claim 18, wherein said means for variably controlling
`
`a resistance comprises a passive braking motor.
`
`24.
`
`The platform as claimed in Claim 23, wherein said passive braking motor
`
`5
`
`comprises:
`
`a motor braking circuit interconnected to the passive braking motor, including:
`
`a first circuit stage, including:
`
`a switching mechanism, wherein an activation voltage for the first
`
`circuit stage is defined;
`
`10
`
`a load resistor, wherein when the passive braking motor produces an
`
`amount of power sufficient to produce a voltage at the switching mechanism that is equal to
`
`or greater than the activation voltage and above a current is allowed to pass through the load
`
`resistor.
`
`15
`
`25.
`
`A method of using a personal support platform, the method comprising:
`
`providing a drag wheel interconnected to the platform, the drag wheel for
`
`contacting a surface under the platform;
`
`positioning the drag wheel to contact the surface under the platform; and
`
`applying a braking to the platform through the drag wheel by applying at least a
`
`20
`
`first braking resistance to the drag wheel for at least a first velocity range of the drag
`
`wheel.
`
`26.
`
`The method as claimed in Claim 25, further comprising providing at least a
`
`second braking resistance to the drag wheel for at least a second velocity range of
`
`25
`
`the drag wheel.
`
`54
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`27.
`
`The method as claimed in Claim 26, wherein said second velocity range is
`
`automatically selected once a threshold velocity of a braking motor is reached.
`
`28.
`
`The method as claimed in Claim 25, wherein said positioning step further
`
`5
`
`comprises manipulating a transmission control device to lower the drag wheel in
`
`contact with the surface under the platfon11.
`
`29.
`
`The method as claimed in Claim 25, further comprising engaging a stopper to
`
`contact the surface underlying the platform.
`
`10
`
`30.
`
`The method as claimed in Claim 25, further comprising releasably connecting the
`
`platfonn to another structure using at least one grasping mechanism
`
`interconnected to the platform.
`
`15
`
`31.
`
`The method as claimed in Claim 30, further comprising impinging at least a
`
`portion of the other structure against a portion of said grasping mechanism.
`
`32.
`
`A passive variable braking system, comprising:
`
`a motor;
`
`20
`
`a motor braking circuit interconnected to the motor, including:
`
`a first circuit stage, including:
`
`a switching mechanism, wherein an activation voltage for the first
`
`circuit stage is defined;
`
`a load resistor, wherein when the motor produces an amount of
`
`25
`
`power sufficient to produce a voltage at the switching mechanism that is equal to or
`
`55
`
`1082 of 2153
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`
`greater than the activation voltage and above a current is allowed to pass through the load
`
`resistor.
`
`33.
`
`The system of Claim 32, wherein the motor braking circuit further comprises:
`
`5
`
`a second circuit stage in parallel with the first circuit stage, the second circuit stage
`
`including:
`
`a switching mechanism, wherein an activation voltage for the second stage
`
`is defined;
`
`a load resistor,
`
`10
`
`15
`
`greater
`
`through
`
`wherein when the motor produces an amount of power sufficient
`
`to produce a voltage at the switching mechanism that is equal to or
`
`than the activation voltage and above a current is allowed to pass
`
`the load resistor,
`
`wherein the activation voltage for the second stage is greater than
`
`the activation voltage for the first stage, and
`
`wherein when the activation voltage for the second stage is met or
`
`exceeded a current continues to be allowed to pass through the load
`
`resistor of the first circuit stage.
`
`20
`
`34.
`
`The system of Claim 33, further comprising:
`
`a switch,
`
`wherein the first and second circuit stages comprise a number of load
`
`resistors,
`
`wherein the switch is operable to select one of each of the load resistors
`
`25
`
`included in the first and second circuit stages to provide a selected resistance at the motor.
`
`56
`
`1083 of 2153
`
`

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`
`35.
`
`The system of Claim 32, where the motor braking circuit further comprises:
`
`a second circuit stage in parallel with the first circuit stage, the second circuit stage,
`
`including:
`
`a switching mechanism, wherein an activation voltage for the second stage
`
`5
`
`is defined;
`
`a load resistor,
`
`wherein when the motor produces an amount of power
`
`sufficient to produce a voltage at the switching mechanism that is equal to
`
`or greater than the activation voltage and above a current is allowed
`
`10
`
`to
`
`pass through the load resistor, and
`
`wherein the activation voltage for the second stage has a polarity
`
`that is opposite the activation voltage for the first stage.
`
`36.
`
`The system of Claim 32, wherein the switching mechanism comprises a zener
`
`15
`
`diode.
`
`37.
`
`The system of Claim 32, wherein the switching mechanism comprises a pair of
`
`voltage dividing resistors and a transistor, wherein a voltage divided by the pair
`
`of resistors is provided to a gate of the transistor.
`
`20
`
`38.
`
`The system of Claim 32, wherein the switching mechanism comprises a resistor
`
`interconnected to a Silicon Controlled Rectifier.
`
`39.
`
`The system of Claim 32, further comprising:
`
`25
`
`a drag wheel interconnected to the motor, wherein the motor is driven by the drive
`
`wheel.
`
`57
`
`1084 of 2153
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`40.
`
`The system of Claim 39, wherein the drive wheel is interconnected to the motor
`
`by a gearbox.
`
`5
`
`41.
`
`The system of Claim 33, wherein the switching mechanisms of the first and
`
`second circuit stages each comprise a zener diode, and wherein the first and
`
`second stages each additionally include a blocking diode.
`
`58
`
`1085 of 2153
`
`

`

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`
`PCT /US2006/000893
`
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`
`1086 of 2153
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`WO 2006/074473
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`
`PCT/US2006/000893
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`
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`WO 2006/074473
`
`PCT /US2006/000893
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`WO 2006/074473
`
`PCT /US2006/000893
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`1089 of 2153
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`WO 2006/074473
`
`PCT /US2006/000893
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`WO 2006/07 44 73
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`PCT /US2006/000893
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`WO 2006/074473
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`PCT /US2006/000893
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`
`1112 of 2153
`
`

`

`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`I lllll llllllll II llllll lllll lllll lllll llll I II Ill lllll lllll lllll 111111111111111111111111111111111
`
`( 43) International Publication Date
`6 March 2008 (06.03.2008)
`
`(51) International Patent Classification:
`A61M 5120 (2006.01)
`
`PCT
`
`(10) International Publication Number
`WO 2008/028165 A2
`(74) Agents: BENSON, Stephen, P. et al.; Welsh & Katz, Ltd.,
`120 South Riverside Plaza, Floor 22, Chicago, IL 60606-
`3912 (US).
`
`(21) International Application Number:
`PCT/US2007 /077460
`
`(22) International Filing Date: 31 August 2007 (31.08.2007)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`60/824,222
`
`31 August 2006 (31.08.2006) US
`
`(71) Applicant (for all designated States except US):
`CATHOLIC HEALTHCARE WEST(D/B/A ST.
`JOSEPH'S HOSPITAL AND MEDICAL CENTER)
`[US/US]; 3200 North Central Avenue, 10th, Phoenix, AZ
`85012 (US).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): DESHMUKH,
`Vivek, R. [US/US]; 2150 Pennsylvania Avenue, N.W.,
`Washington, DC 20037
`(US). CRAWFORD, Neil
`[US/US]; 350 West Thomas Road, Phoenix, AZ 85013
`(US).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH,
`CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG,
`ES, Fl, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL,
`IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK,
`LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW,
`MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL,
`PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY,
`TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA,
`ZM, ZW.
`
`(84) Designated States (unless othe1wise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, Fl,
`FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, MT, NL, PL,
`PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM,
`GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`
`Published:
`without international search report and to be republished
`upon receipt of that report
`
`(54) Title: AUTOMATED BLOOD DRAW SYSTEM
`
`Pressurized
`Saline
`(Heparinized)
`
`76
`
`Blood
`Pressure
`Monitor
`
`-iiiiiiiiiiiiiii
`
`iiiiiiiiiiiiiii
`
`iiiiiiiiiiiiiii -iiiiiiiiiiiiiii ----
`----iiiiiiiiiiiiiii
`iiiiiiiiiiiiiii ----
`
`?"""I
`QO
`M
`0
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`
`0
`0
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`--QO g (57) Abstract: An automated blood draw system operates in conjunction with an arterial or venous line. The aspiration mechanism
`
`M allows the rate of aspiration, volume of aspirate, and the time interval of aspiration to be predetermined. Blood can be collected
`0 in sequential collection vials for subsequent analysis of a given laboratory parameter, or delivered directly to integrated analysis
`
`devices. While a predetermined volume of aspirate can be wasted, excessive aspiration is prevented by monitoring waste obtained
`~ in a colledion receptacle. A flush system maintains the patency of the line without contamination of the specimen.
`
`1113 of 2153
`
`

`

`WO 2008/028165
`
`PCT /US2007 /077 460
`
`TITLE OF THE INVENTION
`
`AUTOMATED BLOOD DRAW SYSTEM
`
`FIELD OF THE INVENTION
`
`(0001)
`
`The invention relates to devices used to secure blood samples from humans
`
`and animals for purposes of medical studies and patient care. More
`
`specifically the invention relates to automated blood drawing devices.
`
`BACKGROUND OF THE INVENTION
`
`(0002)
`
`Periodic sampling of blood is important in a number of applications including
`
`applications related to medical studies and in monitoring patient progress and/
`
`or overall health. For example, it is often desirable to determine blood
`
`glucose levels over time after a meal in order to detem1ine the efficacy of the
`
`body in metabolizing glucose, especially as it relates to diabetic care.
`
`Traditionally, blood drawn for the purposes of monitoring blood parameters
`
`has been done manually.
`
`In a hospital or other research or medical
`
`environment, a phlebotomist will manually draw blood by accessing a port on
`
`an existing venous or arterial line by inserting a needle in a shunt and drawing
`
`blood out using a syringe. In order to best assess the patient's health and/or to
`
`make the best study of blood and the body systems being analyzed, blood is
`
`often drawn at particular intervals known as time-points. When the blood
`
`sampling time-points are spread out, it is possible to manually draw blood,
`
`1114 of 2153
`
`

`

`WO 2008/028165
`
`PCT /US2007 /077 460
`
`with a needle and syringe, without the need to pre-establish a blood line with
`
`an access port.
`
`(0003)
`
`In many applications, the time-points needed for periodic blood sampling is
`
`large and blood is sampled frequently.
`
`In these cases, manual sampling of
`
`blood has numerous disadvantages. Often, manual sampling relies on a
`
`healthcare professional that has additional responsibilities besides sampling
`
`blood from the patient.
`
`In these cases the risk that a time-point sampling
`
`could be delayed or missed entirely is high. However, to avoid missing a
`
`time-point sample one or more full time attendants are required. This is an
`
`expensive and labor intensive requirement.
`
`(0004)
`
`Even where the blood drawing technician timely arrives to sample blood, the
`
`temporal resolution of the time-point sampling is low. It is difficult for the
`
`technician to accurately determine the exact time that the blood was drawn,
`
`and in some cases the difference between the actual time-point sampling
`
`versus the desired time-point sampling may vary, for example, by tens of
`
`seconds to several minutes. With frequent sampling, such variance is
`
`counterproductive to the tests being performed.
`
`(0005)
`
`It is therefore an object of the present invention to provide an improved
`
`system for obtaining periodic time-point sampling of blood so as to, for
`
`example, ease the labor requirements of time-point blood sampling and to
`
`significantly reduce or eliminate inherent error in manual blood sampling
`
`performed according to the current methodology.
`
`2
`
`1115 of 2153
`
`

`

`WO 2008/028165
`
`PCT /US2007 /077 460
`
`SUMMARY OF THE INVENTION
`
`(0006)
`
`It is an object of the present invention to provide for an improved automated
`
`blood drawing apparatus. The improved automated blood drawing system
`
`allows for accurate and efficient sequential sampling of blood with reduced
`
`risk of contamination and ease of use.
`
`(0007)
`
`For the purposes of obtaining periodic blood sampling from a patient or
`
`research participant, in a first embodiment of the device of the present
`
`invention, a 3-way valve assembly is incorporated into a venous or arterial
`
`line in close proximity to a patient. The valve assembly is comprised of a
`
`first, second and third port. The venous or arterial line is connected to a first
`
`port of the valve assembly and an isotonic saline source is connected via a
`
`fluid line to the second port of the valve assembly. The first and second ports
`
`are thereby configured as fluid entry points into the valve assembly. The third
`
`port is attached to aspiration tubing for the purpose of draining the valve
`
`assembly into, either a sample collecting receptacle or into a waste receptacle,
`
`as will be described below. Arterial or venous blood or saline solution may
`
`pass through the valve assembly and enter a fluid line connected to the third
`
`port of the valve assembly. The valve assembly is configured to alternatively
`
`inhibit the flow of blood or the saline solution depending on the valve
`
`assembly setting.
`
`(0008)
`
`In one embodiment of the invention, the valve assembly is a commercially
`
`available 3-way stopcock assembly. The 3-way stopcock assembly may be
`
`3
`
`1116 of 2153
`
`

`

`WO 2008/028165
`
`PCT /US2007 /077 460
`
`manually controlled; however, automated control is preferred and provided for
`
`in embodiments of the present invention. Automated control may be
`
`accomplished, in one embodiment, by a rotary servo motor clamped to a
`
`stopcock assembly comprised of the 3-way stopcock and a durable holding
`
`device or base. The 3-way stopcock is used to control the flow of fluids from
`
`a set of tubes attached, respectively, to the source of blood and to a source of
`
`flushing solution.
`
`(0009)
`
`As will be understood by those having ordinary skill in the art, the automated
`
`or manual control of the valve assembly as configured in one embodiment will
`
`allow for the valve be used to open and/or close, alternatively, two separate
`
`positions (blood and flushing solution) in the system. Therefore, when the
`
`valve assembly is connected to tubing as described above and the stopcock is
`
`turned to a first position, either manually or through automation, saline
`
`solution will be drawn from its source, through the stopcock from the fluid
`
`line attached at the second port and into aspiration tubing attached at the third
`
`port of the valve assembly. Alternatively, when the stopcock is in a second
`
`position, saline solution is prohibited from flowing through the valve body
`
`and into the aspiration tubing. Instead, blood will flow from the arterial or
`
`venous line, though the valve body and into the aspiration tubing. It will be
`
`understood by persons having ordinary skill in the art that a stop position can
`
`be included in the valve assembly or that a separate valve can be installed
`
`4
`
`1117 of 2153
`
`

`

`WO 2008/028165
`
`PCT /US2007 /077 460
`
`upstream of the main valve assembly in the saline solution line such that the
`
`flow of fluid can be stopped completely as needed.
`
`(00010)
`
`Fluid flow through the plurality of fluid lines is controlled by an infusion
`
`pump. Activation of the infusion pump results in fluid flow from the venous
`
`or arterial line or from the saline source depending on the setting of the valve
`
`assembly. In a preferred embodiment of the invention, the infusion pump is
`
`pre-programmed for a specific fluid flow rate, to allow for a specific volume
`
`of fluid and/or to operate for a specific period of time.
`
`In this way, the
`
`healthcare professional can predetermine the volume of blood to be drawn
`
`from a patient at a specific blood sampling time-point.
`
`(00011) The infusion pump used in such embodiments acts in coordination with an
`
`automated control system for the valve assembly. Coordination of the
`
`infusion pump and automated valve assembly may be accomplished via serial
`
`port programming of the infusion pump and valve assembly control. For
`
`example, PC based systems used to control anesthetic drug infusions have
`
`been adapted for use with a variety of commercially available medical
`
`infusion pumps. Alternatively, the infusion pump may be independently
`
`operated by a relay switch controlling power to the infusion pump while the
`
`valve assembly is manually or independently automatically operated.
`
`(00012)
`
`For example, when a sampling of blood is desired, the valve assembly is
`
`automatically set to allow blood from the venous or arterial line to flow
`
`through the valve assembly and into the aspiration tubing. When the desired
`
`5
`
`1118 of 2153
`
`

`

`WO 2008/028165
`
`PCT /US2007 /077 460
`
`amount of blood has been obtained, the valve assembly may be automatically
`
`programmed to inhibit flow from the arterial or venous line and to allow fluid
`
`flow from the saline source into the aspiration tubing. Flushing of the
`
`aspiration tubing following blood sampling is desired. Once flushing of the
`
`aspiration tubing has been obtained, the infusion pump is programmed to shut
`
`off until the next scheduled blood sampling time-point.
`
`(00013) Blood flowing into the aspiration tubing is collected for simultaneous or
`
`subsequent analysis of a given blood parameter or for blood drug
`
`concentration. Blood may be collected upon exit from the aspiration tubing in
`
`a blood collecting vial. Placement of the blood vial in the stream of the blood
`
`exiting
`
`the aspiration
`
`tubing
`
`is accomplished automatically via a
`
`commercially available
`
`fraction collector suitable
`
`for
`
`the purpose.
`
`Alternatively, blood may be collected in a bolus in heat sealable tubing. Date
`
`and time stamping of the bolus identifies the samples for subsequent analysis.
`
`(00014) Appropriate safety features are preferably incorporated into the blood drawing
`
`apparatus.
`
`In those applications where blood exiting the aspiration tubing
`
`flows into an open vial, introduction of air into the arterial or venous line is of
`
`particular concern. To avoid the unwanted introduction of air, prior flushing
`
`of the aspiration tubing prior to a given sampling may be accomplished.
`
`Alternatively, an infusion pump may be incorporated with an internal sensor
`
`able to detect air entering the fluid lines. Other safety features, such as
`
`6
`
`1119 of 2153
`
`

`

`WO 2008/028165
`
`PCT /US2007 /077 460
`
`pressurized expulsion of blood from the aspiration tubing may be used
`
`independently or in coordination with other safety features of the system.
`
`(00015) Malfunction and erroneous programming of the automated blood drawing
`
`apparatus is of particular concern as it may result in excessive pumping of
`
`venous or arterial blood from the a patient, or infusion of excessive saline into
`
`the venous or arterial line attached to the patient. A float sensor may be
`
`incorporated into an overflow tank so as to monitor excessive wasting of
`
`blood or saline flowing from the aspiration tubing. An alann may be activated
`
`when the waste tank contents reach a predetermined level and power from the
`
`infusion pump may be automatically cut. Alternatively, an optical sensor may
`
`be incorporated at a desired location in at least one of the plurality of fluid
`
`lines so as to detect and calculate the volume of blood flowing through the
`
`tubing at a given sampling time. Once the volume exceeds a predetermined
`
`limit the user is notified or the system may be programmed to automatically
`
`shut off Other sensing devices may be used independently or in addition to
`
`the safety features already described, such as mechanical, ultrasonic, or other
`
`acceptable flow sensing technologies.
`
`(00016) An automated blood drawing apparatus consistent with the present invention
`
`may be adapted for use in systems currently established for manual blood
`
`drawing and monitoring. For example, manual systems have been developed
`
`for simultaneous monitoring of blood pressure in between blood sampling.
`
`7
`
`1120 of 2153
`
`

`

`WO 2008/028165
`
`PCT /US2007 /077 460
`
`These systems may be successfully adapted utilizing the automated features
`
`described herein.
`
`(00017) Other modifications and improvements of currently available and described
`
`devices will become apparent to those skilled in the art from the detailed
`
`description of the invention below. The current invention is not limited by the
`
`specific and preferred embodiments described herein.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`(00018)
`
`Further objects of the invention, together with additional features contributing
`
`thereto and advantages occurring therefrom, will be apparent from the
`
`following description of the invention when read in conjunction with the
`
`accompanying drawings; wherein:
`
`(00019)
`
`FIG. 1 depicts a schematic representation of a single time-point sampling of
`
`blood by an automated blood drawing apparatus according to a specific
`
`embodiment of the present invention;
`
`(00020)
`
`FIG. 2 depicts a schematic representation of the blood collection vials on a
`
`carousel-type device and a waste collector all used in association with a
`
`specific embodiment of the present invention;
`
`(00021)
`
`FIG. 3 depicts a specific embodiment of the automated blood draw device
`
`incorporated into an arterial line pre-established to monitor blood pressure;
`
`(00022)
`
`FIG. 4 depicts a specific embodiment of the automated blood draw device
`
`utilizing optical sensors and a timing element to improve efficiency of the
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`device;
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`WO 2008/028165
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`PCT /US2007 /077 460
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`(00023)
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`FIG. 5 depicts a specific embodiment of the automated blood draw device
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`wherein coordination of apparatus components is accomplished via a single
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`computer;
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`(00024)
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`FIG. 6 depicts a specific embodiment of the automated blood draw device
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`wherein sampled blood is collected in a bolus of pliable material;
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`(00025)
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`FIG. 7 depicts another specific embodiment of the automated blood draw
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`device wherein sampled blood is collected in a bolus of pliable material.
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`DETAILED DESCRIPTION OF THE INVENTION
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`(00026) While the present invention is susceptible of embodiment in various forms,
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`there is shown in the drawings and will hereinafter be described a presently
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`preferred embodiment with the understanding that the present disclosure is to
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`be considered an exemplification of the invention and is not intended to limit
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`the invention to the specific embodiments illustrated.
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`It should be f