Blood cell analyzer with tube holder and cap piercer

A vial cap holder and cap piercer for holding vials of varying sizes sealed with pierceable caps, said holder comprising: a frame, a holder adjustably mounted to said frame, a plate mounted on said frame below said holder, the plate having an aperture, a cup mounted on top of said plate for receiving a pierceable cap of said vial, a retractable needle for piercing the pierceable cap of the vial and to communicate with the contents of the vial, a driver for extending and retracting said needle, and a tongue pivotally mounted to the holder, the tongue having a beveled surface for receiving the vial.

FIELD OF THE INVENTION 
The invention relates to a diagnostic medical device, and in particular to 
a blood cell analyzer which by manual or automatic operation withdraws and 
analyzes a minimal amount of blood that is stored in open or sealed vials 
with pierceable caps. 
BACKGROUND OF THE INVENTION 
Blood sample analysis systems are known in which the operator must position 
and hold in place tubes or vials of the samples to be analyzed. The 
systems include needles which pierce a closure on a sample tube to provide 
communication between blood in the sample tube and the system. Such prior 
art systems expose operators to the risk of contamination and infection 
from blood samples, as well as the risk of being cut by broken glass or 
other shattered materials. In addition, the prior art systems can only 
accept a limited number of sizes of tubes or vials. 
It is desired to have a safer, more flexible means for positioning and 
holding blood sample tubes and vials during the cap piercing operation. 
Specifically, it is desired to have a holding and piercing apparatus which 
is "hands off" during the piercing operation, so as to prevent exposure of 
the operator to contamination from the blood in the vial being penetrated. 
It is also desired to improve the safety of such an apparatus by 
incorporating a safety interlock system. It is also desired to make it 
easier to insert and remove tubes or vials from the holder. It also is 
desired to have more flexibility to analyze samples from many sizes of 
vials or tubes (e.g., from 10.25.times.64 mm to 16.times.100 mm). 
SUMMARY OF THE INVENTION 
The present invention is a blood cell analyzer which by manual or automatic 
operation withdraws and analyzes a minimal amount of blood that is stored 
in open or sealed vials. The analyzer includes a manually operated self 
cleaning sampling device for open vials and an automated self cleaning 
sampling device for sealed vials fitted with a pierceable cap. The 
analyzer further includes a red blood cell counter, white blood cell 
counter, hemoglobin detector, valving system, and electronic controller. 
The blood cell analyzer further includes features for precisely measuring 
and mixing whole blood or prediluted blood with diluent as needed in order 
to analyze the blood sample 
The present invention includes an apparatus for holding vials of varying 
sizes sealed with pierceable caps and for piercing the caps of the vials. 
The apparatus comprises a frame, holder, plate, cup, needle, driver, and 
an interlocking safety switch. 
The frame has upper and lower ends. The holder is adjustably mounted on the 
upper end of the frame and is adapted to receive and hold the outer 
surface of a vial opposite the pierceable cap which seals the vial. The 
plate, which has an aperture in it, is mounted on the frame below the 
holder. 
A cup is mounted on the top of the plate. The bottom of the cup has an 
aperture aligned with the aperture in the plate. The cup is adapted to 
receive the pierceable cap which seals the vial. 
The needle is adapted to pierce the pierceable cap of the vial and to 
communicate with the contents of the vial. The needle is extendable and 
retractable through the apertures in the plate and the cup. 
A driver, such as an electric motor, which extends and retracts the needle, 
is interlocked with the holder by a safety switch. The driver cannot 
extend the needle through the aperture in the cup whenever a vial is not 
held by the holder. 
The apparatus may also include a needle cartridge assembly below the plate. 
The needle cartridge assembly has a lower end, a body, and an upper end, 
the top of which has an aperture aligned with the aperture in the plate. 
The body of the needle cartridge assembly contains the needle and a 
biasing means for engaging the needle and biasing the needle away from the 
pierceable cap of the vial. The biasing means may be a compression spring, 
such as a coil spring. 
The apparatus may also include a rinse system for cleaning the needle. The 
needle cartridge assembly is connected to a rinse passage for selectively 
communicating a rinse fluid to the needle. The needle may be contained in 
a chamber within the needle cartridge assembly. The chamber is connected 
to the rinse passage, through which the rinse fluid is injected in one 
direction into the chamber, and from which the rinse fluid is withdrawn in 
another direction.

DETAILED DESCRIPTION OF THE INVENTION 
Referring to the drawings, where like elements are identified by like 
numerals, there is shown in FIG. 1 a blood cell analyzer 10 having a vial 
holder and cap piercer device 11 according to a preferred embodiment of 
the present invention. 
FIG. 2 shows a preferred embodiment of the variable size vial holder and 
cap piercer 11. This apparatus comprises a frame 12, an adjustable holder 
14, a top plate 16, a cup 18, an extendable and retractable needle 20, and 
a driver 22 for extending and retracting the needle 20. A multi-lobe cam 
22a with associated position switches 24 is used to detect needle 
position. In addition, a safety switch 24a is used for interlocking the 
driver with the holder 14 so that the driver 22 cannot extend the needle 
20 when a vial 23 is not fully engaged in and held by the holder 14. 
In one aspect of the invention, an important feature is provided where the 
closed end of the vial 23 opposite the capped end trips the safety switch 
24a, and that the tongue 34 alone can not enable the needle 20 to extend. 
The frame 12 in the preferred embodiment includes two ways 26, which are 
upright members mounted on a base 28. The ways 26 are connected at the top 
plate 16 by a block 30. The holder 14 is adjustably mounted on the upper 
end of the frame 12. The cup 18 and the holder 14 is designed to receive 
and hold a vial 23, also referred to as a tube, such as those shown in 
FIG. 3. The tubes shown in FIG. 3 range in size from 10.5.times.64 mm to 
16.times.100 mm. The tubes are sealed with caps 25 which are typically are 
made of a pierceable material, such as rubber or plastic. The holder 14 is 
designed to receive and hold the outer surface of a vial or tube 23 
opposite the pierceable cap 25 which seals the vial or tube when the cap 
25 is seated in the cup 18. 
In the preferred embodiment, the holder 14 is an over center spring loaded 
mechanism of the configuration shown in FIG. 4. The holder 14 includes a 
U-shaped clamp 32 adjustably mounted to the frame 12 and an oblong-shaped 
tongue 34 mounted between two arms 33 of the clamp 32. The tongue 34 is 
retained in the clamp 32 by a pin 36 which extends across the width of the 
clamp 32. The tongue 34 has a beveled surface 35 and pivots about the axis 
of the pin 36. A spring 38 on one side of the holder 14 biases the tongue 
34 in either the closed or open position as shown in FIG. 2 and FIG. 4. 
The capped end of the vial 23 is inserted into the cup 18 as the vial 23 
is pivoted into contact with the tongue 34. The vial 23 is held into 
position as the tongue 34 pivots into its open and closed position as 
shown in FIGS. 5A and 5B. The vial 23 is removed from the holder 14 by 
reversing this process. 
As shown in FIG. 5A, the underside of the tongue 34 has a recess 31, also 
referred to as an indentation, for receiving and holding the outer surface 
of a vial 23 opposite the pierceable cap 25 which seals the vial 23. When 
the surface of a vial contacts the beveled surface 35 of the tongue 34, 
the tongue 34 rotates or flips into the open position as shown in FIG. 5A. 
Further movement of the vial 23 into the holder causes contact to be made 
with the recessed 31 portion of the tongue 34. As the vial 23 is pivoted 
further into the holder 11 the tongue 34 in turn moves into the closed 
position as shown in FIG. 5B. 
In the preferred embodiment, an adjustable handle 40 is mounted on one arm 
of the U-shaped clamp 32 opposite the spring 38. The adjustable handle 40 
is used to reposition the holder 14, which can be moved higher or lower on 
the frame 12 to adjust for different sizes of tubes or vials. In addition, 
the adjustable handle 40 may be spring loaded. When the holder 14 is moved 
to the desired position, it is locked in place. In the preferred 
embodiment, the adjustable handle 40 lifts and adjusts to 18 detent 
positions in 360.degree., so that the angle can be positioned for operator 
convenience. 
Referring to FIGS. 4 and 5, a plate 16 is mounted on the frame 12 and below 
the holder 14. In the preferred embodiment, the plate 16 has a keyed 
opening 42 with bayonet ramps 43 which are shown in FIG. 6. The keyed 
opening 42 in plate 16 is for receiving the cup 18 which is shown in 
detail in FIGS. 7A and 7B. The opening 42 engages the cup's 18 locking 
device 44 which is typically located at the bottom of cup 18. The locking 
device 44 is inserted in the keyed opening 42 and rotated so that the 
ramped edges 45 of the locking device 44 lock with the bayonet ramps 43 of 
the keyed opening 42 of plate 16. 
Rotation of the cup 18 in the opposite direction unlocks the locking device 
44 allowing removal of the cup 18. Different size cups 18 may be mounted 
on the plate 16 for receiving the pierceable caps 25 on vials 23 like 
those shown in FIG. 3. It has been found that two different cup sizes are 
adequate to handle the range of tube sizes shown in FIG. 3. In one aspect, 
a cup 18 may be used to accept standard size tubes under a 3 milliliter 
volume, and another cup may be used to accept standard size tubes that are 
3 milliliter in volume or greater. The cup 18 has a tapered shape which 
helps guide a tube or vial into position when placed in the holder 14. In 
the preferred embodiment, the cup 18 is made of a clear glass-smooth 
injection molded polycarbonate or acrylic. As shown in FIG. 7B, the bottom 
of the cup 18 has a small aperture aligned with the hole in plate 16 that 
allows the needle 20 to pierce the cap 25 of a vial. 
In the invention includes a needle cartridge assembly 48 as shown in FIG. 
8A. The needle cartridge assembly 48 includes a needle 20, and a needle 
cartridge body 53 with a stepped nosepiece 47 and a needle cartridge 
assembly 48. The needle 20 is attached to a hub assembly 46 that moves 
within the needle cartridge assembly 48. The needle 20 is extendable and 
retractable through apertures 41, 42 which are located in the top plate 16 
and the cup 18 respectively. Referring to FIG. 9A, the needle 20 may be 
extended to pierce the cap 25 of the vial 23 that is held by the holder 
14. The needle 20 is extended so that the needle 20 may communicate with 
the contents of the vial 23. 
As shown in FIGS. 8A and 9A, the needle hub assembly 46 is mounted within a 
needle cartridge assembly 48 which is positioned below plate 16. The 
needle cartridge assembly 48 has a lower end 51, a body 53, and an upper 
end 47, the top of which has an aperture 49 aligned with the aperture 42 
in plate 16. The body 53 of the needle cartridge assembly 48 contains the 
needle 20 and a biasing means 50 for engaging the needle 20. The biasing 
means 50 applies a bias to the needle 20 retracting it away from the 
pierceable cap 25 of the vial 23. In addition, needle cartridge assembly 
48 can be removable from the holder 14. 
As a safety feature, the biasing means 50 will retract the needle into the 
needle cartridge assembly 48 whenever the cartridge assembly 48 is removed 
from the holder 14. In one aspect of the invention, the biasing means 50 
may be a coil compression spring. 
In one aspect of the invention as shown in FIG. 10, the needle 20 is 
positioned concentrically with respect to the needle cartridge assembly 
48, but eccentrically with respect to the center longitudinal axis of the 
vial 23 and its cap 25. As an example, in FIG. 9B the nosepiece 47 is 
shown to be made eccentric with needle cartridge assembly 48. This design 
allows the needle 20 to extend and retract eccentrically with respect to 
the center axis of the cap 25. This feature prevents the pierceable caps 
25 of the vials 23 to be pierced in the same location, typically the 
center of the vial's cap 25 when multiple samples are taken from the same 
vial. After the cap 23 has been pierced and a sample drawn the needle 20 
is retracted. 
In order to extract a precise amount of sample a circuit is formed by the 
sample which is conductive, the needle 20 which is conductive, and a 
second electrode (not shown) located at a fixed distance from the needle 
in and along a confined path formed by the sample as it is drawn from the 
vial 23. The sample may be drawn through a non-conductive tube made of 
plastic or rubber. As the sample is drawn from the vial 23 through the 
needle 20 the sample comes in contact with the second electrode to form a 
closed circuit between the conductive needle and-the other second 
electrode. The closed conductive path is used to indicate that a precise 
amount of sample has been drawn. 
In one example, a current can be applied to the needle through pin 56 and 
carried by the fluid to the electrode down stream. When the current 
reaches the electrode it can be used to indicate that a sufficient amount 
of fluid has been drawn and/or that the needle 20 should be withdrawn. As 
the needle 20 is withdrawn its outer surface is cleaned by a squeegee 
effect produced by the material of pierceable cap 23 which is typically 
made of rubber or plastic. 
Referring to FIGS. 8B and 9B, a rinse system is used to clean the inside of 
the needle 20. In the preferred embodiment, the needle cartridge assembly 
48 is connected to a rinse passage 52 for selectively communicating a 
rinse fluid to the needle 20. The needle 20 may be contained in a chamber 
within the needle cartridge assembly 48. The chamber is connected to the 
rinse passage 52 through which the rinse fluid is injected in one 
direction into the chamber, and from which the rinse fluid is withdrawn in 
another direction. A first pump (not shown) is used to inject the rinse 
fluid through the rinse passage 52. A second (not shown) pump is used to 
withdraw the rinse fluid. 
Referring to FIG. 4, movement of the needle 20 is controlled by a driver 22 
which causes the needle 20 to extend and retract. In a preferred 
embodiment the driver 22 includes an electric motor 21. The motor 21 has a 
shaft that is connected to a scotch yoke mechanism 54, which translates 
rotary motion to linear motion. Needle 20 rides on a pin 56 connected to 
the scotch yoke mechanism 54 causing the needle 20 to move up or down 
during operation. Movement of the needle 20 is controlled by electric 
circuitry illustrated in FIG. 2A. Switches 24 are used to control the 
piercing and retracting strokes of the needle 20. 
For example, to indicate needle position, one switch is open when the 
needle 20 is fully retracted, while another switch is open when the needle 
20 is fully extended. A safety switch 24a interlocks the driver 22 with 
holder 14. When the tongue 34 of the holder 14 is in the open position, 
safety switch 24a is open, and needle 20 cannot be extended through the 
aperture in cup 18. When a vial or tube is placed in holder 14 and the 
tongue 34 moves to the closed position, switch 24a closes, allowing driver 
22 to extend the needle 20 to pierce the pierceable cap of the vial. 
Prior to running samples, the operator should adjust the height of the 
holder 14 to fit the size of the vials to be tested. The operator loosens 
the clamp handle 40, allowing the holder 14 to slide on the ways 26 and 
moves the holder 14 upward or downward. A vial is then placed in the cup 
18 (cap end down). The opposite end of the vial is positioned in the 
holder 14 until the interlock switch 24a is tripped. The spring applying a 
bias off the center axis of the tongue 34 keeps it in either an open or 
closed position in the holder 14. 
After inserting the cap end of a vial or tube in the cup 18, the operator 
pivots the opposite end of the vial or tube into the holder 14. When the 
tongue 34 is in the open position, the tube or vial first contacts the 
beveled front of the tongue 34 and kicks it open. With the tongue 34 in 
the open position the capped end of the vial 23 enters and is engaged by 
the conical-shaped pocket area of cup 18, and with a pivoting motion is 
further inserted to close the holder 14. As the closed uncapped end of the 
vial moves into the recessed portion of the tongue 34 of the holder 14, it 
trips the recessed interlock switch 24a, which enables the electric motor 
drive 22 to function. The vial seats securely and stays in position until 
the needle 20 is fully retracted. The operator may then remove the vial 
from the holder 14. If an attempt is made to remove the vial 23 from the 
holder 14 when the cap 25 is being pierced, the interlocking switch 24a 
will disable the motor drive 22 to prevent injury to the operator by 
unintended movement of the needle 20. 
The present invention may be embodied in other variant forms where the 
variation does not substantially differentiate from the essential novelty 
and uniqueness revealed in the foregoing disclosure. Reference should 
therefore be made to the appendant claims rather than the foregoing 
specification, as indicating the scope of the invention. It should be 
understood that many modifications, variations and changes may be made 
without departing from the spirit and scope of the invention as defined in 
the claims.