Blood collection assembly

A blood microcollection container and associated lancet-collection assembly is provided for making a puncture wound, engaging the wound and rapidly receiving blood from the wound. The assembly incorporates a lancet together with a scoop arrangement for engaging the blood source, and for directing in a rapid and efficient manner the blood to a collection chamber. A two-position cap is provided for sealing the scoop collector of the assembly prior to use, and for permanently locking to the collector after use to prevent exposure of the lancet and collector to the person handling the blood sample, or contamination of the blood sample from outside sources.

BACKGROUND AND STATEMENT OF THE INVENTION 
This invention relates to a blood collection assembly incorporating a 
microcollection container, and is related to the subject matter disclosed 
in co-pending application Ser. No. 695,121, filed Jan. 28, 1985. The 
invention is an improvement over the collection assembly described and 
claimed in U.S. Pat. No. 4,397,318, issued Aug. 9, 1983, which is hereby 
incorporated by reference in its entirety. Reference should be made to 
that patent for background information concerning the teachings of the 
invention here. The earlier patent involved the use of a scoop collector 
for connection to a blood microcollection container for engaging a 
puncture wound to obtain a blood sample from an individual for subsequent 
examination of that sample for the determination of the presence or 
absence of some disease or other problem in a patient. The scoop-type 
blood collection device provides a substantially larger engaging surface 
for engaging the puncture for collecting the blood, and a substantially 
larger transfer surface for rapidly transferring the blood from the 
collector into the microcollection container. Because of the relatively 
large engaging surface for engaging the puncture wound, the arrangement 
does not require a precise positioning of the scoop engaging surface in 
order to initiate and rapidly transfer a quantity of blood to the 
microcollection container. 
As will be appreciated by practitioners-in-the-art, recent advancements in 
analytical instrumentation have made it possible to carry out a variety of 
hematological or chemical diagnostic procedures on very small quantities 
of blood. Because of this, a patient's heel, finger or earlobe may be 
punctured and a very small quantity of blood rapidly collected into a 
microcollection container for such testing. Such arrangements obviate the 
need to withdraw venous blood from patients. However, such collection 
arrangements must be such that the blood is rapidly collected prior to any 
coagulation thereof. In the past, prior to the scoop collector disclosed 
in the above-noted U.S. Pat. No. 4,397,318, a cap or top arrangement was 
configured to fit on the top of a microcollection container with the top 
having an integral capillary tube for engaging the puncture and 
transferring blood to the container. However, with such an arrangement, 
the tip of the capillary tube had to be arranged precisely adjacent the 
puncture wound and the entire apparatus had to be so positioned that the 
blood flow along the bottom surface of the tubular microcollection 
container moved continuously in order to engage the surface of the 
container. Otherwise, if a precise positioning was not carried out, 
capillary action was not initiated or was slowed with subsequent clotting. 
Representative such collectors are taught in U.S. Pat. No. 4,024,857, 
issued May 24, 1977. 
One problem with the scoop collector taught and claimed in U.S. Pat. No. 
4,397,318, although the arrangement taught therein is highly efficient for 
the rapid collection of a blood sample into a microcollection container, 
is the fact that the assembly for making the collection must be 
distributed with the microcollection container or tube having a separate 
cap. Typically, the technician must remove the cap, and place on the 
container the scoop collector prior to making a collection of a blood 
sample. Subsequent to this collection, moreover, the scoop collector must 
then be removed, and the cap replaced on the container for delivery to a 
lab for investigation of the sample. Such removal and replacement of parts 
on the top of the blood microcollection container is cumbersome, as one 
will understand, particularly if the technician is, for example, 
attempting to take a blood sample from a screaming, wiggly baby. Moreover, 
the technician or nurse or doctor may become exposed to the blood sample 
during this transfer procedure in removing the blood collection scoop 
arrangeent and replacing the cap on the blood microcollection container. 
With the invention claimed in the above-noted co-pending application Ser. 
No. 695,121, by contrast, a scoop arrangement is incorporated into a blood 
microcollection assembly in such a way that the scoop collector does not 
have to be removed until such time as the technician in the laboratory 
wishes to obtain access to the sample in the blood microcollection 
container. This is achieved by the use of a cap which is a two-position 
cap. That is, the assembly is distributed to potential users with the cap 
in place over the scoop collector on the top of the blood microcollection 
container. 
When the nurse or doctor wishes to take a blood sample, the cap is removed 
and the front end of the scoop collector is placed adacent the wound for 
collection of blood. Once the blood sample has been taken, the cap is 
again placed over the scoop collector without any removal of the scoop 
collector, as in the past. Then, the technician merely has to press-fit 
the cap down over the scoop collector. This press-fit movement has the 
effect of permanently locking the cap onto the scoop collector. Therefore, 
access to the blood sample in the container cannot be obtained unless the 
cap and the scoop collector arrangement are removed simultaneously. For 
this reason, no one can be exposed to any blood left in or around the 
scoop collector arrangement after the sample has been taken, and until 
such time as the sample is to be obtained from the microcollection tube at 
the lab. 
As practitioners-in-the-art will understand, this arrangement reduces the 
amount of fumbling and movements necessary during the course of taking a 
blood sample while at the same time reducing the possibility of 
contamination to the nurse or anyone else present during the taking of the 
sample. 
With the invention claimed in this application, any difficulty engendered 
in taking a blood sample is further reduced dramatically by providing in 
the assembly itself a built-in lancet for making the wound for collecting 
the blood sample. That is, the lancet is positioned in the blood collector 
of the assembly and covered by the cap of the assembly prior to use. This 
allows for sterilization of the lancet and preservation of the sterile 
condition prior to use. 
When a sample of blood is to be collected with the combination assembly of 
the invention, the cap is removed. Then, the nurse or technician has an 
exposed collector and an exposed lancet simultaneously. The wound is made 
with the lancet and the sample collection made without the laying down or 
picking up of separate devices. The technician's hand is in place at the 
site of the wound for immediate collection. 
Once collection of the sample is completed, the cap is again placed over 
the collector of the assembly, and moved or forced into its second locking 
position, as described in the above-noted co-pending application. By this 
capping procedure, not only is the blood collector removed from 
contaminating anyone coming into contact, but also, in accordance with 
this invention, the lancet itself is also capped and removed from such 
exposure. They are, as will be appreciated by a review of the co-pending 
application, permanently locked under the cap placed over the blood 
collection assembly. 
Other advantages of the invention include the fact that but a single 
package must be made up and sterilized to achieve collection of a blood 
sample. Moreover, only this one package must be opened and handled to 
obtain collection of the sample followed by proper disposal of 
contaminating objects. 
Other objects and advantages of this invention will be apparent from the 
following description, the accompanying drawings and the appended claims.

DETAILED DESCRIPTION OF THE INVENTION 
Referring to the drawings in which like reference characters refer to like 
parts throughout the several views thereof, FIG. 1 illustrates the 
invention as employed with a scoop collector similar to that taught in the 
above-noted United States Patent utilizing a vane or septum separating, in 
the blood collector on the top of the blood collector container, a blood 
collection passage from an air vent passage. 
Incorporated in the collector is a fixed lancet for forming the wound for 
collecting the sample to be collected by the collector. 
In FIG. 1, the device 10 includes a blood microcollection container in the 
form of a tube 12 having a closed end 16 and an open end 14. The tube is a 
conventional blood microcollection tube and may be comprised of such 
materials as polyethylene, polypropylene or glass. Appropriately, tube 12 
will be transparent or translucent to enable the nurse to know the 
quantity of blood collected. For the purpose of understanding the 
invention here and its position in use, reference is made to FIG. 5C in 
U.S. Pat. No. 4,397,318. That is, the top of the device shown in the 
Figures is the front end, and the bottom is the left side as shown in the 
figures because the left side will be held so that it is the bottom of the 
device in use. 
Positioned on the top flange 52 of tube 12 is a blood collector 18 having a 
scoop arrangement 32 extending forwardly thereof. The collector assembly 
18 is generally tubular in cross section with a central bore 22 passing 
therethrough. The scoop collector 18 is different from that taught and 
claimed in U.S. Pat. No. 4,397,318 in that the front end edge 31 of the 
vane or septum 30 does not extend forwardly to form the upper edge of the 
scoop 32. The reason for this shorter vane 30 will be described in further 
detail below. 
The collector 18 includes an annular integral skirt 50, as shown in FIG. 1, 
which is spaced from the lower 28 and upper 26 walls forming the central 
bore 22 of collector 18. This spacing allows for an annular space 61 for 
receiving in press-fit engagement the annular flange 52 surrounding the 
open end 14 of tube 12. The skirt 50 includes an integral internal 
abutment 63 which cooperates with flange 52 for maintaining collector 18 
on the top of tube 12. Annular skirt 50 also includes an annular outer 
abutment 48 which cooperates with cap 20 for holding cap 20 locked on 
collector 18 as will be described below. 
Positioned in end 57 of wall 26 foming a part of bore 22 is lancet 125. As 
can be seen in FIGS. 1 and 2, lancet 125 has one end embedded in the 
material of holder 18 with the opposite sharp or pointed end 126 exposed 
for lancing the skin to obtain a blood sample. It will be appreciated in 
this connection, that lancet 125 may be in several forms or 
configurations, including one with a straight wedge-shaped cutting edge. 
Referring further to FIG. 1, cap 20 includes an annular lower skirt 42, 
with an upper tapered portion 38 integral therewith. When cap 20 is in 
place as shown in FIG. 1, the wall of the annular upper portion converges 
from skirt 42 toward the axis 13 of the assembly shown. The outer surface 
of the lower skirt portion 42 of cap 20 includes a plurality of spaced 
ribs 44, which provide for a better grip on cap 20, when it is to be 
removed from the assembly, as shown. The upper tapered portion 38 also 
includes a plurality of annular ridges 40 which also serve to provide a 
gripping surface to the cap assembly 20. 
The upper tapered portion 38 of cap 20 ends in a tip 64 which connects to a 
central tubular internal well 60 of cap 20. Well 60, as shown in FIG. 1, 
serves to fit internally in bore 22 of collector 18. Well 60 includes an 
annular abutment 56 which cooperates with the front edge 57 of upper wall 
26 of collector 18 in the position of cap 20 in FIG. 1. In this 
connection, the term "upper" as used herein is a designation for the 
right-hand portion of collector 18. The term "upper" as mentioned above is 
used to designate the upper side of collector 18 when the assembly is in 
use. That is, the air vent passage 24 will be positioned upwardly, while 
blood collection passage 35 will be positioned downwardly in the partially 
horizontal position of the collector assembly during collection of a blood 
sample, much in the same manner as the positioning shown in the above 
noted U.S. Pat. No. 4,397,318. 
As can be seen in FIG. 1, skirt 42 of cap 20 includes an integral inner 
abutment 46. Abutment 46, as shown in FIG. 1, cooperates with abutment 48 
on collector 1 for engaging the collector 18 and capping the assembly 
prior to use. That is, the abutment 48 serves as a stop for the abutment 
46 with the latter being in press-fit engagement with the outer annular 
surface of skirt 50 of collector 18. 
Thus, a technician or nurse, wishing to collect a blood sample in the 
assembly 10 of FIG. 1, receives the assembly with the parts thereof in the 
position shown in FIG. 1. The technician removes cap 20 from collector 18, 
makes a skin puncture with lancet 125 and places the front edge 62 of 
scoop collector 32 adjacent the puncture. Blood flows along surface 33 of 
bore 22 in collector 18, and passes from the rear edge 34 of that surface 
into and along the surface 36 of tube 12 to be collected in chamber 54 
thereof. Once a proper quantity of a blood sample has been collected in 
chamber 54, the technician removes the front edge 62 of collector 32 from 
the wound and places cap 20 on collector 18 which in turn is still in 
place on tube 12. When the technician replaces cap 20, the cap is 
press-fit onto collector 18 to the degree wherein the annular abutment 46 
on skirt 42 of cap 20 rides over the abutment 48 of collector 18 to the 
position shown in FIG. 2. 
Thus, the abutment 46 slides down over abutment 48 and locks the cap 20 
onto the collector 18. With this arrangement therefor, the collector 18, 
including lancet 125, is completely covered and cannot be exposed to 
anyone. The entire assembly is conveyed to a lab for proper handling of a 
blood sample contained in chamber 54. At that time, the clinician in the 
lab may remove cap 20 for obtaining access to the sample contained in 
chamber 54. When this happens, the cap 20 automatically removes the 
collector assembly 18, together with lancet 125, as well, so that the 
entire combination of cap 20-collector 18-lancet 125 may be disposed of 
and any contaminated sample contained in collector 20 is removed from 
exposure to anyone handling the sample other than the appropriate handling 
which takes place in a clinical laboratory. 
It should be noted here that in the locked position shown in FIG. 2, the 
annular integral well 60 of cap 20 moves into the bore 22 of collector 18 
to a point immediately adjacent the front end 31 of septum or vein 30 for 
effectively sealing off the bore 22 of collector 18. In this connection, 
the annular abutment 56 on the outer surface of the annular integral 
internal well 60 of cap 20 is press-fit against the wall of bore 22 for a 
positive sealing engagement therewith. It should be noted further that 
abutment 46 on annular skirt 42 of cap 20 includes a tapered surface 47 
for ease of movement of cap 20 into its locked position as shown in FIG. 
2. That is, the tapered surface 47 has the effect of camming the abutment 
46 outwardly over the abutment 48 for cooperating locking engagement 
therewith. 
A further embodiment of blood collection assembly is shown in FIG. 3. This 
collection assembly is similar to that shown and described in the FIGS. 1 
and 2 embodiment. However, in this embodiment, the blood collector 72 does 
not include any centrally positioned vane or septum 30 as shown in the 
FIG. 1 embodiment. The collector 72 includes a central bore 80 defining a 
passage 82 through which a blood sample passes. Therefore, the skin is 
lanced with the sharp sterile front end edge 135 of lancet 136. Then blood 
from the wound is taken by scoop 84 of collector 72, with the front edge 
86 thereof engaging the wound for receiving the blood which passes along 
the lower wall 76 of bore 80 and leaves the end 78 thereof where it 
engages the internal wall 36 of the collector tube 12. In this embodiment, 
the internal tubular well 88 of cap 74 is longer. Therefore, the bottom 92 
of well 88 passes further into the passage 82 of collector 72, as shown in 
FIGS. 3 and 4. In the position of the assembly as shown in FIG. 4, the 
wall 92 extends substantially all the way into and fills up the passage 82 
of bore 80. 
The remaining parts in this embodiment are substantially the same as that 
in the FIGS. 1 and 2 embodiment. That is, collector 72 includes an annular 
integral skirt 94 with an annular outer abutment 98 which cooperates with 
the annular inner abutment 96 of skirt 100 of cap 74. Cap 74 is in the 
same form as cap 20 of FIG. 1 in that it includes an annular lower skirt 
portion 100 with spaced ribs 102 thereon, and tapered front end wall 108 
ending in the front end edge 104. Tapered wall 108 includes a plurality of 
spaced annular abutment ridges 106 which serve together with the ridges 
102 to provide gripping surfaces on the outer surface of cap 74 making it 
easier to grip to remove the entire collector-cap assembly so that the 
clinician in the laboratory can obtain a sample. 
The cap 74, in the same manner as cap 20, has a two-position arrangement 
with a final locking position as shown in FIG. 4, achieved after passage 
of the tapered surface 97 over abutment 98 in a camming action. The 
annular internal well 88 of cap 74 includes an annular abutment 90 which 
cooperates with the front edge 85 of the upper wall portion of collector 
72 in the position shown in the initially capped position of the cap 74 
shown in FIG. 3. This annular abutment wedges into the bore 80 of 
collector 72, as shown in the final locked position of cap 74 in FIG. 4. 
It should be understood, in this connection that annular abutment 90 may 
be positioned at other locations along the length of well 88. Either 
embodiment of the invention here may include an integral strap 112 on cap 
74 which strap 112 is attached to a ring 110 for attaching the cap to tube 
12 to prevent loss or misplacement thereof. Other ataching configurations, 
such as a U-shape partial ring may be used, as will be understood by 
practitioners-in-the-art. Also, either embodiment may include a thumb 
"roll" or flange 200 to facilitate removal of the assembly from tube 12 by 
the use of the thumb pushing up on flange 200. 
Preferably, the assembly of the invention will be comprised of a clear 
molded thermoplastic such as polyethylene, for example. Other materials 
which may be used, as will be appreciated by practitioners-in-the-art, 
include various thermoplastics such as polypropylene and 
polyvinylchloride. The cap may be comprised of Alathon 20-6064, a 
polyethylene formulation of DuPont, for example. Preferably, the 
microcollection container itself is comprised of a clear thermoplastic 
material, such as polypropylene, which has been properly treated to 
provide a hydrophillic internal surface for enhancing the flow of blood 
introduced therein. The internal surface of the container may also utilize 
a surface active agent such as a silicon coating. 
Whereas, as discussed above, a specific embodiment of microcollection 
container has been shown to be used in the assembly of the invention, it 
should be understood that it is within the purview of this invention that 
other forms of microcollection containers may be used configured with 
different cooperating locking arrangements with the associated collection 
assembly and cap of the invention. That is, the lancet may be oriented 
differently relative to the rest of the assembly. For example, it may be 
positioned to extend radially from the assembly. Moreover, other forms of 
collection assemblies may be used with the combined built-in form of 
lancet of the invention. In this connection, it should be noted that the 
collection assembly should be in a form where it serves as the "handle" 
for the lancet-collector combination. 
The arrangement here teaches a press-fit engagement with the container top 
relative to the collector, it is within the purview of the invention that 
a cooperating screw arrangement could be utilized. Also, the lancet may be 
incorporated into the snap-cap rather than the collector of the assembly 
herein. The point is, that the collector itself cannot be removed without 
the cap covering it and the associated lancet to protect the user from 
contamination from the time the sample is collected until such time as the 
lab technician removes the cap for otaining the sample contained in the 
container. 
While the forms of apparatus herein described constitute preferred 
embodients of the invention, it is to be understood that the invention is 
not limited to these precise forms of apparatus, and that changes may be 
made therein without departing from the scope of the invention which is 
defined in the appended claims.