Blood collection device

The present invention involves an integrated double-ended needle and blood collection device assembly which is convenient to use, safely contained and ready for disposal after use. The device allows the user to expose and resheath potentially infectious needles without bringing the user's fingers or hands into close proximity with sharp or broken needle tips. After removing the needle from the patient, the needle is safely resheathed by retracting the needle into the device, thereby reducing the risks of accidental needle wounds and infection. The device also serves as a holder for blood collection tubes which can be easily inserted and removed for multiple sampling.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The present invention relates to an integrated assembly and apparatus for 
the collection of multiple samples of blood specimens. The invention 
further relates to an apparatus for drawing blood samples, wherein a 
double-ended needle is sheathed before use and safely resheathed after 
use, thereby reducing the risk of accidental needle wounds and resultant 
infections to a minimum. In another aspect, the invention relates to a 
blood collection device and integrated double-ended needle, wherein at no 
time is it necessary to cap or cut-off an exposed needle after use. 
2. Related Art 
Apparatus typically used to perform phlebotomy are septum-capped evacuated 
tubes which are used with double-ended hollow needles or sharpened 
cannulae, one end of which is inserted into the patient and the other end 
pierces the septum, thereby withdrawing a volume of blood. Prior to 
disposal of the needle, the needle is either capped or broken-off to 
prevent reuse. 
It is customary to use sterile, single use, disposable devices for taking 
blood samples from patients just as single use, disposable, sterile 
hypodermic needles are widely used for administering therapeutic agents. 
While these conventional single use, disposable devices fully protect the 
patient from the dangers of infectious diseases, such as AIDS and certain 
hepatitis viruses, they present a risk of infection to medical and 
hospital personnel due to accidental wounding with a contaminated needle 
or contact with other contaminated parts of the disposable apparatus. 
Normally, health care workers are especially susceptible to accidental and 
potentially infectious needle wounds due to the careless handling or 
breaking of the needle in disposing of the syringe after use. Accidental 
needle wounds generally result in the need for blood tests for such 
diseases as AIDS and hepatitis. The corresponding costs and inefficiency 
of testing health care workers who have received an inadvertent needle 
wound result in a considerable waste of resources, which may be 
particularly damaging to a health care facility, as well as an ever 
present danger to the worker personally. 
Widely used commercial devices for blood collection include double-ended, 
multiple sample needles having protective caps over both needle ends for 
storage. The needle holder for such a needle is often separate from the 
needle and reusable. The risk of a needle wound to the user, especially 
when recapping the needle after drawing a sample, is unacceptably high. In 
addition, the destruction of the needle in a clipping device has been 
recommended, but this is also a hazardous practice because of aerosol 
production of contaminated blood samples, the continued risk of wounds 
from the resultant blunt needle shaft and the hazards uncapped needles 
present to waste disposal personnel. Furthermore, it is not always 
practical to carry a needle clipping device from patient to patient in a 
hospital or clinic environment. 
SUMMARY OF THE INVENTION 
The present invention involves a novel blood collection device suitable for 
use with a double-ended needle. The device includes a tube having forward 
and rear ends with at least one longitudinal external slot in the tube 
wall. The external slot terminates in a first transverse slot extension in 
the forward end portion of the tube and a second transverse slot extension 
in the rear end portion of the tube. The tube forward end terminates in a 
needle sheath which is axially aligned with the axis of the double-ended 
needle, and the tube rear end terminates with an open tube bore. The 
double-ended needle is mounted centrally and perpendicularly through a 
support member which is slideably positioned in the bore of the tube and 
is capable of movement along the tube bore between the tube forward end 
portion and the tube rear end portion. The support member has arm means 
secured thereto, wherein the arm means projects through the longitudinal 
external slot of the tube and is movable in a slideable and rotatable 
manner from one transverse slot extension to another transverse slot 
extension, thereby enabling the user to secure the support member in 
either a forward end position or a rear end position. When the support 
member is secured in the forward end position, the needle is extended from 
the device. When the support member is secured in the rear end position, 
the needle is withdrawn into the device. 
The support member can be a substantially rigid disc which is rotatably and 
slideably encased within the tube bore. The disc has a center axis, 
axially aligned with the axis of the tube bore, and generally includes two 
finger tabs connected to the disc by the arm means which are slideably 
positioned in and through two longitudinal external slots in the tube 
wall. In a preferred embodiment of the invention, the transverse slot 
extensions include a detaining means whereby the movable arm is secured 
within the forward or rear transverse slot extension, thereby locking the 
needle in either an extended or sheathed position. After withdrawal of the 
needle from the patient, the finger tabs can be rotated, unlocked, pulled 
back and rotated into a retracted locked position either with or without 
the needle having been clipped. The entire assembly is then safely 
contained and ready for disposal. 
In an alternative embodiment, the needle sheath can be capped or covered by 
needle sheath cap. For example, a holding ring on the needle sheath can be 
used to secure the sheath cap by interlocking with an interior groove on 
the sheath cap. In yet another embodiment, the device can include a 
handling flange at the rear end of the tube to facilitate manipulation of 
the device. In a further embodiment, the device includes a tube rear end 
cap to close the rear end of the tube, and optionally, the tube rear end 
cap can be connected to a needle sheath cap by a flexible connector. 
In another preferred embodiment, the device can include an interior or 
exterior tube sleeve having at least one sleeve longitudinal slot which is 
opposed to and of equal length to the tube longitudinal external slot. The 
sleeve is rotatably mounted so that upon rotation the sleeve closes or 
covers the tube longitudinal external slot. 
The integrated double-ended needle and blood collection device of the 
present invention provides an assembly which is highly simplified and 
convenient to use. The assembly also serves as a holder of blood 
collection tubes during sample taking, with the collection tubes being 
easily inserted and removed through the rear bore opening of the device.

DETAILED DESCRIPTION OF THE INVENTION 
The present invention provides a novel blood sample device wherein the 
double-ended needle is completely sheathed in the device until needed for 
use. The hands or fingers of the user need never approach the needle 
either to place it into position for use or for resheathing and disposal. 
The object of the blood collection device is the protection of medical, 
hospital and clinical users or others who might come in contact with the 
device and integrated needle after use but prior to disposal. 
Another object of the invention is to provide a blood collection device, 
having such safety features, and which is highly simplified and therefore, 
relatively economical to manufacture, convenient to use, reliable in its 
operation and construction and operable in such a way that the risk of 
spreading infection with a used device is significantly reduced. Other 
objects and advantages of the invention will become apparent to those 
skilled-in-the-art from the following detailed description. 
Referring to the drawings in detail, wherein like numbers designate like 
parts, two main embodiments of the blood collection device are 
illustrated: an embodiment without a sleeve, FIGS. 1 and 2; and an 
embodiment involving an exterior sleeve, FIG. 4. Although the depicted 
blood collection devices are particularly useful in vacuum tube 
phlebotomy, i.e., the drawing one or more samples of blood into individual 
evacuated blood collection tubes, it will be appreciated that the safety 
features of the present invention are also applicable to a syringe with 
which a fluid is administered to a recipient by means of appropriate 
injection procedures. 
Referring initially to FIG. 1, a side elevation view of the device is 
depicted, with the double-ended needle retracted in a safety position for 
handling, shipping and disposal. The numeral 2 designates the integrated 
double-ended needle and blood collection device. The tube 4 is an 
elongated rigid cylindrical body having a central longitudinal tube bore 
6. The tube 4 has a closed forward end 8 and a tube forward end portion 
10. The tube 4 also has a tube rear end 12 and a tube rear end portion 14, 
with tube side wall 16 connecting tube rear end 12 and tube forward end 8. 
Within the tube side wall 16 are one or more longitudinal slots, such as 
longitudinal external slot 18 and longitudinal external slot 20 which are 
positioned in opposite geometry. Longitudinal slots 18 and 20 both include 
transverse slot extensions 22, in the forward end portion 10, which 
extensions are positioned circumferentially in the same direction from the 
longitudinal slots. The longitudinal slots 18 and 20 also have rear end 
portion transverse slot extensions 24 circumferentially extending from the 
longitudinal slots in the same direction as regard the rear end portion 
14, but which extend in the opposite direction to transverse slot 
extensions 22 in the forward end portion 10. 
The double-ended tubular needle 26 has a forward end 28 and a rear end 30. 
A resealable septum or cover 32 encloses the tubular needle rear end 30. 
The double-ended tubular needle 26 is mounted centrally and 
perpendicularly through rigid disc 34 or a similar support member means 
having a central axis 3. 
The rigid disc 34, as further illustrated in FIG. 4, has arms 38 and 40 
extending through longitudinal external slots 18 and 20 and connected to 
finger tabs 42. The finger tabs 42 and connecting arms 38 and 40 enable 
the positioning of the rigid disc 34 and mounted double-ended tubular 
needle 26 into a retracted and locked position through locking means 44, 
whereby the double-ended tubular needle is totally encased within the 
device. The finger tabs 42, through arms 38 and 40, are used to move the 
rigid disc 34 and double-ended tubular needle 26 forward from the 
retracted position. The arms are moved through longitudinal external slots 
18 and 20 and into the transverse forward slot extensions 22. The arm 
means 38 and 40 lock in place through a detaining means 45 wherein the 
tubular needle forward end 28 is fully extended outside the tube 4. 
The finger tabs, arm means and detention means for positioning and securing 
the needle support member in a rear or forward position can be comprised 
of several configurations. The slot extensions 22 and 24 can be 
constructed with detaining means 45 and 44, respectively, within the 
transverse extension slot to hold the finger tabs and connected arms in 
place, yet the arms can be easily unlocked through an upward or downward 
pressure on the finger tabs. Such a locking means is only one example of a 
simple yet effective method for securing the needle in its rear or forward 
position. The detaining means depicted in FIGS. 1 and 4 involves a 
projecting portion 45 and 44 in both the forward and rear slot extensions 
22 and 24, respectively, but could alternatively be an indent or notch 
which secures the arms within the transverse slot extensions. 
A handling flange 46 can be positioned at the tube rear end 12 and can be 
placed surrounding the open tube bore 52. The flange is convenient for 
handling the device in general and as an aid for inserting and removing an 
evacuated phlebotomy tube 68, as shown in FIG. 5. 
The tube 4 has a needle sheath 48 on the tube forward end 8. FIG. 3 
illustrates that the needle sheath 48 can optionally include a holding 
ring 50 which secures a needle sheath cap or cover 64 to the needle sheath 
when the double-ended tubular needle 26 is fully retracted. The needle 
sheath 48, by means of the holding ring 50, secures the sheath cap 64 by 
interlocking with an interior groove 66 in the sheath cap. In addition, 
FIG. 3 illustrates an optional tube rear end cap 56 locked in place 
through the operation of a cap securing lip 54 which when combined with 
the tube rear handling flange 46 fixes the tube rear end cap to the device 
for handling and/or disposal. Optionally, the tube rear end cap 56 is 
joined to the sheath cap 64 by a flexible connector 60. 
The tube rear end cap 56 is shown to be larger in size than handling flange 
46, allowing the tube rear end cap to cover the handling flange and be 
secured by means of a snap-fit mechanism. In an alternative embodiment, a 
snap-fit cap, could involve an inside fitting means, not shown. 
In FIG. 4, a perspective view is shown of the apparatus including an 
exterior tube sleeve 41 having sleeve longitudinal slots 43. The sleeve 
longitudinal slots 43 are coradial and adjacent to and of equal length to 
longitudinal slots 18 and 20 in the tube side wall 16. There are no 
transverse slot extensions present in the exterior sleeve 41. The 
double-ended needle forward end 28 is shown as fully extended from the 
needle sheath 48. The finger tabs 42 are depicted in an unlocked position, 
as the exterior sleeve 41 has not been turned to allow the arm into the 
slot extensions 22 and into contact with the detention means 45. 
In one embodiment of the invention, the novel blood collection device 
includes the rotatable sleeve positioned inside the needle tube bore. An 
alternative embodiment involves the use of the rotatable sleeve on the 
outside of the tube. The sleeve, whether inside or outside the tube, 
presents no change in the function of the needle support member, slot 
means or detention means. The construction of the device allows the sleeve 
to freely rotate co-axially to the needle tube, while at the same time 
preventing the sleeve from sliding in a direction parallel to the central 
axis of the needle tube. The purpose of the sleeve, as an optional feature 
of the invention, is to close the longitudinal external slots through 
which the finger tabs travel during needle sheathing and unsheathing 
manipulations. When the finger tabs are twisted into the locked position 
with the needle either fully extended or fully retracted, the sleeve will 
cover the slots in the tube wall, thereby minimizing the release of 
aerosol blood or blood droplets created when an evacuated blood collection 
tube is removed from the double-ended needle. In addition, the sleeve will 
minimize the leakage of blood drops which may form if the double-ended 
needle's self-sealing cover does not close-off the flow of blood when the 
evacuated blood collection tube is removed. 
FIG. 5 presents a side elevation view of the integrated double-ended needle 
and blood collection device 2, with the hollow needle forward end 28 fully 
extended from the tube 4. The figure also shows the use of an evacuated 
phlebotomy blood collection tube 68 having a rubber septum 70 which seals 
the evacuated tube. When the tube is placed in position on the tubular 
needle rear end 30, and is forced into contact with and over the tubular 
needle rear end 30, the resealable needle cover 32 is penetrated as is the 
septum 70, thereby allowing communication between the tubular needle 
forward end 28, which is in the patient, and the interior of the evacuated 
tube. By removing filled tubes and inserting new evacuated tubes 68, 
multiple samples can be taken without removing the tubular needle forward 
end 28 from the patient. 
When the last blood sample has been taken, the double-ended needle forward 
end 28 is withdrawn from the patient. To prevent an accidental needle 
injury and the possible spread of contagious disease from a contaminated 
needle, the user can unlock the finger tabs 42 and slideably retract the 
double-ended needle 26 into the tube bore 6. The rear detention means can 
then be engaged, whereby the double-ended needle is totally enclosed 
within the device in the retracted position. By grasping the tabs and 
handling flange as well as the tubular body, the user should never have 
need for placing fingers in the proximity of the exposed needle. 
The double-ended needle can be utilized from readily available commercial 
sources and removably affixed to the needle support member which will 
allow the reuse of the remainder of the device with a new double-ended 
needle. The major benefit of the present invention, however, is the 
concept of an integrated double-ended needle and blood collection device 
wherein the needle is resheathed totally within the device for disposal. 
It will be appreciated by one skilled-in-the-art that the selection of any 
given detention means, component size or appearance is generally not 
critical to the present invention. The sizes and relative angles of the 
component pieces are selected to optimize the manipulation of the device. 
The embodiments described herein are intended as examples rather than as 
limitations. Thus, the description of the invention is not intended to 
limit the invention to the particular embodiments described in detail, but 
it is intended to encompass all equivalents and subject matter within the 
spirit and scope of the invention as described above and as set forth in 
the following claims.