U.S. patent application number 09/873520 was filed with the patent office on 2002-12-05 for non-biohazard blood letting system.
Invention is credited to Kensey, Kenneth R..
Application Number | 20020183652 09/873520 |
Document ID | / |
Family ID | 25361800 |
Filed Date | 2002-12-05 |
United States Patent
Application |
20020183652 |
Kind Code |
A1 |
Kensey, Kenneth R. |
December 5, 2002 |
NON-BIOHAZARD BLOOD LETTING SYSTEM
Abstract
An apparatus that allows a patient to blood let safely and
automatically and which allows for the safe disposal of the
withdrawn blood.
Inventors: |
Kensey, Kenneth R.;
(Malvern, PA) |
Correspondence
Address: |
CAESAR, RIVISE, BERNSTEIN,
COHEN & POKOTILOW, LTD.
12TH FLOOR, SEVEN PENN CENTER
1635 MARKET STREET
PHILADELPHIA
PA
19103-2212
US
|
Family ID: |
25361800 |
Appl. No.: |
09/873520 |
Filed: |
June 4, 2001 |
Current U.S.
Class: |
600/573 ;
604/403 |
Current CPC
Class: |
A61B 5/150366 20130101;
A61B 5/150221 20130101; A61B 5/150503 20130101; A61B 5/150587
20130101; A61L 2/0082 20130101; A61M 2202/206 20130101; A61M 1/3683
20140204; A61M 2202/203 20130101; A61M 1/0011 20130101; A61M 1/80
20210501; A61M 39/285 20130101; A61B 5/150389 20130101; A61L 11/00
20130101; A61M 1/82 20210501; A61B 5/15074 20130101; A61B 5/150305
20130101; A61M 1/882 20210501; A61M 1/69 20210501; A61B 5/154
20130101; A61B 5/15003 20130101; A61B 5/150717 20130101 |
Class at
Publication: |
600/573 ;
604/403 |
International
Class: |
A61B 005/00 |
Claims
1. An apparatus for permitting automatic, self-blood letting of a
living being of a predetermined amount of blood and which renders
the removed blood non-biohazardous for safe disposal.
2. The apparatus of claim 1 comprising: an intubator for coupling
to a blood vessel of the living being; a blood collector, said
blood collector having an interior that contains a micro-biological
inactivating agent; and a blood conveyor coupled between said
intubator and said blood collector for passing blood from said
intubator to said blood collector.
3. The apparatus of claim 2 wherein said blood collector comprises
a first compartment formed of a material that tends to maintain
said container in an expanded condition, said container being
initially evacuated of any atmospheric pressure such that said
container is substantially flat.
4. The apparatus of claim 3 wherein said first compartment
comprises an expandor that is coupled to an exterior surface of
said first compartment and having a pair of free ends, said
expandor comprising a bias that tends to move said pair of free
ends away from each other and wherein said expandor is initially
positioned with said free ends closely adjacent each other.
5. The apparatus of claim 4 wherein said expandor comprises a
frangible link that initially positions said free ends closely
adjacent each other and which can be severed by applying an abrupt
force to said frangible link.
6. The apparatus of claim 5 wherein each of one of said pair of
free ends is positioned in a respective sleeve formed on opposite
sides of the exterior of said container.
7. The apparatus of claim 6 wherein said expandor comprises a leaf
spring having a first side having one of said pair of free ends and
a second side having the other one of said pair of free ends and
wherein said first side and said second side are coupled along a
common edge, said frangible link being located adjacent said common
edge and holding said first side and said second side together
against said bias for positioning said free ends closely adjacent
each other.
8. The apparatus of claim 7 wherein said common edge protrudes from
the exterior of said container and to which an abrupt force is
applied to sever said frangible link.
9. The apparatus of claim 3 wherein said blood collector further
comprises a second compartment that can be opened or closed, said
first and second compartments not being in fluid communication with
one another and wherein said second compartment is used for storing
said intubation portion and said blood conveyor when not in
use.
10. The apparatus of claim 9 wherein said second compartment
comprises a resealable opening.
11. The apparatus of claim 3 wherein said blood conveyor comprises
a catheter having a first end in fluid communication with said
intubator and having a second end that is in fluid communication
with said first compartment via a one-way valve, said one-way valve
permitting only the flow of blood from said blood conveyor to said
first compartment.
12. The apparatus of claim 2 wherein said intubator is a safety
needle.
13. The apparatus of claim 12 wherein said safety needle is coupled
to a housing that can be releasably secured to a limb of the living
being.
14. The apparatus of claim 13 wherein said housing comprises a
releasable fastener.
15. The apparatus of claim 13 wherein said housing further
comprises a manually-releasable clamp for controlling the removal
of blood from the living being.
16. The apparatus of claim 2 wherein said micro-biological
inactivating agent kills any micro-organisms, viruses, bacteria or
the like in blood removed from the living being.
17. The apparatus of claim 16 wherein said micro-biological
inactivating agent comprises the group consisting of bromine,
chlorine, Methylene blue (MB) and its derivatives azure A, B, C and
thionine.
18. The apparatus of claim 2 wherein said predetermined amount of
blood is approximately 1 pint.
19. A method of permitting automatic, self-blood letting of a
living being of a predetermined amount of blood while rendering the
removed blood non-biohazardous for safe disposal, said method
comprising: (a) providing a blood collector that normally has an
expanded state and which contains a micro-biological inactivating
agent; (b) evacuating said blood collector of atmospheric pressure
to form a compressed state of said blood collector; (c) coupling a
releasable biasing member to said blood collector to maintain said
blood collector in said compressed state until a desired time; (d)
coupling the blood vessel of the living being to said blood
collector; (e) activating said releasable biasing member to cause
said blood collector to rapidly expand to draw said predetermined
amount of blood into said blood collector; (f) de-coupling the
blood collector from the blood vessel; and (g) discarding said
blood collector.
20. The method of claim 19 wherein said activating said releasable
biasing member comprises applying an abrupt force to said
releasable biasing member.
21. The method of claim 20 wherein said coupling of the blood
vessel comprises: (a) coupling a tube at one end to said blood
collector; (b) coupling the other end of said tube to a safety
needle; and (c) intubating the living being by inserting said
safety needle into the blood vessel of the living being.
22. The method of claim 21 wherein said coupling a tube at one end
to said blood collector comprises coupling said one end through a
one-way valve to said blood collector, said one-way valve
permitting only the flow of blood from said tube into said blood
collector.
23. The method of claim 22 further comprising providing a storage
compartment with said blood collector, said storage compartment not
being in fluid communication with said blood collector, said
storage compartment holding said tube and safety needle before and
after said self-blood letting.
24. The method of claim 23 wherein said providing a storage
compartment further comprises including a micro-biological
inactivating agent within said storage compartment.
25. The method of claim 19 wherein said micro-biological
inactivating agent kills any micro-organisms, viruses, bacteria or
the like in the blood removed from the living being.
26. The method of claim 25 wherein said micro-biological
inactivating agent comprises the group consisting of bromine,
chlorine, Methylene blue (MB) and its derivatives azure A, B, C and
thionine.
27. The method of claim 19 wherein said activating a releasable
biasing member comprises: (a) placing said blood collector on the
ground; and (b) stepping strongly on a portion of said releasable
biasing member.
28. The method of claim 19 wherein said predetermined amount of
blood is approximately 1 pint.
29. The method of claim 21 wherein said coupling the blood vessel
of the living being to said blood collector further comprises
introducing a manually-operable clamp at said other end of said
tube that is coupled to said safety needle, said manually-operable
clamp being initially closed to prevent any passage of blood.
30. The method of claim 29 wherein said activating a releasable
biasing member further comprises opening said manually-operable
clamp.
Description
FIELD OF THE INVENTION
[0001] The invention pertains to methods and apparatus for reducing
blood viscosity of living beings, and more particularly, to methods
and apparatus for the automatic and safe removal of blood from a
living being.
BACKGROUND OF INVENTION
[0002] The concept of removal of blood from a living being, also
known as blood letting, has been known for centuries.
[0003] However, the particular physiological benefits of removing
blood from a living being, and thereby allowing new blood to be
created, has not been appreciated in the medical community. For
example, a healthy menstruating female removes "old blood" from her
body on a monthly basis that is replenished with "fresh blood." A
male, on the other hand, does not experience such a cycle and his
circulatory system re-circulates "old blood."
[0004] Therefore, there remains a need to provide an individual
with the ability to safely and automatically blood let while
providing a safe and non-biohazardous way of disposing of the
removed blood.
SUMMARY OF THE INVENTION
[0005] An apparatus for permitting automatic, self-blood letting of
a living being of a predetermined amount of blood (e.g.,
approximately 1 pint) and which renders the removed blood
non-biohazardous (e.g., using an internal micro-biological
inactivating agent) for safe disposal.
[0006] A method of permitting automatic, self-blood letting of a
living being of a predetermined amount of blood while rendering the
removed blood non-biohazardous for safe disposal. The method
comprises: (a) providing a blood collector that normally has an
expanded state and which contains a micro-biological inactivating
agent (e.g., bromine, chlorine, Methylene blue (MB) and its
derivatives azure A, B, C and thionine); (b) evacuating the blood
collector of atmospheric pressure to form a compressed state of the
blood collector; (c) coupling a releasable biasing member to the
blood collector to maintain the blood collector in the compressed
state until a desired time; (d) coupling the blood vessel of the
living being to the blood collector; (e) activating the releasable
biasing member to cause the blood collector to rapidly expand to
draw the predetermined amount of blood into the blood collector;
(f) de-coupling the blood collector from the blood vessel; and (g)
discarding the blood collector.
DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is a diagrammatic view of the blood letting system of
the present invention coupled to a blood vessel of a human being at
one end and including a blood collecting portion at another end
before blood letting has begun;
[0008] FIG. 1A is an enlarged view of the portion indicated in FIG.
1;
[0009] FIG. 2 is a cross-sectional view of a blood collector of the
blood letting system of the present invention during blood letting
showing the automatic removal of the blood from the human being to
the blood collecting portion;
[0010] FIG. 2A is an enlarged view of the portion indicated in FIG.
2; and
[0011] FIG. 3 is a cross-sectional view of the blood letting system
of the present invention that is ready for safe disposal.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0012] Referring now in detail to the various figures of the
drawing wherein like reference characters refer to like parts,
there is shown at 20 a non-biohazard blood letting system,
hereinafter "the system 20." The system 20 is a self-contained
system that allows a patient, or a technician to assist a patient,
to blood let safely and automatically. The system 20 basically
comprises an intubation portion 22, a blood conveyor 24 and a blood
collector 26.
[0013] The intubation portion 22 basically comprises a safety
needle 34 having a safety cap 36 (FIG. 3). The safety needle 34 is
coupled in fluid communication with the blood conveyor 24 via a
housing 38. The housing 38 is affixed to an attachment strap 40
that aids in holding the safety needle 34 in place once inserted
into a blood vessel. The strap may include a hook/pile 42 (e.g.,
the fastener sold under the mark VELCRO.RTM.) configuration for
permitting the strap 40 to be releasably secured to the limb of the
living being. The housing 38 may also comprise, although not
required, a manually-operable clamp 44 that the patient can use to
control the flow of blood, as will be discussed later.
[0014] The blood conveyor 24 (e.g., a catheter, a pliable tube or
any equivalent structure that can convey a fluid therein and that
is pliable so that it can be stowed inside a bag or other similar
structure) is coupled at a first end 46 (FIG. 1A) to the safety
needle 34 and to a one-way valve 48 adjacent its other end 50 (FIG.
2).
[0015] The blood collector 26 comprises two compartments: a blood
collecting portion 30 and a resealable storage portion 28. These
two compartments are isolated from each other via an inner wall 52
having an aperture 53 in which is disposed the one-way valve 48.
The blood collecting portion 30 is formed by a durable material
(e.g., plastic) having a memory that tends to maintain the blood
collecting portion 30 in an expanded state (FIG. 2). An example of
such a material is used in nose cleaners for infants, or other
pliable bulbs used in medicine for creating a suction force (e.g.,
pipette pump, Cole-Parmer EW-24805-10 Pipette Filler).
[0016] On the exterior of the blood collecting portion 30 are a
pair of molded pockets 54A and 54B on opposite sides of the blood
collecting portion 30. These molded pockets 54A/54B form sleeves
into which the free ends 56A and 56B of an expandor, e.g., a leaf
spring 58, are captured. In particular, the leaf spring 58 may
comprise a bent piece of spring steel having a memory or bias
(which tends to move the free ends 56A/56B away from each other)
and which is placed into a closed state (FIG. 1) at the factory
whereby the free ends 56A and 56B are relatively close to each
other. To hold this leaf spring 58 in the closed state, a frangible
link 60 is also formed at the joined side 62 of the leaf spring 58,
at the factory. With the leaf spring 58 in the closed state, the
free ends 56A/56B are positioned in their respective sleeves
54A/54B, resulting in the joined side 62 of the leaf spring 58
being exposed, or otherwise protruding away from the blood
collecting portion 30. As will be discussed in detail later, when
an abrupt force is applied to the joined side 62, the frangible
link 60 breaks, thereby allowing the leak spring 58 to immediately
open so that the free ends 56A and 56B move away from each other
rapidly, thereby causing the respective pockets 54A and 54B to also
move away from each other, resulting in the rapid expansion of the
blood collecting portion 30.
[0017] In addition, the interior of the blood collecting portion 30
comprises a micro-biological inactivating agent(s) (MBIA) which
kill any micro-organisms, viruses, bacteria or the like to render
any blood collected therein (as will be discussed in detail later)
non-biohazardous; such agents may include bromine, chlorine,
Methylene blue (MB) and its derivatives azure A, B, C and thionine.
The inclusion of this agent, and/or other such agents, in the blood
collecting portion 30 can be accomplished in several ways such as
coating the interior surface of the blood collecting portion 30
with a coating of the MBIA; or, the material forming the blood
collecting portion 30 may itself be formed of an MBIA; or, a tablet
of bromine, or chlorine, etc., may be pre-disposed in the blood
collecting portion 30 at the factory. In any case, the presence of
the MBIA in the blood collecting portion 30 renders the collected
blood non-biohazardous, thereby permitting the blood collector 26
to be discarded in a normal fashion.
[0018] The resealable storage portion 28 comprises the same
material as the blood collecting portion 30. The safety needle 34
(along with the cap 36), the blood conveyor 24, the housing 38, the
attachment strap 40 (also referred to as the "contents") are
originally stored in this portion 28 at the factory and then the
opening 32 is releasably sealed using, for example, a tongue 32A
and groove 32B (also known as "pressure interlocking releasable rib
and groove element closure"). When the patient or technician is
ready to use the system 20, the releasable seal is opened, e.g.,
the tongue 32A is removed from the groove 32B and the contents are
pulled out. When the blood letting is completed, the original
contents are stored back into the resealable storage portion 28 and
the releasable seal is closed, e.g., the tongue 32A is friction
fitted into the groove 32B. The resealable storage portion 28 also
contains a MBIA(s) therein so that once the blood letting is
complete, should any blood still in the blood conveyor 24, or even
in the needle 34 or in the housing 38 leak out, such leaking blood
is also rendered non-biohazardous. Like the blood collecting
portion 30, there are many ways to include the MBIA in the
releasable storage portion 28. Once the blood letting is completed,
the entire "used" system 20 can be disposed of in a conventional
manner.
[0019] At the factory, the MBIA is disposed inside both the blood
collecting portion 30 and the releasable storage portion 28 or, as
discussed earlier, or is otherwise present inside both of these
portions 28/30. Next, a vacuum is applied to the aperture 53 to
cause the blood collecting portion 30 to deflate and assume a
substantially flat state, as shown in FIG. 1. Then, the one way
valve 48 is positioned in the aperture 53, thereby maintaining the
vacuum within the blood collecting portion 30. Next, while in the
closed state, the free ends 56A/56B of the leaf spring 58 are
positioned in their respective pockets 54A/54B, as shown in FIG. 1.
Finally, the contents (e.g., the safety needle 34 (along with the
cap 36), the blood conveyor 24, the housing 38, the attachment
strap 40) are placed inside the resealable storage portion 28 and
the opening 32 is closed using the releasable seal (e.g., the
tongue 32A/groove 32B). Thus, except for any packaging, the system
20 is ready for shipment to end users.
[0020] Upon receipt of the system 20, the patient or technician
opens the releasable seal and removes the contents through the
opening 32. The blood collector 26 may be placed on the ground, or
some other lower level with respect to the patient, to have gravity
assist in the withdrawal of blood; however, it should be understood
that this placement is not required. The patient or technician
(hereinafter, "the patient") then operates the intubation portion
22 as follows: If the intubation portion 22 includes the
manually-operable clamp 44, the clamp 44 is placed in the closed
position (FIG. 1A). The cap 36 is removed and the safety needle 34
is coupled to a blood vessel of the patient, e.g., a vein in the
arm 10 of the patient. Once intubation is completed, the patient
then wraps the attachment strap 40 properly around the arm 10 to
secure the needle 34 in place.
[0021] The patient then activates the system 20 by applying an
abrupt force to the joined side 62 of the leaf spring 58; e.g., the
patient can step strongly on the joined side 62 using his/her foot
12. This action fractures the frangible link 60 of the leaf spring
58, which causes the free ends 56A/56B of the leaf spring 58 to
move away from each other suddenly. This movement causes the blood
collecting portion 30 to expand suddenly, (FIG. 2), thereby
creating a suction force to automatically draw a predetermined
amount of blood 64 (e.g., approximately 550 cc or a pint) from the
patient into the blood collecting portion 30. Before the actual
drawing begins, the patient needs to open the clamp 44 (FIG. 2A, if
the clamp 44 is present) at which time the blood in the blood
vessel is exposed to the suction force from expanding blood
collecting portion 30 which draws out the blood.
[0022] The one-way valve 48 permits only the flow of blood from the
blood conveyor 24 into the blood collecting portion 30. There is no
flow permitted from the blood collecting portion 30 into the blood
conveyor 24, thereby preventing any possibility of air or other gas
making its way toward the blood vessel. Furthermore, the protruding
or exposed joined side 62 of the leaf spring 58 permits the abrupt
force to be applied to the expandor (e.g., leaf spring 58) only,
rather than to the blood collecting portion 30 which could rupture
if the abrupt force were applied thereto.
[0023] It should be further noted, where the manually-operable
clamp 44 is not present in the system 20, the activation of the
system 20 would begin as soon as the abrupt force is applied to the
joined side 62 of the leaf spring 58.
[0024] Given the characteristics of the expandor 58 and the
material of the blood receiving portion 30, the system 20 generates
the appropriate suction force for automatically drawing out the
predetermined amount of blood (e.g., approximately 550 cc or a
pint). Once the suction force is diminished and the predetermined
amount of blood 64 is collected, the patient closes the clamp 44
(FIG. 1) and then disengages the intubation portion 22 by loosening
the attachment strap 40, removing the needle 34 and restoring the
cap 36 onto the needle which renders the needle 34 unusable. Next,
the intubation portion 22 and the blood conveyor 24 are placed into
the resealable storage portion 28 and the opening 32 is closed
using the releasable seal, as shown in FIG. 3. The entire system 20
is now ready for safe disposal since all of the blood present in
the blood collector 26 is rendered non-biohazardous due to the
presence of the MBIA inside the blood collecting portion 30 and in
the resealable storage portion 28.
[0025] Without further elaboration, the foregoing will so fully
illustrate my invention that others may, by applying current or
future knowledge, readily adopt the same for use under various
conditions of service.
* * * * *