U.S. patent application number 11/852935 was filed with the patent office on 2008-03-06 for method and apparatus for sterilely acquiring and separating a fluid.
Invention is credited to Richard W. Yee.
Application Number | 20080058755 11/852935 |
Document ID | / |
Family ID | 32092630 |
Filed Date | 2008-03-06 |
United States Patent
Application |
20080058755 |
Kind Code |
A1 |
Yee; Richard W. |
March 6, 2008 |
Method and Apparatus for Sterilely Acquiring and Separating a
Fluid
Abstract
A method and apparatus are provided by which a fluid may be
drawn and packaged within a series of interconnected sterile units.
Once filled with the fluid, the connectors joining the sterile
units may be sealed and severed to produce a number of separate
sterile units. The volume of the separate sterile units may
correspond to a single dose of the fluid. The technique allows a
fluid to be partitioned into sterile units without exposure to the
air or other potential contaminants.
Inventors: |
Yee; Richard W.; (Houston,
TX) |
Correspondence
Address: |
CHOWDHURY & GEORGAKIS, P.C
P.O. Box 17299
Sugar Land
TX
77496
US
|
Family ID: |
32092630 |
Appl. No.: |
11/852935 |
Filed: |
September 10, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10272650 |
Oct 17, 2002 |
7288082 |
|
|
11852935 |
Sep 10, 2007 |
|
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Current U.S.
Class: |
604/410 |
Current CPC
Class: |
A61B 5/150366 20130101;
A61B 5/150992 20130101; A61B 5/154 20130101; A61M 1/0209 20130101;
A61B 5/15003 20130101 |
Class at
Publication: |
604/410 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61B 19/00 20060101 A61B019/00 |
Claims
1-18. (canceled)
19. An apparatus for forming an asymmetric airtight seal
comprising: a clamping section configured to conformably engage a
deformable tube, wherein the clamping section forms an asymmetric
seal in the deformable tube, such that the asymmetric seal, when
broken, forms an airtight end and an open end in the tube.
20. The apparatus as recited in claim 19, wherein the clamping
section comprises one or more heat-generating elements configured
to heat the deformable tube when the clamping section is
conformably engaged such that the asymmetric seal is formed by the
heat.
21. The apparatus as recited in claim 20, wherein the clamping
section is configured to apply pressure to the deformable tube
while the deformable tube is heated such that the asymmetric seal
is formed by the combination of heat and pressure.
22. The apparatus as recited in claim 19, wherein the clamping
section comprises one or more compressive elements configured to
apply pressure to the deformable tube when the clamping section is
engaged such that the asymmetric seal is formed by the
pressure.
23. A method for sterilely collecting fluid comprising: filling a
sterile assembly with a fluid, wherein the sterile assembly
comprises two or more compartments such that adjacent compartments
are joined by a respective connector; ceasing an inflow of the
fluid when a final compartment is filled with the fluid; and
forming an asymmetric airtight seal in at least one connector
comprising a deformable tube using a clamping section configured to
conformably engage the deformable tube, wherein the clamping
section forms the asymmetric airtight seal in the deformable tube,
wherein the asymmetric airtight seal, when broken, forms an
airtight end and an open end in the deformable tube.
24. The method as recited in claim 23, wherein the clamping section
comprises one or more heat-generating elements configured to heat
the deformable tube when the clamping section is conformably
engaged such that the asymmetric airtight seal is formed by the
heat.
25. The method as recited in claim 24, wherein the clamping section
is configured to apply pressure to the deformable tube while the
deformable tube is heated such that the asymmetric airtight seal is
formed by the combination of heat and pressure.
26. The method as recited in claim 23, wherein the clamping section
comprises one or more compressive elements configured to apply
pressure to the deformable tube when the clamping section is
engaged such that the asymmetric airtight seal is formed by the
pressure.
27. The method as recited in claim 23, further comprising forming a
symmetric airtight seal within a respective connector between
respective compartments not having an asymmetric airtight seal
therebetween, wherein the symmetric airtight seal, when broken,
forms a first airtight end and a second airtight end in the
respective connector.
28. The method as recited in claim 27, wherein forming the
symmetric airtight seal in the respective connector between the
respective compartments comprises at least one of heating and
compressing the respective connector between the respective
compartments to form the symmetric airtight seal in the respective
connector.
29. The method as recited in claim 27, further comprising detaching
each compartment from one or more adjacent compartments at each
respective symmetric airtight seal such that one or more sterile
storage compartments are formed from the disconnected sterile
assembly.
30. The method as recited in claim 23, wherein filling the sterile
assembly with the fluid comprises applying one of positive pressure
and negative pressure to fill the sterile assembly with the
fluid.
31. An apparatus for storing a fluid comprising: two or more
sterile sections wherein adjacent sections are joined by a
respective connector, wherein the respective connector allows the
flow of the fluid between the adjacent sections when open; a fluid
inlet connected to an upstream fluid reservoir; and a clamping
section configured to conformably engage at least one connector
comprising a deformable tube, wherein the clamping section is
arranged to form an asymmetric airtight seal in the deformable
tube, such that the asymmetric airtight seal, when broken, forms an
airtight end and an open end in the deformable tube.
32. The apparatus as recited in claim 31, wherein the clamping
section comprises one or more heat-generating elements configured
to heat the deformable tube when the clamping section is
conformably engaged such that the asymmetric airtight seal is
formed by the heat.
33. The apparatus as recited in claim 32, wherein the clamping
section is configured to apply pressure to the deformable tube
while the deformable tube is heated such that the asymmetric
airtight seal is formed by the combination of heat and
pressure.
34. The apparatus as recited in claim 31, wherein the clamping
section comprises one or more compressive elements configured to
apply pressure to the deformable tube when the clamping section is
engaged such that the asymmetric airtight seal is formed by the
pressure.
35. The apparatus as recited in claim 31, wherein the fluid inlet
is a mechanism for drawing blood.
36. The apparatus as recited in claim 31, wherein the respective
connector is closed by one of a symmetric airtight seal and an
asymmetric airtight seal and wherein the adjacent sections are
separable at the one of the symmetric airtight seal and the
asymmetric airtight seal to form separate sections, wherein the
symmetric airtight seal, when broken, forms a first airtight end
and a second airtight end in the respective connector.
37. The apparatus as recited in claim 36, wherein the one of the
symmetric airtight seal and the asymmetric airtight seal is at
least one of a heat shrink seal and a compression seal.
38. The apparatus as recited in claim 31, further comprising a
pressure regulator operatively coupled to the apparatus such that
pressure within the apparatus can be adjusted.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of U.S. application Ser.
No. 10/272,650, filed Oct. 17, 2002, incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to the field of
storage of biomedical samples and fluids. More specifically, the
invention relates to the sterile acquisition and storage of
medications and bodily fluids in dosage packaging without exposing
the fluids to air and contaminants.
[0004] 2. Description of the Related Art
[0005] This section is intended to introduce the reader to aspects
of art that may be related to various aspects of the present
invention, which are described and/or claimed below. This
discussion is believed to be helpful in providing the reader with
background information to facilitate a better understanding of the
various aspects of the present invention. Accordingly, it should be
understood that these statements are to be read in this light, and
not as admissions of prior art.
[0006] The medical and research communities routinely acquire
samples of bodily fluids, such as blood, and store such samples for
subsequent use. Similarly, medications, drugs, or research
compounds may be prepared and stored in large quantities but may
need to be used in substantially smaller doses. In both instances,
it is often desirable to provide the fluids in packaging which is
easy to store and which corresponds to a usable amount, i.e., a
single dose. In the process of placing the fluid into storage
containers, however, it is desirable to prevent contact with the
air or any other potential contaminant which would compromise the
sterility of the fluid packaging.
[0007] For example, if a blood sample is drawn from a patient for
subsequent division and storage, a technician must either switch
sample collection tubes during the process of drawing the blood in
order to obtain multiple samples or must draw a single, larger
sample which is subsequently divided. In both techniques, there is
a risk of contamination due to exposure to air or contact with
other non-sterile environments and/or instrumentation. To obviate
these risks the sample may be heated or otherwise treated to
minimize the risks of contamination. These additional steps may be
undesirable and add a level of complexity to the process. It is
therefore desirable to provide a means by which a fluid or sample
may be obtained and separated into dosage storage containers
without introducing the risks associated with air exposure and
without necessarily requiring additional treatments, such as
heating or irradiation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The foregoing and other advantages of the invention will
become apparent upon reading the following detailed description and
upon reference to the drawings in which:
[0009] FIG. 1 is a depiction of an apparatus for storing a fluid in
the process of filling the sterile chambers of the apparatus with
the fluid;
[0010] FIG. 2 is a depiction of an apparatus for storing a fluid in
which the sterile chambers of the apparatus are filled with the
fluid;
[0011] FIG. 3 is a depiction of an apparatus for storing a fluid in
which connectors joining the sterile chambers of the filled
apparatus have been sealed to form an airtight seal;
[0012] FIG. 4 is a depiction of an apparatus for storing a fluid in
which the filled sterile chambers of the apparatus have been
separated at the airtight seals to form sealed individual doses of
the fluid; and
[0013] FIG. 5 is a depiction of one exemplary embodiment of the
present technique in which a patient's blood is the fluid which is
used to fill the apparatus for subsequent storage.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0014] One or more specific embodiments of the present invention
will be described below. Turning now to the drawings, and referring
initially to FIG. 1, a sterile assembly 10 is depicted which is
connected to a fluid source 12. The fluid source 12 can include a
pressure regulator 14, here depicted as consisting of a piston
action plunger cooperatively configured to apply pressure in an
airtight manner to the fluid 16 within the fluid source 12.
Alternate pressure regulation configurations are of course possible
such as configuring pressure regulator 14 to create an area of
negative pressure away from the fluid source 12, see FIG. 5, or
combinations of positive and negative pressure within the
apparatus. Typically any configuration of one or more pressure
regulators 14 which produce a relative negative pressure downstream
within sterile assembly 10 is acceptable. In instances in which the
sterile assembly 10 is configured for drawing bodily fluids, the
sterile assembly 10 may be created as a sterile vacuum or to
inherently possess low relative pressure such that the bodily fluid
is naturally drawn into the sterile assembly 10.
[0015] The fluid source 12 also consists of a fluid outlet 18
terminating in an airtight junction 20. The fluid 16 flows through
the fluid outlet 18 due to the pressure differential created by the
pressure regulator 14. The fluid 16 typically consists of a drug or
medication stored in a stock supply or of a patient's bodily
fluid.
[0016] In the present technique, the sterile assembly 10 is
connected to the airtight junction 20 via a fluid inlet 22 which
cooperatively engages the junction 20. The fluid inlet 22 provides
fluid access to the remainder of the attached assembly 10, which
consists of at least two compartments 24 joined together by a
connector 26 which, when open, allows the fluid 16 to flow between
the compartments 24. As depicted, the fluid inlet 22 is attached to
an upstream terminal compartment 28. Likewise there is a downstream
terminal compartment 30 from which the fluid 16 does not flow into
another compartment 24. As many compartments 24 as necessary may be
included in the assembly 10 in order to provide sufficient storage
for the quantity of fluid 16 desired.
[0017] Typically the compartments 24 are sized such that they hold
a single or multiple dose of the fluid 16 and are therefore
uniformly sized in most applications. However, the compartments 24
may be differently sized if the quantity comprising a single dose
is to vary over the course of treatment, i.e., dosage gradually
tapering off as treatment progresses. The sterile assembly 10 is
typically constructed from an airtight material, such as one of the
various plastics utilized to make sterile biomedical storage
containers. In one embodiment, the assembly is constructed of a
sterile, flexible biomedical plastic which is vacuum vacated and
sealed such that no contaminants or air are present in the assembly
10 prior to use. In this embodiment, the compartments 24 expand as
they are filled with the fluid 16.
[0018] As depicted in FIG. 1, the sterile assembly 10 is initially
attached to the fluid source 12 via coupling the fluid inlet 22 to
the junction 20. The fluid 16 is then introduced into the assembly
10 by the pressure differential created or maintained by the
pressure regulator 14. While the apparatus 10 is being filled with
the fluid 16, the connectors 26 are open, allowing the fluid 16 to
reach and fill all of the compartments 24.
[0019] Once the sterile assembly 10 is filled with fluid 16, as
depicted in FIG. 2, the pressure differential may be equilibrated
via the pressure regulator 14. Once the pressure differential is
equalized, the connectors 26 are closed by forming an airtight seal
32 within the connector 26, as depicted in FIG. 3. In one
embodiment of this technique, the biomedical plastic of which the
connectors 26 are composed is a heat-shrink plastic. Upon
application of heat to the connector 26, the connector 26 shrinks
in volume to form an airtight seal 32. In other embodiments, the
connector 26 may be composed of a pressure sensitive material such
that pressure may be applied to form the airtight seal 32 or the
connector 26 may be constructed with engaging surfaces along the
interior which engage to form an airtight seal when moved into
contact. In other embodiments, a combination of heat and pressure
may be used to affect the seal. Other means by which the airtight
seal 32 may be formed exist and are within the scope of the
described technique.
[0020] After airtight seal 32 is formed, the compartments 24 may
separated from one another at the seal 32, as depicted in FIG. 4.
Due to the airtight seal 32, the fluid 16 is never exposed to the
air and thus remains sterile. As depicted in FIG. 4, the
compartments 24, once separated, form sterile storage containers 34
which may be stored as needed and which each contain a prescribed
dose of the fluid 16, ready for use by a doctor or patient. The
sterile storage containers 34 consist of a main body 36 and one or
more portions of sealed connector 38 which remain associated with
the main body 36 after separation. The portions of sealed connector
38 provide easy access to the stored fluid 16, when needed, by
either cutting or tearing. In this manner, a single or multiple
dose of the fluid 16 may be provided for subsequent application to
a patient, test subject or process.
[0021] In an alternative embodiment, the sterile assembly 10, once
filled, may be sealed by heat or pressure means at the fluid inlet
22. The sterile assembly may then be stored intact. During storage,
the seals 32 may or may not be formed in the respective connectors
26. In this embodiment, prior to use or during storage, an airtight
seal 32 is be formed in the desired connector and the respective
sterile storage container 34 may then be removed from the sterile
assembly 10 for use.
[0022] In this embodiment a sealing device may be configured to
create an airtight seal 32 which does not break symmetrically. The
configured sealing device may apply heat, pressure, or a
combination of the two via clamping section to form the asymmetric
seal. The clamping section is typically configured to conform to
the shape of the connector when loose and may tighten to deform the
connector as pressure and/or heat are applied. Heat may be
generated by elements within the clamping section which utilize
infrared, RF, electrical, or chemical energy or other heat
generating methods known in the art.
[0023] The airtight seal 32 which is created may be formed to break
such that the compartments 24 remaining connected to the sterile
assembly 10 remain airtight, and thus sterile, while the storage
container 34 which is removed is open and ready for use due to the
asymmetry of the airtight seal 32 formed. In this manner a filled
sterile assembly 10 may be filled, stored and sealed such that,
when desired, a sterile storage containers 34 may be removed from
the assembly 10 ready for use.
[0024] In one exemplary embodiment, the fluid 16 is a patient's
blood 36. In this embodiment, the assembly 10 can be utilized while
the patient's blood 36 is drawn, as depicted in FIG. 5. The
apparatus 10 in this embodiment can utilize negative pressure to
fill the compartments 24 with the blood 36 without allowing
exposure to the air. In particular, a pressure regulator 14 may be
operatively coupled to the terminal compartment 30 to create
negative pressure to draw the blood into the apparatus 10. The
pressure regulator 14 may operate on a piston principle.
Alternately, the apparatus 10 itself may be formed and stored as a
vacuum such that the negative pressure of the vacuum draws the
blood into it once connected to the patient. As with the previously
described embodiment, once the apparatus 10 is filled, the
connectors 26 joining the compartments 24 to each other and to the
fluid inlet 22 and pressure regulator 14 are sealed and then
separated. Once separated, the storage containers of blood may be
stored and subsequently used for medicinal purposes, such as for
the treatment of certain eye disorders.
[0025] While the invention may be susceptible to various
modifications and alternative forms, specific embodiments have been
shown by way of example in the drawings and will be described in
detail herein. However, it should be understood that the invention
is not intended to be limited to the particular forms disclosed.
Rather, the invention is to cover all modifications, equivalents
and alternatives falling within the spirit and scope of the
invention as defined by the following appended claims. Illustrative
embodiments of the present claimed subject matter are described in
detail below. In the interest of clarity, not all features of an
actual implementation are described in this specification. It will
of course be appreciated that in the development of any such actual
embodiment, numerous implementation-specific decisions must be made
to achieve the developers' specific goals, such as compliance with
system-related and business-related constraints, which will vary
from one implementation to another. Moreover, it will be
appreciated that such a development effort might be complex and
time-consuming, but would nevertheless be a routine undertaking for
those of ordinary skill in the art having the benefit of the
present disclosure.
* * * * *