U.S. patent application number 10/014375 was filed with the patent office on 2002-04-11 for platelet collection method.
Invention is credited to Berckmans, Bruce III, Jorgensen, Glen E..
Application Number | 20020042336 10/014375 |
Document ID | / |
Family ID | 22414547 |
Filed Date | 2002-04-11 |
United States Patent
Application |
20020042336 |
Kind Code |
A1 |
Jorgensen, Glen E. ; et
al. |
April 11, 2002 |
PLATELET COLLECTION METHOD
Abstract
A single use system and kit for producing blood platelet
concentrates is described herein. In a preferred form, the kit
includes a bag set in which compartments containing blood
components are adjacent to separate compartments which can be
inflated to express the blood components after their separation by
centrifuging.
Inventors: |
Jorgensen, Glen E.;
(Marlboro, MA) ; Berckmans, Bruce III; (Palm Beach
Gardens, FL) |
Correspondence
Address: |
JENKENS & GILCHRIST, P.C.
225 WEST WASHINGTON
SUITE 2600
CHICAGO
IL
60606
US
|
Family ID: |
22414547 |
Appl. No.: |
10/014375 |
Filed: |
October 26, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10014375 |
Oct 26, 2001 |
|
|
|
09525573 |
Mar 15, 2000 |
|
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60124385 |
Mar 15, 1999 |
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Current U.S.
Class: |
494/37 |
Current CPC
Class: |
A61M 1/029 20130101;
A61M 1/3693 20130101; A61M 1/3698 20140204; Y10S 383/904 20130101;
A61M 1/0209 20130101; B04B 5/0428 20130101; A61M 2202/0427
20130101; B04B 2005/0435 20130101 |
Class at
Publication: |
494/37 |
International
Class: |
B04B 005/02 |
Claims
What is claimed is:
1. A blood platelet collection system comprising (a) a centrifuge
bucket for receiving two pairs of bags, said centrifuge bucket
having an internal wall for separating said pairs of bags; (b) a
first pair of bags for separating whole blood into the components
platelet-poor plasma, red cells, and platelet concentrate, said
bags being connected at the top with a hollow tube in communication
with the interior of said bags, permitting transfer of the
concentrates of one bag to the second bag, said bags being adapted
to fit within said centrifuge bucket on either side of said
internal wall; (c) a second pair of bags for compressing the first
pair of bags of (b), each of said second pair of inflatable bags
being adapted to fit within said centrifuge bucket adjacent to one
of said bags of (b).
2. A blood platelet collection system of claim 1, wherein at least
one of said first pair of bags of (b) and one of said second pair
of inflatable bags of (c) are an integrated structure, each such
structure having a first interior volume for containing whole blood
and the components of (b), and a second interior volume for
receiving air under pressure and expanding to compress the first
interior volume.
3. A blood platelet collection system of claim 2, wherein said
integrated structure comprises three sheets joined with a weld seam
at their peripheries.
4. A method of collecting blood platelets comprising (a)
introducing whole blood into a first expandable bag, said
expandable bag being connected to a second expandable bag by a
hollow tube communicating with the interior of each of said first
and second expandable bags; (b) placing said first and second
expandable bags into a centrifuge bucket having an internal wall,
said first and second expandable bags being disposed on opposite
sides of said internal wall; (c) centrifuging said bucket to
separate the whole blood within said first bag into red cells
concentrated at the bottom of said first bag and platelet-rich
plasma concentrated at the top of said first bag; (d) inflating a
first inflatable bag disposed adjacent to said first expandable bag
in said centrifuge bucket to express platelet-rich plasma into said
second expandable bag; (e) centrifuging said bucket to separate the
platelet-rich plasma in said second expandable bag into
platelet-poor plasma and platelet concentrate; (f) inflating a
second inflatable bag disposed adjacent to said second expandable
bag in said centrifuge bucket to express platelet-poor plasma into
said first expandable bag; (g) removing said platelet concentrate
from said second expandable bag through a sample tube having an
inlet at the bottom of the bag.
5. A method of claim 4, wherein said first expandable bag and said
first inflatable bag are an integrated structure, and said second
expandable bag and said second inflatable bag are an integrated
structure.
6. A method of claim 5, wherein said integrated structure comprises
three sheets joined by a weld seam at their peripheries.
7. A compartmented container for use in separating blood into
component red cells, platelet-poor plasma, and platelet concentrate
comprising an integrated structure consisting of three flexible
sheets sealed at the edges to form two cavities, the first of said
cavities for holding blood components and the second of said
cavities for receiving air under pressure, said integrated
structure having tubulations to provide access to the interior of
said cavities.
8. A compartmented container of claim 7, wherein said compartmented
container is joined by a bridge to a second compartmented
container.
Description
TECHNICAL FIELD OF THE INVENTION
[0001] This invention relates to processing whole blood into
platelet-rich plasma and, more particularly, to improvements in
blood processing systems for generating platelet-rich plasma from
autologous blood.
BACKGROUND OF THE INVENTION
[0002] The science and effectiveness of using platelet-rich plasma
derived from the patient's own blood in surgery are documented in
medical, trade and science journals. A known method for the
preparation of platelets from whole blood is described in the
American Association of Blood Bank's Technical Manual, 12th
Edition, 1996, at pages 700-701, Method 9.11. A system employing
this method collects the patient's whole blood into a collection
unit with two integrally-attached transfer containers. The blood is
collected into the collecting container, the other two transfer
containers are collapsed, and the two transfer containers with the
collecting container are subjected to a "soft spin" in a
centrifuge, which brings the plasma to the top of the collecting
unit, leaving red cells at the bottom. In the next step, the
collecting container containing the blood is squeezed in a plasma
extractor to force the platelet-rich plasma into one of the
transfer containers through a connecting tube. A fraction
comprising red cells remains behind in the collecting container,
which is then removed. Next, the two transfer containers, the first
being empty and the second containing the plasma, are subjected to
a "heavy spin" in a centrifuge to concentrate platelets at the
"bottom" of the second transfer container, leaving a platelet-poor
fraction of the plasma (PPP) above the platelet concentrate (PC) in
the second transfer container. The following step squeezes the
second transfer container to express the PPP into the first
transfer container. The platelet concentrate (PC) is then
resuspended and collected for use. This system uses a process
requiring six separate steps, including two centrifugal steps and
two separation steps. The terms "light spin" and "heavy spin" are
defined in Table 10.5-1 at page 716 of the AABB Technical
Manual.
SUMMARY OF THE INVENTION
[0003] It is an object of this invention to provide a single use
system for producing platelet concentrates (PC). Preferably, the
system is in the form of a kit including disposable components
supplied sterile in disposable packaging, and having all of the
components required to draw blood from the patient, prevent blood
coagulation, process the sample into platelet concentrate, and
deliver the platelet concentrate to a surgical site. It is a
particular object of the invention to provide such a system that
will be useful to medical and dental practitioners, including, but
not limited to, dentists, periodontists, and oral and maxillofacial
surgeons.
[0004] The invention in one of its aspects provides a bag set
comprising two bags joined by a tube which includes a built-in
sample site at the second bag and has sloped top surface geometry
at both bags for improved and more efficient cell separation and
collection. This new bag set may be pre-charged with an
anticoagulant. A preferred size range is 50-100 ml, but the
invention is not limited to any particular size range.
[0005] In another aspect of the invention, each bag consists of two
compartments, the first for the sedimentation of cellular material
and the second to serve as an inflatable device for the purpose of
expressing supernatant liquid from the first compartment.
[0006] In still another aspect, the invention provides a bifurcated
centrifuge bucket having two wells, into each of which one of the
cell bags is placed together with an inflatable device, and a means
successively to inflate each inflatable device to perform each
expression step following the soft spin and the heavy spin, thereby
eliminating the step of removing the bag set from the bucket after
each spin. In a further aspect, the invention provides means to
express the supernatant liquid from within the bucket, thereby
eliminating the need to remove the bag set from the bucket after
the heavy spin.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The invention is disclosed in greater detail with reference
to the accompanying drawings.
[0008] FIG. 1 illustrates a set of two bags according to the
invention.
[0009] FIG. 2 shows the bag set in a bifurcated centrifuge bucket
with adjacent inflatable third and fourth respective bags.
[0010] FIG. 3 illustrates the third bag being inflated.
[0011] FIG. 4 illustrates the fourth bag being inflated.
[0012] FIGS. 5a, b and c illustrate a two chamber bag.
[0013] FIG. 5a is a schematic side view of the two chamber bag.
[0014] FIG. 5b is a sectional edge view of the bag of FIG. 5a.
[0015] FIG. 5c is a top sectional view showing the tubulations
which provide access to the bag of FIG. 5a.
[0016] FIG. 6 is a plan view of a unitary two bag set.
[0017] FIG. 7 illustrates the bag set of FIG. 6 assembled to a
supporting cover for the centrifuge bucket.
[0018] FIG. 8 is an isometric view of a centrifuge bucket.
DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0019] FIGS. 1-4 illustrate the principles by which bags of the
invention operate. FIGS. 5-8 illustrate a preferred embodiment.
[0020] In FIG. 1, a standard needle set (not shown) may be coupled
via access tube 10 to a first bag 12 which is connected via a
transfer tube 14 to a second bag 16. A sample site is provided at
an access tube 18 fitted to the second bag. The top wall 13, 15 of
each bag may be sloped as shown for more efficient cell separation
and collection. The principles on which invention operates are
schematically illustrated in FIGS. 2-4.
[0021] In FIG. 2, the bag set 12, 16 is shown in a bifurcated
centrifuge bucket 20 having two wells 24, 26 separated by a
partition 21. Each cell bag 12, 16 is in one of the respective
wells 24, 26 together with a third or fourth inflatable bag 22, 28,
respectively, which is not connected to the interior of the
associated cell bag. The transfer tube 14 connects the interior of
the two cell bags 12, 16. Each inflatable bag has an access tube
22', 28', respectively. Each of the access tubes, 10, 18, 22' and
28' may be furnished with a valve 30 to control access to the
interior of the respective bags. Transfer tube 14 may also be
provided with a valve 30, as shown, to isolate the cell bags during
centrifugation. The fourth inflatable bag 28 is shorter than its
companion cell bag 16, so that a desired volume (e.g., about 5 ml)
of plasma concentrate will be left in bag 16 when bag 28 is
inflated to a desired pressure.
[0022] In use, the first bag 12 is charged with the patient's blood
sample in preparation for the soft spin. The inflatable bags 22 and
28 are not inflated. The contents of the bucket 20 are then
subjected to a soft spin as described above. After the soft spin,
as shown in FIG. 3, a pump (not shown) or other air source is
connected via the access tube 22' to the third bag 22 and the third
bag is inflated, squeezing the first bag 12 and forcing the plasma
fraction over the transfer tube 14 into the second bag 16, leaving
the red cell fraction behind in the first bag. The contents of the
bucket 20 are then subjected to a heavy spin, as described above.
The third bag may be left inflated during centrifuging of the
bucket and its contents. Following the heavy spin, the contents of
the second bag 16 are a pellet of platelet concentrate 29 (see FIG.
4) at the bottom of the bag and platelet-poor plasma above the
platelet concentrate. A pump (not shown) or other air source may be
attached to the access tube 28' of the smaller fourth bag 28, and
that bag is inflated and platelet-poor plasma may be forced into
the first bag 12 via the transfer tube 14, as shown in FIG. 4.
Expression is continued until the platelet poor plasma above the
platelet concentrate is expressed into first bag 12, leaving the
platelet rich plasma in the second bag 16. With this new
arrangement of the invention, the platelet concentrate fraction is
processed into the second bag 16 without a need to remove the bags
from the centrifuge bucket during the process. Further according to
the invention, the platelet concentrate can be removed from the
second bag 16 via the sample site tube 18 using a known extraction
syringe.
[0023] FIGS. 5a, 5b and 5c illustrate a two chamber bag 40 which
combines a collection chamber 42 and an expression chamber 44 in a
single structure. This bag 40 corresponds to bags 16 and 28 in
FIGS. 2-4. In the edge view shown in FIG. 5b, three sheets 52, 54
and 56 are joined at their peripheries with a weld seam 46 (see
FIG. 5a). Typically, the sheets will be of a flexible plastic. The
outer sheets 52 and 56 are shown expanded for clarity. In addition,
for use of the collection chamber 42 for platelet collection (e.g.,
bag 16 in FIG. 1), a second weld seam 48 joins the intermediate
sheet 54 to the expression chamber sheet 56 to shorten the
expression chamber so as to isolate the desired volume of platelet
concentrate with the PC produced by the invention. FIG. 5b
illustrates the effect of inflating the expression chamber 44. A
similar two chamber structure 70 (see FIG. 6), without the second
weld seam 48, is the equivalent of the first bag 12 and its
associated expression device 22 shown in FIGS. 2-4.
[0024] As shown in FIG. 5a, tubulations 58, 64 and 68 are provided
in this integrated structure 40 for providing access to the
chambers 42 and 44 (FIG. 5b). The first tubulation 58 is sealed
between the sheets 54 and 56 defining the expression cavity 44, and
provides access corresponding to the access tube 28' leading into
the inflatable bag 28 in FIG. 2. The second tubulation 64 is sealed
between the sheets 52 and 54 defining the platelet collection
chamber 42, and provides access for a transfer tube (e.g., tube 14
in FIG. 1). The third tubulation 68 is similarly provided into the
collection chamber, and provides access corresponding to the sample
site tube 18 in FIG. 1. A top view, FIG. 5c, further illustrates
the tubulations 58, 64 and 68, providing access to expression
cavity 44 and collection chamber 42 of FIG. 5b.
[0025] FIG. 6 shows a pair of two chamber structures 40, 70 that
may be joined by an optional bridge 80 between their respective
ends that are fitted with tubulations (58, 64 and 68 for structure
40 and 58.sup.1, 64.sup.1 and 68.sup.1 for structure 70) to
constitute the bag set 85. The bridge may also be omitted. As
shown, structure 40 includes platelet collection chamber 42 (FIG.
5b) corresponding to bag 16 in FIGS. 2-4 (facing upward) and
expression cavity 44 (FIG. 5b) corresponding to bag 28 in FIGS. 2-4
(facing downward). Structure 70 includes a collection chamber
corresponding to bag 12 in FIGS. 2-4 (facing upward) and an
expression cavity (facing downward) corresponding to bag 22 in
FIGS. 2-4. The tubulations 58, 64 and 68 shown in FIG. 5 are shown
in FIG. 6, with the corresponding tabulations 58.sup.1, 64.sup.1
and 68.sup.1 associated with structure 70. In use, this bag set is
placed in the bifurcated bucket 20 (FIGS. 2-4), with the structure
70 corresponding to cell bag 12 in well 24, and the structure 40
corresponding to cell bag 16 in well 26. The optional bridge 80 may
be flexible or rigid but, in either case, it would contact
partition 21 (FIGS. 2-4) with the pairs of bags on the desired side
of the centrifuge bucket. As shown, the bridge is flexible and may
be a part of the two chamber structures. Alternatively, the bridge
could be a relatively rigid plastic molded in a U-shape to fit over
the partition 21.
[0026] The installation of the bag set 85 in a supporting cover 89,
ready for installation in a bifurcated bucket (20 in FIGS. 2-4 and
90 in FIG. 8) is shown in FIGS. 7-8. In FIG. 7, the assembled bags
are shown as they would be seen if 40 and 70 of FIG. 6 were folded
at the middle and viewed from the side of FIG. 6. The larger two
chamber structure 70 is at the right of the drawing, and the
smaller two chamber structure 40, used to collect the PC product,
is at the left in FIG. 7. The tubulations provided for access to
the bags that contain blood or blood products may be fitted with
valves 84, 88. These valves have sufficient mass to require
restraint against moving into the wells 24, 26 (see FIGS. 2-4)
under centrifugal force, and supporting cover 89 is provided to
support and restrain them against such movement and to facilitate
making and breaking connections to the valves.
[0027] Supporting cover 89 is shown in FIG. 8 without the two
chamber structures 40 and 70 of FIG. 7. In FIG. 8, it can be seen
that the supporting cover 89 is intended to seat on the centrifuge
bucket 90. The two chamber structures 40 and 70 will be inserted
into the two sides of the centrifuge bucket, where they will be
used according to the procedure described connection with FIGS.
2-4. The centrifuge bucket will typically be made of a plastic,
which may be clear or translucent to facilitate observation of the
processing of blood into its components as described above.
* * * * *