AU2016222413B2 - Plasma clot serum separation apparatus and method - Google Patents

Abstract

Provided is apparatus 10 useable for separating and extracting plasma clot serum ('PCS') from whole blood 14 in a vial 12. The apparatus 10 generally comprises a selectively permeable piston 20 which is configured for operative fitment into the vial 12, as well as an elongate urging member 22 at one end fast with, or fixed to, the piston 20. This member 22 generally defines an aspiration port 24 at a predetermined distance 26 from the piston 20. The urging member 22 also defines a collection port 28 which is configured for receiving a syringe 30. 2/3 30 10 32 28 24 12 26 n --- -- -- --- -- -- 1618 F FIGURE 2

Description

2/3

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F FIGURE 2

PLASMA CLOT SERUM SEPARATION APPARATUS AND METHOD TECHNICAL FIELD

[0001] This invention relates to apparatus for separating and extracting plasma clot serum from whole blood in a vial, as well as an associated method for separating and extracting plasma clot serum.

BACKGROUND ART

[0002] The following discussion of the background art is intended to facilitate an understanding of the present invention only. The discussion is not an acknowledgement or admission that any of the material referred to is or was part of the common general knowledge as at the priority date of the application.

[0003] Platelet-rich plasma (or "PRP") is plasma containing a large number of platelets. Whole blood, which contains corpuscle components, contains approximately 95% red blood cells, 3% white blood cells, and approximately 1% platelets. On the other hand, platelet-rich plasma contains a higher proportion of platelets. There is, however, no specific definition of the proportion of platelets in PRP. Taking into consideration that the proportion of plasma in whole blood is, in general, approximately 55%, the proportion of platelets in plasma from which the corpuscle components have been removed is assumed to be approximately 2%. Hence PRP contains a higher proportion of platelets than this approximate 2%.

[0004] PRP is generally obtained by centrifuging whole

blood. A typical process involves, firstly, separating red

blood cells from whole blood by weak centrifugation to

obtain a plasma fraction. This plasma fraction contains

white blood cells and platelets, which is then typically

further subjected to strong centrifugation. As a result,

platelets are concentrated in the direction to which

centrifugal force is applied, leaving almost no platelets in

supernatant. PRP is then typically obtained by removing the

supernatant from the plasma which has undergone strong

centrifugation, or by taking out only the predetermined

amount of the plasma from the part in the centrifugal

direction.

[0005] It is known that growth factors, such as PDGF, TGF

beta, and ILGF, exist in alpha granules of platelets. It is

noted that these growth factors play an effective part in

healing of wound and tissue regeneration. For example, PRP

is typically used in regenerative medicine for the treatment

of injury, or the like.

[0006] PRP is in wide use. Examples include US 7,314,617

where a chemical buffer is added. A further example is US

6,322,785 relating to an autologous platelet gel that

includes PRP for bone grafts and dental implants, wherein

the PRP is activated by the addition of collagen. Other uses

see the addition of additives such as calcium in order to

stabilize PRP. Further examples in the art include US

5,585,007; US 5,614,214; and US 5,599,558. Additives or

chemical buffers are generally required for the known

processes for obtaining PRP. However, such additives are

typically undesirable and may have deleterious effects.

[0007] Autologous blood "plasma clot serum" (or "PCS") contains serum without any additives to the patient's blood, alternatively referred to as plasma clot aspirate or extract. This PCS is loaded with growth factors that activate a healing cascade for treating connective tissue disorders or for augmenting connective tissue, without suffering from any potentially unwanted effects due to the use of additives.

[0008] The Applicants have identified a shortcoming in the known art of PRP in that additives are used, which may have undesired effects. The following invention seeks to propose possible solutions, at least in part, to the known shortcomings in the art.

SUMMARY OF THE INVENTION

[0009] According to a first aspect of the invention there is provided apparatus for separating and extracting plasma clot serum ('PCS') from whole blood in a vial, said apparatus comprising: a selectively permeable piston configured for operative fitment into the vial; and an elongate urging member fast at one end with the piston, said member defining an aspiration port at a predetermined distance from said piston and a collection port configured for receiving a syringe, said ports arranged in fluid communication via a conduit, whereby operative urging of the piston facilitates separation of whole blood in the vial into a plasma fraction, so that PCS is aspiratible through the conduit via a syringe.

[0010] Typically, the piston's selective permeability may

be configured to restrict red blood cells from passing

therethrough.

[0011] In one example, the piston's selective permeability

may be configured to allow blood plasma to pass

therethrough.

[0012] Preferably, the piston may be configured to fit

tightly against inner sides of the vial.

[0013] Typically, the elongate urging member may define the

collection port at its other end distal from the piston.

[0014] Preferably, the collection port may be configured so

that a downward force is operatively applicable to the

urging member via a syringe received in said collection

port.

[0015] In one example, predetermined distance at which the

aspiration port is defined may comprise at least an upper

half of the elongate member distal from the piston.

[0016] In one example, the predetermined distance may be in

the range of 5mm to 150mm.

[0017] Typically, the vial may include a conventional blood

collection tube.

[0018] Typically, the conduit is defined internally by the

urging member.

[0019] In one example, the apparatus may include a sealing

cap configured for operative fitment onto the vial to

fluidly seal the vial whilst leaving the collection port

accessible.

[0020] In one example, the apparatus may include a second

cap configured for operative fitment onto the vial with a

selectively permeable membrane that extends into the vial in

a bag-like manner when said second cap is fitted onto the

vial, the bag-like membrane configured to restrict red blood

cells from passing therethrough in order to operatively

facilitate collection of blood plasma therein when fitted to

a vial with whole blood.

[0021] In one example, the apparatus may include a

selectively permeable insert configured for insertion into

the vial, the insert configured to restrict red blood cells

from passing therethrough in order to operatively facilitate

separation of red blood cells and blood plasma when inserted

into the vial.

[0022] In one example, the apparatus may include the vial.

[0023] In one example, the apparatus is configured for

autonomous operation under control of a suitable processor,

i.e. PCS aspiration is largely done automatically.

[0024] According to a second aspect of the invention there

is provided a method for separating and extracting plasma

clot serum ('PCS') from whole blood in a vial, said method

comprising the steps of: inserting a selectively permeable piston into the vial, the piston fast to one end of an elongate urging member defining an aspiration port at a predetermined distance from said piston and a collection port configured for receiving a syringe, said ports arranged in fluid communication via a conduit; connecting a syringe to the collection port; urging the piston into the vial to facilitate separation of the whole blood in the vial into a plasma fraction; and simultaneously aspirating PCS through the conduit via the syringe.

[0025] In one example, the method may include the step of, prior to the step of inserting the piston, fitting a second cap onto the vial, said second cap having a selectively permeable membrane that extends into the vial in a bag-like manner, the bag-like membrane configured to restrict red blood cells from passing therethrough in order to operatively facilitate collection of blood plasma therein.

[0026] The method may include the step of removing the second cap and fitting it to a second vial prior to the step of inserting the piston into the second vial.

[0027] In one example, the method may include the step of, prior to the step of inserting the piston, the step of inserting a selectively permeable insert into the vial, the insert configured to restrict red blood cells from passing therethrough in order to operatively facilitate separation of red blood cells and blood plasma when inserted into the vial.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Further features of the present invention are more

fully described in the following description of several non

limiting embodiments thereof. This description is included

solely for the purposes of exemplifying the present

invention. It should not be understood as a restriction on

the broad summary, disclosure or description of the

invention as set out above. The description will be made

with reference to the accompanying drawings in which:

Figure 1 is a diagrammatic side-view representation of

apparatus for separating and extracting plasma clot serum

from whole blood in a vial;

Figure 2 is a diagrammatic side-view representation of

the apparatus of Figure 1, in use;

Figure 3 is diagrammatic side-view representation of a

further aspect of the apparatus for Figure 1; and

Figure 4 is a diagrammatic side-view representation of

a yet further aspect of the apparatus of Figure 1.

DESCRIPTION OF EMBODIMENTS

[0029] The following modes, given by way of example only,

are described in order to provide a more precise

understanding of the subject matter of a preferred

embodiment or embodiments of the invention.

[0030] In the figures, incorporated to illustrate features of an example embodiment, like reference numerals are used to identify like parts throughout the figures.

[0031] With reference now to the figures, there is shown one example of apparatus 10 useable for separating and extracting plasma clot serum ('PCS') from whole blood 14 in a vial 12. The vial 12 is typically a conventional blood collection tube, or the like.

[0032] The apparatus 10 generally comprises a selectively permeable piston 20 which is configured for operative fitment into the vial 12. Typically, the piston's selective permeability is configured or selected in order to restrict red blood cells 16 from passing therethrough. Similarly, in one example, the piston's selective permeability is configured or selected to allow blood plasma 18 to pass therethrough. Preferably, the piston 20 is configured to fit tightly or snugly against inner sides of the vial 12 in order to facilitate such separation.

[0033] It is to be appreciated that the selective permeability of the piston may be achieved in various ways, as is generally known in the art. For example, miniscule filter channels, piston chemistry, electro-filtration techniques and/or the like may play a role in the selective permeability of the piston.

[0034] The apparatus 10 also includes an elongate urging member 22 at one end fast with, or fixed to, the piston 20. This member 22 generally defines an aspiration port 24 at a predetermined distance 26 from the piston 20. The urging member 22 also defines a collection port 28 which is configured for receiving a syringe 30, i.e. typically sized, shaped and dimensioned to frictionally engage a nozzle of a syringe, or the like. Typically, the elongate urging member 22 defines this collection port 28 at its other end distal from the piston 20, as shown.

[0035] The aspiration port 24 is arranged in fluid communication with the collection port 28 by means of a conduit 32. The conduit 32 is generally defined internally by the urging member 22, as shown. In a preferred example, the collection port 28 is configured so that a downward force can be applied to the urging member 22 by a syringe 30 which is received in the collection port 28. However, this may not be the case in other examples.

[0036] In one example, predetermined distance 26 at which the aspiration port 24 is defined may comprise at least an upper half of the elongate member 22 distal from the piston 20, i.e. the aspiration port 24 is defined in an upper half of the member 22, distal from the piston 20. The predetermined distance 26 may lie in a range of 5mm to 150mm, however this is to be understood as non-limiting and other distances are within the scope of the invention.

[0037] In a particular example, the apparatus 10 may include a sealing cap 34 which is configured for operative fitment onto the vial 12 in order to fluidly seal the vial 12 whilst leaving the collection port accessible to the syringe 30. Such an example may see the sealing cap 34 defining an aperture therethrough for the urging member 22 to slidably pass, so that the piston 20 can be urged whilst the sealing cap 34 seals the vial 12 against fluid spills, or the like.

[0038] In typical use, a syringe 30 may be attached to

the collection port 28 with the apparatus 10 then placed

into the vial 12 with whole blood 14. The piston 20 can now

be urged downwards into the vial 14 in order to facilitate

or assist in the separation of the whole blood 14 into red

bloods cells 16 below the piston 20 and a plasma fraction 18

above the piston 20, as shown in Figure 2.

[0039] By having the aspiration port 24 located the

predetermined distance 26 from the piston, contamination

between the plasma fraction 18, which comprises the PCS, and

the red blood cells 16, can be minimised. PCS can now be

aspirated from the aspiration port 24, via the conduit 32,

through the collection port 28 into the syringe 30.

Typically, a plunger of the syringe 30 is slowly extracted

as the piston 30 is similarly slowly urged downwards into

the vial 12.

[0040] In further examples, as shown in Figure 4, the

apparatus 10 may also include a second cap 36 configured for

operative fitment onto the vial 12 with a selectively

permeable membrane or filter 38 that extends into the vial

12 in a bag-like manner, as shown, when said second cap 36

is fitted onto the vial 12. This bag-like membrane 38 is

generally configured to restrict red blood cells from

passing therethrough in order to operatively facilitate

collection of blood plasma therein when fitted to a vial 12

with whole blood 14

[0041] Alternatively, in an example shown in Figure 3,

the apparatus 10 may include a selectively permeable insert

which is configured for insertion into the vial 12, as

shown. Similarly, this insert 40 is configured to restrict

red blood cells from passing therethrough in order to

operatively facilitate separation of red blood cells and

blood plasma when inserted into the vial 12.

[0042] Typically, either the second cap 36 with membrane

38 or the insert 40 is placed into a vial 12 with whole

blood 14 before the piston 20 and urging member 22 are used

to aspirate PCS. This can be seen as a precursor which

further assists in the separation of the whole blood 14 into

red blood cells 16 and the plasma fraction 18.

[0043] It is to be appreciated that the invention further

provides for an associated method for separating and

extracting plasma clot serum ('PCS') from whole blood 14 in

a vial 12. Such a method generally comprises inserting the

selectively permeable piston 20 into the vial 12, connecting

a syringe 30 to the collection port 28, urging the piston 20

into the vial 12 to facilitate separation of the whole blood

in the vial into a plasma fraction 18, and simultaneously

aspirating PCS through the conduit 32 via the syringe 30.

[0044] As described above, the method may include the

step of, prior to the step of inserting the piston 20,

fitting the second cap 36 onto the vial 12. The method may

then also include a step of removing the second cap 36 and

fitting it to a second vial prior to the step of inserting

the piston 20 into the second vial. Similarly, the method

may alternatively include the step of, prior to the step of inserting the piston 20, the step of inserting the selectively permeable insert 40 into the vial 12.

[0045] It is further to be appreciated that the invention

provides for both manual and automated apparatus configured

to provide the functionality described above. Typically, the

apparatus 10 described above may be manually operated.

However, in other examples, apparatus 10 may be configured

as part of a device or similar assembly which performs the

PCS aspiration automatically or semi-automatically. The

skilled addressee will appreciate that such automated or

semi-automated functionality falls within the scope of the

current invention.

[0046] The Applicants believe it advantageous that the

invention provides for aspiration of PCS and its subsequent

use without the need for additives, as apparatus 10 allows

for quick, simple and easy aspiration of PCS from whole

blood. Using apparatus 10, any delay between extracting

whole blood from a patient and being able to aspirate PCS

for immediate application, may be kept to a minimum.

[0047] Optional embodiments of the present invention may

also be said to broadly consist in the parts, elements and

features referred to or indicated herein, individually or

collectively, in any or all combinations of two or more of

the parts, elements or features, and wherein specific

integers are mentioned herein which have known equivalents

in the art to which the invention relates, such known

equivalents are deemed to be incorporated herein as if

individually set forth.

[0048] It is to be appreciated that reference to "one example" or "an example" of the invention is not made in an exclusive sense. Accordingly, one example may exemplify certain aspects of the invention, whilst other aspects are exemplified in a different example. These examples are intended to assist the skilled person in performing the invention and are not intended to limit the overall scope of the invention in any way unless the context clearly indicates otherwise.

[0049] It is to be understood that the terminology employed above is for the purpose of description and should not be regarded as limiting. The described embodiment is intended to be illustrative of the invention, without limiting the scope thereof. The invention is capable of being practised with various modifications and additions as will readily occur to those skilled in the art.

[0050] Various substantially and specifically practical and useful exemplary embodiments of the claimed subject matter are described herein, textually and/or graphically, including the best mode, if any, known to the inventors for carrying out the claimed subject matter. Variations (e.g. modifications and/or enhancements) of one or more embodiments described herein might become apparent to those of ordinary skill in the art upon reading this application.

[0051] The inventor(s) expects skilled artisans to employ such variations as appropriate, and the inventor(s) intends for the claimed subject matter to be practiced other than as specifically described herein. Accordingly, as permitted by law, the claimed subject matter includes and covers all equivalents of the claimed subject matter and all improvements to the claimed subject matter. Moreover, every combination of the above described elements, activities, and all possible variations thereof are encompassed by the claimed subject matter unless otherwise clearly indicated herein, clearly and specifically disclaimed, or otherwise clearly contradicted by context.

[0052] The use of any and all examples, or exemplary

language (e.g., "such as") provided herein, is intended

merely to better illuminate one or more embodiments and does

not pose a limitation on the scope of any claimed subject

matter unless otherwise stated. No language in the

specification should be construed as indicating any non

claimed subject matter as essential to the practice of the

claimed subject matter.

[0053] The use of words that indicate orientation or

direction of travel is not to be considered limiting. Thus,

words such as "front", "back", "rear", "side", "up", down", "upper", "lower", "top", "bottom", "forwards", "backwards",

"towards", "distal", "proximal", "in", "out" and synonyms,

antonyms and derivatives thereof have been selected for

convenience only, unless the context indicates otherwise.

The inventor(s) envisage that various exemplary embodiments

of the claimed subject matter can be supplied in any

particular orientation and the claimed subject matter is

intended to include such orientations.

[0054] The use of the terms "a", "an", "said", "the",

and/or similar referents in the context of describing

various embodiments (especially in the context of the claimed subject matter) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms

"comprising," "having," "including," and "containing" are to

be construed as open-ended terms (i.e., meaning "including,

but not limited to,") unless otherwise noted.

[0055] Moreover, when any number or range is described

herein, unless clearly stated otherwise, that number or

range is approximate. Recitation of ranges of values herein

are merely intended to serve as a shorthand method of

referring individually to each separate value falling within

the range, unless otherwise indicated herein, and each

separate value and each separate sub-range defined by such

separate values is incorporated into the specification as if

it were individually recited herein. For example, if a range

of 1 to 10 is described, that range includes all values

there between, such as for example, 1.1, 2.5, 3.335, 5,

6.179, 8.9999, etc., and includes all sub-ranges there

between, such as for example, 1 to 3.65, 2.8 to 8.14, 1.93

to 9, etc.

[0056] Accordingly, every portion (e.g., title, field,

background, summary, description, abstract, drawing figure,

etc.) of this application, other than the claims themselves,

is to be regarded as illustrative in nature, and not as

restrictive; and the scope of subject matter protected by

any patent that issues based on this application is defined

only by the claims of that patent.

Claims (14)

1. Apparatus for separating and extracting plasma clot serum

('PCS') from whole blood in a vial, said apparatus comprising:

a selectively permeable piston configured for

operative fitment into the vial; and

an elongate urging member fast at one end with the

piston, said member defining an aspiration port at a

predetermined distance from said piston and a collection port

at an end distal from the piston, said collection port

configured for receiving a syringe, said ports arranged in

fluid communication via a conduit, whereby a downward force is

operatively applicable to the urging member via a syringe

received in said collection port to facilitate separation of

whole blood in the vial into a plasma fraction, so that PCS is

aspiratible through the conduit via a syringe.

2. The apparatus of claim 1, wherein the piston's selective

permeability is configured to restrict red blood cells from

passing therethrough.

3. The apparatus of claim 2, wherein the piston's selective

permeability is configured to allow blood plasma to pass

therethrough.

4. The apparatus of any of claims 1 to 3, wherein the piston

is configured to fit tightly against inner sides of the vial.

5. The apparatus of any of claims 1 to 4, wherein the

predetermined distance at which the aspiration port is defined

comprises at least an upper half of the elongate member distal

from the piston.

6. The apparatus of claim 5, wherein the predetermined distance

is in the range of 5mm to 150mm.

7. The apparatus of any of claims 1 to 6, wherein the vial

includes a conventional blood collection tube.

8. The apparatus of any of claims 1 to 7, wherein the conduit

is defined internally by the urging member.

9. The apparatus of any of claims 1 to 8, which includes a

sealing cap configured for operative fitment onto the vial to

fluidly seal the vial whilst leaving the collection port

accessible.

10. The apparatus of any of claims 1 to 9, which includes the

vial.

11. A method for separating and extracting plasma clot serum

('PCS') from whole blood in a vial, said method comprising the

steps of:

providing apparatus in accordance with any of claims

1 to 10;

inserting the selectively permeable piston into the

vial;

connecting a syringe to the collection port;

urging the piston by means of the syringe into the

vial to facilitate separation of the whole blood in the vial

into a plasma fraction; and simultaneously

aspirating PCS through the conduit via the syringe.

12. The method of claim 11, which includes the step of, prior

to the step of inserting the piston, fitting a second cap onto

the vial, said second cap having a selectively permeable membrane that extends into the vial in a bag-like manner, the bag-like membrane configured to restrict red blood cells from passing therethrough in order to operatively facilitate collection of blood plasma therein.

13. The method of claim 12, which includes the step of removing

the second cap and fitting it to a second vial prior to the

step of inserting the piston into the second vial.

14. The method of claim 11, which includes the step of, prior

to the step of inserting the piston, the step of inserting a

selectively permeable insert into the vial, the insert

configured to restrict red blood cells from passing

therethrough in order to operatively facilitate separation of

red blood cells and blood plasma when inserted into the vial.