WO2001004599A1

WO2001004599A1 - Coring device

Info

Publication number: WO2001004599A1
Application number: PCT/US2000/019144
Authority: WO
Inventors: Joseph Fraccalvieri; David Meyer; Frank Sauers
Original assignee: V.I. Technologies, Inc.
Priority date: 1999-07-13
Filing date: 2000-07-13
Publication date: 2001-01-18
Also published as: AU5933500A

Abstract

One embodiment of the present invention provides a coring apparatus for obtaining a core sample from a target. The coring apparatus includes a coring element adapted for insertion into the target, a driving assembly coupled to the coring element for driving the coring means into and out of said target, and an ejection element coupled to the coring element and adapted for ejecting the core sample from the coring element upon removal of the coring element from the target. A coring apparatus according to another version of the invention includes a coring element adapted for insertion into the target, and a pneumatic driving assembly coupled to the coring element for driving the coring element into and out of the target.

Description

CORING DEVICE

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for obtaining a core sample from a target, and more particularly, to methods and apparatus for inserting a coπng assembly, e g , a cannula-type needle, into a target, e g , a frozen plasma bag, to obtain a core sample, e g , frozen plasma The core sample is then available for testing or examination

BACKGROUND OF THE INVENTION

Blood, plasma, and biological fluid donation programs are essential first steps in the manufacture of pharmaceutical and blood products that improve the quality of life and that are used to save lives in a vaπety of traumatic situations Such products are used for the treatment of immunological disorders, for the treatment of hemophilia, and are also used in maintaining and restoring blood volume m surgical procedures and other treatment protocols. The therapeutic uses of blood, plasma, and biological fluids require that donations of these materials be as free as possible from viral contamination Typically, a serology test sample from each individual blood, plasma, or other fluid donation is tested for various antibodies, which are elicited in response to specific viruses, such as hepatitis-C (HCV) and two forms of the human immunodeficiency virus (HIV-1 and HIV-2) In addition, the serology test sample may be tested for antigens designated for specific viruses such as hepatitis-B (HBV), as well as antibodies elicited in response to such viruses If the sample is serology positive for the presence of either specific antibodies or antigens, the donation is excluded from further use

Although antigen tests for certain viruses, such as hepatitis-B, are thought to be closely correlated with infectivity, antibody tests are not It has long been known that a blood plasma donor may, in fact, be infected with a virus while testing serology negative for antibodies related to that virus For example, a window exists between the time that a donor may become infected with a virus and the appearance of antibodies, elicited in response to that virus, in the donor's system. The time peπod between the first occurrence of a virus in the blood and the presence of detectable antibodies elicited in response to that virus is known as the "window peπod " In the case of HIV, the average window period is approximately 22 days, while for HCV, the average window period has been estimated at approximately 98 days. Therefore, tests directed to the detection of antibodies, may give a false indication for an infected donor if performed during the window period, i.e., the period between viral infection and the production of antibodies. Moreover, even though conventional testing for HBV includes tests for both antibodies and antigens, testing by more sensitive methods have confirmed the presence of the HBV virus in samples which were negative in the HBV antigen test.

One method of testing donations, which have passed available antibody and antigen tests, in order to further ensure their freedom from incipient viral contamination, involves testing the donations by a polymerase chain reaction (PCR) method. PCR is a highly sensitive method for detecting the presence of specific DNA or RNA sequences related to a virus of interest in a biological material by amplifying the viral genome. Because the PCR test is directed to detecting the presence of an essential component of the virus itself, its presence in a donor may be found almost immediately after infection. There is, theoretically therefore, no window period during which a test may give a false indication of freedom of infectivity. A suitable description of the methodology and practical application of PCR testing is contained in U.S. Patent No. 5,176,995, the disclosure of which is incorporated herein by reference.

Plasma donations are often frozen soon after they are received. When samples of individual plasma donations are needed for testing, each donation must be thawed, an aliquot of the blood or plasma removed from the donation, and the donation must then be refrozen for preservation. Multiple freeze-thaw cycles may adversely affect the recovery of the RNA or

DNA of interest, thus adversely affecting the integrity of the PCR test. Multiple freeze-thaw cycles may also adversely affect the proteins contained within the plasma.

Moreover, each time an aliquot of individual plasma donations is withdrawn from the frozen sample, the donation is subject to contamination, both from the surrounding environment, and from the apparatus used to withdraw the aliquot. Further, if the donation contains a virus, it can contaminate other donations. In order to avoid introducing viral contaminants into an otherwise viral free donation, the sample taking apparatus must be either sterilized after each individual use, or used for taking only a single aliquot from a single individual donation and a new sample taking apparatus used for taking an aliquot from a subsequent individual donation. Either of these methods involves considerable expense and is quite time consuming.

Accordingly, there is a need for simple and effective apparatus and methods for obtaining samples of frozen plasma. Hence, it is an object of the invention to provide an effective, rapid, and inexpensive way to sample frozen plasma. It is a further object of the invention to provide a sampling apparatus that is easily sterilized between sampling events. It is yet another object of the invention to provide a sampling apparatus that has no electrical parts.

SUMMARY OF THE INVENTION The present invention provides a coring apparatus for obtaining a core sample from a target. The coring apparatus includes a coring element adapted for insertion into the target, a driving assembly coupled to the coring element for driving the coring element into and out of said target, and an ejection element coupled to the coring element and adapted for ejecting the core sample from the coring element upon removal of the coring element from the target.

A coring apparatus according to another version of the invention includes a coring element adapted for insertion into the target, and a pneumatic driving assembly coupled to the coring element for driving the coring element into and out of the target.

Still another version of the invention provides a method for obtaining a core sample from a target. The method includes the steps of placing the target in a holder, and driving a coring assembly into and out of the target. The coring assembly includes a coring element adapted for insertion into the target, a driving assembly operatively coupled to the coring element for driving the coring element into and out of the target, and an ejection element for ejecting the core sample from the coring element upon removal of the coring element from the target.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic side view of one embodiment of a coring apparatus according to the invention; FIG. IB is a schematic side view of the holder shown in FIG. 1A;

FIG. 1C is a top schematic view of the holder and the collection cup shown in FIG. 1 A;

FIG. 2A shows one embodiment of the ejection element, i.e., the push-rod, shown in FIG. 1A;

FIG. 2B shows one embodiment of the coring element, i.e., the cannula-type needle, shown in FIG. 1A;

FIG. 2C is a top view of the needle block of FIG. 1 A;

FIG. 2D is a side view of the block assembly of FIG. 1 A;

FIG. 2E is a top view of the block assembly of FIG. 1A;

FIG. 2F is a side, view of the nose mount platform of FIG. 1A;

FIG. 2G is a top view of the nose mount platform of FIG. 1A;

FIG. 3 is a schematic side view of an alternative embodiment of a coring apparatus according to the invention; and

FIGS. 4-8 are a series of side views of the embodiment of FIG. 1 A showing the coring device inserting a coring element into and out of the target.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to systems, processes and devices useful for testing blood or plasma donations to detect those specific donations which have a viral contamination above a pre-determined level. Such contaminated donations are then disposed of to thereby prevent their incorporation into the raw material stream for pharmaceutical products or their transfusion into human patients. The viral detection tests used in accordance with practice of the present invention can be any that directly detect a virus instead of antibodies elicited in response to the virus. The tests include polymerase chain reaction (PCR) tests and other tests which are sufficiently sensitive to directly detect a virus.

With reference to FIG. 1 A, one embodiment of a coring device 10 according to the invention includes a coring element such as a cannula-type needle 15, and a driving assembly 19 coupled to the coring element for driving the coring element into and out of the target 14, e.g., a plasma bag. The coring device 10 can also include an ejection element 18, such as a push-rod, for ejecting a core sample from the coring element once the coring element has extracted the core sample from the target 14.

The driving assembly includes a housing 20 and a shaft 29, that slidably extends from the housing 20. With reference to FIGS. 1 A, 2C and 2F, the shaft 29 is coupled to a nose mount 22. The nose mount 22 has nose mount posts 23 for coupling to receiving holes 25 in a needle block 24. The needle block 24 has a needle channel 24a adapted for fixedly supporting needle 15. Push-rod 18 is slidably contained within needle 15. Needle 15 can have a variety of cross-sectional sizes and shapes, e.g., circular, rectangular, and elliptical. Furthermore, needle 15 can be made of a variety of materials, e.g., stainless steel and plastic.

According to a preferred embodiment, the driving assembly 19 includes all pneumatic controls. In other words the apparatus does not include an electric unit. The apparatus 10 has a pneumatic controller where both push buttons (not shown) have to be pushed at the same time for a signal to activate a solenoid valve 27. The air operated solenoid 27 then applies air to a main cylinder 29a. The system operates on float controls, i.e., speed controls on the cylinder 29a. The cylinder itself has a rear damper (not shown) that operates on the last inch of the cylinder's stroke. With reference to FIG. 3, an alternative embodiment of a driving assembly 19 includes a spring element 30, triggered by a release trigger 31.

With reference to FIGS. IB and 1C, the holder 11 includes holder pins 12a and 12b.

Pins 12a are about a half inch off center. There is a needle guide (not shown) that slides up and down on pins 12a. Pins 12b are about ³ inch back from pins 12a and they are about 2 inches off center. Pins 12b hold the standard size plasma bag in place. Pins 12b are removable and replaceable. Thus, when an operator wants to test an oversize target, e.g., an oversize plasma bag, the operator removes pins 12b and inserts the oversize target. The holder

11 also includes a back plate 1 la. The back plate 1 la can be a V* inch stainless plate that's bolted to the holder base plate 1 lb. Thus, the driving assembly 19 pushes the target 14 up against the back plate 1 la as the driving assembly 19 pushes the needle 15 through the bag. In operation, the embodiment of FIG. 1A operates as follows. An operator places a target, such as a plasma bag, in the holder. The driving assembly 19 is activated by two safety push buttons (not shown). The driving assembly pushes the cannula-type needle 15 through the frozen plasma bag 14. The plasma bag is stored at -30 degrees farenheit. The push-rod 18 is prevented from penetrating the bag by the frozen plasma. Thus, as illustrated in FIGS. 4-6, the push-rod 18 automatically backs away as the driving assembly 19 pushes the cylinder 15 through the bag. Once the driving assembly has pushed the needle 15 a pre-defined length, the driving assembly 19 retracts the needle 15 containing an appropriately sized plasma sample. With reference to FIGS. 7-8, as the driving assembly 19 retracts the needle 15, proximal end 18a of the rod 18 comes in contact with the base plate 19a of the driving assembly 19. Thus, as the driving assembly 19 continues to retract the needle, the base plate 19a forces the rod 18 into the needle 15 and consequently, the push-rod 18 pushes the sample 35 into a collection cup 13.

The holder 11, collection cup 13, and needle 15 are removable. Thus, after a particular cycle, a user can remove these parts for cleaning and place a new set of parts in position for the next collection cycle.

In the particular example where the targets are bags of frozen plasma, the plasma bags are normally stored in a box. After sampling, the bags are placed in a bag and returned to their original storage box.

The practice of the present invention results in the blood supply, and blood or plasma products prepared therefrom, being substantially safer by virtue of its being as free as possible from viral contamination, with minimal freeze-thaw cycles. Advantageously, cost-effective, high sensitivity testing is readily performed for the presence of a virus directly. Thus, false indications of virus contamination usually associated with antibody testing during the infectivity window period, is avoided. Moreover, the present invention allows cost-effective use of high sensitivity tests which are capable of detecting the presence of a single virus in the test sample, thus helping insure the freedom of the blood supply from incipient viral contamination. Those skilled in the art will appreciate that the foregoing examples and descriptions of various prefeπed embodiments of the present invention are merely illustrative of the invention as a whole, and that variations in the shape, size and number of the various components of the present invention, as well as the types of tests implemented, may be made within the spirit and scope of the invention. For example, it will be clear to one skilled in the art, that the length of the individual and connected pouches, and therefore their volumetric content, may be progressively increased along the length of the tubing segment. As successive testing subpools are formed from a smaller and smaller number of samples, the volume of plasma comprising the pool necessarily decreases. Those skilled in the art will appreciate that the invention may be embodied in other specific forms without departing form the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of the equivalency of the claims are therefore intended to be embraced therein.

Accordingly, the present invention is not limited to the specific embodiments described herein, but rather is defined by the scope of the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A coring apparatus for obtaining a core sample from a target, said coring apparatus comprising coring means adapted for insertion into said target, driving means coupled to said coring means for driving said coring means into and out of said target, and ejection means coupled to said coring means and adapted for ejecting said core sample from said coring means upon removal of said coring means from said target.

2. The coring apparatus of claim 1 , wherein said coring means comprises a cannula-type needle having a first proximal end, and having a second distal end for insertion into said target.

3. The coring apparatus of claim 2, wherein said ejection means comprises a push-rod slidingly contained in the proximal end of the cannula-type needle.

4. The coring apparatus of claim 1 , wherein said driving means comprises a housing, and a pneumatically driven shaft partially contained within said housing, said shaft having a distal end that extends from said housing.

5. The coring apparatus of claim 1, wherein said coring apparatus further comprises pneumatic controls for pneumatically controlling said driving means.

6. The coring apparatus of claim 4, wherein said driving means further comprises a nose mount mounted on said distal end of said shaft.

7. The coring apparatus of claim 6, wherein said driving means further comprises a block assembly mounted on said nose mount.

8. The coring apparatus of claim 7, wherein said needle is removably and replaceably mounted on said block assembly.

9. The coring apparatus of claim 8, wherein said coring apparatus is configured such that when the needle is extracted from the target, the push rod comes in contact with the driving means housing causing the push rod to slide longitudinally within the needle and push the core sample out of the distal end of the needle.

10. The coring apparatus of claim 1 , wherein said coring apparatus further comprises a holder for said target.

11. The coring apparatus of claim 10, wherein said holder is removably and replaceably mounted on said apparatus.

12. The coring apparatus of claim 1, wherein said coring apparatus further comprises a collection cup for collecting said core sample when said core sample is ejected from said coring means.

13. A coring apparatus for obtaining a core sample from a target, said coring apparatus comprising coring means adapted for insertion into said target, and pneumatic driving means coupled to said coring means for driving said coring means into and out of said target.

14. The coring apparatus of claim 13, wherein said coring apparatus further comprises ejection means coupled to said coring means and adapted for ejecting said core sample from said coring means upon removal of said coring means from said target.

15. A method for obtaining a core sample from a target, said method comprising the steps of placing said target in a holder, and driving a coring assembly into and out of said target, wherein said coring assembly comprises coring means adapted for insertion into said target, driving means operatively coupled to said coring means for driving said coring means into and out of said target, and ejection means for ejecting said core sample from said coring means upon removal of said coring means from said target.

16. The method of claim 15, wherein said method further comprises the step of ejecting the core sample from said coring means upon removal of said coring means from said target.

17. The method of claim 15, wherein said coring means comprises a cannula-type needle removably and replaceably mounted on said driving means.

18. The method of claim 17, wherein said coring assembly further comprises a holder for holding said target, said holder removably and replaceably mounted on said coring assembly.

19. The method of claim 18 wherein said coring assembly further comprises a collection cup for collecting said core sample from said target upon ejection of said core sample from said coring means, said collection cup removably and replaceably mounted on said coring assembly.

20. The method of claim 19, wherein said method further comprises the step of removing said needle, holder, and collection cup subsequent to obtaining a core sample from said target, and inserting a sterile needle, holder, and collection cup into said coring assembly.