JPH0338538B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a novel method and apparatus for transferring fluid from a sealed receptacle to a continuous suction device.

In the field of clinical and biological research, a variety of devices have been constructed for receiving fluid samples under test, separating the fluid components, and removing the components separately for subsequent testing or analysis. July 15, 1980
One such device is described in US Pat. No. 4,212,948, Gordon L. Dorn. The Dawn patent describes a technique for selectively separating microorganisms from antimicrobial factors in a sample fluid, such as a lysed blood sample. The blood sample is injected into a sterile, confined zone containing both a emollient and a lytic agent. The lysed blood sample is then centrifuged to allow microbial pathogens to move out of suspension and collect in a layer adjacent to the interface of the relaxation agent and the blood sample itself.

To facilitate the removal of separated sample components,
A centrifuge receptacle with both top and bottom pourable taps or closures is used. The interior surface of the bottom closure is positioned complementary to the corner where centrifugation is to be accomplished. A venting needle is then inserted through the top closure, a second needle with an aspiration device or a syringe is inserted through the bottom closure a distance past the isolated microbial pathogen and into the remaining blood sample, and then Take out the sample. After swirling, a second needle with a syringe is inserted through the bottom closure at a distance immediately adjacent to the bottom closure inner surface and the microbial pathogen. The pathogen is removed and subjected to further testing.

While the separation method described by Dorn is excellent, it has several drawbacks. One is that it requires a lot of handling: two separate syringes and a third vent tube needle. Furthermore, when approached from the bottom, ``bulging'' of the relief layer and remixing of isolated microbial pathogens with residual blood can occur. This tends to override the full effectiveness of centrifugation to some extent.

Other devices are known that can transfer fluid from a fluid source into a fluid collection receptacle. One of such devices
The first is U.S. Patent No. 2, published September 28, 1971.
No. 3608550, Stawski. Starsky suggests using a cannula to pierce the rubber stopper of the fluid receiver. The cannula has an inner diameter sufficient to allow insertion of the second cannula through the first cannula and also provides an air hole for the fluid receiver. The syringe is used for each sample fraction.
It is connected to a second cannula to take out the. While suitable, this construction is relatively complex, requiring two components plus many syringes for each fluid reservoir. Furthermore, it is not adapted for piercing relatively heavy rubber stoppers that are thick enough to maintain a vacuum within the tube, as is the case with Dawn tubes. Careful guidance of the cannula is required to accurately pierce the rubber stopper along the axis of the fluid reservoir.

Szylowitz, in his US Pat. No. 3,206,073, describes a dispensing receptacle having a plastic tube adapted to pierce a rubber stopper 34. Even here, piercing the stopper 34 is difficult to accomplish in an accurate manner due to the lack of guidance, and would be even more difficult if used to pierce a relatively thick rubber stopper. .

A disadvantage of many of these prior art devices for transferring the contents of a receiver to various suction devices is that it is difficult to reach the interior of the receiver and remove some of the contents using a plastic transfer pipette. This can be prevented by using the method of entering from. More particularly, an apparatus is constructed in accordance with the present invention to facilitate transfer of the contents of a receptacle to at least one set of continuous fluid suction members. Each suction member has a suction chamber and a mandrel communicating with the chamber. The receptacle has an open end hermetically sealed by a pourable closure. The transfer device includes a cannula adapted to pierce the closure. The cannula has a passageway adapted to pass the suction member mandrel through the closure while simultaneously venting the interior of the receptacle to atmosphere. The cannula also has an external shroud adapted to slide over the open receptacle end closure to guide the cannula during penetration.

Preferably the cannula is 'coring'
It has a sharp tip that can penetrate the closure without causing damage and is made of hard plastic. This puncturing normally occurs when using larger diameter syringes, such as those required to pass a thinner needle or mandrel. Caniure and enclosure walls are essential. Any suitable hard plastic can be used, such as acetal resin or nylon. The enclosure wall has an inner diameter that is larger than the outer diameter of the closure to facilitate expansion of the closure during piercing operations. The enclosure wall also has an end face lower than the cannula with an internal flange adapted to fit easily onto the closure for positioning the transfer device on the closure prior to piercing.

The fluid suction member is a pipette having an integral hollow bulb and an associated hollow stem. They are also made of soft plastic material. One of the pipettes has a length shorter than the length of the receptacle so that the mandrel can be inserted through the cannula only to a distance that can remove residual blood and prevent it from immersing into separated microbial pathogens. It has a mandrel. The second pipette is typically slightly longer than the length of the receiver plus the length of the closure so that it can reach the bottom of the receiver and remove microbial pathogens. To facilitate such removal, when using a tapered bottom stopper as described in the Dorn patent, the mandrel is bent around a tubular receptacle in which the beveled bottom stopper fits into the side wall of the tube. The mandrel should be flexible so that it can reach. The tip of the mandrel can also be rounded for ease of use. The hollow bulb of the pipette can be sized to suit the amount of fluid desired to be removed.

In another embodiment of the invention, the cannula is located away from the axis of the enclosure wall in a direction opposite to the direction of the tip of the cannula. This compensates for the tendency of the plastic cannula to bias toward the tip of the oblique cannula during penetration.

Using the transfer device of the present invention, successive fractions of fluid are very easily removed from the receiver. Using this device, the enclosure wall first fits easily and snugly into the receptacle top closure. The internal flange of the enclosure facilitates this by fitting onto the exterior of the closure, keeping the transfer device in place until the closure can be penetrated. The piercing can be done by hand, but is preferably done using a press. During penetration, the cannula is guided by the closure and the shroud of the transfer device, which fits over the receiver. Following the piercing, one of the suction members is inserted through the cannula and into the receptacle to remove fluid. The one suction member is then removed and the second suction member is filled in the same manner. In this way several fractions can be removed in succession, each by using a separate suction member.

In another embodiment of the invention, the transfer device is provided with a septum in the cannula.
This helps contain the aerosol within the receiver,
and serves to sweep the external surface of the pipette mandrel.
The septum may be made of any suitable foam or other compliant material that provides ease of entry into the pipette mandrel when precut.

The invention will be more easily understood upon consideration of the figures.

In FIG. 1, a conventional centrifuge type receiver 1
0, an exploded view incorporating the transfer device 12 and the suction member 14 can be shown. Receptacle 10 is a conventional elongate tubular receptacle of the type used for centrifugation and can typically be made of glass or the usual plastics used for this purpose, such as polycarbonate or polypropylene. Receptacle 10 typically has a rounded bottom, although a stopper closure 18 in the form of the type described in the Dorn patent may also be used. The receptacle 10 is closed at the open end 16 by a closure 18. Closure 18 may be of conventional design. That is, a conventional pourable plug-type member sealing the upper end of the tubular receptacle 10. Typically, the closure is made of a rubber self-sealing stopper. The sample material to be processed, such as that described in the Dorn patent, is injected through closure 18 with a conventional hypodermic syringe, and fluids 20 and 2 are injected through closure 18.
Depicted by 0a.

According to the invention, transferring the contents of the tubular receptacle 10 to the suction member 14 is facilitated by the transfer device 12. Fluid aspiration member 14 is typically in the form of a pipette having an integral hollow bulb 22 and an associated hollow stem 24, all made of a soft plastic material such as polyethylene. The transfer device 12 is cap-like in shape with a cannula or piercing portion 30 and a disc-like portion 34 having a sharply pointed diagonal tip 32 extending downwardly from the top along the central axis of the cap. Extending downwardly from the periphery of disc-shaped portion 34 is a surrounding wall 36 having an inner diameter slightly larger than the diameter of closure 18. An internal flange 40 is formed on the side wall 38 at a portion of the enclosure wall 36 below the closure, the internal diameter of the flange being approximately the same as the internal diameter of the closure 18. Similarly, the transfer device 12 can be easily fitted onto the closure 18 for initial positioning prior to piercing the closure 18. The transfer device should be formed from a moldable, rigid material. Plastics such as acetal resin or nylon are preferred.

In use, sample 20 is injected through closure 18 using a conventional syringe as previously described. Receiver 10 is then centrifuged and the sample is separated into fractions 20 and 20a in FIG. 1 as described by the Dorn patent.
It is separated into two fractions as illustrated in . To effectively transfer these two fractions from the receiver, the transfer device 12 is positioned such that the internal flange fits into the upper outer edge of the closure 18. The transfer device 12 is then pushed downwardly so that the enclosure wall 36 slides over the exterior of the receiver, thereby guiding the transfer device to the cannula 30.
can penetrate the closure 18, providing an opening to the atmosphere for the interior of the receptacle.

The length of the cannula 30 is sufficient to pass and clearly pass under the closure 18. Suction member 14 with mandrel 24 is then inserted through hollow cannula 30 . The external diameter of the mandrel is slightly smaller than the internal diameter of the cannula 30 in order to maintain ventilation to the atmosphere for the interior of the receptacle. The bottom of the mandrel is of suitable length so that it reaches into the layer 20a but not into the lower layer so that all the upper layer 20a can be removed when the bulb 22 fits into the top of the transfer device 12. selected as follows. To remove, remove the spherical part 2 before insertion.
2, and as the bulb enlarges to its original shape, atmospheric pressure directs fluid from layer 20a up mandrel 24 and into bulb 2 of suction member 14.
This is done by taking it out within 2. A second suction member 14' (FIG. 3) having a stem 24' of a suitable length to reach the bottom of the receptacle 10 is then attached.
is inserted through the cannula 30 and the bulbous part 22'
Press to aspirate the remaining fraction 20 into bulb 22.

In another embodiment, the upper surface of the transfer device 12 includes an adhesive-lined metal flap ( (not shown). Furthermore, the volumes of the bulbs 22 and 22' of the different suction devices can be sized approximately to match the volumes of the different fractions 20 and 20a to be removed from the tube. The present transfer device 12 is particularly advantageous in that its enclosure protects the sharp end 32 of the cannula 30 to prevent injury to a person thereby. In addition, the enclosure wall has 30 cannulae and 1 closure.
8 along the axis of the receiver 10. The enclosure also helps maintain the sterility of the cannula.

Another embodiment of the invention is shown in FIGS. 5 and 6, in which cannula 30'
2' in a direction opposite to that of the tip 32', i.e., with the tip 32' moving closer to the axis 44.
is being improved. This construction helps overcome problems caused by the flexibility of plastic materials.
As cannula 30' penetrates closure 18, it tends to be guided to one side by V-shaped tip 32'. With this off-center structure, cannula 3
After the cannula pierces the closure 18 due to the horizontal and diagonal movement of 0',
The cannula can terminate its travel generally along axis 44. In yet another embodiment, an upper rim 39 is formed on the top of the transfer device to help prevent contact with the top of the transfer device.
Sterility is thereby more easily maintained.

Cannula 30 opens hand and closes 1
8 could be pierced, but this operation is made much easier by using a simple press of the type depicted in FIG. FIG. 4 shows a press of conventional design having a base member 50, a side plate member 52, a lever 54 for operating the press, and a press head 56. Depressing the lever 54 causes the press head to move downwardly to compress any object between the press head 56 and the bottom plate 50. By aligning the press head 56 with the top of the transfer device 12 and moving the transfer device downwardly from above the receiver 10, the cannula 30 is guided into the enclosure wall 36 and the closure 18 is moved.
Assemble the press head so that penetration occurs. For ease of operation, a circular bottom plate 58 is placed on the bottom member 50 and covered with a frustoconical shaped stand 60;
The stand has a handle 62 for lifting and rotating it. Along the circumference of the bottom, portions of the stand 60 are formed with recesses 63, each adapted to receive one of the receptacles 10 and to be vertically positioned. Housing 60 thus places each successive tube under press 56.
can be rotated so that the receptacle 10 can be continuously penetrated and opened as required to move the suction device in and out.

In yet another embodiment of the invention,
As illustrated in FIGS. 7-12, the transfer device 12'' is improved to maintain a more sealed receptacle than the device shown in FIGS. 1-6. a receptacle 42 adapted to receive an easily pierceable and sealable septum 49;
A rim 39 is formed. The septum 49 is pierceable by an elongated mandrel 24 made of plastic, preferably polyurethane foam, such as Scott Foam Division.
It can be made from products sold by Foam Division. The material preferably has small pores, approximately 273 pores/cm, and is flexible, spongy, and fluid absorbent. Preferably, the material is hydrophilic on its surface. Diaphragm 49 is depicted as having an elliptical shape in longitudinal section. The oval shape is the result of the natural crimp that occurs when the septum is stamped from a sheet of polyurethane foam. As shown in FIG. 10, the central portion of the diaphragm is cut vertically in a Y-shape 43, and the elongated portion 24' of the suction device is
can pass through it easily, and also keeps the receiver airtight.

As shown in FIG. 9, the retaining ring 46 is annular in shape and maintains the clamped septum in position over the aperture of the cannula 30'' when the ring is positioned in the recess 42 and also serves as a suction device. The periphery of the retaining ring 46 preferably has dimples 48;
The protrusion is adapted to fit into a snap ring 51 formed in the inner wall of the recess 42 in each quadrant. Its small protrusion 48 acts as a detent together with the ring 51 to ensure that the retaining ring 46 remains in place. or,
The outer periphery can be press-fitted without small protrusions in the recess 42, or it can be knurled and press-fitted. Retaining ring 46
The outer wall of extends axially to provide a rim 45 to aid in assembly of the device. The axial length of the retaining ring is such that when rim 45 is flush with rim 39 it firmly clamps the peripheral edge of the system.

In this embodiment, the cannula 30' is somewhat longer and the enclosure wall 38' is likewise longer below the cannula tip 32'' to protect the tip from harm or injury to those handling the device.
The enclosure wall 38' is also provided with four axial ribs 47 on its internal surface to facilitate sliding over the receptacle. As before, the guard ring 46 and the transfer device are formed from the same plastic as previously described.

Use of the receiver and rim 39 with this arrangement reduces cross-contamination between caps from the presser head. Furthermore, in order to use a diaphragm, the receiver 1
0 and any excess of serum contents of the receiver is also removed from the exterior of the mandrel 24 due to the sweeping action of the septum as the mandrel is removed from the receiver.

[Brief explanation of drawings]

FIG. 1 is an exploded view of a transfer device and pipette made in accordance with a preferred embodiment of the present invention. FIG. 2 is an assembled view in cross-section of the combination illustrated in FIG. 1 using one type of pipette. FIG. 3 is an assembled view of the assembly depicted in FIG. 1 depicting the use of a long mandrel pipette to remove the lower portion. 4 is a side view of a press and platform that may be used to facilitate piercing the closure of the receptacle of FIG. 1; FIG. Fifth
The figure is a partial cross-sectional view of a transfer device made in accordance with another embodiment of the invention. 6 is a bottom view of the transfer device of FIG. 5; FIG. FIG. 7 is a plan view of a transfer device constructed in accordance with yet another embodiment of the present invention. FIG. 8 is a cross-sectional side view of the transfer device illustrated in FIG. 7 taken along dashed line 8--8. 9 is a partially cutaway view of a retaining ring used in the transfer device of FIG. 7; FIG. FIG. 10 is a plan view of the diaphragm depicted in FIG. 8. FIG. 11 is a side view of the diaphragm depicted in FIG. 10. FIG. 12 is a bottom view of the transfer device of FIG. 7. 10... Receiver, 12... Transfer device, 14...
Suction member, 16... Open end of receiver, 18... Closure, 20... Fluid, 22... Hollow spherical part, 24... Hollow mandrel, 30... Cannula, 3
2...Tip of canniculus, 34...Disk-shaped part, 36...Enclosure wall, 38...Inner wall of enclosure wall, 3
9... Upper rim, 40... Internal flange, 41...
...Inset ring, 42...Receptacle recess, 43
...Y-shaped cut portion of the diaphragm, 44... Axis of the cannula, 45... Rim, 46... Retaining ring, 47... Rib, 48... Small protrusion, 49...
...Diaphragm, 50...Base member, 51...Fitting ring, 52...Side plate member, 54...Lever, 56...
...Press head, 58...Circular bottom plate, 60...Stand (housing), 62...Handle, 63...
...A recess in the stand.

Claims (1)

Claims: 1. An apparatus for facilitating the transfer of the contents of a tubular receptacle to at least one set of successive fluid suction members, each suction member having a suction chamber and a suction chamber thereof. a cannula adapted to pass through the closure, the receptacle having an open end sealably sealed by a fillable closure, and a cannula adapted to pass through the closure, the receptacle having a cannula adapted to pass through the closure; a cannula having a passageway adapted to pass therethrough and vent the interior of the receptacle to the atmosphere; a cannula adapted to slide over a closure at the distal end of the open receptacle to guide the cannula during penetration; the cannula having an external enclosure wall;
equipment containing. 2. The device of claim 1, wherein the cannula is made of hard plastic. 3. The device of claim 2, wherein the cannula has an angled tip to define a sharp tip for piercing the closure. 4. The device according to claim 2, wherein the cannula and the enclosure wall are integrated. 5. The device of claim 1, wherein the cannula has a tip formed at an angle to define a sharp tip for piercing the closure. 6. The device of claim 1, wherein the enclosure wall has an inner diameter greater than the outer diameter of the closure to facilitate expansion of the closure during piercing. 7. The device of claim 1, wherein the enclosure wall has an internally flanged lower end face adapted to snap into the closure for alignment prior to piercing. 8. The device of claim 7, wherein the cannula is formed from hard plastic. 9. The device of claim 1, wherein each fluid suction member is a pipette having an integral central bulbous portion and an articulated hollow stem, and made of a soft plastic material. 10. The apparatus of claim 9, wherein one of the pipette mandrels has a length that is less than the length of the receptacle. 11. The device of claim 10, wherein the other pipette stem is at least as long as the receiver and closure combined. 12. The device of claim 9, wherein the mandrel has a rounded end. 13. The device of claim 1, wherein the cannula is located off-axis of the enclosure wall at a location opposite to the location of the cannula tip. 14. A method of transferring the contents of a tubular receptacle to at least one series of fluid suction members, each suction member having a suction chamber and a mandrel communicating with the chamber; having an open end sealably sealed by a fillable closure and having a passageway adapted to pass through the suction member mandrel and an external shroud adapted to fit over the aperture receptacle closure. using a transfer device having the cannula, and fitting the shroud over the closure, piercing the closure with the cannula while being guided by the shroud to reach the interior of the receptacle, and moving one of the suction members over the cannula. inserting fluid into a receptacle through the cannula, removing fluid from the receptacle into one suction device, removing one suction device from the receptacle, and filling a second suction member from the receptacle through the cannula. . 15. The device of claim 1, wherein the cannula includes a penetrable and resealable member sealing the passageway. 16. The device of claim 15, wherein the penetrable member is a hydrophilic polyurethane foam. 17. Claim 1, wherein the cannula has an upper rim defining a cap-like receptacle and includes an annular retention device for securing the penetrable member.
The device according to item 5.