In general, this disclosure describes techniques for transferring fluid samples between fluid containment vessels or fluid containing components. Techniques further describe the labeling and handling of sample vessels. In particular, this disclosure describes techniques for transferring or aliquoting medical samples from a sample vessel to one or more aliquot vessels. It should be noted that although the techniques of this disclosure are described with respect to examples for aliquoting medical samples in clinical laboratories, the techniques described herein are generally applicable to the transfer of any manner of fluid samples in laboratory settings or otherwise.
According to one example of the disclosure, an aliquot transfer sample tube adaptor comprises a body having a first end and a second with an axial internal bore running therebetween, a support means intermediate the first end and the second end defining a first receiving cavity and a second receiving cavity, and a needle substantially axially oriented within the internal bore and maintained in position by the support means comprising a first tip intermediate the body first end and the support means and a second tip intermediate the body second end and the support means. In some other embodiments, the needle further comprises at least two apertures on opposing sides of the support means and exposing a lumen internally disposed along a length of the needle. In some embodiments, the adaptor further comprises a needle sheath. In other embodiments, at least one of the needle first tip and needle second tip extend beyond the body first end and body second end, respectively.
According to another example of the disclosure, an aliquot transfer sample tube adaptor as described above can include apertures variously positioned throughout the needle, such as proximate each needle tip. In other examples, the needle may comprise one or more apertures clustered near the support means on one or both sides of the needle. In certain embodiments, one aperture is located proximate to each needle tip, and a radial aperture cluster is located proximate the support means on one needle side. In other embodiments, one or more needle apertures are sized to prevent particulate from passing therethrough.
According to another example of the disclosure, a sample transfer system comprises an aliquot transfer sample tube adaptor comprising a body having a first end and a second with an axial internal bore running therebetween, a support means intermediate the first end and the second end defining a first receiving cavity and a second receiving cavity, and a needle substantially axially oriented within the internal bore and maintained in position by the support means, the needle having a first tip intermediate the body first end and the support means, and a second tip intermediate the body second end and the support means; and a plurality of vessels each having a sealing means actuable by a tip of the adaptor needle when positioned within a receiving cavity of the adaptor, and one or more of a plurality of vessels may be sequentially coupled via the sample vessel adaptor creating fluid communication therebetween. In some other embodiments the needle further comprises at least two apertures on opposing sides of the support means and exposing a lumen internally disposed along a length of the needle. In some embodiments of the sample transfer system, the sealing means of one or more of a plurality of vessels or tubes comprises a pierceable membrane.
According to another example of the disclosure, a method for transferring samples comprises providing a sample vessel adaptor comprising: a body having a first end and a second end with an axial internal bore running therebetween; a support means intermediate the first end and the second end defining a first receiving cavity and a second receiving cavity; and a needle substantially axially oriented within the internal bore and maintained in position by the support means, having a first tip intermediate the body first end and the support means, and a second tip intermediate the body second end and the support means; positioning a sample vessel within the first receiving cavity of the adaptor thereby causing the first needle tip to actuate the sealing means of the sample vessel from a sealed position to an unsealed position; and positioning an aliquot vessel within the second receiving cavity of the adaptor thereby causing the second needle tip to actuate the sealing means of the aliquot vessel; wherein fluid communication is established from the sample vessel to the aliquot vessel and fluid is transferred therebetween. In some other embodiments the needle further comprises at least one aperture on each opposing side of the support means and exposing a lumen internally disposed along a length of the needle. In some other embodiments, fluid communication between the sample vessel and the aliquot vessel is established via the needle lumen. In some embodiments, the sealing means of one or more of the aliquot vessel or sample vessel comprises a pierceable membrane. In still other embodiments, the methods for transferring samples further comprise inverting a coupled adaptor, sample vessel, and aliquot vessel to aid fluid flow into the aliquot vessel. In certain embodiments, the methods for transferring samples further comprise adding a separating gel to the sample tube to separate fluid components.
The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
Diagnostic laboratories play a major role in medicine today. Physicians are heavily dependent of laboratory test results for their clinical decisions. Laboratories have implemented quality control and quality management procedures to ensure the quality of lab results. One focus of efforts to prevent diagnostic errors involves pre-analytic steps. Laboratory test results are heavily affected by the quality of the samples which are impacted by pre-analytical steps. Generally, pre-analytical steps include patient identification and preparation, proper sample collection, accurate labeling of collected samples and transportation of sample to the lab. Correct labeling of patient samples is very crucial and any mistake can have significant medical, social and legal consequences. Mid-size or large clinical laboratories receive hundreds to thousands of patient samples every day for analysis. For a lean process and for better efficiency, many labs have created a specimen processing area which receives all patient samples, processes them and send them to the appropriate laboratory sections for testing.
The usual process after the receipt of sample include logging the sample into the laboratory information system (LIS), if the sample comes with a lab requisition form and if it has not already been ordered by health care provider through a computer system. Most laboratory analyzers cannot read the original label on the patient's sample. Sample processing sections usually create a new label that includes bar coded patient identifiers and test codes that allow automated analyzers in the lab to read the label, to perform the ordered test and to send the result to an electronic medical record. Manual transfer and labeling of these samples pose significant medical, social, and legal consequences. The techniques described herein reduce the risk of contamination of samples, minimize biohazard exposure to laboratory technicians, decrease turn-around time for aliquoting and running the assay, and eliminate some or all human error inherent with manual sample transfer procedures.
As used herein, “fluid” may refer to liquids, homogenous or heterogeneous solutions, colloids, suspensions, gases, gas-infused liquids, or other applicable species as may be determined by one of skill in the art after review of this disclosure. Particularly, “fluid” may refer to medical fluids, such as urine, amniotic fluid, CSF, serums, pericardial fluid, abscess aspirate, whole blood, serum, plasma or other blood products or other bodily fluids.
Tube adaptor 100 is capable of receiving fluid vessel 600 in first receiving cavity 111, wherein needle tip 116 can pierce membrane 615 and establish fluid communication between body 607 and needle lumen 125. The membrane creates a fluid-tight or substantially fluid-tight seal around the needle. Membranes are fashioned from any suitable material, such as elastomeric or polymeric materials, such that a liquid-tight seal is created upon removal of a needle. Needle tips 116 and 117 can be diagonal or flat, as respectively shown, or shaped in other various manners. Factors for needle tip shape can depend on needle diameter, needle wall thickness, needle material, membrane material to be pierced, or other factors as can be determined by one of skill in the art after careful review of this disclosure. Body 105 can be constructed of rigid, semi-rigid, or flexible materials, depending on the desired use. For example, a rigid or semi-rigid body can be used to hold a mated fluid vessel in place. In other examples, a lip or an edge would be located on the interior of body 105, for the purpose of securing the adaptor to the tube or tubes. In other examples, a more flexible body may be used as a safety precaution against fluid spray during mating or un-mating of a tube adaptor with one or more fluid vessels.
In some embodiments, all fluid is transferred to an aliquot tube. In other embodiments, a portion of the fluid is transferred to an aliquot tube. In some other embodiments, a portion of the fluid is transferred to each of a plurality of aliquot tubes, which can be arranged in a queue. Tube adaptor 100 may be utilized to transfer fluid to, from, and/or between fluid vessels in a queue as described in method 530 of
Transfers can be executed manually by laboratory personnel or by an automated process or machine, including, but not limited to, a Secure Aliquoting Machine (SAM). A SAM may comprise a robotic arm attached to a sensored tip. In some embodiments, sensored tips may be metal or plastic, or a combination thereof. A metal tip can use a probe which is sensitive to electrical resistance, while a plastic tip uses a change in pressure to sense a liquid. Use of an aliquot transfer sample tube adaptor as described herein in addition to or as an alternative to sensored tips can provide increased device efficiency and performance, as significantly reduce device costs.
For further demonstration of fluid transfer techniques, and others,
In some embodiments it may be advantageous to exclude radial apertures, or include radial apertures only on certain portions of a tube adaptor needle.
In some embodiments the sample tube 750 position may be manipulated, such as wholly inverted, and the gel will hold a constant position and prevent movement of the blood cellular components. In some embodiments the gel position may change, but a complete or substantially complete isolation of the blood cellular components and blood plasma will be maintained. During a partial or complete inversion of the sample tube, the blood plasma can freely flow to the top or capped end of the tube where it may be extracted using any of the techniques described herein.
In all embodiments herein, the length of one or both aliquot transfer sample tube adaptor needles can depend on one or more of a variety of factors such as the height of a sample tube, the thickness of a pierceable sample tube cap, the amount of fluid being transferred between one or more tubes or sample vessels, the number and the location of radial apertures desired, or a particular layered fluid arrangement within the sample tube. In certain embodiments, having a plurality of radial apertures on the aliquot transfer sample tube adaptor needle ensures that the maximum amount of serum or plasma or other fluid will be transferred from the tube containing the sample to the aliquot tube, independent of the thickness of the pierceable membrane or tube cap. In some embodiments, needle length is determined independently from or in cooperation with the number and/or position of needle.
Throughout this disclosure embodiments of aliquot sample transfer tube adaptors may be described as having one or two needles, although the functional difference between either construction should be construed as minimal, as a two needle configuration will comprise two needles in fluid communication unless otherwise indicated. One of skill in the art after review of this disclosure will appreciate the benefits of a one or two needle construction, such as in ease or cost of manufacture, yet will readily appreciate the applicability of either construction for the techniques described herein.
Further, “needle” as used herein can describe lumenous shafts, or other blunt, sharp, or semi-sharp shafts which can be used to puncture, pierce, penetrate, or otherwise disrupt a seal or enclosure, such as a pierceable membrane.
“Pierceable membrane” as used herein, should be construed to refer to any element which closes, seals, shuts, or otherwise preserves an opening. Pierceable membranes are able to be pierced by sharp objects, such as needles, without leaking fluid, air, or other material around the pierced area. As provided herein, the pierceable membranes of the techniques described herein are capable of reclosing, resealing, self-healing, rehealing, or reshooting once the sharp object is removed from the pierceable membrane. The pierceable membrane described herein is able to recover the ability to be fully sealed or closed. Further, as provided herein, pierceable membranes are capable of retaining a needle or other object used to puncture the stopper without allowing fluids or materials to leak, seep, pass or flow around the area of the stopper that is retaining the needle or object.
The pierceable membrane can be made of rubber, latex, polymeric materials, or any suitable bio-compatible material, or a combination thereof. The pierceable stopper is made of one or more materials that are able to be sterilized via medically approved and acceptable means, and able to be pierced or punctured by an object, including but not limited to a sharp object, such as a needle, without leaking, seeping, passing or flowing around the area of the stopper that is retaining the needle or object. The pierceable stopper is self-healing, gas proof, solvent proof, and liquid proof.
In some embodiments, pierceable membranes can be replaced by, or used in conjunction with, other sealing elements such as check valves, luer locks, or other self-sealing element, or edges, lips or ridges which one of skill in the art would identify as applicable to the techniques described herein after review of this disclosure. These alternative or additional sealing elements can be actuated, unseated, or otherwise removed from a sealing position or condition by a needle, a shaft, or other suitable means. For example, one or more needle tips of an aliquot transfer sample tube adaptor may be used to unseat a check valve from a sealing position. Examples of luer locks or check valves suitable for use with aliquot sample tube adaptors, sample transfer systems and transfer methods provided herein are found in the art, including but not limited to U.S. Pat. No. 5,984,373.
All publications, patents, and patent documents are incorporated by reference herein, as though individually incorporated by reference.
While specific embodiments have been described above with reference to the disclosed embodiments and examples, such embodiments are only illustrative and do not limit the scope of the invention. Changes and modifications can be made in accordance with ordinary skill in the art without departing from the invention in its broader aspects as defined in the following claims.
Filing Document | Filing Date | Country | Kind |
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PCT/US14/68651 | 12/4/2014 | WO | 00 |
Number | Date | Country | |
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61911901 | Dec 2013 | US |