Patent Application
20190001347
The present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to filtration devices for biological samples.
A wide variety of medical devices have been developed for medical use, for example for collecting and/or processing biological samples. Some of these devices include filtration devices.
This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example medical device includes a filtration device. The filtration device comprises a funnel member having a first end region and a second end region; a flange coupled to the first end region; a filter support portion coupled to the second end region; and wherein the filter support portion includes a base, a filter membrane coupled to the base, and a securing member for securing the filter membrane to the base.
Alternatively or additionally to any of the embodiments above, the flange is designed to support the funnel member within a centrifuge tube.
Alternatively or additionally to any of the embodiments above, the securing member includes an outer ring designed to be disposed along an outer surface of the base to secure the filter membrane to the base.
Alternatively or additionally to any of the embodiments above, the base includes an outer retaining region for retaining the outer ring.
Alternatively or additionally to any of the embodiments above, the securing member includes an inner ring designed to be disposed along an inner surface of the base to secure the filter membrane to the base.
Alternatively or additionally to any of the embodiments above, the base includes an inner retaining region for retaining the inner ring.
Alternatively or additionally to any of the embodiments above, the filter support portion is designed to be releasably attached to the funnel member.
Alternatively or additionally to any of the embodiments above, the filter membrane includes a plurality of pores having a diameter of 5 microns or less.
A method for processing a biological sample is disclosed. The method comprises: collecting the biological sample using an aspiration device; transferring the biological sample from the aspiration device to a centrifugation and filtration assembly; wherein the centrifugation and filtration assembly include a centrifuge tube and a filtration device disposed within the centrifuge tube; wherein the filtration device comprises: a funnel member having a first end region and a second end region, a flange coupled to the first end region, a filter support portion coupled to the second end region, and wherein the filter support portion includes a base, a filter membrane coupled to the base, and a securing member for securing the filter membrane to the base; and centrifuging the centrifugation and filtration assembly for processing the biological sample.
A method for processing a biological sample is disclosed. The method comprises: collecting a biological sample using a fine needle aspiration device; transferring the biological sample from the fine needle aspiration device to a centrifugation and filtration assembly; wherein the centrifugation and filtration assembly include a centrifuge tube and a filtration device disposed within the centrifuge tube; wherein the filtration device comprises: a funnel member having a first end region and a second end region, a flange coupled to the first end region, a filter support portion coupled to the second end region, and wherein the filter support portion includes a base, a filter membrane coupled to the base, and a securing member for securing the filter membrane to the base; and centrifuging the centrifugation and filtration assembly.
Alternatively or additionally to any of the embodiments above, further comprising removing the filtration device from the centrifuge tube.
Alternatively or additionally to any of the embodiments above, further comprising disposing the filtration device within a secondary tube.
Alternatively or additionally to any of the embodiments above, the filter support portion is detachable from the funnel member, and further comprising detaching the filter support portion from the funnel member.
Alternatively or additionally to any of the embodiments above, further comprising adding a washing solution to the filtration device.
Alternatively or additionally to any of the embodiments above, the centrifuge tube further comprises a cap designed to secured to the centrifuge tube, and further comprising securing the cap to the centrifuge tube.
Alternatively or additionally to any of the embodiments above, centrifuging the centrifugation and filtration assembly includes centrifuging the centrifugation and filtration assembly at a speed sufficient to generate a relative centrifugal force of 800-1200 times gravitational acceleration.
An assembly for processing a biological sample collected using a fine needle aspiration device is disclosed. The assembly comprises: a centrifugation tube; a cap designed to be secured to the centrifugation tube; a filtration frame disposed within the centrifugation tube, the filtration frame comprising a flange portion designed to engage the centrifugation tube while allowing the cap to be secured to the centrifugation tube, a funnel portion, and a filter member releasably coupled to the funnel portion; and wherein the filter member includes a base, a filter membrane coupled to the base, and a securing member for securing the filter membrane to the base.
Alternatively or additionally to any of the embodiments above, the securing member includes an outer ring designed to be disposed along an outer surface of the base to secure the filter membrane to the base.
Alternatively or additionally to any of the embodiments above, the base includes an outer retaining region for retaining the outer ring.
Alternatively or additionally to any of the embodiments above, the securing member includes an inner ring designed to be disposed along an inner surface of the base to secure the filter membrane to the base.
Alternatively or additionally to any of the embodiments above, the base includes an inner retaining region for retaining the inner ring.
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:
While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
There are a number of methods for the collection of biological samples by a biopsy and/or other surgical processes. Such processes typically result in a tissue sample that can be routinely processed for pathological analysis. In some endoscopic procedures such as those where a fine needle aspiration device is utilized, the sample that is collected includes loose cells and fluids. Prior to tissue processing and/or analysis, additional steps may be necessary to gather the desired cells/tissue and allow the cells/tissue to be further processed. Disclosed herein are devices and methods that allow cells/tissue to be efficiently processes and/or analyzed including cells/tissue gathered by fine needle aspiration devices and/or other devices that collect cells/tissue along with fluids.
A biological sample 16 may be collected and added to the assembly 10. In at least some instances, the biological sample 16 may be collected by a fine needle aspiration device 17. Alternatively, the biological sample 16 may be collected by a surgical and/or biopsy device. In other instances, the biological sample may include a cultured sample or otherwise be derived from a cell culture, a laboratory sample, or the like. The sample 16, for example, may be transferred from the fine needle aspiration device 17 to the filtration device 14. When doing so, the sample 16 may be separated or “filtered” into a first component 16a and a second component 16b. In this example, the biological sample 16 may contain cells/tissue in a fluid. Accordingly, when the sample 16 is transferred to the filtration device 14, the filtration device 14 may begin to separate the cells/tissue (e.g., which may correspond to the first component 16a) from the fluid (e.g., which may correspond to the second component 16b).
In at least some instances, the filtration device 14 is designed to be seated within the tube 12 in a manner that allows the assembly 10 to be centrifuged when the sample 16 is added to the filtration device. Centrifugation may allow the sample 16 to further separate (e.g., such that the first component 16a may be more fully separated from the second component 16b). In addition, the filtration device 14 may also be designed so that the filtration device 14 can be removed from the tube 12. When doing so, the filtration device 14 can be replaced in the same tube 12 (e.g., following the removal of the second component 16b of the sample 16) and/or the filtration device 14 may be disposed within another tube (e.g., a secondary tube that may be same or different from the tube 12). In some instances, the filtration device 14, or more particularly the first component 16a of the sample 16 captured on the filtration device 14, may be subjected to further processing. Such further processing may include rinsing, washing, fixing, and/or the like. For example, the first component 16a may be washed and/or fixed with saline, formalin, and/or the like. If desired, the filtration device 14 can be moved one or more times to additional tubes and/or subjected to further rinsing, washing, fixing, and/or the like, as desired.
When the sample 16 is suitably prepared, the sample 16 (or, more particularly, the first component 16a of the sample 16) can be processed using the desired techniques. This may include fixing the cells (e.g., chemically fixing using a suitable material such as formalin), freezing the cells, dehydrating the cells using a suitable material such as ethanol, clearing or otherwise processing the cells with xylene or another suitable agent, embedding the cells in a suitable material (e.g., in paraffin or the like), transferring the cells to a histology cassette, combinations thereof, or the like.
The filter support portion 20 may be designed to be coupled to a second end region 26 of the funnel portion 18. In some instances, the filter support portion 20 may attach to the funnel portion 18 by a friction fit, an interference fit, a threaded connection, or other suitable bond. In at least some instances, the filter support portion 20 is releasably attached to the funnel portion 18. A releasable bond may allow the filter support portion 20 to be removed from the funnel portion 18 so that cells/tissue collected thereon can be further processed in an efficient manner.
In at least some instances, the securing member 32 is designed so that the filter membrane 30 can be securely attached to the base 28 that allows for the filtration device 14 (and/or the assembly 10) to be centrifuged. For example, the base 28 may include a retaining region 40. The retaining region 40 may take the form of a groove, socket, or the like disposed along an outer surface of the base 28. The securing member 32, which may take the form of a resilient or rigid ring of material, may be passed over the bottom end 36 of the base 28 and be seated in the retaining region 40 in order to more securely attach the filter membrane 30 to the base 28. For example, the filter membrane 30 may be disposed along the bottom end 36 of the base 28 as shown in
While disposing the securing member 32 along the outer surface of the base 28 may be sufficient to secure the filter membrane 30 to the base 28, other arrangements are contemplated. For example,
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Application Ser. No. 62/527,357, filed Jun. 30, 3017, the entirety of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62527357 | Jun 2017 | US |
