Patent Application
20240000442
This invention relates generally to minimally invasive micro-needle array skin sample devices, and more particularly, to a micro-needle array skin sample device having a less invasive micro-needle density to yield ratio to reduce discomfort, and also methods of production thereof.
Various forms of micro-needle array skin sample in patches including that which is disclosed in US 2017/0145489 A1 (MINDERA CORPORATION) 25 May 2017 which a device containing an array of microneedles to which are attached probes specific for one or more biomarkers of interest.
US 2020/0229803 A1 (GE HEALTHCARE UK LIMITED) 23 Jul. 2020 discloses a similar device for obtaining a skin sample which has an array of micro-needles arranged on a base plate.
US 2003/0036710 A1 (MATRIANO et al.) 20 Feb. 2003 discloses a similar device for collecting nucleic acid on surfaces of the microprojections and/or in a separate nucleic acid collection reservoir.
Whereas the above prior art micro-needle sampling devices are less invasive than conventional skin biopsies, they can yet be painful or at least uncomfortable when penetrating the skin.
As such, there is provided herein minimally invasive skin sample collection apparatus specifically suited for home diagnostic use and mail in of samples for analysis.
The apparatus comprises a sampling patch having array of micro-needles on a face surface thereof.
These micro-needles pierce through the outermost layer of the skin and into the underlying epidermis to collect living skin cell samples, including DNA, RNA, or other polynucleic acid material found in the nucleii and/or mitochondria of cells.
Whereas prior art devices employ high concentrations of micro-needles to increase sample yield, our experimentation unexpectedly found that a patch comprising a low micro-needle density of only between 4 and 25 micro-needles, preferably an array of 9 micro-needles, is able to yield adequate sample (as is evident from conventional skin biopsy baseline data being highly correlated with that obtained using the present sampling patch comprising only nine micro-needles as shown in
The apparatus further comprises a sample container into which the skin sample containing patch is inserted. The sample container is relatively small and robust and has a tightfitting lid suitable for mailing in of samples for analysis, such as using Polymerase chain reaction (PCR) or quantitative real-time PCR (qRT-PCR) techniques.
The sample container comprises a buffer solution for preserving the sample during mailing. We further found at a buffer volume of less than 500 μL, preferably approximately 200 μL is suitable to preserve and approximately 1 cm2 sampling patch without overly dilating the sample.
The sampling patch is sized either to fit within the container or is flexibly bendable to fit within the container.
The sampling patch preferably comprises an adhesive surface surrounding the micro-needles to additionally sample skin surface microbiome. The adhesive surface preferably surrounds a micro-needle base plate to avoid interfering with barbs thereof. The entire patch may be inserted into the sample container, thereby comprising both transdermal samples collected by the micro-needles and skin surface microbiome samples sampled by the adhesive surface.
The needles are preferably moulded from polymer and may comprise a cross-sectional profile continuously diminishing towards a barbed edge so that the needles can be de-moulded without damaging the barbed edge. These moulded needles can be subsequently adhered perpendicularly to the base plate.
Other aspects of the invention are also disclosed.
Notwithstanding any other forms which may fall within the scope of the present invention, preferred embodiments of the disclosure will now be described, by way of example only, with reference to the accompanying drawings in which:
The patch 100 comprises only between 4 and 25 micro-needles 101, preferably between 4 and 16 micro-needles and further preferably 9 micro-needles in the 3×3 array shown.
The patch 100 may comprise a base plate 103 which may be plastic and flexible.
Exemplary dimensions are given in
The apparatus further comprises a sample container 104 for the sampling patch 100. The container 104 may be made of plastic and may be small enough to be mailed.
The container 104 may be generally cylindrical having a tapered distal end and an opening enclosed by a tightfitting watertight lid 105 held by a living hinge 106. The container 104 contains buffer solution 107 therein.
The entire patch 100 is then placed within the container 104 and, as shown in
In a preferred embodiment, the container 104 comprises less than 500 μL of buffer solution, preferably approximately 200 μL for an approximately 1 cm2 patch 100. This volume was found to be sufficient to coat the face surface 102 of the patch 100 without over dilution of the sample 111.
The base plate 103 may be sized so as to be able to fit within the interior of the container 104.
Alternatively, the base plate 103 may be wider than the interior of the container 104 wherein the display 103 can bend to fit within the interior of the container 104. In this regard, the base plate 103 may comprise plastic.
In a preferred embodiment, the patch 100 exposes an adhesive surface 112. The adhesive surface 112 may surround the base plate 103. The adhesive surface 112 may be provided by applying an adhesive sheet 113 to a rear of the base plate 103. As shown in
The adhesive surface 112 may further hold the base plate 103 to the skin so that the sampling patch 100 may be worn for a period to obtain adequate sample.
Preferably, the patch 100 is devoid of adhesive between the micro-needles 101 so as not to interfere with the barbs 114 thereof.
As is shown in
The patch 100 may be sized so that the adhesive sheet 113 fits within the container 104. Alternatively, the adhesive sheet 113 may be wider than the interior of the container and the base plate 103 may be narrower than the interior of the container 104. As such, edges of the adhesive sheet 113 can be folded inward to fit within the container 104.
In further embodiments, for especially small containers, both the adhesive sheet 113 and the base plate 103 are wider than the interior of the container but wherein both can be bent or folded to fit within the container 104.
The micro-needles 103 are preferably cast-in moulded from polymer.
In this regard, the micro-needle 103 may comprise a cross-sectional profile along the length thereof and perpendicular to a longitudinal axis thereof which continuously diminishes towards a barbed edge 118, the barbed edge 118 comprising the barbs 114 shown in
As shown in
The barbs 114 may locate along the barbed edge 118 only and the micro-needle 101 may narrow towards a sharpened tip 120.
The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that specific details are not required in order to practise the invention. Thus, the foregoing descriptions of specific embodiments of the invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed as obviously many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, thereby enabling others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the following claims and their equivalents define the scope of the invention.
The term “approximately” or similar as used herein should be construed as being within 10% of the value stated unless otherwise indicated.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2020904483 | Dec 2020 | AU | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/AU2021/051431 | 12/1/2021 | WO |
