Microneedle-based device for the one-step painless collection of capillary blood samples

Abstract

The advancement of point-of-care diagnostics and the decentralization of healthcare have created a need for the simple, safe, standardized and painless collection of blood specimens. Here, we describe the design and implementation of a capillary blood-collection device that is more convenient and less painful than a fingerstick and venepuncture, and collects 100 µl of blood. The technology integrates into a compact, self-contained device an array of solid microneedles, a high-velocity insertion mechanism, stored vacuum, and a microfluidic system containing lithium heparin anticoagulant. The use of the device requires minimal training, as blood collection is initiated by the single push of a button. In a clinical study involving 144 participants, haemoglobin A1c measurements from device-collected samples and from venous blood samples were equivalent, and the pain associated with the device was significantly less than that associated with venepuncture. The device, which has received premarket clearance by the US Food and Drug Administration, should help improve access to healthcare, and support healthcare decentralization.

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Fig. 1: Optimization of the blood-collection device.
Fig. 2: Illustration of the blood-collection device.
Fig. 3: Design of the sample-mixing channel, and controlled release of the anticoagulant.
Fig. 4: Collection of capillary blood samples with the TAP device.
Fig. 5: Comparison of HbA1c measurements obtained from the TAP device and venepuncture (n = 243).

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Acknowledgements

We thank M. Gilpatrick, M. Oster, and J. P. Lock for their clinical operations support during internal pilot testing. We also thank the principal investigators and clinical staff at each of the sites that supported the TAP external study: V. Bush (Mary Imogene Bassett Hospital), G. Allen (Roger Williams Medical Center), and Y. Henry (Geisinger Medical Center). We thank W. Fowle (Northeastern University) for providing the SEM image of the microneedle array. We also thank R. Langer for reviewing the manuscript. This work was funded in part by a grant from the Bill and Melinda Gates Foundation (OPP1028750—Point-of-Care Diagnostics).

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M.D. acquired the high-speed video of actuation mechanisms. C.A.T. analysed the high-speed video data. T.M.B. and P.G. designed and conducted the microneedle length study. R.E.W. conducted the Monte Carlo simulations. B.M.B. and K.M.L. designed and conducted the vacuum optimization and sampling site comparison studies. B.M.B. modelled and evaluated the microfluidic mixer. L.L.C. and R.K. designed and developed in vitro test systems for flowing liquids into the device. B.M.B. and R.K. performed the microfluidic mixing visualization study with coloured solutions. P.G. and S.L.M. designed and conducted the anticoagulant controlled-release studies. T.M.B. designed the TAP device clinical study. T.M.B, K.M.L., and J.A.W. collated and analysed data for the TAP device clinical study. T.M.B., B.M.B. and R.E.W. wrote and revised the paper. R.E.W. produced data analysis plots. S.P.D., R.H., D.E.C. and H.B. conceived of early microneedle-based blood collection device concepts and/or performed initial development work. All co-authors reviewed and edited the paper.

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Correspondence to Timothy M. Blicharz.

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Competing interests

T.M.B., P.G., B.M.B., L.L.C., K.M.L., J.A.W. and R.E.W. are employees of Seventh Sense Biosystems. The technology described in this paper is covered under the US patents 8,827,971 and 9,033,898.

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Blicharz, T.M., Gong, P., Bunner, B.M. et al. Microneedle-based device for the one-step painless collection of capillary blood samples. Nat Biomed Eng 2, 151–157 (2018). https://doi.org/10.1038/s41551-018-0194-1

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