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A battery-less wireless implant for the continuous monitoring of vascular pressure, flow rate and temperature

Abstract

Devices for monitoring blood haemodynamics can guide the perioperative management of patients with cardiovascular disease. Current technologies for this purpose are constrained by wired connections to external electronics, and wireless alternatives are restricted to monitoring of either blood pressure or blood flow. Here we report the design aspects and performance parameters of an integrated wireless sensor capable of implantation in the heart or in a blood vessel for simultaneous measurements of pressure, flow rate and temperature in real time. The sensor is controlled via long-range communication through a subcutaneously implanted and wirelessly powered Bluetooth Low Energy system-on-a-chip. The device can be delivered via a minimally invasive transcatheter procedure or it can be mounted on a passive medical device such as a stent, as we show for the case of the pulmonary artery in a pig model and the aorta and left ventricle in a sheep model, where the device performs comparably to clinical tools for monitoring of blood flow and pressure. Battery-less and wireless devices such as these that integrate capabilities for flow, pressure and temperature sensing offer the potential for continuous monitoring of blood haemodynamics in patients.

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Fig. 1: Implantable, wireless cardiac haemodynamics monitor.
Fig. 2: Implantable, biocompatible sensors for the monitoring of physical parameters of blood flow.
Fig. 3: Subcutaneous implants for wireless power and data transmission.
Fig. 4: Arterial pressure and flow monitoring in artificial heart systems.
Fig. 5: Demonstrations on large animals.
Fig. 6: Comparisons against clinical standard devices on the ovine model.

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Data availability

The main data supporting the results in this study are available within the paper and its Supplementary Information. Source data for Figs. 26 are provided with this paper. The raw and analysed datasets generated during the studies are too large to be publicly shared, yet they are available for research purposes from the corresponding author on reasonable request. Source data are provided with this paper.

Code availability

Custom-developed firmware for BLE SoCs and Android applications (UIs) for use on smartphones are available from the corresponding author on reasonable request. All requests for source code will be reviewed by the corresponding author to verify whether the request is subject to any intellectual property or confidentiality obligations.

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Acknowledgements

K.K. acknowledges support by the National Research Foundation (NRF) grant funded by the Korea government (MSIP; Ministry of Science, ICT & Future Planning; no. 2021R1F1A106387111, no. 2022R1C1C1010555 and no. 2020R1A5A8018367). J.U.K. and T.K. were supported by the NRF funded by the Korean government (MSIT; NRF-2019M3C7A1032076 and NRF-2020M3H4A1A03082897). S.M.W. acknowledges support by the NRF grant funded by the Korea government (MSIP, ICT & Future Planning; no. NRF-2021R1C1C1009410 and no. IITP-2020-0-01821). R.A. acknowledges support from the National Science Foundation Graduate Research Fellowship (NSF grant number DGE-1842165) and Ford Foundation Predoctoral Fellowship. J.A.R. acknowledges support from the National Institute on Aging of the National Institutes of Health (NIH R43AG067835). We acknowledge funding from Wearifi Inc., and the Querrey-Simpson Institute for Bioelectronics at Northwestern University for support of this work. This work made use of the NUFAB facility of Northwestern University’s NUANCE Center, which has received support from the Soft and Hybrid Nanotechnology Experimental (SHyNE) Resource (NSF ECCS-1542205), the MRSEC programme (NSF DMR-1720139) at the Materials Research Center, the International Institute for Nanotechnology (IIN), the Keck Foundation and the State of Illinois, through the IIN.

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K.K. and J.A.R. conceived the idea and designed the research. K.K., J.U.K. and J.A.R. analysed data and wrote the manuscript. K.K. designed the hardware for the wireless electronic system. K.K. and K.S.C. performed software design and software validation. J.U.K. and S.M.W. performed and were involved in the manufacturing of the sensor modules. J.Z., R.A., H.W. and Y.H. performed mechanical modelling. K.K. and J.U.K. performed research and led the experimental works with support from H.J., K.H.L., J.-H.K., S. Y., Y.J.K., J.K., J.L., Y.P., W.L., T.K. and A.B.

Corresponding authors

Correspondence to Kyeongha Kwon or John A. Rogers.

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Competing interests

A.B. and J.A.R. are co-founders of Hemorhythmics Inc., which has potential commercial interest in the technology described in this work. A.B. and J.A.R. are co-founders of the company. A.B is an employee of Wearifi Inc., which may wish to pursue commercialization of this technology in future. The other authors declare no competing interests.

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Nature Biomedical Engineering thanks Jun Chen and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.

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Supplementary Video 1

Movement of the sensing module inside the PA of porcine hearts recorded by a borescope.

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Source Data Fig. 5

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Kwon, K., Kim, J.U., Won, S.M. et al. A battery-less wireless implant for the continuous monitoring of vascular pressure, flow rate and temperature. Nat. Biomed. Eng 7, 1215–1228 (2023). https://doi.org/10.1038/s41551-023-01022-4

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