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A temperature-responsive intravenous needle that irreversibly softens on insertion

Nature Biomedical Engineering volume 8, pages 963–976 (2024)Cite this article

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Abstract

The high stiffness of intravenous needles can cause tissue injury and increase the risk of transmission of blood-borne pathogens through accidental needlesticks. Here we describe the development and performance of an intravenous needle whose stiffness and shape depend on body temperature. The needle is sufficiently stiff for insertion into soft tissue yet becomes irreversibly flexible after insertion, adapting to the shape of the blood vessel and reducing the risk of needlestick injury on removal, as we show in vein phantoms and ex vivo porcine tissue. In mice, the needles had similar fluid-delivery performance and caused substantially less inflammation than commercial devices for intravenous access of similar size. We also show that an intravenous needle integrated with a thin-film temperature sensor can monitor core body temperature in mice and detect fluid leakage in porcine tissue ex vivo. Temperature-responsive intravenous needles may improve patient care.

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Fig. 1: Design and operating principles of a P-CARE needle.
Fig. 2: Thermal and mechanical characterization of the gallium-based P-CARE needle.
Fig. 3: In vivo evaluations of biocompatibility of P-CARE needles in mice.
Fig. 4: In vivo fluid-delivery effectiveness of the P-CARE needle versus the commercial IV catheter.
Fig. 5: Potential utility of the P-CARE needle integrated with a temperature sensor.

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Data availability

The main data supporting the results in this study are available within the paper and its Supplementary Information. The raw and analysed datasets generated during the study are available for research purposes from the corresponding authors on reasonable request. Source data for the figures are provided with this paper.

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Acknowledgements

This work was supported by the National Research Foundation of Korea (NRF) funded by the Ministry of Science and ICT (NRF-2021R1A2C4001483 and NRF-2020M3C1B8A01111568 to J.-W.J.; NRF-2021R1A2C3004589 to W.-I.J.).

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Author notes

  1. These authors contributed equally: Karen-Christian Agno, Keungmo Yang.

Authors and Affiliations

  1. School of Electrical Engineering, Korea Advanced Institute of Science and Technology (KAIST), Daejeon, Republic of Korea

    Karen-Christian Agno, Sang-Hyuk Byun, Subin Oh, Simok Lee, Heesoo Kim, Sungwoo Cho & Jae-Woong Jeong

  2. Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology (KAIST), Daejeon, Republic of Korea

    Keungmo Yang, Kyurae Kim & Won-Il Jeong

  3. Division of Gastroenterology and Hepatology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Keungmo Yang

  4. KAIST Institute for Health Science and Technology, Daejeon, Republic of Korea

    Jae-Woong Jeong

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Contributions

K.-C.A. and J.-W.J. conceptualized the project and designed the experiments for overall technology development. K.-C.A., S.-H.B., S.O., S.L., H.K. and S.C. fabricated and prepared the devices, discussed conceptual illustration, and captured the photographs for proof-of-concept demonstration and set-up. K.Y., K.K. and W.-I.J. designed and performed the experiments, collected data and analysed results in the in vivo biocompatibility and fluid-delivery tests. K.-C.A. and K.Y. performed the in vivo temperature sensing under the supervision of W.-I.J. and J.-W.J. K.-C.A., K.Y., W.-I.J. and J.-W.J. performed the investigation, analysed the data and wrote the results. K.-C.A. and J.-W.J. were responsible for conceptual drawings and data representation. K.-C.A., K.Y., W.-I.J. and J.-W.J. wrote the article. W.-I.J. and J.-W.J. acquired funding and supervised the project. W.-I.J. and J.-W.J. are co-senior authors. All authors discussed the results and contributed to revision of the article.

Corresponding authors

Correspondence to Won-Il Jeong or Jae-Woong Jeong.

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Nature Biomedical Engineering thanks Giuseppe Barillaro, Eoin O’Cearbhaill and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.

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Extended data

Extended Data Fig. 1 Stiffness- and shape-integrity of P-CARE needle under warm temperature.

a, Image of the temperature-controlled experimental set-up in cross section view. b, Plot of time before the needle becomes soft at various temperatures. The plot legends are as follows: blue, the needle is inside the polystyrene box with icepacks; grey, the needle is taken out from the polystyrene box without icepacks; red, the needle is taken out from the polystyrene box with icepacks. The inset shows the magnified plots for the softening time at indicated outside temperatures. Data are presented as mean values ± SD (n = 3 samples). c, Images showing the physical condition of the needle inside the polystyrene box with icepacks, externally heated to 50 °C, (left) needle inside the polystyrene box before heating, (middle) needle inside the polystyrene after 10 hrs of heating on a hotplate (50 °C) in a closed chamber, (right) needle taken out from the insulated box with icepack after 10 hrs of heating at 50 °C. Scale bar, 1 cm. d, Images of the integrated pig skin-transparent multi-layer tissue phantom with artificial vein setup, (left) side view image of the skin-multi-layer transparent tissue phantom, (left, inset) actual image of porcine skin showing small superficial veins in an upside-down view, ~1.5 mm thickness, (right) schematic illustration of integrated pig skin-transparent multi-layer tissue phantom created by using PDMS-oil (10:1 by weight), 13 mm total thickness. Scale bar, 1 cm. e, Images of the rigid insertion of the needle into porcine skin followed by fluid delivery into a customized vein-transparent tissue phantom with an external temperature of 35 °C, highlighting that a rigid insertion through pig skin using P-CARE needle is possible. Scale bars, 5 mm.

Source data

Extended Data Fig. 2 P-CARE needle after insertion and fluid delivery.

a, Image after retracting the softened P-CARE needle from tissue phantom, demonstrating a gravity-bent and completely softened needle after use for an advance safe-handling needle disposal. b, Plot of thermal response during the freezing process of the softened P-CARE needle after usage (that is, rigid insertion). The solidification of the softened needle occurs when the needle was exposed to temperature of −5 °C. At this temperature, it takes about 29.45 s for the gallium needle to solidify (tc), verifying that the softened needle after use (that is, withdrawn from the soft tissue after rigid insertion) will indefinitely exhibit a low modulus of elasticity when use at a healthcare facility (20–24 °C), making the needle completely non-reusable after first usage.

Source data

Extended Data Fig. 3 Characterization of nanomembrane temperature sensor integrated in P-CARE needle.

a, Relative resistance change as a function of temperature, showing that the phase state of P-CARE needle (rigid or soft) has no significant effect on the sensing performance (Tambient= 20 °C) within physiological temperature range (30 to 42 °C). Note that the same sample was measured repeatedly (n = 3 trials). b, Relative resistance change as a function of time, exhibiting that the encapsulated P-CARE needle sensor has a comparable thermal response time (~9 s) with the one of an encapsulation-free thin-film sensor of the same design when immersed in the same medium (Tmedium= 37 °C, Tambient= 25 °C). The slight difference between sensor output is attributed to the polymeric encapsulation of the device. c, Relative resistance change as a function of time of P-CARE needle immersed in a medium of varying temperature (30, 37 and 50 °C). d, Relative resistance change as a function of increasing or decreasing medium temperature, demonstrating no significant device hysteresis within physiological temperature range. Note that the same sample was measured repeatedly (n = 3 trials). e, Plot of sensor output as a function of radius of curvature, indicating electrical stability during bending. f, Relative resistance change as a function of insertion depth into a medium with constant temperature. The result exhibits that the sensor output is independent of insertion depth as needle advances deeper (75% of total needle length is immersed, which is similar to the conventional practice in IV needle placement in a healthcare setting) into a temperature-controlled environment (Tmedium = 36 °C; Tambient = 24 °C; θ = ~ 30°). Error bars show the mean ± standard deviation (n = 3 samples).

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Agno, KC., Yang, K., Byun, SH. et al. A temperature-responsive intravenous needle that irreversibly softens on insertion. Nat. Biomed. Eng 8, 963–976 (2024). https://doi.org/10.1038/s41551-023-01116-z

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