A Wireless Near-Infrared Spectroscopy Device for Flap Monitoring: Proof of Concept in a Porcine Musculocutaneous Flap Model

Changsheng Wu; Alina Y. Rwei; Jong Yoon Lee; Wei Ouyang; Lauren Jacobson; Haixu Shen; Haiwen Luan; Yameng Xu; Jun Bin Park; Sung Soo Kwak; Xiaoyue Ni; Wubin Bai; Daniel Franklin; Shuo Li; Yiming Liu; Xinchen Ni; Amanda M. Westman; Matthew R. MacEwan; John A. Rogers; Mitchell A. Pet

doi:10.1055/s-0041-1732426

Journal of Reconstructive Microsurgery, Table of Contents

J Reconstr Microsurg 2022; 38(02): 096-105
DOI: 10.1055/s-0041-1732426

Original Article

A Wireless Near-Infrared Spectroscopy Device for Flap Monitoring: Proof of Concept in a Porcine Musculocutaneous Flap Model

Changsheng Wu‡^*

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

,

Alina Y. Rwei‡^*

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

²Department of Chemical Engineering, Delft University of Technology, Delft, The Netherlands

,

Jong Yoon Lee

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

³Sibel Inc., Evanston, Illinois

,

Wei Ouyang

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

,

Lauren Jacobson

⁴Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, Washington University, St. Louis, Missouri

,

Haixu Shen

⁵Department of Materials Science and Engineering, Northwestern University, Evanston, Illinois

,

Haiwen Luan

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

,

Yameng Xu

⁶Department of Neurosurgery, School of Medicine, Washington University, St. Louis, Missouri

,

Jun Bin Park

³Sibel Inc., Evanston, Illinois

,

Sung Soo Kwak

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

,

Xiaoyue Ni

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

,

Wubin Bai

⁵Department of Materials Science and Engineering, Northwestern University, Evanston, Illinois

,

Daniel Franklin

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

,

Shuo Li

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

,

Yiming Liu

⁷Department of Electrical and Computer Engineering, Northwestern University, Evanston, Illinois

,

Xinchen Ni

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

,

Amanda M. Westman

⁴Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, Washington University, St. Louis, Missouri

,

Matthew R. MacEwan

⁶Department of Neurosurgery, School of Medicine, Washington University, St. Louis, Missouri

,

John A. Rogers

¹Department of Materials Science and Engineering, Querrey Simpson Institute for Bioelectronics, Northwestern University, Chicago, Illinois

⁵Department of Materials Science and Engineering, Northwestern University, Evanston, Illinois

⁷Department of Electrical and Computer Engineering, Northwestern University, Evanston, Illinois

⁸Department of Mechanical Engineering, Northwestern University, Evanston, Illinois

⁹Department of Biomedical Engineering, Northwestern University, Evanston, Illinois

¹⁰Department of Chemistry, Northwestern University, Evanston, Illinois

¹¹Department of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

,

Mitchell A. Pet

⁴Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, Washington University, St. Louis, Missouri

› Author Affiliations

Abstract

Background Current near-infrared spectroscopy (NIRS)-based systems for continuous flap monitoring are highly sensitive for detecting malperfusion. However, the clinical utility and user experience are limited by the wired connection between the sensor and bedside console. This wire leads to instability of the flap–sensor interface and may cause false alarms.

Methods We present a novel wearable wireless NIRS sensor for continuous fasciocutaneous free flap monitoring. This waterproof silicone-encapsulated Bluetooth-enabled device contains two light-emitting diodes and two photodetectors in addition to a battery sufficient for 5 days of uninterrupted function. This novel device was compared with a ViOptix T.Ox monitor in a porcine rectus abdominus myocutaneous flap model of arterial and venous occlusions.

Results Devices were tested in four flaps using three animals. Both devices produced very similar tissue oxygen saturation (StO₂) tracings throughout the vascular clamping events, with obvious and parallel changes occurring on arterial clamping, arterial release, venous clamping, and venous release. Small interdevice variations in absolute StO₂ value readings and magnitude of change were observed. The normalized cross-correlation at zero lag describing correspondence between the novel NIRS and T.Ox devices was >0.99 in each trial.

Conclusion The wireless NIRS flap monitor is capable of detecting StO₂ changes resultant from arterial vascular occlusive events. In this porcine flap model, the functionality of this novel sensor closely mirrored that of the T.Ox wired platform. This device is waterproof, highly adhesive, skin conforming, and has sufficient battery life to function for 5 days. Clinical testing is necessary to determine if this wireless functionality translates into fewer false-positive alarms and a better user experience.

Keywords

tissue perfusion monitoring - near-infrared spectroscopy - flap monitoring

Full Text

References

References
1 Harashina T, Fujino T, Watanabe S. The intimal healing of microvascular anastomoses. Plast Reconstr Surg 1976; 58 (05) 608-613
2 Chao AH, Meyerson J, Povoski SP, Kocak E. A review of devices used in the monitoring of microvascular free tissue transfers. Expert Rev Med Devices 2013; 10 (05) 649-660
3 Rozen WM, Enajat M, Whitaker IS, Lindkvist U, Audolfsson T, Acosta R. Postoperative monitoring of lower limb free flaps with the Cook-Swartz implantable Doppler probe: a clinical trial. Microsurgery 2010; 30 (05) 354-360
4 Guillemaud JP, Seikaly H, Cote D, Allen H, Harris JR. The implantable Cook-Swartz Doppler probe for postoperative monitoring in head and neck free flap reconstruction. Arch Otolaryngol Head Neck Surg 2008; 134 (07) 729-734
5 Zhang T, Dyalram-Silverberg D, Bui T, Caccamese Jr JF, Lubek JE. Analysis of an implantable venous anastomotic flow coupler: experience in head and neck free flap reconstruction. Int J Oral Maxillofac Surg 2012; 41 (06) 751-755
6 Rozen WM, Chubb D, Whitaker IS, Acosta R. The efficacy of postoperative monitoring: a single surgeon comparison of clinical monitoring and the implantable Doppler probe in 547 consecutive free flaps. Microsurgery 2010; 30 (02) 105-110
7 Berthelot M, Ashcroft J, Boshier P. et al. Use of near-infrared spectroscopy and implantable Doppler for postoperative monitoring of free tissue transfer for breast reconstruction: a systematic review and meta-analysis. Plast Reconstr Surg Glob Open 2019; 7 (10) e2437-e2438
8 Paydar KZ, Hansen SL, Chang DS, Hoffman WY, Leon P. Implantable venous Doppler monitoring in head and neck free flap reconstruction increases the salvage rate. Plast Reconstr Surg 2010; 125 (04) 1129-1134
9 Kagaya Y, Miyamoto S. A systematic review of near-infrared spectroscopy in flap monitoring: current basic and clinical evidence and prospects. J Plast Reconstr Aesthet Surg 2018; 71 (02) 246-257
10 Inbal A, Song DH. Discussion: does increased experience with tissue oximetry monitoring in microsurgical breast reconstruction lead to decreased flap loss? The learning effect. Plast Reconstr Surg 2016; 137 (04) 1102-1103
11 Koolen PGL, Vargas CR, Ho OA. et al. Does increased experience with tissue oximetry monitoring in microsurgical breast reconstruction lead to decreased flap loss? The learning effect. Plast Reconstr Surg 2016; 137 (04) 1093-1101
12 Xu S, Zhang Y, Jia L. et al. Soft microfluidic assemblies of sensors, circuits, and radios for the skin. Science 2014; 344 (6179): 70-74
13 Chung HU, Rwei AY, Hourlier-Fargette A. et al. Skin-interfaced biosensors for advanced wireless physiological monitoring in neonatal and pediatric intensive-care units. Nat Med 2020; 26 (03) 418-429
14 Lee K, Ni X, Lee JY. et al. Mechano-acoustic sensing of physiological processes and body motions via a soft wireless device placed at the suprasternal notch. Nat Biomed Eng 2020; 4 (02) 148-158
15 Suzuki S, Takasaki S, Ozaki T, Kobayashi Y. Tissue oxygenation monitor using NIR spatially resolved spectroscopy. In: Chance B, Alfano RR, Tromberg BJ. eds. Optical Tomography and Spectroscopy of Tissue III. Vol. 3597. SPIE Proceedings. International Society for Optics and Photonics. 1999: 582-592
16 Matcher SJ, Kirkpatrick PJ, Nahid K, Cope M, Delpy DT. Absolute quantification methods in tissue near-infrared spectroscopy. In: Chance B, Alfano RR. eds. Optical Tomography, Photon Migration, and Spectroscopy of Tissue and Model Media: Theory, Human Studies, and Instrumentation. Vol. 2389. SPIE Proceedings. International Society for Optics and Photonics; 1995: 486-495
17 Lindkvist M, Granåsen G, Grönlund C. Coherent derivation of equations for differential spectroscopy and spatially resolved spectroscopy: an undergraduate tutorial. Spectrosc Lett 2013; 46 (04) 243-249
18 Bodin F, Diana M, Koutsomanis A, Robert E, Marescaux J, Bruant-Rodier C. Porcine model for free-flap breast reconstruction training. J Plast Reconstr Aesthet Surg 2015; 68 (10) 1402-1409
19 Rothfuss MA, Franconi NG, Unadkat JV. et al. A system for simple real-time anastomotic failure detection and wireless blood flow monitoring in the lower limbs. IEEE J Transl Eng Health Med 2016; 4: 4100114
20 Unadkat JV, Rothfuss M, Mickle MH, Sejdic E, Gimbel ML. The development of a wireless implantable blood flow monitor. Plast Reconstr Surg 2015; 136 (01) 199-203
21 Rothfuss MA, Unadkat JV, Gimbel ML, Mickle MH, Sejdić E. Totally implantable wireless ultrasonic Doppler blood flowmeters: toward accurate miniaturized chronic monitors. Ultrasound Med Biol 2017; 43 (03) 561-578
22 Oda H, Beker L, Kaizawa Y. et al. A novel technology for free flap monitoring: pilot study of a wireless, biodegradable sensor. J Reconstr Microsurg 2020; 36 (03) 182-190
23 Boutry CM, Beker L, Kaizawa Y. et al. Biodegradable and flexible arterial-pulse sensor for the wireless monitoring of blood flow. Nat Biomed Eng 2019; 3 (01) 47-57
24 Chang EI, Ibrahim A, Zhang H. et al. Deciphering the sensitivity and specificity of the implantable Doppler probe in free flap monitoring. Plast Reconstr Surg 2016; 137 (03) 971-976
25 Anctil V, Brisebois S, Fortier P-H. Free flap anastomosis leak after implantable Doppler removal. OTO Open 2017; 1 (01) X17697057
26 Berthelot M, Yang G-Z, Lo B. A self-calibrated tissue viability sensor for free flap monitoring. IEEE J Biomed Health Inform 2018; 22 (01) 5-14
27 Berthelot M, Henry FP, Hunter J. et al. Pervasive wearable device for free tissue transfer monitoring based on advanced data analysis: clinical study report. J Biomed Opt 2019; 24 (06) 1-8
28 Berthelot M, Chen C-M, Yang G-Z, Lo B. Wireless wearable self-calibrated sensor for perfusion assessment of myocutaneous tissue. In: IEEE; 2016: 171-176
29 Chen CM, Kwasnicki R. Wearable tissue oxygenation monitoring sensor and a forearm vascular phantom design for data validation. In: 2014 11th International Conference on Wearable and Implantable Body Sensor Networks. 2014
30 Kozusko S, Gbulie U. Detecting microsurgical complications with ViOptix tissue oximetry in a pediatric myocutaneous free flap: case presentation and literature review. J Reconstr Microsurg Open 2018; 03 (01) e8-e12