Deep bleeder acoustic coagulation (DBAC)—Part I: development and in vitro testing of a research prototype cuff system

Journal of Therapeutic Ultrasound

Lawrence A. Crum¹  Scott Keneman³  Keith Wong⁵  John Eaton⁵  John C. Kucewicz¹  Barbrina Dunmire¹  Stuart B. Mitchell¹  Gareth Funka-Lea³  Alexis Ahiekpor-Dravi³  Romain Moreau-Gobard³  Xiaozheng (Jenny) Zeng²  A R Ramachandran²  Caroline Maleke²  Chi-Yin Lee²  John Kook²  Stephen J. Hsu²  Jerry D. Hopple²  Liexiang Fan²  Stephen R. Barnes²  K. Michael Sekins⁴ 

[1] Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, 1013 NE 40th Street, Seattle 98105-6698, WA, USA;Siemens Ultrasound Business Unit, 22010 S.E. 51st Street, Issaquah 98029-1271, WA, USA;Siemens Corporate Research and Technology, 755 College Road East, Princeton 08540, NJ, USA;Medical Device and Technology Development and Commercialization (concultancy) , 8808 Points Dr. N.E, Yarrow Point 98004, WA, USA;ETN LLC, 1150 Guinda St., Palo Alto 94301, CA, USA

关键词: Phantom;    Recurrent neural network;    Neural network;    Image compounding;    HIFU;    Combat bleeding;    Cautery;    Bleeding;    ARFI;    Acoustic thermometry;    Acoustic hemostasis;    Acoustic coagulation;    Ultrasound;   

Others  :  1225683
DOI  :  10.1186/s40349-015-0037-4

 received in 2015-06-22, accepted in 2015-09-02,  发布年份 2015

【 摘 要 】

Background

Bleeding from limb injuries is a leading cause of death on the battlefield, with deep wounds being least accessible. High-intensity focused ultrasound (HIFU) has been shown capable of coagulation of bleeding (cautery). This paper describes the development and refereed in vitro evaluation of an ultrasound (US) research prototype deep bleeder acoustic coagulation (DBAC) cuff system for evaluating the potential of DBAC in the battlefield. The device had to meet quantitative performance metrics on automated operation, therapeutic heating, bleeder detection, targeting accuracy, operational time limits, and cuff weight over a range of limb sizes and bleeder depths. These metrics drove innovative approaches in image segmentation, bleeder detection, therapy transducers, beam targeting, and dose monitoring. A companion (Part II) paper discusses the in vivo performance testing of an animal-specific DBAC system.

Materials and methods

The cuff system employed 3D US imaging probes (“Ix”) for detection and localization (D&L) and targeting, with the bleeders being identified by automated spectral Doppler analysis of flow waveforms. Unique high-element-count therapeutic arrays (“Tx”) were developed, with the final cuff prototype having 21 Tx’s and 6 Ix’s. Spatial registration of Ix’s and Tx’s was done with a combination of image-registration, acoustic time-of-flight measurement, and tracking of the cuff shape via a fiber optic sensor. Acoustic radiation force impulse (ARFI) imaging or thermal strain imaging (TSI) at low-power doses were used to track the HIFU foci in closed-loop targeting. Recurrent neural network (RNN) acoustic thermometry guided closed-loop dosing. The cuff was tested on three phantom “limb” sizes: diameters = 25, 15, and 7.5 cm, with bleeder depths from 3.75 to 12.5 cm. “Integrated Phantoms” (IntP) were used for assessing D&L, closed-loop targeting, and closed-loop dosing. IntPs had surrogate arteries and bleeders, with blood-mimicking fluids moved by a pulsatile pump, and thermocouples (TCs) on the bleeders. Acoustic dosing was developed and tested using “HIFU Phantoms” having precisely located TCs, with end-of-dose target ∆T = 33–58 °C, and skin temperature ∆T ≤ 20 °C, being required.

Results

Most DBAC cuff performance requirements were met, including cuff weight, power delivery, targeting accuracy, skin temperature limit, and autonomous operation. The automated D&L completed in 9 of 15 tests (65 %), detecting the smallest (0.6 mm) bleeders, but it had difficulty with the lowest flow (3 cm/sec) bleeders, and in localizing bleeders in the smallest (7.5 cm) phantoms. D&L did not complete within the 9-min limit (results ranged 10–21 min). Closed-loop targeting converged in 20 of 31 tests (71 %), and closed-loop dosing power shut-off at preset ∆Ts was operational.

Summary and conclusion

The main performance objectives of the prototype DBAC cuff were met, however the designs required a number of challenging new technology developments. The novel Tx arrays exhibited high power with significant beam steering and focusing flexibility, while their integrated electronics enabled the required compact, lightweight configurability and simplified driving controls and cable/connector architecture. The compounded 3D imaging, combined with sophisticated software algorithms, enabled automated D&L and initial targeting and closed-loop targeting feedback via TSI. The development of RNN acoustic thermometry made possible feedback-controlled dosing. The lightweight architecture required significant design and fabrication effort to meet mechanical functionalities. Although not all target specifications were met, future engineering solutions addressing these performance deficiencies are proposed. Lastly, the program required very complex limb test phantoms and, while very challenging to develop, they performed well.

【 授权许可】

   
2015 Sekins et al.

【 图 表 】

Fig. 1.

Fig. 2.

Fig. 3.

Fig. 4.

Fig. 5.

Fig. 6.

Fig. 7.

Fig. 8.

Fig. 9.

Fig. 10.

Fig. 11.

Fig. 12.

Fig. 13.

Fig. 14.

Fig. 15.

Fig. 16.

Fig. 17.

Fig. 18.

Fig. 19.

Fig. 20.

Fig. 21.

Fig. 22.

Fig. 23.

Fig. 24.

【 参考文献 】

• [1]Starnes BW, Beekley AC, Sebesta JA, Andersen CA, Rush RM. Extremity vascular injuries on the battlefield: tips for surgeons deploying to war. J Trauma. 2006; 60:432-42.
• [2]Schreiber MA, Tieu B. Hemostasis in Operation Iraqi Freedom III. Surgery. 2007; 142:S61-6.
• [3]Mordon S, Rochon P, Dhelin G, Lesage JC. Dynamics of temperature dependent modifications of blood in the near-infrared. Lasers Surg Med. 2005; 37:301-7.
• [4]Pfefer TJ, Choi B, Vargas G, McNally KM, Welch AJ. Pulsed laser-induced thermal damage in whole blood. J Biomech Eng. 2000; 122:196-202.
• [5]Gorisch W, Boergen KP. Heat-induced contraction of blood vessels. Lasers Surg Med. 1982; 2:1-13.
• [6]Vaezy S, Martin R, Yaziji H, Kaczkowski P, Keilman G, Carter S, Caps M, Chi EY, Bailey M, Crum L. Hemostasis of punctured blood vessels using high-intensity focused ultrasound. Ultrasound Med Biol. 1998; 24(6):903-10.
• [7]Vaezy S, Noble ML, Keshavarzi A, Paun M, Prokop AF, Cornejo C, Sharar S, Chi EY, Crum LA, Martin RW. Liver hemostasis with high intensity ultrasound. J Ultrasound Med. 2004; 23:217-25.
• [8]Noble ML, Vaezy S, Keshavarzi A, Paun M, Prokop AF, Chi EY, Cornejo C, Martin RW, Crum LA. Spleen hemostasis using high intensity ultrasound: an efficacy and safety study. J Trauma. 2002; 53(6):1115-20.
• [9]Vaezy S, Martin R, Kaczkowski P, Keilman G, Goldman B, Yaziji H, Carter S, Caps M, Crum L. Use of high intensity focused ultrasound to control bleeding. J Vasc Surg. 1999; 29(6):533-42.
• [10]Bergdahl B, Stenquist B. An automatic computerized bipolar coagulator for dermatologic surgery. J Derm Oncol. 1993; 19:225-7.
• [11]Hill CR, Rivens I, Vaughan MG, ter Haar GR. Lesion development in focused ultrasound surgery: a general model. J Ultrasound Med Biol. 2001; 20(3):259-69.
• [12]Holt RG, Roy RA, Edson PA, Yang X. Bubbles and HIFU: the good, the bad and the ugly. Proc. 2nd Intl Symp Ther Ultrasound (Amer Inst Physics). 2003; 120-131.
• [13]Williams AR, O’Brien WD, Coller BS. Exposure to ultrasound decreases the recalcification time of platelet rich plasma. J Ultrasound Med Biol. 1976; 2:113-8.
• [14]White RA, Kopchok G, Peng SK, Fujitani R, White G, Klein S, Uitto J. Laser vascular welding—how does it work? Ann Vasc Surg. 1987; 1(4):461-4.
• [15]Sekins KM, Barnes SR, Fan L, Hopple JD, Hsu SJ, Kook J et al. Deep Bleeder Acoustic Coagulation (DBAC)—Part II: in vivo testing of a research prototype system. J Ther Ultrasound. 2015; accompanying partner article in this issue.
• [16]Saparetto SA. Thermal isoeffect dose: addressing the issue of thermotolerance. Int J Hyperthermia. 1987; 3:297-305.
• [17]Dewey WC. Arrhenius relationships from the molecule and cell to the clinic. Int J Hyperthermia. 1994; 10:457-83.
• [18]Sekins KM. Acoustic neural network thermometry in monitoring of thermal therapies. 2011.
• [19]Hsu SJ, Nam JH, Fan L, Brunke SS, Sekins KM. Real-time RNN-based acoustic thermometry with feedback control. 2014.
• [20]Maleke C, Hsu SJ, Fan L, Sekins KM. Acoustic thermometry in HIFU: comparison of a neural network method and thermal strain imaging. 2012.
• [21]King RL, Herman BA, Maruvada S, Wear KA, Harris GR. Development of a HIFU phantom. Proc of 6th Intl Symp Ther Ultrasound (Amer Inst Physics). 2007: 351-6.
• [22]Dunmire B, Kucewicz JC, Mitchell SB, Crum LA, Sekins KM. Characterizing an agar/gelatin phantom for image guided dosing and feedback control of high intensity focused ultrasound. J Ultrasound Med Biol. 2013; 39(2):300-11.
• [23]Dineley J, Meagher S, Peopping TL, McDicken WN, Hoskins PR. Design and characterization of a wall motion phantom. Ultrasound Med Biol. 2006; 32(9):1349-57.
• [24]Liu Y, Maruvada S, King R, Herman BA, Wear KA. Development and characterization of a blood mimicking fluid for high intensity focused ultrasound. J Acoust Soc Am. 2008; 124:1803-10.
• [25]Lacoste F, Schlosser J, Vallancien G. Influence of acoustic intensity on skin damage during extra-corporeal HIFU. Proc 2nd Intnl Symp Ther Ultrasound (Amer Inst Physics). 2003: 229-33
• [26]Bamber JC, Hill CR. Ultrasound attenuation and propagation speed in mammalian tissues as a function of temperature. J Ultrasound Med Biol. 1979; 5:149-57.