A wearable artificial kidney: Technical requirements and potential solutions

Expert Review of Medical Devices

Volumn 8, Issue 5, 2011, Pages 567-579

  Kim, Jeong Chul ^a,b,c   Garzotto, Francesco ^a,b   Nalesso, Federico ^a,b   Cruz, Dinna ^a,b   Kim, Ji Hyun ^c   Kang, Eungtaek ^d   Kim, Hee Chan ^c   Ronco, Claudio ^a,b  

^a SAN BORTOLO HOSPITAL   (Italy)

^b International Renal Research Institute Vicenza (IRRIV)   (Italy)

^c Seoul National University   (South Korea)

^d Chung Ang University College of Medicine   (South Korea)

Author keywords

adsorption; artificial kidney; dialysis membrane; dialysis solution; miniaturization; patient monitoring; vascular access

Indexed keywords

ARTIFICIAL KIDNEY; CLINICAL PRACTICES; DIALYSATES; MEDICAL DEVICES; MINIATURIZATION; POTENTIAL SOLUTIONS; POWER SOURCES; QUALITY OF LIFE; RENAL FUNCTIONS; RENAL REPLACEMENT THERAPIES; SOCIAL ACTIVITIES; TECHNICAL REQUIREMENT; VASCULAR ACCESS;

ADSORPTION; ARTIFICIAL ORGANS; BIOMEDICAL ENGINEERING; BIOMEDICAL EQUIPMENT; DIALYSIS; MINIATURE INSTRUMENTS; PATIENT MONITORING;

DIALYSIS MEMBRANES;

ARTIFICIAL KIDNEY; CLINICAL PRACTICE; DEVICE; DIALYSATE; DIALYSIS MEMBRANE; ELECTRONICS; HEMODIALYSIS PATIENT; KIDNEY FUNCTION; PATIENT MONITORING; QUALITY OF LIFE; RENAL REPLACEMENT THERAPY; REVIEW; VASCULAR ACCESS;

ADSORPTION; EQUIPMENT AND SUPPLIES; EQUIPMENT DESIGN; HUMANS; KIDNEY FAILURE, CHRONIC; KIDNEY, ARTIFICIAL; MICROSCOPY, ELECTRON, SCANNING; MINIATURIZATION; MONITORING, AMBULATORY; NANOPARTICLES; QUALITY OF LIFE; RENAL REPLACEMENT THERAPY; SILICON; SOLUTIONS; ULTRAFILTRATION;

EID: 80052293614     PISSN: 17434440     EISSN: 17452422     Source Type: Journal    
DOI: 10.1586/erd.11.33     Document Type: Review

References (89)

1. Ronco C, Davenport A, Gura V. Toward the wearable artificial kidney. Hemodial. Int. 12(Suppl. 1), S40-S47 (2008).
2. Kjellstrand CM, Rosa AA, Shideman JR, Rodrigo F, Davin T, Lynch RE. Optimal dialysis frequency and duration: The 'unphysiology hypothesis'. Kidney Int. Suppl. (8), S120-S124 (1978).
3. Heidenheim AP, Muirhead N, Moist L, Lindsay RM. Patient quality of life on quotidian hemodialysis. Am. J. Kidney Dis. 42(1 Suppl.), 36-41 (2003).
4. Nesrallah G, Suri R, Moist L, Kortas C, Lindsay RM. Volume control and blood pressure management in patients undergoing quotidian hemodialysis. Am. J. Kidney Dis. 42(1 Suppl.), 13-17 (2003).
5. Blaney TL, Lindan O, Sparks RE. Adsorption: A step toward a wearable artificial kidney. Trans. Am. Soc. Artif. Intern. Organs 12, 7-12 (1966).
6. Blackshear PL Jr. Two new concepts that might lead to a wearable artificial kidney. Kidney Int. Suppl. 8, S133-S137 (1978).
7. Jacobsen SC, Stephen RL, Bulloch EC, Luntz RD, Kolff WJ. A wearable artificial kidney: Functional description of hardware and clinical results. Proc. Clin. Dial. Transplant. Forum 5, 65-71 (1975).
8. Stephens RL, Jacobsen SC, Atkin-thor E, Kolff W. Portable/wearable artificial kidney (WAK) - initial evaluation. Proc. Eur. Dial. Transplant. Assoc. 12, 511-518 (1976).
9. Brown CE, Kramer NC. Factors in membrane design and selection as a step toward a wearable artificial kidney. Trans. Am. Soc. Artif. Intern. Organs 14, 36-42 (1968).
10. Neff MS, Sadjadi S, Slifkin R. A wearable artificial glomerulus. Trans. Am. Soc. Artif. Intern. Organs 25, 71-73 (1979).
11. Bazzato G, Coli U, Landini S et al. A bag-filter model as machineless artificial kidney. Trans. Am. Soc. Artif. Intern. Organs 29, 657-661 (1983).
12. Kolff WJ. Exponential growth and future of artificial organs. Artif. Organs 1(1), 8-18 (1977).
13. Shaldon S, Beau MC, Claret G. Sorbent regeneration of ultrafiltrate as a long-term treatment of end-stage renal failure. Artif. Organs 2(4), 343-347 (1978).
14. Shettigar UR, Kablitz C, Stephen R, Kolff WJ. A portable hemodialysis/hemofiltration system independent of dialysate and infusion fluid. Artif. Organs 7(2), 254-256 (1983).
15. Murisasco A, Reynier JP, Ragon A et al. Continuous arterio-venous hemofiltration in a wearable device to treat end-stage renal disease. Trans. Am. Soc. Artif. Intern. Organs 32(1), 567-571 (1986).
16. Popovich RP, Moncrief JW, Nolph KD, Ghods AJ, Twardowski ZJ, Pyle WK. Continuous ambulatory peritoneal dialysis. Ann. Intern. Med. 88(4), 449-456 (1978).
17. Roberts M, Ash SR, Lee DBN. Innovative peritoneal dialysis: Flow-thru and dialysate regeneration. ASAIO J. 45(5), 372-378 (1999).
18. Lukowicz P, Kirstein T, Troster G. Wearable systems for health care applications. Methods Inf. Med. 43(3), 232-238 (2004).
19. Rubel P, Fayn J, Simon-Chautemps L et al. New paradigms in telemedicine: Ambient intelligence, wearable, pervasive and personalized. Stud. Health Technol. Inform. 108, 123-132 (2004).
20. Gura V, Ronco C, Davenport A. The wearable artificial kidney, why and how: From holy grail to reality. Semin. Dial. 22(1), 13-17 (2009).
21. Polaschegg HD. What is required for a WAK? Presented at: World Conference on Portable-Wearable and Miniaturized Systems for Dialysis and Ultrafiltration. Vicenza Italy, 30th September-1st October 2010.
22. Fissell WH, Roy S. The implantable artificial kidney. Semin. Dial. 22(6), 665-670 (2009).
23. Morti SM, Zydney AL. Protein-membrane interactions during hemodialysis: Effects on solute transport. ASAIO J. 44(4), 319-326 (1998).
24. Huang Z, Gao D, Letteri JJ, Clark WR. Blood-membrane interactions during dialysis. Semin. Dial. 22(6), 623-628 (2009).
25. Ronco C, Davenport A, Gura V. The future of the artificial kidney: Moving towards wearable and miniaturized devices. Nefrologia 31(1), 9-16 (2011).
26. Kim JC, Garzotto F, Cruz DN et al. Enhancement of solute removal in a hollow-fiber hemodialyzer by mechanical vibration. Blood Purif. 31(4), 227-234 (2011).
27. Kim JC, Garzotto F, Chung SG, Ronco C. Effects of ambulation on hemodynamics of hollow-fiber hemodialyzer in the wearable artificial kidney. Presented at: World Conference on Portable-Wearable and Miniaturized Systems for Dialysis and Ultrafiltration. Vicenza, Italy, 30 September-1 October 2010.
28. Humes HD, MacKay SM, Funke AJ, Buffington DA. Tissue engineering of a bioartificial renal tubule assist device: In vitro transport and metabolic characteristics. Kidney Int. 55(6), 2502-2514 (1999).
29. Humes HD, Weitzel WF, Bartlett RH et al. Initial clinical results of the bioartificial kidney containing human cells in ICU patients with acute renal failure. Kidney Int. 66(4), 1578-1588 (2004).
30. Haase M, Bellomo R, Baldwin I et al. b2-microglobulin removal and plasma albumin levels with high cut-off hemodialysis. Int. J. Artif. Organs 30(5), 385-392 (2007).
31. Leonard EF, West AC, Shapley NC, Larsen MU. Dialysis without membranes: How and why? Blood Purif. 22(1), 92-100 (2004).
32. Nissenson AR, Ronco C, Pergamit G, Edelstein M, Watts R. The human nephron filter: Toward a continuously functioning, implantable artificial nephron system. Blood Purif. 23(4), 269-274 (2005).
33. Weinberg E, Kaazempur-Mofrad M, Borenstein J. Concept and computational design for a bioartificial nephron-on-a-chip. Int. J. Artif. Organs 31(6), 508-514 (2008).
34. Humes HD, Fissell WH, Tiranathanagul K. The future of hemodialysis membranes. Kidney Int. 69(7), 1115-1119 (2006).
35. Fissell WH, Dubnisheva A, Eldridge AN, Fleischman AJ, Zydney AL, Roy S. High-performance silicon nanopore hemofiltration membranes. J. Memb. Sci. 326(1), 58-63 (2009).
36. Chouard T. Structural biology: Breaking the protein rules. Nature 471(7337), 151-153 (2011).
37. Striemer CC, Gaborski TR, McGrath JL, Fauchet PM. Charge- and size-based separation of macromolecules using ultrathin silicon membranes. Nature 445(7129), 749-753 (2007).
38. Gu Y, Miki N. Multilayered microfilter using a nanoporous PES membrane and applicable as the dialyzer of a wearable artificial kidney. J. Micromech. Microeng. 19(6), 065031 (2009).
39. Gordon A, Better OS, Greenbaum MA, Marantz LB, Gral T, Maxwell MH. Clinical maintenance hemodialysis with a sorbent-based, low-volume dialysate regeneration system. Trans. Am. Soc. Artif. Intern. Organs 17, 253-258 (1971).
40. Blagg CR, Vizzo JE, Jensen WB, Cole JJ. Experience with a sorbent-based dialysate regeneration system for hemodialysis. Prog. Biochem. Pharmacol. 9, 239-248 (1974).
41. Blumenkrantz MJ, Gordon A, Roberts M. Applications of the Redy® sorbent system to hemodialysis and peritoneal dialysis. Artif. Organs 3(3), 230-236 (1979).
42. Agar JWM. Review: Understanding sorbent dialysis systems. Nephrology (Carlton) 15(4), 406-411 (2010).
43. Giordano C, Esposito R, Bello P. Cold carbon apparatus for hemodialysis. J. Dial. 1(2), 165-179 (1976).
44. Kim JH, Kim JC, Moon JH et al. Development of a cold dialysate regeneration system for home hemodialysis. Blood Purif. 28(2), 84-92 (2009).
45. Tada Y, Horiuchi T, Ohta Y, Dohi T. A new approach for the filtrate regeneration system in the wearable artificial kidney. Artif. Organs 14(6), 405-409 (1990).
46. Giordano C, Esposito R, Bello P, Quarto E. A resin-sorbent system for dialysate regeneration. Kidney Int. 13(Suppl. 8), S138-S144 (1978).
47. Weber C, Rajnoch C, Loth F, Schima H, Falkenhagen D. The microspheres based detoxification system (MDS): A new extracorporeal blood purification technology based on recirculated microspherical adsorbent particles. Int. J. Artif. Organs 17(11), 595-602 (1994).
48. Ash SR. Sorbents in treatment of uremia: A short history and a great future. Semin. Dial. 22(6), 615-622 (2009).
49. Gura V, Macy AS, Beizai M, Ezon C, Golper TA. Technical breakthroughs in the wearable artificial kidney (WAK). Clin. J. Am. Soc. Nephrol. 4(9), 1441-1448 (2009).
50. Gura V, Beizai M, Ezon C, Polaschegg HD. Continuous renal replacement therapy for end-stage renal disease. The wearable artificial kidney (WAK). Contrib. Nephrol. 149, 325-333 (2005).
51. Boehm DA, Gottlieb PA, Hua SZ. On-chip microfluidic biosensor for bacterial detection and identification. Sens. Actuators B Chem. 126(2), 508-514 (2007).
52. Walter A, Marz A, Schumacher W, Rosch P, Popp J. Towards a fast, high specific and reliable discrimination of bacteria on strain level by means of SERS in a microfluidic device. Lab Chip 11(6), 1013-1021 (2011).
53. Vanholder R, Ringoir S. Pitfalls of wearable artificial kidney. Int. J. Artif. Organs 13(11), 715-719 (1990).
54. Verhallen AM, Kooistra MP, van Jaarsveld BC. Cannulating in haemodialysis: Rope-ladder or buttonhole technique? Nephrol. Dial. Transplant. 22(9), 2601-2604 (2007).
55. Struthers J, Allan A, Peel RK, Lambie SH. Buttonhole needling of ateriovenous fistulae: A randomized controlled trial. ASAIO J. 56(4), 319-322 (2010).
56. Trakarnvanich T, Chirananthavat T, Maneerat P, Chabsuwan S, Areeyakulnimit S. Is single-needle hemodialysis still a good treatment in end-stage renal disease? Blood Purif. 25(5-6), 490-496 (2007).
57. Rostoker G, Griuncelli M, Loridon C, Bourlet T, Welsch K, Benmaadi A. Improving the efficiency of short-term single-needle hemodialysis. Ren. Fail. 31(4), 261-266 (2009).
58. Beathard GA, Posen GA. Initial clinical results with the LifeSite Hemodialysis Access System. Kidney Int. 58(5), 2221-2227 (2000).
59. Rosenblatt M, Caridi JG, Hakki FZ et al. Efficacy and safety results with the LifeSite hemodialysis access system versus the Tesio-Cath hemodialysis catheter at 12 months. J. Vasc. Interv. Radiol. 17(3), 497-504 (2006).
60. Canaud B, My H, Morena M et al. Dialock: A new vascular access device for extracorporeal renal replacement therapy. Preliminary clinical results. Nephrol. Dial. Transplant. 14(3), 692-698 (1999).
61. Quarello F, Forneris G, Formica M et al. Dialock® subcutaneous port for hemodialysis: A twelve-month experience in a single center. J. Vasc. Access 2(2), 73-79 (2001).
62. Lee BH, Nam HY, Kwon T et al. Paclitaxel-coated expanded polytetrafluoroethylene haemodialysis grafts inhibit neointimal hyperplasia in porcine model of graft stenosis. Nephrol. Dial. Transplant. 21(9), 2432-2438 (2006).
63. Avci-Adali M, Ziemer G, Wendel HP. Induction of EPC homing on biofunctionalized vascular grafts for rapid in vivo self-endothelialization - a review of current strategies. Biotechnol. Adv. 28(1), 119-129 (2010).
64. Gould WR, Leadley RJ. Recent advances in the discovery and development of direct coagulation factor Xa inhibitors. Curr. Pharm. Des. 9(28), 2337-2347 (2003).
65. Kubitza D, Becka M, Wensing G, Voith B, Zuehlsdorf M. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939 - an oral, direct Factor Xa inhibitor - after multiple dosing in healthy male subjects. Eur. J. Clin. Pharmacol. 61(12), 873-880 (2005).
66. Astapova EV, Stachura ME, Chernecky C, Rosenkoetter MM. Low-end videoconferencing for vascular access device site assessment in homecare. J. Assoc. Vasc. Access 13(3), 135-138 (2008).
67. Eloot S, Dhondt A, Hoeben H, Vanholder R. Comparison of different methods to assess fistula flow. Blood Purif. 30(2), 89-95 (2010).
68. Zeman HD, Lovhoiden G, Vrancken C. The clinical evaluation of vein contrast enhancement. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2, 1203-1206 (2004).
69. Kikuchi M, Hosokawa K. Visualized sclerotherapy of varicose veins. Dermatol. Surg. 36(Suppl. 2), 1050-1055 (2010).
70. Heidenheim AP, Leitch R, Kortas C, Lindsay RM. Patient monitoring in the London Daily/Nocturnal Hemodialysis Study. Am. J. Kidney Dis. 42(1 Suppl.), 61-65 (2003).
71. Gatzoulis L, Iakovidis I. Wearable and portable eHealth systems. Technological issues and opportunities for personalized care. IEEE Eng. Med. Biol. Mag. 26(5), 51-56 (2007).
72. Lymberis A, Olsson S. Intelligent biomedical clothing for personal health and disease management: State of the art and future vision. Telemed. J. E. Health. 9(4), 379-386 (2003).
73. Zheng JW, Zhang ZB, Wu TH, Zhang Y. A wearable mobihealth care system supporting real-time diagnosis and alarm. Med. Biol. Eng. Comput. 45(9), 877-885 (2007).
74. Giansanti D, Macellari V, Maccioni G. Telemonitoring and telerehabilitation of patients with Parkinson's disease: Health technology assessment of a novel wearable step counter. Telemed. J. E. Health 14(1), 76-83 (2008).
75. Connolly P, Cotton C, Morin F. Opportunities at the skin interface for continuous patient monitoring: A reverse iontophoresis model tested on lactate and glucose. IEEE Trans. Nanobioscience 1(1), 37-41 (2002).
76. Sixsmith A, Hine N, Neild I, Clarke N, Brown S, Garner P. Monitoring the well-being of older people. Top. Geriatr. Rehabil. 23(1), 9-23 (2007).
77. Hayes TL, Abendroth F, Adami A, Pavel M, Zitzelberger TA, Kaye JA. Unobtrusive assessment of activity patterns associated with mild cognitive impairment. Alzheimers Dement. 4(6), 395-405 (2008).
78. Baek HJ, Lee HB, Kim JS, Choi JM, Kim KK, Park KS. Nonintrusive biological signal monitoring in a car to evaluate a driver's stress and health state. Telemed. J. E. Health 15(2), 182-189 (2009).
79. Rasouli M, Phee LSJ. Energy sources and their development for application in medical devices. Expert Rev. Med. Devices 7(5), 693-709 (2010).
80. Takeuchi ES, Leising RA, Spillman DM et al. Lithium batteries for medical applications. In:Lithium Batteries: Science and Technology. Nazri G-A, Pistoia G (Eds). Springer, NY, USA, 686-700 (2003).
81. Peng B, Cheng F, Tao Z, Chen J. Lithium transport at silicon thin film: Barrier for high-rate capability anode. J. Chem. Phys. 133(3), 034701 (2010).
82. Nishide H, Oyaizu K. Materials science. Toward flexible batteries. Science 319(5864), 737-738 (2008).
83. Davenport A, Gura V, Ronco C, Beizai M, Ezon C, Rambod E. A wearable haemodialysis device for patients with end-stage renal failure: A pilot study. Lancet 370(9604), 2005-2010 (2007).
84. Kooman JP, Van Der Sande FM, Leunissen KML. The long road to wearable blood-cleansing devices. Blood Purif. 25(4), 377-382 (2007).
85. Ronco C, Fecondini L. The vicenza wearable artificial kidney for peritoneal dialysis (ViWAK PD). Blood Purif. 25(4), 383-388 (2007).
86. Lee DBN, Roberts M. A peritoneal-based automated wearable artificial kidney. Clin. Exp. Nephrol. 12(3), 171-180 (2008).
87. Gura V, Ronco C, Nalesso F et al. A wearable hemofilter for continuous ambulatory ultrafiltration. Kidney Int. 73(4), 497-502 (2008).
88. Fissell WH, Fleischman AJ, Humes HD, Roy S. Development of continuous implantable renal replacement: Past and future. Transl. Res. 150(6), 327-336 (2007).
89. Handley HH, Gorsuch R, Peters H et al. Slow continuous intravenous plasmapheresis (SCIP): Clinical applications and hemostability of extracorporeal ultrafiltration. Contrib. Nephrol. 149, 334-342 (2005).