Penetration-enhanced ultrasharp microneedles and prediction on skin interaction for efficient transdermal drug delivery

Journal of Microelectromechanical Systems

Volumn 16, Issue 6, 2007, Pages 1429-1440

  Roxhed, Niclas ^a   Gasser, T Christian ^a   Griss, Patrick ^a   Holzapfel, Gerdard A ^a,b   Stemme, Göran ^a  

^a ROYAL INSTITUTE OF TECHNOLOGY   (Sweden)

^b ZÜHLKE ENGINEERING AG   (Switzerland)

Author keywords

Biological systems; Drug delivery; Drugs; Force; Microneedles; Needles; Skin; Skin modeling; Transdermal

Indexed keywords

BIOMARKERS; BIOMEDICAL ENGINEERING; COMPUTER SIMULATION; SKIN; TISSUE;

INSERTION FORCE; PENETRATION-ENHANCED ULTRASHARP MICRONEEDLES;

DRUG DELIVERY;

EID: 36949000879     PISSN: 10577157     EISSN: None     Source Type: Journal    
DOI: 10.1109/JMEMS.2007.907461     Document Type: Article

References (51)

1. B. Barry, "Novel mechanisms and devices to enable successful transdermal drug delivery," Eur. J. Pharm. Sci., vol. 14, no. 2, pp. 101-114, Sep. 2001.
2. M. Prausnitz, S. Mitragotri, and R. Langer, "Current status and future potential of transdermal drug delivery," Nat. Rev. Drug Discov., vol. 3, no. 2, pp. 115-124, Feb. 2004.
3. S. Kaushik, A. Hord, D. Denson, D. McAllister, S. Smitra, M. Allen, and M. Prausnitz, "Lack of pain associated with microfabricated microneedles," Anesth. Analg., vol. 92, no. 2, pp. 502-504, Feb. 2001.
4. R. Sivamani, B. Stoeber, G. Wu, H. Zhai, D. Liepmann, and H. Maibach, "Clinical microneedle injection of methyl nicotinate: Stratum corneum penetration," Skin Res. Technol., vol. 11, no. 2, pp. 152-156, May 2005.
5. M. Gerstel and V. Place, "Drug delivery device," U.S. Patent 3 964 482, Jun. 22, 1976.
6. W. Lin, M. Cormier, A. Samiee, A. Griffin, B. Johnson, C. Teng, G. Hardee, and P. Daddona, "Transdermal delivery of antisense oligonucleotides with microprojection patch (Macroflux) technology," Pharm. Res., vol. 18, no. 12, pp. 1789-1793, Dec. 2001.
7. J. A. Matriano, M. Cormier, J. Johnson, W. Young, M. Buttery, K. Nyam, and P. Daddona, "Macroflux microprojection array patch technology: A new and efficient approach for intracutaneous immunization," Pharm. Res., vol. 19, no. 1, pp. 63-70, Jan. 2002.
8. J. A. Mikszta, J. B. Alarcon, J. M. Brittingham, D. E. Sutter, R. J. Pettis, and N. G. Harvey, "Improved genetic immunization via micromechanical disruption of skin-barrier function and targeted epidermal delivery," Nat. Med., vol. 8, no. 4, pp. 415-419, Apr. 2002. 10.1038/nm0402-415. [Online]. Available: http://dx.doi.org/10.1038/nm0402-415
9. W. Martanto, S. Davis, H. Holiday, J. Wang, H. Gill, and M. Prausnitz, "Transdermal delivery of insulin using microneedles in vivo," Pharm. Res., vol. 21, no. 6, pp. 947-952, Jun. 2004.
10. P. Griss, P. Enoksson, H. Tolvanen-Laakso, P. Merilainen, S. Ollmar, and G. Stemme, "Micromachined electrodes for biopotential measurements," J. Microelectromech. Syst., vol. 10, no. 1, pp. 10-16, Mar. 2001.
11. P. Åberg, P. Geladi, I. Nicander, J. Hansson, U. Holmgren, and S. Ollmar, "Non-invasive and microinvasive electrical impedance spectra of skin cancer - A comparison between two techniques," Skin Res. Technol., vol. 11, no. 4, pp. 281-286, Nov. 2005. [Online]. Available: http://www.blackwellsynergy.com/doi/abs/10.1111/ j.0909-725X.2005.00125.x
12. H. Gardeniers, R. Luttge, E. Berenschot, M. de Boer, S. Yeshurun, M. Hefetz, R. van't Oever, and A. van den Berg, "Silicon micromachined hollow microneedles for transdermal liquid transport," J. Microelectromech. Syst., vol. 12, no. 6, pp. 855-862, Dec. 2003.
13. D. V. McAllister, P. M. Wang, S. P. Davis, J.-H. Park, P. J. Canatella, M. G. Allen, and M. R. Prausnitz, "Microfabricated needles for transdermal delivery of macromolecules and nanoparticles: Fabrication methods and transport studies," Proc. Nat. Acad. Sci. USA, vol. 100, no. 24, pp. 13755-13760, Nov. 2003. [Online]. Available: http://www.pnas.org/cgi/content/abstract/100/24/13755
14. S. Davis, W. Martanto, M. Allen, and M. Prausnitz, "Hollow metal microneedles for insulin delivery to diabetic rats," IEEE Trans. Biomed. Eng., vol. 52, no. 5, pp. 909-915, May 2005.
15. M. Prausnitz, "Microneedles for transdermal drug delivery," Adv. Drug Deliv. Rev., vol. 56, no. 5, pp. 581-587, Mar. 2004.
16. S. Davis, B. Landis, Z. Adams, M. Allen, and M. Prausnitz, "Insertion of microneedles into skin: Measurement and prediction of insertion force and needle fracture force," J. Biomech., vol. 37, no. 8, pp. 1155-1163, Aug. 2004.
17. Y. S. Papir, K.-H. Hsu, and R. H. Wildnauer, "The mechanical properties of stratum corneum: I. The effect of water and ambient temperature on the tensile properties of newborn rat stratum corneum," Biochim. Biophys. Acta Gen. Subj., vol. 399, no. 1, pp. 170-180, Jul. 1975. [Online]. Available: http://www.sciencedirect.com/science/article/ B6TIW-47MJGNP-12G/2/2364f2314e822139542b8f40205ef87e
18. A. Hendley, R. Marks, and P. Payne, "Measurement of forces for point indentation of the stratum corneum in vivo: The influence of age, sex, site delipidisation, and hydration," Bioeng. Skin, vol. 3, pp. 234-240, 1982.
19. K. S. Wu, W. W. van Osdol, and R. H. Dauskardt, "Mechanical properties of human stratum corneum: Effects of temperature, hydration, and chemical treatment," Biomaterials, vol. 27, no. 5, pp. 785-795, Feb. 2006. [Online]. Available: http://www.sciencedirect.com/science/ article/B6TWB-4GV8TBN-2/2/3e54ed86c790f1f253892faac3dc7bfe
20. P. Loeters, R. Duwel, F. Verbaan, R. Lunge, D. van den Berg, J. Bouwstra, and A. van den Berg, "Measuring the insertion of microfabricated microneedles into skin with a penetration sensor," in Proc. μTAS 8th Int. Conf. Miniaturized Syst. Chem. Life Sci., 2004, vol. 1, pp. 497-499.
21. W. Martanto, J. Moore, O. Kashlan, R. Kamath, P. Wang, J. O'Neal, and M. Prausnitz, "Microinfusion using hollow microneedles," Pharm. Res. vol. 23, no. 1, pp. 104-113, Jan. 2006.
22. P. M. Wang, M. Cornwell, J. Hill, and M. R. Prausnitz, "Precise microinjection into skin using hollow microneedles," J. Investig. Dermatol., vol. 126, no. 5, pp. 1080-1087, May 2006. [Online]. Available: http://dx.doi.org/10.1038/sj.jid.5700150
23. W. Martanto, J. S. Moore, T. Couse, and M. R. Prausnitz, "Mechanism of fluid infusion during microneedle insertion and retraction," J. Control. Release, vol. 112, no. 3, pp. 357-361, May 2006. [Online]. Available: http://www.sciencedirect.com/science/article/B6T3D-4JS206B-1/ 2/adf0925867608d5b4734cf1bfca4c487
24. L. Norlén, "The skin barrier - Structure and physical function," Ph.D. dissertation, Karolinska Inst., Stockholm, Sweden, 1999.
25. R. C. Haut, "Biomechanics of soft tissue," in Accidental Injury: Biomechanics and Prevention, 2nd ed. A. M. Nahum and J. W. Melvin, Eds. New York: Springer-Verlag, 2002, pp. 228-253.
26. P. A. Payne, "Measurement of properties and function of skin," Clin. Phys. Physiol. Meas., vol. 12, no. 2, pp. 105-129, May 1991.
27. G. A. Holzapfel, "Biomechanics of soft tissue," in The Handbook of Materials Behavior Models. Volume III, Multiphysics Behaviors, Chapter 10, Composite Media, Biomaterials, J. Lemaitre, Ed. Boston, MA: Academic, 2001, pp. 1049-1063.
28. F. M. Hendriks, "Mechanical behaviour of human epidermal and dermal layers in vivo," Ph.D. dissertation, Technische Universiteit Eindhoven, Eindhoven, The Netherlands, 2005.
29. R. Reihsner, B. Balogh, and E. J. Menzel, "Two-dimensional elastic properties of human skin in terms of an incremental model at the in vivo configuration," Med. Eng. Phys., vol. 17, no. 4, pp. 304-313, Jun. 1995.
30. K. Langer, "On the anatomy and physiology of the skin i-iv," Br. J. Plast. Surg., vol. 31, pp. 3-8, 1978. Sitzungsbericht der Akademie der Wissenschaften in Wien, 1861. Translated by T. Gibson and reprinted: 1978, 93-106, 185-99, 273-8.
31. O. A. Shergold and N. A. Fleck, "Experimental investigation into the deep penetration of soft solids by sharp and blunt punches, with application to the piercing of skin," J. Biomech. Eng., vol. 127, no. 5, pp. 838-848, Oct. 2005.
32. F. M. Hendriks, D. Brokken, C. W. Oomens, D. L. Bader, and F. P. Baaijens, "The relative contributions of different skin layers to the mechanical behavior of human skin in vivo using suction experiments," Med. Eng. Phys., vol. 28, no. 3, pp. 259-266, Apr. 2006. [Online]. Available: http://linkinghub.elsevier.com/retrieve/pii/s1350453305001451
33. P. Griss and G. Stemme, "Side-opened out-of-plane microneedles for microfluidic transdermal liquid transfer," J. Microelectromech. Syst., vol. 12, no. 3, pp. 296-301, Jun. 2003.
34. S. Davis, "Hollow microneedles for molecular transport across skin," Ph.D. dissertation, Georgia Inst. Technol., Atlanta, GA, 2003.
35. M. Teo, C. Shearwood, K. C. Ng, J. Lu, and S. Moochhala, "In vitro and in vivo characterization of MEMS microneedles," Biomed. Microdevices vol. 7, no. 1, pp. 47-52, Mar. 2005. [Online]. Available: http://dx.doi.org/10.1007/s10544-005-6171-y
36. M. Hefetz, G. Fruchtman, and Y. Levine, "Devices and methods for transporting fluid across a biological barrier," WO Patent 03/074 102 A2, Sep. 12, 2003.
37. Y. Yeshurun, M. Hefetz, Y. Sefi, Y. Levine, and G. Lavi, "System and methods for delivering fluid into flexible biological barrier," WO Patent 2006/054 280 A2, May 26, 2006.
38. K. E. Petersen, "Silicon as a mechanical material," Proc. IEEE, vol. 70, no. 5, pp. 420-457, May 1982.
39. T. Ravi, R. Marcus, and D. Liu, "Oxidation sharpening of silicon tips," J. Vac. Sci. Technol. B, Microelectron. Process. Phenom., vol. 9, no. 6, pp. 2733-2737, Nov. 1991. [Online]. Available: http://dx.doi.org/10.1116/1.585680
40. O. C. Zienkiewicz and R. L. Taylor, The Finite Element Method: The Basis, 5th ed, vol. 1. Oxford, UX.: Butterworth Heinemann, 2000.
41. O. C. Zienkiewicz and R. L. Taylor, The Finite Element Method: The Basis, 5th ed, vol. 2. Oxford, U.K.: Butterworth Heinemann, 2000.
42. B. Stoeber and D. Liepmann, "Arrays of hollow out-of-plane microneedles for drug delivery," J. Microelectromech. Syst., vol. 14, no. 3, pp. 472-479, Jun. 2005. [Online]. Available: http://dx.doi.org/10.1109/JMEMS.2005.844843
43. O. Coussy, Poromechanics. Hoboken, NJ: Wiley, 2004.
44. O. A. Shergold and N. A. Fleck, "Mechanisms of deep penetration of soft solids with application to the injection and wounding of skin," Proc. R. Soc. Lond. A, Math. Phys. Sci., vol. 460, no. 2050, pp. 3037-3058, 2004.
45. R. Reihsner and E. J. Menzel, "On the orthogonal anisotropy of human skin as a function of anatomical region," Connect. Tissue Res., vol. 34, no. 2, pp. 145-160, 1996.
46. R. W. Ogden, "Large deformation isotropic elasticity - On the correlation of theory and experiment for incompressible rubberlike solids," Proc. R. Soc. Lond. A, Math. Phys. Sci., vol. 326, no. 1567, pp. 565-584, Feb. 1972.
47. L. H. Jansen and P. B. Rottier, "Some mechanical properties of human abdominal skin measured on excised strips: A study of their dependence on age and how they are influenced by the presence of striae," Dermatologica, vol. 117, no. 2, pp. 65-83, Aug. 1958.
48. P. Wriggers, Computational Contact Mechanics. Chichester, U.K.: Wiley, 2002.
49. V. C. Mow, M. H. Holmes, and W. M. Lai, "Fluid transport and mechanical properties of articular cartilage: A review," J. Biomech., vol. 17, no. 5, pp. 377-394, 1984.
50. S. M. Klisch and J. C. Lotz, "A special theory of biphasic mixtures and experimental results for human annulus fibrosus tested in confined compression," J. Biomech. Eng., vol. 122, no. 2, pp. 180-188, Apr. 2000.
51. D. Armani, C. Liu, and N. Aluru, "Re-configurable fluid circuits by PDMS elastomer micromachining," in Proc. 12th IEEE Int. Conf. Micro Electro Mech. Syst. Tech. Dig., 1999, pp. 222-227. [Online]. Available: http://dx.doi.org/10.1109/MEMSYS.1999.746817