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Implantable Medical Devices

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Focal Controlled Drug Delivery

Part of the book series: Advances in Delivery Science and Technology ((ADST))

Abstract

Implantable medical devices remain as one of the major research areas because of their potential applications in health care. The targeted, controlled delivery of a drug by an implantable device is an optimum therapy to treat a range of conditions. For example, coronary stenting presents both the need and the opportunity for local drug delivery. Various classes of implantable devices are listed in this chapter. This chapter focuses on requirements of implantable devices such as mechanical properties which are essential for structural support, types and prevention methods of corrosion, biocompatibility of devices and sterilisation to prevent implant associated infections. Properties of metallic, ceramic and polymeric biomaterials used in the manufacturing of implantable devices are also emphasised. Drug delivery applications of cardiovascular and orthopaedic implantable devices are discussed in detail.

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Abbreviations

MEMS:

Microelectromechanical systems

NEMS:

Nano-electromechanical systems

PCL:

Polycaprolactone

PET:

Polyethylene terephthalate

PGA:

Polyglycolic acid

PLA:

Polylactic acid

PU:

Polyurethane

PTFE:

Poly(tetrafluoroethylene)

PMMA:

Polymethylmethacrylate

UHMWPE:

Ultrahigh molecular weight polyethylene

References

  1. Regar E, Sianos G, Serruys PW (2001) Stent development and local drug delivery. Br Med Bull 59:227–248

    Article  CAS  PubMed  Google Scholar 

  2. Ginebra MP, Traykova T, Planell JA (2006) Calcium phosphate cements as bone drug delivery systems: a review. J Control Release 113:102–110

    Article  CAS  PubMed  Google Scholar 

  3. Long M, Rack HJ (1998) Titanium alloys in total joint replacement-a materials science perspective. Biomaterials 19:1621–1639

    Article  CAS  PubMed  Google Scholar 

  4. Gultepe E, Nagesha D, Sridhar S, Amiji M (2010) Nanoporous inorganic membranes or coatings for sustained drug delivery in implantable devices. Adv Drug Deliv Rev 62:305–315

    Article  CAS  PubMed  Google Scholar 

  5. Park GE, Webster TJ (2005) A review of nanotechnology for the development of better orthopedic implants. J Biomed Nanotechnol 1:18–29

    Article  CAS  Google Scholar 

  6. Gunn J, Cumberland D (1999) Stent coatings and local drug delivery. State of the art. Eur Heart J 20:1693–1700

    Article  CAS  PubMed  Google Scholar 

  7. Zuckerman DM, Brown P, Nissen SE (2011) Medical device recalls and the FDA approval process. Arch Intern Med 171:1006–1018

    PubMed  Google Scholar 

  8. Santos MH, Valerio P, Goes AM, Leite MF, Heneine LGD, Mansur HS (2007) Biocompatibility evaluation of hydroxyapatite/collagen nanocomposites doped with Zn+2. Biomed Mater 2:135

    Article  CAS  PubMed  Google Scholar 

  9. Jung F, Wischke C, Lendlein A (2010) Degradable, multifunctional cardiovascular implants: challenges and hurdles. MRS Bull 35:607–613

    Article  Google Scholar 

  10. Ajili SH, Ebrahimi NG, Soleimani M (2009) Polyurethane/polycaprolactane blend with shape memory effect as a proposed material for cardiovascular implants. Acta Biomater 5:1519–1530

    Article  CAS  PubMed  Google Scholar 

  11. Wischke C, Lendlein A (2011) Designing multifunctional polymers for cardiovascular implants. Clin Hemorheol Microcirc 49:347–355

    PubMed  Google Scholar 

  12. Andukuri A, Kushwaha M, Tambralli A, Anderson JM, Dean DR, Berry JL et al (2011) A hybrid biomimetic nanomatrix composed of electrospun polycaprolactone and bioactive peptide amphiphiles for cardiovascular implants. Acta Biomater 7:225–233

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  13. Kelly A (1990) Concise encyclopedia of composite materials. MIT Press, Cambridge

    Google Scholar 

  14. Balkany TJ, Hodges AV, Eshraghi AA, Butts S, Bricker K, Lingvai J et al (2002) Cochlear implants in children—a review. Acta Otolaryngol 122:356–362

    Article  PubMed  Google Scholar 

  15. Yasukawa T, Ogura Y, Sakurai E, Tabata Y, Kimura H (2005) Intraocular sustained drug delivery using implantable polymeric devices. Adv Drug Deliv Rev 57:2033–2046

    Article  CAS  PubMed  Google Scholar 

  16. Choonara YE, Pillay V, Danckwerts MP, Carmichael TR, du Toit LC (2010) A review of implantable intravitreal drug delivery technologies for the treatment of posterior segment eye diseases. J Pharm Sci 99:2219–2239

    Article  CAS  PubMed  Google Scholar 

  17. Williams DF (2009) On the nature of biomaterials. Biomaterials 30:5897–5909

    Article  CAS  PubMed  Google Scholar 

  18. Williams D (2008) The relationship between biomaterials and nanotechnology. Biomaterials 29:1737

    Article  CAS  PubMed  Google Scholar 

  19. Khan W, Kapoor M, Kumar N (2007) Covalent attachment of proteins to functionalized polypyrrole-coated metallic surfaces for improved biocompatibility. Acta Biomater 3:541–549

    Article  CAS  PubMed  Google Scholar 

  20. Khan W, Marew T, Kumar N (2006) Immobilization of drugs and biomolecules on in situ copolymerized active ester polypyrrole coatings for biomedical applications. Biomed Mater 1:235–241

    Article  CAS  PubMed  Google Scholar 

  21. Agrawal CM (1998) Reconstructing the human body using biomaterials. J Miner Met Mater Soc 50:31–35

    Article  CAS  Google Scholar 

  22. Davis JR (2003) Handbook of materials for medical devices. ASM International, Materials Park, OH

    Google Scholar 

  23. Rack HJ, Qazi JI (2006) Titanium alloys for biomedical applications. Mater Sci Eng C 26:1269–1277

    Article  CAS  Google Scholar 

  24. Roach M (2007) Base metal alloys used for dental restorations and implants. Dent Clin N Am 51:603–627

    Article  PubMed  Google Scholar 

  25. BomBac DD, Brojan M, Fajfar P, Kosel F, Turk R (2007) Review of materials in medical applications. RMZ Mater Geoenviron 54:471–499

    CAS  Google Scholar 

  26. Angelova N, Hunkeler D (1999) Rationalizing the design of polymeric biomaterials. Trends Biotechnol 17:409–421

    Article  CAS  PubMed  Google Scholar 

  27. Venkatraman S, Boey F, Lao LL (2008) Implanted cardiovascular polymers: natural, synthetic and bio-inspired. Prog Polym Sci 33:853–874

    Article  CAS  Google Scholar 

  28. Commandeur S, Van Beusekom HMM, Van Der Giessen WIMJ (2006) Polymers, drug release, and drug eluting stents. J Interv Cardiol 19:500–506

    Article  PubMed  Google Scholar 

  29. Metzger A (1976) Polyethylene terephthalate and the pillarTM palatal implant: its historical usage and durability in medical applications. Biomed Eng 11:301–306

    Google Scholar 

  30. Lyu SP, Untereker D (2009) Degradability of polymers for implantable biomedical devices. Int J Mol Sci 10:4033–4065

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  31. Gogolewski S (2000) Bioresorbable polymers in trauma and bone surgery. Injury 31:D28–D32

    Article  Google Scholar 

  32. Santos AR Jr (2010) Bioresorbable polymers for tissue engineering. In: Eberlin D (ed) Tissue engineering. In-Teh, Olajnica, pp 235–246

    Google Scholar 

  33. Middleton JC, Tipton AJ (2000) Synthetic biodegradable polymers as orthopedic devices. Biomaterials 21:2335–2346

    Article  CAS  PubMed  Google Scholar 

  34. Geiger M, Li RH, Friess W (2003) Collagen sponges for bone regeneration with rhBMP-2. Adv Drug Deliv Rev 55:1613–1629

    Article  CAS  PubMed  Google Scholar 

  35. Patino MG, Neiders ME, Andreana S, Noble B, Cohen RE (2002) Collagen as an implantable material in medicine and dentistry. J Oral Implantol 28:220–225

    Article  PubMed  Google Scholar 

  36. Ramshaw JAM, Werkmeister JA, Glattauer V (1995) Collagen-based biomaterials. Biotechnol Genet Eng Rev 13:335–382

    Article  Google Scholar 

  37. Roohpour N, Wasikiewicz JM, Paul D, Vadgama P, Rehman IU (2009) Synthesis and characterisation of enhanced barrier polyurethane for encapsulation of implantable medical devices. J Mater Sci Mater Med 20:1803–1814

    Article  CAS  PubMed  Google Scholar 

  38. Diener T, Hensel B, Heublein B, Barlach S, Rohde R, Sternberg K et al (2003) Biodegradable drug depots on coronary stents-local drug delivery in interventional cardiology. Prog Biomed Res 8:82–91

    Google Scholar 

  39. Khan W, Farah S, Domb AJ (2012) Drug eluting stents: developments and current status. J Control Release 161:703–712

    Article  CAS  PubMed  Google Scholar 

  40. Levy Y, Khan W, Farah S, Domb AJ (2012) Surface crystallization of rapamycin on stents using a temperature induced process. Langmuir 28:6207–6210

    Article  CAS  PubMed  Google Scholar 

  41. Wu P, Grainger DW (2006) Drug/device combinations for local drug therapies and infection prophylaxis. Biomaterials 27:2450–2467

    Article  CAS  PubMed  Google Scholar 

  42. Nag S, Banerjee R (2012) Fundamentals of Medical Implant Materials. In: Narayan R (eds) Materials for medical devices. ASM International, pp 6–16

    Google Scholar 

  43. Dujovne AR, Bobyn JD, Krygier JJ, Miller JE, Brooks CE (1993) Mechanical compatibility of noncemented hip prostheses with the human femur. J Arthroplasty 8:7–22

    Article  CAS  PubMed  Google Scholar 

  44. Sumner DR, Galante JO (1992) Determinants of stress shielding: design versus materials versus interface. Clin Orthop Relat Res 274:202–212

    PubMed  Google Scholar 

  45. Kamachimudali U, Sridhar TM, Raj B (2003) Corrosion of bio implants. In: Sadhana: Academy proceedings in engineering sciences. Indian Academy of Sciences, pp 601–637

    Google Scholar 

  46. Black J (1988) Orthopaedic biomaterials in research and practice. Churchill Livingstone, New York, NY

    Google Scholar 

  47. Jacobs JJ, Gilbert JL, Urban RM (1998) Current concepts review-corrosion of metal orthopaedic implants. J Bone Joint Surg Am 80:268–282

    CAS  PubMed  Google Scholar 

  48. Hallab NJ, Urban RM, Jacobs JJ (2004) Corrosion and biocompatibility of orthopedic implants. In: Yaszemski MJ, Trantolo DJ, Lewandrowski KU, Hasici V, Altobelli DE, Wise DL (eds) Biomaterials in orthopedics. Dekker, New York, NY, p 75

    Google Scholar 

  49. Williams DF (2008) On the mechanisms of biocompatibility. Biomaterials 29:2941–2953

    Article  CAS  PubMed  Google Scholar 

  50. Onuki Y, Bhardwaj U, Papadimitrakopoulos F, Burgess DJ (2008) A review of the biocompatibility of implantable devices: current challenges to overcome foreign body response. J Diabetes Sci Technol 2:1003–1015

    Article  PubMed Central  PubMed  Google Scholar 

  51. Ratner BD, Hoffman AS, Schoen FJ, Lemons JE (2004) Biomaterials science: an introduction to materials in medicine. Academic, San Diego, CA

    Google Scholar 

  52. Kirkpatrick CJ, Peters K, Hermanns M, Bittinger F, Krump-Konvalinkova V, Fuchs S et al (2005) In vitro methodologies to evaluate biocompatibility: status quo and perspective. ITBM-RBM 26:192–199

    Article  Google Scholar 

  53. Matthews IP, Gibson C, Samuel AH (1994) Sterilisation of implantable devices. Clin Mater 15:191–215

    Article  CAS  PubMed  Google Scholar 

  54. Band JD, Maki DG (1979) Infections caused by arterial catheters used for hemodynamic monitoring. Am J Med 67:735–741

    Article  CAS  PubMed  Google Scholar 

  55. Rae T (1975) A study on the effects of particulate metals of orthopaedic interest on murine macrophages in vitro. J Bone Joint Surg Br 57:444–450

    CAS  PubMed  Google Scholar 

  56. Foraker AB, Walczak RJ, Cohen MH, Boiarski TA, Grove CF, Swaan PW (2003) Microfabricated porous silicon particles enhance paracellular delivery of insulin across intestinal Caco-2 cell monolayers. Pharm Res 20:110–116

    Article  CAS  PubMed  Google Scholar 

  57. Losic D, Cole MA, Dollmann B, Vasilev K, Griesser HJ (2008) Surface modification of nanoporous alumina membranes by plasma polymerization. Nanotechnology 19:245704

    Article  PubMed  Google Scholar 

  58. Tao SL, Desai TA (2003) Microfabricated drug delivery systems: from particles to pores. Adv Drug Deliv Rev 55:315–328

    Article  CAS  PubMed  Google Scholar 

  59. Grayson ACR, Shawgo RS, Johnson AM, Flynn NT, Li Y, Cima MJ et al (2004) A BioMEMS review: MEMS technology for physiologically integrated devices. Proc IEEE 92:6–21

    Article  CAS  Google Scholar 

  60. Ekinci KL, Roukes ML (2005) Nanoelectromechanical systems. Rev Sci Instrum 76:061101–061112

    Article  Google Scholar 

  61. Grayson ACR, Choi IS, Tyler BM, Wang PP, Brem H, Cima MJ et al (2003) Multi-pulse drug delivery from a resorbable polymeric microchip device. Nat Mater 2:767–772

    Article  CAS  Google Scholar 

  62. Finkelstein A, McClean D, Kar S, Takizawa K, Varghese K, Baek N et al (2003) Local drug delivery via a coronary stent with programmable release pharmacokinetics. Circulation 107:777–784

    Article  PubMed  Google Scholar 

  63. Luginbuehl V, Meinel L, Merkle HP, Gander B (2004) Localized delivery of growth factors for bone repair. Eur J Pharm Biopharm 58:197–208

    Article  CAS  PubMed  Google Scholar 

  64. Leach JK, Mooney DJ (2004) Bone engineering by controlled delivery of osteoinductive molecules and cells. Expert Opin Biol Ther 4:1015–1027

    Article  CAS  PubMed  Google Scholar 

  65. Schmitt JM, Hwang K, Winn SR, Hollinger JO (2005) Bone morphogenetic proteins: an update on basic biology and clinical relevance. J Orthop Res 17:269–278

    Article  Google Scholar 

  66. Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL et al (2011) A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a prospective, randomized, multicenter trial to assess an everolimus-eluting coronary stent system [PROMUS element] for the treatment of up to two de novo coronary artery lesions) trial. J Am Coll Cardiol 57:1700–1708

    Article  CAS  PubMed  Google Scholar 

  67. Jaff MR (2012) Advances in the management of patients with vascular disease. Expert Rev Cardiovasc Ther 10:151–153

    Article  PubMed  Google Scholar 

  68. Kretz B, Steinmetz E, Brenot R, Bouchot O (2012) First results of clampless distal anastomosis in peripheral vascular bypass with LeGoo, a thermoreversible polymer. J Vasc Surg 55:1821–1825

    Article  PubMed  Google Scholar 

  69. Kennedy DW (2012) The PROPELTM steroid-releasing bioabsorbable implant to improve outcomes of sinus surgery. Expert Rev Respir Med 6:493–498

    Article  CAS  PubMed  Google Scholar 

  70. Mani G, Feldman MD, Patel D, Agrawal C (2007) Coronary stents: a materials perspective. Biomaterials 28:1689–1710

    Article  CAS  PubMed  Google Scholar 

  71. Geller J (2011) CDRH issues nonapproval letter to EES for SEDASYS system. J Clin Eng 36:88–91

    Article  Google Scholar 

  72. Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL et al (2010) Single, intra-articular treatment with 6 ml hylan GF 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis 69:113–119

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  73. Nagele H, Azizi M, Hashagen S, Castel MA, Behrens S (2007) First experience with a new active fixation coronary sinus lead. Europace 9:437–441

    Article  CAS  PubMed  Google Scholar 

  74. Junkins-Hopkins JM (2011) Biologic dressings. J Am Acad Dermatol 64:e5–e7

    Article  PubMed  Google Scholar 

  75. Glassman SD, Carreon L, Djurasovic M, Campbell MJ, Puno RM, Johnson JR et al (2007) Posterolateral lumbar spine fusion with INFUSE bone graft. Spine J 7:44–49

    Article  PubMed  Google Scholar 

  76. Young VL, Boswell CB, Centeno RF, Watson ME (2005) DMSO: applications in plastic surgery. Aesthet Surg J 25:201–209

    Article  CAS  PubMed  Google Scholar 

  77. Jordan WD Jr, Moore WM Jr, Melton JG, Brown OW, Carpenter JP (2009) Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg 50:979

    Article  PubMed  Google Scholar 

  78. Pagnano M, Westrich G (2005) Successful nonoperative management of chronic osteoarthritis pain of the knee: safety and efficacy of retreatment with intra-articular hyaluronans. Osteoarthritis Cartilage 13:751–761

    Article  PubMed  Google Scholar 

  79. Glogau RG (2012) Fillers: from the past to the future. Semin Cutan Med Surg 31:78–87

    Article  CAS  PubMed  Google Scholar 

  80. Chau M, Patterson ME, Yi S, Geist S, Oba T. (2012) Prosthetic apparatus for implantation at mitral valve. US Patent 20,120,323,316

    Google Scholar 

  81. Kablik J, Monheit GD, Yu L, Chang G, Gershkovich J (2009) Comparative physical properties of hyaluronic acid dermal fillers. Dermatol Surg 35:302–312

    Article  CAS  PubMed  Google Scholar 

  82. Altman RD (2010) Non-avian-derived hyaluronan for the treatment of osteoarthritis of the knee. Expert Rev Clin Immunol 6:21–27

    Article  CAS  PubMed  Google Scholar 

  83. Roten L, Stortecky S, Scarcia F, Kadner A, Tanner H, Delacretaz E et al (2012) Atrioventricular conduction after transcatheter aortic valve implantation and surgical aortic valve replacement. J Cardiovasc Electrophysiol 23:1115–1122

    Article  PubMed  Google Scholar 

  84. Klijian A (2012) A novel approach to control air leaks in complex lung surgery: a retrospective review. J Cardiothorac Surg 7:49–55

    Article  PubMed Central  PubMed  Google Scholar 

  85. Burgess CM (2008) Treatment of facial asymmetry with poly-L-lactic acid: a case study. Aesthetic Plast Surg 32:552–554

    Article  CAS  PubMed  Google Scholar 

  86. Shoshani D, Markovitz E, Cohen Y, Heremans A, Goldlust A (2007) Skin test hypersensitivity study of a cross linked, porcine collagen implant for aesthetic surgery. Dermatol Surg 33:S152–S158

    Article  CAS  PubMed  Google Scholar 

  87. Jamieson WRE, Koerfer R, Yankah CA, Zittermann A, Hayden RI, Ling H et al (2009) Mitroflow aortic pericardial bioprosthesis-clinical performance. Eur J Cardiothorac Surg 36:818–824

    Article  PubMed  Google Scholar 

  88. Becker LC, Bergfeld WF, Belsito DV, Klaassen CD, Marks JG Jr, Shank RC et al (2009) Final report of the safety assessment of hyaluronic acid, potassium hyaluronate, and sodium hyaluronate. Int J Toxicol 28:5–67

    Article  CAS  PubMed  Google Scholar 

  89. Busso M, Voigts R (2008) An investigation of changes in physical properties of injectable calcium hydroxylapatite in a carrier gel when mixed with lidocaine and with lidocaine/epinephrine. Dermatol Surg 34:S16–S24

    Article  CAS  PubMed  Google Scholar 

  90. Spear SL, Parikh PM, Reisin E, Menon NG (2008) Acellular dermis-assisted breast reconstruction. Aesthetic Plast Surg 32:418–425

    Article  CAS  PubMed  Google Scholar 

  91. Cohen SR, Berner CF, Busso M, Gleason MC, Hamilton D, Holmes RE et al (2006) ArteFill: a long-lasting injectable wrinkle filler material-summary of the US Food and Drug Administration trials and a progress report on 4-to 5-year outcomes. Plast Reconstr Surg 118:64S–76S

    Article  CAS  PubMed  Google Scholar 

  92. Suman T (2011) Enhancing facial esthetics by other modalities. Int J Dent 2011:1–6

    Article  Google Scholar 

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Authors and Affiliations

  1. Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, 500037, India

    Wahid Khan & Eameema Muntimadugu

  2. Medical Device Concept Laboratory, New Jersey Institute of Technology, Newark, NJ, USA

    Michael Jaffe

  3. Faculty of Medicine, Institute of Drug Research, School of Pharmacy, The Hebrew University of Jerusalem, Jerusalem, 91120, Israel

    Abraham J. Domb

Authors
  1. Wahid Khan
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  2. Eameema Muntimadugu
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  3. Michael Jaffe
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  4. Abraham J. Domb
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Correspondence to Abraham J. Domb .

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Editors and Affiliations

  1. School of Pharmacy-Faculty of Medicine The Hebrew University of Jerusalem, Jerusalem, Israel

    Abraham J. Domb

  2. Department of Pharmaceutics, National Institute of Pharmaceutical Education & Research (NIPER), Balanagar, Hyderabad, Andhra Pradesh, India

    Wahid Khan

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Khan, W., Muntimadugu, E., Jaffe, M., Domb, A.J. (2014). Implantable Medical Devices. In: Domb, A., Khan, W. (eds) Focal Controlled Drug Delivery. Advances in Delivery Science and Technology. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-9434-8_2

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