Flowchart for Basic Non-destructive Testing Technologies in Biomaterials

S.H. Kurra, J.M. Zhang, and A. Pennathur

Industrial Engineering, The University of Texas at El Paso, El Paso, USA Abstract Many accidents result in bone loss, tissue loss or vein loss either in the limbs, hands, spinal, skull or teeth. Biomaterials have their applications in orthopedic, vascular, tissue, dental and spinal implants to augment and replace the loss. However, the biomaterials which are to be implanted into the human body must be compatible with the human body and hence a close, long follow up observation should be employed to monitor for any adverse effects that may occur. Currently we have a few non-destructive testing technologies available to characterize the various features that may arise during and after the implantation. Depending on the different types of biomaterials, different features interested, different purposes of testing, the different nondestructive testing technologies should be used. This study aims to provide a general flowchart to determine the most suitable nondestructive evaluation technologies based on their working mechanism and applications. A flowchart has been drawn based on the review of the current non destructive testing techniques in biomaterials. All the steps that are to be followed in non destructive testing are indicated in the flowchart. Keywords Nondestructive testing, biomaterial, implant, flowchart, reworking.

A. Bone structure Bone consists of a mineral phase (hydroxyapatite), collagen, non-collagenous proteins, lipids and water [1]. It should be able to carry the load and adapt to deformations resulting from normal stress and strain. Vibrational spectroscopy in the mid infrared region can provide molecular structure information about mineralized and nonmineralized connective tissues [2-5]. B. Osseointegration Bioinert material like titanium can be successfully fused into bone by means of the osseointegrated implant which is the most accepted and successful implant discovered by Swedish professor Per-Ingvar Branemark. Healing process plays an important role to the long term success of restoration after implantation [6]. Any premature load can result in severe damage or fracture on the host bone tissues [7]. Osseointegration is the direct structural and functional connection between living bone and the surface of a load bearing artificial implant, typically made of titanium. C. Tissue engineering Bone loss is a major problem in orthopedics, and tissue engineering is a promising therapeutic solution for large bone defect repairs. Tissue engineering makes use of hydroxyapatite (HA) and/or tri-calcium phosphate (TCP) with osteogenic cells [8]. Cemented hip implants need to be monitored to study the failure of composite implants [9-10] and damage accumulation in bone [11]. D. Dental structure Dental structures can be observed using ultrasound [12]. The effect of fluoride toothpaste [13] and imaging of the enamel-dentine boundary for thickness measurement [14] can be carried out using ultrasound.

I. INTRODUCTION
Biomaterials are nonviable materials used in medical devices and they are intended to interact with a biological system. These biomaterials must be compatible with the body so that the body does not reject them. In general there are three types of biomaterials - bio inert materials like stainless steel, titanium, alumina which have the minimum interaction when placed inside the human body with its surrounding tissues; bio active materials like hydroxyapatite, glass ceramic, bio glass which have significant interaction with the surrounding bones and tissues; bio resorbable materials like tricalcium phosphate, calcium oxide, calcium carbonate which when placed inside the human body dissolve and are placed by advancing tissues. The remaining section will summarize the major applications of biomaterials and the critical needs of testing.

A. McGoron, C. Li, and W.-C. Lin (Eds.): 25th Southern Biomedical Engineering Conference 2009, IFMBE Proceedings 24, pp. 3538, 2009. www.springerlink.com

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S.H. Kurra, J.M. Zhang, and A. Pennathur

E. Flowchart Development Based on the objectives of biomaterial testing, different nondestructive (NDT) methods can be applied and based on the results of NDT, the biomaterial can be accepted if it is safe to be implanted inside the body. A flowchart developed in this paper demonstrates the step by step procedures to be followed in the testing and evaluation of any biomaterial which needs to be implanted inside the body.

II. MATERIAL AND NDT TECHNOLOGY

A. Material selection Bio inert, bio active or bio resorbable materials are selected to carry out the non destructive testing. They are tested for defects or some important parameters like cracks, crystal structure, cavities, inclusions, degree of impregnation, structure of composites, wear, composition, chemical analysis and biomaterial modeling using the available NDT methods like analytical, electromagnetic, electronic, ultrasonic, infrared and image generation before they are actually implanted inside the body [15]. B. Dental implants Damage evaluation can be carried out in the dental implants using the image generation and analysis method. A 3D finite element (FE) analysis model can be developed based on the computerized tomography (CT) scan technology to investigate the load induced damage in bone tissues and implants at different stages of the healing process. Damage analysis on the FE model reveals the damage in the surrounding bone tissues and on the bone implant interfaces at different stages of the healing process [16]. C. Orthopedic, spinal, and tissue implants Synchrotron radiation based spectroscopy can help in the study of micro damage to canine vertebrae [17]. Fourier transform infrared (FT-IR) microscopy and imaging techniques are utilized for analyses of micro and molecular structure of bone, cartilage and other related engineered constructs in healthy and diseased tissues [18]. Structure of ceramic scaffolds and tissue engineered bones are obtained based on two X-ray techniques namely microtomography

(micro CT) and microdiffraction. MicroCT investigations can provide three dimensional (3D) images and quantitative data like the kinetics of newly formed bone growth, replacement of resorbable scaffold by tissue engineered bone to micro resolution. Microdiffraction provides useful information on interfaces to the atomic scale [19]. Acoustic emission (AE) technique can be used in the assessment of bone cement failure [20]. By using high frequency ultrasound transducers and applying various signal processing algorithms, a 3D representation of the enamel layer and the dentine junction can be constructed for accurate characterization of cracks and lesions [21].

III. DEVELOPMENT OF FLOWCHART

Based on the above description of NDT technologies, an attempt has been made to determine the common objectives of the biomaterial testing and also the NDT technologies which can be employed to examine whether these objectives are met. The methodology is explained in detail in the flowchart for NDT of biomaterials (Fig.1). The applicable testing technology can be determined to test the desired parameters in the biomaterial which needs to be implanted inside the body. Based on the NDT results, we can determine if it is safe to implant these biomaterials. Look at the available database if any of the parameters or methods to carry out the NDT in biomaterials is not listed in the flowchart.

IV. RESULTS
By following the step by step procedures provided in the flowchart, the biomaterial to be implanted can be tested, using the available NDT technologies. If the tested parameters are within the specification limits, we can conclude that the biomaterial is safe to be implanted in the body. Otherwise, the biomaterial should be rejected. If possible, the reasons for rejection should be investigated and analyzed based on the tests, recommendation for reworking could be proposed if any, and the feasibility of reworking could be evaluated. If it is feasible, rework this biomaterial and continue the testing procedures again. If not feasible, discard the biomaterial. Necessary precautions should be taken so that the rejected implant will be disposed carefully.

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Fig. 1 Flowchart for NDT of biomaterials

V. CONCLUSION
This paper presents a flowchart for nondestructive testing and evaluation of biomaterials that are to be implanted in a human body. A systematic step by step procedure of testing and evaluation has been developed based on the different purposes of testing and the available nondestructive testing technologies.

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S.H. Kurra, J.M. Zhang, and A. Pennathur

14. Culjat M, Singh R, Yoon D, Brown E (2003) Imaging of human teeth using ultrasound. IEEE Transactions on Medical Imaging, vol 22, pp 526-529 15. http://www.asnt.org/ 16. Misch C, Bidez M, Sharawy M (2001) Periodontol J p.1276 17. Ruppel M, Burr D, Miller L (2006) Chemical makeup of microdamaged bone differs from undamaged bone. Bone 9:318 -24 18. Boskey A, Camacho N (2006) FT-IR imaging of native and tissue engineered bone and cartilage. Biomaterials vol.28, pp 2465-2478 19. Cancedda R, Cedola A, Giuliani A, Komlev V, Lagomarsino S, Mastrogiacomo M, Peyrin F, Rustichelli F (2007) Bulk and interface investigations of scaffolds and tissue engineered bones by X-ray microtomography and X-ray microdiffraction. Biomaterials J vol 28, pp 2505-2524 20. Roques A, Browne M, Thompson J, Rowland C, Taylor A (2004) Investigation of fatigue crack growth in acrylic bone cement using the acoustic emission technique. Biomaterials Journal vol 25, pp 769778 21. Hughes D, Button T, Cochran S, Elgoyhen J, Girkin J, Hughes H, Longbottom C, Meggs C, Poland S (2007) 3D Imaging of teeth using High Frequency Ultrasound. IEEE 1051-0117 Author: S.H. KURRA Institute: THE UNIVERSITY OF TEXAS AT EL PASO Street: 500 W. UNIVERSITY AVE. City: EL PASO Country: U.S.A Email: shkurra@miners.utep.edu

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