A study on the use of artificial networks for prediction of Tensile strength of Silk Braided surgical sutures used in medical

application By Gurumurthy.B.Ramaiah1, Radhalakshmi Y. CHENNAIAH1, Gurumurthy K. Satyanarayana rao2

1.

Central Silk Technological Research Institute (CSTRI), Central Silk Board, Ministry of Textiles, Madivala, Bangalore-560 068. INDIA,2. Department of Electronics and Communication University Visveshvaraya College of Engineering (UVCE), Bangalore University K. R. Circle, Bangalore-560 001. INDIA ; E-mail:brgmurthy@live.com

Medical textiles are one of the fast growing areas of technical textiles today. The nonabsorbable sutures made from natural fibers like silk sutures finds wide application used due to its characteristic properties. Silk sutures are nonabsorbable, sterile, nonmutagenic surgical sutures composed of natural proteinaceous silk fibers called fibroin. Artificial Neural networks are used extensively to predict material properties in various sections of Textiles. This paper focuses on the study of tensile strength of silk braided surgical sutures for medical application using artificial neural networks. Silk braided surgical sutures confirming to USP (United States pharmacopeias) is used for experimental data generation along with standard ASTM methods for determination of input parameters to the model. Constant rate elongation testers confirming to USP have been used for experimental data generation and Neural network modeling is carried out using Matlab.7.1 software. In the present research comparisons were made with the Experimental and Network predicted tensile strength values which fall within the objectives of the study. Keywords: Linear tensile strength, Knot-breaking strength, Knot-holding capacity 1. Introduction

Figure 1: Use of Textiles in Medical Products

Textile Medical products (Figure 1) typically employed in cords and sutures are braided structures. Braided structures can be designed using several different patterns, either with or without a core. Because the yarns criss-cross each other, braided materials are usually porous and may imbibe fluids within the interstitial spaces between yarns or filaments. To reduce their capillarity, braided materials are often treated with a biodegradable (polylactic acid) or nonbiodegradable (Teflon) coating. Such coatings also serve to reduce chatter or noise during body movement, improve hand or feel, and help position suture knots that must be transported by pressure from a surgeon's finger from outside the body to the wound itself. A suture is a medical device that doctors, embalmers, and surgeons use to hold skin, internal organs, blood vessels and all other tissues of the human body together after they have been severed by injury, incision or surgery. They must be strong so that they do not break, non-toxic, hypoallergenic (to avoid adverse reactions in the body), and flexible (so they can be tied and knotted easily). In addition, they must lack the so called "wick effect", which means that sutures must not allow fluids to penetrate the body through them from outside, which could easily cause infections. For nonabsorbable surgical sutures, the predominant areas of concern are strength, capillarity, sliding and positioning of knots, knot security, and handling characteristics. The recent focus of suture research has been on improving the structure of the braids.The present study is limited to use of physical properties of fibres and yarns with braiding parameters, particularly its resistance to tensile strength of the knotted thread and predicting their properties using back-propagation neural networks. The need to test the tensile strength of the knotted thread is based on the fact that, as the surgeon tightens the suture's knot, it is expected that the stitch will not loosen until the proliferative phase of the tissular healing is reached. The analysis of the mechanical test results underlines such importance, since the strength data of the knotted thread investigated in this study is used for building a prediction model using neural networks. The tensile strength characteristics of suture threads has been studied using artificial neural networks viewing to guide surgeons in the selection of the optimal thread by comparing several suture materials .In the present study comparisons were made with the Experimental and Network predicted tensile strength values which fall within the objectives of the study. The analysis of the results of network predicted tensile strength of the knotted thread with the experimental samples of this study for different silk braid threads showed that such results are similar to the ones reported by experimental trial ones. 2. Theoretical Modeling for circular braids

Research in the past has presented mechanical models based on the concept of a fabric structure of repeated unit cells (e.g. Ko et al. 1989, Phoenix 1978). Goff introduced parameters such as crimp into the equations of braid geometry (1976) and more recently

differential geometry has been used by Du and Popper (1990) to describe the braid structure. One missing element from the literature is a study of the changes in yarn crosssectional geometry as a function of braid structure. Most models assume that the yarn in the braid is either round or race-track shaped, and that this shape is a known parameter prior to modeling. The work of Gowayed (1992) for three dimensional braided fabrics shows that the yarn cross-section of the yarns in such a fabric go through substantial changes in cross-sectional shape depending on location within the braided unit cell. Kawabata (1973) has presented models of yarn deformation in woven fabrics as a function of axial applied tension and transverse compression, but this has not been linked to braided fabrics. Pastore (1993) presented a model of yarn cross-sectional changes in a woven fabric as a result of transverse pressure applied to the yarns, but this has not been extended to braided fabrics.

The purpose of this study is to present a neural network model which would overcome the non-linear constraints which are present in theoretical modeling and experimental results of tensile knot strength is predicted and correlated with Network predicted ones. Traditionally, braid diameter and cover factor were configured through manual adjustment of machine settings until a satisfactory result was achieved. More recently, scientists have derived equations that make it easier to predict such values. A brief review of the literature relevant to both diameter and cover factor is presented below.

Figure 2: Illustration of effect of braid angle on the apparent yarn width. Braid Diameter Ko and Pastore (1989) assume circular yarns will be inserted into the braid and approximate the yarn diameter with the equation

(1)

Where: Ly= linear density of the yarn in denier = packing factor (volume of fiber / volume of yarn) = fiber volumetric density (g/cm3) When this circular yarn is introduced into the braid, it has an angle, , with respect to the braid axis (Figure 2). Considering the contribution of this yarn to the total perimeter of the braid, the elliptical shape of the yarn causes the apparent width (Wy) to be: Wy = Dy / cos (/2) where Wy = apparent width of yarn Dy = diameter of yarn = angle between the two yarn systems (twice the angle between the braid axis and one yarn). In reality, the yarns that are inserted into the braid are not circular but rather they are closer to elliptical. As a result of their non-circular nature, elliptical yarns can be described in terms of an aspect ratio, which is defined as the ratio of major radius to minor radius, as seen in Figure 3. (2)

Figure 3: Aspect ratio in an elliptical yarn Using equation (1) to get the total area occupied by a yarn that is assumed to be circular, we can calculate area as A = D2/4 (3)

It is reasonable to assume that the elliptical yarn has the same area as the circular yarn. In such a case, the area of the ellipse can be approximated as

A = D2/4 Braid Cover Factor

(3)

Zhang et al. (1997) also explored braids and developed equations designed to determine the cover factor of the braid based on three variables: braid angle, helical length, and braid diameter. Zhang defined cover factor as the ratio of yarn-occupied area within a unit cell to the area of the unit cell. His research proved that if any two variables are specified, the third could be determined. The first case is when braid diameter is held constant. The cover factor of a braided structure is determined as:

(4) where: K = cover factor wy = width of yarn Nc = number of carriers db = braid diameter (constant) /2 = braid angle 3. Silk Braids for suture threads

Silk was first widely used as a suture material in the 1890s. It is a braided material formed from the protein fibers produced by silk worm larvae. Although silk is considered a nonabsorbable material it is eventually degraded in tissue within 2 years. Silk has excellent handling and knot-tying properties and is the standard to which all other suture materials are compared. Its knot security is high, its tensile strength is good, and its tissue reactivity is high. Silk suture threads are produced from filaments of natural silk of 20-22 deniers. Degummed, scientifically twisted, treated, colored & compactly braided to give excellent strength & handling properties. Flexible, elongates to support for optimum knotting. Wax coated for smooth tissue passage & does not soak up in body fluids. Braided silk surgical sutures having increased tensile strength and knot strength are prepared by (1) presoaking conventionally-prepared unstretched braided silk sutures in a non-corrosive liquid (preferably water) for at least about 30 minutes to wet the silk fibers, (2) stretching the presoaked sutures while the same are immersed in a non-corrosive liquid (preferably water), and then (3) drying the stretched silk sutures while maintaining

the stretched length and not allowing shrinkage to occur during drying. The wetstretching method of the invention makes possible the stretching of braided silk sutures to a greater extent than that obtainable by conventional hot-stretching techniques, up to about 21/2 times greater, without damage to the sutures. The wet-stretched sutures of the invention have greater tensile strength and knot strength than the prior art hot-stretched sutures of comparable diameter.

Figure 4 : Silk suture thread manufacturing The United States Pharmacopoeia(USP) is one of the official compendium for the suture industry. It sets standards and guidelines for suture manufacture. Suture sizes are given by a number representing diameter ranging in descending order from 10 to 1 and then 1-0 to 12-0, 10 being the largest and 12-0 being the smallest at a diameter smaller than a human hair. The ideal suture would be totally biologically inert and cause no tissue reaction. It would be very strong but simply dissolve in body fluids and lose strength at the same rate that the tissue gains strength. It would be easy for the surgeon to handle and knot reliably. It would neither cause nor promote complications. Currently, sutures are designed to result in the most desirable effect for any given situation as determined by those administering the sutures. Taken into consideration in the manufacture and use of sutures are properties such as stress-strain relationship, tensile strength (and rate of retention), flexibility, intrinsic viscosity, wettability, surface morphology, degradation, thermal properties, contact angle of knots, and elasticity. In an attempt to achieve this "ideal" suture the textile industry has come up with many options. Properties such as stress-strain relationship and tensile strength have a direct effect on how much force at a given rate the closure will be able to withstand. For example, a cough would impose a fast rate of elongation whereas edema or hemorrage would impose a slow rate of elongation.

4. Materials and Methods As technology advances, testing techniques improve and become more specific for the application of sutures. The greatest percentage of testing that is done on sutures is done on those suture materials already existing in practice. This is due to the virtual newness of the application of testing techniques to the suture product although, a fairly small, yet increasingly important number of tests are done on possible new suture materials. In the testing of sutures, conclusions such as the fact that it is possible to predict long-term tensile properties of material under dynamic load from their dynamic loss factor and loss modulus attract significant importance. Some of the research test areas for sutures are: breaking strength, elongation-to-break, Young's modulus, knot security, viscoelastic properties, tissue reaction, cellular response, cellular enzyme activity, suture metabolism chronic toxicity, teratologics, mutagenicity, carcinogenicity, suture allergenicity, immunigenicity, cell cultures etc. Physical tests for sutures are either standard methods used to demonstrate agreement or compliance with compendum requirements or research tests measuring fundamental properties simulating performance under use conditions. Some of the most common methods by which tests are conducted are also methods widely used in other areas of medicine or industry. A few examples of these methods or instruments are as follows: infrared spectrophotometers, nuclear magnetic resonance spectrophotometers, projection microscopes, tensile testers, light microscopy, and degradation studies in vivo. The knotted specimens were prepared using surgeons knot as shown in figure 5 and 6 respectively.

Figure 5 : Surgeons knot stage I

Figure 6: Surgeons knot stage II

The tensile strength test specimens are prepared as shown in Figure 7 and Tensile tests re carried out shown in Figure 8. The tensile strength testing machine consists of suitable clamps for holding the specimen firmly and using either the principle of constant rate of load on specimen or the principle of constant rate of elongation of specimen, as described in the USP standards for surgical sutures[16][17].

Figure 7: Rubber tube with specimen

Figure 8: Specimen placed between clamps

Sutures are tested immediately after removal from their sterile packages without drying or conditioning as per United States Pharmacopoeia, except when testing for compliance with BP (British Pharmacopoeia) or EP (European Pharmacopoeia) requirements which specify prior conditioning as described in the monographs for various suture types. Diameters of sutures are measured using a gauge of the dead-weight type with a presserfoot 12.7 +/- 0.02mm in diameter. The diameter of each strand is measured at three points corresponding roughly to one-fourth, one-half, and three-fourths of the strand length. For knot pull breaking strength, the suture is tied with a surgeon's knot with one turn around a flexible rubber tubing of 6.5 mm inside diameter and 1.6 mm wall thickness. The suture is then attached to a suitable testing machine and tested at a rate such that the specimen breaks in less than twenty seconds. In all strength tests, it is important to keep in mind that the breaking strength retention of absorbable and nonabsorbable sutures should be considered separately because the strength retention of the absorbable sutures will be quite different than that of the nonabsorbable suture. The apparatus has two clamps for holding the strand. One of these clamps is mobile. The clamps are designed so that the strand being tested can be attached without any possibility of slipping. Gauge length is defined as the interior distance between the two clamps. For gauge lengths of 125 to 200mm, the mobile clamp is driven at a constant rate of elongation of 30 +/- 5 cm per minute. For gauge lengths of less than 125mm, the rate of elongation per minute is adjusted to equal 2 times the gauge length per minute. For example. A 5cm gauge length has a rate of elongation of 10cm per minute. Tensile test results for different surgical silk braid sutures are shown in Table 1.

Table 1: Braided surgical suture material description and their tensile test results (Tests carried as per USP standards )

4.

Neural Network Modeling

Neural networks provide significant benefits in medical research. They are actively being used for such applications as locating previously undetected patterns in mountains of research data, controlling medical devices based on biofeedback, and detecting characteristics in medical imagery, Here we propose a Back-propagation neural network to predict the tensile knot strength of surgical silk braided sutures. The Model is shown in Figure 9. with Inputs to the model being Average Diameter, Linear density of the yarn, Fiber density, Apparent yarn width, braid angle and Number of carriages. The output of the neural network model is Tensile strength and the data for targets was experimentally generated.

Figure 9: A silk braid surgical suture neural network model 4.1 Silk braid yarn structural parameters used for Neural network model Inputs a) Average Braid diameter of the yarn: The average braid diameter (mm) is calculated based on the 10 strands of suture as directed under sutures- Diameter (861). The average diameter of the strands being measured is within the tolerances prescribed in the accompanying table for the size stated on the labels. IN the case of braided or twisted suture, none of the observed diameters is less than the midpoint of the range for the next smaller size or is greater than the midpoint of the range for the next larger size.

b) Linear density of yarn (denier): Denier is a unit of measure for the linear mass density of fibers and yarns. It is defined as the Mass in grams per 9,000 meters c) Fiber density (g/cm3) - Fiber density is the ratio of mass to volume of the fiber. Fiber density is determined by using a Psychometer, density balance (Archimedes principle) or Density gradient method. ASTMD3800 [5] gives Archimedes and sink/float method of determining fiber density where as ASTM D1505 [6] gives the determination of fiber density using density gradient column methods. d) Apparent yarn width This gives the measurement of the width of the yarn which is calculated from Diameter of the braid and cosine of its braid angle. This is a process variable and varies with braid angle. Apparent yarn width is given by the equation Wy = Dy / cos (/2) where Wy = apparent width of yarn Dy = diameter of yarn = angle between the two yarn systems (twice the angle between the braid axis and one yarn). e) Braid angle () - A type of finger weaving, braiding is a process of interlacing lengths of hair or of intertwining strands of yarn or other material to form a fabric. Although the terms braiding and plaiting are often used to mean the same thing, there is a difference in method. In plaiting, the strands being braided are linked with adjoining ones; in braiding, the strands simply cross over or under one another Braid angles for surgical sutures range from approximately 15 to 75 (/2). f) No of carriages - A braiding machine carrier is fitted to a frame; a fiber spool mounted is attached to the frame; A carriage is a fiber take-up assembly including a spiral spring; gear train on the frame for mechanically connecting the take-up spring assembly to the fiber spool mount for winding the spiral spring as a spool on the mount rotates; and a magnetic clutch, coupled to the take-up spring assembly, for preventing over winding of the spiral spring. No of carriages determine the thickness of the braid. 4.2 Back-propagation neural networks

Back propagation neural networks (Algorithm) (figure 10- Back Propagation algorithm) are loosely based on the neuronal structure of the brain and provide a powerful statistical approach for exploring solutions of non-linear systems (Rumelhart 1986). This study employs a back propagation neural network which was used to correlate input information with matched output values. The solution space is the set of all combinations of coefficients for the equations that are being used for modeling a system of interest. Table 2 gives the Neural Network model parameters and training graphs are given in Figure 11 and 12 respectively.

Figure 10: Back-propagation neural network algorithm

Table 2: Neural Network Model parameters for silk braid surgical suture prediction model Model parameter Value/Description 1.No. of Input Nodes 6 2.No of output nodes 1 3. No of Hidden layers 2 4. Activation function log sigmoid 5. Scaling of inputs 0 to 1 and outputs 6. Network learning Back-propagation algorithm gradient descent method

10

Performance is 0.00351063, Goal is 1e-005

10

10

Performance is 9.96309e-006, Goal is 1e-005

Training-Blue Goal-Black

10

-1

10

10

-2

10 Training-Blue Goal-Black 10 10 10 10 10

-1

10

-3

-2

10

-4

-3

-4

10

-5

-5

10

-6

4 5 90000 Epochs

8 x 10

9
4

10

-6

0.5

1.5

2.5 3 53889 Epochs

3.5

4.5

5 x 10
4

Figure 11 and 12 : Training graphs for Tensile knot strength prediction tests using Matlab 7.1 software Neural Network model

Table 3: Selected Input parameters for silk braid surgical suture used for Neural Network model

Table 4 : Outputs for silk braid surgical suture used for Neural Network Mode 5. Results and Discussions

Figure 13: Best linear fits between Experimental tensile strength and Network predicted tensile strength for silk braid surgical suture material Training set

Figure 14: Best linear fits between Experimental tensile strength and Network predicted tensile strength for silk braid surgical suture material Testing set

The analysis of the results of network predicted tensile strength of the knotted thread with the experimental samples of this study for different silk braid threads showed that such results are similar to the ones reported by experimental trial ones. Their best linear fits are shown in figure 13 and 14 respectively. Conclusion The tensile strength characteristics of suture threads has been studied using artificial neural networks viewing to guide surgeons in the selection of the optimal thread by comparing several suture materials .In the present study comparisons were made with the Experimental and Network predicted tensile strength values which fall within the objectives of the study. Acknowledgements The authors wish to thank Mr.Shrish Nene, Lifeline sutures, Bangalore, Bangalore Test House, Vasanth Kumar, Sutures India for their help in conducting this study and providing necessary information during analysis and investigation of surgical suture materials.

References : 1. Hatch KL, Textile Science, New York, West Publishing Co., pp 318370, 1993. 2. Soldani G, Panol G, Sasken HF, et al., "Small-Diameter PolyurethanePolydimethylsiloxane Vascular Prostheses Made by a Spraying, Phase-Inversion Process," J Mat Sci, Mat in Med, 3:106113, 1992. 3. Kapadia I, and Ibrahim IM, Woven vascular grafts, U.S. Pat. 4,816,028, 1989. 4. Brennan KW, Skinner M, and Weaver G, Braided surgical sutures, U.S. Pat. 4,959,069, 1990. 5. Gupta BS, Milam BL, and Patty RR, "Use of Carbon Dioxide Lasers in Improving Knot Security in Polyester Sutures," J App Biomat, 1:121125, 1990. 6. Gupta BS, and Kasyanov VA, "Biomechanics of the Human Common Carotid Artery and Design of Novel Hybrid Textile Compliant Vascular Grafts," J Biomed Mat Res, 34:341349, 1997. 7. Williams SK, Carter T, Park PK, et al., "Formation of a Multilayer Cellular Lining on a Polyurethane Vascular Graft Following Endothelial Cell Seeding," J Biomed Mat, 26(1):103117, 1992. 8. Merhi Y, Roy R, Guidoin R, et al., "Cellular Reactions to Polyester Arterial Prostheses Impregnated with Cross-Linked Albumin: In Vivo Studies in Mice," Biomat, 10(1): 56 58, 1989. 9 Bordenave L, Caix J, Basse-Cathalinat B, et al., "Experimental Evaluation of a GelatinCoated Polyester Graft Used as an Arterial Substitute," Biomat, 10(3): 235242, 1989. 10. Guidoin R, Marceau D, Couture J, et al., "Collagen Coatings as Biological Sealants for Textile Arterial Prostheses," Biomat, 10(3): 156165, 1989. 11. Frey O, Dittes P, and Koch R, Prosthetic implant, U.S. Pat. 5,176,708, 1993. 12.F. K. Ko, C. M. Pastore, and A. A. Head, Handbook of Industrial Braiding, Covington, KY, Atkins and Pearce, 1989. 13. S. L. Phoenix, Text. Res. J., February, 1978. 14. J. R. Goff, M.Sc. Thesis, Georgia Institute of Technology, Atlanta, 1976. 15. Y. A. Gowayed, Ph.D. Thesis, North Carolina State University, Raleigh, 1992.

16. United states Pharmacopeias, Official compendia of standards, volume 1, USP3 NF25, Pg.376 17 United States Pharmacopeias, Official compendia of standards, volume 3, USP3 NF25, Pg.3262-3265.