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Injectable Silicone Cheek Implants
Gingers and Friends

3/17/11

Rachel Bethancourt Marissa Hill Dillon Lynch Robert Welsh

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Report Title: Multi Component Cheek Implants
1. ABSTRACT
The current method of chin implants involves the insertion of a solid silicone form into the malar area via an intraoral incision. This method requires a large incision in order to fit the implant into the zygomatic cavity. The malar region is accessed via the mouth as to leave no unsightly scars on the facial area, but his choice of incision location also leads to higher risk of infection. The goal of the project is to create an implant consisting of a silicone elastomer shell and an injectable silicone rubber core. This will allow the incision site to be moved to an extraoral location, lowering the risk of infection, minimizing invasiveness, and expediting recovery time/ reducing patient discomfort. The functional requirements of the implant are to last a minimum of 15 years, to be non toxic, biocompatible, and have similar facial integration of current solid silicone cheek implants. The silicone filler will be created with 3 varying proportions of base to catalyst and the presence and absence of a calcium carbonate filler to attempt to best replicate the current solid silicone implants currently in use. The samples will be subjected to a weighted load for 24 hours and the change in thickness will be measured. The combination of these factors and levels with the least amount of change in thickness is the most desirable.

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Design and Development Planning

1.1. Introduction 1.1.1. The process of cheek augmentation requires an intraoral incision to place the solid silicon implants into a cavity located anterior to the zygomatic bone. 1.1.2. The incision location is selected to minimize the appearance of the resulting scar, but also increases the risk of infection due to bacteria in the mouth. The size of the implant also creates the need for a large incision. 1.1.3. The availability of medical grade polymer shells is low and will not be incorporated in testing. The filler alone will be tested to determine if its properties correlate to the solid silicone implant. 1.2. Problem Statement 1.2.1. The use of solid silicone cheek implants requires too large of an incision. A new technology needs to be created to allow for a smaller, extraoral incision. 1.3. Project Goals, Solution and Objectives 1.3.1. The goal of the project is to create an implant which can be inserted into the zygomatic region of the face through a smaller incision. This will allow the incision site to be moved to an extraoral location, lowering the risk of infection, minimizing invasiveness, and expediting recovery time/ reducing patient discomfort 1.3.2. By creating an implant consisting of a silicone elastomer shell and an injectable silicone rubber core, the implant can be inserted into the facial cavity in the form of a rolled up shell. This requires a biocompatible shell material to be obtained and an injectable polymer which can mimic the properties of current solid silicone implants. 1.4. Testing Justification and Overview 1.4.1. Three proportions of base to catalyst will be tested from a two part castable silicone kit. After full curing, weights will be placed on top of the samples for 24 hours to measure the change in thickness. 1.4.2. In order to determine if the castable silicone can accurately match the properties of solid silicone the elastic modulus will need to be tested. This ensures that the new product meets the specifications and natural abilities of the current solid silicone implant in place.

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1.4.3. This new method will lower the risk of infection in patients and is beneficial for them. The introduction of this technology will not require surgeons to obtain new skills to use and will be easily received by current surgical teams. 1.5. Important Terminology 1.5.1. Zygomatic- the cheek bone region Intraoral- inside the mouth Extraoral- outside the mouth Maxillofacial- the upper jaw and area of face above Malar- the cheek, zygomatic bone, and side of the head 1.6. Organizational Responsibilities 1.6.1. Rachel Bethancourt will be responsible for obtaining the silicone rubber mixture to test for the appropriate properties. Dillon Lynch will obtain syringes and shells for testing. Marissa Hill will be in charge of determining testing methodology. Robert Welsh is in charge of data acquisition and organization. 1.7. Document Tracking, Deliverables and Timeline 1.7.1. Robert Welsh will be responsible for all important documents. There will be a specified folder in which all documents will be filed and it will be present at all group meetings. 1.7.2. A medical journal review will be published so that all data can be reviewed and read by any who has interest. 1.7.3. All physical procedural tools and equipment will be obtained by the group by the second week in February. Testing methodology will be created to match specific materials obtained within one week of full material acquisition. Data collection will be completed 10 days before the final presentation.

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2. DESIGN INPUTS
2.1. User and Patient Needs The surgeon responsible for the procedure is the main user of the implant. The patient is a secondary user. The surgeon needs an implant which they can confidently insert into the patient. The process of filling the shell cannot be too complicated as to lead to increased risk of patient infection or rejection. The patient needs the new implant to mimic the natural properties of the cheek. 2.2. Performance Requirements 2.2.1. The functional requirements of the implant are to last a minimum of 15 years, to be non toxic, biocompatible, and have similar facial integration of current solid silicone cheek implants. 2.2.2. The device will be placed on top of the zygomatic bone of the face. This region of the body is fairly static with the exception of facial expressions. The implant will be placed under the muscle, simulating a larger zygomatic bone and will not be affected by muscle movement, 2.3. Design Input Assessment Plan The shape, location, and outer material of this implant will be the same as the implants currently in use. This accounts for the same appearance superficially, environment of the implant, and biocompatibility as in current methods. The only major change will be the core of the implant and the insertion method. The insertion method is known to have a lower risk of infection, but is not chosen currently because of the scarring. The core of the material will have no interaction with the body because it is sealed in the plastic shell. The chosen silicone elastomer is currently used in breast augmentations. This certifies its capability to be used in the body with no harmful results.

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3. PROPOSED SOLUTION
3.1. Conceptual Design Description In order to reduce the invasiveness of intraoral malar and submalar insertion a process, similar to breast augmentation, will be used in which a small shell is inserted surgically extraorally into the malar region and filled with a solidifying silicone core . The shell will be made from a (Silicon elastomer) must have a negligible volume but a surface are of approximately 50.6 cm2. This shell will be made of the same elastomer as used in breast implants and therefore proven to be leak free during filling and compatible with the human body. The core will be made of (silicone rubber) with will be injected in gel form into the shell were it will undergo solidification. The volume of the silicone core is approximately 25.75 cm3 and is nontoxic to the human body, though it will be completely enclosed by the shell and will therefore not be exposed to human tissue. In order to meet the patient’s needs the (silicone rubber) will have the same elastic modulus when hardened as current implants in order to provide the same support and feel. This procedure will allow surgeons to improve malar and submalar augmentation with a lower chance of infection and will allow the procedure to be completed extraorally with miniscule scarring to the face. 3.2. Design Performance Current malar and submalar implants meet all of this procedure’s performance specifications; therefore in order to maintain the quality of the implant those values such as volume and elastic modulus will be reproduced. The current implants meet all FDA standards and since there is no change in the final product just the process in which it is surgically inserted it meets all requirements. 3.3. Patient Safety Assurance The outer shell which will be the only part in contact with the patient’s facial tissue has been used in breast augmentation for many years and its biocompatibility has been shown by its history. The castable silicone inserted into the shell should never come in contact with human tissue, though in the case of leak during the procedure the material is non-toxic and will not harm the patient. If a leak occurs, then the implant and any leaked silicone rubber will have to be removed surgically in order to preserve the correct appearance of the face and for patient comfort.

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4. DESIGN VERIFICATION PLAN
4.1. Design of Experiment 4.1.1. The silicone epoxy was mixed at three different percentages of catalyst, by weight (amount catalyst/total amount), at 6%, 9%, and 13%, with 9% being the manufacturer’s recommended proportion. There was also calcium carbonate filler added to a second batch of all three proportions. The amount of filler added to the silicone was calculated by the equation to determine mass fraction of matrix and filler in a composite based on elastic modulus. 4.1.2. After all samples had properly cured they were labeled with a letter (A-F) to indicate which of the 6 treatments they had received as well as the number (1-6) within each lettered group to identify each from one another. The initial thickness of each sample was measured at 3 locations on the sample and the average was calculated. 4.2. Sample Description 4.2.1. Silicone V-340 was used. It is a two part mix which can have the proportions of the parts varied. 4.2.2. The samples were mixed during the same period of time on the same day to reduce the possibilities of variation due to uncontrollable factors such as temperature and humidity. The samples were mixed indoors using the same producer to prepare all samples. 4.3. Test Procedures 4.3.1. The procedures that will be used to conduct each test will be to do the compression over time test for samples A-F (A-C have no filler with the three ratios while D-F have fillers). The samples numbered 1-2 for each letter A-F were placed underneath a 45 pound weight. It was left there for 24 hours. The difference of the thickness was then evaluated. Samples 34 for letters A-F were then placed underneath two 10 pound weights. Each 10 pound weight had three samples underneath it in order to distribute the weight evenly throughout all samples. 4.3.2. We are assuming that the samples are the same thickness and are evenly distributed underneath the weights to ensure equal weight is on each sample. 4.4. Equipment

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4.4.1. Square candy molds were used to create uniform 1 inch2 samples. The batches of different compositions were mixed in paper cups with wooden stirring sticks and the proportions of base, catalyst, and calcium carbonate filler were weighed on a digital scale. Weighted plates were used for compression of the samples. One 45lb. weight and four 10lb. weights were used. 4.5. Analytical Techniques 4.5.1. Four averages were taken for each level and factor combination, one from each of four different samples per composition which were given the weighted treatment. 4.5.2. A Design of Experiment analysis was performed to view the main effects and interactions. A p-value less than .05 would indicate a significant difference in performance between samples. 4.5.3. The modulus of the solid silicone implant will be charted compared to the tested modulus.

5. RESULTS
5.1. DOE Analysis 5.1.1. An analysis of the data was run to determine the effects of the levels and factors alone as well as their interaction with one another. The following graphs were generated:
Main Effects Plot for C7
Data Means A B

0.009 0.008

Mean

0.007 0.006 0.005

0.004 6% 9% Weight % Catalyst 13% FILLER NO FILLER

Figure 1.

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Interaction Plot for C7
Data Means 0.010 0.009 0.008
A 6% 9% 13%

Mean

0.007 0.006 0.005 0.004 0.003 FILLER B NO FILLER

Figure 2.

5.2. Interpretation of Analysis 5.2.1. In Figure 1, the plot on the left shows that the 9wt% catalyst samples exhibited the least amount of compression over time. The p-value for weight % catalyst was .168. In accordance to our selected cut off of .05, this is not a significant difference between the different proportions. More advanced testing with more data could show that this factor could contribute to a significant difference in performance, but this experiment has not shown it to be so. 5.2.2. Also in Figure 1, the plot on the left shows the performance based on the presence of calcium carbonate filler. The slope of the line is very small, but does show the absence of filler to give the least amount of compression over time. The p-value for this test is .744, certainly showing no significance. As with the proportion further testing could give more certainty but the interaction of filler with the silicone polymer has given inconclusive results. 5.2.3. Figure 2 shows the interaction of both variables giving a more detailed look at the results. The cause of the not-significant difference in the filler can be attributed to the fact that 2 of the proportions showed a higher compressibility over time with the

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presence of filler, but the third, 6wt%, showed a reduced compression over time with the presence of the filler. The filler did not perform the same in all samples. The interaction plot also shows that the 9wt% sample did not exhibit the least amount of compression over time for both filler and non filler; the 6wt% with filler showed less compression over time than the 9wt% with filler. The p-value of this test is .655, showing no significant difference. The inconsistency of samples to perform based on filler most likely lead to this. As with all tests, more data would need to be collected to come to a more certain conclusion.

6. DISCUSSION
6.1. Viscoelastic Polymers 6.1.1. The properties that determine the elastic deformation of a polymer are not as simple as many of the ideal models. In fact solid state deformation is time-dependent and nonlinear and so resembles some combination of elastic and viscous responses. If a material is linear and elastic then the applied stress σ directly proportional to the strain ε, however; for polymers because of time-dependence and nonlinearity, E is not a constant and the term tensile modulus is used instead. When the stresses are taken away from a polymeric material before fracture, the strain recovery path is not the same as the loading part of the deformation cycle another difference from ideal behaviors. Since both the deformation and recovery are timedependent, some part of their behavior must be viscous. Most polymers contain a combination of elastic and viscous behavior called viscoelasticity. The degree of viscoelasticity is strongly dependent upon the temperature of test, the rate at which the polymer is deformed, degree of crystallinity, cross linking, and molecular mass. strain are not recoverable is viscous flow therefore when a polymers undergoes stress not all strain is able to be recovered. The amount of strain that can be recovered is largely due to the temperature under which the stress is applied. Time dependence is also a key factor, if mechanical stress is held constant then the strain will increase with time resulting in creep. 6.2. Reaction Effects 6.2.1. During the process of creating our implant we attempted to alter the manufactures ratio of catalyst and the base in order to result in a silicone with different properties. We created three

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types of samples with the ideal sample percent being 9 percent catalyst, and the other samples being 6 percent and 12 percent. We predicted that the sample with a higher catalyst (12%) would react more and result in more cross linking and thus a stronger material. The 6 percent sample behaved as we expected and resulted in a less stiff more elastic material due to the fact not as much cross linking occurred due to the fact that the reaction was not able to complete itself. However our prediction on the 12% sample was off base due to the fact that at the ideal ration the reaction completes itself and with a higher catalyst it does not continue and all that remains is some unreacted catalyst which lends the material its viscous behavior and results in a higher viscoelasticity. 6.3. Calcium Carbonate Filler Interactions 6.3.1. During the experiment we hypothesized that filler would allow the silicone mix to solidify more efficiently therefore resulting in a stronger viscoelasticity. We predicted that the filler wouldn’t have a major effect on the amount of cross linking and would just add its properties to the mold resulting in a stiffer piece of silicone. In reality however the filler had the opposite effect. It severely reduced the amount o f cross linking and resulted in a material with much lower viscoelasticity due to the fact that the lack of cross linking caused the polymer to behave in a much more viscous manner. This resulted in seeing a significantly higher amount of deformation during stress testing therefore eliminating the samples with filler as a plausible choice for an implant.

7. CONCLUSION
Overall, we created a material that was injectable and could hypothetically be used as a cheek implant therefore our project was a Success. However future study would be necessary to test the effect our implant would have on the body. The surgical procedure would also have to be designed in order to achieve the goals we had set forth.

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