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Protection of active implant electronics with organosilicon open air plasma coating for plastic overmolding

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Current Directions in Biomedical Engineering
From the journal Current Directions in Biomedical Engineering Volume 2 Issue 1

Abstract

To overcome challenges for manufacturing of modern smart medical plastic parts by injection molding, e.g. for active implants, the optimization of the interface between electronics and the polymer component concerning adhesion and diffusion behavior is crucial. Our results indicate that a nano-sized SiOxCyHz layer formed by plasma-enhanced chemical vapour deposition (PE-CVD) via open air atmospheric pressure plasma jet (APPJ) and by use of a hexamthyldisiloxane (HMDSO) precursor can form a non-corrosive, anti-permeable and biocompatible coating. Due to the open air character of the APPJ process an inline coating before overmolding could be an easy applicable method and a promising advancement.

Keywords: active implants; APPJ; HMDSO; injection molding; PE-CVD

1 Introduction

An important requirement in manufacturing of modern smart medical plastic parts will be the ability for direct, assembly free integration of various electronic elements, like sensors or components for information storage, part identification/ traceability or plagiarism protection. In this context injection molding as an established and economically proven process to manufacture plastic parts must be considered. However diverse challenges occur from the assembly free integration of electronic parts by injection molding and the intended use as an active implant: Electronic insert parts have to face high mechanical, thermal and thermo-mechanical stresses [1] as well as chemical or other application related loads (see Figure 1).

Figure 1: Challenges for direct, assembly free integration of electronic components by injection molding and for use as a smart medical device.
Figure 1:

Challenges for direct, assembly free integration of electronic components by injection molding and for use as a smart medical device.

An additional challenge is the optimization of the interface between electronics and polymer component concerning form-fitting connection, adhesion and diffusion behavior.

Especially for implants with integrated electronics, which are so far protected to the human body with metal or glass packaging a coating is suggested as an alternative [2], [3], [4]. In the present study nano-sized SiOxCyHz layers, formed by PE-CVD via APPJ and by use of a HMDSO precursor, are evaluated as an appropriate barrier between sensitive, potentially non-biocompatible electronic materials and a part forming overmolded polymer casting.

Different authors already reported advanced surface properties after plasma coating [5], [6], [7], [8], [9], [10]. For example Pihan et al. state better adhesion properties with SiOxCyHz coating [7]. Other groups achieve sufficient protection against corrosion [8], [9], [10].

Especially an inline SiOxCyHz thin film coating combined with polymer overmolding is a promising approach to form a non-corrosive, anti-permeable, biocompatible packaging for active implants.

2 Material and methods

2.1 Test specimen and plasma parameters

In this study different test specimen are coated by PE-CVD with use of a hexamethyldisiloxane (Sigma-Aldrich Chemie GmbH, Germany, ≥ 98%) precursor. Different materials, comprising stainless steel, aluminum, and a FR-4 based printed circuit board (PCB, 6 × 10 × 1.5 mm) with and without a digital temperature/humidity SHT21 sensor (Sensirion AG, Switzerland), have been coated.

The 10 × 10 × 1 mm stainless steel (316L) and aluminum specimens first have been cleaned in an ultrasonic cleaning bath filled with acetone (VWR, USA) and following with ethanol (Sigma-Aldrich, 30%). Subsequently the samples have been etched for 10 min with nitric acid and cleaned again. The PCB specimen have been cleaned only with compressed air.

The PlasmaPlus® jet (Plasmatreat GmbH, Germany) was operated at 23 kHz plasma power (280 V, 14.3 A) and a plasma cycle time of 100% with clean dry industrial air as ionization gas at a flow of 2000 l/h. The precursor was mixed with nitrogen gas (carrier gas, 300 l/h) in an evaporator at 100°C and added to the plasma flame.

In a distance of 20 mm to the nozzle the test substrates first have been pre-treated/activated two times by moving through the precursor-free plasma torch with a speed of 10 m/min (see Figure 2). After adding the precursor with a flow rate of 40 g/h the materials have been coated by two or respectively eight coating passes.

Figure 2: APPJ with evaporator and electronic test specimen (FR-4 based printed circuit board with/without sensor).
Figure 2:

APPJ with evaporator and electronic test specimen (FR-4 based printed circuit board with/without sensor).

2.2 Experimental setup

Film deposition and properties have been studied by SEM surface analysis (JSM-5400, Jeol GmbH, Germany) and contact angle (CA) measurement (OCA20, Data Physics Instruments GmbH, Germany). The character of the film regarding thickness and roughness has been exemplarily measured by ellipsometry (SE 800, SENTECH Instruments GmbH, Germany) on silicon wafers.

Additionally a cytotoxicity analysis according to DIN EN ISO 10993-5 (elution test, 72 h eluting time) using Hs27 fibroblasts and a CCK-8 cell counting kit (Dojindo Laboratories, Japan) has been performed to study the bioprotective effect of the SiOxCyHz thin film coating. As a substrate for the coating exemplarily stainless steel specimens were used which in advance have been etched according to ASTM D2651 to gain cytotoxic properties.

To analyse corrosion effects all coated specimens have been visually checked after immersion in 5% NaCl solution for 48 h at 37°C by use of a VHX-5000 digital microscope (Keyence Corporation, Germany).

3 Results and discussion

3.1 Film deposition and properties

Film deposition could be shown by static measurement of the contact angle before and after coating (see Figure 3). Measurements of CA on stainless steel and on FR-4 PCB substrates showed approximately hydrophilic properties (54–59°) before coating and a shift to hydrophobic surfaces after two (84–86°) as well as after eight coating passes (88–101°).

Figure 3: CA measurement of uncoated and 8x coated stainless steel (SS, n = 7) and FR-4 (n = 4) samples.
Figure 3:

CA measurement of uncoated and 8x coated stainless steel (SS, n = 7) and FR-4 (n = 4) samples.

In SEM analysis after two passes a coating was not visible, but CA measurement indicate a polymer-like SiOxCyHz film. After eight coating passes a homogenous particle distribution on the surfaces could be seen (see Figure 4).

Figure 4: SEM images of PCB surface, uncoated (A) and after 8 coating passes with polymer-like SiOxCyHz film and homogeneous particle distribution (B).
Figure 4:

SEM images of PCB surface, uncoated (A) and after 8 coating passes with polymer-like SiOxCyHz film and homogeneous particle distribution (B).

Ellipsometry after eight passes showed a film thickness of up to 200 nm and a surface roughness of 10–20 nm.

3.2 Cytotoxicity

The ASTM D2651 etching procedure with no post treatment ensured a guaranteed cytotoxic surface on the stainless steel specimen as can be seen in Figure 5 (stainless steel).

Figure 5: Proliferation of Hs27 fibroblast cells compared to control (n = 3).
Figure 5:

Proliferation of Hs27 fibroblast cells compared to control (n = 3).

As additional positive control a copper substrate and as negative control biocompatible silicon has been used.

According to DIN EN ISO 10993-5 for a classification of non-cytotoxicity a minimum proliferation rate of 70% has to be reached. No cytotoxic effect could be measured on the steel substrate after two (85% proliferation) and eight (79% proliferation) coating passes.

This shows that the coating, at least for the cytotoxic stainless steel specimens, very effectively protects against the cytotoxic properties of the substrate.

3.3 Sensor function after coating

Function studies showed that SiOxCyHz film coating did not affect the function of the sensors (see Table 1).

Table 1:

Sensor functional test without and after 2x coating (Sensor precision: temperature ±0.3°C humidity ±2% RH).

ParameterSensor uncoatedSensor coated
Temperature [°C]22.9423.17
Humidity [%RH]39.3939.10

This was not expected because a temperature of up to 181°C was measured on the specimen surface during treatment. This is an interesting observation since also in overmolding high temperature loads occur.

3.4 Corrosion protection

Immersion in 5% NaCl leads to a definite pitting corrosion of uncoated aluminum specimens. This could clearly be reduced already by two coating passes (see Figure 6).

Figure 6: Aluminium samples without (left) and with 2 plasma coating passes (right) after 48 h immersion in 5% NaCl solution.
Figure 6:

Aluminium samples without (left) and with 2 plasma coating passes (right) after 48 h immersion in 5% NaCl solution.

4 Outlook and conclusion

Our studies showed that the APPJ process is an easy applicable method to deposit SiOxCyHz films on different substrates and sensitive electronic components. It works as an effective protection against cytotoxic properties of the substrate and corrosive attacks, which supports observations of other groups [3], [5; 6; 7; 8; 9; 10].

In further experiments we showed that the surface of the SiOxCyHz film coating could be hydrophilized by additional plasma activation (without precursor). This would lead to optimized surface adhesion properties for a subsequent polymer casting [11] of the insert by overmolding, which is currently under investigation in our group.

In summary the SiOxCyHz film coating applied by APPJ is a very promising and inline applicable technology to prepare electronic parts for assembly free integration in plastic components to realize smart medical devices.

Author’s Statement

Research funding: The author state no funding involved. Conflict of interest: Authors state no conflict of interest. Material and Methods: Informed consent: Informed consent has been obtained from all individuals included in this study. Ethical approval: The conducted research is not related to either human or animal use.

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Published Online: 2016-9-30
Published in Print: 2016-9-1

©2016 Matthias Zeppenfeld et al., licensee De Gruyter.

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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https://doi.org/10.1515/cdbme-2016-0011
Keywords for this article
active implants; APPJ; HMDSO; injection molding; PE-CVD
Creative Commons
BY-NC-ND 4.0

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  103. Classification of indirect immunofluorescence images using thresholded local binary count features
  104. Analysis of muscle fatigue conditions using time-frequency images and GLCM features
  105. Numerical evaluation of image parameters of ETR-1
  106. Fabrication of a compliant phantom of the human aortic arch for use in Particle Image Velocimetry (PIV) experimentation
  107. Effect of the number of electrodes on the reconstructed lung shape in electrical impedance tomography
  108. Hardware dependencies of GPU-accelerated beamformer performances for microwave breast cancer detection
  109. Computer assisted assessment of progressing osteoradionecrosis of the jaw for clinical diagnosis and treatment
  110. Evaluation of reconstruction parameters of electrical impedance tomography on aorta detection during saline bolus injection
  111. Evaluation of open-source software for the lung segmentation
  112. Automatic determination of lung features of CF patients in CT scans
  113. Image analysis of self-organized multicellular patterns
  114. Effect of key parameters on synthesis of superparamagnetic nanoparticles (SPIONs)
  115. Radiopacity assessment of neurovascular implants
  116. Development of a desiccant based dielectric for monitoring humidity conditions in miniaturized hermetic implantable packages
  117. Development of an artifact-free aneurysm clip
  118. Enhancing the regeneration of bone defects by alkalizing the peri-implant zone – an in vitro approach
  119. Rapid prototyping of replica knee implants for in vitro testing
  120. Protecting ultra- and hyperhydrophilic implant surfaces in dry state from loss of wettability
  121. Advanced wettability analysis of implant surfaces
  122. Patient-specific hip prostheses designed by surgeons
  123. Plasma treatment on novel carbon fiber reinforced PEEK cages to enhance bioactivity
  124. Wear of a total intervertebral disc prosthesis
  125. Digital health and digital biomarkers – enabling value chains on health data
  126. Usability in the lifecycle of medical software development
  127. Influence of different test gases in a non-destructive 100% quality control system for medical devices
  128. Device development guided by user satisfaction survey on auricular vagus nerve stimulation
  129. Empirical assessment of the time course of innovation in biomedical engineering: first results of a comparative approach
  130. Effect of left atrial hypertrophy on P-wave morphology in a computational model
  131. Simulation of intracardiac electrograms around acute ablation lesions
  132. Parametrization of activation based cardiac electrophysiology models using bidomain model simulations
  133. Assessment of nasal resistance using computational fluid dynamics
  134. Resistance in a non-linear autoregressive model of pulmonary mechanics
  135. Inspiratory and expiratory elastance in a non-linear autoregressive model of pulmonary mechanics
  136. Determination of regional lung function in cystic fibrosis using electrical impedance tomography
  137. Development of parietal bone surrogates for parietal graft lift training
  138. Numerical simulation of mechanically stimulated bone remodelling
  139. Conversion of engineering stresses to Cauchy stresses in tensile and compression tests of thermoplastic polymers
  140. Numerical examinations of simplified spondylodesis models concerning energy absorption in magnetic resonance imaging
  141. Principle study on the signal connection at transabdominal fetal pulse oximetry
  142. Influence of Siluron® insertion on model drug distribution in the simulated vitreous body
  143. Evaluating different approaches to identify a three parameter gas exchange model
  144. Effects of fibrosis on the extracellular potential based on 3D reconstructions from histological sections of heart tissue
  145. From imaging to hemodynamics – how reconstruction kernels influence the blood flow predictions in intracranial aneurysms
  146. Flow optimised design of a novel point-of-care diagnostic device for the detection of disease specific biomarkers
  147. Improved FPGA controlled artificial vascular system for plethysmographic measurements
  148. Minimally spaced electrode positions for multi-functional chest sensors: ECG and respiratory signal estimation
  149. Automated detection of alveolar arches for nasoalveolar molding in cleft lip and palate treatment
  150. Control scheme selection in human-machine- interfaces by analysis of activity signals
  151. Event-based sampling for reducing communication load in realtime human motion analysis by wireless inertial sensor networks
  152. Automatic pairing of inertial sensors to lower limb segments – a plug-and-play approach
  153. Contactless respiratory monitoring system for magnetic resonance imaging applications using a laser range sensor
  154. Interactive monitoring system for visual respiratory biofeedback
  155. Development of a low-cost senor based aid for visually impaired people
  156. Patient assistive system for the shoulder joint
  157. A passive beating heart setup for interventional cardiology training
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