Evaluation of breast skin and tissue stiffness using a non-invasive aspiration device and impact of clinical predictors.

A personalized 3D breast model could present a real benefit for preoperative discussion with patients, surgical planning, and guidance. Breast tissue biomechanical properties have been poorly studied in vivo, although they are important for breast deformation simulation. The main objective of our study was to determine breast skin thickness and breast skin and adipose/fibroglandular tissue stiffness. The secondary objective was to assess clinical predictors of elasticity and thickness: age, smoking status, body mass index, contraception, pregnancies, breastfeeding, menopausal status, history of radiotherapy or breast surgery. Participants were included at the Montpellier University Breast Surgery Department from March to May 2022. Breast skin thickness was measured by ultrasonography, breast skin and adipose/fibroglandular tissue stiffnesses were determined with a VLASTIC non-invasive aspiration device at three different sites (breast segments I-III). Multivariable linear models were used to assess clinical predictors of elasticity and thickness. In this cohort of 196 women, the mean breast skin and adipose/fibroglandular tissue stiffness values were 39 and 3 kPa, respectively. The mean breast skin thickness was 1.83 mm. Only menopausal status was significantly correlated with breast skin thickness and adipose/fibroglandular tissue stiffness. The next step will be to implement these stiffness and thickness values in a biomechanical breast model and to evaluate its capacity to predict breast tissue deformations.

Degradable Bioadhesives Based on Star PEG-PLA Hydrogels for Soft Tissue Applications.

Tissue adhesives are interesting materials for wound treatment as they present numerous advantages compared to traditional methods of wound closure such as suturing and stapling. Nowadays, fibrin and cyanoacrylate glues are the most widespread commercial biomedical adhesives, but these systems display some drawbacks. In this study, degradable bioadhesives based on PEG-PLA star-shaped hydrogels are designed. Acrylate, methacrylate, and catechol functional copolymers are synthesized and used to design various bioadhesive hydrogels. Various types of mechanisms responsible for adhesion are investigated (physical entanglement and interlocking, physical interactions, chemical bonds), and the adhesive properties of the different systems are first studied on a gelatin model and compared to fibrin and cyanoacrylate references. Hydrogels based on acrylate and methacrylate reached adhesion strength close to cyanoacrylate (332 kPa) with values of 343 and 293 kPa, respectively, whereas catechol systems displayed higher values (11 and 19 kPa) compared to fibrin glue (7 kPa). Bioadhesives were then tested on mouse skin and human cadaveric colonic tissue. The results on mouse skin confirmed the potential of acrylate and methacrylate gels with adhesion strength close to commercial glues (15-30 kPa), whereas none of the systems led to high levels of adhesion on the colon. These data confirm that we designed a family of degradable bioadhesives with adhesion strength in the range of commercial glues. The low level of cytotoxicity of these materials is also demonstrated and confirm the potential of these hydrogels to be used as surgical adhesives.

Finite Element Tissue Strains Computation to Evaluate the Mechanical Protection Provided by a New Bilayer Dressing for Heel Pressure Injuries.

OBJECTIVE: Pressure injuries (PIs) result in an extended duration of care and increased risks of complications for patients. When treating a PI, the aim is to hinder further PI development and speed up the healing time. Urgo RID recently developed a new bilayer dressing to improve the healing of stages 2 and 3 heel PIs. This study aims to numerically investigate the efficiency of this new bilayer dressing to reduce strains around the PI site. METHODS: The researchers designed three finite element models based on the same heel data set to compare the Green-Lagrange compressive and maximal shear strains in models without a PI, with a stage 2 PI, and with a stage 3 PI. Simulations with and without the dressing were computed. Analysis of the results was performed in terms of strain clusters, defined as volumes of tissues with high shear and compressive strains. RESULTS: Decreases in the peak and mean values of strains were low in all three models, between 0% and 20%. However, reduction of the strain cluster volumes was high and ranged from 55% to 68%. CONCLUSIONS: The cluster analysis enables the robust quantitative comparison of finite element analysis. Results suggest that use of the new bilayer dressing may reduce strain around the PI site and that this dressing could also be used in a prophylactic manner. Results should be extended to a larger cohort of participants.

New pressure ulcers dressings to alleviate human soft tissues: A finite element study.

Pressure Ulcers (PU) are real burdens for patients in healthcare systems, affecting their quality of life. External devices such as prophylactic dressings may be used to prevent the onset of PU. A new type of dressing was designed to alleviate soft tissue under pressure, with the objective to prevent PU and to improve the healing conditions of category-1 and category-2 wounds. The mechanical interactions of this dressing with a generic model of human skin/hypodermal soft tissue was simulated using the Finite Element (FE) method. Different cases with intact skin tissues and injured tissues with a category-2 PU, with and without dressings in place, were modeled. The tissues were deformed under compressive load; internal strains were computed. The results showed a clear benefit from the use of the dressing to reduce the peak internal strains both in the intact and injured tissues models by 17-25%, respectively. The intact soft tissues model was evaluated via sacral pressure measurements performed on one healthy volunteer. Results showed a good agreement between pressure measurements and estimations both with and without the dressing in place; particularly under the bony prominence and in surrounding tissues. As a conclusion, the importance of dressings to maintain a proper biochemical environment for the healing of PU is incontestable. Yet, new concepts of dressings may be developed to prevent the onset of PU, but also to provide local stress and strain reliefs and create mechanical conditions as less damaging as possible for the tissues.

Mechanical experimentation of the gastrointestinal tract: a systematic review.

The gastrointestinal (GI) organs of the human body are responsible for transporting and extracting nutrients from food and drink, as well as excreting solid waste. Biomechanical experimentation of the GI organs provides insight into the mechanisms involved in their normal physiological functions, as well as understanding of how diseases can cause disruption to these. Additionally, experimental findings form the basis of all finite element (FE) modelling of these organs, which have a wide array of applications within medicine and engineering. This systematic review summarises the experimental studies that are currently in the literature (n = 247) and outlines the areas in which experimentation is lacking, highlighting what is still required in order to more fully understand the mechanical behaviour of the GI organs. These include (i) more human data, allowing for more accurate modelling for applications within medicine, (ii) an increase in time-dependent studies, and (iii) more sophisticated in vivo testing methods which allow for both the layer- and direction-dependent characterisation of the GI organs. The findings of this review can also be used to identify experimental data for the readers' own constitutive or FE modelling as the experimental studies have been grouped in terms of organ (oesophagus, stomach, small intestine, large intestine or rectum), test condition (ex vivo or in vivo), number of directions studied (isotropic or anisotropic), species family (human, porcine, feline etc.), tissue condition (intact wall or layer-dependent) and the type of test performed (biaxial tension, inflation-extension, distension (pressure-diameter), etc.). Furthermore, the studies that investigated the time-dependent (viscoelastic) behaviour of the tissues have been presented.

Characterization of the layer, direction and time-dependent mechanical behaviour of the human oesophagus and the effects of formalin preservation.

The mechanical characterization of the oesophagus is essential for applications such as medical device design, surgical simulations and tissue engineering, as well as for investigating the organ's pathophysiology. However, the material response of the oesophagus has not been established ex vivo in regard to the more complex aspects of its mechanical behaviour using fresh, human tissue: as of yet, in the literature, only the hyperelastic response of the intact wall has been studied. Therefore, in this study, the layer-dependent, anisotropic, visco-hyperelastic behaviour of the human oesophagus was investigated through various mechanical tests. For this, cyclic tests, with increasing stretch levels, were conducted on the layers of the human oesophagus in the longitudinal and circumferential directions and at two different strain rates. Additionally, stress-relaxation tests on the oesophageal layers were carried out in both directions. Overall, the results show discrete properties in each layer and direction, highlighting the importance of treating the oesophagus as a multi-layered composite material with direction-dependent behaviour. Previously, the authors conducted layer-dependent cyclic experimentation on formalin-embalmed human oesophagi. A comparison between the fresh and embalmed tissue response was carried out and revealed surprising similarities in terms of anisotropy, strain-rate dependency, stress-softening and hysteresis, with the main difference between the two preservation states being the magnitude of these properties. As formalin fixation is known to notably affect the formation of cross-links between the collagen of biological materials, the differences may reveal the influence of cross-links on the mechanical behaviour of soft tissues.

Current poisson's ratio values of finite element models are too low to consider soft tissues nearly-incompressible: illustration on the human heel region.

Tissues' nearly incompressibility was well reported in the literature but little effort has been made to compare volume variations computed by simulations with in vivo measurements. In this study, volume changes of the fat pad during controlled indentations of the human heel region were estimated from segmented medical images using digital volume correlation. The experiment was reproduced using finite element modelling with several values of Poisson's ratio for the fat pad, from 0.4500 to 0.4999. A single value of Poisson's ratio could not fit all the indentation cases. Estimated volume changes were between 0.9% - 11.7%.

Development and Operation of an Experimental System to Measure the Moments Generated in the Finger Joints.

Little information is available on the forces that fingers can generate, and few devices exist to measure the forces they can create. The objective of this paper is to propose an experimental device to measure the moments generated by finger joints. The idea is to focus on a single joint and not on the effort generated by the whole finger. A system leaving only one joint free is developed to measure the maximum attainable moment in different joint positions between the extended and flexed finger. The device is tested on the proximal interphalangeal joints of the index fingers of thirty people for both hands. The results show a dispersion of results from one person to another but with similar trends in the evolution of the maximum achievable moment depending on the angle. Average values of the maximum moments attained by men and women for both hands are given for all angular positions of the joint. The results are analysed using principal component analysis. This analysis shows that four main modes represent more than 99% of the signal and allow the reconstruction of all the data for all the subjects. The four modes obtained can be used as a basis for the development of finger devices by hospital practitioners.

Experimental investigations of the human oesophagus: anisotropic properties of the embalmed mucosa-submucosa layer under large deformation.

Mechanical characterisation of the layer-specific, viscoelastic properties of the human oesophagus is crucial in furthering the development of devices emerging in the field, such as robotic endoscopic biopsy devices, as well as in enhancing the realism, and therefore effectiveness, of surgical simulations. In this study, the viscoelastic and stress-softening behaviour of the passive human oesophagus was investigated through ex vivo cyclic mechanical tests. Due to restrictions placed on the laboratory as a result of COVID-19, only oesophagi from cadavers fixed in formalin were allowed for testing. Three oesophagi in total were separated into their two main layers and the mucosa-submucosa layer was investigated. A series of uniaxial tensile tests were conducted in the form of increasing stretch level cyclic tests at two different strain rates: 1% s[Formula: see text] and 10% s[Formula: see text]. Rectangular samples in both the longitudinal and circumferential directions were tested to observe any anisotropy. Histological analysis was also performed through a variety of staining methods. Overall, the longitudinal direction was found to be much stiffer than the circumferential direction. Stress-softening was observed in both directions, as well as permanent set and hysteresis. Strain rate-dependent behaviour was also apparent in the two directions, with an increase in strain rate resulting in an increase in stiffness. This strain rate dependency was more pronounced in the longitudinal direction than the circumferential direction. Finally, the results were discussed in regard to the histological content of the layer, and the behaviour was modelled and validated using a visco-hyperelastic matrix-fibre model.

Experimental investigations of the human oesophagus: anisotropic properties of the embalmed muscular layer under large deformation.

The oesophagus is a primarily mechanical organ whose material characterisation would aid in the investigation of its pathophysiology, help in the field of tissue engineering, and improve surgical simulations and the design of medical devices. However, the layer-dependent, anisotropic properties of the organ have not been investigated using human tissue, particularly in regard to its viscoelastic and stress-softening behaviour. Restrictions caused by the COVID-19 pandemic meant that fresh human tissue was not available for dissection. Therefore, in this study, the layer-specific material properties of the human oesophagus were investigated through ex vivo experimentation of the embalmed muscularis propria layer. For this, a series of uniaxial tension cyclic tests with increasing stretch levels were conducted at two different strain rates. The muscular layers from three different cadaveric specimens were tested in both the longitudinal and circumferential directions. The results displayed highly nonlinear and anisotropic behaviour, with both time- and history-dependent stress-softening. The longitudinal direction was found to be stiffer than the circumferential direction at both strain rates. Strain rate-dependent behaviour was apparent, with an increase in strain rate resulting in an increase in stiffness in both directions. Histological analysis was carried out via various staining methods; the results of which were discussed with regard to the experimentally observed stress-stretch response. Finally, the behaviour of the muscularis propria was simulated using a matrix-fibre model able to capture the various mechanical phenomena exhibited, the fibre orientation of which was driven by the histological findings of the study.

Evaluation of a biodegradable PLA-PEG-PLA internal biliary stent for liver transplantation: in vitro degradation and mechanical properties.

Internal biliary stenting during biliary reconstruction in liver transplantation decrease anastomotic biliary complications. Implantation of a resorbable internal biliary stent (RIBS) is interesting since it would avoid an ablation gesture. The objective of present work was to evaluate adequacy of selected PLA-b-PEG-b-PLA copolymers for RIBS aimed to secure biliary anastomose during healing and prevent complications, such as bile leak and stricture. The kinetics of degradation and mechanical properties of a RIBS prototype were evaluated with respect to the main bile duct stenting requirements in liver transplantation. For this purpose, RIBS degradation under biliary mimicking solution versus standard phosphate buffer control solution was discussed. Morphological changes, mass loss, water uptake, molecular weight, permeability, pH variations, and mechanical properties were examined over time. The permeability and mechanical properties were evaluated under simulated biliary conditions to explore the usefulness of a PLA-b-PEG-b-PLA RIBS to secure biliary anastomosis. Results showed no pH influence on the kinetics of degradation, with degradable RIBS remaining impermeable for at least 8 weeks, and keeping its mechanical properties for 10 weeks. Complete degradation is reached at 6 months. PLA-b-PEG-b-PLA RIBS have the required in vitro degradation characteristics to secure biliary anastomosis in liver transplantation and envision in vivo applications.

From in vitro evaluation to human postmortem pre-validation of a radiopaque and resorbable internal biliary stent for liver transplantation applications.

The implantation of an internal biliary stent (IBS) during liver transplantation has recently been shown to reduce biliary complications. To avoid a potentially morbid ablation procedure, we developed a resorbable and radiopaque internal biliary stent (RIBS). We studied the mechanical and radiological properties of RIBS upon in vivo implantation in rats and we evaluated RIBS implantability in human anatomical specimens. For this purpose, a blend of PLA50-PEG-PLA50 triblock copolymer, used as a polymer matrix, and of X-ray-visible triiodobenzoate-poly(ε-caprolactone) copolymer (PCL-TIB), as a radiopaque additive, was used to design X-ray-visible RIBS. Samples were implanted in the peritoneal cavity of rats. The radiological, chemical, and biomechanical properties were evaluated during degradation. Further histological studies were carried out to evaluate the degradation and compatibility of the RIBS. A human cadaver implantability study was also performed. The in vivo results revealed a decline in the RIBS mechanical properties within 3 months, whereas clear and stable X-ray visualization of the RIBS was possible for up to 6 months. Histological analyses confirmed compatibility and resorption of the RIBS, with a limited inflammatory response. The RIBS could be successfully implanted in human anatomic specimens. The results reported in this study will allow the development of trackable and degradable IBS to reduce biliary complications after liver transplantation. STATEMENT OF SIGNIFICANCE: Biliary reconstruction during liver transplantation is an important source of postoperative morbidity and mortality although it is generally considered as an easy step of a difficult surgery. In this frame, internal biliary stent (IBS) implantation is beneficial to reduce biliary anastomosis complications (leakage, stricture). However, current IBS are made of non-degradable silicone elastomeric materials, which leads to an additional ablation procedure involving potential complications and additional costs. The present study provides in vitro and human postmortem implantation data related to the development and evaluation of a resorbable and radiopaque internal biliary stent (RIBS) that could tackle these drawbacks.

Optimized needle shape reconstruction using experimentally based strain sensors positioning.

Needles are tools that are used daily during minimally invasive procedures. During the insertions, needles may be affected by deformations which may threaten the success of the procedure. To tackle this problem, needles with embedded strain sensors have been developed and associated with navigation systems. The localization of the needle in the tissues is then obtained in real time by reconstruction from the strain measurements, allowing the physician to optimize its gesture. As the number of strain sensors embedded is limited in number, their positions on the needle have a great impact on the accuracy of the shape reconstruction. The main contribution of this paper is a novel strain sensor positioning method to improve the reconstruction accuracy. A notable feature of our method is the use of experimental needle insertion data, which increases the relevancy of the resulting sensor optimal locations. To the best of the author's knowledge, no experimentally based needle sensor positioning method has been presented yet. Reconstruction validations from clinical data show that the localization accuracy of the needle tip is improved by almost 40% with optimal locations compared with equidistant locations when reconstructing with two sensor triplets or more. Graphical Abstract Improvement of the reconstruction accuracy of a deformed needle shape by using experimental data to position strain sensors.

Geometry-Based Model for U-Shaped Strain Gauges on Medical Needles.

The knowledge of needle location during insertions is essential for the success of interventional radiology procedures. As the needle is susceptible to undergo deformations during its insertion into tissues, several methods have been proposed to monitor the needle deformed shape. Thus, instrumented needles with U-shaped strain gauges are currently being developed to reconstruct the shape of the needle from gauge acquisitions. These acquisitions are used in combination with gauge model to obtain estimate of the strain of the needle. The current modeling is limited as it does not consider the geometry of the gauge. This paper introduces a more complete model for U-shaped strain gauge which, unlike the current model, takes into account the width of the gauge. Thus, the impact of width modeling on the strain estimate can be measured and used to improve strain estimation accuracy. Results with real characteristics of instrumented needle devices show that the differences of strain estimate are around few percents. Finally, by taking into account the width and the length of the gauge our model includes the effets of the gauge size on the strain estimation and makes the miniaturization of the gauge less necessary.

Influence of processing parameters on the macroscopic mechanical behavior of PVA hydrogels.

This paper investigates the influence of three different processing parameters on the global mechanical behavior of PVA (Polyvinyl alcohol)/DMSO (Dimethylsulfoxide) hydrogels: the initial concentration of PVA, the DMSO:H2O ratio and the number of freeze/thaw cycle applied to the material. A specific thermo-regulated testing apparatus for hydrophilic materials is presented, along with the performed cyclic and rupture tests. The observed mechanical responses are explained by an in-depth analysis of the cross-linking phenomenon. Using the Neo-Hookean hyperelastic model, the experimental data is fitted and a link between the density of macro-molecular chains in the material and its mechanical behavior is established. Strong differences are observed and discussed.

Advanced sensors placement for accurate 3D needle shape reconstruction.

Needles are tools widely used in minimally invasive surgery. During such procedures the localization of the needle and its tip is a challenging situation because of the needle deformations due to its interactions with tissues. To tackle this problem, instrumented needles with sensors have been currently developed to allow needle reconstruction and tip localization. In conventional surgery this difficulty is overcome by medical imaging. The interest in using an instrumented needle resides in the possible dispense of medical imaging. This papers develops new methods to reconstruct needles in three dimensions and to find the locations of sensors which minimizes the error of reconstruction of the needle. A notable feature of our method is that input data are based on real needle data, that should assure a better representation of reality. Reconstructions simulated with 22 gauge 200 mm long needles show that the localization of the needle tip is more accurate by 18% to 52% with optimal sensors positions compared to equidistant sensors positions.

A generic three-dimensional static force distribution basis for a medical needle inserted into soft tissue.

In this paper, the static interaction forces between a medical needle and soft tissue during CT (Computerized Tomography) guided insertion are studied. More precisely a set of linearly independent elements describing the forces (a basis) is identified. This forms a generic basis from which any forces that act on a static needle (that is not fixed at its base and that is inserted into human tissue) can be described accurately. To achieve this purpose, the same needle was inserted 62 times into fresh porcine shoulder tissue and CT scans were acquired after each push to determine the final trajectory of the needle. From this set of trajectories, a generic static force basis was determined by using static Beam, B-spline theories and Principal Component Analysis (PCA). This generic basis was first validated on theoretical simulations and then on 20 different needles inserted into in vivo human tissues during real clinical interventions. Such a basis could be of use to highlight the forces acting all along the length of a needle inserted into a complex tissue and enables models of needle deflection to be developed. These models could be used in the development of automated robot assisted and/or image guided strategies for needle steering.