Background: In hip arthroplasties, surgeons rely on their experience to assess the stability and balance of hip tissues when fitting the implant to their patients. During the operation, surgeons use a modular, temporary set of implants to feel the tension in the surrounding soft tissues and adjust the implant configuration. This process is naturally subjective and therefore depends on the operator. Inexperienced surgeons undertaking hip arthroplasties are twice as likely to experience errors than their experienced colleagues, leading to dislocations, pain and discomfort for the patients. Methods: To address this issue, a new, 3DOF force measurement system was developed and integrated into the modular, trial implants that can quantify forces and movements intraoperatively in 3D. The prototypes were evaluated in three post-mortem human specimens (PMHSs), to provide surgeons with objective data to help determine the optimal implant fit and configuration. The devices comprise a deformable polymer material providing strain-based displacements measured with electromagnetic-based sensors and an inertial measurement unit (IMU) for motion data. Results: Device results show a relative accuracy of approx. 2% and a sensitivity of approx. 1%. PMHS results indicated that soft tissue forces on the hip joint peak in the order of ~100 N and trend with positions of the leg during range of motion (ROM) tests, although force patterns differ between each PMHS. Conclusion: By monitoring forces and force patterns of hip soft tissues, in combination with standardised ROM tests, the force patterns could shed a light on potential anomalies that can be addressed during surgery. Clinical and Translational Impact Statement: The development of an instrumented hip implant device for use during surgery knowledge will eventually allow us to develop a predictive model for soft tissue balancing, that can be used for pre- and intra-operative planning for each patient on a tailored and personalised basis. Ultimately, we hope that with this device, patients will benefit from a faster recovery, from a more-precisely fitted hip, and an improved quality of life.@en

The success of total hip arthroplasty depends on the experience of the surgeon, and one of the ways the surgeon currently determines the final implant insertion depth is to listen to the change in audible pitch of the hammering sound. We investigated the use of vibration emissions as a novel method for insertion quality assessment. A non-invasive contact microphone-based measurement system for insertion depth estimation, fixation and fracture detection was developed using a simplified in vitro bone/implant (n = 5). A total of 2583 audio recordings were analyzed in vitro to obtain energy spectral density functions. Out of the four main resonant peaks under in vitro conditions, broach insertion depth statistically correlates to increasing 3rd and 4th peak frequencies. Degree of fixation was also observed as higher goodness of fit (0.26–0.78 vs. 0.12–0.51 between two broach sizes, the latter undersized). Finally, however, the moment of fracture could not be predicted. A cadaveric in situ pilot study suggests comparable resonant frequencies in the same order of magnitudes with the bone model. Further understanding of the signal patterns are needed for an early warning system diagnostic system for imminent fractures, bone damage, improving accuracy and quality of future procedures@en

With the development of wearable technologies, the interfacial properties of skin and devices have become much more important. For research and development purposes, porcine skin is often used to evaluate device performance, but the differences between in vivo, in situ and ex vivo porcine skin mechanical properties can potentially misdirect investigators during the development of their technology. In this study, we investigated the significant changes to mechanical properties with and without perfusion (in vivo versus in vitro tissue). The device focus for this study was a skin-targeting Nanopatch vaccine microneedle device, employed to assess the variance to key skin engagement parameters – penetration depth and delivery efficiency – due to different tissue conditions. The patches were coated with fluorescent or ¹⁴C radiolabelled formulations for penetration depth and delivery efficiency quantification in vivo, and at time points up to 4 h post mortem. An immediate cessation of blood circulation saw mean microneedle penetration depth fell from ∼100 μm to ∼55 μm (∼45%). Stiffening of underlying tissues as a result of rigor mortis then augmented the penetration depths at the 4 h timepoint back to ∼100 μm, insignificantly different (p = 0.0595) when compared with in vivo. The highest delivery efficiency of formulation into the skin (dose measured in the skin excluding leftover dose on skin and patch surfaces) was also observed at this time point of ∼25%, up from ∼2% in vivo. Data obtained herein progresses medical device development, highlighting the need to consider the state and muscle tissues when evaluating prototypes on cadavers.

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Skin-targeting microscale medical devices are becoming popular for therapeutic delivery and diagnosis. We used cryo-SEM, fluorescence lifetime imaging microscopy (FLIM), autofluorescence imaging microscopy and inflammatory response to study the puncturing and recovery of human skin ex vivo and in vivo after discretised puncturing by a microneedle array (Nanopatch®). Pores induced by the microprojections were found to close by ~25% in diameter within the first 30 min, and almost completely close by ~6 h. FLIM images of ex vivo viable epidermis showed a stable fluorescence lifetime for unpatched areas of ~1000 ps up to 24 h. Only the cells in the immediate puncture zones (in direct contact with projections) showed a reduction in the observed fluorescence lifetimes to between ~518–583 ps. The ratio of free-bound NAD(P)H (α1/α2) in unaffected areas of the viable epidermis was ~2.5–3.0, whereas the ratio at puncture holes was almost double at ~4.2–4.6. An exploratory pilot in vivo study also suggested similar closure rate with histamine administration to the forearms of human volunteers after Nanopatch® treatment, although a prolonged inflammation was observed with Tissue Viability Imaging. Overall, this work shows that the pores created by the microneedle-type medical device, Nanopatch®, are transient, with the skin recovering rapidly within 1–2 days in the epidermis after application.

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