Management of long-term and reversible hysteroscopic sterilization: a novel device with nickel-titanium shape memory alloy.
ABSTRACT: Female sterilization is the second most commonly used method of contraception in the United States. Female sterilization can now be performed through laparoscopic, abdominal, or hysteroscopic approaches. The hysteroscopic sterilization may be a safer option than sterilization through laparoscopy or laparotomy because it avoids invading the abdominal cavity and undergoing general anaesthesia. Hysteroscopic sterilization mainly includes chemical agents and mechanical devices. Common issues related to the toxicity of the chemical agents used have raised concerns regarding this kind of contraception. The difficulty of the transcervical insertion of such mechanical devices into the fallopian tubes has increased the high incidence of device displacement or dislodgment. At present, Essure® is the only commercially available hysteroscopic sterilization device being used clinically. The system is irreversible and is not effective immediately.Our new hysteroscopic sterility system consists of nickel-titanium (NiTi) shape memory alloy and a waterproof membrane. The NiTi alloy is covered with two coatings to avoid toxic Ni release and to prevent stimulation of epithelial tissue growth around the oviducts. Because of the shape memory effect of the NiTi alloy, the device works like an umbrella: it stays collapsed at low temperature before placement and opens by the force of shape memory activated by the body temperature after it is inserted hysteroscopically into the interstitial tubal lumen. The rim of the open device will incise into interstitial myometrium during the process of unfolding. Once the device is fixed, it blocks the tube completely. When the patient no longer wishes for sterilization, the device can be closed by perfusing liquid with low temperature into the uterine cavity, followed by prospective hysteroscopic removal. After the device removal, the fallopian tube will revert to its physiological functions.Currently, experimental and clinical studies are needed to attest the safety, efficiency and reversibility of the novel sterilization device.If our hypothesis is confirmed, appropriate and reversible contraceptive can be achieved with the device we have designed, which may have significant repercussions for numerous women worldwide.
Project description:Fallopian tube catheterization is used for treatment of infertility caused by proximal tubal occlusion, and has replaced surgical treatment for this condition. More recently, fallopian tube catheterization has been used for tubal sterilization. Interventional radiologists tested numerous methods for tubal occlusion using the rabbit as an animal model. As a result, a tubal device has recently been Food and Drug Administration approved for permanent sterilization using hysteroscopic guidance; it can also be placed fluoroscopically by fallopian tube catheterization as an "off-label" procedure. This is a 5-year continuation and update on a procedure that has been done by interventional radiologists for 25 years; history of the development of fallopian tube catheterization in women has been published in detail in this journal. Highlighted in this article will be description of the basic components needed for fallopian tube catheterization.
Project description:Safety of hysteroscopic sterilization has been recently questioned following reports of general symptoms such as allergy, tiredness, and depression in addition to associated gynecological results such as pelvic pain, perforation of fallopian tubes or uterus, and unwanted pregnancy.To compare the risk of reported adverse events between hysteroscopic and laparoscopic sterilization.French nationwide cohort study using the national hospital discharge database linked to the health insurance claims database. Women aged 30 to 54 years receiving a first hysteroscopic or laparoscopic sterilization between 2010 and 2014 were included and were followed up through December 2015.Hysteroscopic sterilization vs laparoscopic sterilization.Risks of procedural complications (surgical and medical) and of gynecological (sterilization failure that includes salpingectomy, second sterilization procedure, or pregnancy; pregnancy; reoperation) and medical outcomes (all types of allergy; autoimmune diseases; thyroid disorder; use of analgesics, antimigraines, antidepressants, benzodiazepines; outpatient visits; sickness absence; suicide attempts; death) that occurred within 1 and 3 years after sterilization were compared using inverse probability of treatment-weighted Cox models.Of the 105?357 women included (95.5% of eligible participants; mean age, 41.3 years [SD, 3.7 years]), 71?303 (67.7% ) underwent hysteroscopic sterilization, and 34?054 (32.3%) underwent laparoscopic sterilization. During the hospitalization for sterilization, risk of surgical complications for hysteroscopic sterilization was lower: 0.13% for hysteroscopic sterilization vs 0.78% for laparoscopic sterilization (adjusted risk difference [RD], -0.64; 95% CI, -0.67 to -0.60) and was lower for medical complications: 0.06% vs 0.11% (adjusted RD, -0.05; 95% CI, -0.08 to -0.01). During the first year after sterilization, 4.83% of women who underwent hysteroscopic sterilization had a higher risk of sterilization failure than the 0.69% who underwent laparoscopic sterilization (adjusted hazard ratio [HR], 7.11; 95% CI, 5.92 to 8.54; adjusted RD, 4.23 per 100 person-years; 95% CI, 3.40 to 5.22). Additionally, 5.65% of women who underwent hysteroscopic sterilization required gynecological reoperation vs 1.76% of women who underwent laparoscopic sterilization (adjusted HR, 3.26; 95% CI, 2.90 to 3.67; adjusted RD, 4.63 per 100 person-years; 95% CI, 3.38 to 4.75); these differences persisted after 3 years, although attenuated. Hysteroscopic sterilization was associated with a lower risk of pregnancy within the first year of the procedure but was not significantly associated with a difference in risk of pregnancy by the third year (adjusted HR, 1.04; 95% CI, 0.83-1.30; adjusted RD, 0.01 per 100 person-years; 95% CI, -0.04 to 0.07). Risks of medical outcomes were not significantly increased with hysteroscopic sterilization compared with laparoscopic sterilization.Among women undergoing first sterilization, the use of hysteroscopic sterilization was significantly associated with higher risk of gynecological complications over 1 year and over 3 years than was laparoscopic sterilization. Risk of medical outcomes was not significantly increased over 1 year or over 3 years. These findings do not support increased medical risks associated with hysteroscopic sterilization.
Project description:To compare the safety and efficacy of hysteroscopic sterilization with the "Essure" device with laparoscopic sterilization in a large, all-inclusive, state cohort.Population based cohort study.Outpatient interventional setting in New York State.Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013.Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis.We identified 8048 patients undergoing hysteroscopic sterilization and 44,278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization.Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making.
Project description:Magnetoelectric coupling effect has provided a power efficient approach in controlling the magnetic properties of ferromagnetic materials. However, one remaining issue of ferromagnetic/ferroelectric magnetoelectric bilayer composite is that the induced effective anisotropy disappears with the removal of the electric field. The introducing of the shape memory alloys may prevent such problem by taking the advantage of its shape memory effect. Additionally, the shape memory alloy can also "store" the magnetoelectric coupling before heat release, which introduces more functionality to the system. In this paper, we study a FeGaB/NiTi/PMN-PT multiferroic heterostructure, which can be operating in different states with electric field and temperature manipulation. Such phenomenon is promising for tunable multiferroic devices with multi-functionalities.
Project description:Nickel-titanium shape memory alloy (NiTi-SMA) implants might allow modulating fracture healing, changing their stiffness through alteration of both elastic modulus and cross-sectional shape by employing the shape memory effect (SME).a novel NiTi-SMA plate stabilizes tibia osteotomies in rabbits. After noninvasive electromagnetic induction heating the alloy exhibits the SME and the plate changes towards higher stiffness (inverse dynamization) resulting in increased fixation stiffness and equal or better bony healing. In 14 rabbits, 1.0?mm tibia osteotomies were fixed with our experimental plate. Animals were randomised for control or induction heating at three weeks postoperatively. Repetitive X-ray imaging and in vivo measurements of bending stiffness were performed. After sacrifice at 8 weeks, macroscopic evaluation, µCT, and post mortem bending tests of the tibiae were carried out. One death and one early implant dislocation occurred. Following electromagnetic induction heating, radiographic and macroscopic changes of the implant proved successful SME activation. All osteotomies healed. In the treatment group, bending stiffness increased over time. Differences between groups were not significant. In conclusion, we demonstrated successful healing of rabbit tibia osteotomies using our novel NiTi-SMA plate. We demonstrated shape-changing SME in-vivo through transcutaneous electromagnetic induction heating. Thus, future orthopaedic implants could be modified without additional surgery.
Project description:Advances in actuating fabrics can enable a paradigm shift in the field of smart wearables by dynamically fitting themselves to the unique topography of the human body. Applications including soft wearable robotics, continuous health monitoring, and body-mounted haptic feedback systems are dependent upon simultaneous body proximity and garment stiffness for functionality. Passive fabrics and fitting mechanisms are unable to conform around surface concavities and require either high elasticity or a multiplicity of closure devices to achieve garment fit. The design, manufacture, and validation of the first circumferentially contractile and topographic self-fitting garments composed of NiTi-based shape memory alloy (SMA) knitted actuators that dynamically conform to the unique shape and size of the wearer's body in response to a change of the garment's temperature is introduced. Advanced materials and systems innovations 1) enable novel garment manufacturing and application strategies, 2) facilitate topographical fitting (spatial actuation) through garment architectural design, and 3) provide tunable NiTi-based SMA actuation temperatures to enable actuation on the surface of human skin. This research represents a paradigm shift for wearable applications by redefining garment fit to fully topographical conformation to the wearer through advanced materials and structures design.
Project description:Based on the experimental results and the finite element analysis, a constitutive model is proposed for two phase shape memory alloys by introducing a compensative volumetric strain into a constrained relationship between the two phases, accounting for the reduced constraint due to the growth of martensite band. The pseudoelasticity of NiTi shape memory alloy micro-tube, subjected to pure tension, is analyzed and compared with the experimental results. It can be seen that the pseudoelastic behavior, especially the phenomena of a stress drop during tension processes, can be well described with the proposed model. The proposed model separates the complicated constitutive behavior of a shape memory alloy (SMA) into simple responses arising respectively from its two phases, taking into account laminar microstructure, the thickness of martensite phase and the interaction between the two phases, and provides an easy but comprehensive method for the description of the constitutive behavior of SMAs under complex thermomechanical loading.
Project description:The biomaterials used to maintain or replace functions in the human body consist mainly of metals, ceramics or polymers. In orthopedic surgery, metallic materials, especially titanium and its alloys, are the most common, due to their excellent mechanical properties, corrosion resistance, and biocompatibility. Aside from the established Ti6Al4V alloy, shape memory materials such as nickel-titanium (NiTi) have risen in importance, but are also discussed because of the adverse effects of nickel ions. These might be reduced by specific surface modifications. In the present in vitro study, the osteoblastic cell line MG-63 as well as primary human osteoblasts, fibroblasts, and macrophages were cultured on titanium alloys (forged Ti6Al4V, additive manufactured Ti6Al4V, NiTi, and Diamond-Like-Carbon (DLC)-coated NiTi) to verify their specific biocompatibility and inflammatory potential. Additive manufactured Ti6Al4V and NiTi revealed the highest levels of metabolic cell activity. DLC-coated NiTi appeared as a suitable surface for cell growth, showing the highest collagen production. None of the implant materials caused a strong inflammatory response. In general, no distinct cell-specific response could be observed for the materials and surface coating used. In summary, all tested titanium alloys seem to be biologically appropriate for application in orthopedic surgery.
Project description:We present a procedure to determine temperature-dependent thermodynamic properties of crystalline materials from density functional theory molecular dynamics (DFT-MD). Finite temperature properties (structural, thermal, and mechanical properties) of the phases (ground state monoclinic B33, martensitic B19', and austenitic B2) of the shape memory alloy NiTi are investigated. Fluctuation formulas and numerical derivatives are used to evaluate mechanical and thermal properties. A modified version of thermodynamic upsampling is used to enable simulations with lower DFT convergence thresholds. In addition, a thermodynamic integration expression is developed to compute free energies from isobaric DFT-MD simulations that accounts for volume changes. Structural parameters, elastic constants, volume expansion, and specific heats as a function of temperature are evaluated. Phase transitions between B2 and B19' and between B19' and B33 are characterized according to their thermal energy, entropy, and free energy differences as well as their latent heats. Anharmonic effects are shown to play a large role in both stabilizing the austenite B2 phase as well as suppressing the martensitic phase transition. The quasiharmonic approximation to the free energy results in large errors in estimating the martensitic transition temperature by neglecting these large anharmonic components.
Project description:If the shape memory alloy is subjected to the subloop loading under the stress-controlled condition, creep and creep recovery can appear based on the martensitic transformation. In the design of shape memory alloy elements, these deformation properties are important since the deflection of shape memory alloy elements can change under constant stress. The conditions for the progress of the martensitic transformation are discussed based on the kinetics of the martensitic transformation for the shape memory alloy. During loading under constant stress rate, temperature increases due to the stress-induced martensitic transformation. If stress is held constant during the martensitic transformation stage in the loading process, temperature decreases and the condition for the progress of the martensitic transformation is satisfied, resulting in the transformation-induced creep deformation. If stress is held constant during the reverse transformation stage in the unloading process, creep recovery appears due to the reverse transformation. The details for these thermomechanical properties are investigated experimentally for TiNi shape memory alloy, which is most widely used in practical applications. The volume fraction of the martensitic phase increases in proportion to an increase in creep strain.