Development of a biodegradable microstent for minimally invasive treatment of Fallopian tube occlusions

Obstructions of the Fallopian tube represent one of the most common reasons for an unfulfilled desire to have children. Microstent technology opens up new therapeutic possibilities to restore the natural lumen of the Fallopian tube within a single treatment. Within the current work we developed a self-expandable biodegradable microstent for gynecological applications. Based on a novel microstent design, prototypes were manufactured from poly-L-lactide tubing by means of fs-laser cutting. Microstent prototypes were characterized morphologically by means of scanning electron microscopy and biaxial laser scanning. As manufactured, a microstents outside diameter of about 2.3 mm and a strut thickness/width of about 114 µm/103 µm was measured. Mechanical characterization of microstents included bending as well as crimping and release behavior. After crimping to a minimum diameter of 0.8 mm and consecutive release, a microstent recovery to a diameter of 1.8 mm was found. Therefore, proof-of-concept for the self-expandable microstent could be successfully provided. © 2020 by Walter de Gruyter Berlin/Boston 2020

Evaluation of loading behavior of a selfexpanding polymeric microstent for the treatment of Fallopian tube occlusions

Female sterility is caused by Fallopian tube occlusions in one of three cases. Current treatment methods achieve unsatisfying pregnancy rates and are associated with high costs or significant psychological and physiological stress. Our previously described microstent technology opens up new therapeutic possibilities to restore the lumen of the Fallopian tube without surgery. In this work, a Finite Element Analysis model of a physiologically relevant loading of the device is presented. Therefore, microstent radial force was analysed as a function of the device diameter up to a minimum diameter of 1.4 mm, which was found after microstent implantation ex vivo. A bilinear constitutive material model considering isotropic hardening was used for modeling of the microstent. The Finite Element Analysis results were validated using corresponding results of experimental investigations. In this context, a maximum deviation of 15% between experimental radial force and the corresopnding simulation results (1.33 N vs. 1.13 N) was found. Maximum von Mises stresses of approximately 88 MPa were determined. A good agreement between simulation and experiments was found. Therefore, future simulations will be carried out as a basis for microstent design optimisation

Radial compliance of porcine Fallopian tubes ex vivo – perspectives for the development of a gynecological microstent

Fallopian tube occlusions represent one of the most common causes of female sterility. As an innovative treatment approach for affected persons, we previously presented the concept of a novel polymeric, self-expanding, and bioresorbable microstent. As a basis for microstent development, knowledge of the mechanical properties of the anatomical target structure represents a crucial requirement. The current work describes a methodological approach for the experimental determination of radial Fallopian tube compliance using optical coherence tomography. It could be shown that a quantitative assessment of the mechanical properties of porcine Fallopian tube samples - as a whole anatomical structure including the Tunica mucosa, the Tunica muscularis, and the Tunica serosa - is possible, using the described test setup. Future investigations on human samples will allow for valuable information regarding the structural-mechanical properties of the Fallopian tube. Therefore, the current work offers perspectives for the development of a novel gynecological microstent for the treatment of Fallopian tube occlusions

Development of a limbal fixation mechanism for a minimally invasive implantable glaucoma microstent

Glaucoma represents a chronic eye disease that becomes increasingly prevalent worldwide. Therapies are commonly based on the reduction of intraocular pressure (IOP). Implant devices for micro-invasive glaucoma surgery (MIGS) represent a promising therapy option in refractory cases but suffer from limitations in long term efficacy or from dislocation associated complications. Our approach of an innovative drug-eluting glaucoma microstent for MIGS was presented previously. Within the current work we developed concepts and prototypes of a mechanism for the fixation of our glaucoma microstent in the region of the corneal limbus. A tripod and a haptics design of the fixation mechanism were developed and manufactured. Semifinished products were tested with regard to dimensional stability and mechanical properties according to the standard ANSI Z80.27-2014. Considering the mechanical properties of ocular target tissues, a gelatin based in vitro model for the measurement of microstent retention force was developed. Retention force testing of microstent prototypes in vitro resulted in a proof of concept for the fixation mechanism. Future studies will focus on the use of smaller fixation fibers, for example commercially available suture material, and on an overall miniaturization of the fixation mechanism enabling the use of our applicator device with a 22G x 1½” cannula

Fallopian tube occlusion – anatomical ex vivo studies in advance of preclinical in vivo models for future microstent-based therapeutic concept evaluation

An unfulfilled pregnancy is often due to impaired patency of the female Fallopian tubes. To circumvent tubal obstruction, cost-intensive in vitro fertilisation (IVF) is currently indicated. The only therapeutic treatment concepts available are transvaginal tubal lavage/catheterization or laparoscopy with minimally invasive or complex surgical tubal reconstruction, which are associated with side effects. The development of new and cost-effective non- or minimally invasive therapeutic concepts that can restore the patency of the Fallopian tubes would be key in the treatment of female infertility and can fulfil the desire to have children. Therefore, in the present work, ex vivo anatomical studies are carried out on various laboratory mammals (pigs, rabbits, guinea pigs). Using these animal models, it was also evaluated whether a sensor-ureterorenoscope can be inserted through the whole female reproductive tract to the Fallopian tubes. This device will be used for endoscopically guided implantation of a novel tubal microstent prototype via its tailor-made delivery system into the isthmus region of the Fallopian tubes in upcoming studies. This work serves to identify an optimal species for a longitudinal animal study, in which the feasibility as well as the tissue reaction to the implant will be evaluated

Development of a biodegradable microstent for minimally invasive treatment of Fallopian tube occlusions

Obstructions of the Fallopian tube represent one of the most common reasons for an unfulfilled desire to have children. Microstent technology opens up new therapeutic possibilities to restore the natural lumen of the Fallopian tube within a single treatment. Within the current work we developed a self-expandable biodegradable microstent for gynecological applications. Based on a novel microstent design, prototypes were manufactured from poly-L-lactide tubing by means of fs-laser cutting. Microstent prototypes were characterized morphologically by means of scanning electron microscopy and biaxial laser scanning. As manufactured, a microstents outside diameter of about 2.3 mm and a strut thickness / width of about 114 μm / 103 μm was measured. Mechanical characterization of microstents included bending as well as crimping and release behavior. After crimping to a minimum diameter of 0.8 mm and consecutive release, a microstent recovery to a diameter of 1.8 mm was found. Therefore, proof-of-concept for the self-expandable microstent could be successfully provided