This invention increases the mechanical stiffness of biological tissue and may be used for the treatment of cervical insufficiency.
Cervical insufficiency occurs when the cervix softens and dilates without uterine contractions causing it to be too weak to stay closed during pregnancy. This condition leads to premature birth and accounts for 20-25% of second trimester miscarriages. The current treatment for cervical insufficiency is a cervical cerclage, which is a suture placed around the cervix to provide mechanical support. But a cerclage may become displaced or otherwise fail especially in the case of multiple pregnancy. Furthermore, cerclages may be difficult to place and can cause intrauterine infection, utero-placental bleeding, or cervical trauma. This invention is an injectable gel to increase the mechanical stiffness of cervical tissue for the treatment of cervical insufficiency.
In this invention a silk fibroin-based composition may be injected into the cervix using a syringe to increase the mechanical stiffness of the cervical tissue. Upon injection, the composition forms a gel by using at least two functionally-activated PEG components capable of reacting with one another to form a crosslinked matrix, and silk fibroin to form beta-sheets to further stabilize the crosslinked matrix. This method allows the mechanical properties of the gel to be easily modulated by altering the number of beta-sheets. Alternatively, gelation may be achieved with ultrasound or electric fields.
- Non-surgical procedure
risk for infection than cerclage
- Mechanical properties of the gel may be tailored
- Active agents may be incorporated into the gel