Methods for Treatment of Cervical Insufficiency

Technology #15219

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Stress-strain graph showing the mechanical performance of different silk fibroin-PEG gels subjected to uniaxial compression. In some embodiments, the silk fibroin-PEG gels comprised S wt% silk fibroin and either 10 wt% or S wt% of total PEG. The stress-strain graph indicates that higher percents of PEG and/or post-treatment with alcohol such as ethanol (EtOH) yield a stiffer gel (indicated by a higher elastic modulus E). Stress-strain graph showing the mechanical performance of a cervical tissue injected with a silk fibroin-based composition comprising 10 wt% PEG, when the injected tissue was subjected to uniaxial compression. The stress-strain graph indicates that the cervical tissue injected with one embodiment of the silk fibroin-based composition described herein is stiffer than the untreated one (e.g., native cervical tissue). Quantitative results of the swelling behavior of the cervical tissues injected with silk fibroin-based compositions comprising at least about 10 wt% silk fibroin. When the cervical tissue was injected with one or more embodiments of the silk fibroin-based composition comprising PEG, they demonstrated in PBS comparable swelling behavior as the native cervical tissue. The swelling property was determined by weight (e.g., percent in mass, in mg).
Categories
Inventors
Simona Socrate
Institute for Soldier Nanotechnologies, MIT
External Link (www.edx.org)
Professor Errol Norwitz
School of Medicine, Tufts Univeristy
Professor David Kaplan
Department of Biomedical Engineering, Tufts University
External Link (engineering.tufts.edu)
Professor Michael House
School of Medicine, Tufts Univeristy
Managed By
Jon Gilbert
MIT Technology Licensing Officer
Patent Protection

Methods for treatment of cervical insufficiency

US Patent Pending 2015-0064155

Applications

This invention increases the mechanical stiffness of biological tissue and may be used for the treatment of cervical insufficiency.

Problem Addressed

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.

Technology

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.

Advantages

  • Non-surgical procedure
  • Lower risk for infection than cerclage
  • Mechanical properties of the gel may be tailored
  • Active agents may be incorporated into the gel