Recovery and processing of human embryos formed in vivo

Inventors

CARSON, Sandra Ann • Buster, John E. • Cesario, Moses • Woodard, Steven Paul

Assignees

Butterfly Biosciences Inc

Abstract

A kit having instructions for use for performing uterine lavage in a female patient includes a uterine lavage catheter configured for insertion into a woman's uterus to remove viable blastocysts from the uterus, and one or more first containers having a sufficient dosage amount of a GnRH antagonist to cause desynchronization of the endometrium of the patient prior to, during and/or following recovery of viable blastocysts from the uterus.

Core Innovation

The invention relates to uterine lavage in vivo for removing blastocysts from a woman’s uterus, using a uterine lavage catheter configured for insertion into the uterus. The approach includes administration of a GnRH antagonist with a sufficient dosage amount to cause corpus luteum apoptosis, which leads to desynchronization of the endometrium of the uterus. This coordinated uterine desynchronization is used in connection with recovery of viable blastocysts from the uterus.

The disclosed system further includes kit components for handling collected lavage fluid and recovered embryos, including one or more containers such as a cell-culture container for collecting lavage fluid and/or a cell transport vial for transport of lavage fluid containing one or more blastocysts to a laboratory. The document also describes that molecular genetic diagnosis and related embryo biopsy and subsequent genetic or other therapeutic intervention can be performed on embryos recovered following uterine lavage.

In some embodiments, the kit includes a lavage controller to control delivery of pressure and application of vacuum to the lavage catheter, and/or a programmable lavage controller for automatically controlling delivery of pressure and application of vacuum to the lavage catheter. Additional kit concepts described include support for endometrial desynchronization and timing relative to blastocyst recovery, with device concepts aimed at directing lavage flow and avoiding flow into the fallopian tubes, along with controller-controlled pulsatile pressure/vacuum lavage using a seal between the uterus and an external environment.

Claims Coverage

The independent claims describe a uterine lavage kit that combines a uterine lavage catheter, a GnRH antagonist arranged to cause corpus luteum apoptosis and endometrial desynchronization, and optional collection, transport, and controller-based pressure and vacuum delivery features. Across the independent set, there are five main inventive feature groupings covering the core kit composition and selected system augmentations.

Across the independent claims, the core kit combines a uterine lavage catheter with one or more containers containing a sufficient dosage amount of a GnRH antagonist configured to cause corpus luteum apoptosis and thereby desynchronize the endometrium. The claims further cover optional inclusion of cell-culture and transport containers for lavage fluid or blastocysts and controller features that control or automatically control delivery of pressure and application of vacuum to the lavage catheter.

Stated Advantages

Documented Applications

No documented applications found