US Patent:
20200367868, Nov 26, 2020
Inventors:
Mrinal K. Sanyal - Guilford CT, US
International Classification:
A61B 10/02
G01N 33/574
C12Q 1/6886
Abstract:
This invention provides devices and methods for self-administered noninvasive retrieval of biological materials of the uterus and cervix, and preimplantation stage embryos. The procedure uses a Uterine Device, with a receptacle of variable volume, a controller configured to change the volume of the receptacle cavity, a flexible pouch for generation of suction to facilitate their retrieval, and an Absorption Capsule, which is a surface for collection of the above biological materials. The biological materials retrieved include cells and secretions, directly from the site of pathology, not metabolized or diluted in the body fluids, allow comprehensive analysis of various biomarkers of diseases and disorders of reproduction. Information generated by analyzing these biological materials permits early diagnosis and assessment of prognosis of diseases and disorders of the female reproductive organs, irregularities of pregnancy, anomalies of the fetus in utero, and microbial infections. The preimplantation stage embryos are recovered from normal subjects or those received treatment of gonadotrophins and/or other methods for induction of ovulation or superovulation to improve the yield of ovulated oocytes (ova). Multiple ova released from the ovaries travel through the fallopian tubes, which may be fertilized with sperms made available by artificial or normal insemination (copulation). The fertilized embryos divide and differentiate further into free preimplantation stage embryos at morula- and blastocyst-stages are deposited on the Absorption Capsule. These embryos, retrieved from the Absorption Capsule and may be processed by a variety of methods routinely utilized in the Assisted Reproductive procedures, including, screening for various genomic diseases, karyotype errors of trisomy and other chromosomal anomalies, and deleterious mutations. The screening procedures may involve Preimplantation Genetic Diagnosis (PGD) and Trophectoderm biopsy methods. Normal embryos free of disease potential are transferred to the mothers or surrogates for further in utero development. These procedures allow prevention of human birth defects and pre- and post-natal genomic diseases by selection of disease-free normal embryos for further in utero development, and possible cure of genomic diseases at this stage, in the future.