Recovery and processing of human embryos formed in vivo

Abstract

A process for recovering one or more blastocysts from a uterus of a human is disclose which comprises placing a device transvaginally into a cervical canal of the patient; delivering fluid through the device to the uterus and applying a vacuum to the uterus to aspirate fluid and entrained one or more blastocysts from the uterus; and causing a disruption of to the uterus and/or to one or more embryos remaining in the uterus following removal of one or more blastocysts from the uterus to reduce the chance that any such retained embryos remaining in the uterus will form a viable pregnancy, wherein the causing a disruption comprises one or more of the following: inducing a mechanical disruption of the uterus, delivering a hormonal agent to the uterus, delivering a chemical agent to the uterus, inducing a thermal disruption of the uterus, or using ultrasound or radiofrequency energy to induce said disruption. Kits and uterine lavage systems are further provided for performing the processes described in the invention.

What is claimed is: 
     
         1 . A process for recovering one or more blastocysts from a uterus of a human, comprising:
 placing a device transvaginally into a cervical canal of the patient;   delivering fluid through the device to the uterus and applying a vacuum to the uterus to aspirate fluid and entrained one or more blastocysts from the uterus; and   causing a disruption of to the uterus and/or to one or more retained embryos remaining in the uterus following removal of one or more blastocysts from the uterus to reduce the chance that any such retained embryos remaining in the uterus will form a viable pregnancy, wherein said causing a disruption comprises one or more of the following: inducing a mechanical disruption of the uterus, delivering a hormonal agent to the uterus, delivering a chemical agent to the uterus, inducing a thermal disruption of the uterus, or using ultrasound or radiofrequency energy to induce said disruption.   
     
     
         2 . The process of  claim 1 , wherein said causing a disruption comprises delivering a hormonal agent to the uterus comprising a prostaglandin, kisspeptin antagonist, gonadotropin inhibitory hormone (GnIH); a natural steroid such as progesterone, estradiol, testosterone, or cortisol; or an artificial steroid such as medroxy progesterone acetate (MPA). 
     
     
         3 . The process of  claim 2 , wherein said hormonal agent is delivered to the uterus via the device. 
     
     
         4 . The process of  claim 1 , wherein said causing a disruption comprises delivering a chemical agent to the uterus comprising methotrexate, a hypertonic saline solution, potassium chloride, sodium chloride, or hypertonic glucose, or an anti-biotic such as penicillin or clindamycin. 
     
     
         5 . The process of  claim 1 , wherein said causing a disruption comprises delivering a cytotoxic agent to the uterus. 
     
     
         6 . The process of  claim 1 , wherein said causing a disruption comprises delivering a chemotherapeutic agent to the uterus. 
     
     
         7 . The process of  claim 4 , wherein said chemical agent is delivered to the uterus via the device. 
     
     
         8 . The process of  claim 1 , wherein said causing a disruption comprises causing a thermal disruption of the uterus by delivering a heated solution through the device. 
     
     
         9 . The process of  claim 1 , wherein said causing a disruption comprises inducing a mechanical disruption of the uterus by introducing a copper IUD into the uterus. 
     
     
         10 . The process of  claim 1 , wherein said causing a disruption comprises using ultrasound energy in the uterus. 
     
     
         11 . The process of  claim 1 , wherein said causing a disruption comprises using RF energy in the uterus. 
     
     
         12 . The process of  claim 1 , wherein said causing a disruption comprises introducing a chemical or hormonal agent into the uterus by introducing a bioabsorbable rod having the chemical or hormonal agent associated therewith following removal of the device from the uterus. 
     
     
         13 . The process of  claim 1 , further comprising storing recovered one or more blastocysts in a container. 
     
     
         14 . The process of  claim 1 , further comprising diagnosing at least one of the one or more blastocysts. 
     
     
         15 . The process of  claim 13 , further comprising treating at least one of the one or more blastocysts. 
     
     
         16 . The process of  claim 1 , further comprising selecting at least one of the one or more blastocysts for implantation. 
     
     
         17 . The process of  claim 1 , further comprising returning at least one of the one or more blastocyst to the woman's uterus. 
     
     
         18 . The process of  claim 1 , further comprising receiving electronically at a clinic information from a host, the information derived from containers that uniquely identify the one or more blastocysts and associates the one or more blastocysts with respective women, the information including data that tracks transportation and processing of the one or more blastocysts. 
     
     
         19 . The process of  claim 1 , wherein delivering fluid comprises automatically delivering fluid through the device to the uterus and automatically applying a vacuum to the uterus to aspirate fluid and entrained one or more blastocysts from the uterus. 
     
     
         20 . The process of  claim 1 , wherein automatically delivering fluid comprises automatically cyclically delivering fluid through the device to the uterus and automatically applying a vacuum to the uterus includes infusing fluid in periodic pulses and applying a vacuum intermittently. 
     
     
         21 . The process of  claim 20 , wherein the vacuum is applied intermittently to be syncopated to pulsations of the fluid. 
     
     
         22 . The process of  claim 21 , wherein the process avoids delivering fluid and the entrained one or more blastocysts out the Fallopian tubes of the human. 
     
     
         23 . The process of  claim 1 , wherein said causing a disruption comprises causing the disruption to the uterus and/or to any retained embryos prior to said retained embryos implanting into the uterine wall. 
     
     
         24 . The process of  claim 1 , wherein said causing a disruption comprises causing the disruption to the uterus and/or to any retained embryos subsequent to said retained embryos implanting into the uterine wall. 
     
     
         25 . A kit comprising:
 a device that is configured to be transvaginally inserted into a cervical canal of a patient;   instructions for use for using said device in the uterus to perform a lavage procedure to remove one or more blastocysts from the uterus, wherein the instructions for use comprises instructions for cyclically delivering fluid through the device to the uterus and applying a vacuum to the uterus to aspirate fluid and entrained one or more blastocysts from the uterus; and   a copper IUD which is configured to be inserted into the uterus following blastocyst recovery to cause a disruption of the endometrium to reduce the chance that any embryos remaining in the uterus will form a viable pregnancy.   
     
     
         26 . A kit comprising:
 a device that is configured to be transvaginally inserted into a cervical canal of a patient;   instructions for use for using said device in the uterus to perform a lavage procedure to remove one or more blastocysts from the uterus, wherein the instructions for use comprises instructions for cyclically delivering fluid through the device to the uterus and applying a vacuum to the uterus to aspirate fluid and entrained one or more blastocysts from the uterus; and   a bioabsorbable rod which is configured to be inserted into the uterus following blastocyst recovery and which comprises a chemical or hormonal agent in an amount sufficient to cause a disruption of the endometrium of the uterus and/or to one or more retained embryos remaining in the uterus to reduce the chance that any such retained embryos will form a viable pregnancy.   
     
     
         27 . The kit of  claim 26 , wherein bioabsorbable rod comprises a hormonal agent selected from the group comprising a prostaglandin, kisspeptin antagonist, gonadotropin inhibitory hormone (GnIH); a natural steroid such as progesterone, estradiol, testosterone, or cortisol; or an artificial steroid such as medroxy progesterone acetate (MPA). 
     
     
         28 . The kit of  claim 26 , wherein said bioabsorbable rod comprises a chemical agent selected from the group comprising methotrexate, a hypertonic saline solution, potassium chloride, sodium chloride, or hypertonic glucose, or an anti-biotic such as penicillin or clindamycin. 
     
     
         29 . The kit of  claim 26 , wherein said bioabsorbable rod comprises a chemical agent selected from the group comprising a cytotoxic agent or a chemotherapeutic agent. 
     
     
         30 . A uterine lavage system comprising:
 a device that is configured to be transvaginally inserted into a cervical canal of a patient;   a controller for controlling cyclical delivery of fluid through the device to the uterus and for applying a vacuum to the uterus to aspirate fluid and entrained one or more blastocysts from the uterus;   at least a first container comprising a hormonal or chemical agent in an amount sufficient to cause a disruption to the uterus and/or to one or more retained embryos remaining in the uterus following removal of the one or blastocysts from the uterus; and   an in-line heater coupled to the device and to the at least first container for heating the hormonal or chemical agent prior to delivering the agent to the uterus via the device.   
     
     
         31 . The system of  claim 30 , wherein the in-line heater is also fluidly coupled to a source of the fluid which is delivered to the uterus. 
     
     
         32 . A uterine lavage system comprising:
 a fluid delivery and collection device; and   a controller programmed to deliver lavage liquid to the uterus to assist with the recovery of blastocysts from the uterus at a flow of fluid supply that does not exceed a fluid pressure of about 350 mm Hg to substantially limit or prevent leakage of fluid out the fallopian tubes.   
     
     
         33 . The system of  claim 32 , wherein the controller is programmed to control the flow of fluid supply such that it does not exceed a pressure of about 250 mm Hg. 
     
     
         34 . The system of  claim 32 , wherein the controller is programmed to control the flow of fluid supply such that it does not exceed a pressure of about 150 mm Hg. 
     
     
         35 . The system of  claim 34 , wherein the controller is programmed to control the delivery of the fluid through the fluid delivery and collection device into the uterus in a series of pulses at a pre-determined pulse rate. 
     
     
         36 . The system of  claim 35 , wherein the pulse rate has a preset frequency in the range of one pulse per 0.5 to 4 seconds. 
     
     
         37 . A process for recovering one or more cells from the uterus of a human, comprising:
 placing a device transvaginally into the cervical canal; and   delivering fluid to the uterus via the device to assist with the recovery of cells from the uterus at a set fluid flow rate that does not exceed a fluid pressure of about 350 mm Hg to substantially limit or prevent leakage of fluid out the fallopian tubes.   
     
     
         38 . The process of  claim 37 , wherein the set fluid flow rate does not exceed a pressure of about 250 mm Hg. 
     
     
         39 . The process of  claim 37 , wherein the set fluid flow rate does not exceed a pressure of about 150 mm Hg. 
     
     
         40 . The process of  claim 37 , wherein the fluid flow rate does not exceed a pressure of about 50 mm Hg. 
     
     
         41 . The process of  claim 37 , wherein the fluid is heated prior to delivering the fluid to the uterus. 
     
     
         42 . The process of  claim 41 , wherein the fluid is heated with a heater that is positioned distally of a fluid delivery source and fluidly coupled thereto. 
     
     
         43 . The process of  claim 37 , wherein the fluid delivery is controlled by a controller which is programmed to automatically deliver fluid through the device to the uterus and to automatically apply a vacuum to the uterus to aspirate fluid and entrained one or more cells from the uterus. 
     
     
         44 . The process of  claim 37 , wherein the one or more cells comprises one or more blastocysts. 
     
     
         45 . The process of  claim 37 , wherein the one or more cells comprises one or more of endometrial cells, red blood cells, white blood cells, sperm cells, unfertilized oocytes, embryos, fallopian tube cells, and/or ovarian cells. 
     
     
         46 . A process for recovering one or more blastocysts from the uterus of a human, comprising:
 placing a device transvaginally into the cervical canal; and   delivering fluid to the uterus via the device to assist with the recovery of blastocysts from the uterus in a series of at least three or more fluid delivery cycles wherein the total volume of fluid delivered in any one cycle is less than about 5 mL.   
     
     
         47 . The process of  claim 46 , wherein the total volume of fluid delivered in any one cycle is less than about 3 mL. 
     
     
         48 . The process of  claim 46 , wherein the total volume of fluid delivered in any one cycle is less than about 2 mL.