Uterine lavage for embryo retrieval

• US 9,498,252 B2
• Filed: 09/18/2015
• Issued: 11/22/2016
• Est. Priority Date: 06/21/2013
• Status: Active Grant

• Current Assignee: Butterfly Biosciences Incorporated
• Original Assignee: Previvo Genetics, LLC
• Inventors: Buster, John E., Cesario, Moses, Woodard, Steven Paul
• Primary Examiner(s): Matthews, Christine H
• Application Number:
  US14/858,145
• Publication Number:
  US 20160008030A1
• Time in Patent Office: 431 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 17/435 for embryo or ova transplantation
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2050/185 Drawers
• CPC Class Codes: A61B 2050/311 Cases
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts

Abstract

A device for recovering one or more blastocysts from the uterus of a human includes an outer guide member for insertion into a cervical canal of the human. The outer guide member includes a distal portion with an activatable seal for isolating the uterus from the external environment and defines a lumen having a longitudinal axis. The device also includes an inner catheter located within the lumen and slidable along the longitudinal axis of the lumen relative to the outer guide member. The inner catheter has a distal tip positionable distally of the seal to extend into the uterus and includes a fluid delivery lumen terminating at a distal fluid delivery port for delivering fluid into the uterus. The device defines a distal suction port for aspirating fluid and entrained blastocysts from the uterus. The distal fluid delivery port and the distal suction port are arranged such that, in use, fluid delivered from the distal fluid delivery port travels through the distal suction port to the uterus.

Claims

1. A system for recovering one or more blastocysts from the uterus of a human, comprising:

a uterine lavage device which is configured to be trans-vaginally inserted into the cervical canal;

a controller programmed to cyclically deliver fluid through the lavage device to the uterus in at least two cycles, wherein the controller is programmed to deliver, in a first cycle of the at least two cycles, a first amount of fluid to form a first puddle encompassing one or more blastocysts and to apply a vacuum to the device to aspirate fluid and entrained blastocysts within the first puddle from the uterus, and, in a second cycle of the at least two cycles, to deliver a larger amount of fluid into the uterus to form a second, larger puddle and to apply a vacuum to the device to aspirate fluid from the uterus; and

further comprising a pharmaceutically acceptable container comprising a GnRH antagonist in an amount sufficient to cause desynchronization of the endometrium to reduce a chance that any embryos remaining in the uterus will form a viable pregnancy.

2. The system of claim 1, wherein the controller is programmed to automatically cyclically deliver lavage liquid to the uterus via the device and automatically apply vacuum to the device from a vacuum source remote from the device.

3. The system of claim 1, wherein the controller includes a pump for delivering lavage liquid and a pump for applying the vacuum.

4. The system of claim 3, wherein the controller includes electro-mechanical means for controlling the delivery of the lavage fluid and the application of vacuum.

5. The system of claim 1, wherein the controller is programmed to cyclically deliver varying amounts of lavage liquid to the uterus via the device in three or more cycles with the amount of liquid delivered increasing in each subsequent cycle.

6. The system of claim 1, further comprising a container for storing the one or more recovered blastocysts.

7. The system of claim 6, wherein the container is configured to uniquely identify the one or more blastocysts and associate the one or more blastocysts with the human, and include data that tracks transportation and processing of the one or more blastocysts.

8. The system of claim 1, wherein the container comprising the GnRH antagonist comprises doses ranging from 0.25 to 3.0 mg.

9. The system of claim 1, further including a lavage fluid bag for supplying lavage fluid.

10. The system of claim 1, further including an embryo recovery trap for receiving the aspirated fluid and entrained blastocysts.

11. A system for recovering one or more blastocysts from the uterus of a human, comprising:

a uterine lavage device which is configured to be trans-vaginally inserted into the cervical canal;

a controller programmed to cyclically deliver fluid through the lavage device to the uterus in at least two cycles, wherein the controller is programmed to deliver, in a first cycle of the at least two cycles, a first amount of fluid to form a first puddle encompassing one or more blastocysts and to apply a vacuum to the device to aspirate fluid and entrained blastocysts within the first puddle from the uterus, and, in a second cycle of the at least two cycles, to deliver a larger amount of fluid into the uterus to form a second, larger puddle and to apply a vacuum to the device to aspirate fluid from the uterus; and

further comprising a pharmaceutically acceptable container comprising a composition in an amount sufficient to cause desynchronization of the endometrium to reduce a chance that any embryos remaining in the uterus will form a viable pregnancy.