UTERINE LAVAGE FOR EMBRYO RETRIEVAL

• US 20140378753A1
• Filed: 06/21/2013
• Published: 12/25/2014
• 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
• Granted Patent: US 9,216,037 B2
• Time in Patent Office: Days
• US Class Current: 600/33
• 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 device for recovering one or more blastocysts from the uterus of a human, comprising:

an outer guide member for insertion into a cervical canal of the human, the outer guide member including a distal portion with an activatable seal for isolating the uterus from the external environment, the outer guide member defining a lumen having a longitudinal axis; and

an inner catheter located within the lumen and slidable along the longitudinal axis of the lumen relative to the outer guide member, the catheter having a distal tip positionable distally of the seal to extend into the uterus, the inner catheter including a fluid delivery lumen terminating at a distal fluid delivery port for delivering fluid into the uterus,

wherein 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 being arranged such that in use fluid delivered from the distal fluid delivery port travels through the distal suction port to the uterus.

2. The device of claim 1, wherein the inner catheter includes a tubular member that surrounds the fluid delivery lumen, the tubular member defining the first distal suction port proximally of the distal fluid delivery port.

3. The device of claim 1, wherein the inner catheter includes an atraumatic tip positioned distally of the fluid delivery port.

4. The device of claim 1, wherein the distal fluid delivery port is non-circular in shape to provide directional control of fluid spray.

5. The device of claim 1, wherein the activatable seal is a balloon collar.

6. The device of claim 1, wherein the activatable seal is an expandable foam.

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

a device, comprising;

an outer guide member for insertion into a cervical canal of the human, the outer guide member including a distal portion with an activatable seal for isolating the uterus from the external environment, the outer guide member defining a lumen having a longitudinal axis; and

an inner catheter located within the lumen and slidable along the longitudinal axis of the lumen relative to the outer guide member, the catheter having a distal tip positionable distally of the seal to extend into the uterus, the inner catheter including a fluid delivery lumen terminating at a distal fluid delivery port for delivering fluid into the uterus;

wherein 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 being arranged such that in use fluid delivered from the distal fluid delivery port travels through the distal suction port to the uterus; and

a controller programmed to cyclically deliver lavage liquid to the uterus via the fluid delivery lumen and apply vacuum to the device from a vacuum source remote from the device.

8. The system of claim 7, wherein the controller includes a pump for delivering the lavage liquid and a pump for applying the vacuum.

9. The system of claim 7, wherein the controller includes electro-mechanical means for controlling the delivery of lavage fluid and the application of vacuum.

10. The system of claim 7, wherein the controller is programmed to cyclically deliver varying amount of lavage liquid.

11. The system of claim 7, further including a lavage fluid bag for supplying the lavage liquid.

12. The system of claim 7, further including an embryo recovery trap for receiving the aspirated fluid and entrained blastocysts.

14. The process of claim 8, wherein placing the device comprises locating the seal in the cervical canal.

15. The process of claim 8, wherein locating the seal comprises locating the seal between the internal cervical os and the external cervical os such that the seal does not extend into the vagina or the uterus.

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

placing a device trans-vaginally into the cervical canal, the device including an outer guide member and an inner catheter located within the outer guide member, the outer guide member including a seal for isolating the uterus from the external environment;

advancing the inner catheter relative to the outer guide member positioning a distal region of the inner catheter within the uterus;

delivering fluid through the inner catheter to the uterus; and

applying a vacuum to the uterus to aspirate fluid and entrained blastocysts from the uterus, wherein a distal fluid delivery port and a 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.

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

placing a device trans-vaginally into the cervical canal; and

cyclically delivering fluid through the device to the uterus and applying a vacuum to the uterus to aspirate fluid and entrained blastocysts from the uterus without introducing air into the uterus, wherein a distal fluid delivery port and a 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.

17. The process of claim 16, wherein cyclically delivering fluid includes increasing the amount of fluid delivered between cycles.