Recovery and processing of human embryos formed in vivo

• US 9,282,995 B2
• Filed: 12/22/2011
• Issued: 03/15/2016
• Est. Priority Date: 12/22/2011
• Status: Active Grant

• Current Assignee: Butterfly Biosciences Incorporated
• Original Assignee: Previvo Genetics, LLC
• Inventors: Carson, Sandra Ann, Buster, John E.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US13/335,170
• Publication Number:
  US 20130165744A1
• Time in Patent Office: 1,545 Days
• Field of Search: 600 33- 35, 604/27, 604/35, 604/36, 604 39- 43, 604/93.01
• 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 2017/00154 pulsed
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/567 substituted in position 17 alpha, e.g. mestranol, norethandrolone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: A61K 38/09 Luteinising hormone-releasing hormone [LHRH] , i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 2210/1433 Uterus
• CPC Class Codes: A61M 2210/145 Embryo, fetus
• CPC Class Codes: A61M 3/0283 with at least two inner passageways, a first one for irrigating and a second for evacuating suction-irrigation systems A61M1/77; aspiration tips with fluid supply means A61M1/85; for negative pressure wound therapy A61M1/92
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61P 15/04 for inducing labour or abortion; Uterotonics
• CPC Class Codes: C12N 5/0604 : Whole embryos; Culture medium therefor
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records

Abstract

Among other things, uterine lavage is performed to withdraw at least 50% of in vivo fertilized preimplantation embryos produced after superovulation of a woman and artificial insemination using sperm of her sexual partner. After genetic diagnosis or sex determination or gene therapy, or any combination of any two or more of them, of the recovered embryos and selection of at least one of the embryos to be implanted, the selected embryos are returned to the woman for implantation in her uterus.

Claims

1. A system for recovering one or more blastocysts from a 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 a seal for isolating the uterus from an 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 inner 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; and

a controller programmed to automatically deliver lavage liquid to the uterus via the fluid delivery lumen and programmed to automatically apply vacuum to the device from a vacuum source remote from the device, the controller programmed to apply intermittent vacuum in between each pulse of lavage liquid at a preset frequency.

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

3. The system of claim 1, wherein the controller is programmed to infuse lavage liquid in periodic pulses having a preset frequency in the range of one pulse per 0.5 to 4 seconds.

4. A system for recovering one or more blastocysts from a 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 a seal for isolating the uterus from an 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 inner 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, and

wherein the system is programmed to automatically deliver lavage liquid to the uterus via the fluid delivery lumen and programmed to automatically apply vacuum to the device from a vacuum source remote from the device, the system programmed to apply intermittent vacuum in between each pulse of lavage liquid at a preset frequency.

5. The system of claim 4, wherein the system is programmed to infuse lavage liquid in periodic pulses at a preset frequency in the range of one pulse per 0.5 to 4 seconds.

6. A uterine lavage system comprising:

a fluid delivery and collection device that is configured to recover one or more blastocysts from a uterus of a patient; and

a controller programmed to automatically deliver lavage liquid to the uterus via the fluid delivery and collection device and programmed to automatically apply vacuum to said device from a vacuum source remote from the device, the controller programmed to apply intermittent vacuum in between each pulse of lavage liquid at a preset frequency.

7. The system of claim 6, wherein the system is programmed to infuse lavage liquid in periodic pulses at a preset frequency in the range of one pulse per 0.5 to 4 seconds.

8. A device for recovering one or more blastocysts from a 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 a seal for isolating the uterus from an external environment and a cervical stop adjustably mounted on the outer guide member relative to the seal for positioning against an external cervical os, the outer guide member defining a lumen having a longitudinal axis;

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 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; and

a second catheter located within the lumen of the outer guide member and slidable along the longitudinal axis of the lumen relative to the outer guide member, the second catheter having a distal tip positionable distally of the seal to extend into the uterus, the second 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,

wherein the inner catheter and the second catheter have corresponding coupling elements at their distal ends, and

wherein the coupling elements are magnetic.

9. A uterine lavage system comprising:

a fluid delivery and collection device that is configured to recover one or more blastocysts from a uterus of a patient; and

a controller programmed to cyclically deliver lavage liquid to the uterus via the fluid delivery and collection device and apply vacuum to said device from a vacuum source remote from the device, wherein the system is programmed to infuse lavage liquid in periodic pulses at a preset frequency in the range of one pulse per 0.5 to 4 seconds and to apply intermittent vacuum in between each pulse of lavage liquid.