Device for retrieval of ovum

Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation

Reexamination Certificate

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Details

C600S565000

Reexamination Certificate

active

06461302

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to medical devices, and more particularly to a device for retrieval of ovum and its associated follicular fluid.
2. Prior Art
Fertilization outside of the body is a process which offers women who are having difficulty in conceiving a child, a possible means of having a successful pregnancy. Essentially, an ovum or egg is removed from the perspective mother's ovaries at the time of ovulation and is fertilized in a glass dish or test tube with the sperm from a male donor. This process of fertilization has four distinct components: ovarian hyperstimulation; ultrasound “US” guided transvaginal ovum retrieval; actual in vitro fertilization and embryo maturation; and embryo transfer into the intrauterine cavity. In present practice, an ultrasound guided transvaginal ovum retrieval is accomplished by advancing a very long (36 inch) large bore needle through the posterior vagina, the cul-de-sac and into the peritoneal cavity. The proximal end of the needle is affixed with a fluid trap and is connected to a constant linear pressure suction device via a suction tubing. The suction initially “off” on entry into the peritoneal cavity through the cul-de-sac, because of a large volume of peritoneal fluid. The intent of the ovum retrieval is to isolate the follicular fluid and the ovum contained in it, within the fluid trap without spilling the follicular fluid into the peritoneal fluid and without contaminating the secured specimen with the peritoneal fluid. The fluid trap is blanketed with a small amount of IVF media that acts as a cushion to prevent ovum damage when the ovum is suctioned into the hard fluid trap. The current success rate in ovum retrieval is about a 90%. Some physicians will flush the deflated follicle with IVF media to attempt to increase the yields of the ovum retrieval to over 90%. Some physicians will flush the deflated follicle with IVF media in order to attempt to increase the yield of the ovum retrieval to over 90%.
The current practice of the ovum retrieval however, is cumbersome and requires at least four hands: the surgeon's and an assistant's. The mature follicle has a very friable thin wall, under tension by the pressure of the fluid therewithin. Ovum retrieval is usually scheduled 6 to 8 hours before the anticipated normal follicular rupture, or ovulation. When the sharp IVF needle, typical of the prior art, punctures the follicle, the follicular wall will tear and possibly release the ovum into the surrounding peritoneal fluid. Therefore, it is imperative that the puncture of the follicle with the distal tip of the IVF needle be simultaneous with the initiation of suction at the proximal end of the IVF needle. As the surgeon advances the IVF needle to penetrate the follicle, he/she directs the assistant to initiate suction at the fluid trap. When the follicle is completely deflated, he/she instructs the assistant to discontinue the suction. The fluid cap containing the follicular fluid and the ovum from a single follicle is disconnected from the proximal end of the IVF needle and suction source, and passed to the second assistant. All of these steps are completed as the surgeon controls the sharp needle within the patient's peritoneal cavity as well as the ultrasound in the patient's vagina. A new fluid trap is then attached to the IVF needle and suction is applied to retrieve the next ovum from the next mature follicle. It is typical practice to retrieve six to eight ova sequentially without removing the IVF needle from the peritoneal cavity or without removing the ultrasound probe from the patient's vagina.
It is an object of the present invention to obviate the need of multiple assistants for the surgeon to facilitate ovum retrieval.
It is a further object of the present invention, to provide a method and apparatus that will more safely and more efficiently retrieve multiple ova from a patient.
BRIEF SUMMARY OF THE INVENTION
The present invention comprises of an ovum retrieval apparatus as part of a system for the treatment of fertility conditions which includes the withdrawal of a gamete or egg from an ovary. The ovum retrieval device comprises a housing having a manually workable handle disposed off of one side thereof. The housing has an internal chamber with a forward wall. A long bore needle is arranged through the forward wall and has a proximal end within the chamber of the housing. The proximal end of the needle has a sharpened end thereon.
In one preferred embodiment of the present invention, a vacuum cartridge of generally cylindrical configuration is arranged within the chamber of the housing. The vacuum cartridge is arranged to sit on a slide member. The slide member is movable forwardly and rearwardly on a track arranged within the housing. The track is perpendicular with respect to the forward wall of the retrieval device. A trigger is connectively arranged to the slide member, adjacent to the handle, to permit advancement of the slide member and the vacuum cartridge carried thereon, forward or distally toward the proximal end of the long bore needle secured within the forward wall. The vacuum cartridge has a pierceable membrane on its first end to permit the proximal end of the long bore needle to pierce therethrough. The vacuum cartridge has a second end that may, in one embodiment, have a discharge valve, normally closed, therewithin. The discharge valve is adjacent a discharge port which port is in communication with the internal chamber of the vacuum cartridge. A cartridge-receiving notch may be arranged at the forward end of the slide, to snuggly receive and secure the vacuum cartridge therein. A biased pusher arrangement may be disposed between the perimeter of the first end of the vacuum cartridge and the inside edge of the forward wall of the housing retrieval device. The biased arrangement provides a rearward thrust to the slide member and the vacuum cartridge thereon.
The distal end of the long bore needle has a sharpened tip end thereon. An opening is arranged preferably within the sidewall of the needle adjacent to the sharpened tip end. The opening is in communication with a lumen extending the length of the long bore needle.
In a further embodiment of the present invention, the lumen of the long bore needle may have an arrangement of bumps, internal threads or the like to agitate any fluid passing therealong. In yet a further embodiment the needle may have a further therewithin for the carrying of an ultrasound probe, of the ultrasound probe may be slidably attached to the outerside of the needle shaft, to assist in the guidance and proper placement of the needle tip. In yet a still further preferred embodiment of the present invention, a pressurized rinse-fluid reservoir is arranged in communication with the needle tip, through a further lumen extending therethrough.
In operation of the present invention, the surgeon would pull the trigger on the housing so as to effect a forward motion to the slide member by a lever arranged between the trigger and that slide member. The forward motion of the slide member would effect a piercing of the membrane at the first end of the vacuum cartridge by the proximal end of the long bore needle. As the vacuum cartridge is being pierced, and a vacuum is being applied to the lumen of the long bore needle, the surgeon advances the sharp distal end, into a follicle to penetrate that follicle. The suction created by the piercable vacuum chamber would be non-linear and diminish during the process of the operation. This non-linear suction drawn procedure favors the capture of the ovum as the lumen of the long bore needle fills with follicular fluid, and the negative pressure becomes less within this system. The nonlinear suction may be used to separate the ovum and firmly attended cumulus from other cellular debris. The internal bumps or threads or a cochlear arrangement on the internal surface of the lumen may also be used to agitate the follicle fluid as it enters the ovum, so as to break u

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