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The LYKOS Assisted Reproduction Laser with Dynamic Target System (DTS) is intended for in vitro fertilization (IVF) laboratory use in assisted reproduction procedures to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate assisted reproduction hatching procedures and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.

The LYKOS with DTS is comprised of hardware, software and firmware. Hardware components include a laser control unit, communication cable, optional foot pedal, microscope mount(s) and a 40x objective. Fully integrated within the objective is the laser, a rotating mirror frame and motors that rotate the mirror and control the direction of the laser beam. The objective can be mounted on most commercially available inverted microscopes. The laser hardware interfaces with a computer and camera, providing a live image of the objective's field of view on the computer monitor. The system also records images and videos of the laser procedures. The system includes three laser modes: Clinical, Multipulse, and Validation. The Clinical Mode includes laser settings recommended for zona thinning and embryo hatching procedures. The Multipulse Mode allows the use of a series of laser pulses and is intended for trophectoderm biopsy procedures. The Validation Mode is intended to validate the proper operation of the laser including RED-i and laser alignment. Targeting of the laser beam (i.e., either aiming its direction or plotting its ablation path) may be performed in two modes: fixed direction or DTS. In the fixed direction mode of operation, the direction of the beam remains fixed and the embryo is manually guided to the laser by the user. In the DTS Mode, the embryo remains fixed and the direction of the laser is computer-controlled, navigating a user defined plot as drawn on the computer monitor. The system can be programmed to aim and fire the laser anywhere in the field of view or along a user-defined ablation path. In both Manual and DTS modes, because the laser operates in the invisible infrared wavelength (lambda = 1460 mm), to aim and visually verify the position of the laser beam at all times prior to firing, the laser is concentrically aligned with a visible red LED beam (RED-i). Through an automated mapping and verification system using the X-Y coordinates of the computer monitor, the laser can be aimed and an ablation path plotted and verified by the user prior to each use.

GM501 Wash is intended for in vitro procedures involving handling and micromanipulation of human occytes and embryos outside of a CO> incubator. Include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash is not intended for use in transferring embryos into the uterine cavity.

GM501 Wash is a ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside of a CO2 incubator, including washing and micromanipulation procedures. GM501 Wash is aseptically filled into sterilized bottles (20, 50 and 500 ml) and has a six-month shelf-life when stored as recommended. This product can also be used for up to seven days after bottle opening.

This system is intended to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as advanced maternal age, prior failed IVF procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.

There are two configurations offered. The ZILOS-tk has already been cleared [510(k) K063636], and the LYKOS is a new design version. The assembled Infrared Laser Optical System (ZILOS-tk) is the same length as a microscope 40x objective and can be fitted onto the turret of any inverted microscope. In addition a slightly different configuration is offered (Infrared Laser Optical System LYKOS system) in which the laser is integrated within a microscope 40X objective. As with Zilos-tk, it mounts on the turret of any inverted microscope and has the same intended use. The ZILOS-tk and LYKOS are used in the reproductive laboratory for cutting a hatching hole in the zona pellucida (ZP) of embryos. The hole cut in the zona pellucida can be used to extract blastomere(s) for PGD. The devices can also be used to cut a herniated trophectoderm-cell biopsy from the embryo. The devices use an infra-red [IR] laser beam [of wavelength in the range 1450 < A < 1480 nm] to locally heat a small spot on the embryo zona pellucida. The IR beam is projected through the microscope objective in a direction opposite to the image light, so that it focuses on the embryo. The thermal effect of the beam is to liquefy the zona pellucida in a small region surrounding the focal point, and thereby provide access to the embryo itself. The hole drilled in this manner can be used either to aid hatching or for biopsy cell extraction. Weakening or breaking the junction between the trophectoderm cells so that they can be aspirated into the biopsy micropipette is also facilitated by using multiple pulses. Therefore a software change was made to add a multi-pulse mode which will allow for sequential multiple-pulse firing of the laser by a single footswitch press.