An ultrasound and needle guide apparatus for animal oocyte collection

Abstract

An apparatus for targeting an ovarian follicle and collecting one or more oocytes from an ovary in an animal. The apparatus includes an ultrasound transducer having a transducer head and a transducer body, a needle guide having a needle guide body containing a needle channel, and a housing arranged to position and hold the needle guide and the transducer body with respect to each other. The housing includes a needle guide pass-through channel and a transducer body pass-through channel. The ultrasound transducer is arranged to align a needle with a target follicle to collect one or more oocytes from the target follicle.

Description

Docket No. 069296.11216-35WO1 PatentAN ULTRASOUND AND NEEDLE GUIDE APPARATUS FOR ANIMAL OOCYTE COLLECTION CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Application No. 63 / 779,500, entitled “Ultrasound and Needle Guide Apparatus for Animal Oocyte Collection,” filed March 28, 2025. the disclosure of which is hereby incorporated by reference in its entirety.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates generally to a method, system, and device for oocyte retrieval, and, more particularly, a method, a system, and a device for collecting oocytes from animals.BACKGROUND OF THE DISCLOSURE

[0003] State of the art oocy te cell retrieval (OCR) technologies commonly use an ultrasound device to guide a specialized needle to locate and aspirate an oocyte from a follicle within an ovary. This is commonly performed during in vitro fertilization (IVF) treatment procedures in which the ultrasound device is used to provide real-time imaging of the ovary7to precisely target the follicle and collect an oocyte using the needle.

[0004] International Publication No. WO 2024 / 009796 Al, entitled “Swine Egg Collection Method and Fertilized Swine Egg Product Method,” describes a method for non-invasively collecting multiple eggs from living pigs. The method includes, among other things, confirming the position of an ovary and the condition of the follicles within the ovary from outside the body using an ultrasound diagnostic device. Once a target follicle is identified, a specialized needle is injected into the pig — for example, between the inguinal region and the navel — and one or more eggs collected.

[0005] U.S. Patent No. 6,296,614 Bl, entitled “Needle Guide for Attachment to Ultrasound Transduce Probe,” describes a versatile needle guide for attachment to an ultrasound transducer probe. The needle guide includes an open topped vertical passageway formed between a base member and a gauge top that is hingedly mounted to the base member. A spring urges a grooved face on the gauge top into abutment with a flat face on the base member. The gauge top can pivot about the hinge mounting to separate the grooved face from the flat face to open the side of the passageway to allow a needle to be removed from the needle guide. The gauge top can be disassembled from the base for interchange with another gauge top having a different size of groove.4926-9582-5308 1 1Docket No. 069296.11216-35WO1 Patent

[0006] U.S. Patent No. 6,475,152 Bl, entitled “Biopsy Needle Guide for Attachment to an Ultrasound Transducer,” describes a biopsy needle guide arranged in two sections, including an inner attachment block and an outer attachment block. The inner attachment block includes (i) a coupler which attaches the inner attachment block to the ultrasound transducer and (ii) a first engagement structure which extends from a surface thereof. The outer attachment block includes a biopsy needle guide through hole and a second engagement structure. The second engagement structure releasably mates with the first engagement structure even when the inner attachment block is covered by a sterile film sheath.

[0007] U.S. Patent Application Publication No. 2007 / 0167808 Al, entitled “Ultrasound Probe for Paracentesis and Ultrasound Diagnostic Apparatus,” describes an ultrasound probe for paracentesis with a biopsy needle attached to a probe body that permits an operator to insert the biopsy needle into an exact position of a patient. The ultrasound probe includes a probe body and a biopsy needle attached to the probe body, wherein the center of an acoustic elements array provided in the probe body is offset toward the biopsy needle attached to the probe body with respect to a central vertical line of the probe body.

[0008] Currently available OCR technologies, however, are designed for humans or farm animals such as cows, horses, and pigs, and are not suitable for other types of animals, such as, for example, ory x, eland, roan antelope, or various species of Canidae, Felidae, Metatheria, Crocodylus, Loxodonta, to name a few. Similarly, existing OCR technologies are not adapted for operation with only one hand, which is necessary at times to enable the operator to use the other hand to manipulate the position of the target ovary.SUMMARY OF THE DISCLOSURE

[0009] The inventors have discovered that state of the art technologies for oocyte retrieval are unsuitable for animals other than humans or traditional farm animals such as cows, horses, or pigs. For instance, the inventors have discovered that the unique size and procedure in certain animals such as, for example, but not limited to, ory x, eland, and roan antelope, or various species of Canidae, Felidae, Metatheria, Crocodylus, Loxodonta, to name a few, requires a device having a minimized profile, a specific length, and a removable and washable housing.

[0010] In various embodiments an apparatus is provided for targeting an ovarian follicle and collecting one or more oocytes from an ovary in an animal. The apparatus comprises: an ultrasound transducer having a transducer head and a transducer body; a needle guide having aneedle guide body containing a needle channel; and ahousing configured to position andhold4926-9582-5308 1 2Docket No. 069296.11216-35WO1 Patentthe needle guide and the transducer body with respect to each other. The housing includes a needle guide pass-through channel and a transducer body pass-through channel. The ultrasound transducer can be arranged to align a needle with a target follicle to collect one or more oocytes from the target follicle.

[0011] At least one of the needle guide and the housing can be: made of a material comprising a polymer; made of a material that is compatible with a disinfectant, a disinfection process, or a sterilization process; coated with an antimicrobial material; and / or made of a material compatible with a coating comprising a disinfectant or an antimicrobial material. The antimicrobial material can include stainless steel.

[0012] In an embodiment the housing comprises an anterior housing portion and a pair of side body housing portions. The pair of side housing portions can clamp together to form the needle guide pass-through channel and the transducer body pass-through channel. The housing can include at least one of an articulated needle guide attachment (ANGA) device and a needle guide attachment (NGA) device. The articulated needle guide attachment (ANGA) device can include a dorsal ANGA member that includes the needle guide pass-through channel and forms a portion of the transducer body pass-through channel.

[0013] The articulated needle guide attachment (ANGA) device can include a ventral ANGA member that forms a portion of the transducer body pass-through channel. The articulated needle guide attachment (ANGA) device can include at least one gate that forms a portion of the transducer body pass-through channel. The at least one gate can include a latch portion that attaches to the dorsal ANGA member and a pivot portion that attaches to the ventral ANGA member. The needle guide attachment (NGA) device can include at least one hinge that attaches the pivot portion to the dorsal NGA member, wherein the hinge is configured to allow the gate to swing about the hinge. The dorsal ANGA member, the ventral ANGA member, and the at least one gate can assemble to form a contiguous wall that forms the transducer body pass-through channel.

[0014] In certain embodiments the needle guide attachment (NGA) device can include: a dorsal NGA member that includes the needle guide pass-through channel and forms a portion of the transducer body pass-through channel; or a ventral NGA member that forms a portion of the transducer body pass-through channel. The dorsal NGA member and the ventral NGA member can assemble to form a contiguous wall that forms the transducer body pass-through channel.

[0015] The animal can be an oryx, an eland, or a roan antelope. The apparatus can be sized and configured for vaginal insertion in the oryx, the eland, or the roan antelope.4926-9582-5308 1 3Docket No. 069296.11216-35WO1 Patent

[0016] In various embodiments, at least one of the ultrasound transducer and the needle guide can be removable from the apparatus.

[0017] The apparatus can include a needle arranged for installation in the needle guide, wherein the needle slides in, and is supported by, the needle channel.

[0018] The apparatus can include an aspirator that connects to the needle to retrieve fluid and an oocyte from a follicle.

[0019] The transducer head has an ultrasound field of view and the ultrasound transducer and the needle channel are arranged to position to position the needle in the ultrasound field of view. A distance between an axial centerline of the transducer head and an axial centerline of the needle guide is minimal. In various embodiments the distance is less than 0.20 mm, preferably less than 0.10mm, and most preferably 0. The axial centerline of the needle guide can be arranged at angle with respect to the axial center line of the transducer head such that the needle tip is proximate to the axial centerline of the transducer head when collecting an oocyte.

[0020] The apparatus can be constructed to have any suitable diameter, including, for example, a diameter between 20 mm and 60 mm, and preferably 25 mm and 33 mm. The diameter can be a radial diameter.

[0021] The housing can be constructed by three-dimensional (3D) printer. The housing can be made of a material comprising at least one of: a 3D printed material; a molded polymer material; a polyurethane material; a silicone material; a biocompatible polymer material; and a metal. The biocompatible polymer material can be PEEK, PEKK, PMMA, or PC.

[0022] At least a portion of the apparatus can be coated or treated to be more lubricious and / or at least as portion of the apparatus can be treated with a sterilization process or an antimicrobial agent or coating. The sterilization process can include EtO, gamma, or HPV.

[0023] In an embodiment the apparatus includes a v-shaped feature attached to, integrally formed with, or located proximate to, an opening in the needle guide and arranged to stabilize a local position of an ovary with respect to the needle guide to prevent movement of the ovary during insertion of the needle and oocyte collection.

[0024] According to another aspect of the disclosure a method is provided for collecting one or more oocytes with the apparatus described above. The method includes inserting an anterior end of the apparatus vaginally into the animal; rectally manipulating the ovary to a vaginal wall; visualizing the ovary on a display screen; while holding the ovary in place, aligning the needle channel with a follicle; inserting an aspiration needle into the follicle; and collecting an oocyte from the follicle.4926-9582-5308 1 4Docket No. 069296.11216-35WO1 Patent

[0025] According to a further aspect of the disclosure a kit is provided for targeting an ovarian follicle and collecting one or more oocytes from an ovary in an animal. The kit comprises at least one needle guide and at least one housing for use with an ultrasound transducer. The kit further includes a needle guide having a needle guide body that contains a needle channel; and a housing configured to attach the needle guide to the ultrasound transducer. The housing includes a needle guide pass-through channel and a transducer body pass-through channel. The kit can include at least one needle arranged for installation in the needle guide. The needle can be configured to slide in, and be supported by, the needle channel. The kit can include an aspirator that connects to the needle to retrieve fluid and an oocyte from a follicle.

[0026] Additional features, advantages, and embodiments of the disclosure may be set forth or apparent from consideration of the detailed description and drawings. Moreover, it is to be understood that the foregoing summary of the disclosure and the following detailed description and drawings provide non-limiting examples that are intended to provide further explanation without limiting the scope of the disclosure as claimed.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings, which are included to provide a further understanding of the disclosure, are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the detailed description serve to explain the principles of the disclosure. No attempt is made to show structural details of the disclosure in more detail than may be necessary for a fundamental understanding of the disclosure and the various ways in which it may be practiced.

[0028] FIG. 1 shows a partial view of a nonlimiting embodiment of an ovum pickup (OPU) device constructed according to the principles of the disclosure.

[0029] FIG. 2 shows a proximal end view of the OPU device of FIG. 1.

[0030] FIG. 3 shows a nonlimiting embodiment of an articulated needle guide attachment (ANGA) device constructed according to the principles of the disclosure. The ANGA device can be included in the OPU device of FIG. 1.

[0031] FIGS. 4A - 4D show various views of another nonlimiting embodiment of the ovum pickup (OPU) device, according to the principles of the disclosure.

[0032] FIG. 5 shows a perspective view of the OPU device of FIGS. 4A - 4D.

[0033] FIG. 6 shows an exploded view of the OPU device of FIGS. 4A - 4D and 5.4926-9582-5308 1 5Docket No. 069296.11216-35WO1 Patent

[0034] FIG. 7 shows a view of the OPU device of FIGS. 4A-4D and 5 connected to a connector interface.

[0035] FIG. 8 shows a side view of a nonlimiting embodiment of the OPU device that can be used for oocyte extraction in scimitar homed oryx or similar animals, according to the principles of the disclosure.

[0036] FIG. 9 shows a nonlimiting embodiment of an oocyte collection kit comprising the OPU device of FIG. 8, constructed according to the principles of the disclosure.

[0037] FIG. 10 shows another nonlimiting embodiment of the OPU device, constructed according to the principles of the disclosure.

[0038] FIG. 11 shows a further nonlimiting embodiment of the OPU device, constructed according to the principles of the disclosure.

[0039] The present disclosure is further described in the detailed description that follows.DETAILED DESCRIPTION OF THE DISCLOSURE

[0040] The disclosure and its various features and advantageous details are explained more fully with reference to the non-limiting embodiments and examples that are described or illustrated in the accompanying drawings and detailed in the following description. It should be noted that features illustrated in the drawings are not necessarily drawn to scale, and features of one embodiment can be employed with other embodiments as those skilled in the art would recognize, even if not explicitly stated. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments of the disclosure. The examples are intended merely to facilitate an understanding of ways in which the disclosure can be practiced and to further enable those skilled in the art to practice the embodiments of the disclosure. Accordingly, the examples and embodiments should not be construed as limiting the scope of the disclosure. Moreover, it is noted that like reference numerals represent similar parts throughout the several views of the drawings.

[0041] The present disclosure provides a technological solution for oocyte collection in various species of animals not possible or practical before. The technological solution includes one or more embodiments of an ovum pickup (OPU) device for oocyte collection in various animals, such as, for example, scimitar- homed oryx (Oryx dammah), various antelope species (for example, eland and roan antelope), including rare antelope species, or various species of Canidae, Felidae. Metatheria, Crocodylus. Loxodonta, to name a few. The OPU device includes a needle guide, an ultrasound transducer, and a housing. The OPU device can4926-9582-5308 1 6Docket No. 069296.11216-35WO1 Patentinclude a needle or, in various embodiments, can be used with a needle provided separately. The OPU device can be configured for use in a particular target animal.

[0042] The present disclosure provides various nonlimiting OPU device configurations, including at least one configuration designed for use in a scimitar-homed oryx, another configuration designed for use in eland or roan antelope, and another configured designed for use in Loxodonta. In certain embodiments the OPU device housing, needle guide, and / or needle can be made of a material that is compatible with disinfection or stenlization, or that is compatible with a coating of a disinfectant or antimicrobial material. In some embodiments the OPU device housing, needle guide, and / or needle can be made, for example, at least in part, of an antimicrobial material such as, for example, stainless steel, copper, gold, silver or other material having antimicrobial properties. At minimum, the distal end of the needle that contacts the oocyte collection site should be made a of a material that does not in any way impact reproduction. For instance, the needle tip should not be made of a material such as, for example, copper or other material that has metal ions or other properties that might affect reproduction. In certain embodiments in which components of the OPU device are made of one or more polymer materials, antimicrobial treatments or coatings can be applied to polymer surfaces.

[0043] In various embodiments of the OPU device, the ultrasound transducer can include a transvaginal ultrasound transducer or an endocavity ultrasound transducer. The transvaginal ultrasound transducer can include, for example, an E.I. Medical Imaging EVO C6E / C9E probe, a GE 8C-RS Micro-convex probe, an iScan2 probe, a Sonosite ICTx probe, an Esaote SE3133 probe, a GE Healthcare E8C probe, a Phillips C10-3v probe, a BK Medical 8848 probe, or other transvaginal ultrasound transducer suitable for targeting follicle for oocyte collection. In certain embodiments the endocavity ultrasound transducer can include, for example, a VI 1-3Ws Endocavity probe, a microconvex probe (for example. Cl l-3s Micro-Convex Array Probe), a BK Medical E10C4 probe, a GE Healthcare E8C probe, a Phillips C10-3v probe, an Esaote SE3133 probe, or other endocavity ultrasound transducer suitable for targeting follicle for oocyte collection.

[0044] In various embodiments the OPU device is designed and adapted for a single user. The OPU device is arranged to align a needle in the ultrasound path of the ultrasound transducer for follicle targeting and oocyte collection. The OPU device is arranged to facilitate finding, constraining, and aligning a target follicle with the needle so that the needle can collect one or more oocytes. One or more parts of the OPU device, including, for example, the needle, can be coated with a lubricious material to help the needle glide smoothly through ovarian tissue,4926-9582-5308 1 7Docket No. 069296.11216-35WO1 Patentminimizing trauma and discomfort for the animal. The lubricious material can include, for example, silicone, polytetrafluoroethylene, or hydrophilic coating materials. The OPU device can be placed in a thin plastic sterile sheath prior to insertion into the animal. The sheet can be disposable. The OPU device can be made of rigid materials arranged to have a reduced or minimal profile. In certain embodiments, the OPU device can be configured such that the ultrasound transducer can be replaced with commercially available ultrasound transducer probes.

[0045] In at least one embodiment, the OPU device can be provided as a part of a system that includes an articulated arm for larger animals to facilitate follicle alignment and aspiration.

[0046] FIGS. 1 and 2 show, respectively, a partial side view and an anterior view of a nonlimiting embodiment of an ovum (or oocyte) pickup (OPU) device 1 constructed according to the principles of the disclosure. In various embodiments the OPU device 1 includes an ultrasound transducer 10, a needle guide 20, and one or more of an articulated needle guide attachment (ANGA) device 30 and / or a needle guide attachment (NGA) device 40. The OPU device 1 can include a needle, or the needle can be provided separately and installed in the OPU device 1 (for example, in the needle guide 20) before use.

[0047] In various embodiments the ultrasound transducer 10 includes a transducer head 11 , a transducer body 15 having a longitudinal axis 16, and an electronic connector 18 (shown in FIG. 5). In some embodiments the ultrasound transducer 10 can include, for example, an endocavity probe such as VI l-3Ws Endocavity Probe or a microconvex probe such as Cl 1-3 s Micro-Convex Array Probe. The ultrasound transducer 10 can be connected to electronics equipment such as a display (not shown) and a computer (not shown) via the electronic connector 18. In at least one embodiment the transducer 15 includes all electronic components (not shown) for powering, operating, and controlling the transducer 10, including generation and emission of ultrasound waves and reception of reflected ultrasound waves for generating a detailed ultrasound image of a field of view of the transducer head 11 at the anterior end of the ultrasound transducer 10.

[0048] The transducer head 11 can be configured to emit high-frequency ultrasound waves and receive reflected waves to create a detailed image of a follicle on an ovary for oocyte retrieval. The ultrasound head 11 can be configured to emit ultrasound waves having a frequency of, for example, between 2 MHz and 8MHz. The ultrasound image can be used to precisely locate and guide the OPU device 1 to the desired follicle so that an aspiration needle (not shown) can be supported and guided by the needle guide 20 to collect one or more oocytes.4926-9582-5308 1 8Docket No. 069296.11216-35WO1 Patent

[0049] The needle guide 20 has a needle guide body 25 that includes a channel 23 (shown in FIG. 2) along its entire length. The channel 23 can be formed by the inner walls of the needle guide body 25. The channel 23 has a diameter that is greater than a diameter of the aspiration needle (not shown) so that the needle can be inserted in and travel through to the length of the channel 23 as the walls of the channel 23 support and guide an anterior end of the aspiration needle (not shown) to the oocyte retrieval location. The needle guide body 25 and / or the walls that forms the channel 23 can be made of, or coated with, an antimicrobial material such as, for example, stainless steel, copper, silver, gold, or other material having antimicrobial properties.

[0050] The ANGA device 30 and the NGA device 40 can each be configured to position and support the needle guide 20 in a predetermined fixed location proximate to the transducer body 15. The ANGA device 30 and the NGA device 40 can be configured to fasten and secure the needle guide 20 to the transducer body 15 such that the longitudinal axis 26 of the needle guide 20 (including the internal channel 23) is parallel to the longitudinal axis 16 of the transducer body 15. The ANGA device 30 and the NGA device 40 can each be configured to position the channel 23 with respect to the transducer body 15 such that the channel opening 21 at the anterior end of the channel 23 is located at a distance d from a nearest point on the transducer head 11 so that the anterior (or collection) end of the aspiration needle (not shown) can exit the channel 23 at the channel opening 21 and pass the transducer head 11 unobstructed to collect one or more oocyte from the target follicle(s).

[0051] In various embodiments the distance d can be 0 or another value between, for example, from 0 mm to about 20.0 mm, or more. In an embodiment, the OPU device can be configured such that the channel 23 is located in the middle of the transducer head 11 and configured such that the center of the channel 23 is the center of the transducer head 11. The predictability of the needle's location is important. In at least one embodiment the transducer head 11 and channel 23 are arranged such that the user can see the needle enter the image field of view at the same instant it exits the opening 21.

[0052] FIG. 3 shows a nonlimiting embodiment of the ANGA device 30 constructed according to the principles of the disclosure. Referring to FIGS. 1 and 3 contemporaneously, the ANGA device 30 includes a dorsal (or upper) NGA member 31, a ventral (or lower) NGA member 32, and a pair of gates 33, which when assembled form a transducer channel body 38 (shown in FIG. 1) that attaches to and holds to the transducer body 15. Each of the dorsal member 31, the ventral member 32, and the gates 33, including all contact surfaces of their respective inner walls, can be constructed to encircle and match the outer perimeter wall surface of the transducer body 15 so as to provide a snug and secure fit between the ANGA device 304926-9582-5308 1 9Docket No. 069296.11216-35WO1 Patentand the transducer body 15 that ensures fixed and precise colocation of the ultrasound transducer 10 and needle guide 20 with respect to each other during repeated usage and operation of the OPU device 1.

[0053] The pair of gates 33 can be arranged such that one gate 33 is provided on each side of the transducer body 15. The dorsal member 31 can include a guide pass-through channel 34 that is arranged to allow the needle guide 20 to slide therethrough and, when the needle guide 20 reaches its final position, hold the needle guide 20 in position. In an alternative embodiment the dorsal member 31 can be integrally formed with the needle guide 20 as a single piece. The dorsal member 31 can include a pair of recesses (or cutouts) 31R, with each recess 31R being located on a side ofthe dorsal member 31, as seen in FIG. 3. Each recess 31R can be configured to receive and securely fasten to a latch portion 33L of one of the pair of gates 33.

[0054] The latch portion 33L can include a fastener channel 36 having a longitudinal axis that is parallel to the needle guide longitudinal axis 26. As seen in FIG.3, the fastener channel 36 can run along the entire width of the latch portion 33L such that an end of the fastener 35 can pass through the fastener channel 36 (through the entire width of the latch portion 33L) and exit the fastener channel 36 to engage a portion of the ventral member 31 that is on the opposite side of the recess 31R, thereby fixedly securing the latch portion 33L to the dorsal member 31.

[0055] In an alternative embodiment a respective pair of fasteners 35 can be used to fasten each latch portion 33L to the dorsal member 31, such that each of the respective pair of fasteners 35 is installed opposite the other of the pair of fasteners 5. For example, referring to FIG. 3, the left side of the dorsal member 31 can include a second fastener (not show n) on the opposite side of the fastener 35 seen in the figure.

[0056] In various embodiments the dorsal member 31 and / or the fastener channel 36 can include threading that engages corresponding threading on the fastener 35.

[0057] The ventral (or lower) member 32 can include a recess (or cutout) 32R that connects to a pivot portion 33P of the gate 33, as seen in FIG. 3. The ventral member 32 can be connected to the pivot portion 33P by a single hinge 37 or a pair of hinges 37, one on each side of the recess 32R, to allow the pivot portion 33P to pivot about the hinges(s) 37 and the gate 33 to swing and move into the corresponding recess 31R in the dorsal member 31, where it can be secured to the dorsal member 31 using the fastener(s) 35. In certain embodiments the hinge 37 can include a pin, a rod, a screw, a living hinge, or other mechanism that can hold and secure the pivot portion 33P to the ventral member 32, while allowing the gate 33 to swing about the hinge(s) 37.4926-9582-5308 1 10Docket No. 069296.11216-35WO1 Patent

[0058] In certain embodiments the gate 33 can be hinged to the recess 31R in the dorsal member 31 and fastened (via fastener(s) 35) in the recess 32R of the ventral member 32.

[0059] Referring to FIG. 1, the NGA device 40 includes an upper NGA member 41 and a lower NGA member 42. The inner wall surfaces of the upper NGA member 41 and the lower NGA member 42 can be configured such that when assembled form a transducer channel body 48 (shown in FIG. 1) that attaches to and holds to the transducer body 15. The upper NGA member 41 and the lower NGA member 42 are configured to encircle and match the outer perimeter wall surface of the transducer body 15 to provide a snug and secure fit. The upper NGA member 41 can include an NGA guide pass-through channel 44 that is arranged to allow the needle guide 20 to slide therethrough and, when the needle guide 20 reaches its final position, hold the needle guide 20 in position. In an alternative embodiment the upper NGA member 41 can be integrally formed with the needle guide 20 as a single piece.

[0060] The upper NGA member 41 can be fastened to lower NGA member 42 by means of one or more fasteners 45. The upper NGA member 41 and the lower NGA member 42 can be constructed to form a variable inner diameter, for example, such that as the fasteners 45 are tightened, the inner walls of the upper NGA member 41 and the lower NGA member 42 simultaneously move toward each other to engage and press against the outer wall of the transducer body 15.

[0061] In various embodiments the fasteners 35 and / or the fasteners 45 can include a pin, a screw, a bolt, a weld, a rivet, or any mechanism that can securely fasten two or more components to each other.

[0062] In at least one embodiment, the OPU device 1 can be configured to operate without the needle guide 20. In the embodiment the ANGA guide pass-through channel 34 in the ANGA device 30 and the NGA guide pass-through channel in the NGA device 40 can be constructed to have a length and a diameter to hold and guide the aspiration needle to precise location on a target follicle for oocyte collection.

[0063] FIGS. 4 A - 4D show various views of another nonlimiting embodiment of the OPU device according to the principles of the disclosure. FIG. 4A shows a perspective anterior end side view of the OPU device; FIG. 4B shows a top view of the OPU device; FIG. 4C shows a side view of the OPU device; and FIG. 4D shows a front (or anterior end) view of the OPU device. The embodiment depicted in FIGS. 4A - 4D can be used for oocyte collection in animals such as eland antelope. As seen in the Figures, the OPU device can have an overall length of, for example, 500 mm (or 19.7 inches), an anterior end height and width of, for example, 39 mm (or 1.5 inches) and 29.7 mm (or 1.2 inches), respectively.4926-9582-5308 1 11Docket No. 069296.11216-35WO1 Patent

[0064] FIGS. 5 and 6 show, respectively, a perspective side-anterior end view and an exploded view of the embodiment of the OPU device of FIGS. 4A - 4D. As seen, the OPU device can be configured to be isometric. The OPU device can have a housing 50 that includes an anterior (or front) housing portion 52 and a pair of side body portions 54, including a left side body housing portion 54L and a right-side housing portion. The front housing portion 52 and the side body portions 54 can be assembled around the transducer 10 and needle guide 20 and fastened together (for example, via a plurality of fasteners) to form the OPU device.

[0065] In at least one embodiment, the left side housing portion 54L and the right side housing portion 54R each include a needle guide pass-through channel portion 56L and 56R, respectively, such that when the two side housing portions 54L, 54R are assembled a needle guide-pass-through channel 56 is formed to secure the needle guide 20 to the housing 50 and at a fixed position with respect to the ultrasound transducer 10. The left side housing portion 54L and the right-side housing portion 54R each can also include a transducer body pass-through channel portion 58L and 58R, respectively, such that when the two side housing portions 54L. 54R are assembled a transducer body pass-through channel 58 is formed to secure the transducer array 10 to the housing 50 and at a fixed position with respect to the needle guide 20. The housing 50 is configured to securely hold in place the needle guide 20 and transducer body 15 (including connector 18) with respect to each other.

[0066] FIG. 7 shows a side view of the OPU device of FIGS. 4A-4D and 5 connected to a connector interface. The connector interface can be configured to attach to external equipment such as, for example, a display device (not shown), a computer (not shown), or other hardware, as will be understood by those skilled in the art.

[0067] Referring to the OPU device 1 in FIGS. 1-3, in various applications of the disclosure one or more oocytes can be collected from an animal by, for example, inserting the anterior end of the OPU device 1 vaginally into an animal, rectally manipulating the ovary to the vaginal wall, and visualizing the ovary on an ultrasound display screen (not shown). Then, the ovary can be held in place and a follicle aligned with the needle channel 23 while a collection end of an aspiration needle (not shown) is passed through the needle channel 23 and into the follicle on the ovary. Once the follicle is punctured, the contents (including the oocyte) are aspirated into a collection vessel (not shown), which can be coupled to and in fluid communication with the posterior end of the aspiration needle (not shown). This process can be repeated for each visible follicle on each ovary.

[0068] In the various embodiments of the OPU device, the connection of the needle guide 20 to the ultrasound transducer 10 should be as smooth and non-abrasive as possible as the OPU4926-9582-5308 1 12Docket No. 069296.11216-35WO1 Patentdevice will be placed in a body cavity (vaginal). In certain embodiments the needle guide 20 can be removable from the ultrasound transducer 10, thereby allowing the ultrasound transducer 10 to be used in applications other than in the OPU device, and enabling sufficient cleaning and sterilization of the components between uses.

[0069] In various embodiments the OPU device can include three main components: the ultrasound transducer 10; the needle guide 20; and the housing 50. The OPU device can further include an aspiration needle. Referring to the embodiment depicted in FIG. 6, the front housing portion 52 can be constructed to securely hold the transducer 10 and needle guide 20 in place, ensuring consistent alignment between the needle guide 20 (and, thereby, the aspiration needle) and the transducer 10. The side body housing portions 54 can be made from two clamshell halves 54R, 54L that encase the needle guide and the transducer cable 18. providing additional security. The housing body 50 is engineered to an optimal length for each specific animal, ensuring ease of use for both the operator and the animal.

[0070] In various embodiments, the OPU device is constructed for operation in minimally invasive procedures used to retrieve oocytes (eggs) from the ovaries of animals. Guided by ultrasound, an aspiration needle can be carefully inserted, for example, through a vaginal wall into the ovarian follicles to aspirate one or more oocytes. The ultrasound transducer 10 can provide real-time ultrasound imaging to ensure accurate needle placement, reducing discomfort for the animal. The OPU device can be employed in various reproductive technologies and methodologies, including in in vitro fertilization (IVF), embryo transfer, and genetic preservation, enabling efficient collection of viable eggs while prioritizing animal welfare.

[0071] FIG. 8 shows a side view of a nonlimiting embodiment of the OPU device that can be used for oocyte extraction in animals such as, for example, scimitar homed oryx or the like; and FIG. 9 shows a nonlimiting embodiment of an oocyte collection kit comprising the OPU device depicted in FIG. 8.

[0072] FIGS. 10 and 11 show further nonlimiting embodiments of the OPU device, constructed according to the principles of the disclosure. The embodiments of the OPU device depicted in FIGS. 10 and 11 are designed with a reduced number of parts compared to other embodiments herein. In the depicted embodiments, the OPU device is arranged to increase robustness, making the device simpler to fabricate, assemble, and clean.

[0073] Various embodiments of the OPU device are designed for use in animals such as, for example, oryx, eland, roan antelope, or various species of Canidae, Felidae, Metatheria, Crocodylus, Loxodonta, to name a few. The dimensions of the OPU device can be matched to the particular target animal, including a minimized profile, specific length, as well as a4926-9582-5308 1 13DockctNo. 069296.11216-35WO1 Patentremovable and washable housing, depending on the animal. The needle guide attaches to an aspirator that retrieves the fluid (and oocyte) from follicles. The OPU device can be configured to be usable on the same animal for multiple collections.

[0074] In at least one embodiment, needle guide (and / or needle) can be removed from OPU device and replaced with a cleaned needle guide (and / or needle) before proceeding to the next animal. Speed is important because the animals may be under anesthesia (less time is better) and the process and experts are costly. The kit depicted in FIG. 9 can include one or more additional needles, needle guides, or portions of the housing for quick replacement of used parts with cleaned and / or sterilized parts.

[0075] The following table provides a nonlimiting example of a schedule of ovum pickup procedures performed with an embodiment of the OPU device in Scimitar Homed Oryx (Oryx dammah) and Roan (Hippotragus equinus) Antelope.Parity July Aug Gc-t Nov Bee Jan Fab Mar SHU 2324 j 2B25 s i MP OPU _ _ I PPG OfU pPU 3 P C-Pi; GPU GPU OPU OPU OPU t RestPertorf j 4 UP OPU CPU OPU OPU O?U { Rest Period ■ 5 : P GPU OPU OPU OPU UPG GPU GPU GPU s p ©•■ 6 ! _ FteatPeried _ i OPU GPU OPU y i p OPU OPU GPU GPU OPU OPU O»O OPU S «P MW Z / / 9 UP GPU 10 P GPU OPU OPU OPU GPU I Rest Period ■ ;.i i OPU OPU _ iteMPwjco _ [ OPU OPU OPU 12 i P OPU OPU G$>i,< GPU OPU OPU OPU Xi «p SMI js is i-i i P OPU CPU OPU OPU OPU if; : UP OPU i Rest Period j OPU GPU OPU •6 i P OPU OPU OPU OPU OPU GPU GPU OPU 2S i p GPU OPU OPU OPU OPU 27 i p OPU OPU OPU OPU UPU Rose 1 MP GPU GPU X i MF OPU GPU 3 ; UP OFU UPG 4 MP GPU GPU 5 MF OPU OPUP: parous, HP". noroparous. GPU: ovrsoi pickup procedure; SHCt #ss 8, 9, 13 were reinoved from tpe program

[0076] The following table provides an example of the number of oocytes collected by month, per the schedule above, in the procedures performed with the embodiment of the OPU device in Scimitar Homed Oryx (Oryx dammah) and Roan (Hippotragus equinus') Antelope. OocytesM{# OPUs'; July Aug Sept Oct Ms?v Sas Jan Feb Mat2821 [ 28255HG 3-75 8$) 9(8) 1819; 21 H (IQi 41U8J 32(18) 3? {28} Totct 203 {S8}9>f55 i ts;Rust io cts)4926-9582-5308.1 14Docket No. 069296.11216-35WO1 Patent

[0077] The terms “a,” “an,” and “the,” as used in this disclosure, means “one or more,” unless expressly specified otherwise.

[0078] The term “computer,” as used in this disclosure, means any machine, device, circuit, component, or module, or any system of machines, devices, circuits, components, or modules that are capable of manipulating data according to one or more instructions. The term “computer” can include, for example, without limitation, a processor, a microprocessor (pC), a central processing unit (CPU), a graphic processing unit (GPU), a data processing unit (DPU), an application specific integrated circuit (ASIC), a general purpose computer, a super computer, a personal computer, a laptop computer, a palmtop computer, a notebook computer, a desktop computer, a workstation computer, a server, a server farm, a computer cloud, or an array or system of processors. pCs. CPUs, GPUs, ASICs, general purpose computers, super computers, personal computers, laptop computers, palmtop computers, notebook computers, desktop computers, workstation computers, or servers.

[0079] The terms “including,” “comprising” and variations thereof, as used in this disclosure, mean “including, but not limited to,” unless expressly specified otherwise.

[0080] Devices that are in communication with each other need not be in continuous communication with each other unless expressly specified otherwise. In addition, devices that are in communication with each other may communicate directly or indirectly through one or more intermediaries.

[0081] Although process steps, method steps, or algorithms may be described in a sequential or a parallel order, such processes, methods and algorithms may be configured to work in alternate orders. In other words, any sequence or order of steps that may be described in a sequential order does not necessarily indicate a requirement that the steps be performed in that order; some steps may be performed simultaneously. Similarly, if a sequence or order of steps is described in a parallel (or simultaneous) order, such steps can be performed in a sequential order. The steps of the processes, methods or algorithms described in this specification may be performed in any order practical.

[0082] When a single device or article is described, it will be readily apparent that more than one device or article may be used in place of a single device or article. Similarly, where more than one device or article is described, it will be readily apparent that a single device or article may be used in place of the more than one device or article. The functionality or the features of a device may be alternatively embodied by one or more other devices which are not explicitly described as having such functionality or features.4926-9582-5308 1 15Docket No. 069296.11216-35WO1 Patent

[0083] The subject matter described above is provided by way of illustration only and should not be construed as limiting. Various modifications and changes can be made to the subject matter described herein without following the example embodiments and applications illustrated and described, and without departing from the true spirit and scope of the invention encompassed by the present disclosure, which is defined by the set of recitations in the following claims and by structures and functions or steps which are equivalent to these recitations.4926-9582-5308 1 16

Claims

Docket No. 069296.11216-35WO1 PatentCLAIMSWhat is claimed is:

1. An apparatus for targeting an ovarian follicle and collecting one or more oocytes from an ovary in an animal, the apparatus comprising:an ultrasound transducer (10) having a transducer head (11) and a transducer body (15); a needle guide (20) having a needle guide body (25) containing a needle channel (23); anda housing (30, 40, or 50) configured to position and hold the needle guide (20) and the transducer body (15) with respect to each other,wherein the housing (30.

40. or 50) includesa needle guide pass-through channel (34, 44, or 56) anda transducer body pass-through channel (38, 48, or 58), andwherein the ultrasound transducer (10) is arranged to align a needle with a target follicle to collect one or more oocytes from the target follicle.

2. The apparatus in claim 1, wherein at least one of the needle guide (20) and the housing (30, 40, or 50) is made of a material comprising a polymer.

3. The apparatus in claim 1 or claim 2, wherein at least one of the needle guide (20) and the housing (30, 40, or 50) is made of a material that is compatible with a disinfectant, a disinfection process, or a sterilization process.

4. The apparatus in any of claims 1 to 3, wherein at least one of the needle guide (20) and the housing (30, 40, or 50) is coated with an antimicrobial material.

5. The apparatus in any of claims 1 to 3, wherein at least one of the needle guide (20) and the housing (30, 40, or 50) is made of a material compatible with a coating comprising a disinfectant or an antimicrobial material.

6. The apparatus in claim 4 or claim 5, wherein the antimicrobial material includes stainless steel.

7. The apparatus in any of claims 1 to 4, wherein the housing comprises:an anterior housing portion (50); anda pair of side body housing portions (54R, 54L),4926-9582-5308 1 17Docket No. 069296.11216-35WO1 Patentwherein the pair of side housing portions clamp together to form the needle guide pass-through channel (56) and the transducer body pass-through channel (58).

8. The apparatus in any of claims 1 to 4, wherein the housing comprises at least one of an articulated needle guide attachment (ANGA) device (30) and a needle guide attachment (NGA) device (40).

9. The apparatus in claim 8, wherein the articulated needle guide attachment (ANGA) device (30) comprises:a dorsal ANGA member (31) that includes the needle guide pass-through channel (34) and forms a portion of the transducer body pass-through channel (38).

10. The apparatus in claim 8 or claim 9, wherein the articulated needle guide attachment (ANGA) device (30) comprises:a ventral ANGA member (32) that forms a portion of the transducer body pass-through channel (38).

11. The apparatus in any of claims 8 to 10, wherein the articulated needle guide attachment (ANGA) device (30) comprises:at least one gate (33) that forms a portion of the transducer body pass-through channel (38).

12. The apparatus in claim 11, wherein the at least one gate (33) includes a latch portion (33L) that attaches to the dorsal ANGA member (31) and a pivot portion (33P) that attaches to the ventral ANGA member (32).

13. The apparatus in claim 12, wherein the needle guide attachment (NGA) device (30) comprises at least one hinge (37) that attaches the pivot portion (33P) to the dorsal NGA member (31), wherein the hinge (37) is configured to allow the gate (33) to swing about the hinge (37).

14. The apparatus in claim 11, wherein the dorsal ANGA member (31), the ventral ANGA member (32), and the at least one gate (33) assemble to form a contiguous wall that forms the transducer body pass-through channel (38).

15. The apparatus in any of claims 8 to 14, wherein the needle guide attachment (NGA) device (40) comprises:4926-9582-5308 1 18Docket No. 069296.11216-35WO1 Patenta dorsal NGA member (41) that includes the needle guide pass-through channel (44) and forms a portion of the transducer body pass-through channel (48).

16. The apparatus in any of claims 8 to 15, wherein the needle guide attachment (NGA) device (30) comprises:a ventral NGA member (42) that forms a portion of the transducer body pass-through channel (48).

17. The apparatus in claim 16, wherein the dorsal NGA member (11) and the ventral NGA member (42) assemble to form a contiguous wall that forms the transducer body pass-through channel (48).

18. The apparatus in any of claims 1 to 17, wherein the animal is an oryx, an eland, or a roan antelope.

19. The apparatus in claim 18, wherein the apparatus is sized and configured for vaginal insertion in the ory x, the eland, or the roan antelope.

20. The apparatus in any of claims 1 to 19, wherein at least one of the ultrasound transducer (10) and the needle guide (20) is removable from the apparatus.

21. The apparatus in any of claims 1 to 20, further comprising:a needle arranged for installation in the needle guide (20),wherein the needle slides in, and is supported by, the needle channel (23).

22. The apparatus in claim 21, further comprising:an aspirator that connects to the needle to retrieve fluid and an oocyte from a follicle.

23. The apparatus in any of claims 1 to 22, wherein the transducer head (11) has an ultrasound field of view and the ultrasound transducer (10) and the needle channel (23) are arranged to position to position the needle in the ultrasound field of view.

24. The apparatus in claim 23, wherein a distance between an axial centerline of the transducer head (11) and an axial centerline of the needle guide (20) is minimal.

25. The apparatus in claim 24, wherein the distance is less than 0.20 mm, preferably less than 0.10mm, and most preferably 0.4926-9582-5308 1 19Docket No. 069296.11216-35WO1 Patent26. The apparatus in claim 24, wherein the axial centerline of the needle guide (20) is arranged at angle with respect to the axial center line of the transducer head (11) such that the needle tip is proximate to the axial centerline of the transducer head (11) when collecting an oocyte.

27. The apparatus in any of claims 1 to 26, wherein the apparatus is constructed to have a diameter between 20 mm and 60 mm, and preferably 25 mm and 33 mm.

28. The apparatus in claim 27 wherein the diameter is a radial diameter.

29. The apparatus in any of claims 1 to 28, wherein the housing (30, 40, or 50) is constructed by three-dimensional (3D) printer.

30. The apparatus in any of claims 1 to 28, wherein the housing (30, 40, or 50) is made of a material comprising at least one ofa 3D printed material;a molded polymer material;a polyurethane material;a silicone material;a biocompatible polymer material; anda metal.

31. The apparatus in claim 30, wherein the biocompatible polymer material comprises PEEK, PEKK, PMMA, or PC.

32. The apparatus in any of claims 1 to 31, wherein at least a portion of the apparatus is coated or treated to be more lubricious.

33. The apparatus in any of claims 1 to 32, wherein at least as portion of the apparatus is treated with a sterilization process or an antimicrobial agent or coating.

34. The apparatus in claim 33, wherein the sterilization process comprises EtO, gamma, or HPV.

35. The apparatus in any of claims 1 to 34, further comprising:a v-shaped feature attached to, integrally formed with, or located proximate to, an opening (21) in the needle guide (20) and arranged to stabilize a local position of an ovary with4926-9582-5308 1 20Docket No. 069296.11216-35WO1 Patentrespect to the needle guide (20) to prevent movement of the ovary7during insertion of the needle and oocyte collection.

36. A method of collecting one or more oocytes with the apparatus in any of claims 1 to 35, the method comprising:inserting an anterior end of the apparatus vaginally into the animal;rectally manipulating the ovary' to a vaginal wall;visualizing the ovary' on a display screen;while holding the ovary' in place, aligning the needle channel (23) with a follicle; inserting an aspiration needle into the follicle; andcollecting an oocyte from the follicle.

37. A kit for targeting an ovarian follicle and collecting one or more oocytes from an ovary in an animal, the kit comprising at least one needle guide (20) and at least one housing (30, 40, 50) for use with an ultrasound transducer, the kit comprising:a needle guide (20) having a needle guide body (25) that contains a needle channel (23); anda housing (30, 40, or 50) configured to attach the needle guide (20) to the ultrasound transducer,wherein the housing (30, 40, or 50) includesa needle guide pass-through channel (34, 44, or 56) anda transducer body pass-through channel (38, 48, or 58).

38. The kit in claim 37, further comprising:at least one needle arranged for installation in the needle guide (20),wherein the needle is configured to slide in, and be supported by, the needle channel (23).

39. The kit in claim 38, further comprising:an aspirator that connects to the needle to retrieve fluid and an oocyte from a follicle.4926-9582-5308 1 21

Images