Reproductive tract access device and method

Abstract

The present disclosure relates to devices and methods for accessing the reproductive tract of an animal, particularly via the animal's vagina, and deploying reproductive material within the uterus. The device and methods of the disclosure may be particularly suited for embryo transfer processes, such as performed in livestock e.g., cattle.

Description

[0001] "Reproductive tract access device and method"

[0002] Cross-Reference to Related Applications

[0003] This application claims the right of priority to US Provisional No. 63 / 558,039, filed 26 February 2024, the complete contents of which is incorporated by reference herein in its entirety.

[0004] Technical Field

[0005] The present disclosure relates to animal reproductive technologies, including devices and methods for accessing the reproductive tract of an animal, particularly via the animal’s vagina, and deploying reproductive material within the uterus. In some examples, the device and method may also detect the presence and / or location of a corpus luteum (CL) within the uterus. The device and methods of the disclosure may be particularly suited for embryo transfer processes, such as performed in livestock e.g., cattle.

[0006] Background

[0007] Artificial insemination and embryo transfer are important techniques in the field of animal breeding, particularly in livestock animals. These techniques may offer improved control over genetic traits, improving the overall quality of livestock herds.

[0008] Devices for accessing the reproductive tract of an animal are known in the art of animal breeding. Examples include artificial insemination devices and embryo transfer devices. These devices generally include a hollow tube which is inserted through the cervix of the animal to facilitate delivery of reproductive material and / or therapeutic substances to the reproductive tract.

[0009] Accessing the reproductive tract of an animal may present several challenges. For example, bovine anatomy presents a unique challenge due to its relatively complex reproductive tract, which includes multiple interdigitating cervical folds, a uterine body, and dual uterine horns, necessitating specialised techniques for effectively delivering reproductive or therapeutic materials to the bovine uterus. Generally, to access the bovine uterus (for example, to deliver reproductive material), a user must insert a hand into the rectum of the animal in order to manually manipulate the cervix whilst advancing an access device through the cervical folds to the uterus. This insertion technique requires a high degree of experience and skill. Further, such insertion techniques can cause discomfort or tissue trauma to the animal, which may have detrimental effects on future fertility of the animal and reproductive outcomes.

[0010] Furthermore, in species with a bifurcated uterus, such as cattle, swine, and certain small ruminants, it is often important to identify the presence and / or location of the corpus luteum (CL) prior to deploying the reproductive material. This is because pregnancy is typically maintained in the uterine horn located on the same side as the ovary containing the functional corpus luteum, due to the localised effects of progesterone. Misidentifying the location of the CL can result in embryo transfer to the incorrect uterine horn, significantly reducing the chances of successful implantation and pregnancy. Current methods for detecting the presence and / or location of the corpus luteum include manual palpation per rectum, ultrasonography, and hormonal assays. Manual palpation, though widely used, is subjective and requires significant expertise to ensure accurate detection. Ultrasonography, while more precise, requires specialised equipment and trained personnel, making it less accessible for routine use. Hormonal assays, such as progesterone testing via blood or milk samples, provide indirect measurements of CL activity but do not reveal its precise location, limiting their utility.

[0011] In view of the above, there is a need for improved devices and methods for accessing the reproductive tract of an animal via its vagina and deploying reproductive material within the uterus, particularly methods and devices which are easy for a user to operate, which minimise damage to the reproductive tract and / or which are capable of detecting the presence and location of the CL to enable deployment of reproductive material to the desired uterine horn.

[0012] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each of the appended claims.

[0013] Summary

[0014] The present disclosure relates generally to a device and methods for accessing the reproductive tract of an animal via the animal’s vagina to enable seamless deployment of reproductive material to the desired location within the uterus with minimal trauma to the animal. The device and methods of the disclosure may also enable detection and / or localisation of the corpus luteum (CL), which is particularly advantageous when deploying reproductive materials into the uterus of species with a bifurcated uterus, such as cattle, swine, and certain small ruminants. In these species, pregnancy is typically maintained in the uterine horn on the same side as the ovary containing the functional corpus luteum, due to the localised effects of progesterone. Misidentifying the side of the uterus which is localised with the CL can result in embryo transfer to the incorrect uterine horn, significantly reducing the chances of successful implantation and pregnancy. Thus, in developing a device and method for deploying reproductive material within the uterus of an animal, the inventors sought to incorporate means for detecting the location of the CL to enable deployment of the reproductive material, such as an embryo, to the desired uterine horn. As shown Examples 1-3 herein, the device and methods of the disclosure may be particularly suited for embryo transfer processes in livestock species e.g., cattle. However, it is also envisaged that the device and methods of the disclosure may be suitable for delivery of semen to the uterus for artificial insemination in livestock species e.g., cattle.

[0015] According to one aspect of the present disclosure, there is provided a device for accessing the reproductive tract of an animal, the device comprising:

[0016] (a) an introducer comprising a longitudinal shaft extending from a proximal end to a distal end, the introducer having a distal region configured for insertion into a uterine cervix of the animal;

[0017] (b) a first flexible elongate probe; and

[0018] (c) a second flexible elongate probe, wherein the first and second elongate probes are slidably receivable by the introducer and extendable from the distal region of the introducer into first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns.

[0019] The first and second elongate probes may be simultaneously extendable. The first and second elongate probes may be individually extendable.

[0020] The first elongate probe may comprise one or more first sensors at a distal region of the first elongate probe. The second elongate probe may comprise one or more second sensors at a distal region of the second elongate probe. The first and second sensors may be configured to obtain sensed data from the first and second uterine horns. The device may comprise a processor configured to receive and process the sensed data to determine the presence of a corpus luteum in one or both uterine horns of the animal. The sensed data may comprise temperature data.

[0021] The first and second elongate probes may each be configured to receive reproductive material for transfer to a target region of a uterine horn. Each of the first and second elongate probes may comprise a tubular body defining an internal lumen extending from a proximal end to a distal port, the tubular body configured to receive reproductive material therein to facilitate transfer of the reproductive material from the proximal end to the distal end of the elongate probe.

[0022] The first and second elongate probes may comprise first and second deployment ports at respective distal ends thereof. The deployment ports may be configured to facilitate deployment of reproductive material from the distal ends of the elongate probes. The device may be configured for selective deployment of reproductive material from one of the extendable elongate probes. The selective deployment may be based on a detected presence of a corpus luteum. The reproductive material may comprise an embryo.

[0023] The introducer shaft may define first and second elongate channels configured to receive the first and second elongate probes. The first and second elongate channels may extend through the introducer shaft. The first and second elongate channels may extend from the proximal end of the shaft to the distal region of the introducer. The introducer shaft may include a central divider separating the first and second channels. The central divider may include opposed first and second side walls defining respective medial walls of the first and second channels. The central divider includes a flared portion in the distal region of the introducer shaft. At the flared portion, the first and second walls may curve relative to a longitudinal axis of the introducer shaft. For example, the first and second walls may curve such that, during deployment of the probes, the first and second walls deflect the elongate probes away from the longitudinal axis of the introducer. The first and second walls may curve relative to the longitudinal axis in two planes.

[0024] According to another aspect of the present disclosure, there is provided a method for accessing the reproductive tract of an animal, the method including:

[0025] (a) inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end; and

[0026] (b) deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns.

[0027] According to another aspect of the present disclosure, there is provided a method for delivering reproductive material to a uterine horn of an animal, the method including:

[0028] (a) inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end;

[0029] (b) deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, the elongate probes configured to receive reproductive material for transfer to the target regions of the uterine horns; and

[0030] (c) transferring reproductive material through at least one of the elongate probes to at least one target region.

[0031] According to another aspect of the present disclosure, there is provided a method of determining the presence of a corpus luteum in a uterus of an animal, the method including:

[0032] (a) inserting a distal region of an introducer through a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end;

[0033] (b) deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, wherein the first and second elongate probes include respective first and second sensors;

[0034] (c) obtaining sensed data from the first and second sensors;

[0035] (d) providing the sensed data at a processor; and

[0036] (e) processing the sensed data at the processor to determine the presence of a corpus luteum in a uterine horn. The sensed data may comprise temperature data. The method may include applying thermal energy to the uterine horn tissue adjacent to the sensors. The temperature data may be obtained during and or subsequent to applying of the thermal energy. Processing the data may comprise determining a temperature differential between the first uterine horn and the second uterine horn. Processing the data may comprise determining a rate of temperature rise during the application of thermal energy to the tissue and / or determining a rate of temperature drop following cessation of the applying of thermal energy to the tissue.

[0037] According to another aspect of the present disclosure, there is provided a device for accessing the reproductive tract of an animal, comprising an introducer comprising a longitudinal shaft extending from a proximal end to a distal tip and having a distal region configured for insertion into a uterine cervix of the animal, wherein the introducer includes a helical guide member provided on an outer surface of the longitudinal shaft in the distal region, and wherein the introducer comprises a projection extending distally beyond the distal tip of the longitudinal shaft.

[0038] The introducer may be configured for rotation about a longitudinal axis of the longitudinal shaft during insertion to the cervix. The helical guide member may be configured to assist rotational advancement of the introducer through the cervix. The helical guide member may comprise a protruding thread extending from an outer surface of the shaft. The thread may extend around the shaft in a substantially continuous manner. The thread may extend around the shaft in a discontinuous manner.

[0039] The projection may be a distal continuation of the helical guide member. At least part of the projection may extend distally beyond of the distal tip of the longitudinal shaft. The projection may include a portion having a reduced curvature relative to a proximal portion of the helical guide member. The projection may include a portion extending substantially parallel to a central longitudinal axis of the longitudinal shaft in at least one plane.

[0040] The projection may be axially offset from the central longitudinal axis of the longitudinal shaft. The shaft may have a cylindrical shape at least in the distal region. The projection may be radially offset from an outer diameter of the cylindrical shaft. A distal end portion of the projection may have a bulbous shape.

[0041] The helical guide member may extend around the elongate shaft in an anti-clockwise direction when viewed from the distal tip of the introducer. The helical guide member may extend around the shaft for at least one revolution. A distal tip of the longitudinal shaft may have a tapered shape.

[0042] According to another aspect of the present disclosure, there is provided a method for accessing the reproductive tract of an animal, including: (a) advancing an introducer into a uterine cervix of the animal, the introducer comprising:

[0043] (i) a longitudinal shaft extending from a proximal end to a distal tip and having a distal region configured for insertion into the cervix;

[0044] (ii) a helical guide member provided on an outer surface of the longitudinal shaft in the distal region; and

[0045] (iii) a projection extending distally beyond the distal tip of the longitudinal shaft; and

[0046] (b) rotating the introducer about a longitudinal axis of the longitudinal shaft during advancement, wherein the helical guide member is configured to assist rotational advancement of the introducer through the cervix.

[0047] According to another aspect of the present disclosure, there is provided a device for accessing the reproductive tract of an animal, the device comprising an introducer comprising a longitudinal shaft extending from a proximal end to a distal end, the introducer having a distal region configured for insertion into a uterine cervix of the animal, wherein the introducer comprises at least one sensor arrangement configured to obtain sensed data indicative of an optical property of tissue adjacent to the distal end of the introducer.

[0048] The optical property may comprise a reflectivity of the tissue and / or a colour of the tissue.

[0049] The sensor arrangement may comprise a light source configured to emit illuminating light and at least one optical sensor configured to detect reflected light.

[0050] The device may comprise a first light guide. The device may comprise a second light guide. The first light guide may be configured to transmit the illuminating light from the light source and emit the illuminating light from the distal end of the introducer. The second light guide may be configured to receive light reflected from the tissue and transmit the reflected light to the optical sensor.

[0051] The first and second light guides may extend through the longitudinal shaft of the introducer toward the distal end of the introducer. The first and second light guides may comprise respective first and second optical fibres.

[0052] The device may comprise a controller including a processor configured to receive the sensed data from the sensor arrangement and process the sensed data to determine a position of the distal end of the introducer within the reproductive tract of the animal. The controller may be configured to detect a change in the optical property of the tissue as the introducer is advanced through the cervix, to identify a transition between the cervix and the uterus. The controller may be configured to trigger a notification to alert a user when the distal end of the introducer reaches the transition between the cervix and the uterus. According to another aspect of the present disclosure, there is provided a method for accessing the reproductive tract of an animal, including:

[0053] (a) inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end and at least one sensor arrangement,

[0054] (b) obtaining, from the at least one sensor arrangement, sensed data indicative of an optical property of tissue adjacent to the distal end of the introducer;

[0055] (c) receiving the sensed data from the sensor arrangement at a processor; and

[0056] (d) processing the sensed data to determine a position of the distal end of the introducer within the reproductive tract of the animal.

[0057] According to another aspect of the present disclosure, there is provided a device for accessing the reproductive tract of an animal, the device comprising:

[0058] (a) a body including a handle for facilitating gripping by a user;

[0059] (b) an introducer axially fixed relative to the body and extending distally from the body, the introducer comprising a longitudinal shaft extending from a proximal end to an opposed distal end, the introducer having a distal region configured for insertion into a uterine cervix of the animal; and

[0060] (c) an outer shaft extending from an open proximal end to an open distal end, the outer shaft mounted to the body being slidably movable between an extended position and a retracted position relative to the introducer.

[0061] The outer shaft may be configured for insertion into a vagina of the animal. The outer shaft may be substantially rigid. The outer shaft may be configured for insertion to a position in which the open distal end of the outer shaft is adjacent to or abutting the cervix and such that the open distal end of the outer shaft is aligned with a proximal opening of the cervix.

[0062] When the outer shaft is in the extended position, the distal end of the introducer may be aligned with or positioned proximally of the open distal end of the outer shaft. When the outer shaft is in the retracted position, the distal end of the introducer may extend beyond the open distal end of the outer shaft.

[0063] The outer shaft may be configured to move from the extended position toward the retracted position as the introducer is advanced through the cervix.

[0064] The device may comprise an imaging system. The imaging system may include at least one camera configured to capture image data representative of an area ahead of and / or surrounding the distal end of the device.

[0065] The at least one camera may be mounted on the outer shaft of the device. The at least one camera may be mounted on the body of the device. The at least one camera may be mounted on the introducer of the device. The distal end of the introducer may be positioned within a field of view of the camera. The introducer may include a marker at or adjacent to the distal end of the introducer.

[0066] The device may comprise a processor configured to receive and process the image data from the camera. The device may include a display configured to receive the processed image data from the processor and cause display of images based on the processed image data.

[0067] The device may comprise a stop member configured for limiting a depth of insertion of the outer shaft and / or the introducer into the animal. The stop member may be provided on the body, proximal of the outer shaft and the introducer. The stop member may be provided on the outer shaft.

[0068] A longitudinal position of the stop member relative to the outer shaft and / or the introducer is adjustable. The device may comprise a releasable stop member securing mechanism for inhibiting relative movement between the stop member and the outer shaft and / or the introducer. The stop member may comprise a plate extending substantially transverse to a longitudinal axis of the introducer shaft. The plate may be configured to abut an external surface of the animal’s body adjacent to a vaginal opening.

[0069] The device may comprise at least one flexible elongate probe slidably receivable by the introducer and extendable from the distal region of the introducer into a uterine horn of the animal to reach a target region of the uterine horn. The device may comprise first and second flexible elongate probes. The first and second elongate probes may be slidably receivable by the introducer and extendable from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns.

[0070] The handle may be configured for actuating longitudinal rotation of the introducer during insertion of the introducer to the cervix.

[0071] According to another aspect of the present disclosure, there is provided a method of accessing the reproductive tract of an animal using the device described above, the method including:

[0072] (a) positioning the outer shaft at the extended position;

[0073] (b) gripping the body by the handle;

[0074] (c) inserting the outer shaft into a vagina of the animal until the open distal end is positioned adjacent to or abutting the cervix;

[0075] (d) advancing the introducer relative to the outer shaft to insert the distal end of the introducer through an opening of the cervix; and

[0076] (e) manipulating the device by the handle to navigate the distal tip of the introducer through annular folds of the cervix to advance the distal region of the introducer into the cervix. The method may comprise:

[0077] (a) capturing image data from a camera of the device, the image data representative of an area ahead of and / or surrounding the distal end of the outer shaft during insertion of the outer shaft to the vagina;

[0078] (b) causing display of images based on the captured image data at a display device; and

[0079] (c) guiding insertion of the distal end of the introducer to the cervical opening, based on the displayed images.

[0080] The device may include at least one flexible elongate probe slidably receivable by the introducer and extendable from the distal region of the introducer, wherein the method includes, after advancing the introducer into the cervix, extending the at least one flexible elongate probe into a uterine horn of the animal to reach a target region of the uterine horn.

[0081] The device may comprise first and second flexible elongate probes slidably receivable by the introducer and extendable from the distal region of the introducer, and wherein the method includes extending the first and second flexible elongate probe into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns. The first and second elongate probes may be extended into the first and second uterine horns simultaneously. The first and second elongate probes may be extended into the first and second uterine horns sequentially.

[0082] The method may include selectively deploying reproductive material through at least one elongate probe to at least one target region.

[0083] The method may include positioning a stop member of the device abutting an external surface of the animal’s body adjacent to a vaginal opening, to inhibit further insertion of the outer shaft and / or the introducer once a desired position of the outer shaft and / or the introducer within the reproductive tract has been reached. The method may comprise, after positioning of the stop member, securing a stop member securing mechanism to inhibit relative movement of the stop member relative to the outer shaft and / or the introducer. The method may include, securing an outer shaft securing mechanism configured to inhibit relative movement of the introducer relative to the outer shaft once a desired position of the introducer within the reproductive tract has been reached.

[0084] The present disclosure relates generally to a method and device for identifying the presence or absence and / or location of a corpus luteum (CL) in an animal. As shown the examples herein, the methods and device of the disclosure may be particularly suited for detecting the corpus luteum (CL) in livestock species, such as those having a bifurcated uterus e.g., cattle and other ruminants.

[0085] According to one aspect of the present disclosure, there is provided a method of determining the presence or absence of a corpus luteum in a uterus of an animal, the method comprising:

[0086] (a) obtaining sensed temperature data indicative of temperature at a target region in the uterus;

[0087] (b) providing the sensed temperature data at a processor; and

[0088] (c) processing the sensed temperature data at the processor to determine the presence or absence of a corpus luteum in the animal.

[0089] According to another aspect of the present disclosure, there is provided a method of determining the presence or absence of a corpus luteum in a uterus of an animal, the method comprising:

[0090] (a) receiving, at a processor, sensed temperature data indicative of temperature at a target region in the uterus;

[0091] (b) processing the sensed temperature data at the processor to determine the presence or absence of a corpus luteum in the animal.

[0092] According to another aspect of the present disclosure, there is provided a non-transitory computer-readable medium configured to perform the method according to one or more examples of the present disclosure.

[0093] In any aspect disclosed herein, the method may comprise one or more of the following features.

[0094] In some examples, the method may comprise determining a basal body temperature of the animal. Processing the sensed data may comprise comparing the sensed temperature data to the basal body temperature. The sensed data may be obtained from within at least one uterine horn of the animal. The target region may be located within the uterine horn.

[0095] In some examples, the method may comprise obtaining sensed temperature data indicative of temperature at first target region within a first uterine horn of the animal. The method may comprise obtaining sensed temperature data indicative of temperature at a second target region within a second uterine horn of the animal. The first target region and the second target region may be corresponding regions with the first and second uterine horns respectively.

[0096] In some examples, the method comprises determining the location of the corpus luteum based on the sensed temperature data. For example, the method may comprise determining whether the CL is located at an ovary associated with a first uterine horn or an ovary associated with a second uterine horn.

[0097] Processing the sensed temperature data may comprise comparing the sensed temperature data from the first target region in the first uterine horn to the sensed data from the second target region in the second uterine horn. Processing the sensed temperature data may comprise determining a temperature differential between the first uterine horn and the second uterine horn. In some examples, the method may comprise inserting a probe into at least a first uterine horn of the animal to reach a first target region in the first uterine horn, wherein the probe includes a sensor, and obtaining the sensed temperature data indicative of temperature at the first target region from the sensor. In some examples, the method may comprise inserting the probe into a second uterine horn of the animal to reach a second target region in the second uterine horn, and obtaining the sensed temperature data indicative of temperature at the second target region from the sensor.

[0098] In some examples, the method may comprise inserting first and second probes into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, wherein the first and second elongate probes include respective first and second sensors, and obtaining sensed temperature data indicative of temperature at the first and second target regions from the first and second sensors, respectively.

[0099] In some examples, the method may comprise applying thermal energy to tissue of the first uterine horn and / or the second uterine horn, adjacent the first and / or second probes at the first and / or second target regions. The sensed temperature data may be obtained prior to, during, and / or subsequent to the applying of the thermal energy. Processing the data may comprise determining a rate of temperature change at the first and / or second target regions during and / or following the applying of the thermal energy, such as determining a rate of temperature rise during the application of thermal energy to the tissue and / or determining a rate of temperature drop following cessation of the applying of the thermal energy to the tissue. Processing the data may include determining a temperature rise at the first and / or second target regions over a predetermined period of time. Processing the data may include determining a temperature rise in response to applying of a predetermined amount of thermal energy.

[0100] In some examples, processing the data may comprise comparing the rate of temperature change at the first target region to the rate of temperature change at the second target region. Processing the data may comprise determining, based on the comparison, a presence or absence of a corpus luteum in the animal. Processing the data may comprise determining, based on the comparison, a location of a corpus luteum as associated with the first uterine horn or second uterine horn.

[0101] In each of the foregoing examples describing a method of determining the presence or absence, and / or location, of a corpus luteum in a uterus of an animal, the method further comprises transferring an indication of the presence or absence of a corpus luteum, and / or the location of the corpus luteum, to a user via a display.

[0102] According to one aspect of the present disclosure, there is provided a device for accessing the reproductive tract of an animal to determine the presence of a corpus luteum, the device comprising: at least one elongate probe, the elongate probe including at least one sensor; wherein the elongate probe is extendable into the uterus of the animal to reach a target region of the uterus.

[0103] The at least one sensor may be provided at a distal region of the elongate probe. The at least one sensor may be configured to obtain sensed data from the uterus. The sensed data may comprise temperature data indicative of temperature at the target region.

[0104] The at least one elongate probe may comprise a heating element.

[0105] The device may comprise an introducer having a distal region configured for insertion into a uterine cervix of the animal. The introducer may comprise a longitudinal shaft extending from a proximal end to a distal end. The at least one elongate probe may be slidably receivable by the introducer. The at least one elongate probe may be flexible. The at least one elongate probe may be configured to be extendable from the distal region of the introducer into a uterine horn of the animal.

[0106] According to another aspect of the present disclosure, there is provided a device for accessing the reproductive tract of an animal to determine the presence of a corpus luteum, the device comprising: a first flexible elongate probe; and a second flexible elongate probe, wherein the first and second elongate probes are configured to be extendable into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, wherein the first and second elongate probes each comprise at least one sensor.

[0107] The first and second elongate probes may be simultaneously extendable. The first and second elongate probes may be individually extendable.

[0108] The first elongate probe may comprise one or more first sensors at a distal region of the first elongate probe. The second elongate probe may comprise one or more second sensors at a distal region of the second elongate probe. The first and second sensors may be configured to obtain sensed data from the first and second uterine horns. The sensed data may comprise temperature data indicative of temperature at the first and second target regions.

[0109] The first and second elongate probe may each comprise a respective heating element.

[0110] The introducer shaft may define first and second elongate channels configured to receive the first and second elongate probes. The first and second elongate channels may extend through the introducer shaft. The first and second elongate channels may extend from the proximal end of the shaft to the distal region of the introducer. The introducer shaft may include a central divider separating the first and second channels. The central divider may include opposed first and second side walls defining respective medial walls of the first and second channels. The central divider may include a flared portion in the distal region of the introducer shaft. At the flared portion, the first and second walls may curve relative to a longitudinal axis of the introducer shaft. For example, the first and second walls may curve such that, during deployment of the probes, the first and second walls deflect the elongate probes away from the longitudinal axis of the introducer. The first and second walls may curve relative to the longitudinal axis in two planes.

[0111] The device may comprise (and / or may be configured to be communicatively coupled with) a processor. The processor may be configured to receive and process the sensed data to determine the presence or absence of a corpus luteum in one or both uterine horns of the animal. The processor may be configured to receive and process the sensed data to determine a location of the corpus luteum as associated with one or both uterine horns of the animal.

[0112] According to another aspect of the present disclosure, there is provided a method for accessing the reproductive tract of an animal to determine the presence or absence of a corpus luteum, the method including: inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end; and deploying an elongate probe from the distal region of the introducer to reach a target region of the uterine horns; obtaining sensed temperature data indicative of temperature at a target region in the uterus; providing the sensed temperature data at a processor; and processing the sensed temperature data at the processor to determine the presence or absence of a corpus luteum in the animal.

[0113] In some examples, the method may comprise deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns. The method may comprise obtaining sensed temperature data indicative of temperature at first target region within a first uterine horn of the animal and obtaining sensed temperature data indicative of temperature at a second target region within a second uterine horn of the animal.

[0114] Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. Brief Description of the Drawings

[0115] Embodiments will not be described by way of example only with reference to the drawings in which:

[0116] Figure 1 is a partial perspective view of an introducer and probes of a device for accessing the reproductive tract of an animal according to one embodiment of the present disclosure, with the probes shown in a partially extended position;

[0117] Figure 2 is a partial perspective view of the introducer and probes of the device of Figure 1, with the probes shown in a partially retracted position;

[0118] Figure 3 is a partial front view of the introducer and probes of the device of Figure 1, with the probes shown in a partially extended position;

[0119] Figure 4 is a partial front view of the introducer and probes of the device of Figure 1, with the probes shown in a partially retracted position;

[0120] Figure 5 is a partial side view of the introducer and probes of the device of Figure 1, with the probes shown in a partially retracted position;

[0121] Figure 6 is a partial front view of the introducer and probes of the device of Figure 1, with the probes shown in a partially extended position;

[0122] Figure 7 is a partial top cross-section view of the introducer and probes of the device of Figure 1, with the probes shown in a partially retracted position;

[0123] Figure 8 is a partial perspective view of the device of Figure 1, showing the introducer and body of the device;

[0124] Figure 9 is a partial perspective view of a probe of the device of Figure 1 ;

[0125] Figure 10 is a partial cut-away side view of the probe of Figure 9;

[0126] Figure 11 is a partial cut-away perspective view of the probe of Figure 9;

[0127] Figure 12 illustrates a deployment syringe according to one embodiment of the present disclosure configured to receive a straw of reproductive material, and a proximal end of a probe of the device of Figure 1,

[0128] Figure 13 illustrates the deployment syringe of Figure 12 connected to the proximal end of the probe;

[0129] Figure 14 illustrates the deployment syringe of Figure 12 connected to the proximal end of the probe, a plunger of the syringe depressed; Figure 15 illustrates a proximal end of the probe of Figure 9;

[0130] Figure 16 is a partial perspective view of a proximal end of a device for accessing the reproductive tract of an animal including probes according to one example of the present disclosure;

[0131] Figure 17 is a partial perspective view of an introducer of a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure;

[0132] Figure 18 is a partial side view of the introducer of the device of Figure 17;

[0133] Figure 19 is a partial top view of the introducer of the device of Figure 17;

[0134] Figure 20 is a partial perspective view of an introducer of a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure;

[0135] Figure 21 is a partial perspective view of the introducer and probes of the device of Figure 20, showing probes in a partially extended position;

[0136] Figure 22 is a partial side view of the introducer and the probes of the device of Figure 20, showing the probes in a partially extended position;

[0137] Figure 23 is a partial perspective view of a distal end of an introducer of a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure;

[0138] Figure 24 is a partial perspective view of a distal end of an introducer and outer shaft of a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure;

[0139] Figure 25 is a partial front view of a distal end of an introducer of the device of Figure 24;

[0140] Figure 26 is a perspective view of a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure;

[0141] Figure 27 is a side view of the device of Figure 26;

[0142] Figure 28 is a perspective cut-away view of the device of Figure 26, showing the introducer in a first rotational orientation, with the outer shaft in a partially retracted position;

[0143] Figure 29 is a perspective cut-away view of the device of Figure 26, showing the introducer in a second rotational orientation;

[0144] Figure 30 is a perspective cut-away view of the device of Figure 26, showing the introducer in the first rotational orientation, with the outer shaft in a retracted position; Figure 31 is a perspective view of the device of Figure 26, showing the outer shaft in an extended position and a stop member in an intermediate position;

[0145] Figure 32 is a perspective view of the device of Figure 26, showing the outer shaft in a retracted position and the stop member in a distal position;

[0146] Figure 33 is a perspective view of the device of Figure 26, showing the outer shaft in a retracted position and the stop member in a proximal position;

[0147] Figure 34 is a partial perspective view of the device of Figure 26, showing a mounting collar and securing mechanism of the stop member;

[0148] Figure 34 is a partial perspective cut-away view of the device of Figure 26, showing the mounting collar and securing mechanism of the stop member;

[0149] Figure 36 is a partially cut-away side view of a device for accessing the reproductive tract of an animal according to another example of the present disclosure;

[0150] Figure 37 is a partial perspective view of a distal end of the device of Figure 36;

[0151] Figure 38 is a partial perspective view of a proximal end of the device of Figure 36;

[0152] Figure 39 illustrates a system for transfer of reproductive material to the reproductive tract of an animal, including a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure, a deployment syringe, a straw of reproductive material and probes;

[0153] Figures 40-44 illustrate steps in a method for transfer of reproductive material to a bovine uterus using the system of Figure 39;

[0154] Figure 45 is a perspective view of a deployment syringe according to one embodiment of the present disclosure, shown connected to a probe;

[0155] Figure 46 is a partial perspective view of the deployment syringe of Figure 45, shown with the proximal end in a retracted position;

[0156] Figure 47 is a partial perspective view of a proximal end of the deployment syringe of Figure 45, shown with the proximal end in a deployed position;

[0157] Figure 48 is a partial side view of a distal end of the deployment syringe of Figure 48;

[0158] Figure 49 is a partial side view of an introducer of a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure, including a detail call-out; Figure 50 is a partial perspective view of a body of an introducer of a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure;

[0159] Figure 51 is a transparent partial perspective view of an introducer and outer shaft of a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure;

[0160] Figure 52 is a partial perspective view of the introducer and outer shaft of Figure 51;

[0161] Figure 53 is a partial perspective view of a proximal end of the introducer and outer shaft of Figure 51;

[0162] Figure 54 illustrates a system for transfer of reproductive material to the reproductive tract of an animal, including a display screen, a power pack, a device for accessing the reproductive tract of an animal according to another embodiment of the present disclosure, a deployment syringe, a straw of reproductive material and a probe;

[0163] Figure 55 is a cross-section of an elongate probe of according to one embodiment of the present disclosure;

[0164] Figure 56 is a cross-section of an elongate probe of according to another embodiment of the present disclosure;

[0165] Figure 57 shows temperature data recorded in response to a delivered bolus of thermal energy by two elongate probes according to the disclosure deployed in respective uterine horns of a cow; and

[0166] Figure 58 illustrates the use of a random forest model to determine the most significant covariates for predicting the presence / absence of a CL and location within the uterus (left vs right horn).

[0167] Detailed Description

[0168] In the drawings, reference numeral 10 generally designates a device for accessing the reproductive tract of an animal according to the present disclosure. The device 10 may be configured for transfer of reproductive material into the uterus of the animal.

[0169] The term “reproductive material” as used herein may refer to a substance including biological material, such as semen or an embryo. In such cases, the device may be referred to as a reproductive material transfer device or, more specifically, an artificial insemination (Al) device and / or embryo transfer (ET) device. Although the device 10 is described below primarily in the context of embryo transfer, it should be appreciated that the concepts disclosed herein are not limited to this use and that the device may be used for artificial insemination, delivery of a therapeutic substance, collection of samples or sensing of data (e.g. for diagnostic or monitoring purposes).

[0170] The term “animal” as used herein may refer to a female mammal. The animal may be a livestock animal. Although the examples described herein are configured particularly for use with bovine animals, this is not intended to be limiting on the scope of the disclosure. The device may be configured for use with animal species including but not limited to bovine, caprine, ovine or porcine.

[0171] The term “proximal end” as used herein refers to the end of the device (or component) that is closes to the user in use.

[0172] The term “distal end” as used herein refers to the end of the device (or component) that is furthest from the user in use.

[0173] Referring initially to Figures 1-8, the device 10 comprises an introducer 100. A partial view of an example introducer 100 is shown in Figure 1. The introducer 100 comprises an introducer shaft 110 extending longitudinally from a proximal end 111 (shown in Figure 8) to a distal end 112. A distal region 115 of the introducer 100 is configured for insertion into and / or through a uterine cervix of the animal. The introducer shaft 110 may have a length configured for insertion through a cervix of the animal. The length of the introducer shaft 110 may be configured for use with a desired type of animal, for example a particular species and / or breed. A length of the shaft 110 may be configured based on an expected maximum cervical length of the animals with which the device 10 is to be used, to facilitate insertion of the introducer shaft 110 through the cervix. For example, the introducer shaft 110 may have a length of between about 10 cm and about 20 cm, between about 12 cm and about 18 cm, between about 14 cm and about 16 cm or about 15 cm.

[0174] The introducer 100 may be formed from a metal, for example, stainless steel. The introducer 100 may be formed by 3D printing. Additionally, or alternatively, the introducer 100 may be formed from plastics. For example, one or more portions of the introducer 100 may be injection moulded or over-moulded.

[0175] The device may comprise one or more elongate probes 200. In illustrated examples, the introducer 100 is configured to receive first and second elongate probes 200a, 200b. In other examples, the device 10 may have only a single elongate probe 200a. The first and second elongate probes 200a, 200b are each slidably receivable by the introducer 100 and extendable from the distal region 215 of the introducer 100. The first and second elongate probes 200a, 200b may be configured to extend from the introducer 100 into respective first and second uterine horns of the animal, to reach respective first and second target regions of the uterine horns. The first and second elongate probes 200a, 200b may be individually and / or simultaneously extendible from the introducer 100. In other examples, the device 10 may comprise at least one elongate probe 200, configured to be slidably receivable by the introducer 100 and extendable from the distal region 115 of the introducer 100 into a single uterine horn of the animal to reach a target region of the uterine horn.

[0176] The target region(s) may be identified as a desired location for deposition of the reproductive material (or therapeutic substance) within the uterine horn. In some examples, the target region(s) may be identified as a desired location for obtaining of the sensed data (e.g. temperature data) within uterus. For example, it may be desirable to obtain the sensed data and / or deploy the reproductive material (e.g. embryo) in proximity to an oviduct in the uterine horn.

[0177] The first and second elongate probes 200a, 200b may be configured to be received within the introducer 100. The introducer shaft 110 defines first and second channels 120a, 120b configured to receive the first and second elongate probes 200a, 200b, respectively. As shown in Figure 8, the first and second channels 120a, 120b extend along the introducer shaft 110 from the proximal end 111 to the distal region 115. The channels 120a, 120b each define a distal opening 121a, 121b through which the first and second elongate 200a, 200b may extend. The first and second elongate probes 200a, 200b may be slidable in the distal direction to advance the probes distally relative to the introducer such that respective distal tips 202a, 202b of the first and second elongate probes 200a, 200b extend beyond the distal end 112 of the introducer shaft 100.

[0178] As shown in Figure 7, the introducer shaft 100 includes a central divider 130 separating the first and second channels 120a, 120b. The central divider 130 includes opposed first and second side walls 131a, 131b defining respective medial walls of the first and second channels 120a, 120b. The channels 120a, 120b may define a path along which the probes travel during sliding movement through the introducer shaft 110. The channels 120a, 120b extend generally parallel with a longitudinal axis X of the introducer shaft 110.

[0179] The introducer shaft 110 may include one or more structures configured to deflect the probes as they extend from the distal region 115 of the introducer 100. The probes may be deflected in one or more planes. As shown in Figure 7, in this example, the central divider 130 of the introducer shaft 110 includes a flared portion 132 in the distal region of the introducer shaft. The central divider 130 may increase in width toward the distal end 112 of the introducer shaft 110. At the flared portion 132, the first and second side walls 131a, 131b may extend in a direction away from a longitudinal axis X of the introducer shaft 110. For example, as shown in Figure 7, the walls 131a, 131b curve away from the longitudinal axis X in a transverse plane. The walls 131a, 131b at the flared portion may define a curved path of the channels 120a, 120b. The curved path may follow an arc having a radius of about 40 mm, for example. The distal portion of the walls 131a, 131b in the flared portion therefore acts as a wedge, deflecting the first and second elongate probes 200a, 200b laterally away from each other, and away from the distal end 112, as they extend from the introducer 100. In some examples, the first and second side walls 131a, 131b may extend in a direction away from the longitudinal axis in two planes. In the illustrated examples, the first and second side walls 131a, 131b curve away from the longitudinal axis X in a second plane. As can be seen in the side view of Figure 5, a portion of side wall 131b curves downward (based on a reference orientation of the device as shown in Figure 5) relative to the longitudinal axis X. As such, the probe 200b is deflected downward, away from the longitudinal axis X as it extends from the introducer shaft 110, as shown in Figure 6. In this example, the channels 120a, 120b are configured to deflect the probes downwards at an angle of approximately 45 degrees relative to the horizontal plane in the reference orientation.

[0180] Deflection of the probes in at least the transverse plane may assist accurate deployment of the first and second elongate probes 200a, 200b into the respective uterine horns of the animal. For example, deflection of the first and second elongate probes 200a, 200b during extension from the introducer 100 may promote the distal tips 202a, 202b of the first and second elongate probes 200a, 200b moving away from each other laterally as they are extended, inhibiting the first and second elongate probes 200a, 200b from entering the same uterine horn. That is, when the probes are extended in vivo, lateral deflection of the first and second elongate probes 200a, 200b may promote the first and second elongate probes 200a, 200b extending on opposite sides of the internal bifurcation, or the point at which the uterine horns begin to fork.

[0181] The channels 120a, 120b may be at least partially open. For example, the channels 120a, 120b may be open along at least part of a length of the channel. In the example introducer 100 of Figures 1-8, the walls 131a, 131b partially enclose the channels 120a, 120b, such that the channels 120a, 120b are open on one side. Open channels may enhance ease of cleaning after use of the device 10, for example by increasing access to an inner region of the channels and visibility of any residual mucus or other material accumulated in the channels 120a, 120b after use.

[0182] The walls 131a, 131b may be curved to define a C-shaped cross-section of the channels 120a, 120b. The walls 131a, 131b may be configured to enclose the channels 120a, 120b to a sufficient extent to retain the first and second elongate probes 200a, 200b within the channels 120a, 120b as the probes slide through the channels 120a, 120b.

[0183] In some examples, the walls 131a, 131b may include one or more projecting lip portions at an outer edge of the walls 131a, 131b. For example, Figure 49 shows an introducer 100 including lip portions 133. The lip portions 133 may be provided at one or more locations along the length of the channels 120a, 120b. The lip portions 133 may extend toward a centre of the channel to further enclose the channels 120a, 120b at the location(s) of the lip portions 133. In some examples, the lip portions 133 may be provided extending from either side of the channels 120a, 120b. For example, the lip portions 133 may extend substantially symmetrically on either side of the channels 120a, 120b. The lip portions 133 may be configured to facilitate improved retention of the first and second elongate probes 200a, 200b within the channels 120a, 120b as the probes slide through the channels 120a, 120b, for example during retraction of the probes 200a, 200b.

[0184] In other examples, the channels 120a, 120b may be substantially enclosed. For example, Figures 20-22 illustrate an introducer 100 having closed channels in the form of lumens which extend through an interior of the introducer 100 from the proximal end 111 toward the distal end 112 and are configured to receive the first and second elongate probes 200a, 200b.

[0185] Probes

[0186] In some examples, the first and second elongate probes 200a, 200b may be configured for transfer of material to the target region of the uterine horns. The material may include a reproductive material and / or a therapeutic substance.

[0187] The first and second elongate probes 200a, 200b may each comprise a tubular body 205a, 205b. The tubular body 205a, 205b may extend between a proximal end of the probes and the distal tips 202a, 202b. The first and second elongate probes 200a, 200b may be configured to receive the material, such as the reproductive and / or therapeutic substance for transfer through the probes to the target region of the uterine horn. For example, the probes may each comprise a tubular body 205a, 205b. The tubular body 205a, 205b may extend between a proximal end 201a, 201b of the probes and the distal tips 202a, 202b. The tubular body 205a, 205b may define one or more internal lumens. For example, the tubular bodies 205a, 205b may comprise at least a first lumen configured for receiving material (such as reproductive material) and facilitating transfer of the material from the proximal end 201a, 201b to the distal tip 202a, 202b of the first and second elongate probes 200a, 200b. In some examples, the first and second elongate probes 200a, 200b may include at least a lumen configured to receive one or more sensors and / or electrical connecting members, such as a cable or lead. In some examples, the first and second elongate probes 200a, 200b may define a plurality of lumens.

[0188] An example first elongate probe 200a is shown in detail in Figures 9-11 and discussed further below. Unless specified otherwise, second elongate probe 200b should be understood to include equivalent features as described in relation to the first elongate probe 200a.

[0189] As shown in the example of Figures 10 and 11, the first elongate probe 200a includes a tubular body 205a. The tubular body 205a may be configured to receive one or more sensor units and / or may be configured to deploy material from the distal end of the first elongate probe 200a into the uterine horn.

[0190] The first elongate probe 200a may be configured to have a desired level of rigidity. The rigidity may be configured to be high enough to inhibit kinking or buckling of the first elongate probe 200a during insertion through the channel 120a of the body 300 and introducer 100, while maintaining a degree of flexibility sufficient to allow the first elongate probe 200a to conform to the shape of the uterine horn during deployment through the horn. The tubular body 205a of the first elongate probe 200a may be configured to confer a desired level of rigidity to the first elongate probe 200a. The tubular body 205a may include a stiffening member, such as a wire or one or more ridge elements. Additionally, or alternatively, the tubular body 205a may include a braided structure.

[0191] In some examples, a portion of the first elongate probe 200a (e.g. at least a distal region of tubular body 205a) may be configured to be resiliently flexible. For example, the first elongate probe 200a may be formed with a curved shape in the longitudinal direction (for example, by thermoforming the tubular body 205a). The first elongate probe 200a may be configured to straighten during insertion through the channel 120a and to return to the curved shape as the first elongate probe 200a exits the distal end of the channel. This may enhance conforming of the first elongate probe 200a to the natural shape of the uterine horn during insertion and / or minimise forces applied between the probe first elongate 200a and the horn.

[0192] The tubular body 205a defines an internal transfer lumen 220a. The transfer lumen 220a extends to the distal tip of the first elongate probe 200a. The transfer lumen 220a may be provided in fluid connection with one or more openings, such as one or more deployment ports, allowing transfer of material from the transfer lumen to an exterior of the first elongate probe 200a. The deployment ports may be positioned at or adjacent to the distal tip 202a of the first elongate probe 200a and configured to facilitate release of reproductive material from at or adjacent to a distal end of the first elongate probe 200a.

[0193] In the example of Figures 9-11, the first elongate probe 200a comprises a deployment port 210a. The deployment port 210a may define one or more openings connecting the transfer lumen with an exterior of the first elongate probe 200a. As shown in Figures 10 and 11, in this example, the deployment port comprises a cylindrical bore extending through the distal tip 202a of the first elongate probe 200a, transverse to a longitudinal axis of the first elongate probe 200a. The bore extends through the distal tip 202a to define two openings on opposed sides thereof. In other examples, a plurality of discrete deployment ports may be provided in fluid communication with the transfer lumen 220a. For example, one or more deployment ports may be provided through a side wall of the tubular body 205a. The deployment ports may be provided at or adjacent to the distal tip 202a, or spaced from the distal tip 202a. The position of the deployment ports relative to the distal tip 202a of the first elongate probe 200a may be selected to facilitate release of the material at one or more desired locations within the uterine horn.

[0194] In some examples, the first and second elongate probes 200a, 200b may be configured for transfer of the material from proximal ends of the first and second elongate probes 200a, 200b to the respective deployment ports. In Figures 12 to 16, the first elongate probe 200a includes a connector 260a configured for connection to the proximal end 201a of the tubular body 205a. The connector 260a may comprise at least one connector port. The connector port may be configured for connection to a source of material for transfer to the uterine horns.

[0195] A bolus of fluid may be delivered through the connector 260a to drive the reproductive material through the first elongate probe 200a. The fluid bolus may comprise a liquid and / or a gas.

[0196] In some examples, the connector may comprise a Luer fitting 261a. The Luer fitting 261a may be configured for connection to a fluid source, such as deployment syringe 500 as shown in Figures 12-14, or as shown in Figures 45-48. The syringe 500 may be configured to receive the material for introduction to one of the first and second elongate probes 200a, 200b. For example, as shown in Figure 12, the syringe 500 may comprise a body 510 defining an opening 511 configured to receive the reproductive material. The syringe may be configured to receive a flushing fluid. The syringe may comprise a fluid opening 512 configured for connection to the connector 260a and a plunger 513 configured to translate relative to the syringe body 511 to drive the contents of the syringe 500 through the fluid opening 512.

[0197] The fluid may be used to effect ejection of the material out of the deployment port 210a by displacement. For example, fluid may be driven through the probe by application of pressure to the fluid, for example from the proximal end of the first elongate probe 200a.

[0198] The plunger 513 may be configured to eject a volume of fluid sufficient to drive the material through the first elongate probe 200a to the distal end and through the deployment port 210a. In some examples, the plunger 513 may be configured for manual actuation. In other examples, the plunger 513 may be automatically actuated.

[0199] In some examples, the plunger 513 may be configured to be actuated by application of linear force to move the plunger 513 relative to the syringe body 510. In the syringe 500 shown in Figures 12-13, the plunger 513 is configured to be pushed and / or pulled to translate the plunger 513 relative to the syringe body 510. In some examples, the plunger 513 may be configured to be actuated by application of rotational force, wherein rotation of the plunger 513 causes the plunger 513 to move linearly relative to the syringe body 510. For example, the syringe 500 shown in Figures 45-48 includes a rotatable plunger 513 configured to be rotated to advance or retract the plunger 513 from the syringe body. Rotational advancement of the plunger 513 may facilitate greater control over the rate of ejection of the syringe contents.

[0200] The syringe 500 and / or plunger 513 may comprise a rate limiting mechanism configured to limit a rate at which the plunger may be translated relative to the syringe. For example, the plunger 500 may include a screw, gear and / or ratchet mechanism, or other suitable mechanism. The surface area to volume ratios in the internal diameter of the transfer lumen may result in relatively high resistance forces, which must be overcome to effect movement of fluid through the tube. However, application of excess force to the plunger may result in undesirable pressure levels and / or ejection velocity. The rate limiting mechanism may inhibit application of excess pressure by a user and promote introduction of the fluid bolus to the first elongate probe 200a at a rate which will not cause damage to the probe, reproductive material and / or animal.

[0201] The deployment syringe 500 may be configured to draw fluid (e.g. transfer medium or air) into the syringe body 510. For example, the syringe 500 may be configured to draw fluid into the syringe prior to loading of the reproductive material (e.g. straw 20) to the syringe 500. Drawing fluid into the syringe body 510 may be accomplished by retracting the plunger 513. Figures 12, 13 and 46 show the plunger 513 in a retracted position relative to the syringe body 510. In some examples, the syringe 500 (for example the syringe body 510 and / or the plunger 513) may include an indicator, such as one or more markings, to indicate to a user a position of the plunger 513 relative to the syringe body 510. The indicator may indicate a desired or maximum retraction position for the syringe. The retraction position may correspond to a desired or maximum fill level for the syringe 500. For example, Figure 46 shows an indicator in the form of the word “MAX” and associated arrow to show a position of the plunger 513 relative to the syringe body, corresponding to a maximum recommended fill level for the syringe 500.

[0202] In other examples, the first elongate probe 200a may be configured to receive the material at or adjacent to a distal region of the first elongate probe 200a. In such examples, a fluid bolus may be introduced to the transfer lumen 220a of the first elongate probe 200a to effect deployment of the material from the distal end of the first elongate probe 200a.

[0203] In other examples, the fluid may be thermally expanded to displace the material, to force the material out of the deployment port 210a.

[0204] Reproductive material may be provided in a straw 20, as is common practice in the art. The straw may contain the reproductive material (e.g. semen or an embryo) and may be sealed at its proximal and distal ends, for example by removable plugs. The probe transfer lumen 220a may be configured to receive the straw 20 at a proximal end of the straw, for example via the syringe 500. The syringe 500 and / or the proximal end of the first elongate probe 200a (for example, connector 260a) may include a seat configured to inhibit distal movement of the straw 20. In other examples, the first elongate probe 200a may be configured to receive a straw of reproductive material into a receiving region at a distal end of the first elongate probe 200a.

[0205] Probe sensors

[0206] The first and second elongate probes 200a, 200b may be configured to receive one or more sensors. The first and second elongate probes 200a, 200b may comprise one or more sensors, such as a temperature sensor. In some examples, the first elongate probe 200a comprises one or more first sensors and the second elongate probe 200b comprises one or more second sensors. The sensors may be configured to be positioned at or adjacent to a distal region of the first and second elongate probes 200a, 200b. The sensors may be configured to obtain sensed data from one or both of the first and second uterine horns when one or both of the first and second elongate probes 200a, 200b are extended into the uterine horns.

[0207] The elongate probes 200a / b may comprise one or more sensors, such as a temperature sensor. The elongate probes 200a / b may comprise a heating element.

[0208] The first elongate probe 200a may be configured to receive the one or more sensors within the first elongate probe 200a, for example within a lumen thereof, such as within tubular body 205a. Referring again to Figures 10 and 11, in this example, the first elongate probe 200a includes a sensor lumen 225a. The sensor lumen 225a is configured to receive a sensor 250a and one or more associated sensor leads 251a. When inserted, the sensor 250a may be positioned at or adjacent to the distal tip 202a of the first elongate probe 200a. The sensor 250a and lead 251a may be slidably insertable to the sensor lumen 225a. The sensor lumen 225a may include a stop member configured to inhibit movement of sensor 250a in a distal direction beyond the stop member. For example, the sensor 250a may be configured to abut the stop member when in an assembled position. In some examples, such as shown in Figures 10 and 11, the sensor lumen 225a may comprise a blind distal end. The sensor 250a may be configured to abut the blind distal end when inserted.

[0209] The sensor 250a may be configured to obtain data from the target region of the uterine horn when the distal tip 202a of the probe is positioned at or adjacent to the target region. The probe 200b may be similarly configured to receive a discrete sensor, which may be substantially as described for sensor 250a. The lead 251a may be configured to provide power to the sensor 250a and / or transfer signals to and / or from the sensor 250a.

[0210] As shown in Figure 16, leads 251a, 251b may include respective connector portion 252a, 252b configured for connection to respective ports for facilitating power supply to the sensor and / or data transfer. The leads 251a, 25 lb may be configured to plug into a port in the body 300 of the device 10 via the connector portions 252a, 251b. The device 10 may include a cable 420 for connection with the controller 400 for data and / or power transfer. In some examples, the leads 251a, 251b may be configured for direct connection with the controller 400, and / or an alternative electronic device.

[0211] The device 10 may be configured for selective deployment of the material (for example, an embryo) from one of the first and second extendable probes 200a, 200b. In some examples, deployment of the material may be based on the sensed data obtained from the sensors.

[0212] The device 10 may comprise, or may be associated with, one or more processor or computing devices. The processor may be configured to receive and process sensed data from the sensor 250a. The device 10 may include, or be configured for use with, a controller. The controller may be configured to receive and process the sensed data to determine the presence or absence and / or location of a corpus luteum in a uterine horn. In some examples, the device 10 may be configured to determine the presence of a corpus luteum in one or both uterine horns of the animal, based on the sensed data. For example, the device 10 may include, or be configured for use with, a controller 400. The controller 400 may be configured to receive and process the sensed data to determine the presence of a corpus luteum in a uterine horn. In some examples, the sensed data may comprise temperature data.

[0213] In some examples, processing the data may comprise determining a temperature differential between the first uterine horn and the second uterine horn. The presence of a corpus luteum may be determined based on the determined temperature differential. For example, a higher temperature may indicate the presence of a corpus luteum.

[0214] Additionally, or alternatively, the presence of a corpus luteum may be determined based on a difference in heat flux between the first and second uterine horn. The device 10 may be configured to applying thermal energy to tissues adjacent to the first and second probes 200a, 200b. For example, the first and second elongate probes 200a, 200b may each include a heating element (such as a resistive heating element). The heating elements may be actuatable to increase a temperature of the heating element, thereby to apply thermal energy to the surrounding tissue. The thermal energy may be applied for a predetermined period of time. The device may be configured to sense temperature data during and / or after applying of the thermal energy. Processing the data may comprise determining a rate of temperature increase of the tissue during applying of the thermal energy and / or determining a rate of temperature decrease following cessation of applying of the thermal energy. A slower rise in temperature during applying of the thermal energy and / or a faster decrease in temperature following cessation of application of the thermal energy may indicate relatively higher perfusion of the tissue, which may serve as an indicator of the presence of a corpus luteum.

[0215] Examples an elongate probe 200a including a heating element (e.g. resistor) 203a and a temperature sensor (e.g. thermistor) 204a are shown in cross section in Figures 55 and 56. In the illustrated examples, the heating element 203a and temperature sensor 204a are located within tubular body 205a. In some examples, the heating element 203a and temperature sensor 204a may be provided as a surface mount on an exterior surface of the probe 200a. In the example probe 200a of Figure 55, the heating element 203a and temperature sensor 204a are located within tubular body 205a, surrounded by a pocket of air. By contrast, in the example probe 200a of Figure 57, the heating element 203a and temperature sensor 204a are encased with a layer of plastic material 206a within the tubular body 205a. The plastic material 206a may be an epoxy resin or other suitable material, such as other plastic material. Encasing the heating element 203a and temperature sensor 204a may increase the thermal diffusivity of the probe 200a, improving heat conductivity out of the probe 200a to the surrounding tissues.

[0216] In some examples, the temperature sensor may comprise a printed resistance temperature detector (RTD). In some examples, the temperature sensor 204a and / or the heating element 203a may be provided as part of a flexible circuit. The temperature sensor 204a and / or the heating element 203a may be provided on a substrate. The substrate may be printed directly onto the respective probe 200a, or may be printed on a flexible substrate and attached (e.g. laminated, or applied via adhesive) to the probe 200a.

[0217] In some examples, device 10 may include a control mechanism for controlling the applying of thermal energy. For example, Figure 50 shows a device 10 including a button 307 on the body 300 for activating and / or deactivating the heating element to start / stop applying of the thermal energy. In some examples, the applying of thermal energy may be automated or semiautomated. For example, the device 10 may be configured to allow a user to trigger heating (e.g. by pressing button 307), after which the device 10 runs an automated heating and cooling cycle, based on a one or more of a predetermined heating time, and a predetermined temperature rise.

[0218] The device 10 may be configured to facilitate selective deployment of reproductive material from one of the first and second elongate probes 200a, 200b, based on the determined presence of a corpus luteum (CL). For example, the device may be configured to activate deployment of reproductive material from only one of the extended probes 200a, 200b into the horn in which a corpus luteum is detected. In other examples, the device 10 may be configured to provide an indication to a user to indicate the presence of the corpus luteum and the horn (e.g. left or right) in which the corpus luteum was detected. The user may then manually deploy the material (e.g. an embryo) into the horn with the corpus luteum.

[0219] In some examples, the elongate probes 200a and 200b are configured to detect the presence of a CL and deploy the reproductive material. In other examples, these functions may be performed by separate sets of probes 200a / 200b having different characteristics. For example, a first pair of elongate probes 200a and 200b including sensors may be used for detecting the presence of a CL, while a second probe (or probes) 200a and / or 200b including a tubular body 205a / 205b may be used for deploying the reproductive material.

[0220] Introducer

[0221] The distal region 115 of an example introducer 100 is shown in detail in Figures 17 to 19. In this example, the introducer 100 includes a helical guide member 150 provided on an outer surface of the introducer shaft 110 in the distal region 115.

[0222] The introducer 100 is configured for rotation about the longitudinal axis of the introducer shaft 110 during insertion to the cervix. The helical guide member 115 may be configured to assist rotational advancement of the introducer 100 through the cervix.

[0223] The helical guide member 150 may comprise a protruding thread extending from an outer surface of the introducer shaft 110 in the distal region. The outer surface of the introducer shaft 110 may have a substantially cylindrical shape, and the helical guide member may comprise a projecting ridge extending from the surface of the shaft 110 and extending along and around the outer surface of the introducer shaft 110 to form a helix.

[0224] The helical guide member 150 may extend around the introducer shaft 110 for at least one revolution. In some examples, the helical guide member may extend around the introducer shaft 110 for more than one revolution. For example, as shown in Figures 17 to 19, the helical guide 150 extends around the shaft for about 1.5 revolutions. In other examples, the helical guide may extend around the shaft for 2 or more revolutions, such as for 2.5, 3, 3.5, 4, 4.5, 5 or more revolutions. For example, the introducer 100 shown in Figure 23 includes a helical guide which extends around the shaft for approximately 4 revolutions. The helical guide member 150 may extend around the introducer shaft 110 at least in the distal region 115 of the introducer shaft 110. In some examples, the helical guide member 150 may extend along a length of the introducer shaft 110.

[0225] The helical guide member 150 may extend around the introducer shaft 110 in an anticlockwise direction, when viewed from the distal end 112 of the introducer 100. In other examples, helical guide member 150 may extend around the introducer shaft 110 in a clockwise direction when viewed from the distal end 112 of the introducer 100.

[0226] The helical guide member 150 may extend around the shaft in a continuous manner. In other examples, the helical guide member 150 may extend around the shaft in a discontinuous manner. In the example shown in Figures 17-19, the helical guide member is divided into discrete segments, interrupted by the channels 200a and 200b in the shaft. In other embodiments, the helical guide member may extend around the introducer shaft 110 in a substantially continuous manner. For example, the helical guide member 150 may extend over the channels 120a and 120b. In the example of Figures 20-22, the channels 121a, 121b are substantially enclosed and the helical guide member extends continuously about the outer surface of the introducer shaft 110 in the distal region 115.

[0227] The distal end 112 of the longitudinal shaft may have a tapered shape. For example, as best shown in Figures 17-25, the distal end 112 of the introducer shaft 110 has a curved taper with a rounded distal point, defining a bullet shaped tip.

[0228] The introducer 100 may comprise a projection 160 extending distally beyond the distal end 112 of the longitudinal shaft 100. In the examples shown in Figures 15-20, projection 160 is a continuation of the helical guide member 150. However, in other examples, the projection may include a structure separate from the guide member 150. The projection 160 may include a distal portion which extends distally beyond of the distal end 112 of the longitudinal shaft 110. The distal portion may be substantially straight. In some examples, the distal portion may extend substantially parallel to the longitudinal axis X of the introducer shaft 110 in at least one plane. In some examples, the distal portion may be curved in one or more planes, but may have a decreased degree of curvature relative to a proximal portion of the helical guide member 150, for example as shown in Figures 24 and 25.

[0229] The projection 160 may be axially offset from the central longitudinal axis X of the introducer shaft 110. Further, the projection 160 may be offset from an outer surface of the introducer shaft 110. As indicated in Figure 22, in this example, the shaft 110 has a cylindrical shape in the distal region 115 and the projection 160 is radially offset relative to an outer diameter of the cylindrical introducer shaft 110.

[0230] The projection 160 may be positioned relative to the introducer shaft 110 such that, in use, it is vertically offset relative to a central axis of the introducer shaft 110 when the introducer shaft 110 is in an initial position prior to rotation of the introducer 110 during navigation of the cervix. For example, the projection 160 may be positioned above or below the central axis of the introducer shaft 110 in the initial position. The projection 160 may be additionally or alternatively laterally offset relative to a central axis of the introducer shaft 110 in the initial position. For example, as shown in Figure 25, the projection 160 is positioned on an upper surface of the introducer shaft 110, and the distal end 161 of the projection 160 is laterally offset form the central axis of the introducer shaft 110.

[0231] The projection 160 may have an enlarged distal end. For example, the projection 160 may thicken toward its distal end 161. The distal end 161 of the projection 160 may be rounded and / or may have a bulbous shape. For example, the distal end 161 of the projection 160 shown in Figure 24 includes a bulbous nib. A rounded and / or bulbous shape may reduce the risk of the projection causing damage to tissues of the cervix and / or uterus as the device is introduced.

[0232] The helical guide 150 and / or the projection 160 may assist in advancing the introducer 100 through the cervix of the animal. In some examples, the introducer 100 may be configured for axial rotation during insertion to the cervix. The cervix of the animal may not be positioned in longitudinal alignment with the vaginal canal. The off-centre position of the projection 160, in combination with rotational movement of the introducer 100, results in a sweeping motion of the tip 161 of the projection as the introducer 100 is rotated, which may assist in locating the cervical opening and inserting the introducer 100 to the cervix. Further, the projection 160 may assist in navigating through overlapping plicae circulares of the cervix, which may be interdigitated with one another to obstruct the cervical canal. The helical guide 150 may further assist in advancing the introducer 100 through the cervix. This may be, for example, by a screwlike mechanism in which the helical guide engages the tissue to exert a pulling force on the introducer shaft 110.

[0233] In some examples, the introducer 100 may include a projection without a helical guide member, or a helical guide member without a projection. The example introducer 100 shown in Figure 49, includes a projection 160 but does not include a helical guide member. In this example, the projection 160 comprises a forwardly extending finger, which is radially offset from the outer surface of the longitudinal shaft 110. The projection 160 has a distal portion which extends distally beyond the distal end 112 of the longitudinal shaft 110. The distal end 161 of the projection 160 has a rounded, bulbous shape.

[0234] Body

[0235] Figures 21-25, illustrate an example device 10 of the disclosure, including a body 300. The body 300 may be elongate and may extend from a proximal end 301 to a distal end 302. The body 300 may include a main body portion 303 between the proximal and distal ends 301, 302. The main body portion 303 may be substantially cylindrical.

[0236] The introducer 100 (or at least the distal region 115 of the introducer) may extend distally from the distal end 302 of the body 300. The main body portion 303 may have an outer circumference, which may be larger than an outer circumference of the introducer shaft 110.

[0237] A transition region 304 may be provided at or adjacent to the distal end 302. The transition region 304 may be tapered (or otherwise diminish in diameter), for example to provide a substantially smooth transition between the outer diameter of the main body portion 303 and the outer diameter of the introducer shaft 110.

[0238] In some examples, the introducer 100 may be axially and / or rotationally fixed relative to the body 300. For example, the introducer 100 and the body 300 may be integral with each other (and / or the body 300 may form part of the introducer 100). As shown in the examples of Figures 8 and 24-33 the introducer 100 is integral with the body 300 and extends distally from the distal end 302 of the body 300.

[0239] The channels 120a, 120b may extend through and / or along the body 300. For example, as shown in Figure 23, channel 120b extends along one side of the introducer 100 and continues along the body 300 toward the proximal end 301 of the body. In the example of Figure 23, the channel 120b stops short of the proximal end 301, distal of the handle portion 305. In other examples, the channel 120b may extend further toward the handle 305 and / or all the way to the proximal end 301 of the body 300.

[0240] In other examples, the introducer 100 and the body 300 may be separate components. The introducer may be axially and / or rotationally movable relative to the body 300. In such examples, the introducer 100 may be substantially housed by the body. In the example device 10 shown in Figures 36-38, the introducer 100 extends through a central bore in the cylindrical main body potion 303.

[0241] The body 300 in this example has a blunt distal end 302. The introducer 100 may be positioned substantially coaxially with an axis of the main body portion 303. The introducer 100 may be axially movable relative to the body 300 between an extended position and a retracted position, relative to the body 300. The distal region 115 of the introducer may be configured to extend beyond the distal end 302 of the body 300 in at least the extended position. In some examples, the distal region 115 of the introducer may also extend beyond the distal end 302 of the body 300 in the retracted position. In examples where the introducer 100 extends through

[0242] In the example of Figures 36 to 38, the channels 120a, 120b may extend along and / or through the introducer shaft 110 between the proximal end 111 and the distal end 112, through the body 300. The introducer 100 may include openings at a proximal end configured to provide access to the channels 120a, 120b for insertion of the first and second elongate probes 200a, 200b. For example, Figure 38 shows a proximal portion of the first and second elongate probes 200a, 200b extending from the proximal end 111 of the introducer shaft 110.

[0243] The body 300 may include a handle 305 for facilitating gripping by a user. In some examples, the handle may be provided substantially in line with the main body portion 303, as shown in Figures 26-33.

[0244] In other examples, the handle may be offset from the main portion of the body. For example, the handle 305 may be provided in the form of a “pistol grip”, as shown in the example of Figures 36 to 38.

[0245] The introducer 100 may additionally or alternatively include a grip portion 105 configured to enable manipulation of the introducer 100 by a user. For example, the user may grip the handle 305 of the body and the grip portion 105 of the introducer simultaneously with two hands. This may enable a user to easily manipulate an insertion angle of the device 10 (for example by manipulating the handle 305), while axially advancing and / or rotating the introducer 100 to navigate through the cervix of the animal.

[0246] The grip 105 may function as a stopping member, inhibiting longitudinal movement of the introducer 100 in the distal direction beyond a point at which the grip 105 abuts the proximal end of the main body portion 303. The length of the introducer shaft 110 and grip portion 105, relative to a length of the main body portion, may be configured such that the distal region 115 of the introducer protrudes beyond the distal end 302 of the body 300 by a predetermined distance, when the introducer 100 is in the extended position. The predetermined distance may be configured based on a desired depth of insertion of the introducer 100 through the cervix. Additionally, or alternatively, a separate means for limiting relative movement between the introducer 100 and the body 300 may be provided.

[0247] Outer shaft

[0248] Referring to Figures 26-33, the device 10 may comprise an outer shaft 310. The outer shaft 310 may be mounted to the body 300. The outer shaft 310 may partially enclose the body 300, to sheath at least a portion of the body 300. For example, the outer shaft 310 may comprise a hollow elongate structure extending from an open proximal end 311 to an open distal end 312. The outer shaft 310 may be configured to at least partially receive the body 300 within an internal lumen of the outer shaft 310. The outer shaft 310 may be slidably mounted to the body 300. The lumen may be configured to receive the body 300 in a close-fitting, nested relationship. The outer shaft 310 may be telescopically slidable relative to the body.

[0249] The outer shaft 310 may be configured for insertion into a vagina of the animal. For example, diameter and / or material of the outer shaft 310 may be configured to allow the outer shaft 310 to pass through the vagina of the animal without injuring the animal. The outer shaft 310 may function as a speculum. For example, the outer shaft 310 may function to set-off tissue from the introducer 100. The outer shaft 310 may be substantially rigid and / or otherwise configured to withstand forces applied to the shaft during insertion to the vagina without significant deformation.

[0250] The outer shaft 310 may be configured for vaginal insertion to a position in which the open distal end 312 of the outer shaft 310 is positioned adjacent to, or abutting, the cervix of the animal. A length of the outer shaft 310 may be selected such that the open distal end 312 can reach the cervix of the animal while the proximal end 311 remains external of the animal. In the inserted position, the open distal end 312 of the outer shaft 310 may be aligned with a proximal opening of the cervix. For example, a distal rim of the outer shaft 310 extending around the open distal end 312 may extend around the opening of the cervix when the outer shaft 310 is abutting the cervix. The open distal end 312 of the outer shaft 310 may provide a reference plane for relative extension of the introducer 100 through the cervix.

[0251] The outer shaft may be slidably movable between an extended position and a retracted position relative to the body 300 and / or the introducer 100. Figure 31 shows an example of the outer shaft 310 in the extended position. In the extended position, the open distal end 312 of the outer shaft 310 may be positioned substantially aligned with the distal end 112 of the introducer 100, or substantially aligned with the distal tip 161 of the helical guide. In other examples, in the extended position, the introducer 100 may be substantially covered by the outer shaft 310, being positioned wholly proximally of the open distal end 311 of the outer shaft 310.

[0252] Figures 28 and 29 show an example of the outer shaft 310 in a partially retracted position. In this position, at least the distal end 112 of the introducer 100 extends distally beyond the open distal end 311 of the outer shaft 310. As shown in Figure 30, all (or substantially all) of the introducer shaft 110 may extend beyond distally beyond the open distal end 311 of the outer shaft 310 when the outer shaft 310 is in the retracted position.

[0253] The outer shaft 310 may be configured to facilitate rotation of the body 300 and / or introducer 300 relative to the outer shaft 310. For example, the body 300 may be axially rotatable and longitudinally slidable relative to the outer shaft 310 to facilitate navigation of the introducer 100 through the cervix. Figure 28 shows the device 10 with the introducer 100 and body 300 in a first orientation relative to the outer shaft 310, with the outer shaft 310 in a partially retracted position. Figure 29 shows the body 300 and introducer axially rotated relative to the outer shaft 310. As mentioned previously, rotation of the introducer 100 may assist in advancing the distal region 115 of the introducer 100 through the cervix.

[0254] The outer shaft 310 may be releasably securable to the body 300 to inhibit axial and / or rotational movement of the outer shaft relative to the body 300. The outer shaft 310 and / or the body 300 may include a releasable outer shaft securing mechanism configured to secure the outer shaft 310 relative to the body 300. The securing mechanism may include a frictional engagement mechanism for increasing frictional resistance between outer shaft 310 and the body 300. For example, the outer shaft 300 may be secured in the extended position to inhibit retraction of the outer shaft 310 during insertion to the vagina. When released from the body 300, the outer shaft 310 may be configured to move substantially freely between the extended position and the retracted position. For example, the outer shaft 310 may move from extended position toward the retracted position as the introducer 100 is advanced through the cervix.

[0255] Imaging

[0256] The device 100 may comprise an imaging system. The imaging system may be configured to capture image data representative of an area ahead of and / or surrounding a distal end of the outer shaft 310 and / or the distal end 112 of the introducer. The imaging system may include at least one camera. In some examples, one or more cameras may be provided on the body 300 and / or the introducer 100. The imaging system may include a light source. The light source may be integrated with the camera. Alternatively, a separate light source may be provided.

[0257] In some examples, the imaging system may be configured to capture image data representative of an area ahead of and / or surrounding a distal end of the introducer 100 and / or the first elongate probe 200a and / or second elongate probe 200b. The system may include at least one camera and / or a light source provided at or adjacent to a distal tip of the introducer 100. This may enable visualisation of deployment of the probes 200a / 200b when the introducer 100 is positioned in the uterine body.

[0258] As shown in Figures 8 and 28-30, a camera 320 may be provided at or adjacent to a distal end of the body 300. The camera 320 may be provided in a port 321 extending through the tapered transition region 304.

[0259] Additionally, or alternatively, the camera 320 may be provided on the outer shaft 310. For example, one or more cameras may be mounted in or on the outer shaft 310, at or adjacent to the open distal end 312. Figures 51 and 52 illustrate an example device 10 having a camera provided on the outer shaft 310. In this example, the camera 320 is positioned on an internal surface of the outer shaft 310, adjacent to but offset from the open distal end 312. The outer shaft 310 includes a camera housing 322 defining a camera port 321 extending through the housing 322 for receiving the camera 320. The camera housing 322 may have a shape corresponding to an outer surface of the tapered transition region 304 of the introducer 100 to facilitate rotation of the introducer 100 without causing damage to the camera when the outer shaft 310 is in the retracted position relative to the introducer 100. In the example shown in Figures 51 and 52, an inner surface of the camera housing 322 is sloped and curved to correspond to a shape of the tapered transition region 304 such that the camera housing 322 is slidably mated with the introducer 100. In some examples, the device 10 may comprise one or more stops 306. The stops 306 may be configured to abut one another to limit motion between the body 300 and the outer shaft 310. The stops 306 may be positioned to inhibit the tapered transition region 304 from impacting the camera housing 322, thereby to inhibit damage of the camera 320 during relative movement of the various components of the device 10.

[0260] Providing a camera on the outer shaft 310 may enable improved visualisation of the region surrounding distal end 112 of the introducer during insertion of the device 10 to the vagina due to a decreased distance between the camera and the distal end 112. Further, positioning a camera on the outer shaft 310 may decouple movement of the introducer 100 from movement of the camera, which may enhance ease of visualisation of the area ahead of and / or surrounding the distal end 112 of the introducer 100, particularly when the introducer 100 is rotated during insertion. Providing a camera spaced from the distal end 112 may enhance ease of visualisation of the position of the tip 112 relative to surrounding anatomical features, particularly the cervical opening.

[0261] The device 10 may include a processor configured to receive and process image data from the camera, for example camera 320. The images may be provided for display, for example on a display device, such as display 415 of controller 400 shown in Figure 39.

[0262] The camera 320 may be configured such that the distal end 112 of the introducer is positioned within a field of view of the camera 320. In some examples, the introducer 100 may include a marker at or adjacent to the distal end 112 of the introducer 100. The marker may assist a user in visualising the position of the distal end 112. For example, the marker may comprise a coloured portion, or other visually distinguishing feature of the introducer 100. In some examples, the bulbous distal tip 161 of the projection 160 may function as the marker. The distal tip 161 may include a coloured portion or may be over- moulded or otherwise provided with a coating (e.g. of a distinctive colour) to visually distinguish the distal tip 161 from the rest of the device 10 and the surrounding environment. Brace plate

[0263] The device 10 may comprise a stop member configured for limiting a depth of insertion of the device into the animal. The stop member may be configured to limit a depth of insertion of the outer shaft 310 and / or the introducer 100 into the animal. A longitudinal position of the stop member relative to the outer shaft and / or the introducer may be adjustable to set a desired depth of insertion and / or to prevent further insertion once a desired depth of insertion has been achieved.

[0264] The device 10 may comprise a releasable stop member securing mechanism for inhibiting relative movement between the stop member and the outer shaft 310 and / or the introducer 100. The stop member securing mechanism may secure the stop member by frictional engagement between the stop member securing mechanism and the outer shaft 310 and / or the introducer 100. For example, the stop member may be configured to inhibit further insertion of the outer shaft 310 once the distal opening 312 is positioned adjacent to or abutting the cervix. Additionally, or alternatively, the stop member may be configured to inhibit further insertion of the body 300 and / or introducer 100 once a desired position of the distal end 112 of the introducer 100 within the cervix or uterus has been reached.

[0265] One example of a stop member 350 is shown in Figures 26-35. In this example, the stop member 350 includes a brace plate 355 extending substantially transverse to a longitudinal axis of the introducer shaft. The brace plate 355 is configured to abut an external surface of the animal’s body, adjacent to a vaginal opening during insertion of the device 10 to the animal as shown in Figures 40 to 44.

[0266] In the example of Figures 26-35, the brace plate 355 is provided mounted on the outer shaft 310 and axially movable relative to the outer shaft 310. The stop member 350 includes a mounting collar 351 configured to mount to an outer surface of the shaft 310.

[0267] In some examples, the brace plate 355 may be removable from the device 10. A removable brace plate 355 may enable the brace plate 355 to be attached to the device and used with the device 10 based on the discretion or preference of the user.

[0268] In some examples, the brace plate 355 may comprise a substantially planar structure, extending radially from the mounting collar. The brace plate 355 may substantially surround the mounting collar. The brace plate 355 may be sized to provide adequate area for a user’s hand to press against the brace plate 355 against the rear of the animal. In some examples, the brace plate may have a width of about 14cm, 16cm, 18cm, 20cm, 22cm or more.

[0269] In some examples, the brace plate 355 may be substantially rigid. In other examples, the brace plate 355 may be formed from a flexible material. A rigidity of the brace plate 355 may be configured to be flexible enough to allow tactile feedback of the animal’s muscle movements and tension through the brace plate 355. This may allow a user to sense subtle movements of the animal during the insertion procedure and react accordingly.

[0270] In some examples, the brace plate 355 may be configured to extend partially into the vagina of the animal when in use. The brace plat 355 may be configured to inhibit airflow into and / or out of the vagina of the animal in use.

[0271] The mounting collar 351 may include a releasable stop member securing mechanism for inhibiting movement of the mounting collar 351 and brace plate 355 relative to the outer shaft 310. The stop member securing mechanism may include a pin 352, for example as shown in Figures 34 and 35. The pin 352 may be configured to engage a longitudinal track 313 in the outer shaft 310 to guide adjustment of the longitudinal position of the brace plate 355 relative to the outer shaft 310. Engagement of the pin 352 in the track 313 may also inhibit rotation of the stop member 350 relative to the outer shaft 310. In the illustrated examples, the track 313 is serrated and configured to receive the pin 352 at a predetermined plurality of engagement locations along the length of the track. The pin 352 comprises a threaded shaft 353, engageable with a correspondingly threaded interface of the collar 351 to enable tightening of the collar 351. Tightening of the collar 351 secures the stop member 350 to the outer shaft 310 and inhibits relative movement between the stop member 350 and the outer shaft 310. In other examples, other suitable securing mechanisms may be used.

[0272] Figures 31-33 show the body 300, introducer 100, outer shaft 310 and stop member 350 in various positions relative to each other. Figure 31 shows the outer shaft 310 in a telescopically extended position relative to the body 300, covering the introducer 100, with the stop member 350 at an intermediate position. Figure 32 shows the outer shaft 310 in the retracted position, with the introducer 100 exposed and the brace plate in a distal-most position relative to the outer shaft 310. Figure 33 shows the brace place moved to a proximal-most longitudinal position relative to the outer shaft 310.

[0273] In other examples, the stop member 350, may be mounted to the body 300 of the device 10. The stop member 350 may be provided on the body 300, proximally of the outer shaft 310. In such examples, the position of the stop member 350 may be configurable to limit a depth of insertion of the body 300 to the animal. For example, as shown in Figure 36, the stop member 350 is mounted to the main body portion 303. A position of the stop member 350 relative to the body may be longitudinally adjustable. The stop member 350 may be secured to the body 300 via one or more securing mechanisms, such as the stop member securing mechanism described above. For example, the track 313 may be provided in the main body portion 303 and engagable with the pin 352 to guide longitudinal movement and / or positioning of the stop member 350 relative to the body 300. Cavity sensing

[0274] In some examples, the device 10 the device may include at least one optical sensor arrangement configured to obtain sensed data indicative of an optical property of tissue adjacent to the distal end 112 of the introducer 100. For example, a sensor arrangement may be configured to obtain sensed data indicative of a reflectivity of the tissue and / or a colour of the tissue adjacent to the distal end 112 of the introducer 100.

[0275] In some examples, the optical sensor arrangement may comprise a light source configured to emit illuminating light and at least one optical sensor configured to detect reflected light. The introducer 100 may include one or more sensor ports at or adjacent to the distal end 112 of the introducer, configured to house the light source and / or the optical sensor.

[0276] In some examples, the light source may be configured to emit white light. Additionally and / or alternatively, in some examples, the light source may be configured to emit light of a selected colour, such as at a selected wavelength or in a selected band of wavelengths.

[0277] As shown in Figure 2, in some examples, the introducer 100 includes an optical sensor arrangement 140 including a first sensor port 141 and a second sensor port 142 provided in the distal end 112 of the introducer 100. The first and second sensor ports 141, 142 may be configured to house the light source and optical sensor (for example, a camera).

[0278] In some examples, the device 10 comprises a first light guide configured to transmit the illuminating light from the light source and emit the illuminating light from the distal end of the introducer 100. The device 10 may further comprise a second light guide configured to receive light reflected from the tissue and transmit the reflected light to the optical sensor. The first and second light guides may extend through the longitudinal shaft to the distal end of the introducer 100. In such examples, the sensor ports 141, 142 may be configured to house distal ends of the light guides. The first and second light guides may comprise first and second optical fibres, for example.

[0279] Additionally, or alternatively, one or more light sources may be provided on the device in other positions. For example, the distal end 161 of the projection 160 may be configured to emit light. The distal end 161 may include a light source, or a light conduit in connection with a light source.

[0280] The positions and configuration of the sensor ports 141, 142 may be configured to enhance detection of light reflected from the tissue. For example, positioning the sensor ports 141, 142 relatively close together may reduce the chance that the reflected light is blocked by surrounding tissues rather than reaching the second sensor port 142. In some examples, the sensor ports 141, 142 may extend substantially parallel to the longitudinal axis of the introducer shaft. In other examples, the sensor ports 141, 142 may be angled toward the longitudinal axis of the introducer shaft and / or toward each other, for example as shown in Figure 3.

[0281] A processor may be configured to receive sensed data from the optical sensor arrangement 140 and process the received data to determine a position of the distal end 112 of the introducer shaft 110 within the reproductive tract of the animal. The controller 400 may be configured to detect a change in the optical property of the tissue as the introducer 100 is advanced through the cervix. Based on the change in the optical property, controller 400 may be configured to identify a transition between the cervix and the uterus. The processor may therefore enable determining when the distal end 112 of the introducer shaft 110 is at or adjacent to a transition region between the cervix and the uterus, based on a change in the colour and / or reflectivity of the tissue. In some examples, the controller 400 may be configured to trigger a notification to alert a user when the distal end 112 of the introducer 100 reaches the transition between the cervix and the uterus during insertion of the introducer 100.

[0282] In some examples, the introducer 100 further comprise an image capture element, such as a camera, positioned at or adjacent to the distal end 112 of the introducer. The image capture element may be provided in addition to, or instead of, camera 320. Additionally, or alternatively, the second light guide may be configured to transmit received light to an image capture element remote from the distal end 112. The image capture element may be configured to facilitate visualisation of the first elongate probe 200a and / or second elongate probe 200b during extension from the introducer 100 into the uterine horns. Visualisation of probe extension into may enable a user to verify that the probes have been successfully deployed into separate uterine horns.

[0283] Controller

[0284] As described above, the device may comprise (or may be configured for use with) a controller 400. One or more components of the controller 400 may be housed within or provided on the body 300 of the device 10. Additionally, or alternatively, one or more components may be separate from the body 300 of the device 10.

[0285] In some examples, the device 10 is connected directly to the controller 400 by cable connection (e.g. by cable 420). In some examples, the device 10 may connect indirectly to the controller 400, for example via wireless connection.

[0286] The controller 400 may be configured to receive data from the sensors of the first and second elongate probes 200a, 200b, the optical sensor arrangement 140 and / or the camera 320. The controller 400 may include one or more processors configured to process the received data. In some examples, the controller 400 may include a communications module 430, for example as shown in Figure 54. The communication module may be configured for wireless data communication with the display 410 and / or with an external computing device.

[0287] The communication module 430 may include a power source, such as a battery. In other examples, the device 10 may comprise a discrete power source, a power source integral with the body 300, or may be connectable to mains power. The power source may be rechargeable.

[0288] The communication module 430 in Figure 54 is connected to the device 10 via a power and / or data transfer cable. In some examples, the communication module 430 may be integral with the device 10. The communication module 430 may be configured to be secured to the user (e.g. via a clip) or stowed in a pocket of the user while in use.

[0289] The controller 400 may be configured to provide feedback to a user to indicate one or more of a condition, state or position of the device. Additionally, and / or alternatively, the controller 400 may be configured to indicate one or more sensed parameters associated with the animal.

[0290] In some examples, the controller 400 may include one or more indicators, such as visual, audible or haptic indicators. For example, as shown in Figure 39, the display device 410 includes a visual indicator configured to illuminate to indicate the detected location of the tip 112 of the introducer and the side on which a corpus luteum is detected. In some examples, additionally or alternatively, one or more indicators may be provided on the body 300 of the device 10 and / or on the communication module 430. The controller 400 may be configured to display images based on the sensed data. For example, the display device 410 may be configured to display real-time video capture from the camera 320. The display device 410 may include a display screen 415 configured for displaying the images.

[0291] In some examples, the controller 400 may include a user interface. In some examples, the user interface may include one or more user input mechanisms such as buttons, dials and / or switches. The user input mechanisms may be carried by the body 300 and / or by the display device 410, and / or by the communication module 430. For example, the display device 410 may facilitate user input to the controller 400 to operate one or more functions of the device and / or to manipulate the display. Additionally, and / or alternatively the display screen 415 may comprise a touch-screen configured to receive user input.

[0292] System

[0293] In some examples, the device 10 may be provided, or configured to function, as part of a system. An example of a system 1 for accessing the reproductive tract of an animal is shown in Figure 38. One or more components of the system may be provided in a kit. The system 1 may include the device 10. The system 1 may include one or more deployment syringes 500 and one or more straws 20 containing material for delivery to the reproductive tract.

[0294] The first and second elongate probes 200a, 200b may be provided pre-assembled with the device 10 or separately from the device 10. For example, the first and second elongate probes 200a, 200b may be provided separately for assembly by the user prior to insertion to the device 20 via the channels 120a, 120b. The system 1 may include the first and second elongate probes 200a, 200b. One or more components of the system may be disposable and / or replaceable. For example, the tubular body 205a of the first elongate probe 200a may be disposable, while the associated electronic components, sensor 250a and / or lead 251a may be reusable. In other examples, the entire probe 200a may be disposable. The system 1 may include one or more additional elongate probes 200, as shown in Figure 39, as spares and / or to enable use of the system 1 with multiple animals.

[0295] The system may further comprise the controller 400, comprising the display device 410.

[0296] Another example of a system 1 for accessing the reproductive tract of an animal is shown in Figure 55. The system 1 shown in Figure 55 includes the device 10, one or more probes (one probe 200a is shown in this example), one or more deployment syringes 500, and a straw 20 containing material for delivery to the reproductive tract, and a controller 400, comprising a display 410 and communication module 430. The communication module 430 in this example is configured as a rechargeable power and data pack and connected to the body 300 via a cable 420 configured for power and data transfer.

[0297] Method

[0298] The device 10 as described in examples above may be used to access the reproductive tract of an animal. Figures 40 to 44 illustrate a method of accessing the reproductive tract of an animal according to the present disclosure. In the illustrated example, the method includes transferring an embryo to a target transfer site within a uterine horn of the animal. However, it will be appreciated that the reproductive tract may be accessed for other purposes.

[0299] Prior to insertion, the user may perform preliminary steps of assembling one or more components of the device 10. For example, the user may assemble the probes 200a, 200b by inserting the sensor 250a with connected sensor lead 251a into the sensor lumen 225a to position the sensor 250a at or adjacent to the distal tip 202a of the first elongate probe 200a. In other examples, the first and second elongate probes 200a, 200b may have the sensors 250a, 250b and leads 251a, 251b pre-assembled therein.

[0300] Once prepared, the first and second elongate probes 200a, 200b may be inserted into the channels 120a, 120b of the device 10, for example by inserting the distal tips of the first and second elongate probes 200a, 200b into a proximal end of the channels 120a, 120b and applying force to the probes (e.g. via a user’s fingers) to slide the first and second elongate probes 200a, 200b through the channels 120a, 120b in the distal direction. The first and second elongate probes 200a, 200b may be positioned with their distal tips at or adjacent to respective distal ends of the channels 120a, 120b. The user may plug the connectors 252a, 252b into sensor connector ports on the body 300 of the device 10.

[0301] The user may prepare a deployment syringe 500 by loading a prepared straw 20 containing an embryo into the body 510 of the syringe 500. In some examples, the straw 20 may be loaded through the opening 511, as indicated in Figure 12. In some examples, the straw 20 may be loaded into a distal end of the syringe 500, as shown in Figure 48.

[0302] The user may prime the deployment syringe 500 with dispensing fluid (e.g. air or transfer medium or other suitable dispensing fluid). Priming the deployment syringe 500 may be performed prior to loading the straw 20. Priming the syringe 500 may comprise retracting the plunger 513. For example, the user may pull the plunger 513 to retract the plunger 513 as shown in Figure 12. In some examples, as in Figure 46, the user may retract the plunger 513 by rotating the plunger 513 to cause the plunger 513 to translate relative to the syringe body 510, as in Figure 46. In some examples, the user may prime one or both of the elongate probes 200a / 200b. The user may connect the deployment syringe 500 to the elongate probe 200a / 200b and retract the plunger 513 to draw dispensing fluid into the probe 200a / 200b and the body 510 of the syringe 500.

[0303] The user may assemble the body 300 and introducer 100 with the outer shaft 310 and stop member 350. The device 10 may be configured, prior to insertion to the animal, with the outer shaft 310 in the extended position relative to the introducer 100, with the distal end 112 of the introducer 100 positioned proximally of the distal opening 312. The outer shaft 310 may be secured to the body 300 prior to insertion, such that the outer shaft 310 and body 300 move together as one unit during initial insertion. The stop member 350 may be allowed to slide longitudinally relative to the outer shaft 310.

[0304] In order to introduce the embryo to the animal, the user may insert the distal end of the device into the vagina of the animal, as shown in Figure 40. During insertion, the user may visualise an area ahead of and / or surrounding the open distal end 312 of the outer shaft 310 and / or the distal end 112 of the introducer, via image data captured from camera 320 and displayed on the display screen 415. The user may adjust an angle of the device 10 within the vagina of the animal to view and identify particular anatomical features in the images displayed on the display screen 415. In particular, the user may identify the cervix and / or an opening of the cervix in the displayed images.

[0305] The device may be manipulated to position the outer shaft 310 with the distal end opening 312 at or adjacent to the cervix and surrounding the opening of the cervix. At this point, the securing mechanism of the stop member 350 may be adjusted to secure the brace plate to the outer shaft 310, to inhibit further insertion of the outer shaft 310 to the animal. The outer shaft 310 may then be released from the body 300 to allow the body 300 and introducer 100 to slide longitudinally through the outer shaft 310.

[0306] The user may place one hand on the brace plate, applying pressure through the stop member 350 to the body of the animal surrounding the vaginal opening and grip the body 300 of the device 10 by the handle 305, as shown in Figure 41.

[0307] The user may adjust an angle of the device, using the distal tip 161 of the introducer as a visual marker to gauge when the distal tip 161 is positioned at or adjacent to the opening of the cervix. The user may then advance the distal tip 161 into the cervical opening. The user may then push the handle 305 in the distal direction to advance introducer 100 through the cervix. As shown in Figure 42, the user may rotate the body 300 and introducer 100 by applying a rotating force to the handle 305 as the introducer 100 traverses into the cervix, enabling the distal tip 161 and helical member to assist in navigating the introducer 100 through the cervical folds. During insertion of the introducer 100, the stop member 350 and outer shaft 310 remain substantially stationary relative to the animal. The stop member 350 may assist in holding the outer shaft 310 in place during any movements of the animal.

[0308] When the distal end 112 of the introducer 100 reaches a transition between the cervix and the uterus, the device 10 may detect a change in detected colour and / or light reflectivity of the tissue surrounding the distal end 112, via the optical sensor arrangement. As shown in Figure 43, the display device 410 may provide an indication that the distal tip of the device is now located at the uterus. The user may then return the body 300 to a reference rotational orientation and secure the body 300 and introducer 100 to the outer shaft 310 to inhibit further insertion of the introducer 100 to the animal and to inhibit rotation of the introducer 100 relative to the outer shaft 310.

[0309] The user may then deploy one or both of the first and second elongate probes 200a, 200b into the uterine horns. For example, the user may feed a slack length of the first and second elongate probes 200a, 200b at the proximal end thereof through the channels 120a, 120b such that the distal ends of the probes 200a, 200b are pushed forward to extend beyond the distal end 112 of the introducer shaft 110. Figure 43 shows both probes 200a, 200b extending simultaneously into the respective uterine horns. As discussed previously, the shaft 110 of the introducer 100 is configured to cause the first and second elongate probes 200a, 200b to diverge away from each other and to curve downwards as they extend from the introducer 100. Further, the probes 200a, 200b may be configured to curve as they extend from the introducer 100 to conform to the anatomical shape of the uterine horns. This may allow the first and second elongate probes 200a, 200b to enter respective first and second uterine horns and to extend through the horns to reach the target transfer region. Once the distal tips of the first and second elongate probes 200a, 200b are positioned at the target transfer regions within the respective horns, the device may obtain sensed data (e.g. temperature data) via the sensors of the first and second elongate probes 200a, 200b. In some examples, sensed data (e.g. temperature data) may be obtained from each of the uterine horns sequentially via the sensor of a single probe 200a. In some examples, the device 10 may deliver a bolus of thermal energy to the tissue in the target region via heating elements in the first and second elongate probes 200a, 200b. The device 10 may obtain sensed data temperature data during delivery of the thermal energy and / or following cessation of delivery of the thermal energy.

[0310] The sensed data may be provided to a processor in the controller 400 and processed to determine the presence of a corpus luteum in one of the horns, for example, based on a temperature differential between the horns and / or based on a difference in a rate of heat dissipation in the horns. The controller 400 may cause display device 410 to indicate the side on which the corpus luteum was detected. In the example shown in Figure 44, an indicator light is lit to indicate detection of data indicative of a corpus luteum in the “right” horn.

[0311] The user may then affect deployment of the reproductive material (e.g. embryo) into the horn in which the corpus luteum was detected. Figure 44 shows a user connecting the deployment syringe 500 to the connector 261a of the first elongate probe 200a, which is inserted into the right-hand horn. The user may actuate the syringe 500 (e.g. by depressing or twisting the plunger 513) to effect transfer of the embryo through the transfer lumen of the first elongate probe 200a and to the target transfer region.

[0312] After use, the device 10 may be withdrawn from the animal. One or more components of the device 10 may be configured to be cleanable for re-use. In general, the device 10 may be hermetically sealed and configured to be cleaned, for example by wiping of external surfaces of the device 10. Additionally, or alternatively, one or more component of the device 10 may be disposable and / or replaceable.

[0313] A device 10 according to examples of the present disclosure may facilitate easier access to the reproductive tract of an animal. For example, the device 10 may enable a user to traverse the cervix of a bovine animal without the need for rectal palpation. This may decrease training requirements and increase accessibility of animal reproductive tract access techniques for less experienced users. Accessing the reproductive tract and / or transferring of material to the reproductive tract may be able to be achieved by a single user of the device, without requiring an assistant.

[0314] The device 10 according to examples of the present disclosure may provide the ability to detect the corpus luteum and selectively deliver the embryo within the same procedure, which may facilitate faster, more accurate and effective embryo transfer practices. Further, the device 10 according to the present disclosure may enable access to the reproductive tract of an animal, while minimising discomfort and / or trauma to the animal.

[0315] In one example, a method of the disclosure includes the following general method steps:

[0316] (a) obtaining sensed temperature data indicative of temperature from at least one target region in the uterus;

[0317] (b) providing the sensed temperature data at a processor; and

[0318] (c) processing the sensed temperature data at the processor to determine the presence or absence of a corpus luteum in the animal.

[0319] In some examples, the method may comprise determining a basal body temperature of the animal. Processing the sensed data may comprise comparing the sensed temperature data to the basal body temperature.

[0320] The sensed data may be obtained from within at least one uterine horn. The target region may be located within the uterine horn. In some examples, the method may comprise obtaining sensed temperature data indicative of temperature at first target region within a first uterine horn of the animal and a second target region within a second uterine horn of the animal. In such examples, the method may comprise determining the location of the corpus luteum based on the sensed temperature data. For example, the method may comprise determining whether the CL is located at an ovary associated with a first uterine horn or an ovary associated with a second uterine horn.

[0321] Processing the sensed temperature data may comprise comparing the sensed temperature data from the first target region in the first uterine horn to the sensed data from the second target region in the second uterine horn and / or determining a temperature differential between the first uterine horn and the second uterine horn.

[0322] In some examples, the method may comprise applying thermal energy to tissue of the first uterine horn and / or the second uterine horn. The sensed temperature data may be obtained prior to, during, and / or subsequent to the applying of the thermal energy. Processing the data may comprise determining a rate or a degree of temperature change.

[0323] In some examples, processing the data may comprise comparing the rate of temperature change at the first target region to the rate of temperature change at the second target region. Processing the data may comprise determining, based on the comparison, a presence or absence of a corpus luteum in the animal. Processing the data may comprise determining, based on the comparison, a location of a corpus luteum as associated with the first uterine horn or second uterine horn.

[0324] The method may be performed using a device 10, for example as described herein, for accessing the reproductive tract of an animal. The device 10 may be configured to obtain sensed data to determine the presence of a corpus luteum. It will be appreciated that the disclosure is not limited to the illustrated device and that the disclosed methods may be performed with other devices suitable for obtaining the sensed data from the uterus of the animal.

[0325] The method and device 10 according to examples of the present disclosure may provide the ability to detect the presence and location of corpus luteum. This may enable selective delivery of reproductive material (for example an embryo), facilitating more accurate and effective embryo transfer (or artificial insemination) practices.

[0326] Example 1 - embryo transfer testing

[0327] An embodiment of a device 10 for accessing the reproductive tract of an animal according to the present disclosure was tested for use in embryo transfer. In the present example, the device was configured as an embryo transfer device 10. The elongate probes 200a, 200b were configured for embryo transfer to the target region of the uterine horns. In this example, the elongate probes 200a, 200b did not include any sensors.

[0328] The objective of the trial was to demonstrate that the embryo transfer device 10 could successfully result in pregnancies after embryo transfer, in bovine recipient females.

[0329] To meet the objective, three sub-studies were performed:

[0330] 1. Confirmation of the deployment of embryos;

[0331] 2. Transfer of in vitro produced embryos into bovine recipient females;

[0332] 3. Confirmation of embryo viability after deployment.

[0333] In this example, the elongate probes 200a, 200b each comprised a tubular body 205a, 205b formed from a catheter tube. Two types of catheter tubes were used for the elongate probes 200a, 200b in the trial: single lumen catheters (0.0787" OD, 0.0394" ID, 0.0197" Wall) and dual lumen catheters (0.093" OD, 0.040" / 0.041" ID, 0.003" Septum, 0.003" Wall) that were 40 inch long in length were sourced from GenX Medical. The elongate probes 200a, 200b protypes were made from catheters comprising custom extruded polyurethane tubes. Of the single lumen catheters, two prototypes were supplied for the trial i) 75 Durometer (Pellethane 2363-75D, Nat.) or ii) 65 Durometer (Pellethane 2363-65D, Nat.). Each of the elongate probes 200a, 200b was fitted with a luer lock fitting, to enable a secure connection with the deployment syringe.

[0334] A deployment syringe 500 as described herein was used in the trial. The deployment syringe 500 utilised current conventional *4 cc straws. The plunger on the deployment syringe 500 used had a twist function to control even flow and controlled pressure differential to minimise shear stress. Fresh in vitro produced (IVP) grade 2 day 7 embryos (n = 11) were used in the trial. The embryos were loaded in straws, according to International Embryo Technology Society (IETS) guidelines. The deployment syringe 500 was charged with air, prior to loading the embryo straw into the deployment syringe 500.

[0335] Each embryo was deployed through an elongate probe 200a, 200b by turning the twisthandle of the deployment syringe 500. 10 embryos were deployed using rotation of the twisthandle at approximately 1 revolution per second, smoothly. One embryo was deployed with a faster twisting action, at approximately 3 revolutions per second. Each embryo was deployed into a petri dish and examined under a stereo microscope to confirm it had been deployed through the elongate probe successfully. All the embryos deployed at 1 revolution per second were found intact. The embryo deployed at 3 revolutions per second was not found, even after subsequent flushing of the elongate probe. The assumption is that the embryo was deployed from the elongate probe but may have been lost in bubbles in the holding media on deployment.

[0336] Air is the ideal choice to avoid contamination from the deployment syringe 500. As all embryos were successfully deployed from the prototype elongate probe design by charging the deployment syringe 500 with air, charging the deployment syringe 500 with other fluids was not tested. However, in other examples, liquid (such as a transfer media) may be used in place of air.

[0337] The results of the embryo deployment testing are summarised in Table 1 below.

[0338] Table 1 - Results from the in-vitro embryo deployment trial

[0339] Transfer of in vitro produced embryos into bovine recipient females

[0340] Ovum pick up (OPU) was performed on Ultrablack donor females (n = 10). Oocytes were transported to the laboratory. Embryos for the trial were produced using proprietary media and protocols. A total of 18 Grade 1 embryos were produced for fresh transfer.

[0341] Brangus recipient females (n = 24) ranging from 3 to 7 years old were synchronised for fixed-time embryo transfer. Embryos were transferred on day 7 post synchronised ovulation. As the recipient females entered the crush, the presence, grade and side of the CL was determined by transrectal ultrasonography using a “Mindray DP-30 Vet” ultrasound equipped with an endorectal linear array transducer (50L60EAV). The grade of the CL was assessed according to morphometric appearance including size (>2 cm) and echogenicity, and also by luteal blood flow. Only recipient females that had a Grade 1 CL according to morphometric ultrasound assessment (as per technician assessment) were used for embryo transfer. Selected recipients were also had their uterus scored by palpation by an experienced embryo transfer technician. Uterus size was estimated (Small, Medium or Long) and also the degree of curvature was graded (Easy, Medium or Hard) to apply a measure of difficulty for the elongate probes 200a, 200b to traverse to the deep uterine horn. A total of 15 recipient females were selected to be suitable for transfer.

[0342] Prior to the trial, the device 10 was tested a sub-sample of recipient females (n = 5) to select a catheter type for the elongate probes 200a, 200b. The single lumen 75 durometer catheter routinely travelled through the device 10 and into the correct uterine horns. This catheter was selected for use for the elongate probes 200a, 200b in the transfer trial.

[0343] Prior to embryo transfer, each elongate probe 200a, 200b was rinsed with approximately 10 ml BoviFlush (Minitube), followed by 10 to 20 ml of air depressed firmly through the deployment syringe 500 to facilitate removal of residual medium from the elongate probe 200a / 200b.

[0344] One of the elongate probes 200a, 200b was loaded onto the side of the device 10 corresponding to the selected recipient female with a confirmed corpus luteum (CL). A protective chemise was placed over the introducer and speculum before insertion into the recipient female. Before vaginal entry, the chemise was pierced to allow the introducer to pass into the cervix. The introducer was then guided through the cervix using rectal palpation, similar to the artificial insemination procedure.

[0345] Standard practice for embryo transfer involves administering epidural anaesthesia to the recipient to relax the sacral nerves and prevent straining during the procedure. However, because manipulation of the ipsilateral horn was not required, no epidural was performed for any of the transfers. Rectal palpation was used to guide the catheter through the cervix and confirm its passage into the ipsilateral horn.

[0346] Once the introducer tip passed through the internal OS of the cervix, the elongate probe 200a / 200b was advanced as far as possible through the channel of the device 10. After placement, an embryo was loaded into the deployment syringe 500. To load the embryo, the cotton plugs were precisely cut with a razor blade and placed into the air-charged deployment syringe 500. The syringe 500 was then attached to the luer lock system on the elongate probe 200a / 200b within the transfer device 10. The embryo was deployed by slowly depressing the syringe 500 at a rate of approximately one revolution per second. After deployment, the device 10 was removed, completing the embryo transfer. The catheter length, from the tip of the nib to the end, was measured to determine the depth at which the embryo was deposited in the uterus.

[0347] Following transfer, the used elongate probe 200a / 200b and straw were taken to the laboratory, where they were flushed with BoviFlush into a petri dish to confirm successful embryo deployment. No embryos were recovered from any procedures, indicating that all were successfully transferred into recipient females.

[0348] The embryo transfer device 10 and elongate probes 200a, 200b were thoroughly cleaned with BoviFlush between recipients to remove all visible material. Transfers using both new and re-used elongate probes 200a, 200b were recorded.

[0349] Pregnancy diagnosis was performed at Day 31 of gestation by transrectal ultrasound. Pregnancy was further confirmed later in gestation to assess any late embryonic loss that may have occurred.

[0350] Four out of the 15 cows (27%) that had embryos transferred were diagnosed as pregnant at Day 31. Of the 4 cows that were diagnosed pregnant, two were noted to have low uterine fluid and required further assessment at later gestation to confirm pregnancy.

[0351] The elongate probes 200a / 200b were inserted into the uterus of recipient females on average 28 cm (Range: 17.5 to 38 cm). There appeared to be no correlation between uterus score and length and the depth in which the probe reached within the uterine body.

[0352] Confirmation of embryo viability after deployment

[0353] Embryos were produced in the laboratory using proprietary media and protocols as part of a routine quality assurance and control process for media production. Oocytes for embryo production were aspirated from abattoir-derived ovaries. A total of 26 Grade 1 fresh embryos were produced for use in the trial.

[0354] All embryos were loaded into straws following the standard fresh embryo transfer procedure and maintained in a traveling incubator for approximately one hour. Embryos were assigned based on odd and even numbers to ensure even selection across media batches and loading times.

[0355] The study used the same catheter type (75 durometer) for the elongate probes 200a, 200b as in the embryo transfer trial. The elongate probes 200a, 200b were sterilised prior to use. Odd- numbered embryos were deployed through elongate probes 200a, 200b using a syringe equipped with a pipette tip, maintaining a deployment velocity of approximately one revolution per second, consistent with the embryo transfer study. Three different catheters were used for the elongate probes 200a, 200b. Even-numbered embryos were deployed directly from the straw to simulate the standard transfer process. All embryos were successfully recovered after deployment through both catheters of the elongate probes 200a, 200b and straws.

[0356] All embryos from each method were deployed into a petri dish in individual drops. Embryos were then located and transferred to extended culture media and were cultured out to Day 13 with an interim assessment at Day 10.

[0357] The results from the trial are shown in Table 2 below.

[0358] Table 2 - Embryo viability after extended culture at Day 10 and Day 13

[0359] On Day 10 after extended culture, all embryos deployed from the elongate probes 200a, 200b were alive, and on Day 13, four of the probe deployed embryos remained alive, suggesting that deployment via the elongate probes 200a, 200b has no detrimental effect on embryo viability.

[0360] Conclusion

[0361] This study aimed at validating the embryo transfer capabilities of the device 10 development. The outcomes of the study confirmed that the embryo transfer subsystem successfully deploys embryos and maintains their viability and confirmed that pregnancies were achievable.

[0362] All embryo transfer procedures were conducted without the need for epidural, and without the need for palpation of the ipsilateral horn to transfer the embryo. Elongate probes 200a, 200b were deployed with ease and resulted in no apparent disturbance to the endothelial wall of the uterus. These are significant steps in overcoming the skills barrier for embryo transfer. Based on the skill level of an average artificial insemination technician, this sub-system would enable transfer by this user group, rapidly increasing the amount and availability of user that are able to transfer embryos.

[0363] Example 2 - Corpus Luteum (CL) detection A study was conducted to determine the reliability of the device to predict the presence or absence of the Corpus Luteum (CL), as well as the ability of the device to determine location of the CL within the uterus (right or left horn).

[0364] Temperature differential

[0365] Elongate probes 200a, 200b including temperature sensors were inserted into both uterine horns of a cow and fluctuations over time in the temperature of the respective horns were measured. The cow’s resting body temperature was also measured. The difference between the temperature observations and the starting temperature of each horn was also derived for analysis. These variables are expressed as:

[0366] Temp_lt: temperature observations at each timestamp;

[0367] Cowbody temp: resting temperature of the cow:

[0368] Temp_diff: difference from the starting temperature at each timestamp

[0369] The measurements above were repeated for n=44 animals. A Generalised Additive Model was developed to determine the relationship between the CL and the above variables. This model was used as the relationship between the temperature and CL was observed to be non-linear.

[0370] There is an observable difference in the temperature between the horns when a CL is present. Initial analysis shows a significant relationship between the observed variables and the response variables (p<0.001). The model is moderately robust when predicting the CL side (R2= 0.63). A confusion matrix shows that the model can predict the CL side with >75% accuracy when trained on the dataset. The model was less robust when predicting the CL presence or absence (R2= 0.2). A confusion matrix shows that the model can predict the CL presence or absence with >55% accuracy when trained on the dataset.

[0371] The model for this example was tested on the same dataset that it was trained on. This can result in ‘overfitting’ which reduces the strength of the model. Additionally, improvements can be made to the accuracy of the model, for example by including further observations. A power analysis was conducted to determine the number of additional observations required for the model to improve to >80% accuracy (n=80).

[0372] Heat flux

[0373] Further testing was conducted to determine the reliability of predicting the presence or absence of the Corpus Luteum (CL), and side of the uterine horn, based on a “heat flux” technique to determine relative perfusion in the uterine horns.

[0374] Elongate probes 200a, 200b each including a temperature sensor (e.g. a thermistor), and heating element (e.g. a resistor) were inserted into both uterine horns of a cow. Heating was applied to each uterine horn via the heating elements and temperature measurements taken during a heating phase, cooling phase and idle state. This is to prevent excessive heating, which could produce tissue damage and / or an undesirable hormonal response.

[0375] A perfusion calculation was made based on the measured temperature data, after the measured temperature fell below the initial starting temperature, or after 45 seconds had elapsed. In this study, the perfusion algorithm used temperature data obtained from the rising temperature portion of the testing. The presence of a CL was determined based on a difference in temperature rise time between the two elongate probes 200a, 200b. The rise time was calculated using the formula rise time = (cooling start time) - (baseline rise time). The baseline rise time was determined as the time at which the temperature had increased by 1 degree from the initial temperature (i.e. the temperature before commencement of heating). The cooling start time was determined as the time at which the temperature had increased by 3 degrees Celsius from the initial temperature. The system was configured to cease the heating phase and commence the cooling phase once a temperature rise of 3 degrees Celsius or more was detected.

[0376] If a difference in rise time between the two horns was detected, the side with the slower temperature rise was selected as likely having the CL. This is because the presence of a CL usually correlates with increased perfusion (i.e. increased blood flow), which would slow the heating of the probe and surrounding tissue. In the present example, a difference in rise time of greater than 0.2 seconds was used to determine the presence and side of the CL.

[0377] One example of data collected using the technique described above shown in Figure 57. In this example, the white data points represent the temperature data recorded in “horn A” by the first elongate probe 200a and the black data points represent the temperature data recorded in “horn B” by the second elongate probe 200b. In this case, the first elongate probe 200a recorded a steep increase in temperature. Active heating ceased once the temperature rise was over 3 degrees. By contrast, the second elongate probe recorded a slower increase in temperature, reaching a steady- state temperature condition in approximately 10 seconds. This indicates that horn A had a greater capacity for heat dissipation than horn B. This may be due to less perfusion in horn A relative to horn B, indicating likely presence of the CL in horn B.

[0378] Preliminary testing using the above-described method was performed on 14 cows. The predicted CL side was compared to data indicating CL side as determined by conventional methods. The heat flux method as described above was able to predict the correct CL side in 11 out of 14 tests (78% success rate).

[0379] Further testing was performed on 3 cows, with a prediction of CL side agreeing with conventional assessment in all 3 cases (100% success rate).

[0380] Further testing was performed on 28 cows, with usable data obtained from 19 tests. The predicted CL side was compared to data indicating CL side as determined by conventional methods. The results indicated 6 tests with no clear high / low heat flux indication, which would indicate no CL. Of these 6 results, 3 correlated with a determination of no CL by conventional methods. The remaining results may have failed to detect a difference due to the probes not being deployed deep enough within the horns, or possibly due to the probes being deployed into the same horn. 13 results showed a clear high / low heat flux differentiation between the left and right sides. Of these 13 results, 7 correlated with the CL side as determined using conventional methods (54% success rate). Individual variation between the probes and / or variation from protocol may have contributed to lower success rate in this trial.

[0381] Testing was performed on a further 8 cows, with a prediction of CL side agreeing with conventional assessment in 6 out of 8 cases (75% success rate).

[0382] Example 3 - Corpus Luteum (CL) detection and localisation

[0383] A further study was conducted to determine the reliability of the device to predict the presence or absence of the Corpus Luteum (CL), as well as the ability of the device to determine location of the CL within the uterus (right or left horn).

[0384] The presence of a CL within a uterine horn correlates with higher blood perfusion compared to the uterine horn in which the CL is absent. At the time of writing, measurement of blood perfusion is performed by a skilled technician using ultrasound (e.g., Doppler sonography), and this is typically performed during pregnancy to assess blood perfusion and flow to the reproductive tract. However, the use of ultrasound is unlikely to be feasible or practical when performing embryo transfer in many circumstances and requires the presence of a skilled technician to operate the sonography equipment, which may not be available. Based on the positive evidence in Example 2, the inventors undertook a further study to assess whether the Nbryo device was capable of detecting changes or differences in blood perfusion status with similar effectiveness to ultrasound, albeit using thermal sensing probes inside the uterus deployed using the device. A statistical model was also developed to enable machine prediction of the CL presence or absence (CL BINARY), as well as the side of the uterus (CL LEFT RIGHT).

[0385] This model was developed using data collected from two animal trials. The first trial (n=60) was conducted in December 2024 and preliminary analysis showed a significant relationship (p<0.01) between temperature in the respective uterine horns and the ability to predict in which of the uterine horns the CL is located. In order to improve the model’s accuracy and power, a second trial was conducted in January 2025 (n=81).

[0386] Analysis of the data from both trials has produced a model that can accurately predict (>75%) the presence or absence of a CL and predict to a reasonable degree (>70%) the uterine horn (i.e., left or right) in which the CL is located. In both cases, the prediction is made with 90% power. These models show that there is a statistically significant relationship between the temperature of the cow (p>0.1), the temperature of the uterus (p>0.01) and the difference between those two temperatures (p>0.01). The addition of phenotypic covariates (cow age, number of pregnancies) would improve analysis further. Methods

[0387] Animal Trials

[0388] Cows were synchronized 21 days before the trial. The cow’s body temperature was taken using a rectal thermometer. The device probes were entered into the cow on both sides of the uterus and a perfusion detection program was run for 35 seconds. The temperature of the uterus was recorded on both sides each second.

[0389] Covariates

[0390] Several covariates were collected and synthesised for analysis, as summarised in Table 3:

[0391] Table 3 - Covariates for analysis

[0392] COVARIATE DESCRIPTION TYPE

[0393] COWBODYTEMP Body tempe rature of the cow Predictor STARTINGTEMP Temperature of the uterus before perfusion detection Predictor STARTTEMPDIFF Difference between the cow body temp and starting temp Predictor MEANTEMP Mean temperature of the uterus Predictor MEATEMPDIFF Difference between cow body temp and mean temp Predictor MAXTEMP Maximum temperature of the uterus Predictor MAXTEMPDIFF Difference between the cow body temp and max temp Predictor TEMP LT Continuous temperature of the uterus Predictor CL BINARY Binary variable noting presence or absence of the CL Outcome

[0394] CL LEFT RIGHT Binary variable describing the side of the CL (left=0, Outcome right=l) Random Forest Importance

[0395] R programming software was used to run a random forest model to determine the most significant covariates for both the presence / absence of the CL and the side. The temperature difference (starting and mean) between the uterus and the cow’s body temperature were both found to be the most significant predictors of both the presence or absence of the CL as well as the CL side (Fig. 58).

[0396] Modelling - Presence / Absence

[0397] A training dataset was produced to train generalized linear model (GLM) in determining the CL presence or absence based on the most significant covariates described above in Table 3. The GLM was then assessed against a test dataset and a confusion matrix produced to show the model’s accuracy. The GLM was then tested using an ROC curve to determine the most suitable threshold for classifying the result

[0398] Modelling - Left / Right

[0399] A training dataset was produced for training. A stepwise logistic regression model was used to determine the combination of variables providing the most suitable fit for a GLM. A random forest model was also used as a predictive model. The models were each tested using an ROC curve to determine the most suitable threshold for classifying the result.

[0400] Power Analysis

[0401] A power analysis was undertaken to assess the power of the model’s predictive accuracy.

[0402] Results

[0403] Modelling - Presence / Absence

[0404] The models tested show good accuracy (-75%), suggesting that the method and device correctly detects CL presence in more than 3 out of 4 cows. Two threshold scenarios that produce acceptable results were determined, as shown in Table 4:

[0405] Table 4 - Threshold scenarios

[0406] Threshold - 0.81

[0407] Sensitivity (model ability to CL if present) 81%

[0408] Specificity (model ability to CL if present ) 57% Overall Accuracy - 77.55%

[0409] Threshold - 0.84

[0410] Sensitivity (model ability to CL if present) 73%

[0411] Specificity (model ability to CL if present) 86%

[0412] Overall Accuracy - 75.51%

[0413] Modelling - Left / Right

[0414] Both models showed acceptable accuracy overall (-70%), predicting which of the two uterine horns possessed the CL in more than 3 out of 5 cows. Addition of phenotypic or genetic data is likely to improve these results. The two models used were the Stepwise Model and the Random Forest Model, as shown in Table 5 below.

[0415] Table 5 - Models used for predicting CL side

[0416] Stepwise Model

[0417] Random Forest

[0418] Sensitivity (accuracy to predict presence) 69%

[0419] Specificity (accuracy to predict absence) 75%

[0420] Overall - 70.83% Power Analysis

[0421] With a sample size of 140, the models tested range from 70% to 80% accuracy in their ability to predict which side of the uterus contained the CL, with 90% confidence.

[0422] Conclusions:

[0423] The additional and larger dataset enabled training of the models on a portion (80%) of the data and the ability to evaluate performance of the models on the remaining data (train and test datasets). The evidence from this study demonstrates that temperature profiles within the uterus can be used to determine the presence and location (left vs. right) of the corpus luteum (CL).

[0424] Furthermore, modelling of the data suggests that the probability of these findings occurring due to random chance (false positives) is relatively low.

[0425] The following statements describe certain statements according to the present disclosure.

[0426] 1A. A method of determining the presence or absence of a corpus luteum in a uterus of an animal, the method comprising:

[0427] (a) obtaining sensed temperature data indicative of temperature from at least one target region in the uterus;

[0428] (b) providing the sensed temperature data at a processor; and

[0429] (c) processing the sensed temperature data at the processor to determine the presence or absence of a corpus luteum in the animal.

[0430] 2A. The method of statement 1A comprising determining a basal body temperature of the animal, wherein processing the sensed data comprises comparing the sensed temperature data to the basal body temperature.

[0431] 3A. The method of statement 1A or statement 2A, wherein the sensed data is obtained from within at least one uterine horn.

[0432] 4A. The method of any one of the preceding statements, comprising:

[0433] (a) obtaining sensed temperature data indicative of temperature at first target region within a first uterine horn of the animal; and

[0434] (b) obtaining sensed temperature data indicative of temperature at a second target region within a second uterine horn of the animal.

[0435] 5A. The method of statement 4A, wherein processing the sensed temperature data comprises comparing the sensed temperature data from the first target region in the first uterine horn to the sensed data from the second target region in the second uterine horn.

[0436] 6A. The method of statement 5A, wherein processing the sensed temperature data comprises determining a temperature differential between the first uterine horn and the second uterine horn.

[0437] 7A. The method of any one of the preceding statements, comprising inserting a probe into at least a first uterine horn of the animal to reach a first target region in the first uterine horn, wherein the probe includes a sensor; and obtaining the sensed temperature data indicative of temperature at the first target region from the sensor. A. The method of statement 7A, further comprising: inserting the probe into a second uterine horn of the animal to reach a second target region in the second uterine horn; and obtaining the sensed temperature data indicative of temperature at the second target region from the sensor. A. The method of any one of the preceding statements, comprising: inserting first and second probes into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, wherein the first and second elongate probes include respective first and second sensors; obtaining the sensed temperature data indicative of temperature at the first and second target regions from the first and second sensors, respectively. 0A. The method of statement 9A, comprising applying thermal energy to tissue of the first uterine horn and the second uterine horn adjacent the first and second probes at the first and second target regions. 1 A. The method of statement 10A, wherein processing the data comprises: determining a rate of temperature change at the first and second target regions during and / or following the applying of the thermal energy. 2A. The method of statement 11 A, wherein processing the data further comprises: comparing the rate of temperature change at the first target region to the rate of temperature change at the second target region; and determining, based on the comparison, a presence or absence of a corpus luteum in the animal. 3A. The method of claim 12A, wherein processing the data further comprises: determining, based on the comparison, a location of a corpus luteum as associated with the first uterine horn or second uterine horn. 4A. A device for accessing the reproductive tract of an animal to determine the presence of a corpus luteum, the device comprising: an introducer having a distal region configured for insertion into a uterine cervix of the animal; and at least one elongate probe, the elongate probe including at least one sensor; wherein the elongate probe is extendable from the distal region of the introducer into the uterus of the animal to reach a target region of the uterus. 15A. The device of statement 14A, comprising: a first flexible elongate probe; and a second flexible elongate probe, wherein the first and second elongate probes are extendable from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, wherein the first and second elongate probes each comprise at least one sensor.

[0438] 16A. The device of statement 15 A, wherein the first and second elongate probes comprise respective heating elements.

[0439] The following statements describe further statements according to the present disclosure.

[0440] IB. A device for accessing the reproductive tract of an animal, the device comprising:

[0441] (a) an introducer comprising a longitudinal shaft extending from a proximal end to a distal end, the introducer having a distal region configured for insertion into a uterine cervix of the animal;

[0442] (b) a first flexible elongate probe; and

[0443] (c) a second flexible elongate probe, wherein the first and second elongate probes are slidably receivable by the introducer and extendable from the distal region of the introducer into first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns.

[0444] 2B. The device of statement IB, wherein the first elongate probe comprises one or more first sensors at a distal region of the first elongate probe and wherein the second elongate probe comprises one or more second sensors at a distal region of the second elongate probe, wherein the first and second sensors are configured to obtain sensed data from the first and second uterine horns.

[0445] 3B. The device of statement 2B, wherein the device comprises a processor configured to receive and process the sensed data to determine the presence of a corpus luteum in one or both uterine horns of the animal.

[0446] 4B. The device of statement 3B, wherein the sensed data comprises temperature data.

[0447] 5B. The device of any one of the preceding statements, wherein the first and second elongate probes are each configured to receive reproductive material for transfer to a target region of a uterine horn.

[0448] 6B. The device of statement 5B, wherein each of the first and second elongate probes comprises a tubular body defining an internal lumen extending from a proximal end to a distal port, the tubular body configured to receive reproductive material therein to facilitate transfer of the reproductive material from the proximal end to the distal end of the elongate probe. B. The device of statement 6B, wherein the first and second probes comprise first and second deployment ports at respective distal ends of the probes, the deployment ports configured to facilitate deployment of reproductive material from the distal ends of the probes. B. The device of statement 7B, wherein the device is configured for selective deployment of reproductive material from one of the extendable elongate probes. B. The device of statement 8B, wherein the selective deployment is based on a detected presence of a corpus luteum. 0B. The device of statement 9B, wherein the reproductive material comprises an embryo. IB. The device of any one of the preceding statements, wherein the introducer shaft defines first and second elongate channels configured to receive the first and second elongate probes, the first and second channels extending through the introducer shaft from at or adjacent to the proximal end to the distal region. 2B. The device of statement 11, wherein the introducer shaft includes a central divider separating the first and second channels. 3B. The device of statement 12B, wherein the central divider includes opposed first and second side walls defining respective medial walls of the first and second channels. 4B. The device of statement 13B, wherein the central divider includes a flared portion in the distal region of the introducer shaft. 5B. The device of statement 14B, wherein, at the flared portion, the first and second walls curve relative to a longitudinal axis of the introducer shaft such that, during deployment of the probes, the first and second walls deflect the probes away from the longitudinal axis of the introducer. 6B. The device of statement 15B, wherein the first and second walls curve relative to the longitudinal axis in two planes. 7B. A method for accessing the reproductive tract of an animal, the method including:

[0449] (a) inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end; and

[0450] (b) deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns. 18B. A method for delivering reproductive material to a uterine horn of an animal, the method including:

[0451] (a) inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end;

[0452] (b) deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, the probes configured to receive reproductive material for transfer to the target regions of the uterine horns; and

[0453] (c) transferring reproductive material through at least one of the probes to at least one target region.

[0454] 19B. A method of determining the presence of a corpus luteum in a uterus of an animal, the method including:

[0455] (a) inserting a distal region of an introducer through a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end;

[0456] (b) deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, wherein the first and second elongate probes include respective first and second sensors;

[0457] (c) obtaining sensed data from the first and second sensors;

[0458] (d) providing the sensed data at a processor; and

[0459] (e) processing the sensed data at the processor to determine the presence of a corpus luteum in a uterine horn.

[0460] 20B. The method of statement 19B, wherein the sensed data comprises temperature data.

[0461] 2 IB. The method of statement 20B, wherein processing the data comprises determining a temperature differential between the first uterine horn and the second uterine horn.

[0462] 22B. The method of statement 20B or statement 2 IB, wherein the method includes applying thermal energy to the uterine horn tissue adjacent to the sensors and wherein processing the data comprises determining a rate of temperature rise during the application of thermal energy to the tissue and / or determining a rate of temperature drop following cessation of the applying of thermal energy to the tissue.

[0463] 23B. A device for accessing the reproductive tract of an animal, comprising an introducer comprising a longitudinal shaft extending from a proximal end to a distal tip and having a distal region configured for insertion into a uterine cervix of the animal, wherein the introducer includes a helical guide member provided on an outer surface of the longitudinal shaft in the distal region, wherein the introducer comprises a projection extending distally beyond the distal tip of the longitudinal shaft.

[0464] 24B. The device of statement 23B, wherein the introducer is configured for rotation about a longitudinal axis of the longitudinal shaft during insertion to the cervix.

[0465] 25B. The device of statement 24B, wherein the helical guide member is configured to assist rotational advancement of the introducer through the cervix.

[0466] 26B. The device of any one of statements 23B to 25B, wherein the helical guide member comprises a protruding thread extending from an outer surface of the shaft.

[0467] 27B. The device of any one of statements 23B to 26B, wherein the projection is a distal continuation of the helical guide member.

[0468] 28B. The device of any one of statements 23B to 27B, wherein at least part of the projection extends distally beyond of the distal tip of the longitudinal shaft.

[0469] 29B. The device of any one of statements 23B to 28B, wherein the projection includes a portion having a reduced curvature relative to a proximal portion of the helical guide member.

[0470] 30B. The device of statement 29B, wherein the projection includes a portion extending substantially parallel to a central longitudinal axis of the longitudinal shaft in at least one plane.

[0471] 3 IB. The device of any one of statements 23B to 30B, wherein the projection is axially offset from the central longitudinal axis of the longitudinal shaft.

[0472] 32B. The device of statement 3 IB, wherein the shaft has a cylindrical shape in the distal region and wherein the projection is radially offset from an outer diameter of the cylindrical shaft.

[0473] 33B. The device of any one of statements 23B to 32B, wherein a distal end portion of the projection has a bulbous shape.

[0474] 34B. The device of any one of statements 23B to 33B, wherein the helical guide member extends around the elongate shaft in an anti-clockwise direction when viewed from the distal tip of the introducer.

[0475] 35B. The device of any one of statements 23B to 34B, wherein the helical guide member extends around the shaft for at least one revolution.

[0476] 36. The device of any one of statements 23B to 35B, wherein a distal tip of the longitudinal shaft has a tapered shape. B. A method for accessing the reproductive tract of an animal, including:

[0477] (a) advancing an introducer into a uterine cervix of the animal, the introducer comprising:

[0478] (i) a longitudinal shaft extending from a proximal end to a distal tip and having a distal region configured for insertion into the cervix;

[0479] (ii) a helical guide member provided on an outer surface of the longitudinal shaft in the distal region; and

[0480] (iii) a projection extending distally beyond the distal tip of the longitudinal shaft; and

[0481] (b) rotating the introducer about a longitudinal axis of the longitudinal shaft during advancement, wherein the helical guide member is configured to assist rotational advancement of the introducer through the cervix. 8B. A device for accessing the reproductive tract of an animal, the device comprising an introducer comprising a longitudinal shaft extending from a proximal end to a distal end, the introducer having a distal region configured for insertion into a uterine cervix of the animal, wherein the introducer comprises at least one sensor arrangement configured to obtain sensed data indicative of an optical property of tissue adjacent to the distal end of the introducer. 9B. The device of statement 38B, wherein the sensor arrangement comprises:

[0482] (a) a light source configured to emit illuminating light; and

[0483] (b) at least one optical sensor configured to detect reflected light. B. The device of statement 39B, wherein the device comprises:

[0484] (a) a first light guide configured to transmit the illuminating light from the light source and emit the illuminating light from the distal end of the introducer; and

[0485] (b) a second light guide configured to receive light reflected from the tissue and transmit the reflected light to the optical sensor. IB. The device of statement 40B, wherein the first and second light guides extend through the longitudinal shaft of the introducer to the distal end of the introducer. B. The device of statement 40B or statement 4 IB, wherein the first and second light guides comprise first and second optical fibres. 3B. The device of any one of statements 38B to 42B, wherein the optical property comprises a reflectivity of the tissue and / or a colour of the tissue. B. The device of any one of statements 38B to 43B comprising a controller including a processor configured to receive the sensed data from the sensor arrangement and process the sensed data to determine a position of the distal end of the introducer within the reproductive tract of the animal. B. The device of statement 44B, wherein the controller is configured to detect a change in the optical property of the tissue as the introducer is advanced through the cervix, to identify a transition between the cervix and the uterus. B. The device of statement 45B, wherein the controller is configured to trigger a notification to alert a user when the distal end of the introducer reaches the transition between the cervix and the uterus. B. A method for accessing the reproductive tract of an animal, including:

[0486] (a) inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end and at least one sensor arrangement,

[0487] (b) obtaining, from the at least one sensor arrangement, sensed data indicative of an optical property of tissue adjacent to the distal end of the introducer;

[0488] (c) receiving the sensed data from the sensor arrangement at a processor; and

[0489] (d) processing the sensed data to determine a position of the distal end of the introducer within the reproductive tract of the animal. B. A device for accessing the reproductive tract of an animal, the device comprising:

[0490] (a) a body including a handle for facilitating gripping by a user;

[0491] (b) an introducer axially fixed relative to the body and extending distally from the body, the introducer comprising a longitudinal shaft extending from a proximal end to an opposed distal end, the introducer having a distal region configured for insertion into a uterine cervix of the animal, and

[0492] (c) an outer shaft extending from an open proximal end to an open distal end, the outer shaft mounted to the body being slidably movable between an extended position and a retracted position relative to the introducer. B. The device of statement 48B, wherein the outer shaft is substantially rigid and configured for insertion into a vagina of the animal to a position in which the open distal end of the outer shaft is adjacent to or abutting the cervix and such that the open distal end of the outer shaft is aligned with a proximal opening of the cervix. B. The device of statement 48B or statement 49B wherein, when the outer shaft is in the extended position, the distal end of the introducer is aligned with or positioned proximally of the open distal end of the outer shaft and wherein, when the outer shaft is in the retracted position, the distal end of the introducer extends beyond the open distal end of the outer shaft. 51B. The device of any one of statements 48B to 50B, wherein the outer shaft is configured to move from the extended position toward the retracted position as the introducer is advanced through the cervix.

[0493] 52B. The device of any one of statements 48B to 51B, comprising an imaging system including at least one camera configured to capture image data representative of an area ahead of and / or surrounding the distal end of the device.

[0494] 53B. The device of statement 52B, wherein the at least one camera is mounted on the outer shaft.

[0495] 54B. The device of statement 53B, wherein the at least one camera is mounted on the body and / or on the introducer.

[0496] 55B. The device of any one of statements 52B to 54B, wherein the distal end of the introducer is positioned within a field of view of the camera.

[0497] 56B. The device of statement 55B, wherein the introducer includes a marker at or adjacent to the distal end of the introducer.

[0498] 57B. The device of any one of statements 52B to 56B, comprising a processor configured to receive and process the image data from the camera.

[0499] 58B. The device of statement 57B, including a display configured to receive the processed image data from the processor and cause display of images based on the processed image data.

[0500] 59B. The device according to any one of statements IB to 58B, further comprising a stop member configured for limiting a depth of insertion of the outer shaft and / or the introducer into the animal.

[0501] 60B. The device of statement 59B, wherein the stop member is provided on the body, proximal of the outer shaft and the introducer.

[0502] 6 IB. The device of statement 60B, wherein the stop member is provided on the outer shaft.

[0503] 62B. The device of any one of statements 59B to 61B, wherein a longitudinal position of the stop member relative to the outer shaft and / or the introducer is adjustable.

[0504] 63B. The device of statement 62B, comprising a releasable securing mechanism for inhibiting relative movement between the stop member and the outer shaft and / or the introducer.

[0505] 64B. The device of any one of statements 59B to 63B wherein the stop member comprises a plate extending substantially transverse to a longitudinal axis of the introducer shaft, the plate configured to abut an external surface of the animal’s body adjacent to a vaginal opening.

[0506] 65B. The device of any one of statements 48B to 64B, comprising at least one flexible elongate probe slidably receivable by the introducer and extendable from the distal region of the introducer into a uterine horn of the animal to reach a target region of the uterine horn.

[0507] 66B. The device of statement 65B, comprising:

[0508] (a) a first flexible elongate probe; and

[0509] (b) a second flexible elongate probe, wherein the first and second elongate probes are slidably receivable by the introducer and extendable from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns.

[0510] 67B. The device of any one of statements 48B to 66B, wherein the handle is configured for actuating longitudinal rotation of the introducer during insertion of the introducer to the cervix.

[0511] 68B. A method of accessing the reproductive tract of an animal using the device of any one of statements IB to 67B, the method including:

[0512] (a) positioning the outer shaft at the extended position;

[0513] (b) gripping the body by the handle;

[0514] (c) inserting the outer shaft into a vagina of the animal until the open distal end is positioned adjacent to or abutting the cervix;

[0515] (d) advancing the introducer relative to the outer shaft to insert the distal end of the introducer through an opening of the cervix; and

[0516] (e) manipulating the device by the handle to navigate the distal tip of the introducer through annular folds of the cervix to advance the distal region of the introducer into the cervix.

[0517] 69B. The method of statement 68B, including:

[0518] (a) capturing image data from a camera of the device, the image data representative of an area ahead of and / or surrounding the distal end of the outer shaft during insertion of the outer shaft to the vagina;

[0519] (b) causing display of images based on the captured image data at a display device; and

[0520] (c) guiding insertion of the distal end of the introducer to the cervical opening, based on the displayed images.

[0521] 70B. The method of statement 68B or 69B, wherein the device includes at least one flexible elongate probe slidably receivable by the introducer and extendable from the distal region of the introducer, wherein the method includes, after advancing the introducer into the cervix, extending the at least one flexible elongate probe into a uterine horn of the animal to reach a target region of the uterine horn.

[0522] 7 IB. The method of statement 70B, wherein the device comprises first and second flexible elongate probes slidably receivable by the introducer and extendable from the distal region of the introducer, and wherein the method includes extending the first and second flexible elongate probe into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns.

[0523] 72B. The method of statement 7 IB, wherein the first and second probes are extended into the first and second uterine horns simultaneously.

[0524] 73B. The method of any one of statements 71B or 72B, wherein the method includes selectively deploying reproductive material through at least one probe to at least one target region.

[0525] 74B. The method of any one of statements 68B to 73B, including positioning a stop member of the device abutting an external surface of the animal’s body adjacent to a vaginal opening, to inhibit further insertion of the outer shaft and / or the introducer once a desired position of the outer shaft and / or the introducer within the reproductive tract has been reached.

[0526] 75B. The method of statement 74B, including, after positioning of the stop member, securing a stop member securing mechanism to inhibit relative movement of the stop member relative to the outer shaft and / or the introducer.

[0527] 76B. The method of any one of statements 68B to 75B, including securing an outer shaft securing mechanism configured to inhibit relative movement of the introducer relative to the outer shaft once a desired position of the introducer within the reproductive tract has been reached.

[0528] It will be appreciated by persons skilled in the art that numerous variations and / or modifications may be made to the above-described embodiments and examples, without departing from the broad general scope of the present disclosure. The present embodiments and examples are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS1. A device for accessing the reproductive tract of an animal, the device comprising:(a) an introducer comprising a longitudinal shaft extending from a proximal end to a distal end, the introducer having a distal region configured for insertion into a uterine cervix of the animal;(b) a first flexible elongate probe; and(c) a second flexible elongate probe, wherein the first and second elongate probes are slidably receivable by the introducer and extendable from the distal region of the introducer into first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns.

2. The device of claim 1, wherein the first elongate probe comprises one or more first sensors at a distal region of the first elongate probe and wherein the second elongate probe comprises one or more second sensors at a distal region of the second elongate probe, wherein the first and second sensors are configured to obtain sensed data from the first and second uterine horns.

3. The device of claim 2, wherein the device comprises a processor configured to receive and process the sensed data to determine the presence of a corpus luteum in one or both uterine horns of the animal.

4. The device of any one of the preceding claims, wherein the first and second elongate probes are each configured to receive reproductive material for transfer to a target region of a uterine horn, and / or wherein each of the first and second elongate probes comprises a tubular body defining an internal lumen extending from a proximal end to a distal port, the tubular body configured to receive reproductive material therein to facilitate transfer of the reproductive material from the proximal end to the distal end of the elongate probe.

5. The device of claim 4, wherein the first and second probes comprise first and second deployment ports at respective distal ends of the probes, the deployment ports configured to facilitate deployment of reproductive material from the distal ends of the probes and / or wherein the device is configured for selective deployment of reproductive material from one of the extendable elongate probes.

6. The device of claim 5, wherein the selective deployment is based on a detected presence of a corpus luteum.

7. The device of any one of the preceding claims, wherein the introducer shaft defines first and second elongate channels configured to receive the first and second elongate probes, the first and second channels extending through the introducer shaft from at or adjacent to the proximal end to the distal region.

8. The device of claim 7, wherein the introducer shaft includes a central divider separating the first and second channels.

9. The device of claim 8, wherein the central divider includes opposed first and second side walls defining respective medial walls of the first and second channels; and / or wherein the central divider includes a flared portion in the distal region of the introducer shaft.

10. The device of claim 9, wherein, at the flared portion, the first and second walls curve relative to a longitudinal axis of the introducer shaft such that, during deployment of the probes, the first and second walls deflect the probes away from the longitudinal axis of the introducer; and / or wherein the first and second walls curve relative to the longitudinal axis in two planes.

11. A method for accessing the reproductive tract of an animal, the method including:(a) inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end; and(b) deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns.

12. A method for delivering reproductive material to a uterine horn of an animal, the method including:(a) inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end;(b) deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, the probes configured to receive reproductive material for transfer to the target regions of the uterine horns; and(c) transferring reproductive material through at least one of the probes to at least one target region.

13. A method of determining the presence of a corpus luteum in a uterus of an animal, the method including:(a) inserting a distal region of an introducer through a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end;(b) deploying first and second elongate probes from the distal region of the introducer into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns, wherein the first and second elongate probes include respective first and second sensors;(c) obtaining sensed data from the first and second sensors;(d) providing the sensed data at a processor; and(e) processing the sensed data at the processor to determine the presence of a corpus luteum in a uterine horn.

14. The method of claim 13, wherein processing the data comprises determining a temperature differential between the first uterine horn and the second uterine horn; and / or wherein the method includes applying thermal energy to the uterine horn tissue adjacent to the sensors and wherein processing the data comprises determining a rate of temperature rise during the application of thermal energy to the tissue and / or determining a rate of temperature drop following cessation of the applying of thermal energy to the tissue.

15. A device for accessing the reproductive tract of an animal, comprising an introducer comprising a longitudinal shaft extending from a proximal end to a distal tip and having a distal region configured for insertion into a uterine cervix of the animal, wherein the introducer includes a helical guide member provided on an outer surface of the longitudinal shaft in the distal region; and / or wherein the introducer comprises a projection extending distally beyond the distal tip of the longitudinal shaft; and / or wherein the introducer is configured for rotation about a longitudinal axis of the longitudinal shaft during insertion to the cervix.

16. The device of claim 15, wherein the helical guide member comprises a protruding thread extending from an outer surface of the shaft; and / orwherein the projection is a distal continuation of the helical guide member; and / or wherein at least part of the projection extends distally beyond of the distal tip of the longitudinal shaft; and / or wherein the projection includes a portion having a reduced curvature relative to a proximal portion of the helical guide member; and / or wherein the projection includes a portion extending substantially parallel to a central longitudinal axis of the longitudinal shaft in at least one plane; and / or wherein the projection is axially offset from the central longitudinal axis of the longitudinal shaft; and / or wherein the shaft has a cylindrical shape in the distal region and wherein the projection is radially offset from an outer diameter of the cylindrical shaft; and / or wherein a distal end portion of the projection has a bulbous shape; and / or wherein the helical guide member extends around the elongate shaft in an anticlockwise direction when viewed from the distal tip of the introducer; and / or wherein the helical guide member extends around the shaft for at least one revolution; and / or wherein a distal tip of the longitudinal shaft has a tapered shape.

17. A method for accessing the reproductive tract of an animal, including:(a) advancing an introducer into a uterine cervix of the animal, the introducer comprising:(i) a longitudinal shaft extending from a proximal end to a distal tip and having a distal region configured for insertion into the cervix;(ii) a helical guide member provided on an outer surface of the longitudinal shaft in the distal region; and(iii) a projection extending distally beyond the distal tip of the longitudinal shaft; and(b) rotating the introducer about a longitudinal axis of the longitudinal shaft during advancement, wherein the helical guide member is configured to assist rotational advancement of the introducer through the cervix.

18. A device for accessing the reproductive tract of an animal, the device comprising an introducer comprising a longitudinal shaft extending from a proximal end to a distal end, the introducer having a distal region configured for insertion into a uterine cervix of the animal, wherein the introducer comprises at least one sensor arrangement configured toobtain sensed data indicative of an optical property of tissue adjacent to the distal end of the introducer.

19. The device of claim 18, wherein the sensor arrangement comprises:(a) a light source configured to emit illuminating light; and(b) at least one optical sensor configured to detect reflected light.

20. The device of claim 19, wherein the device comprises:(a) a first light guide configured to transmit the illuminating light from the light source and emit the illuminating light from the distal end of the introducer; and(b) a second light guide configured to receive light reflected from the tissue and transmit the reflected light to the optical sensor.

21. The device of claim 20, wherein the first and second light guides extend through the longitudinal shaft of the introducer to the distal end of the introducer; and / or wherein the first and second light guides comprise first and second optical fibres.

22. The device of any one of claims 18 to 21, wherein the optical property comprises a reflectivity of the tissue and / or a colour of the tissue.

23. The device of any one of claims 18 to 22 comprising a controller including a processor configured to receive the sensed data from the sensor arrangement and process the sensed data to determine a position of the distal end of the introducer within the reproductive tract of the animal.

24. The device of claim 23, wherein the controller is configured to detect a change in the optical property of the tissue as the introducer is advanced through the cervix, to identify a transition between the cervix and the uterus; and / or wherein the controller is configured to trigger a notification to alert a user when the distal end of the introducer reaches the transition between the cervix and the uterus.

25. A method for accessing the reproductive tract of an animal, including:(a) inserting a distal region of an introducer into a uterine cervix of the animal, the introducer comprising a longitudinal shaft extending from a proximal end to a distal end and at least one sensor arrangement,(b) obtaining, from the at least one sensor arrangement, sensed data indicative of an optical property of tissue adjacent to the distal end of the introducer;(c) receiving the sensed data from the sensor arrangement at a processor; and(d) processing the sensed data to determine a position of the distal end of the introducer within the reproductive tract of the animal.

26. A device for accessing the reproductive tract of an animal, the device comprising:(a) a body including a handle for facilitating gripping by a user;(b) an introducer axially fixed relative to the body and extending distally from the body, the introducer comprising a longitudinal shaft extending from a proximal end to an opposed distal end, the introducer having a distal region configured for insertion into a uterine cervix of the animal, and(c) an outer shaft extending from an open proximal end to an open distal end, the outer shaft mounted to the body being slidably movable between an extended position and a retracted position relative to the introducer.

27. The device of claim 26, wherein the outer shaft is substantially rigid and configured for insertion into a vagina of the animal to a position in which the open distal end of the outer shaft is adjacent to or abutting the cervix and such that the open distal end of the outer shaft is aligned with a proximal opening of the cervix; and / or wherein, when the outer shaft is in the extended position, the distal end of the introducer is aligned with or positioned proximally of the open distal end of the outer shaft and wherein, when the outer shaft is in the retracted position, the distal end of the introducer extends beyond the open distal end of the outer shaft; and / or wherein the outer shaft is configured to move from the extended position toward the retracted position as the introducer is advanced through the cervix.

28. The device of any claim 26 or claim 27, comprising an imaging system including at least one camera configured to capture image data representative of an area ahead of and / or surrounding the distal end of the device.

29. The device of claim 28, wherein the at least one camera is mounted on the outer shaft, or wherein the at least one camera is mounted on the body and / or on the introducer, and / or wherein the distal end of the introducer is positioned within a field of view of the camera.

30. The device according to any one of claims 26 to 29, further comprising a stop member configured for limiting a depth of insertion of the outer shaft and / or the introducer into the animal.

31. The device of claim 30 wherein the stop member comprises a plate extending substantially transverse to a longitudinal axis of the introducer shaft, the plate configured to abut an external surface of the animal’s body adjacent to a vaginal opening.

32. A method of accessing the reproductive tract of an animal using the device of any one of claims 26 to 31, the method including:(a) positioning the outer shaft at the extended position;(b) gripping the body by the handle;(c) inserting the outer shaft into a vagina of the animal until the open distal end is positioned adjacent to or abutting the cervix;(d) advancing the introducer relative to the outer shaft to insert the distal end of the introducer through an opening of the cervix; and(e) manipulating the device by the handle to navigate the distal tip of the introducer through annular folds of the cervix to advance the distal region of the introducer into the cervix.

33. The method of claim 32, including:(a) capturing image data from a camera of the device, the image data representative of an area ahead of and / or surrounding the distal end of the outer shaft during insertion of the outer shaft to the vagina;(b) causing display of images based on the captured image data at a display device; and(c) guiding insertion of the distal end of the introducer to the cervical opening, based on the displayed images.

34. The method of claim 32 or claim 33, wherein the device includes at least one flexible elongate probe slidably receivable by the introducer and extendable from the distal region of the introducer, wherein the method includes, after advancing the introducer into the cervix, extending the at least one flexible elongate probe into a uterine horn of the animal to reach a target region of the uterine horn.

35. The method of claim 34, wherein the device comprises first and second flexible elongate probes slidably receivable by the introducer and extendable from the distal region of the introducer, and wherein the method includes extending the first and second flexible elongate probe into respective first and second uterine horns of the animal to reach respective first and second target regions of the uterine horns.

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