Device and method for artificial insemination

Abstract

The present invention encompasses improved catheters comprising a plurality of tubular bodies, as well as methods of using the improved catheters in artificial insemination.

Description

[0001] This application is a divisional application of the patent application for "Device and Method for Artificial Insemination" with the filing date of August 29, 2019, application number 201980055015.9 (International Application Number: PCT / US2019 / 048889).

[0002] Citation of Related Applications

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 725,829, filed on August 31, 2018. The entire disclosure of the patent application is incorporated herein by reference. Background Art

[0004] There is a need in the swine industry to reduce the number of sperm cells used in artificial insemination (i.e., low-dose insemination). One such need stems from the desire to use sex-sorted sperm in swine. However, in order to use sex-sorted semen more effectively and commercially viable in swine, the number of sperm cells used in artificial insemination must be significantly reduced relative to the number of sperm cells typically used with conventional (i.e., unsorted) sperm cells. Another need for low-dose insemination stems from the desire to use sperm cells from core or high-index boars with limited sperm cell supplies. While laparoscopic insemination techniques allow for the use of small sperm cell doses, such techniques are relatively expensive and typically require the presence of a veterinarian. Additionally, such techniques can cause infections and may stress the animals. Therefore, there is a need to improve non-invasive devices and methods for low-dose insemination in the prior art. Summary of the Invention

[0005] One embodiment of the present invention includes a catheter, the catheter comprising: a first tubular body; a cervical anchor connected to an outer surface of the first tubular body; and a second tubular body axially and slidably extending within the first tubular body, the second tubular body comprising a flexible polyether block amide and a proximal end and a distal end, the distal end including an orifice formed in: i) a beveled, rounded or chamfered end, or ii) a terminal flange including a beveled, rounded or chamfered edge. In another embodiment, the second tubular body has an outer diameter between 1.5 mm and 5 mm. In yet another embodiment, the second tubular body has an inner diameter between 0.5 mm and 1.5 mm. In another embodiment, the second tubular body has a hardness between 30 (Shore D) and 70 (Shore D). In additional embodiments, the second tubular body has a wall thickness between 1.0 mm and 2.0 mm. In another embodiment, the second tubular body has a hardness between 40 (Shore D) and 60 (Shore D), an outer diameter between 1 mm and 3 mm, and an inner diameter between 0.2 mm and 1.3 mm. In a specific embodiment, the flexible polyether block amide includes In another embodiment, the distal end of the second tubular body includes a generally hook-shaped or U-shaped portion.

[0006] Another aspect of the present invention encompasses a method of delivering or collecting fluid, embryos or gametes using a catheter, the catheter comprising: a first tubular body; a cervical anchor connected to an outer surface of the first tubular body; and a second tubular body axially and slidably extending within the first tubular body, the second tubular body comprising a flexible polyether block amide and a proximal end and a distal end, the distal end including an orifice formed in: i) a beveled, rounded or chamfered end; or ii) a terminal flange including a beveled, rounded or chamfered edge, the method comprising: inserting the first tubular body into the vagina of a sow; advancing the first tubular body into the cervical canal of the sow such that the cervical anchor abuts against the cervical canal; axially advancing the second tubular body within the first tubular body through the cervix; and applying a positive or negative pressure within the second tubular body. In another embodiment, in the step of advancing the second tubular body, the second tubular body is advanced at least 600 mm into the uterine horn. In a further embodiment, the method includes the step of delivering 300 x 10 6 or fewer sperm cells into the uterine horn, or delivering 150 x 10 6or fewer sperm cells are deposited into the uterine horn. In certain embodiments, the deposited sperm are sex-sorted sperm. In another embodiment of the method, the flexible polyether block amide comprises In yet another embodiment, the deposited sperm cells are from a high-index boar. In another embodiment, the method further comprises a step of freezing and thawing the sperm cells prior to the step of depositing the sperm cells.

[0007] Another embodiment of the present invention includes a catheter comprising: a first tubular body, a second tubular body, and a third tubular body, the third tubular body axially and slidably extending within the first tubular body, and the second tubular body axially and slidably extending within the third tubular body, the third tubular body including a proximal end, a distal end, and a deflecting element at the distal end. In another embodiment, the catheter further comprises a cervical anchor connected to the outer surface of the first tubular body. In a further embodiment, the second tubular body comprises a polyether block amide. In a specific embodiment, the second tubular body has a hardness between 30 (Shore D) and 60 (Shore D), an outer diameter between 1 mm and 3 mm, and an inner diameter between 0.2 mm and 1.5 mm. In certain embodiments, the polyether block amide comprises In another embodiment, the distal end of the second tubular body includes a generally hook-shaped or U-shaped portion.

[0008] Another embodiment of the present invention includes a catheter comprising: a first tubular body, a second tubular body, a third tubular body, and a fourth tubular body, the third tubular body axially and slidably extending within the fourth tubular body, the fourth tubular body axially and slidably extending within the first tubular body, and the second tubular body axially and slidably extending within the third tubular body, the third tubular body including a proximal end, a distal end, and a deflecting element at the distal end. In another embodiment, the first tubular body includes a cervical anchor connected to the outer surface of the first tubular body. In yet another embodiment, the second tubular body comprises a polyether block amide. In a specific embodiment, the second tubular body has a hardness between 30 (Shore D) and 60 (Shore D), an outer diameter between 1 mm and 3 mm, and an inner diameter between 0.2 mm and 1.5 mm. In a more specific embodiment, the polyether block amide comprises In another embodiment, the distal end of the second tubular body includes a generally hook-shaped or U-shaped portion.

[0009] Any of the various embodiments of the invention described above and below can be applied to or include species of individuals or non-human mammals, and the invention should be understood as not limited to the species of non-human mammals described by specific examples within this application. Rather, the specific examples within this application are intended to illustrate the diverse species of non-human mammals to which the devices and methods of the invention can be applied. Embodiments of the invention cover, for example, and are applicable to animals of commercial value for meat or dairy production, such as pigs, sheep, cows, horses, deer, elk, buffalo, etc. (naturally, mammals used for meat or dairy production can vary by culture). The embodiments also cover various domestic non-human mammal species, such as canines and felines, as well as primates, including but not limited to: chimpanzees and gorillas, and whales, dolphins, and other marine mammals. In a specific embodiment of any of the embodiments disclosed above, the non-human mammal species includes pigs. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 An embodiment of the invention is shown including a catheter having two tubular bodies.

[0011] Figure 2A An embodiment of the invention is shown including a catheter having four tubular bodies and a deflecting element.

[0012] Figure 2B A side cross-sectional view of an embodiment of the invention including four tubular bodies and a deflecting element is shown.

[0013] Figure 2C An embodiment of the deflecting element is shown.

[0014] Figure 3A A side cross-sectional view of the distal end of a tubular body having a rounded end is shown.

[0015] Figure 3B A side cross-sectional view of the distal end of a tubular body having a terminal flange with a chamfered edge is shown.

[0016] Figure 4A A side cross-sectional view of a deflector element having a contoured notch is shown.

[0017] Figure 4B A side view of an embodiment of a deflector element having a contoured notch is shown.

[0018] Figure 4C A perspective view of an embodiment of a deflector element having a contoured notch is shown.

[0019] Figure 5AAn embodiment of a tubular body having a generally hooked or U-shaped portion conforming to the outer profile of a deflection element is shown.

[0020] Figure 5B An embodiment of a tubular body is shown having a generally hooked or U-shaped portion conforming to the outer profile of a deflection element, and wherein the hooked or U-shaped portion has been axially advanced away from the deflector element. Detailed Description

[0021] The present invention encompasses a catheter and a method of delivering or collecting fluid, embryos, or gametes using the catheter. Figure 1 Figures 1 to 5 depict various embodiments of the present invention and are described below.

[0022] In Figure 1 , Figure 2A and Figure 2B In the two embodiments shown respectively, the device includes at least a first tubular body 12 and a second tubular body 14. In Figure 2A and Figure 2B , the device is shown to further include a third tubular body 37 and a fourth tubular body 57. In Figure 1 as well as Figure 2A and Figure 2B In each of the embodiments shown, the second tubular body 14 is used to deliver fluid, gametes (e.g., sperm cells), or embryos within its lumen to an intrauterine (i.e., post-cervical) location or to deliver from such an intrauterine location. In contrast, the first tubular body 12, the third tubular body 37, and the fourth tubular body 57 are used to guide the second tubular body 14 within the reproductive tract of a sow including the vagina, cervix, and uterine body (as used herein, the term "sow" is equivalent to a female pig, including gilts), and do not directly contact the fluid, gametes, or embryos delivered by the second tubular body 14. In Figure 1 and each of Figure 2, the second tubular body 14 has an outer diameter less than that of the first tubular body 12 ( Figure 1 ) as well as the third tubular body 37 and the fourth tubular body 57 ( Figure 2A and Figure 2B ), such that the second tubular body 14 can axially slide within the first tubular body 12 or the third tubular body 37 as the case may be.

[0023] In some embodiments of the present invention, the second tubular body 14 comprises a flexible polyether block amide, which allows the second tubular body 14 to be advanced deeper into the uterine horns of a sow without kinking and without the risk of damaging the uterus or uterine horns of the sow. In a specific embodiment, the polyether block amide comprises (Arkema Specialty Polyamides, Colombes, France), comprising a polyether block amide selected from Series 33 (with a hardness between 40 and 70 (Shore D)). In a more specific embodiment, the second tubular body 14 comprises Material 4033SA 01, which has the following properties:

[0024] Table 1.

[0025]

[0026] 4033SA 01MED is processed under the following conditions:

[0027] Table 2.

[0028]

[0029] Now referring to Figure 3A , in this embodiment, the distal end 41 of the second tubular body 14 comprises an orifice formed in the rounded end 18. In other embodiments (not shown), the second tubular body 14 may comprise an orifice formed in a chamfered end or a beveled end. In Figure 3B the alternative embodiment shown, the second tubular body 14 comprises an orifice formed in the end flange 44 including the chamfered edge 27. In another embodiment (not shown), the end flange 44 may comprise a beveled edge. In another embodiment, as Figure 5B shown, the second tubular body 14 may comprise an oval orifice 19 formed by a cutting plane angled / inclined with respect to the longitudinal axis of the second tubular body 14.

[0030] In some embodiments, the second tubular body 14 has an outer diameter between 1.5 mm and 5 mm. The diameter must be small enough to allow the second tubular body 14 to pass through the cervix. Other variables that affect the size of the second tubular body 14 include the type of material to be delivered and the target location for delivering or retrieving the material. For example, a viscous liquid may require the second tubular body 14 to have a relatively large lumen. For delivering fluids, gametes, or embryos, in some embodiments of the present invention, the second tubular body 14 has an inner diameter between 0.2 mm and 1.5 mm, and in more specific embodiments between 0.5 mm and 1.3 mm. For a given outer diameter, the target location for delivery or retrieval affects the length, stiffness, and wall thickness of the second tubular body 14. For example, to reach the uterotubal junction, the length of the second tubular body 14 should be at least 100 cm to 300 cm. In some embodiments, the length of the second tubular body 14 is at least 110 cm, at least 120 cm, at least 130 cm, at least 140 cm, at least 150 cm, at least 160 cm, at least 170 cm, at least 180 cm, at least 190 cm, at least 200 cm, at least 210 cm, at least 220 cm, at least 230 cm, at least 240 cm, or at least 250 cm. Additionally, to reach the uterotubal junction or any other distal anatomical target, the second tubular body 14 must be soft enough to traverse the highly curved uterine horns without damaging them, and must also be elastic enough to resist kinking, which would compromise the ability of the second tubular body 14 to deliver the desired material. Thus, in some embodiments of the present invention, the second tubular body 14 has a stiffness between 30 (Shore D) and 70 (Shore D), and in more specific embodiments between 40 (Shore D) and 60 (Shore D), and a wall thickness between 1.0 mm and 2.0 mm. In very specific embodiments, the second tubular body 14 has a stiffness between 30 and 50 (Shore D), an outer diameter between 2.5 mm and 3.0 mm, and an inner diameter between 1.0 mm and 1.5 mm. As Figure 1 shown in the embodiment of

[0031] The first tubular body 12, the third tubular body 37, and the fourth tubular body 57 comprise any suitable polymeric material and are relatively more rigid than the second tubular body 14 in certain embodiments. Due to having sufficient stiffness, the first tubular body 12, the third tubular body 37, and the fourth tubular body 57 can be independently advanced into and through the cervix of a sow, which typically presents significant resistance to a catheter. In some embodiments, the first tubular body 12 has a length of 40 cm to 60 cm and an outer diameter between 10 cm and 20 mm. In some embodiments of the present invention, the third tubular body 37 and the fourth tubular body have a length of 60 cm to 75 cm. In some embodiments, the third tubular body 37 has an outer diameter of 4 mm and an inner diameter of 3.5 mm. In other embodiments, the third tubular body 37 has an outer diameter between 3 mm and 5 mm and an inner diameter between 2.5 mm and 4.5 mm. In some embodiments, the fourth tubular body 57 has an outer diameter of 4.58 mm and an inner diameter of 4.15 mm. In other embodiments, the fourth tubular body 57 has an outer diameter between 3.5 mm and 5.5 mm and an inner diameter between 3.15 mm and 5.15 mm.

[0032] In certain embodiments, as Figure 1 , Figure 2A and Figure 2B shown, the first tubular body 12 may also include a cervical anchor 17 at its distal end. The cervical anchor 17 has a shape and material (e.g., soft foam polymer) that substantially conforms to the inner wall of the distal portion of the cervical canal so as to stably and reversibly anchor or "lock" the first tubular body 12 within the cervical canal. The use of the cervical anchor 17 also minimizes the risk of fluid reflux into the uterus introduced via the second tubular body 14 and minimizes the risk of inadvertently entering the urethra when the distal end of the first tubular body 12 is advanced into the reproductive tract. The cervical anchor 17 can be bonded to the outer surface of the first tubular body 12 using an adhesive or a suitable bonding method. Optionally, in some embodiments (not shown), the cervical anchor 17 can be molded as part of the first tubular body 12.

[0033] As Figure 2A and Figure 2B shown, the third tubular body 37 includes a deflection element 33 at its distal end. As used herein, the term "deflection element" includes a surface that is angled relative to the longitudinal axis of the third tubular body 37 and is part thereof. The deflection element 33, as Figures 2A to 2C shown, includes a ramp surface 77. As Figures 2A to 2C shown, the deflection element 33 also includes an aperture 88 through which the second tubular body 14 passes when the second tubular body is axially advanced within the third tubular body 37. As Figure 2BAs shown, the surface 16 of the ramp surface 77 forms an angle 53 with respect to the longitudinal axis of the third tubular body 37. In Figure 2B the embodiment shown, the angle 53 is about 19 degrees. In other embodiments (not shown), the angle 53 can be between 10 and 30 degrees, between 15 and 25 degrees, or between 17 and 23 degrees. In Figures 4A to 4C Another embodiment of the present invention is shown in which the deflection element 33 includes a contoured notch 98.

[0034] As Figure 2A shown, when the second tubular body 14 is axially advanced within the third tubular body 37, the deflection element 33 causes the second tubular body 14 to exit the third tubular body 37 at an angle that matches, or is approximately equal to, the angle 53. By deflecting the second tubular body 14 relative to the longitudinal axis of the third tubular body 37, the user can precisely direct the second tubular body 14 into the left or right uterine horn, which has several advantages. Specifically, for low-dose artificial insemination applications (such as when using sex-sorted sperm or sperm from a high-index boar), the user can now reliably perform bilateral insemination (i.e., deposit sperm in both uterine horns). In certain embodiments (not shown), at its proximal end, the first tubular body 12, the third tubular body 37, or the fourth tubular body 57 has one or more guiding marks that can be used to determine the deflection direction when the user rotates the third tubular body 37 about its longitudinal axis.

[0035] In Figure 5A and Figure 5B Another embodiment of the present invention shown, the distal end of the second tubular body 14 includes a generally hook-shaped or U-shaped portion 101 that is used to bend the distal end of the lumen of the second tubular body 14 backward in the direction of the proximal end of the second tubular body 14. As Figure 5A shown, in certain embodiments of the present invention, the generally hook-shaped or U-shaped portion 101 substantially conforms to the distal end of the deflection element 33 (the distal end of which may also optionally include a contoured notch 98 within which the bent portion of the generally hook-shaped or U-shaped portion 101 of the second tubular body 14 can rest). In certain embodiments, the total width of the generally hook-shaped or U-shaped portion 101 at its widest dimension is between 2 mm and 10 mm, between 2 mm and 8 mm, between 2 mm and 7 mm, between 2 mm and 5 mm, between 3 mm and 10 mm, between 3 mm and 8 mm, between 3 mm and 7 mm, or between 3 mm and 5 mm. In alternative embodiments of the present invention not shown, the distal end of the second tubular body 14 includes an inflatable balloon instead of the hook-shaped or U-shaped portion 101, which can be inflated by the user once the second tubular body 14 has passed through the cervix and into the uterine body.

[0036] In some embodiments, the deflection element 33 may be bonded to the third tubular body 37 or attached to the third tubular body 37 using a coupling member 109 that fits within the lumen of the third tubular body 37 and within the lumen of the deflection element 33 (as Figure 5A and Figure 5B shown)—the coupling member 109 itself includes a lumen through which the second tubular body 14 can pass, or alternatively, the deflection element 33 may be formed as part of the third tubular body 37. Additionally, in some embodiments, as Figures 2A to 2C shown, the deflection element 33 may include a distal structure 48 that is rounded to prevent damage to the cervix or uterus. The deflection element 33 may be formed from a polymeric material. The surface 16 of the ramp surface 77 of the deflection element 33 is angled relative to the longitudinal axis of the third tubular body 37, and in various embodiments, is flat (as Figure 2B ) along the longitudinal axis of the deflection element 33 when viewed in a longitudinal cross-section (e.g., Figures 2A to 2C shown), convex, or concave (not shown). In some embodiments, the surface 16 is serrated to form a rounded groove such that the end 18 of the second tubular body 14 can smoothly advance as it traverses the deflection element 33 and such that the deflection element 33 can impart greater directional accuracy to the second tubular body as the second tubular body 14 is axially advanced within the third tubular body 37.

[0037] Referring Figure 1 to, one embodiment of the present invention encompasses a catheter 10 that includes a first tubular body 12 and a second tubular body 14. The second tubular body 14 may also include a connector 24 as shown in this particular embodiment.

[0038] Another aspect of the present invention encompasses a method of delivering or collecting fluid, embryos, or gametes using the Figure 1 catheter 10 shown. The method includes: inserting the first tubular body 12 into the vagina of a sow; advancing the first tubular body 12 into the cervical canal of the sow such that the cervical anchor 17 is positioned against the cervical canal; axially advancing the second tubular body 14 within the first tubular body 12 through the cervix; and applying positive or negative pressure (e.g., via a syringe or other aspiration device) within the second tubular body 14 to deliver, or collect, fluid, embryos, or gametes as appropriate. In some embodiments, the second tubular body 14 is advanced at least 600 mm into the uterine horn. In one embodiment, it is contemplated that 300 x 10 6 or fewer sperm cells are delivered into the uterine horn, and in a more specific embodiment, it is contemplated that 150 x 10 6or fewer sperm cells are deposited into the uterine horns.

[0039] Reference Figure 2A and Figure 2B , one embodiment of the present invention encompasses a catheter 19 that includes a first tubular body 12, a second tubular body 14, a third tubular body 37, and a fourth tubular body 57. Figure 2B is Figure 2A A cross-sectional view of the catheter 19 shown. In this embodiment, the third tubular body 37 includes a deflection element 33. The second tubular body 14 is assembled within the lumen of the third tubular body 37; the third tubular body 37 is in turn assembled within the lumen of the fourth tubular body 57; and the fourth tubular body 57 is in turn assembled within the first tubular body 12. Thus, the second tubular body 14, the third tubular body 37, and the fourth tubular body 57 are each capable of being axially advanced within the tubular body in which they are snugly seated.

[0040] One aspect of the present invention is a method of using Figure 2A and Figure 2B the catheter 19 shown to deposit or collect fluids, embryos, or gametes. The method includes: inserting the first tubular body 12 into the vagina of a sow; advancing the first tubular body 12 into the cervical canal of the sow such that the cervical anchor 17 is seated against the cervical canal; axially advancing the fourth tubular body 57 within the first tubular body 12 through the cervix; axially advancing the third tubular body 37 within the fourth tubular body 57 sufficiently to expose the orifice 88 of the third tubular body 37 to the interior of the uterine body; axially advancing the second tubular body 14 within the third tubular body 37 away from the orifice 88 and into the uterine horn; and applying positive or negative pressure within the second tubular body 14. Another embodiment of the method includes the additional steps of: withdrawing the second tubular body 14 from the uterine horn; rotating the third tubular body 37 about its longitudinal axis, and then advancing the second tubular body 14 into the opposite uterine horn in order to deposit or collect fluids, embryos, or gametes in the opposite uterine horn. In a particular embodiment, the second tubular body 14 is advanced at least 600 mm into the uterine horn. Another embodiment encompasses depositing 300 x 10 6 or fewer sperm cells into each uterine horn, or depositing 150 x 10 6 or fewer sperm cells into each uterine horn.

[0041] Another aspect of the present invention encompasses another embodiment of the method described above, wherein the second tubular body 14 includes a distal end having a generally hooked or U-shaped portion 101. In this particular embodiment, the generally hooked or U-shaped portion 101 of the second tubular body 14 rests on the deflector tip 33 of the third tubular body 37 when the third tubular body 37 is advanced into the cervix.

[0042] Example 1

[0043] The objectives of this example were 1) to test the effect of semen deposition site (uterine body vs. uterine horn); 2) to test the effect of a stepwise reduction in sperm dose; and 3) to test the effect of the interval from insemination to ovulation (for a single fixed-time artificial insemination (“AI”), using transrectal ultrasound for monitoring follicle disappearance and 6000 (pregnant mare serum gonadotropin / equine chorionic gonadotropin (“PMSG / eCG”)) and (GnRH agonist) to synchronize ovulation).

[0044] Semen was collected from three boars and the semen was pooled. Six hundred and thirty-five sows were divided into eight treatment groups based on the deposition location of the AI sperm dose (i.e., uterine body vs. uterine horn) and the number of sperm cells in the AI dose (ranging from 1.2 billion to 75 million sperm cells per dose).

[0045] Sows received a 2 mL IM injection (18-gauge, 1.5” needle) of 600 IU of eCG ( 6000, Vetoquinol-Calier, Lavaltrie, Quebec) or sterile saline vehicle alone at approximately 0.5” outside the vulva. On the afternoon of the 3rd day after weaning (Thursday and Sunday) from 3:00 to 5:00 PM, the ovaries of the sows were scanned by transrectal ultrasound (Aloka 500 + UST-5561 7.5 MHz transducer fixed to a custom PVC handle) to estimate the mean follicle diameter. Estrus was detected by backpressure testing (BPT) during boar exposure controlled by a boar cart at this time. At 5:00 PM (80 hours after weaning), all sows received a 2 mL (200 mcg of triptorelin acetate) intravaginal infusion. On the afternoon of the 4th day after weaning (Friday and Monday) from 3:00 to 5:00 PM, another BPT was performed, and the sows were scanned at this time and every 8 hours (midnight 12:00; 8:00 AM; 4:00 PM) to record the ovulation time. Regardless of estrus, all sows received one insemination at approximately 4:00 to 6:00 PM (24 to 26 hours after infusion ) according to one of the eight treatment groups.

[0046] Insemination in the uterine body is accomplished using a conventional post-cervical AI catheter. In contrast, insemination in the uterine horn is accomplished using the catheter of the present invention (the catheter comprising two tubular bodies, wherein the first tubular body has a cervical anchor, and the second tubular body comprises 4033SA 01MED (hardness 40 (Shore D)) and having a length of 254 cm, an inner diameter of 1.27 mm, and an outer diameter of 2.794 mm). Insemination in the uterine horn is accomplished by advancing the first tubular body into the cervix and, once properly positioned, advancing the second tubular body until the second tubular body cannot be advanced further in the reproductive tract. Table 3 below shows the results for each treatment group in terms of pregnancy rate and the average number of viable and non-viable embryos per sow.

[0047] Table 3.

[0048]

[0049] Table 4 below shows the pregnancy rates varying with sperm dose achieved for each ovulation group (ovulating between 18.5 and 34.5 hours post-treatment; ovulating between 38.5 and 42.5 hours post-treatment; ovulating between 46.5 and 54.0 hours post-treatment; or ovulating 55 hours or more post-treatment).

[0050] Table 4.

[0051]

[0052] Table 5 below shows the average number of embryos varying with sperm dose obtained from sows within each ovulation group.

[0053] Table 5.

[0054]

[0055] Example 2

[0056] The purpose of this example was to determine the distance that the catheter of the present invention can be advanced in the reproductive tract of sows in comparison with a catheter comprising metal and polymer (DeepBlue swine AI catheter, reference 17113 / 0100, Minitüb GmbH, Tiefenbach, Germany (“Catheter A”)). The catheter of the present invention comprises two tubular bodies, wherein the first tubular body has a cervical anchor, and the second tubular body comprises 4033SA 01MED (hardness 40 (Shore D)) and having a length of 254 cm, an inner diameter of 1.27 mm, and an outer diameter of 2.794 mm. Catheter A has a length of 182.88 cm.

[0057] In this example, seven sows in estrus were utilized. "Catheter 1" was advanced into the reproductive tract of the sow until significant resistance was encountered, and then the catheter was withdrawn. After 40 minutes, "Catheter 2" was advanced into the reproductive tract of the same sow until significant resistance was encountered. Table 6 below provides an overview of the order in which each sow received Catheter A and the catheter of the present invention.

[0058] Table 6.

[0059] sow catheter 1 catheter 2 1 catheter A the present invention 2 the present invention catheter A 3 catheter A the present invention 4 the present invention catheter A 5 catheter A the present invention 6 the present invention catheter A 7 catheter A the present invention

[0060] The results are provided in Table 7 below. In Table 7, the improvement in distance achieved by the catheter of the present invention in each sow was normalized to 182.88 cm, the length of Catheter A, such that more accurate comparisons could be made. Additionally, Table 7 provides "% corrected improvement", where the percentage improvement was corrected by excluding the results achieved for sows 4 and 7, as for each of these sows, the entire length of Catheter A could be advanced into the reproductive tract of the sow.

[0061] Table 7.

[0062]

[0063] Although the foregoing invention has been described in some detail, those of ordinary skill in the art will understand that certain changes and modifications may be made within the scope of the claims.

Claims

1. A method for delivering or collecting fluids, embryos or gametes using a catheter, the catheter comprising: First tubular body; A cervical anchor connected to the outer surface of the first tubular body; And a second tubular body that axially and slidably extends within the first tubular body, the second tubular body comprising a polyether block amide and a proximal end and a distal end, the distal end including an orifice formed in: i) a chamfered, rounded or beveled end, or ii) a distal flange including a chamfered, rounded or beveled edge, the method comprising: Inserting the first tubular body into the vagina of a sow; Advancing the first tubular body into the cervical canal of the sow such that the cervical anchor is seated against the cervical canal; Axially advancing the second tubular body within the first tubular body through the cervix of the sow; and Applying a positive or negative pressure within the second tubular body.

2. The method of claim 1, wherein in the step of advancing the second tubular body, the second tubular body is advanced at least 600 mm into the uterine horn.

3. The method according to claim 2, wherein the method further comprises the step of introducing 300x10 6 or fewer sperm cells into the uterine horn.

4. The method according to claim 2, the method comprising depositing 150x10 6 or fewer sperm cells into the uterine horn.

5. The method of claim 3, wherein the sperm are sex-sorted sperm.

6. The method according to claim 1, wherein the polyether block amide comprises 7. The method of claim 3, wherein the sperm cells are from a high-index boar.

8. The method of claim 3, the method further comprising the step of freezing and thawing the sperm cells prior to the dispensing step.

9. The method of claim 1, wherein the distal end of the second tubular body includes a generally hook-shaped or U-shaped portion.

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