ASSEMBLY AND METHOD FOR PENETRATING THE UTERUS OF AN ANIMAL DURING A NON-SURGICAL PROCEDURE

Abstract: An assembly for penetrating the uterus of an animal during a non-surgical procedure, said assembly comprising a probe having an elongated body with a longitudinal axis and a probing member extending at least laterally outwardly at the forward end of the probe body, the assembly further comprising a channel extending between an inlet opening at a distance from the probing member and an outlet opening near the probing member, wherein the channel comprises at least one bend or curve, such that the axis of the channel near the outlet opening encloses an angle different from 180 DEG with the longitudinal axis of the probe body, said probe being adapted to be inserted, forward end first, inside the cervix of said animal, said probe body then being manipulatable to gently maneuver the probing member in a forward direction through the cervix to a position in which the probing member and the outlet opening are within or adjacent the body of the uterus.

Description: Title: Assembly and method for penetrating the uterus of an animal during a non-surgical procedure. The invention relates to an assembly for penetrating the uterus of an animal during a non-surgical procedure, especially for the introduction of material such as embryos into the uterus of an animal . Such an assembly is known from international publication WO 96/35384. The known assembly comprises a rigid metal probe, having a long tubular body with a central longitudinal axis and a probing member curving forwardly and laterally outwardly, substantially beyond the forward end of the probe body, the probe body having open forward and rearward ends. The probe is adapted to be inserted, forward and first, inside the cervix of said animal, said probe body then being manipulatable to gently maneuver the probing member in a forward direction through the cervix, to a position in which the probing member and the forward open end of the probe body are adjacent the body of the uterus. For introduction of the probe into the cervix a long tubular gripping instrument is provided, having an open forward end and an external formation configured for gripping the walls of the cervix when the instrument is inserted. The gripping instrument has to be pulled in a rearward direction to straighten the cervix to be able to introduce the probe. The probe body is sized for a coaxial insertion inside the gripping instrument from the forward end thereof, such that the rearward end of the probe body extends outside the rearward end of the gripping instrument . When the probing member is brought into the position adjacent the body of the uterus, as tested with a stainless steel detecting bar, a fluid carrier can be inserted through the probe body, into a position wherein the front end of the elongated fluid carrier extends in longitudinal direction from the forward, open end of the probe body into the uterus body. Fluid containing the embryos or semen can then be expelled from the fluid carrier into the uterus body. This known assembly has the disadvantage that it is complex, both in composition as well as in use. The assembly comprises a large number of separate parts to be positioned inside and maneuvered relative to each other, which can be difficult, time consuming and irritating for the animal, which will be detrimental to the result. Therefore the animals have to be anaesthetized especially for enabling positioning of the animal on its back before introduction of the instrument. Furthermore, due to the rigidity of the probe and probe member and the fact that the probe member has to be introduced into the forward end of the gripping instrument, such that the probing member is enclosed within the soft, cork-screw like forward part of said gripping member, whereby the rearward end of the probe body extends far outside the rearward end of the gripping member, this known assembly is difficult to maneuver. Furthermore, since the probe body is tubular, having open forward and rearward ends, the channel extending through said probe body can easily be contaminated with material from the vagina, cervix and/or uterus, prior to introduction of the fluid carrier into said channel. This can easily result in contamination of said fluid within said fluid carrier, thus influencing the result of said procedure negatively. Moreover, since said channel extends longitudinal through the probe body, the fluid carrier will depart from the probe body in the longitudinal direction of said probe body, and will thus be driven directly into the wall thereof, perpendicular to the longitudinal direction of the cervix. This can be irritating and hazardous for the animal and can furthermore result in further contamination of the fluid. Upon further introduction of the fluid carrier the forward end, extending outside the probe body, will bend and will be pushed into one of the horns of the uterus, which could result in a fold in the fluid carrier, resulting in a blockade of the through bore of said fluid carrier, thus preventing or at least hindering the delivery of said fluid into said uterus body and cause lethal damage to the fragile embryos due to squeezing. A main object of the present invention is to provide for an assembly for penetrating the uterus of an animal during a non-surgical procedure, wherein the drawbacks of the known method are overcome, maintaining the advantages thereof. To this aim, an assembly according to the present invention is characterized by the features of claim 1. An assembly according to the present invention comprises only a limited number of components, which are easy to manufacture and use, the probe body can be introduced into the cervix of said animal directly, via the vagina and can then be manipulated such that the probing member passes the cervix to a position within or adjacent the uterus body. Since the axis of the outlet opening encloses an angle with the longitudinal axis of the probe body, accumulation of contamination within the channel can be easily prevented, whereas blockage of the outlet opening by the wall of the uterus body, when the probe body is fully inserted, is easily prevented. An assembly according to the present invention provides for easy and safe penetration of the uterus of an animal during a non-surgical procedure, whereby the outlet opening of the channel and thus the place of introduction of for example embryos or semen is accurately reproducable. Thus the chances of success of a non-surgical procedure performed with an assembly according to the present invention are very high. Thereby the animals have not to be anaesthetized or restrained to perform the procedure, but can be housed similar as when performing usual artificial inseminations. In an advantageous embodiment an assembly according to the present invention is characterized by the features of claim 4. By providing a tubular member extending along at least part of the probe body and the probing member, the channel can be easily provided. The tubular member can be attached to the probe body, at least near the probing member, for example by adhesive or a mutual relatively soft and flexible coating, whereas the rearward end of the probe body and the tubular member can be separated. The rearward end of the tubular member can then be easily manipulated for introduction of for example a fluid carrier, a cannula or the needle of a syringe, without having to grip the rearward end of the probe body and vice versa. In an alternative embodiment an assembly according to the present invention is characterized by the features of claim 5. In this embodiment the channel extends through the probe body and the probing member, the assembly thus being very easy to manufacture, for example by bending from an elongated tubular piping. The invention further relates to an assembly for penetrating the uterus of an animal during a non-surgical procedure, characterized by the features of claim 6. In some animals at least part of the inside walls of the cervical channel is convulated and lined with rounded prominences, some of which dovetail, occluding the canal. With an assembly according to the present invention, the probe being sufficiently flexible, the probe can be introduced into the cervix and manipulated such that the probing member can be maneuvered inbetween said prominences, partly pushing these apart, whereby the probe body can follow the curves of the cervical canal and at least partly follow the convolution of the inner walls by flexing, thereby passing the occlusions of the canal . The outlet opening of the channel can thus be brought easily, conveniently and accurately within or adjacent the uterus body. In a further advantageous embodiment an assembly according to the present invention is characterized by the features of claim 9. The second tubular member, being slidably insertable through the channel can be easily used as a fluid carrier. Since the length of said second tubular member is greater than the length of the channel , the forward end of the second tubular member, provided with an outlet opening, can be pushed through the outlet opening of the channel, by manipulating a rearward part of the second tubular member still extending outside the channel from the inlet opening thereof. In combination with the axis of the outlet opening of the channel enclosing an angle with the longitudinal axis of the probe body, the direction of extension of the forward end of the second tubular member through said outlet opening of said channel will be advantageous since said forward end of said second tubular member will not be driven directly into the inside wall of the uterus body but into one of the horn- like protrusions of the uterus body. Thus blockage of the outlet openings is easily prevented. Furthermore, the tubular member can be introduced from the rearward end of the channel, after the probe body has been fully introduced. In further elaboration an assembly according to the present invention is characterized by the features of claim 10. By providing the outlet opening in the wall of the second tubular member, the forward end of the tubular member being closed, provides for an advantageous direction for expelling fluid from said outlet opening, approximately perpendicular to the longitudinal direction of said tubular member, thereby even better preventing blockage of the outlet opening of said second tubular member, should the forward end thereof even be driven into the inner wall of the uterus body. Since the forward end of the second tubular member, extending from the channel within the uterus body, will be approximately straight, that is not bend over 180° or more, as the fluid carrier used with the known assembly, folding thereof is easily prevented, thus preventing occlusion of the channel within said second tubular member. The invention further relates to a method for non- surgical introduction of material such as embryos into the uterus of an animal, characterized by the features of claim 13. Such method necessitates only the use of a probe with an elongated channel and a tubular member slidably insertable into said channel . A method according to the present invention can easily and very accurately be performed with a very high rate of success . Such method is very animal friendly, quick and relatively inexpensive. Further advantageous embodiments of an assembly and a method according to the present invention are described in the subclaims and the description. To further clarify the invention exemplary embodiments of a method and assembly according to the present invention will be described hereafter with reference to the drawings. Fig. 1 is a schematic illustration of the uterus of a pig; fig. 2 is a side view of a probe according to the present invention, partly broken away, in a first embodiment; fig. 3 is a side view of a probe according to the present invention, partly broken away, in a second embodiment ; * fig. 4 is a side view of an assembly according to the present invention, introduced into the uterus of a pig; fig. 5 is an enlarged side view of an assembly according to the present invention, in cross-section, on an enlarged scale; fig. 6 a further embodiment of an assembly according to the present invention; and fig. 7 a still further embodiment of an assembly according to the invention. Corresponding parts are designated by corresponding reference signs throughout the description. Figure 1 shows schematically the anatomical configuration of the uterus of a pig. The uterus 1 comprises a uterus body 2, a pair of horn-like extensions 3A, 3B, extending from the uterus body 2, and a cervix 4 connecting the vagina 5 of the pig to the uterus body 2. The inside walls defining the cervical canal 6 of the cervix are convulated and lined with rounded prominences 7, some of which interconnect to occlude the canal 6. An assembly and method according to the present invention are illustrated with respect to the non-surgical transplant of fluid comprising for example semen or especially embryos into the uterus of a pig. However, it will be understood that the same assembly and method can be used to carry out artificial insemination, non-surgical transfers and similar non-surgical methods of transfer of other fluids and material in porcine, bovine and other species. Figure 2 shows a first embodiment of a probe 8 according to the present invention, said probe 8 comprising a probe body 9 and a channel 10. The probe body 9 is relatively long and has a longitudinal axis A, a probing member 11 extending at least laterally outward at the forward end 12 of the probe body and a gripping means 13 extending from the opposite rearward end 14 of the probe body 9. In the shown embodiment the probe body 9, the probing member 11 and the gripping means 13 are made by bending a plastic rod into the desired shape, for example a PVC-rod. The longitudinal axis B of the probing member 11 encloses an angle α with the longitudinal axis A of the probe body, which angle α in the shown embodiment is approximately 90°. However, the angle α can also be a sharp or blunt angle, for example between 45° and 135°, preferably between 60° and 120°. The length of the probing member 11 and the enclosed angle α can be chosen such that by manipulating the probe body the probing member 11 can be introduced in between and manoevered past the prominences 7 of the canal 6 of the cervix 4, as will be explained hereafter. The gripping means 13 comprises the bent rearward end of the probe body 9. The probing member 11 and the gripping means 13 are preferably positioned in the same plane when the probe 8 is in its initial position. This has the advantage that the position of the gripping means 13 provides for a direct indication for the position of the probing member 11 when introduced into the uterus 1. The length of the probe body 9 is at least such that when the probing member 11 is positioned in or adjacent to the uterus body 2 or one of the horn-like extensions 3A, 3B, the rearward end 14 of the probe 8 extends well outside the vagina 5, as is shown in figure 4. Thus the probe 8, especially the probing member 11 can be manipulated within the uterus body 2 by manipulation of the gripping means 13, which extend well outside the uterus. The channel 10 is provided for by a tube 15, preferably made of a flexible material such as plastic, silicone, rubber or the like, positioned alongside at least a substantial part of the probe body 9 and the probing member 11. The channel 10 comprises an inlet opening 16 near the rearward end 14 of the probe 8 and an outlet opening 17 near the free end of the probing member 11, that is near the forward end 12 of the probe 8. Since the part 18 of the tube 15 near the outlet opening 17 extends alongside the probing member 11, the central axis C of said part 18 extends at least approximately parallel to the axis B of the probing member 11, enclosing approximately said angle α with the longitudinal axis A of the probe body 9. The forward end of the tube 15, and the forward end of the probe body 9 are embedded in a casing 19 made of preferably a relatively soft, flexible material, such as elastomere, silicone, rubber or the like, to connect the forward end of the tube 15 to the probe body 9 and probing member 11 and might also protect the inside walls of the uterus 1 and cervix 4. The outlet opening 17 is positioned approximately adjacent the free end of the probing member 11, and is closed by a membrane 20, which is piercable or which can be pushed away, as will be explained later. The membrane 20 prevents contamination of the inside of the channel 10 during manipulation of the probe through the vagina into the cervix and uterus body 2. The tube 15, and thus the channel 10, preferably has a length which is substantially greater than the length of the probe body 9, whereby the flexible rearward part 21 is free from the probe body 9. Thus the inlet opening 16 of the channel 10 is easily accessible, for example from an angle different from the axis A of the probe body when introduced into the uterus 1. In figure 5 an assembly according to the present invention is shown, in an enlarged scale, comprising a probe 8 according to figure 2, through which a tubular element 21 is introduced, as will be explained hereafter. The probe 8 is covered, with at least its forward part to be introduced into the uterus, by a thin, flexible sheet, for example a plastic foil, which can be tubular (not shown) . Then the forward end 12 of the probe 8 is introduced through the vagina into the cervix, until the probing member 11 abuts one of the prominences 7 at the entrance of the canal 6. Then, if necessary, the probe 8 is rotated, preferably in a reciproce manner, mainly around its longitudinal axis A, by manipulation of the gripping means 13, such that the probing member 11 is gently urged in between the prominences 7, thereby partly moving the prominences 7 apart and partly flexing the probe body 9. The said protective sheet can be pulled away over the probe body 9. Thus the forward end 12 of the probe can be gently urged forward past the prominences 7, at least partly following the bends and curves of the cervix, as is shown in figure 4. Once the forward end 12, that is the probing member 11 has been pushed past the prominences 7 of the cervix 4 , the forward end of the probe 8 can be introduced into the uterus body 2, until the probing member 11 is positioned near one of the horn-like extensions 3A, 3B. An indication 23 has been provided on the probe body 9,- for example a colouring, at a distance from the probing member 11 corresponding to the average length of the uterus body, cervix and vagina of the relevant animal taken together. Furthermore, the resistance of the inside wall of the uterus body in comparison to the resistance of the cervical canal will provide an indication of the position of the probing member 11 within the uterus body 2. When the probe 8 is brought into the position as shown in figure 4, the tip 24 of the tubular member 22 is slidably introduced into the inlet opening 16 of the channel 10 within the tube 15. The forward end of the tip 24 is closed, whereby an outlet opening 25 is provided in the wall 26 of the tubular member 22, at a relatively short distance from the tip 24. The tubular member 22 further comprises an inlet opening 27 at the tail 28, that is the opposite rearward end of the tubular member 22, in which for example the needle 29 of for example a syringe 30 has been introduced. The tip 24 of the tubular member 22 is pushed forward through the channel 10 until the tip 24 abuts the membrane 20. By forcing the tip 24 forward the membrane 20 will be pierced or pushed aside, after which the outlet opening 25 will be pushed past the outlet opening 17 of the channel 10, the tip 24 extending freely within the uterus body 2 or one of the horn-like extensions 3A, 3B thereof. Then a fluid, containing for example semen or embryos to be introduced into the uterus 1 is introduced from the syringe 30, through the channel 32 of the tubular member 22 and out the outlet opening 25 into the uterus body 2 or horn-like extension 3B. Since the tubular member 22 is fully guided by the channel 10, that is the tube 15, folding of said tubular member 22 or any other occlusion thereof is prevented. Therefore a proper introduction of said fluid into the uterus body 2 or horn-like extension 3 is guaranteed. Depending on for example the form and position of the horn-like extensions 3 and the uterus body 2 and cervix 4 relative to each other, the length of the probe body 9, the enclosed angle α between the longitudinal axis A and B, the angle enclosed between the longitudinal axis A and C and the flexibility of at least the probe body 9 can be chosen appropriately. By way of example, which should by no means be understood as limiting the scope of the present invention, dimensions are given for an assembly according to the present invention, convenient to be used for introduction into the uterus of a pig. The probe body can have an overall length of approximately 950 mm, with a circular cross-section having a diameter of 3 mm. A first indicator is positioned at approximately 115 mm, a second indicator at approximately 310 mm from the rearward end 14. The enclosed angle α is approximately 110°, the length of the probing member 11 approximately 10 mm. The tube 15 has an inside diameter of 1.5 mm, the tubular element 22 an inside diameter of approximately 0.7 mm. The excess length of the tube 15 is for example 170 mm over the length of the probe body 9, the excess length of the tubular element 22 over the tube 15 for example 350 mm. The distance between the tip and the outlet opening 25 of the tubular member 22 will be approximately 5 mm. The modulus of elasticity of the probe body, which is made of PVC, is preferably just under 3000 N/mm 2 . An appropriate choice of dimensions and materials to be used will nevertheless be sufficiently clear to the person skilled in the art . Figure 3 shows an alternative embodiment of a probe 108 according to the present invention, made of a single, bent tube-like probe body 109. The probe body 109 is for example made of plastic, such as PVC, PE, PA, silicone or any other suitable material. The forward end 112 of the probe body 109 has been bent over an angle α, again for example 90°, for forming the probing member 111. The forward end 112 might be embedded in a soft casing 119, as discussed before. The rearward end 114 of the tube-like probe body 109 has been bent over an angle β for forming the gripping means 113. The gripping means 113 and the probing member 111 are once again positioned in the same plane. Through the probing member 111 and the probe body 108 extends the channel 110. In the rearward end 114 of the probe 108 an inlet opening 116 has and stored. To this end the connecting member 31 can be replaced by a stopper element (not shown) . Directly before use said stopper element is removed and the first element 22A is connected to the second element 22B through said connecting element, after which the tubular member 22 is brought into position for introduction of the embryos (or semen) through said outlet opening by said syringe 30. In an embodiment as shown in fig. 7 said stopper element 33 is connected to a rod or wire 34 sufficiently flexible to follow bends and curves in the tubular member and sufficiently rigid to push the stopper element 33 through at least the first part 22A of the tubular member 22, which wire 34 extends through the second part 22B of the tubular member 22, such that the free end 35 thereof extends outside said member 22. By this wire 34 the stopper element 33 can be pushed forward, such that the embryos or semen are forced out trough the opening 25. The wire 34 can be fixed to the stopper 33 or positioned free in said tubular member 22. An assembly according to figures 2 and 3 can be amended in a similar way. Such assembly has the advantage that storage and transport of the semen or embryos is easy, as is handling thereof. As can be understood from the description and the drawings, the outlet opening 25, 125 of the tubular element 22, 122 can be brought into a position with minimal pressure of the inside wall of the uterus very easily, even though the forward end of the probe assembly cannot be seen by the person manipulating the probe assembly. Thus a proper delivery of the fluid into the uterus body is guaranteed. It will be directly clear that said fluid could also be introduced into the uterus body directly through the channel 10, 110 without the use of the tubular element 22, 122, as long as the opening 25, 125 is open or opened before or upon introduction. A flexible assembly according to the present invention has the advantage that it can be introduced into the vagina, cervix and uterus of an animal, even if it is not ) to to F 1 J in O in o in o in 22, 122 through the outlet opening 25, 125 prior to introduction of the tip into the channel, whereby said material can be introduced into the uterus body or horn-like extensions thereafter by using a syringe, forcing a fluid through said tubular element, thus pushing the material, contained in the tip of the tubular element, out through said outlet opening. Thus only a limited volume of fluid has to be introduced into the uterus . Furthermore the said material could be brought into the channel or tubular member by different means, for example by using a pump or the like. The probe body can be partly relatively rigid and partly be relatively flexible, due to a choice of material and/or construction. Those and similar variations are considered to fall within the scope of the present invention.

Claims: > to to o in o in o in mem b er. 6. An assembly for penetrating the uterus of an animal during a non-surgical procedure, preferably according to any one of claims 1 - 5, said assembly comprising a probe having an elongated body with a central longitudinal axis and a probing member extending at least laterally outwardly at the forward end of the probe body, the assembly further comprising a channel extending between an inlet opening at a distance of the probing member and an outlet opening near the probing member, the probe being sufficiently flexible for introduction into said uterus, especially in between the bends and curves of the walls of the cervix, said probe being adapted to be inserted, forward end first, inside the cervix of said animal, said probe body then being manipulatable to gently maneuver the probing member in a forward direction through the cervix, thereby mainly following the walls of said cervix to a position in which the probing member and the outlet opening are adjacent or in the body of the uterus . 7. An assembly according to any one of claims 1 - 6, wherein the probe body is at least mainly made of plastic. 8. An assembly according to claim 7, wherein the probe body has a cross-section having a height and width of less then 5 mm, preferably a circular cross section with a diameter of approximately 3 mm and a Modulus of Elasticity of less then 6000 N/mm2 , more specifically less then 4000 N/mm2 and preferably approximately 3000 N/mm2. 9. An assembly according to any one of the preceding claims, wherein the assembly further comprises a second tubular member, being slidably insertable through the channel and having a length greater then the length of the channel, the second tubular member having an inlet opening and an outlet opening 10. An assembly according to claim 9, wherein the outlet opening is provided in the wall of the second tubular member, whereby the end of the second tubular member near the outlet opening is closed. 11. An assembly according to any one of the preceding claims, wherein at least during introduction of the probe into the cervix and uterus the outlet opening of the channel is closed, preferably by a membrane. 12. An assembly according to any one of the preceding claims, wherein the probe body is provided with gripping means near the rearward end thereof, whereby during use the gripping means provide for an indication of the position of the probing member . 13. Method for non-surgical introduction of material such as embryos into the uterus of an animal, said method involving the use of a probe-assembly, comprising: - a probe with an elongated, preferably flexible probe body, a probing member extending in a non-longitudinal direction from the probe body, near the forward end thereof, a channel having an inlet opening near the rearward end of the probe body and an outlet opening near the probing member, and a tubular member slidably insertable into the channel via the inlet opening, the tubular member having a length such that the forward end thereof can be pushed outside the outlet opening of the channel, involving the steps of: inserting the probe body into the cervix of said animal, forward end first, rotating the probe body generally around the longitudinal axis, in a constant or reciprocating direction, thereby pushing the probe body forward into the direction of the uterus body of said animal, the probe body preferably at least partly following the curvatures of at least said cervix, inserting, when the probing member is at least partly extending into or is adjacent to the uterus body, the tubular member into the inlet opening of the channel, forward end first, such that the forward end of the tubular member extends outside the outlet opening of the channel, and introducing the material into the uterus body or uterine horn through the outlet opening of the tubular member . 14. Method according to claim 13, wherein the tubular member is at least partly pushed through a bend or curve in the channel, such that its forward end becomes extending into the uterus body or uterine horn enclosing an angle with the longitudinal axis of the probe body, said angle being different from 180°. 15. Method according to claim 13 or 14, wherein the forward end of the tubular member is pushed through or past a closure in or near the outlet opening of the channel, before introduction into the uterus body of said forward end of said tubular member. 16. Method according to any one of claims 13-15, wherein the probe body is inserted into the cervix at least partly surrounded by a sleeve, which sleeve is preferably made of thin flexible foil and is pulled away over the probe body after sufficient insertion.

Inventors: HAZELEGER WOUTER, HAZELEGER, WOUTER
Applicants: BOND VAN VERENIGINGEN VOOR KUN, DALLAND B V, EURIBRID B V, HAZELEGER WOUTER, INST PIG GENETICS B V, BOND VAN VERENIGINGEN VOOR KUNSTMATIGE INSEMINATIE VAN VARKENS, DALLAND B.V., EURIBRID B.V., HAZELEGER, WOUTER, INSTITUTE FOR PIG GENETICS B.V.
Application year: 1998
Main classification: A61D19
IPC codes: A61D19