Detachable fluid controller and insemination device

Abstract

A fluid controller configured to be removably attached to a fluid introduction device is disclosed, the fluid controller comprising: a body configured to extend at least partially over the fluid introduction device; an orifice disposed relative to the body to facilitate transfer of fluid from the fluid introduction device through the fluid controller; a fluid retention structure extending outwardly from at least a portion of the body, the fluid retention structure configured to engage a wall of a vaginal canal and impede flow of the fluid from the vaginal canal; and at least one connector configured to releasably attach the fluid controller to the fluid introduction device.

Description

[Technical field]

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 317,213, filed March 7, 2022, U.S. Provisional Patent Application No. 63 / 362,601, filed April 7, 2022, and U.S. Provisional Patent Application No. 63 / 358,321, filed July 5, 2022, each of which is hereby incorporated by reference in its entirety. [Background technology]

[0002] Infertility is a common condition that affects as many as one in six couples trying to conceive. Although the causes of infertility can be varied, almost 60% of infertility can be attributed to a low sperm count or its motility. Some fertility treatments, such as medications to aid in hormone balance and / or ovulation, intrauterine insemination (IUI), and in vitro fertilization (IVF), are invasive, often have unwanted side effects, and can be cost-prohibitive for those seeking fertility treatment.

[0003] There is a need for new and improved devices and methods to provide people with safe, simple, and affordable treatments that can be used frequently to increase the overall chances of successful conception. The disclosed devices and methods are intended to address one or more of these issues. For example, the disclosed methods and fluid introduction systems may provide benefits for any application in which it may be desirable to introduce a fluid into a volume and then retain or partially retain the fluid within the volume over time. In some applications, the disclosed systems and methods are intended to promote conception. Summary of the Invention

[0004] An insemination device is disclosed having a fluid controller and a fluid introduction device, the fluid controller configured to be removably attached to the fluid introduction device. For example, the disclosed fluid controller may include a body configured to extend at least partially over the fluid introduction device (e.g., a syringe or other fluid carrier). The fluid controller may further comprise an orifice disposed relative to the body to facilitate transfer of fluid from the fluid introduction device through the fluid controller; a fluid retention structure extending outwardly from at least a portion of the body, the fluid retention structure configured to engage a wall of the vaginal canal and impede flow of the fluid from the vaginal canal; and at least one connector configured to releasably attach the fluid controller to the fluid introduction device. Also described are methods of potentially assisting conception using the disclosed insemination devices.

[0005] In some embodiments, the fluid retaining structure is configured such that attachment of the fluid controller to the fluid introduction device reduces at least one dimension associated with the fluid retaining structure, hi some embodiments, the at least one dimension includes a radial dimension.

[0006] In some embodiments, the at least one connector is further configured such that the fluid controller can be separated from the fluid introduction device after insertion into the vaginal canal and the fluid introduction device can be removed from the vaginal canal without removing the fluid controller from the vaginal canal.

[0007] In some embodiments, the fluid retaining structure is configured to expand in at least one dimension upon separation of the fluid controller from the fluid introduction device.

[0008] In some embodiments, the fluid introduction device comprises a syringe.

[0009] In some embodiments, the fluid retention structure has a maximum cross-sectional diameter in the range of 12 mm to 50 mm when the fluid controller is not attached to the fluid introduction device.

[0010] (In some embodiments, the fluid controller is configured such that the maximum cross-sectional diameter of the fluid retaining structure is reduced when the fluid controller is attached to the fluid introduction device.

[0011] In some embodiments, the fluid retention structure has a Shore A hardness in the range of 0-70.

[0012] In some embodiments, the fluid retaining structure comprises one or more of a flap, a bulb, a plug, or a valve.

[0013] In some embodiments, the fluid retaining structure comprises a plug.

[0014] In some embodiments, the fluid retaining structure comprises at least two flaps.

[0015] In some embodiments, the at least one connector has one or more of a loop, a notch, a slot, a hook, or a ridge.

[0016] In some embodiments, the at least one connector is configured to receive a protrusion associated with the fluid introduction device.

[0017] In some embodiments, the fluid controller comprises silicone.

[0018] In some embodiments, the fluid controller comprises between 10 weight percent and 100 weight percent silicone, by total weight of the fluid controller.

[0019] In some embodiments, the fluid retention structure is configured to engage the vaginal wall and retain the fluid controller at least partially within the vaginal canal after the fluid introduction device is separated from the fluid controller and removed from the vaginal canal.

[0020] In some embodiments, the coefficient of friction between the fluid controller and the vaginal wall is greater than the coefficient of friction between the fluid controller and the fluid introduction device.

[0021] In some embodiments, the orifice has at least two intersecting slots.

[0022] In some embodiments, the at least one connector comprises at least one resilient section configured to stretch when the fluid controller is attached to the fluid introduction device.

[0023] In some embodiments, at least a portion of the fluid controller comprises a thermally responsive material configured to change shape or color when at least partially within the vaginal canal.

[0024] In some embodiments, at least a portion of the fluid controller comprises a pH responsive material configured to change shape or color when at least partially within the vaginal canal.

[0025] In some embodiments, at least a portion of the fluid controller comprises a moisture responsive material configured to change shape or color after being introduced at least partially into the vaginal canal.

[0026] In some embodiments, the fluid introduction device is a syringe including a barrel flange, and the at least one connector is configured to be removably attached to a portion of the barrel flange.

[0027] In some embodiments, the fluid controller further comprises a quick release element configured to facilitate separation of the fluid controller from the fluid introduction device.

[0028] In some embodiments, the fluid controller further comprises one or more alignment guides configured to orient the fluid controller relative to the fluid introduction device.

[0029] In some embodiments, the fluid comprises semen.

[0030] In some embodiments, the fluid comprises at least one pharmaceutical agent.

[0031] In some embodiments, the fluid comprises progesterone.

[0032] Also disclosed are methods for assisting conception using the disclosed insemination devices. [Brief description of the drawings]

[0033] [Figure 1] Illustrates cup and syringe insemination methods.

[0034] [Figure 2A] 1 illustrates an exemplary insemination device having a fluid controller and a fluid introduction device.

[0035] [Figure 2B] 1 illustrates an exemplary fluid controller.

[0036] [Figure 2C] 1 illustrates an exploded assembly view of an exemplary fluid controller and fluid introduction device.

[0037] [Figure 2D] 1 illustrates an exemplary fluid controller assembled to a fluid introduction device.

[0038] [Diagram 3] 1 illustrates an exemplary fluid controller in both a relaxed and deformed state.

[0039] [Figure 4] 1 illustrates an exemplary embodiment of a fluid retaining structure.

[0040] [Diagram 5] 1 illustrates an exemplary fluid retaining structure and orifice embodiment.

[0041] [Figure 6] 1 illustrates an exemplary orifice embodiment.

[0042] [Figure 7] 1 illustrates a cross-sectional view of an exemplary embodiment of a fluid retaining structure and orifice.

[0043] [Figure 8A] 1 illustrates an exemplary embodiment of a fluid retaining structure.

[0044] [Figure 8B] 1 illustrates an exemplary embodiment of a fluid retaining structure.

[0045] [Figure 9] 1 illustrates an exemplary embodiment of a fluid retaining structure.

[0046] [Figure 10] 1 illustrates an exemplary embodiment of a fluid retaining structure.

[0047] [Figure 11] 1 illustrates an exemplary embodiment of a fluid retaining structure.

[0048] [Figure 12] 1 illustrates an exemplary fluid controller embodiment.

[0049] [Figure 13]1 illustrates an exemplary alignment structure to aid in mounting a fluid controller to a fluid introduction device.

[0050] [Figure 14] 1 illustrates an exemplary connector embodiment for attaching a fluid controller to a fluid introduction device.

[0051] [Figure 15] 1 illustrates an exemplary barrel flange tab embodiment for mounting a fluid controller to a fluid introduction device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] FIG. 1 provides an overview of an insemination technique for introducing semen into the vaginal cavity. For example, in step 100, ejaculate is collected in a cup 102 and drawn into a syringe 101. The syringe 101 is then positioned in the vaginal canal where the ejaculate is introduced 105. While this technique can be effective in promoting conception, in some cases, once the syringe 101 is removed, the ejaculate may freely exit the vaginal canal. Even before the syringe is removed, the ejaculate may leak out of the vaginal canal through gaps between the syringe barrel and the vaginal wall. Additionally, leaving the syringe in the vaginal canal for an extended period of time may cause discomfort to the user.

[0053] The disclosed insemination devices are intended to enhance conception by promoting retention of ejaculate within the vaginal canal (or by reducing leakage of ejaculate from the vaginal canal). The disclosed insemination devices may include or be used in conjunction with various types of fluid introduction devices.

[0054] FIG. 2A illustrates an insemination device including an exemplary fluid controller 200 coupled with a fluid introduction device 201. In the example of FIG. 2A, the fluid controller has an orifice 202 disposed relative to a body of the fluid controller. The orifice 202 may facilitate the transfer of fluid (e.g., semen, medicinal fluid, etc.) from the fluid introduction device 201 through the fluid controller 200. As shown in FIG. 2A, the fluid retaining structure 203 extends outwardly from at least a portion of a body 204 of the fluid controller 200, where the body 204 is configured to extend at least partially over the fluid introduction device 201. In some cases, the fluid controller 200 may include one or more connectors 205 configured to releasably attach the fluid controller 200 to one or more structures associated with the fluid introduction device 201. For example, in some cases, as discussed in more detail in the following section, the connector 205 may include one or more slots, hooks, loops, etc. configured to engage one or more structures associated with the fluid introduction device 201. 2A, the connector 205 includes a slot for attachment to a protrusion (not shown) associated with the fluid introduction device 201. In some cases, the fluid introduction device 201 may include a syringe having a barrel flange 206 that includes tabs, protrusions, etc. for connecting with the connector 205.

[0055] The disclosed fluid controller may take many different forms and may be arranged to operate with various types and configurations of fluid introduction devices. In some cases, for example, the fluid controller may be integrated with the fluid introduction device. In other cases, the fluid controller may be formed as a separate component to the fluid introduction device, as described above. In such cases, the fluid controller may be used with a number of different types of fluid introduction devices, including, for example, certain syringes, plunger-based devices, or other types of fluid introduction devices (off-the-shelf or otherwise). In addition to providing a path for fluid flow (e.g., via orifice 202), the disclosed fluid controller may also include one or more structures intended to retain the fluid within the volume into which the fluid is introduced (e.g., the vaginal canal, or other type of cavity, including a body cavity or otherwise).

[0056] For example, as shown in the example of FIG. 2B, the fluid controller 200 may include a fluid retention structure 203, which may take the form of a plug, shield, flange, etc., to retard or prevent leakage of fluid through the fluid retention structure and out of the volume into which the fluid has been introduced. In particular, the fluid retention structure may be designed to retard or prevent such leakage of fluid whether the fluid controller 200 is left attached to the fluid introduction device 201 after introduction of fluid (e.g., insemination) or whether the fluid controller 200 is separated from the fluid introduction device 201. As discussed further below, the fluid controller may include structural features that facilitate separation of the fluid controller from the fluid introduction device and structural features that allow the fluid introduction device to be pulled away from the fluid controller without moving the fluid controller from its installed position. For example, the fluid introduction device may be separated from the fluid controller and removed from the vaginal canal while the fluid controller remains in the vaginal canal and retains or at least partially retains the deposited insemination fluid proximal to the cervix.

[0057] In the example of FIG. 2B, the fluid controller 200 includes a ring-shaped connector 205 configured to slide over a corresponding protrusion associated with the fluid introduction device 201. FIG. 2C shows an exploded assembly view of the fluid introduction device 201 having a body 234, a plunger 232, and a barrel flange 236. The barrel flange 236 includes a tab 238 extending outwardly from the body 234. In this example, the ring-shaped connector 205 is sized to slide over corresponding tabs 238 (of the barrel flange 236) extending from both sides of the body 234. FIG. 2D provides an isometric view of the fluid controller 200 assembled to the fluid introduction device 201 to provide (in this particular example) a fluid insemination device 240. It should be noted that device 240 may be used to introduce any type of fluid (e.g., semen, medication, etc.) into a desired volume (e.g., the vaginal cavity, or any other type of volume in the body or elsewhere). As shown, fluid controller 200 includes two legs 242 that terminate in a ring-shaped connector 205. To assemble fluid controller 200 to fluid introduction device 201, head 244 of fluid controller 200 is placed over the fluid introduction end of fluid introduction device 201 (in this case a syringe) and legs 242 are extended until ring-shaped connector 205 can be attached to tab 238 of barrel flange 236.

[0058] The tabs of the barrel flange (such as tab 238 shown in FIG. 2C) may have one or more recesses, which may have a variety of configurations. FIG. 15 shows an exemplary barrel flange tab showing recesses 1500 having a radius of curvature 1501. Each recess may have a radius of curvature ranging from 0.5 mm to 8 mm. Each recess may be, for example, circular, oval, square, rectangular, etc. The length 1502 of each tab may vary, for example, from 5 mm to 5 cm, and may have a radius of curvature 1503 ranging, for example, from 5 mm to 5 cm. The recesses may be configured to receive, for example, a loop on a connector to connect the fluid controller to the fluid introduction device and to allow a user to easily attach and detach the connector from the fluid introduction device. Varying the length 1502 and radius of curvature 1501 and / or 1502 of the barrel flange tabs may facilitate ease of engagement of the fluid controller connector with the barrel flange, aid in holding the fluid controller connector on the tab during operation, and aid in disengaging the fluid controller connector from the tab to pull the fluid introduction device away from the fluid controller after introducing fluid into the volume. Additionally, while the barrel flange tabs in the example of FIG. 15 are shown as including two recesses 1500 each (one on either side of the tab), more or fewer recesses may be included. For example, in some cases, the flange tabs may result from forming a single recess 1500 in the barrel flange. In other cases, such as the example of FIG. 15, the barrel flange tabs may be provided by forming two recesses 1500 in the barrel flange. In still other examples, the disclosed tabs may be associated with more than two recesses (e.g., multi-notch tabs, graduated multi-step tabs, etc.). The radius of curvature may also extend over a range of angles. In some cases, the radius may extend over a range between 30 degrees and 90 degrees (as shown in FIG. 15). In other cases, the angle range may be greater than 90 degrees (e.g., up to 180 degrees or more) to create a notch in the barrel flange.Such notches may increase the ability of the flange to retain the fluid controller connector, but may come at a cost in terms of ease of disengaging the fluid controller connector from the barrel flange.

[0059] Fluid may be loaded into the fluid introduction device (e.g., a syringe) 201 before or after the fluid controller 200 is connected to the fluid introduction device 201. In either case, the fluid-loaded insemination device 240 may then be positioned within the vaginal canal. The insemination fluid may then be introduced into the vaginal canal, for example, by forcing at least a portion of the fluid through an orifice in the fluid controller 200 using the plunger 232 of the fluid introduction device 201. In some cases, after passing the fluid from the fluid introduction device into the vaginal canal, the fluid controller / fluid introduction device assembly may be retained within the vaginal canal (e.g., for a predetermined amount of time). However, in other cases, the fluid controller 200 may be separated from the fluid introduction device 201, and the fluid introduction device may be removed from the vaginal canal while the fluid controller remains within the vaginal canal.

[0060] The disclosed fluid controllers may be configured such that attachment of the fluid controller 200 to the fluid introduction device 201 reduces one or more dimensions associated with the fluid controller, which may aid in the introduction of the fluid controller / fluid introduction device assembly into the vaginal canal. For example, the fluid controller 200 may be configured such that the maximum cross-sectional diameter of the fluid retention structure 203 is reduced when the fluid controller 200 is attached to the fluid introduction device 201. That is, stretching the connector 242 may cause the fluid controller 200 to deform in at least one radial direction. For example, as shown in FIGS. 2B and 2D, stretching the legs 242 so that the connector 205 engages the tabs 238 also stretches the material of the head 244. Attaching the fluid controller 200 to the fluid introduction device 201 results in a reduction in diameter D associated with the fluid retention structure 203 in an unstretched state (FIG. 2B) to diameter d in a stretched state (FIG. 2D). More specifically, the fluid controller 200 may be characterized by an axial dimension (e.g., length) and a radial dimension (e.g., D / 2). The axial dimension of the fluid controller 200 may be increased by attaching the fluid controller 200 to the fluid introduction device 201, while the radial dimension may be decreased.

[0061] The fluid retention structure 203 may be configured such that an outer circumferential region of the fluid retention structure 203 engages an inner wall of the vaginal canal after the fluid controller / fluid introduction device assembly is introduced into the vaginal canal. Thus, deformation of the fluid retention structure 203 in at least one radial direction may aid in the insertion of the insemination device assembly. For example, stretching of the connector 242 may cause the fluid controller 200, including the fluid retention structure 203, to deform (e.g., narrow) in at least one radial direction, which may facilitate introduction of the fluid controller 200 into the vaginal canal.

[0062] Deformation of the fluid controller 200 may also provide other potential benefits: for example, such stretching and the associated deformation can open or change the shape of an orifice (see FIG. 5).

[0063] As described above, in some cases, after fluid is introduced into the volume from the fluid introduction device 201 through the fluid controller 200, the fluid introduction device 200 may be separated from the fluid introduction device 201. The fluid introduction device may be removed from the vaginal canal while the fluid controller remains in the vaginal canal. By separating the fluid controller 200 from the fluid introduction device 201, the fluid controller 200 may relax from a deformed state (e.g., a stretched or narrowed state) to an undeformed or at least less deformed state (e.g., a wider state). Relative to the deformed state, the less deformed or undeformed state may more firmly engage the vaginal wall to reduce backflow of insemination fluid out of the vaginal canal. For example, in the less deformed or undeformed state, the radial dimension of the fluid retention structure 203 may increase to increase the level of engagement between the vaginal wall and the fluid retention structure 203.

[0064] FIG. 3 illustrates an exemplary fluid controller (300) in which mounting the fluid controller to a fluid introduction device (301→302) reduces the radial dimension associated with the fluid retention structure (303).

[0065] Removing the fluid introduction device 201 from the vaginal canal may be more comfortable for the subject than maintaining the complete fluid controller / fluid introduction device assembly within the vaginal canal. Additionally, removing the fluid introduction device while leaving the fluid controller in place within the vaginal canal may promote conception as the fluid controller may be maintained in place for any suitable period of time (e.g., 10 minutes, 30 minutes, 1 hour, 8 hours, etc.). Additionally, while the fluid controller 200 is maintained in the vaginal canal, backflow of insemination fluid through the fluid controller 200 and out of the vaginal canal may be reduced or eliminated, for example, by the fluid retention structure 203 fully or partially engaging the vaginal wall.

[0066] Various structures may be included in the fluid controller 200 and / or the fluid introduction device 201 to facilitate removable attachment of the fluid controller 200 to the fluid introduction device 201. For example, the connector 205 may be shaped to allow quick removal from the barrel flange 236 of the syringe. Such shapes may include a ring as shown in FIG. 2D or may include a recess as shown in FIG. 6, FIG. 12, or FIG. 14, among other shapes. A quick release mechanism or other type of quick release element may also be attached to the fluid introduction device 201 to facilitate disconnection of the fluid controller 200 from the fluid introduction device 201. Such a quick release mechanism may include a plunger, winged structure, spring-loaded button, or the like configured to disengage the fluid controller 200 from the fluid introduction device 201 (e.g., move the connector 205 from the tab 238, etc.).

[0067] Other aspects of the fluid controller and fluid introduction device may also be configured to facilitate detachment of the fluid controller 200 from the fluid introduction device 201. For example, in some cases, the coefficient of friction between the fluid controller and the fluid introduction device may be selected to be less than a known or estimated coefficient of friction between the fluid controller and the vaginal wall. Such a relative coefficient of friction may aid in removal of the fluid introduction device from the vaginal canal without also removing the fluid controller from the vaginal canal. It is believed that a coefficient of friction between the fluid controller and the vaginal wall that is greater than the coefficient of friction between the fluid controller and the fluid introduction device may aid in removal of the fluid introduction device from the vaginal canal while the fluid controller is maintained in place inside the vaginal canal after introduction of the insemination fluid. In some examples, the fluid controller 200 and the fluid introduction device 201 may be fabricated such that the interface between the fluid controller and the fluid introduction device has a coefficient of friction that is less than the coefficient of friction between the fluid controller 200 and the vaginal wall. For example, mating surfaces between the fluid controller and the fluid introduction device may be coated with one or more friction-reducing materials, such as polytetrafluoroethylene (PTFE). Additionally or alternatively, one or more exterior surfaces of the fluid controller 200 may be fabricated with textured features, such as ridges, ribs, soft spikes, etc., to reduce slippage of the fluid controller 200 once it engages the vaginal wall. Such structure / texture may result in a greater coefficient of friction between the fluid controller 200 and the vaginal wall than the coefficient of friction between the fluid controller and a fluid introduction device.

[0068] The fluid controller 200 may be sized according to the requirements of a particular application. In some embodiments, the fluid controller 200 has a length in the range of 50 mm to 100 mm when not attached to the fluid introduction device 201. In some embodiments, the fluid controller has a length in the range of 60 mm to 90 mm when not attached to the fluid introduction device. In some embodiments, the fluid controller has a length in the range of 70 mm to 90 mm when not attached to the fluid introduction device. In some embodiments, the fluid controller has a length in the range of 75 mm to 85 mm when not attached to the fluid introduction device.

[0069] 2B-2D show fluid retention structure 203 including a dome shape, the fluid retention structures associated with the disclosed fluid controllers may include a number of different shapes, each providing different performance characteristics. For example, FIG. 4 shows an exemplary retention structure 400 having four flaps, and another exemplary retention structure 401 having eight flaps. In either case, the spaces between adjacent flaps allow retention structures 400 and 401 to freely change diameter or at least one radial dimension (402→403) when introduced into the vaginal canal.

[0070] The disclosed fluid retention structure may have any suitable dimensions. In some embodiments, the fluid retention structure has a maximum cross-sectional diameter in the range of 12 mm to 50 mm when the fluid controller is not attached to the fluid introduction device. In some embodiments, the fluid retention structure has a maximum cross-sectional diameter in the range of 15 mm to 35 mm when the fluid controller is not attached to the fluid introduction device. In some embodiments, the fluid retention structure has a maximum cross-sectional diameter in the range of 20 mm to 30 mm when the fluid controller is not attached to the fluid introduction device.

[0071] Additionally, the disclosed fluid retention structures may be made from materials that provide suitable hardness and / or elasticity properties. In some embodiments, the fluid retention structures have a Shore A hardness in the range of 0-70. In some embodiments, the fluid retention structures have a Shore A hardness in the range of 10-70. In some embodiments, the fluid retention structures have a Shore A hardness in the range of 20-70. In some embodiments, the fluid retention structures have a Shore A hardness in the range of 30-70. In some embodiments, the fluid retention structures have a Shore A hardness in the range of 10-60. In some embodiments, the fluid retention structures have a Shore A hardness in the range of 10-50. In some embodiments, the fluid retention structures have a Shore A hardness in the range of 0-40.

[0072] In some embodiments, the fluid retention structure may include one or more of a flap, a bulb, a plug, or a valve. In some embodiments, the fluid retention structure may include at least two flaps. In some embodiments, the fluid retention structure is configured to engage the vaginal wall and retain the fluid controller at least partially within the vaginal canal after the fluid introduction device is separated from the fluid controller and removed from the vaginal canal. Without wishing to be bound by theory, it is believed that the fluid retention structure may assist in conception by retaining the insemination fluid introduced within the vaginal canal after the fluid introduction device is removed.

[0073] In some embodiments, when the vaginal wall is allowed to collapse onto the unsupported fluid retention structure (e.g., after separation and removal of the fluid introduction device), the fluid retention structure may flatten in at least one radial direction and widen in another radial direction. Allowing the fluid retention structure to conform to the contours of the vaginal wall may provide an improved seal between the fluid retention structure and the vaginal wall.

[0074] In some embodiments, the fluid retention structure includes an orifice configured to allow insemination fluid from the fluid introduction device to pass through the fluid controller. For example, returning to Figure 4, an orifice 410 is shown at the center of the fluid retention structures 400 and 401. The orifice may be configured in a variety of shapes.

[0075] 5 illustrates fluid controller 520 in different views, including a side view 501, a cross-sectional view 502, and an isometric view 503. As shown, fluid controller 520 includes a single slit orifice 504 that is configured such that when the fluid controller is attached to a fluid introduction device, the slit opens wider than when the fluid controller is not attached to the fluid introduction device. For example, single slit orifice 504 may be configured to open wider when tension is applied to head 510 (e.g., when legs 512 are extended to fit fluid controller 520 onto fluid introduction device 506).

[0076] FIG. 6 illustrates different orifice configurations according to disclosed exemplary embodiments. For example, in a first configuration, fluid controller 601 may include a circular opening orifice 603. In another exemplary embodiment, fluid controller 605 may include a cross-shaped orifice 607. Cross-shaped orifice 607 may include any arrangement of at least two intersecting (e.g., intersecting at a perpendicular or non-perpendicular angle) slots. The slits included in the cross-shaped orifice may include rounded openings at the ends of the slits, as represented by orifice 610, or may include uniform width slits without rounded ends, as represented by orifice 612. The number of slits, the intersecting angle of the slits, and the shape of the slits can all affect the degree to which the orifices open upon assembly of the fluid controller to a fluid introduction device. These parameters can also affect the flow of fluid through the orifices.

[0077] FIG. 7 shows various fluid retention structures 701-705 with different cross sections. For example, fluid retention structures 701, 702, and 703 all include inner walls that exhibit a convex shape in cross section. This convex shape may help open an orifice, such as orifice 710, in response to contact between the inner wall of the fluid retention structure and a fluid introduction device (e.g., as a result of sliding the fluid controller over the fluid retention device to stretch the fluid controller into place). On the other hand, fluid retention structures 704 and 705 include inner walls with a concave cross section. Such a structure may help widen an orifice, such as orifice 712, in response to tension being applied to the fluid retention structure (e.g., by stretching a connector attached to the fluid retention structure, as shown in FIG. 2D).

[0078] 8A and 8B show various embodiments of fluid retaining structures and orifices. For example, in some cases, the fluid retaining structures included in the disclosed fluid controllers may include a tubular interface 802, a trapezoidal interface 803, a conical interface 804, various spherical interfaces 805 and 806, a dome interface 807, an irregular interface 808, a cylindrical interface 809, an inverted conical interface 810, or a bicuspid valve interface 811.

[0079] 9 shows additional fluid retention structure and orifice embodiments. Such embodiments may include, for example, a concave trumpet shaped embodiment 901, a convex trumpet shaped embodiment 902, a conformal embodiment (903 is a top view and 904 is a bottom view), a long sided conformal embodiment 905, a conical embodiment 906, and a rugby ball shaped (long) embodiment 907.

[0080] FIG. 10 illustrates further fluid retention structure and orifice embodiments. As shown in FIG. 10, the exemplary fluid retention structure may include a trumpet-shaped retention structure 1000 having a wavy flange 1001 shown in cross section 1003. The exemplary fluid retention structure may also include a disk-shaped embodiment 1004, a four-flap embodiment 1005, an eight-flap embodiment 1006, and a kirigami embodiment 1007. FIG. 11 illustrates additional exemplary fluid retention structure and orifice embodiments including a dome-shaped embodiment 1100 having an internal sub-dome interface 1101 that may be configured to communicate with the tip of a fluid introduction device, such as a syringe. Similarly, the fluid retention structure 1102 may include a bell-shaped outer structure and a pseudo-spherical internal interface element 1103 that may be configured to communicate with the tip of a fluid introduction device.

[0081] FIG. 12 shows additional examples of fluid controller configurations. For example, FIG. 12 shows fluid controller 1201 (cross section 1201a) and fluid controller 1203 (cross section 1203a). Similar to the other disclosed fluid controllers described above, both fluid controllers 1201 and 1203 include at least one connector 1215 that includes one or more grooves, slots, or another type of recess, hole, etc. for attaching the fluid controller to a fluid introduction device (e.g., a syringe). Fluid controllers 1201 and 1203 also include legs 1217 that join the connector 1215 to a corresponding fluid retaining structure, i.e., fluid retaining structure 1219 of fluid controller 1201 and fluid retaining structure 1221 of fluid controller 1203. It should be noted that the disclosed fluid controllers may include a variety of different connector configurations. For example, fluid controller 1201 includes two connectors 1215 located at the end of each leg 1217. Fluid controller 1203 , on the other hand, only includes one connector 1215 spanning between two legs 1217 .

[0082] In these examples, the fluid retention structures 1219 and 1221 have substantially symmetrical cross-sections (a bellows-shaped cross-section for the fluid retention structure 1219 and an oval cross-section for the fluid retention structure 1221). Other shapes are possible. In these examples, similar to the fluid retention structures described above, tensioning the fluid retention structures 1219 or 1221, for example by tensioning the legs 1217, changes the shape of the fluid retention structures 1219 and 1221. For example, the axial dimension (along the length of the fluid controller) may increase while the radial dimension (e.g., related to the diameter of the fluid retention structures 1219 and 1221) may decrease. Similar to the fluid retention structures described above, such a decrease in radial dimension may aid in the introduction of the fluid controller into the vaginal canal.

[0083] The configuration of the fluid retention structure 1219 or 1221 may provide certain benefits. For example, given their symmetrical configuration, engagement of the fluid retention structure 1219 or 1221 may be established as the respective fluid controller moves in a direction towards the cervix, but can also be maintained when the respective fluid controller moves towards the vaginal opening (e.g., before or after the respective fluid controller is separated from the fluid introduction device).

[0084] Various structures may be included on the fluid controller and / or fluid introduction device to aid in mounting the fluid controller to the fluid introduction device. For example, as shown in FIG. 13, the fluid introduction device 201 may include alignment guides 1301 to aid in aligning the fluid controller 200 and the fluid introduction device 201 during assembly. In some cases, the alignment guides 1301 may include ribs, wings, posts (or other types of protrusions). In other cases, the alignment guides 1301 may include grooves or other types of recesses. The fluid controller 200 may include mating structures (e.g., corresponding grooves, detents, protrusions, etc.) (not shown) configured to mate with the alignment guides 1301. In some cases, the mating structures may be included on the fluid controller 200 on the underside of the head 244.

[0085] The disclosed fluid controllers may include a variety of structural features. For example, the disclosed fluid controllers (e.g., fluid controller 200) may include a variety of numbers and arrangements of legs, connectors, and fluid retaining structures. The body of the fluid controller may also have a variety of shapes, e.g., a cylindrical body, partial cylinder, various leg shapes, etc. For example, the fluid controller may have a cylindrical and / or partially cylindrical body configured to fit over the body of a syringe.

[0086] The disclosed connectors may also be configured in a variety of shapes for use in connecting a fluid controller to a fluid introduction device. As noted above, the connectors may include partial slots, full slots, holes, loops, notches, hooks, ridges, rings, or any other structure usable to attach the fluid controller to a corresponding structure associated with the fluid introduction device (e.g., a tab, barrel flange, hook, pin, etc. on a syringe or other type of fluid introduction device). The connectors may be part of and / or attached to the fluid controller.

[0087] 14 shows various exemplary connector embodiments. The embodiments include, for example, an enclosed opening 1402, a slotted opening 1403, two slotted openings 1404 (also 1406), and two semicircular connections with no openings 1405, for fitting over a flange of, for example, a syringe barrel. Additional features may include a shoulder portion 1401 to relieve stress and reduce the risk of the legs 1410 of the connector breaking off from the head 1412.

[0088] Regarding additional options, in some embodiments, the fluid controller may include one or two long elements (e.g., legs 1410) that extend from a fluid retaining structure associated with the head 1412 to one or more connector elements (e.g., 1402-1406 or any other type of connector).

[0089] The fluid controller may be made using a variety of materials and / or combinations of materials. For example, the fluid controller may include silicone. In some embodiments, the fluid controller includes 10 weight percent to 100 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller includes 20 weight percent to 100 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller includes 30 weight percent to 100 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller includes 40 weight percent to 100 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller includes 50 weight percent to 100 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller includes 60 weight percent to 100 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller includes 70 weight percent to 100 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller includes 80 weight percent to 100 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller comprises between 90 weight percent and 100 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller comprises between 10 weight percent and 90 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller comprises between 10 weight percent and 80 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller comprises between 10 weight percent and 70 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller comprises between 10 weight percent and 60 weight percent silicone, by total weight of the fluid controller.In some embodiments, the fluid controller comprises between 10 weight percent and 50 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller comprises between 30 weight percent and 70 weight percent silicone, by total weight of the fluid controller. In some embodiments, the fluid controller comprises between 40 weight percent and 60 weight percent silicone, by total weight of the fluid controller.

[0090] The fluid controller may be made using a variety of materials and / or combinations of materials. For example, at least a portion of the fluid controller includes a thermally responsive material configured to change shape or color when at least partially within the vaginal canal. The shape change may aid in conception by improving fluid retention within the vaginal canal, and the color change may improve ease of use and / or user experience.

[0091] In some cases, at least a portion of the fluid controller includes a pH responsive material configured to change shape or color when at least partially within the vaginal canal. The shape change may aid in conception by improving fluid retention within the vaginal canal, and the color change may improve ease of use, indicate suitability of pH for improved conception, and / or improve user experience. The fluid controller may change its shape in response to pH or temperature and may be configured to move semen closer to the cervix when the fluid controller is positioned within the vaginal canal.

[0092] At least a portion of the fluid controller may include a moisture responsive material configured to change shape or color after being at least partially introduced into the vaginal canal. The shape change may aid in conception by improving fluid retention within the vaginal canal, and the color change may improve ease of use and / or user experience.

[0093] In some embodiments, the fluid controller is a monolithic material, for example, the fluid controller may be molded and / or 3D printed silicone.

[0094] The disclosed fluid controllers and fluid introduction devices may be used to deliver a variety of different fluids to one or more volumes. For example, in some cases, the fluid includes semen. In other cases, the fluid includes at least one pharmaceutical agent, such as progesterone.

[0095] As used herein, the term "about" refers to ±5% of the stated number.

[0096] A claim or description including "or" or "and / or" between at least one member of a group is deemed to be satisfied if one, more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process, unless otherwise indicated or otherwise clear from the context. The present disclosure includes embodiments in which exactly one member of a group is present in, employed in, or otherwise relevant to a given product or process. The present disclosure includes embodiments in which more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process.

[0097] Furthermore, the disclosure covers all variations, combinations, and permutations in which at least one limitation, element, clause, and descriptive term from at least one of the enumerated claims is introduced into another claim. For example, any claim that is dependent on another claim can be amended to include at least one limitation found in any other claim that is dependent on the same base claim. When elements are presented as a list, such as in Markush group format, each subgroup of elements is also disclosed, and any element can be removed from the group. In general, when the disclosure or aspects of the disclosure are referred to as including certain elements and / or features, it should be understood that the embodiments of the disclosure or aspects of the disclosure consist of or consist essentially of such elements and / or features. For purposes of brevity, these embodiments have not been specifically described in this specification in these exact terms. When ranges are given, the endpoints are included. Furthermore, unless otherwise indicated or otherwise apparent from the context and the understanding of one of ordinary skill in the art, values ​​expressed as ranges can take any specific value or subrange within the ranges stated in different embodiments of this disclosure, unless otherwise clearly indicated from the context.

[0098] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein which equivalents are intended to be covered by the following claims.

Claims

1. A fluid controller configured to be removably attached to a fluid introduction device, comprising: a body configured to extend at least partially over the fluid introduction device; an orifice disposed relative to the body to facilitate transfer of fluid from the fluid introduction device through the fluid controller; a fluid retention structure extending outwardly from at least a portion of the body, the fluid retention structure configured to engage a wall of the vaginal canal and impede the flow of the fluid from the vaginal canal; and At least one connector configured to releasably attach the fluid controller to the fluid introduction device. A fluid controller comprising:

2. The fluid controller of claim 1 , wherein the fluid retaining structure is configured such that mounting the fluid controller to the fluid introduction device reduces at least one dimension associated with the fluid retaining structure.

3. The fluid controller of claim 2 , wherein the at least one dimension includes a radial dimension.

4. 2. The fluid controller of claim 1, wherein the at least one connector is further configured to allow the fluid controller to be separated from the fluid introduction device after insertion into the vaginal canal and to allow the fluid introduction device to be removed from the vaginal canal without removing the fluid controller from the vaginal canal.

5. The fluid controller of claim 1 , wherein the fluid retention structure is configured to expand in at least one dimension upon separation of the fluid controller from the fluid introduction device.

6. The fluid controller of claim 1 , wherein the fluid introduction device comprises a syringe.

7. The fluid controller of claim 1 , wherein the fluid retention structure has a maximum cross-sectional diameter in the range of 12 mm to 50 mm when the fluid controller is not attached to the fluid introduction device.

8. The fluid controller of claim 7 , wherein the fluid controller is configured such that the maximum cross-sectional diameter of the fluid retaining structure is reduced when the fluid controller is attached to the fluid introduction device.

9. The fluid controller of claim 1 , wherein the fluid retention structure has a Shore A hardness in the range of 0-70.

10. The fluid controller of claim 1 , wherein the fluid retaining structure comprises one or more of a flap, a bulb, a plug, or a valve.

11. The fluid controller of claim 1 , wherein the fluid retaining structure comprises a plug.

12. The fluid controller of claim 1 , wherein the fluid retaining structure comprises at least two flaps.

13. The fluid controller of claim 1 , wherein the at least one connector has one or more of a loop, a notch, a slot, a hook, or a ridge.

14. The fluid controller of claim 1 , wherein the at least one connector is configured to receive a protrusion associated with the fluid introduction device.

15. The fluid controller of claim 1 , wherein the fluid controller comprises silicone.

16. 10. The fluid controller of claim 1, wherein the fluid controller comprises between 10 weight percent and 100 weight percent silicone, based on a total weight of the fluid controller.

17. 2. The fluid controller of claim 1, wherein the fluid retention structure is configured to engage a vaginal wall to retain the fluid controller at least partially within the vaginal canal after the fluid introduction device is separated from the fluid controller and removed from the vaginal canal.

18. The fluid controller of claim 1 , wherein a coefficient of friction between the fluid controller and a vaginal wall is greater than a coefficient of friction between the fluid controller and the fluid introduction device.

19. The fluid controller of claim 1 , wherein the orifice has at least two intersecting slots.

20. The fluid controller of claim 1 , wherein the at least one connector has at least one resilient section configured to stretch when the fluid controller is attached to the fluid introduction device.

21. The fluid controller of claim 1 , wherein at least a portion of the fluid controller comprises a thermally responsive material configured to change shape or color when at least partially within the vaginal canal.

22. The fluid controller of claim 1 , wherein at least a portion of the fluid controller comprises a pH responsive material configured to change shape or color when at least partially within the vaginal canal.

23. 10. The fluid controller of claim 1, wherein at least a portion of the fluid controller comprises a moisture responsive material configured to change shape or color after being at least partially introduced into the vaginal canal.

24. The fluid controller of claim 1 , wherein the fluid introduction device is a syringe including a barrel flange, and the at least one connector is configured to be removably attached to a portion of the barrel flange.

25. The fluid controller of claim 1 , further comprising a quick release element configured to facilitate separation of the fluid controller from the fluid introduction device.

26. The fluid controller of claim 1 , further comprising one or more alignment guides configured to orient the fluid controller relative to the fluid introduction device.

27. The fluid controller of claim 1 , wherein the fluid comprises semen.

28. The fluid controller of claim 1 , wherein the fluid comprises at least one pharmaceutical agent.

29. The fluid controller of claim 1 , wherein the fluid comprises progesterone.

30. 30. A fluid controller as claimed in any one of claims 1 to 29, wherein the orifice is a single slit and the orifice is configured to open wider when the configured fluid controller is attached to the fluid introduction device than when the configured fluid controller is not attached to the fluid introduction device.

31. The fluid controller of claim 30 , wherein the orifice is configured to open wider when tension is applied to the at least one connector.

32. 25. The fluid controller of claim 24, wherein the barrel flange includes one or more recesses having a radius of curvature in a range of 0.5 mm to 8 mm, and the at least one connector is configured to be removably attached to one or more of the recesses.

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