Releasable fluid controller and insemination device

Abstract

A fluid controller is disclosed, the fluid controller configured to be removably attached to a fluid introduction device, where the fluid controller comprises: a body configured to extend at least partially over the fluid introduction device; an orifice arranged 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, where the fluid retention structure is configured to engage with a wall of a vaginal cavity and inhibit flow of the fluid from the vaginal cavity; and at least one connection member configured to releasably attach the fluid controller to the fluid introduction device.

Description

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

[0002] Infertility is a common condition that affects up to one in six couples trying to conceive. While the causes of infertility can vary, almost 60% of infertility cases can be attributed to low sperm count or low motility. Several infertility treatments, such as medications to assist with hormone balance and / or ovulation, intrauterine insemination (IUI), and in vitro fertilization (IVF), are invasive, often accompanied by undesirable side effects, and can be prohibitively expensive for those seeking infertility treatment.

[0003] New and improved devices and methods are needed to provide people with safe, easy and affordable treatments that can be used frequently to increase the overall likelihood of successful pregnancy. The disclosed devices and methods are intended to address one or more of these challenges. For example, the disclosed methods and fluid introduction systems can 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 in 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 including a fluid controller and a fluid introduction device is disclosed, wherein the fluid controller is 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 a fluid introduction device (e.g., a syringe or other fluid carrier). The fluid controller may also include: an orifice, the orifice being arranged relative to the body to facilitate the transfer of fluid from the fluid introduction device through the fluid controller; a fluid retaining structure extending outwardly from at least a portion of the body, wherein the fluid retaining structure is configured to engage with a wall of the vaginal cavity and inhibit the flow of fluid from the vaginal cavity; and at least one connector, the at least one connector being configured to releasably attach the fluid controller to the fluid introduction device. A method of using the disclosed insemination device to potentially assist conception is also described.

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

[0006] In some embodiments, the at least one connector is further configured to enable the fluid controller to be detached from the fluid introduction device after insertion into the vaginal cavity, and the fluid introduction device to be removed from the vaginal cavity without removing the fluid controller from the vaginal cavity.

[0007] In some embodiments, the fluid retention structure is configured to expand in at least one dimension after the fluid controller is detached from the fluid introduction device.

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

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

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

[0011] In some embodiments, the fluid retention structure has a Shore A hardness ranging from 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 fins.

[0015] In some embodiments, the at least one connector comprises 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 includes 10 wt % to 100 wt % silicone, based on the total weight of the fluid controller.

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

[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 aperture comprises at least two intersecting slots.

[0022] In some embodiments, the at least one connector includes at least one elastic segment 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 includes a thermally responsive material configured to change shape or color when at least partially within the vaginal cavity.

[0024] In some embodiments, 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 cavity.

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

[0026] In some embodiments, the fluid introduction device is a syringe comprising 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 the 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 includes at least one drug.

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

[0032] Also disclosed are methods of assisted conception using the disclosed insemination devices. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 The cup and syringe insemination method is depicted.

[0034] Figure 2A An exemplary insemination device including a fluid controller and a fluid introduction device is depicted.

[0035] Figure 2B An exemplary fluid controller is depicted.

[0036] Figure 2C Depicted are exploded assembly views of exemplary fluid controllers and fluid introduction devices.

[0037] Figure 2D An exemplary fluid controller mounted on a fluid introduction device is depicted.

[0038] Figure 3 An exemplary fluid controller is depicted in a relaxed state and a deformed state.

[0039] Figure 4 Exemplary fluid retaining structure embodiments are depicted.

[0040] Figure 5 Exemplary fluid retaining structure and orifice embodiments are depicted.

[0041] Figure 6 Exemplary orifice embodiments are depicted.

[0042] Figure 7 Depicted are cross-sectional views of exemplary fluid retaining structure and orifice embodiments.

[0043] Fig. 8A Exemplary fluid retaining structure embodiments are depicted.

[0044] Figure 8B Exemplary fluid retaining structure embodiments are depicted.

[0045] Fig. 9 Exemplary fluid retaining structure embodiments are depicted.

[0046] Fig.10 Exemplary fluid retaining structure embodiments are depicted.

[0047] Fig.11 Exemplary fluid retaining structure embodiments are depicted.

[0048] Fig.12 Exemplary fluid controller embodiments are depicted.

[0049] Fig.13 Exemplary alignment structures for assisting in attaching a fluid controller to a fluid introduction device are depicted.

[0050] Fig.14 Exemplary connector embodiments for attaching a fluid controller to a fluid introduction device are depicted.

[0051] Fig.15 Exemplary cartridge flange tab embodiments for attaching a fluid controller to a fluid introduction device are depicted. DETAILED DESCRIPTION

[0052] Figure 1 An overview of an insemination technique for introducing semen into the vaginal cavity is provided. For example, at step 100, ejaculated semen is collected in a cup 102 and aspirated into a syringe 101. Next, syringe 101 is positioned within the vaginal cavity, where ejaculated semen 105 is placed. Although this technique can effectively promote conception, in some cases, once syringe 101 is removed, the ejaculated semen can freely leave the vaginal cavity. Even before the syringe is removed, the ejaculated semen can leak from the vaginal cavity through the gap between the syringe barrel and the vaginal wall. In addition, leaving the syringe in the vaginal cavity for a long time may cause discomfort to the user.

[0053] The disclosed insemination device is intended to improve conception by promoting retention of ejaculated semen within the vaginal cavity (or by reducing leakage of ejaculated semen from the vaginal cavity).The disclosed insemination device may include or may be used in conjunction with various types of fluid introduction devices.

[0054] Figure 2A An insemination device is depicted that includes an exemplary fluid controller 200 coupled to a fluid introduction device 201. Figure 2A In the example of FIG. 2 , the fluid controller includes an orifice 202 disposed relative to the body of the fluid controller. The orifice 202 can facilitate the transfer of fluid (eg, semen, drug fluid, etc.) from the fluid introduction device 201 through the fluid controller 200. Figure 2A As shown, the fluid retaining structure 203 extends outward from at least a portion of a body 204 of the fluid controller 200, wherein 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, and the one or more connectors 205 are 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 will be discussed in more detail in the following sections, the connector 205 may include one or more slots, hooks, loops, etc., which are configured to engage with one or more structures associated with the fluid introduction device 201. Figure 2A In an exemplary embodiment of the present invention, the connector 205 includes a slot for attaching to a protrusion (not shown) associated with the fluid introduction device 201. In some cases, the fluid introduction device 201 may include a syringe including a barrel flange 206 including a tab, protrusion, etc. for docking / interfacing with the connector 205.

[0055] The disclosed fluid controller can take many different forms and can be arranged to operate with fluid introduction devices of various types and configurations. In some cases, for example, the fluid controller can be integrated with the fluid introduction device. In other cases, as described above, the fluid controller can be formed as a separate component relative to the fluid introduction device. In this case, the fluid controller can be used with a variety of different types of fluid introduction devices, including, for example, certain syringes, plunger-based devices, or other types of fluid introduction devices (ready-made or other devices). In addition to providing a path for fluid flow (e.g., via orifice 202), the disclosed fluid controller can also include one or more structures intended to keep the fluid in a volume (e.g., a vaginal canal or other type of cavity, including a body cavity or other cavity) into which the fluid has been introduced.

[0056] For example, Figure 2B As shown in the example of, the fluid controller 200 may include a fluid retaining structure 203, which may take the form of a plug, a shield, a flange, etc., to slow down or prevent the fluid from leaking through the fluid retaining structure from the volume into which the fluid is introduced. It is worth noting that the fluid retaining structure can be designed to slow down or prevent such fluid leakage, regardless of whether the fluid controller 200 remains attached to the fluid introduction device 201 or whether the fluid controller 200 is detached from the fluid introduction device 201 after the fluid is introduced (e.g., insemination). As will be discussed further below, the fluid controller may include structural features that facilitate the detachment of the fluid controller from the fluid introduction device and allow the fluid introduction device to be separated from the fluid controller without moving the fluid controller from the seated position. For example, the fluid introduction device can be detached from the fluid controller and removed from the vaginal cavity, while the fluid controller remains in the vaginal cavity and retains or at least partially retains the insemination fluid placed near the cervix.

[0057] exist Figure 2B In the example of FIG. 2 , the fluid controller 200 includes an annular connector 205 configured to slide on a corresponding protrusion associated with the fluid introduction device 201 . Figure 2CAn exploded assembly view of the fluid introduction device 201 is shown, which includes a body 234, a plunger 232, and a barrel flange 236. The barrel flange 236 includes a tab 238 extending outward from the body 234. In this example, the annular connector 205 is sized to slide on a corresponding tab 238 (of the barrel flange 236) extending from the opposite side of the body 234. Figure 2D An isotropic view of a fluid controller 200 mounted on a fluid introduction device 201 is provided to provide (in this particular example) a fluid insemination device 240. It should be noted that the device 240 can be used to place any type of fluid (e.g., semen, medication, etc.) into a desired volume (e.g., a vaginal cavity or any other type of volume in the body or elsewhere). As shown, the fluid controller 200 includes two legs 242 terminated by an annular connector 205. In order to mount the fluid controller 200 on the fluid introduction device 201, the head 244 of the fluid controller 200 is placed on the fluid placement end of the fluid introduction device 201 (in this case, a syringe), and the legs 242 are stretched until the annular connector 205 can be attached to the tabs 238 of the barrel flange 236.

[0058] The tabs on the cylinder flange (such as Figure 2C The tab 238 shown may have one or more recesses, and these recesses may have various configurations. Fig.15 An example barrel flange tab is depicted showing a recess 1500 having a radius of curvature 1501. Each recess can have a radius of curvature ranging from 0.5 mm to 8 mm. Each recess can be, for example, circular, oval, square, rectangular, etc. The length 1502 of each tab can vary, for example from 5 mm to 5 cm, and can have a radius of curvature 1503 ranging from, for example, 5 mm to 5 cm. The recess can be configured to receive a ring on a connector, for example, to connect a fluid controller to a fluid introduction device, and to allow a user to easily attach and detach the connector from the fluid introduction device. Changing the length 1502 and radius of curvature 1501 and / or 1502 of the barrel flange tab can facilitate easy engagement of the fluid controller connector with the barrel flange, can help keep the fluid controller connector on the tab during operation, and can also help disengage the fluid controller connector from the tab to separate the fluid introduction device from the fluid controller after the fluid is introduced into the volume. In addition, although Fig.15 The example barrel flange tabs of are shown as each including two recesses 1500 (one on each side of the tab), but may include more or fewer recesses, for example, in some cases, the flange tab may be produced by forming a single recess 1500 on the barrel flange. In other cases, such as Fig.15In an example, the barrel flange tab may be provided by forming two recesses 1500 on the barrel flange. In still other cases, the disclosed tab may be associated with more than two recesses (e.g., a multi-notch tab, a graded multi-step tab, etc.). The radius of curvature may also extend over a varying range of angles. In some cases, the radius of curvature may extend over a range between 30 degrees and 90 degrees (e.g., 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 a notch may increase the ability of the flange to retain the connector of the fluid controller, but may be at the expense of easy disengagement of the fluid controller connector from the barrel flange.

[0059] Before or after the fluid controller 200 is connected to the fluid introduction device 201, the fluid can be loaded into the fluid introduction device (e.g., a syringe) 201. In either case, the insemination device 240 loaded with the fluid can then be positioned in the vaginal cavity. Then, for example, by using the plunger 232 of the fluid introduction device 201 to pass at least a portion of the fluid through the orifice of the fluid controller 200, the insemination fluid can be placed in the vaginal cavity. In some cases, after the fluid is transferred from the fluid introduction device to the vaginal cavity, the fluid controller / fluid introduction device assembly can remain in the vaginal cavity (e.g., for a predetermined amount of time). However, in other cases, the fluid controller 200 can be detached from the fluid introduction device 201, and the fluid introduction device can be removed from the vaginal cavity, while the fluid controller remains in the vaginal cavity.

[0060] The disclosed fluid controller can be configured such that attachment of the fluid controller 200 to the fluid introduction device 201 results in a reduction in one or more dimensions associated with the fluid controller, which can aid in introducing the fluid controller / fluid introduction device assembly into the vaginal cavity. For example, the fluid controller 200 can be configured such that when the fluid controller 200 is attached to the fluid introduction device 201, the maximum cross-sectional diameter of the fluid retaining structure 203 is reduced. That is, the stretch connector 242 can cause the fluid controller 200 to deform in at least one radial direction. For example, as Figure 2B and Figure 2D As shown, the stretching of the legs 242 causes the connector 205 to engage with the tabs 238, causing the material of the head 244 to also stretch. Since the fluid controller 200 is attached to the fluid introduction device 201, the material of the head 244 is also stretched. Figure 2B ) of the fluid retaining structure 203 is reduced to a diameter D in a stretched state ( Figure 2D) diameter d. More specifically, the fluid controller 200 may be characterized by an axial dimension (e.g., length) and a radial dimension (e.g., D / 2). Although the axial dimension of the fluid controller 200 may be increased by attaching the fluid controller 200 to the fluid introduction device 201, the radial dimension may be reduced.

[0061] The fluid retaining structure 203 can be configured so that after the fluid controller / fluid introduction device assembly is introduced into the vaginal cavity, the area at the periphery of the fluid retaining structure 203 engages with the inner wall of the vaginal cavity. Therefore, deformation of the fluid retaining structure 203 in at least one radial direction can help insert the insemination device assembly. For example, stretching of the connector 242 can cause the fluid controller 200 including the fluid retaining structure 203 to deform (e.g., narrow) in at least one radial direction, which can help introduce the fluid controller 200 into the vaginal cavity.

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

[0063] As described above, in some cases, after the fluid is placed into the volume from the fluid introduction device 201 through the fluid controller 200, the fluid controller 200 can be disengaged from the fluid introduction device 201. The fluid introduction device can be removed from the vaginal cavity while the fluid controller remains in the vaginal cavity. Disengaging the fluid controller 200 from the fluid introduction device 201 can relax the fluid controller 200 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 can more firmly engage the vaginal wall to reduce the reflux of the insemination fluid out of the vaginal cavity. For example, in a less deformed or undeformed state, the radial dimension of the fluid retaining structure 203 can be increased to increase the level of engagement between the vaginal wall and the fluid retaining structure 203.

[0064] Figure 3 An exemplary fluid controller 300 is depicted, wherein attachment of the fluid controller to a fluid introduction device ( 301 → 302 ) results in a radial dimension associated with a fluid retaining structure 303 being reduced.

[0065] Removing the fluid introduction device 201 from the vaginal cavity may be more comfortable for the subject than retaining the complete fluid controller / fluid introduction device assembly in the vaginal cavity. In addition, removing the fluid introduction device while leaving the fluid controller in place in the vaginal cavity may facilitate conception because the fluid controller may remain in place for any suitable period of time (e.g., 10 minutes, 30 minutes, 1 hour, 8 hours, etc.). And while the fluid controller 200 remains in the vaginal cavity, backflow of insemination fluid flowing out of the vaginal cavity through the fluid controller 200 may be reduced or eliminated, for example, by full or partial engagement of the fluid retaining structure 203 with the vaginal wall.

[0066] Various structures may be included on 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 be quickly removed from the barrel flange 236 of the syringe. Such shapes may include rings, such as Figure 2D As shown, or may include a recess, such as Figure 6 , Fig.12 or Fig.14 The fluid introduction device may also be equipped with a quick release mechanism or other types of quick release elements to facilitate disconnection of the fluid controller 200 from the fluid introduction device 201. Such a quick release mechanism may include a plunger, a winged structure, a spring-loaded button, etc., which is configured to disengage the fluid controller 200 from the fluid introduction device 201 (e.g., drive the connector 205 away from the tab 238, etc.).

[0067] Other aspects of the fluid controller and the fluid introduction device can also be configured to facilitate the separation of the fluid controller 200 from the fluid introduction device 201. For example, in some cases, the friction coefficient between the fluid controller and the fluid introduction device can be selected to be less than the known or estimated friction coefficient between the fluid controller and the vaginal wall. This relative friction coefficient can help remove the fluid introduction device from the vaginal cavity without also removing the fluid controller from the vaginal cavity. It is believed that the friction coefficient between the fluid controller and the vaginal wall is greater than the friction coefficient between the fluid controller and the fluid introduction device, which can help remove the fluid introduction device from the vaginal cavity after placing the insemination fluid, while the fluid controller remains in the appropriate position in the vaginal cavity. In some examples, the fluid controller 200 and the fluid introduction device 201 can be manufactured so that the interface between the fluid controller and the fluid introduction device has a lower friction coefficient than the friction coefficient between the fluid controller 200 and the vaginal wall. For example, the mating surface between the fluid controller and the fluid introduction device can be coated with one or more friction-reducing materials (polytetrafluoroethylene (PTFE) and the like). Additionally or alternatively, one or more outer surfaces of the fluid controller 200 can be manufactured with texture features, such as ridges, ribs, soft peaks, etc., to prevent sliding of the fluid controller 200 when engaging the vaginal wall. Such structures / textures can result in a coefficient of friction between the fluid controller 200 and the vaginal wall that is greater than the coefficient of friction between the fluid controller and the fluid introduction device.

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

[0069] Although FIG. 2B to FIG. 2D The fluid retaining structure 203 is shown to include a dome shape, but the fluid retaining structure associated with the disclosed fluid controller can include many different shapes, each providing different performance characteristics. For example, Fig. 9 An exemplary retention structure 400 having four fins and another exemplary retention structure 401 including eight fins are depicted. In either case, and due to the spaces between adjacent fins, retention structures 400 and 401 are free to deform to a smaller diameter or at least one radial dimension when introduced into the vaginal cavity (402→403).

[0070] The disclosed fluid retaining structure can have any suitable size. In some embodiments, when the fluid controller is not attached to the fluid introduction device, the fluid retaining structure has a maximum cross-sectional diameter ranging from 12 mm to 50 mm. In some embodiments, when the fluid controller is not attached to the fluid introduction device, the fluid retaining structure has a maximum cross-sectional diameter ranging from 15 mm to 35 mm. In some embodiments, when the fluid controller is not attached to the fluid introduction device, the fluid retaining structure has a maximum cross-sectional diameter ranging from 20 mm to 30 mm.

[0071] In addition, the disclosed fluid retaining structure can be made of a material that provides suitable hardness and / or elastic properties. In some embodiments, the fluid retaining structure has a Shore A hardness ranging from 0 to 70. In some embodiments, the fluid retaining structure has a Shore A hardness ranging from 10 to 70. In some embodiments, the fluid retaining structure has a Shore A hardness ranging from 20 to 70. In some embodiments, the fluid retaining structure has a Shore A hardness ranging from 30 to 70. In some embodiments, the fluid retaining structure has a Shore A hardness ranging from 10 to 60. In some embodiments, the fluid retaining structure has a Shore A hardness ranging from 10 to 50. In some embodiments, the fluid retaining structure has a Shore A hardness ranging from 0 to 40.

[0072] In some embodiments, the fluid retaining structure includes one or more of a wing, a bulb, a plug, or a valve. In some embodiments, the fluid retaining structure includes at least two winglets. In some embodiments, the fluid retaining structure is configured to engage the vaginal wall and retain the fluid controller at least partially within the vaginal cavity after the fluid introduction device is disengaged from the fluid controller and removed from the vaginal cavity. Without wishing to be bound by theory, it is believed that the fluid retaining structure can assist conception by retaining the placed insemination fluid within the vaginal cavity 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 the fluid introduction device is disengaged and removed), the fluid retention structure can flatten in at least one radial direction and widen in another radial direction. Allowing the fluid retention structure to deform to the contour of the vaginal wall can result in an improved seal between the fluid retention structure and the vaginal wall.

[0074] In some embodiments, the fluid retaining structure includes an orifice configured to allow insemination fluid from the fluid introduction device to pass through the fluid controller. Figure 4 , shows an orifice 410 at the center of the fluid retaining structures 400 and 401. The orifice can be configured to have a variety of shapes.

[0075] Figure 5The fluid controller 520 is depicted in different views, including a side view (reference numeral 501), a cross-sectional view (reference numeral 502), and an isotropic view (reference numeral 503). As shown, the fluid controller 520 includes a single slit orifice 504 that is configured so that when the fluid controller is attached to a fluid introduction device, the slit is more open than when the fluid controller is not attached to the fluid introduction device. For example, the single slit orifice 504 can be configured to open wider when the head 510 is under tension (e.g., when the legs 512 are stretched to fit the fluid controller 520 to the fluid introduction device 506).

[0076] Figure 6 Depicted are different orifice configurations according to the disclosed exemplary embodiments. For example, in a first configuration, the fluid controller 601 may include a circular opening orifice 603. In another exemplary embodiment, the fluid controller 605 may include a cross-shaped orifice 607. The cross-shaped orifice 607 may include any arrangement of at least two intersecting slots (e.g., intersecting at a vertical or non-vertical angle). The slits included in the cross-shaped orifice may include circular openings at the ends of the slits, as shown in orifice 610, or may include slits of uniform width without circular ends, as shown in orifice 612. The number of slits, the slit intersection angle, and the slit shape can all affect the degree to which the orifice opens in response to mounting the fluid controller on the fluid introduction device. These parameters can also affect the flow of fluid through the orifice.

[0077] Figure 7 Various fluid retaining structures 701 to 705 with different cross-sections are depicted. For example, fluid retaining structures 701, 702, and 703 all include inner walls that have a convex shape in cross-section. The convex shape can help cause an orifice (such as orifice 710) to open in response to contact between the inner wall of the fluid retaining structure and the fluid introduction device (e.g., due to sliding a fluid controller onto the fluid retaining device and stretching the fluid controller into place). On the other hand, fluid retaining structures 704 and 705 include inner walls with concave cross-sections. Such structures can help cause an orifice such as orifice 712 to widen in response to tension applied to the fluid retaining structure (e.g., by stretching a connector attached to the fluid retaining structure, such as Figure 2D shown).

[0078] Fig. 8A and Figure 8BVarious fluid retaining structures and orifice embodiments are depicted. For example, in some cases, the fluid retaining structures included on the disclosed fluid controller 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 cone interface 810, or a bicuspid valve-shaped interface 811.

[0079] Fig. 9 Additional fluid retaining structure and orifice embodiments are depicted. Such embodiments may include, for example, a concave trumpet embodiment 901, a convex trumpet embodiment 902, an isometric embodiment (903 top view and 904 bottom view), an isometric embodiment with elongated sides 905, a conical embodiment 906, and a rugby ball (elongated) embodiment 907.

[0080] Fig.10 Additional fluid retaining structure and orifice embodiments are depicted. Fig.10 As shown, an exemplary fluid retaining structure may include a trumpet-shaped retaining structure 1000 having a corrugated flange 1001 shown in cross section 1003. Exemplary fluid retaining structures may also include a disc-shaped embodiment 1004, a four-fin embodiment 1005, an eight-fin embodiment 1006, and a kirigami embodiment 1007. Fig.11 Additional exemplary fluid retention structures and orifice embodiments are depicted, including a dome embodiment 1100 having an inner sub-dome interface 1101 that can be configured to communicate with the tip of a fluid introduction device, such as a syringe. Similarly, a fluid retention structure 1102 can include a bell-shaped outer structure and a pseudo-spherical inner interface element 1103 that can be configured to communicate with the tip of a fluid introduction device.

[0081] Fig.12 Additional examples of fluid controller configurations are depicted. For example, Fig.12Fluid controller 1201 (1201a in cross section) and fluid controller 1203 (1203a in cross section) are shown. Similar to the other disclosed fluid controllers described above, fluid controllers 1201 and 1203 both include at least one connector 1215, which 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, which connect the connector 1215 to the corresponding fluid retaining structure (i.e., the fluid retaining structure 1219 of fluid controller 1201 and the 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 ends of the corresponding legs 1217. On the other hand, fluid controller 1203 includes only one connector 1215 spanning between the two legs 1217.

[0082] In these examples, fluid retaining structures 1219 and 1221 have substantially symmetrical cross-sections (a bellows-shaped cross-section for fluid retaining structure 1219 and an elliptical cross-section presented by fluid retaining structure 1221). Other shapes are also possible. In these examples, and similar to the fluid retaining structures described above, applying tension to fluid retaining structures 1219 or 1221, such as by applying tension to legs 1217, causes the shapes of fluid retaining structures 1219 and 1221 to change. For example, the axial dimension (along the length of the fluid controller) can increase, while the radial dimension (e.g., associated with the diameter of fluid retaining structures 1219 and 1221) can decrease. As with the fluid retaining structures described above, this reduction in radial dimension can facilitate introduction of the fluid controller into the vaginal cavity.

[0083] The configuration of fluid retention structures 1219 or 1221 may provide certain advantages. For example, given their symmetrical configuration, engagement of fluid retention structures 1219 or 1221 may be established when the corresponding fluid controller is moved in a direction toward the cervix, but may be similarly maintained even if the corresponding fluid controller is moved toward the vaginal opening (e.g., before or after the corresponding fluid controller is disengaged from the fluid introduction device).

[0084] The fluid controller and / or the fluid introduction device may include various structures to help attach the fluid controller to the fluid introduction device. Fig.13As shown, the fluid introduction device 201 may include an alignment guide 1301 to help align the fluid controller 200 with the fluid introduction device 201 during assembly. In some cases, the alignment guide 1301 may include a rib, a wing, a column (or other types of protrusions). In other cases, the alignment guide 1301 may include a groove or other types of recesses. The fluid controller 200 may include a mating structure (e.g., a corresponding groove, claw, protrusion, etc.) (not shown) configured to cooperate with the alignment guide 1301. In some cases, the mating structure may be included on the fluid controller 200 on the underside of the head 244.

[0085] The disclosed fluid controllers can include various structural features. For example, the disclosed fluid controllers (e.g., fluid controller 200) can include various numbers and arrangements of legs, connectors, and fluid retaining structures. The body of the fluid controller can also have various shapes, such as a cylindrical body, a partially cylindrical body, various leg shapes, etc. For example, the fluid controller can have a cylindrical body and / or a partially cylindrical body that is configured to be assembled on the body of a syringe.

[0086] The disclosed connectors may also be configured with various shapes for connecting the fluid controller to the fluid introduction device. As described above, the connector may include a partial slot, a full slot, a hole, a ring, a notch, a hook, a ridge, a ring, or any other structure that may be used to attach the fluid controller to a corresponding structure associated with the fluid introduction device (e.g., a tab, a hook, a pin, etc. on a barrel flange on a syringe or other type of fluid introduction device). The connector may be part of and / or attached to the fluid controller.

[0087] Fig.14 Various exemplary connector embodiments are depicted. These embodiments include, for example, a closed opening 1402, a slotted opening 1403, a double slotted opening 1404 (also 1406), and two semicircular connectors 1405 without openings for mounting on, for example, a syringe barrel flange. Additional features may include a shoulder section 1401 for relieving stress and reducing the risk of the connector leg 1410 tearing off from the head 1412.

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

[0089] The fluid controller can be manufactured using various materials and / or combinations of materials. For example, the fluid controller may include silicone. In some embodiments, the fluid controller includes 10% to 100% silicone by weight of the total weight of the fluid controller. In some embodiments, the fluid controller includes 20% to 100% silicone by weight of the total weight of the fluid controller. In some embodiments, the fluid controller includes 30% to 100% silicone by weight of the total weight of the fluid controller. In some embodiments, the fluid controller includes 40% to 100% silicone by weight of the total weight of the fluid controller. In some embodiments, the fluid controller includes 50% to 100% silicone by weight of the total weight of the fluid controller. In some embodiments, the fluid controller includes 60% to 100% silicone by weight of the total weight of the fluid controller. In some embodiments, the fluid controller includes 70% to 100% silicone by weight of the total weight of the fluid controller. In some embodiments, the fluid controller includes 80% to 100% silicone by weight of the total weight of the fluid controller. In some embodiments, the fluid controller comprises 90% to 100% silicone by weight, based on the total weight of the fluid controller. In some embodiments, the fluid controller comprises 10% to 90% silicone by weight, based on the total weight of the fluid controller. In some embodiments, the fluid controller comprises 10% to 80% silicone by weight, based on the total weight of the fluid controller. In some embodiments, the fluid controller comprises 10% to 70% silicone by weight, based on the total weight of the fluid controller. In some embodiments, the fluid controller comprises 10% to 60% silicone by weight, based on the total weight of the fluid controller. In some embodiments, the fluid controller comprises 10% to 50% silicone by weight, based on the total weight of the fluid controller. In some embodiments, the fluid controller comprises 30% to 70% silicone by weight, based on the total weight of the fluid controller. In some embodiments, the fluid controller comprises 40% to 60% silicone by weight, based on the total weight of the fluid controller.

[0090] The fluid controller can be manufactured 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 that is configured to change shape or color when at least partially within the vaginal cavity. The shape change can aid conception by improving retention of the fluid within the vaginal cavity, and the color change can 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 that is configured to change shape or color when at least partially within the vaginal cavity. The shape change can aid conception by improving retention of the fluid within the vaginal cavity, and the color change can improve ease of use, indicating whether the pH is appropriate for enhanced conception and / or user experience. The fluid controller can change its shape in response to pH or temperature, and can be configured to drive sperm and bring semen closer to the cervix when the fluid controller is positioned within the vaginal cavity.

[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 cavity. The shape change may aid conception by improving retention of fluid within the vaginal cavity, and the color change may improve ease of use and / or user experience.

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

[0094] The disclosed fluid controller and fluid introduction device can 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 drug, 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 the group is deemed satisfied if one member, more than one member, or all members of the group are present in, employed in, or otherwise related to a given product or process, unless indicated to the contrary or otherwise obvious from the context. The present disclosure includes embodiments in which exactly one member of the group is present in, employed in, or otherwise related to a given product or process. The present disclosure includes embodiments in which more than one member of the group or all members of the group are present in, employed in, or otherwise related to a given product or process.

[0097] In addition, the present disclosure encompasses all variations, combinations and arrangements in which at least one limitation, element, clause and descriptive term from at least one of the listed claims is introduced into another claim. For example, any claim subordinate to another claim may be modified to include at least one limitation found in any other claim subordinate to the same basic claim. In the case where an element is presented as a list (such as, for example, in Markush group format), each subgroup of the element is also disclosed, and any element can be removed from the group. It should be understood that, generally, in the case where the present disclosure or the various aspects of the present disclosure are referred to as including specific elements and / or features, the embodiments of the present disclosure or the various aspects of the present disclosure are made up of or substantially made up of such elements and / or features. For simplicity, these embodiments are not specifically described in the same words herein. In the case of giving a range, endpoints are included. In addition, unless otherwise indicated or otherwise apparent from the context and the understanding of a person of ordinary skill in the art, otherwise in different embodiments of the present disclosure, the value expressed as a range may present any specific value or subrange within the range, unless the context clearly indicates otherwise.

[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. Such equivalents are intended to be encompassed by the following claims.

Claims

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

2. The fluid controller according to claim 1, wherein: The fluid retaining structure is configured such that attachment of the fluid controller to the fluid introduction device causes a reduction in at least one dimension associated with the fluid retaining structure.

3. The fluid controller according to claim 2, wherein: The at least one dimension includes a radial dimension.

4. The fluid controller according to claim 1, wherein: The at least one connector is also configured to enable the fluid controller to be detached from the fluid introduction device after insertion into the vaginal cavity, and the fluid introduction device to be removed from the vaginal cavity without removing the fluid controller from the vaginal cavity.

5. The fluid controller according to claim 1, wherein: The fluid retaining structure is configured to expand in at least one dimension after the fluid controller is detached from the fluid introduction device.

6. The fluid controller according to claim 1, wherein: The fluid introduction device includes a syringe.

7. The fluid controller according to claim 1, wherein: When the fluid controller is not attached to the fluid introduction device, the fluid retaining structure has a maximum cross-sectional diameter ranging from 12 mm to 50 mm.

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

9. The fluid controller according to claim 1, wherein: The fluid retaining structure has a Shore A hardness ranging from 0 to 70.

10. The fluid controller according to claim 1, wherein: The fluid retaining structure includes one or more of a flap, a ball, a plug, and a valve.

11. The fluid controller according to claim 1, wherein: The fluid retaining structure includes a plug.

12. The fluid controller according to claim 1, wherein: The fluid retaining structure includes at least two fins.

13. The fluid controller according to claim 1, wherein: The at least one connector includes one or more of a loop, a notch, a slot, a hook, and a ridge.

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

15. The fluid controller according to claim 1, wherein: The fluid controller includes silicone.

16. The fluid controller according to claim 1, wherein: The fluid controller includes 10 wt % to 100 wt % of silicone resin based on the total weight of the fluid controller.

17. The fluid controller according to claim 1, wherein: The fluid retention structure is configured to engage a vaginal wall and at least partially retain the fluid controller within the vaginal cavity after the fluid introduction device is disengaged from the fluid controller and removed from the vaginal cavity.

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

19. The fluid controller according to claim 1, wherein: The aperture includes at least two intersecting slots.

20. The fluid controller according to claim 1, wherein: The at least one connector includes at least one elastic segment configured to stretch when the fluid controller is attached to the fluid introduction device.

21. The fluid controller according to claim 1, wherein: 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 cavity.

22. The fluid controller according to claim 1, wherein: 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 cavity.

23. The fluid controller according to claim 1, wherein: At least a portion of the fluid controller includes a moisture-responsive material configured to change shape or color after being at least partially introduced into the vaginal cavity.

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 detachment 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 includes semen.

28. The fluid controller of claim 1, wherein: The fluid includes at least one drug.

29. The fluid controller of claim 1, wherein: The fluid includes progesterone.

30. The fluid controller of claim 1, 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 aperture is configured to open wider when the at least one connection member is under tension.

32. The fluid controller of claim 24, wherein: The barrel flange comprises one or more recessed portions having a radius of curvature ranging from 0.5 mm to 8 mm, and wherein the at least one connector is configured to be removably attached to one or more of the recessed portions.

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