HK40095412A - Device and method for artificial insemination - Google Patents

Description

Devices and methods for artificial insemination

This application is a divisional application of PCT international invention patent application No. 201780081384.6, filed on November 30, 2017, entitled "Apparatus and Method for Artificial Insemination".

Cross-referencing

This application claims priority to PCT application No. PCT/US2016/064243, filed November 30, 2016, which is incorporated herein by reference.

Technical Field

Preferred embodiments of the present invention generally relate to apparatus and methods for artificial insemination.

Background Technology

Artificial insemination aims to introduce semen into a patient's reproductive system to promote pregnancy. It is typically performed when semen has difficulty or cannot enter the patient's reproductive system during intercourse. Intracervical insemination, where a semen sample is introduced into the patient's cervical canal, and intrauterine insemination, where a semen sample is introduced into the patient's uterine cavity, are two common procedures currently in use. In such procedures, the patient's vaginal walls are typically kept open by a medical device such as a dilator. Then, depending on the procedure being performed, a semen sample is usually introduced into the patient's cervical canal or uterine cavity via a catheter-syringe assembly. After the semen sample is introduced, it is left for the patient's reproductive system to receive. However, due to reflux caused by uterine contractions, some of the semen sample may be lost as it leaks from the cervix into the patient's vaginal cavity.

Some known devices, such as vaginal sponges and cervical caps, attempt to address leakage by creating a barrier between the cervix and vaginal cavity after a semen sample is introduced. However, these devices only attempt to block the upper region of the vaginal cavity near the cervix and may not effectively retain the semen sample within the cervix. Therefore, using vaginal sponges and cervical caps during artificial insemination may not effectively prevent reduced insemination efficacy due to reflux caused by uterine contractions. These devices may also cause discomfort to the patient during insertion and removal.

The device disclosed in the applicant's application PCT/US2016/064243 attempts to address the aforementioned problems. This device is designed to be inserted into and held in place in the cervical canal for a period of time during which fertilization occurs, while preventing leakage of semen from the cervical canal. The device also allows a catheter to be inserted through an extension through a hole in the device, enabling the introduction of semen into the cervical canal or uterine cavity when the device is in place in the patient's cervical canal. However, during the period during which the device is intended to be held in place to allow fertilization to occur, the device may sometimes dislodge from the cervical canal, or a small amount of leakage may occur through the extension through the hole in the device.

Therefore, there is a need in the art for an apparatus for improving the effectiveness of artificial insemination procedures and a method for using the apparatus. Furthermore, there is a need in the art for an apparatus that increases the effectiveness of artificial insemination procedures without causing significant patient discomfort during insertion and removal of the device.

Summary of the Invention

This disclosure provides apparatus and methods for artificial insemination according to the independent claims. Preferred embodiments of the invention are reflected in the dependent claims. The claimed invention can be better understood in light of the embodiments described and illustrated in this disclosure, namely in this specification and the accompanying drawings. Generally, this disclosure reflects preferred embodiments of the invention. However, a careful reader will notice that certain aspects of the disclosed embodiments are beyond the scope of the claims. Given that the disclosed embodiments do indeed exceed the scope of the claims, they are considered to be supplementary background information and do not constitute a limitation of the invention itself.

In one aspect of this disclosure, a medical device is provided for use during artificial insemination to prevent leakage of semen samples from the cervical canal of a patient. The medical device can be configured to function as a cervical plug. The medical device has a shield configured to cover an orifice and an arm having a proximal end and a distal end. The proximal end is attached to the shield, and the distal end is configured to be inserted into the orifice. For example, the shield can be configured to cover an orifice ("external opening") between the patient's cervical canal and the vaginal cavity, and the arm can be configured to be inserted into the patient's cervical canal. Because the arm is inserted into the cervical canal and the shield covers the external opening, the medical device can effectively hold itself in place during use. The arm may have a circumferential protrusion located near the distal end of the arm to help hold the device in place if the arm is inserted into the cervical canal during use.

By inserting a medical device into the vaginal cavity and into the patient's cervical canal, with the arm inserted into the cervical canal and the shield covering the patient's external opening, the medical device can establish a physical barrier that retains the semen sample within the patient's cervical canal and prevents leakage into the vaginal cavity. In this way, after the semen sample has been introduced into the patient's cervical canal or uterine cavity, the medical device can act as a cervical plug to prevent leakage of the semen sample into the vaginal cavity, thereby preventing loss of the semen sample. Therefore, this disclosure can also relate to a method for artificial insemination, wherein a semen sample is first introduced into the patient's cervical canal or uterine cavity, and then the medical device is inserted into the patient's cervical canal in the manner described above.

Additionally, the medical device can be configured to function as both a cervical plug and a guide or cannula for a catheter. The device has a shield and an arm with proximal and distal ends. The proximal end is attached to the shield, and the distal end is configured for insertion into the patient's cervical canal. The device may also have a port extending longitudinally through the arm and through the shield, such that the port has an opening at the distal end of the arm and an opening on the side of the shield opposite the arm. A valve operable between an open and closed position may be located at the distal end of the arm. This valve includes a plurality of elastomeric valve flaps integrally attached to the distal end of the arm. When the valve is in the closed position, the elastomeric valve flaps are elastically biased inward toward the center of the port and abut against each other. The elastomeric valve flaps are sized and shaped to form a substantially fluid-impermeable seal over the opening at the distal end of the arm when the valve is in the closed position. To use the device, a catheter can be inserted into the opening of the port on the side of the shield opposite the arm and pushed through the opening at the distal end of the arm. When pushed through the opening at the distal end of the arm, the catheter forces the elastomeric valve flap outward, thereby moving the valve to the open position. In this way, the catheter can pass through the medical device to deliver a semen sample to the patient's cervical canal or uterine cavity, and then be removed from the medical device, leaving the device in place. When the catheter is removed, the valve moves to the closed position, preventing the semen sample from leaking back into the vaginal cavity through the medical device. Therefore, this disclosure can also relate to a method for artificial insemination in which a medical device is inserted into the patient's cervical canal in the manner described above, a catheter is inserted into the opening of the medical device, a semen sample is guided through the catheter into the patient's cervical canal or uterine cavity, and then the catheter is removed, leaving the medical device in place.

For insertion and removal of the medical device, the medical device may have an insertion member secured to the shield on the side opposite the arm. The insertion member may have a cord attached thereto to facilitate removal of the medical device. To minimize patient discomfort during insertion and removal of the medical device, the shield may be made of a flexible material.

Additional features and advantages of this disclosure will be set forth in the description which follows, and will be apparent from the description, or may be learned by practice of this disclosure. The foregoing general description and the following detailed description are exemplary and illustrative, and are intended to provide further explanation of this disclosure.

Attached Figure Description

These and other features, aspects, and advantages of this disclosure will be better understood in light of the following description, the appended claims, and the accompanying drawings, wherein:

Figure 1 shows a perspective view of the apparatus according to the present disclosure.

Figure 2 shows a perspective view of the device according to the present disclosure.

Figure 3 shows a perspective view of the device according to the present disclosure.

Figure 4 shows a front view of the device according to the present disclosure.

Figure 5 shows a front view of the device according to the present disclosure.

Figure 6 shows a partial perspective view of the device according to the present disclosure.

Figure 7 shows a cross-sectional view of the device according to the present disclosure.

Figure 8 shows a top plan view of the device according to the present disclosure.

Figure 9 shows a bottom plan view of the device according to the present disclosure.

Figure 10 shows a front view of the device according to the present disclosure.

Figure 11 shows a perspective view of the device according to the present disclosure.

Figure 12 shows a perspective view of the device according to the present disclosure, in which a conduit is inserted through the device.

Figure 13 shows a perspective view of the device according to the present disclosure, in which a conduit is inserted through the device.

Figure 14 shows a device according to the invention inserted into a patient's reproductive system, used in conjunction with a catheter and syringe.

Detailed Implementation

In the foregoing summary and specific embodiments herein, as well as in the following claims and in the accompanying drawings, reference is made to specific features of the claimed invention, including method steps. In this disclosure, many features are described as optional, for example, by using the verb "may" or by using parentheses. For brevity and readability, this disclosure does not explicitly describe every permutation that can be obtained by selecting from this set of optional features. However, this disclosure is to be construed as explicitly disclosing all such permutations. For example, a system described as having three optional features can be implemented in seven different ways: having only one of the three possible features, having any two of the three possible features, or having all three of the three possible features. It should be understood that the disclosure in this specification includes all possible combinations of these specific features. For example, where a specific feature is disclosed in the context of a particular aspect or embodiment or a particular claim, that feature may also be used, to the extent possible, in combination with or in the context of other particular aspects or embodiments, and generally in the claimed invention.

The term "comprising" and its grammatical equivalents are used herein to mean that other parts, components, steps, etc. may optionally be present. For example, an article of manufacture that "comprising" parts A, B, and C may contain only parts A, B, and C, or it may contain not only parts A, B, and C, but also one or more other parts.

When a method is referred to herein as comprising two or more defined steps, the defined steps may be performed in any order or simultaneously (unless the context precludes such a possibility), and the method may include one or more other steps performed before any defined step, between two defined steps, or after all defined steps (unless the context precludes such a possibility).

Turning now to the accompanying drawings, Figures 1-14 illustrate embodiments of a medical device for retaining material in an orifice and preventing leakage of material from the orifice. The medical device 100 can be designed as a cervical plug for retaining semen in the patient's cervical canal 730 and preventing leakage of semen from the patient's cervical canal 730 after a semen sample has been introduced into the patient's cervical canal 730 or uterine cavity 740. The medical device 100 has a shield 110 configured to cover the orifice and an arm 120 configured to insert into the orifice, wherein one end of the arm 120 is secured to the shield 110. The shield 110 can be configured to cover the patient's external opening 720, and the arm 120 can be configured to insert into the patient's cervical canal 730, as shown in Figure 14. By inserting the medical device 100 through the vaginal cavity 710 and into the patient's cervical canal 730, with the arm 120 inserted into the cervical canal 730 and the shield 110 covering the patient's external opening 720, the medical device 100 can establish a physical barrier between the patient's cervical canal 730 and the vaginal cavity 710. In this way, the medical device 100 can be used as a cervical plug to prevent a semen sample from leaking from the cervical canal 730 into the vaginal cavity 710 after the semen sample has been introduced into the patient's cervical canal 730 or uterine cavity 740.

It should be understood that the medical device can be used to cover and block other body orifices, including but not limited to the internal orifice of the cervix, without departing from the scope of this disclosure.

As shown in Figures 1-5, the medical device 100 includes a shield 110 and an arm 120 fixed to the shield 110. To accommodate the contours of the cervical portion surrounding the patient's external opening 720, the shield 110 may have a concave shape with concave and convex sides, as shown in Figure 14, where, when the medical device 100 is in place, the concave side of the shield 110 faces the external opening 720, and the convex side faces the vaginal cavity 710. The shield 110 may be shaped such that the concave side of the shield 110 abuts against the external opening 720 and fits flush with the cervical tissue surrounding the patient's external opening. The curvature of the shield 110 can be adjusted for different patients. The arm 120 may be fixed to the concave side of the shield 110, as shown in Figure 1. Alternatively, the shield 110 may have a generally circular shape, and the arm 120 may be fixed to the shield 110 approximately at the center of the shield, as shown in Figure 1. Alternatively, the shield may have another shape suitable for covering the patient's external opening 720, such as an ellipse.

The shape and size of the shield 110 can be configured such that it can cover the external opening 720 of a woman who has not given birth, is a primiparous woman, or has given birth multiple times. To minimize pain or discomfort experienced by the patient during insertion or removal of the medical device 100, the shield 110 may be made of a slightly flexible material, allowing it to deform under pressure applied by the user of the device but returning to its original shape after the pressure is released. Alternatively, the shield 110 may be made of a substantially rigid or semi-rigid material. Additionally, the shield 110 may be made of at least a partially translucent or transparent material, which can aid in insertion of the device into the cervical canal. Alternatively, the shield 110 may be made of an opaque material. The shield 110 may include medical-grade silicone rubber. However, the shield can be made of any suitable material, including but not limited to plastics, glass, ceramics, metals, any type of rubber, or any combination thereof.

The arm 120 of the medical device 100 is configured to be inserted into an opening covered by a shield 110 during use. The arm 120 is an elongated member having a proximal end 121 and a distal end 122. When the device is in use, the proximal end 121 is secured to the shield 110, and the distal end 122 is inserted into the opening. The arm 120 may be permanently secured to the shield 110. For example, the arm 120 and the shield 110 may be molded as a single piece of material. Alternatively, the arm 120 may be secured to the shield 110 with an adhesive. To facilitate entry and exit of the arm 120 from the patient's cervical canal 730, the arm 120 may have a generally cylindrical shape.

Arm 120 may have a circumferential protrusion 180 to help hold device 100 in place during use when arm 120 is inserted into cervical canal 730. The protrusion 180 is positioned along the length 185 of arm 120 between the midpoint of the arm (midway between proximal end 121 and distal end 122) and the distal end 122 of the arm, and may preferably be positioned closer to the distal end 122 of arm 120 than the midpoint of arm 120, as shown in FIG1. Once arm 120 is inserted into cervical canal 730, as shown in FIG14, the larger diameter of the circumferential protrusion 180 provides resistance to the removal of arm 120 from cervical canal 730, thereby helping to hold device 100 in place for a period of time after semen has been introduced into cervical canal 730 or uterine cavity 740, preventing semen leakage from cervical canal 730 into vaginal cavity 710. As shown in Figure 4, the protrusion 180 preferably has a wavy surface to prevent discomfort when inserting the arm 120 into the cervical canal 730.

The arm 120 is rigid enough to be inserted into the patient's cervical canal 730, but the arm 120 may have a degree of flexibility to minimize pain or discomfort experienced by the patient during insertion or removal of the device 100. Alternatively, the arm 120 may be made of a substantially rigid material. Additionally, the arm 120 may be made of a material that is at least partially translucent or transparent. Alternatively, the arm 120 may be made of an opaque material. The arm 120 may include medical-grade silicone rubber. However, the arm may be made of any suitable material, including but not limited to plastics, glass, ceramics, metals, any type of rubber, or any combination thereof.

The shield 110 and arm 120 can be configured to hold the medical device 100 in place during use, as shown in FIG. 14, such that the shield 110 remains covering the orifice until the medical device 100 is removed by the user. When used herein, the terms "during use" or "in use" refer to any point when the arm 120 of the medical device 100 is inserted into the orifice and the shield 110 of the medical device 100 covers the orifice. FIG. 14 illustrates the device 100 used with a syringe 170 and catheter 160 for introducing semen into the reproductive system. However, as described below, after the introduction of semen, the syringe 170 and catheter 160 are removed, and the device 100 remains in place in the position shown in FIG. 14 for a period of time to prevent semen leakage into the vaginal cavity 710. The proximal end 121 of arm 120 may have a sufficient diameter to form a substantially fluid-impermeable seal between the cervical canal 730 and the vaginal cavity 710 when the proximal end 121 of arm 120 is positioned within the patient's cervical canal 730 after insertion of the device. This fluid-impermeable seal formed by inserting arm 120 into the cervical canal 730 facilitates gentle suction between the concave shield 110 and the area of the cervix covered by the shield 110, further securing the medical device 100 in place. When secured, shield 110 may substantially cover the external opening 720 and fit flush with the tissue surrounding the external opening 720, such that shield 110, together with arm 120, prevents leakage of semen samples around the device 100 and into the vaginal cavity 710.

As shown in Figures 3-6, the medical device 100 may further include an insertion member 130 fixed to a shield 110. The insertion member 130 serves as an aid in inserting and removing the medical device 100 from the cervical canal 730. The insertion member 130 is fixed to the side of the shield 110 opposite the proximal end 121 of the arm 120. The insertion member 130 may be permanently fixed to the shield 110. For example, the medical device 100 may be molded as an integral piece of material including the shield 110, the arm 120, and the insertion member 130. Alternatively, the insertion member 130 may be fixed to the shield 110 with an adhesive. As shown in Figures 4 and 5, the insertion member 130 may be fixed to the shield 110 such that the insertion member 130 forms a generally straight line with the arm 120.

Insertion member 130 provides protrusions that can be grasped with tweezers to guide insertion into or removal from medical device 100. Insertion member 130 may be rigid enough to maintain its shape so that it can be grasped with tweezers or a similar device. Alternatively, insertion member 130 may be slightly flexible. Additionally, insertion member 130 may be made of at least partially translucent or transparent material. Alternatively, insertion member 130 may be made of opaque material. Insertion member 130 may include medical-grade silicone rubber. However, insertion member may be made of any suitable material, including but not limited to plastics, glass, ceramics, metals, any type of rubber, or any combination thereof.

To facilitate removal of the medical device 100 after use, the insertion member 130 may optionally have a cord 140 attached thereto, as best shown in Figures 10 and 13. While any suitable material may be used, the cord 140 may be a medical-grade suture. To facilitate attachment of the cord 140 to the insertion member 130, the insertion member 130 may have an annular cavity 200 located outside the insertion member 130, as best shown in Figures 6 and 7. The insertion member 130 has at least one external opening 210 providing external access to the annular cavity 200. Preferably, as best shown in Figure 5, the insertion member 130 has two external openings 210 on opposite sides of the insertion member 130. To secure the cord 140 to the insertion member 130, one end of the cord 140 may pass through the external opening 210, be inserted into the annular cavity 200, and be inserted around the insertion member 130 until the inserted end of the cord 140 exits the external opening 210. The cord 140 can then be knotted to secure it to the insertion member 130. When used herein, the “tie” cord may include any suitable method of securing the insertion end of the cord 140 to a portion of the cord after inserting it through the annular cavity 200, thereby securing the cord 140 to the insertion member 130. Figure 8 shows a top view of the device 100, illustrating the insertion member 130 and portions of the two external openings 210.

As shown in Figure 14, when the medical device 100 is inserted into the cervical canal 730, the cord 140 can be of sufficient length to extend through the vaginal cavity 710 and outside the patient's body. By pulling the cord 140, the medical device 100 can be removed through the vaginal cavity 710 without forceps or similar devices. Alternatively, the cord 140 can be permanently attached to the insertion member 130. For example, the device 100 can be molded such that one end of the cord 140 is molded into the insertion member 130.

As shown in Figure 7, the medical device 100 may have a hole 150 extending longitudinally through the arm 120 and through the shield 110, such that the hole 150 has an opening 610 at the distal end 122 of the arm 120 and an opening 600 on the side of the shield 110 opposite to the arm 120. The hole 150 may extend through the insertion member 130 such that the opening 600 on the side of the shield 110 opposite to the arm 120 is located at the end of the insertion member 130, as shown in Figure 3. Therefore, the hole 150 can extend completely through the device 100 in a generally straight line. When the device 100 is in place during use, as shown in Figure 14, the hole 150 forms a passage through the device 100 between the vaginal cavity 710 and the cervical canal 730 or the uterine cavity 740. To use device 100, catheter 160 can be inserted into opening 600 of hole 150 on the side of shield 110 opposite to arm 120 and pushed through hole 150, then through opening 610 at distal end 122 of arm 120, as shown in Figures 12-14. Hole 150 has a sufficient diameter to allow catheter 160 to pass through. Thus, medical device 100 can be used as a guide or cannula to facilitate the passage of catheter 160, which can be used as an insemination catheter for introducing a semen sample into a patient's reproductive system. In this way, medical device 100 can be used during intracervical or intrauterine insemination procedures to introduce a semen sample into the cervical canal 730 or uterine cavity 740 as needed. Catheter 160 can then be removed while device 100 remains in place.

The device 100 may also include a valve 190 disposed at the distal end 122 of the arm 120. The valve 190 is operable between an open position as shown in Figures 10 and 11 and a closed position as shown in Figures 1 and 2. The valve 190 includes a plurality of elastomeric valve flaps 195 integrally attached to the distal end 122 of the arm 120. The elastomeric valve flaps 195 are elastically biased inward toward the center of the orifice 150 and abut against each other when the valve 190 is in the closed position. The elastomeric valve flaps 195 are sized and shaped to form a substantially fluid-impermeable seal over the opening 610 at the distal end 122 of the arm 120 when the valve 190 is in the closed position. As used herein, the term "elastomeric" refers to any flexible and/or stretchable material such that the material can be bent and/or stretched and then return to its original position. In this case, the original position refers to the closed position of the valve. Preferably, the valve 190 has three elastomeric valve flaps 195, each having a generally triangular shape, as best shown in Figure 2. When valve 190 is in the closed position, the three triangular valve discs 195 engage together to form a substantially fluid-impermeable seal, preventing fluid leakage through valve 190. Figure 9 shows a bottom view of device 100 with valve 190 in the closed position.

During an artificial insemination procedure, the insemination catheter 160 can pass through the entire device 100. As the catheter 160 is pushed through the opening 610 at the distal end 122 of the arm 120, as shown in Figures 12 and 13, the catheter 160 pushes the elastomeric valve flap 195 of the valve 190 outward, as optimally shown in Figures 11 and 12, thereby moving the valve 190 to the open position. In this way, the catheter 160 can pass through the medical device 100 to deliver a semen sample to the patient's cervical canal 730 or uterine cavity 740, and then be removed from the medical device, leaving the device 100 in place. After delivery of the semen sample, the insemination catheter 160 can be completely or partially removed from the medical device 100. When the catheter 160 is removed, the elastomeric valve flap 195 of the valve 190 returns to its initial position, thereby moving the valve 190 to the closed position. When valve 190 is in the closed position, it prevents the semen sample from leaving the cervical canal 730 through orifice 150, thus preventing leakage back into the vaginal cavity 710 through medical device 100. Therefore, medical device 100 can be effectively used as a cannula for insemination instruments and as a cervical plug to prevent semen already introduced into the patient's cervical canal 730 or uterine cavity 740 from leaking into the patient's vaginal cavity 710.

This disclosure also relates to a method for artificial insemination. The medical device 100 can be configured to function as a cervical plug, as shown in Figure 14. A semen sample can first be introduced into the patient's cervical canal 730 or uterine cavity 740, depending on whether intracervical or intrauterine insemination is used. The semen sample can be artificially introduced into the patient's reproductive system, or alternatively, the sample can be introduced into the patient's reproductive system during sexual intercourse. After the semen sample has been introduced into the cervical canal 730 or uterine cavity 740, the medical device 100 can be inserted into the patient's cervical canal 730 such that the arm 120 extends into the patient's cervical canal 730 and the shield 110 substantially covers the external opening 720 of the patient's cervix, as shown in Figure 14. As previously stated, Figure 14 shows the device 100 used with a syringe 170 and a catheter 160; however, by inserting the device 100 into the position shown in Figure 14 and leaving the device in place, the device 100 can be used as a cervical plug without the syringe 170 and catheter 160. If used only as a cervical plug, the orifice 150 extending through the device 100 and the valve 190 located at the distal end 122 of the arm 120 may be optional features. Once the device 100 is secured in place with the arm 120 inserted into the cervical canal 730 and the shield 110 covering the external opening 720, the shield 110 and arm 120 of the medical device 100 prevent leakage of semen samples from the cervical canal 730 into the patient's guide cavity 710. The circumferential protrusion 180 of the arm 120 provides resistance to the removal of the arm 120 of the device 100 from the cervical canal 730, thereby helping to ensure that the device 100 remains in place during use, as shown in Figure 14. In this way, the medical device 100 can increase the efficacy of intracervical or intrauterine insemination by reducing semen sample loss. After a suitable period of time, the device 100 can be removed.

It should be understood that the medical device 100 used in the contemplated method (whereby the medical device 100 is configured to function as a cervical plug) may have some or all of the structural features consistent with the embodiments detailed above. Furthermore, it should be understood that the methods of this disclosure contemplate methods requiring additional or fewer steps, depending on the presence of such structural features. For example, the method may further include the step of removing the medical device 100 via the insertion member 130 using forceps or similar instruments. Alternatively, the device may be removed by pulling the device 100 through the vaginal cavity 710 via the rope 140.

Medical device 100 can be configured to additionally serve as a guide or cannula for a catheter, as shown in Figures 12-14. Medical device 100 has an orifice 150 extending through it, a valve 190 disposed at the distal end 122 of arm 120, and an optional circumferential protrusion 180 positioned along the length 185 of arm 120. Device 100 is insertable into a patient's cervical canal 730 such that arm 120 extends into the patient's cervical canal 730 and a shield 110 substantially covers the external opening 720 of the patient's cervix. Catheter 160 can be inserted into orifice 150 through opening 600 on the side of shield 110 opposite arm 120. When catheter 160 is inserted into orifice 150, catheter 160 can be pushed through opening 610 at the distal end 122 of arm 120, thereby forcing valve 190 into an open position, as shown in Figure 12, up to the extent required by a particular insemination procedure. The semen sample can then be introduced into the patient's cervical canal 730 or uterine cavity 740 via catheter 160.

Before inserting device 100 into cervical canal 730, catheter 160 may be partially inserted into orifice 150, and then after insertion of medical device 100, catheter 160 may be pushed through orifice 610 and valve 190 at distal end 122 of arm 120. Alternatively, catheter 160 may be inserted into orifice 150 and through valve 190 after insertion of medical device 100, or catheter 160 may be inserted into orifice 150 before insertion of device 100 to push catheter 160 through orifice 610 and valve 190 at distal end 122 of arm 120, as shown in Figures 12 and 13.

When valve 190 is in the closed position, the elastomeric valve discs 195 of valve 190 are elastically biased against each other, as shown in Figure 2. When catheter 160 is inserted into orifice 150, catheter 160 can be pushed through opening 610 at distal end 122 of arm 120, causing catheter 160 to force elastomeric valve discs 195 outward, thereby moving valve 190 to the open position. Before device 100 is inserted into cervical canal 730, catheter 160 can be partially inserted into orifice 150, keeping valve 190 in the closed position. Catheter 160 can then be pushed through opening 610 at distal end 122 of arm 120, causing valve 190 to move to the open position after medical device 100 is inserted into cervical canal 730.

Once the device 100 is secured in place, with arm 120 inserted into the cervical canal 730, shield 110 covering the external opening 720, and catheter 160 inserted through orifice 150 and valve 190, a semen sample can be introduced into the patient's cervical canal 730 or uterine cavity 740 via catheter 160, depending on whether intracervical or intrauterine insemination is being performed. As shown in Figure 14, the semen sample can be introduced into the cervical canal 730 or uterine cavity 740 by injecting it through catheter 160 using syringe 170. After the semen sample has been introduced, catheter 160 can be removed, leaving device 100 in place. After catheter 160 is removed, the elastically biased elastomeric valve flap 195 of valve 190 returns to its initial position, as shown in Figure 2, where valve 190 is in the closed position, thereby preventing backflow of the semen sample through valve 190 and orifice 150. With the medical device 100 securely in place, the shield 110 and arm 120 of the device 100 prevent semen samples from leaking from the cervical canal 730 around the device 100 and into the patient's vaginal cavity 710, thereby increasing the effectiveness of intracervical or intrauterine insemination by reducing semen sample loss. The circumferential protrusion 180 of the arm 120 helps to secure the device 100 in place to prevent leakage around the device 100.

After a suitable period of time, the device 100 can be removed. The device 100 can be removed via the insertion member 130 using tweezers or a similar instrument. Alternatively, the device 100 can be removed by pulling it through the vaginal cavity 710 via the rope 140.

To ensure that the semen sample is introduced into the proper location, the catheter 160 can extend completely through the medical device 100, such that one end of the catheter 160 is located in the cervical canal 730 or uterine cavity 740 before guiding the semen sample through the catheter 160. Figure 14 shows the catheter 160 extending through the entire device 100 into the patient's uterine cavity 740 and the syringe 170 for injecting the sample. Alternatively, the semen sample can be guided through the orifice 150 of the medical device 100 using the syringe 170 or a similar instrument without the aid of the catheter 160.

The overall size of the device 100 or the specific dimensions of its components can be varied to accommodate different patients. As an example, the device 100 may have the following dimensions: the shield 110 may be circular with a diameter of 22.50 mm; the arm 120 may be cylindrical with a diameter of 3.40 mm; and the circumferential protrusion 180 may have a diameter of 4.46 mm at its widest point and extend along the length 185 of the 3.18 mm arm 120. These dimensions are illustrative only and are not intended to be limiting.

This disclosure may also relate to insemination kits that can be used by a healthcare provider or by a patient at home. An insemination kit may include: a medical device 100 having the features described herein, wherein the medical device 100 serves as a guide or cannula for a cervical plug and catheter; a catheter 160; and a syringe 170 configured to be attached to the catheter 160. The catheter 160 and syringe 170 of the kit may optionally be permanently attached to each other or molded together as a single component.

The insemination kit can be provided to the user with the components pre-assembled so that the catheter 160 is inserted into the port 150 of the medical device 100 and the syringe 170 is secured to one end of the catheter 160. The catheter 160 can be partially inserted into the port 150 of the medical device 100 such that the valve 190 is in the closed position upon user receipt. Alternatively, the catheter 160 can be inserted into the port 150 of the medical device 100 such that the catheter 160 extends through an opening 610 in the distal end 122 of the arm 120 such that the valve 190 is in the open position upon user receipt.

It should be understood that versions of the present invention may have different forms and embodiments. Furthermore, it should be understood that those skilled in the art will recognize that these various forms and embodiments fall within the scope of the invention disclosed herein.

The claims are:

1) A medical device comprising:

Constructed to cover the opening;

An arm having a proximal end fixed to the shield and a distal end configured to insert into an aperture, wherein the shield and the arm are configured to hold the medical device in place during use.

The medical device has a hole extending longitudinally through the arm and through the shield, such that the hole has an opening at the distal end of the arm and an opening on the side of the shield opposite the arm; and

A valve is disposed at the distal end of the arm, wherein the valve is operable between an open position and a closed position, wherein the valve includes a plurality of elastomeric valve discs integrally attached to the distal end of the arm, wherein the elastomeric valve discs are elastically biased against each other when the valve is in the closed position, wherein each of the elastomeric valve discs is sized and shaped to form a substantially fluid-impermeable seal over an opening at the distal end of the arm when the valve is in the closed position.

2) The medical device according to claim 1, wherein the valve has three elastomeric valve flaps.

3) The medical device of claim 1, wherein the arm has a circumferential protrusion positioned along the length of the arm between a midpoint of the arm and a distal end of the arm.

4) The medical device of claim 1, wherein the orifice has a sufficient diameter to allow a catheter to pass through the orifice.

5) The medical device of claim 1, wherein the shield has a concave shape, and wherein the proximal end of the arm is fixed to the concave side of the shield.

6) The medical device of claim 1 further includes an insertion member fixed to the shield, wherein the insertion member is fixed to the side of the shield opposite to the proximal end of the arm.

7) The medical device of claim 6, wherein the insertion member has an annular cavity, and wherein the insertion member has an external opening that provides an external passage to the annular cavity.

8) The medical device according to claim 1, wherein the protective cover is flexible.

9) The medical device according to claim 1, wherein the protective cover is semi-transparent.

10) A medical device comprising:

A protective cover constructed to cover the opening; and

An arm having a proximal end fixed to the shield and a distal end configured to be inserted into an aperture, wherein the arm has a circumferential protrusion positioned along the length of the arm between a midpoint of the arm and the distal end of the arm, wherein the shield and the arm are configured to secure the medical device in place during use.

11) The medical device of claim 10, wherein the medical device has a hole extending longitudinally through the arm and through the shield, such that the hole has an opening at the distal end of the arm and an opening on the side of the shield opposite to the arm.

12) The medical device of claim 11 further includes a valve disposed at the distal end of the arm, wherein the valve is operable between an open position and a closed position, wherein the valve includes a plurality of elastomeric valve flaps integrally attached to the distal end of the arm, wherein when the valve is in the closed position, the elastomeric valve flaps are elastically biased against each other, wherein each of the elastomeric valve flaps is sized and shaped to form a substantially fluid-impermeable seal over an opening at the distal end of the arm when the valve is in the closed position.

13) The medical device of claim 10, wherein the orifice has a sufficient diameter to allow a catheter to pass through the orifice.

14) The medical device of claim 10, wherein the shield has a concave shape, and wherein the proximal end of the arm is fixed to the concave side of the shield.

15) The medical device of claim 10 further includes an insertion member fixed to the shield, wherein the insertion member is fixed to the side of the shield opposite the proximal end of the arm.

16) The medical device of claim 15, wherein the insertion member has an annular cavity, and wherein the insertion member has an external opening that provides an external passage to the annular cavity.

17) The medical device of claim 10, wherein the protective shield is flexible.

18) The medical device of claim 10, wherein the protective cover is translucent.

19) A method for artificial insemination, the method comprising the following steps:

Provide a medical device, the medical device comprising:

A protective shield, constructed to cover the external opening of the patient's cervix;

An arm having a proximal end fixed to a shield and a distal end configured for insertion into the cervical canal of a patient, wherein the shield and the arm are configured to hold the medical device in place during use, and wherein a hole extends longitudinally through the arm and through the shield, such that the hole has an opening at the distal end of the arm and an opening on the side of the shield opposite to the arm; and

A valve, disposed at the distal end of an arm, is operable between an open position and a closed position. The valve includes a plurality of elastomeric valve discs integrally attached to the distal end of the arm. When the valve is in the closed position, the elastomeric valve discs are elastically biased against each other. Each elastomeric valve disc is sized and shaped to form a substantially fluid-impermeable seal above an opening at the distal end of the arm when the valve is in the closed position.

The medical device is inserted into the patient's cervical canal, such that the arm extends into the patient's cervical canal, and the shield substantially covers the external opening of the patient's cervix;

Provide catheter;

The conduit is inserted into the opening through the hole on the side of the shield opposite to the arm;

Pushing the conduit through the opening at the distal end of the arm causes the conduit to force the valve's elastomeric valve disc outward, thereby moving the valve to the open position;

Semen samples are introduced into the patient's cervical canal or uterine cavity via a catheter; and

Remove the catheter.

20) The method of claim 19, wherein the arm has a circumferential protrusion positioned along the length of the arm between a midpoint of the arm and a distal end of the arm.

21) The method of claim 19, wherein the step of inserting the catheter into the orifice comprises: partially inserting the catheter into the orifice before the step of inserting the medical device into the cervical canal, and the step of pushing the catheter through the opening at the distal end of the arm is performed after the step of inserting the medical device into the cervical canal.

22) The method of claim 19, wherein the semen sample is introduced into the patient's cervical canal or uterine cavity by injecting the semen sample through a catheter using a syringe.

23) The method of claim 19, wherein the shield has a concave shape, wherein the proximal end of the arm is fixed to the concave side of the shield.

24) The method of claim 19, wherein the medical device further comprises an insertion member fixed to the shield, wherein the insertion member is fixed to the side of the shield opposite the proximal end of the arm.

25) The method of claim 24, wherein the insertion member has an annular cavity, and wherein the insertion member has an external opening that provides an external passage to the annular cavity, the method further comprising the steps of inserting an end of a rope into the annular cavity through the external opening and tying the rope to secure the rope to the insertion member.

26) The method of claim 19, wherein the protective cover is flexible.

27) The method of claim 19, wherein the shield is translucent.

28) The method of claim 19 further includes the step of removing the medical device from the patient after a period of time.

Claims (13)

1. A medical device comprising: It is constructed to form a protective shield covering the external opening of the cervix; An arm having a proximal end fixed to the shield and a distal end configured to insert into an aperture, wherein the shield and the arm are configured to hold the medical device in place during use. The medical device has a hole extending longitudinally through the arm and through the shield, such that the hole has an opening at the distal end of the arm and an opening on the side of the shield opposite the arm; and A valve, disposed at the distal end of the arm, is operable between an open position and a closed position, wherein the valve is operable to form a substantially fluid-impermeable seal over an opening at the distal end of the arm when the valve is in the closed position. The method involves creating a fluid-impermeable seal by inserting the distal end of the arm into the cervical canal, thereby facilitating suction between the shield and the area of the cervix covered by the shield. 2. The medical device according to claim 1, wherein the valve comprises a plurality of elastomeric valve discs. 3. The medical device of claim 1, wherein the arm includes a circumferential protrusion positioned along the length of the arm, wherein the circumferential protrusion is operable to secure the arm in place during use. 4. The medical device of claim 1, wherein the orifice is operable to receive a catheter. 5. The medical device of claim 4, wherein the valve is operable to form a substantially fluid-impermeable seal around the catheter at the distal end of the arm when the valve is in the open position. 6. The medical device of claim 1, wherein the shield has a concave shape, and wherein the proximal end of the arm is fixed to the concave side of the shield. 7. The medical device of claim 1, further comprising an insertion member fixed to the shield, wherein the insertion member is fixed to the side of the shield opposite the proximal end of the arm. 8. The medical device of claim 7, wherein the insertion member has an annular cavity, wherein the insertion member has an external opening providing external access to the annular cavity, and wherein the annular cavity is operable to receive a retaining cord. 9. A medical device comprising: It is constructed to form a protective shield covering the external opening of the cervix; An arm having a proximal end fixed to the shield and a distal end configured to insert into an aperture, wherein the shield and the arm are configured to hold the medical device in place during use. The medical device has a hole extending longitudinally through the arm and through the shield, such that the hole has an opening at the distal end of the arm and an opening on the side of the shield opposite the arm; and An insertion member is fixed to the shield, wherein the insertion member is fixed to the side of the shield opposite the proximal end of the arm, wherein the insertion member has an annular cavity, wherein the insertion member has an external opening providing external passage to the annular cavity, and wherein the annular cavity is operable to receive a retaining cord. The method involves creating a fluid-impermeable seal by inserting the distal end of the arm into the cervical canal, thereby facilitating suction between the shield and the area of the cervix covered by the shield. 10. The medical device of claim 9, wherein the valve is disposed at the distal end of the arm, wherein the valve is operable between an open position and a closed position, wherein the valve is operable to form a substantially fluid-impermeable seal over the opening at the distal end of the arm when the valve is in the closed position. 11. The medical device of claim 10, wherein the valve comprises a plurality of elastomeric valve discs. 12. The medical device of claim 9, wherein the arm includes a circumferential protrusion positioned along the length of the arm, wherein the circumferential protrusion is operable to secure the arm in place during use. 13. The medical device of claim 9, wherein the shield has a concave shape, and wherein the proximal end of the arm is fixed to the concave side of the shield.