JP2021505229A - Artificial insemination device and artificial insemination method - Google Patents

Abstract

The medical device has a shield and an arm that is attached to the shield at one end and extends outward from the shield. The arm is inserted into the patient's cervix and the shield covers the patient's outer mouth. Hold the sperm sample in the cervix and into the vaginal cavity by inserting the medical device into the patient's cervix before artificial insemination and leaving the device in place after artificial insemination. A physical barrier is established to prevent leakage of the uterus. The device may have a bore that extends through the device for the catheter to pass through. The bore has a valve to allow passage of the catheter and prevent sperm regurgitation. The arm may have multiple longitudinal ridges, circumferential ridges or circumferential barbs to help keep the device in place.

Description

(Cross reference)
The present invention claims the priority of PCT application number PCT / US2017 / 064028 filed on November 30, 2017 and is incorporated herein by reference.

(Technical field)
A preferred practice of the present invention is generally a device and method for artificial insemination.

Artificial insemination aims to introduce sperm into the patient's reproductive system to promote pregnancy. Artificial insemination is typically performed when sperm are difficult or impossible to enter the patient's reproductive system during sexual intercourse. Two currently in use are intracervical insemination, in which a sperm sample is inserted into the patient's cervix, and intrauterine insemination, in which a sperm sample is inserted into the patient's uterine cavity. It is a general artificial insemination procedure. Generally, during such procedures, the patient's vaginal wall is left open by a medical device such as a speculum. The sperm sample is then inserted into the patient's cervix or uterine cavity, typically via a catheter-syringe assembly, depending on which procedure is being performed. After introduction of the sperm sample, sperm remain in place and are taken up by the patient's reproductive system. However, due to the regurgitation caused by uterine contractions, some sperm samples are often lost by leaking from the cervix into the patient's vaginal cavity.

Several known devices, such as vaginal sponges and cervical caps, seek to solve the problem of leakage by forming a barrier between the patient's cervix and vaginal cavity after introduction of the sperm sample. However, these devices merely occlude the upper region of the patient's vaginal cavity near the patient's cervix and may not be able to effectively hold the sperm sample within the cervix. Therefore, the use of vaginal sponges and cervical caps in artificial insemination may not be effective in preventing the regurgitation caused by uterine contractions from reducing the effectiveness of the insemination procedure. Also, these devices can cause discomfort to the patient during insertion and removal.

The device disclosed in PCT / US 2017/064028 of the application filed by this applicant attempts to solve the above problems. The device is designed to be inserted into the cervix and stay there for the duration of insemination to prevent sperm leakage from the cervix. Also, the device may be capable of inserting a catheter through a bore extending through the device so that sperm can be introduced into the cervix or uterine cavity while the device is in place within the patient's cervix. Good. However, it is sometimes possible that the device disengages from the cervix or a small amount of leakage occurs through a bore that extends through the device during the period intended to keep the device in place to allow insemination.

Therefore, in the present technology, there is a demand for a device and a method of using the device for enhancing the effectiveness of artificial insemination treatment. In addition, there is a need in the art for devices to enhance the effectiveness of artificial insemination procedures that do not cause significant discomfort to the patient when inserting and removing the device.

The present disclosure provides devices and methods for artificial insemination according to the independent claims. Preferred embodiments of the present invention are reflected in the dependent claims. The inventions described in the claims can be better understood by considering the present disclosure, i.e., the embodiments described and illustrated in the specification and drawings. In general, the disclosure reflects a preferred embodiment of the invention. However, careful readers will find that some aspects of the disclosed embodiments extend beyond the claims. In that the disclosed embodiments are extended beyond the claims, the disclosed embodiments should be considered as supplementary background technology information and constitute the definition of the invention. is not it.

One aspect of the disclosure provides a medical device (or medical device) used during artificial insemination to prevent leakage of sperm samples from the patient's cervix. The medical device can be configured to function as a cervical plug (or cervical plug). The medical device has a shield configured to cover an orifice and an arm having proximal and distal ends. The proximal end is attached (or fixed) to the shield and the distal end is configured to be inserted into the opening. For example, the shield may be configured to cover the opening between the patient's cervix and the vaginal cavity (the "external os"), and the arm may be inserted into the patient's cervix. Can be configured in. Since the arm is inserted into the cervix and the shield covers the external cervix, the medical device can effectively attach (or fix) itself in place during use. To help keep the device in place with the arm inserted into the cervix during use, the arm is placed near the distal end of the arm with a circumferential bulge, a circumferential ridge. ), Circumferential barb (or barb) or longitudinal ridge may be optionally provided.

By inserting the medical device into the patient's cervix through the vaginal cavity so that the arm is inserted into the patient's cervix and the shield covers the patient's outer cervix, the medical device inserts a sperm sample into the patient's cervix. A physical barrier can be established that is held in the canal and prevented from leaking into the vaginal cavity. In this way, the medical device can be utilized as a cervical plug after introducing the sperm sample into the patient's cervix or uterine cavity, preventing the sperm sample from leaking into the vaginal cavity. Can prevent sperm sample loss. Therefore, the present disclosure can also cover artificial insemination methods in which a sperm sample is first introduced into the patient's cervix or uterine cavity and then a medical device is inserted into the patient's cervix as described above.

In addition, the medical device can be configured to act as both a cervical plug and a guide or cannula for the catheter. The medical device has a shield and an arm with proximal and distal ends. The proximal end is attached (or fixed) to the shield and the distal end is configured to be inserted into the patient's cervix. The medical device further extends longitudinally through the arm and the shield such that the bore has an opening at the distal end of the arm and on the shield side opposite the arm. It may have a bore. A valve that can operate between the open and closed states may be located at the distal end of the arm. The valve includes multiple elastic flaps that are integrally attached to the distal end of the arm. When the valve is closed, the elastic flaps are elastically urged against each other inward toward the center of the bore. The elastic flap is sized and shaped such that it covers the opening at the distal end of the arm to form a substantially liquidtight seal when the valve is closed. To use the device, a catheter can be inserted into the bore opening on the shield side opposite the arm and pushed through the opening at the distal end of the arm. When the catheter is pushed through the opening at the distal end of the arm, the catheter pushes the elastic flap of the valve outward, which causes the valve to move open. In this way, the catheter can pass through the medical device, deliver the sperm sample to the patient's cervix or uterine cavity, and then remove the medical device from the medical device, leaving it in place. When the catheter is removed, the valve moves to a closed state, preventing sperm samples from leaking through the medical device into the vaginal cavity. Thus, the present disclosure also inserts a medical device into the patient's cervix as described above, inserts a catheter into the bore of the medical device, guides a sperm sample through the catheter into the patient's cervix or cervix, and then the medical device. It can be targeted for artificial insemination methods in which the catheter is removed while leaving the catheter in place.

To insert and remove the medical device, the medical device may have, as an arm, an insertion member attached (or fixed) to the shield on the opposite shield. To facilitate the removal of the medical device, the insertion member may have a string attached (or fixed) to it. The shield may be formed from a flexible material to minimize patient discomfort during insertion and removal of the medical device.

Further features and advantages of the present disclosure are described in the following description, which will become apparent or may be learned by the practice of the present disclosure. The general description described above and the detailed description below are exemplary and descriptive and are intended to provide further description of the present disclosure.

These and other features, aspects, and advantages of the present disclosure will be better understood with respect to the following description, the appended claims, and the accompanying drawings.

FIG. 1 is a perspective view of the device according to the present disclosure. FIG. 2 is a perspective view of the device according to the present disclosure. FIG. 3 is a perspective view of the device according to the present disclosure. FIG. 4 is an elevational view of the device according to the present disclosure. FIG. 5 is an elevational view of the device according to the present disclosure. FIG. 6 is a partial perspective view of the device according to the present disclosure. FIG. 7 is a cross-sectional view of the device according to the present disclosure. FIG. 8 is a top view of the device according to the present disclosure. FIG. 9 is a bottom view of the device according to the present disclosure. FIG. 10 is an elevational view of the device according to the present disclosure. FIG. 11 is a perspective view of the device according to the present disclosure. FIG. 12 is a perspective view of the device according to the present disclosure and a catheter inserted through the device. FIG. 13 is a perspective view of the device according to the present disclosure and a catheter inserted through the device. FIG. 14 shows a device inserted into the patient's reproductive system, which is used with a catheter and syringe. FIG. 15A is a side view of the device according to the present disclosure. FIG. 15B is a cross-sectional view of the device according to the present disclosure. FIG. 16A is a side view of the device according to the present disclosure. FIG. 16B is a cross-sectional view of the device according to the present disclosure. FIG. 17A is a side view of the device according to the present disclosure. FIG. 17B is a cross-sectional view of the device according to the present disclosure.

(Detailed explanation)
The above outline and this detailed description, the claims below, and the accompanying drawings refer to the particular features described in the claims, including the steps of the method of the invention. In the present disclosure, many features are described as optional or optional, for example, using the verb "can" or "may", or using parentheses. To. For the sake of brevity and readability, this disclosure does not explicitly list every possible variant that can be obtained by choosing from a set of optional features. However, this disclosure should be construed as explicitly disclosing all such variations. For example, a system described as having three optional features can be described in seven different ways: only one out of three possible features, any two or three out of three possible features. It can be implemented by all three of the possible features. The disclosure herein should be understood to include all possible combinations of such particular features. For example, if a particular feature is disclosed in a particular aspect or embodiment, or in the context of a particular claim, that feature, to the extent possible, in combination with other particular aspects or embodiments and / Or can be used in the context and generally in the claimed invention.

As used herein, the term "comprise" and its grammatically equivalent terms are used to mean that other elements, materials, processes, etc. are present at will. For example, an article that "contains" elements A, B and C may contain only elements A, B and C, or may include not only elements A, B and C but also one or more other elements.

When referred to herein as a method involving two or more specified steps, the specified steps may be performed in any order or at the same time (if the context excludes that possibility). ), And the method comprises one or more other steps performed before any of the specified steps, between two specified steps, or after all specified steps. It may be (unless the context excludes that possibility).

Next, when the drawings are examined, FIGS. 1 to 17 show embodiments of a medical device for retaining a material in the opening and preventing leakage of the material from the opening. The medical device 100 acts as a cervical plug to hold the sperm into the patient's cervix 730 and prevent it from leaking after the sperm sample has been introduced into the patient's cervix 730 or uterine cavity 740. Can be designed to do. The medical device 100 has a shield 110 configured to cover the opening and an arm 120 configured to be inserted into the opening, one end of the arm 120 being attached to the shield 110 (or It is fixed). As shown in FIG. 14, the shield 110 can be configured to cover the patient's external cervix 720 and the arm 120 can be configured to be inserted into the patient's cervical 730. The medical device 100 is inserted into the patient's cervix 730 through the vaginal cavity 710 so that the arm 120 is inserted into the patient's cervix 730 and the shield 110 covers the patient's external cervix 720. , A physical barrier can be established between the patient's cervix 730 and the vaginal cavity 710. Thus, the medical device 100 functions as a cervical plug that prevents the sperm sample from leaking from the cervix 730 into the vaginal cavity 710 after the sperm sample has been introduced into the patient's cervical 730 or uterine cavity 740. be able to.

It should be understood that medical devices can be used to cover and block other human body openings, including but not limited to internal cervical openings, without departing from the scope of the present disclosure.

As shown in FIGS. 1 to 5, the medical device 100 includes a shield 110 and an arm 120 attached to the shield 110. The shield 110 can have a concave shape with a concave side and a convex side so as to correspond to the contour of the cervix surrounding the patient's external uterine ostium 720, the medical device 100 as shown in FIG. When in place, the concave side of the shield 110 faces the external cervix 720 and the convex side faces the vaginal cavity 710. The shield 110 can be shaped such that the concave side of the shield 110 is in close contact with and fits the patient's external uterine ostium 720 and the cervical tissue surrounding the external uterine ostium. The curvature of the shield 110 can be adjusted for different patients. As shown in FIG. 1, the arm 120 can be attached to the concave side of the shield 110. Further, as shown in FIG. 1, the shield 110 may have a generally circular shape, and the arm 120 can be attached to the shield 110 approximately in the center of the shield. Alternatively, the shield can have another shape suitable for covering the patient's external uterine ostium 720, such as an oval shape.

The shield 110 can be shaped and sized to cover the external uterine ostium 720 of minors, primiparas, or large numbers of women. In order to minimize the pain or discomfort that the patient suffers when inserting or removing the medical device 100 into or out of the patient's body, the shield 110 deforms the material due to the pressure exerted by the user of the device, although It can be formed of a somewhat flexible material so that it returns to its original shape when pressure is released. Alternatively, the shield 110 can be made of a material that is substantially hard or semi-hard. In addition, the shield 110 can be formed of a material that is at least partially translucent or transparent, which can help the user insert the device into the cervix.

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 plastic, glass, ceramics, metals, any kind of rubber, or any combination thereof.

The arm 120 of the medical device 100 is configured to be inserted into an opening covered by the shield 110 during use of the medical device 100. The arm 120 is an elongated member having a proximal end 121 and a distal end 122. The proximal end 121 is attached to the shield 110 and the distal end 122 is inserted into the opening during use of the device. The arm 120 may be permanently attached (or fixed) to the shield 110. For example, the arm 120 and shield 110 may be molded as a single piece of material.

Alternatively, the arm 120 may be glued to the shield 110. The arm 120 may have a generally cylindrical shape to facilitate access of the arm 120 to and from the patient's cervix 730.

The arm 120 may have a circumferential bulge 180 to help keep the device 100 in place with the arm 120 inserted into the cervical 730 during use. The bulge 180 is located between the midpoint of the arm (middle between the proximal and distal ends 122) and the distal end 122 of the arm along the length 185 of the arm 120. Preferably, as shown in FIG. 1, it may be placed closer to the distal end 122 of the arm 120 than to the midpoint of the arm 120. When the arm 120 is inserted into the cervix 730, as shown in FIG. 14, the wide diameter of the circumferential bulge 180 provides resistance to the arm 120 being removed from the cervix 730, thereby sperm. Helps hold the device 100 in place for a period of time after introduction into the cervix 730 or cervix 740 to prevent the device 100 from leaking sperm from the cervix 730 into the patient's vaginal cavity 710. .. As shown in FIG. 4, the bulge 180 preferably has a curved surface (or a contoured surface) in order to prevent discomfort when inserting the arm 120 into the cervical canal 730.

In addition to the circumferential bulge 180, additional alternative embodiments that help provide resistance to the arm 120 being removed are shown in FIGS. 15-17. As shown in FIGS. 15A and 15B, the arm 120 has a plurality of longitudinal ridges 175 to keep the device 100 in place with the arm 120 inserted into the cervix 730 during use. You may have. The ridge 175 is located along the length 185 of the arm 120 between the midpoint of the arm (intermediate between the proximal end 121 and the distal end 122) and the distal end 122 of the arm, in FIG. It is preferably located closer to the distal end 122 of the arm 120 than the midpoint of the arm 120, as well as where the circumferential bulge 180 is located. As shown in FIG. 14, when the arm 120 is inserted into the cervix 730, the wider diameter of the longitudinal ridge 175 provides resistance to removal of the arm 120 from the cervix 730, thereby allowing semen to flow. After being introduced into the cervix 730 or uterine cavity 740, it helps to keep the device 100 in place for a period of time, which prevents semen from leaking from the cervix 730 into the vaginal cavity 710. As shown in FIGS. 15A and 15B, the longitudinal ridge 175 preferably has a convex outer surface to prevent patient discomfort when inserting the arm 120 into the cervix 730.

Instead, as shown in FIGS. 16A and 17B, the arm 120 has a plurality of circumferential ridges 205 to keep the device 100 in place with the arm 120 inserted into the cervix 730 during use. You may have. The circumferential ridge 205 is located along the length 185 of the arm 120 between the midpoint of the arm (intermediate between the proximal and distal ends 122) and the distal end 122 of the arm. It is preferred that it be located closer to the distal end 122 of the arm 120 than the midpoint of the arm 120, as well as where the circumferential bulge 180 of 1 is located. As shown in FIG. 14, when the arm 120 is inserted into the cervix 730, the wider diameter of the circumferential ridge 205 provides resistance to removal of the arm 120 from the cervix 730, thereby allowing semen to flow. It helps keep the device 100 in place for a period of time after being introduced into the cervix 730 or the uterine cavity, which prevents the leakage of semen from the cervix 730 into the vaginal cavity 710. As shown in FIGS. 16A and 16B, the integrated circumferential ridge 205 provides a curved outer surface (or undulating outer surface:) to prevent patient discomfort when inserting the arm 120 into the cervical canal 730. It is preferable to form a contoured outer surface).

Instead, as shown in FIGS. 17A and 17B, the arm 120 has a plurality of circumferential barbs (in order to keep the device 100 in place with the arm 120 inserted into the cervix 730 during use. Barbs) 215 may be included. The barb 215 is located along the length 185 of the arm 120 between the midpoint of the arm (intermediate between the proximal and distal ends 122) and the distal end 122 of the arm, in FIG. It is preferably located closer to the distal end 122 of the arm 120 than the midpoint of the arm 120, as well as where the circumferential bulge 180 is located. Although not necessarily necessary, preferably, the diameter of the return portion 215 in each circumferential direction increases as the return portion 215 approaches the proximal end of the arm 120. As shown in FIG. 14, when the arm 120 is inserted into the cervix 730, the gradually increasing diameter of the barb 215 and the upwardly inclined shape provide resistance to removal of the arm 120 from the cervix 730. It helps to keep the device 100 in place for a period of time after the semen has been introduced into the cervix 730 or uterine cavity 740, which allows the device 100 to leak semen from the cervix 730 into the vaginal cavity 710. To prevent. The shape of the circumferential barbs 215 allows them to contract inward while inserting the arms 120 into the cervix 730 to prevent discomfort.

The arm 120 is rigid enough (or rigid enough) to insert the arm 120 into the patient's cervix 730, but minimizes the pain or discomfort experienced by the patient when inserting or removing the device 100. It may have some flexibility to limit it. Alternatively, the arm 120 may be made of a material that is substantially rigid (or rigid). Further, 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 can include medical grade silicone rubber. However, the arm may be made of any suitable material, including but not limited to plastic, glass, ceramic, metal, any kind of rubber, or any combination thereof.

The shield 110 and arm 120 are configured to attach the medical device 100 in place during use so that the shield 110 remains covering the opening until the user removes the medical device 100. You may. As used herein, the terms "during use" or "in use" mean that the arm 120 of the medical device 100 is inserted into the opening and the shield 110 of the medical device 100 is the opening. Refers to any point in time when covering. FIG. 14 shows a device 100 used with a syringe 170 and a catheter 160 for introducing sperm into the reproductive system. However, as described below, the syringe 170 and catheter 160 are removed after sperm introduction and the device 100 remains in place for a period of time as shown in FIG. 14 to prevent sperm from leaking into the vaginal cavity 710. .. When the proximal end 121 of the arm 120 is positioned within the patient's cervix 730 after insertion of the device, a substantially liquidtight seal is formed between the patient's cervix 730 and the vaginal cavity 710. , The proximal end 121 of the arm 120 can have a sufficiently large diameter. The liquid-tight seal formed by inserting the arm 120 into the cervical canal 730 promotes slight adsorption between the concave shield 110 and the area of the cervix covered by the shield 110, thereby medical. The device 100 can be further mounted in place. When installed in place, the shield 110 works with the arm 120 to prevent sperm samples from leaking into the vaginal cavity 710 from around the device 100 so that the shield 110 can prevent the external uterine ostium 720. Can be adhered and fitted to the tissue surrounding the external uterine ostium 720.

As shown in FIGS. 3-6, the medical device 100 may further include an insertion member 130 attached to the shield 110. The insertion member 130 may serve as an aid for inserting the medical device 100 into the cervix 730 and removing the device from the cervix. The insertion member 130 is attached to the opposite side of the shield 110, similar to 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 a single piece of material that includes a shield 110, an arm 120, and an insertion member 130. Alternatively, the insertion member 130 may be fixed to the shield 110 with an adhesive. As shown in FIGS. 4 and 5, the insertion member 130 may be fixed to the shield 110 so that the insertion member 130 forms a substantially straight line with the arm 120.

The insertion member 130 provides a protrusion that can be gripped using forceps to guide the device and insert or remove the medical device 100. The insertion member 130 may be sufficiently rigid (or sufficiently rigid) to retain its shape so that it can be gripped using forceps or a similar device. Alternatively, the insertion member 130 may be somewhat flexible. Further, the insertion member 130 may be made of a material that is at least partially translucent or transparent. Alternatively, the insertion member 130 may be made of an opaque material. The insertion member 130 can include medical grade silicone rubber. However, the insert member can be formed of any suitable material, including but not limited to plastic, glass, ceramic, metal, any kind of rubber, or any combination thereof.

As best shown in FIGS. 10-10, the insertion member 130 may optionally have a string 140 attached to it to facilitate removal of the medical device 100 after use. .. The string 140 may be a medical grade suture, but any suitable material may be utilized. As best shown in FIGS. 6 and 7, the insertion member 130 is an annular cavity (or annular) located outside the insertion member 130 to facilitate attachment of the string 140 to the insertion member 130. It may have a void) 200. The insertion member 130 has at least one outer opening 210 that provides external access to the annular cavity 200. Preferably, as best shown in FIG. 5, the insertion member 130 has two outer openings 210 on opposite sides of the insertion member 130. To attach the string 140 to the insertion member 130, one end of the string 140 is inserted into the annular cavity 200 through the outer opening 210 and inserted around the insertion member 130 until the insertion end of the string 140 exits the outer opening 210. You may. Next, the string 140 can be tied to attach the string 140 to the insertion member 130. As used herein, "tying" means inserting the end of the string 140 through the annular cavity 200 so that the string 140 can be attached to the insertion member 130, and then the insertion end of the string 140. It may include any suitable method of fixing to a part of the string 140. FIG. 8 shows a top view of the device 100 showing the insertion member 130 and the portions of the two outer openings 210.

As shown in FIG. 14, when the medical device 100 is inserted into the cervical canal 730, the cord 140 can be long enough to extend through the vaginal cavity 710 to outside the patient's body. By pulling on the string 140, the medical device 100 can be removed through the vaginal cavity 710 without forceps or a similar device. Alternatively, the string 140 may be permanently attached to the insertion member 130. For example, the device 100 may be molded so that one end of the string 140 is molded into the insertion member 130.

As shown in FIG. 7, in the medical device 100, the bore 150 has an opening 610 at the distal end 122 of the arm 120 and an opening 600 on the shield 110 side opposite to the arm 120. As such, it can have a bore 150 extending longitudinally through the arm 120 and the shield 110. As shown in FIG. 3, the bore 150 may extend through the insertion member 130 so that the opening 600 on the shield 110 side opposite to the arm 120 is located at the end of the insertion member 130. In this way, the bore 150 may extend completely through the device 100 and extend substantially linearly. As shown in FIG. 14, when the device 100 is in place during use, the bore 150 forms a passage through the device 100 between the vaginal cavity 710 and the cervical 730 or uterine cavity 740. As shown in FIGS. 12-14, to use the device 100, a catheter 160 is inserted into the opening 600 of the bore 150 on the shield 110 side opposite the arm 120, pushed through the bore 150, and the arm 120. It may be passed through the opening 610 of the distal end 122. The bore 150 is large enough in diameter to allow the catheter 160 to pass through the bore. Thus, the medical device 100 can act as a guide or cannula to facilitate passage of the catheter 160, where the catheter 160 can be used as an insemination catheter for introducing a sperm sample into the patient's reproductive system. .. In this way, the medical device 100 can be used to introduce sperm samples into the cervix 730 or uterine cavity 740, as needed, during intracervical or intrauterine artificial insemination procedures. The catheter 160 can then be removed, leaving the device 100 in place.

The device 100 may further include a valve 190 located at the distal end 122 of the arm 120. The valve 190 can operate between the open state as shown in FIGS. 10 and 11 and the closed state as shown in FIGS. 1 and 2. The valve 190 includes a plurality of elastic flaps 195 integrally attached to the distal end 122 of the arm 120. When the valve 190 is in the closed state, the elastic flaps 195 are elastically urged against each other inward toward the center of the bore 150. The elastic flap 195 is sized and shaped to cover the opening 610 of the distal end 122 of the arm 120 to form a substantially liquidtight seal when the valve 190 is in the closed state. The term "elastomer" as used herein is flexible and / or extensible so that a material can flex and / or stretch and then return to its original state. Refers to any material. In this case, the original state is the closed state of the valve. As best shown in FIG. 2, preferably the valve 190 has three elastic flaps 195, each having a substantially triangular shape. When the valve 190 is in the closed state, the three triangular flaps 195 fit together to form a substantially liquidtight seal, preventing liquid from leaking through the valve 190. FIG. 9 shows a bottom view of the device 100 when the valve 190 is in the closed state.

During the artificial insemination procedure, the insemination catheter 160 may pass through the entire device 100. As shown in FIGS. 12 and 13, the catheter 160 is pushed through the opening 610 of the distal end 122 of the arm 120 and is valved by the catheter 160, as best shown in FIGS. 11 and 12. The elastic flap 195 of 190 is pushed outward, thereby moving the valve 190 in the open state. In this way, the catheter 160 can pass through the medical device 100, feed the sperm sample into the patient's cervical 730 or uterine cavity 740, and then remove the device 100 from the medical device while leaving it in place. Once the sperm sample has been delivered, the insemination catheter 160 can be completely or partially removed from the medical device 100. When the catheter 160 is removed, the elastic flaps 195 of the valve 190 move to their original state, thereby moving the valve 190 to the closed state. When the valve 190 is in the closed state, the sperm sample is prevented from exiting the cervical 730 through the bore 150, which prevents it from regurgitating through the medical device 100 into the vaginal cavity 710. Thus, the medical device 100 is both as a cannula for an insemination device and as a cervical plug that prevents sperm introduced into the patient's cervical 730 or uterine cavity 740 from leaking into the patient's vaginal cavity 710. , Can work effectively.

The present disclosure can also cover artificial insemination methods. As shown in FIG. 14, the medical device 100 can be configured to function as a cervical plug. Depending on whether intracervical insemination or intrauterine insemination is utilized, sperm samples can first be introduced into the patient's cervical 730 or uterine cavity 740. The sperm sample may be artificially introduced into the patient's reproductive system, or instead the sample may be introduced into the patient's reproductive system during sexual intercourse. As shown in FIG. 14, after introducing the sperm sample into the cervix 730 or cervix 740, the medical device 100 has an arm 120 extending into the patient's cervix 730 and a shield 110 extending into the patient's cervical external cervix It may be inserted into the patient's cervix 730 so as to substantially cover the 720. As mentioned above, FIG. 14 illustrates the device 100 used with the syringe 170 and the catheter 160, but by inserting the device 100 in the position shown in FIG. 14 and leaving the device in place, the device 100 Can be used as a cervical plug without the syringe 170 and catheter 160. When used only as a cervical plug, the bore 150 extending through the device 100 and the valve 190 located at the distal end 122 of the arm 120 may be of any feature. When the device 100 is placed in place with the arm 120 inserted into the cervix 730 and the shield 110 covering the external cervix 720, the shield 110 and arm 120 of the medical device 100 have sperm samples in the cervix 730. Prevents leakage into the patient's vaginal cavity 710. The circumferential bulge 180 of the arm 120 (or instead, the circumferential ridge 205, the circumferential barb 215 or the longitudinal ridge 175, shown in FIGS. 15-17) is the arm 120 of the device 100. Provides resistance to being removed from the cervical 730, thereby helping to ensure that the device 100 stays in place during use, as shown in FIG. In this way, the medical device 100 can enhance the effectiveness of intracervical or intrauterine artificial insemination by reducing the loss of sperm samples. After an appropriate period, the device 100 can be removed.

The medical device 100 used in the planned manner, wherein the medical device 100 is configured to function as a cervical plug, has structural features consistent with the embodiments described in detail above. It is understood that it may have some or all. Further, it is understood that the methods of the present disclosure are intended to be methodologies that require 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 through the insertion member 130 using forceps or a similar instrument. Alternatively, the device may be removed by pulling the device 100 through the vaginal cavity 710 via the string 140.

As shown in FIGS. 12-14, the medical device 100 may be configured to further function as a guide or cannula for a catheter. The medical device 100 includes a bore 150 extending through it, a valve 190 located at the distal end 122 of the arm 120, and an arbitrary circumferential bulge 180 (or) located along the length 185 of the arm 120. Instead, it has a circumferential ridge 205, a circumferential return 215, or a longitudinal ridge 175), as shown in FIGS. 15-17. The medical device 100 may be inserted into the patient's cervix 730 such that the arm 120 extends into the patient's cervix 730 and the shield 110 substantially covers the external cervix 720 of the patient's cervix. .. The catheter 160 can be inserted into the bore 150 through an opening 600 on the shield 110 side opposite the arm 120. When inserting the catheter 160 into the bore 150, the catheter 160 can be pushed through the opening 610 of the distal end 122 of the arm 120, which is required for a particular insemination procedure, as shown in FIG. As long as the valve 190 can be forcibly opened. A sperm sample can then be introduced into the patient's cervical 730 or uterine cavity 740 via the catheter 160.

The catheter 160 may be partially inserted into the bore 150 before the device 100 is inserted into the cervical 730, and after the device 100 is inserted, the catheter 160 is inserted into the distal end 122 of the arm 120 opening 610. And may be pushed through the valve 190. Alternatively, the catheter 160 may be inserted into the bore 150 and passed through the valve 190 after inserting the medical device 100, or the catheter 160 may be armed prior to inserting the device 100, as shown in FIGS. 12 and 13. The catheter 160 may be inserted into the bore 150 so as to push through the opening 610 and valve 190 of the distal end 122 of the 120.

As shown in FIG. 2, the elastic flaps 195 of the valve 190 are elastically urged to each other when the valve 190 is in the closed state. When the catheter 160 is inserted into the bore 150, the catheter 160 may be pushed through the opening 610 of the distal end 122 of the arm 120 so that the catheter 160 pushes the elastic flap 195 outward, thereby opening the valve 190. You may move to. Before inserting the device 100 into the cervical 730, the catheter 160 may be partially inserted into the bore 150 so that the valve 190 remains closed. Then, after inserting the medical device 100 into the cervical canal 730, the catheter 160 may be pushed through the opening 610 of the distal end 122 of the arm 120 so that the valve 190 moves in the open state.

Once the device 100 is in place, the arm 120 is inserted into the cervix 730, the shield 110 covers the external cervix 720, and the catheter 160 is inserted into the bore 150 and through the valve 190. Depending on whether intracervical insemination or intrauterine insemination is utilized, sperm samples can be introduced into the patient's cervical 730 or uterine cavity 740 via the catheter 160. As shown in FIG. 14, the sperm sample can be introduced into the cervical 730 or uterine cavity 740 by injecting the sperm sample through the catheter 160 using a syringe 170. After introduction of the sperm sample, the catheter 160 can be removed, leaving the device 100 in place. After removing the catheter 160, the elastically urged elastic flaps 195 of the valve 190 return to their original state, as shown in FIG. 2, when the valve 190 is in the closed state, thereby. Prevents sperm samples from flowing back through valve 190 and bore 150. With the medical device 100 in place, the shield 110 and arm 120 of the device 100 prevent sperm samples from leaking from the cervix 730 around the device 100 and into the patient's vaginal cavity 710, thereby. Increase the effectiveness of intracervical or intrauterine artificial insemination by reducing sperm sample loss. The circumferential bulge 180 of the arm 120 (or instead, the circumferential ridge 205, the circumferential barb 215 or the longitudinal ridge 175, shown in FIGS. 15-17) puts the device 100 in place. It can be left attached to help prevent leaks around the device 100.

After an appropriate period, the device 100 can be removed. The device 100 can be removed via the insertion member 130 using forceps or a similar instrument. Alternatively, the device may be removed by pulling the device 100 through the vaginal cavity 710 via the string 140.

To ensure that the sperm sample is introduced in place, the catheter 160 is placed with one end of the catheter 160 in the cervical 730 or in the uterine cavity 740 before the sperm sample is passed through the catheter 160. As such, it may extend through the entire medical device 100. FIG. 14 shows a catheter 160 extending through the entire device 100 into the patient's uterine cavity 740 and a syringe 170 for injecting a sample. Alternatively, the sperm sample may be guided through the bore 150 of the medical device 100 using a syringe 170 or similar instrument without the help of a catheter 160.

The overall size or individual dimensions of the parts of the device 100 according to the present application may be modified to accommodate different patients. As an example, the device 100 can have the following dimensions: The shield 110 may be circular with a diameter of 22.50 mm. The arm 120 may have a cylindrical shape with a diameter of 3.40 mm. The circumferential bulge 180 (or instead, the circumferential ridge 205, the circumferential barb 215 or the longitudinal ridge 175, shown in FIGS. 15-17) has a maximum diameter of 4.46 mm. It may be present and may extend along the length 185 of the 3.18 mm arm 120. These dimensions are exemplary only and are not intended to be limiting.

The disclosure may also cover artificial insemination kits that can be used by healthcare professionals or home-based patients. The insemination kit is a medical device 100 having the features described herein that can be attached to a medical device 100; catheter 160; and catheter 160 that acts as both a cervical plug and a guide or cannula for the catheter. Includes a syringe 170 configured to allow. The catheter 160 and syringe 170 of the kit may optionally be permanently attached to each other or integrally molded as a single part.

The artificial insemination kit may be supplied to the user together with pre-assembled parts, such as by inserting the catheter 160 into the bore 150 of the medical device 100 and attaching the syringe 170 to one end of the catheter 160. The catheter 160 may be partially inserted into the bore 150 of the medical device 100 so that the valve 190 is closed when the user receives it. Instead, the catheter 160 extends within the bore 150 of the medical device 100 so that the catheter 160 extends through the opening 610 of the distal end 122 of the arm 120 and the valve 190 is open when the user receives it. It may be inserted in.

It should be understood that the versions of the invention may be in different forms and embodiments. Further, it will be appreciated by those skilled in the art that these various forms and embodiments will be recognized as included within the scope of the invention disclosed herein.

Claims (30)

It ’s a medical device,
A shield configured to cover the opening,
An arm having a proximal end attached to the shield and a distal end configured to be inserted into the opening so that the shield and the arm secure the medical device in place during use. Consists of, including the arm and
The arm is a medical device having a plurality of longitudinal ridges arranged along the length of the arm between the midpoint of the arm and the distal end of the arm. 1. A bore further comprising a bore extending longitudinally through the arm and the shield so that the bore has an opening at the distal end of the arm and the shield side opposite to the arm. The medical device described in. Further including a valve located at the distal end of the arm, the valve is capable of operating between open and closed states, the valve being integrally attached to the distal end of the arm. When the valve is in the closed state, the elastic flaps are elastically urged to each other, and each of the elastic flaps has the valve in the closed state. The medical device of claim 1, which is sized and shaped such that it sometimes covers the opening at the distal end of the arm to form a substantially liquidtight seal. The medical device of claim 3, wherein the valve has three elastic flaps. The medical device of claim 2, wherein the bore is of a diameter sufficient to allow the catheter to pass through the bore. The shield has a concave shape and has a concave shape.
The medical device of claim 1, wherein the proximal end of the arm is attached to the concave side of the shield. Further including an insertion member attached to the shield
The medical device of claim 1, wherein the insertion member is attached to the opposite side of the shield, similar to the proximal end of the arm. The insertion member has an annular cavity and has an annular cavity.
The medical device of claim 7, wherein the insertion member has an outer opening that provides external access to the annular cavity. The medical device of claim 1, wherein the shield is flexible. The medical device of claim 1, wherein the shield is translucent. It ’s a medical device,
A shield configured to cover the opening,
An arm having a proximal end fixed to the shield and a distal end configured to be inserted into the opening, the shield and said arm to secure the medical device in place during use. Consists of, including the arm and
The arm is a medical device having a plurality of circumferential ridges arranged along the length of the arm between the midpoint of the arm and the distal end of the arm. 11. A claim further comprises a bore extending longitudinally through the arm and the shield such that the bore has an opening at the distal end of the arm and the shield side opposite to the arm. The medical device described in. Further including a valve located at the distal end of the arm, the valve is capable of operating between open and closed states, the valve being integrally attached to the distal end of the arm. When the valve is in the closed state, the elastic flaps are elastically urged to each other, and each of the elastic flaps has the valve in the closed state. 11. The medical device of claim 11, which is sized and shaped such that it sometimes covers the opening at the distal end of the arm to form a substantially liquidtight seal. 13. The medical device of claim 13, wherein the valve has three elastic flaps. The medical device of claim 12, wherein the bore is of a diameter sufficient to allow the catheter to pass through the bore. The shield has a concave shape and has a concave shape.
11. The medical device of claim 11, wherein the proximal end of the arm is attached to the concave side of the shield. Further including an insertion member attached to the shield
The medical device of claim 11, wherein the insertion member is attached to the opposite side of the shield, similar to the proximal end of the arm. The insertion member has an annular cavity and has an annular cavity.
17. The medical device of claim 17, wherein the insertion member has an outer opening that provides external access to the annular cavity. 11. The medical device of claim 11, wherein the shield is flexible. The medical device of claim 11, wherein the shield is translucent. It ’s a medical device,
A shield configured to cover the opening,
An arm having a proximal end attached to the shield and a distal end configured to be inserted into the opening so that the shield and the arm secure the medical device in place during use. Consists of, including the arm and
The arm is a medical device having a plurality of circumferential barbs arranged along the length of the arm between the midpoint of the arm and the distal end of the arm. 21. Claim 21 further comprises a bore extending longitudinally through the arm and the shield such that the bore has an opening at the distal end of the arm and the shield side opposite to the arm. The medical device described in. Further including a valve located at the distal end of the arm, the valve is capable of operating between open and closed states, the valve being integrally attached to the distal end of the arm. When the valve is in the closed state, the elastic flaps are elastically urged to each other, and each of the elastic flaps has the valve in the closed state. 21. The medical device of claim 21, which is sized and shaped such that it covers the opening at the distal end of the arm to form a substantially liquidtight seal. 23. The medical device of claim 23, wherein the valve has three elastic flaps. 22. The medical device of claim 22, wherein the bore is of a diameter sufficient to allow the catheter to pass through the bore. The shield has a concave shape and has a concave shape.
21. The medical device of claim 21, wherein the proximal end of the arm is attached to the concave side of the shield. Further including an insertion member attached to the shield
21. The medical device of claim 21, wherein the insertion member is attached to the opposite side of the shield, similar to the proximal end of the arm. The insertion member has an annular cavity and has an annular cavity.
27. The medical device of claim 27, wherein the insertion member has an outer opening that provides external access to the annular cavity. 21. The medical device of claim 21, wherein the shield is flexible. The medical device of claim 21, wherein the shield is translucent.

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