阅读说明：本技术 用于人工授精的装置和方法 (Device and method for artificial insemination ) 是由 K·J·普莱萨拉 P·T·福克纳 于 2018-11-29 设计创作，主要内容包括：医疗装置具有护罩和臂,该臂在一端固定到护罩并且从护罩向外延伸。臂插入患者的子宫颈管中,并且护罩覆盖患者的外部口。通过在授精前将医疗装置插入患者的子宫颈管中,并在授精后将装置留在原位,可以建立物理屏障,其将精液样本保持在子宫颈管内,并防止从子宫颈管泄漏回到阴道腔。该装置可具有延伸穿过该装置的孔,以使导管穿过。该孔具有阀,以允许导管通过并防止精液回流。臂可具有多个纵向脊部、周向脊部或周向倒钩,以帮助将装置保持就位。(The medical device has a shield and an arm secured at one end to the shield and extending outwardly therefrom. The arm is inserted into a cervical canal of a patient, and the shield covers an external orifice of the patient. By inserting the medical device into the patient's cervical canal prior to insemination and leaving the device in place after insemination, a physical barrier can be established that retains the semen sample within the cervical canal and prevents leakage from the cervical canal back into the vaginal cavity. The device may have an aperture extending through the device to allow passage of a catheter therethrough. The hole has a valve to allow passage of the catheter and prevent backflow of semen. The arms may have a plurality of longitudinal ridges, circumferential ridges or circumferential barbs to help hold the device in place.)

1. A medical device, comprising:

a shroud configured to cover the aperture;

an arm having a proximal end secured to the shield and a distal end configured to be inserted into an aperture, wherein the shield and the arm are configured to secure the medical device in place during use,

wherein the arm has a plurality of longitudinal ridges positioned along a length of the arm between a halfway point of the arm and a distal end of the arm.

2. The medical device of claim 1, further comprising a bore extending longitudinally through the arm and through the shield such that the bore has an opening at a distal end of the arm and an opening on a side of the shield opposite the arm.

3. The medical device of claim 1, further comprising 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 comprises a plurality of elastomeric flaps integrally attached to the distal end of the arm, wherein the elastomeric flaps are resiliently biased against each other when the valve is in the closed position, wherein each of the elastomeric flaps is sized and shaped to form a substantially fluid-tight seal over an opening at the distal end of the arm when the valve is in the closed position.

4. The medical device of claim 3, wherein the valve has three elastomeric flaps.

5. The medical device of claim 2, wherein the hole has a sufficient diameter to allow a catheter to pass therethrough.

6. The medical device of claim 1, wherein the shield has a concave shape, wherein the proximal end of the arm is secured to the concave side of the shield.

7. The medical device of claim 1, further comprising an insertion member secured to the shield, wherein the insertion member is secured to a side of the shield opposite the proximal ends of the arms.

8. The medical device of claim 7, wherein the insert member has an annular cavity, and wherein the insert member has an external opening that provides external access to the annular cavity.

9. The medical device of claim 1, wherein the shield is flexible.

10. The medical device of claim 1, wherein the shield is translucent.

11. A medical device, comprising:

a shroud configured to cover the aperture; and

an arm having a proximal end secured to the shield and a distal end configured to be inserted into an aperture, wherein the shield and the arm are configured to secure the medical device in place during use,

wherein the arm has a plurality of circumferential ridges positioned along a length of the arm between a halfway point of the arm and a distal end of the arm.

12. The medical device of claim 11, further comprising a bore extending longitudinally through the arm and through the shield such that the bore has an opening at a distal end of the arm and an opening at a side of the shield opposite the arm.

13. The medical device of claim 11, further comprising 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 comprises a plurality of elastomeric flaps integrally attached to the distal end of the arm, wherein the elastomeric flaps are resiliently biased against each other when the valve is in the closed position, wherein each of the elastomeric flaps is sized and shaped to form a substantially fluid-tight seal over the opening of the distal end of the arm when the valve is in the closed position.

14. The medical device of claim 13, wherein the valve has three elastomeric flaps.

15. The medical device of claim 12, wherein the hole has a sufficient diameter to allow a catheter to pass therethrough.

16. The medical device of claim 11, wherein the shield has a concave shape with the proximal end of the arm secured to the concave side of the shield.

17. The medical device of claim 11, further comprising an insertion member secured to the shield, wherein the insertion member is secured to a side of the shield opposite the proximal ends of the arms.

18. The medical device of claim 17, wherein the insert member has an annular cavity, and wherein the insert member has an external opening that provides external access to the annular cavity.

19. The medical device of claim 11, wherein the shield is flexible.

20. The medical device of claim 11, wherein the shield is translucent.

21. A medical device, comprising:

a shroud configured to cover the aperture; and

an arm having a proximal end secured to the shield and a distal end configured to be inserted into an aperture, wherein the shield and the arm are configured to secure the medical device in place during use,

wherein the arm has a plurality of circumferential barbs positioned along the length of the arm between a halfway point of the arm and the distal end of the arm.

22. The medical device of claim 21, further comprising a bore extending longitudinally through the arm and through the shield such that the bore has an opening at a distal end of the arm and an opening at a side of the shield opposite the arm.

23. The medical device of claim 21, further comprising 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 comprises a plurality of elastomeric flaps integrally attached to the distal end of the arm, wherein the elastomeric flaps are resiliently biased against each other when the valve is in the closed position, wherein each of the elastomeric flaps is sized and shaped to form a substantially fluid-tight seal over the opening of the distal end of the arm when the valve is in the closed position.

24. The medical device of claim 23, wherein the valve has three elastomeric flaps.

25. The medical device of claim 22, wherein the hole has a sufficient diameter to allow a catheter to pass therethrough.

26. The medical device of claim 21, wherein the shield has a concave shape with the proximal end of the arm secured to the concave side of the shield.

27. The medical device of claim 21, further comprising an insertion member secured to the shield, wherein the insertion member is secured to a side of the shield opposite the proximal ends of the arms.

28. The medical device of claim 27, wherein the insert member has an annular cavity, and wherein the insert member has an external opening that provides external access to the annular cavity.

29. The medical device of claim 21, wherein the shield is flexible.

30. The medical device of claim 21, wherein the shield is translucent.

Technical Field

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

Background

Artificial insemination aims at placing semen into the reproductive system of a patient to facilitate pregnancy. Artificial insemination is often performed when semen is difficult or impossible to access to the reproductive system of a patient during sexual intercourse. Intracervical insemination where a semen sample is inserted into the patient's cervical canal and intrauterine insemination where a semen sample is inserted into the patient's uterine cavity are the two most common artificial insemination procedures in use today. Typically, during such procedures, the vaginal wall of the patient is held open by a medical device, such as an opener. A semen sample is then inserted into the patient's cervical canal or uterine cavity, typically through a catheter-injector assembly, depending on the procedure being performed. After insertion, the semen is left to the reproductive system of the patient for acceptance. However, due to reflux caused by uterine contractions, a portion of the semen sample is often lost due to leakage from the cervical canal into the vaginal cavity of the patient.

Some known devices, such as vaginal sponges and cervical caps, attempt to address the problem of leakage by creating a barrier between the patient's cervical canal and vaginal cavity after introduction of a semen sample. However, these devices merely attempt to occlude the upper region of the patient's vaginal canal near the patient's cervical canal and may not be effective in retaining the semen sample within the cervical canal. Thus, the use of vaginal sponges and cervical caps in artificial insemination may not be effective in preventing reduced efficacy of the insemination procedure due to reflux caused by uterine contractions. These devices may also cause patient discomfort when inserted and removed.

The device disclosed in application PCT/US2017/064028 filed by the present applicant attempts to solve the above-mentioned problems. The device is designed to be inserted into the cervical canal and held in place for a period of time during which insemination occurs while semen is prevented from leaking from the cervical canal. The device may also allow a catheter to be inserted through a hole extending through the device so that semen may be introduced into the cervical canal or the uterine cavity when the device is in place in the patient's cervical canal. However, during periods of time when the device is intended to remain in place to allow insemination to occur, the device may sometimes fall out of the cervical canal, or a small amount of leakage may occur through the aperture extending through the device.

Accordingly, there is a need in the art for a device for improving the efficacy of artificial insemination procedures and methods of using the same. Furthermore, there is a need in the art for a device for increasing the efficacy of an artificial insemination procedure without causing significant patient discomfort when inserting and removing the device.

Disclosure of Invention

The present disclosure provides a device and a method for artificial insemination according to the independent claims. Preferred embodiments of the invention are reflected in the dependent claims. The claimed invention may be better understood in view of the embodiments described and illustrated in this disclosure, i.e., in the present specification and drawings. In general, this disclosure reflects preferred embodiments of the invention. However, the careful reader will note that certain aspects of the disclosed embodiments are beyond the scope of the claims. In view of the fact that the disclosed embodiments do not depart from the scope of the claims, they are intended to be included therein as supplementary background information and not as a limitation on the invention itself.

In one aspect of the present disclosure, a medical device for use during artificial insemination to prevent leakage of a semen sample from a patient's cervical canal is provided. The medical device may be configured for use as a cervical plug. The medical device has a shield configured to cover the aperture and an arm having a proximal end and a distal end. The proximal end is fixed to the shield and the distal end is configured to be inserted into the aperture. For example, the shield may be configured to cover an aperture ("external ports") between the patient's cervical canal and the vaginal canal, and the arm may be configured to be inserted into the patient's cervical canal. Since the arm is inserted into the cervical canal and the shield covers the external orifice, the medical device can effectively hold itself in place during use. The arms may optionally have circumferential protrusions, circumferential ridges, circumferential barbs, or longitudinal ridges positioned near the distal ends of the arms to help hold the device in place if the arms are inserted into the cervical canal during use.

By inserting the medical device into the vaginal cavity and into the patient's cervical canal such that the arms are inserted into the patient's cervical canal and the shield covers the patient's external port, 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 manner, after introducing a semen sample into a patient's cervical canal or uterine cavity, the medical device may be used as a cervical plug to prevent leakage of the semen sample into the vaginal cavity, thereby preventing loss of the semen sample. Thus, the present disclosure may 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 a medical device is inserted into the patient's cervical canal in the manner described above.

In addition, the medical device may be configured to function as both a cervical plug and a guide or cannula for a catheter. The medical device has a shield and an arm having a proximal end and a distal end. The proximal end is secured to the shield and the distal end is configured to be inserted into a cervical canal of a patient. The medical device may also have a bore extending longitudinally through the arm and through the shield such that the bore has an opening at the distal end of the arm and an opening at a side of the shield opposite the arm. A valve operable between an open position and a closed position may be provided at the distal end of the arm. The valve includes a plurality of elastomeric valve flaps integrally attached to the distal end of the arm. The elastomeric valve flaps are resiliently biased inwardly toward the center of the orifice and abut one another when the valve is in the closed position. The elastomeric flap is sized and shaped to form a substantially fluid-tight 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 may be inserted into the opening of the bore on the opposite side of the shield from 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 conduit forces the elastomeric flap of the valve outward, moving the valve to the open position. In this manner, the catheter may be passed through the medical device, delivering a semen sample to the patient's cervical canal or uterine cavity, and then removed from the medical device while leaving the device in place. When the catheter is removed, the valve moves to a closed position so that the semen sample does not leak back into the vaginal cavity through the medical device. Thus, the present disclosure may also relate to a method for artificial insemination, wherein a medical device is inserted into a cervical canal of a patient in the above-described manner, a catheter is inserted into a bore of the medical device, a semen sample is introduced into the cervical canal or a uterine cavity of the patient through the catheter, and the catheter is then removed, leaving the medical device in place.

To insert and remove the medical device, the medical device may have an insertion member secured to the shroud on a side of the shroud opposite the arms. The insertion member may have a cord secured 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 the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the disclosure. The foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the disclosure.

Drawings

These and other features, aspects, and advantages of the present disclosure will become better understood with regard to the following description, appended claims, and accompanying drawings where:

fig. 1 shows a perspective view of a device according to the present disclosure.

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

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

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

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

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

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

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

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

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

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

Fig. 12 shows a perspective view of a device according to the present disclosure with a catheter inserted through the device.

Fig. 13 shows a perspective view of a device according to the present disclosure with a catheter inserted through the device.

Figure 14 shows a device according to the invention inserted into the reproductive system of a patient for use with a catheter and syringe.

Fig. 15 shows a profile view (15A) and a cross-sectional view (15B) of a device according to the present disclosure.

Fig. 16 shows a profile view (16A) and a cross-sectional view (16B) of a device according to the present disclosure.

Fig. 17 shows a profile view (17A) and a cross-sectional view (17B) of a device according to the present disclosure.

Detailed Description

In the foregoing summary and in this detailed description, 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 being optional, for example, by using the verb "may" or using parentheses. For the sake of brevity and readability, this disclosure does not explicitly recite each permutation that may be obtained by selecting from the set of selectable features. However, the present disclosure is to be construed as specifically disclosing all such permutations. For example, a system described as having three optional features may be implemented in seven different ways, i.e., 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 is to be understood that the disclosure in this specification includes all possible combinations of these specific features. For example, where a particular 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 in general in the context of the claimed invention.

The term "comprising" and its grammatical equivalents are used herein to mean that there are optionally other components, elements, steps, etc. For example, an article of manufacture that "includes" components A, B and C may contain only components A, B and C, or may contain not only components A, B and C, but one or more other components as well.

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

Turning now to the drawings, fig. 1-17 illustrate an embodiment of a medical device for retaining material in an orifice and preventing leakage of material from the orifice. The medical device 100 may be designed to function as a cervical plug for holding semen in the patient's cervical tube 730 and preventing semen from leaking from the patient's cervical tube 730 after a semen sample is introduced into the patient's cervical tube 730 or uterine cavity 740. The medical device 100 has a shield (shield)110 configured to cover an aperture and an arm 120 configured to be inserted into the aperture, wherein one end of the arm 120 is fixed to the shield 110. The shield 110 may be configured to cover the external port 720 of the patient, and the arm 120 may be configured to be inserted into the cervical canal 730 of the patient, as shown in fig. 14. By inserting the medical device 100 through the vaginal cavity 710 and into the patient's cervical tube 730 such that the arms 120 are inserted into the patient's cervical tube 730 and the shield 110 covers the patient's external port 720, the medical device 100 can establish a physical barrier between the patient's cervical tube 730 and the vaginal cavity 710. In this manner, the medical device 100 may be used as a cervical plug that prevents a semen sample from leaking from the cervical tube 730 into the vaginal cavity 710 after the semen sample has been introduced into the patient's cervical tube 730 or uterine cavity 740.

It is understood that the medical device may be used to cover and occlude 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 fig. 1-5, the medical device 100 includes a shield 110 and an arm 120 secured to the shield 110. To accommodate the contour of the cervical portion around the external port 720 of the patient, the shield 110 may have a concave shape with a concave side and a convex side, wherein when the medical device 100 is in place, the concave side of the shield 110 faces the external port 720 and the convex side faces the vaginal cavity 710 as shown in fig. 14. The shield 110 may be shaped such that the concave side of the shield 110 fits flush against the external os 720 and the cervical tissue surrounding the patient's external os. The curvature of the shield 110 may be adjusted for different patients. The arm 120 may be secured to the concave side of the shroud 110, as shown in fig. 1. In addition, the shield 110 may have a generally circular shape, and the arm 120 may be fixed to the shield 110 generally at the center of the shield, as shown in fig. 1. Alternatively, the shield may have another shape, such as an oval, suitable for covering the external orifice 720 of the patient.

The shield 110 may be shaped and sized such that the shield 110 may cover the exterior orifice 720 of an infertile, primordial, or prolific female. To minimize the pain or discomfort experienced by the patient when inserting or removing the medical device 100 from the patient, the shield 110 may be made of a somewhat flexible material such that the material may be deformed by the pressure applied by the user of the device, but returns to its original shape after the pressure is removed. Alternatively, the shroud 110 may be made of a substantially rigid or semi-rigid material. Additionally, the shield 110 may be made of any material that is at least partially translucent or transparent, which may assist a user in inserting the device into the cervical canal.

Alternatively, the shield 110 may be made of an opaque material. The shield 110 may comprise medical grade silicone rubber. However, the shroud may be made of any suitable material, including but not limited to plastic, glass, ceramic, metal, any type of rubber, or any combination thereof.

The arms 120 of the medical device 100 are configured to be inserted into the aperture covered by the shield 110 when the medical device 100 is in 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 aperture. The arm 120 may be permanently secured to the shroud 110. For example, the arm 120 and the shroud 110 may be molded as a unitary piece of material.

Alternatively, the arm 120 may be secured to the shroud 110 with an adhesive. To facilitate entry and exit of the arm 120 into and out of the patient's cervical canal 730, the arm 120 may have a generally cylindrical shape.

The arms 120 may have circumferential protrusions 180 to help hold the device 100 in place if the arms 120 are inserted into the cervical canal 730 during use. The projection 180 is positioned along the length 185 of the arm 120 between the halfway point of the arm (halfway between the proximal end 121 and the distal end 122) and the distal end 122 of the arm, and may preferably be positioned closer to the distal end 122 of the arm 120 than the halfway point of the arm 120, as shown in fig. 1. Once the arm 120 is inserted into the cervical tube 730, as shown in fig. 14, the larger diameter of the circumferential protrusion 180 provides resistance to removal of the arm 120 from the cervical tube 730, thereby helping to hold the device 100 in place for a period of time after semen is introduced into the cervical tube 730 or the uterine cavity 740, such that the device 100 prevents semen from leaking from the cervical tube 730 into the vaginal cavity 710. As shown in fig. 4, the protrusions 180 preferably have a contoured surface to prevent discomfort when inserting the arm 120 into the cervical canal 730.

In addition to circumferential protrusion 180, additional alternative embodiments that help provide resistance to removal of arm 120 are shown in fig. 15-17. As shown in fig. 15A and 15B, the arm 120 may have a plurality of longitudinal ridges 175 to hold the device 100 in place with the arm 120 inserted into the cervical canal 730 during use. The ridge 175 is located along the length 185 of the arm 120 between the halfway point of the arm (halfway between the proximal end 121 and the distal end 122) and the distal end 122 of the arm, and may preferably be located closer to the distal end 122 of the arm 120 than the halfway point of the arm 120, similar to the location of the circumferential projection 180 in fig. 1. Once the arms 120 are inserted into the cervical tube 730, as shown in fig. 14, the larger diameter of the longitudinal ridges 175 provides resistance to removal of the arms 120 from the cervical tube 730, thereby helping to hold the device 100 in place for a period of time after semen is introduced into the cervical tube 730 or the uterine cavity 740, such that the device 100 prevents semen from leaking from the cervical tube 730 into the vaginal cavity 710. As shown in fig. 15A and 15B, the longitudinal ridge 175 preferably has a convex outer surface to prevent discomfort when inserting the arm 120 into the cervical canal 730.

Alternatively, as shown in fig. 16A and 16B, the arm 120 may have a plurality of circumferential ridges 205 to hold the device 100 in place with the arm 120 inserted into the cervical canal 730 during use. The circumferential ridge 205 is positioned along the length 185 of the arm 120 between the halfway point of the arm (halfway between the proximal end 121 and the distal end 122) and the distal end 122 of the arm, and may preferably be positioned closer to the distal end 122 of the arm 120 than the halfway point of the arm 120, similar to where the circumferential projection 180 in fig. 1 is located. Once the arms 120 are inserted into the cervical tube 730, as shown in fig. 14, the larger diameter of the circumferential ridge 205 provides resistance to removal of the arms 120 from the cervical tube 730, thereby helping to hold the device 100 in place for a period of time after semen is introduced into the cervical tube 730 or the uterine cavity 740, such that the device 100 prevents semen from leaking from the cervical tube 730 into the vaginal cavity 710. As shown in fig. 16A and 16B, the circumferential ridges 205 together preferably form an outer surface having a contoured profile to prevent discomfort when inserting the arm 120 into the cervical canal 730.

Alternatively, as shown in fig. 17A and 17B, the arms 120 may have a plurality of circumferential barbs 215 to hold the device 100 in place with the arms 120 inserted into the cervical canal 730 during use. The barb 215 is positioned along the length 185 of the arm 120 between the halfway point of the arm (halfway between the proximal end 121 and the distal end 122) and the distal end 122 of the arm, and may preferably be positioned closer to the distal end 122 of the arm 120 than the halfway point of the arm 120, similar to the location of the circumferential projection 180 in fig. 1. Preferably, but not necessarily, the diameter of each circumferential barb 215 will increase as the barb 215 approaches the proximal end of the arm 120. Once the arms 120 are inserted into the cervical tube 730, as shown in fig. 14, the increasing diameter and upward angled shape of the barbs 215 provide resistance to removal of the arms 120 from the cervical tube 730, thereby helping to hold the device 100 in place for a period of time after semen is introduced into the cervical tube 730 or the uterine cavity 740, such that the device 100 prevents semen from leaking from the cervical tube 730 into the vaginal cavity 710. The shape of the circumferential barbs 215 allows them to contract inwardly during insertion of the arms 120 into the cervical canal 730 to prevent discomfort.

The arms 120 are sufficiently rigid to insert the arms 120 into the patient's cervical canal 730, but the arms 120 may have a certain amount of flexibility in order to minimize pain or discomfort experienced by the patient when inserting or removing 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 comprise medical grade silicone rubber. However, the arms may be made of any suitable material, including but not limited to plastic, glass, ceramic, metal, any type of rubber, or any combination thereof.

The shield 110 and the arms 120 may be configured to secure the medical device 100 in place during use, as shown in fig. 14, such that the shield 110 remains covering the aperture until the medical device 100 is removed by the user. As 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 an orifice and the shield 110 of the medical device 100 covers the orifice. Figure 14 shows the device 100 used with a syringe 170 and a catheter 160 for introducing semen into the reproductive system. However, as described below, the syringe 170 and catheter 160 are removed after semen is introduced, and the device 100 remains in place for a period of time in the position shown in fig. 14 to prevent semen from leaking into the vaginal cavity 710. The proximal end 121 of the arm 120 may have a diameter of sufficient size such that a substantially fluid tight seal is formed between the patient's cervical canal 730 and the vaginal cavity 710 when the proximal end 121 of the arm 120 is positioned in the patient's cervical canal 730 after insertion of the device. The fluid-tight seal formed by insertion of the arm 120 into the cervical tube 730 may facilitate a slight 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 in place, the shroud 110 may substantially cover the external port 720 and fit flush against tissue surrounding the external port 720, such that the shroud 110, together with the arms 120, may prevent the semen sample from leaking around the device 100 and into the vaginal cavity 710.

As shown in fig. 3-6, the medical device 100 may also include an insert member 130 secured to the shield 110. Insertion member 130 may serve as an aid to inserting medical device 100 into cervical canal 730 and removing the device from the cervical canal. The insert member 130 is secured to the side of the shield 110 opposite the proximal ends 121 of the arms 120. The insert member 130 may be permanently secured to the shroud 110. For example, the medical device 100 may be molded as a unitary piece of material that includes the shield 110, the arm 120, and the insert member 130. Alternatively, insert member 130 may be secured to shroud 110 with an adhesive. As shown in fig. 4 and 5, the insert member 130 may be fixed to the shield 110 such that the insert member 130 forms a substantially straight line with the arm 120.

Insertion member 130 provides a protrusion that can be grasped using forceps to guide the insertion or removal of the device 100. Insertion member 130 may be sufficiently rigid to maintain its shape so that it can be grasped using forceps or similar devices. Alternatively, insert member 130 may be somewhat flexible. Additionally, insert member 130 may be made of a material that is at least partially translucent or transparent. Alternatively, insert member 130 may be made of an opaque material. Insert member 130 may comprise medical grade silicone rubber. However, the insert member may be made of any suitable material, including but not limited to plastic, glass, ceramic, metal, any type of rubber, or any combination thereof.

To facilitate removal of medical device 100 after use, insertion member 130 may optionally have a cord 140 attached thereto, as best shown in fig. 10 and 13. The cord 140 may be a medical grade suture, although any suitable material may be used. To facilitate attachment of the cord 140 to the insert member 130, the insert member 130 may have an annular cavity 200 located outside of the insert member 130, as best shown in fig. 6 and 7. The insert member 130 has at least one external opening 210 that provides external access to the annular cavity 200. Preferably, as best shown in fig. 5, insert member 130 has two external openings 210 on opposite sides of insert member 130. To secure the cord 140 to the insertion member 130, an end of the cord 140 may be inserted into the annular cavity 200 through the outer opening 210 and around the insertion member 130 until the inserted end of the cord 140 exits the outer opening 210. Tether 140 may then be tied to secure tether 140 to insertion member 130. As used herein, "tying" the cord may include any suitable method of securing the insertion end of the cord 140 to a portion of the cord after inserting the end through the annular cavity 200 such that the cord 140 is secured to the insertion member 130. Fig. 8 shows a top view of device 100, showing insert member 130 and portions of two outer openings 210.

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

As shown in fig. 7, the medical device 100 may have a bore 150, the bore 150 extending longitudinally through the arm 120 and through the shield 110 such that the bore 150 has an opening 610 at the distal end 122 of the arm 120 and an opening 600 on a side of the shield 110 opposite the arm 120. The aperture 150 may extend through the insert member 130 such that an opening 600 on a side of the shroud 110 opposite the arms 120 is located at an end of the insert member 130, as shown in fig. 3. Thus, the aperture 150 may extend completely through the device 100 in a substantially straight line. When the device 100 is in place during use, as shown in fig. 14, the aperture 150 forms a channel through the device 100 between the vaginal cavity 710 and the cervical canal 730 or uterine cavity 740. To use the device 100, the catheter 160 may be inserted into the opening 600 of the bore 150 on the opposite side of the shroud 110 from the arms 120 and pushed through the bore 150 and then through the opening 610 at the distal ends 122 of the arms 120, as shown in fig. 12-14. The bore 150 has a sufficient diameter to allow the conduit 160 to pass therethrough. Thus, the medical device 100 may serve as a guide or cannula to facilitate passage of the catheter 160, and the catheter 160 may serve as an insemination catheter for introducing semen samples into the reproductive system of a patient. In this manner, the medical device 100 may be used to introduce semen samples into the cervical canal 730 or the uterine cavity 740 as needed during an endocervical or intrauterine insemination procedure. The catheter 160 may then be removed while leaving the device 100 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 fig. 10 and 11, and a closed position, as shown in fig. 1 and 2. The valve 190 includes a plurality of elastomeric flaps 195 integrally attached to the distal end 122 of the arm 120. The elastomeric flaps 195 are resiliently biased inwardly toward the center of the aperture 150 and abut each other when the valve 190 is in the closed position. The elastomeric flap 195 is sized and shaped to form a substantially fluid tight 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 material that is flexible and/or stretchable such that the material can bend and/or stretch and then return to its original position. In this case, the home position refers to a closed position of the valve. Preferably, the valve 190 has three elastomeric flaps 195, each elastomeric flap 195 having a generally triangular shape, as best shown in fig. 2. When the valve 190 is in the closed position, the three triangular flaps 195 fit together to form a substantially fluid-tight seal to prevent fluid from leaking through the valve 190. Fig. 9 shows a bottom view of the device 100 with the valve 190 in a closed position.

The insemination catheter 160 may be passed through the entire device 100 during the artificial insemination procedure. When the conduit 160 is pushed through the opening 610 at the distal end 122 of the arm 120, as shown in fig. 12 and 13, the conduit 160 pushes the elastomeric flap 195 of the valve 190 outward, as best shown in fig. 11 and 12, thereby moving the valve 190 to the open position. In this manner, the catheter 160 may be passed through the medical device 100, delivering a semen sample to the patient's cervical canal 730 or uterine cavity 740, and then removed from the medical device while leaving the device 100 in place. After delivery of the semen sample, the insemination catheter 160 may be completely or partially removed from the medical device 100. When the conduit 160 is removed, the elastomeric flap 195 of the valve 190 moves to its original position, thereby moving the valve 190 to the closed position. When the valve 190 is in the closed position, the semen sample is prevented from exiting the cervical canal 730 via the aperture 150 and thus does not leak back into the vaginal cavity 710 through the medical device 100. Thus, the medical device 100 may effectively serve as a cannula for an insemination instrument and a cervical plug that prevents semen that has been introduced into the patient's cervical canal 730 or uterine cavity 740 from leaking into the patient's vaginal cavity 710.

The disclosure also relates to methods for artificial insemination. Medical device 100 may be configured for use as a cervical plug, as shown in fig. 14. A sperm sample may first be introduced into the patient's cervical canal 730 or uterine cavity 740, depending on whether endocervical or intrauterine insemination is used. The semen sample may be introduced manually into the patient's reproductive system, or alternatively, the sample may be introduced into the patient's reproductive system during sexual intercourse. After introducing the semen sample into the cervical tube 730 or the uterine cavity 740, the medical device 100 can be inserted into the patient's cervical tube 730 such that the arms 120 extend into the patient's cervical tube 730 and the shield 110 substantially covers the external port 720 of the patient's cervix, as shown in fig. 14. As previously mentioned, FIG. 14 shows device 100 in use with syringe 170 and catheter 160, but by inserting device 100 into the position shown in FIG. 14 and leaving the device in place, device 100 can be used as a cervical plug without syringe 170 and catheter 160. If used only as a cervical plug, the bore 150 extending through the device 100 and the valve 190 disposed 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 port 720, the shield 110 and arm 120 of the medical device 100 prevent the semen sample from leaking from the cervical canal 730 to the patient's guide lumen 710. The circumferential protrusion 180 of the arms 120 (or alternatively, the circumferential ridge 205, circumferential barb 215, or longitudinal ridge 175, as shown in fig. 15-17) provides resistance to removal of the arms 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 fig. 14. In this manner, the medical device 100 may increase the efficacy of endocervical or intrauterine insemination by reducing loss of semen samples. After a suitable period of time, the device 100 may be removed.

It should be understood that medical device 100 used in contemplated methods (where medical device 100 is configured for use as a cervical plug) may have some or all of the structural features consistent with the embodiments detailed above. Further, it should be understood that the methods of the present disclosure contemplate methods requiring additional or fewer steps, depending on the presence of such structural features. For example, the method may further comprise the step of removing the medical device 100 via the insertion member 130 using forceps or similar instrument. Alternatively, the device may be removed by pulling the device 100 through the vaginal canal 710 via the tether 140.

The medical device 100 may be configured to additionally function as a guide or cannula for a catheter, as shown in fig. 12-14. The medical device 100 has a bore 150 extending therethrough, a valve 190 disposed at the distal end 122 of the arm 120, and an optional circumferential protrusion 180 (or alternatively, a circumferential ridge 205, a circumferential barb 215, or a longitudinal ridge 175, as shown in fig. 15-17) positioned along the length 185 of the arm 120. The device 100 is insertable into a patient's cervical canal 730 such that the arms 120 extend into the patient's cervical canal 730 and the shield 110 substantially covers the external os 720 of the patient's cervix. The conduit 160 may be inserted into the aperture 150 through an opening 600 on a side of the shroud 110 opposite the arms 120. When the catheter 160 is inserted into the aperture 150, the catheter 160 may be pushed through the opening 610 at the distal end 122 of the arm 120, thereby forcing the valve 190 into an open position, as shown in fig. 12, to the extent required for a particular insemination procedure. A semen sample may then be introduced into the patient's cervical canal 730 or uterine cavity 740 via catheter 160.

The catheter 160 may be partially inserted into the bore 150 prior to insertion of the device 100 into the cervical canal 730, and then after insertion of the medical device 100, the catheter 160 may be pushed through the opening 610 and the valve 190 at the distal end 122 of the arm 120. Alternatively, the catheter 160 may be inserted into the bore 150 and the catheter 160 inserted through the valve 190 after insertion of the medical device 100, or the catheter 160 may be inserted into the bore 150 prior to insertion of the device 100 to push the catheter 160 through the opening 610 and the valve 190 at the distal end 122 of the arm 120, as shown in fig. 12 and 13.

When the valve 190 is in the closed position, the elastomeric flaps 195 of the valve 190 are resiliently biased against each other, as shown in FIG. 2. When the conduit 160 is inserted into the bore 150, the conduit 160 may be pushed through the opening 610 at the distal end 122 of the arm 120 such that the conduit 160 forces the elastomeric flap 195 outward, thereby moving the valve 190 to the open position. Prior to inserting device 100 into cervical canal 730, catheter 160 may be partially inserted into bore 150 such that valve 190 remains in a closed position. The catheter 160 may then be pushed through the opening 610 at the distal end 122 of the arm 120 such that the valve 190 moves to the open position after the medical device 100 is inserted into the cervical canal 730.

Once the device 100 is secured in place with the arms 120 inserted into the cervical canal 730, the shield 110 covering the external port 720, and the catheter 160 inserted into the bore 150 and through the valve 190, a semen sample can be introduced into the patient's cervical canal 730 or uterine cavity 740 through the catheter 160, depending on whether endocervical or intrauterine insemination is used. As shown in fig. 14, a semen sample may be introduced into cervical canal 730 or uterine cavity 740 by injecting the semen sample through catheter 160 using syringe 170. After introduction of the semen sample, the catheter 160 may be removed while leaving the device 100 in place. After removal of the catheter 160, the resiliently biased elastomeric flap 195 of the valve 190 returns to its original position, as shown in FIG. 2, in which the valve 190 is in a closed position, thereby preventing backflow of the semen sample through the valve 190 and the aperture 150. With the medical device 100 secured in place, the shield 110 and arms 120 of the device 100 prevent leakage of semen samples from the cervical canal 730 around the device 100 and into the vaginal cavity 710 of the patient, thereby increasing the efficacy of intracervical or intrauterine insemination by reducing semen sample loss. The circumferential protrusion 180 of the arm 120 (or alternatively, the circumferential ridge 205, circumferential barb 215, or longitudinal ridge 175, as shown in fig. 15-17) helps to secure the device 100 in place to prevent leakage around the device 100.

After a suitable period of time, the device 100 may be removed. Device 100 may be removed via insertion member 130 using forceps or similar instrument. Alternatively, the device may be removed by pulling the device 100 through the vaginal canal 710 via the tether 140.

To ensure that the semen sample is introduced into the proper location, the catheter 160 may extend completely through the medical device 100 such that one end of the catheter 160 is positioned within the cervical canal 730 or the uterine cavity 740 prior to introducing the semen sample through the catheter 160. Fig. 14 shows the catheter 160 extending through the entire device 100 into the patient's uterine cavity 740 and the syringe 170 used to inject the sample. Alternatively, the semen sample may be introduced through the bore 150 of the medical device 100 without the aid of the catheter 160 using a syringe 170 or similar instrument.

The overall size of the present device 100 or the specific dimensions of the components may be varied to accommodate different patients. As one example, the apparatus 100 may have the following dimensions: the shroud 110 may be circular, 22.50mm in diameter; the arm 120 may be cylindrical, 3.40mm in diameter; the circumferential projection 180 (or alternatively, the circumferential ridge 205, circumferential barb 215, or longitudinal ridge 175, as shown in fig. 15-17) may have a diameter of 4.46mm at its widest point and extend along the length 185 of the 3.18mm arm 120. These dimensions are merely illustrative and are not intended to be limiting.

The present disclosure may also relate to an insemination kit that may be used by a healthcare provider or at home by a patient. An insemination kit may include: medical device 100 having the features described herein, wherein medical device 100 is used as a guide or cannula for cervical plugs and catheters; a conduit 160; and a syringe 170 configured to be secured to the catheter 160. The catheter 160 and syringe 170 of the kit may optionally be permanently attached to one another or molded together as a single component.

The insemination kit may be provided to the user with the components pre-assembled into the catheter 160 inserted into the aperture 150 of the medical device 100 and the syringe 170 secured to one end of the catheter 160. The catheter 160 may be partially inserted into the bore 150 of the medical device 100 such that the valve 190 is in a closed position when received by the user. Alternatively, the catheter 160 may be inserted into the bore 150 of the medical device 100 such that the catheter 160 extends through the opening 610 in the distal end 122 of the arm 120 such that the valve 190 is in the open position when received by the user.

It is to be understood that the versions of the invention may have different forms and embodiments. In addition, it is understood that one of ordinary skill in the art would understand that these various forms and embodiments fall within the scope of the invention disclosed herein.