WO2018101934A1

WO2018101934A1 - Device and method for artificial insemination

Info

Publication number: WO2018101934A1
Application number: PCT/US2016/064243
Authority: WO
Inventors: Kirby J. PLESSALA; Peter T. FALKNER
Original assignee: Innovative Medicine, Llc
Priority date: 2016-11-30
Filing date: 2016-11-30
Publication date: 2018-06-07
Also published as: US20210128198A1; US20210153901A9; AU2021200042A1; CN116250903A; IL266890B; JP6868693B2; US20200022728A1; IL287871B2; EP3547942A4; CN110114024B; WO2018102590A1; US11020146B2; CA3044673C; MX2020005537A; AU2017367648B2; IL287871B1; CN110114024A; ZA201903481B; MA46155B1; AU2017367648A1

Abstract

A medical device and method for artificial insemination are provided. The medical device has a shield and an arm secured to the shield at one end and extending outwardly from the shield. The arm is inserted into the cervical canal of a patient and the shield covers the external os of the patient. By inserting the medical device into a patient's cervical canal after insemination, a physical barrier that holds a semen sample within the cervical canal and prevents leakage from the cervical canal back into the vaginal cavity is established.

Description

DEVICE AND METHOD FOR ARTIFICIAL INSEMINATION

FIELD OF THE INVENTION

[0001] A preferred implementation of the present invention refers generally to a device and method for artificial insemination.

BACKGROUND

[0002] Artificial insemination aims to introduce sperm into the reproductive system of a patient to promote pregnancy. Typically, artificial insemination is carried out when it is difficult or impossible for sperm to enter a patient's reproductive system during sexual intercourse. Intracervical insemination, where a semen sample is introduced into a patient's cervical canal, and intrauterine insemination, where a semen sample is introduced into a patient's uterine cavity, are two common artificial insemination procedures currently used. Generally, during such procedures, a patient's vaginal walls are held open by a medical device, such as a speculum. A semen sample is then introduced into to the patient's cervical canal or uterine cavity, depending on which procedure is being performed, typically via a catheter-syringe assembly. After introduction of the semen sample, the semen is left to take by the patient's reproductive system. However, a portion of the semen sample may be lost by leaking from the cervical canal into the vaginal cavity of the patient due to reflux caused by uterine contractions.

[0003] Some known devices, such as vaginal sponges and cervical caps, attempt to solve the problem of leaking by creating a barrier between the patient's cervical canal and vaginal cavity after the semen sample is introduced. However, these devices merely attempt to blockade the upper region of the patient's vaginal cavity near the patient's cervical canal and may not effectively hold 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 a reduction in the efficacy of the insemination procedure due to reflux caused by uterine contractions. These devices may also cause patient discomfort when inserted and removed.

[0004] Accordingly, a need exists in the art for a device for increasing the efficacy of artificial insemination procedures and for a method of using the device. Furthermore, a need exists in the art for a device for increasing the efficacy of artificial insemination procedures without causing significant patient discomfort upon insertion and removal of the device.

SUMMARY

[0005] The present disclosure provides a device and methods for artificial insemination in accordance with the independent claims. Preferred embodiments of the invention are reflected in the dependent claims. The claimed invention can be better understood in view of the embodiments described and illustrated in the present disclosure, viz. in the present specification and drawings. In general, the present disclosure reflects preferred embodiments of the invention. The attentive reader will note, however, that some aspects of the disclosed embodiments extend beyond the scope of the claims. To the respect that the disclosed embodiments indeed extend beyond the scope of the claims, the disclosed embodiments are to be considered supplementary background information and do not constitute definitions of the invention per se.

[0006] In one aspect of the present disclosure, a medical device for use during artificial insemination in order to prevent semen sample leakage from the cervical canal of a patient is provided. The medical device may be configured to function as a cervical plug. The medical device has a shield configured to cover an orifice and an arm having a proximal end and a distal end. The proximal end is secured to the shield, and the distal end is configured to insert into the orifice. For instance, the shield may be configured to cover the orifice between a patient's cervical canal and vaginal cavity ("external os"), and the arm may be configured to insert into the patient's cervical canal. Due to the arm's insertion within the cervical canal and the shield's coverage of the external os, the medical device may effectively secure itself in place during use.

[0007] By inserting the medical device through the vaginal cavity and into the cervical canal of a patient such that the arm is inserted into the patient's cervical canal and the shield covers the patient's external os, the medical device may establishe a physical barrier that holds a semen sample within the patient's cervical canal and prevents leakage into the vaginal cavity. In this manner, the medical device may be utilized as a cervical plug after a semen sample is introduced into the cervical canal or uterine cavity of a patient to prevent the semen sample from leaking into the vaginal cavity, thereby preventing semen sample loss. Accordingly, the present disclosure may also be directed toward a method for artificial insemination wherein a semen sample is first introduced into a patient's cervical canal or uterine cavity, and the medical device is then inserted into the patient's cervical canal in the manner described above.

8] In addition, the medical device may be configured to function as both a cervical plug as well as 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 insert into the patient's cervical canal. The medical device may further 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 on the side of the shield opposite the arm. The opening at the distal end of the arm may be resiliently biased to a closed position such that the opening at the distal end is substantially sealed when in a closed position. To use the device, a catheter may be inserted into the opening of the bore on the side of the shield opposite the arm and pushed through the opening at the distal end of the arm. When pushed through the opening at the distal end of the arm, the catheter may force the opening at the distal end into an open position. In this manner, a catheter may pass through the medical device, deliver a semen sample to a patient's cervical canal or uterine cavity, and be removed from the medical device. When the catheter is removed, the opening at the distal end of the arm may return to the closed position such that the semen sample cannot leak back through the medical device into the vaginal cavity. Accordingly, the present disclosure may also be directed toward a method for artificial insemination wherein the medical device is inserted into a patient's cervical canal in the manner described above, a catheter is inserted into the bore of the medical device, a semen sample is directed through the catheter into the patient's cervical canal or uterine cavity, and the catheter is then removed leaving the medical device in place.

[0009] To insert and remove the medical device, the medical device may have an insert member secured to the shield on the opposite side of the shield as the arm. The insert member may have a string secured thereto in order 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.

[00010] Additional features and advantages of the present disclosure will be set forth in the description which follows, and will be apparent from the description, or may be learned by practice of the present disclosure. The foregoing general description and following detailed description are exemplary and explanatory and are intended to provide further explanation of the present disclosure.

DESCRIPTION OF THE DRAWINGS

[00011] 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 front perspective view of a device embodying features consistent with the principles of the present disclosure.

FIG. 2 shows a rear perspective view of a device embodying features consistent with the principles of the present disclosure.

FIG. 3 shows rear elevational view of a device embodying features consistent with the principles of the present disclosure. FIG. 4 shows a front elevational view of a device embodying features consistent with the principles of the present disclosure.

FIG. 5 shows a side perspective view of a device embodying features consistent with the principles of the present disclosure.

FIG. 6 shows a side perspective view of a device embodying features consistent with the principles of the present disclosure.

FIG. 7 shows a device embodying features consistent with the principles of the present disclosure inserted in a patient's reproductive system.

FIG. 8 shows device embodying features consistent with the principles of the present disclosure inserted in a patient's reproductive system, said device being used with a catheter and syringe.

DETAILED DESCRIPTION

12] In the Summary above and in this Detailed Description, and the claims below, and in the accompanying drawings, reference is made to particular features, including method steps, of the invention as claimed. In the present disclosure, many features are described as being optional, e.g. through the use of the verb "may" or the use of parentheses. For the sake of brevity and legibility, the present disclosure does not explicitly recite each and every permutation that may be obtained by choosing from the set of optional features. However, the present disclosure is to be interpreted as explicitly disclosing all such permutations. For example, a system described as having three optional features may be embodied in seven different ways, namely with just one of the three possible features, with any two of the three possible features, or with all three of the three possible features. It is to be understood that the disclosure in this specification includes all possible combinations of such particular features. For example, where a particular feature is disclosed in the context of a particular aspect or embodiment, or a particular claim, that feature can also be used, to the extent possible, in combination with/or in the context of other particular aspects or embodiments, and generally in the invention as claimed.

[00013] The term "comprises" and grammatical equivalents thereof are used herein to mean that other components, ingredients, steps, etc. are optionally present. For example, an article "comprising" components A, B, and C can contain only components A, B, and C, or can contain not only components A, B, and C, but also one or more other components.

[00014] Where reference is made herein to a method comprising two or more defined steps, the defined steps can be carried out in any order or simultaneously (except where the context excludes that possibility), and the method can include one or more other steps which are carried out before any of the defined steps, between two of the defined steps, or after all the defined steps (except where the context excludes that possibility).

[00015] Turning now to the drawings, Figs. 1-8 illustrate embodiments of a medical

device for holding materials in and preventing material leakage from an orifice. The medical device 100 may be designed to function as a cervical plug for holding semen in and preventing semen leakage from the cervical canal 730 of a patient after a semen sample is introduced into the patient's cervical canal 730 or uterine cavity 740. The medical device 100 has a shield 110 configured to cover an orifice and an arm 120 configured to insert into the orifice, wherein one end of the arm 120 is secured to the shield 110. The shield 110 may be configured to cover a patient's external os 720, and the arm 120 may be configured to insert into the patient's cervical canal 730, as illustrated in Fig. 7. By inserting the medical device 100 through the vaginal cavity 710 and into the cervical canal 730 of a patient such that the arm 120 is inserted into the patient's cervical canal 730 and the shield 110 covers the patient's external os 720, the medical device 100 may establish a physical barrier between a patient's cervical canal 730 and vaginal cavity 710. In this manner, the medical device 100 may function as a cervical plug that prevents leakage of a semen sample from the cervical canal 730 into the vaginal cavity 710 after the semen sample has been introduced into the cervical canal 730 or uterine cavity 740 of a patient.

[00016] It should be understood that the medical device may be utilized for covering and plugging other bodily orifices including, but not limited to, the internal orifice of the cervix, without departing from the scope of the present disclosure.

[00017] As illustrated in Figs. 1-2 and 5-6, the medical device 100 comprises a shield 110 and an arm 120 secured to the shield 110. To accommodate the contours of the portion of the cervix surrounding a patient's external os 720, the shield 110 may have a concave shape having a concave side and a convex side, wherein the concave side of the shield 110 faces the external os 720 and the convex side faces the vaginal cavity 710 when the medical device 100 is in place, as shown in Fig. 7. The arm 120 may be secured to the concave side of the shield 110, as shown in Fig. 1. In addition, the shield 110 may have a generally circular shape, and the arm 120 may be secured to the shield 110 generally at the center of the shield, as shown in Fig. 1. Alternatively, the shield may be of another shape suitable for covering the external os 720 of a patient, such as an elliptical shape. [00018] The shield 110 may be shaped and sized such that the shield 110 can cover the external os 720 of nulliparous, primiparous, or multiparous women. To minimize pain or discomfort experienced by a patient as the medical device 100 is inserted or removed from the patient's body, the shield 110 may be made of a material that is somewhat flexible such that the material may be deformed by pressure applied by a user of the device but return to its original shape when the pressure is removed. Alternatively, the shield 110 may be made of a material that is substantially rigid or semi-rigid. In addition, the shield 110 may be made of a material that is at least partially translucent or transparent, which may aid a user in inserting the device in 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 shield may be made of any suitable material including, but not limited to, plastic, glass, ceramic, metal, any type of rubber, or any combination thereof.

[00019] The arm 120 of the medical device 100 is configured to insert into the orifice 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. The proximal end 121 is secured to the shield 110, and the distal end 122 is inserted into the orifice when the device is in use. The arm 120 may be permanently secured to the shield 110. For instance, the arm 120 and shield 110 may be molded as a unitary piece of material.

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

[00020] The arm 120 is sufficiently rigid for inserting the arm 120 into the cervical canal 730 of a patient, but the arm 120 may have some amount of flexibility in order to minimize pain or discomfort experienced by the patient as the device 100 is inserted or removed. Alternatively, the arm 120 may be made of a material that is substantially rigid. In addition, 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 arm may be made of any suitable material including, but not limited to, plastic, glass, ceramic, metal, any type of rubber, or any combination thereof.

21] The shield 110 and the arm 120 may be configured to secure the medical device 100 in place during use, as shown in Figs. 7 and 8, such that the shield 110 remains covering an orifice until the medical device 100 is removed by a 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 is covering the orifice. The diameter of the arm 120 may decrease as the arm 120 extends toward the distal end 122 of the arm 120, as shown in Fig. 1. The proximal end 121 of the arm 120 may have a diameter of sufficient size such that when the proximal end 121 of the arm 120 is positioned in the cervical canal 730 of a patient after insertion of the device, a substantially airtight seal is formed between the cervical canal 730 and the vaginal cavity 710 of the patient. The airtight seal formed by insertion of the arm 120 into the cervical canal 730 may facilitate a slight suction between the concave shield 110 and the area of the cervix covered by the shield 110, thereby further securing the medical device 100 in place. When secured in place, the shield 110 may substantially cover the external os 720 such that the shield 110, in conjunction with the arm 120, may prevent leakage of a sperm sample around the device 100 and into the vaginal cavity 710.

[00022] As illustrated in Figs. 1-2 and 5-6, the medical device 100 may further comprise an insert member 130 secured to the shield 110. The insert member 130 may function as an aid for inserting the medical device 100 into the cervical canal 730 and removing the device from the cervical canal. The insert member 130 may be secured to the opposite side of the shield 110 as the proximal end 121 of the arm 120. The insert member 130 may be permanently secured to the shield 110. For instance, the medical device 100 may be molded as a unitary piece of material including the shield 110, arm 120, and insert member 130. Alternatively, the insert member 130 may be secured to the shield 110 with an adhesive. As illustrated in Figs. 5 and 6, the insert member 130 may be secured to the shield 110 such that the insert member 130 forms a generally straight line with the arm 120.

[00023] The insert member 130 provides a protrusion that may be grabbed using forceps for the purpose of guiding the device to insert or remove the medical device 100. The insert member 130 may be sufficiently rigid to retain its shape such that it can be grabbed using forceps or a similar device. Alternatively, the insert member 130 may be somewhat flexible. In addition, the insert member 130 may be made of a material that is at least partially translucent or transparent. Alternatively, the insert member 130 may be made of an opaque material. The 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.

[00024] To facilitate removal of the medical device 100 after use, the insert member 130 may optionally have a string 140 attached thereto. The string 140 may be permanently attached to the insert member 130. For instance, the device 100 may be molded such that one end of the string 140 is molded into the insert member 130. The string 140 may be of a sufficient length to extend through the vaginal cavity 710 and outside of the patient's body when the medical device 100 is inserted in the cervical canal 730, as seen in Fig. 7. By pulling the string 140, the medical device 100 may be removed through the vaginal cavity 710 without forceps or a similar device. To ensure the string 140 does not detach from the insert member 130 when pulled, one end of the string 140 may be tied to a metal insert molded into the body of the insert member 130. The string 140 may be a medical- grade suture, though any suitable material may be utilized. Fig. 3 illustrates the device showing the string 140 attached to the insert member 130. Fig. 4 illustrates the device showing the arm 120 and the concave side of the shield 110 with a portion of the string 140 visible.

25] As shown in Fig. 6, the medical device 100 may have a 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 the side of the shield 110 opposite the arm 120. The bore 150 may extend through the insert member 130 such that the opening 600 on the side of the shield 110 opposite the arm 120 is located at the end of the insert member 130. Thus, the bore 150 may extend completely through the device 100 in a generally straight line. When the device 100 is in place during use, the bore 150 creates a passageway between the vaginal cavity 710 and the cervical canal 730 or uterine cavity 740 through the device 100. To use the device 100, a catheter 160 may be inserted into the opening 600 of the bore 150 on the side of the shield 110 opposite the arm 120 and pushed through the opening 610 at the distal end 122 of the arm 120, as shown in Fig. 8. The bore 150 may be of sufficient diameter to allow the catheter 160 to pass therethrough. Accordingly, the medical device 100 may function as a guide or cannula to facilitate passage for the catheter 160, which may be used as an insemination catheter for introducing a semen sample into the reproductive system. In this manner, the medical device 100 may be utilized during intracervical or intrauterine insemination procedures for introducing a semen sample into the cervical canal 730 or the uterine cavity 740, as desired. The catheter 160 may then be removed while leaving the device 100 in place.

26] The opening 610 at the distal end 122 of the arm 120 may be resiliently biased to a closed position such that the opening 610 at the distal end 122 is substantially sealed when in a closed position. When the catheter 160 is inserted through the opening 610 at the distal end 122 of the arm 120, the catheter 160 forces the opening 610 at the distal end 122 into an open position. The arm 120, or at least a portion of the arm 120

surrounding the opening 610 at the distal end 122, may be made of a material that is somewhat stretchable or flexible such that the material defining the opening 610 can move to an open position to allow passage of the catheter 160 and then return to its original position, which is a closed position. In this manner, the catheter 160 may pass through the medical device 100, deliver a semen sample to a patient's cervical canal 730 or uterine cavity 740, and then be removed from the medical device 100 while leaving the device 100 in place. When the catheter 160 is removed, the opening 610 at the distal end 122 of the arm 120 may return to the closed position such that the semen sample cannot leak back through the medical device 100 into the vaginal cavity 710. Thus, the medical device 100 may effectively function both as a cannula for an insemination instrument and as a cervical plug that prevents semen delivered to the patient's cervical canal 730 or uterine cavity 740 from leaking into the patient's vaginal cavity 710.

[00027] For instance, during intrauterine insemination, an insemination catheter may pass through the entirety of the medical device 100, thereby opening the resiliently biased opening 610 at the distal end 122 of the arm 120, and deliver a semen sample to the uterine cavity 740 of a patient. Upon delivery of the semen sample, the insemination catheter may be entirely or partially removed from the medical device 100. When the insemination catheter is removed from the opening 610 at the distal end 122, the opening 610 may return to a closed position, thereby preventing the semen sample from exiting the cervical canal 730 via the bore 150. Accordingly, the medical device 100 may be utilized in any application requiring delivery of a material through a plugged orifice.

[00028] The present disclosure may also be directed to a method for artificial

insemination. The medical device 100 may be configured to function as a cervical plug, as shown in Fig. 7. A semen sample may first be introduced into a patient's cervical canal 730 or uterine cavity 740, depending on whether intracervical insemination or intrauterine insemination is utilized. The semen sample may be introduced artificially into the patient's reproductive system or, alternatively, the sample may be introduced into a patient's reproductive system during sexual intercourse. After the semen sample is introduced into the cervical canal 730 or uterine cavity 740, the medical device 100 may be inserted into the cervical canal 730 of the patient such that the arm 120 extends into the patient's cervical canal 730 and the shield 110 substantially covers the external os 720 of the patient's cervix, as shown in Fig. 7. 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 os 720, the shield 110 and the arm 120 of the medical device 100 may prevent the semen sample from leaking from the cervical canal 730 into the patient's vaginal cavity 710. In this manner, the medical device 100 may increase the efficacy of intracervical or intrauterine insemination by reducing semen sample loss. After a suitable period of time, the device 100 may be removed.

[00029] It is understood that the medical device 100 used within the contemplated method, wherein the medical device 100 is configured to function as a cervical plug, may have some or all of the structural features consistent with the embodiments detailed above. Moreover, it is understood that the method of the present disclosure contemplates methodologies requiring additional or fewer steps dependent upon the presence of such structural features. For instance, the method may further comprise the step of removing the medical device 100 via the insert 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.

[00030] The medical device 100 may be configured to function both as a cervical plug as well as a guide or cannula for a catheter, as shown in Fig. 8. The medical device 100 having a bore 150 extending therethrough may be inserted into the cervical canal 730 of the patient such that the arm 120 extends into the patient's cervical canal 730 and the shield 110 substantially covers the external os 720 of the patient's cervix. A catheter 160 may be inserted into the bore 150 through the opening 600 on the side of the shield 110 opposite the arm 120. When inserting the catheter 160 into the bore 150, the catheter 160 may be pushed through the opening 610 at the distal end 122 of the arm 120 as far as desired for a particular insemination procedure. A semen sample may then be introduced into the patient's cervical canal 730 or uterine cavity 740 via the catheter 160.

[00031] The catheter 160 may be partially inserted into the bore 150 prior to inserting the device 100 into the cervical canal 730, and the catheter 160 may then be pushed through the opening 610 at the distal end 122 of the arm 120 after inserting the medical device 100. Alternatively, the catheter 160 may be inserted into the bore 150 after inserting the medical device 100, or the catheter 160 may be inserted into the bore 150 such that the catheter 160 is pushed through the opening 610 at the distal end 122 of the arm 120 prior to insertion of the device 100.

[00032] The opening 610 at the distal end 122 of the arm 120 may be resiliently biased to a closed position. As the catheter 160 is inserted into the bore 150, the catheter 160 may be pushed through the opening 610 at the distal end 122 of the arm 120 such that the opening 610 moves to an open position. The catheter 160 may be partially inserted into the bore 150 prior to inserting the device 100 into the cervical canal 730 such that the opening 610 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 opening 610 moves to an open position after insertion of the medical device 100 into the cervical canal 730.

[00033] Once the device 100 is secured in place with the arm 120 inserted into the cervical canal 730, the shield 110 covering the external os 720, and the catheter 160 inserted into the bore 150, a semen sample may be introduced into a patient's cervical canal 730 or uterine cavity 740, depending on whether intracervical insemination or intrauterine insemination is utilized, via the catheter 160. The sample may be introduced into the cervical canal 730 or uterine cavity 740 by injecting the semen sample through the catheter 160 using a syringe 170, as shown in Fig. 8. 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 opening 610 at the distal end 122 of the arm 120 may return to a closed position, thereby preventing the semen sample from flowing back through the bore 150. With the medical device 100 secured in place, the shield 110 and the arm 120 of the device 100 may prevent the semen sample from leaking from the cervical canal 730 into the patient's vaginal cavity 710, thereby increasing the efficacy of intracervical or intrauterine insemination by reducing semen sample loss.

[00034] After a suitable period of time, the device 100 may be removed. The device 100 may be removed via the insert 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.

[00035] To ensure the semen sample is introduced into the proper location, the catheter

160 may extend entirely through the medical device 100 such that one end of the catheter 160 is located in the cervical canal 730 or in the uterine cavity 740 before directing the semen sample through the catheter 160. Fig. 8 illustrates a catheter 160 extending through the entirety of the device 100 into the uterine cavity 740 of a patient and a syringe 170 for injecting the sample. Alternatively, the semen sample may be directed through the bore 150 of the medical device 100 using a syringe 170 or similar instrument without the aid of a catheter 160.

[00036] The present disclosure may also be directed to an insemination kit, which may be used by a health care provider or by a patient at home. The insemination kit may comprise: a medical device 100 having the features described herein, wherein the medical device 100 functions both as a cervical plug and a guide or cannula for a catheter; a catheter 160; and a syringe 170 configured to secure to the catheter 160. The catheter 160 and the syringe 170 of the kit may optionally be permanently attached to each other or molded together as a single component.

[00037] The insemination kit may be supplied to a user with the components pre- assembled such that the catheter 160 is inserted into the bore 150 of the medical device 100, and the syringe 170 is 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 opening 610 at the distal end 122 of the arm 120 is in a closed position upon user receipt.

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 so that the opening 610 is in an open position upon user receipt.

[00038] It is understood that versions of the invention may come in different forms and embodiments. Additionally, it is understood that one of skill in the art would appreciate these various forms and embodiments as falling within the scope of the invention as disclosed herein.

What is claimed is:

1) A medical device comprising:

a shield configured to cover an orifice; and

an arm having a proximal end secured to the shield and a distal end configured to insert into an orifice,

wherein the shield and the arm are configured to secure the medical device in place during use. ) The medical device of claim 1, wherein the diameter of the arm decreases as the arm extends toward the distal end of the arm.

) The medical device of any of claims 1-2, wherein the medical device has 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 on the side of the shield opposite the arm.

) The medical device of claim 3, wherein the opening at the distal end of the arm is resiliently biased to a closed position.

) The medical device of any of claims 3-4, wherein the bore is of sufficient diameter to allow a catheter to pass through the bore.

) The medical device of any of claims 1-5, wherein the shield has a concave shape, wherein the proximal end of the arm is secured to the concave side of the shield.) The medical device of any of claims 1-6, further comprising an insert member secured to the shield, wherein the insert member is secured to the opposite side of the shield as the proximal end of the arm.

) The medical device of claim 7, wherein the insert member has a string attached thereto.

) The medical device of any of claims 1-8, wherein the shield is flexible.

0) The medical device of any of claims 1-9, wherein the shield is translucent.

1) A method for artificial insemination, said method comprising the steps of:

providing a medical device comprising:

a shield configured to cover the external os of a patient's cervix; and an arm having a proximal end secured to the shield and a distal end configured to insert into a patient's cervical canal,

wherein the shield and the arm are configured to secure the medical device in place during use;

introducing a semen sample into a patient's cervical canal or uterine cavity; and inserting the medical device into the cervical canal of the patient such that the arm extends into the patient's cervical canal and the shield substantially covers the external os of the patient's cervix.

) The method of claim 11, wherein the medical device further comprises an insert member secured to the shield, wherein the insert member is secured to the opposite side of the shield as the proximal end of the arm.

) The method of any of claims 11-12, further comprising the step of removing the medical device from the patient after a period of time.

) A method for artificial insemination, said method comprising the steps of:

providing a medical device comprising:

a shield configured to cover the external os of a patient's cervix; and an arm having a proximal end secured to the shield and a distal end

configured to insert into a patient's cervical canal, wherein the shield and the arm are configured to secure the medical device in place during use, and wherein a bore extends 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 on the side of the shield opposite the arm,

inserting the medical device into the cervical canal of a patient such that the arm extends into the patient's cervical canal and the shield substantially covers the external os of the patient's cervix;

providing a catheter;

inserting the catheter into the bore through the opening of the bore on the side of the shield opposite the arm;

introducing a semen sample into the patient's cervical canal or uterine cavity via the catheter; and

removing the catheter.

) The method of claim 14, wherein the step of inserting the catheter into the bore comprises the steps of: partially inserting the catheter into the bore prior to inserting the medical device into the cervical canal, and pushing the catheter through the opening at the distal end of the arm after inserting the medical device.

) The method of any of claims 14-15, wherein the opening at the distal end of the arm is resiliently biased to a closed position.

) The method of claim 16, wherein the step of inserting the catheter into the bore comprises pushing the catheter through the opening at the distal end of the arm such that the opening at the distal end of the arm moves to an open position.

) The method of any of claims 14-17, wherein the semen sample is introduced into the patient's cervical canal or uterine cavity by injecting the semen sample through the catheter using a syringe.

) The method of any of claims 14-18, wherein the medical device further comprises an insert member secured to the shield, wherein the insert member is secured to the opposite side of the shield as the proximal end of the arm. ) The method of any of claims 14-19, further comprising the step of removing the medical device from the patient after a period of time.

Claims

What is claimed is:

1) A medical device comprising:

a shield configured to cover an orifice; and

wherein the shield and the arm are configured to secure the medical device in place during use.

2) The medical device of claim 1, wherein the diameter of the arm decreases as the arm extends toward the distal end of the arm.

3) The medical device of any of claims 1-2, wherein the medical device has 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 on the side of the shield opposite the arm.

4) The medical device of claim 3, wherein the opening at the distal end of the arm is resiliently biased to a closed position.

5) The medical device of any of claims 3-4, wherein the bore is of sufficient diameter to allow a catheter to pass through the bore.

6) The medical device of any of claims 1-5, 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 any of claims 1-6, further comprising an insert member

secured to the shield, wherein the insert member is secured to the opposite side of the shield as the proximal end of the arm. 8) The medical device of claim 7, wherein the insert member has a string attached thereto.

9) The medical device of any of claims 1-8, wherein the shield is flexible.

10) The medical device of any of claims 1-9, wherein the shield is translucent.

11) A method for artificial insemination, said method comprising the steps of:

providing a medical device comprising:

configured to insert into a patient's cervical canal,

12) The method of claim 11, wherein the medical device further comprises an insert member secured to the shield, wherein the insert member is secured to the opposite side of the shield as the proximal end of the arm.

13) The method of any of claims 11-12, further comprising the step of removing the medical device from the patient after a period of time.

14) A method for artificial insemination, said method comprising the steps of:

providing a medical device comprising:

a shield configured to cover the external os of a patient's cervix; and an arm having a proximal end secured to the shield and a distal end configured to insert into a patient's cervical canal, wherein the shield and the arm are configured to secure the medical device in place during use, and wherein a bore extends 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 on the side of the shield opposite the arm,

providing a catheter;

removing the catheter.

15) The method of claim 14, wherein the step of inserting the catheter into the bore comprises the steps of: partially inserting the catheter into the bore prior to inserting the medical device into the cervical canal, and pushing the catheter through the opening at the distal end of the arm after inserting the medical device.

16) The method of any of claims 14-15, wherein the opening at the distal end of the arm is resiliency biased to a closed position. 17) The method of claim 16, wherein the step of inserting the catheter into the bore comprises pushing the catheter through the opening at the distal end of the arm such that the opening at the distal end of the arm moves to an open position.

18) The method of any of claims 14-17, wherein the semen sample is introduced into the patient's cervical canal or uterine cavity by injecting the semen sample through the catheter using a syringe.

19) The method of any of claims 14-18, wherein the medical device further comprises an insert member secured to the shield, wherein the insert member is secured to the opposite side of the shield as the proximal end of the arm.

20) The method of any of claims 14-19, further comprising the step of removing the medical device from the patient after a period of time.