U.S. patent application number 16/767680 was filed with the patent office on 2020-09-17 for device and method for artificial insemination.
This patent application is currently assigned to InnoMed One, LLC. The applicant listed for this patent is InnoMed One, LLC. Invention is credited to PETER T FALKNER, KIRBY J. PLESSALA.
Application Number | 20200289160 16/767680 |
Document ID | / |
Family ID | 1000004887023 |
Filed Date | 2020-09-17 |
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United States Patent
Application |
20200289160 |
Kind Code |
A1 |
PLESSALA; KIRBY J. ; et
al. |
September 17, 2020 |
DEVICE AND METHOD FOR ARTIFICIAL INSEMINATION
Abstract
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 patients cervical canal prior to insemination and leaving
the device in place 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. The device may have a bore extending through the
device for a catheter to pass through. The bore has a valve to
allow passage of the catheter and prevent backflow of semen. The
arm may have a plurality of longitudinal ridges, circumferential
ridges, or circumferential barbs to help keep the device in
place.
Inventors: |
PLESSALA; KIRBY J.; (MOBILE,
AL) ; FALKNER; PETER T; (MOBILE, AL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
InnoMed One, LLC |
Mobile |
AL |
US |
|
|
Assignee: |
InnoMed One, LLC
Mobile
AL
|
Family ID: |
1000004887023 |
Appl. No.: |
16/767680 |
Filed: |
November 29, 2018 |
PCT Filed: |
November 29, 2018 |
PCT NO: |
PCT/US18/63100 |
371 Date: |
May 28, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
PCT/US2017/064028 |
Nov 30, 2017 |
|
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16767680 |
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PCT/US2016/064243 |
Nov 30, 2016 |
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PCT/US2017/064028 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/43 20130101;
A61B 2017/4225 20130101 |
International
Class: |
A61B 17/43 20060101
A61B017/43 |
Claims
1) A medical device comprising: a shield configured to cover an
orifice; 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, wherein the arm has a plurality of longitudinal ridges
positioned along a length of the arm between a midway point of the
arm and the 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 the distal end of the arm and
an opening on the 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 the elastomeric flaps are each
sized and shaped to for a substantially fluid-tight seal over the
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 bore is of sufficient
diameter to allow a catheter to pass through the bore.
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 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 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 shield configured to cover an
orifice; 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, wherein the arm has a plurality of circumferential
ridges positioned along a length of the arm between a midway point
of the arm and the 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 the distal end of the arm and
an opening on the 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 the elastomeric flaps are each
sized and shaped to for a substantially fluid-tight seal over the
opening at 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 bore is of
sufficient diameter to allow a catheter to pass through the
bore.
16) The medical device of claim 1 1, wherein the shield has a
concave shape, wherein the proximal end of the arm is secured to
the concave side of the shield.
17) The medical device of claim 11, 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.
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 shield configured to cover an
orifice; 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, wherein the arm has a plurality of circumferential
barbs positioned along a length of the arm between a midway 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 the distal end of the arm and
an opening on the 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 the elastomeric flaps are each
sized and shaped to for a substantially fluid tight seal over the
opening at 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 bore is of
sufficient diameter to allow a catheter to pass through the
bore.
26) The medical device of claim 21, wherein the shield has a
concave shape, wherein the proximal end of the arm is secured to
the concave side of the shield.
27) The medical device of claim 21, 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.
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.
Description
CROSS REFERENCES
[0001] This application claims priority to PCT Application No.
PCT/US2017/064028, filed on Nov. 30, 2017, which application is
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] A preferred implementation of the present invention refers
generally to a device and method for artificial insemination.
BACKGROUND
[0003] Artificial insemination aims to place 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 inserted into a patient's cervical canal, and
intrauterine insemination, where a semen sample is inserted into a
patient's uterine cavity, are the two most 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 inserted into to
the patient's cervical canal or uterine cavity, depending on which
procedure is being performed, typically via a catheter-syringe
assembly. After insertion, the semen is left to take by the
patient's reproductive system. However, a portion of the semen
sample is often lost by leaking from the cervical canal into the
vaginal cavity of the patient due to reflux caused by uterine
contractions.
[0004] 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 ear
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.
[0005] The device disclosed in application PCT/US2017/064028, filed
by the present Applicant, attempts to solve the above-outlined
problems. This device is designed to be inserted into the cervical
canal and remain in place for a period of time during which
insemination occurs while preventing leakage of semen from the
cervical canal. The device may also allow a catheter to be inserted
through a bore extending through the device so that semen may be
introduced into the cervical canal or uterine cavity while the
device is in place in a patient's cervical canal. However, the
device may sometimes become dislodged from the cervical canal
during the period of time in which the device is intended to remain
in place to allow insemination to occur, or a small amount of
leakage may occur through the bore that extends through the
device.
[0006] 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
[0007] 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.
[0008] 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 shields coverage
of the external os, the medical device may effectively secure
itself in place during use. The arm may optionally have a
circumferential bulge, circumferential ridges, circumferential
barbs, or longitudinal ridges positioned near the distal end of the
arm to help keep the device in place with the arm inserted into the
cervical canal during use.
[0009] 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 establish 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.
[0010] 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. A
valve that s operable between an open position and a closed
position may be disposed at the distal end of the arm. The valve
comprises a plurality of elastomeric flaps integrally attached to
the distal end of the arm. The elastomeric flaps are resiliently
biased inwardly toward the center of the bore and against each
other when the valve is in the closed position. The elastomeric
flaps are 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 side of the shield opposite the
arm and pushed through the opening at the distal end of the arm.
When pushed through the opening at the distal end of the arm, the
catheter forces the elastomeric flaps of the valve outward, thereby
moving the valve into the 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 then be removed
from the medical device while leaving the device in place. When the
catheter is removed, the valve moves 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
[0011] 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.
[0012] 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
[0013] 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:
[0014] FIG. 1 shows a perspective vie of a device in accordance
with the present disclosure.
[0015] FIG. 2 shows a perspective view of a device in accordance
with the present disclosure.
[0016] FIG. 3 shows a perspective view of a device in accordance
with the present disclosure.
[0017] FIG. 4 shows an elevational view of a device in accordance
with the present disclosure.
[0018] FIG. 5 shows an elevational view of a device in accordance
with the present disclosure.
[0019] FIG. 6 shows a partial perspective view of a device in
accordance with the present disclosure.
[0020] FIG. 7 shows a cross-sectional view of a device in
accordance with the present disclosure.
[0021] FIG. 8 shows a top plan view of device in accordance with
the present disclosure.
[0022] FIG. 9 shows a bottom plan view of a device in accordance
with the present disclosure.
[0023] FIG. 10 shows an elevational view of a device in accordance
with the present disclosure.
[0024] FIG. 11 shows a perspective view of a device in accordance
with the present disclosure.
[0025] FIG. 12 shows a perspective view of a device with a catheter
inserted through the device in accordance with the present
disclosure.
[0026] FIG. 13 shows a perspective view of a device with a catheter
inserted through the device in accordance with the present
disclosure.
[0027] FIG. 14 shows a device in accordance with the present
disclosure inserted in a patient's reproductive system, said device
being used with a catheter and syringe
[0028] FIG. 15 shows a profile view (15A) and cross-sectional view
(15B) of a device in accordance with the present disclosure.
[0029] FIG. 16 shows a profile view (16A) and cross-sectional view
(16B) of a device in accordance with the present disclosure.
[0030] FIG. 17 shows a profile view (17A) and cross-sectional view
(17B) of a device in accordance with the present disclosure.
DETAILED DESCRIPTION
[0031] 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.
[0032] 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.
[0033] 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).
[0034] Turning now to the drawings, FIGS. 1-17 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. 14. 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.
[0035] 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.
[0036] As illustrated in FIGS. 1-5, 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. 14. The shield 110 may be shaped such that
the concave side of the shield 110 fits flush against the external
os 720 and cervical tissue surrounding the external os of the
patient. The curvature of the shield 110 may be adjusted for
different patients. 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.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] The arm 120 may have a circumferential bulge 180 to help
keep the device 100 in place with the arm 120 inserted into the
cervical canal 730 during use. The bulge 180 is positioned along a
length 185 of the arm 120 between a midway point of the arm (midway
between the proximal end 121 and the distal end 122) and the distal
end 122 of the arm, and may preferably be positioned nearer to the
distal end 122 of the arm 120 than to the midway point of the arm
120, as shown in FIG. 1. Once the arm 120 is inserted into the
cervical canal 730, as shown in FIG. 14, the wider diameter of the
circumferential bulge 180 provides resistance to removal of the arm
120 from the cervical canal 730, thereby helping to keep the device
100 in place for a period of time after semen has been introduced
into the cervical canal 730 or uterine cavity 740 so that the
device 100 prevents leakage of semen from the cervical canal 730
into the vaginal cavity 710. As shown in FIG. 4, the bulge 180
preferably has a contoured surface to prevent discomfort when
inserting the arm 120 into the cervical canal 730.
[0042] In addition to the circumferential bulge 180, additional
alternative embodiments that assist in providing resistance to
removal of the arm 120 are shown in FIGS. 15-17. As shown in FIGS.
15A and 15B, the arm 120 may have a plurality of longitudinal
ridges 175 to keep the device 100 in place with the arm 120
inserted into the cervical canal 730 during use. The ridges 175 are
positioned along a length 185 of the arm 120 between a midway point
of the arm (midway between the proximal end 121 and the distal end
122) and the distal end 122 of the arm, and may preferably be
positioned nearer to the distal end 122 of the arm 120 than to the
midway point of the arm 120, similar to where the circumferential
bulge 180 is located in FIG. 1. Once the arm 120 is inserted into
the cervical canal 730, as shown in FIG. 14, the wider diameter of
the longitudinal ridges 175 provides resistance to removal of the
arm 120 from the cervical canal 730, thereby helping to keep the
device 100 in place for a period of time after semen has been
introduced into the cervical canal 730 or uterine cavity 740 so
that the device 100 prevents leakage of semen from the cervical
canal 730 into the vaginal cavity 710. As shown in FIGS. 15A and
15B, the longitudinal ridges 175 preferably have a convex outer
surface to prevent discomfort when inserting the arm 120 into the
cervical canal 730.
[0043] Alternatively, as shown in FIGS. 16A and 16B, the arm 120
may have a plurality of circumferential ridges 205 to keep the
device 100 in place with the arm 120 inserted into the cervical
canal 730 during use. The circumferential ridges 205 are positioned
along a length 185 of the arm 120 between a midway point of the arm
(midway between the proximal end 121 and the distal end 122) and
the distal end 122 of the arm, and may preferably be positioned
nearer to the distal end 122 of the arm 120 than to the midway
point of the arm 120, similar to where the circumferential bulge
180 is located in FIG. 1. Once the arm 120 is inserted into the
cervical canal 730, as shown in FIG. 14, the wider diameter of the
circumferential ridges 205 provides resistance to removal of the
arm 120 from the cervical canal 730, thereby helping to keep the
device 100 in place for a period of time after semen has been
introduced into the cervical canal 730 or uterine cavity 740 so
that the device 100 prevents leakage of semen from the cervical
canal 730 into the vaginal cavity 710. As shown in FIGS. 16A and
16B, the circumferential ridges 205 taken together preferably form
a contoured outer surface to prevent discomfort when inserting the
arm 120 into the cervical canal 730.
[0044] Alternatively, as shown in FIGS. 17A and 17B, the arm 120
may have a plurality of circumferential barbs 215 to keep the
device 100 in place with the arm 120 inserted into the cervical
canal 730 during use. The barbs 215 are positioned along a length
185 of the arm 120 between a midway point of the arm (midway
between the proximal end 121 and the distal end 122) and the distal
end 122 of the arm, and may preferably be positioned nearer to the
distal end 122 of the arm 120 than to the midway point of the arm
120, similar to where the circumferential bulge 180 is located in
FIG. 1. Preferably, but not necessary, the diameter of each
circumferential barb 215 will increase as the barbs 215 approach
the proximal end of the arm 120, Once the arm 120 is inserted into
the cervical canal 730, as shown in FIG. 14, the gradual increase
in diameter and the upward angled shaped of the barbs 215 provides
resistance to removal of the arm 120 from the cervical canal 730,
thereby helping to keep the device 100 in place for a period of
time after semen has been introduced into the cervical canal 730 or
uterine cavity 740 so that the device 100 prevents leakage of semen
from the cervical canal 730 into the vaginal cavity 710. The shape
of the circumferential barbs 215 allow them to contract inwards
during insertion of the arm 120 into the cervical canal 730 to
prevent discomfort.
[0045] 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, hut not limited
to, plastic, glass, ceramic, metal, any type of rubber, or any
combination thereof.
[0046] The shield 110 and the arm 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 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. FIG. 14
illustrates the device 100 being used with a syringe 170 and
catheter 160 for introducing semen into the reproductive system.
However, as discussed below, the syringe 170 and catheter 160 are
removed after the introduction of semen, and the device 100 remains
in place in the position shown in FIG. 14 for a period of time to
prevent leakage of semen into the vaginal cavity 710, 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 fluid-tight seal is formed between the cervical canal
730 and the vaginal cavity 710 of the patient. The fluid-tight 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 and fit
flush against the tissue surrounding 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.
[0047] As illustrated in FIGS. 3-6, 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 is 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.
4 and 5, 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.
[0048] 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.
[0049] To facilitate removal of the medical device 100 after use,
the insert member 130 may optionally have a string 140 attached
thereto, as best seen in FIGS. 10 and 13. The string 140 may be a
medical-grade suture, though any suitable material may be utilized.
To facilitate attachment of the string 140 to the insert member
130, the insert member 130 may have an annular cavity 200 located
on the exterior of the insert member 130, as best seen in FIGS. 6
and 7. The insert member 130 has at least one external opening 210
that provides external access to the annular cavity 200.
[0050] Preferably, as best seen in FIG. 5, the insert member130 has
two external openings 210 on opposing sides of the insert member
130. To secure the string 140 to the insert member 130, an end of
the string 140 may be inserted through the external opening 210
into the annular cavity 200 and around the insert member 130 until
the inserted end of the string 140 exits the external opening 210.
The string 140 may then be tied to secure the string 140 to the
insert member 130. As used herein, "tying" the string may include
any suitable method of securing the inserted end of the string 140
to a portion of the string after inserting the end through the
annular cavity 200 so that the string 140 is secured to the insert
member 130. FIG. 8 shows a top view of the device 100 illustrating
the insert member 130 and portions of two external openings
210.
[0051] 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. 14. By pulling the string 140, the medical device
100 may be removed through the vaginal cavity 710 without forceps
or a similar device. Alternatively, the string 140 may be
permanently attached to the insert member 130. For instance, the
device 100 may be melded such that one end of the string 140 is
molded into the insert member 130.
[0052] As shown in FIG. 7, the medical device 100 may have a bore
150 extending longitudinally through the aim 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, as shown in FIG. 3. 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, as shown in FIG. 14,
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 bore 150 and then through the
opening 610 at the distal end 122 of the arm 120, as shown in FIGS.
12-14. The bore 150 is 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 a patient's 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.
[0053] The device 100 may further comprise 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 FIGS. 10 and 11, and a closed
position, as shown in FIGS. 1 and 2. The valve 190 comprises a
plurality of elastomeric flaps 195 integrally attached to the
distal end 122 of the arm 1200 The elastomeric flaps 195 are
resiliently biased inwardly toward the center of the bore 150 and
against each other when the valve 190 is in the closed position.
The elastomeric flaps 195 are 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 flex and/or stretch and then return to its original position.
In this case, the original position refers to the closed position
of the valve. Preferably, the valve 190 has three elastomeric flaps
195 each having a generally triangular shape, as best seen in FIG.
2. The three triangular flaps 195 fit together when the valve 190
is in the closed position to form a substantially fluid-tight seal
to prevent fluid leakage through the valve 190. FIG. 9 shows a
bottom view of the device 100 with the valve 190 in the closed
position.
[0054] During an artificial insemination procedure, an insemination
catheter 160 may pass through the entirety of the device 100, When
the catheter 160 is pushed through the opening 610 at the distal
end 122 of the arm 120, as shown in FIGS. 12 and 13, the catheter
160 forces the elastomeric flaps 195 of the valve 190 outward, as
best seen in FIGS. 11 and 12, thereby moving the valve 190 into the
open position. In this manner, a 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 while leaving the device 100 in place. Upon delivery
of the semen sample, the insemination catheter 160 may be entirely
or partially removed from the medical device 100. When the catheter
160 is removed, the elastomeric flaps 195 of the valve 190 move to
their 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
bore 150 and thus 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 hat 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.
[0055] 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. 14. 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. 14. As
previously noted, FIG. 14 illustrates the device 100 being used
with a syringe 170 and catheter 160, though the device 100 may be
used as a cervical plug without the syringe 170 and catheter 160 by
inserting the device 100 into the position shown in FIG. 14 and
leaving the device in place. 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 os 720, the shield 110 and the arm 120 of the medical
device 100 prevent the semen sample from leaking from the cervical
canal 730 into the patient's vaginal cavity 710. The
circumferential bulge 180 (or alternatively, the circumferential
ridges 205, circumferential barbs 215, or longitudinal ridges 175
shown in FIGS. 15-17) of the arm 120 provides resistance to removal
of the arm 120 of the device 100 from the cervical canal 730,
thereby helping to ensure that the device 100 stays in place during
use, as shown in FIG. 14. 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.
[0056] 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.
[0057] The medical device 100 may be configured to additionally
function as a guide or cannula for a catheter, as shown in FIGS.
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 bulge 180 (or alternatively,
circumferential ridges 205, circumferential barbs 215, or
longitudinal ridges 175 shown in FIGS. 15-17) positioned along a
length 185 of the arm 120. The 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. 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, thereby forcing the valve 190 into the open position, as shown
in FIG. 12, 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.
[0058] 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 and the
valve 190 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 and through the valve 190 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 and the valve 190 at the distal end 122 of the arm 120 prior to
insertion of the device 100, as shown in FIGS. 12 and 13.
[0059] The elastomeric flaps 195 of the valve 190 are resiliently
biased against each other when the valve 190 is in the closed
position, as shown in FIG. 2. 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 so that the catheter 160
forces the elastomeric flaps 195 outward, thereby moving the valve
190 to the 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 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 insertion of the medical device
100 into the cervical canal 730.
[0060] 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
and through the valve 190, 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. 14. 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 flaps 195
of the valve 190 return to their original position, as shown in
FIG. 2, in which the valve 190 is in a closed position, thereby
preventing the semen sample from flowing back through the valve 190
and the bore 150. With the medical device 100 secured in place, the
shield 110 and the arm 120 of the device 100 prevent the semen
sample from leaking from the cervical canal 730 around the device
100 and into the patient's vaginal cavity 710, thereby increasing
the efficacy of intracervical or intrauterine insemination by
reducing semen sample loss. The circumferential bulge 180 (or
alternatively, the circumferential ridges 205, circumferential
barbs 215, or longitudinal ridges 175 shown in FIGS. 15-17) of the
arm 120 helps to keep the device 100 secured in place to prevent
leakage around the device 100.
[0061] 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.
[0062] 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. 14 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.
[0063] The overall size or specific dimensions of components of the
present device 100 may be varied to accommodate different patients.
As one example, the device 100 may have the following dimensions:
The shield 110 may be circular with a diameter of 22.50 mm; the arm
120 may be cylindrical with a diameter of 3.40 mm; and the
circumferential bulge 180 (or alternatively, the circumferential
ridges 205 circumferential barbs 215, or longitudinal ridges 175
shown in FIGS. 15-17) may have a diameter of 4.46 mm at their
widest point and extend along a length 185 of the arm 120 of 3.18
mm. These dimensions are illustrative only and are not intended to
be limiting.
[0064] 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.
[0065] 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 valve 190 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 valve 190 is in an open position upon user receipt.
[0066] 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.
* * * * *