U.S. patent number 3,918,431 [Application Number 05/432,700] was granted by the patent office on 1975-11-11 for fallopian tube obturating device.
Invention is credited to Manfred Sinnreich.
United States Patent |
3,918,431 |
Sinnreich |
November 11, 1975 |
Fallopian tube obturating device
Abstract
A surgical device for obturating the fallopian tubes at the
point of juncture with the walls of the uterus to effect temporary
female sterilization. The device is positioned through the cervix
using an endoscope and pneumatic insuflating means, and includes a
removable plug member which permits normal ovulation.
Inventors: |
Sinnreich; Manfred (Scarsdale,
NY) |
Family
ID: |
23717253 |
Appl.
No.: |
05/432,700 |
Filed: |
January 11, 1974 |
Current U.S.
Class: |
128/831; 128/887;
128/840 |
Current CPC
Class: |
A61F
6/22 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/22 (20060101); A61B
019/00 () |
Field of
Search: |
;128/1R,127,130,131,129,128,283,303,241,DIG.25 ;3/1R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Temko & Temko
Claims
I claim:
1. A fallopian tube obturator for use in effecting permanent or
reversible female sterilization by positioning the same to overlie
the lumen of said fallopian tube, said obturator comprising: a main
body element including a frusto-conically-shaped member of diameter
permitting entry into a fallopian tube, and a radially-extending
flange forming a stop means located at a larger end thereof, said
frusto-conical member including a tapered through bore, the larger
end of which is threaded, said plug element being of
correspondingly tapered configuration and having a mating threaded
outer surface; whereby the tapered fit between said plug element
and said frusto-conical member serves as a guide to facilitate
engagement therebetween, and limit the extent of said engagement to
a predetermined degree.
2. A fallopian tube obturator for use in effecting permanent or
reversible female sterilization by positioning the same to overlie
the opening to the lumen of said fallopian tube, said obturator
comprising a main body element having means thereon for engaging
tissue bordering said lumen, and defining a generally centrally
positioned threaded opening overlying said opening to said lumen, a
plug element having threaded means selectively engaged with said
opening to close said lumen; said main body element having first
tool-engaging means, said plug element including second
tool-engaging means concentrically arranged with respect to said
first tool-engaging means, whereby said obturator may be installed
in position as a unit, and engagement of said first and second
tool-engaging means permits the holding of said body element in
installed position while disengaging said plug element
therefrom.
3. Structure in accordance with claim 2, further characterized in
said main body element being of a generally planar configuration
and having an inner surface having hooked means extending therefrom
for positive engagement with a portion of a uterine wall
surrounding the lumen of a fallopian tube; said main body element
defining a threaded centrally disposed opening, said plug element
including a domed inner wall adapted to exert a sealing pressure
against the opening to said lumen.
4. The method of effecting reversible female sterilization,
comprising the steps of: providing a composite fallopian tube
obturator including a main body element having means thereon for
engaging tissue bordering said lumen and defining a generally
centrally positioned threaded opening overlying the opening to said
lumen, and a plug element having threaded means selectively engaged
with said opening to close said lumen, said main body element
having first tool-engaging means, said plug element having
tool-engaging means; providing a composite manipulative tool
including a hollow tube having first means engaging said first
tool-engaging means, and a shaft disposed within said hollow tube
and rotatably and axially movable relative thereto, said shaft
having means selectively engaging said second tool-engaging means;
engaging said obturator, using said tool whereby said plug element
engaged with said main body element overlies and closes the opening
to the lumen of a fallopian tube, and removing said plug element,
as required, by engaging said first means with said first
tool-engaging means on said main body element to hold said main
body element in installed position while engaging said means on
said shaft with said second tool-engaging means to disengage and
remove said plug element with respect to said main body element.
Description
BACKGROUND OF THE INVENTION
This invention relates generally to the field of female
sterilization, and more particularly to an improved device for
obturating the fallopian tubes to prevent ovulation, as well as
means and techniques for positioning and removal of such
devices.
It is known in the art to effect permanent sterilization by
cauterization performed through an endoscope, without the necessity
of making an abdominal incision, and in cases where this procedure
is not feasible or desirable, the tubes can be reached for
cauterization through the abdomen by inserting a
pneumoperitoneum-forming device.
The above procedures effect, with varying degrees of reliability, a
permanent sterilization, and is normally resorted to in cases where
other methods of birth control are not feasible. Aside from the
factor of reliability, the performance of surgical procedures of
the above type are not without risk, particularly where body
cavities are pneumatically inflated using an inert gas. Aside from
injury due to overinflation, numerous cases of the formation of
embolisms have been reported.
Recently, liquid silicone has been used to block the oviducts of
rabbits, successfully preventing pregnancy. Using this technique,
the silicone, as it solidifies, conforms precisely to the lumen of
the oviduct. The success of such a technique with the human female
has yet to be established, and one obvious shortcoming is the lack
of any means with such a plug for positive engagement within the
tube, so that it will not be subsequently expelled.
BRIEF DESCRIPTION OF THE PRESENT INVENTION
Briefly stated, the invention contemplates the provision of an
obturating device which is positioned through the uterus into the
communicating lumen of the fallopian tube, using an endoscope and
associated manipulating means. The device includes a first element
which remains relatively permanently in position at the end of the
fallopian tube, and a removable plug element uncovering an opening
establishing communication from the tube and permitting normal
ovulation. The device is preferably formed of synthetic resinous
materials which will not be incompatible with the installed situs,
and include means for positive engagement at the situs, so as not
to be expelled. The plug element may include a permanent magnet to
improve tool engagement retention. One form of device includes a
tapered member extending into the fallopian tube. Another form is
of generally planar configuration, and is attached to the uterine
wall surrounding the lumen of the tube by integrally molded snelled
hooks.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings, to which reference will be made in the
specification, similar reference characters have been employed to
designate corresponding parts throughout the several views.
FIG. 1 is a fragmentary longitudinal sectional view showing a first
embodiment of the invention in installed condition, with a
positioning tool engaged therewith.
FIG. 2 is a similar fragmentary sectional view showing the
disengagement of a plug element to permit normal ovulation.
FIG. 3 is a view in elevation showing a device upon the end of a
positioning tool prior to installation.
FIG. 4 is an enlarged fragmentary view in elevation, partly in
section, showing the engagement of tool means with tool receiving
means on the plug element.
FIG. 5 is a transverse sectional view as seen from the plane 5--5
in FIG. 1.
FIG. 6 is a view in elevation showing a second embodiment of the
invention.
FIG. 7 is a central sectional view of the second embodiment as seen
from the plane 7--7 in FIG. 6.
DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENTS
In accordance with the first embodiment of the invention, the
device, generally indicated by reference character 10, comprises
broadly: a main body element 11 and a detachable plug element
12.
As best seen in FIGS. 1 to 3, inclusive, the main body element 11
is of generally tapered configuration, and includes a
frusto-conically shaped member 15 having a first or outer end 16,
and a second or inner end 17, and an axially disposed tapered bore
18, the outer end of which is threaded at 19. The outer end may be
slightly flaired as at 20, to facilitate engagement of the plug
element 12, as will be more fully apparent hereinafter.
The outer surface 21 of the member 15 is provided with a plurality
of arcuate projections 22 each having first and second surfaces 23
and 24, respectively, meeting in a relatively thin edge 25 which
provide means for engaging the inner wall of the fallopian tube,
generally indicated by reference character 29, to resist untended
withdrawal. An annular flange 26 provides positioning means whereby
the main body element 11 is prevented from being inserted to an
excessive degree within the tube. At the outer end 16 of the member
15, there are provided first and second curvate recesses 27 and 28,
respectively, for the selective engagement of a manipulating tool
to be subsequently described.
The plug element 12, like the main body element 11 is preferably
formed from a suitable synthetic resinous material, and includes a
magnetized hard metallic insert 30 which serves as tool retention
means, the insert being surrounded by a synthetic resinous sheath
31, the plug being preferably formed by insert molding operations
well known in the molding art. The insert 30 is preferably tubular
in configuration, and extends between first and second ends 32-33,
and may include a knurled surface 34 to prevent shifting in
position during the molding operation. The sheath 31 includes a
distal end 36, a tapered cylindrical wall 37, the outer surface 38
of which is threaded, and a proximal end 39 defining an end surface
40 having toolengaging bores 41 extending thereinto. The bores 41
each include oppositely positioned inner recesses 42 which assist
in tool retention.
To position the device in situ, employing an endoscope requires a
manipulating tool 44 adapted to be inserted within the longitudinal
bore of the endoscope (not shown). The tool 44 includes a first or
outer element 45 and a concentrically disposed second or inner
element 46.
The outer element 45 comprises a hollow flexible tube 48
approximately 5mm in diameter having an outer manually engagable
knurled member 49 which projects outwardly of the proximal end of
the endoscope. The inner end 50 thereof mounts first and second
prongs 51-52 arranged in slightly converging relation to permit
convenient engagement with the curvate recesses 27-28, as best seen
in FIGS. 1 and 2. Proper seating is determined by the engagement of
the terminals 53 with the outer surface of the flange 26.
The inner element 46 comprises a solid tube 56 of diameter
sufficiently small to fit within the bore of the tube 48. An outer
end 57 includes a manually engageable knurled member 58 which
projects outwardly of the member 49. An inner end 61 mounts first
and second prongs 62-63 which selectively engage the bores 41 as
best seen in FIG. 4.
Insertion of the device within the fallopian tube commences with
the positioning of the same with the plug element 12 in position on
the end of the tool 44 as seen in FIG. 3. The entire assembly is
then positioned within the bore of the endoscope (not shown) and
the endoscope is inserted in well known manner within the uterus,
following which the uterus is insuflated to expose the fallopian
tubes. Upon location of the lumen of the tubes, the tool 44 is
moved outwardly from the distal end of the endoscope, whereby the
narrow end of the member 15 is inserted into the lumen to the
position shown in FIG. 1 wherein the device 10 is fully seated.
Next, keeping the inner element 46 engaged with the plug element
12, the outer element 45 is withdrawn, leaving the device in fully
seated condition. Following this, the inner element 46 is
disengaged, the amount of force necessary to effect such
disengagement being insufficient to overcome the reactive force
provided by the engagement of the arcuate projections 26 with the
inner walls of the tube. The device may be left in this position as
long as required, and may be removed in its entirety by re-engaging
the device as shown in FIG. 1, and exerting a combined rotational
and retractive movement to both the outer element 45 and the inner
element 46.
Should it be desired to permit normal ovulation, the plug element
12 can be separately removed as shown in FIG. 2 by first
re-engaging the tool 44 as shown in FIG. 1, and while holding the
outer element 45 stationary, the inner element 46 is rotated to
threadedly disengage the plug element 12 from the main body element
11. Once disengaged, the plug element 12 may be backed off into the
tube 48 as shown in FIG. 2, the retentive effect of the prong 62-63
being assisted by the magnetic attraction of the insert 30.
Normally, by the time this procedure is required, the device will
have firmly seated itself within the fallopian tube, and the outer
element 45 may be withdrawn without difficulty. Replacement of the
plug as desired may be made at any time, the tapered configuration
of both the plug element and the bore 18 facilitating the
repositioning of the former.
Turning now to the second embodiment of the invention, illustrated
in FIGS. 6 and 7, the device, generally indicated by reference
character 68, differs from the first embodiment in the elimination
of the frusto-conical portion of the main body element, and the
substitution thereof of a planar main body element 69.
The element 69 includes an outer surface 70, and an inner surface
71 and is bounded by a generally circular peripheral edge 72. A
threaded bore 73 extends through the plane of the element 69 to
accommodate a plug element 74. Extending from the inner surface 71
are a plurality of snelled hooks 75 which are adapted to directly
engage the inner surface of the uterine wall to be retained
thereby. The plug element 74 is of relatively short axial length,
and is provided with a domed inner surface 77 adopted to directly
overlie the lumen of the tube to exert a sealing force
thereagainst. Two engaging bores 78 and 79 correspond to those of
the first embodiment, and the device is installed and removed as is
the case in the first embodiment.
I wish it to be understood that I do not consider the invention
limited to the precise details of structure shown and set forth in
this specification, for obvious modifications will occur to those
skilled in the art to which the invention pertains.
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