U.S. patent number 3,855,996 [Application Number 05/337,071] was granted by the patent office on 1974-12-24 for contraceptive apparatus and procedure.
This patent grant is currently assigned to Medtronic, Inc.. Invention is credited to Lee R. Bolduc.
United States Patent |
3,855,996 |
Bolduc |
December 24, 1974 |
CONTRACEPTIVE APPARATUS AND PROCEDURE
Abstract
An instrument for implanting a ring in the tissue around the
intramural portion of the Fallopian tube and the method of closing
the canal of the intramural portion of a Fallopian tube with a
ring. The instrument is an elongated member having an annular knife
surrounding a forwardly projected guide rod. The knife is located
at the forward edge of a cylindrical member used to carry the
expanded annular device, as an elastic ring. The knife is used to
make an annular incision in the intramural tissue of a Fallopian
tube. The instrument has a second movable member for removing the
expanded ring past the knife, thereby implanting the ring in the
annular incision made by the knife. The ring returns to its
original position, thereby closing the canal of the Fallopian
tube.
Inventors: |
Bolduc; Lee R. (St. Louis Park,
MN) |
Assignee: |
Medtronic, Inc. (Minneapolis,
MN)
|
Family
ID: |
23318991 |
Appl.
No.: |
05/337,071 |
Filed: |
March 1, 1973 |
Current U.S.
Class: |
128/831 |
Current CPC
Class: |
A61F
6/225 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/22 (20060101); A61b
019/00 () |
Field of
Search: |
;128/1R,33A,305,306,310,311,326,346 ;30/124 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. An instrument for implanting an annular device in tissue around
the canal of a Fallopian tube to close the canal of the Fallopian
tube comprising: first means for making an annular incision in the
tissue around the exit section of the canal of the Fallopian tube,
said first means having a member for carrying an expanded annular
device and knife means for cutting the annular incision in the
tissue, and second means movable relative to the first means for
moving the annular device from the member and into the annular
incision in the tissue around the canal whereby said annular device
contracts closing said canal.
2. The instrument of claim 1 wherein: the knife means is a circular
knife at one end of the member.
3. The instrument of claim 1 including: guide means projected
longitudinally outwardly from the member to concentrically locate
the knife means around the canal.
4. The instrument of claim 3 wherein: the guide means comprises an
axial rod extended outwardly from the member, said knife means
located concentrically about the rod.
5. The instrument of claim 1 wherein: the member is a cylindrical
member having an axial recess, said knife means comprising a
circular sharp edge at the outer end of the recessed end of the
cylindrical member.
6. The instrument of claim 1 wherein: the first means has an
elongated section, said member being attached to one end of the
elongated section, said second means comprising a sleeve slideably
mounted on the elongated section, said sleeve having a portion
surrounding the member, said portion engageable with the annular
device to move the annular device from the member on movement of
the sleeve relative to the elongated section.
7. The instrument of claim 6 including: a head attached to the
other end of the elongated section.
8. The instrument of claim 1 wherein: the member is a cylindrical
member having an elongated cylindrical outer surface, said annular
device being an expandable ring locatable on said cylindrical outer
surface.
9. The instrument of claim 1 wherein: the second means surrounds
the first means and is movably mounted thereon.
10. A method of closing the canal of a Fallopian tube with an
annular device comprising: making an annular incision around the
exit portion of the canal of a Fallopian tube from the uterine
cavity, placing an expanded annular device in the annular incision
and allowing the expanded annular device to contract to close the
canal of the Fallopian tube.
11. The method of claim 10 wherein: the annular incision is made by
inserting an instrument having an annular knife into the uterine
cavity, guiding a portion of the instrument into the exit section
of the canal during the annular cutting of the tissue around the
canal with the annular knife.
12. The method of claim 10 including: expanding an annular device
on an instrument having an annular knife, inserting the instrument
carrying the annular device into the uterine cavity; said annular
incision is made by cutting an annular incision in the tissue
around the canal of the Fallopian tube, said annular device is
placed into the incision by moving the annular device from the
instrument whereby the annular device contracts closing the canal,
and removing the instrument from the uterine cavity.
13. The method of claim 12 wherein: the instrument is rotated about
its longitudinal axis during the cutting of the annular
incision.
14. The method of claim 12 wherein: a portion of the instrument is
guided into the exit section of the canal during the cutting of the
annular incision.
15. The method of claim 10 wherein: the annular incision is made
with an instrument having a knife portion and a guide portion, said
guide portion of the instrument is inserted longitudinally into the
canal to locate the knife portion concentrically about the canal
whereby the knife portion makes the annular incision around the
canal.
Description
BACKGROUND OF THE INVENTION
A common surgical procedure to sterilize a female primate is a
procedure wherein each Fallopian tube is severed and tied to block
the oviduct and thereby prevent ova from entering the uterus. This
procedure includes placing the patient under general anesthesia and
making an abdominal incision of 8 to 10 centimeters in the pubic
region to provide access to the body cavity. After severing and
tying the Fallopian tubes, the incision is closed with clamps and
stitches. This requires a period of hospitalization and is
extremely uncomfortable and painful to the patient.
Mechanical contraceptive devices are used for temporarily
sterilizing a female. These devices include plugs which are
inserted into the oviduct of the Fallopian tube to prevent the ova
from passing through the duct of the tube. The plugs do not insure
that the ova cannot flow through the duct of the tube into the
uterus. Also, the plugs may be dislodged and lost without the
female being aware of it. There is no assurance that the device is
effective. Plugs attached to the uterus wall to block both the
entrance of ova into the uterus from the duct and the exit of sperm
from the uterus into the duct have been proposed by Cimber in U.S.
Pat. Nos. 3,675,639 and 3,680,542. These plugs are designed to
effect temporary sterilization in that they can be removed and do
not cause permanent blockage of the duct of the Fallopian tube.
This type of plug is not entirely effective in that it is possible
for ova to bypass the plug and enter the uterus.
SUMMARY OF THE INVENTION
The invention is related to an instrument or tool for implanting an
annular device in the tissue around the canal of a Fallopian tube
to close the canal of the Fallopian tube, thereby preventing ova
from flowing down the tube into the uterus. The instrument has a
first means for making an annular incision in the tissue around the
exit section of the canal of the Fallopian tube. The first means
has a member for carrying an expanded annular device and a knife
means for cutting an annular incision. A second means movable
relative to the first means is used to remove the annular device
from the member and place the annular device in the incision. The
annular device, when removed from the member, contracts to its
original size, thereby closing the canal of the Fallopian tube. The
annular device is removed from the instrument in a manner whereby
the annular device is placed in the incision to locate the annular
device in the muscle tissue around the canal of the Fallopian tube.
The muscle tissue will reunite, thereby embedding the annular
device in the tissue so that the annular device will not be
dislodged or inadvertently removed to reopen the canal of the
Fallopian tube.
The invention also includes the method of closing the canal of a
Fallopian tube with an annular contracting device. An annular
incision is made in the tissue around the intramural or exit
portion of the Fallopian tube by inserting an instrument having an
annular knife into the uterine cavity. The instrument is guided
into the canal to make an annular incision concentric about the
canal. The expanded annular device is placed in the annular
incision. The expanded annular device is allowed to contract while
it is located in the annular incision to close the canal of the
Fallopian tube. The instrument is removed from the uterine cavity
with the annular device embedded in the tissue surrounding the
canal of the Fallopian tube. The tissue will heal and thereby
permanently embed the annular device in the tissue around the canal
of the Fallopian tube.
It is an object of the invention to provide an apparatus and
procedure whereby the canal of a Fallopian tube can be permanently
closed without making an incision in the body cavity. Another
object of the invention is to close the intramural portion of the
Fallopian tube with an annular contracting device that is placed
about the canal of the Fallopian tube from the uterine cavity. A
further object of the invention is to provide a device which is
implanted in the muscle tissue of a Fallopian tube that will not
dislodge and permanently close the canal of the Fallopian tube. A
still further object of the invention is to provide a device for
closing the canal of a Fallopian tube which does not interfere with
the normal erection and contraction of the Fallopian tubes.
IN THE DRAWINGS
FIG. 1 is a side elevational view of the cutting and insertion
instrument of the invention in the cutting position;
FIG. 2 is a side elevational view similar to FIG. 1 showing the
instrument in the position for inserting the ring in an incision to
close the canal of a Fallopian tube;
FIG. 3 is an enlarged end view of the cutting end of the instrument
of FIG. 1;
FIG. 4 is a sectional view of a part of the uterus and Fallopian
tube of a female primate;
FIG. 5 is a sectional view showing the instrument making an annular
incision into the uterus tissue around the Fallopian tube;
FIG. 6 is a sectional view taken along the lines 6--6 of FIG.
5;
FIG. 7 is a sectional view similar to FIG. 5 showing the ring
removed from the instrument;
FIG. 8 is a sectional view similar to FIG. 7 with the instrument
removed from the uterus; and
FIG. 9 is a sectional view taken along the line 9--9 of FIG. 8.
Referring to the drawings, there is shown in FIGS. 1 and 2 an
instrument 10 for implanting an annular contracting device or
member, as a ring, around the canal or aqueduct of a Fallopian tube
to close the canal and thereby prevent the passage of ova through
the canal. Instrument 10 has a first member indicated generally at
11 operable to cut an annular incision in the exit portion or
intramural portion of the Fallopian tube and a second member
indicated at 12 movably mounted on the first member to implant an
annular contracting device, as a ring, to close the canal of the
Fallopian tube. The closed canal and annular incision in the tissue
about the canal will heal forming tissue which embeds the annular
device in the tissue. The annular device cannot remove itself and
thereby reopen the canal of the Fallopian tube.
First member 11 has a crylindrical body 13. The outer end of body
13 has an annular or circular knife 14. A cylindrical recess 16
extends axially into the body 13 whereby the outer portion of the
body is a cylindrical sleeve or collar. The outer portion or
surface of body 13 has a smooth cylindrical configuration. Secured
to the body 13 is a guide means or rod 17. Rod 17 extends axially
through recess 16 and terminates in a point 17A located outwardly
from the knife 14. Knife 14 is concentrically located about the rod
17.
Cylindrical body 13 is attached to an elongated linear member or
rod 18. The end of member 18 is attached to a cylindrical head 19.
The member 18 extends into head 19 and is attached thereto with a
fastener 20.
Second member 12 is slideably disposed on the cylindrical body 13
and elongated linear member 18. Second member 12 is a one-piece
plastic unit having an elongated body 21 with a longitudinal
passage 22 for slideably accommodating linear member 18. One end of
body 21 has a cylindrical recess 23 forming a sleeve 24
concentrically positioned about the cylindrical body 13. Sleeve 24
terminates in a circular end 26 surrounding the cylindrical outside
wall of the body 13. The recess 23 has a longitudinal length which
allows the cylindrical body 23 to be longitudinally moved relative
to the body 21 whereby the end 26 will move past or outwardly of
the knife 14 as shown in FIG. 7.
The instrument 10 is used to implant an annular elastic contracting
device or member 27, as a ring or torus of plastic or metal. The
member 27 is made of bio-inert material which can be expanded and
will contract to its initial shape. Examples of the material are
Silastic plastic and stainless steel. Other materials can be used
for the annular device 27. The annular device 27 shown in FIGS. 5-9
is an elastic ring of plastic material having a uniform circular
cross section. Ring 27 can be expanded or enlarged to place it on
the cylindrical member 13 adjacent end 26 of the second member.
When ring 27 is removed from member 13, it contracts or returns to
its original size. A cap 45 shown in broken lines in FIG. 1 placed
on rod 17 and covering knife 14 is used to load the ring 27 on
member 13.
Referring to FIG. 4, there is shown a section of a uterus 28 of a
female. Uterus 28 has a top portion or fundus 29 and a body 31. The
entire uterus is a pear-shaped, thick walled, hollow organ situated
between the bladder and rectum. The uterus 28 has a uterine cavity
32 which is flattened and triangular in shape. The uterine wall is
composed of an outer serosal layer 30, or peritoneum, a firm,
thick, intermediate coat of smooth muscle 33 or myometrium, and an
inner mucosal lining 34 or endometrium.
Leading to the upper part of the uterus are Fallopian tubes 36. The
Fallopian tubes are paired, trumpet-shaped muscular canals which
extend from the superior angles of the uterine cavity to the
ovaries. The ovaries, not shown, are solid, slightly irregular
shaped bodies situated on either side of the uterus behind and
below the Fallopian tubes.
Fallopian tube 36 is a musculomembranous structure about 12 cm in
length commonly divided into isthmus 37, intramural 38 and
ampullary sections (not shown). The tube 36 has an aqueduct or
canal 39 providing a passage for the movement of ova from the
ovaries into the uterus. The intramural section 38 traverses the
uterine wall in more or less straight fashion. It has an
ampulla-like dilation just before it communicates with the uterine
cavity 32. The canal 39 is the narrowest at the intramural section
38. The isthmus section 37 is long and wavy and the canal is not as
narrow as the canal in the intramural section. The wall of the
Fallopian tube consists of three layers, a serosal coat, a muscular
layer and a mucosal lining. The muscular lining includes
longitudinal muscle fibers which, when contracted, bring the ends
of the Fallopian tubes into close contact with the surface of the
ovaries. Blood vessels are abaundant in the muscular layer where
they form with the muscle bundles a kind of erectal tissue which,
if engorged, enables the Fallopian tube to sweep over the surface
of the ovary. This action of the Fallopian tubes is impaired when
the tubes are severed and tied. The closing of the intramural
section of the Fallopian tubes with the annular device 27 according
to the invention does not interfere with the erectal action of the
Fallopian tubes.
In use, the instrument 10 is equipped with an elastic annular
device 27, such as a Silastic ring. The ring 27 is placed about the
cylindrical body 13 adjacent the end 26 of the sleeve 24. This is
accomplished by moving ring 27 over cap 45 onto the cylindrical
body 13. The cap 45 is then removed. The instrument 10 carrying the
expanded annular device 27 is inserted into the uterine cavity 32.
The cylindrical body 13 is directed toward the outlet of the canal
39 of the Fallopian tube 36. The rod 17 is moved into the canal 39
to guide the instrument and locate the circular cutting knife 14
concentric with the canal 39.
Referring to FIG. 5, the cylindrical body 13 is rotated, as shown
by arrow 41, as it is moved into the tissue forming an elongated
circular incision 42. Incision 42 is in the muscular tissue
surrounding the canal 39 and is radially spaced from the outer
walls of the aqueduct to leave a core of muscle tissue 43. The
incision 42 is approximately 1 to 1.5 mm in length.
Referring to FIG. 7, the annular elastic device 27 is removed from
cylindrical body 13. The second member 12 is moved in the direction
of arrow 44 while the first member 11 is held in a stationary
position. The sleeve 24 moves outwardly along the cylindrical body
23, moving the annular device 27 past the knife edge 14. This
places the annular device 27 at the base of the circular incision
42. The annular device 27, being expanded, will contract to its
normal size and thereby contract the muscle tissue about the rod
17. This implants the annular device 27 in the tissue around the
canal 39.
As shown in FIG. 8, the instrument 10 has been removed from the
uterus. The annular device 27 is contracted, closing the canal 39.
The core of muscle tissue 43 closes the incision 42 rearwardly of
the annular device 27. The annular incision will in time heal and
provide a permanent closure of the opening of the canal 39. Part of
the tissue 43 will slough off. The remaining tissue will
permanently cover the annular device 27 and close canal 39.
While there have been shown and described a preferred embodiment of
the instrument for implanting a ring to close the aqueduct of a
Fallopian tube and a method of inserting the ring around the
aqueduct of the Fallopian tube, it is understood that modifications
and alterations in the instrument as well as the method may be made
by those skilled in the art without departing from the invention.
The invention is defined in the following claims.
* * * * *