U.S. patent number 3,811,435 [Application Number 05/190,769] was granted by the patent office on 1974-05-21 for intrauterine device and injection mechanism.
Invention is credited to Samuel Soichet.
United States Patent |
3,811,435 |
Soichet |
* May 21, 1974 |
**Please see images for:
( Certificate of Correction ) ** |
INTRAUTERINE DEVICE AND INJECTION MECHANISM
Abstract
An improved intrauterine device that may be injected into the
uterine cavity without puncturing the uterus and without subsequent
expulsion therefrom. The improved injector mechanism used to
introduce the device into the uterus is applied only in the
cervical canal, towards but not beyond the internal os. Regardless
of the conformation of the uterus the device automatically expands
in the endometrial cavity.
Inventors: |
Soichet; Samuel (New York,
NY) |
[*] Notice: |
The portion of the term of this patent
subsequent to April 21, 1987 has been disclaimed. |
Family
ID: |
26886423 |
Appl.
No.: |
05/190,769 |
Filed: |
October 20, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
5466 |
Jan 26, 1970 |
3678927 |
|
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|
713825 |
Mar 18, 1969 |
3507274 |
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Current U.S.
Class: |
128/840 |
Current CPC
Class: |
A61F
6/144 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/14 (20060101); A61f
005/46 () |
Field of
Search: |
;128/127,128,129,130,260 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Dunne; G. F.
Attorney, Agent or Firm: Ostrolenk, Faber, Gerb &
Soffen
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
The present invention is a continuation-in-part of application Ser.
No. 5,466, filed Jan. 26, 1970, now U.S. Pat. No. 3,678,927 in the
name of Samuel Soichet and entitled INTRAUTERINE DEVICE AND
INJECTOR THEREOF. This application discloses new and useful
improvements in the device and injector mechanism disclosed in that
prior application. Application Ser. No. 5,466 is in turn a
continuation-in-part of application Ser. No. 713,825, filed Mar.
18, 1968, now U.S. Pat. 3,507,274, issued Apr. 21, 1970 and
entitled INTRAUTERINE DEVICE.
Claims
What is claimed is:
1. A Y-shaped intrauterine device with an inert metal backbone,
each resilient Y-arm member terminating in a promontory or loop at
its apex and a base portion at the lower most portion or vertex
between Y-arm members in the inert metal backbone, the inert metal
backbone and said promontories being encapsulated in medical grade
rubber or plastic material, said encapsulated promontories defining
bead surfaces which may abut when said resilient coated Y-arm
members are pressed into contact, the contoured outer face of each
bead being substantially circular and the surface of each bead
parallel to a plane passing through said resilient member being
substantially flat; said device further having a flexible extension
or tail member integrally connected with the bulbous coated base
portion of the device, and a web member extending between the
resilient, coated Y-arm members and joining the divergently
extending Y-arm members at a vertex point defining the incipient
bulbous coated base portion of the device, the web member joining
each divergent coated Y-arm member, one to the other, at a
substantially intermediate portion of each extending coated Y-arm
member and continuously descending to the vertex between the coated
Y-arm members.
2. The improved intrauterine device of claim 1 in which the beads
engaging and encapsulating the promontories formed at the apexes of
the inert metal backbone in the device have the following
dimensions:
3. An injector for a Y-shaped intrauterine device, said injector
including a tubular barrel having an insert end, a collar
positioned below the insert end to limit the insertion of the
barrel, a finger grip portion at the lower end of the barrel, and a
piston member capable of telescoping into the barrel and expelling
a Y-shaped device from the insert end of the barrel, a hollow
piston member adapted to receive the flexible extension or tail
member of the Y-shaped device integrally connected with the bulbous
coated base portion of the device, and having an annular lip
providing a circular seat for the circular recess formed in the
bulbous coated base portion of the Y-shaped device and having
slotted side walls extending downwardly from the annular lip which
characteristically provide a leaf spring effect as the hollow
piston member telescopes into and out of the tubular barrel.
4. An intrauterine device comprising a resilient Y-shaped member,
said resilient member having two arms gradually and continuously
diverging upwardly and outwardly from the intersection thereof
adjacent the base portion of said resilient member; each of said
arms being, at the uppermost portion thereof, curved outwardly,
downwardly, and inwardly to form a bent-back portion in the form of
a partial loop terminating short of contacting the body of the
adjacent arm; said resilient member being totally encased in a
plastic or rubber material; the encasement about each of said
partial loops being in the form of a bead having a flat surface
parallel to a plane passing through said resilient member, and a
curved outside face along said bent-back portion, said curved
outside face adapted to contact the adjacent sidewall of the uterus
when said intrauterine device is in position within the uterus,
said contact being maintained during use by the resilient nature of
said resilient member; said arms being sufficiently resilient so
said arms can be urged together during positioning of said
intrauterine device in an inserter for inserting said intrauterine
device into the uterus whereby said flat surfaces on said beads
will abut one another, and said curved outside faces will define a
smooth leading-edge portion adapted to facilitate insertion of said
intrauterine devices into the uterus.
5. The intrauterine device of claim 4 including a flexible tail
extending downwardly from said intersection and adapted to extend
outwardly from the uterus through the cervix when said intrauterine
device is in position within the uterus.
6. The intrauterine device of claim 4 further including a unitary
web member extending between said encased arms, all of said web
member being between said intersection and an imaginary line
passing through said beads but covering less than the entire area
between said intersection and said imaginary line.
7. The intrauterine device of claim 6 wherein said web member
continuously descends, without opening or separation, from the
upper edge thereof to said intersection.
8. The intrauterine device of claim 4 wherein said resilient member
comprises stainless steel wire.
9. The intrauterine device of claim 4 wherein said plastic or
rubber material comprises medical grade silicone rubber.
10. An intrauterine device comprising a resilient Y-shaped member,
said resilient member having two arms gradually and continuously
diverging upwardly and outwardly from the intersection thereof
adjacent the base portion of said resilient member; each of said
arms being, at the uppermost portion thereof, curved outwardly,
downwardly and inwardly to form a bent-back portion in the form of
a partial loop terminating short of contacting the body of the
adjacent arm; said resilient member being totally encased in a
plastic or rubber material; the encasement about each of said
partial loops being in the form of a bead having two flat surfaces
parallel to each other and parallel to a plane passing through said
resilient member, and a curved outside face along said bent-back
portion, said curved outside face adapted to contact the adjacent
sidewall of the uterus when said intrauterine device is in position
with the uterus, said contact being maintained during use in the
uterus by the resilient nature of said resilient member; said arms
being sufficiently resilient so said arms can be urged together
during positioning of said intrauterine device in an inserter for
insertion of said intrauterine device into the uterus whereby
adjacent flat surfaces on said beads will abut one another, and
said curved outside faces will define a smooth leading-edge portion
adapted to facilitate insertion of said intrauterine device into
the uterus; a unitary web member extending between said encased
arms, all of said web member being between said intersection and a
line passing through said beads, said web member continuously
descending, without opening or separation, from the upper edge
thereof to said intersection; and a flexible tail portion extending
downwardly from said intersection and adapted to extend outwardly
from the uterus through the cervix when said intrauterine device is
in position within the uterus.
11. The intrauterine device of claim 10 wherein said resilient
member comprises medical grade stainless steel wire and said
medical grade plastic or rubber material comprises silicone rubber.
Description
BACKGROUND OF THE INVENTION
This invention relates to an improved Y-shaped intrauterine
contraceptive device that keeps its rigid contour after insertion
into the uterine cavity without puncturing the uterus and without
subsequent expulsion therefrom. More particularly, this invention
relates to an improved silicone covered Y-shaped stainless steel
intrauterine contraceptive device capable of reaching from the
cornua to the endocervical canal.
Prior intrauterine contraceptive devices, still in current use,
have generated serious problems for the user concommitant with the
purpose for which they have been designed. The most common and
prevalent problems and difficulties with which the user must be
concerned in utilizing prior art devices are expulsion of the
device after insertion, perforation of the uterus walls on or after
insertion and failure of the device to prevent a pregnancy.
The improved device of this invention is so sensitive to uterine
contact that it may be used, without ill effects, in even
nulligravidae or women who have never been pregnant. The device
may, in addition, be easily and simply removed by grasping the tail
portion of the device seated in the endocervical canal. The device
of this invention also exhibits the desirable characteristics of
contour retention after prolonged periods of use.
Other advantages and objects of this invention will become apparent
from the more detailed description that follows:
SUMMARY OF THE INVENTION
The improved intrauterine device of this invention includes two
resilient outwardly springing inert medical grade metal wires, for
instance nickel alloy wires, or preferably medical grade stainless
steel wires, turned inwardly at their outer ends to form
promontories or loops which provide an engaging structure. The
resilient outwardly springing inert metal wires are joined at a
common base portion and the base and wire arm elements
substantially form a Y-shaped structure.
The Y-shaped wire structure may, preferably, be formed from a
single strip of inert metal wire. The metal strip may be contoured
and bent back upon itself at a common junction point and the
divergent outwardly springing Y-members may be urged inwardly
towards each other causing the base wire members to cross each
other substantially at that junction point, as described in my
copending application Ser. No. 5,466, of which this application is
a continuation-in-part, and as shown in FIG. 3 thereof.
The springing Y-members and base wire members may thereafter be
coated with or embodied in medical grade silicone rubber or tubing
or other suitable thermoplastic material. For example, a preferred
coating composition or tubing that may be used to encapsulate the
Y-members and base member is "Silastic" a trademark of the Dow
Corning Corp., Midland, Mich. used in connection with a composition
comparable in physical character to milled and compounded rubber
prior to vulcanization, but containing organo-silicon polymers. The
encapsulated base portion may be connected to an extension or tail
member suitably formed of silicone rubber or other suitable
material such as "Silastic." This extending member or tail member
is loosely seated within the endocervical canal and serves to
facilitate removal of the device in addition to providing a guide
means for ascertaining whether or not the device is properly in
place.
In this particularly improved form of the device, a web or bridging
member extends between the resilient Y-member and joins the
extending Y-members at a vertex point defining the incipient base
portion of the device. The bridging member or web member joins each
Y-member, one to the other, at a substantially intermediate portion
of each extending Y-member and continuously descends to the vertex
between Y-members.
The descending continuous web joining the Y-members increases the
utility of the device and enhances its effectiveness. Devices
formed with this web portion cover a larger surface area within the
uterine cavity and in the event of a pregnancy prevent nidation or
seeding of the fertilized egg. The web portion also serves to
retain the resilient posture of the Y-members within the uterine
cavity by preventing each Y-member from submitting to an outwardly
urging pressure which would deform the members from their contoured
shape.
The promontories or loops which provide an engaging surface at the
outer end of each Y-member are designed to receive and be embodied
in a plastic bead, such as silicone rubber, polyethylene or
polypropylene beads and preferably beads formed from "Silastic"
adhesive. The design of the bead is directly related to the success
of the device. The beads must be designed to accomplish their
function as deflectors or stimulate utera-tubal contractions during
those periods of time when the user becomes susceptible to
pregnancy; yet the design must be such as to avoid chronic
irritation of the uterine walls in proximity to the device. In the
improved device of this invention, the beads have been reduced in
size to minimize the possibility that intrauterine pressure and
bleeding may occur; however, the device still performs
satisfactorily and under certain circumstances performs better than
the device disclosed in my prior application.
According to an improved bead design, the face of each bead is
substantially flat and the sides of the beads that may be mated,
one with the other, when the Y-shaped members are urged towards and
in contact with each other, are flattened to facilitate
introduction of the device into the injector. The outward extension
of each bead from the mating surface of each Y-member may be curved
outwardly of the mating surface to provide an ovular end portion
seated in the mouth of the injector and which may be readily
inserted within the entrance of the uterine cavity.
The injector includes an elongated tubular member with a collar
adjacent the inlet or injector end of the tubular member. The
collar limits the extent to which the tubular member may be
inserted through the cervix of the uterine cavity. The collar
extends outwardly from the elongated tubular member and around the
entire perimeter of the tubular member. The tubular member is of
sufficient dimension or diameter to receive the extension or tail
member of the device as well as the upwardly extending Y-members
when pressed together. When the device is fully inserted within the
elongated tubular member the beads engaging the loops or
promontories formed in the resilient inert metal backbone of the
device are seated within the injector mouth of the elongated
tubular member and form a smooth, conical-like member for insertion
through the cervix of the uterine cavity.
The injector may have a collar at the lower end of the elongated
tubular member which facilitates manipulation of the injector by
the second and third fingers during application by a user. Sliding
within the outer elongated tubular member is a hollow pusher or
piston member which telescopes into the elongated tubular member to
force the conical-like beaded members through the cervix of the
uterine cavity.
It is a particular feature of this improved injector mechanism that
the hollow piston member receives the extension or tail member of
the device and has an annular lip portion which accommodates or
seats the base portion of the device to which the tail member is
joined within the elongated tubular member. It is another improved
feature of the hollow piston member that it contains slotted
sidewalls which extend downwardly from the annular seat portion of
the piston member downwardly toward the pusher or insert member or
knob affixed to the hollow piston member. As the hollow piston
member telescopes upwardly through the elongated tubular member the
abutting conical-like bead members may be thrust upwardly through
the cervix of the uterine cavity releasing the resilient Y-members
of the device within the uterine cavity and as the insert or mouth
portion of the injector mechanism is withdrawn the extension or
tail member of the device remains within the endocervical canal and
vagina. The slotted hollow piston member facilitates entry and
insertion of the device by providing a smoother easier application
of the device. The slots are formed in the hollow piston member to
characteristically provide a leaf-spring effect which provides the
proper telescoping resistance to insure the smooth application of
the device.
BRIEF DESCRIPTION OF THE DRAWINGS
Additional advantages of the present invention will become more
apparent from the following drawings in which like reference
characters denote corresponding parts throughout the several
views:
FIG. 1 is a side elongated longitudinal sectional view of the
injector mechanism, with the intrauterine device in position before
injection;
FIG. 2 is a diagrammatic side elevational view showing the
intrauterine device with the Y-members in position in the body
organ after injection and prior to retraction of the injector
mechanism;
FIG. 3 is a side elongated longitudinal sectional view of the
hollow piston member of the injector mechanism with a cutaway
portion along the slots in the member;
FIG. 4 is an enlarged side sectional view showing the intrauterine
device fully extended in isolation; and
FIG. 5 is a cross section through FIG. 3 taken along the line 5--5
in FIG. 3.
DETAILED DESCRIPTION OF THE EMBODIMENTS
Referring now to FIGS. 1, 2 and 4, the device 10 is pressed into
injection position within injector mechanism 12 for subsequent
insertion into uterine cavity 14. Device 10 is formed with metal or
plastic backbone 16 contoured substantially into a V-shape. The
backbone is, in this embodiment, a single strip of resilient
stainless steel. The apex of each outwardly springing arm of
resilient metal backbone member 16 is contoured to form a
promontory 18. Backbone member 16 is coated with silicone rubber,
"Silastic" or other suitable thermoplastic material. A metallic
component such as copper or other metals with contraceptive
properties, in powder form, may be incorporating within the
silicone rubber or "Silastic" coating to impart well-known and
desirable characteristics to the coating. Resilient Y-members or
coated arms 20 are contoured to form common coated base portion 22.
Web or bridging member 24 extends between resilient coated arms 20
and joins contoured coated arm members 20 at a vertex point
defining incipient bulbous base member 22. The lower end 24 of
bulbous base member 22 is inwardly recessed to form integrally with
extension or tail member 26.
Tail member 26 is not formed about any portion of the resilient
metallic backbone 16. It is readily deformable and may be easily
manipulated without applying pressure thereto. It is similarly
formed of silicone rubber or "Silastic" and is compatible with the
coating material applied to resilient backbone 16.
Promontories 18 formed at the apex of each outwardly springing arm
of resilient metal backbone member 16 are embodied in thermoplastic
beads 28 made, for instance, of silicone rubber, polyethylene,
polypropylene and preferably "Silastic." The bead surfaces which
abut when resilient Y-members 20 are pressed into contact are
substantially flat as shown at 30. The outer face of each bead
curves outwardly and is substantially circular in appearance as
shown at 32. The face of each bead 28 parallel to web 24 is
substantially flat. According to the improved bead construction of
this invention the beads have been reduced in size to minimize the
possibility that uterine irritation and bleeding may occur. Typical
dimension in the new small bead construction are 3 mm. (length)
.times. 2 mm. (width) .times. 2 mm. (thick). These dimensions may
be compared with the ellipsoidally constructed beads disclosed in
my U.S. Pat. No. 3,507,274 in which typical, respective, dimensions
may be 6.5 mm. .times. 4 mm. .times. 3 mm.
Resilient Y-members 20 may be pressed inwardly towards an abutting
position. In sequence, tail member 26, base member 22 and resilient
abutting Y-members 20 may be thrust downwardly into outlet or
injector mouth 33 of tubular member 34. As shown in FIG. 1, when
intrauterine device 10 is fully inserted within elongated tubular
member 34 beads 28 are seated within injector mouth 33 of elongated
tubular member 34. In an abutting position, beads 28 assume a
conicallike shape which may be readily and easily forced through
the cervix of the uterine cavity.
Collar 36 extends outwardly from elongated tubular member 34 and
around the entire perimeter of tubular member 34. Collar 38
similarly extends outwardly and around the entire perimeter of
tubular member 34 at the lower end of tubular member 34 and
facilitates manipulation of injector mechanism 12 by the second and
third fingers during application by a user.
Hollow piston member 40 is of a smaller diameter than tubular
member 34 and hollow piston member 40 slides within outer elongated
tubular member 34 and telescopes into tubular member 34. In a
normal position, prior to injection of device 10 through the cervix
of the uterine cavity, hollow piston member 40 receives extension
member 26 of device 10 through annular lip portion 42 as beads 28
remain seated within injector mouth 33 of elongated tubular member
34. The dimensions of annular lip portion 42 are such as to
accommodate only extension member 26 of device 10 and the recessed
porton of the lower base 24 is seated on annular lip 42 of hollow
piston member 40.
After injection outlet 33 is properly placed in position at the
cervix an upward pressure may be exerted on knob 44, connected to
hollow piston member 40, and hollow piston member 40 may be
telescoped upwardly within tubular member 34 and device 10 may be
expelled through injector outlet 33 into the uterine cavity 14.
Collar 36 restrains entry of tubular member 34 beyond the cervix of
the uterine cavity.
As resilient Y-members are released through injector outlet 33 of
elongated tubular member 34 they respond to the pressure release by
leaving their abutting positions and reassuming their outward
position. As shown in FIG. 2, after Y-members 20 and base member 22
are injected within uterine cavity 14, beads 28 rest upon uterine
walls 46 in proximity to passageways 48 which lead to the Fallopian
tubes (not shown) which in turn lead to the ovaries (not shown).
After Y-members 20 and base member 22 of device 10 are expelled
from within elongated tubular member 34 by the telescoping pressure
exerted by hollow piston member 40, annular lip portion 42 of
hollow piston member 40 is contiguous with injector mouth 33 of
elongated tubular member 34.
Referring particularly to FIG. 2, as injector 12 is withdrawn from
the cervix, extension member 26 remains seated within endocervical
canal 50 to facilitate removal of device 10.
As particularly shown in FIGS. 3 and 5, hollow piston member 40 is
slotted. Slot 52 extends downwardly along each side of piston
member 40. Slot 52 begins at annular lip 42 and extends downwardly
along each side of piston member 40 towards knob 44. The length and
width of the slot is not critical, however, the slot should be deep
enough on each side to provide a leaf spring action as hollow
piston member 40 telescopes into and is withdrawn from elongated
tubular member 34.
The reduced bead design as described in conjunction with the
improved intrauterine device of this invention facilitates
insertion of this improved device particularly in nulligravidae or
women who have never been pregnant. Women who have never been
pregnant usually appear more sensitive to uterine irritation and
concomitant bleeding. The improved bead design while still
effective in women who have undergone one or more pregnancies may
also be more effectively used in conjunction with
nulligravidae.
Contraceptive results with all women whether or not they previously
became pregnant may be attributed to the introduction of the fine
web between the Y-member arms of the device. The web design enables
the device to cover a larger surface area within the uterine cavity
after insertion, prevents outward deformation of the Y-member arms
and in the event that a pregnancy occurs would contribute in
avoiding nidation or seeding of the fertilized egg.
While the present invention has been described in terms of specific
embodiments, such as a stainless steel backbone with a silicone or
"Silastic" covering it should be understood that various changes
may be made in the preceding description without departing from the
scope of the invention. In view of the above and other possible
variations, therefore, it should be understood that the preceding
description is intended as illustrative and not in a limiting
sense.
* * * * *