US3401689A - Intra-uterine contraceptive device and method and apparatus for inserting and retaining the same - Google Patents

Description

p 1968 E c. GREENWOOD 3,401,689

INTRA-UTERINE CONTRACEPTIVE DEVICE AND METHOD AND APPARATUS FOR INSERTING AND RETAINING THE SAME Original Filed April 8, 1965 INVENTOR. uge7v5 6f 'e'i/vwaop United States Patent 14 Claims. (Cl. 128-129) ABSTRACT OF THE DISCLOSURE An intra-uterine contraceptive device comprising an inflatable member sufiiciently small to be inserted through the cervix when in deflated condition, and sufficiently large to be retained within the uterus when in inflated condition. A method of inserting the device by mounting the same within an elongated small-diameter sheath or sleeve.

This application is a continuation of patent application Ser. No. 446,546, filed Apr. 8, 1965, now abandoned, for an Intra-Uterine Contraceptive Device, and Method and Apparatus for Inserting and Retaining the Same.

This invention relates to an intra-uterine contraceptive device, to a method of inserting such device and eflecting retention thereof in the uterus, and to an apparatus for effecting such insertion and retention.

It is known that, in a vast majority of cases, conception may not occur when a foreign body is present in the uterus. Despite this fact, intra-uterine contraceptive devices have been relatively unsuccessful because they were frequently expelled and thus rendered inoperative to prevent pregnancy. Numerous prior-art devices have been designed for the purpose of preventing such expulsion, and/ or permitting the wearer to ascertain whether or not expulsion has occurred, but these have been unsatisfactory for various reasons. Such devices have included small coil springs, and have also included units incorporating tail portions which extend continuously through the cervix. In some prior-art devices, a member having a diameter larger than that of the cervix has been inserted by dilating the cervix prior to insertion. This, however, is undesirable for the reason that dilation of the cervix is a diflicult and costly operation.

It is, therefore, a primary object of the present invention to provide an intra-uterine contraceptive device which may be readily inserted without the necessity for dilation of the cervix, which will remain in place for any desired length of time, and which is readily removed when it is desired to achieve conception.

A further object of the invention is to provide a method and apparatus for inserting an intra-uterine contraceptive device in the uterus, and thereafter locking such device in position, such method and apparatus accomplishing the indicated objectives in a manner of minutes and Without the necessity for dilation of the cervix.

A further object of the invention is to provide an intrauterine contraceptive device which incorporates means to warn the wearer of the possibility of inadvertent expulsion from the uterus, which does not necessitate manual verification of the presence of the device.

These and other objects will become apparent from the following detailed description taken in connection with the accompanying drawing in which:

FIGURE 1 is an enlarged sectional view illustrating the intra-uterine contraceptive device in inflated condition;

FIGURE 2 is a transverse sectional view on line 2-2 of FIGURE 1;

3,401,689 Patented Sept. 17, 1968 FIGURE 3 is a sectional view illustrating the apparatus for effecting insertion of the collapsed intra-uterine device through the cervix, and showing in phantom lines the positions of the parts during an intermediate portion of the insertion procedure;

FIGURE 4 is a view schematically illustrating the insertion into the uterus of the shielded contraceptive device shown at the upper left portion of FIGURE 3;

FIGURE 5 is a view corresponding to FIGURE 4 but illustrating the condition of the parts after retraction of the shield and after inflation of the device;

FIGURE 6 is an enlarged fragmentary sectional view illustrating an injection means through which fluid is introduced into the device to .eflect expansion thereof; and

FIGURE 7 is a schematic view corresponding to FIG- URES 4 and 5 but showing the fully-expanded device locked in the uterus and after withdrawal of the insertion means.

Stated generally, the intro-uterine contraceptive device comprises a hollow flexible element adapted to be inserted through the cervix when in collapsed condition, and thereafter inflated to a substantially expanded condition preventing undesired expulsion. Throughout the present specification and claims, the term inflate is intended to denote not only expansion by means of gas but also expansion by introduction of a liquid, or by introduction of a solid in finely-divided particulate form.

The contraceptive device is sufliciently small and flexible to be readily inserted, when in deflated or collapsed condition, through the cervix into the uterus. The size of the expanded device is suflicient to insure against expulsion from the cervix, unless it is desired to remove the device in which case deflation is effected intentionally. The shape and composition of the device are such that the tissues of the wearer will not be injured, nor will the menstrual or other functions be impaired.

Stated more specifically, the device is toroidal in shape, and is shown as having an enlarged or bulbous region adjacent an inlet means through which a fluid (including particulate material) may be introduced. The toroidal body of the device is indicated generally at 10, the bulbous region at 11, and the inlet means at 12. The outer diameter of the toroid is preferably about one inch.

The inlet means 12 is so constructed that it will close automatically in response to withdrawal of a fluid-injecting means therefrom. For example, the inlet means 12 may comprise the re-entrant cylindrical portion shown in FIGURES 1, 2 and 6, such portion being made suf ficiently resilient to contract (by plastic memory) and thus prevent flow of fluid through a capillary passage 13 therethrough, except during periods when the fluid-injecting means is in communication with the passage. Alternatively, or additionally, a suitable check-valve means (for example, opposed flexible lips) may be provided in the wall of the device 10 and so oriented that fluid may be introduced but not expelled (except in response to a manual opening of the check-valve means when expulsion is desired).

It is a feature of the majority of embodiments of the invention that deflation (collapsing) of the device 10 may be performed. Deflation may be eflected by withdrawing fluid through the inlet means 12, and also by puncturing the wall of the element 10. It follows that the contraceptive device may be readily removed, when pregnancy is desired or for other reasons, by any physician.

The contraceptive device 10 is constructed of a relatively thin-walled and flexible material which is inert to body chemicals (and to the inflation fluid) and is readily inflated to the illustrated (or other) suitable expanded shape. Suitable materials include polyethylene, Teflon, and others.

One method of manufacture is to vacuum-form or injection-mold two corresponding halves and 16 (FIG- URE 2) and then secure such halves together by suitable adhesive means, heat-sealing means, etc. The resulting seam or joint is indicated at 17 in FIGURE 2. In accordance with another method of manufacture, the device is slush molded of a suitable substance in the nature of soft vinyl.

Referring next to FIGURE 3 in particular, there is illustrated the apparatus for introducing the device 10 into the uterus and thereafter inflating the device to the condition shown in FIGURES 1 and 2. The insertion and inflation apparatus comprises an elongated tubular sheath or sleeve (shield) 19 having an internal diameter sufficiently large to receive the contraceptive device when in collapsed or deflated condition, and an external diameter sufficiently small to permit insertion thereof through the cervix without the necessity for substantial dilation. Sheath 19 preferably has a flange portion 20 at the outer end thereof and adapted to facilitate longitudinal movement of the sheath by the physician during the insertion method to be described. The inner end of the sheath is indicated at 21, and is shown as being closed and slit to form two lips through which the device 10 may be expelled.

Provided coaxially within the sheath 19, and longitudinally movable relative thereto, is an inner tube 22 through which the fluid for inflation of the device 10 may be passed in the desired direction. The tube 22, like sheath 19, is formed of a suitable flexible plastic (or other suitable material) which is inert to body chemicals and to the fluid employed for inflation of the contraceptive device. The tube 22 is sufficiently long to permit substantial longitudinal movement of sheath 19 thereon.

Mounted or integrally formed at the inner end of tube 22 is a fluid-injecting means which may comprise an elongated hollow needle 23 adapted to be introduced into capillary pasage 13 as shown in FIGURE 6. At the outer end of the needle 23 is formed a head portion 24 which is embedded within sheath 19 to insure against loss of the needle during retraction of the tube from the device 10.

The outer end of tube 22 communicates axially through a check valve member 26, illustrated as being of the spring-pressed ball type, with a hypodermic syringe 27 or other suitable means to pum fluid under pressure through tube 22 into the contraceptive 10. The check valve 26 is adapted to permit flow of fluid only in a direction from syringe 27 toward tube 22, and performs the function of preventing fluid from flowing outwardly from the inflated device 10 during the interval immediately preceding withdrawal of needle 23 therefrom.

Description of the method of insertion and retention In those cases where the fluid to be employed is something other than air, the first step in the method comprises filling the syringe 27 (or other fluid source) with the desired fluid, and thereafter effecting flow of such fluid through check valve 26 and tube 22 to needle 23, thereby expelling all air from the tube 22.

The next (or a previous) step comprises shifting the flange 20 toward syringe 27, for example to the phantomline position shown in FIGURE 3, until the needle 23 is extended through the slit end portion 21 as shown in FIGURE 6.

The device 10 is then (or previously) substantially completely collapsed into an elongated small-diameter condition as shown in FIGURE 3, such collapsing being manually performed and being accompanied by retention of a suitable hollow needle (unshown) in the capillary passage 13 to thus permit outflow of air from the device. Such unshown needle is then withdrawn from the capillary passage 13, and in its place is introduced the fluid-introduction needle 23 shown in FIGURE 6.

It is then merely necessary to manually manipulate the flange 20 to shift the same to the solid-line position shown in FIGURE 3, thus causing the sheath or sleeve 19 to be shifted over the collapsed device 10 until the inner end portion 21 closes over the end of the device as shown in FIGURE 3. Stated in the reverse manner, the flange 20 may be maintained stationary and the physician may pull on the tube 22 to draw the collapsed contraceptive 10 through end 21 into the sheath or sleeve 19. The device remains connected to the needle because of the frictional gripping of the needle by inlet means 12.

The parts being in the solid-line positions shown in FIGURE 3, it is then merely necessary for the physician to introduce the sheath 19 and the contents thereof through the vagina 28 and cervix 29 into uterus 30 (FIG- URE 4). The device is inserted to any desired location adapted to insure against expulsion after inflation occurs.

The physician then holds the syringe 27 (and thus tube 22) in position, and shifts flange 20 from the solid-line to the phantom-line position shown in FIGURE 3. This strips the inner end portion of sheath 19 from the collapsed device 10, leaving the latter in exposed condition within the uterus 30. The syringe 27 is then employed to pump the fluid (indicated at 32 in FIGURES 1, 3 and 6) through tube 22 and needle 23 into the device 10, until the latter is substantially fully inflated. As previously indicated, the check valve 26 prevents (after release of pressure from the syringe 27) outflow of fluid through the tube 22.

The physician then shifts flange 20 inwardly until the end 21 of sheath 19 is in engagement with the device 10, thereby stabilizing the position of the latter during withdrawal of the needle 23 therefrom. The tube 22 is then pulled to withdraw needle 23 from inlet means 12. The needle is retracted into sheath or sleeve 19, which shields the needle during withdrawal from the patient. As previously stated, the inlet means 12 closes automatically in response to withdrawal of the needle 23 therefrom, so that the fluid 32 is retained within the device 10 to maintain inflation thereof.

The insertion and inflation apparatus may be withdrawn simultaneously, or the tube 22 may be withdrawn from the patient while the flange 20 (and thus sleeve 19) is held stationary.

The fluid employed to inflate the device 10 may be one which is opaque on a fluoroscope screen, so that the placement or position of the device may be determined at any desired time. Thus, for example, the fluid may be a barium liquid.

In accordance with another form of the method, the fluid employed is a liquid containing an insert and harmless vegetable dye, for example a blue or green dye. When a dye is employed, any leakage from the device 10 after insertion may be readily detected by the user, who then knows that expulsion of the device may be imminent and that checking by a physician is therefore necessary.

In accordance with another embodiment, the fluid is a liquid adapted to solidify (or become highly viscous) after introduction into the device 10. For example, the liquid may be a mixture of epoxy resin and a suitable catalyst adapted to polymerize within the device. Such a liquid produces the advantage that leakage is substantially impossible, but also the disadvantage that withdrawal of the device is rendered much more diflicult.

Tube 22 is sufficiently rigid, in an axial direction, to hold the collapsed device 10 in position as the sheath 19 is stripped therefrom. Similarly, the collapsed device has suflicient axial rigidity to permit the described stripping operation.

It is pointed out that the syringe 27, valve 26 and tube 22 may be formed integrally, and may be disposable if desired. The needle 23 may be integral with the tube. De-

vice may be fully collapsed at the factory, and shipped and stored in a sterile disposable tube.

' The foregoing detailed description is to be clearly understood as given by way of illustration and example only, the spirit and scope of this invention being limited solely by the appended claims.

I claim:

1. An intra-uterine contraceptive device, which comprises:

a hollow, inflatable member having a size sufficiently small to permit insertion of such member through the cervix when such member is in deflated condition,

said member having a size sufficiently large to prevent expulsion through the cervix when such member is in substantially inflated condition, and

inlet means adapted to permit introduction of a fluid into said member when the same is in the uterus,

said inlet means being automatically responsive to withdrawal of a fluid-introduction element to prevent leakage of said fluid from said member.

2. An intra-uterine contraceptive device, which comprises:

a generally toroidal, hollow member formed of flexible material and having a 'wall thickness sufliciently small to permit deformation of said member when in deflated condition into an elongated shape adapted to permit insertion through the cervix.

the diameter of said toroidal member being sufficiently large to prevent expulsion through the cervix after inflation of said member into a toroidal shape.

3. An intra-uterine contraceptive device,

prises:

a hollow inflatable element adapted to be inserted through the cervix when in deflated condition and thereafter inflated to a size sufliciently large to prevent expulsion from the uterus, and

a substance contained within said element to maintain the same in inflated condition Within the cervix,

said substance being a colored liquid.

4. An intra-uterine contraceptive device, which comprises:

a hollow inflatable element adapted to be inserted through the cervix when in deflated condition and thereafter inflated to a size sufliciently large to prevent expulsion from the uterus, and

a substance contained within said element to maintain the same in inflated condition within the cervix,

said substance being introduced into said element in liquid form and thereafter caused to substantially solidify whereby to insure against leakage of said substance from said element.

5. An intra-uterine contraceptive device, which comprises:

a hollow inflatable element adapted to be inserted through the cervix when in deflated condition and thereafter inflated to a size sufliciently large to prevent expulsion from the uterus, and

a substance contained within said element to maintain the same in inflated condition within the cervix,

said substance being a material which is readily detected by a fluoroscope.

6. An intra-uterine contraceptive device, which cornprises:

a generally toroidal hollow inflatable element formed of a flexible plastic inert to body chemicals,

said element being thin walled and having a diameter on the order of about one inch, and

valve means provided in said element to permit introduction of a fluid into said element,

.said Valve means being adapted to close automatically in response to removal of a fluid-introduction device therefrom.

which com- 7. The invention as claimed in claim 6, in which said valve means is an elongated flexible re-entrant stem having a capillary passage therethrough and adapted to expand in response to the presence of a fluid-introduction needle therein, and in which said toroidal element has a bulbous region adjacent said stem.

8. A method of inserting an intra-uterine contraceptive device, and thereafter effecting retention thereof in the uterus, which method comprises:

providing a hollow inflatable member the size of which is sufliciently small to permit introduction of said member through the cervix when said member is in deflated condition, and is sufficiently large to prevent expulsion from the uterus when said member is in inflated condition, introducing said member through the cervix into the uterus when said member is in deflated condition,

introducing a fluid into said member, while the same is in the uterus, to inflate said member to a size sufficiently large to prevent expulsion from the uterus, and preventing leakage of substantial amounts of the inflation fluid from said member to thereby effect retention of said member in the uterus.

9. The invention as claimed in claim 8, in which said method includes the steps of providing said fluid in the form of an inflation liquid adapted to be introduced into said member when the same is in the uterus, and effecting solidification of said liquid after introduction thereof into said member whereby to prevent leakage therefrom.

10. A method of inserting an intra-uterine contraceptive device and effecting retention thereof in the uterus, which comprises:

providing an intra-uterine contraceptive device adapted to be disposed in an elongated small-diameter condition,

inserting said device into a sheath or sleeve the diameter of which is sufliciently small to permit insertion thereof through the cervix in the absence of substantial dilation of the cervix,

introducing said sheath and the contained device through the cervix into the uterus,

expelling said device from said sheath and effecting expansion of said device in the uterus to thereby prevent movement of said device out of the uterus, and withdrawing said sheath. 11. A method of inserting an intra-uterine contraceptive device and elfecting retention thereof in the uterus, which comprises:

providing a hollow inflatable intra-uterine contraceptive device adapted to be deformed into an elongated small-diameter shape when in deflated condition,

placing said device in deflated condition in one end portion of a tubular sheath having a sufficiently small outer diameter to permit insertion through the cervix in the absence of substantial dilation of the cervix,

introducing said .sheath and the contained device through the cervix into the uterus, expelling said device from said sheath whereby said device is in exposed condition within the uterus,

introducing fluid through said sheath into said device to thereby expand said device and prevent expulsion thereof from the uterus, and

withdrawing said sheath.

12. The invention as claimed in claim 11, in which said method comprises eflecting said fluid-introduction step through a tube provided coaxially within said sheath, the inner end of said tube being removably connected to said device for inroduction of fluid therein.

13. The invention as claimed in claim 12, in which said method further comprises disconnecting said tube from said device while said sheath is in position, causing the extreme inner portion of said tube to be contained within said sheath, and withdrawing said tube in such manner that contact thereof with the patient is prevented by said sheath.

14. A combination contraceptive device and apparatus for inserting the same into the uterus and effecting retention of said device therein, comprising:

an inflatable hollow flexible element adapted to be deformed into elongated small-diameter condition when deflated, a flexible sheath mounted around said device sheath mounted around said device when the same is in deflated condition,

said device being disposed longitudinally in one end of said sheath,

:1 flexible tube disposed coaxially within said sheath,

means to connect said tube to said device in such manner that fluid may be introduced from said tube into said device,

said last-named means being adapted to permit automatic disconnection of said tube from said device and to close said device against leakage of fluid therefrom, and

means connected to said tube to introduce fluid through said tube and said connecting means into said device.

References Cited UNITED STATES PATENTS ADELE M. EAGER, Primary Examiner.

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