CA1046372A - Method and apparatus for non-surgical reversible sterilization of females - Google Patents

Method and apparatus for non-surgical reversible sterilization of females

Info

Publication number
CA1046372A
CA1046372A CA193,336A CA193336A CA1046372A CA 1046372 A CA1046372 A CA 1046372A CA 193336 A CA193336 A CA 193336A CA 1046372 A CA1046372 A CA 1046372A
Authority
CA
Canada
Prior art keywords
oviduct
terminal end
tip
uterine
tubular
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA193,336A
Other languages
French (fr)
Inventor
Robert A. Erb
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Franklin Institute
Original Assignee
Franklin Institute
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Franklin Institute filed Critical Franklin Institute
Priority to CA313,134A priority Critical patent/CA1062110A/en
Application granted granted Critical
Publication of CA1046372A publication Critical patent/CA1046372A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/20Vas deferens occluders; Fallopian occluders
    • A61F6/22Vas deferens occluders; Fallopian occluders implantable in tubes
    • A61F6/225Vas deferens occluders; Fallopian occluders implantable in tubes transcervical

Abstract

Abstract of the Disclosure A method and apparatus is provided for non-surgical reversible sterilization of females. An apparatus to which a removable tip is attached is inserted into the uterus. The tip is aligned with the uterine end of the oviduct. A curable elastomeric composition is injected, through an aperture in the tip, into the oviduct in an amount sufficient to fill the portion of the oviduct adjacent to the uterus. The tip is larger in diameter than the uterine end of the oviduct and substantially seals the end thereof during the filling of the end portion of the oviduct with the liquid elastomeric composition. The elastomeric composition is allowed to solidify and adhere to the tip to form the oviduct block. The apparatus is then removed with the tip being ejected from the apparatus so as to remain adhered to and part of the resulting oviduct block. The above procedure is repeated for the oppo-site oviduct. The resulting oviduct blocks prevent the passage of ovum from the ovaries to the uterus and sperm from entering the oviduct thereby pre-venting conception. The oviduct blocks if desired can be removed non-surgically by utilizing an apparatus which grips the larger tip portion of the oviduct block within the uterus and extracts the entire oviduct block from the oviduct.

Description

-~o4~3~Z
This invention is concerned with apparatus for non-surgical, re-versible sterilization of females.
One of the more pressing problems which is encountered in the world today is that of over population. The problem of over population which has been a substantial problem for a considerable period of time in certain highly populated areas, such as Asia and the Indian Sub-Continent is now becoming a problem in less populated areas of the world such as Europe and the Americas. Over population results in such long range problems as pollution, famine and even war.
Birth control has been relied on as the principal means to control over population. In the field of birth control the prevention of conception is considerably more acceptable for controlling population growth than abor-tion. However, the methods heretofore suggested for contraception have had certain inherent problems which limited the applicability and effectiveness.
The ideal contraception method should be 100% effective in prevent-ing conception; should not rely on will-power, should not interfere with the satisfaction of sexual relationships, and should be low in cost taking into consideration the effective life of the contraceptive method. In addition the contraceptive method must not have any harmful psychological side effects.
An extremely important feature of an ideal contraceptive method especially for family planning is that it be reversible so that it will be possible to have additional children if desired.
The most common methods of contraception which are currently employed on a mass scale each have certain inherent deficiencies which limit their usefulness. The use of such techniques and devices such as rhythm, withdrawal,condoms and diaphragms and vaginal foams all have been found to be highly unreliable. The more recently promoted methods such as intraute-rlne devices and use of contraceptive pills likewise have certain defects which limit their effectiveness. The intrauterine devices cannot be utilized by all females and there is some indlcation that they cause irrita-tion and discomfort and are often re~ected by females. The contraceptive pill cannot be utilized by many females due to incompatability with their ~., -- 1 -- ~ .

': ' ' -104ti3'72 normal hormone balance. Furthermore, the use of the pill has been found to increase the risks of certain carcinogenic conditions.
There are currently two methods in wide use which are generally con-sidered to be effective contraceptive methods. These are oviduct ligation for females and vasectomy for males. In both these methods the ducts from the reproductive organs are severed and accordingly the contraceptive technique if properly performed and if there is no natural regeneration is 100% effective. However, both methods have the defect that it is difficult, if not impossible, to reverse the procedure so as to restore th~ normal reproductive capacityO
It has been well established by gynecologists that a primary cause of infertility in females is blockage of the oviducts from the ovary to the uterus. The ovum when discharged from the ovaries is absorbed by the body and is prevented from coming in contact with the sperm and accordingly con-ception does not occurO Females having this natural condition normally do not even realize it exists and do not suffer any adverse side effects besides being infertileO Having been made aware of this natural condition those skilled in the art have suggested artificial blocking of the oviduct to Lmpart sterilityO
It was reported by Corfman et al in Obstetrics and Gynecology VolO
27 No. 6 pages 880-883 (June 1966) that various substances could be injected transcervically into the oviducts.
Hefnawi et al Amr. J. Obst ~ Gynec, Vol. 99, No. 3 pages 421-427 (October 1, 1967) reported attempts to block the oviducts by the injecting of medical grate elastomeric materials in the uncured state into the oviducts and allowing the material solidify in the oviducts. The elastomeric material was thinnet prior to injection so as to have a relatively fluid mixture for injectionO The reported results obtained with rabbits was quite unsatis-factory. The incidence of pregnancy after insertion of the oviduct blocks was quite higho Effective sterilization was only achieved if the plug was placed in the medial portion of the oviductO To remove the plug it was necessary to conduct laparotomy. A further problem which was reported was the tendency for the plug to migrate from the oviduct into either the uterine cavity or even more dangerously into the peritoneal cavity.
Rakshit reported in the Calcutta Med. J. 65, No. 3 (March, 1968) attempts to use various materials to block the oviducts to prevent concep-tion. It was suggested to use a plastic material of a nature which solidi-fies after being mixed with a catalyst to form the oviduct blocks. Rakshit specifically taught however that because of high viscosity the silicone rubbers could not be injected transvaginally and laparotomies were conducted to inject the material directly into the uterus. The material was then allowed to flow into oviducts. It was suggested in this article by Rakshit that it may be possible to introduce a plastic material transcervically into the uterus and then to allow it to flow in the oviducts. Using this method however the resulting oviduct blocks would have to be removed surgically to reestablish fertility.
Rakshit further rePo~tedinHuman Sterilization, edited by Ralph Rechart (1971) pages 213-221 the technique of attempting to form oviduct blocks by inserting a cannula directly into the uterus through the cervix and filllng the uterus with a curable liquid silicone plastic. The in~ected silicone plastic was allowed to flow into the oviducts and cure in place to form the desired oviduct blocks. The excess material was then removed from the uterus. The reported results were not promising. On tests reported on 14 women there were 9 satlsfactory blockages, 3 doubtful cases and 2 nega-tlve cases. Further, in order to remove the oviduct blocks it was necessary to conduct a laparotomy.
Accortingly, the invention resides in apparatus for forming a non-surgically removable oviduct block in a female. The apparatus comprises a tubular means of a length sufficient to extend from vagina area of the female to the uterine ends of the oviducts and having a diameter sufficient-ly small to pass through the cervix of the female. The tubular means has flrst and second terminal ends, the first terminal end has an apertured tip : .

~, member detachably connected thereto and also means for releasably holding and ejecting the tip member, the tubular member including means for positioning said first terminal end with the tip member thereon adjacent the uterine end of the oviduct. The tubular member further includes means for transmission of the self-curing elastomeric material from a point adjacent to the second terminal end to and through the aperture in the tip member secured to the first terminal end. -In drawings which illustrate embodiments of the invention, Figure 1 is an illustration in partial cross-section of an apparatus especially adapted for use in the method of this invention;
Figure 2 is an illustration in partial cross-section of a uterus, the cervix and a portion of the vagina. The uterus is illus-trated with an oviduct block insert in one of the oviductsand the terminal end of the apparatus Qf Figure 1 positioned for insertion of an oviduct block into the opposite oviduct;
Figure 3 is an inlarged illustration taken in partial cross-section of the terminal end of the apparatus of Figure l;
Figure 4 is an illustration in cross-section of the terminal end of the apparatus of Figure 3 shown with fluid uncured elastomeric material shown in the internal feed tube; and Figure 5 is an illustration shown in cross-section showing the separation of the tip from the apparatus of Figure 1.
With the apparatus of the invention, an oviduct block is formed in situ in the oviduct. The oviduct block is more preferable formed from a medical inert plastic which has approximately the same modulus of elasticity as the oviduct. The selection of material having the proper modulus of elasticity appears to both prevent explosion of the oviduct block and substantially eliminates any physical discomfort.
3Q The materials which have been found most useful in the method of this 104~37Z
invention are the commercially available medical grade silicone elastomers. The uncured silicone elastomer in the fluid state is blended with a catalyst for solidifying the elastomer and a dilution fluid to control the viscosity during injection and also to control the modulus of elasticity of the cured solidified material. It is preferable to also include a radiopaque material in the mixture to facilitate the placement of the oviduct block and to facilitate removal of the oviduct block if desired.
A tip 10 is molded from an inert plastic material to which the injected elastomeric material will adhere on solid-ification. In this regard it should be noted that silicone-rubber is ideally suited for this purpose when a silicone elastomer is used for formation of the oviduct block.
As shown in the drawing the portion of the tip 10 which will be in contact with uterine end of the oviduct 12 has a spherical configuration. The tip is larger in diameter than the uterine end of the oviduct and seals the lumen or ent opening thereof during the filling of the end portion of the oviduct with the liquid elastomeric composition. The tip 10 has an aperture 14 which extends throughout the entire length of the tip 14.
In addition the tip as illustrated has a series of annular piston rings 16 molded into the interior portion surface of the aperture 14. The tip 10 in one embodiment may include a loop 18 which is preferably a thread of a material which is inert in uterine fluids, such as nylon or polyester.
The apparatus 20 shown in Figure 1 is specifically de signed for use in the method of this invention. The apparatus 20 includes a tubular extension 22, a dispensing apparatus 24, and a control handle 26 both for operat-B

10~tj3~7Z
ing the dispensing means and for positioning the tip 10 on the end of the tubular extension 220 The tubular extension 22 has a rigid section 26 which is adjacent to the control handleO The opposite terminal end portion 28 on which the tip 10 is secured is flexibleO One end of each control wire 30 or 32 is attached to the end portion of the flexible section 280 The control wires 30 and 32 are connected at their opposite ends to a part of separately controlled drums 34 (only one drum is shown) mounted on the control handle 260 By adjustment of the drums 34 to either collect or release the wires 30 or 32 the position of the tip 10 can be adjusted and bent in a curved configuration as shown in Figure 20 At the flexible terminal end 28 a metal connector 36 is provided which has annular piston rings 38 which mate with the piston rings 16 on the tip lOo The metal connector 36 further has defined in it a constricted area having a sharp cut off portion 400 A tube 42 extends from the dispensing means 24, through the tubular extension 22 to the aperture 14 in the tip lOo The dispensing means 24 consists of a mixing syringe 44 in which the plunger 46 is adapted to provide mixing of a fluid elastomeric material, a catalyst and other additive as may be requiredO The syringe 44 is mounted on top of the control handle 26 with the plunger 46 in contact with a rack 48 and a pivotal mounted pawl 50. The pawl SO is connected to a trigger 52.
Squeezing the trigger 52 causes the plunger 46 to be advanced within the syringe 44 and material within the syringe 44 to be dispensed through the tube 42 to the tip lOo In the method of this invention the tip 10 is inserted over the end of the flexible portion 28 of the tubular extension. The tip 10 being pre-molded of a silicone~rubber is somewhat elastic and deforms somewhat until the piston ring 16 of the tip 10 engages and locks with the mating piston rings 38.
The tubular extension 22 with tip 10 installed is inserted into the vagina 54, through the cervix 56 into the uterine cavity 580 Then, preferably ~0~37Z
using fluoroscopic techniques, the tip 10 is aligned with the uterine end of one of the oviducts 12. It should be noted that because of the shape of the uterine cavity 58 the tip can be guided blindly into the proper position.
The relative position of the flexible end 28 is controlled by adjustment of the drums 34.
Once the tip 10 is in position, the fluid mixture of the elastomer, catalyst and other additives are injected through the tube 42 to the tip 10 by operation of the trigger 52 as noted above. The uncured fluid elastomeric composition 60 flows through the aperture 14 in the tip 10 and then into the oviduct 12. A sufficient amount of the mixture is injected to fill approxi-mately one third or more of the length of the oviduct 12. Some of the material will flow back around the tip 10 so that the surface of the tip 10 will conform to the shape of the uterine end of the oviduct 12 as shown by the portion 62 in Figure 5.
The in;ected elastomeric material 60 is allowed to cure and solidify.
The cured material will adhere to the tip 10 to make essentially an oviduct block having a prefor~ed larger tip in a single unit.
Once the elastomeric material has cured, the tube 42 and the terminal end 28 are withdrawn within the tubular extension 22. The edge 40 cuts the cured material which remains in the tube 42 from the cured material in the aperture 14 of ~he tip 10. Continued withdrawal of the terminal end 28 results in the tip 10 being stripped from the terminal end as shown in phantom in Figure 5.
The procedure noted above is repeated for the opposite oviduct to complete the sterilization procedure.
The solidified oviduct blocks each has a configuration which con-forms to the interior of the oviduct in which it is cast, thus effectively preventing conception. The shaped tip member has an aperture defined therein and a configuration such as to fit in substantial sealing contact adjacent to the uterine end of the oviduct of the female. It has a size larger than the lumen of said oviduct and is positioned within the uterine cavity of said female adjacent to the uterine end of said oviduct with the aperture of said tip member being in axial alignment with the lumen of said oviduct, whereby Il . .
i~ ~ _7-- ' - : ' ' 10L~j3 7Z
the tip member remains within the uterine cavity where it can be gripped by mechanical means to remove the oviduct block non-surgically.
The oviduct block can remain in place until it is desired to remove it. The use of a material having approximately the same modulus of elasticity as the oviducts assists in maintaining the oviduct blocks 64 in position. The natural convolution of the oviduct likewise results in - .~

10~372 stabilization of the oviduct blocks 64. The tip 10 serves a most important function of preventing the oviduct block 64 from migrating into the cavity, a problem that was a serious and relatively common problem with other similar prior art technique.
As noted above the oviduct block is inserted non-surgically. The method is relatively simple to learn by those skilled in the medical art.
The time required is likewise quite short with a skilled person being able to block both oviducts in about 15 to 30 minutes.
As noted above the oviduct block can be removed non-surgically if desired. An instrument of the type in Figure 1 is used for this purpose.
The tip 10 i6 replaced with a hooked member wnich is adapted to engage the loop 18. Once the loop 18 is engaged the oviduct block 64 is withdrawn.
It is also possible to use a pronged member to grip the tip and then pull out the oviduct block.
Both the insertion and removal of the oviduct block 64 are relat-ively painless. However a local anesthetic can be used if desired.
The effectlveness of the contraception method utllizing this in-vention was found to be excellent. On rabbit tests it was found that the method i8 100% effective if the oviduct blocks are properly placed. In further rabbit tests it was found that after the oviduct blocks were removed that fertility was restored. There was no indication of explosion of the oviduct blocks either into the uterine cavity or into the intraperitonal cavity.
Histologic examination and scanning election microscopic examination have not indlcated that there is any adverse reaction to the tissue of the oviducts.
The apparatus of this invention has been described in the preferred embodiment. It should be appreciated that various difications can be made to the apparatus without departing from the scope of this invention. For example, the control handle 26 has been provided to enable a simple one handed operation of the apparatus. It is possible, however, to simply use control wires which are operated by the fingers of the hand rather than the drums.

Further, the dispensing apparatus consisting of the trigger 52, rack 48 and pawl 50, could likewise be removed and the syringe operated manually. Further-104~37Z
more, the configuration of the tip 10 can be modified to a different shape o~
~- ~ such as a conical configuration 4~ other suitable shapes and still be satis-factory for use in this invention. These and other modifications which would be obvious to those skilled in the art are included within the scope of the subjoined claims.

_g_

Claims (10)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. Apparatus for forming an oviduct block said apparatus comprising:
a tubular means of a length sufficient to extend from the vagina area of said female to the uterine ends of said oviducts and having a diameter sufficiently small to pass through the cervix of said female; said tubular means having first and second terminal ends; said first terminal end having an apertured tip member detachably connected thereto and also means for releasably hold-ing and ejecting said tip member, said tubular member including means for positioning said first terminal end with said tip member thereon adjacent the uterine end of said oviduct, and said tubular member further including means for transmission of a self-curing elastomeric material from a point adjacent to the second terminal end to and through said aperture in said tip member secured to the first terminal end.
2. The apparatus of claim 1, in which the first terminal end portion is flexible.
3. The apparatus according to claim 1, in which the position of the first terminal end is controlled by means operable from the second terminal end.
4. The apparatus according to claim 1, wherein the means for holding and ejecting said tip member comprises a slideable member positioned within said tubular member whereby when a tip member is secured at the first terminal end to said slideable member and said slideable member is drawn through said tubular member toward the second terminal end, said tip is removed from said slideable member.
5. The apparatus according to claim 1, wherein the dispensing means is a syringe having a barrel and a plunger and wherein the plunger is advance-able within the barrel by a rack and pawl drive operated from the second terminal end.
6. Apparatus for forming an oviduct block comprising: a tubular means having a length sufficient to extend from the vagina area of a female to the uterine end of the oviduct and having a diameter sufficiently small to pass through the cervix of said female; said tubular means having first and second terminal ends; said first terminal end including means for holding and releasing a tip member, said tubular means including means for position-ing said first terminal end with said tip member thereon adjacent the uterine end of said oviduct to at least temporarily block said uterine end; said tubular means further including fluid passage means for transmission of a plastic material from a point adjacent to the second terminal end into said oviduct beyond said tip member at first terminal end of said tubular means, and means to dispense a sufficient amount of said material to fill a pre-determined length of the oviduct and to flow into engagement with the tip member at the uterine end of said oviduct, to form a block having an enlarged end portion exposed in the uterine end of the oviduct, said holding and releasing means comprising a slideable member positioned within said tubular means, whereby when the tip member is held at the first terminal end by said slideable member and said slideable member is drawn through said tubular means toward the second terminal end, said tip member is released from said slideable member.
7. Apparatus for forming an oviduct block comprising: a tubular means having a length sufficient to extend from the vagina area of a female to the uterine end of the oviduct and having a diameter sufficiently small to pass longitudinally through the cervix of said female; said tubular means having first and second terminal ends; said first terminal end having means to engage and connect a tip member thereto, said tubular means including means therein for adjustably displacing said first terminal end laterally relative to said second terminal end to position said first terminal end adjacent the uterine end of said oviduct to cause the tip member to at least temporarily block said uterine end; said tubular means further including fluid passage means for transmission of a plastic material from a point adjacent to the second terminal end into said oviduct beyond said tip member at first terminal end of said tubular means, and means to dispense a sufficient amount of said material to fill a predetermined length of the oviduct and to flow into engagement with the tip member at the uterine end of said oviduct, to form a block having an enlarged end portion exposed in the uterine end of the oviduct.
8. The apparatus of claim 7 in which the tubular means adjacent the first terminal end has a flexible portion separable from the block formed by said plastic material, said flexible portion affording displacement of said first terminal end relative to said second terminal end.
9. The apparatus according to claim 7 in which the adjustable means is operable from the second terminal end.
10. The apparatus according to claim 7 in which the means for dispensing said plastic material is a syringe having a barrel and a plunger, the plung-er being advanceable within the barrel by a rack and pawl drive operated from the second terminal end to dispense said sufficient amount.
CA193,336A 1973-02-26 1974-02-25 Method and apparatus for non-surgical reversible sterilization of females Expired CA1046372A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA313,134A CA1062110A (en) 1973-02-26 1978-10-11 Method and apparatus for non-surgical, reversible sterilization of females

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US00335816A US3805767A (en) 1973-02-26 1973-02-26 Method and apparatus for non-surgical, reversible sterilization of females

Publications (1)

Publication Number Publication Date
CA1046372A true CA1046372A (en) 1979-01-16

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Application Number Title Priority Date Filing Date
CA193,336A Expired CA1046372A (en) 1973-02-26 1974-02-25 Method and apparatus for non-surgical reversible sterilization of females

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US (1) US3805767A (en)
JP (1) JPS5239595B2 (en)
AU (1) AU465515B2 (en)
BE (1) BE811539A (en)
BR (1) BR7401387D0 (en)
CA (1) CA1046372A (en)
CH (1) CH578876A5 (en)
FR (1) FR2218907B1 (en)
GB (1) GB1430045A (en)
IL (1) IL44203A (en)
IT (1) IT1015818B (en)
NL (1) NL154660B (en)
SE (1) SE419698B (en)
ZA (1) ZA74931B (en)

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BR7401387D0 (en) 1974-11-05
IL44203A0 (en) 1974-05-16
DE2407652A1 (en) 1974-09-12
BE811539A (en) 1974-06-17
JPS49135486A (en) 1974-12-26
FR2218907A1 (en) 1974-09-20
IL44203A (en) 1977-03-31
SE419698B (en) 1981-08-24
NL7402502A (en) 1974-08-28
ZA74931B (en) 1974-12-24
DE2407652B2 (en) 1976-01-15
FR2218907B1 (en) 1978-07-21
JPS5239595B2 (en) 1977-10-06
AU465515B2 (en) 1975-10-02
CH578876A5 (en) 1976-08-31
GB1430045A (en) 1976-03-31
IT1015818B (en) 1977-05-20
US3805767A (en) 1974-04-23
AU6603174A (en) 1975-08-28
NL154660B (en) 1977-10-17

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