WO2004021864A2

WO2004021864A2 - Method and apparatus for reversible obturator contraception

Info

Publication number: WO2004021864A2
Application number: PCT/US2003/027625
Authority: WO
Inventors: Young S. Koo
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-09-04
Filing date: 2003-09-04
Publication date: 2004-03-18
Anticipated expiration: 2005-03-04
Also published as: AU2003268418A8; AU2003268418A1; WO2004021864A3

Abstract

A reversible hysteroscopic contraceptive procedure is disclosed which utilizes a small physical barrier, an obturator, which is lodged into the Pars Uterine Tube of a female to prevent spermatozoa from reaching and fertilizing an egg. The obturator comprises a plurality of spines which hare radially attached to a rotatable spine rod. The spines are extendable for reversible inserting into the Pars Uterine Tube to form a physical barrier blocking the tube. The obturator is further provided with an integrated trap chamber which may trap any ovum or spermatozoa inadvertently penetrating the obturator thereby preventing either fertilization, or implantation in the uterine wall. A hysteroscope is utilized to insert and remove the obturator as required.

Description

METHOD AND APPARATUS FOR REVERSIBLE OBTURATOR CONTRACEPTION

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application is a non-provisional application claiming priority from Provisional Application Serial Number 60/408,217, entitled "Method and Apparatus for Reversible Obturator Contraception" filed September 4, 2002.

TECHNICAL FIELD

[0002] The present disclosure relates to semi-permanent female contraception and, more particularly, to a method and apparatus for reversible obturator contraception.

BACKGROUND

[0003] Devices for female contraception that form a physical barrier include, for example, temporary devices such as a cervical cap, diaphragm, or sponge, semipermanent devices such as intrauterine devices (IUDs), and permanent devices such as fallopian tube plugs or sterilization. Physical barrier devices typically offer one or more distinct advantages over hormone contraception. For example, physical barrier devices avoid the physical and mental complications that are typically associated with hormone contraception as well as the cost associated with hormone contraception. Thus, physical barrier contraception may be particularly well suited for long term, worry free economic birth control.

[0004] Patients often enjoy the flexibility associated with temporary physical barriers, however, insertion errors and basic intimacy may result in the failure of these devices, leading to unwanted pregnancies. To decrease the chance of an unwanted pregnancy, some females resort to permanent barriers. However, contraceptive methods are often practiced by females who someday desire to conceive, making permanent physical barriers impractical. Therefore, many patients desire semipermanent contraceptive options, which combine the flexibility of temporary barriers with the security of permanent barriers. [0005] One such semi-permanent device is described in U.S. Patent No. 3,858,571, which discloses a bullet shaped cornual plug which may be inserted into the cornual area of the uterus where the fallopian tube enters the uterine cavity. The cornual plug is inserted by a physician using an insertion tool and is secured into the surrounding uterine muscle by extending two biased wires. The cornual plug may be extracted at a later date by pulling the plug from the uterine wall, overcoming the securing force of the wires and possibly causing uterine muscle trauma. Moreover, if a spermatozoa or ovum happens to pass the singular plug blockage, fertilization is still possible.

[0006] Another semi-permanent device is described in U.S. Patent No. 6,357,443, which discloses a generally cylindrical fallopian tube plug with a plurality of flexible fingerlike protrusions affixed to at least a portion of the shaft and biased into an extended position. The fallopian tube plug is inserted by a physician into the fallopian tube wherein the protrusions are pushed against the shaft. Once seated in the proper location, the biased protrusions engage the fallopian tube to secure the plug. The plug may be extracted by pulling the plug from the fallopian tube either by overcoming the securing force or by breaking the protrusions, either of which causes tissue injury. Moreover, the flexible protrusions only form singular blockage, which is susceptible to failures such as perforation, bleeding and/or reproductive cell passage.

[0007] Therefore, despite attempts at providing a semi-permanent physical barrier for female contraception, there is a continuing need for improvements in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Certain features and advantages in the method and apparatus disclosed herein will become apparent to those of ordinary skill in the art upon reading the following description in conjunction with the drawing figures, in which:

[0009] FIG. 1 is a side perspective view of an obturator according to an illustrative embodiment of the invention;

[0010] FIG. 2 is a side elevational view of an hysteroscope used to facilitate the insertion of the obturator of FIG. 1, according to an illustrative embodiment of the invention; [0011] FIG. 3 is a cross sectional view of the obturator taken along line 3-3 of FIG. i;

[0012] FIG. 4 is a cross sectional view of the obturator taken along line 4-4 of FIG. l;

[0013] FIG. 5 is a front elevational view of the obturator of FIG. 1, shown with the spine rod in its first rotated position;

[0014] FIG. 6 is a front elevational view similar to FIG. 5 but illustrating the spine rod in its second rotated position; and

[0015] FIG. 7 is an illustration of a method of inserting the obturator into the pars uterine tube of a female uterus.

DETAILED DESCRIPTION

[0016] Although the following text sets forth a detailed description of certain embodiments of the invention, it should be understood that the legal scope of the invention is defined by the words of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention since describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims defining the invention.

[0017] It should also be understood that, unless a claim element is defined by reciting the word "means" and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. § 112, sixth paragraph.

[0018] An obturator shown in the accompanying drawings comprises a plug-type housing and a plurality of spines which are provided for reversible insertion into the pars uterine tube of a female to form a semi-permanent physical barrier blocking the tube and preventing the fertilization of an ovum by spermatozoa. In the unlikely event that an ovum or spermatozoa inadvertently passes the blockage, the obturator housing may be provided with an integrated trap chamber which will catch or "trap" the ovum or spermatozoa preventing either fertilization, or implantation of the fertilized egg in the uterine wall.

[0019] To lodge the obturator in the correct location, the obturator comprises a rotatable rod which is operatively connected to the spines for extending and retracting the spines, providing the ability to secure the obturator within the female indefinitely while allowing for the removal of the obturator at any time with minimal trauma to the pars uterine tube.

[0020] The obturator is inserted into the female uterus by a hysteroscope which may be specially designed to allow for the quick identification of the correct insertion location within the uterus. Once seated properly, the obturator may be secured within the pars uterine tube by rotating the rod and extending the spines to implant the spines within the uterine wall. The obturator will thereby remain securely lodged within the tube during any physiological trauma. When it is desired to remove the obturator, the hysteroscope may be reinserted, the spines may be retracted by rotating the provided rod, and the obturator may be removed from the female with little or no damage to the uterine wall.

[0021] Referring now to the drawings, and particularly to FIG. 1, and FIGS. 3-4, there is illustrated an example of an obturator 10. As shown, the obturator 10 may have, for example, a generally cylindrical housing 12 defining a chamber 14. In the illustrated embodiment, the housing 12 is comprised of a first housing segment 12a and a second housing segment 12b and may have an overall length of approximately 5mm. The housing 12 may be formed by any known, or yet to be developed manufacturing method as would be appreciated by those of ordinary skill in the art. It will be further understood that the housing 12 may be constructed of any biocompatible material, preferably one that is non-magnetic and opaque to x-ray and/or magnetic resonance imaging (MRI) machines. For example the housing 12 may be constructed of aluminum.

[0022] Each housing segment 12a and 12b may have a housing end plate 13a and 13b respectively. The housing end plates 13a and 13b may be integrally formed with their respective housing segments 12a and 12b, or alternatively, the housing end plates may be separate elements joined to their respective housing segment 12a and 12b by any appropriate means. Furthermore, each housing segment 12a and 12b may have a plurality of septum 15, as illustrated in FIG. 3, which may divide the housing segments 12a and 12b. The septum 15 may provide strength to the obturator housing 12, and may aid in the securing of the obturator as will be described in detail herein after.

[0023] As illustrated in FIG. 1 and FIG. 4, the two housing segments 12a and 12b may be to be joined in complementary coaxial relation to each other by a housing bridge segment 12c to form a trap chamber 16. Alternatively, the trap chamber may be an aperture within the housing 12. The trap chamber 16, is large enough to allow the entrance of ovum or spermatozoa. The housing bridge segment 12c may comprise a plurality of housing bridges 17, along the periphery of the housing 12, for example four bridges 17. A plurality of openings 19 may be circumferentially spaced along the housing 12 to allow the extension of spines as will be explained in detail herein below.

[0024] Referring again to FIG. 1 , located within the obturator 10 is an spine rod 20 generally aligned with the housing 12 along the longitudinal axis. The spine rod 20 extends through the housing 12 and is constructed so as to be rotatable between a first rotated position and a second rotated position. Housing end plates 13a and 13b are provided with apertures 22 which hold and support the spine rod 20 in relation to the housing 12. Alternatively, the apertures 22 may be flanges, or the like. The spine rod 20 may be provided with a knob 23 which may engage insertion forceps which will be described hereinafter.

[0025] As illustrated in FIG. 3 and FIG. 4, radially extending from the spine rod 20 is a plurality of spines 24 circumferentially spaced about the spine rod 20. The spines 24 are made of a resilient, flexible material, biased in a straight configuration shown in FIG. 4. For example, the spines 24 may be manufactured out of flexible aluminum. When in the straight configuration, the spines 24 are of sufficient length so as to extend outside of the housing 12 through the openings 19. hi the illustrated example. the spines 24 extend beyond the housing approximately one-half of the radius R of the housing 12. In other words, the overall length of the spines 24 may be one and one- half times the radius R of the housing 12. It will be appreciated that the radius R of the obturator will be sized sufficiently so as to fit inside the pars uterine tube.

[0026] Referring specifically to FIG. 3 and FIG. 5, the spine rod 20 is shown in the first rotation position, wherein the spines 24 are retracted within the housing 12. Alternatively, as shown in FIG. 4 and FIG. 6, the spine rod 20 is in the second rotation position, wherein the spines 24 are extended through the openings 19 through the housing 12. It will be appreciated by those of ordinary skill in the art that the spine rod 20 may be provided with a locking element, as shown in FIG. 5 and FIG. 6, which may serve to hold or "lock" the spine rod 20 in either the first of second rotated position, or any position therein between. For example, the spine rod 20 may be provided with at least one wire 26 which may engage a corresponding stopper 28 located on the end plate 13a to hold the spine rod in the corresponding position. Of course, it will be appreciated by those of ordinary skill in the art that the locking element may be any element suitable for locking the spine rod in the predetermined positions.

[0027] Referring now to FIG. 2, there is illustrated an example of a hysteroscope 50. The hysteroscope 50 may comprise a hollow, generally cylindrical housing 52 having one or more working channel 54. The hysteroscope 50 may include a light source 56 and a viewing element (not shown) as are well known in the art. The hysteroscope 50 may preferably be constructed of a non-flexible stainless steel material and it maybe shaped to correspond to the natural curvature of the female uterus. For example, the hysteroscope 50 may be a Dilation and curettage (D&C) probe as are commonly known in the art. The hysteroscope 50 may also be sufficiently thin enough to fit within the female cervix with little or no dilation requirements. A grasping forceps 58, for example, a GF-558 Grasping Forceps, provided by Circon ACMI of Stamford, Connecticut, may be inserted through the working channel 54 (shown in FIG. 5) to securly grip the obturator 10 at the knob 23 and manipulate the spine rid 20. [0028] Referring now to FIG. 5, the insertion of the obturator 10 within the female uterus is illustrated. In general, a physician will insert the hysteroscope 50 through the cervix of the female, and due to its shape, the hysteroscope 50 will naturally tend through the uterine cavity 100 towards the ostium uterine tube 102. To further aid the hysteroscope 50 in the obtaining the correct orientation, the physician may utilize the light source and the viewing element provided with the hysteroscope 50, as well as . the guide 54. Specifically, the guide 54 is shaped so that by applying forward pressure to the hysteroscope 50, the guide will follow the contours of the uterine cavity 100 directly to the pars uterine tube 104.

[0029] Once the physician has correctly placed the hysteroscope 50 within the uterine cavity 100, the physician may thread the grasping forceps 58 and attached obturator 10 through the hysteroscope 50. The physician may then visually identify the location of the obturator 10 and place the obturator 10 within the pars uterine tube 104. Once the physician is satisfied with the location of the obturator 10, the grasping forceps 58 is rotated, thereby rotating the knob 23 and spine rod 20 from the first rotation position to the second rotation position.

[0030] By rotating the spine rod 20, the spines 24 are thereby extended outwardly from the obturator 10, and implanted within the Tunica Muscularis 106. The extension of the spines 24 may be aided by the septum 15. For example, as the spine rod 20, and thus the spines 24, are rotated, the spines 24 may contact the septum 15 and be guided towards the openings 19. The obturator 10 is thus securely held in place by the extended spines 24, creating a substantially complete barrier within the pars uterine tube 104. The grasping forceps 58 may then release the obturator 10 and the entire wire 58, and hysteroscope 50 is removed from the female, leaving only the lodged obturator 10. The process may be repeated to insert another obturator 10 within the complimentary pars uterine tube as required. The location of the obturator 10 may be verified by the physician utilizing a MRI, or other imaging technique.

[0031] Once correctly placed, the obturator 10 remains securely lodged within the pars uterine tube 104 until it becomes desirable to remove the apparatus. While in use, the obturator 10 prevents any discernable transmission of spermatozoa into the fallopian tube 108, and furthermore substantially prevents any ovum from transporting through to the uterine cavity 100. As described above, in the event that an ovum or spermatozoa inadvertently passes the end plates 13a and 13b of the obturator 10, the integrated trap chamber 16 will catch or "trap" the ovum or spermatozoa, thereby preventing either fertilization, or implantation of the zygote in the uterine wall, effectively preventing pregnancy.

[0032] When removal of the obturator 10 is desired, the physician once again may insert the hysteroscope 50 through the cervix of the female, and into the uterine cavity 100 to locate the obturator 10. Once located, the physician may insert the grasping forceps 58 to grab the knob 23 and rotate the knob 23 and the spine rod 20 from the second rotation position to the first rotation position, thereby retracting the spines 24 within the housing 12. With the spines 24 safely retracted, the obturator 10 may be removed from the female, once again allowing the natural flow of spermatozoa and ovum through the female reproductive system.

[0033] Although certain embodiments have been disclosed and described herein in accordance with the teachings of the present invention, the scope of coverage of this patent is not limited thereto. On the contrary, this patent covers all embodiments of the teachings of the invention fairly falling within the scope of the appended claims, either literally or under the doctrine of equivalents.

Claims

What is claimed is:

1. An obturator for reversibly plugging a uterine tube, the obturator comprising: a generally cylindrical housing having a first end and a second end; a spine rod longitudinally aligned with the housing and extending through the housing, the spine rod being rotatable between a first rotated position and a second rotated position; a plurality of spines coupled to the spine rod, wherein the spines extend radially from the spine rod, the spines being stored within the housing when the spine rod is in the first rotated position, and the spines being radially extended from the housing when the spine rod is in the second rotated position so as to lodge the obturator in the uterine tube to prevent the passage of an ovum or a spermatozoa.

2. An obturator according to claim 1, further comprising a trap chamber formed within the housing.

3. An obturator according to claim 2, further comprising a locking mechanism for holding the spine rod in the second rotated position.

4. An obturator according to claim 2, further comprising a wire coupled to one of the housing and the spine rod, and a corresponding stopper formed in the other one of the housing and the spine rod, the wire and stopper cooperating to hold the spine rod in the second rotated position.

5. A method for reversibly plugging a uterine tube, the method comprising: holding an obturator at a first obturator end, the obturator comprising: a generally cylindrical housing having a first end and a second end; a spine rod longitudinally aligned with the housing and extending through the housing, the spine rod being rotatable between a first rotated position and a second rotated position; and a plurality of spines coupled to the spine rod, wherein the spines extend radially from the spine rod, the spines being stored within the housing when the spine rod is in the first rotated position, and the spines being radially extended from the housing when the spine rod is in the second rotated position so as to lodge the obturator in the uterine tube to prevent the passage of an ovum or a spermatozoa; inserting the obturator through the uterus and into the uterine tube with a hysteroscope; rotating the spine rod from the first rotated position to the second rotated position to secure the obturator within the uterine tube; and removing the hysteroscope, permitting the obturator to remain secured within the uterine tube.

6. A method according to claim 5, further comprising the steps of: inserting the hysteroscope into the uterus; rotating the spine rod from the second rotated position to the first rotated position to free the obturator from the uterine wall; and removing the obturator from the uterus.