Surgery – Reproduction and fertilization techniques – Embryo transplantation
Reexamination Certificate
2000-04-03
2003-08-26
Kearney, Rosiland S. (Department: 3739)
Surgery
Reproduction and fertilization techniques
Embryo transplantation
C600S033000, C604S003000, C604S194000, C604S197000, C604S198000, C604S200000
Reexamination Certificate
active
06610005
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a catheter system for implanting embryos into a woman's uterus. More particularly, this invention concerns such a catheter system utilizing a protective catheter sleeve for introducing a catheter into the uterus without mucus contamination. And it concerns an improved catheter construction for embryo protection and deposit.
2. Description of the Prior Art
Typically, in present fertility clinics, three or four embryos are placed in a tiny, flexible catheter near the opening in the depositing end (the distal end) of the catheter. The catheter is then inserted through the woman's cervix and the embryos flushed hydraulically from the catheter and, hopefully, the embryos become implanted in the uterus wall. But the small catheter required is difficult to insert and mucus from the mouth of the cervix may be caught at the mouth of the catheter and interfere with the embryos. So, a stiffer and larger sleeve catheter may be used for insertion through the cervix; and then the smaller catheter may be pushed through and out the larger sleeve catheter to implant the embryos. This sleeve use helps, but cervix mucus may still be caught in the introduction end (the distal end) of the larger catheter and then transferred to the smaller catheter, thus still possibly interfering with the embryos.
The prior art includes some catheter-type devices for use in embryo implantation. In particular, Bacich U.S. Pat. No. 5,472,419 and Fischl U.S. Pat. No. 4,790,814 both employ the use of a catheter-type device, each having distal end openings to allow passage of the embryos to the uterus. Though these devices may be used for embryo implantation, they do not adequately address the problem of preventing the accumulation of mucuslike material at the distal end opening, which may interfere with embryo implantation. Other embryo implanting devices employ the use of a catheter enclosed within an outer sleeve. For example, Wallace's GB No. 2,118,840 employs the use of an inner catheter slidable within an outer sleeve where the distal end of the outer sleeve is open. Though this device might also be suitable for embryo implantation, it fails to teach or implement an efficient way to protect against mucus accumulation within the outer sleeve during insertion. Other medical devices in fields other than embryo implantation employ the use of a catheter enclosed within an outer sleeve. For example, Pokorney U.S. Pat. No. 5,083,572 employs the use of an inner catheter slidable within an outer sleeve for use in obtaining vaginal secretions; but the purpose and construction are to bring in secretions/mucus within the outer sleeve, not to keep them out. And Pokorney's use of side sampling ports near the distal end of the outer sleeve do not prevent mucus accumulation within the outer sleeve nor does the sleeve permit the inner catheter to slide out of the sleeve to deposit an embryo or for any purpose whatsoever.
Other background art, still further removed from addressing such problems as mucus accumulation during embryo implanting include Kalayjian U.S. Pat. No. 3,513,830, which discloses an instrument for obtaining body cultures. This instrument employs the use of a cotton swab slidable within a plastic sterilizable outer sleeve. The outer sleeve has a friction-fitted cap, outwardly convex, which can be inserted into a body cavity closed and then opened once inside the desired cavity to allow the cotton-tipped swab to project out of the outer sleeve to take a tissue sample. An object of the Kalayjian invention is apparently to prevent the swab from becoming contaminated either before or after the swab comes in contact with the desired tissue. Kalayjian differs from the present invention in many ways: it is not designed for the purpose of embryo implanting; it is not designed to hold an inner catheter (it holds a wooden swab); it is not designed to be “opened” by a fragile inner catheter (and might well destroy an emerging inner catheter); the cap/tip is deigned (internally indented) to match the swab; etc. O'Neil, U.S. Pat. No. 4,652,259, is even further afield. It discloses a.urinary catheter assembly and has to do with bacteria protection of the bladder in collecting urine, not mucus and embryo protection for transplanting. The sleeve is built for specific use only in the outer urethra and only the inner catheter is permitted to travel alone through the inner urethra and into the bladder for catheterization. Similarly, Vega, U.S. Pat. No. 4,249,536, discloses a urological catheter with a soft pliable cone-shaped tip (containing spiral grooves or hair-like projections) which can open by means of strings attached to the tip. This device also uses magnetic forces to advance the catheter through the urethra. This device differs in many important ways from the present invention; e.g., the Vega tip opens to a very wide position which could cause significant trauma if used for embryo transfer; the Vega device uses strings to pull open the tip of the catheter, and the tip itself is not a unitary small, light, part of the distal end of the catheter, openable by the pushing of a fragile embryo-transfer type of inner catheter, etc.; and closing such a device is difficult. Whatever end system may be used on a sleeve for embryo transfer, it is obviously vitally important that pieces of the end do not break off and remain in the cervix.
Thus there is a need for a catheter system for implanting embryos which will better protect the embryos from mucus and other damage in an efficient manner.
OBJECTS OF THE INVENTION
A primary object of the present invention is to fulfill the above-mentioned needs by the provision of an improved catheter system for implanting embryos. A further primary object of the present invention is to provide such a catheter system which is efficient, inexpensive, and handy. Other objects of this invention will become apparent with reference to the following invention descriptions.
SUMMARY OF THE INVENTION
According to a preferred embodiment of the present invention, this invention provides a catheter system for assisting implanting embryos in a uterus, comprising: catheter sleeve means, having a sleeve distal end and a sleeve proximal end and having, between such sleeve distal end and such sleeve proximal end, a longitudinal cylindrical hollow having a central longitudinal axis, such catheter sleeve means being structured and arranged for containing an inner catheter in such cylindrical hollow, such catheter sleeve means comprising end cap means, disposed along an intersection of such central axis at such sleeve distal end, for substantially enclosing such cylindrical hollow at such sleeve distal end to protect such cylindrical hollow from accumulating mucuslike material when such catheter sleeve means is pushed through a cervix, such end cap means comprising end opening means, disposed along such intersection of such central axis at such sleeve distal end, for permitting passage of an inner catheter along such central axis from within such cylindrical hollow into a such uterus; such catheter sleeve means being structured and arranged for travel of such sleeve distal end through the cervix for assistance in implanting embryos.
Further, this invention provides such a system wherein such end opening means of such sleeve distal end comprises swivel means constructed and arranged in such manner that such end cap means swivels outward when an inner catheter is pushed through such sleeve distal end; and, further, wherein such end cap means comprises an outwardly convex flexible end on such catheter sleeve means and such end cap opening means comprises a partial transverse cut separating, except for a remaining transverse hinge portion, such outwardly convex flexible end from such catheter sleeve means, whereby such end cap means is constructed and arranged to swivel outward when an inner catheter is pushed through such sleeve distal end. And it provides such a system further comprising: an inner catheter means, ha
Kearney Rosiland S.
Schmeiser Olsen & Watts LLP
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