Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-07-30
2001-09-18
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S048000, C604S096010, C604S097020
Reexamination Certificate
active
06290672
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to an improved catheter for dispensing fluid within a fallopian tube and uterus in conjunction with expandable balloons for sealing the entrance to the fallopian tube and uterus to allow the injection of a saline fluid for improving uterine and fallopian tube ultrasonic examination and to provide for corrective procedures such as catheterization of blockages.
2. Description of the Background Art
Using present day state of the art equipment, surgeons can perform medical procedures to open a closed or blocked fallopian tube. Sonograms and ultrasonics are employed to locate the entrance to the fallopian tube and the blockage in the fallopian tube, in conjunction with a saline fluid that is used to fill the uterus to aid in the ultrasonic locating process. The primary objective is to guide or aid, through the use of ultrasonics, the surgeon in locating obstructions in the fallopian tube. The use of ultrasonics is a desired method, but requires skill on the part of the surgeon to ultimately locate blockages within the fallopian tube. Saline fluid in the fallopian tube and the uterus is essential for proper ultrasonic examination results. Instruments may be utilized for catheterization of blockages in a fallopian tube once the obstruction is located.
The use of balloon catheters which allow for inflation of a balloon around the outside of the catheter and injection of a fluid or liquid while simultaneously placing the balloon against the walls of an opening has been used for filling the uterus with a saline solution.
Devices are known in the prior art for introducing fluids into the uterine cavity and, ultimately, into the fallopian tubes. U.S. Pat. No. 3,948,259, issued Apr. 6, 1976 to Bolduc et al., describes a dispensing instrument for placing a material in the uterine cavity and moving the material from the uterine cavity through the canals of the fallopian tubes of a female. U.S. Pat. No. 5,188,595, issued Feb. 23, 1993 to Jocobi, discloses a method for enhanced retention of a balloon catheter in a body cavity which uses a pair of inflatable balloons which have a device for forming a suction between them to act to positively retain the catheter in position in a body cavity. U.S. Pat. No. 5,104,377, issued Apr. 14, 1992 to Levine, describes a uterine access device with an automatic cervical adjustment. The device includes expandable distal and proximate members to secure a shaft to the uterus by adjusting to the length of the cervical canal.
None of the prior art references describe a catheter to assist in inspection of the fallopian tubes using ultrasonics through the introduction of liquids into the fallopian tubes, as described in the present invention. The present invention may also be used for catheterization of blockages found in the fallopian tubes.
SUMMARY OF THE INVENTION
The present invention provides an improved catheter that permits diagnostic and therapeutic examination of the uterus and fallopian tubes using ultrasonics and can provide delivery and retention of a predetermined necessary liquid, such as saline, into the fallopian tube and the uterus for proper ultrasonic examinations.
Infertility in women is often the result of fallopian tube blockage. Blockage in the fallopian tube prevents the ova from reaching the uterus. It is therefore necessary for a physician or surgeon to determine whether or not there is any blockage occurring in the fallopian tube. One method of determining blockage is through the use of ultrasonics or ultrasound in the form of sonograms, which can provide imaging on a visual display that shows various physiological conditions present in the uterus and in the fallopian areas. In order to get a good sonogram or ultrasonic picture, it is essential that the areas in question contain the proper density of liquid, such as a saline solution, for best results.
The catheter in accordance with the present invention is comprised of a plurality of lumens joined together as a single unit having first and second expandable balloons adjustable between strategically determined locations relative to the proximal and distal ends of the lumens. Each expandable balloon is connected to a separate lumen that provides for liquid under pressure through a syringe piston disposed at the proximal end of the device.
Disposed adjacent each expandable balloon is a liquid orifice which is the termination of a particular lumen that provides for the proper fluid distribution from a piston or other fluid dispensing device that transmits fluid through the lumen for expulsion at the particular lumen orifice.
The present invention may also include a separate lumen having a probe with a distal end tip made of an echogenic material for improved visual display guidance using the sonogram. The echogenic tip will be more visible on the sonic display relative to the catheter probe end and the body tissue. The catheter may also provide for tissue catheterization with the echogenically tipped probe to remove blockage tissue or other undesirable tissue.
A syringe can be connected at the proximal end of each lumen for the delivery of saline liquid to the appropriate location. Each syringe is conventional and includes a piston and an on/off locking valve at its end to retain the liquid in the particular lumen once it has been filled.
In one embodiment, two syringes can be utilized each having a three position valve to connect one syringe to either the lumen feeding the first balloon or the lumen feeding the first liquid orifice, and the other syringe to either the lumen feeding the second balloon or the lumen feeding the second liquid orifice.
In the preferred embodiment, the distance is adjustable between each of the expandable balloons to accommodate the distance of various sized women or various distances between the cervix and the fallopian tube opening, such as to custom fit the more distal balloon within a fallopian tube while the proximal balloon is positioned in the cervical opening. Upon inflation, the cervix opening is blocked with the first balloon to prevent fluid leakage outside the uterus. When the fallopian tube balloon is inflated, saline fluid can be injected into the fallopian tube that is being examined.
In an alternative embodiment, the distance is fixed between the cervix opening balloon and the fallopian tube balloon to fit an average woman's body or for a typical distance between the cervical opening and the fallopian tube.
The catheter device can include a flexible, precurved distal end section having memory that, upon insertion of the distal end, is directed by longitudinal insertion predisposed toward either one fallopian tube opening or the other, because the fallopian tube openings are offset relative to the cervix and uterus. The curved end directs the entire catheter distal end in a preferred direction toward the selected fallopian tube opening, reducing the amount of manipulation required by the surgeon to position the balloon in the fallopian tube opening.
In the preferred embodiment, a three position valve can be provided to connect a first syringe to either a lumen leading to the first balloon or a lumen leading to the first liquid orifice. The third valve position is an “off” position effectively sealing off the lumens and the syringe. When filled with fluid from the first syringe, the first balloon seals the entrance to the uterus permitting fluid flowing from the first syringe to the first liquid orifice to fill the uterus.
A second three position valve can be provided to connected a second syringe to either a lumen leading to the second balloon or a lumen leading to the second liquid orifice. The third valve position being an “off” position effectively sealing off the lumens and the second syringe.
The preferred embodiment of the catheter includes a first and second lumen set side by side in the catheter tube. The first lumen supplies fluid to the first balloon and contains a conduit having a third lumen to supply fluid to the first liquid orifice. The second lumen s
Malin, Haley and Dimaggio, P.A.
Rodriguez Cris
Seidel Richard K.
LandOfFree
Exploratory tubular sonogenic catheter does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Exploratory tubular sonogenic catheter, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Exploratory tubular sonogenic catheter will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2539874