Tubal sterilization device having expanding electrodes and method for performing sterilization using the same

Abstract

A sterilization device which causes occlusion to the fallopian tubes of a patient is designed to be trancervically positioned in the intramural portion of the tube without perforating the tube. The device includes a flexible hollow catheter having an interior passageway, a distal end for insertion trancervically into a patient, and a proximal end opposite the distal end for grasping and manipulation by a physician. The device further includes a pair of diametrically opposed electrodes, each being movably mounted on the distal end of the catheter and radially movable with respect to the distal end. The electrodes are elongated axially and arcuate transversely and are expandable from a closed state, which defines the distal end of the catheter with a reduced diameter for proper transcervical delivery and placement in the fallopian tube of a patient, and an open state, where the electrodes are separated from one another a greater distance than when they are in the closed state, to define the distal end of the catheter with an enlarged diameter. In the expanded state, the diametrically opposed electrodes stretch the tissue of the fallopian tube to reduce blood flow and to help localize heating of the surrounding tissue. The electrodes are provided with RF (radio frequency) energy in their expanded state to heat the tissue of the fallopian tube which they contact. A temperature sensor situated at the distal end of the catheter measures the temperature of the heated tissue. The RF energy provided to the electrodes is controlled to ensure that the tissue is not overheated.

Description

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention generally relates to devices for occluding a body lumen, and more specifically relates to a permanent contraceptive or sterilization device for occluding a reproductive tract or lumen. Even more particularly, the present invention relates to a device which causes sterility in women by occluding the female reproductive fallopian tubes using RF (radio frequency) energy. [0003] 2. Description of the Prior Art [0004] Many methods of female sterilization have been investigated. One method is surgical tubal ligation, which is a procedure in which the uterine tubules are tied and cut or clamped through an incision made through the wall of the abdomen. Tubal ligation done with a laparotomy requires a surgical incision in the abdomen under general anesthesia. Drawbacks of this procedure necessarily include the risks inherent with anesthesia and the permanent scar formation at the site of the incision. A...

AI Technical Summary

Benefits of technology

[0008] It is an object of the present invention to provide a transcervically deliverable tubal sterilization device which obviates the need for surgery.

[0011] It is a further object of the present invention to provide a tubal sterilization device employing a catheter which only enters the fallopian tube in the wall of the uterus, thus reducing the risk of perforation.

[0012] It is yet a further object of the present invention to provide a tubal sterilization device which effectively causes occlusion of the fallopian tube by heating the intramural portion of the tube, thereby being safer and reducing any risk of heating adjacent structures or organs, such as the bladder or bowel.

[0013] It is still a further object of the present invention to provide a tubal sterilization device which expands when properly positioned within the fallopian tube to reduce blood flow in the adjacent tissue, thereby helping to localize the heating.

[0014] It is still another object of the present invention to provide a sterilization device for sterilizing human females, which device employs bipolar RF energy to avoid stray currents and unnecessary heating.

[0019] In accordance with one form of the present invention, a sterilization device which causes occlusion to the fallopian tubes is designed to be transcervically positioned in the intramural portion of the tube without perforating the tube. The device preferably includes a hollow, at least partially flexible, catheter having an interior passageway. The catheter has a first end (or patient end) for insertion transcervically into a patient, and a second end opposite the first end for grasping and manipulation by a physician. The device further includes a pair of diametrically opposed electrodes, each being movably mounted on the catheter at the first end. The electrodes are radially movable with respect to the first end of the catheter so that they may reside in either a first, closed state, thereby defining the patient end of the catheter with a reduced diameter for proper transcervical delivery and placement in the tubal osteum (and, in particular, the intramural portion) of the fallopian tube, and are expandable to a second, open position to define the patient end with an enlarged diameter. In this second, expanded state, the diametrically opposed electrodes stretch the tissue of the fallopian tube and reduce blood flow to help localize heating of the surrounding tissue.

Problems solved by technology

Drawbacks of this procedure necessarily include the risks inherent with anesthesia and the permanent scar formation at the site of the incision.

Drawbacks of this procedure include the need of repeat applications and a significant level of side effects.

This technique is time consuming and requires a high level of technical skill.

), an electrically energizable electrode is advanced into the fallopian tube and energized to thermally damage the fallopian tube, thereby causing enough scarring of the fallopian tube to permanent occlude it.

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