Deployable constrictor for uterine artery occlusion

Abstract

Devices, systems and methods for occluding blood vessels include a deployable constrictor having opposed pressure-applying portions, a delivery shaft configured to intravaginally advance the constrictor to the patient's cervix, a location sensor configured to detect a blood vessel, a deployment member for deploying the constrictor about the patient's cervix, and optionally a guide. The constrictor has a first configuration to receive a cervix and a second configuration to apply pressure to the cervical area to occlude a uterine artery by compression from the pressure-applying members. The pressure-applying members may be released from the cervix after a limited therapeutically effective time. The invention finds use in, for example, treating uterine disorders and conditions which may be treated by occlusion of the uterine arteries, such as uterine fibroids, dysfunctional uterine bleeding, post-partum hemorrhage, and bleeding associated with caesarian sections.

Description

FIELD OF THE INVENTION [0001] The invention relates generally to the field of devices and methods for treating diseases and conditions by regulating blood flow in blood vessels. In particular, the invention is directed to the treatment of uterine conditions by detecting and reducing or abolishing blood flow to the uterus. BACKGROUND OF THE INVENTION [0002] Hysterectomy (surgical removal of the uterus) is performed on approximately 600,000 women annually in the United States. Hysterectomy is often the therapeutic choice for the treatment of uterine cancer, adenomyosis, menorrhagia, uterine prolapse, dysfunctional uterine bleeding (abnormal menstrual bleeding that has no discrete anatomic explanation such as a tumor or growth), and muscular tumors of the uterus, known as leimyoma or uterine fibroids. [0003] However, hysterectomy is a drastic treatment, having many undesirable characteristics. Thus, any method which can approximate the therapeutic result of a hysterectomy without remov...

AI Technical Summary

Benefits of technology

[0011] The elongate delivery shaft is configured to intravaginally advance a constrictor in the first expanded configuration to the patient's cervix and to position the constrictor about tissue near to the uterine arteries with the aid of the locating sensors. Preferably, the delivery shaft is configured to slidably fit within a lumen of the deployment member. The deployment member lumen is oriented generally in a longitudinal direction, and is configured to receive at least part of the delivery shaft as the deployment member moves longitudinally along and around the shaft. Such longitudinal motion of the deployment member over the delivery shaft forward is effective to deploy the constrictor from the delivery shaft and onto or about the cervix. The delivery shaft may be configured to engage a suitable guide, such as a tenaculum, guidewire, or the like.

[0015] Methods embodying features of the invention include methods of occluding a uterine artery of a female human patient, the patient having a uterus, a cervix with a cervical os and a vaginal wall with a vaginal fornix, comprising pushing a pressure-applying member so as to distend the vaginal wall near the vaginal fornix near to a uterine artery, compressing the uterine artery with a pressure-applying member effective to reduce or abolish blood flow in the uterine artery. Compression may also be effective to retain in place a constrictor having a pressure-applying member. In embodiments of the devices, pressure-applying members comprise tissue-retaining features such as spikes, serration, rough surfaces, ridges, or scallops. Such tissue-retaining features are configured to prevent undesired movement of the pressure-applying members over the surface of the tissue to which they are attached.

[0017] The invention thus provides instruments and methods of utilizing such instruments for effective treatment of diseases and conditions that might otherwise require invasive and irreversible treatments such as removal of a patient's uterus. The devices and methods are simple and easy to use, simple to remove, and thus provide many advantages over other methods and devices. The invention provides improved treatments for serious conditions and diseases, including uterine fibroids, adenomyosis, dysfunctional uterine bleeding (DUB), postpartum hemorrhage, and other uterine disorders.

Problems solved by technology

However, hysterectomy is a drastic treatment, having many undesirable characteristics.

However, catheter-based uterine artery embolization under radiologic direction is a complicated procedure requiring highly sophisticated equipment.

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