Uromedica, Inc.

American Medical Systems, Inc.

Timothy C Cook

John H Burton

Claude Tihon

Richard A Noddin

Dale L Schreiner

James E Cabak

David Rhum

Ronald Svejkovsky

An implantable device includes a conduit, an adjustable membrane element coupled to the conduit near the front end of the conduit for controllable coaptation of a body lumen, such as coaptation of a urethra as treatment for urinary incontinence, and a fixation mechanism at or near the front end of the conduit. In various embodiments, the fixation mechanism can anchor the implantable device to the tissue using a movement of a push wire. Optionally, the fixation mechanism can also allow the implantable device to be released from the tissue using another movement of the push wire, to allow for repositioning or removal of the implantable device.

Method and apparatus for fixation of implantable device for urinary continence

The present application relates to method and apparatus for reducing migration and rotation of implantable devices including an expandable element and an elongate portion.

Method and apparatus for fixation of implantable devices adjacent a body lumen

An implantable device includes a conduit, an adjustable membrane element coupled to the conduit near the front end of the conduit for controllable coaptation of a body lumen, such as coaptation of a urethra as treatment for urinary incontinence, and a fixation mechanism at or near the front end of the conduit. In various embodiments, the fixation mechanism can anchor the implantable device to the tissue using a movement of a push wire. Optionally, the fixation mechanism can also allow the implantable device to be released from the tissue using another movement of the push wire, to allow for re-positioning or removal of the implantable device.

One or more sensors are incorporated onto one or more of an implantable device and a surgical tool used for placement and/or adjustment of the implantable device. The implantable device includes an adjustable membrane element for controllable coaptation of a body lumen, such as coaptation of a urethra as treatment for urinary incontinence. In various embodiments, the one or more sensors can be configured to detect information indicative of at least one of a shape of the adjustable membrane element, a position of the adjustable membrane element relative to the body lumen, or a shape of the body lumen.

Method and apparatus for monitoring implantable device for urinary continence

The present subject matter provides a trocar and sheath assembly for placement of implantable devices adjacent a body lumen, and a method of using the trocar and sheath assembly for implanting an implantable device at a target site for controllable coaptation of a patient's urethra.

Trocar and sheath assembly for placement of implantable device adjacent a body lumen

The present subject matter provides method and apparatus for placement of implantable devices adjacent a body lumen. A method of implanting an implantable device at a target site for controllable coaptation of a patient's urethra using an ultrasonic probe inserted into a rectum of the patient comprises inserting a Foley catheter into the urethra, expanding a Foley balloon in the bladder neck, inserting the ultrasonic probe into the rectum of the patient, using the ultrasonic probe to image the urethra and Foley balloon at the bladder neck, placing a small puncture in the perineum, passing a delivery device to the target site under ultra sonic guidance, injecting echogenic fluid at the target site adjacent the urethra, delivering the implantable device to the target site, and adjusting the implantable device to improve coaptation of the urethra.

Method and apparatus for placement of implantable device adjacent a body lumen

An implantable device and method for adjustably restricting a selected body lumen such as the urethra of a patient to treat urinary incontinence. The device includes an expandable element or membrane such as a balloon attached pressure-tightly to a flexible conduit at its forward end and includes a rear port portion containing an elastic septum and flow connected to the expandable element by a first passageway. The conduit contains a second passageway which allows it to be slid along an elongated guide probe initially inserted surgically into a patient's body adjacent the body lumen which is to be adjustably restricted. A suitable flowable material is injected from a syringe source into the device rear port sufficient to expand the membrane element and restrict the body lumen to the desired degree. The syringe and guide probe are removed and the skin incision is closed over the rear port end of the implanted device. The rear port septum is located under but near the patient's skin so that if it becomes necessary to post-operatively increase or decrease the degree of body lumen restriction it may be easily accessed with the needle of the syringe.

Implantable device and method for adjustably restricting a body lumen

An implantable medical device and method for adjustably restricting a selected body lumen such as a urethra or ureter of a patient to treat urinary incontinence or ureteral reflux. The device includes an adjustable element and a tubular elongate body, where the adjustable element includes a chamber and the tubular elongate body includes at least a first interior passageway which extends longitudinally in the tubular elongate body from a first opening at the proximal end to a second opening in fluid communication with the chamber. Fluid volume passed through the first passageway is used for adjustably expanding or contracting the adjustable element. The implantable medical device further includes a sheath and a sleeve, where the sheath includes a wall having an inner surface which defines a channel through which at least a portion of the implantable device and the sleeve can pass. Alternatively, the implantable medical device includes a tip suitable to penetrate tissue so that the implantable medical device can be implanted within the tissue of a patient.

Apparatus and method for inserting an adjustable implantable genitourinary device

An implantable medical device and method for adjustably restricting a selected body lumen such as a urethra or ureter of a patient to treat urinary incontinence or ureteral reflux. The device includes an adjustable element and a tubular elongate body, where the adjustable element includes a chamber and the tubular elongate body includes at least a first interior passageway which extends longitudinally in the tubular elongate body from a first opening at the proximal end to a second opening in fluid communication with the chamber. Fluid volume passed through the first passageway is used for adjustably expanding or contracting the adjustable element. The implantable medical device further includes a sheath, where the sheath includes a wall having an inner surface which defines a channel through which at least a portion of the implantable device can pass. Alternatively, the implantable medical device includes a tip suitable to penetrate tissue so that the implantable medical device can be implanted within the tissue of a patient.

An method and apparatus for an adjustable sling for treatment of urinary stress incontinence. The present system includes apparatus and methods for postoperative adjustment of sling tension using adjustable elements in the sling assembly. The present system also provides a number of demonstrative embodiments for an adjustable sling where positioning of the bladder is controlled using the adjustable sling and where coaptation of the urethra is controlled by postoperative inflation of one or more balloons mounted in a sling cup. Methods and apparatus are provided for adjusting the adjustable sling after surgical implantation. In one embodiment a self sealing septum is located near the skin for convenient filling using a syringe. Multiple port embodiments are also discussed.

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Wayzata, MN, United States of America

Timothy C Cook