Abstract: Noninvasive methods for therapeutically heating a collagenous structural support tissue of a pelvic support system to a desired temperature range are provided. One method comprises delivering energy to the structural support tissue to heat the tissue to the desired temperature range by ramping up a power level for a first period of time. A first constant high power level is then maintained for a second period of time. The power level is then ramped down for a third period of time. A second constant lower power level is then maintained for a fourth period of time. This power application treatment yields a favorable heat treatment maximizing predictability and efficacy while maintaining sufficient levels of safety. Further, such open loop power algorithms advantageously provide control without the need for subsidiary tissue temperature feedback measurements from sensors or tissue penetrating needles.

Abstract: Retrograde methods of accessing and treating collagenous pelvic tissue from a fixed point behind the endo-pelvic fascia, particularly from a space of retzius, are disclosed. Performing treatment from the space of retzius provides for simple and reliable placement and application of the system which in turn enhances both safety and efficacy of such retrograde methodologies. Generally, the systems of the present invention comprise at least a two-part assembly including a penetrating cannula or trocar and an expansible energy applying applicator that is preferably dismounted from behind the endo-pelvic fascia, particularly the space of retzius. The systems and methods are particularly well suited for the treatment of incontinence and other conditions related to insufficient collagenous pelvic tissue support.

Abstract: The invention provides improved devices, methods, and systems for shrinking of collagenous tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient's own support tissues. This energy gently heats fascia and other collagenous support tissues, causing them to contract. The energy will preferably be applied between a pair of large plate electrodes having cooled flat electrode surfaces separated by an insulating rib or film. Such cooled plate electrodes are capable of directing electrical energy through an intermediate tissue and into fascia while the cooled electrode surface prevents injury to the intermediate tissue.

Abstract: Devices and methods for aligning a probe body and a treatment surface adjacent a target tissue. A guide shaft can be positioned in a urethra. The probe body can be positioned in a vagina and registered relative to the guide so as to position the treatment surface in alignment with the target tissue.

Abstract: The invention provides improved devices, methods, and systems for shrinking of collagenated tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient's own support tissues. This energy heats fascia and other collagenated support tissues, causing them to contract. The energy can be applied intermittently, often between a pair of large plate electrodes having cooled flat electrode surfaces, the electrodes optionally being supported by a clamp structure. Such cooled plate electrodes are capable of directing electrical energy through an intermediate tissue and into fascia while the cooled electrode surface prevents injury to the intermediate tissue, particularly where the electrode surfaces are cooled before, during, and after an intermittent-heating cycle. Ideally, the plate electrode comprises an electrode array including discrete electrode surface segments so that the current flux can be varied to selectively target the fascia.

Abstract: The invention provides improved devices, methods, and systems for shrinking of collagenated tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient's own support tissues. This energy heats fascia and other collagenated support tissues, causing them to contract. The energy can be applied intermittently, often between a pair of large plate electrodes having cooled flat electrode surfaces, the electrodes optionally being supported by a clamp structure. Such cooled plate electrodes are capable of directing electrical energy through an intermediate tissue and into fascia while the cooled electrode surface prevents injury to the intermediate tissue, particularly where the electrode surfaces are cooled before, during, and after an intermittent heating cycle. Ideally, the plate electrode comprises an electrode array including discrete electrode surface segments so that the current flux can be varied to selectively target the fascia.

Abstract: The present invention provides devices and methods for treating tissue. In one embodiment the present invention provides a method of controlling a temperature of an applicator body, the method comprising providing an applicator body that comprises at least one contact surface A coolant is delivered through at least a portion of the applicator body at a substantially constant rate. Energy is delivered to the coolant through a heating element so that the contact surface of the applicator body is cooled to a desired temperature.

Abstract: Systems, software, devices, and methods are disclosed for therapeutically heating a collagenous structural support tissue within a pelvic support system of a patient body. The present invention may monitor the delivery of energy and dynamically adjust the delivery of energy during the treatment so that an actual treatment time for reaching a target temperature falls within a desired treatment time range of reaching the target temperature. The present invention may also dynamically adjust the power level after the target temperature has been reached so that the tissue is held at the target temperature for a desired dwell time.

Abstract: Systems and methods are disclosed for therapeutically heating a target zone of a collagenous support tissue within a patient body. In exemplary embodiments, the present invention provides electronically determining an acceptable or unacceptable contact condition between an energy source and a first tissue layer disposed proximally to the target zone. Upon determining an acceptable contact condition, the target zone is irradiated or otherwise heated for a finite time period with energy. A determination of an unacceptable contact condition causes cessation of irradiating.

Abstract: Systems and methods are disclosed for therapeutically heating a target zone of a collagenous support tissue within a patient body. In exemplary embodiments, the present invention provides electronically determining an acceptable or unacceptable contact condition between an energy source and a first tissue layer disposed proximally to the target zone. Upon determining an acceptable contact condition, the target zone is irradiated or otherwise heated for a finite time period with energy. A determination of an unacceptable contact condition causes cessation of irradiating.

Abstract: Methods and devices for improving contact between tissue and a probe. In exemplary embodiments, methods of the present invention include a deploying a needle into a target tissue and retracting the needle so that tenting around the needle is reduced. The retracting of the needle can increase the amount of tissue contact between a surface of the tissue and a surface contacting portion of a probe body.

Abstract: The present invention enhances the effectiveness of treatment of support tissue structures. Generally, such tissue structures support organs and hold the organs in their proper position for appropriate functioning. When such tissue structures become weak, hyper-elastic, and/or excessively lengthy, the organs of are no longer supported in their proper position. This often leads to physical manifestations such as incontinence, hernias, and the like. Remedies often involve thermal treatment of the support tissue structures, such as thermally inducted controlled shrinkage, contraction, or stiffening of the support tissue structure. To enhance such thermal treatment and diminish the possibility of undesirable heating and damage to nearby tissue surfaces, vasoconstrictive agents are used.

Abstract: Methods, devices, and systems for treating the support structures of the body, particularly for incontinence, take advantage of two mechanisms to enhance the support provided by the fascia, ligaments and tendons: first, the invention increases a modulus of elasticity of these tissues, and particularly of the fascial tissues. The increase in modulus can be effected by directing sufficient energy to the fascial tissue so as to promote the formation of scar tissue. The second mechanism attaches tissue planes together, often by directing energy to an interface between adjacent fascial tissues.

Abstract: Devices, systems, and method for treating urinary incontinence generally rely on energy delivered to a patient's own pelvic support tissue to selectively contract or shrink at least a portion of that pelvic support tissue so as to reposition the bladder. The energy will preferably be applied to the endopelvic fascia and/or an arcus tendineus fascia pelvis. The invention provides a variety of devices and methods for applying gentle resistive heating of these and other tissues to cause them to contract without imposing significant injury on the surrounding tissue structures. Alternatively, heat-applying probes are configured to heat tissue structures which comprise or support a patient's urethra. By applying sufficient energy over a predetermined time, the tissue can be raised to a temperature which results in contraction without significant necrosis or other tissue damage.

Abstract: Devices, systems, and method for treating urinary incontinence generally relying on energy delivered to a patient's pelvic support tissue to selectively contract or shrink at least a portion of that pelvic support tissue so as to reposition the bladder. The energy will preferably be applied to the endopelvic fascia and/or an arcus tendineus fascia pelvis. A variety of devices and methods are provided for applying gentle resistive heating of these and other tissues to cause them to contract without imposing significant injury on the surrounding tissue structures. By applying sufficient energy over a predetermined time, the tissue can be raised to a temperature which results in contraction without significant necrosis or other tissue damage. By selectively contracting the support tissues, the bladder neck, sphincter, and other components of the urinary tract responsible for the control of urinary flow can be reconfigured or supported in a manner which reduces urinary leakage.

Abstract: The present invention provides methods, devices, and systems for supporting the urethra in a patient to treat urinary incontinence. Support of the urethra involves forming a loop under the urethra with a structure referred to as a urethral support and applying an upward force with the support to hold the urethra in a more desired position. The present invention utilizes the space of Retzius within which portions of the urethral support are positioned. Ingrowth by surrounding tissues to the urethral support material provide further stability and such ingrowth, combined with the position of the support, allow sufficient tension to be applied to support to hold the urethra in place. Placement of such a urethral support is achieved by minimally invasive techniques, such as with the use of laparoscopic instruments. Such techniques allows placement of the urethral support by accessing the space of Retzius through the vaginal wall without penetrating the abdominal wall.

Abstract: The invention provides improved devices, methods, and systems for repeatably and reliably contracting fascia and other support tissues, particularly for the treatment of urinary incontinence. Rather than relying on a surgeon's ability to observe, direct, and control the selective shrinking of pelvic support tissues, a relatively large surface of a tissue contraction system is placed statically against the target tissue. Sufficient controlled energy is transmitted from the surface into the engaged tissue to contract the tissue and inhibit incontinence (or otherwise provide the desired therapeutic results).

Abstract: Devices, systems, and method for treating urinary incontinence generally rely on energy delivered to a patient's own pelvic support tissue to selectively contract or shrink at least a portion of that pelvic support tissue so as to reposition the bladder. Devices and methods apply gentle resistive heating of tissues to cause them to contract without imposing significant injury on the surrounding tissue structures. Alternative heat-applying probes heat tissue structures which comprise or support a patient's urethra. By selectively contracting the support tissues, the bladder neck, sphincter, and other components of the urinary tract responsible for the control of urinary flow can be reconfigured or supported in a manner which reduces urinary leakage.

Abstract: Devices and methods for aligning a probe body and a treatment surface adjacent a target tissue. A guide shaft can be positioned in a urethra. The probe body can be positioned in a vagina and registered relative to the guide so as to position the treatment surface in alignment with the target tissue.

Abstract: Devices, systems, and methods can treat incontinence by heating between about 100 and about 800 cubic millimeters of endopelvic fascia for sufficient time to effect substantial collagenous tissue shrinkage. A probe body may directly engage the endopelvic fascia, or may be separated from the endopelvic fascia, heating through (for example) the vaginal wall. In either case, tissue-penetrating electrodes may be inserted from the probe body so as to heat the endopelvic fascia.