Noninvasive devices, methods and systems for shrinking of tissues

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. Alternatively, chilled “liquid electrodes” may direct current through a selected portion of the bladder (or other body cavity) while also cooling the bladder wall, an insulating gas can prevent heating of an alternative bladder portion and the adjacent tissues, and/or ultrasound transducers direct energy through an intermediate tissue and into fascia with little or no injury to the intermediate tissue. Cooled electrodes may be used to chill an intermediate engaged tissue so as to cause the maximum temperature difference between the target tissue and the intermediate tissue prior to initiating RF heating. This allows the dimensions of tissue reaching the treatment temperature to be controlled and/or minimized, the dimensions of protected intermediate tissue to be maximized, and the like.

1 . A method for teaching, the method comprising: 
 demonstrating cooling of a surface with a probe; and    demonstrating directing of energy from the probe through the surface and into an underlying structure to effect shrinkage of the structure.    
     
     
         2 - 32 . (canceled)  
     
     
         33 . A method for selectively heating a predetermined target tissue, the target tissue adjacent another tissue, the method comprising: 
 generating a temperature differential between the adjacent tissue and the target tissue; and    heating the target tissue by conducting a heating electrical current into the target tissue after generating the temperature differential so that the temperature differential urges the heating current from the adjacent tissue into the target tissue;    wherein the heating step ablates the target tissue, the target tissue comprising a tumor.    
     
     
         34 . A system for selectively heating a predetermined target tissue, the target tissue adjacent another tissue, the system comprising: 
 a probe having a surface oriented for engaging a tissue surface;    a member selected from the group consisting of a pre-cooler and a pre-heater coupled to the probe surface so as to produce a temperature differential between the target tissue and the adjacent tissue; and    at least one tissue heating electrode coupleable to the target tissue to conduct an electrical current into the tissues, the at least one heating electrode defining a nominal current distribution when the current is conducted into the tissues and the tissues are at a uniform body temperature, the at least one heating electrode producing a tailored current distribution when the current is conducted into the tissues and the tissues exhibit the temperature differential, the tailored current distribution resulting in less collateral damage to the adjacent tissues than the nominal current distribution when the target tissue is heated by the current to a treatment temperature.    
     
     
         35 . The system of  claim 34 , further comprising a processor coupled to the member to align the temperature differential between the target tissue and the adjacent tissue.  
     
     
         36 . The system of  claim 35 , wherein the processor initiates heating once a predetermined temperature differential is achieved.  
     
     
         37 . The system of  claim 36 , wherein the processor is coupled to the pre-heater and to the pre-cooler, and wherein the pre-heater comprises an energy transmitting element that is separate from the at least one electrode.  
     
     
         38 . The system of  claim 35 , further comprising a first temperature sensor coupled to the processor, the first temperature sensor transmitting an adjacent tissue temperature signal to the processor, wherein the processor determines the temperature differential at least in part from the adjacent tissue temperature signal.  
     
     
         39 . The system of  claim 38 , further comprising a second temperature sensor coupled to the processor, the second temperature sensor transmitting a target tissue temperature signal to the processor, wherein the processor determines the temperature differential at least in part from the target tissue temperature signal.  
     
     
         40 . The system of  claim 35 , wherein the member comprises a pre-heat electrode, and wherein the processor can vary at least one element of the group consisting of electrical pre-heat current from the pre-heat electrode, a pre-heat current duty cycle, and a total pre-heat time.  
     
     
         41 . The system of  claim 35 , wherein the member comprises a pre-cooler, and wherein the processor can vary at least one element selected from the group consisting of a total pre-cooling time, a probe surface temperature, and a pre-cooling duty cycle.  
     
     
         42 . The system of  claim 34 , wherein the at least one heating electrode is mounted to the probe.  
     
     
         43 . The system of  claim 42 , wherein the pre-cooler can cool the at least one heating electrode so that the at least one heating electrode pre-cools the adjacent tissue when the adjacent tissue is disposed between the at least one heating electrode and the target tissue.  
     
     
         44 . The system of  claim 43 , wherein the at least one heating electrode comprises a pair of bipolar heating electrodes along the probe surface, wherein the pre-cooler comprises cooled electrode surfaces of the heating electrodes and a cooled heat transfer surface disposed therebetween.  
     
     
         45 . The system of  claim 44 , wherein the heating electrodes define a width and are separated by a separation distance in a range from about ⅓ to about 5 times the width.  
     
     
         46 . The system of  claim 44 , further comprising a pair of bipolar pre-heat electrodes disposed along the probe surface with the heating electrodes disposed therebetween.  
     
     
         47 . The system of  claim 34 , further comprising a processor coupled to the at least one heating electrode and to the member, the processor controlling the temperature differential and the current so as to shrink the target tissue while avoiding collateral damage to the adjacent tissue, the target tissue comprising collagen.  
     
     
         48 . The system of  claim 34 , wherein the probe has a size and shape suitable for transvaginal insertion, the at least one heating electrode, the temperature differential member, and processor being capable of selectively shrinking an endopelvic support tissue so as to inhibit incontinence.