Device and methods useable for treatment of glaucoma and other surgical procedures

Abstract

A device and method for cutting or ablating tissue in a human or veterinary patient includes an elongate probe having a distal end, a tissue cutting or ablating apparatus located adjacent within the distal end, and a tissue protector extending from the distal end. The protector generally has a first side and a second side and the tissue cutting or ablating apparatus is located adjacent to the first side thereof. The distal end is structured to be advanceable into tissue or otherwise placed and positioned within the patient's body such that tissue adjacent to the first side of the protector is cut away or ablated by the tissue cutting or ablation apparatus while tissue that is adjacent to the second side of the protector is not substantially damaged by the tissue cutting or ablating apparatus.

1 . A device for cutting or ablating tissue in a human or veterinary patient, said device comprising: 
 an elongate probe having a distal end;    a tissue cutting or ablating apparatus; and    a protector that extends from the probe, said protector having a first side and a second side, said protector being positionable such that tissue that is to be cut or ablated is adjacent to the first side of the protector and tissue that is to be protected is adjacent to the second side of the protector, said protector being at least partially formed of an insulating material;    the tissue cutting or ablating apparatus being useable to cut or ablate tissue that is located adjacent to the first side of the protector without causing substantial damage to tissue located adjacent to the second side of the protector.    
     
     
         2 . A device according to  claim 1  wherein the tissue cutting or ablating apparatus causes thermal cutting or ablation of tissue and wherein the protector is at least partially formed of a thermal insulating material that deters thermal energy from causing substantial damage to tissue located adjacent to the second side of the protector.  
     
     
         3 . A device according to  claim 1  wherein the tissue cutting or ablating apparatus comprises an electrosurgical apparatus and wherein the protector is at least partially formed of an insulating material that deters conduction of electrical power through the protector.  
     
     
         4 . A device according to  claim 1  wherein the protector is formed entirely of insulating material.  
     
     
         5 . A device according to  claim 1  herein the protector is formed of metal that is at least partially covered by an insulating material.  
     
     
         6 . A device according to  claim 1  wherein the insulating material comprises a at least partial polymer coating.  
     
     
         7 . A device according to  claim 6  wherein the polymer coating comprises a polyimide coating.  
     
     
         8 . A device according to  claim 7  wherein the polymer coating is applied to at least a portion of the protector by dipping at least a portion of the protector into a liquid polymer solution which subsequently dries and forms a coating.  
     
     
         9 . A device according to  claim 1  further comprising an infusion lumen through which fluid can be infused into the patient's body and an aspiration lumen through which fluid can be aspirated out of the patent's body.  
     
     
         10 . A device according to  claim 1  wherein the tissue cutting or ablating apparatus comprises an electrosurgical tissue cutting or ablating apparatus.  
     
     
         11 . A device according to  claim 10  wherein the tissue cutting or ablating apparatus comprises a bipolar electrode configuration having first and second electrode surfaces.  
     
     
         12 . A device according to  claim 10  wherein the tissue cutting or ablating apparatus comprises a monopolar electrode and wherein the device further comprises a return electrode that is electrically couplable to the patient's body.  
     
     
         13 . A device according to  claim 1  wherein the tissue cutting or ablating apparatus comprises a light emitting apparatus which emits light energy to cut or ablate tissue.  
     
     
         14 . A device according to  claim 13  wherein the tissue cutting or ablating apparatus emits laser energy.  
     
     
         15 . A device according to  claim 13  wherein the tissue cutting or ablating apparatus emits light energy that causes thermal destruction of tissue.  
     
     
         16 . A device according to  claim 13  wherein the tissue cutting or ablating apparatus emits ultraviolet light.  
     
     
         17 . A device according to  claim 1  wherein the tissue cutting or ablating apparatus comprises an ultrasonic apparatus which uses ultrasound to cut or ablate tissue.  
     
     
         18 . A device according to  claim 1  wherein the tissue cutting or ablating apparatus comprises a mechanical tissue cutting apparatus.  
     
     
         19 . A device according to  claim 18  wherein the tissue cutting or ablating apparatus comprises at least one knife blade.  
     
     
         20 . A device according to  claim 19  wherein the tissue cutting or ablating apparatus comprises at least first and second knife blades located a spaced distance apart to cut a strip of tissue the width of which is substantially equal to the distance between the first and second knife blades.  
     
     
         21 . A device according to  claim 18  wherein the tissue cutting or ablating apparatus comprises at least one scissor.  
     
     
         22 . A device according to  claim 21  wherein the tissue cutting or ablating apparatus comprises at least first and second scissors located a spaced distance apart to cut a strip of tissue, the width of which is substantially equal to the distance between the first and second scissors.  
     
     
         23 . A device according to  claim 18  wherein the tissue cutting or ablating apparatus comprises at least one rotating cutter.  
     
     
         24 . A device according to  claim 1  wherein the device comprises: 
 an outer tube that has a lumen and a distal end; and    an inner tube that has a lumen and a distal portion, said inner tube extending through the lumen of the outer tube such that the distal portion of the inner tube extends out of and beyond the distal end of the outer tube;    wherein the protector is located on the portion of the inner tube that extends out of and beyond the distal end of the inner tube.    
     
     
         25 . A device according to  claim 24  wherein the outer diameter of the inner tube is smaller than the inner diameter of the outer tube such that fluid may flow through the lumen of the outer and wherein at least one aperture is formed in the outer tube to permit fluid to pass into or out of the lumen of the outer tube.  
     
     
         26 . A device according to  claim 24  wherein a power transmitting member extends through the lumen of the inner tube to deliver energy to the tissue ablating or cutting apparatus.  
     
     
         27 . A device according to  claim 26  wherein the power transmitting member is an electrically conductive member for delivering electrical energy to the tissue cutting or ablating apparatus.  
     
     
         28 . A device according to  claim 26  wherein the power transmitting member is a light guide for delivering light energy to the tissue cutting or ablating apparatus.  
     
     
         29 . A device according to  claim 26  wherein the power transmitting member is an ultrasound transmission member for delivering ultrasonic energy to the tissue cutting or ablating apparatus.  
     
     
         30 . A device according to  claim 26  wherein the power transmitting member is a mechanical drive member for driving the tissue cutting or ablating apparatus.  
     
     
         31 . A device according to  claim 26  wherein the power transmitting member is a rotatable drive shaft for rotatably driving the tissue cutting or ablating apparatus.  
     
     
         32 . A device according to  claim 1  wherein the tissue cutting or ablating apparatus emits energy which causes cutting or ablation of tissue and wherein the intensity and/or configuration of energy emitted by the tissue cutting or ablating apparatus is such that a strip of tissue of substantially predetermined width is cut or ablated.  
     
     
         33 . A device according to  claim 24  wherein the protector is formed by forming cuts in the distal portion of the inner tube and then bending at least a part of the distal portion of the inner tube to form said protector.  
     
     
         34 . A device according to  claim 33  wherein the protector is further formed by applying an insulating material to the part of the distal end of the inner tube that is bent to form the protector, thereby forming a protector having an insulating material disposed thereon.  
     
     
         35 . A method for manufacturing a device useful for cutting or ablating tissue in a human or veterinary patient, the method comprising: 
 A) providing an outer tube and an inner tube;    B) positioning the inner tube within the outer tube such that a distal portion of the inner tube extends beyond a distal end of the outer tube;    C) forming a protector on the distal end of the outer tube by 
 a. cutting at least one notch in the distal end of the inner tube to form at least one leg, and  
 b. bending the first leg to form a protector having a first side and a second side, and  
   D) positioning an electrosurgical cutting or ablating apparatus at the distal portion of the inner tube and spaced apart from an adjacent the first side of the protector.    
     
     
         36 . A method according to  claim 35  wherein the step of positioning an electrosurgical cutting or ablating apparatus comprises forming an electrode member from a portion of the inner tube.  
     
     
         37 . A method according to  claim 36  wherein the step of forming an electrode includes forming a second leg in the distal portion of the inner tube.  
     
     
         38 . A method according to  claim 35  wherein the step of bending the first leg comprises the first leg radially inwardly.  
     
     
         39 . A method according to  claim 35  wherein the step of forming the protector further comprises applying an insulating coating on the first leg.  
     
     
         40 . A method according to  claim 36  wherein the step of forming an electrode comprises forming a first electrode from a portion of the inner tube and positioning an electrically conductive member including a second electrode spaced apart from and adjacent to the first electrode.  
     
     
         41 . A method for cutting or ablating a strip of tissue from a tissue mass, said method comprising the steps of: 
 A) providing a device which comprises; 
 i. an elongate probe having a distal end;  
 ii. a tissue cutting or ablating apparatus; and  
 iii. a protector that extends from the probe, said protector having a first side and a second side, said protector being positionable such that tissue that is to be cut or ablated is adjacent to the first side of the protector and tissue that is to be protected is adjacent to the second side of the protector, said protector being at least partially formed of an insulating material;  
 wherein the tissue cutting or ablating apparatus is useable to cut or ablate tissue located adjacent to the first side of the protector without causing substantial damage to tissue located adjacent to the second side of the protector  
   B) positioning the device within or adjacent to the mass of tissue; and    C) advancing the device such that some of the in a first direction while using the tissue cutting or ablating apparatus to cut or ablate tissue that becomes positioned adjacent to the first side of the protector.    
     
     
         42 . A method according to  claim 41  wherein the mass of tissue is in vivo.  
     
     
         43 . A method according to  claim 41  wherein the mass of tissue is in vitro.  
     
     
         44 . A method according to  claim 1  wherein the mass of tissue is located within the body of a human or animal subject.  
     
     
         45 . A method according to  claim 44  wherein the strip of tissue is removed for a diagnostic or therapeutic purpose.  
     
     
         46 . A method according to  claim 45  wherein the subject suffers from glaucoma and wherein the method is carried out to remove a strip of trabecular meshwork from an eye of the subject to facilitate drainage of aqueous humor from the eye, thereby lowering intraocular pressure.  
     
     
         47 . A method according to  claim 46  wherein Steps B and C comprise: 
 inserting the device into the anterior chamber of the eye;    advancing the protector through the trabecular meshwork of the eye and into Schlemm's Canal;    advancing the device such that the protector moves through Schlemm's Canal and the cutting or ablation apparatus cuts or ablates trabecular meshwork tissue that becomes positioned adjacent to the first side of the protector.    
     
     
         48 . A method according to  claim 41  wherein the method is carried out to form an incision in skin, mucous membrane, an organ, a tumor or other anatomical structure.  
     
     
         49 . A method according to  claim 41  wherein the device provided in step A has at least one lumen formed therein and wherein the method further comprises the step of: 
 C) removing fluid or matter through a lumen of the device.    
     
     
         50 . A method according to  claim 49  wherein a lumen of the device is attached to a source of negative pressure to aspirate the tissue or matter through the lumen of the probe.  
     
     
         51 . A method according to  claim 41  wherein the device has at least two lumens and wherein the method further comprises: 
 infusing a fluid through one of the lumens; and    aspirating fluid and/or matter through the other of said lumens.    
     
     
         52 . The device of  claim 1  wherein the cutting or ablating apparatus comprises a plasma generating apparatus which utilizes properties of plasma to cut or ablate tissue.  
     
     
         53 . The device of  claim 1  wherein the cutting or ablating apparatus emits infrared light.