Devices, systems and methods for treating benign prostatic hyperplasia and other conditions

Abstract

Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

1 - 249 . (canceled) 
     
     
         250 . A method for treating a condition in a human or animal subject wherein the prostate gland is causing undesirable constriction of the urethra, said method comprising the steps of:
 A) inserting an introducer device into the subject's body;   B) advancing a cutting device from the introducer device;   C) using the cutting device to cut at least a portion of the prostate without substantially damaging the urethra such that the constriction of the urethra is lessened; and   D) implanting at least one tissue compressing device to compresses the prostate in a manner that lessens constriction of the urethra.   
     
     
         251 . A method according to  claim 250  wherein the introducer device inserted in Step A comprises a scope lumen and a working lumen and wherein a scope is inserted into the scope lumen and the cutting device is advanced through the working lumen. 
     
     
         252 . A method according to  claim 250  further comprising the step of using the scope to view at least a portion of the performance of the method. 
     
     
         253 . A method according to  claim 250  wherein Step A comprises inserting the introducer to a position within the urethra and wherein Steps B and C comprise forming an opening in the wall of the urethra, advancing either the introducer or the cutting apparatus though the opening formed in the wall of the urethra and thereafter causing the cutting apparatus to form a cut that extends through the capsule of the prostate gland. 
     
     
         254 . A method according to  claim 250  wherein Step B comprises advancing the cutting device into the prostate gland. 
     
     
         255 . A method according to  claim 250  wherein Step B comprises advancing the cutting device to a position adjacent to the outer surface of the prostate capsule. 
     
     
         256 . A method according to  claim 250  wherein Step B comprises advancing a guide to a position within or near the prostate and advancing the cutting device over or through said guide. 
     
     
         257 . A method according to  claim 256  wherein the guide comprises a guidewire and wherein the cutting device comprises a guidewire lumen that facilitates advancement of the cutting device over the guidewire. 
     
     
         258 . A method according to  claim 256  further comprising the step of anchoring the guide. 
     
     
         259 . A method according to  claim 250  wherein Step C comprises using the cutting device to form a subcapsular cut within the prostate gland. 
     
     
         260 . A method according to  claim 250  wherein Step C comprises using the cutting device to form a cut through the capsule of the prostate gland. 
     
     
         261 . A method according to  claim 250  wherein Step C comprises forming a cut between the lobes of the prostate gland such that the lobes separate from one another. 
     
     
         262 . A method according to  claim 250  wherein the cutting device comprises an elongate shaft and a cutting element that is deployable from the shaft. 
     
     
         263 . A method according to  claim 262  wherein the cutting element comprises a cutting member that is initially in a non-cutting configuration substantially parallel to a longitudinal axis of the shaft and may be caused to bow outwardly from the shaft thereby cutting tissue as it bows outwardly. 
     
     
         264 . A method according to  claim 263  wherein the cutting device is advanced into the prostate gland with the cutting member in its non cutting configuration and, thereafter, causing the cutting member to bow outwardly thereby forming a cut in the prostate gland. 
     
     
         265 . A method according to  claim 262  wherein Step C comprises causing the cutting member to emit energy to facilitate formation of said cut. 
     
     
         266 . A method according to  claim 250  further comprising the step of maintaining separation of opposing surface of the cut for at least a period of time after formation of the cut. 
     
     
         267 . A method according to  claim 250  further comprising the step of delivering a therapeutic substance to a location within or near the prostate gland wherein the therapeutic substance is selected from the group consisting of:
 hemostatic agents; antimicrobial agents; antibiotics; antifungals; antiprotozoals; antivirals; antimicrobial metals; hemostatic and/or vasoconstricting agents; pseudoephedrine; xylometazoline; oxymetazoline; phenylephrine; epinephrine; cocaine; local anesthetic agents; lidocaine; cocaine; bupivacaine; hormones; anti-inflammatory agents; corticosteroids; non-steroidal anti-inflammatory agents; hormonally active agents; agents that enhance potency; substances that dissolve, degrade, cut, break, weaken, soften, modify or remodel connective tissue or other tissue; enzymes; collagenase; trypsin; EDTA; trypsin combined with EDTA; hyaluronidase; tosyllysylchloromethane (TLCM)); chemotherapeutic or antineoplastic agents; substances that prevent adhesion formation; hyaluronic acid gel; space occupying substances; substances that promote desired tissue ingrowth into an anchoring device or other implanted device; substances that promote or facilitate epithelialization; substances that create a coagulative lesion which is subsequently resorbed causing the tissue to shrink, substances that cause the prostate to decrease in size; phytochemicals that cause the prostate to decrease in size; alpha-1a-adrenergic receptor blocking agents; 5-alpha-reductase inhibitors; smooth muscle relaxants and agents that inhibit the conversion of testosterone to dihydrotestosterone.   
     
     
         268 . A method according to  claim 267  wherein the step of delivering a therapeutic substance to a location within or near the prostate gland comprises injecting said therapeutic substance into or near the prostate gland. 
     
     
         269 . A method according to  claim 267  wherein the step of delivering a therapeutic substance to a location within or near the prostate gland comprises placing a substance eluting implant in or near the prostate gland. 
     
     
         270 . A method according to  claim 269  wherein the substance eluting implant is further operative to maintain separation of opposing surface of the cut for at least a period of time after formation of the cut. 
     
     
         271 . A method according to  claim 250  further comprising the step of:
 forming a lesion within the tissue which subsequently causes shrinkage of the tissue.   
     
     
         272 . A method according to  claim 271  wherein a coagulative lesion is formed by heating the tissue. 
     
     
         273 . A method according to  claim 272  wherein the coagulative lesion subsequently becomes resorbed thereby causing the tissue to shrink. 
     
     
         274 . A method according to  claim 250  wherein the step of implanting at least one tissue compressing device to compresses the prostate in a manner that lessens constriction of the urethra comprises:
 placing a first anchor at a first location on, in or adjacent to the prostate;   placing a second anchor at a second location on, in or adjacent to the prostate; and   placing a connecting member between the first and second anchors, said connecting member drawing at least one of said first and second anchors toward the other thereby compressing at least a portion of the prostate.   
     
     
         275 . A transvesicular method for delivering a treatment to the prostate gland of a human or animal subject, said method comprising the steps of:
 A) percutaneously inserting a device through the wall of the abdomen;   B) forming a first opening in the wall of the urinary bladder;   C) advancing the device inserted in Step A through the first opening and into the urinary bladder;   D) forming a second opening in the wall of the bladder;   E) advancing at least one treatment delivering device through the second opening in the wall of the urinary bladder to a position within or near the urinary bladder; and   F) using said at least one treatment delivering device to deliver the treatment to the prostate gland.   
     
     
         276 . A method according to  claim 275  wherein the treatment comprises implantation of an implant device within or near the prostate gland. 
     
     
         277 . A method according to  claim 276  wherein the prostate is causing constriction of the urethra and wherein the implant comprises a device that compresses the prostate in a manner that lessens constriction of the urethra. 
     
     
         278 . A method according to  claim 276  wherein the implant delivers a therapeutic substance to treat a condition of the prostate. 
     
     
         279 . A method according to  claim 278  wherein the implant delivers a therapeutic substance selected from the group consisting of:
 hemostatic agents; antimicrobial agents; antibiotics; antifungals; antiprotozoals; antivirals; antimicrobial metals; hemostatic and/or vasoconstricting agents; pseudoephedrine; xylometazoline; oxymetazoline; phenylephrine; epinephrine; cocaine; local anesthetic agents; lidocaine; cocaine; bupivacaine; hormones; anti-inflammatory agents; corticosteroids; non-steroidal anti-inflammatory agents; hormonally active agents; agents that enhance potency; substances that dissolve, degrade, cut, break, weaken, soften, modify or remodel connective tissue or other tissue; enzymes; collagenase; trypsin; EDTA; trypsin combined with EDTA; hyaluronidase; tosyllysylchloromethane (TLCM)); chemotherapeutic or antineoplastic agents; substances that prevent adhesion formation; hyaluronic acid gel; space occupying substances; substances that promote desired tissue ingrowth into an anchoring device or other implanted device; substances that promote or facilitate epithelialization; substances that create a coagulative lesion which is subsequently resorbed causing the tissue to shrink, substances that cause the prostate to decrease in size; phytochemicals that cause the prostate to decrease in size; alpha-1a-adrenergic receptor blocking agents; 5-alpha-reductase inhibitors; smooth muscle relaxants and agents that inhibit the conversion of testosterone to dihydrotestosterone.   
     
     
         280 . A method according to  claim 275  wherein the treatment comprises forming a cut in the prostate in a manner that lessens constriction of the urethra. 
     
     
         281 . A method according to  claim 280  wherein the cut extends through the capsule of the prostate gland. 
     
     
         282 . A method according to  claim 281  wherein the cut is formed at or near the commissure of the prostate gland. 
     
     
         283 . A method according to  claim 275  wherein the treatment comprises forming a lesion in the prostate gland that subsequently causes shrinkage of the prostate gland. 
     
     
         284 . A method according to  claim 283  wherein the lesion is a coagulative lesion is formed by heating the tissue. 
     
     
         285 . A method according to  claim 284  wherein the coagulative lesion subsequently becomes resorbed thereby causing the tissue to shrink. 
     
     
         286 . A method for compressing at least one region of the prostate in a manner that relieves constriction of the urethra, said method comprising the steps of
 placing a first member in an anatomical structure outside of the urethra;   placing a second member in the lumen or wall of the urethra;   bringing the first member closer to the second member in a manner that relieves constriction of the urethra.   
     
     
         287 . A device for compressing at least one region of the prostate comprising
 a first element configured to communicate force to an anatomical structure outside of the urethra;   a second element configured to communicate force to the urethra; and   a tethering element capable of linking the first and second elements.   
     
     
         288 . A method of relieving obstruction of the urethra by the prostate, said method comprising the steps of:
 delivering at least one device through the wall of the urethra;   using said at least one device to performing at least one action on the prostate which changes the force exerted by the prostate on the urethra without removing or destroying prostatic tissue.   
     
     
         289 . A device for relieving a urethral obstruction caused by the prostate gland, said device comprising
 an implant that modifies at least one property of the tissue beyond the prostatic urethra without destroying or removing tissue.   
     
     
         290 . A method for decompressing a compressed lumen within the body of a human or animal subject, said method comprising the steps of.
 forming an opening in the wall of the lumen;   placing a first attachment element in or near the lumen,   placing a second attachment element in the subject's body at a location farther away from the lumen than the first attachment element;   
       placing a tensioning element between the first attachment element and the second attachment element said tensioning element being under sufficient tension to decompress the lumen;
 wherein the lumen within the body comprises the lumen of the urethra and the first attachment element, second attachment element and tensioning element are placed so as to modify forces exerted on the urethra. 
 
     
     
         291 . A system for treating a condition where a prostate tissue or anatomical structure causes constriction or interferes with an adjacent tissue or anatomical structure in the body of a human or animal subject, said system comprising:
 a first anchor;   a second anchor; and   a tensioning member that extends between the first and second anchors.   
     
     
         292 . A system according to  claim 291  wherein at least one of the first and second anchors comprises a crumpling anchor. 
     
     
         293 . A system according to  claim 291  wherein at least one of the first and second anchors comprises T shaped anchor. 
     
     
         294 . A system according to  claim 291  wherein at least one of the first and second anchors comprises a bow shaped anchor. 
     
     
         295 . A system according to  claim 291  wherein at least one of the first and second anchors comprises a cross shaped anchor. 
     
     
         296 . A system according to  claim 291  wherein at least one of the first and second anchors comprises a woven fabric, screen, textile, paper or other porous material. 
     
     
         297 . A system according to  claim 291  wherein at least one of the first and second anchors comprises an adhesive. 
     
     
         298 . A system according to  claim 291  wherein at least one of the first and second anchors comprises a plurality of arms extending outwardly from a central hub. 
     
     
         299 . A system according to  claim 291  wherein at least one of the first and second anchors comprises a spiral anchor. 
     
     
         300 . A system according to  claim 291  wherein at least one of the first and second anchors is configured to generally conform to the shape of an anatomical structure against which it is intended to rest. 
     
     
         301 . A system according to  claim 291  wherein at least one of the first and second anchors comprises a screw. 
     
     
         302 . A system according to  claim 291  wherein at least one of the first and second anchors comprises a plurality of splayable members. 
     
     
         303 . A system according to  claim 291  wherein at least one of the first and second anchors comprises a molly bolt anchor. 
     
     
         304 . A system according to  claim 291  wherein at least one of the first and second anchors is constructed to receive a trocar during insertion of the anchor. 
     
     
         305 . A system according to claim  191  wherein at least one of the first and second anchors comprises a device that is a) implantable in tissue before it is connected to the tensioning member and b) is configured to facilitate connection of the tensioning member thereto after it has been implanted in tissue. 
     
     
         306 . A system according to claim  191  wherein at least one of the first and second anchors comprises a spring. 
     
     
         307 . A system according to claim  191  wherein at least one of the first and second anchors comprises a screw. 
     
     
         308 . A system according to claim  191  wherein the tensioning member comprises an elongate member having at least one toothed surface. 
     
     
         309 . A system according to claim  191  wherein the tensioning member comprises a helical member. 
     
     
         310 . A system according to claim  191  wherein the tensioning member comprises a telescoping member. 
     
     
         311 . A system according to claim  191  wherein the tensioning member comprises a first elongate portion, a second elongate portion and a connecting body, the first elongate portion being connected to and extending from the connecting body in a first direction and the second elongate portion being connected to and extending from the connecting body in a second direction. 
     
     
         312 . A system according to claim  191  wherein the tensioning member is capable of being shortened after at least one of the anchors has been implanted. 
     
     
         313 . A system according to claim  191  further comprising apparatus for placing the tensioning member under a desired amount of tension. 
     
     
         314 . A system according to claim  191  further comprising a delivery device for delivering the system into the subject's body wherein the delivery device comprises an elongate member having a lumen and wherein the system is initially disposed within the lumen of the elongate member and wherein the system is expellable out of the lumen of the elongate member. 
     
     
         315 . A system according to  claim 314  wherein the delivery device is attached to at least one of said first anchor, second anchor and tensioning member and wherein the system further comprises apparatus for severing that attachment. 
     
     
         316 . A method for treating a prostate, comprising:
 passing an anchor through a prostate in a first orientation; and   releasing the anchor to a second orientation for retention in anatomy adjacent the prostate.   
     
     
         317 . A method for treating a prostate involving an anchor delivery device including a needle assembly and at least one anchor assembly including a connector attached to an anchor, comprising:
 placing the needle assembly at an interventional site;   advancing the anchor assembly through the needle assembly by applying a force on the connector; and   deploying the anchor assembly at the interventional site.