Methods and devices for urethral treatment

Abstract

A system and method for treating a constricted bodily lumen, for example, a urethra constricted due to BPH. The method includes a planning stage, during which an area requiring treatment is visually identified, and an execution stage during which the lumen is expanded, a cut is formed in the inner surface of the tissue defining the lumen, and an implant is deployed in the cut. The implant can be an open C-shaped ring, and can be formed of a biodegradable material, or can be removed at a selected time after implantation. The system is formed of a planning device anchorable in the lumen and constructed to facilitate location of an area to be treated, and execution device constructed to deliver an implant, to expand the lumen, to form a cut in the inner surface of tissue defining the lumen, and to release the implant for deployment into the cut.

1 . A system for treatment of a urethra that is constricted due to BPH comprising:
 a positioning device including a positioning guide visible outside the urethra for determining the location of the area to be treated   an execution device for executing the treatment comprising:
 a dilation unit including an expandable element positionable to enlarge the urethra in the area to be treated and a delivery shaft connected to the expandable element; 
 a cutter including a blade positionable to form a cut in the inner surface of the tissue surrounding the area to be treated as indicated by the positioning device; and 
   an implant carrier releasably connectable to an implant for delivery to the area to be treated including a shaft operable to release the implant into the cut;   wherein the dilation unit is operable before release of the implant.   
     
     
         2 . A system according to claim  664 , wherein the second positioning guide comprises spaced markings configured to be visible using an optical device inserted in the urethra. 
     
     
         3 . (canceled) 
     
     
         4 . A system according to  claim 66 , wherein the anchor and the expandable element of the dilation unit are balloons and the delivery shafts for the balloons include fluid passages connectable to a source of inflation fluid to expand the balloons. 
     
     
         5 . (canceled) 
     
     
         6 . A system according to  claim 4 , wherein the anchor balloon is substantially toroidal in shape upon inflation. 
     
     
         7 . A system according to  claim 1 , wherein the dilation unit delivery shaft is comprised of two concentric tubes partially attached together at least distally, the fluid path being defined by a substantially annular passage between the two tubes. 
     
     
         8 . A system according to  claim 66 , wherein the anchor and the dilation element are self-expanding, and the delivery shaft for each is configured to release the respective self-expanding elements for expansion. 
     
     
         9 . A system according to  claim 1 , wherein the cutter includes the implant carrier. 
     
     
         10 . A system according to  claim 1 , wherein the implant carrier is comprised of an elongated pin, the pin including a projection at its distal end sized and positioned to engage a hole or a loop at one end of an implant and an actuator configured to pull the pin proximally to disconnect the implant from the projection. 
     
     
         11 - 12 . (canceled) 
     
     
         13 . A system according to  claim 1 , wherein:
 the cutter blade is delivered to the treatment area retractable outer sheath;   the cutter is rotatable;   the cutter blade is formed of a resilient material and is comprised of a proximal portion and a distal portion;   upon retraction of the outer sheath, the blade assumes an operating configuration with its distal end in contact with the surface of the prostate tissue surrounding the urethra to form a cut as the cutter is rotated.   
     
     
         14 . (canceled) 
     
     
         15 . A device according to  claim 13 , wherein the cutter further comprises a delivery tube for the blade and a pusher-wire coupled to the proximal end of the blade to push it distally out of its delivery tube so that it assumes its operating configuration and to pull the blade proximally to retract the blade back into the delivery tube for withdrawal of the execution device from the lumen. 
     
     
         16 - 20 . (canceled) 
     
     
         21 . A system according to  claim 66 , wherein the positioning device anchor and its delivery shaft are configured to be coupled to the execution device during treatment or the execution device includes a dedicated anchor and delivery shaft. 
     
     
         22 - 23 . (canceled) 
     
     
         24 . A system according to  claim 1 , wherein the positioning and execution devices are integrated in a single unit. 
     
     
         25 - 29 . (canceled) 
     
     
         30 . A system according to  claim 1 , wherein:
 the dilation unit is rotatable; and   the implant carrier, the implant release mechanism, and the cutter are coupled to the dilation unit and are rotatable thereby.   
     
     
         31 - 33 . (canceled) 
     
     
         34 . A system according to  claim 1 , further comprising an operating handle for the execution device comprising:
 a mechanism configured to retract an outer sheath;   a mechanism configured to push an implant out of the outer sheath;   a gear assembly including an actuator to rotate the cutter; and   a mechanism configured to release an implant from the carrier.   
     
     
         35 . A system according to  claim 4 , further comprising a pressure sensor connectable to the inflation tube for the anchor; and
 a pressure indicator,   wherein the pressure indicator is responsive to the pressure in the anchor inflation tube when tension is applied during the planning stage to provide a visual and/or aural indication when the same pressure is applied while locating the area of treatment and during execution of treatment.   
     
     
         36 . (canceled) 
     
     
         37 . A system according to  claim 30 , further comprising an operating handle for the execution device including an inflation port configured to provide inflation fluid for the dilation balloon while the dilation unit rotates. 
     
     
         38 . The system according to  claim 37 , wherein the inflation port comprises:
 a body;   a tubular passage, wherein one end of the passage is coupled to the body and   the other end terminates in a fitting connectable to a source of inflation fluid; and   end sections on proximal and distal ends of the body including portions formed of a resilient material, wherein:   the distal end section is coupled to the dilation unit inflation tube and provides a fluid-tight rotatable seal for the dilation unit inflation tube.   
     
     
         39 . A system according to  claim 1 , further including a mechanism for closing the implant-receiving cut by application of an adhesive, or by a clamp, or by a suture. 
     
     
         40 . A method for treating a urethra that is constricted due to BPP comprising:
 identifying a constricted area of the urethra requiring treatment;   using a transurathrally inserted execution device,
 delivering a substantially C-shaped implant in a compressed condition for deployment at the treatment area; 
 expanding the urethra in the treatment area; 
 forming a cut in the inner surface of the prostate surrounding the constricted area; and 
 inserting the implant into the cut after the urethra has been expanded with an open portion facing the rectum wall to maintain the expansion of then urethra. 
   
     
     
         41 . A method according to  claim 40 , wherein forming the cut includes connecting a cutter to a diathermy machine or a piezoelectric transducer to provide a source of electrical or electromechanical energy and rotating the cutter around an inner surface of the prostate tissue surrounding an area of the urethra requiring treatment. 
     
     
         42 . (canceled) 
     
     
         43 . A method according to  claim 40 , further comprising removing the implant after a predetermined time, or wherein the implant is formed of a material that is biodegradable. 
     
     
         44 - 49 . (canceled) 
     
     
         50 . A method according to  claim 68 , wherein the anchor and an element for expanding the urethra are balloons, and the balloons are inflated using a liquid as an inflation fluid. 
     
     
         51 . A method according to  claim 68 , further including connecting the positioning device to the execution device for use during the treatment. 
     
     
         52 . A method according to  claim 40 , further comprising:
 delivering two or more implants to the area to be treated simultaneously;   forming cuts for all of the implants simultaneously, and   deploying all of the implants simultaneously.   
     
     
         53 . A method according to  claim 40 , wherein two or more implants are delivered simultaneously using a single unit for delivery of all the implants or delivering each implant separately, and further comprising forming cuts for the implants at the time the respective implants are delivered. 
     
     
         54 - 57 . (canceled) 
     
     
         58 . The method according to  claim 40 , wherein the cut is formed by a cutter delivered to the implantation site, or by the implant, or by cooperation of a cutter and the implant. 
     
     
         59 . The method according to  claim 40 , further including closing the implant-receiving cut after deployment of the implant by application of an adhesive, or by a clamp, or by a suture. 
     
     
         60 - 64 . (canceled) 
     
     
         65 . An execution device for a system for treatment of a constricted intrabody lumen comprising:
 a dilation unit including an expandable element to enlarge the lumen in an area to be treated;   an implant carrier to releasably deliver an implant to the area of the lumen to be treated as identified during a preliminary planning stage of the treatment;   a cutter including a blade positionable to form a cut in the inner surface of the tissue surrounding the area to be treated to receive the implant by application of electrical or electromechanical energy to the tissue; and   a release mechanism for separating the implant from the implant carrier.   
     
     
         66 . Apparatus according to  claim 1 , wherein the positioning device includes:
 an anchor shaped and sized to lodge in the neck of a bladder;   an elongated delivery shaft insertable transurathrally connected to the anchor; and   a second positioning guide at the distal end of the anchor delivery shaft for visually determining the location of the area to be treated before treatment is executed.   
     
     
         67 . Apparatus according to  claim 66 , wherein the second positioning guide is comprised of spaced reference marks extending proximally along the anchor delivery shaft from adjacent to the positioning device anchor and the treatment positioning guide comprises spaced reference marks at the proximal end of the anchor delivery shaft wherein the proximal and distal markers are positionally correlated. 
     
     
         68 . A method according to  claim 40 , wherein the one or more areas requiring treatment are identified by:
 transurathrally inserting a positioning device into the urethra, the positioning device including an anchor and an anchor delivery shaft;   anchoring the positioning device in the neck of the bladder;   inserting an optical device into the urethra; and   visually identifying a desired location for forming the cut relative to spaced markings extending proximally on the anchor delivery shaft from adjacent to the anchor.   
     
     
         69 . A method according to  claim 68 , wherein the cut is performed using a cutter that is positioned at the time of treatment relative to a second set of spaced markers located at the proximal end of the anchor delivery shaft that are located outside the urethra and and are positionally correlated with the set of markers at the distal end of the anchor delivery shaft.