Method and apparatus for treating hypertrophy of the prostate gland

An apparatus for relieving the symptoms of prostatic hypertrophy, comprising:

• an axially elongate catheter shaft having a proximal and a distal end of a size suitable to be inserted in a human urethra;
• an inflation port at the proximal end of said catheter shaft, in fluid communication with a radially expandable balloon disposed near the distal end of said catheter shaft by means of a first lumen extending axially therethrough;
• a vent port at the proximal end of said catheter shaft in fluid communication with said expandable balloon by means of a second lumen extending axially through said catheter shaft;
• a removably mounted, radially outwardly expandable tubular supportive stent coaxially disposed about the expandable balloon, said stent being formed from a malleable material which is biologically compatible with a urethra and comprising an opening at each end and a central lumen therethrough;
• wherein said stent is radially deformable from a first unexpanded state to a second, expanded deformed state in response to pressure from said balloon and is capable of withstanding said expanded, deformed configuration against inward forces exerted from a hypertrophied prostate;
• and
• the outer diameter of the stent in its first, unexpanded state is not substantially greater than the outer diameter of the adjacent catheter shaft, the catheter shaft and stent mounted thereon thereby having a substantially uniform cylindrical profile such that the apparatus may be transurethrally positioned within the prostatic urethra by way of the external opening of the urethra with said stent substantially totally exposed to the wall of the urethra, without the use of a sheath, and with said stent substantially totally exposed to the wall of the urethra.

An apparatus for relieving the symptoms of hypertrophy of the prostate gland, comprising:

• an axially elongate catheter shaft;
• an expandable region on said shaft disposed near the distal end of said shaft;
• a removably mounted, radially outwardly expandable tubular stent disposed on top of said expandable region and adapted for insertion into the prostatic urethra;
• and
• means on said catheter shaft for protecting the urethral lining from damage due to sliding contact with said stent, said protecting means comprising at least one circumferential shoulder on said catheter abutting said stent and said expandable region, the diameter of said shoulder being at least as great as the diameter of said stent so that said stent does not extend radially beyond said shoulder, wherein said stent is radially expandable by deformation thereof to a preselected stable configuration in response to pressure from said expandable region on said shaft.

An apparatus for relieving the symptoms of hypertrophy of the prostate gland, comprising:

• an axially elongate catheter shaft comprising at least one lumen therethrough and having an annular recess thereon for receiving a stent;
• an expandable balloon mounted on said shaft in said recess and in communication with said lumen;
• and
• a removably mounted, radially outwardly deformable and expandable tubular stent coaxially disposed about said balloon and situated in said recess, wherein said stent has an opening at each axial end and a central lumen therethrough,
• wherein said stent is radially expandable by deformation to a preselected configuration in response to pressure from said balloon, and the outside diameter of the stent, in its unexpanded state, is not substantially greater than the outside diameter of the adjacent catheter shaft.

An apparatus for relieving symptoms of hypertrophy of the prostate gland, comprising:

• an axially elongate catheter shaft having at least one lumen therethrough and having a circumferential recess near one end thereof;
• an expandable balloon mounted on said shaft in said recess and in communication with said lumen;
• a removably-mounted, radially outwardly expandable tubular stent coaxially disposed about said balloon, said stent having an opening at each end and a central lumen therethrough;
• wherein said stent is radially expandable by deformation thereof to a preselected configuration in response to pressure from said balloon, and wherein the outside diameter of the stent, in its unexpanded state, is not substantially greater than the outside diameter of the adjacent catheter.