High-friction prostatic stent

• US 4,955,859 A
• Filed: 07/07/1989
• Issued: 09/11/1990
• Est. Priority Date: 07/07/1989
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Zilber, Serge
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): Owens, Kerry
• Application Number:
  US07/376,822
• Time in Patent Office: 431 Days
• Field of Search: 604/8, 604/43, 604/280, 604/175, 604/164, 604/282, 604/96, 128/343
• US Class Current: 604/8
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 25/0043 characterised by structural features

Abstract

A urethral stent is disclosed for the nonsurgical management of bladder outlet obstruction caused by an enlarged prostate. The stent is sufficiently rigid to provide support to assure patency of an intact but contracted urethral lumen but is sufficiently flexible to accommodate the natural anatomical bend of the prostatic urethra. The stent further includes means for frictionally engaging the urethral walls to anchor the device within the prostatic urethra and to prevent migration back into the bladder or down the urethra. When the need arises, the stent is easily and nonsurgically removed from the prostatic urethra.

Claims

1. An apparatus for the nonsurgical management of bladder outlet obstruction, comprising:

an elongated body having an exterior surface, said body having first and second ends and defining a passage therethrough, said body being dimensioned to be received within a prostatic urethra and having a length sufficient to extend only from a bladder neck approximately to a verumontanum, and said body comprising an inner member of silicone rubber having a durometer hardness of about 80 on the Shore A scale and a concentric outer member of silicone rubber having a durometer hardness of about 40 on the Shore A scale, said outer member being bonded to said inner member, and said concentric outer member having an exterior surface comprising said exterior surface of said body;

said body being sufficiently flexible to accommodate an anatomical bend of said prostatic urethra and sufficiently stiff to maintain patency of said passage in response to accommodation of said anatomical bend of said prostatic urethra and in response to constrictive forces exerted by an enlarged prostate surrounding said prostatic urethra; and

high friction means on said exterior surface of said body for frictionally engaging the walls of said prostatic urethra to prevent said apparatus from migrating proximally;

whereby when said apparatus is positioned within said prostatic urethra with said first end disposed at said bladder neck and said body extending approximately to said verumontanum, said body provides support to said prostatic urethra to ensure patency thereof.

2. An apparatus for the nonsurgical management of bladder outlet obstruction, comprising:

an elongated body having an exterior surface, said body having first and second ends and defining a passage therethrough, said body being dimensioned to be received within a prostatic urethra and having a length sufficient to extend only from a bladder neck approximately to a verumontanum;

said body being sufficiently flexible to accommodate an anatomical bend of said prostatic urethra and sufficiently stiff to maintain patency of said passage in response to accommodation of said anatomical bend of said prostatic urethra and in response to constrictive forces exerted by an enlarged prostate surrounding said prostatic urethra; and

a fabric layer bonded to said exterior surface of said body for frictionally engaging the walls of said prostatic urethra to prevent said apparatus from migrating proximally;

whereby when said apparatus is positioned within said prostatic urethra with said first end disposed at said bladder neck and said body extending approximately to said verumontanum, said body provides support to said prostatic urethra to ensure patency thereof.

3. An apparatus for the nonsurgical management of bladder outlet obstruction, comprising:

an elongated body having an exterior surface, said body having first and second ends and defining a passage therethrough, said body being dimensioned to be received within a prostatic urethra and having a length sufficient to extend only from a bladder neck approximately to a verumontanum;

said body being sufficiently flexible to accommodate an anatomical bend of said prostatic urethra and sufficiently stiff to maintain patency of said passage in response to accommodation of said anatomical bend of said prostatic urethra and in response to constrictive forces exerted by an enlarged prostate surrounding said prostatic urethra;

high friction means on said exterior surface of said body for frictionally engaging the walls of said prostatic urethra to prevent said apparatus from migrating proximally; and

a filament having one end secured to said body, whereby said filament may be manipulated to maneuver said apparatus to a desired location within said prostatic urethra;

whereby when said apparatus is positioned within said prostatic urethra with said first end disposed at said bladder neck and said body extending approximately to said verumontanum, said body provides support to said prostatic urethra to ensure patency thereof.

4. An apparatus for the nonsurgical management of bladder outlet obstruction, comprising:

an elongated body having an exterior surface, said body having first and second ends and defining a passage therethrough, said body being dimensioned to be received within a prostatic urethra and having a length sufficient to extend only from a bladder neck approximately to a verumontanum, said body comprising an inner member of silicone rubber having a durometer hardness of about 80 on the Shore A scale and concentric outer member of silicone rubber having a durometer hardness of about 40 on the Shore A scale bonded to said inner member, said concentric outer member having an exterior surface comprising said exterior surface of said body;

said body being sufficiently flexible to accommodate an anatomical bend of said prostatic urethra and sufficiently stiff to maintain patency of said passage in response to accommodation of said anatomical bend of said prostatic urethra and in response to constrictive forces exerted by an enlarged prostate surrounding said prostatic urethra; and

said exterior surface of said body having a coefficient of friction with relation to a urethral wall which, when multiplied by an area of surface contact between said exterior surface of said body and said urethral wall, exerts a frictional force sufficient to resist a force exerted by a contraction of smooth bladder neck musculature upon completion of micturition to prevent said apparatus from migrating proximally;

whereby when said apparatus is positioned within said prostatic urethra with said first end of said body disposed at said bladder neck and said body extending approximately to said verumontanum, said body provides support to said prostatic urethra to ensure patency thereof.

5. An apparatus for the nonsurgical management of bladder outlet obstruction, comprising:

an elongated body having an exterior surface, said body having first and second ends and defining a passage therethrough, said body being dimensioned to be received within a prostatic urethra and having a length sufficient to extend only from a bladder neck approximately to a verumontanum;

said body being sufficiently flexible to accommodate an anatomical bend of said prostatic urethra and sufficiently stiff to maintain patency of said passage in response to accommodation of said anatomical bend of said prostatic urethra and in response to constrictive forces exerted by an enlarged prostate surrounding said prostatic urethra; and

a fabric layer bonded to said exterior surface of said body and having a coefficient of friction with relation to a urethral wall which, when multiplied by an area of surface contact between said fabric layer and said urethral wall, exerts a frictional force sufficient to resist a force exerted by a contraction of smooth bladder neck musculature upon completion of micturition to prevent said apparatus from migrating proximally;

whereby when said apparatus is positioned within said prostatic urethra with said first end of said body disposed at said bladder neck and said body extending approximately to said verumontanum, said body provides support to said prostatic urethra to ensure patency thereof.

6. An apparatus for the nonsurgical management of bladder outlet obstruction, comprising:

an elongated body having an exterior surface, said body having first and second ends and defining a passage therethrough, said body being dimensioned to be received within a prostatic urethra and having a length sufficient to extend only from a bladder neck approximately to a verumontanum;

said body being sufficiently flexible to accommodate an anatomical bend of said prostatic urethra and sufficiently stiff to maintain patency of said passage in response to accommodation of said anatomical bend of said prostatic urethra and in response to constrictive forces exerted by an enlarged prostate surrounding said prostatic urethra;

said exterior surface of said body having a coefficient of friction with relation to a urethral wall which, when multiplied by an area of surface contact between said exterior surface of said body and said urethral wall, exerts a frictional force sufficient to resist a force exerted by a contraction of smooth bladder neck musculature upon completion of micturition to prevent said apparatus from migrating proximally; and

a filament having one end secured to said body, whereby said filament may be manipulated to maneuver said apparatus to a desired location within said prostatic urethra;

whereby when said apparatus is positioned within said prostatic urethra with said first end of said body disposed at said bladder neck and said body extending approximately to said verumontanum, said body provides support to said prostatic urethra to ensure patency thereof.