Flow obstruction treatment method

• US 5,527,336 A
• Filed: 03/02/1995
• Issued: 06/18/1996
• Est. Priority Date: 12/09/1986
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Lenker, Jay A., Rosenbluth, Robert F., Greene, George R., Calvarese, Barry M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US08/398,049
• Time in Patent Office: 474 Days
• Field of Search: 604/96-103, 604/280, 604/264, 604/104, 604/170, 128/898, 128/4-6, 128/7, 606/191-196, 606/108, 623/12, 600/116, 600/157
• US Class Current: 606/192
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/30187 D-shaped or half-disc-shaped
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Disclosed is an apparatus and method for the treatment of the symptoms of obstructive prostatism. The apparatus comprises an expandable dilation catheter and preferably an axially elongate sheath, adapted for transurethral insertion via the external opening of the urethra. The sheath is ellipsoid in cross-section, and provides an initial path through which the catheter and a standard cystoscope lens is guided. The dilation catheter or the sheath are provided with a non-radiological locating means for positioning the dilation portion of the catheter with respect to an anatomical landmark. Once the catheter has been properly positioned with respect to both the bladder neck and the sphincter, the dilation balloon may be inflated to force open the affected prostatic urethra and eliminate the obstruction.

Claims

1. A method of treating the symptoms of a flow obstruction of a urethra, comprising the steps of:

inserting an instrument into the urethra, said instrument having a support structure removably, coaxially disposed about a radially expandable region of said instrument, said instrument also having a visual indicator thereon proximal to said support structure for positioning the support structure relative to the obstruction while avoiding an external urethral sphincter;

positioning the support structure within the obstruction by positioning the visual indicator within the urethra at the lower end of the affected prostatic urethra under direct vision without use of x-rays;

ensuring that the visual indicator does not extend onto any portion of the external urethral sphincter in order to avoid dilation of the external urethral sphincter; and

expanding the support structure so as to radially outwardly dilate the urethra, whereby the obstruction is also dilated.

2. The method of claim 1, wherein said instrument is a balloon catheter having a balloon thereon for radially outwardly dilating the support structure.

3. The method of claim 1, wherein said support structure is axially elongate.

4. The method of claim 1, wherein the instrument is removed, leaving the support structure within the dilated portion of the urethra.

5. The method of claim 1, wherein the visual indicator comprises a radial enlargement on said instrument.

6. The method of claim 5, wherein the radial enlargement comprises a radially outwardly extending annular ridge on said instrument.

7. The method of claim 1, wherein the visual indicator comprises a line on said instrument.

8. The method of claim 1, wherein the support structure is a stent.

9. The method of claim 8, wherein the radially expandable region, in its unexpanded state, has an outer diameter that is slightly smaller than the outer diameter of the adjacent region of said instrument, whereby the radially expandable region, in its unexpanded state, forms an annular depression about said instrument.

10. The method of claim 9, wherein the stent is disposed within the annular depression.