Balloon dilation catheter

• US 5,030,227 A
• Filed: 06/01/1989
• Issued: 07/09/1991
• Est. Priority Date: 06/02/1988
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Advanced Surgical Intervention, Inc.
• Inventors: Rosenbluth, Robert F., Lenker, Jay A., Greene, George R., Calvarese, Barry M.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/360,088
• Time in Patent Office: 768 Days
• Field of Search: 604/96-102, 604/164, 604/170, 604/8, 604/280, 604/104, 606/192-194, 128/660.01, 128/660.07, 128/4, 128/662.06
• US Class Current: 606/192
• 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 obstructive prostatism by dilation of the prostatic urethra, comprising the steps of:

inserting a dilation means into the urethra, said dilation means having a non-radiological locating means for positioning the dilation means relative to an anatomical landmark within the urethra which produces a radially inwardly directed force;

determining the location of the anatomical landmark by detecting the radially inwardly directed force;

adjusting the location of the dilation means within the urethra with respect to the anatomical landmark; and

expanding the dilation means so as to radially outwardly dilate the prostatic urethra.

2. An intraluminal dilation apparatus for relieving flow obstructions within a body lumen, comprising:

an axially elongate dilation catheter adpated for insertion into a body lumen and having a dilation means secured thereto, the catheter being axially movable so as to permit positioning of the dilation means within the obstructed body lumne; and

a muscle contractility detector, which detects radially inwardly directed forces, positioned relative to the dilation means such that, when the detector is axially aligned with the anatomical landmark, the dilation means is disposed within said body lumen.

3. An intraluminal dilation apparatus as in claim 2, additionally comprising an axially elongate introduction sheath adapted for insertion into the body lumen, wherein the muscle contractility detector is mounted on the sheath.

4. An intraluminal dilation apparatus as in claim 2, wherein the muscle contractility detector is mounted on the dilation catheter.

5. An intraluminal dilation apparatus for relieving flow obsturctions within the urethra, comprising:

an axially elongate introduction sheath, adapted for insertion into the urethra;

an axially elongate dilation catheter, ahving a dilation means secured thereto, the catheter extending through and axially movable within said sheath, so as to permit positioning of the dilation means within the urethra;

non-radiological locating means substantially parallel to the sheath for ascertaining the position of said dilating means within the urethra; and

an obturator integral with said dilatation catheter for facilitating introduction of the dilating means into the urethra.

6. An intraluminal dilation apparatus for relieving flow obstructions within the urethra, comprising:

an axially elongate introduction sheath, adapted for insertion into the urethra;

an axially elongate dilation catheter, having a dilation means secured thereto, the catheter extending through and axially movable within said sheath, so as to permit positioning of the dilation menas within the obstructed urethra;

non-radiological locating menas substantially parallel to the sheath for ascertaining the position of said dilating means within the urethra;

a locking bridge for facilitating control over the sheath, dilation means and locating means;

a first securing means on the locking bridge for fixing the position of the locating means in relation to the sheath.

7. An intraluminal dilation apparatus as in claim 6, further comrpising a second securing means on the locking bridge for fixing the position of the dilating means relative to the sheath.

8. An intraluminal dilation apparatus as in claim 7, further compising a third securing means on the locking bridge for fixing the position of the locating means relative to the dilating means.

9. An intraluminal dilation apparatus for relieving flow obstructions within a body lumen, comprising:

an axially elongate dilation catheter, having proximal and distal ends and a dilation means secured thereto;

a non-radiological locating means on the catheter for ascertaining the position of the dilating means within the body lumen; and

an obturator integrally secured to the distal end of the dilation catheter for facilitating introduction of the dilation catheter into the urethra.

10. A method of treating the symptoms of obstructive prostatism by dilation of the prostatic urethra, comprising the steps of:

inserting a dilation means into the urethra, said dilation means having a tubular support structure disposed thereon and a non-radiological locating means for positioning the dilation means and support structure relative to an anatomical landmark within the urethra;

adjusting the location of the support structure within the urethra with respect to the anatomical landmark using said non-radiological locating means;

expanding the dilation means so as to radially outwardly dilate the prostatic urethra; and

removing the dilation means leaving the support structure within the dilated portion of the prostatic urethra.

11. The method of claim 10 wherein said expanding step radially outwardly expands at leat a portion of the support structure.

12. A method of treating the symptoms of obstructive prostatism as in claim 10 wherein the adjusting step is accomplished under direct visualization using an endoscope.

13. An intraluminal dilation apparatus for relieving flow obstructions within the urethra, comprising:

an axially elongate introduction sheath, adapted for insertion into the urethra;

an axially elongate dilation catheter, having a dilation means secured thereto, the catheter extending through and axially movable within said sheath, so as to permit positioning of the dilation means within the obstructed urethra;

non-radiological locating means substantially parallel to the sheath for ascertaining the position of said dilating means within the urethra under direct division; and

a locking bridge and means on said locking bridge for limiting axial movement of the dilation means with respect to the non-radiological locating means;

wherein the dilation means is axially movable with respect to the locating means.

14. A method of treating the symptoms of urethral outflow obstructions by dilation of the urethra, comprising the steps of:

inserting a dilation means into the urethra, said dilation means having an axailly elongate support structure disposed thereon and a non-radiological locating means for positioning the dilation means and support structure relative to an anatomica landmark within the urethra;

adjusting the location of the support structure within the urethra wtih respect to the anatomical landmark using said non-radiological locating means;

expanding the dilation means so as to radially outwardly dilate the urethra; and

removing the dilation means leaving the support structure within the dilated portion of the urethra.

15. An intraluminal dilation apparatus for restoring patency to a collapsed portion of the urethra, comprising:

an axially elongate dilation catheter adapted for insertion into the urethra and having a dilation means secured thereto, the catheter being axially movable so as to permit positioning of the dilation means within the obstructed urethra;

an axially elongate support structure disposed on said dilation means, the support structure being outwardly radially expandable in response to dilation of the dilation means; and

non-radiological locating means substantially parallel to the urethra for ascertaining the position of said dilation means within the urethra under direct vision.

16. A method of treating the symptoms of urethral outflow obstructions by dilation of the urethra, comprising the steps of:

inserting an instrument into the urethra, said instrument having an axially elongate support structure disposed thereon for radially outwardly dilating the urethra;

adjusting the location of the support structure within the urethra with respect to the anatomical landmark using said non-radiological locating means under direct vision;

expanding the support structure so as to radially outwardly dilate the urethra; and

removing the instrument, leaving the support structure within the dilated portion of the urethra.