Balloon dilatation catheter

• US 5,007,898 A
• Filed: 06/02/1988
• Issued: 04/16/1991
• Est. Priority Date: 06/02/1988
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Advanced Surgical Intervention, Inc.
• Inventors: Lenker, Jay A., Rosenbluth, Robert F., Greene, George R.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/201,686
• Time in Patent Office: 1,048 Days
• Field of Search: 606/192, 606/108, 604/96-103, 604/264, 604/280, 128/898, 128/7, 128/693, 600/18
• US Class Current: 606/108
• 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 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 dilatation catheter and 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. Disposed near the proximal end of the expandable dilation portion of the catheter is a plurality of irrigation ports. A saline solution travels through an irrigation conduit and is secreted through the irrigation ports so as to flush away blood, etc., away from the lens of a cystoscope and provides the urologist with an unobstructed view of the dilation catheter and external urethral sphincter muscle. 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. An intraurethral dilatation apparatus for relieving the symptoms of obstructive prostatism, said device comprising:

an axially elongate introduction sheath, adapted for insertion into the urethra to receive and guide both a catheter shaft and a cystoscopic lens therethrough, so as to minimize trauma to the urethral lining during the insertion of said catheter and said lens;

a tubular, axially elongate, catheter shaft for insertion through said sheath, having a distal end to facilitate manipulation of said device within the urethra;

an expansible locating balloon, disposed near the distal tip of said catheter shaft and bonded thereto; and

a dilatation balloon, on said catheter shaft situated proximally of said expansible locating balloon, said dilatation balloon outwardly radially expandable to a preselected configuration in response to inflation thereof, wherein said dilatation balloon exhibits proximal and distal shoulders, and wherein a portion of said locating balloon overlaps at least a portion of said distal shoulder of said dilatation balloon.

2. An intraurethral dilatation apparatus for relieving the symptoms of obstructive prostatism, said device comprising:

an axially elongate introduction sheath, adapted for insertion into the urethra to receive and guide both a catheter shaft and a cystoscopic lens therethrough, so as to minimize trauma to the urethral lining during the insertion of said catheter and said lens;

a tubular, axially elongate, catheter shaft for insertion through said sheath, having a distal end to facilitate manipulation of said device within the urethra;

an expansible locating balloon, disposed near the distal tip of said catheter shaft and bonded thereto; and

a dilatation balloon, on said catheter shaft situated proximally of said expansible locating balloon, said dilatation balloon outwardly radially expandable to a preselected configuration in response to inflation thereof, wherein said dilatation balloon is made of a less resilient material than said locating balloon, and wherein said dilatation balloon, after being deflated, remains in a somewhat enlarged state, and wherein said introduction sheath has flexible tip at the distal end thereof adapted to temporarily deform upon receiving said enlarged dilatation balloon, so as to coerce said balloon back to said sheath prior to the removal of said device.

3. A method of treating the symptoms of obstructive prostatism, comprising the steps of:

measuring the length of the affected prostatic urethra using a calibration catheter;

inserting an introduction sheath into the urethra through the penile meatus using an obturator;

inserting a dilatation catheter, having a location balloon and a dilatation balloon secured thereto, and a standard endoscopic lens into said introduction sheath;

inflating said locating balloon and gradually withdrawing said catheter from the urethra, so as to lodge said locating balloon in the neck of the bladder;

visually confirming proper positioning of said dilatation balloon with respect to the external urethral sphincter; and

inflating said dilatation balloon so as to radially outwardly dilate said obstruction.

4. A method as defined by claim 3, further comprising:

providing an irrigation system within said catheter, said irrigation system adapted to flush blood away from said endoscopic lens, so as to facilitate enhanced visualization within the urethra.

5. In an intraluminal introduction sheath of the type for insertion into a body lumen for facilitating in vivo removal of a catheter having a compressible portion which is somewhat larger in cross-section than the inner cross-section of said sheath, said sheath having an axially elongate hollow shaft providing a path through which said catheter is guided into and out of a body lumen;

the improvement comprising;

a tip attached to the intraluminal end of said shaft, said tip formed of a material substantially more flexible than that of said shaft so that said tip will temporarily deform in response to the contours of said compressible portion of said catheter so as to facilitate compression and withdrawal of said compressible portion of said catheter.

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

inserting a dilatation means into the urethra, said dilatation means having an associated visualization means within the urethra for positioning the dilatation means relative to an anatomical landmark within the urethra;

adjusting the location of the dilatation means within the urethra with respect to the anatomical landmark using said visualization means; and

expanding said dilatation means so as to radially outwardly dilate said obstruction.

7. A method of treating the symptoms of obstructive prostatism as in claim 6, wherein said adjusting step comprises visually observing the location of an anatomical landmark using an endoscope.

8. A method as in claim 6 wherein the visualization means comprises a visual transmission means introduced substantially in parallel to the catheter within at least a portion of the urethra.

9. A method of treating the symptoms of obstructive prostatism as in claim 6, further comprising a step of flushing the visual field of the visualization means with a substantially visually transparent flushing fluid to optimize vision through the visualization means.

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

inserting a dilatation means into the urethra, said dilatation means having an associated non-radiological locating means for positioning the dilatation means relative to an anatomical landmark within the urethra, said locating means being proximal to said dilatation means;

locating the position of the dilatation means within the urethra using said non-radiological locating means;

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

expanding said dilatation means so as to radially outwardly dilate said obstruction.

11. A method of treating the symptoms of obstructive prostatism as in claim 10, wherein said non-radiological locating means in the adjusting step permits direct vision of the anatomical landmark.

12. A method of treating the symptoms of obstructive prostatism as in claim 11, wherein said direct vision locating means is an endoscopic viewing system.

13. A method of treating the symptoms of obstructive prostatism as in claim 10, wherein the dilatation means is disposed on a triple lumen catheter.

14. An intraurethral dilatation apparatus for relieving the symptoms of obstructive prostatism, said device comprising:

an axially elongate introduction sheath, adapted for insertion into the urethra to receive and guide both a catheter shaft and a cystoscopic lens therethrough, so as to minimize trauma to the urethral lining during the insertion of said catheter and said lens;

a tubular, axially elongate, catheter shaft for insertion through said sheath, having a distal end to facilitate manipulation of said device within the urethra;

a locating balloon, disposed on said catheter shaft and bonded thereto; and

a dilatation balloon, on said catheter shaft situated adjacent to said locating balloon, said dilatation balloon outwardly radially expandable to a preselected configuration in response to inflation thereof, wherein said dilatation balloon is made of a less resilient material than said locating balloon, and wherein said dilatation balloon, after being deflated, remains in a somewhat enlarged state, and wherein said introductions heat has a flexible tip at the distal end thereof adapted to temporarily deform upon receiving said enlarged dilatation balloon, so as to coerce said balloon back into said sheath prior to the removal of said device.

15. A method for providing substantially continuous visual verification of the position of an intraurethral dilatation balloon catheter apparatus even when existent blood and other fluids caused by the medical procedure are blocked by said dilatation balloon from flowing into the patient'"'"'s bladder, comprising the steps of:

inserting into the urethra a dilatation catheter shaft having a dilatation balloon secured thereto;

viewing the location of said apparatus within the urethra to position said dilatation balloon within said urethra;

inflating said dilatation balloon to substantially obstruct the urethra so that passage of said existent blood and fluids from the proximal side of said balloon to the bladder is blocked;

flowing an irrigation flushing fluid substantially parallel to said shaft from outside the patient to said viewing location; and

draining said flushing fluid along with said existent blood and fluids substantially parallel to said shaft away from said viewing location.

16. A method of treating the symptoms of obstructive prostatism, comprising the steps of:

inserting into the urethra a dilatation catheter shaft having a dilatation balloon secured thereto, a visual marking on the exterior wall of said catheter shaft, an irrigation conduit substantially parallel to said catheter shaft, and an irrigation port at the distal end of said irrigation conduit associated with said catheter shaft;

inserting a cystoscopic lens into the urethra after initial placement therein of the uninflated dilatation balloon;

flowing a flushing fluid through said irrigation port to wash away existent blood from said cystoscopic lens and draining said flushing fluid and blood from the region of said cystoscopic lens;

positioning said catheter shaft by viewing the position of said visual marking relative to the external urethral sphincter muscle so as to avoid accidental dilatation of the sphincter;

flowing pressurized fluid into said dilatation balloon for dilating said balloon until sufficient pressure dilatation is achieved to dilate the urethra and prostate thereby treating the urinary outflow obstruction;

withdrawing said fluid from said dilatation balloon so that said balloon is deflated; and

withdrawing said cystoscopic lens and said dilatation catheter from the urethra.