Balloon assembly with separately inflatable sections
First Claim
1. An inflatable tubular member formed of polymeric material having:
- a first inflatable working section which has an interior adapted to receive inflation fluid, which upon inflation to a first internal pressure within a first pressure range expands substantially to a first inflated diameter and which is significantly less compliant at pressures above the first pressure range than pressures within the first pressure range; and
a second inflatable working section longitudinally disposed from the first inflatable working section which has an interior adapted to receive inflation fluid and in fluid communication with the interior of the first inflatable working section, which does not expand significantly upon inflation to the first internal pressure and upon inflation to a second internal pressure within a second pressure range, higher than the first internal pressure, expands to a second inflated diameter.
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Accused Products
Abstract
A dilatation or other similar catheter for intraluminal use which has an elongated shaft and an inflatable member or section on the distal extremity of the catheter shaft which has multiple working sections, a first working section which elastically expands upon inflation to a first pressure within a first pressure range and a second working section which elastically expands upon inflation to a second pressure within a second pressure range which is at least in part higher than the first pressure range. The first working section may be inflated to secure the catheter within the body lumen and then the second working section may be inflated to dilatate the body lumen.
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Citations
29 Claims
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1. An inflatable tubular member formed of polymeric material having:
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a first inflatable working section which has an interior adapted to receive inflation fluid, which upon inflation to a first internal pressure within a first pressure range expands substantially to a first inflated diameter and which is significantly less compliant at pressures above the first pressure range than pressures within the first pressure range; and a second inflatable working section longitudinally disposed from the first inflatable working section which has an interior adapted to receive inflation fluid and in fluid communication with the interior of the first inflatable working section, which does not expand significantly upon inflation to the first internal pressure and upon inflation to a second internal pressure within a second pressure range, higher than the first internal pressure, expands to a second inflated diameter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 26, 27)
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12. A method of making a inflatable member having first and second working sections which inflate at different pressure levels, comprising:
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a) extruding a tube formed of an olefinic polymer; b) expanding a first section of the tube to a first outer diameter by subjecting the first section to an elevated temperature within 50°
C. of the crystalline melting point thereof and to an elevated internal fluid pressure;c) heat shrinking the expanded first section of the tube to a second outer diameter which is significantly less; d) heat treating a second section of the tube at a temperature within 50°
C. of the crystalline melting point thereof without significant expansion thereof; andd) heat shrinking the expanded first section to a second outer diameter which is significantly smaller than the first outer diameter. - View Dependent Claims (13)
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14. A balloon dilatation catheter comprising:
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a) an elongated catheter shaft having proximal and distal extremities and an inner inflation lumen extending therein; and b) a inflatable portion on the distal extremity of the catheter shaft in fluid communication with the inflation lumen having a first working section which has an interior adapted to receive inflation fluid from the inflation lumen, which upon inflation to a first internal pressure within a first pressure range expands to a first inflated diameter and which has relatively low compliance at pressures above the first pressure range; a second inflatable working section longitudinally disposed from the first inflatable working section which has an interior adapted to receive inflation fluid from the inflation lumen and in fluid communication with the interior of the first inflatable working section, which does not expand significantly upon inflation to the first internal pressure and which, upon inflation to a second internal pressure within a second pressure range, higher than the first internal pressure, expands to a second inflated diameter, and which has relatively low compliance at pressures above the second internal pressure. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 28, 29)
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23. A method of performing a diagnostic or therapeutic procedure within a patient'"'"'s body lumen, comprising:
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a) advancing into a patient'"'"'s body lumen an elongated catheter having on the distal portion thereof an inflatable tubular member formed of polymeric material; with a first inflatable working section which has an interior adapted to receive inflation fluid, which upon inflation to a first internal pressure within a first pressure range expands to a first inflated diameter and which is significantly less compliant at pressures above the first pressure and with a second inflatable working section longitudinally disposed from the first inflatable working section which has an interior adapted to receive inflation fluid and in fluid communication with the interior of the first inflatable working section, which does not expand significantly upon inflation to the first internal pressure and upon inflation to a second internal pressure within a second pressure range, higher than the first pressure range, expands to a second inflated diameter within a second pressure range; b) positioning the inflatable member at a desired location within the body lumen; c) inflating the inflatable member to the first pressure within the first pressure range to expand the first working section to the first diameter within the body lumen; and d) further inflating the inflatable member to the second pressure within the second pressure range higher than the first pressure to expand the second working section to the second diameter within the within the body lumen.
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24. A method of dilatating a stenosis in a patient'"'"'s arterial system comprising:
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a) advancing into the patient'"'"'s arterial system a dilatation catheter having on the distal portion thereof an inflatable member having; a first inflatable working section which has an interior adapted to receive inflation fluid, which upon inflation to the first internal pressure within the first pressure range expands to the first inflated diameter, and a second inflatable working section longitudinally disposed from the first inflatable working section which has an interior adapted to receive inflation fluid and in fluid communication with the interior of the first inflatable working section, which does not expand significantly upon inflation to the first internal pressure and upon inflation to a second internal pressure within a second pressure range, higher than the first pressure range, expands to a second inflated diameter within a second pressure range; b) positioning the first inflatable working section of the inflatable member adjacent the stenosis and the second inflatable working section of the inflatable member within the stenosis; c) inflating the inflatable member to a first pressure within the first pressure range to expand the first inflatable working section to a first diameter to thereby position the inflatable member within the artery; and d) further inflating the inflatable member to a second internal pressure within the second pressure range higher than the first internal pressure to expand the second inflatable working section to the second diameter within the stenosis to dilatate the stenotic region within the patient'"'"'s artery.
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25. A method of dilatating a prostatic urethra of a male patient comprising:
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a) advancing into a male patient'"'"'s urethra a dilatation catheter having on the distal portion thereof an inflatable member having; a first inflatable working section which has an interior adapted to receive inflation fluid, which upon inflation to the first internal pressure and which upon inflation to a first internal pressure within a first pressure range expands to a first inflated diameter, and a second inflatable working section located proximal to the first inflatable working section which upon inflation to a second internal pressure within a second pressure range, higher at least in part than the first internal pressure, expands to a second inflated diameter within a second pressure range and which has relatively low compliance at pressures above the second internal pressure; b) positioning the first working section of the inflatable member within the patient'"'"'s bladder and the second working section of the inflatable member within the patient'"'"'s prostatic urethra; c) inflating the inflatable member to the first internal pressure within the first pressure range to expand the first inflatable working section to the first diameter to thereby position the remainder of the inflatable member within the patient'"'"'s urethra; and d) further inflating the inflatable member to a second internal pressure within the second pressure range higher than the first pressure to expand the second inflatable working section to the second diameter within the prostatic urethra to dilatate the prostatic urethra.
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Specification