US5415635A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Balloon assembly with separately inflatable sections
Assignee: Abbott Cardiovascular Systems Inc
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Filing: 1992-07-21
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Granted: 1995-05-16
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Expires: 2012-07-21
Abstract
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.
Inventors
- 👤 Celso J. Bagaoisan
- 👤 Ketan P. Muni
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 02:35
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/1027; A61M25/1029; A61M25/104; A61M2025/1043; A61M2025/1059; A61M2025/1072
Claims Analysis
Total Claims: 35
Claim 1
Independent Claim
136 words
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.
Claim 2
Dependent Claim
136 words
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.
Claim 3
Dependent Claim
19 words
The inflatable member of claim 1 wherein the first working section is located proximal to the second working section.
Claim 4
Dependent Claim
19 words
The inflatable member of claim 1 wherein the first working section is located distal to the second working section.
Claim 5
Dependent Claim
43 words
The inflatable member of claim 2 wherein a third working section is located distal to the second working section which upon inflation within a third pressure range, lower at least in part than the second pressure range, expands to a third inflated diameter.
Claim 6
Dependent Claim
18 words
The inflatable balloon of claim 4 wherein the first pressure and the third pressure are essentially the same.
Claim 7
Dependent Claim
20 words
The inflatable member of claim 1 wherein an essentially noninflatable section is disposed between the first and second working sections.
Claim 8
Dependent Claim
37 words
The inflatable member of claim 1 wherein the working sections are formed of a polymer containing at least 70% of an olefinic ionomer selected from the group consisting of sodium, lithium and zinc ionomers and blends thereof.
Claim 9
Dependent Claim
40 words
The inflatable member of claim 7 wherein the second working section thereof has been given a thermal treatment within 50° C. of the crystalline melting point of the ionomer for a period of about 5 minutes to about 60 minutes.
Claim 10
Dependent Claim
55 words
The inflatable member of claim 7 wherein the first working section thereof has been formed by thermal treating a tubular member of the requisite olefinic ionomer within 50° C. of the crystalline melting point of the ionomer and subjecting the tubular member at elevated temperature to internal fluid pressure at elevated pressure to expand it.
Claim 11
Dependent Claim
29 words
The inflatable member of claim 9 wherein the expanded tubular member is heat shrunk to a diameter smaller than the expanded diameter thereof to form the first working section.
Claim 12
Dependent Claim
30 words
The inflatable member of claim 1 wherein the second working section of the balloon exhibits little expansion at pressures within the first pressure range which expands the first working section.
Claim 13
Independent Claim
133 words
A method of making a inflatable member having first and second working sections which inflate at different pressure levels, comprising: 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; and d) heat shrinking the expanded first section to a second outer diameter which is significantly smaller than the first outer diameter.
Claim 14
Independent Claim
133 words
A method of making a inflatable member having first and second working sections which inflate at different pressure levels, comprising: 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; and d) heat shrinking the expanded first section to a second outer diameter which is significantly smaller than the first outer diameter.
Claim 15
Dependent Claim
21 words
The method of claim 12 wherein the extruded tube is irradiated in those sections which are to be inflatable working sections.
Claim 16
Dependent Claim
182 words
A balloon dilatation catheter comprising: 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.
Claim 17
Dependent Claim
182 words
A balloon dilatation catheter comprising: 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.
Claim 18
Dependent Claim
24 words
The dilatation catheter of claim 14 wherein the catheter shaft has an inner tubular member which extends through the interior of the inflatable portion.
Claim 19
Dependent Claim
37 words
The dilatation catheter of claim 15 wherein the first working section is located proximal to the second working section and the second working section has a distal end which is sealingly secured about the inner tubular member.
Claim 20
Dependent Claim
37 words
The dilatation catheter of claim 15 wherein the first working section is located distal to the second working section and the first working section has a distal end which is sealingly secured about the inner tubular member.
Claim 21
Dependent Claim
76 words
The dilatation catheter of claim 14 wherein the first working section is located proximal to the second working section and wherein the dilatation catheter includes a third working section which has an interior in fluid communication with the inner lumen within the catheter shaft, which is located distal to the second working section, and which inflates to a third inflated diameter within a third pressure range lower at least in part than the second pressure range.
Claim 22
Dependent Claim
25 words
The dilatation catheter of claim 18 wherein the first working section and the third working section are adapted to expand at essentially the same pressure.
Claim 23
Dependent Claim
24 words
The dilatation catheter of claim 14 wherein an essentially noninflatable section is disposed between the first and second working sections of the inflatable member.
Claim 24
Dependent Claim
16 words
The dilatation catheter of claim 14 wherein the inner member is a guidewire receiving tubular member.
Claim 25
Dependent Claim
14 words
The dilatation catheter of claim 14 wherein the inner member is a guiding member.
Claim 26
Independent Claim
242 words
A method of performing a diagnostic or therapeutic procedure within a patient's body lumen, comprising: 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.
Claim 27
Independent Claim
242 words
A method of performing a diagnostic or therapeutic procedure within a patient's body lumen, comprising: 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.
Claim 28
Independent Claim
250 words
A method of dilatating a stenosis in a patient's arterial system comprising: 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.
Claim 29
Independent Claim
250 words
A method of dilatating a stenosis in a patient's arterial system comprising: 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.
Claim 30
Independent Claim
244 words
A method of dilatating a prostatic urethra of a male patient comprising: 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.
Claim 31
Independent Claim
244 words
A method of dilatating a prostatic urethra of a male patient comprising: 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.
Claim 32
Dependent Claim
27 words
The inflatable tubular member of claim 1 wherein the first working section is adapted to expand in an elastic mode when inflated to the first internal pressure.
Claim 33
Dependent Claim
37 words
The inflatable tubular member of claim 1 wherein the second working section is adapted to expand in an elastic mode when inflated to a internal pressure above the first internal pressure up to the second internal pressure.
Claim 34
Dependent Claim
27 words
The balloon dilatation catheter of claim 14 wherein the first working section is adapted to expand in an elastic mode when inflated to the first internal pressure.
Claim 35
Dependent Claim
37 words
The balloon dilatation catheter of claim 14 wherein the second working section is adapted to expand in an elastic mode when inflated to an internal pressure above the first internal pressure up to the second internal pressure.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1998-05-15 | 1998-11-14 | 1999-05-16 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2002-05-15 | 2002-11-14 | 2003-05-16 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2006-05-15 | 2006-11-14 | 2007-05-16 | $7700.00 | Window Closed / Lapsed |