Balloon assembly with separately inflatable sections

• US 5,415,635 A
• Filed: 07/21/1992
• Issued: 05/16/1995
• Est. Priority Date: 07/21/1992
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Muni, Ketan P., Bagaoisan, Celso J.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/917,812
• Time in Patent Office: 1,029 Days
• Field of Search: 604/96-103, 606/191-197
• US Class Current: 604/101.05
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 used for angioplasty

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.

Claims

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.

2. The inflatable member of claim 1 wherein the first working section is located proximal to the second working section.

3. The inflatable member of claim 1 wherein the first working section is located distal to the second working section.

4. 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.

5. The inflatable balloon of claim 4 wherein the first pressure and the third pressure are essentially the same.

6. The inflatable member of claim 1 wherein an essentially noninflatable section is disposed between the first and second working sections.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

26. 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.

27. 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.

12. 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.

13. The method of claim 12 wherein the extruded tube is irradiated in those sections which are to be inflatable working sections.

14. 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.

15. The dilatation catheter of claim 14 wherein the catheter shaft has an inner tubular member which extends through the interior of the inflatable portion.

16. 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.

17. 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.

18. 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.

19. 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.

20. The dilatation catheter of claim 14 wherein an essentially noninflatable section is disposed between the first and second working sections of the inflatable member.

21. The dilatation catheter of claim 14 wherein the inner member is a guidewire receiving tubular member.

22. The dilatation catheter of claim 14 wherein the inner member is a guiding member.

28. 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.

29. 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.

23. 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.

24. 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.

25. 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.