Multi-sinus perfusion balloon dilatation catheter

• US 5,232,446 A
• Filed: 10/30/1991
• Issued: 08/03/1993
• Est. Priority Date: 10/30/1991
• Status: Expired due to Fees

• Current Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Arney, Michelle
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Gutowski, Anthony
• Application Number:
  US07/784,968
• Time in Patent Office: 643 Days
• Field of Search: 604/96, 604/101-103, 606/192, 606/194
• US Class Current: 604/103.07
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A perfusion dilatation balloon catheter is formed by a balloon having opposing intermediate chamber surfaces connected by a seal along the length of the balloon to form two symmetrical, communicating segments of the balloon. The outer surface of the balloon, which is common to both segments, incurves as the balloon is inflated causing the segments to juxtapose. The outer surfaces of the two segments cooperate to dilate the wall of an artery. The outer surfaces of the segments further define two sinuses adjacent to the juxtaposed outer surfaces of the segments, which allow passive perfusion of blood through the balloon during a dilatation procedure.

Claims

1. A perfusion dilation catheter comprising:

a shaft having a proximal end, a distal end, and an inflation lumen extending between the proximal and distal end;

an elongated member extending distally from the distal end of the shaft; and

a balloon having a proximal end connected to the distal end of the shaft and a distal end connected to the elongated member, the balloon having a first intermediate inner surface connected by a seal to a second intermediate inner surface along a length of the balloon which forms a first inflatable region and a second inflatable region having a proximal and distal end, the first inflatable region being in fluid communication with the inflation lumen, and the second inflatable region being in fluid communication with the first inflatable region;

the first and second inflatable regions contacting one another, when inflated, to apply radial outward force and to form a perfusion passage with at least a portion of an outer surface of the first inflatable region contacting at least a portion of an outer surface of the second inflatable region to form the perfusion passage adjacent contacting portions of the first and second inflatable regions, the perfusion passage extending from the proximal end to the distal end of the balloon.

2. The perfusion dilatation catheter of claim 1 wherein the first inflatable region and the second inflatable region are eccentric and are symmetrical relative to the seal.

3. The perfusion dilatation catheter of claim 1 wherein the seal has a length less than a length of the balloon so that a fluid passage which connects the first and second inflatable regions is formed between an end of the balloon and the seal.

4. The perfusion dilatation catheter of claim 1 wherein the seal has a first seal segment and a second seal segment which are not contiguous, and a fluid passage extending between the first and second seal segments which connects the first and second inflatable regions.

5. The perfusion dilatation catheter of claim 1 and further including:

a flexible sheath which encircles the balloon.

6. The perfusion dilatation catheter of claim 1 and further including:

a guide wire sleeve carried at a distal end of the elongated member, distal to the balloon.

7. The perfusion dilatation catheter of claim 1 wherein the elongated member is a tube which defines a guide wire lumen.

8. The perfusion catheter of claim 1 wherein the elongated member is a core wire having a spring tip at a distal end.

9. The perfusion catheter of claim 1 wherein the first and second inflatable regions, when inflated, form a pair of generally parallel sinuses which act as the perfusion passage.

14. The dilatation catheter of claim 9 and further including:

a generally tubular sheath which surrounds the balloon.

10. A dilatation catheter comprising:

a shaft having a proximal end, a distal end, and an inflation lumen extending from the proximal end to the distal end;

a balloon having a proximal end attached to the distal end of the shaft and a sealed distal end, the balloon having an outer surface, an inner surface and an interior in fluid communication with the inflation lumen, the balloon having a generally longitudinal seal which connects the inner surface and divides the balloon into a first balloon segment and a second balloon segment, the first balloon segment having its interior in fluid communication with the inflation lumen, and the second balloon segment having its interior connected to the interior of the first balloon segment by a fluid passage, the first and second balloon segments being generally parallel to one another and spaced apart by the seal with the first balloon segment positioned between the shaft and the second balloon segment so that when inflated within an artery the segments push against one another with at least a portion of an outer surface of the first balloon segment contacting at least a portion of an outer surface of the second balloon segment so as to form a perfusion passage adjacent to the contacting portions of the first and second balloon segments which permits blood flow past both the first and second balloon segments.

11. The dilatation catheter of claim 10 and further including:

an elongated member extending through the interior of the first balloon segment and connected to a distal end of the first balloon segment.

12. The dilation catheter of claim 11 wherein the elongated member is a tube having a guide wire passage extending from its proximal end to its distal end.

13. The dilatation catheter of claim 11 and further including:

a guide wire sleeve carried at a distal end of the elongated member, distal to the balloon.

15. A perfusion dilatation catheter comprising:

a shaft having a proximal end, a distal end, and an inflation lumen;

an elongated member within the shaft and extending distally beyond the distal end of the shaft;

a first balloon through which the elongated member extends, the first balloon having a proximal end connected to the distal end of the shaft and a distal end connected to the elongated member, the first balloon having an interior in fluid communication with the inflation lumen;

a second balloon separated from the shaft and the elongated member by the first balloon, the second balloon being connected to the first balloon, having an interior and generally parallel to the first balloon and to the elongated member; and

means for fluidly connecting the interior of the first balloon to the interior of the second balloon so that when the first and second balloons are inflated they press against one another to apply a radially outward force with at least a portion of an outer surface of the first balloon contacting at least a portion of an outer surface of the second balloon to form a perfusion passage adjacent to the contacting portions.

16. A perfusion dilatation catheter comprising:

a shaft having a proximal end, a distal end, and an inflation lumen extending between the proximal and distal end;

an elongated member comprising a core wire having a spring tip at a distal end, the elongated member extending distally from the distal end of the shaft; and

a balloon having a proximal end connected to the distal end of the shaft and a distal end connected to the elongate member, the balloon having a first intermediate inner surface connected by a seal to a second intermediate inner surface, wherein the seal has a length less than a length of the balloon so that a fluid passage which connects a first and a second inflatable region is formed between an end of the balloon and the seal, the first inflatable and the second inflatable region having a proximal end and a distal end, the first inflatable region being in fluid communication with the inflation lumen, wherein the first inflatable region is eccentric relative to the second inflatable region;

the second inflatable region being in fluid communication with the first inflatable region; and

the first and second inflatable regions contacting one another, when inflated, to apply radial outward force and to form a perfusion passage adjacent the inflatable regions and extending from the first proximal end to the distal end of the balloon.

17. A perfusion dilatation catheter comprising:

a shaft having a proximal end, a distal end, and an inflation lumen extending between the proximal and distal end;

an elongated member extending distally from the distal end of the shaft; and

a balloon having a proximal end connected to the distal end of the shaft and a distal end connected to the elongated member, the balloon having a first intermediate inner surface connected by a seal to a second intermediate inner surface along a length of the balloon wherein the seal has a length less than a length of the balloon so that a fluid passage which connects a first and second inflatable region is formed between an end of the balloon and the seal, thereby forming a first inflatable region and a second inflatable region having a proximal end and a distal end, the first inflatable region being in fluid communication with the inflation lumen, and the second inflatable region being in fluid communication with the first inflatable region, wherein the first inflatable region is eccentric relative to the second inflatable region, and wherein the first and second inflatable regions, when inflated, form a pair of generally parallel sinuses adjacent the inflatable regions which act as the perfusion passage.