Perfusion catheter

• US 5,158,540 A
• Filed: 05/22/1990
• Issued: 10/27/1992
• Est. Priority Date: 12/19/1985
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Leocor, Inc.
• Inventors: Wijay, Bandula, Angelini, Paolo
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Gutowski, Anthony
• Application Number:
  US07/527,009
• Time in Patent Office: 889 Days
• Field of Search: 604/53, 604/96, 604/101, 604/102, 604/164, 604/167, 604/246, 604/264, 604/30, 604/35, 604/39-43, 604/132, 604/151, 604/152, 606/194
• US Class Current: 604/43
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• 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 with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• 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 low-profile angioplasty catheter is disclosed which is insertable through a guiding catheter. The angioplasty catheter has two balloons. The distal balloon dilates the stenosis. The proximal balloon is separately inflatable and selectively closes the annular passage between the angioplasty catheter and the guiding catheter. The angioplasty catheter has a central lumen with a series of openings allowing fluid communication from the central lumen into the annular passage proximally of the balloon which seals the annular passage. While the first balloon is inflated to dilate the stenosis, blood can be withdrawn from an arterial source through a lumen (or plurality thereof) in the guiding catheter and pumped into the annular passage between the angioplasty catheter and the guiding catheter. The blood then passes through the openings proximal to the proximal balloon into the central lumen of the PTCA catheter and flows beyond the distal tip of the angioplasty catheter to maintain circulation of the patient'"'"'s blood at a point distal of the stenosis.

Claims

1. An apparatus for perfusing blood beyond a blockage created in a patient'"'"'s circulatory system during catheterization, comprising

an elongated catheter having a proximal end and a distal end;

at least one first catheter lumen extending through the distal end of said catheter;

guide means for guiding said catheter in a vessel, said guide means surrounding at least a portion of said catheter, creating an annular passage therebetween;

valve means on said catheter between said proximal and said distal ends thereof for selectively closing said annular passage;

said first catheter lumen having flow communication with said annular passage at a point proximal to said valve means;

sheath means coaxially surrounding and extending along said guide means for at least a portion of the length of said guide means to a distal end proximally of said valve means;

a first sheath means lumen extending through the sheath means to an opening at the distal end of said sheath means, said first sheath means lumen having flow communication with said annular passage adjacent a proximal end of said sheath means; and

pump means including a fluid inlet in fluid communication with said first sheath lumen adjacent a proximal end thereof and further including a fluid outlet in fluid communication with said annular passage, for drawing a patient'"'"'s blood through said distal opening of said sheath lumen during catheterization and, upon selective energization of said valve means, for pumping said drawn blood through said annular passage into said catheter lumen and out said distal end of said catheter lumen to the vascular anatomy of the patient distal to said blockage.

2. The apparatus of claim 1 further comprising at least one second channel in said sheath means having a distal opening for fluid communication with a patient'"'"'s circulatory system during catheterization and a proximal opening to allow continuous measurement of the pressure in the system where the distal opening is disposed during catheterization.

3. The apparatus of claim 2, wherein said catheter further comprises:

expanding means disposed on said catheter distally of said guide means for expanding a passageway in a patient'"'"'s circulatory system during catheterization, and means for actuating said expanding means from the proximal end of said catheter.

4. The apparatus of claim 1 wherein said pump means further comprises:

a pump body including said fluid inlet;

means on said body for elevating pressure of blood passing through said body; and

means in flow communication with said body for dampening pulsation of the blood as it emerges from said pump body, said pulsation dampening means having said fluid outlet and further comprising;

a housing defining an accumulator cavity therein; and

isolating from said cavity blood passing to said outlet.

5. The apparatus of claim 3, wherein:

said valve means is mounted to said catheter proximally of said expanding means; and

further comprising

means operatively connected to said valve means from said proximal end of said catheter for selectively energizing said valve means from such proximal end.

6. The apparatus of claim 5, wherein:

said guide means is coaxial with said catheter and extends from said proximal end of said catheter, over said valve means and terminates proximally of said expanding means.

7. The apparatus of claim 6, wherein:

said actuating means for said expanding means is a second lumen in said catheter, extending from adjacent its proximal end to said expanding means; and

said energizing means is a third lumen in said catheter, extending from adjacent its proximal end to said valve means.

8. The apparatus of claim 7, wherein:

said first catheter lumen is larger in cross-sectional area than said second or third catheter lumens; and

further comprising

stiffener means disposed in said second or third catheter lumen to stiffen the proximal portion of said catheter; and

a removable guidewire selectively extendable through and beyond said first catheter lumen.

9. The apparatus of claim 7 wherein said expanding and valve means are balloons selectively inflatable independently of each other through said second and third lumens respectively;

and

said guide means is a guiding catheter.

11. The apparatus of claim 1, wherein said elongated catheter further comprises:

an elongated body having a proximal and distal segment, said body defining said first lumen extending therethrough;

an elongated tip segment connected adjacent to the distal end of said distal segment of said body, said tip defining at least one substantially smooth bore lumen therethrough, said first lumen in said body in flow communication with said smooth bore lumen in said tip, thereby allowing the catheter to be advanced over a guide extending through said lumen in said body in said tip;

said body being made of a harder material than the material of said tip;

a balloon mounted in close proximity to the outer surface of said distal segment of said body defining a balloon cavity therebetween, said balloon having a proximal and distal neck, said balloon disposed substantially proximally to said tip, juncture means for providing a transition between said tip and said distal segment of said body, said distal neck of said balloon mounted adjacent to the juncture between said elongated tip segment and said distal end of said distal segment of said body;

said proximal neck of said balloon mounted to said elongated body;

said distal segment of said body being substantially nondistensible as the balloon is inflated to substantially its full normal operating inflation pressure; and

means within said body for selectively inflating and deflating said balloon through said cavity.

10. The apparatus of claim 26, wherein:

said annular passage has a cross-sectional area at least 10 times greater than said first catheter lumen; and

wherein said

pump means in fluid communication with said annular passage is capable of pumping blood at least 60 cc/min. out the distal end of said first catheter lumen when said catheter is about 140 cm long with a developed pressure at said pump means not exceeding 100 psig.

12. The apparatus of claim 10, wherein said pump means further comprises:

a pump body including said fluid inlet;

means on said body for elevating pressure of blood passing through said body; and

means in flow communication with said body for dampening pulsation of the blood as it emerges from said pump body, said pulsation dampening means having said fluid outlet and further comprising

a housing defining an accumulator cavity therein; and

isolating from said cavity blood passing to said outlet.

13. A method of perfusing blood during balloon angioplasty, comprising:

inserting a guiding catheter into a patient;

inserting a balloon angioplasty catheter through said guiding catheter;

inflating a distal balloon on said angioplasty catheter to perform angioplasty;

inflating a proximal balloon to seal between said guiding catheter and said angioplasty catheter, closing off an annular passage therebetween;

drawing blood from the patient through a channel in a sheath on the guiding catheter;

pumping the blood back into said annular passage up to said proximal balloon; and

directing the blood into the angioplasty catheter proximally of said proximal balloon to pump it into a lumen extending distally of said inflated second balloon, to the distal vascular anatomy.

14. An apparatus for perfusing blood beyond a blockage created in a patient'"'"'s circulatory system during catheterization, comprising

an elongated catheter having a proximal end and a distal end;

at least one catheter lumen extending through the distal end of said catheter;

guide means for guiding said catheter in said vessel, said guide means coaxially surrounding at least a portion of said catheter, creating an annular passage therebetween;

first balloon means on said catheter between said proximal and said distal ends thereof for selectively closing said annular passage, said guide means extending over said first balloon means;

second balloon means disposed on said catheter distally of said guide means for expanding a passageway in a patient'"'"'s circulatory system during catheterization;

actuating means for actuating said second balloon means from the proximal end of said catheter, said actuating means including a second lumen in said catheter extending from adjacent its proximal end to said second balloon means;

means for selectively energizing said first balloon means from the proximal end of said catheter, said energizing means including a third lumen in the catheter extending from adjacent the proximal end thereof to said first balloon;

said first catheter lumen being larger in cross-sectional area than said second or third catheter lumens;

sheath means coaxially surrounding and extending along said guide means for at least a portion of the length of said guide means to a distal end proximally of said first balloon means;

a first sheath means lumen extending through the sheath means to an opening at the distal end of said sheath means;

said catheter lumen having flow communication with said annular passage at a point proximal to said first balloon means; and

pump means including a fluid inlet in fluid communication with said first sheath lumen adjacent a proximal end thereof and further including a fluid outlet in fluid communication with said annular passage, for drawing a patient'"'"'s blood through said distal opening of said sheath lumen during catheterization and, upon selective energization of said valve means, for pumping said drawn blood through said annular passage into said catheter lumen and out said distal end of said catheter lumen to the vascular anatomy of the patient distal to said blockage.

15. The apparatus of claim 14 further comprising at least one second lumen in said sheath means having a distal opening for fluid communication with a patient'"'"'s circulatory system during catheterization and having a proximal opening to allow continuous measurement of pressure in the patient'"'"'s circulatory system where the distal opening of said second sheath lumen is disposed during catheterization.

16. The apparatus of claim 15, wherein said pump means further comprises:

a pump body including said fluid inlet;

means on said body for elevating pressure of blood passing through said body; and

means in flow communication with said body for dampening pulsation of the blood as it emerges from said pump body, said pulsation dampening means having said fluid outlet and further comprising

a housing defining an accumulator cavity therein; and

isolating from said cavity blood passing to said outlet.