Thrombolysis catheter system

• US 5,279,546 A
• Filed: 08/07/1992
• Issued: 01/18/1994
• Est. Priority Date: 06/27/1990
• Status: Expired due to Term

• Current Assignee: Lake Region Manufacturing Incorporated (Integer Holdings Corporation Inc)
• Original Assignee: Lake Region Manufacturing Incorporated (Integer Holdings Corporation Inc)
• Inventors: Iannone, Liberato A., Mische, Hans A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/927,934
• Time in Patent Office: 529 Days
• Field of Search: 128/24 AA, 604/19-22, 604/96-101, 606/159, 606/191, 606/192, 606/194
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens

Abstract

An apparatus and method for dissolving and removing material which tends to occlude a body passage way, such as an artery. The device employs a dual catheter system arranged in coaxial fashion. Each of the catheters has an inflatable balloon at its distal tip. Inflating the two balloons occludes the body passage way both proximal and distal to the treatment area, thus isolating it from fluid contact with the rest of the body. Because concentric catheters are used, the distance between the balloons and hence the size of the treatment area is adjustable. The thrombolytic agent is infused through orifices in the inner catheter in the region between the two balloons. A piezo electric device supplies ultrasonic agitation within the treatment area. A pressure device monitors the body passage way for unsafe conditions. Aspiration is accomplished through one or more lumens in the outer catheter. Ultrasonic agitation may be employed with the aspiration also to break up masses of material which may be too big to pass through the exit lumen cross section.

Claims

1. A two catheter thrombolysis catheter system for the occlusion and treatment of a vessel obstruction comprising:

a. A first catheter having a catheter wall, a proximal end, a distal end, and first means for occluding a vessel located adjacent said first catheter distal end;

b. a second catheter having a catheter wall, a proximal end, a distal end, a central lumen which passes entirely through said second catheter and a second means for occluding a vessel located adjacent said second catheter distal end, said second catheter being slidingly engaged and coaxial with said first catheter so that the distance between said first means for occluding a vessel and said second means for occluding a vessel is variable and defines a treatment zone;

c. means in said second catheter for administering a thrombolytic agent into said treatment zone, said administering means including said central lumen of said second catheter and a plurality of radially disposed ports located in said second catheter wall between said first and second means for occluding a vessel, the ports being in fluid communication with said central lumen;

d. means in said central lumen of said second catheter for restricting the flow of thrombolytic agent therethrough;

e. means in said first catheter for aspirating said vessel, said aspirating means also being located between said first and second means for occluding a vessel; and

f. means attached to said second catheter wall between said first and second means for occluding a vessel for supplying agitation energy in said vessel to said treatment zone.

2. A system according to claim 1 which further includes means associated with said second catheter wall for monitoring pressure within an occluded zone of a vessel.

3. A system according to claim 1 wherein said means for supplying agitation energy comprises a transducer.

4. A system according to claim 1 wherein the central lumen of said second catheter has a diameter which is slightly larger than that of a guide wire.

5. A system according to claim 1 wherein a guide ware is positioned in said central lumen of said second catheter.

6. A system according to claim 1 wherein the means for supplying agitation energy is a source of ultrasonic energy coupled with a piezoelectric band.

7. A system according to claim 1 wherein the means for monitoring pressures within an occluded zone of a vessel is a pressure transducer.

8. A system according to claim 1 wherein said central lumen includes therein a lumen occlusion means.

9. A system according to claim 8 wherein said central lumen occlusion means comprises a seal located on said guidewire.

10. A two catheter thrombolysis catheter system for the occlusion and treatment of a vessel obstruction comprising:

a. A first catheter having a catheter wall, a proximal end, a distal end, and first means for occluding a vessel located adjacent said first catheter distal end;

b. a second catheter having a catheter wall, a proximal end, a distal end, a central lumen which passes entirely through said second catheter and a second means for occluding a vessel located adjacent said second catheter distal end, said second catheter being slidingly engaged and coaxial with said first catheter so that the distance between said first means for occluding a vessel and said second means for occluding a vessel is variable and defines a treatment zone, said catheters being closely slidingly engaged so as to preclude the presence of an interluminal space between said catheters;

c. means in said second catheter for administering a thrombolytic agent into said treatment zone, said administering means including said central lumen of said second catheter and a plurality of radially disposed ports located in said second catheter wall between said first and second means for occluding a vessel, the ports being in fluid communication with said central lumen;

d. means in said central lumen of said second catheter for restricting the flow of thrombolytic agent therethrough;

e. means in said first catheter for aspirating said vessel, said aspirating means also being located between said first and second means for occluding a vessel; and

f. means attached to said second catheter wall between said first and second means for occluding a vessel for supplying agitation energy in said vessel to said treatment zone.

11. A system according to claim 10 which further includes means associated with said second catheter wall for monitoring pressure within said treatment zone.

12. A system according to claim 10 wherein the means for supplying agitation energy is a source of ultrasonic energy coupled with a piezoelectric band.