Ultrasonic recanalization system

• US 5,209,719 A
• Filed: 01/22/1991
• Issued: 05/11/1993
• Est. Priority Date: 01/23/1990
• Status: Expired due to Fees

• Current Assignee: Urcan Medical Limited
• Original Assignee: Urcan Medical Limited
• Inventors: Einav, Shmuel, Baruch, David
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/643,427
• Time in Patent Office: 840 Days
• Field of Search: 128/24 AA, 128/657, 604/22, 606/169-171
• 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 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2017/00853 low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
• CPC Class Codes: A61B 2017/00973 pedal-operated
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208

Abstract

An ultrasonic recanalization system includes an ultrasonic transducer member energized by a switch and connected to a console containing control elements. The transducer transfers ultrasonic energy through a tube into a patient'"'"'s artery through a triple lumen catheter. The tube has at its end a bent portion with a flexible tip and the catheter has a flow blocking device which is inflatable to secure the position of the tip of the hollowed tube in the artery and to obstruct the flow of blood near a stenosis site in the artery. A liquid solution can be pumped into a concentric canal passage around the hollowed tube and the solution can then flow out through the hollowed tube after washing off the stenosis splinters.

Claims

1. An ultrasonic recanalization system comprising an ultrasonic transducer in a handle and energized by a switch, said transducer connected at its proximal end to a console containing control means of the ultrasonic energy level applied, determined by a measuring device of the frequency and amplitude provided at the distal end of the transducer, a triple lumen catheter that can be entered into a patient, and a hollowed tube which can be entered into the patient'"'"'s artery through said catheter, said hollowed tube operatively connected to said transducer for receiving ultrasonic energy and transferring such energy into the patient'"'"'s artery, said tube having an ending with a bent portion having a flexible tip, and said catheter having a flow blocking device on its outer circumference which includes means for inflating when required to secure said tip in position and obstruct the flow of blood near a stenosis blockage site in the artery, and said catheter having a concentric canal passage for surrounding said hollowed tube through which a liquid solution can be pumped in from a reservoir by a pump provided in said console, said hollowed tube including aspiration means whereby said solution can then flow out after washing off the stenosis splinters and blood into a second reservoir provided in said console, through said hollowed tube.

2. An ultrasonic recanalization system as in claim 1 wherein said ending of said hollowed tube is provided with a spring having high flexibility to enable maximal adaptability to movement variation of said tube in the arteries, giving different reactions when in contact with rigid stenosis or plaque blockage, or with soft artery tissue.

3. An ultrasonic recanalization system as in claim 1 wherein said hollowed tube ending is provided with a three-cheek rotor, preventing blockage of said hollowed tube ending by stenosis fragments.

4. An ultrasonic recanalization system as in claim 1 wherein said flow blocking device on said triple lumen catheter is a balloon.

5. An ultrasonic recanalization system as in claim 1 wherein said console comprises three knob controls to control manually the frequency, gain and flow levels of the ultrasonic transducer, and the solution liquid supply.

6. An ultrasonic recanalization system as in claim 1 wherein a computerized control circuit is provided in said console, having a computer programme for controlling the ultrasonic energy level transmitted by said ultrasonic transducer, and the flow rate of said solution pumped in through said triple lumen catheter in reference to the temperature of the washout liquid sucked out through said hollowed tube.

7. An ultrasonic recanalization system as in claim 1 wherein said reservoir containing said solution is included in the console and the hollow tube is provided with a temperature controller to secure the desired solution temperature.

8. An ultrasonic recanalization system as in claim 1 wherein said solution is saline containing appropriate chemicals for cleaning the artery treated by the ultrasonic tube, as well as applying an agent to avoid overreaction to sudden increase in oxygen content

9. An ultrasonic recanalization system as in claim 7 wherein said solution also contains strained blood

11. An ultrasonic recanalization system as in claim 1 wherein said ultrasonic transducer is in a handle and energized by a switch mounted on said handle, or on a pedal.

12. An ultrasonic recanalization system as in claim 1 wherein a strain gauge measuring the frequency and amplitude at said hollowed tube tip is mounted at the proximal end of said hollowed tube.

13. An ultrasonic recanalization system as in claim 1 wherein said catheter has an adaptor and said balloon at the proximal ending of said catheter is inflated by a syringe connected through an air connecting tube to said adaptor of said triple triple catheter.

14. An ultrasonic recanalization system as in claim 1 wherein said hollowed tube and its tip are made, of a material that is longitudinally rigid but flexible in all other directions.

15. An ultrasonic recanalization system as in claim 1 wherein a thermocouple is provided at the distal ending of said hollowed tube, which causes an alert when an excess temperature is recorded, indicating potential danger at the ultrasonic tip in the proximal position near the artery.

10. An ultrasonic recanalization system comprising an ultrasonic transducer in a handle and energized by a switch, said transducer connected at its proximal end to a console containing control means of the ultrasonic energy level applied, determined by a measuring device of the frequency and amplitude provided at the distal end of the transducer, a triple lumen catheter that can be entered into a patient, and a hollowed tube which can be entered into the patient'"'"'s artery through said catheter, said hollowed tube operatively connected to said transducer for receiving ultrasonic energy and transferring such energy into the patient'"'"'s artery, said tube having an ending with a bent portion having a flexible tip, and said catheter having a flow blocking device on its outer circumference which includes means for inflating when required to secure said tip in position and obstruct the flow of blood near a stenosis blockage site in the artery, and said catheter having a concentric canal passage for surrounding said hollowed tube through which a liquid solution can be pumped in from a reservoir by a pump provided in said console, said hollowed tube including aspiration means whereby said solution can then flow out after washing off the stenosis splinters and blood into a second reservoir provided in said console, through said hollowed tube, wherein the inward flow of said solution is through the outer lumen of said triple lumen catheter, and the outward flow of said wash-out liquid containing the stenosis splinters with blood is through the inner lumen of said hollowed tube, thus providing a cooling system to the tip of said hollowed tube, emitting ultrasonic energy in the artery.