Method and apparatus for thrombolytic therapy

• US 5,368,034 A
• Filed: 09/04/1992
• Issued: 11/29/1994
• Est. Priority Date: 09/04/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Isner, Jeffrey M.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): MANUEL, GEORGE C
• Application Number:
  US07/939,896
• Time in Patent Office: 816 Days
• Field of Search: 128/662.04, 128/662.06, 128/662.03, 128/661.08, 128/661.09, 128/661.10, 128/660.03, 128/691, 128/903
• US Class Current: 600/439
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

A method and system for facilitating thrombolytic therapy includes a perfusion tube, in the form of an infusion guidewire or catheter, for delivering a lytic agent at a thrombosis. The perfusion tube includes, as an integral part thereof, at its distal end a sensor that connects to monitoring and announcing circuit. The monitoring and announcing circuit may include local and remote audio and visual announcing mechanisms for indicating the existence of blood flow above a predetermined minimum flow rate thereby to indicate lysis.

Claims

1. A system for reperfusing an occluded vessel comprising:

A. perfusion tube means having a proximal end and having a distal end for location in the vessel for enabling the introduction of a reperfusion agent to the occluded vessel,

B. flow monitoring means including sensor means mounted to said perfusion tube means at said distal end thereof for generating a flow rate signal in response to blood flow through the vessel parallel to and past said perfusion tube means,

C. comparing means for comparing the value of the flow rate signal with a set point signal representing a predetermined flow rate, and

D. announcing means connected to said comparing means for announcing a flow rate signal that exceeds the predetermined flow rate thereby to announce the onset of blood flow through the vessel.

2. A system as recited in claim 1 wherein said sensor means comprises ultrasound transducer means at the distal end of said infusion tube and said monitoring means additionally includes signal processing means for converting signals from said transducer means into the flow rate signal for said comparing means and conductor means intermediate said transducer means and said signal processing means.

3. A system as recited in claim 2 wherein transducer means includes a Doppler crystal means for transmitting signals in response to blood parallel said perfusion tube means and said signal processing means includes means for energizing said Doppler crystal means and for receiving signals therefrom.

4. A system as recited in claim 3 wherein said Doppler crystal means includes first and second crystal means and said signal processing means includes means for continuously driving said first crystal means and means for receiving signals from the second crystal means.

5. A system as recited in claim 3 wherein said signal processing means includes means for transmitting pulses in succession to said Doppler crystal means and means for receiving signals from said Doppler crystal means intermediate successive pulses.

6. A system as recited in claim 3 wherein said perfusion tube means includes a lumen extending between said distal and proximal ends for enabling the injection of a therapeutic agent to the occluded vessel.

7. A system as recited in claim 6 wherein said lumen additionally carries said conductor means.

8. A system as recited in claim 6 wherein said perfusion tube means includes a second lumen for carrying said conductor means.

9. A system as recited in claim 6 wherein said perfusion tube means comprises a guidewire means having a plurality of apertures proximate the distal end thereof for allowing the passage of a therapeutic agent into the vessel, said transducer means being located distally of said apertures.

10. A system as recited in claim 6 wherein said perfusion tube means includes a catheter means having a plurality of apertures proximate the distal end thereof for allowing the passage of a therapeutic agent into the vessel, said transducer means being located distally of said apertures.

11. A system as recited in claim 1 wherein said announcing means includes means for generating an audio signal to announce the onset of blood flow.

12. A system as recited in claim 1 wherein said announcing means includes means for generating a visual signal to announce the onset of blood flow.

13. A system as recited in claim 1 wherein said announcing means includes transmitter means for broadcasting an encoded signal when said comparing means indicates the onset of blood flow in the vessel and remote receiver means responsive to said broadcast signal for announcing the onset of blood flow remotely to the patient.

14. A system as recited in claim 13 wherein said announcing means includes means for generating an audio signal to announce the onset of blood flow.

15. A system as recited in claim 13 wherein said announcing means includes means for generating a visual signal to announce the onset of blood flow.

16. A method for reperfusing a vessel occluded by a thrombosis using a lytic agent comprising the steps of:

A. positioning the distal end of a perfusion tube with a flow sensor means into the vessel,

B. administering the lytic agent in a continuous fashion through the perfusion tube into the vessel from the proximal end thereof,

C. continuously energizing and monitoring the flow sensor means to determine blood flow rate through the vessel parallel to and past said perfusion tube means,

D. announcing the onset of blood flow through the vessel above a predetermined flow rate, and

E. discontinuing the administration of the lytic agent in response to said announcement.

17. A method as recited in claim 16 wherein the flow sensor means comprises ultrasonic transducer means positioned at the distal end of the perfusion tube for directing ultrasonic energy parallel to the perfusion tube and said energizing and monitoring uses Doppler information derived from the transducer means for determining the blood flow rate through the vessel parallel to and past the distal end of the perfusion tube and for comparing the measured blood flow rate with the predetermined blood flow rate thereby to enable said announcement.

18. A method as recited in claim 17 wherein said transducer means includes a Doppler crystal means and said energizing and monitoring causes the Doppler crystal means to transmit energy and receive energy.

19. A method as recited in claim 18 wherein the Doppler crystal means includes first and second crystals, said energizing and monitoring continuously driving the first crystal and receiving signals from the second crystal.

20. A method as recited in claim 18 wherein said energizing and monitoring drives the Doppler crystal means with discrete energy pulses and receives signals from the crystal intermediate the driving pulses.

21. A method as recited in claim 17 wherein said announcement includes broadcasting an encoded signal upon the onset of blood flow in the vessel and remotely receiving the broadcast signal for announcing the onset of blood flow at a location that is remote to the patient.

22. A method as recited in claim 21 wherein said announcement includes generating an audio signal to provide the announcement of the onset of blood flow at the remote location.

23. A method as recited in claim 21 wherein said announcement includes generating a visual signal to provide the announcement of the onset of blood flow at the remote location.

24. A method as recited in claim 16 wherein said announcement includes generating an audio signal.

25. A method as recited in claim 16 wherein said announcement includes generating a visual signal.