Synchronous, pulsatile angioplasty system

• US 5,885,244 A
• Filed: 05/14/1997
• Issued: 03/23/1999
• Est. Priority Date: 05/14/1997
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation & University of Miami
• Inventors: Leone, James E., deMarchena, Eduardo
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/856,349
• Time in Patent Office: 678 Days
• Field of Search: 604/49, 604/96-100, 604/131-133, 604/151-154, 604/246-249, 606/192-194
• US Class Current: 604/508
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A synchronous, pulsatile angioplasty system utilizes a control apparatus which controls balloon inflation and deflation in a pulsatile fashion synchronized with the heartbeat of a patient. A heart monitor provides an input, a signal to the control apparatus which serves as a baseline for operation of the pulsatile inflation and deflation of the balloon. A triggering circuit reads the baseline signal and generates a control signal to selectively generate valves interconnecting the angioplasty catheter with sources of inflation media and low pressure. Time delay circuits may be utilized which delay either the duration of the control signal or the receipt thereof by the control valves.

Claims

1. A method for performing synchronous, pulsatile angioplasty on a patient, comprising the steps of:

providing an angioplasty balloon catheter having an elongated shaft, an inflatable balloon disposed on said shaft at a distal end thereof, and an inflation lumen extending lengthwise along said shaft, the inflation lumen having an inflation opening disposed at the catheter shaft distal end and communicating with said balloon, the inflation lumen further having an inflation media opening at a proximal end of said catheter shaft;

inserting said angioplasty balloon catheter into a blood vessel of the patient and positioning said balloon catheter into a predesired location within the blood vessel;

providing a source of inflation media, a source of low pressure and an inflation-deflation control apparatus;

operatively interconnecting said angioplasty balloon catheter, the inflation media source, the low pressure source and the inflation-deflation control apparatus together;

providing means for monitoring a heart rate of said patient and for generating a signal indicative of the heart rate of said patient;

generating a triggering signal within said inflation-deflation control apparatus in response to the heart rate signal by said heart rate monitoring means; and

inflating and deflating said inflatable balloon in a cyclical, pulsatile pattern in response to said triggering signal received by said inflation-deflation control apparatus in synchronization with a particular heartbeat of said heart rate signal by alternatingly introducing said inflation media into said inflatable balloon from said inflation media source and evacuating said inflation media from said inflatable balloon.

2. The angioplasty method according to claim 1, further including the steps of:

interposing a manifold between said inflation media and low pressure sources and said inflatable balloon, the manifold having respective control valves associated therewith, and

operating the control valves in response to the triggering signal in order to alternatively open and close said control valves to achieve said alternating inflation and deflation of said inflatable balloon.

3. The angioplasty method according to claim 2, further include the step of providing pressure regulating means for regulating inflation pressure of said inflation media entering said inflatable balloon.

4. The angioplasty method according to claim 3, wherein said inflation pressure regulating means is operatively connected to said heart rate monitoring means, said inflation media pressure regulating means being responsive to signals generated by said heart rate monitoring means to thereby regulate inflation pressure of said inflatable balloon.

5. The angioplasty method according to claim 1, further including the steps of:

providing counting means for counting the number of heartbeats of the patient in response to the signal from said heart rate monitoring means for a preselected time period;

selecting a particular number N of heart beats; and

,

generating said triggering signal in response to a heart rate signal to coincide with every Nth heartbeat signal received from said heart rate monitoring means to thereby inflate said balloon in synchronization with said Nth heartbeat.

6. The angioplasty method according to claim 4, further including means for inhibiting inflation of said inflatable balloon, the inflation inhibiting means being operatively connected to said inflation media pressure regulating means.

7. The angioplasty method according to claim 1, further including the steps of monitoring pressure of said inflation media entering said inflatable balloon to determine the integrity of said inflatable balloon and said balloon catheter.

8. The angioplasty method according to claim 7, further including means for inhibiting the generating of said triggering signal if the pressure of said inflation media entering said balloon catheter and inflatable balloon exceeds a predetermined value.

9. The angioplasty method according to claim 5, wherein said heartbeat counting means includes a filter circuit that receives said heart rate signal from said heart rate monitoring means, said filter circuit being selectively adjustable for selecting said heart beat number N.

10. The angioplasty method according to claim 1, further including means for counting time intervals between receipt of said triggering signal by said inflation-deflation control apparatus and the additional step of delaying inflating said inflatable balloon until after a preselected time interval has passed.

11. The angioplasty method according to claim 2, wherein said source of pressure is a vacuum source.

12. The angioplasty method according to claim 2, further including means for counting the number of heartbeats received from said heart rate signal, an inflation control valve and a deflation control valve, the inflation control valve being interposed between said inflation media source and said inflatable balloon and the deflation control valve being interposed between said low pressure source and said inflatable balloon, means for generating a deflation triggering signal, said inflation control valve being activated by said triggering signal to introduce said inflation media into said inflatable balloon and said deflation control valve being activated by said deflation triggering signal after a preselected number of heartbeats.

13. An angioplasty apparatus for inflating and deflating an inflatable balloon inserted into a blood vessel of a patient in a pulsatile manner in synchronization with the heart rate of the patient, the angioplasty apparatus comprising:

an angioplasty catheter having an elongated catheter shaft, an inflatable balloon disposed on the catheter shaft at a distal end thereof, an inflation lumen extending along said catheter shaft having an outlet at said catheter shaft distal end in communication with said inflatable balloon and an opposite inlet at a proximal end of said catheter shaft;

a pressurized supply of inflation media;

a low pressure supply;

an inflation-deflation media conveyance network interconnecting said proximal end of said catheter to said inflation media and low pressure supplies;

control valves disposed within said network and interposed between said catheter lumen inlet and said inflation media and low pressure supplies for selectively controlling flow of pressurized inflation media and low pressure in an alternating fashion through said network and into said catheter shaft lumen inlet in order to selectively inflate and deflate said inflatable balloon within the patient'"'"'s blood vessel;

means for monitoring the heartbeat of the patient and for providing an input signal indicative of said heartbeat;

control means for activating said control valves in synchronization with said heartbeat input signal and alternatingly introducing and evacuating said pressurized inflation media into and from said catheter shaft lumen inlet to selectively inflate and deflate said inflatable balloon in synchronization with said heartbeat signal.

14. The angioplasty apparatus of claim 13, further including means for counting a preselected number N of heartbeats, said heartbeat counting means sending a control signal to said control means every Nth heartbeat to thereby generate a control valve triggering signal for inflating said balloon every Nth heartbeat.

15. The angioplasty apparatus of claim 13, wherein said inflation-deflation network includes an inflation pressure manifold and a low pressure manifold, at least one inflation control valve interposed in the inflation pressure manifold and operatively connected to said control means and at least one deflation control valve interposed in the low pressure manifold and operatively connected to said control means.

16. The angioplasty apparatus of claim 13, wherein said low pressure supply includes a vacuum source.

17. The angioplasty apparatus of claim 16, wherein said vacuum source includes a vacuum pump.

18. The angioplasty apparatus of claim 13, further including a plurality of pressure regulators operatively connected to said control valves and to said control means.

19. The angioplasty apparatus of claim 18, wherein said pressure regulators are responsive to said control valve triggering signals.

20. The angioplasty apparatus of claim 18, wherein said pressure regulators are interposed in said network between said inflation media supply and said control valves.

21. The angioplasty apparatus of claim 14, wherein said counting means control signal is received by said control means and generates a triggering signal every Nth heartbeat which triggers deflation of said balloon.

22. The angioplasty apparatus of claim 13, further including means for selectively filtering said heartbeat input signal to generate filtered heartbeat input signals above a preselected baseline and means for counting a predetermined number N of filtered heartbeat input signals, and generating a count signal every Nth filtered heartbeat, said count signal being received by said control means which thereupon generates a first control valve triggering signal which activates an inflation control valve to introduce said pressurized inflation media into said catheter in order to inflate said inflatable balloon every Nth filtered heartbeat.

23. The angioplasty apparatus of claim 22, further including means for generating a second control valve that connects said low pressure source to said catheter and evacuates said pressurized inflation media from said catheter in order to deflate said inflatable balloon after inflation thereof.

24. The angioplasty apparatus of claim 23, further including means for delaying deflation of said inflatable balloon for a predetermined time interval after inflation of said balloon.