System and method for coronary angioplasty

• US 5,891,089 A
• Filed: 11/13/1996
• Issued: 04/06/1999
• Est. Priority Date: 05/17/1994
• Status: Expired due to Term

• Current Assignee: Hadasit Medical Research Services and Development Limited
• Original Assignee: Hadasit Medical Research Services and Development Limited
• Inventors: Weiss, Teddy A., Licht, Abraham, Katz, Iony
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/746,564
• Time in Patent Office: 874 Days
• Field of Search: 604/97, 604/98, 604/99, 606/191, 606/192
• US Class Current: 604/97.01
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10188 Inflation or deflation data displays
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

There is provided a fluid pressure sensing and activating control system for coronary angioplasty, including a fluid pressure sensor and transducer connected to feed signals via an A/D converter to a processor and control unit, a pulse width generator receiving signals from the processor for activating a balloon inflator, and a fluid conduit connector attached to the output of the inflator and to the input of the fluid pressure sensor and transducer, and having a further output port connectable to an inflatable balloon. A method for dilating a section of an elastic conduit by means of an inflatable balloon inserted therein is also provided.

Claims

1. A fluid pressure sensing and activating control system for coronary angioplasty, said system comprising:

a balloon inflation means having an output leading to a balloon inflatable by fluid for effecting predetermined controlled change in the volume of said balloon;

a fluid conduit connector attached to the output of said balloon inflation means;

a fluid pressure sensor and transducer connected to the output of said balloon inflation means and directly contacting said fluid for measuring the actual fluid pressure applied to the balloon by said inflation means;

a processor and control unit for receiving signals from said pressure sensor and transducer via an A/D converter;

a pulse width generator for receiving signals from said processor for activating said balloon inflation means.

2. The system as claimed in claim 1, wherein said balloon go inflation means comprises a stepping motor controlling a balloon inflator fluid pump.

3. The system as claimed in claim 1, further comprising display and/or data printing means, electrically connected to said processor and control unit.

4. The system as claimed in claim 1, wherein said generator is set to emit pulses of constant width and said processor and control unit controls the duration of time between emission of consecutive pulses.

5. A method for dilating a section of an elastic conduit by means of an inflatable balloon inserted therein, comprising the steps of:

a) providing a system including balloon means, balloon inflating means, pressure monitoring means, pulse width generator means, and control means;

b) gradually inflating said balloon by means of fluid to a first maximal pressure, during a preset first period of time;

c) generating pressure signals representing pressure in said balloon by means of said pressure monitoring means during inflation;

d) generating inflation signals by means of said control means and said pulse width generator means in response to said pressure signals, said inflation signals being used to control the rate of inflating said balloon during said preset first period of time;

e) retaining said first maximal pressure inside the balloon for a preset second period of time;

f) rapidly deflating said balloon to a minimal pressure;

g) retaining said minimal pressure for a predetermined period of time; and

h) repeating steps (b) to (g), each time increasing the pressure of step (b) to a pressure higher than the previously inflated maximal pressure.

6. The method as claimed in claim 5, wherein in step (b) the balloon is gradually inflated so as to substantially at least partially follow an exponential pressure vs. time curve, or an exponential pressure vs. volume curve.

7. The method as claimed in claim 6, wherein said minimal pressure in step (f) is a vacuum.

8. The method as claimed in claim 5, further comprising the step of constantly monitoring the pressure inside said balloon during step (e), and determining whether there is a loss of pressure caused by a puncture or rupture of the balloon, or any by any other fluid leak in the system.

9. The method as claimed in claim 5, wherein the durations of steps (b), (e) and (g) are substantially equal.

10. The method as claimed in claim 5, wherein said pressure monitoring means comprises pressure sensing means and an analog to digital converter which produces digital signals received by said control means, said control means in turn producing digital signals which are transmitted to said pulse width generator.