Power-assisted inflation apparatus

• US 5,273,537 A
• Filed: 03/06/1992
• Issued: 12/28/1993
• Est. Priority Date: 03/06/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Prather, Richard R., Serdar, David J., Humphrey, John W., Kratoska, William F., Haskvitz, David J.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US07/847,826
• Time in Patent Office: 662 Days
• Field of Search: 604/96-100, 604/118, 604/121, 604/151-155, 604/65, 604/67, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/99.01
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation

Abstract

Inflation apparatus for inflating a dilatation balloon of a catheter includes a frame having a first receiver supporting the barrel of a syringe. An operator has a second receiver supporting the plunger of the syringe. The syringe includes a fluid port for connecting the syringe chamber to the lumen of the catheter. A motor is supported by the frame and operatively connected to the operator to move the piston to change fluid pressure within the syringe chamber. A release device permits quick release of the pressure in the balloon catheter without the use of the motor. A pressure sensor is mounted to the frame to measure the pressure in the chamber through a diaphragm on the syringe. The pressure sensor operates a microprocessor-controlled display, which provides display of inflation and duration information and calculates other information. A circuit selectively operates the motor. An inflation control connected to the circuit permits operation of the motor at selected rates of inflation/deflation or to selected specific inflation pressures.

Claims

1. Inflation apparatus for inflating a dilatation balloon in fluid communication with the lumen of a catheter, the inflation apparatus comprising:

a syringe having a longitudinal axis, a barrel having opposite ends and forming a chamber for containing an inflation fluid, a piston within the chamber, a fluid port in fluid communication with the chamber for connection to the lumen of the catheter, a plunger rod connected to the piston and extending through an end of the barrel and a plunger actuator connected to the end of the plunger rod extending through the end of the barrel, the apparatus further including a plunger operator connected to the drive rod, the plunger operator having second receiver supporting the plunger actuator;

a frame having a first receiver removably supporting an end of the barrel such that the longitudinal axis of the syringe has a fixed position relative to the frame;

a motor supported by the frame;

a drive rod operatively connected to the motor and supporting the piston, the motor being operable to move the piston such that the piston moves along the longitudinal axis under influence of the motor to change fluid pressure within the chamber;

control means for selectively operating the motor; and

release means for releasing the piston from the influence of the motor without altering the fixed position of the longitudinal axis relative to the frame, the release means being supported by the plunger operator and so disposed and arranged to disconnect the plunger actuator from the second receiver.

2. Inflation apparatus according to claim 1 wherein the release means includes a mechanical latch having a closed position in which the plunger actuator is retained in the second receiver and an open position in which the plunger actuator is axially released from the second receiver, and manually operable means operating the latch between its closed and open positions.

3. Inflation apparatus according to claim 1 wherein the control means includes first means for operating the motor to move the piston at a first rate, and second means for operating the motor to move the piston to rapidly reduce fluid pressure in the chamber.

4. Inflation apparatus according to claim 1 further including sensor means supported by the frame and so disposed and arranged as to be operatively connected to the chamber to provide a data signal representative of fluid pressure within the chamber.

5. Inflation apparatus according to claim 4 further including display means responsive to the data signal for displaying information.

6. Inflation apparatus according to claim 5 wherein the display means includes a clock providing a clock signal, a processor connected to the sensor means and clock for processing the data signal and the clock signal to derive information concerning pressure within the chamber and duration of inflation, and a display device connected to the processor for displaying the information derived by the processor.

7. Inflation apparatus for inflating a dilatation balloon in fluid communication with the lumen of a catheter, the inflation apparatus comprising:

a syringe having a longitudinal axis, a barrel having opposite ends and forming a chamber for containing an inflation fluid, a piston within the chamber, and a fluid port in fluid communication with the chamber for connection to the lumen of the catheter;

a frame having a first receiver removably supporting an end of the barrel such that the longitudinal axis of the syringe has a fixed position relative to the frame;

a motor supported by the frame;

a drive rod operatively connected to the motor and supporting the piston, the motor being operable to move the piston such that the piston moves along the longitudinal axis under influence of the motor to change fluid pressure within the chamber;

control means for selectively operating the motor, the control means including first means for operating the motor to move the piston at a first rate, and second means for operating the motor to move the piston to rapidly reduce fluid pressure in the chamber, the control means being operatively connected to the motor by wireless transmission; and

release means for releasing the piston from the influence of the motor without altering the fixed position of the longitudinal axis relative to the frame.

8. Inflation apparatus for inflating a dilatation balloon in fluid communication with the lumen of a catheter, the inflation apparatus comprising:

a syringe having a longitudinal axis, a barrel having opposite ends and forming a chamber for containing an inflation fluid, a piston within the chamber, and a fluid port in fluid communication with the chamber for connection to the lumen of the catheter;

a frame having a first receiver removably supporting an end of the barrel such that the longitudinal axis of the syringe has a fixed position relative to the frame;

a motor supported by the frame;

a drive rod operatively connected to the motor and supporting the piston, the motor being operable to move the piston such that the piston moves along the longitudinal axis under influence of the motor to change fluid pressure within the chamber;

control means for selectively operating the motor;

release means for releasing the piston from the influence of the motor without altering the fixed position of the longitudinal axis relative to the frame;

sensor means supported by the frame and so disposed and arranged as to be operatively connected to the chamber to provide a data signal representative of fluid pressure within the chamber; and

display means responsive to the data signal for displaying information, the display means including a clock providing a clock signal, a processor connected to the sensor means and clock for processing the data signal and the clock signal to derive information concerning pressure within the chamber and duration of inflation, and a display device connected to the processor for displaying the information derived by the processor, the processor including a memory having a look-up table containing relational data relating the diameter of a dilatation balloon to pressure within the respective balloon for a plurality of dilatation balloons, the processor having input means for receiving data identifying the dilatation balloon in fluid communication with the catheter connected to the chamber, the processor being responsive to the dilatation balloon identification data and the data signal derived by the sensor means to select diameter information from the look-up table, the display device being responsive to the processor to display diameter information.

9. Inflation apparatus for inflating a dilatation balloon in fluid communication with the lumen of a catheter, the inflation apparatus comprising:

a syringe having a longitudinal axis, a barrel having opposite ends and forming a chamber for containing an inflation fluid, a piston within the chamber, and a fluid port in fluid communication with the chamber for connection to the lumen of the catheter;

a frame having a first receiver removably supporting an end of the barrel such that the longitudinal axis of the syringe has a fixed position relative to the frame;

a motor supported by the frame;

a drive rod operatively connected to the motor and supporting the piston, the motor being operable to move the piston such that the piston moves along the longitudinal axis under influence of the motor to change fluid pressure within the chamber;

control means for selectively operating the motor;

release means for releasing the piston from the influence of the motor without altering the fixed position of the longitudinal axis relative to the frame; and

sensor means supported by the frame and so disposed and arranged as to be operatively connected to the chamber to provide a data signal representative of fluid pressure within the chamber, the sensor means including a pressure sensor for producing a signal having a magnitude representative of fluid pressure within the barrel, an oscillator responsive to the magnitude of the signal from the pressure sensor to provide a signal having a frequency representative of fluid pressure within the barrel, and a multivibrator responsive to the oscillator to provide a pulse signal having a repetition rate representative of the frequency of the signal provided by the oscillator.

10. Inflation apparatus for inflating a dilatation balloon in fluid communication with the lumen of a catheter, the inflation apparatus comprising:

a syringe having a longitudinal axis, a barrel having opposite ends and forming a chamber for containing an inflation fluid, a piston within the chamber, and a fluid port in fluid communication with the chamber for connection to the lumen of the catheter;

a frame having a first receiver removably supporting an end of the barrel such that the longitudinal axis of the syringe has a fixed position relative to the frame;

a motor supported by the frame;

a drive rod operatively connected to the motor and supporting the piston, the motor being operable to move the piston such that the piston moves along the longitudinal axis under influence of the motor to change fluid pressure within the chamber;

control means for selectively operating the motor;

release means for releasing the piston from the influence of the motor without altering the fixed position of the longitudinal axis relative to the frame;

sensor means supported by the frame and so disposed and arranged as to be operatively connected to the chamber to provide a data signal representative of fluid pressure within the chamber; and

a diaphragm closing an end of the barrel, the diaphragm being so disposed and arranged relative to the sensor means as to transfer fluid pressure within the chamber to the sensor means to permit measurement of pressure within the chamber.

11. Inflation apparatus according to claim 10 wherein the diaphragm closes the end of the barrel opposite the end through which the plunger rod extends.

12. A power operator for operating a syringe to inflate a dilatation balloon in fluid communication with the lumen of a catheter, wherein the syringe has a longitudinal axis, a barrel arranged to be in fluid communication with the lumen and a piston movable in the barrel to change fluid pressure in the barrel, the power operator comprising:

a frame having a first receiver for removably supporting an end of the barrel to fix the position of the longitudinal axis of the syringe position relative to the frame;

a motor supported by the frame;

a drive rod operatively connected to the motor, the drive rod having a second receiver for removably supporting the piston of a syringe, the motor being operable to move the drive rod relative to the frame to move the piston along the longitudinal axis under influence of the motor to change fluid pressure within the barrel supported by the first receiver;

the piston being connected to a plunger, the second receiver including a plunger operator connected to the drive rod, the second receiver being arranged to support the plunger;

control means for selectively operating the motor; and

release means for releasing the piston from the influence of the motor without altering the fixed position of the longitudinal axis relative to the frame, the release means being supported by the plunger operator and arranged to disconnect the plunger from the second receiver.

13. A power operator according to claim 12 wherein the release means includes a mechanical latch having a closed position in which the plunger actuator is retained in the second receiver and an open position in which the plunger actuator is axially released from the second receiver, and manually operable means operating the latch between its closed and open positions.

14. A power operator for operating a syringe to inflate a dilatation balloon in fluid communication with the lumen of a catheter, wherein the syringe has a longitudinal axis, a barrel arranged to be in fluid communication with the lumen and a piston movable in the barrel to change fluid pressure in the barrel, the power operator comprising:

a frame having a first receiver for removably supporting an end of the barrel to fix the position of the longitudinal axis of the syringe position relative to the frame;

a motor supported by the frame;

a drive rod operatively connected to the motor, the drive rod having a second receiver for removably supporting the piston of a syringe, the motor being operable to move the drive rod relative to the frame to move the piston along the longitudinal axis under influence of the motor to change fluid pressure within the barrel supported by the first receiver;

control means for selectively operating the motor, the control means including first means for operating the motor to move the piston at a first rate, and second means for operating the motor to move the piston to rapidly reduce fluid pressure in the chamber, the control means being operatively connected to the motor by wireless transmission; and

release means for releasing the piston from the influence of the motor without altering the fixed position of the longitudinal axis relative to the frame.

15. A power operator for operating a syringe to inflate a dilatation balloon in fluid communication with the lumen of a catheter, wherein the syringe has a longitudinal axis, a barrel arranged to be in fluid communication with the lumen and a piston movable in the barrel to change fluid pressure in the barrel, the power operator comprising:

a frame having a first receiver for removably supporting an end of the barrel to fix the position of the longitudinal axis of the syringe position relative to the frame;

a motor supported by the frame;

a drive rod operatively connected to the motor, the drive rod having a second receiver for removably supporting the piston of a syringe, the motor being operable to move the drive rod relative to the frame to move the piston along the longitudinal axis under influence of the motor to change fluid pressure within the barrel supported by the first receiver;

control means for selectively operating the motor;

release means for releasing the piston from the influence of the motor without altering the fixed position of the longitudinal axis relative to the frame;

sensor means supported by the frame and so disposed and arranged as to be operatively connected to a barrel which may be supported by the first receiver to provide a data signal representative of fluid pressure within the barrel; and

display means responsive to the data signal for displaying information, the display means including a clock providing a clock signal, a processor connected to the sensor means and clock for processing the data signal and the clock signal to derive information concerning pressure within the chamber and duration of inflation, and a display device connected to the processor for displaying the information derived by the processor, the processor including a memory having a look-up table containing relational data relating the diameter of a dilatation balloon to pressure within the respective balloon for a plurality of dilatation balloons, the processor having input means for receiving data identifying the dilatation balloon in fluid communication with the catheter connected to the chamber, the processor being responsive to the dilatation balloon identification data and the data signal derived by the sensor means to select diameter information from the look-up table, the display device being responsive to the processor to display diameter information.

16. Power operator according to claim 15 further including a diaphragm closing an end of the barrel, the diaphragm being so disposed and arranged relative to the sensor means as to transfer fluid pressure to the chamber within the sensor means to permit measurement of pressure within the chamber.

17. Power operator according to claim 16 wherein the diaphragm closes the end of the barrel opposite the end through which the plunger rod extends.

18. A power operator for operating a syringe to inflate a dilatation balloon in fluid communication with the lumen of a catheter, wherein the syringe has a longitudinal axis, a barrel arranged to be in fluid communication with the lumen and a piston movable in the barrel to change fluid pressure in the barrel, the power operator comprising:

a frame having a first receiver for removably supporting an end of the barrel to fix the position of the longitudinal axis of the syringe position relative to the frame;

a motor supported by the frame;

a drive rod operatively connected to the motor, the drive rod having a second receiver for removably supporting the piston of a syringe, the motor being operable to move the drive rod relative to the frame to move the piston along the longitudinal axis under influence of the motor to change fluid pressure within the barrel supported by the first receiver;

control means for selectively operating the motor;

release means for releasing the piston from the influence of the motor without altering the fixed position of the longitudinal axis relative to the frame; and

sensor means supported by the frame and so disposed and arranged as to be operatively connected to a barrel which may be supported by the first receiver to provide a data signal representative of fluid pressure within the barrel, the sensor means including a pressure sensor for producing a signal having a magnitude representative of fluid pressure within the barrel, an oscillator responsive to the magnitude of the signal from the pressure sensor to provide a signal having a frequency representative of fluid pressure within the barrel, and a multivibrator responsive to the oscillator to provide a pulse signal having a repetition rate representative of the frequency of the signal provided by the oscillator.

19. Power operator according to claim 18 further including a diaphragm closing an end of the barrel, the diaphragm being so disposed and arranged relative to the sensor means as to transfer fluid pressure within the chamber to the sensor means to permit measurement of pressure within the chamber.

20. Power operator according to claim 19 wherein the diaphragm closes the end of the barrel opposite the end through which the plunger rod extends.

21. A disposable syringe for use with a power operator for inflating a dilatation balloon of a catheter during a percutaneous transluminal angioplasty procedure wherein the power operator has a pressure sensor, the catheter having a lumen in fluid communication with the dilatation balloon, the syringe comprising:

a barrel having opposite ends and forming a chamber for containing an inflation fluid, one end of the barrel being so sized and arranged as to be operatively supported in a first receiver of the power operator;

a diaphragm closing an end of the barrel, the diaphragm being so disposed and arranged relative to the pressure sensor when the barrel is operatively supported by the power operator as to transfer fluid pressure within the chamber to the pressure sensor to permit measurement of pressure within the chamber;

a piston within the chamber;

a connection connected relative to the piston and so sized and arranged as to be operatively supported by a second receiver of the power operator to move the piston within the chamber to change fluid pressure in the chamber; and

a fluid port in fluid communication with the chamber for connection to the lumen of the catheter.

22. The disposable syringe according to claim 21 wherein the piston includes means for connection to the drive rod of a motor.

23. The disposable syringe according to claim 21 further including a plunger rod having a first end connected to the piston and a second end extending through an end of the barrel, and the connection comprises a plunger actuator connected to the second end of the plunger rod, the plunger actuator being so sized and arranged relative to the second receiver as to be supportable thereby.