Balloon catheter inflation device including apparatus for monitoring and wireless transmission of inflation data, and system

• US 5,318,533 A
• Filed: 02/21/1992
• Issued: 06/07/1994
• Est. Priority Date: 02/21/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Serdar, David J., Yates, John M., Haskvitz, David J., Holman, Thomas J., Adams, Daniel O., Penny, William H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US07/839,628
• Time in Patent Office: 837 Days
• Field of Search: 128/903, 604/96-103, 604/110, 606/192-196, 340/870.18
• US Class Current: 604/97.03
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

An inflation device includes a syringe forming a cylindrical chamber containing a plunger carrying a stopper or piston arrangement. The chamber is designed to contain an inflation fluid and is in fluid communication with the lumen of a balloon catheter. Movement of the plunger within the chamber will increase or decrease the pressure of the fluid within the chamber and lumen, thereby inflating or deflating the balloon at the distal end of the catheter. A pressure sensor is mounted to the housing in fluid communication with the lumen and is electrically connected to a battery-operated transmitter. The transmitter broadcasts signals representing pressure within the lumen and balloon to a remote receiver. The receiver includes a microprocessor containing a clock and operable to display time and pressure data. A flexible insulator strip is interposed between the battery and the transmitter circuit to prevent operation of the transmitter until desired by the cardiologist. The housing of the inflation device may be opened to remove the batteries for separate disposal and to render the circuit inoperative to prevent reuse. A look-up table associated with the microprocessor permits display of balloon diameter during the procedure.

Claims

1. An inflation device for inflating a dilatation balloon of a catheter during a percutaneous transluminal angioplasty procedure, the catheter having a lumen in fluid communication with the dilatation balloon, the inflation device comprising:

a housing having a chamber for containing a fluid and a plunger within the chamber for changing fluid pressure in the chamber, the housing comprising first and second members, fastening means on the first and second members for removably fastening the first and second members together to form an enclosure;

means for connecting the catheter to the housing so that the lumen of the catheter is in fluid communication with the chamber;

sensing means responsive to fluid pressure within the chamber for deriving a signal representative of fluid pressure within the chamber; and

a wireless transmitter connected to the sensing means for wireless transmission of a broadcast signal containing data representative of the signal derived by the sensing means, the wireless transmitter and sensing means comprising an electronic circuit having first and second circuit portions within the enclosure and electrical connection means connecting the first and second circuit portions together, one of the circuit portions being mechanically supported by one of the first and second members, a battery support within the enclosure for operating the electronic circuit, the fastening means permitting separation of the first and second members to permit removal of the battery, wherein the electronic circuit includes a pressure transducer mechanically supported by the first member and operatively connected to the chamber to provide an electronic signal representative of fluid pressure within the chamber, the first circuit portion being mechanically supported by the second member, said electrical connection means including a unitary frangible portion electrically connecting the transducer to the first circuit portion and so disposed and arranged as to break said frangible portion upon separation of the first and second members, and thereby electrically disconnect the transducer from the first circuit portion prohibiting use of the electrical connection means.

2. An inflation device according to claim 1 further including a strip of insulator material removably insulating the battery from the electronic circuit, the housing having an opening through which a portion of the strip extends, the strip being removable to electrically connect the battery to the electronic circuit.

3. An inflation device according to claim 1 wherein the sensing means is responsive to fluid pressure within the chamber to provide a pulse signal having a pulse repetition rate representative of fluid pressure within the chamber and the transmitter includes infrared transmission means for transmitting infrared pulses at a repetition rate representative of the pulse signal.

4. An inflation device according to claim 3 wherein the infrared transmission means comprises a plurality of infrared transmitters mounted to the exterior of the housing in spaced relation.

5. An inflation device according to claim 1 further including a switch mounted to the housing for initiating operation of the electronic circuit.

6. An inflation device according to claim 5 wherein the electronic circuit includes a latch responsive to the operation of the switch to latch the electronic circuit to an operating condition.

7. An inflation device for inflating a dilatation balloon of a catheter during a percutaneous transluminal angioplasty procedure, the catheter having a lumen in fluid communication with the dilatation balloon, the inflation device comprising:

first and second members;

fastening means carried on the first and second members for removably fastening the first and second members together to form an enclosure;

a chamber carried by the first member for containing a fluid;

a plunger within the chamber, the plunger being operable to change fluid pressure in the chamber;

means for connecting the catheter to the chamber so that the lumen of the catheter is in fluid communication with the chamber;

an electronic circuit in the enclosure including sensing means responsive to fluid pressure within the chamber, the electronic circuit comprising first and second circuit portions and electrical connection means connecting the first and second circuit portions together, one of the circuit portions being mechanically supported by one of the first and second members, the electronic circuit including a pressure transducer mechanically supported by the first member and operatively connected to the chamber to provide an electronic signal representative of fluid pressure within the chamber, the first circuit portion being mechanically supported by the second member, the electrical connection means including a first unitary frangible portion electrically connecting the transducer to the first circuit portion and so disposed and arranged as to break the frangible portion upon separation of the first and second members and thereby electrically disconnect the transducer from the first circuit portion prohibiting the use of the electrical connection means;

a battery supported within the enclosure for operating the electronic circuit; and

the fastening means permitting separation of the first and second members to permit removal of the battery.

8. An inflation device according to claim 7 wherein the connection means includes a second frangible portion so disposed and arranged as to break electrical connection between the first and second circuit portions upon separation of the first and second members.

9. An inflation device according to claim 7 wherein the first and second members together form a generally cylindrical housing, the fastening means comprising a first fastener supported by the first member and a second fastener supported by the second member, the first and second fasteners being engagable to fasten the first and second members together to form the housing and being disengagable upon relative rotation of the first and second members to permit separation of the first and second members.

10. An inflation device according to claim 9 wherein one of the first and second fasteners includes a circumferentially-disposed ramp surface and a circumferentially-disposed recess forming a radial lip, and the other of the first and second fasteners includes a circumferentially-disposed clamp surface, the first and second fasteners being engaged by relatively rotating the first and second members so that the clamp surface rotationally engages the ramp surface to cam over the radial lip and be received in the recess.

11. An inflation device for inflating a dilatation balloon of a catheter during a percutaneous transluminal angioplasty procedure, the catheter having a lumen in fluid communication with the dilatation balloon, the inflation device comprising:

a housing having an opening, the opening extending outside the housing;

a chamber carried by the housing for containing a fluid;

a plunger within the chamber, the plunger being operable to change fluid pressure in the chamber;

means for connecting the catheter to the chamber so that the lumen of the catheter is in fluid communication with the chamber;

an electronic circuit including sensing means responsive to fluid pressure within the chamber, the electronic circuit being located within the housing;

a battery supported within the housing for operating the electronic circuit;

a strip of insulator material extending through the opening and removably insulating the battery from the electronic circuit, the strip being removable to electrically connect the battery to the electronic circuit.

12. An inflation device according to claim 11 further including a switch mounted to the housing for initiating operation of the electronic circuit.

13. An inflation device according to claim 12 wherein the electronic circuit includes a latch responsive to the operation of the switch to latch the electronic circuit to an operation condition.

14. An inflation device according to claim 11 wherein the electronic circuit includes a pressure transducer operatively connected to the chamber to provide an electronic signal representative of the fluid pressure within the chamber, and a wireless transmitter connected to the electronic circuit for wireless transmission of data representative of the electronic signal derived by the pressure transducer.

15. An inflation device according to claim 14 wherein the electronic circuit includes an oscillator responsive to the electronic signal from the pressure transducer to provide a signal having a frequency representative of fluid pressure within the chamber.

16. An inflation device according to claim 15 wherein the electronic circuit further includes 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 and having a small pulse duration.

17. An inflation device according to claim 16 wherein the pulse repetition rate varies between about 5 and 15 KHz and the pulse duration is of the order of between about 2 and 5 microseconds.

18. An inflation device according to claim 14 wherein the electronic circuit is responsive to the pressure transducer to provide a pulse signal having a pulse repetition rate representative of fluid pressure within the chamber, and the transmitter includes infrared transmission means for transmitting infrared pulses at a repetition rate representative of the pulse signal.

19. An inflation device according to claim 18 wherein the infrared transmission means comprises a plurality of infrared transmitters mounted to the exterior of the housing in spaced relation.

20. An inflation device according to claim 18 wherein the pulse repetition rate varies between about 5 and 15 KHz and the pulse signal has a pulse duration of the order of between about 2 and 5 microseconds.

21. A monitoring system for inflating and monitoring the condition of a dilatation balloon of a catheter during a percutaneous transluminal angioplasty procedure, the catheter having a lumen in fluid communication with the dilatation balloon, the monitoring system comprising:

an inflation device comprising a housing supporting a chamber for containing a fluid, a plunger within the chamber for changing the pressure of fluid in the chamber, means for connecting the catheter to the chamber so that the lumen of the catheter is in fluid communication with the chamber, pressure sensing means within the housing and responsive to fluid pressure within the chamber for providing a signal representative of the fluid pressure within the chamber, and a wireless transmitter supported by the housing and connected to the circuit and responsive to the signal provided by the pressure sensing means for wireless transmission of a broadcast signal containing data representative of the fluid pressure within the chamber, the housing of the inflation device comprising first and second members, fastening means on the first and second members for removably fastening the first and second members together to form an enclosure, the wireless transmitter and sensing means comprising an electronic circuit having first and second circuit portions within the enclosure and electrical connection means connecting the first and second circuit portions together, one of the circuit portions being mechanically supported by one of the first and second members, a battery supported within the enclosure for operating the electronic circuit, the fastening means permitting separation of the first and second members to permit removal of the battery, the electronic circuit including a pressure transducer mechanically supported by the first member and operatively connected to the chamber to provide an electronic signal representative of fluid pressure within the chamber, the first circuit portion being mechanically supported by the second member, the electrical connection means including a unitary frangible portion electrically connecting the transducer to the first circuit portion and so dispose and arranged as to break the frangible portion upon separation of the first and second members and thereby electrically disconnect the transducer from the first circuit portion prohibiting use of the electrical connection means; and

a remote receiver comprising a broadcast signal sensor responsive to the broadcast signal for deriving a data signal, a clock providing a clock signal, a processor connected to the broadcast signal sensor 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.

22. A monitor system according to claim 21 further including a strip of insulator material removably insulating the battery from the electronic circuit, the housing having an opening through which a portion of the strip extends, the strip being removable to electrically connect the battery to the electronic circuit.

23. A monitor system according to claim 21 further including a switch mounted to the housing for initiating operation of the electronic circuit.

24. A monitor system according to claim 23 wherein the electronic circuit includes a latch responsive to the operation of the switch to latch the electronic circuit to an operating condition.

25. A monitor system according to claim 21 wherein the remote receiver includes 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 broadcast signal sensor to select diameter information from the look-up table, the display device being responsive to the processor to display diameter information.

26. A monitor system according to claim 21 wherein the sensing means of the inflation device includes a pressure transducer in fluid communication with the chamber producing a signal having a magnitude representative of fluid pressure within the chamber, and an oscillator responsive to the magnitude of the signal from the pressure transducer to provide a signal having a frequency representative of fluid pressure within the chamber.

27. A monitor system according to claim 26 wherein the sensing means further includes 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 and having a small pulse duration.

28. A monitor system according to claim 27 wherein the pulse repetition rate varies between about 5 and 15 KHz and the pulse duration is of the order of between about 2 and 5 microseconds.

29. A monitor system according to claim 27 wherein the wireless transmitter includes infrared transmission means responsive to the oscillator to transmit infrared pulses at a repetition rate representative of the pulse signal.

30. A monitor system according to claim 29 wherein the infrared transmission means comprises a plurality of infrared transmitters mounted to the exterior of the housing in spaced relation.

31. A monitor system according to claim 29 wherein the broadcast signal sensor of the remote receiver includes an infrared detector responsive to infrared pulses transmitted by the wireless transmitter to produce the data signals.