Detachable and reusable digital control unit for monitoring balloon catheter data in a syringe inflation system

• US 5,449,345 A
• Filed: 03/30/1994
• Issued: 09/12/1995
• Est. Priority Date: 03/17/1989
• Status: Expired due to Term

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Stout, Thomas D., Nelson, Arlin D., Lampropoulos, Fred P., Stevens, Brian W., Taylor, Steven R., Durham, Christopher L.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/221,351
• Time in Patent Office: 531 Days
• Field of Search: 604/118, 604/121, 604/97-100, 604/189, 604/246
• US Class Current: 604/100.03
• 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 25/10188 Inflation or deflation data displays
• CPC Class Codes: G01D 9/00 Recording measured values

Abstract

An electronically controlled syringe system for connection to a balloon catheter or other balloon-type member and for monitoring, displaying and optionally recording inflation or deflation data when the syringe system is used to inflate or deflate the balloon of the catheter or other balloon-type member. A syringe having a barrel and a syringe plunger is selectively operable to increase fluid pressure applied to the balloon catheter or other balloon member by sliding the plunger further into the barrel. Positive pressure applied to the balloon catheter or member is released by withdrawing the syringe plunger toward the rear of the barrel. A piezoresistive semiconductor transducer placed in fluid communication with the fluid pressure applied by the syringe, senses the fluid pressure and outputs an electrical signal representative of that pressure. The electric signal is input to a controller where the signal is digitally processed so as to derive and record therefrom electronic data representing the magnitude of applied fluid pressure, and so as also to derive the length of time that fluid pressure is applied. The electronic data representing this information is displayed and optionally recorded. In one embodiment, the electronic signal is received by a detachable and reusable electronic circuit module that detachably mounts to a housing formed on the syringe barrel.

Claims

1. A system for monitoring inflation or deflation of a balloon-type member and for displaying monitored inflation or deflation data, the system comprising:

a syringe for connection to the member through tubing, the syringe comprising a barrel and a plunger selectively operable to inflate the member by applying fluid pressure to the member through the tubing by sliding the plunger within the barrel, and operable to deflate the member by withdrawing the plunger from the barrel;

transducer means for sensing fluid pressure and for outputting an electrical pressure signal proportional to the sensed fluid pressure, the transducer means adapted for placement in communication with the fluid pressure within the syringe and the tubing connected thereto;

detachable electronic circuit means for receiving the electrical pressure signal when operatively coupled to the syringe or tubing, and for thereafter electronically processing the pressure signal;

display means for outputting a visual display of monitored data derived from the electrical pressure signal; and

means for operatively coupling the detachable electronic circuit means to the syringe or tubing, and the electrical pressure signal being thereafter received by the detachable electronic circuit means so as to enable the data to be derived and monitored, and the detachable electronic circuit means being detachable from the syringe for re-use in another system upon completion of monitoring.

2. A system as defined in claim 1 further comprising a power means for providing electrical power to the transducer means and the detachable electronic circuit means.

3. A system as defined in claim 2 wherein the power means comprises a battery.

4. A system as defined in claim 2 wherein the system further comprises conductive means mounted on the syringe for providing a releasable electrical connection between at least one of the transducer means Or the battery means and the detachable electronic circuit means when the detachable electronic circuit means is mounted to the syringe.

5. A system as defined in claim 4 wherein the transducer means and the power means are mounted to the syringe.

6. A system as defined in claim 4 wherein the transducer means is mounted to the syringe and the power means is included as part of the detachable electronic circuit means.

7. A system as defined in claim 4 wherein the transducer means is included as part of the detachable electronic circuit means and the power means is mounted to the syringe.

8. A system as defined in claim 4 wherein the conductive means comprises:

at least one first electrical connector mounted on the syringe barrel;

at least one second electrical connector mounted on the detachable electronic circuit means; and

wherein the first electrical connector is placed in electrical contact with the second electrical connector when the detachable electronic circuit means is mounted to the syringe.

9. A system as defined in claim 2 wherein the power means and the transducer means are both included as part of the detachable electronic circuit means.

10. A system as defined in claims 1 or 9 wherein the means for operatively coupling comprises a housing mounted on the syringe and comprising means for receiving and holding in a releasable manner the detachable electronic circuit means in an enclosed compartment formed by the housing.

11. A system as defined in claim 10 wherein the housing comprises door means for selectively opening and closing an entrance to the compartment, whereby the detachable electronic circuit means is completely encapsulated within the compartment of the housing when the door means is closed.

12. A system as defined in claim 11 wherein the housing further comprises:

at least one switch means for electronically activating the detachable electronic circuit means; and

a transparent viewing portion that allows for the visual inspection of the detachable electronic circuit means when enclosed within the housing.

13. A system as defined in claims 7 or 9 further comprising fluid coupling means for providing fluid communication between the transducer means and the fluid pressures within the syringe barrel.

14. A system as defined in any one of claims 1, 5, 6, 7 or 9 wherein the detachable electronic circuit means comprises:

means for amplifying the electrical pressure signal;

means for converting the amplified electrical pressure signal from an analog to a digital form;

digital processor means for processing the digital form of the electrical pressure signal so as to derive therefrom digital transmission data which represents the magnitude of the applied pressure and the length of time the pressure is applied to the member;

data memory means for storing the digital transmission data derived by the digital processor means;

program memory means for storing machine-readable instructions utilized by the digital processor means to derive and store the digital transmission data for transmission; and

transmission means for converting the digital transmission data derived by the digital processor means into a transmission signal and for wirelessly transmitting the transmission data via the transmission signal.

15. A system as defined in claim 14 further comprising a remote console means for receiving the transmission signal from the transmission means and for electronically processing the transmission signal.

16. A system as defined in claim 15 wherein the display means is electrically connected and included as part of the remote console means.

17. A system as defined in claim 15 wherein the remote console means comprises:

receiver means for receiving the transmission signal transmitted by the transmission means and for converting the transmission signal into a digital form;

digital processor means for processing the digital form of the received transmission signal so as to derive, store and display digital data which represents the magnitude of the applied pressure and the length of time the pressure is applied to the member;

data memory means for storing the digital data derived by the digital processor means; and

program memory means for storing machine-readable instructions utilized by the digital processor means to monitor the detachable electronic circuit means and to derive, store, retrieve and display the digital data.

18. A system as defined in claim 17 wherein the transmission means comprises RF transmitter circuit means for wirelessly transmitting the transmission signal as a radio frequency signal having a predetermined radio frequency.

19. A system as defined in claim 18 wherein the receiver means comprises RF receiver circuit means for receiving the RF transmission signal transmitted by the RF transmitter circuit means.

20. A system as defined in claim 17 wherein the transmission means comprises infrared transmitter circuit means for wirelessly transmitting the transmission signal as a modulated infrared light beam signal.

21. A system as defined in claim 20 wherein the receiver means comprises infrared receiver circuit means for receiving the infrared transmission signal transmitted by the infrared transmitter circuit means.

22. A system as defined in claim 1 wherein the detachable electronic circuit means comprises:

means for amplifying the electrical pressure signal;

means for converting the amplified electrical pressure signal from an analog to a digital form;

digital processor means for processing the digital form of the electrical pressure signal so as to derive therefrom digital data which represents the magnitude of the applied pressure and the length of time the pressure is applied to the member;

data memory means for storing the digital data derived by the digital processor means; and

program memory means for storing machine-readable instructions utilized by the digital processor means to derive, store, retrieve and display the digital data.

23. A system as defined in any one of claims 1, 5, 6, 7, 9, or 22 wherein the display means is electrically connected and is included as part of the detachable electronic circuit means.

24. A disposable syringe apparatus for use with a system for generating a series of discrete inflations or deflations of a balloon located at a distal end of a balloon catheter adapted for coupling to the syringe apparatus through tubing, wherein the system is adapted for displaying data corresponding to each said discrete inflation or deflation and wherein the system includes a transducer for sensing the applied pressure of said inflations or deflations and for generating an electrical pressure signal that is proportional to said sensed pressure and wherein the system further includes a detachable and reusable electronic circuit module for electronically processing the electrical pressure signal, the disposable syringe apparatus comprising:

a barrel adapted for connection through said tubing to the balloon that is located at the distal end of said balloon catheter;

a plunger received within said barrel and operable therein so as to selectively apply and then release fluid pressure on said balloon by movement of the plunger within the barrel; and

means for operatively and detachably coupling the detachable and reusable electronic circuit module to one of the syringe barrel or tubing while maintaining patient sterility relative to the circuit module, and the electronic pressure signal thereafter being received by the electronic circuit module while the inflation data is monitored, and the electronic circuit module being thereafter detachable for re-use in another system upon completion of monitoring, while the syringe apparatus is disposable.

25. A detachable and reusable electronic circuit module for use with a system for generating a series of discrete inflations or deflations of a balloon located at a distal end of a balloon catheter that is coupled to a disposable syringe through tubing, the disposable syringe being comprised of a barrel, a plunger, and a housing for detachably receiving the detachable electronic circuit module, and wherein the system further includes a transducer for sensing the applied pressure of said inflations and deflations and for generating an electrical pressure signal that is proportional to said sensed pressure, and a display for outputting a visual display of the sensed fluid pressure, the detachable electronic circuit module comprising:

means for receiving the electrical pressure signal when the circuit module is operatively coupled to the syringe or tubing, and thereafter electronically processing the electronic pressure signal; and

means for operatively coupling the electronic circuit module to the syringe or tubing, and the electrical pressure signal being thereafter received by the detachable electronic circuit module while the inflation or deflation data is monitored, and the detachable circuit module being thereafter detachable for re-use in another system upon completion of monitoring.

26. A system for monitoring inflation and deflation of a balloon-type member and for displaying inflation or deflation data, the system comprising:

a syringe adapted for connection to the member through tubing, the syringe comprising a barrel and a plunger selectively operable to inflate the member by applying fluid pressure to the member through the tubing by sliding the plunger within the barrel, and operable to deflate the member by withdrawing the plunger from the barrel;

transducer means for sensing fluid pressure and for outputting an electrical pressure signal proportional to the sensed fluid pressure, the transducer means being adored for placement in communication with the fluid pressure within the syringe and the tubing connected thereto;

detachable electronic circuit means for receiving the electrical pressure signal when the circuit means is operatively coupled to the syringe or tubing, and for thereafter electronically processing the pressure signal;

display means for outputting a visual display of the inflation or deflation data by displaying the magnitude of the sensed fluid pressure and the corresponding length of time the pressure is sensed;

means for operatively coupling the detachable electronic circuit means to the syringe or tubing, and the electrical pressure signal being received by the detachable electronic circuit means while the inflation or deflation data is monitored, and the detachable electronic circuit means being detachable from the syringe for re-use in another system upon completion of monitoring;

power means for providing electrical power to the transducer means and the detachable electronic circuit means; and

conductive means for providing a releasable electrical connection between at least one of the transducer means or the battery means and the detachable electronic circuit means when the detachable electronic circuit means is operatively mounted to the syringe or tubing.

27. A system as defined in claim 26 wherein the transducer means is mounted to the syringe.

28. A system as defined in claim 26 wherein the transducer means is included as part of the detachable electronic circuit means.

29. A system as defined in claim 26 wherein the conductive means comprises:

at least one first electrical connector mounted on the syringe barrel; and

at least one second electrical connector mounted on the detachable electronic circuit means; and

wherein the first electrical connector is placed in electrical contact with the second electrical connector when the detachable electronic circuit means is mounted to the syringe thereby providing a conductive path between the detachable electronic circuit means and the syringe.

30. A system as defined in claim 29 wherein the detachable electronic circuit means comprises:

means for amplifying the electrical pressure signal;

means for converting the amplified electrical pressure signal from an analog to a digital form;

digital processor means for processing the digital form of the electrical pressure signal so as to derive therefrom digital data which represents the magnitude of the applied pressure and the length of time the pressure is applied to the member;

data memory means for storing the digital data derived by the digital processor means; and

program memory means for storing machine-readable instructions utilized by the digital processor means to derive, store, retrieve and display the digital data.

31. A system as defined in any one of claims 26 to 30 wherein the display means is electrically connected and is included as part of the detachable electronic circuit means.

32. A system as defined in claim 29 wherein the detachable electronic circuit means comprises:

means for amplifying the electrical pressure

signal;

means for converting the amplified electrical pressure signal from an analog to a digital form;

digital processor means for processing the digital form of the electrical pressure signal so as to derive therefrom digital transmission data which represents the magnitude of the applied pressure and the length of time the pressure is applied to the member;

data memory means for storing the digital transmission data derived by the digital processor means;

program memory means for storing machine-readable

instructions utilized by the digital processor means to derive and store the digital transmission data for transmission; and

transmission means for converting the digital transmission data derived by the digital processor means into a transmission signal and for wirelessly transmitting the transmission data via the transmission signal.

33. A system as defined in claim 32 further comprising a remote console means for receiving the transmission signal from the transmission means and for electronically processing the transmission signal.

34. A system as defined in claim 33 wherein the display means is electrically connected and included as part of the remote console means.

35. A system as defined in claim 33 wherein the remote console means comprises:

receiver means for receiving the transmission signal transmitted by the transmission means and for converting the transmission signal into a digital form;

digital processor means for processing the digital form of the received transmission signal so as to derive, store and display digital data which represents the magnitude of the applied pressure and the length of time the pressure is applied to the member;

data memory means for storing the digital data derived by the digital processor means; and

program memory means for storing machine-readable instructions utilized by the digital processor means to monitor the detachable electronic circuit means and to derive, store, retrieve and display the digital data.

36. A system as defined in claim 35 wherein the transmission means comprises RF transmitter circuit means for wirelessly transmitting the transmission signal as a radio frequency signal having a predetermined radio frequency.

37. A system as defined in claim 36 wherein the receiver means comprises RF receiver circuit means for receiving the RF transmission signal transmitted by the RF transmitter circuit means.

38. A system as defined in claim 35 wherein the transmission means comprises infrared transmitter circuit means for wirelessly transmitting the transmission signal as a modulated infrared light beam signal.

39. A system as defined in claim 38 wherein the receiver means comprises infrared receiver circuit means for receiving the infrared transmission signal transmitted by the infrared transmitter circuit means.