Totally self-contained, digitally controlled, disposable syringe inflation system, and method for monitoring, displaying and recording balloon catheter inflation data

• US 5,201,753 A
• Filed: 03/04/1991
• Issued: 04/13/1993
• Est. Priority Date: 03/17/1989
• Status: Expired due to Term

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Salisbury, Jeffrey D., Lampropoulos, Fred P., Taylor, Steven R., Stout, Thomas D.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/664,587
• Time in Patent Office: 771 Days
• Field of Search: 604/96-100, 606/191-194
• US Class Current: 606/192
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/10182 Injector syringes
• 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 automatically monitoring, displaying and recording inflation data when the syringe system is used to inflate 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 housed on the barrel of the syringe senses fluid pressure applied by the syringe. The electric signal output by the transducer 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 automatically displayed and recorded. In one embodiment, the controller is also mounted onto the syringe barrel to provide a digitally controlled inflation syringe system that is completely self-contained, and disposable.

Claims

1. A system for monitoring inflation of a balloon-type member and for automatically recording inflation data, comprising:

a syringe connected to said member through tubing, said syringe comprising a barrel and a plunger selectively operable to inflate said member by applying fluid pressure to said member through said tubing by sliding the plunger within the barrel;

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

electronic circuit means, electrically connected to said transducer means and mounted on said syringe barrel, for receiving said electrical signal and for electronically processing said signal so as to derive and so as to automatically display or record therefrom electronic data representing the magnitude of said fluid pressure applied to said member and the length of time said fluid pressure is applied to said member; and

display means, electrically connected to said electronic circuit means and mounted on said syringe barrel, for outputting a visual display of the magnitude of said applied fluid pressure and the corresponding length of time said pressure is applied to said member.

2. A system as defined in claim 1 wherein said transducer means comprises a piezoresistive semiconductor transducer.

3. A system as defined in claim 2 wherein said transducer is mounted to said syringe barrel.

4. A system as defined in claim 1 wherein said transducer means, said electronic circuit means and said display means are all included within a controller mounted on said syringe barrel.

5. A system as defined in claim 1 wherein said electronic circuit means comprises:

means for amplifying said signal output by the transducer means;

means for converting said amplified signal from an analog to a digital form;

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

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

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

6. A system as defined in claim 5 wherein said transducer means, said electronic circuit means and said display means are all included within a controller mounted on said syringe barrel.

7. A system as defined in claims 4 or 6 further comprising battery means included within said controller for providing electrical power to said transducer means, said electronic circuit means and said display means.

8. A system as defined in claim 6 wherein said controller comprises a control panel and wherein said display means comprises a digital readout on said panel.

9. A system as defined in claim 8 further comprising means for lighting said digital readout to provide increased visibility.

10. A system as defined in claim 2 wherein said lighting means comprises an LED at opposite ends of said digital readout.

11. A system as defined in claim 8 wherein said digital processor means is programmed to turn said lighting means on when inflation pressure is sensed and to turn said lighting means off if no change in inflation pressure is sensed within a selected interval of time.

12. A system as defined in claim 8 wherein said control panel comprises switch means for retrieving and reviewing previously stored digital data at said digital readout.

13. A system as defined in claim 12 wherein said switch means comprises an elastomeric button switch and means for preventing entry of liquids at said button switch.

14. A system for generating a series of discrete balloon catheter inflations and for automatically displaying and recording inflation data corresponding to each said discrete inflation, comprising:

(a) a control syringe connected to a balloon of said balloon catheter through tubing, said syringe comprising a barrel and a plunger selectively operable to first apply and then remove positive fluid pressures to said balloon through said tubing by sliding the plunger within the barrel;

(b) a piezoresistive semiconductor transducer connected in fluid communication with said fluid pressures applied to said balloon catheter such that said transducer senses fluid pressures applied to said balloon and generates an electrical signal proportional to the sensed fluid pressure; and

(c) a controller mounted on said syringe barrel and electrically connected to said transducer, said controller comprising;

(i) means for amplifying said signal output by said transducer;

(ii) means for converting said amplified signal from an analog to a digital form;

(iii) digital processor means for processing said digital form of said signal so as to electronically monitor, display and record inflation pressure applied to said balloon and the duration of inflation by performing the steps of;

(A) deriving data from said digital signals which represents a numerical value of the magnitude of said applied pressure;

(B) deriving data from said digital signals which represent a numerical value of the duration of said inflation pressure;

(C) electronically storing all said derived data; and

(D) displaying said numerical values in a visually perceptible manner to a system user;

(iv) data memory means for storing the digital data derived by said digital processor means;

(v) program memory means for storing machine-readable instructions utilized by said digital processor means to perform said steps; and

(vi) display means for visually identifying said numerical value of the magnitude of said applied pressure together with a corresponding numerical value of said duration of said inflation pressure.

15. A system as defined in claim 14 wherein said transducer is included within said controller.

16. A system as defined in claim 15 further comprising battery means included within said controller for providing electrical power to said transducer and to each said means of said controller.

17. A system as defined in claim 16 wherein said controller comprises a control panel and wherein said display means comprises a digital readout on said panel.

18. A system as defined in claim 17 further comprising means for lighting said digital readout to provide increased visibility.

19. A system as defined in claim 18 wherein said lighting means comprises an LED at opposite ends of said digital readout.

20. A system as defined in claim 17 wherein said digital processor means is programmed to turn said lighting means on when inflation pressure is sensed and to turn said lighting means off if no change in inflation pressure is sensed within a selected interval of time.

21. A system as defined in claim 17 wherein said control panel comprises switch means for retrieving and reviewing previously stored digital data at said digital readout.

22. A system as defined in claim 21 wherein said switch means comprises an elastomeric button switch and means for preventing entry of liquids at said button switch.

23. In a system for generating a series of discrete balloon catheter inflations and for automatically recording inflation data derived from an electrical signal corresponding to each said discrete inflation, an improved control syringe comprising:

a barrel comprised of plastic material and connected through tubing to a balloon of said balloon catheter;

a plunger comprised of plastic material and slidably mounted within said barrel and operable to selectively apply and then release fluid pressure on said balloon by movement of the plunger within said barrel;

a piezoresistive semiconductor transducer mounted on said syringe barrel and in fluid communication with the interior of said syringe barrel through a hole formed in a side of said syringe barrel such that changes in fluid pressure applied to said balloon by sliding said plunger are sensed by said transducer, which in turn generates an electrical signal proportional to the sensed positive fluid pressure;

means for preventing said syringe plunger from ever occluding said hole; and

whereby toxic elements cannot be introduced into said fluid from said transducer.

24. In a system comprising an inflatable balloon member connected through tubing to a syringe barrel and wherein a plunger slidably mounted within said barrel is moveable to selectively apply and then release fluid pressures exerted on said balloon member so as to selectively inflate said balloon member one or more times, a method of monitoring, displaying and automatically recording inflation data comprising the steps of:

electronically sensing whether a transducer is connected to said system and if so, electronically measuring any offset signal at zero pressure;

electronically comparing the measured offset signal with a previously electronically stored value of an offset signal, and if the measured offset signal is within a selected range of the stored offset signal, using the measured offset signal in subsequent determinations of applied pressure, and if the measured offset signal is not within said selected range, using the previously stored value of the offset signal in subsequent determinations of applied pressure;

selectively increasing fluid pressure applied to the balloon member by pushing said plunger into said syringe barrel;

sensing the fluid pressure applied by said syringe and outputting an electrical signal proportional to the sensed fluid pressure;

amplifying said electrical output signal;

converting said amplified signal from an analog to a digital form;

digitally processing the digital form of said signal so as to derive therefrom digital data from which said magnitude of said applied fluid pressures and the length of time said fluid pressures are applied to said balloon member may be output in numeric form;

storing the digital data;

selectively retrieving and outputting said stored digital data in a form which can be visually perceived and read by an operator of the system; and

releasing the fluid pressure applied to the balloon member by pulling said plunger toward the rear of the syringe barrel.

25. A method as defined in claim 24 further comprising the step of repeating each of said steps in connection with a second inflation of the balloon member.

26. In a system comprising a balloon catheter connected through tubing to a syringe barrel and wherein by movement of a plunger through the barrel fluid pressure applied to a balloon of the balloon catheter may be selectively increased or decreased, a method of electronically monitoring, displaying and recording the applied fluid pressure each time the balloon is inflated, the method comprising the steps of:

electronically sensing whether a transducer is connected to said system and if so, electronically measuring any offset signal at zero pressure;

electronically comparing the measured offset signal with a previously electronically stored value of an offset signal, and if the measured offset signal is within a selected range of the stored offset signal, using the measured offset signal in subsequent determinations of applied pressure, and if the measured offset signal is not within said selected range, using the previously stored value of the offset signal in subsequent determinations of applied pressure;

inflating the balloon a first time by pushing the plunger into the syringe barrel so as to apply a positive inflation pressure to the balloon;

sensing any applied fluid pressure using a piezoresistive semiconductor transducer placed in fluid communication with the applied pressure, and generating at said transducer an electrical signal proportional in magnitude and duration to said applied pressure;

converting said electrical signal to a series of corresponding digital signals and inputting said digital signals to a digital processor;

processing the digital signals using said digital processor to carry out a programmed method comprising the steps of;

deriving data from said digital signals which represents a numerical value of the magnitude of said applied pressure;

deriving data from said digital signals which represent a numerical value of the duration of said positive inflation pressure;

electronically storing all said derived data; and

displaying said numerical values in a visually perceptible manner to a system user;

deflating the balloon by withdrawing the syringe plunger so as to remove the positive fluid pressure applied to the balloon catheter; and

repeating each of the above-recited steps for a second inflation of the balloon.

27. A method as defined in claim 26 wherein said step of displaying said numerical values comprises the steps of:

connecting a digital display means and a backlighting means to a battery source; and

disconnecting at least one of said digital display means and said backlighting means from said battery source if a zero pressure is sensed during a selected time interval.

28. A method as defined in claim 27 wherein said step of displaying said numerical values further comprises the steps of:

disconnecting the other of said digital display means and said backlighting means from said battery source if a zero pressure is sensed during a second selected time interval; and

re-connecting said digital display means and said backlighting means to said battery source at any time by activating a switch means.

29. In a system comprising a balloon catheter connected through tubing to a syringe barrel and wherein by movement of a plunger through the barrel fluid pressure applied to a balloon of the balloon catheter may be selectively increased or decreased, a method of electronically monitoring, displaying and recording the applied fluid pressure each time the balloon is inflated, the method comprising the steps of:

inflating the balloon a first time by pushing the plunger into the syringe barrel so as to apply a positive inflation pressure to the balloon;

sensing any applied fluid pressure using a piezoresistive semiconductor transducer placed in fluid communication with the applied pressure, and generating at said transducer an electrical signal proportional in magnitude and duration to said applied pressure;

converting said electrical signal to a series of corresponding digital signals and inputting said digital signals to a digital processor;

processing the digital signals using said digital processor to carry out a programmed method comprising the steps of;

deriving data from said digital signals which represents a numerical value of the magnitude of said applied pressure;

deriving data from said digital signals which represent a numerical value of the duration of said positive inflation pressure;

electronically storing all said derived data;

connecting a digital display means and a backlighting means to a battery source; and

disconnecting at least one of said digital display means and said backlighting means from said battery source if a zero pressure is sensed during a selected time interval;

deflating the balloon by withdrawing the syringe plunger so as to remove the positive fluid pressure applied to the balloon catheter; and

repeating each of the above-recited steps for a second inflation of the balloon.

30. A method as defined in claim 29 wherein said step of displaying said numerical values further comprises the steps of:

disconnecting the other of said digital display means and said backlighting means from said battery source if a zero pressure is sensed during a second selected time interval; and

re-connecting said digital display means and said backlighting means to said battery source at any time by activating a switch means.

31. In a system comprising an inflatable balloon member connected through tubing to a syringe barrel and wherein a plunger slidably mounted within said barrel is moveable to selectively apply and then release fluid pressures exerted on said balloon member so as to selectively inflate said balloon member one or more times, a method of monitoring, displaying and automatically recording inflation data comprising the steps of:

electronically sensing whether a transducer is connected to said system and if so, electronically measuring any offset signal at zero pressure;

electronically comparing the measured offset signal with one of several previously stored values corresponding to different offset signals, whereby the measured offset signal is determined to be within one of several previously selected ranges;

outputting a visual display identifying a selected range and a corresponding type of syringe that is in use;

using selected parameters previously electronically stored for the type of syringe in use in subsequent determinations of applied pressure;

selectively increasing fluid pressure applied to the balloon member by pushing said plunger into said syringe barrel;

sensing the fluid pressure applied by said syringe and outputting an electrical signal proportional to the sensed fluid pressure;

amplifying said electrical output signal;

converting said amplified signal from an analog to a digital form;

digitally processing the digital form of said signal so as to derive therefrom digital data from which said magnitude of said applied fluid pressures and the length of time said fluid pressures are applied to said balloon member may be output in numeric form;

storing the digital data;

selectively retrieving and outputting said stored digital data in a form which can be visually perceived and read by an operator of the system; and

releasing the fluid pressure applied to the balloon member by pulling said plunger toward the rear of the syringe barrel.