System and method for monitoring and displaying balloon catheter inflation and deflation data

• US 5,300,027 A
• Filed: 03/18/1992
• Issued: 04/05/1994
• Est. Priority Date: 03/17/1989
• Status: Expired due to Term

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Lampropoulos, Fred P., Foote, Jerrold L., Gill, Darla R.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US07/853,522
• Time in Patent Office: 748 Days
• Field of Search: 604/96, 604/97, 604/98, 604/99, 604/100, 604/101, 604/102, 604/103, 604/104, 604/105, 604/106, 604/192, 604/193, 604/194, 604/672, 604/673, 604/674, 604/675
• US Class Current: 604/100.03
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10187 Indicators for the level of 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 automatically monitoring, displaying and recording inflation data when the syringe system is used to inflate the balloon 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 can be released by withdrawing the syringe plunger toward the rear of the barrel. A piezoresistive semiconductor transducer housed on the barrel of the syringe senses positive 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 positive fluid pressure is applied and the electronic data representing this information is automatically displayed and recorded. The controller is also programmable to permit optional selection and input of various control parameters, such as a maximum positive inflation pressure that is to be applied, maximum duration for applying positive inflation pressure, initialization of the date and time of an inflation procedure and/or retrieving and displaying inflation data previously recorded for any prior inflation of the balloon catheter or other balloon member.

Claims

1. A system for monitoring a balloon-type member that is selectively inflated and deflated and for displaying the condition of the balloon-type member, comprising:

a syringe connected to said balloon-type member through tubing, said syringe comprising a barrel and a plunger selectively operable to inflate said balloon-type member by sliding the plunger into the barrel to apply fluid pressure, and by withdrawing the plunger from the barrel to essentially totally deflate the balloon-type member;

transducer means for sensing whether the balloon-type member is inflated due to applied fluid pressure or is deflated due to removal of 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, operatively connected to said transducer means and said display means, for processing said electrical signal, whereby said electronic circuit means electronically derives both a status of pressure applied to said balloon-type member during a first condition of inflation and the corresponding duration thereof, and a status of the removal of applied pressure during a second condition of essentially total deflation of the balloon-type member and the corresponding duration thereof; and

display means operatively connected to the electronic circuit means for outputting a visual display of the sensed pressure and the corresponding duration thereof.

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

means for converting said signal output from said transducer means into a series of corresponding digital signals;

data memory means for storing digital data for later retrieval and output;

digital display means for outputting a visual digital display;

program memory means for storing machine-readable instructions to carry out programmed steps; and

digital processor means, operatively connected to said data memory means, said program memory means and said display means, for processing said digital signals in accordance with the programmed steps so as to electronically monitor, store in said data memory means and display at said digital display means both a status of pressure applied to said balloon-type member during a first condition of inflation and the corresponding duration thereof and a status of the removal of applied pressure during a second condition of essentially total deflation of the balloon-type member and the corresponding duration thereof, and wherein said digital processor means further performs the steps of;

calculating from said digital signals a numerical value of the magnitude of said applied pressure;

deriving data representing said status of pressure being applied to said balloon-type member from a comparison of said numerical value of the magnitude of said applied pressure to a pre-set numerical value;

electronically storing all said derived data for retrieval and output; and

automatically displaying said derived data in a visually perceptible manner.

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

4. A system as defined in claim 3 wherein said piezoresistive semiconductor transducer is mounted to said syringe so as to form an integral part thereof.

5. A system as defined in claim 4 wherein said converting means, said data memory means, said digital display means, and said program memory means are electrically connected to said digital processor means.

6. A system as defined in claim 5 further comprising an electrical cable attached at one end thereof to said piezoresistive semiconductor transducer and comprising at the other end thereof a connector for attachment to said digital processor means.

7. A system as defined in claim 6 wherein said electrical cable comprises a first length permanently attached to said piezoresistive semiconductor transducer mounted on said syringe, and a second length of cable detachably connected to the first length, such that after said electrical cable is connected to said digital processor means, said syringe and said first length of cable may be disconnected from said second length of said electrical cable at a point along said electrical cable that is intermediate said syringe and said digital processor means.

8. A system as defined in claim 2 wherein said display means is included within a controller.

9. A system as defined in claim 8 wherein said converting means, said digital processor means, said data memory means, and said program memory means are all included within said controller.

10. A system as defined in claim 9 wherein said controller further comprises a control panel and wherein said display means comprises a digital readout on said control panel.

11. A system as defined in claim 10 wherein said display means further comprises means for outputting said derived data previously stored in said data memory means to a printer.

12. A system as defined in claim 11 wherein said control panel comprises:

first switch means for selecting a menu display for presentation at said digital readout at least one of the following optionally selectable functions to be performed by said digital processor means;

a. retrieving and displaying on said digital readout a portion of said previously stored derived data in said data memory means;

b. clearing all said previously stored derived data in said data memory means;

c. initializing data and time;

d. printing said previously stored derived data in said data memory means; and

second switch means for entering to said digital processor means data identifying choices selected with respect to any of said functions.

13. A system as defined in claim 12 wherein said previously stored derived data in said data memory means includes the sequential number for each successive inflation and deflation of the balloon-type member.

14. A system as defined in claim 13 wherein said derived digital data includes the numerical value representing the highest magnitude of said applied pressure to said balloon-type member when said highest magnitude is greater than said pre-set numerical value.

15. A system for generating a series of discrete balloon catheter inflation and deflation balloon conditions and for displaying data corresponding to each said discrete balloon condition comprising:

a control syringe connected to a balloon of said balloon catheter through tubing, said syringe comprising a barrel and a plunger selectively operable to apply or remove fluid pressures from said balloon through said tubing by sliding the plunger respectively into and then withdrawing the plunger out of the barrel;

a piezoresistive semiconductor transducer connected in fluid communication with said fluid pressures applied to said balloon such that said transducer senses the presence or absence of fluid pressures applied to said balloon and generates an electrical signal proportional to the sensed pressure or absence of fluid pressure;

a display means for outputting a visual display; and

a controller electrically connected to said transducer, said controller comprising;

means for amplifying said signal output by said transducer;

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

digital processor means for processing said digital signal form;

data memory means for storing digital data; and

program memory means for storing machine-readable instructions utilized by said digital processor means; and

said digital processor means responding to said machine-readable instructions to electronically derive and digitally display both a first condition of inflation and the duration thereof and a second condition of essentially total deflation and the duration thereof.

16. A system as defined in claim 15 wherein said display means is an integral part of said controller, and comprises a digital readout.

17. A system as defined in claim 16 wherein said controller further comprises:

first switch means for selecting a menu display for presentation at said digital readout at least one of the following optionally selectable functions to be performed by said digital processor means;

a. retrieving and reviewing all previously stored data;

b. clearing all previously stored data;

c. initializing data and time;

d. printing said previously stored data; and

second switch means for entering to said digital processor means data identifying choices selected with respect to any of said functions.

18. In a system comprising a balloon member connected through tubing to a syringe barrel and wherein a plunger slidably mounted within said barrel is moveable to respectively release or apply fluid pressures exerted on said balloon member by respectively pulling said plunger away from or pushing said plunger towards the rear of the syringe barrel so as to instigate a balloon condition respectively of inflation or deflation, said plunger movement occurring one or more times, a method of monitoring and displaying the balloon member'"'"'s condition comprising the steps of:

altering fluid pressure applied to the inflated balloon member by moving said plunger within the syringe barrel to remove the applied pressure and essentially totally deflate the balloon member;

sensing the absence of the fluid pressure applied by said syringe and outputting an electrical signal representing the deflated condition of the balloon member;

electronically processing the output electrical signal so as to derive therefrom the balloon member'"'"'s deflation condition and the duration thereof; and

electronically outputting a visual display representing the balloon member'"'"'s deflation condition and the duration thereof.

19. 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 the balloon catheter may be selectively increased or decreased, a method of electronically monitoring and displaying or recording balloon condition data each time the balloon catheter is in a balloon condition of inflation followed by a balloon condition of deflation, the method comprising the steps of:

moving the syringe plunger so as to effect one of the aforesaid balloon conditions;

sensing any presence and subsequent removal of applied fluid pressure to the balloon catheter using a piezoresistive semiconductor transducer placed in fluid communication with said syringe barrel, and generating at said transducer an electrical signal proportional in magnitude and duration to said sensed fluid pressure and subsequent or absence thereof;

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 represent said balloon condition and the duration thereof;

electronically storing all said derived data in a data memory means;

displaying said balloon condition and the duration thereof in a visually perceptible manner to a system user; and

repeating each of the above-recited steps for each balloon condition occurrence.

20. A method as defined in claim 19 wherein said derived data includes a numerical value of the magnitude of said applied pressure when said balloon condition is inflation.

21. A method as defined in claim 20 wherein said balloon inflation condition is determined by a comparison of said numerical value of the magnitude of said applied pressure to a pre-set numerical value, said balloon condition being inflation when it is greater by said comparison and said balloon condition being deflation otherwise.

22. A method as defined in claim 21 wherein said digital processor is housed within a controller which comprises a control panel having a digital readout, and wherein prior to a change in said balloon condition said digital processor performs the step of presenting a visual display at said digital readout of at least one of the following optionally selectable functions:

a. retrieving and reviewing all said derived data previously stored;

b. clearing all said derived data previously stored;

c. the notice of said balloon condition;

d. initializing data and time;

e. printing all said derived data previously stored.

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

a syringe connected to said balloon-type member through tubing, said syringe comprising a barrel and a plunger selectively operable to inflate said balloon-type member by applying fluid pressure to said balloon-type member through said tubing by sliding the plunger within the barrel, and to deflate said balloon-type member by withdrawing the plunger so as to release the fluid pressure;

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

electronic circuit means, electronically connected to said transducer means, for receiving said electrical signal and for electronically processing said signal, whereby said electronic circuit means derives and automatically displays or records therefrom electronic data representing the magnitude of said fluid pressure when applied to said balloon-type member and the length of time said fluid pressure is applied to said balloon-type member and the absence of fluid pressure and the length of time said fluid pressure is absent and the balloon-type member is essentially totally deflated; and

display means, electronically connected to said electronic circuit means, for outputting a visual display of the magnitude of said fluid pressure when applied and the corresponding length of time said pressure is applied to said balloon-type member, and the absence of said fluid pressure and the corresponding length of time said balloon-type member is essentially totally deflated.