System and method for monitoring, displaying and recording balloon catheter inflation data

• US 5,135,488 A
• Filed: 03/17/1989
• Issued: 08/04/1992
• 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): NOT, DEFINED
• Application Number:
  US07/324,938
• Time in Patent Office: 1,236 Days
• Field of Search: 604/96-106, 606/192-194, 128/672-675
• US Class Current: 604/97.03
• 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 or 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 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;

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

digital processor means for processing said digtial signals so as to electronically monitor, display and record inflation pressure applied to said member and the duration of inflation by performing 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 inflation pressure;

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

automatically displaying said numerical values in a visually perceptible manner to a system user once said applied pressure exceeds a selected threshold level;

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

program memory means for storing machine-readable instructions utilized by said digital processor means to carry out said programmed steps; and

display means, electrically connected to said digital processor means, 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 so as to form an integral part thereof.

4. A system as defined in claim 3 further comprising an electrical cable attached at one end thereof to said transducer and comprising at the other end thereof a connector for attachment to said digital processor means.

5. A system as defined in claim 4 wherein said cable comprises a first length permanently attached to said transducer mounted on said syringe, and a second length of cable detachably connected to the first length, such that after said cable is connected to said digital processor means, said syringe and first length of cable may be disconnected from said second length of cable at a point along said cable that is intermediate said syringe and said digital processor means.

6. A system as defined in claim 1 wherein said display means is included within a controller.

7. A system as defined in claim 6 wherein said converting means, said digital processor means, said data memory means, and said program memory means are all included within said controller.

8. A system as claimed in claim 7 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 wherein said display means further comprises means for outputting said digital data to a printer.

10. A system as defined in claim 9 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 reviewing all previously stored digital data;

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

c. setting a maximum positive inflation pressure value;

d. setting a maximum inflation time value;

e. initializing date and time;

f. selecting units of inflation pressure;

g. printing data stored 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.

11. 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 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;

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

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;

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 inflation pressure;

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

automatically displaying said numerical values in a visually perceptible manner to a system user once said applied pressure exceeds a selected threshold level;

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

program memory means for storing machine-readable instructions utilized by said digital processor means to derive, store, retrieve and display said digital data and to optionally display a series of functions for selection at said display means; and

display means for visually identifying a numerical value for each discrete inflation together with corresponding numerical values of said inflation pressures and duration thereof.

12. A system as defined in claim 11 wherein said transducer is mounted on said barrel so as to form an integral part thereof.

13. A system as defined in claim 11 wherein said display means comprises a digital readout and means for outputting said digital data to a printer.

14. A system as defined in claim 13 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 digital data;

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

c. setting a maximum positive inflation pressure value;

d. setting a maximum inflation time value;

e. initializing date and time;

f. selecting units of inflation pressure;

g. printing data stored 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.

15. 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 connected through tubing to a balloon of said balloon catheter;

a plunger 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; and

means for preventing said syringe plunger from occluding said hole.

16. 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:

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;

automatically electronically digitally processing the output electrical signal once a selected threshold level of the applied fluid pressure is reached so as to automatically derive and automatically record therefrom electronic digital data representing the magnitude of the applied fluid pressures and the length of time said fluid pressures are applied to the balloon member;

electronically outputting a visual display of the magnitude and the corresponding length of time that said fluid pressures are applied to the balloon member; and

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

17. A method as defined in claim 16 further comprising the step of repeating each of said steps in connection with a second inflation of the balloon member.

18. A method as defined in claim 16 further comprising the steps of:

electronically selecting and storing a maximum magnitude of positive fluid pressure to be applied to said balloon member; and

electronically outputting an indication to a system user that signals when said maximum fluid pressure is applied to said balloon member.

19. A method as defined in claim 16 further comprising the steps of:

electronically selecting and storing a maximum duration for which said fluid pressures are to be applied to said balloon member; and

electronically outputting an indication to a system user that signals when said maximum duration has been reached.

20. 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, displaying and recording the applied fluid pressure each time the balloon catheter is inflated, the method comprising the steps of:

inflating a balloon of the balloon catheter 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 once the applied pressure reaches a selected threshold level, said data representing a numerical value of the duration of said positive inflation pressure;

electrically storing all said derived data for later retrieval and output;

automatically displaying said numerical values in a visually perceptible manner to a system user once said applied pressure exceeds a selected threshold level;

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

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

21. A method as defined in claim 20 wherein said digital processor is housed within a controller which comprises a control panel having a digital readout, and wherein prior to said inflating step 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 previously stored digital data;

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

c. setting a maximum positive inflation pressure value;

d. setting a maximum inflation time value;

e. initializing data and time;

f. selecting units of inflation pressure;

g. printing data stored in said data memory means.

22. A method as defined in claim 20 wherein prior to said inflating step said digital processor performs the steps of:

electronically sensing whether said transducer is electrically connected to said digital processor; and

when sensing that said transducer is not so connected, said digital processor outputting to a system user a signal to that effect.

23. A method as defined in claim 20 wherein prior to said inflating step said digital processor performs the steps of:

presenting an optionally selectable input for determining a maximum positive inflation pressure; and

electronically storing digital data corresponding to said maximum positive inflation pressure in response to a user-determined input.

24. A method as defined in claim 23 wherein said method carried out by said digital processor further comprises the step of presenting to a system user an indication of when said selected maximum positive inflation pressure is applied to said balloon.

25. A method as defined in claims 20 or 23 wherein prior to said inflating step said digital processor performs the steps of:

presenting an optionally selectable input for a maximum duration during which positive inflation pressure is to be applied to said balloon; and

electronically storing digital data corresponding to said selected maximum duration in response to a user-determined input.

26. A method as defined in claim 25 wherein said method carried out by said digital processor further comprises the step of presenting to a system user an indication of when said selected duration is reached.