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

• US 5,425,713 A
• Filed: 04/04/1994
• Issued: 06/20/1995
• Est. Priority Date: 03/17/1989
• Status: Expired due to Term

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Lampropoulos, Fred P., Taylor, Steven R.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/223,470
• Time in Patent Office: 442 Days
• Field of Search: 604/96-103, 604/118, 604/121, 604/151-155, 604/49-54, 606/192-196, 600/18
• 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 for automatically monitoring, displaying and recording inflation or deflation data. A syringe having a barrel and a plunger is used to apply or to release pressure to the balloon catheter or other balloon member. A transducer housed on the barrel of the syringe senses fluid pressures applied by the syringe. An electromagnetic signal output by the transducer means 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 the length of time that positive fluid pressure is applied, which derived data is automatically displayed and recorded. The deflation of the balloon-type member is similarly processed and recorded. The controller is also programmable to permit input of various control parameters, such as a lesion location identifier, a maximum positive inflation pressure and maximum duration for applying pressure. Input of the various control parameters can be made at either of two redundant switch sets, where one of the switch sets is located on the syringe barrel.

Claims

1. 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 and recording data comprising the steps of:

electromagnetically coupling a transducer means for detecting pressure and for outputting a voltage in proportion thereto with a means for digital signal processing, said transducer means being in fluid communication with internal pressure of the syringe barrel;

connecting the balloon catheter member through the tubing to the syringe barrel;

electronically visually outputting a system user prompt requesting an inflation location identifier;

electronically accepting the inflation location identifier input from an input means operated by a system user;

inflating the balloon member by pushing the plunger into the syringe barrel so as to increase both the internal pressure of the syringe barrel and the pressure applied to the balloon member;

detecting an electromagnetic pressure signal output by the transducer means;

converting the pressure signal to a digital pressure signal using a means for A/D signal conversion;

automatically electronically digitally processing the digital pressure signal so as to automatically derive and automatically record with the inflation location identifier in the digital signal processor means electronic digital data representing the magnitude of the internal pressure in the syringe barrel and the length of time that fluid pressure is applied to the balloon member.

2. A method as recited in claim 1, further comprising the steps of:

electronically outputting a visual display of the magnitude, the corresponding length of time that fluid pressure is applied to the balloon member, and the inflation location identifier; and

deflating the balloon member by pulling the plunger toward the rear of the syringe barrel so as to decrease the internal pressure in the syringe barrel.

3. The method recited in claim 2, further comprising the step of repeating said electronically visually outputting a system user prompt requesting an inflation location identifier step through said balloon deflation step in connection with a second inflation of the balloon member.

4. The method recited in claim 1, wherein prior to said step of electronically visually outputting a system user prompt requesting an inflation location identifier, a step is performed comprising the steps of:

electronically visually outputting a system user prompt requesting a series of predetermined inflation location identifiers;

electronically accepting the series of predetermined inflation location identifiers input from the input means operated by the system user;

automatically recording in the digital signal processor means the series of predetermined inflation location identifiers in said digital processor means;

wherein the step of electronically visually outputting a system user prompt requesting an inflation location identifier further comprises the step of electronically visually outputting each one of the predetermined inflation location identifiers in the series of predetermined inflation location identifiers recorded in said digital processor means; and

wherein the step of electronically accepting the inflation location identifier input from an input means operated by a system user further comprises accepting input from the input means operated by a system user of one of the predetermined inflation location identifiers in the series of predetermined inflation location identifiers recorded in said digital processor means.

5. A method as recited in claim 4, further comprising the steps of:

electronically outputting a visual display of the magnitude, the corresponding length of time that fluid pressure is applied to the balloon member, and the inflation location identifier; and

deflating the balloon member by pulling the plunger toward the rear of the syringe barrel so as to decrease the internal pressure in the syringe barrel.

6. The method recited in claim 5, further comprising the step of repeating said electronically visually outputting a system user prompt requesting an inflation location identifier step through said balloon deflation step for each one of the predetermined inflation location identifiers in the series of predetermined inflation location identifiers recorded in said digital processor means.

7. The method recited in claim 4, wherein each one of the predetermined inflation location identifiers in the series of predetermined inflation location identifiers recorded in said digital processor means comprises an artery name, a lesion number first proximity, and a lesion number second proximity.

8. The method recited in claim 1, wherein the inflation location identifier comprises an artery name, a lesion number first proximity, and a lesion number second proximity.

9. The method recited in claim 1, wherein said step of electronically visually outputting a system user prompt requesting an inflation location identifier comprises electronically visually outputting a system user prompt requesting an artery name, a lesion number first proximity, and a lesion number second proximity.

10. 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 for connection 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;

input means, manually operable by a system user, for inputting an inflation location identifier;

electronic circuit means, electronically connected to the transducer means and the input 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 inflation location identifier, 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 deflated; and

display means, electronically connected to said electronic circuit means, for outputting a visual display of the inflation location identifier, the magnitude of said fluid pressure when applied, and the corresponding length of time said pressure is applied to said balloon-type member, said display means including a digital readout.

11. The system as defined in claim 10, wherein the input means comprises:

first switch means for selecting a menu display stored in said electronic circuit means for presentation at said digital readout optionally selectable components of the inflation location identifier; and

second switch means for entering to said electronic circuit means data identifying choices selected with respect to said optionally selectable components of the inflation location identifier.

12. The system as defined in claim 11, wherein said components of the inflation location identifier comprises:

an artery name, a lesion number first proximity, and a lesion number second proximity.

13. 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 for connection 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;

input means, manually operable by a system user, for inputting an inflation location identifier;

a display means for outputting a visual display; and

a controller for housing said display means and electrically connected to said transducer and said input means, 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;

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

a control panel;

said display means comprising a digital readout on said control panel; and

said digital processor means responding to said machine-readable instructions to electronically derive, store in said data memory means, and digitally display both a first condition of inflation and the duration thereof with the inflation location identifier and a second condition of essentially total deflation and the duration thereof.

14. The system as defined in claim 13, wherein the input means comprises:

first switch means for selecting a menu display stored in said program memory means for presentation at said digital readout optionally selectable components of the inflation location identifier; and

second switch means for entering to said electronic circuit means data identifying choices selected with respect to said optionally selectable components of the inflation location identifier.

15. The system as defined in claim 14, wherein said components of the inflation location identifier comprises:

an artery name, a lesion number first proximity, and a lesion number second proximity.

16. 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 for connection 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;

input means, manually operable by a system user, for inputting an inflation location identifier;

electronic circuit means, operatively connected to said transducer means, said input means, and said display means, for processing said electrical signal, 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 the inflation location identifier with 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, said digital processor means performing 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 in the data memory means the inflation location identifier with all said derived data for retrieval and output; and

automatically displaying the inflation location identifier with said derived data in a visually perceptible manner.

17. The system as defined in claim 16, wherein the input means comprises:

first switch means for selecting a menu display stored in said program memory means for presentation at said digital readout optionally selectable components of the inflation location identifier; and

second switch means for entering to said electronic circuit means data identifying choices selected with respect to said optionally selectable components of the inflation location identifier.

18. The system as defined in claim 17, wherein said components of the inflation location identifier comprises:

an artery name, a lesion number first proximity, and a lesion number second proximity.

19. 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 for connection 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 comprising a digital readout for outputting a visual display;

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

an input means comprising;

first switch means for selecting a menu display stored in said program memory means for presentation at said digital readout optionally selectable components of an inflation location identifier; and

second switch means for entering to said data memory means data identifying choices selected with respect to said optionally selectable components of the inflation location identifier;

said digital processor means responding to said machine-readable instructions to electronically derive, store in said data memory means, and digitally display both a first condition of inflation and the duration thereof with the data identifying choices selected with respect to said optionally selectable components of the inflation location identifier and a second condition of essentially total deflation and the duration thereof.

20. The system as defined in claim 19, wherein said components of the inflation location identifier comprises:

an artery name, a lesion number first proximity, and a lesion number second proximity.