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

• US 5,431,629 A
• Filed: 04/04/1994
• Issued: 07/11/1995
• Est. Priority Date: 03/17/1989
• Status: Expired due to Term

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Salisbury, Jeffrey D., Lampropoulos, Fred P.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/223,421
• Time in Patent Office: 463 Days
• Field of Search: 604/118, 604/121, 604/96, 604/97-100, 604/151, 604/152, 604/65, 600/18, 606/192, 606/194
• 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 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 maximum positive inflation pressure and maximum duration for applying pressure. Input of the various control parameters can be made a either of two redundant switch sets, where one of the switch sets in located on the syringe barrel.

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 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;

electronic circuit means, operatively connected to said transducer means for processing said electrical signal;

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

a controller for housing said display means and said electronic circuit means, said controller comprising a control panel, and wherein said display means comprises a digital readout on said control panel, said control panel comprising;

control panel input means, manually operatable by a system user, for inputting data to the electronic circuit means;

said syringe further comprising;

syringe input means, manually operatable by a system user, for inputting data to the electronic circuit means, wherein the control panel input means and the syringe input means are functionally redundant one to the other.

2. The system as defined in claim 1, wherein the control panel input means comprises:

first switch means for selecting a menu display for presentation at said digital readout a series of optionally selectable functions to be performed by said electronic circuit means; and

second switch means for entering to said electronic circuit means data identifying choices selected with respect to any of said functions; and

said syringe input means further comprising;

third switch means for selecting a menu display for presentation at said digital readout the series of optionally selectable functions to be performed by said electronic circuit means; and

fourth switch means for entering to said electronic circuit means data identifying choices selected with respect to any of said functions.

3. The system as defined in claim 2, wherein said optionally selectable functions include at least one of the following:

a. accepting input to the electronic circuit means to set a maximum fluid pressure to be applied by the syringe to the balloon-type member;

b. accepting input to the electronic circuit means to set a maximum duration that fluid pressure is to be applied by the syringe to the balloon-type member so as to inflate the balloon-type member;

c. accepting input to the electronic circuit means to set a priority for one of the syringe input means or the control panel input means from which further input is to be accepted.

4. 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;

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 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 deflated; and

a controller for housing said display means and said electronic circuit means, said controller comprising a control panel, and wherein said display means comprises a digital readout on said control panel, said control panel comprising;

control panel input means, manually operatable by a system user, for inputting data to the electronic circuit means;

said syringe further comprising;

syringe input means, manually operatable by a system user, for inputting data to the electronic circuit means, wherein the control panel input means and the syringe input means are functionally redundant one to the other.

5. The system as defined in claim 4, wherein the control panel input means comprises:

first switch means for selecting a menu display for presentation at said digital readout a series of optionally selectable functions to be performed by said electronic circuit means; and

second switch means for entering to said electronic circuit means data identifying choices selected with respect to any of said functions; and

said syringe input means further comprising;

third switch means for selecting a menu display for presentation at said digital readout the series of optionally selectable functions to be performed by said electronic circuit means; and

fourth switch means for entering to said electronic circuit means data identifying choices selected with respect to any of said functions.

6. The system as defined in claim 5, wherein said optionally selectable functions include at least one of the following:

a. accepting input to the electronic circuit means to set a maximum fluid pressure to be applied by the syringe to the balloon-type member;

b. accepting input to the electronic circuit means to set a maximum duration that fluid pressure is to be applied by the syringe to the balloon-type member so as to inflate the balloon-type member;

c. accepting input to the electronic circuit means to set a priority for one of the syringe input means or the control panel input means from which further input is to be accepted.

7. 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 for outputting a visual display; and

a controller for housing said display means and 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;

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

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

control panel input means, manually operatable by a system user, for inputting data to the data memory means;

said syringe further comprising;

syringe input means, manually operatable by a system user, for inputting data to the data memory means, wherein the control panel input means and the syringe input means are functionally redundant one to the other; 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.

8. The system as defined in claim 7, wherein the control panel input means comprises:

first switch means for selecting a menu display for presentation at said digital readout a series of optionally selectable functions to be performed by said controller; and

second switch means for entering to said data memory means data identifying choices selected with respect to any of said functions; and

said syringe input means further comprising;

third switch means for selecting a menu display for presentation at said digital readout the series of optionally selectable functions to be performed by said controller; and

fourth switch means for entering to said data memory means data identifying choices selected with respect to any of said functions.

9. The system as defined in claim 8, wherein said optionally selectable functions include at least one of the following:

a. accepting input to the data memory means to set a maximum fluid pressure to be applied by the syringe to the balloon-type member;

b. accepting input to the data memory means to set a maximum duration that fluid pressure is to be applied by the syringe to the balloon-type member so as to inflate the balloon-type member;

c. accepting input to the data memory means to set a priority for one of the syringe input means or the control panel input means from which further input is to be accepted.

10. 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;

electronic circuit means, operatively connected to said transducer 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 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 all said derived data for retrieval and output; and

automatically displaying said derived data in a visually perceptible manner,

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;

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

a controller for housing said display means, said converting means, said digital processor means, said data memory means, and said program memory means, said controller comprising a control panel, and wherein said display means comprises a digital readout on said control panel, said control panel comprising;

first switch means for selecting a menu display for presentation at said digital readout a series of optionally selectable functions to be performed by said electronic circuit means;

second switch means for entering to said data memory means data identifying choices selected with respect to any of said functions; and

said syringe further comprising;

third switch means for selecting a menu display for presentation at said digital readout the series of optionally selectable functions to be performed by said electronic circuit means, said third switch means being functionally redundant to the first switch means; and

fourth switch means for entering to said data memory means data identifying choices selected with respect to any of said functions, said fourth switch means being functionally redundant to the second switch means.

11. 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 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,

said display means being an integral part of said controller, and comprises a digital readout;

wherein said controller further comprises;

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

second switch means for entering to said data memory means data identifying choices selected with respect to any of said functions; and

said syringe further comprises;

third switch means for selecting a menu display for presentation at said digital readout the series of optionally selectable functions to be performed by said digital processor means, said third switch means being functionally redundant to the first switch means; and

fourth switch means, duplicating the function of said second switch means, for entering to said data memory means data identifying choices selected with respect to any of said functions, said fourth switch means being functionally redundant to the second switch means.