Cardioplegia Apparatus and Method

• US 20130190717A1
• Filed: 09/13/2012
• Published: 07/25/2013
• Est. Priority Date: 09/13/2011
• Status: Active Grant

• Current Assignee: Quest Medical Incorporated (Atrion Corporation)
• Original Assignee: Quest Medical Incorporated (Atrion Corporation)
• Inventors: Dollar, Michael L., Corera, Cristo Suresh, Jones, Kenneth A.
• Granted Patent: US 9,770,554 B2
• Time in Patent Office: Days
• US Class Current: 604/505
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3664 for preparing cardioplegia solutions
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A microplegia console for controlling the delivery of cardioplegia to a patient, comprising an integrated display/touch screen for displaying cardioplegia information and patient information and allowing inputting of parameters via the display/touch screen into the console for computer-controlled perfusion of cardioplegia into the patient. The invention further comprises a method for delivery of cardioplegia to a patient, including defining and selecting a protocol from a displayed list and sequencing a series of the protocols. The invention also comprises a method for cardioplegia delivery to achieve aortic valve closure. Additionally, the invention comprises a method for activating an icon whereby, upon a first selection of the icon, displaying an indicia indicating that the icon has been first selected; and upon a second selection of the icon, activating the icon.

Claims

1. A console for controlling the delivery of cardioplegia to a patient, comprising in combination:

an integrated display/touch screen for displaying cardioplegia information and patient information and allowing inputting of parameters via the display/touch screen into the console for computer-controlled perfusion of cardioplegia into the patient;

a flow knob allowing manual control the cardioplegia flow rate; and

an interface operatively connected between the console and a cardioplegia pump, said interface enabling intercommunication of one or more of diagnostics status, messages and periodic data updates between the console and the pump.

2. The console as set forth in claim 1, wherein manual control of the cardioplegia flow rate via the flow knob takes precedence over any in-process computer-controlled cardioplegia perfusion into the patient.

3. The console as set forth in claim 2, wherein the manual control of the cardioplegia flow rate via the flow knob suspends or cancels any in-process computer-controlled cardioplegia perfusion such that manual control of the cardioplegia perfusion into the patient may be resumed.

4. The console as set forth in claim 1, wherein the interface comprises an interface cable and wherein the console is a physically separate the pump, whereby, during a surgical operation, the console may be located proximate to a perfusionist and the pump may be located elsewhere.

5. The console as set forth in claim 4, wherein the pump provides electrical power to the console via said interface cable such that the console may be powered on when the pump is powered on.

6. The console as set forth in claim 1, further including an electrocardiogram input allowing an electrocardiogram waveform to be displayed on the display/touch screen.

7. The console as set forth in claim 1, further including one or more of a an interface port to export or import data to or from an external storage media, a printer port for network or local printing, a communication port for connectivity communications.

8. The console as set forth in claim 1, further including a switch input for a switch that boots the console into a flash loader mode.

9. The console as set forth in claim 8, wherein said switch comprises a reed switch concealed within a housing of the console, said reed switch including contacts that are closed when a magnet is moved in close proximity to said reed switch.

10. The console as set forth in claim 1, wherein said display/touch screen comprises a graphical user interface.

11. The console as set forth in claim 10, wherein said display/touch screen displays a Select Step allowing selection of a Case Manager Step, a New Case Setup Step, a Resume Case Step or a Menu Step.

12. The console as set forth in claim 11, wherein said Case Manager Step allows setup of protocols and then sequence them in a specific order for a particular patient.

13. The console as set forth in claim 11, wherein said New Case Setup Step allows setup for a new patient based upon one or more of User Defaults, a Previous Case, an Existing Protocol or Existing Sequence.

14. The console as set forth in claim 10, wherein said display/touch screen displays a Prime Step that when selected primes the pump to begin perfusion.

15. The console as set forth in claim 10, wherein said display/touch screen displays a Home Screen Step that when selected allows monitoring the computer-controlled delivery of cardioplegia to the patient.

16. The console as set forth in claim 15, wherein said Home Screen Step allows manual pause or stopping of the delivery of cardioplegia to the patient in which case a Resume Case Step then allows subsequent resumption of delivery of cardioplegia to the patient.

17. The console as set forth in claim 15, wherein said Home Screen Step allows return to a Case Manager Step to temporarily change previously-setup protocol or sequencing parameters.

18. The console as set forth in claim 10, wherein, while either in the Select Screen Step or while in the Home Screen Step, a Menu Screen Step may be selected to perform various administrative functions.

19. The console as set forth in claim 10, wherein said display/touch screen displays active or passive icons for appropriate controls and parameters relevant to a step being performed, the active icons representing such controls and parameters being selectable as desired for manipulation of the parameters or navigation to previous or succeeding screens.

20. The console as set forth in claim 11, wherein said New Case Setup Screen includes one or more of User Defaults, An Existing Protocol, Previous Case Parameters and An Existing Sequence active icons corresponding to the User Defaults Step, Previous Case Step, Existing Protocol Step and Existing Sequence Step.

21. The console as set forth in claim 20, wherein selection of said User Default active icon displays Review/Modify Parameter screens, which may be scrolled through to display the factory-predefined user default parameters.

22. The console as set forth in claim 21, wherein the Review/Modify Parameter screens includes a Prime active icon corresponding to the Prime Step allowing transfer to the Prime Step in preparation for delivering cardioplegia to the patient.

23. The console as set forth in claim 10, wherein at the conclusion of delivery of cardioplegia to the patient, the parameters used are stored in memory as the Previous Case Parameters.

24. The console as set forth in claim 23, wherein selection of the Previous Case Parameters displays the previous-case parameters in the Review/Modify Parameter screens review or modification, and when completed, transfers to the Prime Step in preparation for delivering cardioplegia to the patient.

25. The console as set forth in claim 10, further including predefining a collection of parameters, labeling them and storing in memory as Existing Protocols for later use via Case Manager.

26. The console as set forth in claim 25, wherein in lieu of using User Default or Previous Case parameters respectively corresponding to the User Default Step or Previous Case Step, an Existing Protocol may be selected in the New Case Setup screen corresponding to the Existing Protocol Step, whereupon a listing of the predefined Existing Protocols is displayed.

27. The console as set forth in claim 26, wherein upon selection of one of the Existing Protocols, its predefined parameters are displayed the Review/Modify Parameter screens for review or modification, and when completed, transfer to the Prime Step.

28. The console as set forth in claim 27, further including sequencing a series of Existing Protocols to be used in sequence, labeling and storage in memory as Sequences for later use via Case Manager.

29. The console as set forth in claim 28, wherein upon selection of one of the Existing Sequences listed in the New Case Setup screen, the selected Existing Sequence'"'"'s sequence of Protocols are displayed for review or modification and when completed, transferred to the Prime Step.

30. The console as set forth in claim 29, further including a play icon for initiating the Sequence.

31. The console as set forth in claim 30, further including pause and stop icon to pause or stop the running of the Sequence.

32. The console as set forth in claim 31, further including a skip icon for skipping one or more of the Protocols of the Sequence.

33. The console as set forth in claim 10, further including a data viewer.

34. The console as set forth in claim 10, further including a training simulator.

35. The console as set forth in claim 10, further including vein graft labeling.

36. The console as set forth in claim 10, further including displaying the volume of cardioplegia to be delivered.

37. The console as set forth in claim 36, further including displaying either the total of the volume of cardioplegia to be delivered or the additional volume of cardioplegia to be delivered.

38. A method for delivery of cardioplegia to a patient, including the step of selecting an Existing Protocol from a displayed list, whereupon predefined parameters of the selected Existing Protocol are displayed for review or modification.

39. The method as set forth in claim 38, further including sequencing a series of the Existing Protocols to be used in sequence, labeling and storage in memory as Sequences.

40. The method as set forth in claim 39, further including the step of selecting one of the Sequences from a displayed list, whereupon predefined parameters of the Existing Protocols of the selected Sequence are displayed are displayed for review or modification.

41. The method as set forth in claim 40, further including the step of selecting a play icon for initiating the selected Sequence.

42. The method as set forth in claim 41, further including the step of selecting a pause icon to pause the selected Sequence.

43. The method as set forth in claim 41, further including the step of selecting a stop icon to stop the selected Sequence.

44. The method as set forth in claim 41, further including the step of selecting a skip icon for skipping one or more of the Protocols of the selected Sequence.

45. The method as set forth in claim 38, further including the step of training through simulation.

46. The method as set forth in claim 38, further including the step of labeling vein grafts.

47. The method as set forth in claim 38, further including the step of displaying the volume of cardioplegia to be delivered.

48. The console as set forth in claim 47, further including displaying either the total of the volume of cardioplegia to be delivered or the additional volume of cardioplegia to be delivered.

49. A method for cardioplegia delivery to achieve aortic valve closure, comprising the steps of:

initiating a dose of cardioplegia to a patient via a delivery line;

measuring delivery line pressure or the patient'"'"'s ascending aortic pressure; and

while measuring the delivery line pressure or the patient'"'"'s ascending aortic pressure, dynamically adjusting the dose pressures and flows to achieve aortic valve closure.

50. The method for cardioplegia delivery as set forth in claim 49, wherein the step of measuring the delivery line pressure or the patient'"'"'s ascending aortic pressure comprises the step of determining aortic valve closure based upon the rate of change of the delivery line pressure or the patient'"'"'s ascending aortic pressure.

51. The method for cardioplegia delivery as set forth in claim 49, further including the step of measuring the patient'"'"'s ascending aortic pressure to determine aortic incisura and using the pressure at the aortic incisura to compute a target pressure.

52. The method for cardioplegia delivery as set forth in claim 51, wherein the cardioplegia is delivered to the target pressure to cause the cardioplegia to flow down the coronary arteries and arrest the heart.

53. The method for cardioplegia delivery as set forth in claim 52, wherein, after arresting the heart, the target pressure is maintained to ensure the aortic valve remains closed.

54. The method for cardioplegia delivery as set forth in claim 52, further including the step of analyzing the patient'"'"'s aortic pressure waveform as an indication of rate of delivery and target pressure for arresting the heart ensuring that the cardioplegia dose closes the aortic valve.

55. A method for cardioplegia delivery comprising the step of monitoring electrocardiogram activity for heart activity and dynamically adjusting cardioplegia concentration to maintain quiescent heart activity.

56. The method for cardioplegia delivery as set forth in claim 55, further comprises the step of monitoring the electrocardiogram activity for heart activity over a period of time if present, automatically increasing the cardioplegia concentration until the heart activity is suppressed.

57. The method for cardioplegia delivery as set forth in claim 55, further comprises the step of monitoring the electrocardiogram activity for any heart activity over a period of time and if not present, automatically decreasing the cardioplegia concentration until heart activity becomes present.

58. A method for cardioplegia delivery, comprising the steps of:

presetting a physiologic parameter including one or more of electrocardiogram signals, temperatures, pH levels, oxygen levels or lactate levels;

initiating cardioplegia delivery; and

automatically controlling the flow or concentration of cardioplegia delivery to optimize the physiologic parameter.

59. A method for cardioplegia delivery, comprising the steps of:

presetting a pressure; and

automatically controlling the flow of cardioplegia delivery to the preset pressure.

60. The method for cardioplegia delivery, wherein said pressure comprises at least one of delivery pressure, ante external pressure, ante system pressure, retro external pressure, retro system or vein graft pressure.

61. A method for activating an icon, comprising the steps of:

displaying the icon on a touch/display screen;

upon a first selection of the icon, displaying an indicia indicating that the icon has been first selected; and

upon a second selection of the icon, activating the icon.

62. The method as set forth in claim 61, wherein the indicia comprises a tab.

63. The method as set forth in claim 62, wherein display of the indicia is automatically removed after a time delay, whereupon subsequent activation of the icon requires repeating the first selection and the second selection of the icon.