Method and system for controlled infusion of therapeutic substances

• US 7,938,796 B2
• Filed: 03/29/2007
• Issued: 05/10/2011
• Est. Priority Date: 09/18/2006
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: White, David N., Stevenson, John W., Thomas, Linda, Moubayed, Jay G., Wilson, Larry L., Hyman, Oscar E., Moubayed, Ahmad-Maher
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US11/731,274
• Publication Number:
  US 20080071209A1
• Time in Patent Office: 1,503 Days
• Field of Search: 604/65, 604/67, 604/118, 604/151, 604/153, 705/2, 705/3, 707/104.1
• US Class Current: 604/65
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y10S 707/99948 Application of database or data structure, e.g. distributed, multimedia, or image

Abstract

Programmable infusion systems and method for controlled infusion of diagnostic or therapeutic substances (e.g., drugs, biologics, fluids, cell preparations, etc.) into the bodies of human or animal subjects.

Claims

1. A method for administrating a substance to a subject, said method comprising the steps of:

A) providing a system that comprises i) a pump, ii) a controller that is in communication with the pump and issues control signals to the pump, iii) a substance administering conduit for delivering the substance to the subject'"'"'s body, iv) a subject database containing information on at least one subject, v) a substance reference library, and vi) a user interface; and

B) creating a new infusion protocol or selecting an infusion protocol that is stored in the subject database and loading the infusion protocol into the controller;

C) querying the subject on whether the subject is experiencing an adverse reaction and enabling the subject to respond to the query via the user interface;

D) determining whether the subject'"'"'s response to the query indicates the subject is experiencing an adverse reaction stored in the substance reference library in association with the substance; and

E) comparing the infusion protocol loaded into the controller with infusion protocol limits stored in the subject database and;

i) when a parameter of the infusion protocol is outside of the protocol limits stored in the subject database, taking at least one remedial action selected from the group consisting of;

a) preventing execution of the infusion protocol, b) notifying the operator that the protocol loaded into the controller is outside of the subject'"'"'s limits and c) recording a record of the event in a history database,

ii) when the subject'"'"'s response to the query indicates the subject is experiencing the adverse reaction stored in the substance reference library in association with the substance, the controller automatically causes the pump to stop or modify the rate of infusion, and

iii) when no parameter of the infusion protocol is outside of the protocol limits stored in the subject database, causing the pump to administer the substance through the conduit and into the subject'"'"'s body in accordance with the infusion protocol.

2. A method according to claim 1 further comprising the step of:

establishing a system configuration database with at least one set of configuration parameters.

3. A method according to claim 2 further comprising the step of:

selecting configuration parameters from the system configuration database and loading the selected configuration parameters into the controller, thereby causing the controller to establish limits for the infusion based on the selected configuration parameters.

4. A method according to claim 1 further comprising the step of

creating said subject database by storing at least one subject record in a storage medium that may be accessed by the controller.

5. A method according to claim 4 further comprising the step of:

modifying the subject database by adding, modifying or deleting a subject record.

6. A method according to claim 1 further comprising the step of:

establishing a substance database with at least one substance record.

7. A method according to claim 6 further comprising the step of:

modifying the substance database by adding, modifying or deleting a substance record.

10. A method according to claim 1 further comprising the step of:

establishing the substance reference library with reference information for a plurality of substances.

11. A method according to claim 10 further comprising the step of:

modifying the substance reference library database by adding, modifying or deleting a substance reference record.

12. A method according to claim 1 further comprising the step of:

establishing a history database with historical information relating to at least one subject or substance.

13. A method according to claim 12 further comprising the step of:

modifying the history database by adding, modifying or deleting historical information.

14. A method according to claim 1 wherein the system provided in Step A further comprises an apparatus for measuring at least one physiologic variable of a subject and wherein the method further comprises the step of:

determining whether the measured physiologic variable indicates that the subject is experiencing an adverse reaction to the infusion.

15. A method according to claim 14 wherein said at least one physiologic variable is selected from the group consisting of:

heart rate, blood pressure, body temperature, respiratory rate, oxygen saturation, carbon monoxide saturation, profusion index, methemoglobinemia, skin response and airway resistance.

16. A method according to claim 15 further comprising the step of:

stopping or modifying the rate of infusion if it is determined that the subject is experiencing an adverse reaction.

17. A method according to claim 15 further comprising the step of:

categorizing the monitored physiologic variable(s) into a category selected from;

a) no adverse reaction, b) mild adverse reaction, c) moderate adverse reaction or d) severe adverse reaction.

20. A method according to claim 15 wherein the system provided in Step A includes a history database and wherein the method further comprises the step of:

causing a record of the adverse reaction to be stored in the history database if it is determined that the subject is experiencing an adverse reaction.

21. A method according to claim 1 wherein the subject is queried regarding feelings, sensations, symptoms or other bodily responses experienced by the subject during or after an infusion.

22. A method according to claim 1 wherein the subject is queried regarding at least one feeling, sensation, symptom or other bodily response selected from the group consisting of:

nausea, vertigo, sensations of smell, sensations of taste, confusion, memory, alertness, sleepiness, drowsiness, perception of being warm, perception of being cold, shivering, pain, non-volitional muscle contractions, a symptom of an overdose of the substance, a symptom of an under-dose of the substance, a symptom of the substance being infused too rapidly, a symptom of the substance being infused too slowly, a symptom indicating that the substance is having a desired effect and a symptom indicating that the substance is having an undesired effect.

23. A method according to claim 1 further comprising the step of:

categorizing the subjects response into a category selected from;

a) no adverse reaction, b) mild adverse reaction, c) moderate adverse reaction or d) severe adverse reaction.

24. A method according to claim 17 further comprising the steps of:

if the patient is suffering a mild adverse reaction;

(a) stopping the infusion and providing a user a mild adverse reaction advisory,

(b) providing the user an option of requerying the subject for adverse reactions,

(c) if the user elects to proceed with the requery;

(i) requery the subject, and

(ii) providing the user an option of having the response to the requery analyzed,

(d) if the user does not elect to have the requery analyzed or does not proceed with the requery, suggesting a lower substance administration rate or enabling the user to enter a lower substance administration rate, and

(e) if the user does not accept the suggested lower infusion rate or does not enter the lower infusion rate, enabling the user to override the mild adverse reaction advisory and resuming the substance administration.

25. A method according to claim 17 further comprising the steps of:

if the patient is suffering a severe adverse reaction;

(a) stopping the infusion and providing a user a severe adverse reaction advisory,

(b) providing the user an option of requerying the subject for adverse reactions,

(c) if the user elects to proceed with the requery;

(i) requery the subject, and

(ii) providing the user an option of having the response to the requery analyzed,

(d) if the user does not elect to have the response to the requery analyzed or does not proceed with the requery, terminating the substance administration.

26. A method according to claim 1 wherein the system provided in Step A includes a history database and wherein the method further comprises the step of:

causing a record of the adverse reaction to be stored in the history database if it is determined that the subject is experiencing an adverse reaction.

27. A method according to claim 1 wherein the system provided in Step A further comprises a system configuration database containing protocol limit information and wherein the method further comprises the step of:

comparing the infusion protocol loaded into the controller with protocol limit information contained in the system configuration database.

28. A method according to claim 27 further comprising the step of:

taking at least one responsive measure if it is determined that any parameter of the infusion protocol loaded into the controller is outside of a limit contained in the system configuration database, said responsive measure being selected from the group consisting of;

preventing execution of the protocol loaded into the controller, modifying the protocol loaded into the controller, providing notice to an operator and recording information regarding the event into a history database.

29. A method according to claim 1 wherein the system provided in Step A further comprises an interface by which the system can store and retrieve records or databases to/from one or more connected networked devices and wherein the method further comprises the step of:

storing or retrieving at least one subject record or database, substance record or database, or infusion protocol record or database to/from a connected network device.

30. A method according to claim 1 wherein the system provided in Step A further comprises a history database and wherein the method further comprises the step of:

recording information into the history database.

31. A method according to claim 30 wherein the system provided in Step A further comprises apparatus for displaying information contained in the history database to an operator and wherein the method further comprises the step of:

displaying information contained in the history database to an operator.

32. A method according to claim 30 wherein the system provided in Step A further comprises a filter for filtering to information displayed to an operator so as to include or exclude certain items of information and wherein the method further comprises the step of:

filtering the information to include or exclude certain items of information when displayed to an operator.

33. A method according to claim 30 wherein the system limits the range of history records displayed to the operator based on operator selected start date and end date.

34. A method according to claim 30 wherein the system provided in Step A further comprises a printer and there the method further comprises the step of:

using the printer to print information contained in the history database.

35. A method according to claim 34 wherein the system provided in Step A further comprises a filter for filtering information that is printed from the history database by the printer and wherein the method further comprises the step of:

filtering information printed from the history database by the printer.

36. A method according to claim 35 wherein the step of filtering information comprises limiting the information printed to a range of dates selected by an operator.

37. A method according to claim 1 wherein the system provided in Step A further comprises a wired or wireless interface by which the system can communicate with an external network and wherein the method further comprises the step of:

causing the system to communicate with an external network.

38. A method according to claim 1 wherein the substance delivered in Step C comprises Immune Globulin.

39. A method according to claim 1 wherein the substance delivered in Step C comprises Infliximab.

40. A method according to claim 1 including the step of querying the subject regarding a specific adverse reaction stored in the substance reference library, based on a measurement of a physiological variable.

41. A method according to claim 1, wherein the substance reference library includes at least one cyclic redundancy check parameter which allows a substance reference library configurator program to determine if contents of the substance reference library have changed.

8. A method 1 further comprising the step of:

establishing a therapy-type protocol database with at least one infusion protocol based on therapy type.

9. A method according to claim 8 further comprising the step of:

modifying the therapy-type protocol database by adding, modifying or deleting an infusion protocol.

18. A method for administrating a substance to a subject, said method comprising the steps of:

A) providing a system that comprises i) a pump, ii) a controller that is in communication with the pump and issues control signals to the pump, iii) a substance administering conduit for delivering the substance to the subject'"'"'s body, iv) a subject database containing information on at least one subject, v) a substance reference library, and v) vi) a user interface;

B) creating a new infusion protocol or selecting an infusion protocol that is stored in the subject database and loading the infusion protocol into the controller;

C) querying the subject on whether the subject is experiencing an adverse reaction and enabling the subject to respond to the query via the user interface;

D) determining whether the subject'"'"'s response to the query indicates the subject is experiencing an adverse reaction stored in the substance reference library in association with the substance; and

E) when the patient is suffering a mild adverse reaction stored in the reference library;

(i) the controller automatically causing the pump to stop the infusion and provide a user a mild adverse reaction advisory,

(ii) providing the user an option of initiating a new measurement of the monitored physiological variable(s),

(iii) when the user elects to proceed with the new measurement of the physiological variable(s);

(a) proceeding with the new measurement, and

(b) providing the user an option of having the newly measured physiological variables analyzed,

(iv) when the user does not elect to have the newly measured physiological variable(s) analyzed or does not proceed with the new measurement of the physiological variable(s), suggesting a lower substance administration rate or enabling the user to enter a lower substance administration rate, and

(v) when the user does not accept the suggested lower infusion rate or does not enter the lower infusion rate, enabling the user to override the mild adverse reaction advisory and resuming the substance administration.

19. A method for administrating a substance to a subject, said method comprising the steps of:

A) providing a system that comprises i) a pump, ii) a controller that is in communication with the pump and issues control signals to the pump, iii) a substance administering conduit for delivering the substance to the subject'"'"'s body, iv) a subject database containing information on at least one subject, v) a substance reference library, and v) vi) a user interface;

B) creating a new infusion protocol or selecting an infusion protocol that is stored in the subject database and loading the infusion protocol into the controller;

C) querying the subject on whether the subject is experiencing an adverse reaction and enabling the subject to respond to the query via the user interface;

D) determining whether the subject'"'"'s response to the query indicates the subject is experiencing an adverse reaction stored in the substance reference library in association with the substance; and

E) when the patient is suffering a severe adverse reaction stored in the reference library;

(a) the controller automatically causing the pump to stop the infusion and provide a user a severe adverse reaction advisory,

(b) providing the user an option of initiating a new measurement of the monitored physiological variable(s),

(c) when the user elects to proceed with the new measurement of the physiological variable(s);

(i) proceeding with the new measurement, and

(ii) providing the user an option of having the newly measured physiological variables analyzed, and

(d) when the user does not elect to have the newly measured physiological variable(s) analyzed or does not proceed with the new measurement of the physiological variable(s), terminating the substance administration.