Devices and methods for adjusting basal delivery profile

• US 9,248,231 B2
• Filed: 06/03/2010
• Issued: 02/02/2016
• Est. Priority Date: 06/04/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Shapira, Gali
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US13/376,040
• Publication Number:
  US 20120191061A1
• Time in Patent Office: 2,070 Days
• Field of Search: 604/503
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The present disclosure presents systems, devices and methods for administration of a therapeutic fluid to the body of a patient at a transient basal delivery profile, and enabling modification of the transient profile. Some embodiments include a user interface enabling input of one or more transient basal related parameters, and a processor having a basal programming application operating thereon. The basal programming application configured for determining a transient basal profile based on at least one or more transient basal related parameters. The transient basal profile comprises a plurality of phases and wherein each of the plurality of phases is characterized by a duration and at least one basal rate. In some embodiments, at least one of the plurality of phases includes either a basal overshot or a basal undershot. Some embodiments may also include a pump for dispensing the therapeutic fluid from a reservoir to the body of the patient.

Claims

1. A method for adjusting a transient basal delivery profile for a therapeutic fluid delivered to the body of a patient, the method comprising:

providing a therapeutic fluid dispending device, the device including;

a user interface enabling input of one or more transient basal related parameters;

a processor having a basal programming application operating thereon; and

a pump dispensing the therapeutic fluid from a reservoir to the body of a patient;

receiving, via the user interface, the one or more transient basal related parameters;

determining, via the basal programming application, a transient basal profile based on at least the one or more transient basal related parameters, wherein the transient basal profile comprises two or more phases and wherein at least one of the two or more phases includes either a basal overshot or a basal undershot.

2. The method of claim 1, further comprising controlling, via the basal programming application used in conjunction with the processor, the pump for dispensing the therapeutic fluid according to the transient basal profile.

3. The method of claim 1, wherein determining the one or more transient basal related parameters includes:

determining a therapeutic fluid delivery rate substantially higher than the delivery rate in a steady state; and

receiving a therapeutic fluid delivery duration substantially shorter than the delivery duration in a steady state.

4. The method of claim 1, wherein determining the transient basal profile based on at least the one or more transient basal related parameters includes:

determining a therapeutic fluid delivery rate substantially lower than the delivery rate in a steady state; and

determining a therapeutic fluid delivery duration substantially shorter than the delivery duration in a steady state.

5. The method of claim 1, wherein the therapeutic fluid total dose corresponding to the transient basal profile determined by the basal programming application is substantially equivalent to a total dose delivered in a steady state.

6. The method of claim 1, wherein the one or more transient basal related parameters is selected from a group consisting of time of transient delivery rate, percentage of transient delivery rate compared to the anticipated delivery profile, percentage of transient delivery rate compared to the current delivery profile, absolute value or values of a delivery rate, maximum allowable time shifted bolus, minimum allowable time shifted negative bolus, an absorption rate of the therapeutic fluid, type of therapeutic fluid, intensity of physical activity, and site of cannula insertion.

7. The method of claim 1, further comprising displaying the transient basal delivery profile to a user.

8. The method of claim 1, wherein the transient basal delivery profile further comprises at least one additional basal profile to be delivered during at least one additional basal duration.

9. The method of claim 1, further comprising administering the therapeutic fluid, and wherein such administration complies with pharmacokinetic and/or pharmacodynamic parameters of the therapeutic fluid.

10. The method of claim 1, wherein each of the two or more phases is characterized by a duration and at least one basal rate.

11. A computer program comprising computer-executable instructions, which when executed on a suitable computer device, perform the method comprising:

receiving, via a user interface, one or more transient basal related parameters;

determining, via a basal programming application, a transient basal profile based on at least the one or more transient basal related parameters, wherein the transient basal profile comprises two or more phases and wherein at least one of the two or more phases includes either a basal overshot or a basal undershot.

12. The computer program of claim 11, wherein the method further comprises controlling, via the basal programming application used in conjunction with the processor, the pump for dispensing the therapeutic fluid according to the transient basal profile.

13. The computer program of claim 11, wherein determining the one or more transient basal related parameters includes:

determining a therapeutic fluid delivery rate substantially higher than the delivery rate in a steady state; and

receiving a therapeutic fluid delivery duration substantially shorter than the delivery duration in a steady state.

14. The computer program of claim 11, wherein determining the transient basal profile based on at least the one or more transient basal related parameters includes:

determining a therapeutic fluid delivery rate substantially lower than the delivery rate in a steady state; and

determining a therapeutic fluid delivery duration substantially shorter than the delivery duration in a steady state.

15. The computer program of claim 11, wherein the therapeutic fluid total dose corresponding to the transient basal profile determined by the basal programming application is substantially equivalent to a total dose delivered in a steady state.

16. The computer program of claim 11, wherein the one or more transient basal related parameters is selected from a group consisting of:

time of transient delivery rate, percentage of transient delivery rate compared to the anticipated delivery profile, percentage of transient delivery rate compared to the current delivery profile, absolute value or values of a delivery rate, maximum allowable time shifted bolus, minimum allowable time shifted negative bolus, an absorption rate of the therapeutic fluid, type of therapeutic fluid, intensity of physical activity, and site of cannula insertion.

17. The computer program of claim 11, wherein the method further comprises displaying the transient basal delivery profile to a user.

18. The computer program of claim 11, wherein the transient basal delivery profile further comprises at least one additional basal profile to be delivered during at least one additional basal duration.

19. The computer program of claim 11, wherein the method further comprises administering the therapeutic fluid, and wherein such administration complies with pharmacokinetic and/or pharmacodynamic parameters of the therapeutic fluid.

20. A non-transitory computer readable medium comprising computer-executable instructions recorded thereon for performing the method comprising:

receiving, via a user interface, one or more transient basal related parameters;

determining, via a basal programming application, a transient basal profile based on at least the one or more transient basal related parameters, wherein the transient basal profile comprises two or more phases and wherein at least one of the two or more phases includes either a basal overshot or a basal undershot.