Infusion arrangement and method

• US 9,320,851 B2
• Filed: 02/06/2014
• Issued: 04/26/2016
• Est. Priority Date: 02/07/2013
• Status: Active Grant

• Current Assignee: Medizinische Universitaet Graz
• Original Assignee: Medizinische Universitaet Graz
• Inventors: Regittnig, Werner, Jungklaus, Mir
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US14/174,799
• Publication Number:
  US 20140221965A1
• Time in Patent Office: 810 Days
• 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 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An arrangement for administering a predetermined amount of a substance into an organism is presented. The arrangement includes a member adapted to provide information indicative of a tissue resistance against flow of a fluid containing the substance upon administration into the tissue and a controller adapted to adjust an administration characteristic of the fluid based on the information such as to achieve an intended absorption rate of the substance.

Claims

1. An arrangement for administering a predetermined amount of a substance into an organism, the arrangement comprising:

a member adapted to provide information indicative of a tissue resistance against flow of a fluid containing the substance upon administration into the tissue;

a controller adapted to adjust an administration characteristic of the fluid based on the information such as to achieve an intended absorption rate of the substance;

a pump adapted to be coupled to a reservoir of the fluid and adapted to drive the fluid;

a conduit, in particular comprising a flexible tubing, for guiding the fluid drive by the PUMP from the reservoir into the tissue, the conduit having one end, a cannula, inserterable into the tissue and having another end coupled to the pump unit;

wherein the controller is adapted to control the pump to adjust the flow rate of the fluid to comply with the adjusted administration characteristic;

wherein the member comprises a pressure sensor and is adapted to measure a pressure of the fluid in the conduit;

wherein the arrangement is adapted, using the pressure sensor, to determine a pressure difference based on

a first pressure measurement, when the cannula is inserted into the tissue; and

a second pressure measurement, when the cannula is external to the tissue at atmospheric pressure.

2. The arrangement according to claim 1, wherein the administration characteristic comprises at least one definition of an exogenous factor comprising:

a total administration duration being a total time duration over which fluid is continuously or repeatedly in a pulse wise manner administered;

an administration pulse duration being a time interval over which fluid is continuously administered with a particular flow rate;

an administration pulse height being a flow rate with which the fluid is continuously administered during the administration pulse duration;

an administration pulse frequency being the number of administration pulses per time unit used to administer the fluid during the total administration duration;

an administration pulse shape being a time course of a flow rate with which the fluid is administered during the administration pulse duration;

an anatomical location of the administration site where the fluid is administered into the organism;

or

a duration of use of the administration site for administering the fluid into the organism.

3. The arrangement according to claim 1, wherein the information indicative of the tissue resistance comprises at least one of:

a time interval in which a pressure decreases to a predetermined fraction of a maximum pressure during an administration pulse;

a steepness of a decline at which the pressure decreases from a maximum pressure during an administration pulse; and

a value of the tissue resistance, in particular maximum value during an administration pulse,

wherein the tissue resistance is in particular derived from a pressure measurement, further in particular proportional to an area under a pressure curve, during an administration pulse.

4. The arrangement according to claim 3, wherein the arrangement is adapted to indicate to a user that the administration site should be changed, if the information indicative of the tissue resistance satisfies a criterion, wherein the criterion comprises at least one of:

a time interval threshold;

a steepness threshold;

or

a tissue resistance threshold.

5. The arrangement according to claim 1, wherein the pressure sensor is located

at the pump;

at the reservoir;

or

at a location along the conduit, in particular at or close to the one end or the other end.

6. The arrangement according to claim 1,

wherein the arrangement is further adapted to obtain the tissue resistance based on the determined pressure difference, as a time average of the pressure difference, taking into account a hydrostatic pressure of the liquid during the first pressure measurement and/or the second pressure measurement.

7. The arrangement according to claim 6, wherein the second measurement is performed:

at an instance not related to administration of the substance, in particular at a manufacturer site, and/or

in a time window, in particular between 0 s and 10 min, before inserting the cannula into the organism, and/or

wherein the first measurement is performed;

during basal administration of the substance, and/or

at a beginning of a bolus administration of the substance, in particular during 1 to 10 pulses during a first 1 to 50 pulses of the bolus administration,

wherein the controller is in particular adapted to adjust the flow rate during the first measurement and during the second measurement to a same value.

8. The arrangement according to claim 1, wherein the arrangement is adapted to increase the flow rate when the tissue resistance increases, in order to achieve the intended absorption rate of the substance, when administering the predetermined amount of the substance.

9. The arrangement according to claim 1, wherein a relationship between the absorption rate of the substance and the tissue resistance, in particular depending on controllable extrinsic covariates comprising a total administration duration, administration pulse duration, administration pulse height, administration pulse frequency, administration pulse shape, anatomical location of the administration site and/or duration of use of conduit and administration site has been determined previously, in particular taking into account intrinsic covariates comprising gender, age, body weight, body-mass-index, body surface area, and/or skinfold thickness,

wherein the controlling of flow rate of the fluid is further based on the previously determined relationship and at least one of the covariate values.

10. The arrangement according to claim 1, wherein the intended absorption rate has been determined based on

an appearance study, in particular concentration measurements, of the substance, in particular insulin, in particular in the blood;

and/or

a disappearance study of the substance, in particular comprising labeling the substance with an radioactive isotope; and

/or

a metabolic effect of the substance, in particular an infusion rate of a further substance, in particular a sugar, conveyed into the organism, in order to keep a concentration of the further substance constant.

11. The arrangement according to claim 1,

wherein the controller is adapted to control the administration characteristic based on a changing tissue resistance time.

12. The arrangement according to claim 1, wherein the member comprises:

a storage medium storing the information, the information being based on at least one previous measurement of the tissue resistance, in particular in dependence of a set of covariates, wherein the set of covariates comprises a duration of use of the administration site and conduit and/or tissue type and/or insertion location and/or insertion region within the tissue and/or conduit insertion depth and/or time of day and/or gender and/or age and/or weight and/or height and/or body-mass-index and/or body-surface area and/or skinfold thickness,

wherein obtaining the information comprises;

accessing the information in the storage medium.

13. The arrangement according to claim 1,

wherein the substance comprises insulin and the fluid is an aqueous insulin solution,

wherein in particular the conduit is adapted to be inserted at the one end into the cutaneous or subcutaneous tissue of a human.

14. A method, comprising:

providing a system including;

a member adapted to provide information indicative of a tissue resistance against flow of a fluid containing the substance upon administration into the tissue;

a controller adapted to adjust an administration characteristic of the fluid based on the information such as to achieve an intended absorption rate of the substance;

a pump adapted to be coupled to a reservoir of the fluid and adapted to drive the fluid;

a conduit, in particular comprising a flexible tubing, for guiding the fluid drive by the PUMP from the reservoir into the tissue, the conduit having one end, a cannula, inserterable into the tissue and having another end coupled to the pump unit;

wherein the controller is adapted to control the pump to adjust the flow rate of the fluid to comply with the adjusted administration characteristic;

wherein the member comprises a pressure sensor and is adapted to measure a pressure of the fluid in the conduit;

performing a first pressure measurement with a pressure sensor, when a cannula is inserted into a tissue;

of an organism;

performing a second pressure measurement with the pressure sensor, when the cannula is external to the tissue at atmospheric pressure;

determining a pressure difference from the first pressure measurement and the second pressure measurement with a controller arranged to receive the first pressure measurement and the second pressure measurement from the pressure sensor.

15. The method of claim 14, further comprising:

providing information indicative of a tissue resistance against flow of a fluid containing a substance upon administration into the tissue; and

adjusting an administration characteristic of the fluid based on the information such as to achieve an intended absorption rate of the substance.

16. The method according to claim 15, wherein adjusting is performed at times when a blood glucose concentration of the organism is between 1.05 and 5 times a target level and/or in a time interval 1 sec to 30 min before ingestion of a meal received by the organism.