# US 11,908,562 B2 · Infusion system consumables and related calibration methods

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- Number: US 11,908,562 B2
- Document ID: US11908562B2
- Status: Granted
- Kind: B2
- Application number: 16/725,569
- Filed: 2019-12-23
- Published: 2020-04-30
- Granted: 2024-02-20
- Earliest claimed: 2017-02-07
- Assignees: Medtronic MiniMed, Inc.
- Applicants: Medtronic Minimed, Inc.
- Inventors: Afshin Bazargan
- Web page: https://patentgrep.com/patent/US11908562B2

## CPC

- G16H 20/17: delivered via infusion or injection
- A61M 5/14216: {Reciprocating piston type}
- A61M 5/14228: {with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- F04B 9/045: {the means being eccentrics}
- F04B 19/22: of reciprocating-piston type
- F04B 23/02: having reservoirs
- F04B 43/12: having peristaltic action
- F04B 43/1253: {by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing}
- F04B 43/1269: {the rotary axes of the rollers lying in a plane perpendicular to the rotary axis of the driving motor}
- F04B 51/00: Testing machines, pumps, or pumping installations
- G16H 40/63: for local operation
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/6072: Bar codes
- A61M 2205/70: with testing or calibration facilities
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M 2230/201: Glucose concentration
- F04B 2205/05: Pressure after the pump outlet
- F04B 2205/09: Flow through the pump
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- F04B: POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS (machines for liquids, or pumps, of rotary-piston or oscillating-piston type F04C; non-positive-displacement pumps F04D; pumping of fluid by direct contact of another fluid or by using inertia of fluid to be pumped F04F)

## Abstract

Infusion systems including infusion devices and consumables and related operating methods are provided. An exemplary consumable component includes a housing, a reservoir contained within the housing, a pumping mechanism for dispensing a fluid from the reservoir, and a readable element associated with the housing. The readable element maintains calibration data characterizing a relationship between delivery of the fluid and actuation of the pumping mechanism.

## Claims

### Claim 1

A consumable component comprising:
a housing;
a reservoir contained within the housing;
a pumping mechanism for dispensing a fluid from the reservoir; and
a readable element associated with the housing, the readable element maintaining calibration data indicating an amount of the fluid that is delivered relative to actuation of the pumping mechanism, wherein the amount of the fluid that is delivered relative to the actuation of the pumping mechanism is based on manufacturing of the pumping mechanism, wherein the calibration data is specific only to the consumable component accounting for the amount of fluid that is delivered relative to the actuation of the pumping mechanism as manufactured, wherein the calibration data is pre-determined and maintained on the readable element prior to coupling of the consumable component to a user, and wherein the calibration data that is specific to the consumable component is accessible for controlling signals delivered to the pumping mechanism for delivery of fluid to the user after coupling of the consumable component to the user.

### Claim 2 (depends on 1)

The consumable component of claim 1, wherein the pumping mechanism is integrated into the housing.

### Claim 3 (depends on 1)

The consumable component of claim 1, wherein the pumping mechanism is incorporated with the housing.

### Claim 4 (depends on 1)

The consumable component of claim 1, further comprising a conduit for the fluid exiting the reservoir, wherein the pumping mechanism comprises rollers to compress portions of the conduit to dispense the fluid in response to rotation of a rotor coupled to the rollers.

### Claim 5 (depends on 4)

The consumable component of claim 4, further comprising a port or outlet to engage an infusion arrangement, wherein the conduit comprises tubing providing a path for fluid flow from the reservoir to the port or outlet.

### Claim 6 (depends on 5)

The consumable component of claim 5, wherein the calibration data accounts for variations in a dimension of the tubing.

### Claim 7 (depends on 5)

The consumable component of claim 5, wherein the calibration data accounts for variations associated with an interface between the rollers and the tubing.

### Claim 8 (depends on 5)

The consumable component of claim 5, wherein the calibration data characterizes the amount of the fluid delivered from the reservoir via the tubing per revolution of the rotor.

### Claim 9 (depends on 4)

The consumable component of claim 4, wherein the rotor comprises a central bore for insertion of a rotary shaft.

### Claim 10 (depends on 1)

The consumable component of claim 1, wherein the pumping mechanism comprises tubing providing a path for fluid flow from the reservoir.

### Claim 11 (depends on 10)

The consumable component of claim 10, wherein the tubing is housed within a cutout portion of the housing that corresponds to a rotor of an infusion device that extends into the cutout portion to engage the tubing.

### Claim 12 (depends on 11)

The consumable component of claim 11, wherein the calibration data characterizes the amount of the fluid delivered from the reservoir via the tubing per revolution of the rotor.

### Claim 13 (depends on 11)

The consumable component of claim 11, wherein the calibration data accounts for variations associated with an interface between rollers coupled to the rotor and the tubing.

### Claim 14 (depends on 10)

The consumable component of claim 10, wherein the calibration data accounts for variations in a dimension of the tubing.

### Claim 15

A system comprising:
a consumable comprising:
a housing including a reservoir contained within the housing and a tubing contained within the housing in fluid communication with the reservoir to dispense a fluid from the reservoir; and
a readable element associated with the housing, wherein the readable element maintains calibration data indicating an amount of the fluid that is delivered relative to actuation of a pumping mechanism, wherein the amount of the fluid that is delivered relative to the actuation of the pumping mechanism is based on manufacturing of the pumping mechanism, wherein the calibration data is specific only to the consumable component accounting for the amount of fluid that is delivered relative to the actuation of the pumping mechanism as manufactured, wherein the calibration data is pre-determined and maintained on the readable element prior to coupling of the consumable to a user, and wherein the calibration data that is specific to the consumable component is accessible for controlling signals delivered to the pumping mechanism for delivery of fluid to the user after coupling of the consumable component to the user; and
an infusion device configured to receive the housing and including an interface to obtain the calibration data from the readable element, wherein the infusion device is configured to determine the signals delivered to the pumping mechanism for the delivery of fluid to the user based on the calibration data, and deliver the determined signals to the pumping mechanism.

### Claim 16 (depends on 15)

The system of claim 15, wherein the pumping mechanism comprises:
a rotor contained within the housing of the consumable and configured to engage a rotary shaft of the infusion device; and
rollers coupled to the rotor to compress portions of the tubing to dispense the fluid in response to rotation of the rotor by the rotary shaft.

### Claim 17 (depends on 15)

The system of claim 15, wherein:
the tubing is housed within a cutout portion of the housing;
the pumping mechanism comprises:
a rotary shaft of the infusion device extending into the cutout portion;
a rotor coupled to the rotary shaft; and
rollers coupled to the rotor; and
the rollers are configured to compress portions of the tubing and dispense the fluid in response to rotation of the rotor by the rotary shaft.

### Claim 18 (depends on 15)

The system of claim 15, wherein the calibration data characterizes the amount of the fluid delivered from the reservoir via the tubing per revolution of the rotor.

### Claim 19

A method of manufacturing a consumable component comprising a port or outlet to engage an infusion arrangement and tubing providing a path for fluid flow from a reservoir to the port or outlet, the method comprising:
actuating, by a control module, a peristaltic pumping mechanism by a reference amount, wherein the peristaltic pumping mechanism comprises rollers coupled to a rotor to compress portions of the tubing and dispense a fluid in response to rotation of the rotor;
obtaining, by the control module from a sensing arrangement, a measured response to the reference amount;
determining, by the control module, calibration data associated with the consumable component based on the relationship between the measured response and the reference amount of actuation; and
writing, by the control module, the calibration data to a readable element associated with the consumable component.

### Claim 20 (depends on 19)

The method of claim 19, wherein determining the calibration data comprises determining an amount of the fluid delivered from the reservoir via the tubing per revolution of the rotor.