Infusion pump system and method

• US 9,427,523 B2
• Filed: 12/10/2012
• Issued: 08/30/2016
• Est. Priority Date: 12/10/2012
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Qi, Wenkang, Thrower, David, Brewer, Tracy
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US13/709,296
• Publication Number:
  US 20140163462A1
• Time in Patent Office: 1,359 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 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/31518 designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

Some embodiments of an infusion pump system may be configured to detect when at least one component of the pump system is exposed to an impact above a threshold level. In particular embodiments, the infusion pump system can be equipped with a drive system detection system configured to detect when one or more components of the drive system are damaged or inoperable.

Claims

1. A portable infusion pump system, comprising:

a pump device including a pump housing that defines a space to receive a medicine, a drive system positioned in the pump housing to dispense the medicine from the pump device when the medicine is received in the space of the pump housing, wherein the pump housing houses at least one electrically conductive element of a drive system detector that is mounted to a component of the drive system;

a controller device removably attachable to the pump housing so as to electrically connect with the pump device, wherein the controller device houses control circuitry configured to communicate with the drive system positioned in the pump housing to control dispensation of the medicine from the pump device,

wherein the control circuitry of the controller device is configured to disable the drive system in response to the drive system detector indicating damage to one or more components of the drive system,

wherein the electrically conductive element of the drive system detector is mounted to a piston rod of the drive system and is in electrical communication with the control circuitry that includes computer-readable instructions stored on a computer-readable medium housed in the controller device that, when executed by a processor of the control circuitry, measures an electrical characteristic of the electrically conductive element mounted to the piston rod, and wherein the drive system detector shifts indicates damage to one or more components of the drive system when the electrical characteristic is substantially greater than zero.

2. The portable infusion pump system of claim 1, wherein at least the electrically conductive element of the drive system detector is housed in the pump housing and at least a software component of the drive system detector is stored in a memory device housed in the controller device.

3. The portable infusion pump system of claim 1, wherein at least the electrically conductive element of the drive system detector is in electrical communication with the control circuitry housed in the controller device so that the control circuitry initiates an alarm when the drive system detector indicates damage to one or more components of the drive system.

4. The portable infusion pump system of claim 1, wherein, in response to the drive system detector indicating damage to one or more components of the drive system, the control circuitry is configured to disable the drive system, activate an audible alarm, and display one or more messages on a user interface display located on the controller device.

5. The portable infusion pump system of claim 1, wherein the electrically conductive element mounted to the piston rod includes at least one of (i) an electrically conductive strip applied to the surface of the piston rod, (ii) an electrically conductive wire attached to the surface of the piston rod, and (iii) an electrically conductive wire embedded into the piston rod.

6. The portable infusion pump system of claim 1, wherein the electrically conductive element comprises a conductive paint strip applied to a surface of a piston rod of the drive system and arranged in two substantially parallel lines that connect at a loop back proximate to a leading end of the piston rod to form a continuous U-shaped electrical path.

7. The portable infusion pump system of claim 1, wherein the electrically conductive element comprises a conductive wire attached to a surface of a piston rod of the drive system, wherein first and second portions of the conductive wire are substantially parallel with respective to each other and join together an electrically conductive loopback path proximate to a leading end of the piston rod to form a continuous U-shaped electrical path.

8. The portable infusion pump system of claim 1, wherein the electrically conductive element comprises a conductive wire embedded into a piston rod of the drive system, wherein first and second portions of the conductive wires are substantially parallel with respect to each other and join together at an electrically conductive loopback path proximate to a leading end of the piston rod form a continuous U-shaped electrical path.

9. The portable infusion pump system of claim 1, wherein the pump device is a one-time-use device equipped with one or more structures configured to prevent reuse of the pump device, wherein the pump housing includes an interior wall that defines a space to slidably receives an outer wall of a pre-filled medicine cartridge insertable through an opening defined by the pump housing, wherein the pump device further comprises a cap device that directly engages with the pump housing to enclose the pre-filled medicine cartridge in the pump housing when the pre-filled medicine cartridge is received in the space of the pump housing, and wherein the controller device is a reusable controller device including:

a controller housing that is removably attachable to the pump housing in a fixed relationship;

one or more electrical contacts disposed on the controller housing, the electrical contacts of the controller device being engageable with corresponding electrical contacts of the pump device when removably attached.

10. The portable infusion pump system of claim 1, wherein the pump device is a one-time-use device equipped with one or more structures configured to prevent reuse of the pump device.

11. A portable infusion pump system, comprising:

a pump device including a pump housing that defines a space to receive a medicine, a drive system positioned in the pump housing to dispense the medicine from the pump device when the medicine is received in the space of the pump housing, wherein the pump housing houses at least one electrically conductive element of a drive system detector that is mounted to a component of the drive system;

a controller device removably attachable to the pump housing so as to electrically connect with the pump device, wherein the controller device houses control circuitry configured to communicate with the drive system positioned in the pump housing to control dispensation of the medicine from the pump device,

wherein the control circuitry of the controller device is configured to disable the pump drive system in response to the drive system detector indicating damage to one or more components of the drive system, and further wherein the controller device is configured to monitor when the drive system has sustained an impact and is configured to initiate one or more user safety countermeasures upon detection that the drive system has sustained the impact.

12. The portable infusion pump system of claim 11, wherein the controller device includes at least computer-readable instructions stored on a computer-readable medium housed in the controller device that, when executed by a processor of the control circuitry, measures an electrical characteristic of the electrically conductive element mounted to the piston rod.

13. The portable infusion pump system of claim 12, wherein the drive system detector indicates damage to one or more components of the drive system when the electrical characteristic is substantially greater than zero.

14. The portable infusion pump system of claim 12, wherein the controller device initiates the one or more of the user safety countermeasures, the control circuitry is configured to disable the drive system, activate an audible alarm, and display of one or more messages on a user interface display located on the controller device.

15. The portable infusion pump system of claim 12, wherein the electrically conductive element mounted to the piston rod includes at least one of (i) an electrically conductive strip applied to the surface of the piston rod, (ii) an electrically conductive wire attached to the surface of the piston rod, and (iii) an electrically conductive wire embedded into the piston rod.

16. The portable infusion pump system of claim 12, wherein the electrically conductive element comprises a conductive paint strip applied to a surface of a piston rod of the drive system and arranged in two substantially parallel lines that connect at a loop back proximate to a leading end of the piston rod to form a continuous U-shaped electrical path.

17. A portable infusion pump system, comprising:

a space to receive a medicine;

a drive system to dispense the medicine when the medicine is received in the space;

at least one electrically conductive element of a drive system detector that is mounted to a component of the drive system; and

control circuitry configured to communicate with the drive system to control dispensation of the medicine;

wherein the control circuitry is configured to disable the drive system in response to the drive system detector indicating damage to one or more components of the drive system;

wherein the electrically conductive element of the drive system detector is mounted to a piston rod of the drive system and is in electrical communication with the control circuitry that includes computer-readable instructions stored on a computer-readable medium that, when executed by a processor of the control circuitry, measures an electrical characteristic of the electrically conductive element mounted to the piston rod, and wherein the drive system detector indicates damage to one or more components of the drive system when the electrical characteristic is substantially greater than zero.

18. The portable infusion pump system of claim 17, wherein the electrically conductive element mounted to the piston rod includes at least one of (i) an electrically conductive strip applied to the surface of the piston rod, (ii) an electrically conductive wire attached to the surface of the piston rod, and (iii) an electrically conductive wire embedded into the piston rod.

19. The portable infusion pump system of claim 17, wherein the drive system is equipped with one or more structures configured to prevent reuse of the pump device.

20. The portable infusion pump system of claim 17, wherein, in response to the drive system detector indicating damage to one or more components the drive system, the control circuitry is configured to disable the drive system, activate an audible alarm, and display of one or more messages on a user interface display.