Infusion pump system and method

• US 9,446,187 B2
• Filed: 06/03/2013
• Issued: 09/20/2016
• Est. Priority Date: 06/03/2013
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc. (Abbott Laboratories)
• Inventors: Brewer, Tracy, Qi, Wenkang, Crommenacker, Hans
• Primary Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US13/908,513
• Publication Number:
  US 20140358111A1
• Time in Patent Office: 1,205 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2205/02 characterised by a particular materials
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/44 making noise when used incorrectly
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

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 a moisture level above a threshold level. In particular embodiments, the infusion pump system can be equipped with a moisture level detection system that can sense when a moisture level above the threshold level has occurred to the pump device, which thereby enables the infusion pump system to initiate one or more patient safety countermeasures.

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 through an opening in the pump housing when the medicine is received in the space of the pump housing, the pump housing having one or more predefined liquid weep holes having a predefined size for passage of liquid into the pump housing through an outer wall of the pump housing, and a moisture detector positioned in the pump housing a predetermined distance from said one or more predefined liquid weep holes in the pump housing and in fluid communication with the one or more predefined liquid weep holes, wherein the moisture detector provides an indication of a moisture level in the pump housing; and

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.

2. The portable infusion pump system of claim 1, wherein the indication of the moisture level provided by the moisture detector indicates that the moisture level in the pump housing is greater than or equal to a predetermined threshold level of moisture.

3. The portable infusion pump system of claim 2, wherein when the moisture detector positioned in the pump housing is in electrical communication with the control circuitry positioned in the controller device, the control circuitry is configured to initiate an alarm in response to the indication that the moisture level in the pump housing is greater than or equal to the predetermined threshold level of moisture.

4. The portable infusion pump system of claim 3, wherein, in response to the indication that the moisture level in the pump housing is greater than or equal to the predetermined threshold level of moisture, 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.

5. The portable infusion pump system of claim 1, wherein the indication of the moisture level is communicated by one or more electrical signals provided from the moisture detector to the control circuitry.

6. The portable infusion pump system of claim 1, wherein the moisture detector comprises an absorbent element that can absorb moisture in the pump housing.

7. The portable infusion pump system of claim 6, wherein the indication of the moisture level in the pump housing is based on a change in an electrical resistance of the absorbent element.

8. 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.

9. A medical infusion pump system, comprising:

a portable housing defining a space to receive a medicine, the portable housing having one or more predefined liquid weep holes having a predefined size for passage of liquid into the pump housing through an outer wall of the portable housing;

a pump drive system to dispense medicine from the portable housing through an opening in the pump housing when the medicine is received in the space;

control circuitry that electrically communicates with the pump drive system to control dispensation of the medicine from the portable housing when the medicine is received in the space; and

a moisture detector positioned in the portable housing a predetermined distance from said one or more predefined liquid weep holes in the portable housing in fluid communication with the one or more predefined liquid weep holes and in electrical communication with the control circuitry, wherein the moisture detector provides an indication of a moisture level in the portable housing.

10. The medical infusion pump system of claim 9, wherein the indication of the moisture level provided by the moisture detector indicates that the moisture level in the portable housing is greater than or equal to a predetermined threshold level of moisture.

11. The medical infusion pump system of claim 10, wherein the control circuitry is configured to initiate an alarm in response to the indication that the moisture level in the portable housing is greater than or equal to the predetermined threshold level of moisture.

12. The portable infusion pump system of claim 11, wherein, in response to the indication that the moisture level in the portable housing is greater than or equal to the predetermined threshold level of moisture, 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 portable housing.

13. The portable infusion pump system of claim 9, wherein the indication is one or more electrical signals provided from the moisture detector to the control circuitry.

14. The portable infusion pump system of claim 9, wherein the moisture detector comprises an absorbent element that can absorb moisture in the portable housing.

15. The portable infusion pump system of claim 14, wherein the indication of the moisture level in the portable housing is based on a change in electrical resistance of the absorbent element.

16. The medical infusion pump system of claim 9, wherein the control circuitry is housed in a controller housing that is removably attachable to the portable housing.

17. A method of controlling a portable infusion pump system, comprising:

sensing that a moisture detector in a portable infusion pump system positioned a predetermined distance from one or more predefined liquid weep holes in a having a predefined size for passage of liquid through an outer wall of a housing of the portable infusion pump system into the pump housing indicates a moisture level greater than or equal to a predetermined threshold level, the moisture detector in fluid communication with the one or more predefined liquid weep holes; and

in response to the sensing that the moisture detector indicates said moisture level, disabling a pump drive system housed in the portable infusion pump system to dispense a medicine from the portable infusion pump system through an opening in the pump housing.

18. The method of claim 17, further comprising in response to the sensing that the moisture detector indicates said moisture level, emitting an audible alarm.

19. The method of claim 18, further comprising in response to the sensing that the moisture detector indicates said moisture level, displaying one or more alert messages on a user interface display of the portable infusion pump system.

20. A method of controlling a portable infusion pump system, comprising:

sensing that a moisture detector in a portable infusion pump system positioned a predetermined distance from one or more predefined liquid weep holes having a predefined size for passage of liquid through an outer wall of a housing of the portable infusion pump system into the pump housing indicates a moisture level greater than or equal to a predetermined threshold level, the moisture detector in fluid communication with the one or more predefined liquid weep holes;

in response to the sensing that the moisture detector indicates said moisture level, disabling a pump drive system housed in the portable infusion pump system to dispense a medicine from the portable infusion pump system through an opening in the pump housing; and

in response to the sensing that the moisture detector indicates said moisture level, activating a light source of the portable infusion pump system that is different from the user interface display.