Infusion pump system and method

• US 9,457,141 B2
• Filed: 06/03/2013
• Issued: 10/04/2016
• Est. Priority Date: 06/03/2013
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: VandenCrommenacker, Johannes T., Smith, Ian F., Qi, Wenkang, Parmar, Ashok A., Brewer, Tracy
• Primary Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US13/908,616
• Publication Number:
  US 20140358112A1
• Time in Patent Office: 1,219 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 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/27 preventing use
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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 provide a desired level of resistance to liquid ingress to the pump casing while contemporaneously providing air transmissibility for equalization of air pressure differentials between the interior and exterior of the pump casing. Further, some embodiments can detect when moisture inside a casing of the infusion pump system is greater than or equal to a threshold level and can 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 when the medicine is received in the space of the pump housing, and a structure positioned in the pump housing that defines an open airflow passageway so dimensioned to inhibit ingress of liquid to an interior of the pump housing and provide air pressure equilibrium between an exterior of the pump housing and the interior of 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;

wherein the structure positioned in the pump housing that defines the open airflow passageway comprises an ingress tube having a longitudinal length that is greater than a lateral width of the ingress tube, the open airflow passageway of the ingress tube being exposed to both an exterior of the pump housing and an interior of the pump housing.

2. The portable infusion pump system of claim 1, wherein the ingress tube includes a restriction region having a reduced width that is less than a corresponding width of the passageway at another region of the ingress tube.

3. The portable infusion pump system of claim 2, wherein the reduced width of the restriction region is about 10 to about 40 microns.

4. The portable infusion pump system of claim 1, wherein the open airflow passageway of the structure is so dimensioned to resist water ingress into the pump housing when the pump device is submerged in water at a depth of 1 meter for the period of time of about 1 minute or greater.

5. The portable infusion pump system of claim 1, wherein the pump device further comprises a moisture detector positioned in the pump housing, wherein the moisture detector provides an indication that the moisture level in the pump housing is greater than or equal to a predetermined threshold level of moisture.

6. The portable infusion pump system of claim 5, wherein the structure that defines the open airflow passageway is positioned adjacent to an absorbent element of the moisture detector.

7. The portable infusion pump system of claim 5, 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.

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;

a pump drive system to dispense medicine from the portable 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 liquid ingress resistance structure positioned in the portable housing and exposed to both an exterior of the portable housing and an interior of the portable housing, the liquid ingress resistance structure defining a predefined airflow passageway that provides air pressure equilibrium between the exterior of the portable housing and the interior of the portable housing and that inhibits ingress of water to the interior of the portable housing when the portable housing is submerged in water for a period of time;

wherein the liquid ingress structure positioned in the portable housing that defines the predefined airflow passageway comprises an ingress tube having a longitudinal length that is greater than a lateral width of the ingress tube, the predefined airflow passageway of the ingress tube being exposed to both an exterior of the portable housing and an interior of the portable housing.

10. The medical infusion pump system of claim 9, wherein the ingress tube includes a restriction region having a reduced width that is less than a corresponding width of the passageway at another region of the tube.

11. The medical infusion pump system of claim 10, wherein the reduced width of the restriction region is about 10 to about 40 microns.

12. The medical infusion pump system of claim 9, wherein the predefined airflow passageway of the liquid ingress resistance structure is so dimensioned to resist water ingress into the portable housing when the pump system is submerged in water at a depth of about 1 meter for the period of time of about 1 minute or greater.

13. The medical infusion pump system of claim 9, wherein the pump system further comprises a moisture detector positioned in the portable housing, wherein the moisture detector provides an indication that the moisture level in the portable housing is greater than or equal to a predetermined threshold level of moisture.

14. The medical infusion pump system of claim 13, wherein the liquid ingress resistance structure that defines the predefined airflow passageway is positioned adjacent to an absorbent element of the moisture detector.

15. The medical infusion pump system of claim 13, wherein when the moisture detector positioned in the portable housing is in electrical communication with the control circuitry, 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.

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 operating a portable infusion pump system, comprising:

dispensing a medicine from a reservoir positioned in a pump housing of a portable infusion pump system; and

providing air pressure equilibrium between an exterior of a pump housing of a portable infusion pump system and an interior of the pump housing of the portable infusion pump system via an airflow passageway defined by a structure positioned in the pump housing and exposed to both the exterior of the pump housing and the interior of the pump housing, wherein the airflow passageway of the structure positioned in the pump housing is configured to inhibit ingress of water to the interior of the pump housing when the pump housing is submerged in water for a period of time;

wherein the airflow passageway is defined by an ingress tube having a longitudinal length that is greater than a lateral width of the ingress tube, and wherein the ingress tube includes a restriction region having a reduced width that is less than a corresponding width of the airflow passageway at another region of the ingress tube.

18. The method of claim 17, further comprising:

inhibiting ingress of water from the exterior of the pump housing to the interior of the pump housing when the pump housing is submerged in water for the period of time;

after said period of time, sensing that a moisture detector positioned in a portable infusion pump system indicates a moisture level greater than or equal to a predetermined threshold level; 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 and emitting an audible alarm.