INFUSION DEVICE

• US 20180318497A1
• Filed: 07/12/2018
• Published: 11/08/2018
• Est. Priority Date: 01/12/2016
• Status: Active Grant

• Current Assignee: Infusion Innovations Pty Ltd.
• Original Assignee: Infusion Innovations Pty Ltd.
• Inventors: Sluggett, Andrew, Djurasevich, Danny, Crockett, Paul, Ash, Gabriel
• Granted Patent: US 11,040,136 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2005/1402 Priming
• 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 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/82 Internal energy supply devices
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8268 Fuel storage cells
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• 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: G05B 15/00 Systems controlled by a computer G05B13/00, G05B19/00 take precedence; automatic controllers with particular characteristics G05B11/00
• CPC Class Codes: G06F 12/14 Protection against unauthorised use of memory or access to memory
• CPC Class Codes: G06F 2212/1052 : Security improvement
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

Some embodiments are directed to portable devices for transferring fluids from an external source and controllably infusing the fluids into a patient, particularly portable infusion pump devices, and protective housings for such devices, which include a pump unit, a computer, a portable fuel source, and a seal for securing the contents substantially within the protective housings of the device. Some embodiments may be formed as a single infusion pump unit or may be formed when two infusion pump units are engaged. Some embodiments also relate to methods of use of portable devices and method for the manufacture of portable devices and protective housings for such devices.

Claims

1. A portable device for transferring fluids from an external source and controllably infusing the fluids into a patient comprising;

a protective housing formed from at least one wall, the wall defining one or more infusion line apertures formed therethrough,

a length of infusion tubing, for allowing the fluid to pass therethrough, further comprising,

at least two portions wherein the first portion comprises an infusion line in for transporting fluid from the external source, and

the second portion comprises an infusion line out for transporting fluid to the patient,

wherein the one or more apertures are configured to allow the infusion line in or the infusion line out to pass through the wall of the protective housing,

the wall defining an internal cavity, the internal cavity containing substantially therein,

a pump unit for controllably drawing fluid through the infusion line in or controllably expelling fluid through the infusion line out,

a computer in communication with the pump unit,

a portable fuel source, and

a computer programming interface located substantially within the protective housing or within the wall of the protective housing and adapted to receive a pre-set infusion program thereby rendered substantially non-tamperable or substantially non-editable by a user, and

a sealing means formed around the perimeter of the wall of the protective housing configured to secure the contents of the protective housing substantially within the internal cavity.

2. The portable device of claim 1, wherein the internal cavity further contains substantially therein, an occlusion sensor and a pump actuator.

3. The portable device of claim 1, wherein the computer programming interface comprises an interface at which the computer receives instruction from a user for modulating the activity of the actuator.

4. The portable device of claim 1, wherein the computer programming interface comprises a memory device reader.

5. The portable device of claim 1, wherein the computer programming interface is a removable memory device reader and the computer programming interface is a non-editable computer programming interface configured to receive a pre-programmed memory device.

6. The portable device of claim 1, wherein the computer programming interface is a wireless signal receiver and is a non-editable computer programming interface.

17. A method of manufacturing a portable device according to claim 1 comprising the steps of;

obtaining a portable device,

placing an infusion pump mechanism comprising,

a pump unit for controllably drawing fluid through the infusion line in or controllably expelling fluid through the infusion line out,

a computer in communication with the pump unit,

a portable fuel source, and

a computer programming interface

substantially within a cavity defined by a wall of the first protective housing piece,

placing a length of infusion tubing through one or more apertures in the first protective housing piece,

deploying the sealing means to engage the second protective housing piece with the first protective housing piece to secure the infusion pump mechanism substantially within the internal cavity of the infusion pump housing.

18. A method of controllably infusing fluids into a patient comprising the steps of;

obtaining a portable device according to claim 1,

obtaining the fluids contained within a vessel,

connecting a vascular access device to the patient,

connecting vascular access device fitting to a terminal end of an infusion line out,

connecting the infusion line in to the vessel,

connecting the infusion line out to the patient,

programming the computer programming interface,

priming the infusion line, and

activating the portable device.

7. A portable device for transferring fluids from an external source and controllably infusing the fluids into a patient comprising;

an infusion pump housing formed from at least one wall defining an internal cavity to substantially encase an infusion pump mechanism therein, the infusion pump housing further comprising;

a first protective housing piece formed from at least one wall and defining one or more infusion line apertures formed therethrough, the first protective housing piece configured to receive at least one length of infusion tubing through the one or more infusion line apertures,

a second protective housing piece formed from at least one wall, and a sealing means formed between the perimeter of the wall of the first protective housing piece and the perimeter of the wall of the second protective housing piece configured to secure the infusion pump mechanism substantially within the internal cavity,

wherein the wall of the infusion pump housing is adapted to receive a pre-set infusion program for programming the infusion pump mechanisms substantially encased therein, thereby rendering the infusion pump mechanism substantially non-tamperable or substantially non-editable by a user.

8. The portable device of claim 7, wherein the infusion pump mechanism comprises;

a pump unit for controllably drawing fluid through the infusion line in or controllably expelling fluid through the infusion line out,

a computer in communication with the pump unit,

a portable fuel source, and

a computer programming interface located substantially within the infusion pump housing or within the wall of the infusion pump housing and adapted to receive a pre-set infusion program thereby rendered substantially non-tamperable or substantially non-editable by a user.

9. The portable device of claim 7, wherein the device is a wearable device and wherein the protective housing pieces are formed from a substantially impervious, firm material capable of providing some shock absorption.

10. The portable device of claim 7, wherein the device comprises a switch underlying a protective housing piece configured to be engaged by the user through the infusion pump housing to stop or start the portable device.

11. The portable device of claim 10, wherein the device comprises only one switch.

12. The portable device of claim 7, wherein the computer programming interface is a memory device reader and the computer programming interface is a non-editable computer programming interface configured to receive a pre-programmed memory device.

13. The portable device of claim 12, wherein the infusion pump housing wall is configured to receive a memory device therethrough.

14. The portable device of claim 8, wherein the infusion pump mechanism further comprises an occlusion sensor and a pump actuator, and the computer programming interface comprises an interface at which the computer receives instruction from a user for modulating the activity of the actuator.

15. The portable device of claim 14, wherein the computer programming interface is a memory device reader, the computer programming interface is a non-editable computer programming interface configured to receive a pre-programmed memory device, and the infusion pump housing wall is configured to receive a memory device therethrough.

16. A method of manufacturing a portable device according to claim 8 comprising the steps of;

obtaining a portable device,

placing an infusion pump mechanism comprising,

a pump unit for controllably drawing fluid through the infusion line in or controllably expelling fluid through the infusion line out,

a computer in communication with the pump unit,

a portable fuel source, and

a computer programming interface

substantially within a cavity defined by a wall of the first protective housing piece,

deploying the sealing means to engage the second protective housing piece with the first protective housing piece to secure the infusion pump mechanism substantially within the internal cavity of the infusion pump housing.