MODULAR INFUSION SET WITH AN INTEGRATED ELECTRICALLY POWERED FUNCTIONAL COMPONENT

• US 20120029333A1
• Filed: 01/27/2011
• Published: 02/02/2012
• Est. Priority Date: 01/28/2010
• Status: Abandoned Application

• Current Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Dogwiler, Joerg, Geipel, Andreas, Teutsch, David, Huwiler, Christoph
• Application Number:
  US13/015,063
• Publication Number:
  US 20120029333A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2039/1022 additionally providing electrical connection
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• 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 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281

Abstract

An infusion set for administering a medicament delivered by an infusion pump which can be carried separately from the infusion set as well as an infusion system including the infusion set are disclosed. The infusion set can comprise a disposable part, a reusable part, and an electrically powered functional component. The disposable part can comprise a single lumen infusion cannula that projects from the underside and is the only skin piercing or penetrating element of the infusion set. The reusable part when in the interconnected state is fluidically isolated from the disposable part. The disposable part can comprise a feeding line which fluidically connects an upstream end of the first connector with a downstream end of a cannula to feed and deliver the medicament via the disposable part and bypass the reusable part.

Claims

1. An infusion set for administering a medicament delivered by an infusion pump which can be carried separately from the infusion set, the infusion set comprising:

a disposable part;

a reusable part; and

an electrically powered functional component,

wherein the disposable part comprises;

an adhesive underside for attachment at an infusion site on a person'"'"'s skin,

a single lumen infusion cannula which projects from the underside and is the only skin piercing or penetrating element of the infusion set,

a first connector which fluidically connects the cannula to the infusion pump, and

a second connector, and

wherein the reusable part comprises;

an energy source which electrically powers the functional component, and

a third connector mated with the second connector of the disposable part to interconnect the disposable part and the reusable part,

wherein the reusable part is in the interconnected state fluidically isolated from the disposable part, and

wherein the disposable part comprises a feeding line fluidically connecting an upstream end of the first connector with a downstream end of the cannula to feed and deliver the medicament via the disposable part and bypass the reusable part.

2. The infusion set of claim 1, wherein the functional component is at least one of a stimulator for heating or mechanically stimulating the tissue at the infusion site and a delivery supervisory installation for supervising the delivery of the medicament by sensing a variable which is characteristic for the medicament flow downstream of or at the first connector.

3. The infusion set of claim 2, wherein the stimulator forms part of the underside of the disposable part at least partially surrounding the cannula.

4. The infusion set of claim 2, wherein the delivery supervisory installation comprises a contact sensor element or unit disposed at the disposable part and a non-contact sensor disposed at the reusable part.

5. The infusion set of claim 4, wherein the contact sensor element or unit is in contact with the feeding line for the medicament or directly with the medicament, the feeding line fluidically connecting an upstream end of the first connector with a downstream end of the cannula, and the contact sensor element or unit and further comprises a deformation structure which deforms in dependence of a fluid pressure within the feeding line.

6. The infusion set of claim 4, wherein the non-contact sensor provides for contactless supervision of medicament flow through the feeding line of the infusion set, the feeding line fluidically connecting an upstream end of the first connector with a downstream end of the cannula.

7. The infusion set of claim 4, wherein the non-contact sensor is arranged for sensing the contact sensor element or unit optically.

8. The infusion set according to claim 1, wherein the reusable part further comprises a manipulator to provide manual manipulation of the stimulator.

9. The infusion set according to claim 2, wherein the functional component further comprises:

a lifetimer, disposed at the reusable part, which alerts the person at expiration of a predetermined time of use of the disposable part; and

an alarm means, disposed at the reusable part, which releases an acoustic or vibratory signal.

10. The infusion set according to claim 9, wherein the functional component is at least the stimulator and further comprises:

a motion sensor, disposed at the reusable part, which senses motional activity of a person;

a perspiration sensor in contact with the underside of the disposable part which senses perspiration at the surface of the skin;

a temperature sensor, disposed at the underside of the disposable part, which senses ambient or skin temperature and supervises the stimulator; and

a skin contact sensor which senses whether the infusion set is in contact with the skin.

11. The infusion set according to claim 1, wherein the reusable part further comprises a transceiver electrically powered by an energy source to transmit signals to or receive signals from the infusion pump via a wireless communication for infusion-set-internal signal communication.

12. The infusion set of claim 1, wherein the reusable part comprises a signal processing or control unit for controlling the functional component or processing signals received from the functional component, and the energy source electrically powers the signal processing or control unit.

13. The infusion set of claim 1, wherein the infusion set is electrically or optically coupable or coupled with the infusion pump for signal or data transmission via a fluidic tubing;

and the infusion set comprises flexible tubing for connecting the infusion set fluidically and releasably with the infusion pump.

14. The infusion set of claim 1, wherein the reusable part is interconnected mechanically with the disposable part.

15. The infusion set of claim 1, wherein the reusable part is interconnected with the disposable part and only mechanically and electrically, only mechanically and optically, or only mechanically, electrically and optically.

16. The infusion set according to claim 1, wherein the disposable part further comprises base members which forms the underside and an upper side opposite to the underside of the disposable part, wherein the first connector protrudes from an upright structure which protrudes from the upper side and extends at least parallel to the upper side, and the reusable part is attached to the upper side of the disposable part.

17. An infusion system, comprising:

an infusion set according to claim 1;

an infusion pump with a medicament reservoir, feeding means for feeding medicament from the reservoir, and an energy source for powering the feeding means; and

flexible tubing connecting the infusion pump with the infusion set to administer the medicament from the reservoir via the cannula of the infusion set, the tubing being directly connected releasably or unreleasably with the disposable part.

18. The infusion system according to claim 17 further comprising a monitoring system which includes a sensor which senses a therapy relevant health parameter of the person, the sensor being separate from the infusion set.

19. The infusion system according to claim 18 wherein the sensor is a glucose sensor.

20. The infusion system according to claim 18 wherein the sensor senses the therapy relevant health parameter of the person in vivo.