Procedure and device for flushing a catheter

• US 5,549,548 A
• Filed: 06/08/1994
• Issued: 08/27/1996
• Est. Priority Date: 06/22/1993
• Status: Expired due to Fees

• Current Assignee: Siemens Elema AB
• Original Assignee: Siemens Elema AB
• Inventors: Larsson, Rolf
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/255,992
• Time in Patent Office: 811 Days
• Field of Search: 604/35, 604/30, 604/34, 604/49, 604/52, 604/53, 604/54, 604/246-249, 604/264, 604/280
• US Class Current: 604/35
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175

Abstract

In a procedure for flushing a catheter, connected to an apparatus, implanted in a patient for infusing liquid medication, in particular insulin, through the catheter, the infusion channel in the catheter is isolated from the patient and connected in a circuit separated from the patient. Cleaning fluid is then flushed through the circuit. In a device for flushing a catheter according to this procedure, connected to an implanted apparatus for infusing fluid medication, in particular insulin, through the catheter, the catheter is at least of a double-lumen type. One channel is intended for the infusion of the medication through an outlet valve in the catheter, and a second valve is arranged in the tip of the catheter to interconnect the two channels. The second valve is openable, and the outlet valve is closable, either by pressure actuation or by an externally applied signal, so the catheter'"'"'s two channels are placed in fluid communication to form a circuit, isolated from the patient, for flushing the infusion channel.

Claims

1. A procedure for in vivo flushing of an infusion channel in a catheter connected to an implanted medication infusion apparatus, said infusion channel normally being in fluid communication with a patient in whom said catheter is implanted, said procedure comprising the steps of:

completely isolating said infusion channel in vivo from fluid communication from said patient in whom said catheter is implanted;

connecting said infusion channel, while isolated, to a fluid circuit separated from said patient; and

flushing said fluid circuit with cleaning fluid.

2. The procedure of claim 1 wherein said catheter comprises a double-lumen catheter having a first channel forming said infusion channel, and a second channel and having a distal end, and wherein the step of connecting said infusion channel to a fluid circuit is further defined by interconnecting said first and second channels at said distal end to form said fluid circuit.

3. The procedure of claim 2 wherein said catheter comprises a third, purging channel, and comprising the additional step, after flushing said fluid circuit with cleaning fluid, of filling said infusion channel with medication through said second channel and coupling said second channel to said third channel at said distal end of said catheter for draining medication in said second channel through said purging channel.

4. The procedure of claim 2 wherein said cleaning fluid is flushed in said fluid circuit in a flushing direction, and said procedure comprising the additional step, after flushing said fluid circuit with cleaning fluid, of sucking at least a portion of said cleaning fluid back into said second channel in a direction opposite to said flushing direction for reducing pressure in said second channel.

5. The procedure of claim 4 wherein said infusion channel has a pressure-actuated outlet valve for administering medication from said infusion channel to said patient, and wherein said infusion channel is connectable to a medication pump which operates by generating pressure with a pump stroke, said procedure comprising the additional step, after said pressure is reduced in said second channel, of introducing gas into said second channel at a pressure for causing said outlet valve in said infusion channel to close, and selecting said pressure of said gas in said second channel so that said outlet valve is opened by the pressure generated by a pump stroke of said medication pump.

6. In a catheter having an infusion channel connected to an implanted medication infusion apparatus for infusing liquid medication through said catheter in vivo to a patient, the improvement of a device for in vivo flushing said catheter comprising:

said catheter being at least a double-lumen catheter having a first channel forming said infusion channel, and a second channel and an outlet valve communicating said first channel with said patient;

a further valve disposed at a tip of said catheter openable for interconnecting said first and second channels; and

means for closing said outlet valve and opening said further valve for forming a fluid circuit separated from said patient, and means for introducing cleaning fluid into said fluid circuit for flushing said first channel of said catheter.

7. The improvement of claim 6, wherein said cleaning fluid generates a pressure in each of said first and second channels, wherein said outlet valve comprises a pressure-actuated valve which closes when a difference between the pressure in said first channel and the pressure in said second channel reaches a first threshold value and wherein said further valve comprises a pressure-relief valve which opens when said difference reaches a second threshold value which is higher than said first threshold value.

8. The improvement of claim 7 wherein said outlet valve and said pressure relief valve are contained in a common valve housing in an end area of said catheter, said outlet valve and said pressure relief valve being formed by a membrane disposed axially inside said valve housing, said membrane having an inner part for opening and closing an outlet from said first channel to the patient, and having an outer part for opening and closing a connection between said first and second channels.

9. The improvement of claim 8 wherein said outer part of said membrane is biased by a valve spring.

10. The improvement of claim 9 wherein said valve spring comprises a leaf spring.

11. The improvement of claim 7 wherein said outlet valve comprises a membrane valve, and wherein said catheter has first and second spaces on opposite sides of said membrane valve respectively communicating with said first and second channels.

12. A device as claimed in claim 8 wherein said membrane consists of an elastic material and wherein said membrane is mounted in said valve housing for tensioning said elastic material of said membrane.

13. The improvement of claim 6 wherein said outlet valve and said further valve each comprise a magnetically controlled valve.

14. The improvement of claim 13 wherein said outlet valve and said further valve are formed by at least one movable reed element consisting of magnetic material and operable by the application of an external magnetic field.

15. The improvement of claim 14 wherein said movable reed element comprises a reed element movable between a normal position, wherein it closes an orifice between said first and second channels, and an activated position, wherein it closes an outlet of said first channel to said patient and opens said orifice so that said first and second channels are interconnected to form said fluid circuit separated from the patient.

16. The improvement of claim 15 wherein said movable reed element has a free end, and further comprising a fixed reed element having a free end disposed overlapping said free end of said movable reed element and spaced therefrom when said movable reed element is in said normal position, said free ends of said movable and fixed reed elements each being magnetized with opposite polarity when said external magnetic field is applied, said movable reed element being attracted to said fixed reed element in said activated position.

17. The improvement of claim 15 wherein said movable reed element has a free end, and further comprising a fixed reed element having a free end disposed overlapping said free end of said movable reed element and spaced therefrom when said movable reed element is in said normal position, said free ends of said movable and fixed reed elements each being magnetized with the same polarity when said external magnetic field is applied, said movable reed element being repelled from said fixed reed element in said activated position.

18. The improvement of claim 15 wherein said orifice and said outlet are respectively disposed at opposite sides of said movable reed element, and wherein each opposite side of said reed element has a coating thereon for respectively sealing said orifice and said outlet in said normal and activated positions.

19. The improvement of claim 6 wherein said catheter contains a third, purging channel, and means for connecting said purging channel to said second channel at said end of said catheter as part of said fluid circuit.

20. The improvement of claim 6 wherein each of said outlet valve and said further valve has a valve seating surface, and wherein each of said valve seating surfaces are disposed in the same plane.

21. The improvement of claim 6 wherein said catheter comprises a multi-lumen catheter, and contains a plurality of further outlet valves identical to said outlet valve connected in series for infusing a plurality of different medications.

22. The improvement of claim 6 wherein said catheter comprises a multi-lumen catheter, and contains a plurality of further outlet valves identical to said outlet valve connected in parallel for infusing a plurality of different medications.