Access disconnection systems and methods

• US 20030194894A1
• Filed: 04/10/2002
• Published: 10/16/2003
• Est. Priority Date: 04/10/2002
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Wariar, Ramesh, Han, James, Falkvall, Thore, Lamberson, George, Hartranft, Thomas P.
• Granted Patent: US 7,022,098 B2
• Time in Patent Office: Days
• US Class Current: 439/191
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

Apparatuses, devices, systems and methods for detecting access disconnection are provided. The present invention includes electrical contacts in fluid and electrical communication with a fluid passing between a patient and a medical system during therapy. In this regard, the present invention can use a direct-contact measurement to detect access disconnection, such as dislodgment of an access device from the patient through which fluid can flow during therapy including, for example, medication delivery, dialysis therapy and the like.

Claims

1. A device for providing electrical contact with a medical fluid, the device comprising:

a tube through which the medical fluid can flow; and

a conductive element connected to the tube that has a first portion exposed to the medical fluid and a second portion external to the tube.

2. The device of claim 1 wherein the device is coupled to a blood tubing set used during dialysis therapy.

3. The device of claim 2 wherein the device is attached to a dialysis machine through which the blood tubing can be connected to the dialysis machine.

4. The device of claim 2 wherein the conductive element can be used to detect a disconnection between a patient and the blood tubing set in response to a measurable change in an electrical value associated with an electrical signal passing through the medical fluid.

5. The device of claim 1 wherein the first portion comprises a cylindrically-shaped conductive member.

6. The device of claim 5 wherein the second portion includes a housing with an annular portion through which the cylindrically-shaped conductive member can be secured to the tube.

7. The device of claim 5 wherein the cylindrically-shaped conductive member is composed of stainless steel.

8. The device of claim 1 wherein the second portion includes a clamp mechanism which can be secured to an outer surface of the tube in a closed position.

9. The device of claim 8 wherein the first portion includes a conductive member attached to the clamp mechanism and adapted to pierce the tube allowing fluid contact between the conductive member and the medical fluid in the closed position.

27. The blood tubing set of claim 23 wherein the electrical contact coupling device comprises a device as claimed in claim 1.

36. The dialysis system of claim 29 wherein the electrical contact coupling device comprises a device as claimed in claim 1.

10. A device for providing electrical contact with a medical fluid in a fluid conduit, the device comprising:

a first member including an annular portion capable of accommodating a conductive member in fluid contact with the medical fluid and a first stem portion connected to the annular member wherein the stem portion has an opening extending therethrough to the annular portion;

a second member including a base portion with a groove region and a second stem portion with an opening extending therethrough to the groove region allowing the first member to be inserted and secured to the second member; and

a contact member adapted to fit the first and second stem portions allowing the contact member to abut against at least a portion of the conductive member allowing an electrical connection to be made between the conductive member and the contact member.

11. The device of claim 10 wherein the first member and the second member are attached in frictional engagement.

12. The device of claim 10 wherein the first member and the second member are attached in threaded engagement.

13. The device of claim 10 further comprising a spring mechanism allowing the contact member to abut against the electrical contact.

14. The device of claim 10 wherein the device is coupled to a blood tubing set used during dialysis therapy.

15. The device of claim 14 wherein the device is attached to a dialysis machine through which the blood tubing set can be connected to the dialysis machine.

16. The device of claim 14 wherein the conductive member can be used to detect a disconnection between a patient and the blood tubing set in response to a measurable change in an electrical value associated with an electrical signal passing through the medical fluid.

17. The device of claim 10 wherein the conductive member is composed of a stainless steel material defining a cylindrical body through which fluid can flow.

18. The device of claim 10 further comprising a retainer member adapted to secure the contact member within the second stem portion of the device.

28. The blood tubing set of claim 23 wherein the electrical contact coupling device comprises a device as claimed in claim 10.

37. The dialysis system of claim 29 wherein the electrical contact coupling device comprises a device as claimed in claim 10.

19. A blood tubing set used during medical therapy to connect a patient to a medical system, the blood tubing set comprising:

a first blood line and a second blood line connecting the patient to the medical system via an access device inserted within the patient allowing blood to flow between the patient and the medical system with an electrical signal passing therein; and

a pair of electrical contacts attached to the blood tubing set in fluid connection with the blood allowing detection of dislodgment of the access device during medical therapy.

20. The blood tubing set of claim 19 wherein the first blood line comprises an arterial blood line and the second blood line comprises a venous blood line.

21. The blood tubing set of claim 19 wherein the access device is selected from the group consisting of a needle, a catheter, a venous needle and an arterial needle.

22. The blood tubing set of claim 19 wherein the electrical contact pair is connected to a controller allowing detection of dislodgment using a direct-contact measurement.

23. A blood tubing set used during dialysis therapy to connect a patient to a dialysis system, the blood tubing set comprising:

a first blood line and a second blood line connecting the patient to the dialysis system via an access device inserted within the patient allowing blood to flow between the patient and the dialysis system with an electrical signal passing therein;

a pair of electrical contacts attached to the blood tubing set in fluid connection with the blood; and

an electrical contact coupling device attaching at least one of the electrical contacts to the blood tubing set allowing detection of dislodgment of the access device during dialysis therapy.

24. The blood tubing set of claim 23 wherein the first blood line comprises a venous blood line and the second blood line comprises an arterial blood line.

25. The blood tubing set of claim 23 wherein the electrical contact coupling device is attached to a dialysis machine allowing the blood tubing set to be coupled to the dialysis machine.

26. The blood tubing set of claim 23 wherein the electrical contacts are coupled to a controller allowing dislodgment detection using a direct-contact measurement.

29. A dialysis system comprising:

a dialysis machine including a chassis having one or more connectors for connecting a patient to the dialysis machine;

a blood tubing set including a first blood line and a second blood line coupled to the patient and the dialysis machine thereby defining a blood circuit along which blood can flow between the patient and the dialysis machine having an electrical signal passing therein; and

at least one electrical contact coupling device attaching an electrical contact to the blood circuit in fluid contact with blood allowing detection of access disconnection.

30. The dialysis system of claim 29 wherein the electrical contact coupling device is attached to the dialysis machine.

31. The dialysis system of claim 29 wherein a pair of electrical contact coupling devices each attach a respective electrical contact to the blood circuit.

32. The dialysis system of claim 31 wherein the pair of electrical contacts are attached to a controller allowing detection of access disconnection using a direct-contact measurement.

33. A dialysis system of claim 32 wherein the controller can process a signal derived from the direct-contact measurement allowing blood loss due to access disconnection to be minimized.

34. The dialysis system of claim 33 wherein the signal can be processed allowing a blood pump of the dialysis machine to be shut off.

35. The dialysis system of claim 33 wherein the signal can be processed allowing automatic termination of dialysis therapy.