Access disconnection systems and methods

• US 7,022,098 B2
• Filed: 04/10/2002
• Issued: 04/04/2006
• Est. Priority Date: 04/10/2002
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare Corporation (Baxter International Inc.), Baxter International Inc.
• Inventors: Wariar, Ramesh, Han, James, Falkvall, Thore, Lamberson, George, Hartranft, Thomas P.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/120,703
• Publication Number:
  US 20030194894A1
• Time in Patent Office: 1,455 Days
• Field of Search: 604/5.01, 604/5.04, 604/6.01, 604/6.08, 604/6.09, 604/67, 604/65, 210/646, 210/103, 210/85, 210/87, 738/610.8
• US Class Current: 604/6.08
• 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 portion of a blood tubing set used during dialysis therapy through which the medical fluid can flow; and

a conductive element adapted to self-sealingly pierce the tube portion of the blood tubing set, the conductive element having 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 attached to a dialysis machine through which the blood tubing can be connected to the dialysis machine.

3. The device of claim 1 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.

4. 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 portion 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;

wherein the first and second members and the contact member are adapted to cooperate with a blood tubing set used during dialysis therapy.

5. The device of claim 4 wherein the device is attached to a dialysis machine through which the blood tubing set can be connected to the dialysis machine.

6. The device of claim 4 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.

7. 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 adapted to pierce the first and second blood lines to establish fluid connection with the blood allowing detection of dislodgment of the access device during medical therapy.

8. The blood tubing set of claim 7 wherein the first blood line comprises an arterial blood line and the second blood line comprises a venous blood line.

9. The blood tubing set of claim 7 wherein the access device is selected from the group consisting of a needle, a catheter, a venous needle and an arterial needle.

10. The blood tubing set of claim 7 wherein the electrical contact pair is connected to a controller allowing detection of dislodgment using a direct-contact measurement.

11. 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 adapted to connect 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 adapted to pierce first and second blood lines to establish fluid connection with the blood; and

an electrical contact coupling device attaching at least one of the electrical contacts to the first and second blood lines allowing detection of dislodgment of the access device during dialysis therapy.

12. The blood tubing set of claim 11 wherein the first blood line comprises a venous blood line and the second blood line comprises an arterial blood line.

13. The blood tubing set of claim 11 wherein the electrical contact coupling device is attached to a dialysis machine allowing the blood tubing set to be coupled to the dialysis machine.

14. The blood tubing set of claim 11 wherein the electrical contacts are adapted to be coupled to a controller allowing dislodgment detection using a direct-contact measurement.

15. 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 adapted to connect 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 adapted to pierce the first and second blood lines in fluid connection with the blood; and

an electrical contact coupling device attaching at least one of the electrical contacts to the first and second blood lines allowing detection of dislodgment of the access device during dialysis therapy, the electrical contact coupling device including;

a first member including an annular portion capable of accommodating a conductive member in fluid contact with the blood and a first stem portion connected to the annular portion wherein the first 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.