Access disconnection system and methods

• US 7,138,088 B2
• Filed: 04/10/2002
• Issued: 11/21/2006
• Est. Priority Date: 04/10/2002
• Status: Expired due to Term

• 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.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US10/121,006
• Publication Number:
  US 20030195454A1
• Time in Patent Office: 1,686 Days
• Field of Search: 210645-646, 210/739, 210/746, 210/195.2, 210/203, 210/600, 210/634, 210/321.71, 210/433.1, 210/321.6, 210/416.1, 210/500.21, 604/5.04, 604/6.08, 604 609- 611, 604/6.05, 604/6.06, 604/6.16, 604/43, 604 65- 67, 604/264, 438/611.8, 738/610.2, 738/610.8, 738/611.2, 422/44, 422/48
• US Class Current: 422/44
• 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 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• 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: G01N 27/07 Construction of measuring vessels; Electrodes therefor
• CPC Class Codes: G01N 27/10 Investigation or analysis specially adapted for controlling or monitoring operations or for signalling
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

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 medical device configured to detect an access disconnection during medical therapy comprising

a plurality of electrical contacts in fluid contact with a fluid and spaced apart from an access device insertable within a patient such that the electrical contacts define a conductor loop that detects a change in an electrical value responsive to access disconnection as the fluid flows between the patient and a fluid treatment system connected to the patient via the access device, wherein the conductor loop bypasses the fluid treatment system;

and

a controller configured to correct for a deviation from a baseline measurement of the electrical value detected within the conductor loop due to variations in the fluid during the medical therapy.

2. The medical device of claim 1 wherein the electrical contacts can be used to detect blood loss due to dislodgment of at least one of a catheter, a venous needle and an arterial needle each insertable within the patient during dialysis therapy.

3. The medical device of claim 1 wherein the electrical contacts can be used to detect fluid loss due to dislodgment of a single access device insertable within the patient during medication delivery.

4. The medical device of claim 1 wherein the fluid system can be adapted to administer medical therapy selected from the group consisting of medication delivery, drug delivery, blood delivery, intravenous infusion and dialysis therapy including hemodialysis, hemodiafiltration, hemofiltration and continuous renal replacement therapy.

5. The medical device of claim 1 wherein the plurality of electrical contacts includes a first electrode and a second electrode, the first electrode coupled to a first tube member and the second electrode coupled to a second tube member.

6. The medical device of claim 1 wherein the plurality of electrical contacts includes a first electrode coupled to a blood tubing set and a second electrode configured for attachment to the patient.

7. The medical device of claim 1 wherein the access device includes at least one of a venous needle and an arterial needle.

8. The medical device of claim 1 which includes a source that generates a constant current signal, the measured electrical value associated with the current signal.

9. The medical device of claim 8 which includes a third electrical contact positioned between first and second electrical contacts, the first contact positioned in a first access line, the second contact positioned in a second access line, the first, second and third contacts allowing the current signal to bypass one or more components coupled to the first or second access lines.

10. The medical device of claim 1 which includes an electrical contact coupling device configured to secure at least one of the electrical contacts to an access line in fluid communication with the access device.

11. The medical device of claim 1 which is configured to process a signal from one of the electrical contacts in response to an impedance change due to dislodgment of the access device during dialysis therapy such that blood loss from the dislodgment can be monitored and controlled.

12. The medical device of claim 1 wherein the electrical value is voltage, the measurement of which enables detection of an impedance change in response to dislodgment of the access device.

13. The medical device of claim 1 wherein the electrical value is impedance, and wherein the apparatus is capable of correcting for a change in baseline impedance due to variations in blood characteristics during dialysis therapy.

14. A method of controlling blood loss due to dislodgment of an access device inserted within a patient during medical therapy comprising the steps of:

connecting a patient to a blood treatment circuit;

creating a conductor loop within the blood circuit such that the conductor loop electrically bypasses the blood treatment circuit, the conductor loop having a pair of electrical contacts in fluid contact with blood as it flows through the blood circuit;

passing an at least substantially constant electrical signal through the blood treatment circuit via the electrical contacts thereby defining a signal loop along the blood treatment circuit allowing an electrical value to be measured;

detecting a disconnection between the patient and the blood treatment circuit in response to a change in the electrical value;

producing a signal based on the detectable change in the electrical value and correcting for a deviation from a baseline measurement of the electrical value detected within the conductor loop due to variations in the fluid during the medical therapy; and

processing the signal to minimize blood loss from the patient due to the disconnection.

15. The method of claim 14 wherein the signal is processed to activate an alarm which can trigger automatic termination of dialysis therapy.

16. The method of claim 14 wherein the signal is processed to shut-off a blood pump associated with a dialysis system.

17. The method of claim 14 wherein the signal is processed to activate a venous line clamp of a dialysis system.

18. The method of claim 14 wherein the electrical value is a voltage that can be measured to detect an impedance change in response to dislodgment.

19. The method of claim 18 further comprising correcting for changes in baseline impedance that can be used to detect the impedance change.

20. The method of claim 14 wherein the produced signal is based on a detectable change in impedance and which includes processing the produced signal to activate a venous line clamp such that blood loss due to dislodgment of the access device can be minimized.

21. The method of claim 20 which includes processing the signal to shut-off a blood pump during dialysis therapy.

22. The method of claim 20 which includes processing the signal to activate an alarm.

23. The method of claim 22 which includes at least one of:

(i) administering the medical therapy while the patient is sleeping such that the alarm wakes the patient; and

(ii) terminating the dialysis therapy in response to the alarm.

24. The method of claim 14 wherein the medical therapy is at least one of:

(i) selected from the group consisting of hemodialysis, hemodiafiltration, hemofiltration and continuous renal replacement therapy; and

(ii) performed in the patient'"'"'s home.