Electrical heartbeat access disconnection systems

• US 9,352,078 B2
• Filed: 11/24/2014
• Issued: 05/31/2016
• Est. Priority Date: 02/09/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Roger, Rodolfo, Childers, Robert, Kelly, Thomas D.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US14/551,965
• Publication Number:
  US 20150080782A1
• Time in Patent Office: 554 Days
• Field of Search: 604 401- 616
• US Class Current: 1/1
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• 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 2205/058 with ultrasound therapy
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation

Abstract

An access disconnection system includes a venous line, an arterial line, a first electrode coupled to (i) the arterial line, (ii) a patient, or (iii) a cardiac catheter assembly; and a second electrode coupled to (i) the venous line, or (ii) the cardiac catheter assembly. The access disconnection system further includes electronic circuitry communicating electrically with the first second electrode to sense an electrical heartbeat signal generated by the patient. The electronic circuitry is configured to send a disconnection output indicative of a change in the electrical signal sufficient to expect that an access disconnection of the venous line has occurred.

Claims

1. A blood treatment machine comprising:

an arterial line;

a venous line; and

an access disconnection system including

(i) a first electrode coupled to the arterial line or to a patient,

(ii) a second electrode coupled to the venous line, and

(iii) electronic circuitry communicating electrically with the first electrode and the second electrode to sense an electrical heartbeat signal generated by the patient, the electronic circuitry configured to send a disconnection output indicative of a change in the electrical heartbeat signal sufficient to expect that an access disconnection of the venous line has occurred.

2. The blood treatment machine of claim 1, which includes a blood pump and a venous line clamp, and wherein the disconnection output causes the blood treatment machine to perform at least one of:

(i) stop the blood pump;

(ii) activate the venous line clamp;

or (iii) alert the patient of the access disconnection.

3. The blood treatment machine of claim 1, wherein the first electrode and the second electrode are coupled to the arterial line and the venous line, respectively, via a direct contact, a capacitive coupling or an inductive coupling.

4. The blood treatment machine of claim 1, wherein the disconnection output is of at least one type selected from the group consisting of:

an electrical output, a radio frequency output, a continuous output, an intermittent output or output occurring upon the change.

5. The blood treatment machine of claim 1, wherein the access disconnection system is a redundant system that is combined with:

(i) an optical blood leak detector, (ii) a capacitive sensing pad detector, or (iii) an acoustic blood leak detector.

6. The blood treatment machine of claim 1, wherein the electronic circuitry is configured to send the disconnection output wirelessly to the blood treatment machine.

7. The blood treatment machine of claim 1, wherein the electronic circuitry is in wired communication with the blood treatment machine.

8. The blood treatment machine of claim 1, wherein the electronic circuitry is located remotely from a housing of the blood treatment machine.

9. The blood treatment machine of claim 1, wherein the electronic circuitry is configured to calculate at least one of (i) heart rate, (ii) respiration, (iii) stroke volume, (iv) cardiac output, or (v) central blood volume.

10. The blood treatment machine of claim 1, which generates an electrocardiogram from the electrical heartbeat signal and derives at least one of (i) an enlargement of the patient'"'"'s heart (ii) an insufficient blood flow to the patient, (iii) an injury to the patient'"'"'s heart, (iv) problems with the patient'"'"'s heart rhythm, (v) changes in electrical activities of the patient'"'"'s heart, or (vi) inflation of the sac surrounding the patient'"'"'s heart.

11. The blood treatment machine of claim 1, which includes a board located separately from a housing of the blood treatment machine, wherein at least one of (i) at least a portion of the arterial line is coupled to the board, (ii) at least a portion of the venous line is coupled to the board, or (iii) the electronic circuitry is coupled to the board.

12. A blood treatment machine comprising:

an arterial line;

a venous line; and

an access disconnection system including

(i) a cardiac catheter assembly structured for insertion into a patient'"'"'s (a) vein, (b) artery, (c) graft, or (d) heart, the cardiac catheter assembly including

an arterial access section coupled to the arterial line,

a venous access section coupled to the venous line,

a first electrode, and

a second electrode, and

(ii) electronic circuitry communicating electrically with the first electrode and the second electrode to sense an electrical heartbeat signal generated by the patient, the electronic circuitry configured to send a disconnection output indicative of a change in the electrical heartbeat signal sufficient to expect that an access disconnection of the venous line has occurred.

13. The blood treatment machine of claim 12, which includes a board located separately from a housing of the blood treatment machine, the electronic circuitry positioned on the board.

14. The blood treatment machine of claim 12, wherein the electronic circuitry includes digital signal processing and a wireless communications module, the wireless communications module configured to send the disconnection output wirelessly to the blood treatment machine.

15. The blood treatment machine of claim 12, wherein the electronic circuitry includes a power supply including at least one of a disposable battery or a rechargeable battery.

16. The blood treatment machine of claim 12, wherein the electronic circuitry is configured to send the disconnection output wirelessly to the blood treatment machine.

17. An access disconnection system comprising:

a venous line,

an arterial line,

a first electrode coupled to (i) the arterial line, (ii) a patient, or (iii) a cardiac catheter assembly;

a second electrode coupled to (i) the venous line, or (ii) the cardiac catheter assembly; and

electronic circuitry communicating electrically with the first electrode and the second electrode to sense an electrical heartbeat signal generated by the patient, the electronic circuitry configured to send a disconnection output indicative of a change in the electrical heartbeat signal sufficient to expect that an access disconnection of the venous line has occurred.

18. The access disconnection system of claim 17, wherein the electronic circuitry is configured to send the disconnection output wirelessly to a blood treatment machine.

19. The access disconnection system of claim 17, which includes a board, wherein at least one of (i) at least a portion of the arterial line is coupled to the board, (ii) at least a portion of the venous line is coupled to the board, and (iii) the electronic circuitry is coupled to the board.

20. The access disconnection system of claim 17, wherein the electronic circuitry includes digital signal processing and a wireless communications module, the wireless communications module configured to send the disconnection output to a blood treatment machine.