Blood treatment and electrical blood leak detection device therefore

• US 9,950,105 B2
• Filed: 05/27/2016
• Issued: 04/24/2018
• 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:
  US15/167,417
• Publication Number:
  US 20160271317A1
• Time in Patent Office: 697 Days
• 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

A blood treatment machine includes a blood pump; an arterial line in fluid communication with the blood pump, the arterial line including an arterial needle; a venous line including a venous needle; and a blood leak detection device including (i) at least one electrical component, (ii) a member configured to secure the at least one electrical component onto a patient'"'"'s arm adjacent to patient access of at least one of the arterial and venous needles, the at least one electrical component capable of sensing the presence of a blood leak, and (iii) a controller in operable communication with the at least one electrical component, the controller programmed to allow for an amount of expected blood seepage and to cause an alarm if blood greater than the amount of expected blood seepage is sensed by the at least one electrical component.

Claims

1. A blood treatment machine comprising:

a blood pump;

an arterial line in fluid communication with the blood pump, the arterial line including an arterial needle;

a venous line including a venous needle; and

a blood leak detection device including

(i) a planar array of electrical components,

(ii) a member configured to secure the planar array of electrical components onto a patient'"'"'s arm adjacent to patient access of at least one of the arterial and venous needles, the planar array of electrical components positioned and arranged to sense and enable a blood seepage to be distinguished from a blood leak, wherein the blood seepage is less than or equal to an amount of expected blood seepage and is detected by a first plurality of electrical components in the planar array of electrical components, and wherein the blood leak is greater than the amount of expected blood seepage and is detected by a second plurality of electrical components in the planar array of electrical components, the second plurality of electrical components being greater than the first plurality of electrical components, and

(iii) a controller in operable communication with the planar array of electrical components, the controller programmed to allow for the blood seepage without alarming and to cause an alarm if the blood leak is sensed by the planar array of electrical components.

2. The blood treatment device of claim 1, wherein the member includes a wrap.

3. The blood treatment machine of claim 2, wherein the member includes a pad beneath the wrap.

4. The blood treatment machine of claim 1, wherein the member includes at least one frictional or adhesive releasable securement.

5. The blood treatment machine of claim 1, wherein the planar array of electrical components includes at least one capacitor.

6. The blood treatment machine of claim 1, wherein the planar array of electrical components includes an array of capacitors.

7. The blood treatment machine of claim 1, wherein blood is detected beneath the planar array of electrical components.

8. The blood treatment machine of claim 1, wherein the blood leak detection device is located remote from the blood treatment machine.

9. The blood treatment machine of claim 1, wherein the blood leak detection device is wired to the blood treatment machine.

10. The blood treatment machine of claim 1, which includes a venous line clamp, and wherein the alarm 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.

11. The blood treatment machine of claim 1, wherein the blood leak detection device is used redundantly with another type of access disconnection technology.

12. A blood leak detection device comprising:

a planar array of electrical components;

a member configured to secure the planar array of electrical components onto a patient'"'"'s arm adjacent to patient access of at least one of the arterial and venous needles, the planar array of electrical components positioned and arranged to sense both a blood seepage and a blood leak, wherein the blood seepage is less than or equal to an amount of expected blood seepage and is detected by a first plurality of electrical components in the planar array of electrical components, and wherein the blood leak is greater than the amount of expected blood seepage and is detected by a second plurality of electrical components in the planar array of electrical components, the second plurality of electrical components being greater than the first plurality of electrical components; and

a controller in operable communication with the planar array of electrical components, the controller programmed to allow for the blood seepage without alarming and to cause an alarm if the blood leak is sensed by the planar array of electrical components.

13. The blood treatment device of claim 12, wherein the member includes a wrap.

14. The blood treatment machine of claim 13, wherein the member includes a pad beneath the wrap.

15. The blood treatment machine of claim 12, wherein the member includes at least one frictional or adhesive releasable securement.

16. The blood treatment machine of claim 12, wherein the planar array of electrical components includes at least one capacitor.

17. The blood treatment machine of claim 12, wherein the planar array of electrical components includes an array of capacitors.

18. The blood treatment machine of claim 12, wherein blood is detected beneath the planar array of electrical components.

19. A blood leak detection method comprising:

configuring a device including a planar array of electrical components to electrically look for and enable a blood seepage to be distinguished from a blood leak, wherein the blood seepage is less than or equal to an amount of expected blood seepage and is detected by a first plurality of electrical components in the planar array of electrical components, and wherein the blood leak is greater than the amount of expected blood seepage and is detected by a second plurality of electrical components in the planar array of electrical components, the second plurality of electrical components being greater than the first plurality of electrical components;

programming the device to allow for the blood seepage without alarming; and

programming the device to cause an alarm when the blood leak is electrically detected.

20. The blood leak detection method of claim 19, wherein electrically looking for the blood seepage and the blood leak includes capacitively looking for the blood seepage and the blood leak.