Adaptive algorithm for thoracic drainage therapy

• US 10,124,094 B2
• Filed: 05/24/2012
• Issued: 11/13/2018
• Est. Priority Date: 05/27/2011
• Status: Active Grant

• Current Assignee: Medela Holding AG (Olle Larsson Holding AG)
• Original Assignee: Medela Holding AG (Olle Larsson Holding AG)
• Inventors: Linder, Albert, Ehlert, Hilmar, Walti, Martin
• Primary Examiner(s): Townsend, Guy K
• Application Number:
  US14/122,406
• Publication Number:
  US 20140100540A1
• Time in Patent Office: 2,364 Days
• CPC Class Codes: A61M 1/04 Artificial pneumothorax apparatus
• CPC Class Codes: A61M 1/71 Suction drainage systems containers therefor A61M1/60, A61M1/64; negative pressure wound therapy systems A61M1/90
• CPC Class Codes: A61M 1/732 Visual indicating means for vacuum pressure
• CPC Class Codes: A61M 1/734 Visual indicating means for flow
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2210/101 Pleural cavity

Abstract

Devices and to methods for thoracic drainage for a patient having an air fistula. A vacuum is produced in the pleural cavity of the patient by means of a suction device. In order to adjust the vacuum on the basis of objective criteria, a suitable size measure for the air fistula is determined and the vacuum produced by the suction device is controlled according to said size measure. An adaptive algorithm includes: (a) determining a first value of a size measure for the air fistula; (b) changing the vacuum by a first difference value; (c) determining a second value of the size measure after a first waiting period; (d) changing the vacuum by a second difference value having the opposite sign if the second measure is greater than the first measure; (e) repeating steps (a) to (d) after a second waiting period.

Claims

1. An appliance for thoracic drainage in patients with an air fistula, said appliance comprising:

a suction device with a suction pump and an electric motor for driving the suction pump, in order to generate a vacuum in the pleural space of a patient;

a control device for controlling the electric motor of the suction device; and

at least one measuring device being connected to the control device and comprising at least one of a pressure gauge for measuring the generated vacuum or a flow meter for measuring a volumetric flow,

wherein the control device is configured to determine a size parameter indicating the functional size of the air fistula by using signals received from at least one of the pressure gauge or the flow meter,

wherein the control device is configured to control the electric motor such that the level of the vacuum generated by the suction pump is automatically regulated as a function of said size parameter;

and wherein the control device is configured to carry out a method having the following steps;

(a) determining a first value of the size parameter;

(b) changing the output of the suction pump such that the generated vacuum is changed by a first differential value and in such a way that a vacuum is still generated by the suction device in the pleural space, but with a different negative pressure difference in relation to atmospheric pressure;

(c) determining a second value of the size parameter after a first waiting period;

(d) changing the output of the suction pump such that the generated vacuum is changed by a second differential value, which has an opposite sign and a greater absolute value compared to the first differential value, if the second value of the size parameter is greater than the first value of the size parameter; and

(e) repeating steps (a)-(d) after a second waiting period.

2. The appliance according to claim 1, wherein the first differential value has an absolute value of between 2 and 10 mbar.

3. The appliance according to claim 1, wherein the second differential value has an absolute value of between 5 and 20 mbar.

4. The appliance according to claim 1, wherein the first waiting period is between 20 minutes and 3 hours.

5. The appliance according to claim 1, wherein the second waiting period is longer than the first waiting period.

6. The appliance according to claim 1, wherein the second waiting period is between 1 hour and 6 hours.

7. The appliance according to claim 1, wherein the first differential value has an absolute value of between 4 and 6 mbar.

8. The appliance according to claim 1, wherein the second differential value has an absolute value that is greater than the absolute value of the first differential value by a factor of between 1.5 and 3.

9. The appliance according to claim 1, wherein the second differential value has an absolute value of between 8 and 12 mbar.

10. The appliance according to claim 1, wherein the first waiting period is between 40 minutes and 1.5 hours.

11. The appliance according to claim 1, wherein the second waiting period is longer than the first waiting period by a factor of between 2 and 5.

12. The appliance according to claim 1, wherein the second waiting period is between 2 hours and 4 hours.

13. A method for thoracic drainage in a patient with an air fistula, said method comprising the following steps:

generating a vacuum in the pleural space of the patient by means of a suction device having a suction pump and an electric motor for driving the suction pump;

determining a size parameter indicating the functional size of the air fistula; and

automatically controlling the electric motor by means of a control device, such that the level of the vacuum generated by the suction pump is regulated as a function of said size parameter by carrying out the following steps;

(a) determining a first value of the size parameter for the air fistula based on a pressure measurement of the generated vacuum, the pressure measurement performed by means of a pressure gauge connected to the control device, and/or on a measurement of a volumetric flow, the measurement of volumetric flow being performed by means of a flow meter;

(b) changing the output of the suction pump such that the generated vacuum is changed by a first differential value and in such a way that a vacuum is still generated by the suction device in the pleural space, but with a different negative pressure difference in relation to atmospheric pressure;

(c) determining a second value of the size parameter after a first waiting period based on at least one of a pressure measurement of the generated vacuum or a measurement of a volumetric flow;

(d) changing the output of the suction pump such that the generated vacuum is changed by a second differential value, which has an opposite sign and a greater absolute value compared to the first differential value, if the second value for the size parameter is greater than the first value for the size parameter; and

(e) repeating steps (a)-(d) after a second waiting period.