Cardiopulmonary apparatus and methods for preserving life

• US 9,844,618 B2
• Filed: 09/23/2014
• Issued: 12/19/2017
• Est. Priority Date: 12/07/2010
• Status: Expired due to Fees

• Current Assignee: ZOLL Lifebridge GmbH
• Original Assignee: ZOLL Lifebridge GmbH
• Inventors: Muller-Spanka, Gerhard, Zerkowski, Hans-Reinhard
• Primary Examiner(s): MARCETICH, ADAM M
• Application Number:
  US14/494,470
• Publication Number:
  US 20150141897A1
• Time in Patent Office: 1,183 Days
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 2016/0015 inhalation detectors
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/08 Supports for equipment
• CPC Class Codes: F16K 31/00 Actuating devices; Operating means; Releasing devices regulating means G05D
• CPC Class Codes: F16K 35/00 Means to prevent accidental or unauthorised actuation

Abstract

Apparatus and methods for providing extracorporeal blood circulation and oxygenation control include seven-stage de-airing of blood to provide automated cardiopulmonary replacement to sustain patient life during a medical procedure comprising repairing or replacing the heart valve in a patient.

Claims

1. A method for performing a percutaneous catheter-based heart valve repair or replacement in a patient comprising the steps of:

connecting the patient'"'"'s vasculature to a heart-lung machine which has a controller and a blood flow and treatment circuit, said blood flow and treatment circuit comprising a venous blood inflow conduit, a blood reservoir, an oxygenator, a blood pump, a bubble detector, a filter, and an arterial blood outflow conduit, said controller being programmed to control an automatic priming and air removal process whereby the blood flow and treatment circuit is automatically filled with a priming liquid and air is vented, without the presence of a trained perfusionist or cardio-technician;

connecting the blood flow and treatment circuit to a source of priming fluid;

causing the controller to perform the automatic priming and air removal process whereby the venous blood inflow conduit, blood reservoir, oxygenator, blood pump, bubble detector, filter, and arterial blood outflow conduit become primed with fluid and substantially free of air, without the presence of a trained perfusionist or cardio-technician;

after completion of the automatic priming and air removal process, operating the heart-lung machine to circulate oxygenated blood through the patient'"'"'s vasculature;

percutaneously inserting a heart valve repair or replacement catheter and advancing the heart valve repair or replacement catheter to the location at which the heart valve is to be repaired or replaced; and

using the heart valve repair or replacement catheter to repair or replace the heart valve;

wherein the heart-lung machine is alternately operable using either a battery power supply or by connection to an external electrical power supply; and

wherein the method further comprises the step of operating the heart-lung machine during all or part of the method using a power supply selected from a) a battery power supply and b) an external electrical power supply.

2. The method of claim 1, wherein said blood reservoir is separated into a lower blood-containing space and an upper air-containing space by a membrane that is permeable to blood but not to air bubbles.

3. The method of claim 1, wherein the blood flow and treatment circuit includes a fast closing clamp on the arterial blood outflow conduit and a bypass conduit that extends between the venous inflow conduit and a location on the arterial blood outflow conduit downstream of the bubble detector but upstream of the fast closing clamp, and wherein, if the bubble detector detects a bubble during operation of the heart lung machine, the fast closing clamp is caused to close and blood is automatically caused to recirculate from the arterial outflow conduit, through the bypass conduit and into the venous inflow conduit until the bubble detector no longer detects the bubble, and then the fast closing clamp is reopened and a flow of oxygenated blood from the arterial blood flow conduit to the patient'"'"'s vasculature is recommenced.

4. The method of claim 3, wherein a bypass clamp on the bypass conduit opens when the fast closing clamp closes, thereby permitting flow through the bypass conduit.

5. The method of claim 4, wherein fast closing clamp is opened and the bypass clamp is closed after the blood detector has failed to re-detect any air bubble for a predetermined time interval, thereby discontinuing flow through the bypass conduit and recommencing flow through the arterial blood outflow conduit and into the patient'"'"'s vasculature.

6. The method of claim 4, wherein upon detection of an air bubble by the bubble detector, the blood pump is stopped as the fast closing clamp is closed and the bypass clamp is opened and, thereafter, the blood pump is restarted so that the blood, together with the detected air bubble, flows through the bypass conduit, through the venous inflow conduit and back into the blood reservoir.

7. The method of claim 6, wherein the blood reservoir has an air-containing space in which air bubbles collect.

8. The method of claim 7, wherein an air extraction pump is connected to the air space of the blood reservoir and wherein the method further comprises causing the air extraction pump to extract air that collects in the air space.

9. The method of claim 8, wherein the blood reservoir comprises at least on fill level detector which communicates with the air extraction pump and blood pump, such that a) the air extraction pump is activated when the blood level detected by said at least one fill level detector falls below a first predetermined level and b) the blood pump stops pumping when the blood level detected by said at least one fill level detector in the blood reservoir falls below a second predetermined level.

10. The method of claim 9 wherein said at least one fill level detector comprises first and second fill level sensors located at different positions in the blood reservoir.

11. The method of claim 3 wherein the fast closing clamp comprises a latch device, a clamp jaw and a holding apparatus and wherein detection of an air bubble by the bubble detector causes the latch device to unlatch the clamp jaw from the holding apparatus;

thereby allowing the clamp jaw to move to a clamping position wherein it claps the arterial blood flow outlet conduit thereby preventing flow of blood from the arterial blood flow conduit into the patient'"'"'s vasculature.

12. The method of claim 3 wherein, when a bubble is detected by the bubble detector, the fast acting clamp is closed before the detected air bubble reaches the fast acting clamp.

13. The method of claim 3, wherein the fast-closing clamp closes in less than 300 ms.

14. The method of claim 1, wherein the method is carried out without a perfusionist or cardio-technician being present.

15. The method of claim 1, wherein the heart valve repair or replacement is performed by a transvascular approach.

16. The method of claim 1 wherein, during performance of the method, the heart-lung machine is operated some of the time on the battery power supply and some of the time on an external electrical power supply.

17. The method of claim 16 wherein the method further comprises transporting the patient from one location to another, and wherein the heart-lung machine is operated on the battery power supply while the patient is being transported.