DEVICE AND METHOD FOR CONNECTING A BLOOD PUMP WITHOUT TRAPPING AIR BUBBLES

• US 20090270809A1
• Filed: 03/27/2009
• Published: 10/29/2009
• Est. Priority Date: 03/28/2008
• Status: Active Grant

• Current Assignee: Vitalmex Internacional SA de CV
• Original Assignee: Innovamedica S.A.P.I. De C.V.
• Inventors: Duenas, Benjamin
• Granted Patent: US 8,092,416 B2
• Time in Patent Office: Days
• US Class Current: 604/122
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 39/00 Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use for respiratory devices, e.g. tracheal tubes A61M16/00; artificial heart valves A61F2/24
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/183 drawing blood from both ventricles, e.g. bi-ventricular assist devices [BiVAD]
• CPC Class Codes: A61M 60/859 Connections therefor

Abstract

An apparatus and a method for connecting medical tubing or any other type of fluidic circuit conduits (e.g., cannulae) to a ventricular assist device (“VAD”) or any other pumping device used for blood pumping during cardiac circulatory support for vascular surgery. The apparatus and the method prevent air bubbles from entering a cardiac circulatory support system when connecting cannulae to a VAD that may later enter the blood stream of a patient during cardiac surgery, and also provide for purging any air bubbles that may have entered the cardiac circulatory support system during a cannulae-VAD connection.

Claims

1. A disposable purging (“

DIP”

) device for connecting cannulae to a cardiac circulatory support device for use in a cardiac circulatory support system, the DIP device comprising;

a device body having a distal ending and a proximal ending;

an inner semi-closed flexible ring positioned in the inner surface of the device body;

an air outlet formed in the device body between the distal ending and the proximal ending; and

a radially-disposed external conduit positioned in the air outlet.

2. The DIP device of claim 1, further including:

a female plug configured to fit into the external conduit; and

a male plug configured to cover or plug the female-type plug.

3. The DIP device of claim 2, where the female plug is a luer type plug and the male plug is a luer lock plug.

4. The DIP device of claim 3, wherein the device body includes a detachment section configured to be separable from the device body.

5. The DIP device of claim 4, wherein the detachment section includes a flap extending from the detachment section and positioned to be grasped and pulled from the device body.

6. The DIP device of claim 2, further including means for separating the device body away from a connection of cannulae and the cardiac circulatory device in an assembled state.

7. The DIP device of claim 2, wherein the DIP device is made of a natural or synthetic elastomeric or polymeric material.

8. A method for connecting cannulae to a cardiac circulatory support device, the method comprising:

connecting an inflow disposable purging (“

DIP”

) device and an outflow DIP device to an inflow port and an output port, respectively, of a cardiac circulatory support device to form a support device/DIP device assembly;

purging the support device/DIP device assembly of trapped air;

occluding the inflow DIP device and the outflow DIP device;

inserting an outflow cannula into the inflow DIP device and an inflow cannula into the outflow DIP device;

purging air bubbles from each of the inflow DIP device and the outflow DIP device; and

connecting the cannulae to the cardiac circulatory support device to form a support device/DIP device/cannulae assembly.

9. The method of claim 8, further including the step of removing the inflow DIP device and the outflow DIP device from the support device/DIP device/cannulae assembly.

10. The method of claim 8, wherein the step of connecting the inflow DIP device and the outflow DIP device to the cardiac circulatory support device includes attaching a connector to the inflow port and to the outflow port of the cardiac circulatory support device.

11. The method of claim 8, wherein the step of purging the support device/DIP device assembly of trapped air includes:

filling the support device/DIP device assembly with a liquid;

occluding one of the DIP devices;

pouring additional liquid into the other DIP device to force the trapped air out of a distal ending of the other DIP device; and

occluding the other DIP device.

12. The method of claim 11, where the liquid is a saline solution.

13. The method of claim 8, where the step of inserting an outflow cannula into the inflow DIP device and an inflow cannula into the outflow DIP device includes:

positioning the support device/DIP device assembly facing distal endings of the outflow and inflow cannulae;

inserting the outflow cannula into the inflow DIP device while pouring a liquid over the distal ending of the outflow cannulae and a distal ending of the inflow DIP device;

removing the occlusion from the inflow DIP device; and

further inserting the outflow cannula into the inflow DIP device until the outflow cannula connects to the inflow port of the cardiac circulatory support device.

14. The method of claim 13, further including the step of repeating the steps of claim 13 for the inflow cannula and the outflow DIP device.

15. The method of claim 14, where the step of purging air bubbles from each of the inflow DIP device and the outflow DIP device includes extracting the air bubbles from the DIP devices using a syringe inserted into an external conduit of the DIP devices.

16. The method of claim 14, where the liquid is a saline solution.

17. The method of claim 8, where the cardiac circulatory support device is a ventricular assist device (“

VAD”

).

18. A system for connecting cannulae to a cardiac circulatory support device for use in a cardiac circulatory support system, the system comprising:

two disposable purging (“

DIP”

) devices each having a distal ending and a proximal ending;

a cardiac circulatory support device for use in a cardiac circulatory support system having inflow and outflow ports;

connectors configured to attach the distal ending of a connector to each of the inflow and outflow ports; and

cannulae configured for attachment to each of the inflow and outflow ports.

19. The system of claim 18, where the cardiac circulatory support device is a ventricular assist device (“

VAD”

).

20. The system of claim 19, where the DIP devices include an air outlet adaptable for the removal of air from an assembly including the VAD and the DIP devices.