Vacuum-assisted venous drainage reservoir for CPB systems

• US 6,017,493 A
• Filed: 09/26/1997
• Issued: 01/25/2000
• Est. Priority Date: 09/26/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Knight, Richard, Litzie, Ken, Vijay, Francis, Cambron, Ronald
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Huseman, Cheryl L.
• Application Number:
  US08/938,058
• Time in Patent Office: 851 Days
• Field of Search: 422/44, 422/45, 604/4, 128/DIG. 24
• US Class Current: 422/44
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3632 Combined venous-cardiotomy reservoirs
• CPC Class Codes: A61M 1/3638 with a vapour trap
• CPC Class Codes: A61M 1/3667 with assisted venous return
• CPC Class Codes: A61M 1/604 Bag or liner in a rigid container, with suction applied to both
• CPC Class Codes: A61M 1/631 Emptying the suction container without interrupting suction
• CPC Class Codes: Y10S 128/03 Heart-lung

Abstract

A vacuum-assisted venous drainage reservoir for cardiopulmonary bypass surgery with both hard and soft shell reservoirs. The system utilizes a wall vacuum or other source of negative pressure to create a negative pressure via a regulator within a sealed hard shell reservoir, or within a sealed housing surrounding a soft shell reservoir. The addition of a negative pressure in the venous return line enables the use of smaller cannulas suitable for minimally invasive surgery. The reservoir need not be positioned well below the patient as in conventional gravity venous drainage configurations, thus adding flexibility to the operating room layout and enabling a reduction in the extracorporeal blood prime volume needed. In one embodiment, a flexible membrane in the hard shell reservoir expands to contact the blood surface and reduce blood/air interactions. In another embodiment, a moisture trap is provided between the source of vacuum and hard shell reservoir to reduce environmental contamination. A volume sensor for the hard shell reservoir may be used in a feedback loop for controlling the vacuum, circulation pump, or other device. A pressure relief valve may be included in both systems for safety, and a vacuum stabilizer reduces the severity of large changes in vacuum pressure. A piece of air-permeable material may form a portion of the soft shell reservoir to vent air from within.

Claims

1. A vacuum assisted venous drainage system, comprising:

a reservoir for receiving blood from a venous system of a patient;

a source of vacuum;

a conduit forming a part of a vacuum line provided between the source of vacuum and the reservoir and configured to create a negative pressure within the reservoir;

a pressure regulator in the conduit; and

a vacuum stabilizer positioned in the conduit between the pressure regulator and the reservoir, the vacuum stabilizer allowing air into the conduit from the exterior thereof to modulate extreme changes in pressure within the conduit, but preventing air from escaping from the conduit.

2. The system of claim 1, wherein the reservoir has a rigid blood container and the conduit is attached to create a vacuum within the container.

3. The system of claim 1, wherein the reservoir has a flexible blood container, the system further including a rigid housing surrounding the flexible container, wherein the conduit is attached to create a vacuum within the housing.

4. The system of claim 3, further including a pressure relief valve in fluid communication with the conduit between the pressure regulator and the housing, the pressure relief valve limiting the magnitude of vacuum in the housing.

5. The system of claim 1, further including:

a moisture trap in fluid communication with the conduit between the source of vacuum and the reservoir, the moisture trap serving to collect fluids drawn from the reservoir before reaching the source of vacuum.

6. The system of claim 1, wherein the reservoir comprises a rigid container having an inlet adapted to receive venous blood into an interior space sealed from the atmosphere, the container shaped to contain the blood and form a blood surface, the system further including;

a flexible air impermeable membrane mounted within the container and defining a closed space sealed from the interior space of the container, the membrane having sufficient flexibility so that the closed space expands into the interior space upon a vacuum being drawn within the container, the membrane configured to expand and contact the blood surface.

7. The system of claim 6, wherein the reservoir comprises a generally cylindrical canister having a cap and a central venous chamber into which venous blood flows, the membrane being positioned in a space surrounding the venous chamber and within the container.

8. The system of claim 7, wherein an exterior surface of the venous chamber is defined by a generally cylindrical defoamer.

9. The system of claim 1, further including:

a rigid, sealed outer housing, wherein the reservoir comprises a flexible, blood impermeable reservoir within the housing and a space is created outside of the reservoir and within the housing;

an inlet port in the reservoir;

a blood conduit attached to the inlet port and in communication with the interior of the reservoir, the blood conduit passing through a sealed opening in the housing and being connected to a source of venous blood;

wherein the conduit extending between the source of vacuum and the reservoir passes through a sealed opening in the housing and communicates with the space to create a negative pressure within the flexible, blood impermeable reservoir.

10. The reservoir of claim 9, further including an air permeable membrane forming a portion of the flexible reservoir for venting air from within the reservoir to the housing interior.

11. The reservoir of claim 9, further including a second conduit extending between a source of vacuum and in communication with the interior of the reservoir through a sealed opening in the housing;

and

a pressure regulator between the second conduit and vacuum source.

12. A method of surgery, comprising:

securing a first cannula in a patient;

securing a second cannula in a patient;

connecting the first cannula to a venous reservoir blood inlet port;

creating a negative pressure in the venous reservoir;

regulating the pressure within the venous reservoir;

stabilizing the pressure changes within the reservoir using a vacuum stabilizer positioned in a negative pressure supply conduit, the stabilizer allowing air into the conduit from the exterior thereof to modulate extreme changes in pressure within the reservoir, while preventing air from escaping the conduit; and

pumping blood from the venous reservoir through a blood oxygenator and to the second cannula back to the patient.

13. The method of claim 12, wherein the surgery does not involve opening the patient'"'"'s chest cavity, and the first and second cannulas are inserted through at least one incision.

14. The method of claim 12, wherein the incision is in the patient'"'"'s chest.

15. The method of claim 12, wherein the incision is in the patient'"'"'s leg.

16. The method of claim 12, further including:

providing the venous reservoir having a rigid outer container defining an inner space sealed from the atmosphere, the container being shaped to channel the blood and form a blood surface;

providing a flexible membrane attached within the rigid container and defining a closed space sealed from the container inner space; and

wherein the step of creating a negative pressure comprises drawing a vacuum within the container inner space to subsequently expand the closed space within the membrane into the inner space, the membrane being configured to expand and contact the blood surface.

17. The method of claim 16, further including monitoring the level of the blood surface, and regulating the vacuum in the container based on the blood level.

18. The method of claim 17, wherein the monitoring comprises actuating an ultrasonic transducer mounted to the underside of the container.