DISPOSABLE CARTRIDGE FOR A BLOOD PERFUSION SYSTEM

• US 20080027368A1
• Filed: 10/09/2007
• Published: 01/31/2008
• Est. Priority Date: 09/27/2000
• Status: Abandoned Application

• Current Assignee: Sorin Group USA Incorporated (LivaNova Plc)
• Original Assignee: Sorin Group USA Incorporated (LivaNova Plc)
• Inventors: Carson, Gary, Ellingboe, Bruce, Kappus, John, Kollar, Kevin
• Application Number:
  US11/869,451
• Publication Number:
  US 20080027368A1
• Time in Patent Office: Days
• US Class Current: 604/6.14
• 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 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• 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 1/3664 for preparing cardioplegia solutions
• CPC Class Codes: A61M 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3667 with assisted venous return
• CPC Class Codes: A61M 2202/047 cardioplegic
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards

Abstract

A disposable cartridge for use in extracorporeal blood perfusions systems that have a control unit for controlling the flow of fluids. The cartridge has a housing defining a plurality of internal passageways that connect to a cardiopulmonary circuit, a cardioplegia circuit and a suction circuit. The cartridge may be fitted with one or more of a bubble trap, a filter, and a valve.

Claims

1. A cartridge for use in an extracorporeal perfusion system for cardiopulmonary bypass procedures, the cartridge comprising:

a housing having a first side formed from a first rigid piece and a second side formed from a second flexible piece, the housing defining a plurality of internal fluid flow passageways including first and second passageways, each of the first and second passageways being defined at least partially by the first rigid piece and at least partially by the second flexible piece, the housing including a reservoir for accumulating blood from the patient, the reservoir having a rigid portion formed by the first rigid piece and a flexible portion formed by the second flexible piece.

2. The cartridge of claim 1 wherein the reservoir is selected from the group consisting of a venous reservoir, a cardioplegia reservoir and a cardiotomy reservoir.

3. The cartridge of claim 1 further comprising at least one sensor station configured to interface with at least one external level sensor to sense a level of fluid in the reservoir.

4. The cartridge of claim 3 wherein the at least one sensor station comprises first and second sensor stations configured to interface with first and second external level sensors to sense a high fluid level and a low fluid level in the reservoir.

5. The cartridge of claim 1 wherein the extracorporeal perfusion system includes a plurality of circuits including at least one of an arterial circuit, a venous circuit, a vent circuit, a suction circuit and a cardioplegia circuit and wherein the first passageway is fluidly connected to one of the arterial circuit, the venous circuit, the vent circuit, the suction circuit and the cardioplegia circuit.

6. The cartridge of claim 1 wherein the first passageway crosses over the second passageway at a cross-over point, the first passageway being spaced from the second passageway at the cross-over point such that the first and second passageways do not intersect at the cross-over point.

7. The cartridge of claim 1 further comprising at least one valve station configured to interface with at least one external valve actuator to control fluid flow in at least one of the first and second passageways.

8. The cartridge of claim 1 further comprising at least one sensor station configured to interface with at least one external sensor to sense a characteristic of fluid flowing in at least one the first and second passageways.

9. The cartridge of claim 8 wherein the at least one sensor station is selected from the group consisting of a temperature sensor station, a pressure sensor station, a hematocrit sensor station, an oxygen saturation sensor station, an air sensor station, a level sensor station, and combinations thereof.

10. The cartridge of claim 9 wherein the at least one sensor station is a pressure sensor station that is configured for measurement of one of positive and negative pressure.

11. The cartridge of claim 1 further comprising at least one passive component defined between the first and second sides.

12. The cartridge of claim 11 wherein the at least one passive component is selected from the group consisting of a bubble trap, a filter, a heat exchanger, a pressure diaphragm, a valve diaphragm, and combinations thereof.

13. The cartridge of claim 7 wherein the valve station is positioned in fluid communication with at least two of the plurality of internal fluid flow passageways, the valve station having a flexible member configured to be moveable from a first position allowing fluid flow between the at least two internal fluid flow passageways and a second position preventing fluid flow between the at least two internal fluid flow passageways.

14. A cartridge for use in an extracorporeal blood perfusion system for receiving venous blood from a patient and for returning oxygenated blood to the patient in a cardiopulmonary bypass procedure, the cartridge comprising:

a housing defining a plurality of internal blood flow passageways including first and second passageways, each of the first and second passageways having an entry port and an exit port and defining a fluid path into and out of the cartridge, the fluid path defined by the first passageway intersecting a first plane along the entire length of the fluid path from the entry port to the exit port, the fluid path defined by the second passageway intersecting the first plane at the entry and exit ports of the first passageway, the first and second passageways crossing over one another at a crossover point in the housing such that at the crossover point the fluid path defined by the second passageway does not intersect the first plane.

15. The cartridge of claim 14 wherein the housing comprises a first side formed from a first rigid piece and a second side formed from a second flexible piece, and the portion of the second passageway that crosses the crossover point lies entirely within the first rigid piece.

16. The cartridge of claim 14 wherein the extracorporeal perfusion system includes a plurality of circuits including at least one of an arterial circuit, a venous circuit, a vent circuit, a suction circuit and a cardioplegia circuit and wherein the first passageway is fluidly connected to one of the arterial circuit, the venous circuit, the vent circuit, the suction circuit and the cardioplegia circuit.

17. The cartridge of claim 14 wherein the first and second passageways do not intersect at the cross-over point.

18. A cartridge for use in an extracorporeal perfusion system for cardiopulmonary bypass procedures, the cartridge comprising:

a housing having a first side formed from a first rigid piece and a second side formed from a second flexible piece, the housing defining a plurality of internal fluid flow passageways including first and second passageways, each of the first and second passageways having a rigid portion formed by the first rigid piece and a flexible portion formed by the second flexible piece, the housing further including a valve station, the valve station being in fluid communication with at least two of the internal passageways, the valve station having a flexible member configured to be moveable from a first position allowing fluid flow between the at least two internal passageways and a second position preventing fluid flow between the at least two internal passageways.

19. The cartridge of claim 18 wherein the extracorporeal perfusion system includes a plurality of circuits including at least one of an arterial circuit, a venous circuit, a vent circuit, a suction circuit and a cardioplegia circuit and wherein the first passageway is fluidly connected to one of the arterial circuit, the venous circuit, the vent circuit, the suction circuit and the cardioplegia circuit.

20. The cartridge of claim 18 further comprising at least one valve station configured to interface with at least one external valve actuator to control fluid flow in at least one of the first and second passageways.

21. The cartridge of claim 18 further comprising at least one sensor station configured to interface with at least one external sensor to sense a characteristic of fluid flowing in at least one the first and second passageways.

22. The cartridge of claim 21 wherein the at least one sensor station is selected from the group consisting of a temperature sensor station, a pressure sensor station, a hematocrit sensor station, an oxygen saturation sensor station, an air sensor station, a level sensor station, and combinations thereof.

23. The cartridge of claim 18 further comprising at least one passive component defined between the first and second sides.

24. The cartridge of claim 23 wherein the at least one passive component is selected from the group consisting of a bubble trap, a filter, a heat exchanger, a pressure diaphragm, a valve diaphragm, and combinations thereof.

25. The cartridge of claim 20 wherein the valve station is positioned in fluid communication with at least two of the plurality of internal fluid flow passageways, the valve station having a flexible member configured to be moveable from a first position allowing fluid flow between the at least two internal fluid flow passageways and a second position preventing fluid flow between the at least two internal fluid flow passageways.