VALVED CONNECTOR ASSEMBLY AND STERILITY BARRIERS FOR HEAT EXCHANGE CATHETERS AND OTHER CLOSED LOOP CATHETERS

• US 20090247963A1
• Filed: 03/31/2009
• Published: 10/01/2009
• Est. Priority Date: 10/18/2002
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Tsai, George, Bleam, Jefferey C.
• Granted Patent: US 8,262,716 B2
• Time in Patent Office: Days
• US Class Current: 604/246
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/445 the media being heated in the reservoir, e.g. warming bloodbags

Abstract

A connector assembly for catheters having closed loop flow circuits, such as some balloon catheters and heat exchange catheters. The connector assembly comprises first and second connector bodies that may be connected and disconnected from one another. When the connector bodies are disconnected, a syringe or negative pressure source may be attached to withdraw residual fluid from the catheter'"'"'s closed loop circuit and to deflate any expandable portion of the closed loop circuit (e.g., balloon or expandable heat exchanger). A one way flow valve prevents make up air or other fluid from entering the catheter while the negative pressure is being applied. Also disclosed are sterility barrier assemblies for all types of catheters. Such sterility barrier assemblies are operative to prevent contamination of the portion of a catheter that remains outside of a patient'"'"'s body so that the catheter may subsequently be further advanced into the patient'"'"'s body without introducing microbes or other contaminants into the patient'"'"'s body.

Claims

1. A method for connecting a fluid inflow tube and a fluid outflow tube to a closed loop catheter that has a closed loop fluid flow circuit with a first lumen through which a fluid may flow into the catheter and a second lumen through which fluid that has flowed through the first lumen may subsequently flow back out of the catheter, said method comprising the steps of:

obtaining a first connector that has an inflow lumen port connected to the inflow tube and an outflow lumen port connected to the outflow tube; and

connecting the first connector to a second connector located on the catheter such that the inflow lumen port of the first connector becomes connected to an inflow lumen port of the second connector and the outflow lumen port of the first connector becomes connected to the outflow lumen port of the second connector, whereby fluid from the inflow tube will flow through the inflow lumen of the catheter, through the outflow lumen of the catheter and into the outflow tube.

2. A method according to claim 1 further comprising the step of disconnecting the first connector from the second connector.

3. A method according to claim 2 further comprising the step of blocking one of the inflow and outflow lumens when the first connector is disconnected from the second connector such that fluid may then be evacuated from the closed loop flow circuit through the other of the first and second lumens without concurrent entry of make-up air or other fluid into the closed loop circuit.

4. A method according to claim 3 wherein the step of preventing fluid from entering one of the inflow and outflow lumens is carried out by actuating a valve.

5. A method according to claim 4 wherein the valve is actuated by the act of disconnecting the first connector from the second connector.

6. A method according to claim 1 wherein the closed loop catheter comprises a heat exchange catheter through which heat exchange fluid is circulated.

7. A method according to claim 3 wherein a portion of the closed loop circuit is expandable and contractable such that it contracts when fluid may then be evacuated from the closed loop flow circuit through the other of the first and second lumens without concurrent entry of make-up air or other fluid into the closed loop circuit.

8. A method according to claim 1 further comprising the step of latching the first connector to the second connector to deter inadvertent disconnection of the connector from the inflow source and outflow receiver.

9. A method according to claim 1 further comprising the step of determining the pressure of fluid within the closed loop circuit.

10. A method according to claim 3 further comprising the step of:

applying negative pressure to the lumen which remains open to draw remaining fluid from the closed loop circuit.

11. A method according to claim 10 wherein the step of applying negative pressure comprises attaching a syringe to the lumen that remains open and drawing back the syringe plunger to thereby draw remaining fluid from the closed loop circuit.

12. A method for maintaining sterility of an exteriorized portion of a catheter that has a closed loop fluid flow circuit with a first lumen through which a fluid may flow into the catheter and a second lumen through which fluid that has flowed through the first lumen may subsequently flow back out of the catheter, said catheter having been inserted into the body of a subject using sterile technique such that the exteriorized portion of the catheter remains outside of the subject'"'"'s body, said method comprising the steps of:

affixing a distal hub of the catheter that is attached to a distal end of a generally tubular sterility barrier to the subject'"'"'s body at a first location;

affixing a proximal hub of the catheter that is attached to a proximal end of the sterility barrier to the subject'"'"'s body at a second location such that the exteriorized portion of the catheter resides between the first hub and the second hub and within the sterility barrier and is thereby protected from microbial contamination by the sterility barrier.

13. A method according to claim 12 further comprising the step of adjusting the position of the catheter within the subject'"'"'s body by:

detaching the distal hub from the subject'"'"'s body;

advancing a portion of the exteriorized portion of the catheter through the tubular sterility barrier and into the subject'"'"'s body, thereby causing the length of the exteriorized portion of the catheter to become shorter; and

re-affixing the distal hub to the subject'"'"'s body.

14. A method according to claim 13 wherein the tubular sterility barrier is flexible and has an outer surface and wherein the step of advancing a portion of the exteriorized portion of the catheter through the tubular sterility barrier and into the subject'"'"'s body is carried out by:

placing a hand on the outer surface of the tubular sterility barrier; and

grasping the exteriorized portion of the catheter while it remains within the tubular sterility barrier.

15. A method according to claim 12 wherein the generally tubular sterility barrier is substantially transparent and wherein the method further comprises the step of viewing the exteriorized portion of the catheter body through the sterility barrier.

16. A method according to claim 15 wherein graduated distance markings are formed on the exteriorized portion of the catheter and wherein said graduated distance markings are viewed through the transparent sterility barrier to determine the approximate length of the catheter body that has been inserted into the subject'"'"'s body.