Method for a central venous line catheter having a temperature control system

• US 8,128,595 B2
• Filed: 08/24/2001
• Issued: 03/06/2012
• Est. Priority Date: 04/21/1998
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Walker, Blair D., Evans, Scott M., Balding, David P., Barker, Peter
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US09/939,239
• Publication Number:
  US 20020111584A1
• Time in Patent Office: 3,847 Days
• Field of Search: 604/96.01, 604/113, 604/101.01, 604/101.05, 604/103.01, 607/96, 607/104, 607/105, 607/108, 607/113
• US Class Current: 604/113
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• 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: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

A kit of parts comprises a system and instructions for use for controlling patient temperature which uses a central venous line catheter having a heat exchange element. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the heat exchange element. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Claims

1. A central venous line catheter, said catheter having at least one substantially elongate structure configured for establishing central venous access, said structure having a proximal portion and a distal portion and defining at least a first lumen in communication with the exterior of the elongate structure at said proximal and distal portions, and at least one heat exchange element extending at least along the distal portion adapted to effect heat exchange with the central venous system, characterized in that the catheter is manufactured by flushing the first lumen from its distal portion to its proximal portion with sterile saline, wherein injection caps are clamped to the proximal portion of the first lumen.

2. The catheter of claim 1, characterized in that the volume of the flushing sterile saline is at least 5 ccm.

3. The catheter of claim 2, characterized in that a 5 ccm or larger syringe is used for flushing.

4. A venous line catheter system, said system having a catheter having at least one substantially elongate structure configured for establishing central venous access, said structure having a proximal portion and a distal portion and defining at least a first lumen in communication with the exterior of the elongate structure at said proximal and distal portions, and at least one heat exchange element extending at least along the distal portion adapted to effect heat exchange with the central venous system, characterized by a pump feeding heating/cooling agent at a flow rate in a range of 150-450 milliliters per minute through the heat exchange element.

5. The catheter system of claim 4, characterized in that the heat exchanging element is a balloon.

6. The catheter system of claim 5, characterized in that the balloon length is about 55-60 mm.

7. The catheter system of claim 5, characterized in that the wall thickness of the balloon is between 35 μ

m and 70 μ

m.

8. The catheter system of claim 4, characterized in that the heat exchanging element comprises a plurality of balloons.

9. The catheter system of claim 8, characterized in that the balloon length is about 55-60 mm.

10. The catheter system of claim 8, characterized in that three balloons are disposed in a consecutive order, a first balloon having a diameter of approximately 8-12 mm, a second balloon having a diameter of approximately 5-9 mm, and a third balloon having a diameter of approximately 4-6 mm.

11. The catheter system of claim 4, characterized in that the flow rate is about 240 milliliters per minute.

12. The catheter system of claim 4, characterized in that the temperature of the heating agent is between 38°

C. and 43°

C.

13. The catheter system of claim 4, characterized in that the temperature of the cooling agent is between 1°

C. and 5°

C.

14. The catheter system of claim 4, characterized in that the material from which the balloon is made is selected from the group:

urethane, nylon, PE and PET.

15. The catheter system of claim 4, characterized in that the heat conductivity of the balloon is 0.1 to 1.5 Watt per meter×

Kelvin.

16. The catheter system of claim 4, characterized in that the heating/cooling agent is a sterile Saline.