Vascular introducer with temperature monitoring probe and systems for endovascular temperature control

• US 7,946,996 B2
• Filed: 02/20/2007
• Issued: 05/24/2011
• Est. Priority Date: 09/10/2002
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Hammack, Amy L., Dae, Michael W., Callister, Jeffrey P.
• Primary Examiner(s): Mallari; Patricia C
• Application Number:
  US11/709,108
• Publication Number:
  US 20070173735A1
• Time in Patent Office: 1,554 Days
• Field of Search: 600/526, 600/549
• US Class Current: 600/549
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/6852 Catheters
• 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 25/0662 Guide tubes

Abstract

An introducer sheath/temperature probe assembly that is insertable into a blood vesel of a human or veterinary patent to measure the temperature of blood flowing through that blood vessel. The introducer sheath/temperature probe assembly may be used in conjunction with an indwelling heat exchange catheter system to warm or cool all or a portion of the patient'"'"'s body to a desired target temperature and to maintain such target temperature for a desired period of time.

Claims

1. A system for controlling the body temperature of a human or veterinary patient, said system comprising:

an introducer sheath/temperature probe assembly comprising a tubular introducer sheath having a proximal end, a distal end and a lumen which extends longitudinally therethrough, said introducer sheath being insertable into a blood vessel and an elongate temperature probe having a distal end and a proximal end, said temperature probe being insertable, distal end first, into the lumen of the introducer sheath and useable, when inserted into the lumen of the introducer sheath, to sense the temperature of blood flowing through the blood vessel into which the introducer sheath is inserted, an atraumatic tip member being disposed on the distal end of the temperature probe such that the tip member protrudes beyond the distal end of the introducer sheath when the temperature probe is inserted into the lumen of the introducer sheath, wherein said temperature probe has a temperature sensor, said temperature sensor being located within the elongate temperature probe proximal of said tip member so that said tip member may extend substantially out ofthe distal end of said introducer sheath while said temperature sensor resides within said lumen of the introducer sheath;

a heat exchange catheter having a heat exchanger that is positionable within the vasculature of the patient and useable to alternately add heat to and remove heat from the patient'"'"'s blood;

a heater/cooler apparatus for alternately heating and cooling the heat exchanger of the heat exchange catheter, thereby adjusting the amount and direction of heat exchange occurring between the heat exchanger and the patient'"'"'s blood; and

a controller which receives i) a target temperature input and ii) indications of the body temperature sensed by the temperature probe when the temperature probe is inserted into the introducer sheath, said controller being operative to control the heater/cooler apparatus in response to the indications of the body temperature sensed by the temperature probe such that the patient'"'"'s body temperature as sensed by the temperature probe will be heated or cooled approximately to the target temperature and thereafter maintained at approximately said target temperature;

wherein said tubular introducer sheath has a proximal opening diameter on said proximal end, said temperature probe has a distal length having a first diameter and a proximal length having a second diameter, said first diameter smaller than said opening diameter and said second diameter larger than said opening diameter, and the length of the probe distal of said second diameter up to said sensor is less than the length of said introducer lumen, and the length of said distal portion of said probe between said second diameter and the distal tip of said distal tip member is longer than said introducer sheath, such that when said temperature probe is inserted through said proximal opening the portion of the temperature probe of said first diameter is inserted into said introducer sheath lumen but the portion of said probe having said second diameter will be blocked from entering said opening, and when fully inserted into said introducer sheath, said tip member will extend beyond the distal end of said introducer sheath lumen but the sensor will remain within said introducer sheath lumen.

2. A system according to claim 1 wherein said tip member is coated with a lubricious coating.

3. A system according to claim 2 wherein said tip member is coated with a coating that is both lubricious and anti-thrombogenic.

4. A system according to claim 1, further comprising:

apparatus for connecting the temperature probe to an extracorporeally located temperature monitoring apparatus to effect transmission of at least one signal indicative of blood temperature sensed by the temperature probe to the temperature monitoring apparatus.

5. A system according to claim 4 wherein the apparatus for connecting comprises at least one wire for establishing a wired connection between the temperature probe and the extracorporeally located temperature monitoring apparatus.

6. A system according to claim 4 wherein the apparatus for connecting comprises wireless signal transmitting and receiving apparatus for establishing a wireless connection between the temperature probe and the extracorporeally located temperature monitoring apparatus.

7. A system according to claim 1 wherein the temperature probe comprises first and second temperature sensors such that the temperature probe generates first and second temperature signals indicative of the temperature of the blood flowing through the blood vessel into which the introducer sheath/temperature probe assembly is inserted.

8. A system according to claim 1 further comprising a hemostatic valve for preventing blood from backflowing out of the lumen of the introducer sheath.

9. A system according to claim 1 further comprising a hub on the proximal end of the introducer sheath.

10. A system according to claim 1 further comprising a hub on the proximal end of the temperature probe.

11. A system according to claim 1 further comprising a first hub on the proximal end of the introducer sheath and a second hub on the proximal end of the temperature probe.

12. A system according to claim 11 wherein a portion of the second hub is received within the first hub when the temperature probe is inserted into the introducer sheath.

13. A system according to claim 12 wherein a first engagement surface is formed on the first hub and a second engagement surface is formed on the second hub, the first engagement surface becoming frictionally engaged with the second engagement surface when the temperature probe is inserted into the lumen of the introducer sheath, thereby deterring unintentional withdrawal of the temperature probe from the introducer sheath.

14. A system according to claim 13 wherein the first and second engagement surfaces comprise helical threads such that the first hub of the introducer sheath becomes threadably engaged to the second hub of the temperature probe.

15. A system assembly according to claim 9 wherein a side port is formed on the hub of the introducer sheath.

16. A system assembly according to claim 15 further comprising a side tube having a proximal end and a distal end, the distal end of the side tube being connected to the side port such that fluid may be infused through the side tube, through the side port and through the lumen of the introducer sheath.

17. A system according to claim 16 further comprising a stopcock attached to the proximal end of the side tube.

18. A system according to claim 15 wherein a hemostatic valve is positioned within the hub of the introducer sheath, proximal to the side port.