Intravascular blood parameter sensing system

• US 5,335,658 A
• Filed: 06/29/1992
• Issued: 08/09/1994
• Est. Priority Date: 06/29/1992
• Status: Expired due to Fees

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: Minnesota Mining and Manufacturing Co (3M Company)
• Inventors: Bedingham, William
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): GREEN, BRIAN
• Application Number:
  US07/906,740
• Time in Patent Office: 771 Days
• Field of Search: 128/637, 128/632, 128/634, 128/692, 128/630, 128/633, 128/665, 128/635, 604/236, 604/43, 604/44
• US Class Current: 600/322
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/6852 Catheters

Abstract

A parameter of blood is sensed in vivo with a system which includes a catheter and a probe. The catheter has a lumen extending therethrough, a proximal end, a distal end and a distal opening at the distal end. The probe includes one or more sensing elements at its distal end. In one embodiment, the sensing element or elements are located at least about 4 mm proximal of the distal opening of the lumen. A volume oscillator is provided to control the movement of blood into and out of the lumen. A flush solution is introduced into the lumen so that when the volume oscillator is inactive the sensing element or elements are exposed to pure flush solution, which preferably includes an anti-clotting component. The probe is received within the catheter and affixed thereto. The volume oscillator is activated to move blood into and out of the lumen to expose the sensing element or elements to blood so that they can sense the blood parameter or parameters of interest.

Claims

1. An assembly for the sensing of a blood parameter comprising:

a sensing element for sensing a parameter of blood and providing a signal in response thereto, and an elongated transmission member for transmitting said signal from said sensing element;

a catheter having a proximal end, a distal end, and a lumen extending therethrough, said lumen having an opening in said distal end, said catheter being sized and adapted so that at least said distal end and said opening are receivable within a blood vessel of a patient, said sensing element being located within said lumen at a position away from said proximal end of said catheter and at least 4 mm proximal of said opening, said catheter being configured such that said catheter is capable of being connected to a flush solution source so as to allow for the introduction of flush solution into said lumen;

a volume oscillator in fluid communication with said lumen, said volume oscillator being adapted to periodically cause blood from the blood vessel of the patient to move into and out of said lumen such that said sensing element is exposed to substantially exclusively blood for a portion of the time said volume oscillator is activated and to substantially exclusively said flush solution for another portion of the time said volume oscillator is activated; and

means for calculating the value of said blood parameter based upon both the values sensed by said sensing element when exposed to substantially exclusively blood and when exposed to substantially exclusively said flush solution.

2. The assembly of claim 1 wherein said sensing element is located at least 6 mm proximal of said opening.

3. The assembly of claim 1 wherein said sensing element is located up to 40 mm proximal of said opening.

4. The assembly of claim 1 wherein said sensing element is located up to 20 mm proximal of said opening.

5. The assembly of claim 1 wherein said sensing element is located closer to said opening than to said proximal end of said catheter.

6. The assembly of claim 1 wherein said sensing element is adapted for sensing carbon dioxide.

7. The assembly of claim 1 wherein said catheter has a longitudinal axis and an average diameter within said lumen perpendicular to said longitudinal axis of about 0.56 mm or less.

8. The assembly of claim 1 wherein said volume oscillator is preprogrammed to periodically cause blood to enter said lumen and to exit said lumen in a predetermined time sequence.

9. The assembly of claim 1 wherein said volume oscillator includes a housing and a piston, which are adapted to be disposed of after use with a single patient, and an actuator adapted to be removably coupled to said piston.

10. The assembly of claim 1 wherein said sensing element is adapted for sensing oxygen.

11. An assembly for the sensing of a blood parameter comprising:

a sensing element for sensing a parameter of blood and providing a signal in response thereto, and an elongated transmission member for transmitting said signal from said sensing element;

a catheter having a proximal end, a distal end, and a lumen extending therethrough, said lumen having an opening in said distal end, said catheter being sized and adapted so that at least said distal end and said opening are receivable within a blood vessel of a patient, said sensing element being located within said lumen, said catheter being configured such that said catheter is capable of being connected to a flush solution source so as to allow for the introduction of flush solution into said lumen;

a volume oscillator is fluid communication with said lumen, said volume oscillator being adapted to periodically cause blood from the blood vessel of the patient to move into and out of said lumen such that said sensing element is exposed to substantially exclusively blood for a portion of the time said volume oscillator is activated and to substantially exclusively said flush solution for another portion of the time said volume oscillator is activated; and

means for calculating the value of said blood parameter based upon both the values sensed by said sensing element when exposed to substantially exclusively blood and when exposed to substantially exclusively said flush solution.

12. The assembly of claim 11 wherein said sensing element is located at least 10 mm distal of said proximal end of said catheter.

13. The assembly of claim 11 wherein said sensing element is adapted for sensing carbon dioxide.

14. The assembly of claim 12 wherein said sensing element is adapted for sensing oxygen.

15. A method of sensing a parameter of blood comprising:

providing a catheter having a proximal end, a distal end, and a lumen extending therethrough, said lumen having an opening in said distal end, at least said distal end and said opening being positioned within a blood vessel of a patient;

providing a sensing element for sensing a parameter of blood and providing a signal in response thereto and an elongated transmission member for transmitting said signal from said sensing element, said sensing element being located within said lumen at a position at least 4 mm proximal of said opening;

introducing a flush solution from a flush solution source into said lumen;

providing a volume oscillator which, when activated, moves blood from the blood vessel of the patient into and out of said lumen; and

obtaining said signal from said sensing element while said sensing element is exposed to substantially exclusively blood, wherein said obtaining step further comprises exposing said sensing element to substantially exclusively said flush solution for a portion of the time said volume oscillator is activated and obtaining said signal while said sensing element is exposed to substantially exclusively said flush solution.

16. The method of claim 15 wherein said obtaining step comprises exposing said sensing element to substantially exclusively blood for a major portion of the time said volume oscillator is activated.

17. The method of claim 15 further comprising the step of exposing said sensing element to substantially exclusively said flush solution when said volume oscillator is inactive, and further comprising the step of locating said sensing element at least 6 mm distal of said proximal end of said catheter.

18. The method of claim 15 wherein said obtaining step comprises obtaining said signal from said sensing element which senses carbon dioxide.

19. The method of claim 15 further comprising the step of preprogramming said volume oscillator to periodically cause blood to enter said lumen and to exit said lumen in a predetermined time sequence.

20. The method of claim 15 wherein said introducing step comprises including an anti-clotting component in said flush solution.

21. The method of claim 15 further comprising the step of activating said volume oscillator so as to cause blood to rapidly enter said lumen, to expose said sensing element to substantially exclusively blood for a relatively long period of time, and to cause blood to rapidly exit said lumen without substantially detrimentally effecting the blood.

22. The method of claim 15 wherein said introducing step further comprises introducing the flush solution into said lumen at an increased flow rate for a period of time after blood exits said lumen.

23. The method of claim 15 wherein said obtaining step comprises obtaining said signal from said sensing element which senses oxygen.

24. A method of sensing a parameter of blood comprising:

providing a catheter having a proximal end, a distal end, and a lumen extending therethrough, said lumen having an opening in said distal end, at least said distal end and said opening being positioned within a blood vessel of a patient;

providing a sensing element for sensing a parameter of blood and providing a signal in response thereto, and an elongated transmission member for transmitting said signal from said sensing element, said sensing element being located within said lumen;

introducing a flush solution from a flush solution source into said lumen;

providing a volume oscillator which, when activated, moves blood from the blood vessel of the patient into and out of said lumen so that said sensing element is exposed to substantially exclusively blood for a portion of the time said volume oscillator is activated and to substantially exclusively said flush solution for another portion of the time said volume oscillator is activated; and

obtaining said signal from said sensing element while said sensing element is exposed to substantially exclusively blood and while said sensing element is exposed to substantially exclusively said flush solution.

25. The method of claim 24 further comprising the step of exposing said sensing element to substantially exclusively said flush solution when said volume oscillator is inactive.

26. The method of claim 24 further comprising the step of activating said volume oscillator so as to expose said sensing element to substantially exclusively blood and to substantially exclusively said flush solution at predetermined times, and further comprising the step of calculating the value of said blood parameter using a known value of the parameter in said flush solution.

27. The method of claim 24 wherein said obtaining step comprises obtaining said signal from said sensing element which senses carbon dioxide.

28. The method of claim 24 further comprising the step of preprogramming said volume oscillator to periodically cause blood to enter said lumen and to exit said lumen in a predetermined time sequence.

29. The method of claim 24 wherein said introducing step comprises including an anti-clotting component in said flush solution.

30. The method of claim 24 further comprising the step of activating said volume oscillator so sensing element to substantially exclusively blood for a relatively long period of time, and to cause blood to rapidly exit said lumen without substantially detrimentally effecting the blood.

31. The method of claim 24 wherein said introducing step comprises introducing the flush solution into said lumen at an increased flow rate for a period of time after blood exits said lumen.

32. The method of claim 24 wherein said obtaining step comprises obtaining said signal from said sensing element which senses oxygen.

33. An assembly for the sensing of a blood parameter comprising:

a sensing element for sensing a parameter of blood and providing a signal in response thereto, and an elongated transmission member for transmitting said signal from said sensing element;

a catheter having a proximal end, a distal end, and a lumen extending therethrough, said lumen having an opening in said distal end, said catheter being sized and adapted so that at least said distal end and said opening are receivable within a blood vessel of a patient, said sensing element being located within said lumen; and

a volume oscillator in fluid communication with said lumen, wherein said volume oscillator includes a housing and a piston, which are adapted to be disposed of after use with a single patient, and an actuator adapted to be removably coupled to said piston.

34. A method of sensing a parameter of blood comprising:

providing a catheter having a proximal end, a distal end, and a lumen extending therethrough, said lumen having an opening in said distal end, at least said distal end and said opening being positioned within a blood vessel of a patient;

providing a sensing element for sensing a parameter of blood and providing a signal in response thereto and an elongated transmission member for transmitting said signal from said sensing element, said sensing element being located within said lumen;

introducing a flush solution from a flush solution source into said lumen;

providing a volume oscillator which, when activated, moves blood from the blood vessel of the patient into and out of said lumen;

obtaining said signal from said sensing element while said sensing element is exposed to substantially exclusively blood; and

exposing said sensing element to substantially exclusively said flush solution when said volume oscillator is inactive.

35. A method of sensing a parameter of blood comprising:

providing a catheter having a proximal end, a distal end, and a lumen extending therethrough, said lumen having an opening in said distal end, at least said distal end and said opening being positioned within a blood vessel of a patient;

providing a sensing element for sensing a parameter of blood and providing a signal in response thereto and an elongated transmission member for transmitting said signal from said sensing element, said sensing element being located within said lumen;

providing a volume oscillator which, when activated, moves blood from the blood vessel of the patient into and out of said lumen;

introducing a flush solution from a flush solution source into said lumen, wherein said introducing step further comprises introducing the flush solution into said lumen at an increased flow rate for a period of time after blood exits said lumen; and

obtaining said signal from said sensing element while said sensing element is exposed to substantially exclusively blood.