Multiple-function cardiovascular catheter system with very high lumenal efficiency and no crossovers

• US 4,718,423 A
• Filed: 10/17/1986
• Issued: 01/12/1988
• Est. Priority Date: 10/17/1986
• Status: Expired due to Term

• Current Assignee: Becton Dickinson Critical Care Systems Pte Ltd. (Becton, Dickinson & Co)
• Original Assignee: Spectramed, Inc.
• Inventors: Moran, Byron L., Willis, Allan F.
• Primary Examiner(s): Ramm, William E.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/920,736
• Time in Patent Office: 452 Days
• Field of Search: 128/691-693, 128/713, 128/665-667, 128/632, 128/635, 128/736, 128/734, 128/419 P, 128/786
• US Class Current: 600/325
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• 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 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood

Abstract

Cardiac output, blood oxygen saturation, and oxygen consumption are measured using only two lumens of a catheter that has no interlumen crossover. Therefore this construction avoids costly techniques for modifying the catheter, as well as leakage risk at crossover points. Cardiac output is measured by thermodilution, and venous blood oxygen by optical scattering measurements through optic fibers; oxygen consumption is then claculable from the cardiac output and venous oxygen saturation--and independently measured arterial saturation. Cold-bolus injection uses on lumen. The thermal-sensor leads (electrical or otherwise) and optic fibers share the other lumen, through which they are drawn together: this method of installation effects yet a further economy by saving an expensive labor step, and tends to prevent the leads and fibers from damaging one another. Addition of a balloon and a separate inflation lumen permits balloon functions as well, now using only three lumens and still without lumenal crossovers--and without risk of balloon deflation due to air leaks associated with the thermal sensors. Adding yet another one or two separate lumens permits provision of a pacing wire or pulmonary-artery pressure measurement, or both, with a respective total of only four or five lumens.

Claims

1. A cardiovascular diagnostic and therapeutic catheter system for determining cardiac output, blood oxygen saturation, and oxygen consumption in a human patient;

said system incorporating a catheter of advantageously limited diameter without any interlumen crossovers, and comprising;

a catheter having at least two lumens and having a distal end adapted for insertion through such patient'"'"'s vascular system and heart, and having a proximal end adapted for functional attachment to apparatus outside such patient'"'"'s body;

a first orifice defined in the side of the catheter at a first measured distance from the distal end, communicating with a first one of the two lumens, and adapted for passage of liquid from the first one of the two lumens into such patient'"'"'s vascular system;

injecting means, outside such patient'"'"'s body and communicating with a proximal portion of the first one of the two lumens, for forcing passage of liquid from the first one of the two lumens through the orifice into such patient'"'"'s vascular system;

at least one temperature-measuring device disposed along the catheter near its distal end for exposure to temperatures of such patient'"'"'s vascular system;

long, thin, signal-carrying means, disposed within only the second one of the two lumens, free of interlumen crossover into the first one of the two lumens, and functionally interconnected with the temperature-measuring device;

signal-utilization means, outside such patient'"'"'s body and interconnected with the signal-carrying means at a proximal portion of the second one of the two lumens, for utilizing said temperature-measuring device to measure the temperature within such patient'"'"'s vascular system;

whereby the temperature-measuring device and the signal-utilization means in combination are responsive to temperature variations resulting from forced passage of liquid through said first one of the two lumens;

optical-fiber means also disposed within the second one of the two lumens, adapted to project light from the distal end of the catheter into such patient'"'"'s vascular system and to receive light reflected back from such patient'"'"'s vascular system, for measurement of oxygen saturation of such patient'"'"'s blood;

light-emitting means, disposed outside such patient'"'"'s body and interconnected with the optical-fiber means at a proximal portion of the catheter, for transmitting light through the optical-fiber means to be projected into such patient'"'"'s vascular system; and

light-detecting means, disposed outside such patient'"'"'s body and interconnected with the optical-fiber means at a proximal portion of the catheter, for receiving light through the optical-fiber means after reflection back from such patient'"'"'s vascular system, and adapted for interpretation of the received light to determine oxygen saturation of such patient'"'"'s blood;

wherein said catheter system provides measurements of cardiac output and oxygen saturation, and by calculation therefrom also provides measurement of oxygen consumption in such patient, using only said two lumens and without any interlumen crossover of signal-carrying means.

2. The system of claim 1, further comprising:

an additional lumen defined within the catheter;

an inflatable balloon disposed near the distal end of the catheter and communicating with a distal portion of said additional lumen;

balloon-inflating means outside such patient'"'"'s body and communicating with a proximal portion of the additional lumen;

said signal-carrying means being entirely outside said additional lumen;

wherein said catheter system provides said measurements and also provides balloon functions, using only three lumens and without any interlumen crossover of signal-carrying means; and

wherein operation of said catheter system is free from risk of balloon deflation due to air leaks associated with the temperature-measuring means.

3. The catheter system of claim 2, for use with a voltage supply outside such patient'"'"'s body, and further comprising:

yet another lumen defined within the catheter;

a second orifice defined in the side of the catheter at a second measured distance from the distal end, communicating with said yet another lumen;

a coaxial electrical wire disposed within the yet another lumen, and having a proximal end adapted for functional attachment to such outside voltage supply, and having a distal end that projects through the second orifice into such patient'"'"'s vascular system when the catheter is in such patient'"'"'s vascular system.

4. The catheter system of claim 3, for use with pressure-measuring means disposed outside such patient'"'"'s body, and further comprising:

still another lumen defined within the catheter;

an orifice defined in the catheter substantially at the distal end, and communicating with said still another lumen;

means, disposed outside such patient'"'"'s body for establishing a column of liquid within said still another lumen; and

means for functionally interconnecting such pressure-measuring means to said still another lumen to monitor pressure in the liquid column therein;

whereby the catheter system provides said measurements and in addition such pressure-measuring means monitor pressure within such patient'"'"'s vascular system, substantially at the distal end of the catheter.

5. The catheter system of claim 2, for use with pressure,-measuring means disposed outside such patient'"'"'s body, and further comprising:

still another lumen defined within the catheter;

an orifice defined in the catheter substantially at the distal end, and communicating with said still another lumen;

means, disposed outside such patient'"'"'s body for establishing a column of liquid within said still another lumen; and

means for functionally interconnecting such pressure-measuring means to said still another lumen to monitor pressure in the liquid column therein;

whereby the catheter system provides said measurements and in addition such pressure-measuring means monitor pressure within such patient'"'"'s vascular system, substantially at the distal end of the catheter.

6. The catheter system of claim 1, for use with a voltage supply outside such patient'"'"'s body, and further comprising:

yet another lumen defined within the catheter;

a second orifice defined in the side of the catheter at a second measured distance from the distal end, communicating with said yet another lumen;

a coaxial electrical wire disposed within the yet another lumen, and having a proximal end adapted for functional attachment to such outside voltage supply, and having a distal end that projects through the second orifice into such patient'"'"'s vascular system when the catheter is in such patient'"'"'s vascular system.

7. The catheter system of claim 6, for use with pressure-measuring means disposed outside such patient'"'"'s body, and further comprising:

still another lumen defined within the catheter;

an orifice defined in the catheter substantially at the distal end, and communicating with said still another lumen;

means, disposed outside such patient'"'"'s body for establishing a column of liquid within said still another lumen; and

means for functionally interconnecting such pressure-measuring means to said still another lumen to monitor pressure in the liquid column therein;

whereby the catheter system provides said measurements and in addition such pressure-measuring means monitor pressure within such patient'"'"'s vascular system, substantially at the distal end of the catheter.

8. The catheter system of claim 1, for use with pressure-measuring means disposed outside such patient'"'"'s body, and further comprising:

still another lumen defined within the catheter;

an orifice defined in the catheter substantially at the distal end, and communicating with said still another lumen;

means, disposed outside such patient'"'"'s body for establishing a column of liquid within said still another lumen; and

means for functionally interconnecting such pressure-measuring means to said still another lumen to monitor pressure in the liquid column therein;

whereby the catheter system provides said measurements and in addition such pressure-measuring means monitor pressure within such patient'"'"'s vascular system, substantially at the distal end of the catheter.

9. A multipurpose cardiovascular diagnostic and therapeutic catheter system for use with a human patient, and for use with pressure-measuring means disposed outside such patient'"'"'s body and a voltage supply disposed outside such patient'"'"'s body, comprising:

a catheter defining exactly five lumens and having a distal end adapted for insertion through such patient'"'"'s vascular system and heart, and having a proximal end adapted for functional attachment to apparatus outside such patient'"'"'s body;

an inflatable balloon disposed near the distal end of the catheter and communicating with a distal portion of a first one of the five lumens;

balloon-inflating means outside such patient'"'"'s body and communicating with a proximal portion of the first one of the five lumens;

a first orifice defined in the side of the catheter at a first measured distance from the distal end, communicating with a second one of the five lumens, and adapted for passage of liquid from the second one of the five lumens into such patient'"'"'s vascular system;

injecting means, outside such patient'"'"'s body and communicating with a proximal portion of the second one of the five lumens, for forcing passage of liquid from the second one of the five lumens through the orifice into such patient'"'"'s vascular system;

a second orifice defined in the side of the catheter at a second measured distance from the distal end, communicating with a third one of the five lumens;

a coaxial electrical wire disposed within the third one of the five lumens, and having a proximal end adapted for functional attachment to such outside voltage supply, and having a distal end that projects through the second orifice into such patient'"'"'s vascular system when the catheter is in such patient'"'"'s vascular system;

an orifice defined in the catheter substantially at the distal end, and communicating with the fourth one of the five lumens;

means, disposed outside such patient'"'"'s body, for establishing a column of liquid within the fourth one of the five lumens;

means for functionally connecting such outside pressure-measuring means to the fourth one of the five lumens to monitor pressure in the liquid column therein;

whereby such pressure-measuring means monitor pressure within such patient'"'"'s vascular system, substantially at the distal end of the catheter;

at least one electrothermal temperature-measuring device disposed along the catheter near its distal end for exposure to temperatures of such patient'"'"'s vascular system, and at least two electrical wires disposed within the fifth one of the five lumens and functionally interconnected with the temperature-measuring device;

electrical means, outside such patient'"'"'s body and interconnected with the two electrical wires at a proximal portion of the fifth one of the five lumens, for utilizing said electrothermal device to measure the temperature within such patient'"'"'s vascular system;

whereby the electrothermal device and the electrical means in combination are responsive to temperature variations resulting from forced passage of liquid through said second or third one of the five lumens;

optical-fiber means also disposed within the fifth one of the five lumens, adapted to project light from the distal end of the catheter into such patient'"'"'s vascular system and to receive light reflected back from such patient'"'"'s vascular system, for measurement of oxygen saturation of such patient'"'"'s blood;

light-emitting means, disposed outside such patient'"'"'s body and interconnected with the optical-fiber means at a proximal portion of the catheter, for transmitting light through the optical-fiber means to be projected into such patient'"'"'s vascular system; and

light-detecting means, disposed outside such patient'"'"'s body and interconnected with the optical-fiber means at a proximal portion of the catheter, for receiving light through the optical-fiber means after reflection back from such patient'"'"'s vascular system, and adapted for interpretation of the received light to determine oxyge saturation of such patient'"'"'s blood.

10. The system of claim 9, wherein:

the optical-fiber means comprise at least two optical fibers for transmitting and receiving light in at least two wavelength bands, for determining oxygen saturation of such patient'"'"'s blood.

11. The system of claim 9, wherein:

the optical-fiber means comprise at least three optical fibers for transmitting and receiving light in at least two wavelength bands, for determining both hematocrit and oxygen saturation of such patient'"'"'s blood.

12. The system of claim 9, further comprising:

a strength member, also disposed within the fifth one of the five lumens, for protecting the catheter, the optical-fiber means, and the electrical wires against damage due to application of excessive stress to the catheter.

13. The system of claim 9, wherein:

the electrothermal device is a thermistor.