Intra-aortic balloon catheter having a dual sensor pressure sensing system

• US 6,616,597 B2
• Filed: 12/12/2000
• Issued: 09/09/2003
• Est. Priority Date: 12/12/2000
• Status: Expired due to Term

• Current Assignee: Datascope Corporation (Getinge AB)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Schock, Robert B., Walters, Daniel A., Williams, Jonathan
• Primary Examiner(s): WOLFE JR, WILLIS RAY
• Application Number:
  US09/735,076
• Publication Number:
  US 20020072647A1
• Time in Patent Office: 1,001 Days
• Field of Search: 600/18, 600/470, 600/481, 600/485, 600/486, 600/488, 600/504, 600/505, 604/100.01, 604/103.07, 604/103.13, 604/914
• US Class Current: 600/18
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• 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 25/10 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

Abstract

A balloon catheter having a micromanometer connected to the catheter and also a fluid-filled transducer system for adjusting micromanometer pressure measurements.

Claims

1. A balloon catheter system comprising a balloon catheter, a fluid-filled pressure measurement system, and a tip pressure sensor,

said balloon catheter comprising a balloon membrane, a tip, a proximal fitting, an outer tube, and an-inner tube disposed within an outer surface of said outer tube, said inner tube extending beyond a distal end of the outer tube, a distal end of the balloon membrane being connected to the tip and to a distal end of the inner tube, a proximal end of the inner tube and outer tube being connected to the proximal fitting,

said tip pressure sensor connected to the tip,

said fluid-filled pressure measurement system comprising a fluid source, connected to the proximal fitting via a fluid source line, and a pressure measurement means for measuring pressure in said fluid source line and in communicating inner tube.

2. The balloon catheter system as claimed in claim 1 wherein the pressure measurement means for measuring pressure in the fluid source line comprises a transducer.

3. The balloon catheter system as claimed in claim 1 further comprising a restriction means between the fluid-source and the fluid source line for controlling the rate of drip of fluid from the fluid source into the fluid source line through the inner tube 4.

4. The balloon catheter system as claimed in claim 3 wherein the fluid source comprises a bag of pressurized saline.

5. The balloon catheter system as claimed in claim 1 wherein the inner tube and outer tube have a coaxial arrangement.

6. The balloon catheter system as claimed in claim 1 wherein the inner tube and outer tube have a co-lumen arrangement.

7. The balloon catheter system as claimed in claim 1 wherein the inner tube is connected to the outer tube.

8. The balloon catheter system as claimed in claim 1 wherein the tip comprises a tip lumen communicating with said inner lumen, an outer surface, and a pocket in said outer surface, and wherein the tip pressure sensor is embedded in the tip with at least one surface being exposed in said pocket.

9. The balloon catheter as claimed in claim 8 wherein said pocket is filled with a protective material.

10. The balloon catheter as claimed in claim 9 wherein said protective material is a gel.

11.The balloon catheter as claimed in claim 8 wherein said pocket is sealed by a membrane.

11. The balloon catheter as claimed in claim 8 wherein said pocket is sealed by a distal end of the balloon membrane.

12. A balloon catheter system comprising a balloon catheter, a fluid-filled pressure measurement system, and a secondary catheter,

said balloon catheter comprising a balloon membrane, a tip, a proximal fitting, an outer tube, and an inner tube disposed within an outer surface of said outer tube, said inner tube extending beyond a distal end of the outer tube, a distal end of the balloon membrane being connected to the tip and to a distal end of the inner tube, a proximal end of the inner tube and outer tube being connected to the proximal fitting,

said secondary catheter fitting within the inner tube and having a pressure sensor connected to a distal end,

said fluid-filled, pressure measurement system comprising a fluid source, connected to the proximal fitting via a fluid source line, and a pressure measurement means for measuring pressure in said fluid source line and in communicating inner tube.

13. A method for measuring pressure in a bodily vessel comprising the steps of:

a) inserting a balloon catheter into said bodily vessel, said balloon catheter comprising a balloon membrane, a tip, a tip pressure sensor connected to said tip, a proximal fitting, an outer tube, and an inner tube disposed within an outer surface of said outer tube, said inner tube extending beyond a distal end of the outer tube, a distal end of the balloon membrane being connected to the tip and to a distal end of the inner tube, a proximal end of the inner tube and outer tube being connected to the proximal fitting, said inner tube being connected to a fluid source line, said fluid source line containing a fluid pressure sensor and being connected to a fluid source, said fluid source delivering a slow drip of fluid through fluid source line and inner tube, said fluid pressure sensor and said tip pressure sensor communicating with a processor for computation of pressure based on signals generated by said tip pressure sensor and said fluid pressure sensor;

b) measuring pressure over a period of time in the bodily vessel via the fluid pressure sensor;

c) calculating a true mean pressure based on said fluid pressure sensor measurements;

d) measuring pressure over the same period of time in the bodily vessel via the tip pressure sensor;

e) calculating an indicated mean pressure based on said tip pressure sensor measurements;

f) comparing the true mean pressure and the indicated mean pressure; and

g) outputting the tip pressure sensor measurements adjusted by the difference between the two mean pressures if the true mean pressure is greater or less than the indicated mean pressure by a predetermined amount, otherwise outputting the tip pressure sensor measurements.

16. The method as claimed in claims 13, 14, 15, or 16 wherein the bodily vessel comprises a blood vessel and the pressure being measured being blood pressure.

17. The method as claimed in claims 13, 14, 15, or 16 wherein the tip comprises a tip lumen communicating with said inner lumen, an outer surface, and a pocket in said outer surface, and wherein the tip pressure sensor is embedded in the tip with at least one surface being exposed in said pocket.

14. A method for measuring pressure in a bodily vessel comprising the steps of:

a) inserting a balloon catheter into said bodily vessel, said balloon catheter comprising a balloon membrane, a tip, a tip pressure sensor connected to said tip, a proximal fitting, an outer tube, and an inner tube disposed within an outer surface of said outer tube, said inner tube extending beyond a distal end of the outer tube, a distal end of the balloon membrane being connected to the tip and to a distal end of the inner tube, a proximal end of the inner tube and outer tube being connected to the proximal fitting, said inner tube being connected to a fluid source line, said fluid source line containing a fluid pressure sensor and being connected to a fluid source, said fluid source delivering a slow drip of fluid through fluid source line and inner tube, said fluid pressure sensor and said tip pressure sensor communicating with a processor for computation of pressure based on signals generated by said tip pressure sensor and said fluid pressure sensor;

b) measuring pressure over a period of time in the bodily vessel via the fluid pressure sensor and the tip pressure sensor;

c) outputting the tip pressure sensor measurements;

d) at a predetermined time interval comparing the tip pressure sensor measurement to the fluid pressure sensor measurement, if the measurements are different by over a predetermined amount and if the fluid pressure measurements are within a predetermined range, then outputting the fluid pressure measurements; and

e) repeating steps (b) and (d) and outputting the fluid pressure measurements until the pressure measurements are within said predetermined amount, then outputting the tip pressure sensor measurements.

15. A method for measuring pressure in a bodily vessel comprising the steps of:

a) inserting a balloon catheter into said bodily vessel, said balloon catheter comprising a balloon membrane, a tip, a tip pressure sensor connected to said tip, a proximal fitting, an outer tube, and an inner tube disposed within an outer surface of said outer tube, said inner tube extending beyond a distal end of the outer tube, a distal end of the balloon membrane being connected to the tip and to a distal end of the inner tube, a proximal end of the inner tube and outer tube being connected to the proximal fitting, said inner tube being connected to a fluid source line, said fluid source line containing a fluid pressure sensor and being connected to a fluid source, said fluid source delivering a slow drip of fluid through fluid source line and inner tube, said fluid pressure sensor and said tip pressure sensor communicating with a processor for computation of pressure based on signals generated by said tip pressure sensor and said fluid pressure sensor;

b) measuring pressure over a period of time in the bodily vessel via the tip pressure sensor;

c) measuring the pressure in the bodily vessel at a predetermined time interval via the fluid pressure sensor;

d) comparing the fluid pressure sensor measurement and the tip pressure sensor measurements; and

e) outputting the tip pressure sensor measurement adjusted by the difference between the two measurements if the fluid pressure sensor measurement is greater or less than the tip pressure sensor measurement by a predetermined amount, otherwise outputting the tip pressure sensor measurement.

18. An intra-aortic balloon pump system comprising an intra-aortic balloon pump, an intra-aortic balloon catheter connected to said intra-aortic balloon pump and an independent blood pressure measurement device connected to said intra-aortic balloon pump, said intra-aortic balloon catheter comprising an outer tube, a balloon membrane, and a tip, a proximal end of the balloon membrane being connected to a distal end of the outer tube and a distal end of the balloon membrane being connected to the tip, said tip having a tip pressure sensor connected to it and communicating with the intra-aortic balloon pump.

19. The intra-aortic balloon pump system as claimed in claim 19 wherein the independent blood pressure measurement device comprises a blood pressure cuff.

20. A method for operating an intra-aortic balloon pump system comprising an intra-aortic balloon pump and an intra-aortic balloon catheter,

said intra-aortic balloon catheter comprising a balloon membrane, a tip, a tip pressure sensor connected to said tip, a proximal fitting, an outer tube, and an inner tube disposed within an outer surface of said outer tube, said inner tube extending beyond a distal end of the outer tube, a distal end of the balloon membrane being connected to the tip and to a distal end of the inner tube, a proximal end of the inner tube and outer tube being connected to the proximal fitting, said inner tube being connected to a fluid source line, said fluid source line containing a fluid pressure sensor and being connected to a fluid source, said fluid source delivering a slow drip of fluid through fluid source line and inner tube, said fluid pressure sensor and said tip pressure sensor communicating with a processor communicating with the intra-aortic balloon pump for computation of pressure based on signals generated by said tip pressure sensor and said fluid pressure sensor,

said method comprising the steps of:

a. continuously measuring pressure via the tip pressure sensor;

b. at predetermined time intervals adjusting pressure readings from the tip pressure sensor based on readings from the fluid pressure sensor;

c. contracting the-balloon membrane prior to cardiac ejection as determined based on the tip pressure sensor readings;

d. inflating the balloon membrane coincident with closure of the aortic valve as indicated by the dicrotic notch of the tip pressure sensor readings; and

e. Repeating steps a-d for the duration of therapy.

21. A method for operating an intra-aortic balloon pump system comprising an intra-aortic balloon pump and an intra-aortic balloon catheter,

said intra-aortic balloon catheter comprising a balloon membrane, a tip, a tip pressure sensor connected to said tip, a proximal fitting, an outer tube, and an inner tube disposed within an outer surface of said outer tube, said inner tube extending beyond a distal end of the outer tube, a distal end of the balloon membrane being connected to the tip and to a distal end of the inner tube, a proximal end of the inner tube and outer tube being connected to the proximal fitting, said inner tube being connected to a fluid source line, said fluid source line containing a fluid pressure sensor and being connected to a fluid source, said fluid source delivering a slow drip of fluid through fluid source line and inner tube, said fluid pressure sensor and said tip pressure sensor communicating with a processor communicating with the intra-aortic balloon pump for computation of pressure based on signals generated by said tip pressure sensor and said fluid pressure sensor,

said method comprising the steps of:

a. continuously measuring pressure via the tip pressure sensor;

b. continuously comparing each pressure reading from the tip pressure sensor with each pressure reading from the fluid pressure sensor and adjusting each tip pressure reading if a predetermined pressure differential exists between the tip pressure sensor reading and the fluid pressure sensor reading;

c. contracting the balloon membrane prior to cardiac ejection as determined based on the tip pressure sensor readings;

d. inflating the balloon membrane coincident with closure of the aortic valve as indicated by the dicrotic notch of the tip pressure sensor readings; and

e. repeating steps a-d for the duration of therapy.

22. A method for operating an intra-aortic balloon pump system comprising an intra-aortic balloon pump, an intra-aortic balloon catheter connected to said intra-aortic balloon pump, and an independent blood pressure measurement device connected to said intra-aortic balloon pump, said intra-aortic balloon catheter comprising an outer tube, a balloon membrane, and a tip, a proximal end of the balloon membrane being connected to a distal end of the outer tube and a distal end of the balloon membrane being connected to the tip, said tip having a tip pressure sensor connected to it and communicating with the intra-aortic balloon pump, said method comprising the steps of:

a. continuously measuring pressure via the tip pressure sensor;

b. at predetermined time intervals adjusting pressure readings from the tip pressure sensor based on readings from the independent blood pressure measurement device;

c. contracting the balloon membrane prior to cardiac ejection as determined based on the tip pressure sensor readings;

d. inflating the balloon membrane coincident with closure of the aortic valve as indicated by the dicrotic notch of the tip pressure sensor waveform; and

e. repeating steps a-d for the duration of therapy.

23. The method as claimed in claim 23 wherein the independent blood pressure measurement device comprises a blood pressure cuff.