Apparatus, and method for chemical contact dissolution of gallstones

• US 5,514,088 A
• Filed: 06/02/1995
• Issued: 05/07/1996
• Est. Priority Date: 06/09/1986
• Status: Expired due to Term

• Current Assignee: Development Collaborative Corporation
• Original Assignee: Development Collaborative Corporation
• Inventors: Zakko, Salam F.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/459,532
• Time in Patent Office: 340 Days
• Field of Search: 604/27-34, 604/43, 604/21, 604/48-51, 604/65-67, 604/898, 604/317, 604/151, 128/DIG. 12, 128/DIG. 13, 128/748, 128/750
• US Class Current: 604/31
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/772 operating alternately
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure

Abstract

A fully automatic organ pressure sensitive apparatus for dislodging and removing obstructions in bodily cavities or organs by both delivering and removing fluid thereto, operable by high rate continuous or intermittent infusion of fluid solvent over a set pressure range to effect rapid dissolution and removal of the obstruction without complications to the patient. By continuous feedback monitoring of fluid pressure in the bodily organ or cavity of interest, the apparatus can constantly vary infusion and aspiration rates to maintain the set pressure range. If the pressure persists above or below the set range, the apparatus activates a safety feature leading to a period of maximal aspiration and cessation of infusion, followed by cessation of solvent transfer and triggering of an alarm to alert the operator.

Claims

1. An apparatus for dissolving stones in a gallbladder comprising:

a solvent capable of dissolving stones in the gallbladder;

a catheter having a side wall, and distal and proximal ends, said catheter including first, second and third lumens, each of the lumens including a separate hole in said catheter side wall;

a first pump connected in fluid communication with the proximal end of said first lumen;

said first pump infusing said solvent into the gallbladder at a high rate of flow;

a second pump connected in fluid communication with the proximal end of said second lumen;

said second pump aspirating said solvent and dissolved stones out of the gallbladder;

a transducer connected in fluid communication with the proximal end of the third lumen;

said transducer generating a signal indicative of intragallbladder pressure; and

a microprocessor, connected to said first and second pumps, and to said transducer, and responsive to the intragallbladder pressure indicating signal, said microprocessor controlling operation of said first and second pumps.

2. The apparatus of claim 1 including a program operating said microprocessor to reduce the speed of operation of said first pump when said intragallbladder pressure indicating signal indicates an intragallbladder pressure above a predetermined upper limit at which solvent may leak out of the gallbladder.

3. The apparatus of claim 2 wherein said program operates said second pump at full speed.

4. The apparatus of claim 1 including a program operating said microprocessor to reduce the speed of operation said aspiration pump when said intragallbladder pressure indicating signal indicates an intragallbladder pressure below a predetermined lower limit at which bile may be aspirated from the bile duct into the gallbladder.

5. The apparatus of claim 1 including a program operating said microprocessor to reverse a direction of operation of said first pump when said intragallbladder pressure indicating signal indicates that an intragallbladder pressure has remained above a predetermined upper limit for longer than a predetermined time which may lead solvent to leak out of the gallbladder.

6. The apparatus of claim 5 wherein said program reverses the direction of said second pump to infuse said solvent through the second lumen when said intragallbladder pressure indicating signal indicates an intragallbladder pressure near a predetermined lower limit to clear second lumen blockages.

7. The apparatus of claim 5 including means for signalling an alarm if the direction of operation of said second pump is reversed more than a predetermined number of times during a second predetermined time.

8. The apparatus of claim 1 including means for measuring a first amount of said solvent infused through said first lumen, means for measuring a second amount of said solvent aspirated through said second lumen, and means for comparing the first and second amounts to determine the amount of said solvent in the gallbladder, and wherein said microprocessor controls a speed of operation of said first and second pumps so as to substantially continuously maintain a predetermined amount of said solvent in the gallbladder.

9. The apparatus of claim 1 including means for signalling an alarm when the intragal bladder pressure indicating signal does not indicate a significant change in fluid pressure within the gallbladder during a predetermined time.

10. The apparatus of claim 1 wherein the proximal ends of said first and second lumens include nonstandard connectors for mating with said first and second pumps to minimize the likelihood of injury due to improper use of the apparatus.

11. An apparatus capable of dissolving stones in a gallbladder comprising:

a solvent dissolving stones in the gallbladder.;

a catheter having a side wall, and distal and proximal ends, said catheter including first and second lumens, each of the first and second lumens including a separate hole in said catheter side wall;

said holes exchanging fluid between the gallbladder and respective lumens;

a first pump connected in fluid communication with the proximal end of said first lumen;

a second pump connected in fluid communication with the proximal end of said second lumen;

a transducer mounted near the distal end of the catheter and in direct communication with the gallbladder fluid contents;

said transducer generating a signal indicative of intragallbladder pressure; and

a microprocessor, connected to said first and second pumps, and to said transducer, and responsive to the intragallbladder pressure indicating signal, said microprocessor controlling the speed and direction of operation of said first and second pumps for moving said solvent into and out of the gallbladder.

12. The apparatus of claim 11 including a program operating said microprocessor to reduce the speed of operation of said first pump when said intragallbladder pressure indicating signal indicates an intragallbladder pressure near a predetermined upper limit above which solvent may leak out of the gallbladder.

13. The apparatus of claim 12 wherein said program operates said second pump at full speed.

14. The apparatus of claim 11 including a program operating said microprocessor to reduce the speed of operation of said second pump when said intragallbladder pressure indicates an intragallbladder pressure near a predetermined lower limit below which bile may be aspirated from the bile duct into the gallbladder.

15. The apparatus of claim 11 including a program operating said microprocessor to reverse the direction of operation of said first pump when said intragallbladder pressure indicating signal indicates that an intragallbladder pressure has remained near a predetermined upper limit for longer than a predetermined time which may lead solvent to leak out of the gallbladder.

16. The apparatus of claim 15 wherein said program reverses the direction of said second pump to infuse said solvent through the second lumen when said intragallbladder pressure indicating signal indicates an intragallbladder pressure near a predetermined lower limit to clear second lumen blockages.

17. The apparatus of claim 11 wherein the proximal ends of said first and second lumens includes nonstandard connectors for mating with said first and second pumps to minimize the likelihood of injury due to improper use of the apparatus.

18. A method of dissolving stones in a gallbladder comprising the steps of:

determining an upper fluid pressure limit above which fluid may leak out of the gallbladder;

determining a lower fluid pressure limit below which bile may be aspirated from the bile duct into the gallbladder;

infusing a solvent capable of dissolving stones in the gallbladder through a first lumen to the gallbladder at an infusion flow rate;

aspirating the solvent and dissolved stones through a second lumen and from the gallbladder at an aspiration flow rate;

measuring an intragallbladder pressure; and

controlling the infusion and aspiration rates in response to the measured intragallbladder pressure to maintain the intragallbladder pressure substantially between the upper and lower limits.

19. The method of claim 18 wherein said controlling step comprises stopping infusion of solvent through the first lumen when the measured intragallbladder pressure exceeds the determined upper limit.

20. The method of claim 19 wherein said controlling step comprises aspirating solvent through the first lumen after the measured intragallbladder pressure has exceeded the determined upper limit for longer than a predetermined time.

21. The method of claim 20 wherein said controlling step comprises infusing solvent through the second lumen to clear blockages.

22. The method of claim 21 including the step of signalling an alarm if the gallbladder is infused through the second lumen for more than a predetermined number of occasions during a second predetermined time.

23. The method of claim 18 wherein said controlling step comprises stopping aspiration of solvent through the second lumen when the measured intragallbladder pressure falls below the determined lower limit.

24. The method of claim 18 including the steps of stopping infusion, and aspirating solvent through the first lumen when the measured intragallbladder pressure remains below the determined lower limit for longer than a predetermined time.

25. The method of claim 24 including the step of signalling an alarm.

26. The method of claim 18 including the step of signalling an alarm when the measured intragallbladder pressure does not significantly vary during a predetermined period.

27. The method of claim 18 including the step of signalling an alarm when a predetermined operating intragallbladder pressure has not been obtained after infusing for a predetermined period of time.

28. The method of claim 18 including the steps of determining an available volume of the gallbladder, and stopping infusion and aspirating solvent through the first lumen when a predetermined operating intragallbladder pressure has not been obtained after infusing an amount of solvent about equal to the available volume of the gallbladder.

29. The method of claim 28 including the step of aspirating solvent through the first lumen when a predetermined lower operating intragallbladder pressure has not been obtained after aspirating an amount of fluid equal to the available volume of the gallbladder.

30. The method of claim 18 including the step of measuring the concentration of cholesterol in the aspirated solvent to monitor progress of the stone dissolution.

31. The method of claim 30 including the step of replacing the solvent when the cholesterol concentration reaches a predetermined level.