Apparatus and method for removing obstructions in bodily organs or cavities

• US 4,902,276 A
• Filed: 04/11/1988
• Issued: 02/20/1990
• Est. Priority Date: 06/09/1986
• Status: Expired due to Term

• Current Assignee: Development Collaborative Corporation
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Zakko, Salam F.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/180,099
• Time in Patent Office: 680 Days
• Field of Search: 604/27-34, 604/43, 604/21, 604/48-51, 604/65-67, 604/118-120, 604/151, 604/153, 604/246, 604/284, 604/317, 128/328, 128/748, 128/750, 128/DIG. 12, 128/DIG. 13, 417/2, 417/38, 417/44, 417/279, 417/302
• US Class Current: 604/28
• 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 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
• CPC Class Codes: A61M 2210/1075 Gall bladder

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 passages 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. Apparatus for removal of a soluble obstruction in a bodily organ or cavity, comprising:

source reservoir means for containing a fluid capable of dissolving said obstruction;

first and second fluid conduits attached to and forming a fluid circuit with said reservoir means and said organ or cavity and providing fluid communication between said reservoir means and said organ or cavity;

pump means associated with each of said conduits to move said fluid in said conduits around said circuit;

means for detecting and measuring fluid pressure in said organ or cavity, said means adapted to classify said pressure as high, normal or low according to predetermined physiological criteria; and

means operatively connecting said means for detecting and measuring pressure and each of said pump means and responsive to said organ or cavity fluid pressure to cause said pump means to maintain forward fluid flow at low and normal pressure and to decrease or reverse fluid flow at high pressure.

2. Apparatus as in claim 1 wherein said responsive means comprises:

controller means to operate said pumps;

a first valve situated in said first fluid conduit and opened or closed by said controller means, said first valve being open at low or normal pressures and normally closed at high pressures;

a second valve situated in said second fluid conduit and opened or closed by said controller means, said second valve being open at low or normal pressures and closed shortly after detection of high pressure;

a bypass conduit connected to said first conduit for diverting fluid around said pump in said first conduit; and

a third valve situated in said bypass conduit and opened or closed by said controller means, said third valve being closed at low or normal pressures and normally open at high pressures.

3. Apparatus as in claim 2 wherein said detecting and measuring means comprises a pressure transducer.

4. Apparatus as in claim 3 wherein said responsive means includes a pressure sensing averaging circuit in communication with said pressure transducer.

5. Apparatus as in claim 2 wherein said controller means also causes said valves to cycle between open and closed portions several times while high pressure persists and then to halt operation of all pumps and activate an alarm if said high pressure has not been reduced to normal pressure during said cycling.

6. Apparatus as in claim 1 wherein said responsive means comprises:

motor and motor drive means for each of said pump, and

controller means operatively connected to said pumps and responsive to signals from said pressure transducer to operate each pump through said motor and motor drive means independently as determined by whether said pressure is high, normal or low, said controller means causing said pumps to produce forward flow at low and normal pressure and to halt or reverse flow in at least the pump in the first of said fluid conduits at high pressure.

7. Apparatus as in claim 6 wherein said controller means also causes said pumps to cycle between forward and reverse flow if high pressure persists and to switch said pump to aspiration and activate an alarm if after several such cycles such high pressure has not been reduced to normal pressure during said cycles.

8. Apparatus as in claim 6 wherein said detecting and measuring means comprises a pressure transducer.

9. Apparatus as in claim 8 wherein said responsive means includes a pressure sensing averaging circuit in communication with said pressure transducer.

10. Apparatus as in claim 6 wherein said controller means responds to said transducer through an averaging circuit.

11. Apparatus as in claim 1 wherein the terminal portion of each said first and second fluid conduits distal to said source reservoir means are combined into a catheter.

12. Apparatus as in claim 11 where said catheter is a three-lumen catheter comprising a first lumen for passing fluid from a source reservoir to said organ or cavity, a second lumen for passing said fluid from said organ or cavity to a receiver reservoir and a third lumen for communicating said pressure to said measuring means.

13. A method for removing a soluble obstruction in a bodily organ or cavity, comprising:

inserting a catheter into said organ or cavity, said catheter having at least two fluid conduits each communicating with source and receiver reservoir means for containing a fluid suitable for dissolving said obstruction, said catheter, reservoir means and conduits forming a fluid circuit;

providing a pump in each of said conduits for moving said fluid through said conduits between said reservoir and said organ or cavity;

detecting and measuring fluid pressure in said organ or cavity, said pressure being classified as high, normal or low according to predetermined physiological criteria;

causing said pumps by means responsive to said high, normal or low pressure to produce forward fluid flow in said circuit when said pressure is low or normal and to halt or reverse said fluid flow when said pressure is high, said fluid thus at normal or low pressure contacting and dissolving said obstruction.

14. A method as in claim 13 wherein said fluid is in turbulent flow while in contact with said obstruction.

15. A method as in claim 13 further comprising cycling said fluid flow between forward and reversed flow several times while said high pressure persists.

16. A method as in claim 15 further comprising halting said fluid flow and activating an alarm if said high pressure has not been reduced to normal pressure during said several cycles.

17. A method as in claim 13 wherein said bodily organ is a gallbladder and said obstruction is a gallstone.

18. Apparatus for removal of gallstones from the gallbladder, comprising:

a reservoir for containing fluid capable of dissolving gallstones;

first and second fluid conduits each having one end communicating with said reservoir and another end communicating with the gallbladder;

pump means comprising first and second pumps operatively associated respectively with said first and second conduits for moving said fluid in said first conduit in the infusion direction from said reservoir into the gallbladder, and for moving said fluid in said second conduit in the aspiration direction from the gallbladder to said reservoir;

whereby, by simultaneous infusion and aspiration, continuous withdrawal of said fluid after exposure to said gallstones can be maintained at a substantial rate over prolonged periods;

said apparatus including a control system for selectively inhibiting infusion, said control system including means for continuously monitoring pressure within said gallbladder, means for determining the relationship of said pressure with respect to a desired range based on predetermined physiological criteria, and means for selectively inhibiting infusion in response to said pressure being above said desired range.

19. The apparatus of claim 18 wherein said control system includes means for inhibiting aspiration in response to said pressure being below said desired range.

23. The apparatus of claim 18, 20 or 21 wherein the pump means is adapted to transfer the solvent into the gallbladder at rates in the range between about 50 ml/min to 300 ml/min.

24. The apparatus of claims 18, 20 or 21 programmed to respond to occurrence of a selected irregular pressure condition in said gallbladder by automatically momentarily reversing flow to clear a possible obstruction to normal flow.

25. The apparatus of claim 18, 20 or 21 wherein said control system includes averaging means that functions to prevent response to a transient high pressure signal such as coughing or laughing.

26. The apparatus of claim 18, 20 or 21 wherein said pump means is of the peristaltic type.

27. The apparatus of claim 18, 20 or 21 in combination with a multilumen catheter constructed to infuse and aspirate solvent with respect to said gallbladder, an independent lumen of said catheter adapted to transmit an actual pressure signal from said gallbladder to said control system.

28. The apparatus of claim 27 wherein said catheter is of curved configuration and the opening for said pressure transmitting lumen is on the inside surface of said curved configuration.

29. The apparatus of claim 18, 20 or 21 in which said pump means is provided with a controllable motor and said control system controls said flow by controlling the direction and speed of the motor.

30. The apparatus of claim 29 wherein said pump means comprises an infusion pump and an aspiration pump, each driven by a respective motor controlled by said control system.

31. The apparatus of claim 29 wherein said control system includes a microprocessor.

32. The apparatus of claim 18, 20 or 21 wherein a critical leakage pressure which differs from patient to patient is predetermined and the control system is adapted to conduct said infusion and aspiration in the manner preventing exceeding said pressure while solvent is within the gallbladder.

33. The apparatus of claim 32 including means for causing maximal aspiration upon the occurrence of actual gallbladder pressure of a value related to but below the predetermined critical pressure.

20. In a gallstone removal apparatus which includes a liquid transfer system for introducing liquid solvent to and removing said liquid solvent from the gallbladder of a living patient via a catheter in a manner to cause the gallstone to disintegrate and be removed with the liquid;

the improvement wherein the liquid transfer system includes a control system comprising a controller and means for continuously determining and supplying to the controller the actual liquid pressure within the gallbladder during the treatment;

said controller having means to receive from the attending operator a pressure setting related to the predetermined pressure at which flow of the solvent out of the gallbladder into other parts of the body may occur and said controller being responsive to actual sensed gallbladder pressure to cause pump means to automatically reduce the quantity of solvent within said gallbladder upon the occurrence of actual gallbladder pressure in excess of a high pressure value based upon said setting, thereby preventing release of said solvent into the body.

21. The apparatus of claim 20 wherein said pump means comprises an infusion pump and an aspiration pump, said pumps capable of operating simultaneously to infuse and aspirate said solvent relative to said gallbladder through respective lumens of said catheter whereby continuous flow of said solvent into and out of said gallbladder can be maintained by said controller during normal operation, said controller adapted to stop infusion and continue aspiration when actual gallbladder pressure exceeds said high pressure value.

22. The apparatus of claim 21 wherein said controller is capable of operating said pump means to simultaneously infuse and aspirate over a set pressure range and in response to actual gallbladder pressure below said range, said controller adapted to automatically stop aspiration while maintaining infusion flow.

34. In a method of removing gallstones from the gallbladder of a patient by infusion and aspiration of a solvent, the steps of inputting into a control system a predetermined pressure value for the respective patient representing the pressure at which leakage from the gallbladder into other parts of the body may occur, infusing and aspirating the solvent into and out of the gallbladder, monitoring the actual fluid pressure within the gallbladder and, with said control system, in response to actual pressure approaching said predetermined value, stopping the infusion and aspirating solvent from the patient.

35. The method of claim 34 in which said predetermined value is related to the pressure in the gallbladder during normal contraction of the gallbladder that releases bile to the duodenum.