Apparatus and method for removing obstructions in bodily organs or cavities

Claim 2

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.

Claim 3

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.

Claim 4

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

Claim 5

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

Claim 6

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.

Claim 7

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.

Claim 8

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.

Claim 9

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

Claim 10

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

Claim 11

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

Claim 12

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.

Claim 13

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.

Claim 16

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

Claim 17

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

Claim 18

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.

Claim 19

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

Claim 20

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.

Claim 21

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.

Claim 22

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

Claim 23

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.

Claim 24

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.

Claim 25

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.

Claim 26

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.

Claim 27

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.

Claim 29

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.

Claim 30

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

Claim 31

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.

Claim 32

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.

Claim 33

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.

Claim 34

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.

Claim 35

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

Claim 36

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.

Claim 37

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.

Claim 38

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.

Claim 39

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.

Claim 40

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.