JP3046620B2 - Apparatus and catheter for dissolving gallstones - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to the serial number 06 / 871,775 of June 9, 1986.
Part of a series of inventions filed as serial number 07 / 180,099 on April 11, 1988.

BACKGROUND OF THE INVENTION For most people with gallstone disease, the method of treatment has been cholecystectomy, or removal of gallstones by surgery. In the United States alone, about 500,000 such surgeries are performed each year. Recently, gallstones were removed in situ due to high cost, long recovery times, and possible side effects of surgery.
Itu) has been developed for chemical removal. Generally, this method involves inserting a catheter into the gallbladder and injecting a chemical solvent that dissolves gallstones. Thus, this method avoids surgery and the risks associated therewith.
Various chemical solvents have been tried and are known to exert various dissolving effects, depending on the gallstone chemistry. Gallstones generally consist of cholesterol or calcium salts, especially calcium bilirubate or calcium carbonate. Although lipid solvents are effective in dissolving cholesterol gallstones, they dissolve little or no at all with gallstones composed of calcium salts. Thus, diethyl ether rapidly dissolves cholesterol gallstones, but other solvents such as mono-octanoin and octadiol (glycerol-1-octyl ether).
(Glyceryl-1-octyl ether)) also has good solubility. Unfortunately, few, if any, solvents dissolve calcium gallstones sufficiently. Thus, the present invention has basic utility in removing cholesterol gallstones. Ether compounds, such as diethyl ether, have very good cholesterol dissolving properties, i.e. low viscosity,
Although rapidly soluble, diethyl ether has been found to be dangerous because it boils below body temperature. Conventionally, methyl tertiary butyl ether (MTBE), which has been used mainly as a gasoline additive and a solvent for chromatography, has all the properties of ethers, and has recently been used for dissolving gallstones.
In addition, MTBE boils above body temperature and dissolves gallstones quickly without damaging the gallbladder mucosa.

Due to the effectiveness of these new solvents, MTEB is the fastest and most effective dissolution of gallstones without the side effects of entering the solvent in patients suffering from gallstones.
Considerable effort has been put into the development of devices and methods for injecting and similar solvents. (For simplicity, reference is made here to the use of MTBE as a solvent. However, the present invention is also available for a number of other solvents.) Treats cholesterol gallstones by manually injecting MTEB into the gallbladder with a syringe. [Walker, Lancet,
1 , 874 (1891); Shortsleeve, Radiology 153 , 547 (198
4); Teplick, Radiology, 153 , 379 (1984)]. In addition to this, doctors, for example, have issued patents to
Petent No. 4,655,744 to Thistls et al.) Fixed volume injection pumps for injecting and aspirating MTBE as described are available. There are several side effects associated with manual infusion and pump-based infusion processes. When MTBE is infused manually with a glass syringe or with a fixed-volume circulating pump, spontaneous contraction of the gall bladder or overfilling the gallbladder cannot be detected or adjusted. As a result, MTBE sometimes enters the duodenum and damages the duodenal mucosa. And it causes nausea, vomiting, duodenal swelling, and, associated with it, quite painful enough to require frequent administration of painkillers. In addition, in the duodenum, MTBE is absorbed into the blood and can cause somnolence and hemolysis, with the accompanying extremely irritating MTBE odor appearing in the patient's breath. Come.

Another problem with the manual or pump-based syringe method is the inefficient removal of insoluble gallstone grains, which make up cholesterol gallstones in varying proportions. Such particles often remain in the gall bladder after MTBE has dissolved the cholesterol portion, using methods such as syringes and infusion pumps. These grains often serve as foci for the formation of new gallstones. In addition, both of these methods are time consuming, labor intensive and require sophisticated techniques. As a result, these methods are expensive, due to the labor costs of having highly skilled professionals work long hours, often over 12 hours. Also, fixed-volume infusion pumps cannot prevent bile from entering the gall bladder during secretion from the liver. Bile in the gallbladder prevents solvent from coming into contact with gallstones, slowing dissolution.

Clearly, infusion of MTBE into a patient requires utmost care to avoid solvent entering the patient's body fluids and areas outside the affected area. Therefore, a key idea in developing devices for use in gallstone dissolution chemotherapy is to ensure controlled and elimination of the delivery of the solvent that dissolves gallstones. MT
Given that studies have shown that solvents such as BE are harmful when entering the intestine where they are absorbed, the elimination of such drugs during gallstone removal chemotherapy Is critically needed.
At the same time, such devices must be able to maintain a high circulation rate of the solvent to the gall bladder in order to promote dissolution and to provide the necessary agitation to expel insoluble residues.

Also, it is necessary to ensure the containment of the solvent,
In addition to the above safety features, the device is easy to use (“us
er friendly "), must not require highly skilled technicians, and for the same reason, must be easy to maintain.

With some thought, it can be seen that there are considerable obstacles that must be overcome when developing a device with the above features. For example, it is high performance (“intelligent”)
It must be able to detect instantaneous changes in gallbladder pressure due to gallbladder contraction or solvent injection, and to be able to transmit that information quickly to adjust the feedback circuit. This is a significant feature for such devices. If gallstones prevent the circulation of solvent through the gallbladder in any way, the critical pressure will increase, causing organs to rupture,
Leakage of solvent from the gallbladder to cystic vessels into the general vessels and intestines may occur. Thus, the device senses changes in gall bladder pressure over a predefined range and acts at a rate sufficient to maintain pressure in that range, and if pressure persists outside the range, shuts off or acts properly. It must be high-performance ("intelligent") in the sense that it does. In addition, it is desirable to have a device that can not only cut off, but also allow debris that actually causes interference to flow out and restore normal operation with the debris removed. Such devices are intra-gallbladder
The pressure should be prevented from rising to the point where leakage occurs, and from dropping bile below the pressure that enters the gallbladder through the ducts.

SUMMARY OF THE INVENTION The present invention comprises an apparatus and method for treating obstacles in living organs, particularly stones of the gall bladder and bile ducts, by rapid solvent circulation. The device has features desirable for continuous high-speed infusion and inhalation while preventing leakage of solvent from living organs during treatment. The device consists of a forward and reverse working solvent transporter connected to a feedback regulation circuit with a pressure transducer.

The device can be pre-adjusted to allow perfusion within a set pressure range. Actual intraluminal (intral
The continuous feedback of the uminal organ pressure to the regulating circuit via the transducer regulates the speed and net direction of solvent transport with this device. This feedback determines whether the device works in the forward or reverse direction. Over this range, solvent is constantly delivered from the reservoir to the gallbladder and is aspirated from the gallbladder into a suitable container. The transport and removal of the solvent is a sufficiently effective rate for dissolving, grinding, and agitating and aspirating the debris. If the pressure increases,
A feedback circuit switches the device to a high pressure mode, thereby diverting solvent from the gallbladder. If after a preset time the gallbladder pressure sensing transducer indicates a return to normal operating pressure range, the device automatically resumes normal infusion and aspiration (perfusion) mode.

Another feature of the present invention is an automatic purification mechanism. At pre-set intervals, if the pressure does not decrease, the device enters a reverse mode to clean the suction port of the catheter. This allows liquid to be sucked backward through the inlet and to be injected at discrete short intervals from the inlet for purification. During this time, the organ pressure is continuously monitored. When the obstruction is removed by this "self-cleaning" action, the pressure transducer will again show normal operating pressure and the device will resume operation at normal pressure. However, if an obstacle cannot be removed after a set number of cleaning cycles, an alarm circuit will be activated to alert the user. Further features of the present invention are as follows. The ability to distinguish between therapeutically significant pressure changes that occur in the gall bladder, causing the contents of the gall bladder to overflow into the duodenum, and insignificant changes that occur as a result of coughing, laughter, or similar behavior. This feature prevents unnecessary operating mode changes.

A further outstanding feature of the present invention is a catheter for contact dissolution of gallstones having a side-by-side solvent injection lumen and a solvent suction lumen. The catheter is sized to allow its distal portion to be introduced into the gallbladder from outside the body. Each lumen has at least one opening in the distal portion for communication between the gallbladder and a remotely located pump.
The third lumen provides a means of continuously sensing the pressure of the fluid in the gall bladder and sending instructions to the regulator for adjustment of the infusion and aspiration of the solvent through the lumen. One feature of the present invention is that the cross-sectional area of the suction lumen is larger than the cross-sectional area of the injection lumen. Fluid is injected and drained into each lumen through a series of openings in the catheter wall. The cross-sectional area of each opening is smaller than the cross-sectional area of the opening at the time of communication. The catheter further includes a retention device that prevents the gall bladder from dislodging. The retaining device is of a distally curved shape. The pressure sensing device is mounted inside the curved shape to avoid obstruction of the gallbladder by mucous membranes. The holding device may alternatively be an inflatable balloon next to the distal end.

A pull string is included to hold the distal end of the catheter into a curved configuration. The catheter also has a threading lumen for threading. Alternatively, the thread can be passed through any of the suction, infusion or pressure sensing lumens. The distal opening of the catheter is in communication with the suction lumen. The catheter has at least one suction opening, which is located near all the injection openings. The closely located suction opening is located next to the point of entry of the catheter into the gall bladder when in the catheter use position. The lumen and the distal opening of the lumen are assembled and positioned so that the catheter can pass through the guidewire. The catheter is
It is made of a material that is resistant to solvents injected into the gallbladder, such as polyurethane.

A device for sensing fluid pressure in the gallbladder extends alongside the infusion and aspiration lumens and includes a third fluid pressure transmission lumen having a distal opening at the distal end of the catheter.
The lumen is made to transmit the pressure in the gallbladder through a hydrostatic fluid column to a remote pressure transducer. In the third lumen, the fluid pressure sensing device consists of a pressure transducer located near the catheter. Alternatively, a pressure changer may be placed at the end of the catheter and used for in situ gall bladder pressure measurements. Transducers for such in situ use are made of piezoelectric or light permeable glass or plastic fibers and are removably inserted into the lumen of the catheter. The wires or fibers of the in situ transducer on the distal end of the catheter can be passed through the pressure lumen, the infusion lumen or the suction lumen, or may be embedded in the wall of the catheter. The catheter is positioned at its distal end to prevent inadvertent use with incompatible systems,
It has a structure that can be used only with a solvent delivery system that has a predetermined mating structure. Alternatively, it has electrical or optical fiber terminations at the distal end of the base for use only with a solvent delivery system having predetermined electrical or optical fiber terminations.

One feature of the invention is a pump control module, i.e., an infusion pump that delivers solvent through the infusion lumen to the patient's gall bladder, and a module that adjusts the speed and direction of the aspiration pump that delivers solvent from the patient's gall bladder through the aspiration lumen. And a microprocessor programmed to execute an algorithm in response to an input pressure signal transmitted through the response determination module that adjusts the function of the pump control module in response to the pressure measurement of the pressure measurement module. The reaction determination module may be used to clean the suction lumen for a given time period or when a predetermined volume of pressure change is not detected during a given time period. When an abnormal pressure is detected after the pressure has been detected, when a purification cycle equal to or more than a predetermined time has occurred during a predetermined time, or when the detected pressure remains lower than a predetermined low limit for a predetermined time. , Or when the system is unable to maintain the pressure in the normal range for a predetermined period of time), and an alarm is generated, and maximum continuous aspiration is initiated using both the infusion and aspiration pumps.

The response determination module stops infusion and adjusts aspiration in response to pressure in the gallbladder above the upper limit, and continues aspiration through the infusion lumen until the pressure drops to an acceptable level. The response determination module then reverses the flow to purify the suction lumen. The module also stops aspiration in response to conditions where the pressure drops below a set low limit.

In another aspect of the invention, a means for continuously measuring the pressure in the patient's gall bladder, and controlling the injection and suction of a solvent into the gall bladder in response to the pressure measurement to control the pressure in the gall bladder. Is provided within a predetermined range.

Yet another feature of the present invention is a method of dissolving gallstones that continuously measures the pressure in the patient's gallbladder and controls the infusion and suction of solvent into the gallbladder in response to the measurement. This dissolving method further employs a method of periodically measuring the amount of cholesterol in the solvent and replacing the solvent when the cholesterol concentration in the solvent reaches a predetermined limit.

In addition, this dissolution method measures the critical leak pressure at which fluid in the gall bladder flows to adjacent parts of the body prior to introduction of the solvent into the gall bladder, and uses the measured pressure to control the infusion and aspiration of the solvent. Used for The measurement of the critical leak pressure is also performed by injecting an opaque dye into the gallbladder under increasing pressure until the outflow of the dye is observed on a radiograph. In this case, the pressure value required to cause the dye to leak is recorded as the critical leak pressure,
The amount of fluid required to fill the gallbladder is the tolerance. The process of injecting the solvent into the gall bladder is effected at a rate sufficient to cause turbulence of the solvent near the gallstones.

Further, in another aspect of the present invention, a system bus, a microprocessor connected to the system bus, a memory connected to the bus and holding an arithmetic expression, an input terminal for receiving an analog signal representing the internal pressure of the gallbladder, There is provided a system comprising an analog-to-digital converter having an output terminal for applying a digital signal representing the internal pressure to the bus, and a pressure transducer having a pressure sensor and an output terminal connected to an input terminal of the converter. In this case, the pressure transducer generates a pressure signal related to the solvent pressure in the gallbladder.

The system also includes a reservoir for storing the gallstone dissolving solvent, an infusion pump connected by a conduit to pump the solvent into the gall bladder from the reservoir, and withdrawing the solvent from the gall bladder to drain the solvent into the reservoir. It has a suction pump connected by a conduit.
Further, the system comprises a pump controller having an input terminal connected to the bus and a plurality of output terminals, one of the plurality of output terminals being connected to the suction pump and the other output terminal being connected to the infusion pump. Connected
The microprocessor controls the pump controller, which controls the suction pump and the infusion pump in response to signals provided by the pressure transducer. The microprocessor functions to stop the injection of the solvent and start the suction in response to the signal indicating the excessive pressure in the gallbladder.

Further, the system comprises a catheter having a plurality of lumens, a first lumen connected to the infusion pump at a terminal thereof, and a second lumen connected to the suction pump at a terminal thereof. The system detects fluid pressure in the gallbladder applied to the distal end of the catheter and continuously applies an indication of the fluid pressure to the pressure transducer.

In yet another aspect of the present invention, the ability to safely dissolve gallstones when pressure measurements are indeterminate by intermittent infusions of less than or equal to the gallbladder solvent is provided.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic view of an apparatus for transporting a solvent to the gallbladder and removing the solvent containing dissolved gallstones or fragments thereof.

FIG. 2 is a schematic diagram of a control circuit for adjusting the other features of the apparatus shown in FIG. 1 and the pump unit.

FIGS. 3, 4 and 5 show the features of the three lumen catheter, and FIG. 3 shows a cross-sectional view along line 3-3 in FIG.

 FIG. 6 is a schematic diagram of another specific expression of the apparatus.

7 and 8 illustrate features of another suitable three-lumen catheter, and FIG. 8 is a cross-sectional view taken along line 8-8 of FIG.

FIG. 9 is a schematic view of a part of a specific catheter designed based on a pigtail catheter. FIG. 9A is a cross-sectional view of the catheter taken along line 9A-9A of FIG.

FIG. 10 is a block diagram incorporating a device including a microprocessor control unit of the device.

FIG. 11 is a schematic view of the catheter of the present invention located in the gallbladder of a patient.

FIG. 12 is a flow diagram showing an algorithm that systematizes the present invention depicted in FIG. Figure 12A shows the first
3 is a flow diagram of a pump start subroutine of the algorithm of FIG. 2; FIG. 12B is a flow diagram of the purification subroutine of FIG. FIG. 12C is a flow diagram of the alarm subroutine of FIG. No.
FIG. 12D is a flow diagram of the pressure limit check subroutine of FIG. FIG. 12E is a pump control subroutine of FIG.

DETAILED DESCRIPTION OF THE INVENTION The invention described herein is suitable for use in delivering fluids (solvents) to an organ and removing obstacles therein. First, although the present invention described below details an invention relating to the removal of gallstones from the gall bladder, the present invention can be used for removing various obstacles from body lumens or organs other than the gall bladder, and thus the gallstone treatment. It should be understood that they should not be construed as narrowly limited to Furthermore, it will be readily apparent that the present invention is indeed suitable for removing obstacles from organs and body lumens.

The invention described herein is an apparatus for sensing organ pressure through one or more pressure transducers that monitor pressure in the organ, having a solvent supply in constant communication with a control circuit.

The pressure transducer will be located at the proximal end of the fluid-filled column located in the gall bladder, either within the gall bladder itself or outside the patient. This can be accomplished by using the pressure sensing lumen as a fluid-filled column, or alternatively as an in situ position of the pressure sensing transducer itself. A variety of different pressure transducers are available for both in situ and fluid column use. The in situ transducer must be small and able to withstand the effects of solvent resistance. Suitable transducers include, but are not limited to, fiber optic pressure sensors, pressure-voltage sensors, or capacitive sensors. The wire or fiber of the in situ transducer may penetrate a separate pressure sensing or solvent flow lumen,
Alternatively it would also be fixed to the catheter wall. A suitable transducer for use at the proximal end of the fluid column is the Staysam Gold pressure transducer P23ID. When using an in situ transducer, the transducer can be removed from or inserted into the catheter, provided that the catheter is in the correct position in the gallbladder. In this way, the transducer can be replaced during the position.
Moreover, such an insertable transducer can be located in one of the flow lumens, thus allowing the use of a smaller catheter for the same amount of liquid flow.
The function of the device with respect to the presetting of the pressure range that transports fluid to the gallbladder causes the fluid to contact and dissolve gallstones
Gallstone solutions and debris are removed by collecting fluid from the gallbladder. The rate of solvent transport and removal can be adjusted in response to the necessary turbulence generated by the gallstone solution or debris. If the pressure exceeds the limits of the normal operating range, the device diverts the solvent away from the organ, thereby preventing leakage of the solvent from the treatment site. In addition, it can be programmed to "self-clean" above the normal operating pressure range. It would be desirable in this case if the obstruction only partially dissolves and obstructs solvent removal or aspiration. Below the normal operating pressure range, the aspiration rate is reduced while continuing to inject, thereby restoring normal operating pressure.

Dissolution time is minimized by operation at high solvent flow rates. Maximum flow is obtained when the instantaneous injection volume matches the instantaneous aspiration volume. At such a zero point, the pump is not shut down or shut off by the algorithm determining the pressure. A feature of the present invention is to calibrate the pump catheter system for both infusion and aspiration, and thus to generate flow versus control voltage relationships for both pumps. The input parameter is the desired flow rate. The microprocessor will not accept values not achieved by both pumps and will operate both pumps at the desired flow rate when the pressure is near the pressure set point. The suction pump speed increases as the pressure rises above the set point, and the suction pump speed decreases as the pressure falls below the set point, thus having the ability to drive the system to the set point. During the procedure, the flow is increased to a limited value by aspiration, or by the size and compliance of the infusion lumen, or the patient's gall bladder and / or the associated experienced pressure excursions.

The key consideration regarding the system's sensitivity to organ pressure is that leakage of the solvent from the gallbladder should be based on the intraluminal pressure on the gall bladder, common bile duct, or ampulla (whatever was selected for treatment in the individual patient). ) And that neither the gallbladder volume itself nor the solventno flow itself is closely related. This, on the other hand, leads to the perception that the critical leak pressure from the gall bladder varies from patient to patient and is a function not only of solvent delivery but also of natural gallbladder contraction or external pressure on the gallbladder. The present invention takes into account these pressure changes that have a duration and intensity sufficient to affect the leakage of the solvent.

Because the critical leak pressure from the gallbladder varies from patient to patient, it is important to determine the critical leak pressure for an individual patient. To determine this pressure, a catheter is introduced into the gall bladder and under fluoroscopy, a contrast agent is injected into the gall bladder at high pressure. The pressure at which the contrast agent enters the intestine or leaks at the point of percutaneous introduction is the critical leak pressure. As the gallbladder fills, the contrast agent leaks through the fluent duct at the common bile duct flow or at the percutaneous introduction site.
The pressure will increase until noted on the radiograph. The volume of stain present in the gall bladder at this pressure is the available volume. The critical leak pressure, or a safety pressure less than the critical leak pressure, and the available volume, if desired, are entered into the controller as parameters. From the critical leak pressure value, a high pressure or maximum operating point or upper set limit is determined.

Typically, the maximum operating pressure is set between 75% and 90% of the measured critical leak pressure, and the maximum pressure alarm is typically between 85% and 90% of the critical leak pressure
It is.

Contrast is aspirated from the gallbladder to determine the minimum operating pressure or lower set limit. As the pressure in the gallbladder decreases, bile will eventually begin to be aspirated into the gallbladder from the common bile duct. The pressure at which this occurs is the bile suction pressure. The minimum operating pressure or lower set limit is typically set 2 to 10 cm water above the bile suction pressure to minimize dilution of the solvent with bile. The minimum alarm pressure is set slightly below the bile suction pressure.

Accurate measurement of flow to and from the gallbladder allows calculation of the net fluid retained by the patient. The signal of the net volume of retained fluid can be obtained when the pressure measurement is controlling the pump or in the case of a vagal gallbladder duct without a Hyster valve, for example, where pressure measurement is not possible as the primary control mode. Can be used as a backup safety check. To benefit from flow measurement, pumping should be started when the gallbladder is empty. When the net retained flow approaches the predetermined gallbladder volume, an alarm should be given or the net suction should be increased.

FIG. 1 shows an exemplary device for removing gallstones. Reservoir 10 contains a solvent that is chemically suitable for dissolving gallstones. Gallstones are composed of cholesterol, and a wide variety of solvents can work. Particularly effective is methyl tertiary butyl ether (MTBE). The latter has been shown to readily dissolve cholesterol stone readily, both in vitro and in vivo. Under normal pressure operation, the solvent moves from reservoir 10 via conduit 12 with the aid of an initial pump. Fluid passes through the valve 16 and from the valve through the inlet 17 in the catheter 19 and into the gallbladder. During this operation, the valve is closed to prevent solvent from returning to the reservoir. The solvent is expelled at a predetermined rate to be effective for gallstone dissolution, resulting in turbulent flow of the solvent and sufficient time for effective gallstone dissolution and gallstone crushing and crushing. Contact

Simultaneously with the MTBE burst into the gallbladder, a second pump 18 draws fluid from the gallbladder containing dissolved gallstones and debris. This material comes from the gall bladder via the suction port 20 of the catheter. Fluid is pumped from the gallbladder by pump 18 and passes through valve 23 from where it is placed in the receiving reservoir. Both the reservoir 10 used as a source of solvent and the separate reservoir are suitable for this purpose. FIG. 1 shows that the same reservoir 10 is used both as a source of fluid flowing to the gallbladder and as a reservoir of fluid aspirated there. If the same reservoir was used, gallstone debris, bile and mucus, and the like, removed from the gall bladder would be heavier than the solvent or MTBE and would be placed at the bottom of the reservoir, making gallstone dissolution more effective It is advantageous to note that this does not prevent continuous recovery of essentially pure fluid from the reservoir.

In cases where a single reservoir is used to supply solvent or receive aspirated fluid, the fluid should be sampled periodically to determine the cholesterol concentration in the MTBE. Since heavy debris falls to the bottom of the reservoir, a fluid sample must be taken from the upper part of the reservoir. The sample can be examined, for example, by spectrometry, to determine cholesterol concentration levels. When the cholesterol concentration reaches a predetermined level (eg, about 30%), the fluid is removed or replaced. Note that high and low levels of cholesterol in the solvent only affect the efficiency of dissolution.

In addition, in single reservoir systems, the reservoir needs to be vented since the suction and infusion rates are generally not equal. This method of providing an outlet must not allow the highly flammable solvent to escape. Also, an alternative method of compensating for the rate difference is to use a solvent resistant bladder for the reservoir. Such a sac expands and contracts as the volume of fluid it contains as it changes. This closed reservoir type prevents the escape of evaporative air.

The pump 14 and the pump 18 are controlled by a control circuit 22. Control circuit 22 in turn receives pressure readings from transducer 24, thereby causing control circuit 22 to open and close flow valves 16, 23, and 26. As a result, depending on whether the transducer 24 indicates that the pressure in the gall bladder is within, above, or below the normal pressure range, the need for infusion or aspiration may be necessary to control organ pressure. Can be suppressed. The transducers are in turn placed at the entrance 28 of the catheter 19
Gall bladder fluid pressure is sensed by transmission through the.

For normal pressure operation, the first pump 14 is connected to pipe 12 and valve
It carries fluid from reservoir 10 to the gall bladder through 16. At the same time, at a slightly slower rate, the second pump 18 draws fluid from the gallbladder through the catheter suction port 20. Fluid is a valve
Through 23, from there to the reservoir 10 via conduit 25.

Conduit 12, catheter 19 and conduit 25 are connected to source reservoir 10
And a body organ or lumen into which the catheter is inserted, and further form a fluid circuit leading to a receiving reservoir (also referred to herein as reservoir 10). Pumps 14,18 are in the circuit and are in conduits 12,25, respectively. (For purposes of this description, the “forward” fluid flow direction is defined as the flow in the direction of the arrow in FIGS. 1 and 6 and the “return” flow is the flow in the opposite arrow direction. Control unit 22 is programmed to respond to pressures that go above or below a normally operated pressure range. Above the normally operated pressure range ("high pressure mode"), valve 16 is closed and valve 26 is simultaneously opened. This provides a path to carry incoming fluids away from the gallbladder.

At this time, the valve 23 is kept open to keep the gallbladder empty so that the pressure returns to the normal operating range. if,
If the pressure in the gallbladder is not set to a normally operated pressure within a preset time, for example, within a few seconds,
At that time, the control unit 22 is programmed to reverse the direction of fluid movement, while at the same time
Valves 23 and 26 are closed. The control unit is programmed to close valve 23 after a slight delay so that a small amount of fluid, approximately 1 ml, passes through the valve before the valve closes. Valve 16 is left open to provide a path for fluid back drawing from the gallbladder in this "self-removal" mode. This mode essentially pumps a small amount of fluid through the suction port 20 of the catheter 19 to remove obstructions while suction is being affected by the pump 14 through the valve 16. Before the valve 23 closes in response to the high pressure in the gallbladder, fluid pumped into the gallbladder passes from the reservoir 10 through the valve 23. Typically this will consist of about 1 ml of fluid through valve 23 before the valve closes. This mode of operation continues for a short time, the control unit 22 instructs the machine to resume normal operation, the obstructions are removed, and the pressure transducer 24 indicates a reset of the normal operating pressure range. If the transducer continues to indicate that the pressure in the gallbladder is above normal operating pressure, the control unit 22 will again instruct the pumping device to remove the system. If, after several "self-removal" cycles, the obstruction has not yet been removed, the control unit 22 shuts down the system and activates a warning circuit 34 that informs the user of a potential danger.

FIG. 2 illustrates a typical control unit 22. The control circuit 22 instructs the pumps 14, 18 to carry and aspirate fluid from the gallbladder. Thus the circuit is typically based on the previously mentioned Stayzam Gold pressure transducer P23ID
(Statham Gould pressure transducer P23ID). The pressure transducer 30 relays the information to an amplifier 32. This amplifying device 32 is a converter
Amplifies the signal from 30 and transmits the signal to a high and low pressure warning circuit 34, and then directly or through an averaging circuit 36 to a pressure sensitive circuit 38 which reads a preset high and low pressure value. . This circuit 38 comprises valves 16, 23 and 26
Is bound to. The latter valve is typically a solenoid flow valve with a tube compression valve.
ves). Averaging circuit 36 is coupled if desired. This way, you can tell if the change in pressure in the gallbladder was caused by fluid caused by an obstruction, by hyperventilation, by laughter, or by any activity. . Thus, the averaging circuit essentially sifts through artificial high and low pressures that do not actually lead the gallbladder to the sky.

The pressure sensitive circuit 38 is connected to a cascade timer 40, which in turn is connected to a pump reverse relay circuit 42. Thus, when the gall bladder pressure exceeds the normal operating pressure range and the obstruction is not removed within a prescribed period, the cascade timer 40 activates the pump reverse relay 42. The latter circuit responds to a "self-elimination" system. If, after several short "self-removal" cycles, the high pressure persists, a warning circuit 34 is activated and an initial suction period in reverse mode occurs (valves 16 and 23 open and valve 26 closes), Shutting down the pumping system, such as by turning off the power supply, by a visible or audible trigger, or by alerting another user.
Note that if pressure returns within the normal pressure range during the pump reversal cycle, the device will resume normal operation.

Note that as shown in FIG. 2, the pump power relay circuit 44 and the pump speed control circuit 46 also interact with the overall system. The pump speed control circuit 46 carries power through the pump power relay converter 44 and is controlled by the alarm circuit 34. The pump motor carries its power supply from the pump power relay 44. If a warning condition occurs,
This relay turns off the power to the pump and stops it from pumping. The pump speed control circuit 46 has a manual adjustment capability that allows the operator to set the desired watering rate for a particular situation. The analog pressure input / output 48 provides operations to assign effective operation or mention during calibration. Alternatively or additionally, the output can be sent to a video display terminal 118 (of FIG. 10) operated by suitable software. This provides operation with an intermittent or continuous display of the system, such as operating mode and pressure, and can supervise the instructions and warnings of the warning circuit.

If desired, one or more microprocessors can replace multiple parts of the system. As shown in FIG. 10, in a system controlled by the microprocessor 100, the microprocessor 100 is connected to the system bus 1
An analog-to-digital converter (A / D) 116 connected to 22 connects the pressure transducer 24. A /
The D converter 116 processes the analog signal of the pressure transducer 24 and converts it into a digital signal. Control of the pump is through a digital-to-analog converter (D / A) 112 if the pump controller (PC) 124 requires an analog signal, or digital parallel or serial if the pump controller 124 responds to the digital signal. Achieved by microprocessor 100 through interface (P / SI) 114. D / A 112 or P / SI 114 is also used to control solenoid valve 16. The digital data (only one is shown for illustration) is processed by a microprocessor 100, which performs a function performed by one of the components of the pressure sensitive circuit as shown in FIG. Execute the algorithm located at 110. In particular, the microprocessor 100 itself is a high / low pressure detector 34, a signal averager 36, and a cascade timer.
Can be replaced with 40. The microprocessor 100 connected to the A / D converter 116 can be replaced with a pressure sensitive part of the pressure sensitive or solenoid control interface 38. on the other hand,
Microprocessor 100 connected to D / A 112 and P / SI 114 is pressure sensitive and solenoid control interface 3
Can replace 8 solenoid sites. Further, depending on the type of controller 124 that is actually controlling the pumps 14, 18,
The microprocessor 100, A / D 116, and P / SI 114 can also be replaced with a pump power relay 44, a speed control circuit 46, and a pump reversing relay 42.

FIG. 6 illustrates another alternative system in which the valves for separately controlling the two pumps 14 and 18 have been removed. Each pump motor has its own DC drive 47 and 45
With. Both drives are controlled by controller 22 ',
It has a suitable microprocessor for controlling the speed of each motor (ie, the rate of flow of each pump) in response to the pressure signal from transducer 24. In this way, the control device 2 can be used without opening or closing valves that affect proper injection, suction, and perging.
2 'defines the flow rate and flow direction of the pump.

This system has the advantage that all fluid conduits (tubes, catheters, reservoirs) are made of simple replaceable substances. Thus, each patent is
All wettable surfaces are treated using one patent and one treatment period, using a system limited to use alone. Also, many of the components of this scheme can be replaced with microprocessor systems.

There are several features that enhance the performance of the device. The pump employed in the present invention is a peristaltic pump. This type of pump has several advantages, such as the replaceable wettable surfaces described above. In addition to the individual weaknesses, the solvents used to dissolve the obstacles are all particularly advantageous in such cases where the corrosive agent is present. In addition, peristaltic pumps prevent clogging in contrast to standard syringe type pumps. However, it should be noted that in this example where the fluid used to dissolve or remove the obstruction is a solvent, a manual pump could be employed in the present invention as well, and that It is provided that it consists of a suitable suitable material such as polytetrafluoroethylene (PTFE) or glass. Manual pumps made of plastic are not preferred in cases where the solvent used is not compatible with the composition of the plastic in the syringe. An additional disadvantage associated with the use of a manual pump that does not appear in peristaltic pumps is that in such instances where solvent is utilized, evaporation of the solvent from between the plunger and the body may cause the syringe body And cause it to "freeze" and impede the transport of fluids to the organ being treated.

Finally, peristaltic pumps have greater fluid circulation capacity than manual ones. This has advantages in certain instances where obstacles such as gallstones require a rate of vascular flow across the surface of the gallstones to accelerate the dissolution process.

The preset normal operating pressure range is determined by the controller circuit.
Programmed to 22. The pressure in the gallbladder should exceed the normal operating pressure, and operation of the control circuit 22 prevents leakage of the solvent from the gallbladder through the gall bladder duct in the common bile duct, as well as at the point of entry of the catheter. Because the controller circuit senses true gall bladder pressure, it is easy to adjust for increasing pressure as well as decreasing pressure by adjusting the true delivery rate of solvent to the gall bladder. For example, if the pressure falls below the normal operating pressure range, the controller circuit 22 may interrupt the suction of the solvent or reduce the rate of suction while simultaneously injecting the solvent to re-establish normal operating pressure. To continue. The pressure sensing and warning circuit 34 constantly compares the system operating pressure with the gallbladder pressure. If the gallbladder pressure does not reach within the normal operating pressure range by the operation of the controller circuit 22 within a predetermined time, it returns to the period of maximum suction, then closes the homing system and alerts the operator. Sounds. After correcting the problem, the operator can restart the normal operation by operating the reset button 49.

Referring to FIGS. 10 and 12, in the case of a microprocessor system, the microprocessor 100 monitors the pressure values formed by the transducers 24 and calculates these pressure values by an algorithm stored in the system memory 110. The pumps 14, 18 and the valve 16 are controlled accordingly. The algorithm is generally divided into a module for taking periodic pressure measurements, a module for controlling the speed and direction of rotation of the pump, and a module for determining the correct response to various pressure measurements.

The module for determining the correct response to various pressure measurements checks a number of conditions. If there is no pre-set width change in the pre-measured pressure at the pre-set time, the module will block the pressure lumen or disable the pressure measurement subsystem and set a warning condition Assume that The setting of the warning condition is by the pump control module which sets the highest continuous suction by both pumps and issues a warning.

If the measured pressure is greater than the upper limit, the pressure measurement module commands the pump control module to stop the infusion pump and turn on the suction pump to obtain suction. If the pressure remains above the upper limit for more than the preset time, the module assumes that there is an obstruction in the suction opening or lumen. In response to this condition, the pump control module commands the pump normally used for infusion to draw. When the pressure falls to the lower limit, the pump control module switches the pump used for normal aspiration to inject and injects the pump used for the normal infusion to purge side holes and lumens. Switch to suction. A warning condition is set by the response determination module if the operating pressure does not return to normal within a preset time, or if a preset volume is subsequently used to purge the suction opening and lumen. Is done. Further, if there is more than a preset number of purge cycles within a preset time, the response determination module sets a warning condition.

Suction is stopped if the measured pressure is below the lower limit, and a warning condition is set if the pressure is maintained below the lower limit for a preset time. Finally, a warning condition is also set if the system cannot operate within its normal range for a preset time.

FIG. 12 is a flow diagram of the main program loop of an embodiment of the algorithm used to determine the correct response to various pressure measurements. FIGS. 12A-12E are flow diagrams of subroutines executed during the main program loop. The main program is pressure-limit-check (CHECK-PRESSURE)
Call the LIMITS) subroutine 150 to call a series of other subroutines to form special functions when the pressure and time delay are outside the preferred ranges, when the pressure is above or below the upper limit or below the lower limit. Within the preferred pressure range, the control pump subroutine 152 operates the pump in a proportional manner to keep it within pressure limits. The main program is initiated by the operator entering operating parameters (operating pressure, warning pressure, etc.) into the system via the system keyboard, and then calls the START-PUMPS subroutine 149.

The subroutine pump start is called if the main program is run first for progress or if the pump is stopped and must be restarted. Referring to FIG. 12A, the purpose of the pump start subroutine is to determine from the current pressure measurement that the pump should be started. That is, if the pressure is initially high, only switching triggers will occur, while if the pressure is low, only injection will occur. Further, the system will not reach the correct pressure operating range within the set time, a warning condition will exist and the operator will be notified. To accomplish this,
The subroutine begins by determining if the pressure in the gallbladder is greater than the lower operating pressure limit 160 and not greater, after which the infusion pump is turned on and the suction pump remains stopped 166. If the pressure is high,
The infusion pump remains stopped and the suction pump rotates 162
Then, the suction timer is started and the pressure is again compared 163 to the lower operating pressure limit. Operating limit 163 with still low pressure
In the above case, the elapsed time from the start of suction specified by the suction timer is compared 164 with the maximum suction time allowed by the parameter. If the elapsed time is less than the allowed maximum suction time, the pressure is again compared to the lower operating pressure limit 163. If the elapsed time is greater than the maximum time allowed, the suction loses function to reduce the pressure and the warning subroutine is called with a warning (0) state 165.

If the pressure is lower than the low operating pressure limit 163, the infusion pump is turned on, the suction pump is stopped, the suction timer is cleared, the infusion timer is started, and the pressure is compared to the high operating pressure limit 168. If the pressure is lower than the high operating pressure, the elapsed injection time is compared to the maximum injection time parameter 176. If the elapsed time is greater than the allowed time 176, the warning subroutine is called in a warning (0) state 178, indicating a leak of the solvent out of the gallbladder.

If the pressure is above the high operating pressure limit, the infusion pump is stopped, the aspiration pump is turned on, the infusion timer is cleared, and the aspiration timer is restarted. The pressure is compared to the lower operating pressure limit 184, and if below the lower operating pressure limit, the suction timer is cleared, the infusion pump is turned on, and the suction pump is stopped 187.

If the pressure exceeds the low operating pressure limit 184,
The suction timer is compared with the maximum suction time parameter 186, and if the elapsed time exceeds the maximum time allowed,
A warning subroutine is called with a warning (0) condition, indicating that suction is unable to reduce the pressure. If the elapsed time is less than the maximum suction time, the pressure comparison cycle is repeated 184.

Once the infusion pump is turned on and the suction pump is off 187
Then, the pressure is compared to the operating set pressure 189, and if it is lower, the pressure comparison loop is repeated. If the pressure exceeds the operating point, the subroutine simply returns to the main routine.

If it is determined that the suction pump cannot draw enough to get pressure within the required range below the high pressure limit, the pressure check subroutine will function to pump both pumps to the maximum and the low pressure limit will be achieved If so, and if the allowed number of purges does not exceed 314, 326, 328, 322, and 330 in FIG. 12D, it is assumed that the suction port is obstructed and purging is being attempted. The purge subroutine is called to reverse the flow through the aspiration and infusion lumens to clear the aspiration lumen. Referring to FIG. 12B, the purge subroutine first starts a purge timer 196 and reverses both the infusion and suction pumps at set flow rates 192,194 to clear the suction lumen.
Set to. The elapsed time from the purge timer is compared to the purge cycle cycle 196, and if the elapsed time pointed out by the purge timer is less than the purge cycle cycle, the purge cycle is allowed to continue, and the fluid pressure in the gallbladder is increased to the high operating pressure. Lower than the limit parameter 198. If the pressure is below the high operating pressure limit, the purge continues and the elapsed time is again compared 196. If the pressure exceeds the high operating pressure limit 198, the program proceeds through decision point 200, and if the number of purge cycles has not been exceeded, the pressure check subroutine resulting in the maximum suction purge cycle and another purge cycle are performed again. .

If the purge cycle time is exceeded without exceeding the high pressure limit, the pressure is compared to the operating set point 200. If the pressure is below the set point, the suction pump is stopped 202 and the infusion pump is operated at the set point in the forward direction. If the pressure does not reach operating set point 206 within the maximum infusion time, the system calls alert subroutine 212 with an alert (1) condition. If the operating set point is reached within the time parameter 210, the system returns to the operating cycle via 224,226.

If the time 196 is reached and the pressure is above the set point, the infusion and suction pumps
Turning to 6, the program returns to the operating cycle.

Two alarms depend on whether the abnormal pressure condition is recoverable (alarm (1) condition) or whether the condition is very dangerous and normal surgery should not be resumed (alarm (0) condition). There is a state. In each case, the first thing to do is draw down the pressure from both lumens. If the lower pressure limit can be reached within the alarm suction time, an alarm (1) condition will occur and normal surgery will resume. If the condition is alarm (0), a warning is given and the operator must intervene to stop aspiration. Referring to FIG. 12C, the alarm subroutine is entered from one of two states: alarm (0) 252, or alarm (1) 250. In either case, the infusion pump is set in the maximum reverse direction 254,256, while the suction pump is set in the maximum forward direction 258,260, producing maximum suction. If alarm (0) state 252 is entered, a tone is set 266 and suction is continued until the pump is stopped by operator intervention 270. Pumping does not occur 274 until the pump is manually restarted.

If alarm (1) state 250 is entered, a timer is started and the pressure is compared to the lower operating pressure,
If this is less than the lower operating pressure, the pump is set to operate normally, injecting fluid 268 through the injection lumen and aspirating 272 through the suction lumen. If the pressure is greater than or equal to the lower operating pressure, the elapsed time of maximum aspiration is compared to a parameter that determines the maximum time allowed for maximum aspiration, and if this time has not been reached, the pressure is compared again. . If the elapsed time exceeds the maximum time allowed, a tone is set 266 and the pump is turned on 270 until stopped by manual intervention.
Continue suction at maximum speed. Pumping is not started 274 until the pump is manually restarted.

The Check-Pressure-Limit subroutine is commanded by the main routine to determine an appropriate response to the current pressure. In FIG. 12D, the Check-Pressure-Limit subroutine is started by starting a timer to measure elapsed time and calculating the change in pressure over the last three seconds. If this pressure change is less than 1 Torr, it is presumed that the pressure changer is not working properly and the alarm subroutine is commanded to an alarm (0) condition. If the pressure change is greater than 1 Torr, the pressure is compared to the minimum alarm pressure 304; if the pressure is less than the minimum alarm pressure, the time indicated by the timer is compared to the minimum alarm pressure trigger time parameter 306. . If this time is greater than the minimum alarm pressure trigger time, the pressure has been held too long below the minimum allowable pressure and the alarm subroutine is commanded to the alarm (0) state. If this time is less than the minimum alarm pressure trigger time, the pressure is compared to the maximum alarm pressure 310, and if it is less than the maximum alarm pressure, it is compared to the upper pressure limit 31
8.

In any case, the elapsed time is compared to the upper pressure alarm trigger time 312 or the upper pressure delay time 320, and if it exceeds the upper pressure alarm trigger time, the number of purges is compared to the allowable number 314, too. If many purges have occurred, the alarm subroutine is commanded 316 to the alarm (0) condition.

If the number of purges has not been exceeded, the suction pump is set to the maximum flow 326. The infusion pump is reversed and set to the maximum flow 328, and the purge number counter is incremented. The pressure is then compared 322 to the lower pressure limit. If the pressure is below the lower limit within the alarm suction time, a purge cycle is performed 330, otherwise the alarm subroutine is commanded 332 to the alarm subroutine.

If the pressure is below the alarm pressure 310 and below the upper pressure limit 318, the pressure is within the desired limits and the system returns to the operating cycle.

If the pressure is below the upper limit and above the lower limit, the control pump subroutine will control the pump. In FIG.12E, the infusion pump operates until the upper limit is reached 340,
342. The suction pump is stopped when the lower limit is reached
52. At pressures between the lower limit and 85% of set point pressure, the suction pump operates at 80% of set flow 348,
354. At pressures between 115% of the set pressure and the lower pressure limit, the suction pump operates at 200% of the set flow or the lower of the maximum flow 350,356. When the pressure is ± 15% of the set pressure, both pumps operate at the set flow rate 358,344.

The device is fully automated and can be operated without critical operator input other than critical pressure and available volume. Furthermore, if the treatment fluid is flammable, it is easily converted to a completely enclosed system.
This feature is particularly required for flammable solvents.

Any of a number of tube types are preferably used for the pump of the subject device. However, we are saying, “Tygon Special Formulation (Tygon Sp
It has been found that F-4040A "(vinyl material), or" Nalgene "(polyurethane) is particularly compatible with solvents such as methyl tartbutyl ether. And allows for the acquisition of large volume ratios to rotation, thus allowing the use of low rotation ratios per minute and minimizing torque build-up when switching to high pressure mode results in pump motor reversal. To

As mentioned above, the subject device can be used to remove closure of various organs. However, when used to remove gallstones from the gall bladder, about 50 ml / min to 300 m
A perfusion rate of l / min is generally more effective. This is easily achieved by manually adjusting the pump speed control circuit of FIG. It is important that the flow rate is sufficient to cause turbulence in the gallbladder. Turbulence has been found to increase the rate of gallstone degradation and aid in the removal of non-meltable fragments.

A variety of catheters capable of delivering and aspirating fluids can be suitably used. The catheter must be insoluble in the solvent to be injected. For example, it is suitable for use in polyurethane catheters and MTBE. The 3-lumen catheter shown in FIGS. 3-5 and 7-8 is preferred because pressure measurement and perfusion and aspiration can all be performed simultaneously. A suitable 3-lumen catheter should have an outer diameter no larger than that readily available for surgical insertion of the catheter into the gallbladder, and should have a suction lumen 50, a pressure sensing lumen 52, and an infusion lumen 54. It is. The suction lumen should preferably be larger in cross section than the other two lumens. For safety purposes and to obtain an effective flow through the system,
The suction cross section should be about 2.5 times the injection cross section. In this way, the volume removed by suction can be larger than the volume replaced by injection under emergency conditions, while maintaining a substantial flow rate through the injection lumen. Become.

Each lumen communicates with the gallbladder via a number of openings in the outer wall of the lumen. The sum of the cross-sectional areas of the openings for one lumen should be greater than the cross-sectional area of that lumen to minimize flow impedance. The cross-sectional area of each opening should be smaller than that of the lumen to prevent debris from plugging the lumen. The suction and infusion openings are distributed along the length of the end of the catheter. At least one suction opening is located closest to all the injection openings and is preferably at the point of entry of the catheter into the gallbladder when the catheter is in the operative position. With this configuration, suction is performed closest to the point of insertion of the catheter into the gallbladder. This allows any leakage of solvent from the gallbladder through the catheter entrance to be immediately aspirated without damaging the surrounding tissue.

The suction lumen extends to the end of the catheter and terminates in an opening in the terminal. In FIG. 11, this opening at the end of the catheter also serves as a passage for the guidewire. The number of apertures is not constant and depends on the number of gallstones present in the gall bladder and the therapeutic requirements desired for rapid treatment.

The end of the catheter is preferably curved in the shape of a pig tail, as shown in FIG. 7, to aid in retention and positioning in the organ. In FIGS. 9 and 9A, such a pig-tail shaped catheter may also include a string 74 to allow the patient to exercise,
This string helps the catheter retain the shape of the pig's tail, as the fluid delivered through the catheter during coughing or sneezing tends to stretch the catheter. Single filament or wire can be used instead of string.
This retaining cord can be passed through the opening 72 of its own lumen 70, or through the suction lumen 50 "or the injection lumen 54". Other means of retaining the catheter in the gallbladder are possible. For example, a balloon catheter helps to hold the catheter.

The strap 74 passes through its own lumen 52, and balloon catheters also generally require their own lumen,
It should not be understood that this system is limited to 3-lumen catheters. Various catheters with different lumens will also work satisfactorily if the system is modified to use such a catheter, and such modifications are well known to those skilled in the art.

If a pig tail shaped catheter is used, the opening to the pressure lumen should be located on a radius inside the curve. This location provides a secure opening for accurate pressure sensing and also prevents the gallbladder mucosa from interfering with the pressure measurement.

Since this technique is inherently dangerous due to the use of toxic and flammable solvents, it is desirable that the catheter be used only with a suitable pumping system. To ensure this, the catheter can have a structural, electrical, or fiberoptic connection at its nearest terminal, which can be connected to similar structures in the rest of the system It is. Thus, this system can prevent it from working with an inappropriate catheter.

One skilled in the art will recognize that many variations of electrical circuitry are possible, and that there are generally interrelated features of the present invention that achieve effective elimination of certain organ atresia. Will be done. For example, the automatic "self-purging" feature of the device is desirable, but devices without this feature will not work properly. Furthermore, while the invention has been described as applicable to the removal of gallstones from the gallbladder, it should be noted that this use should not be so narrowly interpreted. Thus, the intention here was
It is an object of the invention to provide a generally applicable invention for the removal of a closure from various organs by dissolving and effecting the closure using a solvent.

 The claims are as follows.

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-3-82460 (JP, A) JP-A-4-500525 (JP, A) JP-B-7-108296 (JP, B2) (58) Field (Int.Cl. ⁷ , DB name) A61M 1/00 A61M 25/00 A61M 31/00 A61B 17/22

Claims (26)

(57) [Claims] 1. A catheter for contact dissolution of gallstones, comprising first and second lumens each having a distal end and a proximal end, and a pull string for retaining the distal end within the gall bladder. Wherein the first lumen is for infusion of solvent, the second lumen is for aspiration of spent solvent and dissolved gallstones, each lumen having a distal end between the gall bladder and the lumen. A catheter having at least one opening for allowing fluid to flow therethrough, wherein the suction lumen has a larger flow cross-sectional area than the injection lumen. 2. The catheter of claim 1, wherein the ratio of the cross-sectional area of the suction lumen to the cross-sectional area of the injection lumen is at least 1.5. 3. The catheter according to claim 1, wherein the area of each opening is smaller than the cross-sectional area of a lumen communicating with the opening. 4. The catheter of claim 1, further comprising a thread passage lumen in which said thread is provided. 5. The catheter according to claim 1, wherein the thread is provided in one of the suction lumen and the injection lumen. 6. The catheter according to claim 1, further comprising a suction opening at a distal end of the catheter in the transmission system having the suction lumen. 7. The catheter according to claim 1, wherein at least one suction opening is perforated in a wall of the catheter in the transmission system having the suction lumen provided near all the injection openings. Item 7. The catheter according to item 1 or 6. 8. The method according to claim 1, wherein the suction opening provided in the vicinity is provided at a portion close to a point of insertion of the catheter into the gallbladder when the catheter is located at the site of action. The catheter according to claim 7, wherein 9. The suction lumen and the suction opening provided at the distal end of the lumen are configured and arranged to allow a catheter to pass over a guide line. The catheter according to claim 6. 10. The catheter according to claim 1, wherein the catheter is made of a substance resistant to a solvent injected into the gallbladder. 11. The catheter according to claim 10, wherein said substance is polyurethane. 12. The means for detecting fluid pressure in the gallbladder includes a third means extending parallel to the infusion lumen and the suction lumen.
A hydraulic transmission lumen having a distal end that opens into the distal end of the catheter, the lumen configured to apply an internal pressure of the gall bladder to a remotely located pressure transducer. The catheter according to claim 1, wherein 13. The catheter of claim 1 wherein said means for detecting fluid pressure in the gallbladder comprises a pressure transducer provided at said distal portion of said catheter. 14. The catheter according to claim 13, wherein said transducer is a piezoelectric transducer. 15. The catheter according to claim 13, wherein said transducer is a fiberoptic transducer. 16. The catheter according to claim 13, wherein said transducer is removably inserted into a lumen of the catheter. 17. The apparatus used to dissolve gallstones includes a microprocessor suitable for executing the algorithm, the microprocessor having the following requirements: in response to an input pressure signal coming from the gallbladder. A gallbladder pressure determination module for determining pressure in the patient's gall bladder; the speed and direction of the infusion pump for pumping solvent through the infusion lumen into the patient's gall bladder and the suction pump for pumping solvent from the patient's gall bladder through the suction lumen An apparatus for dissolving gallstones, comprising: a pump control module for controlling; and a response determining module for controlling the function of the pump control module in response to the pressure determination of the pressure determining module. 18. The gallbladder pressure determining module generates a warning and sets the following conditions: when there is no pressure change of a predetermined amplification degree within a predetermined time; Within, or when a predetermined amount is used to purge the aspiration lumen, does not return to normal range; when more than a predetermined number of release cycles occur within a predetermined time; low during a predetermined time If the pressure persists below the set limit; start the maximum continuous suction by both the infusion pump and the suction pump according to one of the conditions when the pressure cannot be maintained in the normal range within the prescribed time; Stop infusion, maintain maximum aspiration in response to pressure conditions above the upper set limit, aspirate through the injection lumen until the pressure drops to the lower set limit, and exceed the upper set limit for more than a predetermined time A gallbladder pressure determination module that injects 1-2 ml through the suction lumen in response to the pressure being maintained; and stops suction in response to conditions where the pressure is below the lower set limit. 18. The apparatus for dissolving gallstones according to claim 17, wherein the apparatus is used for dissolving gallstones. 19. The following means: means for continuously measuring the pressure in the patient's gallbladder; and means for controlling the infusion of the solvent into the gallbladder and the suction of the solvent from the gallbladder in response to these measurements. An apparatus for dissolving gallstones, comprising: 20. The method according to claim 1, further comprising a means for periodically measuring the amount of cholesterol in the solvent.
Item 19. The gallstone dissolving device according to item 19. 21. The method according to claim 21, further comprising: means for replacing the solvent when the cholesterol concentration in the solvent reaches a predetermined limit.
20. The apparatus for dissolving gallstones according to claim 20. 22. The apparatus for dissolving gallstones according to claim 21, wherein the limiting concentration is set to about 30%. 23. Means for measuring the critical pressure at which fluid in the gall bladder releases to adjacent parts of the body prior to introduction of the solvent into the gall bladder, and adjusting the pressure value to control the infusion and aspiration. 20. The apparatus for dissolving gallstones according to claim 19, further comprising means for utilizing. 24. The means for measuring the critical pressure further comprises means for injecting a radiopaque dye into the gallbladder until release of the dye is noted on radiography. 24. The apparatus for dissolving gallstones according to claim 23. 25. A system bus; a microprocessor connected to the system bus; a memory connected to the system bus and storing an algorithm; and an analog signal representing pressure inside the gallbladder. An analog-to-digital converter having an input terminal and an output terminal for providing the digital signal representing the pressure to the system bus; a pressure converter having a pressure sensor and an output terminal; An output terminal of the pressure transducer is connected to an input terminal of the analog-to-digital converter, and the pressure transducer generates a pressure signal related to the pressure of the solvent in the gallbladder. A reservoir filled with gallstones dissolved in a solvent; An infusion pump connected by a conduit for pumping solvent through the capsule; a suction pump connected by a conduit for collecting solvent from the gall bladder and releasing solvent to the reservoir; an input terminal connected to the system bus and a plurality of outputs. A pump controller having one of the output terminals coupled to the suction pump and one of the output terminals coupled to the infusion pump. The microprocessor for controlling the controller for sequentially controlling the suction pump and the infusion pump in response to a signal received from the pressure transducer, the microprocessor indicating an excessive pressure in the gallbladder; Said microprocessor halting injection and initiating suction in response to the A first lumen of the lumen connected at the end closest to the infusion pump; a first lumen of the lumen connected at the end closest to the suction pump; Means for detecting fluid pressure within the gall bladder to which the distal end of the catheter is coupled to provide a continuous indication of fluid pressure to the pressure transducer. An apparatus for dissolving gallstones, comprising: a catheter provided; 26. The apparatus for dissolving gallstones according to claim 25, wherein said reservoir is a collapsible bladder.