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CA2661242A1 - Method and apparatus for pressurizing a body cavity for diagnostic and rehabilitative purposes - Google Patents

Method and apparatus for pressurizing a body cavity for diagnostic and rehabilitative purposes Download PDF

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Publication number
CA2661242A1
CA2661242A1 CA 2661242 CA2661242A CA2661242A1 CA 2661242 A1 CA2661242 A1 CA 2661242A1 CA 2661242 CA2661242 CA 2661242 CA 2661242 A CA2661242 A CA 2661242A CA 2661242 A1 CA2661242 A1 CA 2661242A1
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Canada
Prior art keywords
fluid
body cavity
outflow
conduit
inflow
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Abandoned
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CA 2661242
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French (fr)
Inventor
Anthony Garabet
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Individual
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Individual
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Priority to CA 2661242 priority Critical patent/CA2661242A1/en
Publication of CA2661242A1 publication Critical patent/CA2661242A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M13/00Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015Control of fluid supply or evacuation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • A61M2210/1064Large intestine

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Anesthesiology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • External Artificial Organs (AREA)

Abstract

A method and apparatus for both the diagnostic measurement and therapeutic treatment of a body cavity. According to one form of the method of the invention, a fluid (liquid or gas) under pressure is introduced into a selected body cavity while monitoring the pressure or flow of the fluid (liquid or gas) into the cavity. Following pressurization of the body cavity, fluid (liquid or gas) inflow and outflow data is collected and analyzed.
The data collected is used to draw various conclusions about the biomechanical properties of the body cavity and the organ in which it is present, and also to draw conclusions about presence or absence of disease as well as the character of disease. According to another method of the invention, a fluid (liquid or gas) is controllably infused into the body cavity to controllably expand the body cavity for purposes of therapeutic treatment.

Description

METHOD AND APPARATUS FOR PRESSURIZING A BODY CAVITY FOR
DIAGNOSTIC AND REHABILITATIVE PURPOSES
SPECIFICATION
BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION

The present invention relates generally to medical devices used in the field of gastroenterology. More particularly the invention concerns a device that can be used to insufflate fluid into the gastrointestinal tract to treat motility disorders.
Devices that insufflate fluid into the colon are traditionally used for the purpose of completely inflating the colon whereas in this invention the intention is to deliver multiple cycles of inflations followed by deflations to avoid full inflation of the colon. Whereas the traditional devices are designed to achieve diagnostic objectives, the present invention is designed for therapeutic purposes.

SUMMARY OF THE INVENTION

The method and apparatus of the present invention involves the infusion of fluid in a body cavity to measure biomechanical properties of the tissues of certain organs that contain cavities. More particularly, in accordance with one method of the invention, the information collected is used to treat disorders within the body cavity.

The apparatus of the invention comprises a device that is connected to the body cavity via tubing. Fluid is then pressurized by the device and transported to the body via the tubing. The control of the flow of fluid toward the body cavity is accomplished using a system having a single valve, or alternating, a system having no valves at all.

The methods of the invention are diverse and cover many aspects of medicine.
In particular, the diagnostic methods of the invention are concerned with biomechanical measurements. Measurements are taken during pressurization (inflow phase) and depressurization (outflow phase). Inflation occurs when the fluid is actively infused into the body cavity, and outflow occurs when the fluid (liquid or gas) is passively allowed to be expelled from the cavity by the organ's own biomechanical rebound.

T I

In one form of the apparatus of the invention in which a flexible tube is used to connect the apparatus of the invention to the body cavity, the apparatus includes the following systems:

= a system to measure inflation and deflation pressure.

= a system that can adjust the flow of fluid in and out of a body cavity in a controlled fashion.
= a system of tubing that can deliver fluid into and out of the body cavity.
= a system in which the caliber of the inflow and outflow tubing can be varied to better control the flow.
= Systems that enables the flow of fluid in and out of the body cavity to be controlled with one or no valves.

Once the user of the apparatus initiates a specific study, the study will proceed from inflow to outflow without interruption so long as the pressure within the body cavity remains within predetermined minimum and maximum levels.

In one form of the diagnostic method of the invention, the apparatus allows for data collection so that the pressure and flow data can be used for purposes of interpretation as to the biomechanical properties of the cavity under investigation.
Ultimately, the same data can also be used for therapeutic planning.

The therapeutic features of the invention are designed to reduce of pain and train to body cavity to properly coordinate its muscular action.

The apparatus of the invention can also be used for motility rehabilitative purposes.
More particularly, the apparatus can be used to train body cavities with motility dysfunction to function more normally. This can be achieved with repetitive inflation and deflation of the body cavity. With repeated training of the body cavity using the device, the organ can be rehabilitated in a manner to achieve long-term, sustainable normal functional motility.

When used for rehabilitation purposes the apparatus can be used to determine the strengths and weaknesses of the body cavity, hence allowing the device to adjust the treatment plan. The treatment can be carried out in a manner that is customized for the unique biomechanical features of the body cavity. The device can be used to mechanically stimulate the body cavity to a finite and predetermined range. It can be used to cause the body cavity to be rehabilitated for proper motility functioning.

In one form of the apparatus of the invention the inflation and deflation can be delivered simultaneously using outflow tubing that is smaller in caliber. This smaller caliber creates higher resistance in the outflow aspect of the apparatus. This allows for a preferential delivery of fluid or air into the body cavity over the outflow during the inflow phase. This caliber differential will obviate the need for any valves. During the outflow phase, the fluid is allowed to flow out of the smaller caliber outflow tubing over an extended period of time. This extended period of time is necessary due to the smaller caliber of the outflow tubing. This extended period of time also allows for additional rest period for the patient undergoing the treatment. Under all circumstances, the direction of flow is always away from the device and in the direction of the discharge bag.

Another aspect of the invention involves the simultaneous delivery of fluid in and out of the body cavity without causing any fluid to flow backwards through the inflow branch of the tubing. This is particularly critical since fluid that travels through the body cavity cannot be allowed to re-enter the medical device and cause contamination. Fluid that is contaminated due to exposure to the body cavity must only travel through the outflow branch of the disposable tubing. Since the pressure on the device end of the disposable tubing (the inflow branch) is always above zero, and since the pressure on the outflow end of the disposable tubing is always zero (the outflow branch that is open to the discharge bag in which the pressure is equal to room/atmospheric pressure), the flow of fluid is always away from the device and towards the disposable bag. This is true regardless of whether the body cavity is being inflated (inflow phase) or deflated (outflow phase).

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a generally perspective view of one form of the apparatus of the invention illustrating the various components that make up the apparatus.
Figure 2 is a top plan, generally diagrammatic view, partly broken away to illustrate the operational interrelationship among the various components of the apparatus during the inflow phase of one form of the operational method of the apparatus.

Figure 3 is a generally diagrammatic view illustrating the inflow phase of one form of the method of the invention using only one outflow valve.

Figure 4 is a generally diagrammatic view illustrating the outflow phase of one form of the method of the invention using only one outflow valve.

Figure 5 is a generally diagrammatic view illustrating the inflow phase of one form of the method of the invention using only one inflow valve.

Figure 6 is a generally diagrammatic view illustrating the outflow phase of one form of the method of the invention using only one inflow valve.

Figure 7 is a generally diagrammatic view illustrating the inflow phase of one form of the method of the invention using no valves.
Figure 8 is a generally diagrammatic view illustrating the outflow phase of one form of the method of the invention using no valves.
Figure 9 is a generally diagrammatic view illustrating the steps of the fixed pump rate method of the invention using an apparatus having only one outflow valve.
Figure 10 is a generally diagrammatic view illustrating the steps of the variable pump rate method of the invention using an apparatus having only one outflow valve.
Figure 11 is a generally diagrammatic view illustrating the steps of an alternate form of the method of the invention using an apparatus having only one inflow valve only method of the invention.
Figure 12 is a generally diagrammatic view illustrating the steps of the fixed inflow rate an apparatus having no valves.
Figure 13 is a generally diagrammatic view illustrating the steps of the variable inflow rate method of the invention using an apparatus having no valves.
Figure 14 is a graphical representation illustrating pressure within the disposable tubing as a function of time during the performance of an alternate, form of the method of the invention.
DESCRIPTION OF THE INVENTION

Referring now to the drawings and particularly to Figure 1, one form of the apparatus of the invention is there illustrated and generally designated by the numeral 21.
Apparatus 21 here comprises a hollow housing 22 having front, rear, top, bottom and side panels 23, 24, 25, 26 and 27 respectively that define an internal chamber 22a (Figure 2).
Provided on side panel 27 is a connector 28 through which the proximal end of a generally "T"-shaped disposable tubing 29 is connected. Disposable tubing 29 includes an inflow branch 30 that is interconnected with an outflow branch 31 at a generally "T"
shaped junction 32. Provided in the outflow branch 31, between junction 32 and a discharge bag 33 is an outflow valve 34. Valve 34 is of conventional construction and is readily commercially available from various sources including the Humphrey Company of Kalamazoo, Michigan and Teknocraft, Inc. of Melbourne, Florida.
Connected to generally "T" shaped junction 32 and in communication with the inflow and outflow branches 30 and 31 is the main branch 35 of the disposable tubing 29.
As indicated in the drawings, when carrying out the latest form of the method of the invention, main branch 35 is placed in communication with the body cavity "B".
As will be discussed hereinafter, in carrying out the method of the invention, fluid flows through the main branch 35 and in and out of the body cavity "B" without any restriction.
Referring to Figure 2 it can be seen that a pump or compressor 36 is disposed within internal chamber 22a. Pump 36, which is of conventional construction, is readily commercially available from various sources including KNF Neuberger of Trenton, New Jersey. Also disposed within internal chamber 22a is the central processing unit (CPU) 37 of a conventional microprocessor that is interconnected with and, in a manner well understood by those skilled in the art, is programmed to control the operation of the outflow valve 34 and the pump 36. Both outflow valve 34 and disposable tubing 29 are located on the exterior aspect 38 of the apparatus. CPU 37 is also connected to a timer 39 and pressure sensor 40 of conventional construction which is housed within internal chamber 22a. Pressure sensor 40 is commercially available from various sources including Omega Engineering of Stamford, Connecticut.

In carrying out the latest form of the method of the invention, activation of the CPU 37 will cause the pump 36 to controllably pump fluid into the inflow branch 30 of the external disposable tubing 29. During the inflation phase The CPU will cause outflow valve 34 to close allowing the pumped air in the disposable tubing 29 to flow into the main branch 35 and into the body cavity B causing it to inflate. During the outflow phase the CPU 37 will cause the outflow valve 34 to open allowing pressurized air from the body cavity B and the disposable tubing 29 to escape into the discharge bag 33. It is to be observed that, since the discharge bag is under no pressure, in this form of the method of the invention the flow of fluid is always away from the pump 36 and in the direction of the discharge bag 33. This is true irrespective of whether the flow through the main branch 35 is in the direction of the body cavity "B", or in a direction away from the body cavity. This is one of the essential aspects of the method of the invention, since contaminated fluid emanating from the body cavity "B" and flowing through the external disposable tubing 29, is not allowed to flow in the direction of the pump 36.

Referring again to Fig. 2 which depicts the flow pattern during the inflow phase, it can be seen that the CPU directs the air pump 36 to start compressing air and the valve 34 to close, thereby blocking fluid flow within the outflow branch 31. This will lead to greater fluid flow and higher pressure within the inflow branch 30 and within the main branch 35. The increased pressure within the main branch 35 overcomes the biomechanical resistance within the walls of the body cavity "B" and causes the body cavity to expand. During this inflow phase, the flow of air within the disposable tubing is away from the compressor and in the direction of the body cavity "B".

Turning to Figure 3 which illustrates one phase of the method of the invention, it is to be noted that the flow of fluid is such that the body cavity "B" is caused to inflate. This phase is designated as the inflow phase. If the outflow valve 34 of the outflow branch 31 is directed by the CPU to close, this will cause the fluid that is pumped into the inflow branch by the pump 36 to flow through the main branch 35 and into the body cavity "B", thereby causing it to inflate.

In the phase of the method of the invention illustrated in Figure 4 of the drawings, the flow of fluid is such that the body cavity "B" is caused to deflate. This phase, which is designated as the outflow phase, occurs when outflow valve 34 of the outflow branch 31 is directed by the CPU to open thereby allowing the pressurized air in the body cavity B to escape into the main branch 35 out through the outflow branch 31 and into the discharge bag 33. During the outflow phase the pump 36 continues to pump air into the disposable tubing 29 through the inflow branch 30 to maintain a steady flow of air away from the pump. This comprises one of the essential aspects of the method of the invention, since contaminated fluid emanating from the body cavity "B" and flowing through the external disposable tubing 29, is not allowed to flow backwards in the direction of the pump 36.

Figure 5 and 6 represent another perspective view of another embodiment of the present invention depicting yet another method of the invention in which only one valve 41, the inflow valve, is present and controlling the flow within inflow branch 30.

During the inflow phase (Figure 5), the CPU directs valve 41 to open, thereby creating lower resistance and increased fluid flow within the inflow branch 30. This greater fluid flow and higher pressure within the inflow branch 30 overcomes the biomechanical resistance within the walls of the body cavity "B" and causes the body cavity to expand. Simultaneously, the fluid flow within the outflow branch 31 of the disposable tubing is away from the body cavity "B" and in the direction of the discharge bag 33. As previously mentioned, this fluid flow condition prevents fluid flow from the body cavity in a reverse direction toward pump 36.

During the outflow phase (Figure 6), the CPU directs valve 41 to close, thereby blocking the flow within the inflow branch 30. This causes the pressure within the inflated body cavity to decrease causing the body cavity to recoil and expel the fluid in the direction of the outflow branch 31 where the resistance towards discharge bag 33 is low.
The increased fluid flow within the outflow branch 31 of the disposable tubing is away from the body cavity "B" and in the direction of the discharge bag 33. As previously mentioned, this fluid flow condition prevents fluid flow from the body cavity in a reverse direction toward pump 36.

Figure 7 and 8 represent another perspective view of another embodiment of the present invention depicting yet another method of the invention in which both valves 41 and 34 are absent. In this aspect of the invention no valves are present and, therefore, the flow of fluid within the inflow, 30, the outflow 31 and the main branches 35 of the disposable tubing is determined by the pump rate of pump 36 within the device and by the internal diameter of the various branches of the disposable tubing.

During the inflow phase (Figure 7), the CPU directs pump 36 to increase the pump rate, thereby creating increased fluid. flow within the inflow branch 30. Due to the larger diameter of main branch 35 as compared to the diameter of the outflow branch 31 a, the flow generated by the pump 36 within inflow tubing 30 will travel preferentially in the direction of the body cavity B and through the main branch 35 of the disposable tubing.
The fluid that is being pressurized into the body cavity will overcome the biomechanical resistance within the walls of the body cavity "B" and causes the body cavity to expand.
Simultaneously, the fluid flow within the outflow branch 31 a of the disposable tubing is away from the body cavity "B" and in the direction of the discharge bag 33. As previously mentioned, this fluid flow condition prevents fluid flow from the body cavity in a reverse direction toward pump 36.

During the outflow phase (Figure 8), the CPU directs the pump 36 to decrease its pump rate thereby creating lower pressure within the tubing. This decrease in pressure within the tubing will cause the pressure within the inflated body cavity to decrease causing the body cavity to recoil and expel the fluid through the main branch 35 in the direction of the outflow branch 31. Since, during the outflow phase, the pump 36 is continuing to pump fluid into the inflow branch, all the flow will then travel in the direction of the outflow branch 31 and toward the discharge bag 33. As previously mentioned, this fluid flow condition prevents fluid flow from the body cavity in a reverse direction toward pump 3 6.

Figure 9 represents the flow of events in one form of the method of the invention as previously described and as depicted in Figures 3 and 4, wherein an outflow valve is used. In this form of the invention, the flow rate out of the pump is fixed.
In carrying out this form of the method of the invention the CPU energizes the compressor causing fluid to flow and pressure to build up in the tubing system. The CPU will then close the outflow valve further increasing the pressure. This additional increase in pressure will cause the body cavity to start inflating. The CPU will then verify if the timer has exceeded the critical time. If it did, the CPU will then terminate the procedure by opening the outflow valve and turning off the compressor. If the timer has not exceeded the critical time, the CPU will then verify if the pressure has exceeded the maximum pressure. If it did not, it will recheck the timer until the pressure reaches the maximum pressure at which time the CPU will open the outflow valve. This will cause the pressure in the tubing to drop and the body cavity to recoil and push the pressurized air inside of it causing it to flow out the outflow tubing. The CPU will then verify if the timer has exceeded the critical time. If it did, the CPU will then terminate the procedure by turning off the compressor.
If it did not, the CPU will verify if the pressure reached or dropped below the Critical Minimum Pressure. If it did not reach the Critical Minimum Pressure, it will recheck the timer until the Critical Minimum Pressure is reached at which time the CPU will close the outflow valve. This will resume pressurization within the tubing and the body cavity until the critical time is reached as monitored by the CPU using the timer, at which time the CPU
will terminate the procedure by opening the outflow valve and turning the compressor off.

Figure 10 represents the flow of events in one form of the method of the invention wherein, as previously described and as depicted in Figures 3 and 4, an outflow valve is used. In this form of the invention, the flow rate out of the pump is variable. In carrying out this form of the method of the invention the CPU energizes the compressor and increases the pump rate causing fluid to flow and pressure to build up in the tubing system.
The CPU will then close the outflow valve further increasing the pressure.
This additional increase in pressure will cause the body cavity to start inflating. The CPU
will then verify if the timer has exceeded the critical time. If it did, the CPU will then terminate the procedure by opening the outflow valve and turning off the compressor. If the timer has not exceeded the critical time, the CPU will then verify if the pressure has exceeded the maximum pressure. If it did not, it will recheck the timer until the pressure reaches the maximum pressure at which time the CPU will open the outflow valve. This will cause the pressure in the tubing to drop and the body cavity to recoil and push the pressurized air inside of it causing it to flow out the outflow tubing. The CPU will direct the pump to reduce the pump rate to reduce the pressure within the tubing system further and ensure complete depressurization within the body cavity and the tubing system. The CPU will then verify if the timer has exceeded the critical time. If it did, the CPU
will then terminate the procedure by turning off the compressor. If it did not, the CPU will verify if the pressure reached or dropped below the Critical Minimum Pressure. If it did not reach the Critical Minimum Pressure, it will recheck the timer until the Critical Minimum Pressure is reached at which time the CPU will direct the pump to increase the pump rate. The CPU
will then close the outflow valve. This will resume pressurization within the tubing and the body cavity until the critical time is reached as monitored by the CPU using the timer, at which time the CPU will terminate the procedure by opening the outflow valve and turning the compressor off.

Figure 11 represents the flow of events in an alternate form of the method of the invention as previously described and as depicted in Figures 5 and 6 wherein only one inflow valve is used. In carrying out this form of the method of the invention the CPU
energizes the compressor and opens the inflow valve causing fluid to flow and pressure to build up in the tubing system. This increase in pressure will cause the body cavity to start inflating. The CPU will then verify if the timer has exceeded the critical time. If it did, the CPU will then terminate the procedure by turning off the compressor and closing the inflow valve. If the timer has not exceeded the critical time, the CPU will then verify if the pressure has exceeded the Critical Maximum Pressure. If it did not, it will continue rechecking the timer until the pressure reaches the Critical Maximum Pressure at which time the CPU will close the inflow valve and turn off the compressor. This will cause the pressure in the tubing to drop and the body cavity to recoil and push the pressurized air inside of it causing it to flow out the outflow tubing. The CPU will then verify if the timer has exceeded the critical time. If it did, the CPU will then terminate the procedure. If it did not, the CPU will verify if the pressure reached or dropped below the Critical Minimum Pressure. If it did not reach the Critical Minimum Pressure, the CPU will recheck the timer until the Critical Minimum Pressure is reached at which time the CPU will turn on the compressor and open the inflow valve. This will resume pressurization within the tubing and the body cavity until the critical time is reached as monitored by the CPU
using the timer, at which time the CPU will terminate the procedure by turning the compressor off and closing the inflow valve.

Figure 12 represents the flow of events in another form of the method of the invention, as previously described and as depicted in Figures 7 and 8, wherein no valves are used and the flow rate is fixed. In carrying out this form of the method of the invention the CPU energizes the compressor causing fluid to flow and pressure to build up in the tubing system. This increase in pressure will cause the body cavity to start inflating. The CPU will then verify if the timer has exceeded the critical time. If it did, the CPU will then terminate the procedure by turning off the compressor. If the timer has not exceeded the critical time, the CPU will then verify if the pressure has exceeded the Critical Maximum Pressure. If it did not, it will continue rechecking the timer until the pressure reaches the Critical Maximum Pressure at which time the CPU will turn off the compressor.
This will cause the pressure in the tubing to drop and the body cavity to recoil and push the pressurized air inside of it causing it to flow out the outflow tubing. The CPU will then verify if the timer has exceeded the critical time. If it did, the CPU will then terminate the procedure. If it did not, the CPU will verify if the pressure reached or dropped below the Critical Minimum Pressure. If it did not reach the Critical Minimum Pressure, the CPU
will recheck the timer until the Critical Minimum Pressure is reached at which time the CPU will turn on the compressor. This will resume pressurization within the tubing and the body cavity until the critical time is reached as monitored by the CPU
using the timer, at which time the CPU will terminate the procedure by turning the compressor off.

Figure 13 represents the flow of events in still another form of the method of the invention wherein no valves are used and the flow rate is variable. This method has previously been described and is depicted in Figures 7 and 8. In carrying out this form of the method of the invention the CPU energizes the compressor causing fluid to flow and pressure to build up in the tubing system. The CPU then directs the pump to increase the inflow rate. This increase in inflow rate will cause a further increase in pressure which will cause the body cavity to start inflating. The CPU will then verify if the timer has exceeded the critical time. If it did, the CPU will then terminate the procedure by turning off the compressor. If the timer has not exceeded the critical time, the CPU will then verify if the pressure has exceeded the Critical Maximum Pressure. If it did not, it will continue rechecking the timer until the pressure reaches the Critical Maximum Pressure at which time the CPU will direct the compressor to decrease the inflow rate. This decrease in inflow rate will cause the pressure in the tubing to drop and the body cavity to recoil and push the pressurized air inside of it causing it to flow out the outflow tubing. The CPU
will then verify if the timer has exceeded the critical time. If it did, the CPU will then terminate the procedure by turning the compressor off. If it did not reach the critical time, the CPU will verify if the pressure reached or dropped below the Critical Minimum Pressure. If it did not reach the Critical Minimum Pressure, the CPU will recheck the timer until the Critical Minimum Pressure is reached at which time the CPU will direct the compressor to increase the pump rate. This will resume pressurization within the tubing and the body cavity until the critical time is reached as monitored by the CPU
using the timer, at which time the CPU will terminate the procedure by turning the compressor off.

Figure 14 graphically depicts yet another form of the method of the invention and illustrates the pressure pattern "P" within the body cavity as a function of time "T". In accordance with this latest method of the invention, fluid flow within the disposable tubing 9 alternates between the various phases described in the preceding paragraphs, namely the inflow phase (IP), the outflow phase (OP), the maximum pressure (Pmax) and the minimum pressure (Pmin).

Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention, as set forth in the following claims.

Claims (24)

1. An apparatus for controllably introducing fluids into a body cavity, said apparatus including fluid inflow and fluid outflow conduits interconnectable with said body cavity, pressurization means operably associated with the fluid inflow conduit for introducing fluid under pressure into said fluid inflow conduit, sensor means operably interconnected with the fluid inflow conduit for sensing fluid pressure within said fluid inflow conduit, said apparatus adapted to (a) pressurize said fluid inflow conduit at a first rate of fluid flow;
(b) pressurize said fluid outflow conduit at a second rate of fluid flow less than said first rate of fluid such that an interconnected body cavity can inflate;
(c) pressurize said fluid inflow conduit at a third rate of fluid flow; and (d) pressurize said fluid outflow conduit at a fourth rate of fluid flow greater than said third rate of fluid flow such that said interconnected body cavity can deflate.
2. The apparatus of Claim 1, wherein said apparatus is adapted to pressurize both said fluid inflow conduit and said fluid outflow conduit at substantially equal fifth rates of fluid flow such that said body cavity can remain partially deflated.
3. The apparatus of Claim 2, wherein said apparatus is adapted to pressurize both said fluid inflow conduit and said fluid outflow conduit at substantially equal sixth rates of fluid flow lesser than said fifth rates of fluid flow, such that said connected body cavity can deflate.
4. An apparatus for controllably introducing fluids into a body cavity, said apparatus including a timer, interconnected fluid inflow and fluid outflow conduits connectable to the body cavity, a pump operably associated with said fluid inflow and fluid outflow conduits for introducing fluid under pressure into said conduits, an inflow valve disposed within said fluid inflow conduit, an outflow valve disposed within said fluid outflow conduit, a sensor operably interconnected with said fluid inflow conduit for sensing fluid pressure within said fluid inflow conduit and a computer operably associated with said pump, said inflow valve and said outflow valve to operate said pump, said inflow valve, and said outflow valve and operably associated with said sensor to receive signals from said sensor, said apparatus adapted to, through use of said computer:
(a) energize said pump to pressurize said fluid inflow and outflow conduits;
(b) adjust said inflow valve to establish a first rate of fluid flow through said fluid inflow conduit ;
(c) adjust said outflow valve to establish a second rate of fluid flow through said fluid outflow conduit less than said first rate of fluid flow such that an interconnected body cavity can inflate;
(d) adjust said inflow valve to establish a third rate of fluid flow through said fluid inflow conduit; and, (e) adjust said outflow valve to establish a fourth rate of fluid flow through said fluid outflow conduit greater than said third rate of fluid flow such that said interconnected body cavity can deflate.
5. The apparatus of Claim 4, wherein said apparatus is adapted to adjust said inflow and outflow valves to establish fluid flow through both said fluid inflow conduit and said fluid outflow conduit at substantially equal fifth rates of fluid flow such that said interconnected body cavity can remain partially deflated.
6. The apparatus of Claim 4, wherein said apparatus is adapted to adjust said inflow and outflow valves to establish fluid flow through said fluid inflow and outflow conduits at substantially equal sixth rates of fluid flow greater than said fifth rates of fluid flow such that said interconnected body cavity can deflate.
7. The apparatus of Claim 5, comprising a timer adapted to, prior to adjusting said outflow valve to establish a second rate of fluid flow through said fluid outflow conduit less than said first rate of fluid flow, check said elapsed time since energizing said pump to verify that it is less than said critical duration time allowable for inflation of said connected body cavity and read said first sensor to verify that said pressure within said inflow conduit is equal to or greater than a critical maximum pressure.
8. The apparatus Claim 7, wherein said apparatus is adapted to, prior to adjustment of said outflow valve to establish a fourth rate of fluid flow through said fluid outflow conduit greater than said third rate of fluid flow to thereby cause said connected body cavity to deflate, determine that said pressure within the inflow conduit is equal to or less than a critical minimum pressure.
9. An apparatus for controllably introducing fluids into a body cavity, said apparatus including a timer, interconnected fluid inflow and fluid outflow conduits connectable to the body cavity, a continuously operating pump operably associated with the fluid inflow and fluid outflow conduits for introducing fluid under pressure into said conduits, an outflow valve disposed within said fluid outflow conduit and a computer operably associated with said outflow valve to operate said outflow valve, said apparatus adapted to, through use of said computer:
(a) close said outflow valve to establish fluid flow through said fluid inflow conduit, thereby causing a connected body cavity to inflate; and, (b) open said outflow valve to establish fluid flow through said fluid outflow conduit, thereby causing said body cavity to deflate.
10. An apparatus for controllably introducing fluids into a body cavity, said apparatus including a fluid inflow conduit of a first size and a fluid outflow conduit connected to said fluid inflow conduit and connectable to said body cavity, said fluid outflow conduit being of a second size smaller than said first size, a pump operably associated with said fluid inflow and fluid outflow conduits for introducing fluid under pressure into said conduits, a sensor operably associable with said body cavity for sensing a predetermined critical pressure within said body cavity, a timer for determining a predetermined critical passage of time and a computer operably associated with said sensor, with said timer and with said pump to operate said pump, said apparatus adapted to, through use of said computer:
(a) energize said pump to pressurize said fluid inflow conduit, such that a connected body cavity can be inflated; and (b) use said timer to verify that said critical time has been exceeded and then use said computer to de-energize said pump.
11. The apparatus of Claim 10, wherein said apparatus is adapted to, prior to use of said timer to verify that said critical time has been exceeded and, use of said computer to de-energizing said pump, use said timer to verify that said critical time has not been exceeded and use said sensor to determine said point at which said critical maximum pressure in said connected body cavity is exceeded and then use said computer to de-energize said pump.
12. A use of the apparatus of any of claims 1-11 in a rehabilitative treatment of a body cavity disorder.
13. The use according to claim 12 wherein said body cavity disorder is a motility disorder.
14. A method of inflating and deflating a body cavity for a diagnostic purpose using an apparatus for controllably introducing fluids into said body cavity, said apparatus including fluid inflow and fluid outflow conduits interconnected with the body cavity, pressurization means operably associated with the fluid inflow conduit for introducing fluid under pressure into the fluid inflow conduit, sensor means operably interconnected with the fluid inflow conduit for sensing fluid pressure within the fluid inflow conduit, said method comprising the steps of:
(a) pressurizing the fluid inflow conduit at a first rate of fluid flow;
(b) pressurizing the fluid outflow conduit at a second rate of fluid flow less than said first rate of fluid flow thereby causing the body cavity to inflate;
(c) pressurizing the fluid inflow conduit at a third rate of fluid flow; and (d) pressurizing the fluid outflow conduit at a fourth rate of fluid flow greater than said third rate of fluid flow thereby causing the body cavity to deflate.
15. The method as defined in Claim 14 including the further step of pressurizing both the fluid inflow conduit and the fluid outflow conduit at substantially equal fifth rates of fluid flow thereby causing the body cavity to remain partially deflated.
16. The method as defined in Claim 15, including the further step of pressurizing both the fluid inflow conduit and the fluid outflow conduit at substantially equal sixth rates of fluid flow lesser than said fifth rates of fluid flow thereby causing the body cavity to deflate.
17. A method of inflating and deflating a body cavity for diagnostic purposes using an apparatus for controllably introducing fluids into said body cavity, said apparatus including a timer, interconnected fluid inflow and fluid outflow conduits connected to said body cavity, a pump operably associated with said fluid inflow and fluid outflow conduits for introducing fluid under pressure into said conduits, an inflow valve disposed within said fluid inflow conduit, an outflow valve disposed within said fluid outflow conduit, a sensor operably interconnected with said fluid inflow conduit for sensing fluid pressure within said fluid inflow conduit and a computer operably associated with said pump, said inflow valve and said outflow valve to operate said pump, said inflow valve, and said outflow valve and operably associated with said sensor to receive signals from said sensor, said method comprising the steps of, through use of said computer:
(a) energizing said pump to pressurize said fluid inflow and outflow conduits;
(b) adjusting said inflow valve to establish a first rate of fluid flow through said fluid inflow conduit;
(c) adjusting said outflow valve to establish a second rate of fluid flow through said fluid outflow conduit less than said first rate of fluid flow thereby causing said body cavity to inflate;
(d) adjusting said inflow valve to establish a third rate of fluid flow through said fluid inflow conduit; and, (e) adjusting said outflow valve to establish a fourth rate of fluid flow through said fluid outflow conduit greater than said third rate of fluid flow thereby causing said body cavity to deflate.
18. The method of Claim 17, including the further step of adjusting said inflow and outflow valves to establish fluid flow through both said fluid inflow conduit and said fluid outflow conduit at substantially equal fifth rates of fluid flow thereby causing said body cavity to remain partially deflated.
19. The method of Claim 17, including the further step of adjusting said inflow and outflow valves to establish fluid flow through said fluid inflow and outflow conduits at substantially equal sixth rates of fluid flow greater than said fifth rates of fluid flow thereby causing said body cavity to deflate.
20. The method of Claim 17, including the further step of prior to adjusting said outflow valve to establish a second rate of fluid flow through said fluid outflow conduit less than said first rate of fluid flow, checking the elapsed time since energizing the pump as shown by the timer to verify that it is less than the critical duration time allowable for inflation of said body cavity and including said further step of reading said first sensor to verify that said pressure within said inflow conduit is equal to or greater than a critical maximum pressure.
21. The method of Claim 20, including the further step of prior to adjusting said outflow valve to establish a fourth rate of fluid flow through said fluid outflow conduit greater than said third rate of fluid flow thereby causing the body cavity to deflate, determining that said pressure within said inflow conduit is equal to or less than a critical minimum pressure.
22. A method of inflating and deflating a body cavity for diagnostic purposes using an apparatus for controllably introducing fluids into said body cavity, said apparatus including a timer, interconnected fluid inflow and fluid outflow conduits connected to said body cavity, a continuously operating pump operably associated with said fluid inflow and fluid outflow conduits for introducing fluid under pressure into said conduits, an outflow valve disposed within said fluid outflow conduit and a computer operably associated with said outflow valve to operate said outflow valve, said method comprising the steps of, through use of said computer:
(a) closing said outflow valve to establish fluid flow through said fluid inflow conduit, thereby causing said body cavity to inflate; and, (b) opening said outflow valve to establish fluid flow through said fluid outflow conduit, thereby causing said body cavity to deflate.
23. A method of inflating and deflating a body cavity for diagnostic purposes using an apparatus for controllably introducing fluids into said body cavity, said apparatus including a fluid inflow conduit of a first size and a fluid outflow conduit connected to said fluid inflow conduit and to said body cavity, said fluid outflow conduit being of a second size smaller than said first size, a pump operably associated with said fluid inflow and fluid outflow conduits for introducing fluid under pressure into said conduits, a sensor operably associated with said body cavity for sensing a predetermined critical pressure within said body cavity, a timer for determining a predetermined critical passage of time and a computer operably associated with said sensor, with said timer and with said pump to operate said pump, said method comprising the steps of, through use of said computer:
(a) energizing said pump to pressurize said fluid inflow conduit, thereby causing said body cavity to commence to inflate; and (b) using said timer, verifying that said critical time has been exceeded and then, using said computer, de-energizing said pump.
24. The method as defined in Claim 23, including the further step of prior to using said timer to verify that said critical time has been exceeded and, using said computer, de-energizing the pump, using said timer, to verify that said critical time has not been exceeded and, using said sensor determining the point at which the critical maximum pressure in the body cavity is exceeded and then, using said computer, de-energizing said pump.
CA 2661242 2009-04-02 2009-04-02 Method and apparatus for pressurizing a body cavity for diagnostic and rehabilitative purposes Abandoned CA2661242A1 (en)

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US10398295B2 (en) 2014-12-22 2019-09-03 Smart Medical Systems Ltd. Balloon endoscope reprocessing system and method
US10610086B2 (en) 2010-03-09 2020-04-07 Smart Medical Systems Ltd. Balloon endoscope and methods of manufacture and use thereof
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US10610086B2 (en) 2010-03-09 2020-04-07 Smart Medical Systems Ltd. Balloon endoscope and methods of manufacture and use thereof
EP3461527A1 (en) * 2011-03-07 2019-04-03 Smart Medical Systems Ltd. Open-loop pressure control system for an endoscope
US10456564B2 (en) 2011-03-07 2019-10-29 Smart Medical Systems Ltd. Balloon-equipped endoscopic devices and methods thereof
AU2020203670B2 (en) * 2011-03-07 2022-03-24 Smart Medical Systems Ltd. Balloon-Equipped Endoscopic Devices And Methods Thereof
US10398295B2 (en) 2014-12-22 2019-09-03 Smart Medical Systems Ltd. Balloon endoscope reprocessing system and method
US10835107B2 (en) 2015-04-03 2020-11-17 Smart Medical Systems Ltd. Endoscope electro-pneumatic adaptor

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