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Title:
INSUFFLATION APPARATUS AND METHOD OF USE
Document Type and Number:
WIPO Patent Application WO/2016/022973
Kind Code:
A1
Abstract:
An insufflations apparatus comprising a solution storage containing a reactant; a reaction chamber containing a reactant; an inlet valve operatively coupled between the solution storage container and the reaction chamber in order to allow solution to flow from the solution storage to the reaction chamber providing the environment for a gas formation reaction capable of increasing pressure within the reaction chamber; and a pressure valve operatively coupled between the solution storage and the reaction chamber; wherein the pressure valve is capable of influencing the relative pressure and in turn impacting the amount of solution that flows between the solution storage and reaction chamber.

Inventors:
SMITH BYRON FITZGERALD (US)
WEAVER GLEN ANTHONY OLSON (US)
HOWSER COLLIN GRAVES (US)
Application Number:
PCT/US2015/044310
Publication Date:
February 11, 2016
Filing Date:
August 07, 2015
Export Citation:
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Assignee:
ENDOINSIGHT INC (US)
International Classes:
A61M13/00; A61M16/00; A61M37/00
Domestic Patent References:
WO2013008070A12013-01-17
Foreign References:
US20010042571A12001-11-22
US6203519B12001-03-20
US6042573A2000-03-28
US20110060272A12011-03-10
Attorney, Agent or Firm:
BALDRIDGE, Julie, R. (Suite 2000Memphis, TN, US)
Download PDF:
Claims:
WHAT IS CLAIMED IS: 1. An insufflation system comprising a chamber with an inlet and an outlet, the chamber further comprising an acid and a base; wherein said chamber is configured to be operabiy coupled with an air/water orifice of an endoscope,

2. The insufflation system of claim 1 , further comprising an igniter capable of inducing an initial pressure change within the chamber.

3. The insufflation system of claim 1 , wherein the acid is citric acid and the base is sodium bicarbonate.

4. An insufflation apparatus comprising: a chamber containing an acid and a base; an inlet port in the chamber for introducing water into the chamber; an outlet port having a pressure regulator for controlling the amount of carbon dioxide {CO2) produced when water is introduced into the chamber and combines with the acid and base to produce carbon dioxide (CO2) that passes through the outlet port.

5. The insufflation apparatus of claim 4, further comprising an igniter capable of inducing an initial pressure change within the chamber.

6. The insufflation apparatus of claim 5, wherein the outlet port is operatively coupled with an endoscope for insufflating an animal body cavity.

7. The insufflation apparatus of claim 4, wherein the acid is citric acid and the base is sodium bicarbonate.

8 An insufflation apparatus comprising; a solution storage containing a reactant; a reaction chamber containing a reactant; an inlet valve operatively coupled between the solution storage container and the reaction chamber in order to allow solution to flow from the solution storage to the reaction chamber providing the environment for a gas formation reaction capable of increasing pressure within the reaction chamber; and a pressure valve operatively coupled between the solution storage and the reaction chamber; wherein the pressure valve is capable of influencing the relative pressure and in turn impacting the amount of solution that flows between the solution storage and reaction chamber.

9. The insufflation apparatus of claim 8, further comprising an outlet port operatively coupled with an endoscope for channeling a reaction product from the gas formation reaction of the reaction chamber to and through the endoscope for insufflating an animal body cavity.

10. The insufflation apparatus of claim 9, further comprising an igniter capable of inducing an initial pressure change within the solution storage chamber.

1 1 . The insufflation apparatus of claim 8, wherein the reactant in the storage container is an acid and the reactant in the reaction chamber is a base.

12. The insufflation apparatus of claim 1 1 , wherein the acid is citric acid and the base is sodium bicarbonate.

13. A method of insufflating a portion of an animal anatomy, comprising: providing an insufflation system, containing an insufflation cartridge having a chamber containing the acid and the base; an inlet port in the chamber for introducing water into the chamber; an outlet port having a pressure regulator for controlling the amount of carbon dioxide {CO2) produced when water is introduced into the chamber and combines with the acid and base to produce carbon dioxide (CO2) that passes through the outlet port, wherein said insufflation system is operatively coupled with an endoscope; reacting the acid with the base to produce carbon dioxide (CO2) by introducing water into the chamber; controlling the level of carbon dioxide pressure passing from the outlet through the endoscope and into a target portion of the human anatomy.

14. An insufflation system support structure comprising a planar support member and two retention members coupled perpendicularly to the support member, where the retention members comprise wall members between which chambers of an insufflation system can be held in place by sandwiching the chambers between the wall members.

15. The insufflation support structure of claim 14, further comprising anchors for affixing the support structure to an appropriate piece of equipment in an endoscopy suite.

16. The insufflation support structure of claim 14, further comprising a handle.

Description:
INSUFFLATION APPARATUS AND METHOD OF USE BACKGROUND [0001 ] This application claims the benefit of U.S. Provisional Application No. 62/034,677, filed August 7, 201 4. [0002] This technology relates generally to endoscopy and, more particularly, to insufflation devices and methods. Minimally invasive procedures decrease the trauma inflicted on patients during medical procedures resulting in decreased recovery times with respect to open access procedures. Advances in minimally invasive procedures have been made possible by the development of dexterous manipulators that are capable of navigating within the confines of restrictive anatomical features. In order to enhance the workspace during minimally invasive procedures, clinicians often inflate body cavities to maximize the unobstructed volume available for manipulating tools within. This practice, commonly referred to as insufflation, makes the task of manipulating instruments easier on the clinician and as a result patient outcomes are enhanced. A number of different media have been proposed for use during various procedures but room-air, carbon dioxide and water are the most commonly used media. Most endoscopic image processing units include diaphragm pumps, which can be used to administer Room-air (RA) insufflation. As a result, RA has the advantage of being free however, because it is not readily absorbed by tissue, pockets of air can become trapped within anatomical features and these pockets can result in great discomfort for the patient. Researchers have shown that water can be used successfully as an insufflating media during some minimally invasive procedures however, because gases are commonly used as an insufflating media, the use of water insufflation requires changes to clinical workflows which can result in longer procedure times, Z. Falchuk and P. Griffin, "A Technique to Facilitate Colonoscopy in Areas of Severe Diverticular Disease," New England Journal of Medicine, vol. 310, pp. 519-525, 1984 and U. Baumann, "Water Intubation of The Sigmoid Colon: Water Instillation Speeds Up Left-Sided Colonoscopy," Endoscopy, vol. 31, pp. 314-317, 1999. [0003] Carbon dioxide offers several advantages over the use of RA and water insufflation. Carbon dioxide insufflation has the advantages of eliminating the risk of combustion during electrosurgical procedures, B.G. Rogers, "The Safety of Carbon Dioxide Insufflation During Colonoscopic Electrosurgical Polypectomy," Gastrointestinal Endoscopy, vol. 20, no. 3, pp. 115-117, 1974, and resulting in reduced patient discomfort, M. Bretthauer, A. Lynge, E. Thiis- Evensen, G. Hoff, O. Fausa and L. Aabakken, "Carbon Dioxide Insufflation in Colonoscopy: Safe And Effective in Sedated Patients," Endoscopy, vol. 37, no. 8, pp. 706-9, 2005 and D. Domagk, M. Bretthauer, P. Lenz, L. Aabakken, H. Ullerich, C. Maaser, W. Domschke and T. Kucharzik, "Carbon Dioxide Insufflation Improves Intubation Depth in Double-Balloon Enteroscopy: A Randomized, Controlled, Double-Blind Trial," Endoscopy, vol. 39, no. 12, pp. 1064-7, 2007, but the use of carbon dioxide insufflation comes with increased equipment cost, W. Hsu, M. Sun, H. Lo, C. Tsai and Y. Tsai, "Carbon Dioxide Insufflation During Withdrawal of The Colonoscope Improved Postprocedure Discomfort: A Prospective, Randomized, Controlled Trial," Kaohsiung Journal of Medical Sciences, vol. 28, pp. 265- 69, 2012 and E. S. Dellon, J. S. Hawk, I. S. Grimm and N. J. Shaheen, "The Use of Carbon Dioxide For Insuff ation During GI Endoscopy: A Systematic Review," Clinical Endoscopy, vol. 69, no. 4, pp. 843-849, 2009, and additional equipment setup time. [0004] Commercially available carbon dioxide insufflation systems typically consist of a high-pressure reservoir, a flow-control mechanism and a low- pressure outlet channel. While the nature of these systems may vary depending on the intended use, the fundamental components of the system are designed to throttle the flow of gas from a high-pressure source so it can be introduced into an organ or body cavity without resulting in harm to the patient secondary to excessive pressure. The introduction of pressurized gas provides clinical utility by distending tissue in a manner that enhances visualization via imaging devices or, otherwise enlarges a body cavity such that a surgical instrument can be more easily manipulated within said cavity. In order to provide systems that can efficiently throttle the flow of CO2 without risking exposing a patient to potentially harmful pressures, commercially available technologies often employ sophisticated electro-mechanical flow-control systems. The nature of the constitutive components used in these designs renders said systems bulky, expensive and prone to failure. [0005] A number of different carbon dioxide insufflation systems exist that include modified rinse water bottles that are used to introduce carbon dioxide into the pneumatic circuit of a standard endoscope such as that disclosed in U.S. Patent Application No. 20120091092 and U.S. Patent Application No. 20120095293 which applications are incorporated herein in their entireties by this reference. Such systems combine irrigation and rinsing tube sets and backflow preventers, which serve to reduce the risk of cross contamination. [0006] Cartridge-based systems, which use pressurized containers, have also been introduced. [0007] Previous work has shown that effervescent reactions can be leveraged to produce low-cost and disposable CO2 insufflation systems that can be used during traditional endoscopy, B. Smith, P. Valdastri and K. Obstein, CO2 Insufflator For Minimally Invasive Procedures, 2013. These systems have provided a proof-of-principle for the use of effervescence-based CO2 insufflation but they have not yet delivered on the promise of a low-cost system that compliments clinical workflows while remaining cost-effective when compared to traditional compressed-gas CO2 insufflation systems. BRIEF SUMMARY [0008] The effervescent CO2 source cartridge includes a vessel and chemical reactants, which can be used to produce gaseous media, and a means for securely fastening the cartridge to a reusable flow control mechanism. To activate the cartridge, water is introduced to the vessel and its concomitant reactants causing the production of CO2. [0009] Alternatively, The effervescence CO2 source cartridge may include a two-part vessel, an impermeable diaphragm, chemical reactants which can be used to produce gaseous media, and a means for securely fastening said cartridge to a reusable flow control mechanism. To activate the cartridge it is simply attached to the flow control mechanism and as the two parts of the system (cartridge and flow-control mechanism) are joined, a channel on the flow control mechanism comes into contact with the impermeable diaphragm and this contact causes the diaphragm to become punctured or otherwise displaced. The act of disturbing the diaphragm allows a fluid in the upper compartment of the cartridge to flow into the lower chamber of the cartridge and as the fluid comes into contact with the chemicals reactants in the lower chamber, production of gaseous media commences. [0010] A system capable of generating carbon dioxide to serve the needs of an endoscopy suite throughout the course of a normal day can be realized using a tank of citric acid solution and a reaction chamber containing solid sodium bicarbonate. A valve can be used to control the flow of acidic solution into the reaction chamber and the resulting carbon dioxide can be carried out through a flexible tube so it can easily be integrated into various applications for use over the course of the day. The system can be configured such that the gas generated by the reaction can be used to pressurize the solution tank in order to increase the minimum pressure realized during the CO2 production cycle. Alternatively, the solution tank can be pressurized using strain-energy stored within the material used to construct the solution tank, or, a gas charge can be used to pressurize the solution tank without requiring gas to be introduced from gas produced in the reaction chamber. DESCRIPTION OF THE FIGURES [0011 ] FIG. 1 is a plan view of a typical endoscope, showing the water ports with which exemplary embodiments of insufflation systems may be operably coupled. [0012] FIG. 2 is an aerial view of an exemplary embodiment of a two- chamber CO2 generator. [0013] FIG. 3 is a perspective view of an exemplary embodiment of a two- chamber CO2 generator. [0014] FIG. 4A is a frontal view an exemplary holder assembly for a two- chamber CO2 generator of FIG. 2. [0015] FIG. 4A is a perspective view an exemplary holder assembly for a two-chamber CO2 generator of FIG. 2. [0016] FIG. 5 is a perspective view of a single chamber CO2 insufflator assembly. [0017] FIG. 6 is a perspective view of an exemplary single chamber insufflator system comprised of a reactant cartridge and base structure that can be used to activate said cartridge and regulate the flow of gas from the system. [0018] FIG. 7 is a perspective view of a Single chamber insufflation system with integrated flow control mechanism. [0019] FIG. 8 is a perspective view of a two-chamber insufflation system. [0020] FIG. 9 is a perspective view of the hub, which connects the two chambers of the system of FIG. 8, via flow channels between the two chambers and showing an exhaust channel for venting gas. [0021 ] FIG. 1 0 is a perspective view a two-chamber CO2 generator with valve regulated solution flow and simple outlet. [0022] FIG. 1 1 is a perspective view of a diaphragm-based solution flow valve. [0023] FIG. 1 2A is a perspective view of an alternative embodiment of a two-chamber CO2 production system. [0024] FIG. 1 2A is a perspective view of an alternative embodiment of a two-chamber CO2 production system. D ETAILED DESCRIPTION [0025] Described herein are several embodiments of effervescence-based CO2 insufflation systems generally and particularly cartridges that facilitate CO2 production and control. In certain embodiments the systems comprise a single- use chemical cartridge and a multi-use flow-control mechanism. These and other embodiments provide clinicians with a CO2 source that is simple to use and has very few parts so it can be disposed of after a single use. Also disclosed are methods for regulating the flow/pressure of CO2 coming from the CO2 source in a manner that is simple to construct and intuitive to operate. In an exemplary embodiment, this regulation may be achieved by formulating the chemical charge in a manner that limits the rate of reaction such that gaseous media is produced at a volumetric rate slightly exceeding the clinical need and a low-cost flow- control mechanism is then used to regulate output flow/pressure as desired by the clinician. [0026] The following terms are used in this application: [0027] Acid: Any of a class of compounds that form hydrogen ions when dissolved in water, and whose aqueous solutions react with bases. [0028] Air/water orifice: any opening suitable for introducing air and/or water into an endoscope, for example the air/water bottle connector port, the air/water valve, auxiliary channels/ports or the like. [0029] Anhydrase: An enzyme that catalyzes the removal of water from a compound. [0030] Base: Any of a class of compounds that form hydroxide ions when dissolved in water, and whose aqueous solutions react with acids. [0031 ] Biocompatibility: The ability of a material or device to perform with an appropriate host response in a specific application. [0032] Between: Appearing at some point along a relational continuum of amount, weight, distance, etc. with respect to another or others. [0032] Carbonate: Any salt containing the HCO - 3 anion. [0033] Carbon Dioxide (CO2): Carbon dioxide is a naturally-occurring chemical compound composed of 2 oxygen atoms each covalently double bonded to a single carbon atom. [0034] Cartridge: A small modular unit designed to be inserted into or connected to another piece of equipment.

[ 0035] Chamber: A substantially enclosed space.

[ 0036] Channel: A way, course, or direction of thought which something passes.

[ 0037] Couple: To link, associate, put, or connect one or more things together.

[ 0038] Endoscopy: A means of looking inside and typically refers to looking inside the body for medical reasons using an endoscope.

[ 0039] Endoscope: An instrument used to examine the interior of a hollow organ or cavity of the body.

[ 0040] Hub: An interface or connection point that often has one or more ports.

[ 0041 ] Inlet: A place or means of entry.

[ 0042] Insufflation: The act of introducing a powder, vapor, gas, or air into a cavity.

[ 0043] Membrane: A thin layer that covers a surface, lines a cavity, or divides a space.

[ 0044] Outlet: A place or means of exit.

[ 0045] Port: The opening through which something may pass through. [0046] Powder: Any of various preparations consisting of ground, pulverized, or otherwise finely dispersed solid particles. [0047] Pressure: Force per unit area. [0048] Reactant: A substance, which takes part in a reaction and is altered by the reaction. [0049] Reaction: A phenomenon caused by the (inter)action of agents with respect to one another. [0050] Regulator: A substance or process that controls another substance or process. For example, in one embodiment the regulator may be a mechanical part of a gas delivery system that controls gas pressure that allows a manageable flow of vapor to escape. [0051 ] Single Use: Use with a single patient or daily-use in a single surgical room. [0052] Solution: A homogeneous mixture of two or more substances. A solution may exist in any phase. [0053] Structure: The components and their manner of arrangement in constituting a whole. [0054] System: a set of connected things or parts forming a whole. In preferred embodiments disclosed herein, a system may consist of cartridge as a single component system or it may include multiple components. [0055] Valve: The component that opens or closes to let things through or to prevent passage. [0056] The catalytic decomposition of hydrogen peroxide in addition to a number of effervescent reactions for use as possible gas generators in an insufflation platform were investigated. While hydrogen peroxide was found to have an excellent expansion ratio, recent findings have shown that even concentrations on par with the weakest solutions can result in serious damage when ingested. [0057] Carbon dioxide (CO2) for the purpose of colonic insufflation has been found to be advantageous over traditional air insufflation since CO2 is readily absorbed via the colon, thereby reducing patient discomfort due to the effect of colonic distention. The biocompatible chemical reactions can include acetic acid+sodium bicarbonate, Citric acid+sodium bicarbonate, Acetic acid+potassium bicarbonate, Citric acid+potassium bicarbonate, Aluminum Sulfate+sodium bicarbonate, Aluminum Sulfate+potassium bicarbonate, Acetic acid+sodium bicarbonate+Carbonic anhydrase, Citric acid+sodium bicarbonate+Carbonic anhydrase, Acetic acid+potassium bicarbonate+Carbonic anhydrase, Citric acid+potassium bicarbonate+Carbonic anhydrase, acetic acid+sodium carbonate, Citric acid+sodium carbonate, Acetic acid+potassium carbonate, Citric acid+potassium carbonate. [0058] Carbon dioxide is the product responsible for inflation and is produced by the reaction of acid and a base. CO2 is easily absorbed through the internal mucosa into the blood, and its use avoids over distention and post- procedure abdominal discomfort. The reaction between potassium bicarbonate and citric acid has been found to generate the largest output of CO2. However, sodium bicarbonate and citric acid is preferred for human use as potassium bicarbonate may result in complications for patients with renal failure. [0059] Some non-limiting examples utilized citric acid (C5H8O7) and potassium bicarbonate (KHCO3) to generate carbon dioxide (CO2), however, sodium bicarbonate and citric acid are typically used. For citric acid reacted with sodium bicarbonate the stoichiometric ratio is one mole citric acid to three moles sodium bicarbonate. For citric acid with potassium bicarbonate the stoichiometric ratio is one mole citric acid to three moles of potassium bicarbonate. Based on the studies performed with citric acid and sodium bicarbonate, citric acid being in solution and sodium bicarbonate being a powder, a solution of 1 .5 g/mL gave the best compromise between rate of reaction and total output. In certain embodiments, the acid and the base are both in a powder form but in preferred embodiments the acid and/or the base may be in solution to save time. Depending on the intended use and duration of use, the solution make-up may differ and can be determined without undue experimentation. [0060] This reaction achieved a volume of gas that has been found to be sufficient to distend the colon lumen. This chemical reaction also generates an inflation that produces a tangible enhancement to visualizing the colon lining. [0061 ] Effervescent CO2 insufflation has the potential to reduce the per- patient cost for delivering a less-painful colonoscopy and increasing patient outcomes during minimally invasive procedures but in order to realize this, potential systems must be simple to use and inexpensive to construct. In one exemplary embodiment, a CO2 insufflator based on effervescent reactions can be realized by a single chamber system containing dry and preferably hermetically sealed mixture of acidic and basic powders. When water is added to the mixture of powdered reactants the product of carbon dioxide begins. Such a system is depicted in FIG.1 0. [0062] The systems presented above are novel with respect to previous effervescence-based CO2 insufflation systems. While all of the systems disclosed above can be realized using rigid or compliant materials to define the chambers, incorporating elastic materials in the reaction chamber will offer several advantages. The elastic materials will help maintain a relatively constant pressure by exhibiting elastic deformation in response to the stress produced at a desired reaction chamber pressure. The cyclic deformation of the elastic structure will also promote mixing of the reactants. [0063] Referring to FIG. 1 , the insufflation systems of disclosed herein and further illustrated in FIGS. 2-1 2 may be operatively coupled with an of the many variations of endoscopes, which typically have an air/water bottle converter port, an air/water valve or both. port configuration and means of coupling the cartridges to the endoscope has been done by the present inventors consistent with U.S. Patent No. 5,301,656 and U.S. Patent No. 6,346,075, which patents are incorporated herein in their entireties by this reference. [0064] The newly presented insufflation systems can be designed such that they are capable of meeting the insufflation needs for a single procedure or multiple procedures. When considering the latter, integrating the insufflation system with a daily-use bottle cap will allow for ease of use with a standard rinse water bottle. This design configuration offers the ability reduce production costs by eliminating the need for a connector between insufflation system and the rinse water bottle. This integration will also reduce setup time and make for a more useable product. [0065] Referring back to FIG. 1 0, the system can be shipped in a dehydrated state to improve shelf live and reduce storage volume. The system will be set up in the morning by a medical technician or nurse. Water is added to the solution storage tank. As the system is filled, water dissolves citric acid as it flows through a one-way valve and into the reaction chamber. The acidic solution reacts with the powdered base to produce carbon dioxide. As gas fills the unoccupied volume in the reaction chamber, pressure within the chamber rises. This rise in pressure is used to restrict the flow of acidic solution in the reaction chamber. By throttling the flow of acidic solution into the reaction chamber, the production of CO2 can be throttled to preserve reactants when outlet flow is not required or, increased when a higher CO2 outlet flow rate is desired. [0066] The system can be modeled using simplified representations and separated into subsystems in order evaluate the volume flow rate out of the system as a function of time. Fluid from the solution storage tank flows into the reaction chamber. As it come into contact with the powdered base it reacts to form carbon dioxide and other solid and liquid products (when using 1 mol of citric acid and 3 mol of sodium bicarbonate the resulting products are 1 mol of sodium citrate, 3 mol of carbon dioxide and 3 mol of water). As the reaction produces CO2, pressure within the reaction chamber rises. When the pressure in the reaction chamber becomes larger than the pressure of the fluid above the solution valve minus the pressure loss, or, “crack pressure”, of the valve, then acidic solution stops flowing into the reaction chamber. [0067] P3>P2-Pcp (1 )

[0068] The pressure in the reaction chamber will continue to rise as the unreacted mass of citric acid continues to mix with the powdered reactants. If the outlet valve from the reaction chamber is open, high pressure within the reaction chamber will cause CO2 to flow out of the chamber. Once the pressure within the reaction chamber drops to: [0069] P2-Pcp>P3 (2) [0070] Then solution will begin flowing into the reaction chamber and the cycle repeats. Based on this relationship we can see that the maximum pressure within the chamber is achieved during the period within the cycle when acidic solution is not flowing into the reaction chamber. The pressure within the reaction chamber will cycle between this upper value and a lower value of P3t defined by equation (2) with the above valve (P2) defined by the some of the static fluid force and the pressure at the upper surface of the fluid, P1. [0071 ] P2 = P1+ σgh1 (3) [0072] From equation (3) we can see that as fluid leaves the solution tank . If the upper surface of the fluid is open to the atmosphere ( ) then the lower limit of the systems output pressure is dominated by σgh1 . This is the type of limitation that can be overcome by using the CO2 produced by the reaction to control the pressure at P1. It should be kept in mind that the system can be configured such that the gas generated by the reaction can be used to pressurize the solution tank in order to increase the minimum pressure realized during the CO2 production cycle. Alternatively, the solution tank can be pressurized using strain-energy stored within the material used to construct the solution tank, or, a gas charge can be used to pressurize the solution tank without requiring gas to be introduced from gas produced in the reaction chamber. [0073] A recent article published in Gastrointestinal Endoscopy shows that commercially available CO2 insufflators used for endoscopy are capable of delivering a maximum pressure of 375mm Hg (~7psi or 200in of water). Since the proposed product will not fit well in an endoscopy suite if it requires a column of water 200in high simply to achieve the desired output pressure it is proposed that pressure generated within the reaction chamber can be used to pressurize the solution tank such that the value of P2 is dominated by P1 and σgh1 plays a relatively insignificant role in maintaining reaction chamber pressure. A system for implementing such a configuration is shown in Figure 4. As can be seen in the figure, a one-way valve has been added to allow CO2 to flow from the reaction chamber into the solution tank in order to increase the total pressure in the tank. This system also uses a one-way valve to regulate the maximum pressure that must be achieved within the reaction chamber before CO2 can flow out of the system. [0074] In an exemplary embodiment shown in below [0075], the system can be used to produce CO2 by the following steps: Water is added to the solution storage tank. Solution enters the reaction chamber and the pressure within (P3) rises. A one-way valve between P3 and P1 allow P1 to equalize with P3 at P1=P3- P31cp but because a small diameter connection is used P1 approaches P3 slowly. Flow from the solution chamber cuts off when (P1 +· gh1)-P3<Pcp23. Acidic solution continues to react as P3 Į P3overshoot. Acidic solution is forced into reactor by external pressure applied by clinician and pressure builds unit P3 Į P3desired. The system remains in equilibrium as (P3overshoot - Pcp31 +· gh1 )-P3overshoot < Pcp23. CO2 is allowed to exit the reaction chamber when P3 - P4 > Pcp34. When CO2 exits the system, pressure in the reaction chamber drops and flow begins when (P3overshoot - Pcp31 +· gh1 )-P3overshoot > Pcp23. [0075]

[ 0076] While this system will operate about a desired set point, without referencing that set point against a known static pressure during each cycle, the reaction chamber pressure will be subject to drift and over time the output characteristics will change. [0077] While the previous design allowed us to increase the lower limit of the reaction chamber during a given CO2 generation cycle by increasing the pressure in the solution storage tank, it was subject to drift since carbon dioxide production was not regulated with respect to a constant reference pressure like the atmosphere. If the flow between the solution chamber and reaction tank is regulated by a valve with crack pressure, Pcp3r, which is measured between P3 and a reference pressure (atmospheric conditions), then the system should start producing gas whenever the pressure within the reaction chamber drops below a desired threshold. One means of achieve this is to provide a diaphragm actuated valve so solution is free to flow when P3 - Pref<P3r_close. Though reference is made to a diaphragm actuated valve, other relief valves could be suitable such as spring loaded pressure release valves. An exemplary embodiment of such a valve assembly is provided below: [0078]

[ 0079] By adding a diaphragm based pressure regulated control valve to the CO2 outlet channel, CO2 can be delivered at a desired pressure or flow rate even in the presence of reaction chamber pressure variations. In this alternative embodiment, this system may further comprise a diaphragm-based pressure regulator on the CO2 exhaust. As such, the system will step through the same states during a given pressure cycle. The only difference between the two systems occurs when we examine the output flowing from the system’s outlet. Just as the addition of a pressure-regulated diaphragm valve allowed us to throttle the flow of solution into the reaction chamber based on its variation from a desired pressure level, the pressure-regulated diaphragm valve on the system exhaust will allow us to regulate the flow of CO2 out of the system in order to maintain a desired pressure at some intended use. An example application is presented by maintaining a desired pressure within the rinse-water bottle used with a standard endoscope. [0080] In the above embodiment, pressure is maintained in the rinse-water bottle of the endoscope. The system shown regulates acidic solution flow into the reaction chamber based on the pressure within said chamber and it regulates the flow of CO2 to a rinse-water bottle based on the pressure within the bottle. If the pressure within the reaction chamber is held sufficiently above the target pressure for the rinse water bottle, the system will be able to maintain the outlet pressure without issue. From analysis of the previous system we know that the pressure within the reaction chamber will cycle between:

w here is the pressure at which acidic solution beings to flow, is the pressure at which solution flow is cut off, is the maximum valve that the pressure within the reaction take will reach and is the minimum valve that pressure within the reaction chamber will reach. will be dependent on the magnitude of the unreacted mass within the reaction chamber when reaches . Conversely, is the level to which pressure within the reaction chamber drops to before solution entering the chamber causes the pressure within the chamber to start rising. Because will be dependent on how quickly the acidic solution mixes with the base in the reaction chamber, will increase as the concentration of the base within the reaction chamber becomes more diluted during the course of operational use. [0081 ] The effective time constant of the chemical generation cycle can be reduced by actively promoting mixing of the contents of the reaction chamber. This can be achieved by using high velocity jets of solution entering the chamber, agitation of the con-tents secondary to deformation of the structural components used to define the reaction chamber or other mechanical means.

[0082]

[ 0083] One method for reducing is to incorporate methods for actively mixing the contents of the reaction chamber. Two methods which can be implemented for enhancing dispersion of the acidic solution within the reaction chamber are: 1 ) to introduce acidic solution at a high flow rate and 2) to build the reaction chamber out of an elastic material such that the chamber can expand and retract as pressure within the reaction chamber changes. The latter mechanism will serve to promote mixing of the chemicals within the reaction chamber by generating motion secondary to wall movement. The movement of solution within the reaction chamber will be increased when the momentum of high velocity acidic solution is transferred to the mixture of products and reactants housed within the reaction chamber. [0084] The complex nature of flexible endoscopes renders them difficult to clean and sterilize. In order to facilitate cleaning of multi-use items, systems are often design such that they can be disassembled so various regions within the instrument can be more easily accessed. While the resulting modular devices may be easier to clean, the use of many components to realize a given device often results in increased set-up time. In order to reduce the risks and fiscal burdens associated with multi-use devices many healthcare providers are now moving to the adoption of single-use or daily-use devices. In the field of endoscopy, this transition has resulted in the introduction of single-use endoscope valves and daily-use rinse water bottles and daily-use insufflation/irrigation tubing sets. Because the proposed CO2 insufflation system does not need to be disassembled for cleaning and reuse, the associated tubing sets used to facilitate connection to the endoscope, or other device, can be integrated into the design of the device so as to minimize setup time. [0085] Another feature that reduces setup time is an access port, which can be used to facilitate filling the Solution Storage Tank with water. To that end, a removable cap should be included in the design of the solution storage tank. The cap should be capable of with remaining securely fastened so that it is not blown out of position by increased pressure in the solution tank. [0086]

[ 0087] In addition to incorporating a removable filling cap to facilitate the introduction of water, providing a means for hanging the device from a sink fixture during the filling process will decrease the physical demands placed on the clinician during system setup. Since the system will be integrated into the pneumatic circuit of an endoscope through connection to the rinse water bottle, and since said bottle is often located on the side of an endoscope cart, a means for hanging the device from the endoscopy cart such that it is in close proximity to the rinse water bottle will minimize the length of tubing necessary to connect the system. Designing the anchoring system such that it can be used during the filling process and during system operation will enhance use-ability of the device while minimizing the number of components needed to realize the system. [0088] Incorporating a one-way valve (duck bill or umbrella) into the design of the removable-cap provides a safe guard against exposing the patient to excessive pressure by limiting the maximum pressure that can be achieved. It should be pointed out that though the one-way valve is incorporated into the removable cap in the design below [0089] it can be incorporated in alternative locations and forms. [0089]

[ 0090] Many of the teachings described above can be understood when making specific reference to illustrative embodiments shown in FIGS 1 -3. In particular, salient features of a two-chamber system 300 can be seen when making specific reference to FIG. 3. An exemplary two-chamber system 300 comprises a first chamber 31 0 and second chamber 31 5, the second chamber 31 5 preferably a reaction chamber and the first chamber 31 0 preferably a reactant holding chamber. Even though both chambers 31 0 and 31 5 can house reactants, the reaction chamber 31 5 preferably houses a basic reactant and the other changer 31 0 houses an acidic reactant. [0091 ] In an exemplary embodiment, the first chamber 31 0 holds approximately 1 .5L of citric acid solution or other desirable acidic reactant. The chamber 31 0 itself is preferably able to withstand a constant pressure in the range of between about 5-1 5psi for an extended period of time, where that extended period of time is about between 1 2-48hrs. [0092] In an exemplary embodiment, the second chamber 31 5 holds an appropriate amount of sodium bicarbonate or other desirable basic reactant. An appropriate amount would be, for example, when using when using 1 mol of citric acid and 3 mol of sodium bicarbonate the resulting products are 1 mol of sodium citrate, 3 mol of carbon dioxide and 3 mol of water. The chamber 31 5 itself, is preferably able to withstand a constant pressure in the range of between about 5-1 5psi for an extended period of time, where that extended period of time is about between 1 2-48hrs. [0093] In an exemplary embodiment, the two-chamber system 300 may be coupled with a water source, which is preferably a water bottle. The water source would be coupled with the water source cap 308 that is connected to the two- chamber system 300 via a conduit 307 that comprises a valve and stopcock to ensure directionality of water and CO2 flow as well as allowing a user to regulate the CO2 flow via the connector 309 that is configured to allow the two-chamber system 300 to be operatively coupled with an endoscope air/water orifice. [0094] First and second chambers 31 0 and 31 5 are configured to have first conduit 31 8 and second conduit 31 9 that connection the chambers together. On the end of the conduit 31 9 that terminates within chamber 31 5, there is a valve and break away connector that ensures the directionality of flow and prevents reactants from chamber 31 0 from entering into chamber 31 5 before intended use. Additionally, on the end of conduit 31 8 that terminates within chamber 31 5, there is a one-way valve that ensures the directionality of flow for CO2 used to pressurize chamber 31 0. [0095] The acidic solution reacts with the powdered base in the reaction chamber 31 5 to produce carbon dioxide. As gas fills the unoccupied volume in the reaction chamber, pressure within the chamber rises. This rise in pressure is used to restrict the flow of acidic solution in the reaction chamber. By throttling the flow of acidic solution into the reaction chamber, the production of CO2 can be throttled to preserve reactants when outlet flow is not required or, increased when a higher CO2 outlet flow rate is desired. [0096] Fluid from the first chamber 31 0 flows into the second chamber 31 5. As it comes into contact with the powdered base it reacts to form carbon dioxide and other solid and liquid products. As the reaction produces CO2, pressure within the reaction chamber 31 5 rises. When the pressure in the reaction chamber 31 5 becomes larger than the“crack pressure”, then acidic solution stops flowing from the first chamber 31 0 into the reaction chamber 31 5. Once the pressure within the reaction chamber 31 5 drops, solution will begin flowing into the reaction chamber 31 5 and the cycle repeats. Based on this relationship we can see that the maximum pressure within the chamber is achieved during the period within the cycle when acidic solution is not flowing into the reaction chamber 31 5. The pressure within the reaction chamber will cycle between this upper value and a lower value. [0097] The first chamber 31 0 is preferably configured with a pressure release valve 306 that allows CO2 to vent to the atmosphere to limit the max pressure. Additionally, a clamping apparatus may be configured on the conduit 31 9 to prevent activation of the system 300 before intended use and to keep suspended acid reactant from clogging the conduit during storage. [0098] Referring now to FIG. 2, an exemplary two-chamber system 200 is shown with specific detail of the conduits 21 8 and 21 9 that connect the two chambers 21 0 and 21 5 and conduit 207 for connecting the system 200 to the water source and endoscope. Additionally, the water source cap 208 and the endoscope connector 209 are provided as attachments to conduit 207. The safety features comprising a clamp apparatus 203 and a pressure release valve 206 are provided. [0099] Clinicians may find it advisable, when using two-chamber system 300 such as the one shown in FIG. 3, to have support structure 400 that accommodates and supports the system 300. An exemplary embodiment of such as support structure 400, as shown in FIG. 4A and FIG. 4B comprises a planar member 405 over which conduits 31 8 and 31 9 may be draped. Substantially perpendicular to the planar member 405 are side protective walls 401 , 403, 402 and 404. Each of chambers 31 0 and 31 5 would fit between either protective walls 401 and 403 or 402 and 404. Detents 41 3, 41 4, 41 5 and 41 5 may serve as anchors to either permanently or reversibly mount the support structure 400 to an appropriate location in the endoscopy suite. Rails 409 and 41 2 further prevent the chambers 31 0 and 31 5 from sliding off of the planar member. There are several alternatives that could be employed without resort to undue experimentation. In certain embodiments, the support structure has a handle 41 0. [0099] Alternative embodiments outlined in FIGS. 5-9 address cartridge systems with similar features. [0100] Referring specifically to FIG. 5, the system comprises a cartridge 500 having an inlet port 520 for introducing water into a chamber 51 0 which serves to store the reactants 530 and acts as a reaction chamber and pressure vessel once water has been added, an outlet 540 having a pressure regulator 550. [0101 ] In order to allow for a decreased setup time, the cartridge 500 shown in FIG. 5 can be modified to include the water necessary to initiate the reaction. Components of such a cartridge 600, as can be seen in FIG. 6, the system 600 consists of a chamber 61 0 containing a solution 660, a membrane 670, powdered reactants 630 and a structure 680 to which the chamber can be attached. The structure 680 includes a design feature 682, which displaces the membrane 670 when the chamber 61 0 is attached to the structure 680. When the membrane 670 is disturbed and the solution 660 comes into contact with the reactants 630 and pressure builds within the chamber 21 0. Gas products may then exit the chamber 61 0 by flowing through the exhaust channel 284 incorporated in the design feature 682 of structure 680 before passing through the flow regulator 686. [0102] This embodiment decouples the flow regulator 686 from the components of the system, which are used to generate gasous media that can be used for insufflation. In doing so, it allows for a cartridge 600 where a high value regulator can be used with multiple cartridges. While this system could reduce per-patient or per-procedure costs by allowing for the most expensive components of the system to be used multiple times, a similar system could be designed where the cartridge has an integrated regulator. Such a system is shown in FIG. 7. This embodiment comprises a chamber 71 0, a solution 760, a membrane 770, which divides the chamber into two portions, an amount of powdered reactant(s) 730 and an outlet flow regulator 786. In order to activate such a device, the user could apply pressure to the chamber 71 0 in such a way that the membrane 770 is disturbed and the solution 760 and powdered reactant(s) 730 are allowed to mix. Because water facilitates the reaction, the rate at which pressure builds would only be governed by the amount of initial water content stored within the chamber. [0103] Referring now to FIG. 8 and FIG. 9, a system is provided that is capable of maintaining a desired outlet pressure within an acceptable level of variation by throttling the flow a reactant into the reaction chamber. The system has a first chamber 81 0 and a second chamber 81 5 each chamber 81 0 and 81 5 storing a solution 860 including one reactant 830, a hub 880 which connects the two chambers 81 0 and 81 5 of the system. The hub 880 provides flow channels 888 and 889 between the two chambers 81 0 and 81 5 and the system incorporates a mounting structure 890 with a valve assembly 892 and provides an exhaust channel 894 for venting gas. Each chamber 81 0 and 81 5 is capable of storing solid or liquid reactant(s) 830 or 865. The system shown in FIG. 8 can be realized with, or, without, a regulator 484 on the gas outlet 840. If a regulator 884 is not used on the outlet 840 gas flow, the desired pressure within the reaction chamber can be adjusted by incorporating a means for adjusting the preload on the elastomeric valve to tailor the cracking pressure. [0104] In each of the embodiments, whether single chamber, double chamber or cartridge systems, the acid-containing chamber can be pressurized by a variety of igniters. That igniter could be an initial pressure charge that's provided by some gas during manufacturing, a small bladder containing base reactant that is housed within the solution tank or popped by the clinician during setup so the resulting reaction can take place within the solution tank to provide the desired pressurization, or, it could be as simple as hooking a small pump up to the solution tank so room air is used to pressurize the solution tank. In short, the igniter, could be electrical, mechanical or chemical in composition and function without departing from the spirit of this disclosure. [0105] The description and illustrations are by way of example only. While the description above makes reference to various embodiments, it should be understood that many changes and modifications could be made without departing from the scope of the disclosure. Many more embodiments and implementations are possible within the scope of this invention and will be apparent to those of ordinary skill in the art. For example, the various embodiments have a wide variety of applications including endoscopy. It is intended that the appended claims cover such changes and modifications that fall within the spirit, scope and equivalents of the invention. The invention is not to be restricted except in light as necessitated by the accompanying claims and their equivalents. Therefore, the invention is not limited to the specific details, representative embodiments, and illustrated examples in this description.