WO2008081417A1

WO2008081417A1 - Dilators for body lumens

Info

Publication number: WO2008081417A1
Application number: PCT/IB2008/050009
Authority: WO
Inventors: Arieh Vadasz; Alexander Condrea
Original assignee: Tylerton International Inc.
Priority date: 2007-01-03
Filing date: 2008-01-03
Publication date: 2008-07-10

Abstract

A device for dilating a body lumen, the device comprising a flexible cartridge comprising a sealed single envelope, said flexible cartridge including at least two portions: i) an expandable portion configured for insertion into a body lumen; and ii) a fluid storage portion in fluid communication with said expandable portion, said fluid storage portion configured to release stored fluid thereby inflating said expandable portion.

Description

DILATORS FOR BODY LUMENS

RELATED APPLICATION

This application takes priority from US Provisional Application 60/878,085 filed 03 January 2007, the contents of which is incorporated by reference as if fully set forth herein.

FIELD AND BACKGROUND OF INVENTION

The present invention, in some embodiments thereof, relates to medical devices for dilating body lumens and, more particularly but not exclusively, to inflatable dilation devices.

The human cervical canal, the passage leading to the uterus, is about 2 to 5 centimeters in length and usually closed. Dilation to a diameter of between

10 and 12 millimeters is often required in order to perform medical procedures, for example taking a tissue biopsy or the application of one or more drugs to specific areas of the uterus.

One common method for dilating the cervical canal is with Hegar dilators. Hegar dilators consist of a series of tapered rod-like instruments of increasing diameters that are serially forced through the cervical canal.

A first Hegar dilator of a small diameter is initially pushed through the longitudinal axis of the cervical canal, thereby minimally dilating the cervical canal.

The first Hegar rod is removed, and a second Hegar rod of slightly larger diameter is forced into cervical canal to cause further dilation. The second Hegar rod is then removed, and process is repeated, each time with a Hegar rod of a larger diameter, until the desired dilation diameter has been achieved.

Each insertion of a Hegar rod requires significant force to radially outwardly force the walls of the cervical canal; forces that often create inordinate intra-operative pain. Inordinate intra-operative pain may be indicative of chaffing, exfoliation and ulceration of the mucosal tissue of the cervical canal which is often accompanied by inordinate post-operative pain. Cervical canal ulcers may additionally become infected, requiring treatment of the infection with antibiotics and/or additional dilation procedures in order to clean and drain the infected tissue.

In addition to the above-noted intra-operative pain and risk of post- operative ulceration and infection, insertion the Hegar rods too far past the cervical canal, may perforate the walls of the uterus. Additionally, if any of the Hegar rods are inserted oblique to the longitudinal axis of the cervical canal, the operator may lacerate or puncture the cervical canal and/or uterus, requiring emergency closure through an immediate surgical procedure. Surgical repair, in addition to the untoward risks of blood loss and postoperative infection, necessitates general anesthesia with the additional risk of patient death, particularly in an unhealthy and/or a weak geriatric patient.

SUMMARY OF INVENTION According to an aspect of some embodiments of present invention there is provided a cartridge for dilating an organ lumen with an inflation transducer. According to some aspects of the invention the cartridge is provided separate (optionally in packs of a plurality of cartridges) and there is provided a separate inflation transducer or inflation impellor. The various exemplary options described below may be combined across embodiments.

There is provided in accordance with an exemplary embodiment of the invention, a device for dilating a body lumen, the device comprising a flexible cartridge comprising a sealed single envelope, said flexible cartridge including at least two portions: an expandable portion configured for insertion into a body lumen; and a fluid storage portion in fluid communication with said expandable portion, said fluid storage portion configured to release stored fluid thereby inflating said expandable portion.

In an exemplary embodiment of the invention, said expandable portion comprises an inelastic material.

In an exemplary embodiment of the invention, said expandable portion is covered by a removable protective sheath. In an exemplary embodiment of the invention, said removable sheath includes screw threads that mate with screw threads on the pressure transducer.

In an exemplary embodiment of the invention, said cartridge includes a pressure sensor with a readout.

In an exemplary embodiment of the invention, said anchor portion has an inflated length of between about 5 millimeters and 15 millimeters.

In an exemplary embodiment of the invention, said anchor portion has an inflated length of about 10 millimeters. In an exemplary embodiment of the invention, the body lumen comprises at least one of: a cervical canal, a urethra, a bladder portion, an esophageal sphincter, a pyloric sphincter, and an anal opening.

In an exemplary embodiment of the invention, the body lumen comprises a cervical canal. In an exemplary embodiment of the invention, said expandable portion has an inflated diameter of between about 4 and 8 millimeters.

In an exemplary embodiment of the invention, said expandable portion has an inflated diameter of between about 6 and 20 millimeters.

In an exemplary embodiment of the invention, said expandable portion has an inflated diameter of between about 9 and 13 millimeters.

In an exemplary embodiment of the invention, said fluid guide includes a washer.

In an exemplary embodiment of the invention, said dilator is included in a kit including a pressure transducer. In an exemplary embodiment of the invention, said dilator divides into at least two portions when placed in said pressure transducer: a luminal portion that inserts into the organ lumen; and a fluid reservoir portion.

In an exemplary embodiment of the invention, said pressure transducer includes at least one washer positioning projection.

In an exemplary embodiment of the invention, said washer seals against said pressure transducer. There is provided in accordance with an exemplary embodiment of the invention, a device for dilating a body lumen, the device comprising: an inelastic expandable portion; and a handle sized to fit in one hand, said handle including a pressure inducer.

In an exemplary embodiment of the invention, said inelastic expandable portion comprises an inelastic material.

In an exemplary embodiment of the invention, said pressure inducer is manually operated. In an exemplary embodiment of the invention, said pressure inducer includes a fluid reservoir.

In an exemplary embodiment of the invention, said pressure inducer comprises a syringe.

In an exemplary embodiment of the invention, said pressure inducer includes a piston that presses on a portion of said fluid reservoir.

In an exemplary embodiment of the invention, said pressure inducer includes an electromagnetically driven piston.

In an exemplary embodiment of the invention, said pressure inducer includes a roller that rolls along a portion of said fluid reservoir. In an exemplary embodiment of the invention, said pressure inducer is electrically driven.

In an exemplary embodiment of the invention, said pressure inducer is driven by a motor.

In an exemplary embodiment of the invention, said pressure inducer includes a fluid expanding driver.

In an exemplary embodiment of the invention, said expanding fluid comprises a compressed gas.

In an exemplary embodiment of the invention, said expanding fluid comprises expands in response to radiation. In an exemplary embodiment of the invention, said radiation comprises at least one of: ultrasound, light, heat and radio waves. In an exemplary embodiment of the invention, said fluid guide comprises a rigid tube.

In an exemplary embodiment of the invention, said fluid guide comprises a flexible tube. In an exemplary embodiment of the invention, said fluid guide extends into said anchor portion.

In an exemplary embodiment of the invention, said device does not extend beyond the one hand of an operator.

In an exemplary embodiment of the invention, said device does not include cables that extend beyond the one hand of an operator.

In an exemplary embodiment of the invention, said device does not include wires or tubes that extend beyond the one hand of an operator.

A device for dilating a body lumen, the device comprising a flexible envelope comprising an expandable portion comprising two portions: an inelastic expandable portion section configured to pass through a body lumen; and an anchor portion configured to anchor said flexible envelope in a body cavity, said anchor section being connected to said lumen section in a manner which does not define a reduced diameter area suitable for receiving tissue.

In an exemplary embodiment of the invention, said anchor portion and said inelastic expandable portion are inflatable.

In an exemplary embodiment of the invention, said anchor portion and said inelastic expandable portion comprise an inelastic material. In an exemplary embodiment of the invention, said anchor portion and said inelastic expandable portion comprise a biocompatible material.

In an exemplary embodiment of the invention, the body lumen comprises a cervical canal.

In an exemplary embodiment of the invention, said inelastic expandable portion has an inflated diameter of between about 4 and 8 millimeters.

In an exemplary embodiment of the invention, said inelastic expandable portion has an inflated diameter of between about 6 and 20 millimeters.

In an exemplary embodiment of the invention, said fluid guide includes at least one opening positioned to fluid movement into said inelastic expandable portion.

In an exemplary embodiment of the invention, said at least one pressure sensitive plug positioned to be compressed by said flexible portion during passage through a body lumen.

In an exemplary embodiment of the invention, said at least one pressure sensitive plug is configured to be released by fluid pressure within said fluid guide upon reaching a body cavity. In an exemplary embodiment of the invention, said fluid guide includes at least two openings: at least one second opening positioned to allow fluid movement into said anchor portion; and at least one first opening positioned to allow fluid movement into said inelastic expandable portion. In an exemplary embodiment of the invention, said at least one pressure sensitive plug is positioned to be compressed by said flexible portion during passage through a body lumen.

In an exemplary embodiment of the invention, said at least one pressure sensitive plug is configured to be released by fluid pressure within said fluid guide upon reaching a body cavity.

In an exemplary embodiment of the invention, said at least one pressure sensitive plug is configured to be released by fluid pressure following expansion of said anchor portion. In an exemplary embodiment of the invention, said fluid control comprises at least one manually operated valve.

In an exemplary embodiment of the invention, said fluid control comprises at least one electronically operated valve.

In an exemplary embodiment of the invention, said fluid guide includes at least two openings.

In an exemplary embodiment of the invention, said at least two openings have different diameters. In an exemplary embodiment of the invention, at least one of said at least two openings is covered by a membrane that is moveable in response to fluid pressure.

In an exemplary embodiment of the invention, said membrane includes a pressure sensitive adhesive. In an exemplary embodiment of the invention, said flexible envelope is surrounded by a retractable tube.

There is provided in accordance with an exemplary embodiment of the invention, a device for dilating a body lumen, the device comprising a flexible envelope including: a lumen section configured passing into a body lumen; an anchor section configured to anchor said flexible envelope in a body cavity; and a fluid guide comprises a tube having an expanded end having a fluid passage, said fluid guide being contained within said flexible envelope. There is provided in accordance with an exemplary embodiment of the invention, a device for dilating a body lumen, the device comprising a flexible envelope comprising an inelastic expandable portion including two sections: a lumen section configured passing into a body lumen; and an anchor section configured for anchoring said flexible envelope in a body cavity, said anchor section being contained within said lumen section. In an exemplary embodiment of the invention, said conical support comprises a fluid guide configured to guide fluid into said inelastic expandable portion.

There is provided in accordance with an exemplary embodiment of the invention, a device for dilating a body lumen, the device comprising: a flexible envelope comprising a expandable portion configured for insertion into a body lumen; and a flexible rod having a circumferential washer configured to guide fluid into said expandable portion.

There is provided in accordance with an exemplary embodiment of the invention, a device for dilating a body lumen, the device comprising a flexible envelope comprising an expandable portion configured for insertion into a body lumen and configured to fit in a pressure transducer comprising a syringe.

There is provided in accordance with an exemplary embodiment of the invention, a device for dilating a body lumen, the device comprising: a flexible envelope comprising two portions: a lumen section configured passing into a body lumen; an anchor section configured to anchor said flexible envelope in a body cavity; and a fluid guide including a fluid passage and a tab around a hole in said fluid passage. There is provided in accordance with an exemplary embodiment of the invention, a device for dilating a body lumen, the device comprising a flexible envelope comprising an expandable portion configured for insertion into a body lumen and configured to fit in a syringe. In an exemplary embodiment of the invention, said syringe includes a plunger having a plate that presses against a portion of said expandable portion.

In an exemplary embodiment of the invention, said plate includes at least one perforation configured to allow the escape of air trapped between said plate and said flexible envelope.

In an exemplary embodiment of the invention, said plunger comprises a shaft that passes through a pressure resistant washer.

In an exemplary embodiment of the invention, said pressure resistant washer is configured to form a partial vacuum against a portion of said plate while said plate is pressed against said portion of said expandable portion.

In an exemplary embodiment of the invention, said flexible envelope comprises an expandable portion.

In an exemplary embodiment of the invention, said expandable portion comprises an inelastic material. In an exemplary embodiment of the invention, said expandable portion includes a fluid guide.

In an exemplary embodiment of the invention, said expandable portion and said fluid guide have a diameter that allows simultaneous passage through a forward opening in said syringe during assembly. In an exemplary embodiment of the invention, said forward opening has a diameter configured to press against said expandable portion during assembly.

In an exemplary embodiment of the invention, said forward opening has a diameter configured to express at least a portion of residual fluid within said expandable portion during assembly.

There is provided in accordance with an exemplary embodiment of the invention, a method for dilating a body lumen, the method comprising: placing said the rearward portion of a flexible envelope in a syringe; positioning the forward portion of said flexible envelope in a body lumen; positioning the rearward portion of said flexible envelope external to the body lumen; placing pressure on said rearward portion with said syringe; expressing fluid contained within said rearward portion into said forward portion; and dilating a body lumen. Unless otherwise defined, all technical and/or scientific terms used herein have same meaning as commonly understood by one of ordinary skill in the art to which invention pertains. Although the methods and materials similar or equivalent to those described herein can be used in practice or testing of embodiments of invention, exemplary methods and/or materials are described below.

In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

BRIEF DESCRIPTION OF DRAWINGS

Some embodiments of invention are herein described, by way of example only, with reference to accompanying drawings.

With specific reference now to drawings in detail, it is stressed that particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced. In drawings:

Figure 1 a shows an organ lumen dilator, according to embodiments of the invention;

Figure 1 b shows the lumen dilator of Figure 1 a assembled in a pressure transducer, according to embodiments of the invention; Figures 1 c-5b3 show alternative configurations of the lumen dilator of Figure 1 b and their deployment, according to embodiments of the invention;

Figures 6a-7k show configurations of lumen dilators with anchor portions forward of lumen dilator portions, according to embodiments of the invention;

Figures 8a-13b show configurations of lumen dilators with anchor portions internal to lumen dilator portions, according to embodiments of the invention;

Figures 14a-20l and 33a-34e show lumen dilators configured with conical inserts optionally including fluid guides, according to embodiments of the invention; and

Figures 21 a-32c and 35a-35c show lumen dilators configured with internal fluid flow controls, according to embodiments of the invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF INVENTION

The present invention, in some embodiments thereof, relates to medical devices for dilating body lumens and, more particularly but not exclusively, to inflatable dilation devices. In exemplary embodiments of the invention, the lumen is a cervix. Some embodiments of the invention provide an inflatable dilator configured for insertion into a body lumen. The inflatable dilator has two portions; a deflated portion, comprising the portion configured for insertion into the body lumen, optionally sterile, and a fluid reservoir portion that is connected to the deflated portion via a fluid guide. In other embodiments, a separate fluid source is provided, for example, a saline pump or a pressurized gas source.

In an exemplary embodiment of the invention, placing pressure on the fluid reservoir portion causes the fluid to pass through the fluid guide and fill the deflated portion and, when so disposed, to dilate the body lumen. In some embodiments, the fluid guide (or a separate insert) includes an elongate tapered portion configured to gradually dilate lumen tissue during insertion, thereby providing the patient with a comfortable introduction of the dilator into the lumen. Optionally, when inflated, the dilator exhibits a generally fixed diameter compatible with a uniform dilation of the lumen.

Optionally, the body lumen and corresponding dilator length, diameter, and/or material are is selected for a cervix, a urethra, a bladder portion, an esophageal sphincter, a pyloric sphincter, or an anal opening.

Some embodiments of the invention provide an inflatable dilator configured to insert into a body lumen in which the fluid reservoir portion is sized to fit into a syringe, or a pressure inducing apparatus, while a deflated portion extends beyond the syringe with a fluid guide therebetween. Fluid passage to the deflated portion occurs when the operator presses the syringe plunger. In an exemplary embodiment of the invention, the fluid guide serves also to support the dilator during insertion into the body and is optionally rigid and/or semi-rigid. A separate insert may be provided.

In still further embodiments the inflatable dilator is configured to pass through a barrel of a syringe so that as the forward portion passes through the neck of the syringe, fluid is squeezing out of the forward portion and into the fluid reservoir. The fluid reservoir remains the syringe barrel and, by pressing a syringe plunger that is thereafter assembled, fluid inflates the deflated portion.

Optionally, the inflatable dilator is modular and configured to be discarded following dilation. Optionally, the syringe or other pressure providing handle is reused with a different dilator.

In some embodiments the inflatable dilator is configured to be held in one hand. The operator, while holding the pressure transducer in one hand and pressing on a pressure activator, causes fluid to pass into the deflated portion and dilate a body lumen, freeing the second hand of the operator to assist in the dilation, for example by palpating the area adjacent to the dilation and ensuring proper dilation. In some embodiments the pressure activator is assisted, for example, with a device comprising an electric motor or a levered pump. Some embodiments of the invention provide an inflatable dilator, having an anchor section seamlessly transitioning to a lumen section. In embodiments, the seamless transition between the two sections is flat and smooth without a depression that could traumatize body lumen tissue during insertion into the body lumen. In some embodiments, the transition is selected so that there is little chance that during deployment cervical tissue may remain in the transitional area and maintain a smaller diameter than desired. In some embodiments, the fluid guide and the deflated portion have a diameter that allows easy introduction through the cervical canal with small or no resistance by the tissue surrounding the canal. For example, the initial diameter may be, for example, 1 mm, 2 mm, 3 mm, 5 mm or intermediate or greater sizes (which may depend on the dilated organ). In some embodiments, the anchor portion and the lumen portion are configured to serially fill with fluid as pressure is applied to the fluid reservoir portion. Optionally, the portions start filling together, but the anchor is filled and expanded before the lumen portion is substantially filled and expanded.

In some embodiments the fluid guide comprises a hollow tube through which the fluid passes during filling of the deflated portion. The tube end positioned in the deflated portion has a closed end and a side hole position so that during filling, the fluid passes through a first end and out the side hole, thereby optionally providing radial outward pressure against the wall of the deflated portion that aids in dilating the body lumen. In some embodiments, for example to provide additional support to the deflated portion during insertion, the fluid guide comprises a solid tube and a washer that includes one or more passages through which the fluid may quickly pass.

In some embodiments, the washer serves to divide the deflated portion from the fluid reservoir disposed in a syringe. Optionally, when placed in a syringe or alternative pressure transducer, the washer seats against a forward wall and seals the fluid reservoir to prevent unplanned fluid passage.

In some embodiments, the syringe barrel or a pressure transducer chamber includes positioning projections that seal the washer against a forward wall, thereby preventing accumulation of fluid in the volume between the washer and the forward wall. In some embodiments, a pressure sensitive plug is positioned in the tube hole in the deflated portion and prevents fluid passage prior to deployment. Upon applying pressure to the fluid reservoir, the plug pops out of the hole, allowing passage of fluid. In some embodiments, the fluid guide includes two openings; a first opening adjacent a portion of the body lumen and a second opening adjacent the in vivo body cavity, wherein the pressure of the body lumen presses the dilator wall against first opening so that fluid passes only through the second opening and fills the portion in the body cavity, thereby anchoring the inflatable dilator.

In embodiments, after the anchoring portion is inflated, increased pressure in the ex vivo portion exceeds the pressure of the lumen and fluid pressure pushes the away dilator wall from the second opening so that fluid filling the body lumen portion dilates the lumen. In embodiments, the anchoring portion prevents ejection of the inflatable dilator from the body lumen during luminal portion inflation.

In some embodiments of the invention, for example to allow rapid filling of the forward portion and/or under less pressure, the forward fluid opening has a larger average diameter than the rearward opening; thereby further aiding in filling the forward portion to fully fill with fluid prior to inflation of the rearward external portion.

In embodiments, for example to facilitate entry into the lumen, the end of fluid guide configured for passing through the body lumen includes a flexible bulb that gently opens the closed canal. In embodiments, the flexible bulb includes a fluid passage that extends from the fluid guide. During in vivo positioning of the inflatable dilator, pressure of the lumen wall presses the inflatable dilator wall against the fluid guide, preventing fluid movement even under mild pressure exerted on the ex vivo inflatable dilator portion. Upon reaching the body cavity, the pressure decreases and the walls of the dilator are released from the fluid guide so that the operator is provided with a tactile indication indicating proper positioning of the flexible bulb within the body cavity and/or allowing easy filling of the anchor section of the dilator.

In embodiments, a pressure sensor is juxtaposed on the inflatable dilator and includes a readout that apprises the operator of the pressure exerted, allowing the operator to fill the lumen portion without exceeding a pressure that could cause patient discomfort.

In embodiments, the deflated portion is covered by a removable sheath that protects the deflated portion against damage due to knocks.

Additionally or alternatively, the removable sheath prevents premature filling of the deflated portion prior to a dilation procedure.

In some embodiments of the invention, an extension unit is provided to allow more remote operation of the dilator.

In some dilation procedures, automatic evacuation of fluid from the external portion may be desirable. To this end, an embodiment of the pressure transducer includes an unperforated piston connected to a shaft that passes through a seal that serves to create a partial vacuum as the piston moves forward in the pressure transducer. Upon release of pressure against the shaft, the piston is drawn back into the barrel under the influence of the partial vacuum. In some embodiments, the portion of the adjacent the body lumen includes one or more partitions that divide the deflated portion into multiple sections that may be serially inflated through multiple openings in the fluid guide.

In some embodiments, the serial openings are controlled by one or more valves. After inflating a first section, the operator has the option to adjust the position of a second, deflated, portion within the body lumen, thereby optimizing the dilation pressure and/or minimizing patient discomfort; following which the operator changes the valve position to inflate a second section.

In embodiments, each of the multiple openings in the fluid guide optionally includes a plug configured to be discharged from the opening at a given pressure. Upon discharge of a first plug at a first given pressure, the adjacent portion of the dilator fills with fluid until the pressure therein reaches a second given pressure.

Optionally, the fluid guide includes a second plug and an adjacent deflated section. With increasing pressure the second plug is discharged, allowing the adjacent deflated area to fill with fluid.

In some embodiments of the invention, there is provided a method for dilating a body lumen with a disposable inflatable dilator in which a deflated portion of an inflatable dilator is passed through a body lumen into an in vivo body cavity. An ex vivo portion is pressed so that fluid contained therein passes into, and fills, a forward portion in the body cavity, thereby forming an anchor portion that prevents ejection of the dilator during luminal dilation.

As the pressure within the anchor portion exceeds the pressure of the body lumen against the luminal portion, fluid fills the luminal portion, thereby dilating the body lumen.

In embodiments, the inflatable dilator is configured to be held in one hand of an operator so that upon inflation of the anchor portion the operator's second hand is free to palpate ex vivo tissue adjacent the body lumen, for example to determine proper positioning of the inflatable dilator portion in the body cavity.

The operator then gently presses the ex vivo portion to incrementally dilate the body lumen to a first dilation diameter for example of 1 millimeter. Following a pause to allow the tissue of the body lumen to adjust to the increased diameter of the adjacent portion, the operator again gently presses the ex vivo portion to achieve a second lumen dilation diameter, for example of 2 millimeters. The filling and pausing process is repeated thereafter until the lumen is dilated to allow execution of a chosen medial procedure on the lumen and/or in vivo body cavity.

In embodiments, the inflatable dilator is deflated removed from the patient and disposed of; and the medical procedure is executed.

Before explaining at least one embodiment of invention in detail, it is to be understood that the invention is not necessarily limited in its application to details of construction and arrangement of components and/or methods set forth in the following description and/or illustrated in the drawings and/or the examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. In some embodiments of the invention, a single smooth flexible cartridge having a constant diameter is assembled with a pressure transducer comprising a syringe, for example. As assembled in the pressure transducer, the smooth cartridge is formed into two portions; a first portion within the pressure transducer filled with fluid and a second deflated portion extending from the pressure transducer. Means may be provided, for example an elastic band constricting the cartridge, so that fluid does not flow from the first portion to the second portion prior to deployment.

Dual Portion Dilator One example of a catheter 1 that assembles into a syringe 10 is shown in Figures 1 a and 1 b. Catheter 1 comprises an inflatable flexible cartridge 3 manufactured from a plastic material and formed in one piece.

In embodiments, flexible cartridge 3 comprises a smooth, flat cylinder, herein a smooth, monotonous cylinder, that is inserted into an organ lumen, as explained below. Smooth, monotonous flexible cartridge 3 inserts into the organ lumen without catching on tissue that could result in patient discomfort, as might be the case in non-smooth configurations and/or configurations that have steps; abrupt changes in diameter. Optionally, changes in diameter in which tissue may catch and thereby avoid complete dilation are avoided. One region where such changes may be found is at a distal end of cartridge 3, on the border between the cervix and the uterus. Optionally catheter 1 and/or parts thereof are disposable.

Following coupling of catheter 1 to pressure transducer 10, for example syringe 10, a plunger 21 is loaded into the barrel of syringe 10. Optionally syringe 10 is disposable. As described below, pressure sources other than a syringe may be used. Optionally, the barrel is open and/or transparent at a side, to facilitate loading and/or viewing of the state of the catheter, for example, using one or more markers on a transparent window which indicate, by alignment with an internal element (e.g., plunger, catheter) how far the plunger is pushed in or catheter compressed.

When assembled, flexible cartridge 3, is divided into two portions; a fluid reservoir portion 3b containing fluid and contained within the barrel of syringe 10; and a deflated portion 3a.

As used herein, the term fluid refers to any gas, liquid or solid that can be induced to exhibit fluid-like movement between fluid reservoir portion 3b and deflated portion 3a. In some embodiments, a non-compressible fluid, such as sterile saline, is used

As used herein, the term "deflated", meaning substantially empty of fluid while the term "deflated portion" refers to a portion that is initially substantially empty of fluid and fills with fluid during lumen dilation. This portion may be, for example, pleated or folded while deflated. Plunger 21 includes a shaft 11 with a piston 19 that presses against fluid reservoir portion 3b, forcing fluid into deflated portion 3a during organ lumen dilation as explained below.

In embodiments, a fluid guide comprising a tube 2 passes between fluid reservoir portion 3b and deflated portion 3a. Tube 2 serves as a conduit for the passage of fluid between fluid reservoir portion 3b and deflated portion

3a and comprises a passage having a fluid intake opening 16, alternatively referred to as passage 16 or, more simply hole 16.

While catheter 1 is shown assembled in syringe 10, catheter 1 could be connected to any pressure transducer that provides pressure on catheter 1 in a manner that causes fluid from fluid reservoir portion 3b to flow into deflated portion 3a with a sufficient pressure to cause dilation of a body lumen, as will be explained below.

As used herein, the term syringe 10 refers to any pressure-transducer, including, inter alia: i) a pressing mechanism that places pressure on a portion of flexible cartridge 3; for example a mechanically activated roller that moves along a portion of flexible cartridge 3 or a mechanically activated press that moves linearly to press a portion of flexible cartridge 3; ii) an electromagnetically activated pressing mechanism or other motorized mechanism, such as a battery operated motor with gears that advance a plunger; iii) a pressurized chamber in which a pressurized gas is released to create pressure on flexible cartridge 3; the pressurized gas comprising, for example: a) compressed Carbon Dioxide that is released, e.g., at a constant temperature; b) a fluid that is heated to cause expansion; or c) a fluid that responds to transmitted energy such as ultrasound.

As seen in Figures 1c1 through 1 c3, tube 2 optionally includes a washer 5, comprising for example a flexible material 5 that surrounds a rearward portion of tube 2 and serves to divide deflated portion 3a from fluid reservoir portion 3b when catheter 1 is in syringe 10.

As seen in Figures 1f through 1o, catheter 1 , is configured to be assembled with a syringe 10, for example, by pushing deflated portion 3a through forward syringe opening 15, thereby squeezing any fluid out of deflated portion 3a; with fluid remaining in rear portion 3b contained in syringe

10.

In embodiments, one or more spring-like locks 9 are found inside syringe 10 near forward syringe opening 15 (Figures 1d1 and 1d2). During operation, locks 9 serve to maintain the position of washer 5 in syringe 10 preventing, for example, backward movement of washer 5.

Locks 9 are optionally short enough to permit washer 5 to be pushed forwardly past locks 9 while being of sufficient length to lock washer 5 in place during dilation.

Locks 9 may be directed toward a forward end 6 of syringe 10, or perpendicular to the longitudinal axis of syringe 10. As shown in Figure 1 e, tube 2 comprises two fluid ejection openings 14 and 18, alternately referred to herein as ejection holes 14 and 18 or, more simply, holes 14 and 18.

As shown in Figures 1 k through 1 m, plunger 21 is pressed so that deflated portion 3a inflates.

In some embodiments, shown in Figures 1d3 and 1d4, piston 19 optionally has small perforations 19a through which air, trapped between piston 19 and flexible cartridge 3, escapes as plunger 21 is depressed so that syringe 10 efficiently compresses cartridge 3; thereby facilitating smooth operation of plunger 21.

Additionally, as shown in Figure 1 e, tube 12 comprises two fluid ejection openings 14 and 18, alternately referred to herein as ejection holes 14 and 18 or, more simply, holes 14 and 18.

As shown in Figures 1 k through 1 m, plunger 21 is pressed so that deflated portion 3a inflates

In embodiments, cartridges are provided as a kit and can have uniform diameter or base portion can be large, also not an anchor, as described below may have a greater diameter.

Optionally, the uniform diameter is for at least 50%, 70%, 90% or intermediate parts of the cartridge. Optionally, the lumen expanding part being designed to have uniform diameter. Optionally, a connection-lumen connecting the reservoir and the expanding portion is provided. Optionally, this connection lumen is short, for example, less than 10 cm, less than 5 cm, or relatively short, for example, less than 80%, 60%, 40%, 20%, 10% of the overall length of the cartridge and/or device (depending on the embodiment). An Exemplary Dilation Procedure

There are many configurations and methods for providing dilation of an organ lumen while using catheter 1 to provide comfortable radially outward dilation of the organ lumen. One method of dilating a cervical canal 22 using the above-noted configurations of catheter 1 is shown in Figures 3a through 3e. Tube 2 is optionally provided with a guide bulb 7 at forward end 6 that gently separates the narrow walls of the closed cervical canal 22. Guide bulb 7 is introduced into cervical canal 22 with deflated portion 3a deflated and collapsed around tube 2 so that deflated portion 3a and tube 2 easily pass into cervical canal 22.

In embodiments, prior to entry into cervical canal 22, portions of catheter 1 are lubricated with KyGeI, to insure smooth insertion. Alternatively, gels containing local anesthetic, for example Esracain gel are applied to the external surface of catheter 1. Forward end 6 is positioned in a uterus 20, at the end of cervical canal

22 (Figure 3a). The deflated diameter of forward end 6 is between about 1 millimeter and 4 millimeters, preferable about 3 millimeters.

Fluid is delivered from fluid reservoir portion 3b to deflated portion 3a, also referred to as expandable portion 3b. Initially, plunger 21 is optionally pressed with low pressure so that forward end 6 of deflated portion 3a easily inflates within uterus 20 under the low pressure cavity of uterus 20. Forward end 6 easily inflates within uterus 20 to form an anchoring portion 141.

The length of anchoring portion 141 , may be between about 5 millimeters and 20 millimeters, any typically about 10 millimeters; as judged by the operator or, in some embodiments, fixed in dimension.

Anchoring portion 141 is then pulled in a rearward direction 4 to press against cervical canal 22 that opens into uterus 20, thereby anchoring catheter 1 against ejection due to pressure that will develop during dilation within cervical canal 22.

The posterior section of deflated portion 3a is between about 60 and 100 millimeters with a typical length being about 80 millimeters. The ex-vivo length of catheter 1 is between 10 and 90 millimeters, with typical lengths between 20 and 70 millimeters. Following inflation of anchoring portion 141 , the posterior section of deflated portion 3a inflates, for example stepwise, until a final diameter is reached (Figure 3d) and dilation is terminated. Alternatively, inflation of deflated portion 3a may be terminated when the operator determines that cervical canal 22 has dilated to a sufficient diameter.

Dilation diameters are determined by the anticipated procedure. For example in operative hysteroscopy for cauterization or in which small polyps are resected, the final dilation diameter may be between 4 and 8 millimeters with a typical dilation diameter being about 5.5 millimeters.

For resection of large masses, for example fibroids, large polyps and late stage termination of pregnancy, the final diameter may be between about

10 and 20 millimeters, with a typical dilation diameter of between about 14 and 18 millimeters.

After waiting a period of time, for example a few minutes, to allow cervical canal to adjust to the larger diameter of deflated portion 3a, pressure is released, deflated portion 3a and anchor portion 141 are typically partially emptied of fluid and catheter 1 is removed (Figure 3e) from cervical canal 22. There are various configurations of dual catheter 1 that can provide comfortable dilation of cervical canal 22.

Dual Catheter Embodiments

In one such configuration, shown in Figures 1 a and 1 b, forward hole 14 may open laterally. Alternatively, hole 14 may open forward 6 at the end of guide bulb 7 as shown in Figure 1 n.

Fluid passes via rearward hole 16 from one side of washer 5, as shown in Figures 1 k and 11, through passage to other side of washer 5. Fluid enters deflated portion 3a via holes 18 and 14. Hole 18 may be typically located near washer 5. Alternatively, hole 18 may be located at any other location along forward side 6 of washer 5 of tube

2. The average diameters of the tube passage 12 and/or hole 16 may be configured to allow a specific rate of filling from fluid reservoir portion 3b to deflated portion 3a. In further embodiments, the diameter of syringe opening 15 is optionally smaller than diameter of passage 16, thereby limiting the rate at which deflated portion 3a can be filled and preventing patient discomfort caused by rapid inflation of deflated potion 3a.

Alternatively, the diameter of each of holes 14 and 18 may be of different diameters, each configured to allow a specific rate of filling of a different section of deflated portion 3a. The diameters of tube 2, syringe opening 15, and holes 14, 16 and 18 and the associated rates of fluid movement associated with these diameters are known to those familiar with the art.

Flexible cartridge 3 is optionally cylindrical but may be configured with any shape dependent upon the application. For example, for dilating the entry to the colon, a portion of flexible cartridge 3 may have a conical shape that facilitates easy insertion into the colon, as will be seen below.

Additionally, flexible cartridge 3 may be configured with a small diameter for easy entry and dilation of a urethra. Furthermore, flexible cartridge 3 may be configured with a relatively short length for dilating the relatively short entry into the bladder.

Alternatively, catheter 1 may be configured with a long length for dilation of the relatively long urethra. The many varieties of dimensions and shape of flexible cartridge 3 that provide easy dilation of a variety of organ lumens are known to those familiar with the art.

In some embodiments, flexible cartridge 3 may comprise a relatively inelastic biocompatible material, for example a plastic, so that final diameter and length of flexible cartridge 3 is fixed such that inflation beyond these dimensions is relatively difficult, if not impossible so that patient comfort is maintained. In embodiments, the flexible cartridge 3 is elastic with radial fibers that prevent expansion past a specific diameter for the body lumen.

Flexible cartridge 3 optionally comprising a relatively inelastic biocompatible material may have use in dilating the cervical canal wherein dilation beyond the above-noted maximum limit of about 12 millimeters may be unnecessary and/or cause unacceptable discomfort. In embodiments, flexible cartridge 3 is color coded according to the final diameter, the color coding corresponding to the procedure, the body lumen, the desired dilation diameter of the body lumen and/or the surgical tools required for the procedure. Alternatively, flexible cartridge 3 may comprise a relatively elastic biocompatible material, for example a rubber, so that final diameter and length of flexible cartridge 3 may be adjusted by the operator according to the chosen medical procedure and/or size of the organ lumen.

Flexible cartridge 3 optionally comprising a relatively elastic biocompatible material may have use in dilating the rectum and include one or more channels for introduction of an endoscope. For example, in the colon, following deployment of a first, small diameter instrument, the operator may determine that a second, larger diameter instrument is required. In such cases, the operator reinserts flexible cartridge 3 and dilates the opening to the colon to a greater diameter that accommodates the second, larger diameter instrument.

The many varieties of diameters, shapes and properties of the biocompatible material of flexible cartridge 3 for organ lumens of varying sizes and/or instrumentation are known to those familiar with the art In some embodiments, the volume of fluid contained within fluid reservoir portion 3b (Figure 1 b), may be equal to the volume of fluid that is required to fully inflate deflated portion 3a, as shown in Figure 1 e. This arrangement prevents the operator from over-filling, and possibly bursting deflated portion 3a. For the purposes of protection, catheter 1 may be manufactured with a variety of adjunct devices that provide protection.

Protective Sheath

In just one example of protection configurations, as shown in Figure 1 p, catheter 1 includes a removable protective sheath 25 to protect deflated portion 3a against damage due to knocks. Optionally or alternatively, protective sheath 25 may prevent premature filling of deflated portion 3a prior to a dilation procedure. In exemplary embodiments, removable protective sheath 25 is rigid to provide good protection. In other embodiments, removable protective sheath 25 is transparent and provides the operator with the above-noted color codes regarding, inter alia, the organ and dilation diameter.

In one example, removable protective sheath 25 includes screw threads 102 that mate with threads 103 on syringe 10. Prior to a dilation procedure, the operator rotates protective sheath 25 until protective sheath separates from syringe 10, thereby allowing the above-noted dilation procedure using catheter 1.

Automatic Evacuation

In some dilation procedures, automatic evacuation of fluid from filled or post-dilation deflated portion 3a without pulling on syringe plunger 21 may be desirable. Automatic evacuation of deflated portion 3a may be desirable, for example, when the operator must rapidly introduce instruments with both hands into an organ lumen even as deflated portion 3a is in the process of deflating. Alternatively, between serial inflations, the operator may wish to slightly deflate deflated portion 3a to increase patient comfort. Just one example of an automatic evacuation configuration is shown in

Figures 2a1 through 2b, wherein the forward outer surface of syringe 10 is provided with outer screw threads 110 that mate with inner screw threads of a sealing cap 27. In the assembled form, seen in Figure 2b, with inner screw threads 112 mated with outer screw threads 110, locking washer 5 between the forward outer surface of syringe 10 and the inner surface of sealing cap 27.

Deflated portion 3a and tube 2 pass through a sealing cap opening 15a.

Piston 19 is optionally manufactured as a plate without small perforations 19a, shown in Figure 1d4 and syringe 10 includes a vacuum chamber 114 that forms a partial vacuum as plunger 21 is depressed. Following completion of dilation or one or more serial dilations, the operator releases pressure on plunger 21 , and vacuum chamber 114 serves to cause fluid movement in rearward direction 4, thereby at least partially evacuating fluid from deflated portion 3a. Deflated portion 3a thereby at least partially deflates, for example to allow removal or repositioning of deflated portion 3a and/or the above-noted tissue adjustments.

There are also alternative configurations for sealing washer 5 within syringe 10 and figures 2c1 through 2c8, show but just a few alternative configurations. For example, inwardly facing hooks 9b on sealing cap 27 mate with outwardly pointing hooks 9a; thereby pressing washer 5 against the forward surface of syringe 10.

Figure 2c5 shows an alternative embodiment in which deflated portion 3a is attached to tube 2 with a sealing ring S2 located around fluid reservoir portion 3b against a forward portion of sealing cap 27. A second sealing ring Si is located between washer 5 and the internal surface of sealing cap 27. Figure 2c6 shows an aerial view of sealing rings Si and S2. Figures 2c7 and 2c8 show still another embodiment in which washer 5 held in place against syringe 10 with transverse retaining tacks 9c that insert through transverse retainer passages 9a in sealing cap 27 and syringe 10 respectively.

In embodiments, sealing cap 27 and syringe 10 are connected by one or more latches, ridges or biocompatible adhesive or ridges, the many options for connections being known to those familiar with the art. Figures 6e through 6f show assembly of an alternative embodiment in which cap 27 and syringe 10 include ratchets 151 that interface to press seals Si and S₂ against adjacent surfaces of washer 5. Manometer Configuration

As shown in Figure 4, to measure pressure inside flexible cartridge 3, an optional pressure sensor M1 attached to a manometer M2, is optionally positioned inside syringe 10 between piston 19 and fluid reservoir portion 3b. Manometer M2 displays the pressure within flexible cartridge 3 so that the operator can easily adjust the pressure on plunger 21 to maintain the pressure of fluid release at a comfortable level for the patient.

In dilation of certain organ lumens and/or in certain situations where greater resistance of tissue may be expected, it may be preferable to provide strong support, for example increased rigidity, to deflated portion 3a.

Fluid Passage Configurations

Just one example of a greater support of forward portion 3a is shown in Figures 5a1 and 5a2. Tube 2 comprises a solid shaft and washer 5 including holes 16 through which fluid passes. Inflation and deflation of deflated portion 3a occurs through the passage of fluid through holes 16.

In an alternative example, shown in figures 5b1 through 5b3, washer 5 includes a hollow cylindrical collar 119 that surrounds a portion of tube 2 comprising a solid shaft and washer 5 includes the above-noted holes 16.

Sequential Inflation

As shown in Figures 6a through 6d, catheter 1 optionally includes a division (a), or alternatively attachment (a), to divide deflated portion 3a into an anterior section 3a', and a posterior section 3a"; alternatively referred to as anterior portion 3a', and posterior portion 3a"; or forward section 3a', and rearward section 3a".

Anterior section 3a' and hole 14 are divided from posterior section 3a" and hole 18 by attachment (a) to a portion of tube 2. Anterior section 3a' is inflated with fluid passing through hole 14 and posterior section 3a" is inflated with fluid passing through hole 18.

In embodiments, the rate of fluid passing into anterior section 3a' can be set to provide a different fluid passage than the fluid rate passing into posterior section 3a", for example by varying the diameters of holes 14 and 18. For example a larger diameter hole 14 in conjunction with a small diameter hole 18 allows anterior section 3a' to fill at a faster rate than posterior section 3a". Additionally or alternatively, large diameter hole 14 allows anterior section 3a' to be filled with a relatively low depression force on plunger 21 , while small diameter hole 18 requires greater force on plunger 21.

Following inflation of anterior section 3a', tube 2 is optionally manipulated, for example to seat anterior section 3a' against the internal opening of cervical canal 22. The position of anterior section 3a' is easily manipulated as posterior section 3a" remains fully, or at least partially, deflated.

Additionally, following inflation of anterior section 3a', small diameter hole 18 prevents the operator from filling posterior section 3a" at a rate which might cause the patient discomfort.

In some procedures, for example dilating a relatively resistant organ lumen, it may be desirable for catheter 1 to be configured to prevent fluid backup.

Sealing Configurations

Returning to Figure 6b, one example in which portion 3a" is sealed against fluid backup is shown in which a sealing attachment (b) is positioned between posterior section 3a" and tube 2.

In some embodiments, to ensure that fluid passes exclusively through passage into forward portions 3a' and 3a", sealing ring Si is located inside fluid reservoir portion 3b; a configuration that ensures that filling of forward portions 3a' and 3a" is carried out through holes 14 and 18, respectively.

Shown in Figures 6g through 6i is an alternative method of attachment of deflated portion 3a to tube 2 in which tube 2 has one or more circular grooves 31 on its external surface (Figure 6g).

As shown in Figures 6h and 6i, section 3a is attached to tube 2 by a ring 33 or a tied wire 35 that presses portions of flexible cartridge 3 into groove 31 , thereby forming separate sections 3a' , 3a", and 3a'".

Inflation of sections 3a' , 3a", and 3a'" occurs through holes 14', 14" and 18, respectively.

In some embodiments, when only anterior sections 3a' are 3a" are needed, section 3a"' and hole 18 are absent. In some situations, shown in Figure 6j, only a forward anchor 3a' is inflated while posterior section 3a" remains substantially uninflatable and due to being bound to tube 2 at adhesion point (a) with pressure sensitive adhesive. Following inflation of anterior section 3a', pressure increases and the pressure sensitive adhesive separates from tube, allowing posterior section 3a" to fill with fluid.

Figure 6k shows an alternative arrangement in which seals Si and S2 are placed forward of washer 5 to seal the position of posterior section 3a", instead of adhesion point (b) shown in Figure 6j. There are many alternative configurations that facilitate sequential filling of forward portions 3a' and 3a".

Tube Plugs

In one alternative example, shown in Figure 7a, a tube plug 37 facilitates sequential inflation of forward sections 3a' and 3a".

At low pressures plug 37 prevents filling of posterior section 3a", but anterior section 3a' is inflated readily. As noted above, in this configuration, inflated anterior section 3a' can be easily manipulated as required by the operator. The operator again presses plunger 21 and, as pressure rises above a first level, plug 37 is forced out of hole 18 in rearward portion 3a". Hole 18 is opened and inflation of posterior section 3a" begins.

But a few of the many configurations of plug 37 and hole 18 are shown in Figures 7b1 through 7b4 in which: i) round plug 37 is lodged in round hole 18 (Figure 7b1 ); ii) round plug 37 is lodged in square hole 18 (Figure 7b2); iii) spherical plug 37 is lodged in tapered round hole 18 (Figure 7b3); and iv) conical plug 37 is lodged in tapered round hole 18 (Figure 7b4).

Another option to achieve a sequential filling is with an adhesive membrane 39 shown in Figures 7c1 through 7c3. Adhesive membrane includes a pressure sensitive adhesive 120 shown in a side cross section view in Figure 7c2 that adheres to syringe 10 and blocks fluid from exiting hole 18 at low pressure.

As pressure rises above a higher pressure level, corresponding to the inflation of anterior section 3a' (Figure 7a) fluid pressure at opening 18 breaks the adhesion between adhesive membrane 39 and tube 2. Adhesive membrane 39 opens and fluid passes through opening 18.

In some situations, for example in treating organ lumens that have been scarred due to trauma and/or during repair procedures, the operator may desire greater control over the rate of inflation of section 3a" (Figure 7a).

Inflation Control Valves

Just some examples of configurations that allow operator-controlled inflation rates are shown in Figures 7d through 7k. Tube 2 includes a variety of configurations of a th-directional valve 40 that controls fluid flow through opening 18.

As shown in Figures 7e and 7f, tri-directional valve 40 that is integral to tube 2 is initially positioned with a middle lever 122 in the upward position so that tri-directional valve 40 prevents fluid from entering section 3a" and all fluid flows into forward portion 3a' through opening 14.

Following inflation of forward portion 3a', tube 2 is optionally manipulated, as noted above, to seat anchoring portion 3a' against the internal opening of cervical canal 22 while portion 3a" remains fully deflated.

As shown in Figure 7f middle lever 122 has been rotated to a lower position so that hole 18 is open, allowing fluid to enter rear portion 3a".

Following inflation of rear portion 3a", middle lever 122 is optionally rotated to a rearward pointing intermediate position, shown in Figure 7g, to allow fluid to pass back through hole 18 into tube 2, thereby reducing the pressure in rear portion 3a". When the operator is assured that rear portion 3a" is at the correct inflation diameter and/or correct inflation pressure, middle lever 122 is rotated to a forwardly pointing position, shown in Figure 7h, preventing fluid from passing back through hole 18 into tube 2, thereby maintaining the pressure in rear portion 3a".

Figure 7i shows an embodiment in which fluid reservoir portion 3b is sealed against tube 2 with first sealing ring S₂ while second sealing ring Si is located within fluid reservoir portion 3b forward to washer 5.

Figures 7j and 7k show an alternative embodiment that may aid in the assembly of flexible cartridge 3, in which th-directional valve 40 removably attaches between forward and rearward portions of tube 2. Th-directional valve 40 includes a forward hook-up connection 124 to the forward portion of tube 2 and a rearward hook-up connection 126 to the rearward portion of tube 2.

In addition to the configurations in which anchoring portion 3a' is forward of rearward portion 3a", there are additional configurations that are contemplated.

Anchoring Portion

Figures 8a through 8f show just some of exemplary alternative embodiments in which an anchoring portion 3a' is contained within portion

3a". Figure 8a shows anchoring portion 3a' connected to either side of hole

14 with a rearward connector a" and a forward connector positioned rearward to guide bulb 7.

Figure 8b shows anchoring portion 3a' connected rearward to hole 14 with single rearward connector a". Anchoring portion 3a may comprise various shapes, for example cylindrical, spherical, and/or conical, as will be explained below.

Additionally, anchoring portion 3a may be configured to inflate to virtually any diameter while being contained within portion 3a", depending, for example on the size of the organ lumen in which catheter 1 is deployed, as noted above. Figure 8c shows portion 3a" attached at a singular rearward area b'"; while Figure 8d shows rear portion 3a" attached at two areas; a rearward area b" and at a forward area b'.

Alternatively, rear portion 3a" is has no attachment to tube 2 (Figures 8a, 8b, and 8e).

Anchoring Portion Deployment

One method by which internal anchoring portion 3a' is deployed is presented in Figures 10a through 10e. As shown in Figure 10a, the forward end of catheter 1 is introduced into cervical canal 22 with anchoring portion 3a' and rearward portion 3a" deflated.

Anchoring portion 3a' is positioned in uterus 20 and fluid is delivered through hole 14 to inflate anchoring portion 3a' to a diameter that exceeds diameter of cervical canal 22 (Figure 10b).

After inflation of anchoring portion 3a', catheter 1 is moved rearward in rearward direction 4 until anchoring portion 3a' is anchored against cervical canal 22.

Fluid is delivered from fluid reservoir portion 3b, thereby inflating rearward portion 3a" and cervical canal 22 is dilated as shown in Figure 10d.

As seen in Figure 10e, following dilation and relaxation of cervical canal 22, as explained above, forward anchoring portion 3a' and rear portion 3a" are deflated and catheter is removed (Figure 10e) from cervical canal 22.

Rupturing Portion

In embodiments shown in Figures 9a through 9c, anchoring portion 3a' may be made of a very thin material or otherwise include at least one weakened area that bursts as a specific pressure is exceeded. At low pressure, only anchoring 3a' is inflated through forward hole 14. As pressure rises, portion 3a' ruptures, thereby allowing fluid to expand rear portion 3a" through hole 14. Optionally, the weakened area is mall enough that anchoring 3a' is not significantly deflated by the bursting. An alternative configuration is shown in Figure 11 in which part of forward anchoring portion 3a' is attached to tube 2 with a pressure sensitive adhesive at point (a).

As the pressure within forward anchoring portion 3a' rises beyond the adhesion strength of the pressure sensitive adhesive, forward anchoring portion 3a' partially or fully detaches from tube 2 and fluid passing through hole 14 inflates rearward portion 3a".

Catheter Control In addition to the above-noted method of dilation, forward anchoring portion 3a' may be used to ensure an easy initial insertion of tube 2 through cervical canal 22. For example, forward anchoring portion 3a' may be inflated to a small volume followed by a forward movement of tube 2. The operator then further inflates forward anchoring portion 3a' and presses tube 2 further forwardly and the process is repeated until tube 2 passes through the cervical canal.

Additionally, the inflation of rearward portion 3a" may be done in a gradual fashion and at different rates, for example in small and gradual increments. Optionally or alternatively, the rate of inflation of rear portion 3a" may be guided by directions given by the patient, based upon, for example comfort level. In still further alternative methods, the rate of inflation of rear portion 3a" is governed by a computer system or other circuitry, not shown, that are optionally provided in the handheld portion and determine patient comfort level through pain sensors located, for example, in (anterior) anchoring portion 3a' or along posterior portion 3a". In embodiments, the computer system processes information from the pain sensors that pick up nerve excitement levels in the surrounding tissue and creates a pause in the dilation process when higher levels of nerve excitement, indicating localized pain, are registered.

Optionally or alternatively, the computer system may be programmed to respond to other parameters that may indicate patient comfort level, for example breath and pulse rates that are picked up by appropriately configured sensors. Optionally or alternatively, a patient input, for example a button connected by a cord to the computer system, may be provided.

In embodiments, for example for use in sensitive patients, syringe 10 may be configured to gradually increase inflation pressure.

Graduated Dilation

As shown in Figures 12a and 12b, plunger 21 and barrel may be equipped with screw threads 104 that rotate in a direction 128, thereby causing gradual forward linear movement of a rearward plunger facing 108 as plunger 21 rotates a forward shaft facing 105.

Each rotation of rearward plunger facing 103 imparts a specific amount of forward linear movement to shaft 11 , so that the operator can effectively judge the amount of fluid entering anchoring section 3a'. Optionally, a motor is used to rotate the plunger.

Optionally, syringe 10 includes a threaded connector 101 that allows the operator to remove rearward plunger facing 103 from engagement with shaft 11 facilitating rapid deflation following successful dilation.

In embodiments, Alternative configurations may be required, for example, for high pressure fluid administration, hook ups to external pumps and/or introduction of an endoscope into the organ.

Alternative embodiments

Presented in Figures 13a and 13b is a device in which a tube 2b'" is contained with section 3a'" at its forward end. Tube 2b'" has a single passage

12'" and a forward hole 14'" that serve to inflate internal section 3a'". A flexible cartridge 3b'" is inflated via a rearward chamber 28'" that optionally connects to a fluid pressure source, for example a computer-controlled fluid hose (not shown). Tube 2b'" may be fixed or movable with respect to chamber 28'".

Internal section 3a'" may have the same properties but may be compliant also because it is confined by second flexible cartridge 3b'". Sometimes an organ lumen is tightly sealed and introducing catheter 1 may cause pain, even when passage 12"' is of a narrow diameter.

Conical Dilators

The embodiment presented in Figures 14a through 2Ol comprise tapered rods, the embodiments being referred to herein as conical dilators 190. Conical dilators may substantially reduce pain during introduction into tight organ lumens. Conical dilators 190 include a conical tube 2" to allow gradual parting of the organ lumen. Conical tube 2" additionally includes a tapered tip at forward end 6" to allow easy initial entry into the organ lumen.

Figure 14a shows forward hole 14 facing forward and rear hole 18 facing sideways. Holes 14 and 18 are connected to a large passage in conical tube 2". Figure 14b shows an additional configuration with a narrow passageway and an optional additional side opening.

Figures 15a and 15b show conical tube 2" with one forward hole 14". Figures 16a and 16b show a side hole 41 " connected to a side chamber 40".

Figures 17a and 17b show two conical tubes 12" and 16" that have been joined together, in which hole 14" connects to the interior of conical tube 12" and hole 18" connects to the interior of conical tube 16".

Figures 18a and 18b show sections 3" that receive fluid from passage 12" through hole 14", with the forward portion of sections 3" attached to the end of conical tube 12" (Figure 18a) and the forward portion of forward portion 3" extending beyond conical tube 12".

Anterior section 3a' and rear section 3a" in conjunction with embodiments of conical tube 12" are shown in Figures 19a through 2Od, in which: i) anterior section 3a' is attached to conical tube 12" at an attachment 9" (Figure 19a); ii) anterior section 3a' extends beyond conical tube 12" (Figure

19b); iii) anterior section 3a' is in fluid communication with second conical tube 16" (Figures 20a and 20b); iv) chamber 40" is in fluid communication with a rearward portion 3b" (figures 20c and 2Od); v) an elongate section 3'" is shown extending past solid cone 2"

(Figure 2Oe); and vi) a shaft 19" extending from a solid cone 29" is movably connected to rear portion 131 that is adjacent chamber 40"

(Figures 2Of and 2Og).

Anchor sections 14'" that are internal to elongate sections 3b" are shown in Figures 2Oh through 20I, wherein: i) conical tube 12" extends beyond elongate flexible cartridge 3b" and anchor section 3a" is filled through side hole 14" (Figure

2Oh); ii) elongate flexible cartridge 3b" extends beyond conical tube

12" and anchor section 3a" is attached at two points to conical tube 12" (Figure 2Oi); iii) anchor section 3a" is attached at one point to conical tube

12" (Figure 2Oj); iv) conical tube 12" extends from shaft 19" (Figure 20k); and v) anchor section 3a" is elongate (Figure 20I).

Figures 20k and 2Ol additionally show conical tube 12" attached to tube 2" and passage 19" through which fluid passes into anterior section 3a' via hole 14". Flexible cartridge 3b" is inflated via chamber 40".

Still further embodiments of conical dilators 190 are shown in Figures 33a through 34d. Figure 33a shows cone 12" with side openings 14 and 18. Figure 33b shows conical dilator 190 including anchor portion 3a" adhered to cone 12" around side opening 14. Side opening 18 communicates with elongate cylinder 3a'".

Figures 33c through 33e show conical dilator 190 of Figure 33b being assembled in a syringe 10a so that syringe abutments 10a are secured in cone grooves 91. In alternative embodiments, cone grooves 91 attach to a surgical hose (not shown) that extends from a pressure chamber including one of the above-noted pressure transducers.

Figure 34a shows an alternative embodiment of conical dilator 190 in which a portion of cone 12" extends beyond forward portion 3a' and elongate cylinder 3a'".

Figures 34b and 34c show conical dilator 190 including forward section 3a' and rearward section 3a", with cone 12" protruding from forward section 3a' (Figure 34b) and contained within forward section 3a' (Figure 34b).

Figure 34d shows cone 12" including side opening 18 and forward opening 14 connected via passages to opening 16.

Figure 34e shows elongate cylinder 3a'" extending beyond forward section 3a'.

Figures 35a through 35c show tubes 2 extending from a base portion 92 that includes the above-noted grooves 91 , in which:

Figures 35a and 35b show base portion 92 including a fluid reservoir 12a with guide bulb 7 and a tapered tip 7" respectively; and

Figure 35c shows solid base portion 92 and guide bulb 7. While the present invention is described for dilating cervical canal 22, catheter 1 may be configured for dilation of alternative organ lumens, for example a urethra, a bladder opening and/or the opening to the colon. The many alternative configurations of catheter 1 for use in organ lumens throughout the body are known to those familiar with the art.

Additionally, there are several configurations of catheter 1 that may include specific features for dilation of cervical canal 22. Configurations for Short Lumens

As shown in Figures 21 a through 21 b, there are a variety of configurations that may be advantageous for short organ lumens in which the configurations include chamber 3a, previously referred to as forward portion 3a, attached to tube 2 to limit expansion, including: i) chamber 3a attached to tube 2 at forward point (a) and rear point (b) (Figure 21a); and ii) forward end 6 of section 3a extending past tube 2 (Figure 21 b) and attached at point (a).

Compression Cylinder

In some lumens, for example when the lumen does not exert large amounts of pressure, the operator may inadvertently begin filling section 3a prior to forming an anchor within the lumen. Figures 21 c-21d3 show just one example that aids in preventing premature fluid release in which a compression cuff 179, as shown in Figure 21 c, is positioned around tube 2 at hole 14. Hole 14 is in fluid communication with a fluid source (not shown) via a passage to opening 16. Compression cuff 179 comprises any flexible material, such as rubber, and may have any one of various shapes and dimensions according to specific applications and/or organ lumens.

In the cervical canal (not shown), for example, the pressure of the organ lumen compresses compression cuff 179 against opening 14 and thereby prevents low pressure delivery of fluid to section 3a.

When pressure is reduced, for example as section 3a passes into an organ cavity such as the uterus, the diameter of compression cuff 179 increases so that hole 14 opens and fluid is delivered to section 3a.

Figures 21 e through 21 g show configurations of fluid delivery collars 177 in which the pressure of the organ lumen compresses section 3a against a fluid hole 18 comprising a passage, thereby preventing fluid from passing into section 3a. After passing into the associated organ cavity, pressure on section 3a is released and fluid flows through fluid passage 18.

Fluid passages 18 that extend from hole 14 are positioned with respect to tube 2 in a variety of configurations in which fluid delivery collar 177 is cylindrical, including: i) rearward oblique fluid passage 18 (Figure 21 e); ii) 90 degree fluid passage 18 (Figure 21f1 ); iii) fluid passages 18 parallel to shaft 2 (Figure 21 f2); and iv) forward oblique fluid passage 18 (Figure 21 f3). An elliptical or spherical fluid delivery collar 177 with a 90 degree fluid passage 18 is shown in Figure 21 g.

An alternative embodiment is shown in Figure 30, in which following inflation, a drug may delivered through a drug delivery passage 130 which passes from an external portion of flexible cartridge 3, through fluid delivery collar 177 and out through guide bulb 7. It should be noted that configurations of drug delivery passage 130 may be adapted for use with many of the embodiments associated with the instant inventions, for example, drugs optionally used to treat organ ulcerations, exfoliations, tumors or other local conditions.

Dilation Method

One method in which fluid delivery collars 177 (Figures 21 e through 21 g and 30) are deployed in dilating an organ lumen is shown in Figures 22a through 22f. As seen in Figure 22a, forward end of catheter 1 is introduced into cervical canal 22 with flexible cartridge 3 deflated around tube 2. As long as delivery chamber 177 is found inside cervical canal 22, external pressure by the walls of cervical canal 22 on the walls of catheter 1 (Figures 22a through 22b) maintains fluid passage 18 closed. Any attempt to push fluid through filling system to flexible cartridge 3 using a mild to moderate pressure will meet resistance, signaling the operator that delivery chamber 177 has not yet passed into uterus 20. As delivery chamber 177 passes beyond internal end of cervical canal 22 into uterus 20, external pressure diminishes (Figure 22c) and flexible cartridge 3 loosens so that fluid passage 18 opens.

The free movement of fluid signals the operator that delivery chamber 177 is inside uterus 20 and filling of flexible cartridge 3, for example at increased pressure, may commence (Figure 22c).

As flexible cartridge 3 is inflated, cervical canal 22 expands. Inflation of flexible cartridge 3 is terminated when the operator is satisfied with the dilation diameter of cervical canal 22 (Figure 22d). At end of filling process, fluid is partially removed from flexible cartridge

3 (Figure 22e) and catheter is pulled out of cervical canal 22, as noted above, leaving an expanded cervical canal 22 behind (Figure 22f).

Foam Anchor Figure 23 shows another embodiment in which a forward anchor 17' comprises a foam material attached to a tube 2'.

Forward anchor 17' is firmly attached to tube 2' in such a way that hole 14' is covered all time by foam forward anchor 17'. Fluid that is delivered via passage 12' and hole 14' initially accumulates in foam forward anchor 17'.

Deployment of forward anchor 17' is shown in Figures 24a through

24h. Catheter V is introduced into cervical canal 22' with flexible cartridge 3' deflated and collapsed around shaft 2' (Figures 24a through 24c).

In response to the low pressure of uterus 20', fluid is delivered via hole

14' and accumulates in anchor 17'. The foam material of forward anchor 17' swells (Figure 24d) to form an anchor configuration. Catheter V is then pulled back until forward anchor 17' is anchored against cervical canal 22'. (Figure

24e).

The increased pressure caused by the pulled back anchoring position of forward anchor 17' prevents fluid from passing hole 14; into forward anchor and fluid is delivered to flexible cartridge 3'. As flexible cartridge 3' is inflated, cervical canal 22' is expanded (Figure 24f).

Upon dilation of cervical canal 22', inflation of flexible cartridge 3' is terminated, fluid is partially removed from flexible cartridge 3 (Figure 24g) and catheter V is pulled-out leaving an expanded cervical canal 22' behind (Figure 24h).

An alternative embodiment is shown in Figures 25a and 25b wherein a foam anchor 17 having collapsible pores, is attached to tube 2. When inside cervical canal 22, the pressure maintains the pores of foam anchor 17 in the collapsed position, thereby preventing fluid from being delivered to flexible cartridge 3 via hole14.

Foam anchor 17 decompresses upon passing into the organ cavity, for example uterus (not shown). Under reduced pressure, as shown in Figure 25a, the pores in foam anchor 17 open so that fluid is delivered to flexible cartridge 3 via hole 14, thereby dilating the surrounding tissue.

In alternative embodiments, foam anchor 17 may be sealed with a thin layer of sealing material that disintegrates due to an imbalance of pressure.

As foam anchor 17 passes through the organ lumen, foam anchor 17 maintains its integrity due to the relatively equal pressures inside and outside foam anchor 17.

Upon reaching the organ cavity, external pressure is reduced and the large internal pressure from the fluid causes foam anchor 17 to disintegrate thereby allowing passage of fluid into flexible cartridge 3.

Sleeve Embodiments

Shown in Figures 26 through 28b is an embodiment in which tube 2 has a single passage that conducts the pressurized fluid to deflated portion 3a from fluid reservoir portion 3b via rearward hole 16 passing by an uninflatable portion 3c without causing inflation.

To prevent inflation, uninflatable portion 3c is attached to tube 2 at a forward point (a) and a rearward point (b) and snugly fits against tube 2. As shown in Figure 27, a portion of deflated portion 3a and part of uninflatable flexible cartridge 3c are enclosed within a sleeve 100. Sleeve 100 is optionally rigid to aid in dilation of an organ having a relatively straight lumen. In other embodiments, sleeve 100 is flexible to allow introduction through a lumen having one or more curves, for example the curve associated with the sigmoid colon. Guide bulb 7 and an anterior section of deflated portion 3a protrude forward of sleeve 100.

As shown in Figure 28b, sleeve 100 is pulled toward syringe 10 in rearward direction 4, plunger 21 is pressed in forward direction 6, and section 3a fills anteriorly to form an anchor portion within a body cavity (not shown). Figs. 28c and 28d shows the deployment of the system of Fig. 28B. Fig. 28A shows the sleeve not mounted. Optionally, the sleeve is mounted on the expandable portion in a manner which squeezes fluid out of it. Optionally, a proximal side is flared out, to assist in mounting. In some embodiments, a valve to prevent backflow from the expanding portion is provided in the passageway. Optionally, the valve is openable by a pull-string (not shown) or fails when sufficient backpressure is applied.

Sleeve 100 is then pulled further toward syringe 10, allowing section 3a to fully fill with fluid, thereby causing dilation to a body lumen (not shown). When sleeve 100 comes to rest around the areas between seal (a) and seal (b), section 3a can be fully inflated beyond seal (a).

Section 3a is optionally made of an inelastic material and, upon inflation, further pressure within section 3a may cause seal (a) and/or seal (b) to dislodge. However, the portion of section 3a located inside sleeve 100 cannot expand beyond the internal diameter of sleeve 100.

Cylindrical Section Figures 29a through 29f3 show an embodiment in which a forward portion 3" is long, cylindrical and connected to the forward end of a tube 2a". Forward portion 3" is collapsed and positioned along with a forward part of tube 2a" in a passage 33" of a sleeve 2b" (Figure 29b). Tube 2a" has a single passage and includes a forward bulb 29"' that fills passage 33" of sleeve 2b" but still enables free movement of tube 2a" inside passage 33" of sleeve 2b". Forward bulb 29'" includes a hole 14" that opens into the rearward part of forward portion 3".

Pressurized fluid is delivered from a fluid source, for example syringe 10 through passage 2a" to forward portion 3".

Flexible cartridge 3' optionally comprises an inelastic flexible material so that the final diameter and length of forward portion 3" is fixed and predetermined and further inflation beyond these dimensions is not possible.

As shown in Figure 29c, as sleeve 2b" is pulled rearward in direction 4, forward portion 3" forms an anchor portion. Further rearward movement of sleeve 2b" allows a larger length of forward portion 3" to fill with fluid.

Figure 29f1 shows an aerial view of deflated forward portion cartridge

3" comprising a series of radially outward extending petals 157. During manufacture, petals 157 are folded to form cup-shaped configuration, shown on the right in Figure 29f3 and compressed to form a ball shape, shown on the left.

Deployment of Cylindrical Section

As shown in Figure 29g, a catheter 1 " is introduced through a lumen 22" until, as shown in Figure 29h, the anterior end of forward portion 3" is positioned in a body cavity 20" and sleeve 2b" is pulled back, for example, about 10 millimeters to free an anterior section or forward portion 3a".

As shown in Figure 29i, the anterior section of forward portion 3a" is inflated within organ cavity 20" while tube 2a" is maintained in position with respect to lumen 22". As shown in Figure 29j, sleeve 2b" and tube 2a" are pulled back to cause the anterior section of forward portion 3a" to rest against the opening to lumen 22" and act as an anchor.

As shown in Figure 29k, sleeve 2b" is pulled back further until exiting lumen 22" while tube 2a" is maintained in position. With sleeve 2b" retracted, anterior section of forward portion 3a" partially deflates, passing fluid into rear portion 3".

Rear portion 3" is then inflated by the operator, as shown in Figure 291 to dilate lumen 22". In some procedure and/or lumen configurations, separate inflation portions and/or inflation transducers may be desirable. For example, in when termination of a pregnancy is dependent upon viability of the fetus, an initial small dilation may be required for examination of the fetus and, if the pregnancy requires termination, a larger dilation may be required.

Dual Channels

Another embodiment of the instant invention is shown in Figures 31 a and 31 b in which an elongate section 8^β is contained inside a tube 2^β.

A forward portion 10^β includes a filling tube 40^β and a filling hole 41 ^β. As shown in Figure 31a, elongate section 8^β is deflated and extends past tube 2^β.

Figure 31 b, shows an inflated portion of elongate section 8^β extending past tube 2^β while section 10^β has been inflated with a separate syringe 10".

Tube 2^β is usually made of a plastic material with variable grades of flexibility. Section 8^β may be highly compliant to allow positioning inside section 10^β that has predetermined fixed final dimensions.

An alternative embodiment is shown in Figures 31 c and 31 d in which elongate section 8^β is contained within section 10^β.

Still another alternative embodiment is shown in Figures 32a through 32c in which second syringe 10" includes filling hole 41 ^β, which may comprise a rigid material, with tube 40^β. As shown in Figure 32b, passage 41 ^β and opening 40^β serve to inflate section 10^β.

Still a further embodiment is shown in Figure 32c in which syringe 10 is used to fill anchor section 8^β through passage 12 having a side opening 14^β . It is expected that during life of a patent maturing from this application many relevant materials and manufacturing methods for dilators will be developed and scope of term dilators is intended to include all such new technologies a priori.

As used herein the term "about" refers to ± 10 % The terms "comprises", "comprising", "includes", "including", "having" and their conjugates mean "including but not limited to".

The term "consisting of means "including and limited to".

The term "consisting essentially of means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1 , 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases "ranging/ranges between" a first indicate number and a second indicate number and "ranging/ranges from" a first indicate number "to" a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

As used herein the term "method" refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts. As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claims

WHAT IS CLAIMED IS:

1. A device for dilating a body lumen, the device comprising a flexible cartridge comprising a sealed single envelope, said flexible cartridge including at least two portions: i) an expandable portion configured for insertion into a body lumen; and ii) a fluid storage portion in fluid communication with said expandable portion, said fluid storage portion configured to release stored fluid thereby inflating said expandable portion.

2. The device according to claim 1 , wherein said expandable portion comprises an inelastic material.

3. The device according to claim 1 , wherein said expandable portion is covered by a removable protective sheath.

4. The device according to claim 3, wherein said removable sheath includes screw threads that mate with screw threads on the pressure transducer.

5. The device according to claim 1 , wherein said cartridge includes a pressure sensor with a readout.

6. The device according to claim 1 , including a fluid guide contained within said flexible cartridge and positioned to guide said stored fluid into said expandable portion.

7. The device according to claim 6, including an attachment located between said expandable portion and said fluid storage portion, said attachment configured to compress said flexible cartridge against said fluid guide.

8. The device according to claim 1 , including an anchor portion.

9. The device according to claim 8, wherein said anchor portion has an inflated length of between about 5 millimeters and 15 millimeters.

10. The device according to claim 8, wherein said anchor portion has an inflated length of about 10 millimeters.

11. The device according to claim 1 , wherein the body lumen comprises at least one of: a cervical canal, a urethra, a bladder portion, an esophageal sphincter, a pyloric sphincter, and an anal opening.

12. The device according to claim 1 , wherein the body lumen comprises a cervical canal.

13. The device according to claim 12, wherein said expandable portion has an inflated diameter of between about 4 and 8 millimeters.

14. The device according to claim 12, wherein said expandable portion has an inflated diameter of between about 6 and 20 millimeters.

15. The device according to claim 12, wherein said expandable portion has an inflated diameter of between about 9 and 13 millimeters.

16. The device according to claim 6, wherein said fluid guide includes a washer.

17. The device according to claim 6, wherein said dilator is included in a kit including a pressure transducer.

18. The device according to claim 17, wherein said dilator divides into at least two portions when placed in said pressure transducer: a luminal portion that inserts into the organ lumen; and a fluid reservoir portion.

19. The device according to claim 18, wherein said pressure transducer includes at least one washer positioning projection.

20. The device according to claim 19, wherein said washer seals against said pressure transducer.

21. A device for dilating a body lumen, the device comprising: i) an inelastic expandable portion; and ii) a handle sized to fit in one hand, said handle including a pressure inducer.

22. The device according to claim 21 , wherein said inelastic expandable portion comprises an inelastic material.

23. The device according to claim 21 , wherein said pressure inducer is manually operated.

24. The device according to claim 21 , wherein said pressure inducer includes a fluid reservoir.

25. The device according to claim 24, wherein said pressure inducer comprises a syringe.

26. The device according to claim 25, wherein said pressure inducer includes a piston that presses on a portion of said fluid reservoir.

27. The device according to claim 24, wherein said pressure inducer includes an electromagnetically driven piston.

28. The device according to claim 24, wherein said pressure inducer includes a roller that rolls along a portion of said fluid reservoir.

29. The device according to claim 24, wherein said pressure inducer is electrically driven.

30. The device according to claim 24, wherein said pressure inducer is driven by a motor.

31. The device according to claim 24, wherein said pressure inducer includes a fluid expanding driver.

32. The device according to claim 29, wherein said expanding fluid comprises a compressed gas.

33. The device according to claim 30, wherein said expanding fluid comprises expands in response to radiation.

34. The device according to claim 33, wherein said radiation comprises at least one of: ultrasound, light, heat and radio waves.

35. The device according to claim 31 , including a fluid guide contained within said fluid reservoir and positioned to guide stored fluid into said inelastic expandable portion.

36. The device according to claim 35, wherein said fluid guide comprises a rigid tube.

37. The device according to claim 35, wherein said fluid guide comprises a flexible tube.

38. The device according to claim 35, including an expandable anchor portion.

39. The device according to claim 38, wherein said fluid guide extends into said anchor portion.

40. The device according to claim 31 , wherein said device does not extend beyond the one hand of an operator.

41. The device according to claim 31 , wherein said device does not include cables that extend beyond the one hand of an operator.

42. The device according to claim 31 , wherein said device does not include wires or tubes that extend beyond the one hand of an operator.

43. A device for dilating a body lumen, the device comprising a flexible envelope comprising an expandable portion comprising two portions: i) an inelastic expandable portion section configured to pass through a body lumen; and ii) an anchor portion configured to anchor said flexible envelope in a body cavity, said anchor section being connected to said lumen section in a manner which does not define a reduced diameter area suitable for receiving tissue.

44. The device according to claim 43, wherein said anchor portion and said inelastic expandable portion are inflatable.

45. The device according to claim 43, wherein said anchor portion and said inelastic expandable portion comprise an inelastic material.

46. The device according to claim 43, wherein said anchor portion and said inelastic expandable portion comprise a biocompatible material.

47. The device according to claim 43, wherein said anchor portion has an inflated length of between about 5 millimeters and 15 millimeters.

48. The device according to claim 43, wherein said anchor portion has an inflated length of about 10 millimeters.

49. The device according to claim 48, wherein the body lumen comprises at least one of: a cervical canal, a urethra, a bladder portion, an esophageal sphincter, a pyloric sphincter, and an anal opening.

50. The device according to claim 49, wherein the body lumen comprises a cervical canal.

51. The device according to claim 50, wherein said inelastic expandable portion has an inflated diameter of between about 4 and 8 millimeters.

52. The device according to claim 50, wherein said inelastic expandable portion has an inflated diameter of between about 6 and 20 millimeters.

53. The device according to claim 12, wherein said expandable portion has an inflated diameter of between about 9 and 13 millimeters.

54. The device according to claim 43, including a fluid storage portion connected to said inelastic expandable portion, said fluid storage portion configured to release stored fluid in response to pressure, thereby inflating said inelastic expandable portion.

55. The device according to claim 54, including a fluid guide contained within said inelastic expandable portion and positioned to guide stored fluid from said fluid storage portion into said inelastic expandable portion.

56. The device according to claim 55, wherein said fluid guide includes a washer.

57. The device according to claim 56, including an attachment between said inelastic expandable portion and said washer.

58. The device according to claim 56, wherein said fluid guide includes at least one opening positioned to fluid movement into said inelastic expandable portion.

59. The device according to claim 58, including at least one pressure sensitive plug positioned in said at least one opening.

60. The device according to claim 59, wherein said at least one pressure sensitive plug positioned to be compressed by said flexible portion during passage through a body lumen.

61. The device according to claim 59, wherein said at least one pressure sensitive plug is configured to be released by fluid pressure within said fluid guide upon reaching a body cavity.

62. The device according to claim 56, wherein said fluid guide includes at least two openings: at least one second opening positioned to allow fluid movement into said anchor portion; and at least one first opening positioned to allow fluid movement into said inelastic expandable portion.

63. The device according to claim 59, including at least one pressure sensitive plug positioned in said at least one first opening.

64. The device according to claim 63, wherein said at least one pressure sensitive plug is positioned to be compressed by said flexible portion during passage through a body lumen.

65. The device according to claim 63, wherein said at least one pressure sensitive plug is configured to be released by fluid pressure within said fluid guide upon reaching a body cavity.

66. The device according to claim 65, including at least one pressure sensitive plug positioned in said at least one second opening.

67. The device according to claim 63, wherein said at least one pressure sensitive plug is configured to be released by fluid pressure following expansion of said anchor portion.

68. The device according to claim 47, including a fluid guide contained within said flexible envelope and positioned to guide stored fluid into said inelastic expandable portion.

69. A device for dilating a body lumen, the device comprising: i) a flexible envelope comprising two portions: a lumen portion configured passing into a body lumen; an anchor portion configured to anchor said flexible envelope in a body cavity; and ii) a fluid reservoir portion connected to said flexible envelope and having a fluid control configured to achieve serial inflation of said two portions.

70. The device according to claim 69, wherein said fluid control comprises at least one manually operated valve.

71. The device according to claim 69, wherein said fluid control comprises at least one electronically operated valve.

72. The device according to claim 69, wherein said fluid control comprises at least one electronically operated valve.

73. The device according to claim 69, including a fluid guide contained within said flexible envelope and positioned to guide stored fluid from said fluid reservoir into said two portions.

74. The device according to claim 73, wherein said fluid guide includes at least two openings.

75. The device according to claim 74, wherein said at least two openings have different diameters.

76. The device according to claim 74, wherein at least one of said at least two openings is covered by a membrane that is moveable in response to fluid pressure.

77. The device according to claim 76, wherein said membrane includes a pressure sensitive adhesive.

78. The device according to claim 76, wherein said flexible envelope is surrounded by a retractable tube.

79. A device for dilating a body lumen, the device comprising a flexible envelope including: i) a lumen section configured passing into a body lumen; ii) an anchor section configured to anchor said flexible envelope in a body cavity; and iii) a fluid guide comprises a tube having an expanded end having a fluid passage, said fluid guide being contained within said flexible envelope.

80. A device for dilating a body lumen, the device comprising a flexible envelope comprising an inelastic expandable portion including two sections: i) a lumen section configured passing into a body lumen; and ii) an anchor section configured for anchoring said flexible envelope in a body cavity, said anchor section being contained within said lumen section.

81. The device according to claim 80, including a fluid guide contained within said flexible envelope and positioned to guide stored fluid from a fluid reservoir into said two portions.

82. A device for dilating a body lumen, the device comprising: i) a flexible envelope comprising a inelastic expandable portion configured for insertion into a body lumen; and ii) a conical support.

83. The device according to claim 82 wherein said conical support comprises a fluid guide configured to guide fluid into said inelastic expandable portion.

84. A device for dilating a body lumen, the device comprising: i) a flexible envelope comprising a expandable portion configured for insertion into a body lumen; and ii) a flexible rod having a circumferential washer configured to guide fluid into said expandable portion.

85. A device for dilating a body lumen, the device comprising a flexible envelope comprising an expandable portion configured for insertion into a body lumen and configured to fit in a pressure transducer comprising a syringe.

86. A device for dilating a body lumen, the device comprising: i) a flexible envelope comprising two portions: a lumen section configured passing into a body lumen; an anchor section configured to anchor said flexible envelope in a body cavity; and ii) a fluid guide including a fluid passage and a tab around a hole in said fluid passage.

87. A device for dilating a body lumen, the device comprising a flexible envelope comprising an expandable portion configured for insertion into a body lumen and configured to fit in a syringe.

88. The device according to claim 87, wherein said syringe includes a plunger having a plate that presses against a portion of said expandable portion.

89. The device according to claim 88 wherein said plate includes at least one perforation configured to allow the escape of air trapped between said plate and said flexible envelope.

90. The device according to claim 88 wherein said plunger comprises a shaft that passes through a pressure resistant washer.

91. The device according to claim 90 wherein said pressure resistant washer is configured to form a partial vacuum against a portion of said plate while said plate is pressed against said portion of said expandable portion.

92. The device according to claim 87 wherein said flexible envelope comprises an expandable portion.

93. The device according to claim 87 wherein said expandable portion comprises an inelastic material.

94. The device according to claim 87 wherein said expandable portion includes a fluid guide.

95. The device according to claim 94 wherein said expandable portion and said fluid guide have a diameter that allows simultaneous passage through a forward opening in said syringe during assembly.

96. The device according to claim 95 wherein said forward opening has a diameter configured to press against said expandable portion during assembly.

97. The device according to claim 95 wherein said forward opening has a diameter configured to express at least a portion of residual fluid within said expandable portion during assembly.

98. A method for dilating a body lumen, the method comprising: i) placing said the rearward portion of a flexible envelope in a syringe; ii) positioning the forward portion of said flexible envelope in a body lumen; iii) positioning the rearward portion of said flexible envelope external to the body lumen; iv) placing pressure on said rearward portion with said syringe; v) expressing fluid contained within said rearward portion into said forward portion; and vi) dilating a body lumen.