WO2010002786A2

WO2010002786A2 - Method and system for endoscopic placement of a balloon

Info

Publication number: WO2010002786A2
Application number: PCT/US2009/049051
Authority: WO
Inventors: Rafael Fleites; Fely Bustos
Original assignee: Individual
Current assignee: Individual
Priority date: 2008-06-30
Filing date: 2009-06-29
Publication date: 2010-01-07
Anticipated expiration: 2010-12-30
Also published as: WO2010002786A3

Abstract

The present invention relates to a method and system for performing an endoscopic procedure to place a balloon in a body cavity. The method and system uses a balloon housed in a transparent sleeve located at a distal end of an endoscope. This transparent sleeve and visualization means located proximate to the distal end of the endoscope together enable the accurate deployment of the balloon within a body cavity while viewing the interior of the body cavity via the endoscope and transparent sleeve. The sleeve has serrated portions that permit the secure deployment of the balloon

Description

METHOD AND SYSTEM FOR ENDOSCOPIC PLACEMENT OF A

BALLOON

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a non-provisional of U.S. Provisional Application No. 61/076,992, filed June 30, 2008, pursuant to 35 U.S.C. §119(e), the contents of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

[0002] The present invention relates to the field of endoscopic devices and procedures. In particular, the invention relates to the utilization of an endoscopic device for placement of a balloon in the stomach in order to reduce food intake.

2. Description of the Related Technology

[0003] Obesity is a disease that affects many in industrial nations. Obesity contributes to numerous problems, such as high blood pressure, heart conditions, type-2 diabetes and asthma. Studies have shown that many of these conditions improve as patients lose excess weight.

[0004] It has become increasingly necessary to employ various methods for ameliorating problematic obesity issues. Some methods that have been used have employed pharmaceuticals. Some methods have employed surgical procedures, such as stomach stapling. Another procedure that has been used to help treat obesity has been the use of gastric balloon insertion, where a balloon is inserted into the gastrointestinal tract to reduce food intake.

[0005] However, past gastric balloon procedures have been replete with problems. Some old balloon designs were rectangular or angular in shape and tended to be very abrasive to the gastric mucosa. Some designs would suffer from up to a 20% incidence of balloon deflation; other balloons would migrate to the small intestine. Knowing whether or not the balloon was deflated and where the balloon was located in the gastrointestinal tract was also problematic. These issues impaired the implementation of this procedure on a large scale.

[0006] In order to combat some of these issues some balloons have been provided with x- ray reflective capability so that these balloons can be tracked in the gastrointestinal tract. Other balloons use a dye mixed in the saline solution used to inflate the balloon to provide an immediate indication if the balloon ruptures. Upon rupturing of the balloon a patient's urine will change color due to the dye in the saline solution used to inflate the balloon. Some existing balloons resist deflation and rupture due to improvements in the materials used to fabricate the balloons.

[0007] However, none of the aforementioned methods or systems use an endoscope at the time of actual insertion and deployment of the balloon to ensure safe and accurate balloon positioning and safety of deployment within the stomach thus eliminating blind insertion of the balloon. This method of deployment provides an effective way to accurately position the balloon and ensure that the balloon remains securely positioned during the entire time period it is resident in the patient. Therefore, an improved method and system for positioning the balloon in a body cavity is needed. The present invention provides a way to insure that the placed balloon remains fixed in position.

SUMMARY OF THE INVENTION

[0008] An object of the invention is to provide a method for placing a balloon with the use of an endoscope for placement and deployment of the balloon in the interior of a body cavity such as the stomach.

[0009] Another object of the invention is to provide an endoscopic assembly for placing a balloon in the interior of a body cavity such as the stomach. [00010] An aspect of the present invention may be a system for deploying and inflating a balloon within a body cavity comprising: an endoscope; a transparent sleeve adapted to be fitted onto a distal end of the endoscope; a deflated balloon located within the transparent sleeve; inflation means fluidly connected to the balloon for inflating the balloon, said inflation means extending through said endoscope for connection to a source of fluid; means for visualizing said body cavity located proximate to a distal end of said endoscope and positioned for visualization of said body cavity through a portion of said transparent sleeve; and wherein a portion of said transparent sleeve is perforated so as to permit separation of the transparent sleeve into separated segments.

[00011] Another aspect of the present invention may be a method for deploying and inflating a balloon within a body cavity comprising the steps of: providing an endoscope with a transparent sleeve at a distal end thereof and a visualization means located proximate to the distal end of the endoscope; locating a deflated balloon attached to an inflation means within the transparent sleeve; inserting the endoscope into a body; visualizing the interior of the body cavity through said transparent sleeve using said visualization means; positioning the balloon at a desired location in said body cavity based on information obtained in said visualizing step; inflating the balloon; disconnecting the balloon from the inflation means; and removing the endoscope and transparent sleeve from the body; and wherein a portion of said transparent sleeve is perforated so as to permit separation of the transparent sleeve into separated segments.

[00012] These and various other advantages and features of novelty that characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for a better understanding of the invention, its advantages, and the objects obtained by its use, reference should be made to the drawings which form a further part hereof, and to the accompanying descriptive matter, in which there is illustrated and described a preferred embodiment of the invention BRIEF DESCRIPTION OF THE DRAWINGS

[00013] FIG. 1 shows a balloon for use in the method in accordance with the present invention.

[00014] FIG. 2 shows the endoscope and serrated sleeve for placement of a balloon in accordance with an embodiment of the present invention, which may also be used in the method in accordance with the present invention.

[00015] FIG. 3 shows the inflation of the balloon in accordance with the embodiment of the system shown in FIG. 2.

[00016] FIG. 4 shows removal of the endoscope and transparent sleeve after deployment of the balloon, in accordance with the embodiment of the system shown in FIGS. 2 and 3.

[00017] FIG. 5 illustrates the means for inflation of the balloon.

[00018] FIG. 6 shows the insertion and deployment sleeve for the balloon with the non- inflated balloon and inflation means in accordance with an embodiment of the present invention.

[00019] FIG. 7 shows the distal end of the endoscope in accordance with an embodiment of the present invention.

[00020] FIG. 8 shows a retrieval sleeve for use in the method.

[00021] FIG. 9 shows a flow chart of one example of a method in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

[00022] The present invention pertains to a system and method for transporting a balloon 10 into a body cavity of a patient such as the stomach and deploying the balloon 10 in the body cavity. Preferably, the balloon 10 is deployed in the stomach to reduce food intake so as to induce a loss of weight in the patient.

[00023] FIG. 1 shows a balloon 10 in accordance with an embodiment of the present invention. The balloon 10 shown in FIG. 1 may be made from either a rubber or plastic material. In the embodiment shown a rubber material is used. The rubber material is preferably non-allergenic. It also is preferable that the balloon 10 has the capacity to be x- rayed or visualized using standard medical imaging methods, (i.e. the ability to be seen upon taking an x-ray or other image of the stomach cavity). The material used in the construction of the balloon 10 may also be silicone and in some embodiments the balloon 10 may be constructed so as to be made of a heavy duty smooth silicone that is spherical in shape, with x- ray marking capability and that can withstand acid corrosion for at least 6 months or more. The balloon 10 shown in FIG. 1 may have the capacity to hold up to 700 ccs of fluid. However, it should be understood that the balloon 10 may be constructed to hold more or less fluid depending upon the particular size required for the patient.

[00024] The balloon 10 may be provided with a means for attaching the balloon 10 to a body cavity. Suitable attachment means include portions that can be attached to the body cavity such as wings or other suitable structures known to skilled persons for this purpose. Still referring to FIG. 1, the balloon 10 is shown having a pair of wings 12 that are adapted for receiving clips in order to be clipped to the wall of a patient's stomach. Although shown having a pair of wings 12, it should be understood that more or less, or even no wings 12 may be used depending on preference and/or cost. In the embodiment shown, one end of the balloon 10 may be rounded while the other end of the balloon 10 may have a valve 14, which additionally may have a fastener 13. The rounded shape of the balloon 10 facilitates conformance to the general shape of the surrounding area when placed within a patient's body cavity. This will reduce or prevent discomfort that may occur due to the presence of the balloon 10 in the body cavity.

[00025] Still referring to FIG. 1, the valve 14 may be a self closing valve that automatically closes when the balloon 10 is disconnected from an inflation means 41, as shown in FIG. 5. Referring to FIGS. 2-4, the balloon 10 may additionally include a fastener 13, which preferably is associated with the valve 14 such that the valve 14 closes when the fastener 13 is disengaged from a corresponding fastener 40 located on the inflation means 41. Preferably, fasteners 13, 40 may engage one another and lock upon a half-turn rotation of the fasteners 13, 40 relative to one another.

[00026] Now turning to FIGS. 2-4, during the process of placing the balloon 10 within a body cavity of the patient, the balloon 10 may be housed in the sleeve 65, which in the embodiment shown has a serrated distal end 23 and a proximal end 24. Proximal end 24 has a viewing window 26 which is used for the purpose of viewing the body cavity through the transparent proximal end 24 of the sleeve 65. By "transparent" it is meant that proximal end 24 is made of a material which allows the user to visualize the interior of a patient's body cavity utilizing the endoscope 29. The transparent proximal end 24 is preferably fabricated from plastic and, more preferably, is flexible.

[00027] The transparent proximal end 24 is adapted to attach to the distal end 55 of the endoscope 29 that may form part of an endoscopic assembly 30. The proximal end 24 of the sleeve 65 may be adapted for attachment to commercially available gastric endoscopes in order to fit such an endoscope 29 for use in the method of the present invention. The sleeve 65 comprises the distal end 23 and the proximal end 24. The distal end 23 of the sleeve 65 must be of sufficient size to allow storage and passage of the balloon 10 in a deflated condition, as well as the distal portion of inflation means 41 so that inflation means 41 can be employed to sufficiently cause the serrated portions 27 of the serrated distal end 23 to expand, as shown in FIGS. 3 and 4, so as to move the balloon 10 out of the distal end 23 of transparent sleeve 65 for positioning within a gastric cavity. Furthermore, the non-serrated portion, i.e. proximal end 24, should be sufficiently long enough for the proximal end 24 to be able to engage the endoscope 29 and allow connection of the endoscope 29 for the viewing window 26. The proximal end 24 must be of sufficient size to permit passage of the inflation means 41 therethrough and preferably also permits passage of the inflation means 41 while having a deflated balloon 10 attached to the distal end thereof. [00028] The sleeve 65 can be sized so as to snugly fit over the distal end 55 of the endoscope 29 to provide a tight fit or a friction-fit engagement between the sleeve 65 and the endoscope 29 by careful manual placement of the sleeve 65 on the endoscope 29. Alternatively, other suitable, conventional attachment means such as screw threads, clamps, etc, can be used in order to affix the proximal end 24 of the sleeve 65 on the distal end 55 of the endoscope 29. In certain embodiments, an endoscope 29 may be provided with a transparent sleeve 65 formed integrally with the distal end 55 of the endoscope 29. In the embodiments shown the sleeve 14 is constructed from a clear plastic, biocompatible, nontraumatic flexible material.

[00029] Referring to FIGS. 2-4, in an exemplary delivery method, the sleeve 65 is attached to a distal end 55 of a conventional gastric endoscope 29 before intubation. A deflated balloon 10 is attached to the distal end of the inflation means 41 using fasteners 13, 40. The inflation means 41 and deflated balloon 10 are inserted into the channel 50 of the endoscope 29 which comes out of the tip 20 of the serrated sleeve 65 to enable the engagement of the balloon 10 to the inflation means 41. After attachment of the balloon 10 the inflation means 41 is then pulled back. The sleeve 65 protects the balloon 10 during insertion of the endoscope 29 into the body to ensure that that balloon 10 remains in position for deployment and does not become entangled or detached during insertion of the endoscope 29 into the body.

[00030] Once the balloon 10 is deployed in the body cavity, the endoscope 29 may be used to view the interior of the body cavity to visualize the desired location of the balloon 10. This may be done in order to insure proper placement of the balloon 10. The viewing window 26 permits visualization of the interior of the body cavity before, during and after placement of the balloon 10 to allow very accurate placement of the balloon 10 and to permit verification of the placement of the balloon 10 after it has been inflated and deployed. Once the endoscope 29 has visualized and verified the placement and, more particularly, the desired location for deployment. Now the balloon 10 can be inflated while housed the distal end 23 of the sleeve 65. [00031] The interior of the body can be continuously visualized during this procedure using the endoscope 29 due to the ability to look through the structure of the viewing window 26. Subsequently the balloon 10 may be inflated with a fluid that is transmitted through the inflation means 41 and automatically close the valve 42 of the balloon 10 to retain the inflation fluid in the balloon 10 and thereby maintain the balloon in an inflated condition. Optionally, endoscopic forceps or some other conventional surgical tool may be used to attach the optional wings 12 of the balloon 10 to the body cavity in order to secure balloon 10 in place and thereby prevent migration of the balloon 10 to another location in the body. When inflated the balloon pressure will separate the serrated portions 27 and permit the balloon 10 to inflate, disengage and be deployed. Also shown in FIG. 7 is an endoscope 55 having a lens 28 that can be used for viewing the body cavity through the viewing window 26.

[00032] Referring to FIG 5, the inflation means 41 may be any suitable inflation means 41 known to persons skilled in the art, such as a catheter or cannula that is capable of transporting a fluid into the interior of the balloon 10 via an endoscope 29 while the balloon 10 is positioned in a body cavity. In an exemplary embodiment, fasteners 13 and 40 may form a friction- fit or tight fit between the inflation means 41 and the balloon 10 which can be disengaged by pulling firmly on the inflation means 41. In another embodiment, a clockwise turn of the fastener 13 connects the fastener 40 of the inflation means 41 to the balloon 10 and opens valve 14 to permit inflation of the balloon 10 using the inflation means 41. A counter clockwise turn releases the fastener 13 of the balloon 10 from the fastener 41 of the inflation means 41 and, at the same time, causes the valve 42 to close in order to retain fluid in balloon 10 for use.

[00033] Still referring to FIG. 5, as shown, the inflation means 41 can be a tube that travels in a channel 50 in the endoscope 29. One end of the inflation means 41 has a fastener 40 that is adapted to be connected to the fastener 13 of the balloon 10. At the other end of the inflation means 41, an inflation source 43 and valve 42 are provided to provide a source of fluid for inflating balloon 10. The inflation source 43 contains the fluid that is used in the inflation of the balloon 10. The types of fluids typically used to inflate a balloon are well known in the art and one example of such a fluid is saline. The valve 42 is used to control the flow of inflation fluid during inflation of the balloon 10. The end of the inflation means 41 may alternatively employ a stopcock and adapter for a syringe in order to provide the ability to deliver the inflation fluid via a syringe. Optionally, a dye, such as methylene blue, may be included in the inflation fluid.

[00034] FIG. 6 shows the endoscopic assembly 30. In FIG. 6, the balloon 10 is housed within the serrated portion 23 of the sleeve 65 and is ready for positioning and placement within a patient. The inflation means 41 is located in the channel 50 of the endoscope 29. The inflation means 41 is pushed through the channel 50 and out of the tip of the sleeve 65 to be manually connected to the balloon 10. Visualization lens 28 is located proximate the distal end 55 of endoscope 29 and may be used in viewing a body cavity through the viewing window 26 and in addition to the viewing window 26. Both before and after connection of inflation means 41 to balloon 10, a space may be provided between the balloon 10 and the distal end 55 of the endoscope 29 in order to ensure that a suitable visualization means is located proximate to the distal end 55 of the endoscope 29 and can be used to view the body cavity through the space.

[00035] FIG. 7 shows the distal end 55 of the endoscope 29. Endoscope 29 may be provided with visualization means, such as lenses 28, at a location proximate to distal end 55 of endoscope 29. Visualization means may be any suitable conventional visualization device that can be used with an endoscope, such as lenses, cameras, optical fibers, or other similar means. Preferably, a light source 56 may also be located proximate to distal end 55 of endoscope 29 to assist visualization of the body cavity. Also located at the distal end 55 of the endoscope 29 is an opening to channel 50 through which the inflation means 41 may be inserted and deployed in and through transparent proximal end 24 and expand the serrated distal end 23. It should be understood that additional channels 50 can be provided in endoscope 29, as desired for various known uses.

[00036] Referring to FIG. 8, a retrieval sleeve 70 is shown that is used to retrieve the deflated and used balloon 10 from the body. Thus, for example the retrieval sleeve 70 can be beneficial for use in removing any other foreign object from the esophagus or stomach, for medical emergencies and other medical procedures if desired. The retrieval sleeve 70 may be made of plastic thereby allowing visualization through the whole sides of the sleeve 70 and also direct visualization through the hollow catheter of the sleeve 70.

[00037] In use of the embodiment of FIGS. 2-4, the balloon 10 is housed in the serrated or scored distal end portion 23 of the transparent sleeve 65 during insertion of the endoscopic device 30 into the body. Once the balloon 10 is properly positioned in the body, the balloon 10 may be inflated while still located within serrated or scored portion 25 of the transparent sleeve 65. The serrated or scoring 25 on the transparent sleeve 65 allows the serrated or scored portions 27 of the transparent sleeve 65 to break apart starting from a distal end 23 of the sleeve 65 as shown in FIGS. 3 and 4 as a result of the balloon 10 being inflated within the serrated or scored portion 27 of transparent sleeve 65. Back pressure exerted by the body cavity will cause the transparent sleeve 65 to return substantially to its original position once the balloon 10 has been deployed. Alternatively, the material of transparent sleeve 65 can be selected or fabricated to bias the serrated or scored portion 25 of transparent sleeve 65 to return to substantially its original position, as shown in FIG. 2, once the balloon 10 is deployed by disengaging the balloon 10 from the inflation means 45.

[00038] FIG. 9 is a flow chart illustrating an embodiment of the method of the present invention used for inserting the balloon 10 into a patient's stomach. In step 102 of the method, the transparent sleeve 65 is securely attached to the distal end 55 of a suitable, conventional endoscope 29. The transparent sleeve 65 is securely attached so as to ensure that the sleeve 65 does not accidentally become detached from the endoscope 29 during the procedure.

[00039] In step 104, the inflation means 41 is inserted via the proximal end of, for example, the biopsy inlet channel 50 of the endoscope 29 until the inflation means 41 extends out from the distal end of the biopsy inlet channel 50 of the endoscope 29 and outside the opening 20 of the sleeve 65. In step 104, the inflation means 41 is also attached to the balloon 10 by attaching the fastener 23 of the inflation means 41 to the fastener 13 of the balloon 10. Once the balloon 10 is attached to the inflation means 41, the inflation means 41 is slowly pulled in the proximal direction until the deflated balloon 10 is positioned inside the transparent sleeve 65. The other end of the inflation means 41 may be connected to the inflation source 41 provided with a valve 42 at any suitable time prior to the time of inflation. The deflated balloon 10 is located completely within transparent sleeve 65 at this step in the procedure.

[00040] In step 106, the patient is prepared for the procedure. For example, a monitor may be attached to the patient and, optionally, the patient may be sedated. The patient may be placed on their left side. After the patient is prepared, the mouth may be provided with local anesthetic, and preferably a mouth guard is located in the mouth during the procedure.

[00041] In step 108, the distal end 55 of the endoscope 29 is inserted into the body via the mouth of the patient, through the esophagus and into the stomach.

[00042] In step 110, the visualization means provided proximate to the distal end 55 of the endoscope 29, for example the lenses 28 and the light 56, is used to view the interior of the stomach and visualize the desired location at which the balloon 10 will be placed. The transparent sleeve 65 allows visualization of the stomach using visualization means provided proximate to a distal end 55 of the endoscope 29 at any time during the procedure. Thus, the distal end portion 23 of the transparent sleeve 65 can be positioned at the proper location for deployment of the balloon 10 before deploying the balloon 10 from the transparent sleeve 65 into the stomach. If the initial placement is not within the stomach cavity, the balloon 10 can be safely repositioned before deployment, without having to pull the balloon 10 back inside the transparent sleeve 65.

[00043] In step 112, the inflation means 41 is used to inflate the balloon 10, which in turn due to the increasing size of the balloon 10 breaks and separates the serrated portion 23 out of the transparent sleeve 65 for deployment in the stomach. In step 114, the placement of the balloon 10 is verified by visualization of the balloon 10 via the transparent sleeve 65 using visualization means located proximate the distal end of the endoscope 29. In step 116, the balloon 10 is inflated with inflation fluid. [00044] In step 118, the inflation means 41 is pulled firmly at the proximal end to disengage the fastener 40 from the balloon 10 to disconnect and deploy the inflated balloon 10 and cause the valve 42 to close automatically and thereby maintain the balloon 10 in an inflated condition. The inflation means 41 may then be withdrawn from the body via the channel 50 of the endoscope 29.

[00045] In step 120, before removal of the endoscope 29 from the body, the stomach cavity may be visually examined via transparent sleeve 65 using visualization means proximate to the distal end 55 of the endoscope 29 to verify the placement of the balloon 10. The procedure usually lasts 10-15 minutes and provides very accurate placement of the balloon 10. Optionally, after verification of placement of the balloon 10, a suitable tool may be used to attach the balloon 10 to a part of the body cavity to ensure that the balloon 10 is securely retained in position in the body. Finally, the endoscope 29 and the transparent sleeve 65 may be retracted from the body leaving the inflated balloon 10 in position in the stomach.

[00046] When it is desired to remove the balloon 10, the retrieval sleeve 70 is shown that is used to retrieve the deflated and used balloon 10 from the body. Thus, for example the retrieval sleeve 70 can be beneficial for use to remove any other foreign object from the esophagus or stomach, for medical emergencies and other medical procedures if desired. The retrieval sleeve 70 may be made of plastic thereby allowing visualization through the whole sides of the sleeve 70 and also direct visualization through the hollow catheter of the sleeve 70

[00047] The method and endoscopic assembly 30 of the present system are advantageous in that they use the endoscope 29 to deliver and position the gastric balloon 10 while simultaneously confirming the location of deployment of the balloon 10 within the stomach cavity by visualization of the stomach cavity through the transparent sleeve 65. This ensures the proper placement of the gastric balloon 10. The transparent sleeve 65 also is used to facilitate transportation of the balloon 10 to and from the implantation site, thereby ensuring that it does not accidentally become dislodged from the endoscope 29 or snagged on a part of the body during insertion or removal of the endoscope 29. The transparent sleeve 65 eliminates the problem of blind placement of the balloon 10 by trial and error and diminishes the possibility of an accidental balloon placement or possible complication such as an esophageal perforation or pyloric perforation due to a miscalculation during balloon inflation and deployment. The deployment is assured to not be in the esophagus, inside the hiatus hernia, or duodenum by the ability to visualize the deployment site throughout the procedure. Furthermore, the transparent sleeve 65 prevents the balloon 10 from damaging the esophagus and becoming accidentally separated from the endoscope 29. The method and system of the present invention do not require the performance of a pre-endoscopic procedure to the patient prior to deployment of the balloon for the purpose of taking measurements since direct visualization and assurance of balloon placement is attained at the time of insertion and deployment of the balloon 10.

[00048] It is to be understood, however, that even though numerous characteristics and advantages of the present invention have been set forth in the foregoing description, together with details of the structure and function of the invention, the disclosure is illustrative only, and changes may be made in detail, especially in matters of shape, size and arrangement of parts within the principles of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.

Claims

WHAT IS CLAIMED IS:

1. A system for deploying and inflating a balloon within a body cavity comprising: an endoscope; a transparent sleeve adapted to be fitted onto a distal end of the endoscope; a deflated balloon located within the transparent sleeve; inflation means fluidly connected to the balloon for inflating the balloon, said inflation means extending through said endoscope for connection to a source of fluid; means for visualizing said body cavity located proximate to a distal end of said endoscope and positioned for visualization of said body cavity through a portion of said transparent sleeve; and wherein a portion of said transparent sleeve is perforated so as to permit separation of the transparent sleeve into separated segments.

2. The system of claim 1 , wherein said deflated balloon is positioned in said transparent sleeve at a location which permits visualization of an interior of a body cavity using said endoscope through a portion of said transparent sleeve while said deflated balloon is located in said transparent sleeve.

3. The system of claim 2, wherein said sleeve is of sufficient length to completely house the deflated balloon and simultaneously permit visualization of said body cavity through said transparent sleeve using said visualization means of said endoscope.

4. The system of claim 1, wherein the balloon further comprises a means for attaching the balloon to a stomach cavity.

5. The system of claim 5, wherein the means for attaching the balloon to a body comprises a pair of wings which form part of, or are attached to, the balloon.

6. The system of claim 1, wherein the inflation means is attached to the balloon via a self- closing valve located on said balloon.

7. The system of claim 6, wherein said valve closes upon disconnection of the balloon from the inflation means.

8. The system of claim 1 , wherein the means for visualizing the interior of a body cavity comprises a lens located proximate to a distal end of the endoscope.

9. The system of claim 8, wherein the endoscope further comprises a light located proximate to the distal end thereof.

10. The system of claim 1, wherein the transparent sleeve is flexible.

11. A method for deploying and inflating a balloon within a body cavity comprising the steps of: providing an endoscope with a transparent sleeve at a distal end thereof and a visualization means located proximate to the distal end of the endoscope; locating a deflated balloon attached to an inflation means within the transparent sleeve; inserting the endoscope into a body; visualizing the interior of the body cavity through said transparent sleeve using said visualization means; positioning the balloon at a desired location in said body cavity based on information obtained in said visualizing step; inflating the balloon; disconnecting the balloon from the inflation means; and removing the endoscope and transparent sleeve from the body; and wherein a portion of said transparent sleeve is perforated so as to permit separation of the transparent sleeve into separated segments.

12. The method of claim 11, further comprising the step of attaching the balloon to the body cavity.

13. The method of claim 11, wherein the visualizing means comprises a lens and a camera.

14. The method of claim 11, further comprising the step of verifying the deployment position of the deflated balloon after deploying the balloon into the body cavity and prior to inflation of the balloon by viewing the deflated balloon using said visualization means of said endoscope.

15. The method of claim 14, further comprising the step of positioning the deflated balloon based on information obtained during the step of verifying the deployment position of the deflated balloon.

16. The method of claim 11, further comprising the step of verifying the position of the inflated balloon prior to disconnecting the inflation means from the inflated balloon by viewing said inflated balloon using said visualization means of said endoscope.

17. The method of claim 16, further comprising the step of positioning the inflated balloon based on information obtained during the step of verifying the position of the inflated balloon.

18. The method of claim 15, further comprising the step of verifying the position of the inflated balloon prior to disconnecting the inflation means from the inflated balloon by viewing said inflated balloon using said visualization means of said endoscope.

19. The method of claim 18, further comprising the step of positioning the inflated balloon based on information obtained during the step of verifying the position of the inflated balloon.