WO2001068181A1

WO2001068181A1 - Inflatable cervical dilation device

Info

Publication number: WO2001068181A1
Application number: PCT/US2001/007960
Authority: WO
Inventors: Timothy S. Tracy; James E. Smith
Original assignee: West Virginia University
Priority date: 2000-03-13
Filing date: 2001-03-13
Publication date: 2001-09-20
Also published as: AU2001247390A1

Abstract

A cervical dilation device (100) for dilating a patient's cervix while providing means for easy entry through the patient's cervix and into the uterus. The cervical dilation device (100) comprises an elongated hollow tube (102), having an inflation bulb (104), a means (106) for dilating the cervix. In the preferred embodiment, the tubular balloon (106) has an outer surface(108) and an inner surface (110) which define an access aperture (112) and are connected by supports (114). Upon inflation the outer and inner surfaces move together, enlarging the access aperture. In an alternative embodiment, a second tubular balloon (502), connected to a second catheter (508), is positioned around the first balloon such that the inner surface of the second tubular balloon is integrally connected to the outer surface of the first tubular balloon. The outer surface of the second tubular balloon (502) is perforated for drug delivery.

Description

Inflatable Cervical Dilation Device

Background of the Invention

Field of Technology

The present invention relates to medical devices, and more particularly to a double- or triple-lumen catheter incorporating an inflation means for dilating a woman's cervix while providing access through the woman's cervix to the uterus.

Related Art

Physicians, as well as veterinarians, often need to dilate a patient^'s cervix during medical procedures to acquire access to the patient's uterus. Examples of such medical procedures in human patients include, but are not limited to, endometrial (uterine) biopsy, cervical dilatation and curettage, and cervical dilatation and evacuation procedures. Regarding veterinary procedures requiring cervical dilation, examples include, but are not limited to, artificial insemination, procedures requiring access to the endometrium and similar procedures.

The conventional method for dilating a patient's cervix employs a series of sequentially larger solid metal rods which are progressively, in order of smallest to largest, inserted into the patient's cervix, thereby producing a mechanical dilation of the cervix. There are several disadvantages with using these solid metal rods for cervical dilation. Notwithstanding the obvious discomfort to the patient, once the cervix has been dilated to a desired diameter, the current rod must be removed before access through the cervix to the patient^'s uterus is possible. Upon removal of the metal rods, the patient^" s cervix often constricts thereby reducing the physician's access to the patient^'s uterus and lessening the effectiveness of the dilation. Therefore, repetition of the dilation process is often required. Therefore, there is a need for a cervical dilation device that dilates a patient' s cervix while providing access through the cervix to the patient's uterus. There is a further need for a cervical dilation device that provides a large access aperture through the patient's cervix such that a medical device may be easily and painlessly inserted through the cervix and into the patient's uterus. There is still a further need for a dilation device that is minimally intrusive and comfortable to the patient. There is still a further need to provide the patient with a local anesthetic to minimize the pain.

There are several prior art devices used by medical personnel for accessing a patient's uterus; however, none of these devices enlarge, or dilate, the patient's cervix while providing an enlarged aperture into the patient's uterus. For example, in U.S. Patent No. 5,536,243 to

Jeyendran, a time-release insemination device is disclosed wherein an elongated cylindrical nipple is fit into a patient's cervical canal. In alternative embodiments, the nipple may be extended so that it projects past the cervical canal and into the uterine cavity. Although the Jeyendran device provides access through a patient's cervix into the uterine cavity, the device provides no means for enlarging, or dilating, the cervical canal.

In U.S. Patent No. 5,980,804 to Koch, a custom molded cervical cap is disclosed wherein the finished cervical cap may include a valve having an opening of about 2- 10mm. The valve allows the egress of fluid from the uterus during the use of the cervical cap. As with the Jeyendran device, the Koch cervical cap does not provide a means for enlarging, or dilating, a patient's cervical canal.

In U.S. Patent No. 5,123,424 to Koch, a contraceptive cervical cap is disclosed wherein a marker is inserted into the cervical canal to "mark" the location of the opening of the cervical canal. Again, the marker does not enlarge a patient's cervical canal, but rather is held in place by the canal and the cervical cap until the cervical cap solidifies. Then, once the cap is removed, the marker is removed, thereby creating an effluent tube through the cap.

In addition, to these prior art devices, a conventional uterine injector is commercially available, e.g., a Zirmanti Uterine Injector from BEI Medical Systems Company, Inc., that provides a means for enlarging or dilating a patient's uterus. The injector comprises a balloon positioned on the end of a catheter wherein medical personnel insert the balloon into a patient's uterus and, once properly positioned, inflate the balloon. When the balloon is inflated it acts as a stopper which prevents the catheter from accidentally egressing from the uterus. The disadvantage with this device is that the cervical canal maintains the same size opening; that is, the cervical canal is not enlarged.

Therefore, there is still a need for a cervical dilation device that dilates a patient's cervix while providing access through the dilated cervix to the patient's uterus.

Summary of the Invention

The cervical dilation device of the present invention solves the problems associated with the conventional method for dilating a patient's cervix by providing a double-lumen catheter having a first end and a second end. The double-lumen forms a tubular balloon connected to the second end of the catheter wherein the outer surface of the tubular balloon and the inner surface of the tubular balloon are connected by one or more supports. The catheter is integrally connected to the outer surface of the tubular balloon such that when air is pumped through the catheter, the tubular balloon is inflated. As the tubular balloon is inflated, the supports ensure that the inner surface moves with the outer surface thereby creating an enlarged access aperture through the cervix and into the patient's uterus.

There are several advantages in using the cervical dilation device of the present invention. First, once the tubular balloon is inflated, a physician can access the patient's uterus, such as by inserting medical instruments, without having to remove the dilation device. Thus, the cervical opening of a patient only needs to be penetrated once as compared to the multiple penetrations required by the conventional metal rods. In addition, by maintaining a single and continuous penetration of the cervix, the physician does not have to worry about reflex closure of the cervix that typically occurs when a conventional cervical dilation device is removed from the patient. Finally, the physician can control the rate and level of inflation thereby creating an access aperture only as large as required.

In an alternative embodiment, the present invention comprises a triple-lumen catheter wherein the triple-lumen connected to the second end of the catheter forms an inner, or first, tubular balloon and an outer, or second, tubular balloon. The inner tubular balloon functions as the inflation means, as discussed above, for dilating the patient's cervix, whereas the outer tubular balloon provides a means for delivering a drug, e.g., a local anesthetic, to the surface of the cervix prior to the inflation of the inner tubular balloon. As also discussed above, the inner tubular balloon employs supports for ensuring that the inner surface and the outer surface of the inner tubular balloon maintain the same distance during inflation.

The outer tubular balloon has an interior surface integrally connected to the outer surface of the inner tubular balloon and an exterior surface. The exterior surface is perforated such that when a drug is delivered into the outer tubular balloon, the drug will flow through the perforations and make direct contact to the patient's cervical canal.

Also in this embodiment, two catheters are used: one for inflating the inner tubular balloon and one for delivering a drug into the outer tubular balloon. Each of these two catheters accesses one of the tubular balloons, such as on opposite sides of the device, in order to provide a physician with complete and unhindered access to the uterus. The principal advantage to using a triple-lumen is the ability of the physician to reduce the potential pain and discomfort for the patient prior to the subsequent medical procedure.

Another advantage of the present invention is that the present invention can be used to dilate any portal, orifice, or vessel of a patient in a painless and efficient manner, e.g., with a woman's cervix to enter the uterus, with a patient's portal to an organ or through an artery.

Therefore, an inflation device may dilate the orifice from its original diameter to an enlarged diameter, thereby providing an access aperture having a diameter larger than the original diameter.

Description of the Figures

The present invention is described with reference to the accompanying drawings. In the drawings, like reference numbers indicate identical or functionally similar elements. Additionally, the left-most digit(s) of a reference number identifies the drawings in which the reference number first appears.

FIG. 1 : A perspective side view of a cervical dilation device of the present invention; FIG. 2: A planar side view of a syringe used to inflate the cervical dilation device;

FIG. 3 A: A planar side view of a connection between the catheter and the tubular balloon;

FIG. 3B: A perspective view of an alternate support; FIG. 4A: A perspective cross sectional view of an alternative embodiment of the tubular balloon;

FIG. 4B: A planar end view of the alternative embodiment of the tubular balloon;

FIG. 4C: A perspective view of the alternative embodiment of the tubular balloon;

FIG. 5: A perspective cross-sectional view of an alternative embodiment of the cervical dilation device having a second tubular balloon for drug delivery; FIG. 6: A planar side view showing a deflated cervical dilation device inserted in a cervix; and FIG. 7: A planar side view showing an inflated cervical dilation device inserted in a cervix.

Detailed Description of the Preferred Embodiments

Cervical Dilation Device

FIG. 1 is a perspective side view of a cervical dilation device (CDD) 100 of the present invention. The CDD 100 comprises an elongated hollow tube, e.g., a conventional catheter, 102, about 10-20 centimeters in length, having a first end 1 18 and a second end 120. An inflation means for dilating a patient's cervix is connected to the second end 120 of the catheter 102, and a bulb 104 for introducing air into the catheter 102 is connected to the first end 1 18.

In the preferred embodiment, the inflation means for dilating a patient's cervix comprises a tubular balloon 106 having an outer surface 108. an inner surface 1 10, and an access aperture 112 passing through the entire length of the tubular balloon 106. Also in the preferred embodiment, a plurality of supports 1 14 are used to connect the outer surface 108 to the inner surface 110 of the tubular balloon 106. The supports 114 ensure that the outer surface 108 and the inner surface 110 move together during inflation of the tubular balloon 106. By using the supports 1 14, the diameter of the access aperture 1 12 is enlarged, or increased, during inflation, thereby providing the means for a medical device to pass through the cervix, via the tubular balloon 106, and be used in the uterus. Also in the preferred embodiment, the tubular balloon 106 is about 1.5 to 3 centimeters in length, having an outer diameter about 1-4 millimeters. The supports 1 14 are about 0.5 millimeters in width 308. The tubular balloon 106 and supports 114 are preferably made of a firm, yet elastic, rubber or latex, or a comparable plastic or polymer, that can be inflated as described herein while maintaining its shape. In its initial position, wherein the tubular balloon 106 is deflated, the access aperture 112 has a diameter of about 1 -3 millimeters. However, when the tubular balloon 106 is inflated, the access aperture 112 has a diameter about 1 -5 centimeters.

A bulb 104 is used in the preferred embodiment for introducing air into the catheter 102 and ultimately for inflating the tubular balloon 106. The bulb 104 is a conventional bulb made of a flexible memory rubber that can be squeezed to express air, yet return to its original shape. A physician simply squeezes the bulb 104 to push the air through the catheter 102 and into the tubular balloon 106. When the tubular balloon 106 is inflated to the desired size, the physician closes off the catheter 102 from the bulb 104 by turning the valve 122 to the closed position.

FIG. 2 is a planar side view of an alternate means for inflating the tubular balloon 106 of the present invention. In this embodiment, a syringe connector 204 is integrally connected to the first end 1 18 of the catheter 102. To inflate the tubular balloon 106, a user simply connects an empty syringe 202 to the syringe connector 204 and injects air into the catheter 102 and into the tubular balloon 106. The use of syringe connectors 204 and syringes 202 are well known in the relevant arts. It would be readily apparent for one of ordinary skill to adapt the present invention to use a syringe connector 204 and syringe 202 as described herein.

In addition, bulbs 104 and valves 122, and syringes 202 and syringe connectors 204, are well known in the relevant art and are used for convenience purpose only. It would be readily apparent for one of ordinary skill in the relevant art to use a comparable means for inflating the tubular balloon 106, e.g., air pumps, memory metal actuators, and the like.

FIG. 3 A is a planar side view of a connection between the catheter 102 and the tubular balloon 106, and FIG. 3B is a perspective view showing an alternate embodiment of a support 1 14 of the present invention. Specifically, the use of supports 114 is shown wherein the preferred embodiment comprises a plurality of supports 114 embedded within the tubular balloon 106. Each support 1 14 has a ring shape and lays in the transversal plane 304 to the longitudinal plane 302 of the tubular balloon 106. The supports 1 14 divide the tubular balloon 106 into a plurality of internal compartments 1 16. In the preferred embodiment, a plurality of supports 1 14 are used in the present invention.

However, this is for convenience purpose only. The number of supports 114 needed is based on the length of the tubular balloon 106 actually used. A shorter tubular balloon 106 requires less number of supports 114 than a longer tubular balloon 106.

In order to inflate the tubular balloon 106, air must enter each internal compartment 1 16.

Therefore, as shown in FIG. 3 A, the catheter 102 connects to the tubular balloon 106 along the entire length of the tubular balloon 106 and is open to each internal compartment 116. When air is pumped through the catheter 102, the air enters each internal compartment 116 and inflates the entire tubular balloon 106.

In an alternative embodiment, FIG. 3B, each support 114 may have a notch, or aperture, 306 cut into it. The notch 306 may be positioned against the outer surface 108 or inner surface 1 10 of the tubular balloon 106, or even in the internal surface of the support 1 14. In this embodiment, as air enters a single internal compartment 116 of the tubular balloon 106, the air travels through the notch 306 and into the remaining internal compartments 1 16 of the tubular balloon 106 until the entire tubular balloon 106 is inflated. Using this embodiment, the catheter 102 may only connect to the end of the tubular balloon 106 and not along its entire length. FIGs. 4A-C show an alternative embodiment of the tubular balloon 410 wherein the supports 402 (only two supports 402a and 402b are shown for convenience purpose only) are not ring shaped but rather are rectangular and lay in the longitudinal plane 302 of the tubular balloon 410. FIG.4A is a perspective cross sectional view of an alternative tubular balloon 410, wherein FIG. 4B is an end view and FIG. 4C is a perspective full view of the tubular balloon 410. In this embodiment as in the preferred embodiment, the supports 402a,b are used to connect the outer surface 414 and the inner surface 412, thereby creating an access aperture 416. These supports 402 also dissect the tubular balloon 410 into a plurality of internal compartments 418. In addition, each support 402 contains one or more apertures 404 for allowing air to pass between adjacent internal compartments 418 in order to inflate the tubular balloon 410. In this embodiment, the catheter 102 connects to the tubular balloon 410 at a single entry point 406 at one end of the tubular balloon 410.

FIG. 5 is perspective cross-sectional view of an alternative embodiment of the cervical dilation device (CDD) 500 wherein a first catheter 102 and first tubular balloon 106, having the same structure and function as described above, incorporates a means for delivering a drug 514 to a patient's cervix. In this embodiment, the CDD 500 incorporates a second catheter 508 having a first end 516 and a second end 518 wherein a second tubular balloon 106 is connected to the second end 518 of the second catheter 508 and a drug delivery system 520 is connected to the first end 516 of the second catheter 508. The second tubular balloon 502 surrounds the first tubular balloon 106 such that the inner surface 108 of the second tubular balloon 502 is integrally connected to the outer surface 108 of the first tubular balloon 106. Therefore, as the first tubular balloon 106 is inflated, the second tubular balloon 502 also expands in diameter resulting in the outer surface 504 of the second tubular balloon 502 making direct contact with the patient's cervix.

In addition, the second catheter 508 preferably connects to the second tubular balloon 502 at a point opposite where the first catheter 102 connects to the first tubular balloon 106. The positioning of the first catheter 102 and second catheter 508 is for convenience purpose only to ensure that the bulb 104 of the first catheter 102 does not interfere with the drug delivery system 520 of the second catheter 508. It would be readily apparent to one of ordinary skill in the relevant arts to position the first catheter 102 and second catheter 508 at different points of the first tubular balloon 106 and second tubular balloon 502 respectively. In this embodiment, the drug delivery system 520 comprises a syringe 512 and a syringe connector 510 connected to the first end 516 of the second catheter 508. As the drug 514, e.g., a local anesthetic, is introduced, or inj ected, into the second catheter 508 and then transferred into the second tubular balloon 502, the drug 514 is distributed throughout the length of the second tubular balloon 502. The outer surface 504 of the second tubular balloon 502 contains a plurality of perforations 506. Therefore, as the drug 514 is distributed throughout the second tubular balloon 502 and the first tubular balloon 106 inflates, the drug 514 is pushed through the perforations 506 and onto the cervix.

The use of perforations 506 in the second tubular balloon 502 is for convenience only. The drug 514 may be administered through any comparable means for distributing, such as, by slits, diffusion, micro-pores, and the like.

In addition, the present invention is described in terms of specific dimensions also for convenience purpose only. It would be readily apparent for one of ordinary skill in the relevant art to design, manufacture, and use a device for dilating a patient's orifice, e.g., a woman^'s cervix, while providing access through the patient's dilated orifice, having different dimensions and/or using comparable materials than those described herein. B. Method of Use

FIGs. 6 and 7 illustrate the preferred method for using a cervical dilation device (CDD) 100 of the present invention. A physician or medical personnel inserts the CDD 100 into a patient's vagina 602 until the tubular balloon 106 is properly placed within the patient's cervix

606a,b wherein the cervix 606a,b is its normal, or original, size. The CDD 100 is now in its initial position wherein the tubular balloon 106 is deflated and the access aperture 112 has its original diameter, as shown in FIG. 6.

Once in place, the physician inflates the tubular balloon 106 by pumping air via the bulb 104, or in the alternative, by injecting air via a syringe 202, through the catheter 102 into the tubular balloon 106. As the tubular balloon 106 inflates, the supports 1 14 ensure that the inner surface 1 10 of the tubular balloon 106 moves with the outer surface 108, resulting in the patient's cervix 606a,b being dilated to an enlarged size and the access aperture 1 12 having an enlarged diameter, as shown in FIG. 7. Once the tubular balloon 106 is inflated, the physician has direct access to the patient's uterus 604. The physician may use one or more medical instruments through the tubular balloon 106 during the medical procedure.

Upon completion of the medical procedure, the physician simply deflates the tubular balloon 106 by letting the air escape. This is accomplished by opening the valve 122 on the catheter 102, or if a syringe 202 is used, by drawing back on the syringe 202. Once the tubular balloon 106 is deflated, the physician pulls it from the patient and disposes of it.

The present invention is described in terms of dilating a patient's cervix 606a,b for convenience purpose only. It would be readily apparent for one of ordinary skill in the relevant art to design and implement an inflatable dilation device of the present invention to enlarge any portal, orifice, or vessel, having an original diameter, within a patient's body, e.g., a portal to an organ or through an artery. Therefore, an inflatable dilation device may dilate, or enlarge, the orifice from its original size to an enlarged size, thereby providing an access aperture having a diameter larger than the original diameter. Conclusion

While various embodiments of the present invention have been described, it should be understood that they have been presented by the way of example only, and not limitation. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined in accordance with the described terms and their equivalents.

Claims

What Is Claimed Is:

1. An inflatable dilation device for dilating a patient's orifice from its original size to an enlarged size while providing access through the patient's orifice, comprising: an elongated hollow tube having a first end and second end; and inflation means for dilating the patient's orifice, said inflation means having an access aperture of an original diameter and being connected to the second end of said elongated hollow tube wherein when said inflation means is inflated, the patient's orifice is dilated to the enlarged size and said access aperture is a larger diameter.

2. The inflatable dilation device according to claim 1, wherein said inflation means for dilating the patient's orifice comprises: a means for introducing air into said elongated hollow tube; and a tubular balloon having an inner surface, an outer surface and a length, said elongated hollow tube being integrally connected to said means for introducing air and said tubular balloon such that air passing through said elongated hollow tube from said means for introducing air inflates said tubular balloon.

3. The inflatable dilation device according to claim 2, further comprising one or more supports connecting said inner surface and said outer surface of said tubular balloon, thereby creating a plurality of internal compartments, such that when said tubular balloon is inflated, said inner surface moves in relation to said outer surface resulting in said access aperture having the larger diameter.

4. The inflatable dilation device according to claim 3, wherein the second end of said elongated hollow tube connects to said tubular balloon along the length of said tubular balloon and accesses each said internal compartment.

5. The inflatable dilation device according to claim 3, wherein each said support has an aperture and the second end of said elongated hollow tube connects to said tubular balloon at one said internal compartment.

6. The inflatable dilation device according to claim 2, where said tubular balloon has a length of about 1-3 centimeters.

7. The inflatable dilation device according to claim 6, wherein said tubular balloon has an access aperture having an original diameter within the range of 1 -4 millimeters when said tubular balloon is deflated.

8. The inflatable dilation device according to claim 6, wherein said tubular balloon has an access aperture having a enlarged diameter within the range of 1 -5 centimeters when said tubular balloon is inflated.

9. The inflatable dilation device according to claim 2, wherein said means for introducing air into said elongated hollow tube comprises a bulb and a valve.

10. The inflatable dilation device according to claim 2, wherein said means for introducing air into said elongated hollow tube comprises a syringe connector integrally connected to the first end of said elongated hollow tube and a syringe.

11. The inflatable dilation device according to claim 1 , further comprising: a means for delivering a drug to the patient's orifice.

12. The inflatable dilation device according to claim 1 1, wherein said inflation means for dilating the patient's orifice comprises: a means for introducing air into said elongated hollow tube, and a first tubular balloon having an inner surface, an outer surface and a length, said elongated hollow tube being integrally connected to said means for introducing air and said first tubular balloon such that air passing through said elongated hollow tube from said means for introducing air inflates said first tubular balloon; and said means for delivering a drug to the patient^'s orifice comprises: a second elongated hollow tube having a first end and a second end; a means for introducing the drug into the first end of said second elongated hollow tube; and a second tubular balloon having an inner surface, a perforated outer surface and a length, wherein said inner surface of said second tubular balloon is integrally connected to said outer surface of said first tubular balloon; wherein said second elongated hollow tube is integrally connected to said means for introducing the drug and said second tubular balloon such that the drug passing through said second elongated hollow tube enters said second tubular balloon, passes through said perforated outer surface, and contacts the patient's orifice.

13. The inflatable dilation device according to claim 12, further comprising one or more supports connecting said inner surface and said outer surface of said first tubular balloon, thereby creating a plurality of internal compartments, such that when said first tubular balloon is inflated, said inner surface moves in relation to said outer surface resulting in said access aperture having the larger diameter.

14. The inflatable dilation device according to claim 13, wherein the second end of said elongated hollow tube connects to said first tubular balloon along the length of said first tubular balloon and accesses each said internal compartment.

15. The inflatable dilation device according to claim 13, wherein each said support has an aperture and the second end of said elongated hollow tube connects to said first tubular balloon at one said internal compartment.

16. The inflatable dilation device according to claim 12, wherein said means for introducing air into said elongated hollow tube comprises a bulb and a valve.

17. The inflatable dilation device according to claim 12, wherein said means for introducing air into said elongated hollow tube comprises a syringe connector integrally connected to the first end of said elongated hollow tube and a syringe.

18. The inflatable dilation device according to claim 12, wherein said means for introducing the drug into said second elongated hollow tube comprises a syringe connector integrally connected to the first end of said second elongated hollow tube and a syringe.

19. The inflatable dilation device according to claim 12, wherein said perforated outer surface of said second tubular balloon comprises a plurality of apertures through which the drug is delivered to the patient's orifice.

20. The inflatable dilation device according to claim 1 1, wherein the drug is an anesthetic drug.

21. The inflatable dilation device according to claim 1 , wherein the patient's orifice is a woman's cervix

22. A method for dilating a patient's orifice from an original size to an enlarged size by using an inflatable dilation device having an elongated hollow tube with a first end and second end, and an inflation means for dilating the patient's orifice, wherein the inflation means has an access aperture of an original diameter and is connected to the second end of the elongated hollow tube, said steps comprising: a. inserting the second end of the inflatable dilation device into the patient such that the inflation means is placed within the patient's orifice; and b. inflating the inflation means of the inflatable dilation device resulting in the patient's orifice being dilated to the enlarged size and the access aperture being enlarged to a larger diameter.

23. The method according to claim 22, further comprising the steps of: c. deflating the inflation means of the inflatable dilation device resulting in the patient's orifice returning to its original size; and d. removing the inflatable dilation device from the patient.

24. The method according to claim 22, further comprising the step of: c. delivering a drug to the patient's orifice through a drug delivery system integrally connected with the inflation means.

25. The method according to claim 22, wherein the inflation means comprises: a means for introducing air into the elongated hollow tube, and a tubular balloon having an inner surface, an outer surface and a length, the elongated hollow tube being integrally connected to the inflation means and the tubular balloon such that air passing through the elongated hollow tube from the means for introducing air inflates the tubular balloon.

26. The method according to claim 25, wherein the inflation means further comprises one or more supports connecting the inner surface and the outer surface of the tubular balloon, thereby creating a plurality of internal compartments, such that when the tubular balloon is inflated, the inner surface moves in relation to the outer surface resulting in the access aperture having the larger diameter.

27. The method according to claim 26, wherein the second end of the elongated hollow tube connects to the tubular balloon along the length of the tubular balloon and accesses each internal compartment.

28. The method according to claim 26, wherein each support has an aperture and the second end of the elongated hollow tube connects to the tubular balloon at one internal compartment.

29. The method according to claim 25, wherein the means for introducing air into the elongated hollow tube comprises a bulb and a valve.

30. The method according to claim 25, wherein the means for introducing air into the elongated hollow tube comprises a syringe connector integrally connected to the first end of the elongated hollow tube and a syringe.

31. The method according to claim 22, wherein the patient's orifice is a woman's cervix.

32. The method according to claim 24, wherein the inflation means comprises: a means for introducing air into the elongated hollow tube, and a first tubular balloon having an inner surface, an outer surface and a length, the elongated hollow tube being integrally connected to the inflation means and the first tubular balloon such that air passing through the elongated hollow tube from the means for introducing air inflates the first tubular balloon; and the drug delivery system comprises: a second elongated hollow tube having a first end and a second end; a means for introducing the drug into the first end of the second elongated hollow tube; and a second tubular balloon having an inner surface, a perforated outer surface and a length, wherein the inner surface of the second tubular balloon is integrally connected to the outer surface of the first tubular balloon; wherein the second elongated hollow tube is integrally connected to the means for introducing the drug and the second tubular balloon such that the drug passing through the second elongated hollow tube enters the second tubular balloon, passes through the perforated outer surface, and contacts the patient's orifice.

33. The method according to claim 32, wherein the inflation means further comprises one or more supports connecting the inner surface and the outer surface of the first tubular balloon, thereby creating a plurality of internal compartments, such that when the first tubular balloon is inflated, the inner surface moves in relation to the outer surface resulting in the access aperture having the larger diameter.

34. The method according to claim 33, wherein the second end of the elongated hollow tube connects to the first tubular balloon along the length of the first tubular balloon and accesses each internal compartment.

35. The method according to claim 33, wherein each support has an aperture and the second end of the elongated hollow tube connects to the first tubular balloon at one internal compartment.

36. The method according to claim 32, wherein the means for introducing air into the elongated hollow tube comprises a bulb and a valve.

37. The method according to claim 32, wherein the means for introducing air into the elongated hollow tube comprises a syringe connector integrally connected to the first end of the elongated hollow tube and a syringe.

38. The method according to claim 32, wherein the patient's orifice is a woman's cervix.

39. The method according to claim 32, wherein the means for introducing the drug into the second elongated hollow tube comprises a syringe connector integrally connected to the first end of the second elongated hollow tube and a syringe.

40. The method according to claim 32, wherein the perforated outer surface of the second tubular balloon comprises a plurality of apertures through which the drug is delivered to the patient's orifice.

41. The method according to claim 24, wherein the drug is an anesthetic drug.

42. The inflatable dilation device according to claim 24, wherein the patient's orifice is a woman's cervix