Transparent dilator device and method of use (end-900)

The present invention relates to a transparent dilator device for use in a lumen of a patient\'s body.

Constriction of natural body lumens, such as those of the human gastrointestinal tract, can occur in numerous ways. Some strictures are caused by muscular spasm, others by disease, and others by injury. Regardless of the cause, the typical method of treatment is to physically dilate the region using a medical device designed for that purpose.

Several types of devices are used for dilation. One generally established type is a bougie. Bougie tubes may be in the form of a mercury- or tungsten-filled tube with a tapered end that gradually opens the strictured esophagus as it is pushed past the treatment site. These devices come in a series of increasing sizes, each tube having a single effective dilating diameter, generally between 10 and 60 French. (French is a measure of circumference based on the diameter in millimeters, mm.) The bougie is typically introduced blindly after the physician has judged the proper beginning size with an endoscope. Some physicians follow a rule of thumb not to dilate a stricture more than three successive French sizes (3 mm) in a single session. If the lumen has not satisfactorily been opened after three sizes, the patient returns at a later time for another treatment session.

Another type of device is a wire-guided dilator. These devices are passed into the patient over a guidewire that has been pre-fed along a lumen of the gastrointestinal tract. The guidewire keeps the tip of the device in the lumen while it is being passed, to avoid perforating through the wall of the lumen. These devices have a single outer dilating diameter and typically have a radiopaque component so that they are visible under fluoroscopy. The following patent documents disclose various devices in the art: U.S. Pat. No. 5,366,471; U.S. Pat. No. 6,334,863; U.S. Pat. No. 5,766,202; and GB 2023009A.

A third type of dilating device is a balloon. Balloon dilators may be comprised of polyethylene, and may be introduced through the working channel of an endoscope. The physician views the proximal end of a stricture site with an endoscope and introduces the deflated balloon into the narrowed area. The balloon is then inflated with saline or other fluid to effectively open the stricture site pneumatically. Balloons provide the advantages of multiple dilator diameters with a single intubation, passage through the working channel of an endoscope, and visualization of a stricture site from the proximal end.

Other devices such as double tapered bougies, pneumatic bougies, illuminating bougies, solid dilator devices attached to the distal end of an endoscope, and variable stiffness dilators have been previously described in the art. The following patent documents disclose various types of devices in the art: U.S. Pat. No. 6,010,520; U.S. Pat. No. 4,832,691; U.S. Pat. No. 5,624,432; U.S. Pat. No. 5,718,666; WO 98/47422.

Applicants have recognized the need for a relatively low cost dilator (disposable or non-disposable) which is relatively easy and convenient to use, and which allows the physician to directly visualize the stricture being dilated. In one embodiment, the present invention provides a medical device for use in dilating a body lumen. The medical device comprises at least one generally transparent segment, and a channel associated with the transparent segment for receiving a visualization device. The transparent segment includes at least one outer surface having a diameter sized for providing dilation. In one embodiment, the device can comprise a plurality of transparent sections, each section having an outer surface portion with a different diameter sized for sequential dilation of a stricture. The medical device can include at least one marking associated with the transparent segment for indicating the position and/or value of a dilation diameter.

The present invention also provides a method for dilating a portion of a body lumen. In one embodiment, the method can comprise the steps of providing a medical device having at least one outer surface portion sized for providing dilation of a body lumen; inserting said outer surface portion into said lumen; advancing said outer surface portion in said lumen to dilate said lumen; and viewing dilation of said lumen through said outer surface portion of said medical device, such as by viewing the body lumen with a visualization device positioned within a channel in the medical device. The step of viewing dilation can comprise viewing the lumen through a transparent segment of device, wherein the transparent segment includes multiple outer diameters sized and arranged for sequential dilation.

BRIEF DESCRIPTION OF THE DRAWINGS

While the novel features of the invention are set forth with particularity in the appended claims, the invention in all its embodiments may be more fully understood with reference to the following description and accompanying drawings.

FIG. 1 is a side view of wire-guided dilator 10, described in prior art, including a guidewire channel 13, a first radiopaque marker 14, and a second radiopaque marker 15.

FIG. 2 is a side view of a first embodiment of the present invention, a dilator 18 which includes a handle 19, a tube 20, a transparent segment 21, and a tapered tip 22.

FIG. 3 is a sectional view of dilator 18 from FIG. 2 with an endoscope 50 inside a body lumen 60, proximal to a stricture 61.

FIG. 4 is a detailed view of transparent segment 21 and tapered tip 22 shown in FIG. 2, including a first outer diameter D1, a conical inner contour 32 inside tapered tip 22, an exterior taper angle theta1, and a narrow leading edge 34.

FIG. 5 shows a detail view of a preferred embodiment of transparent segment 21, including a second outer diameter D2, a third outer diameter D3, a plurality of markings 43, and at least one transition 44.

FIG. 6 shows endoscope 50 inside a cross section view of dilator 18 shown in FIG. 5, taken at line 6-6, including a field of view 52.

FIGS. 7A-7D illustrate steps which can be performed in using dilator 18 with an endoscope 50. FIG. 7A) is a sectional view of dilator 18 from FIG. 5 and field of view 52 of endoscope 50 positioned for advancement into body lumen 60 to a stricture 61. FIG. 7 B) is a sectional view of dilator 18 from FIG. 5 and field of view 52 of endoscope 50 positioned at first viewpoint 53 dilating to first outer diameter D1. FIG. 7 C) is a sectional view of dilator 18 from FIG. 5 and field of view 52 of endoscope 50 positioned at second viewpoint 54 dilating to second outer diameter D2. FIG. 7 D) is a sectional view of dilator 18 from FIG. 5 and field of view 52 of endoscope 50 positioned at third viewpoint 55 dilating to third outer diameter D3.

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