WO2016040610A1 - Vaginal dilator - Google Patents

Abstract

Vaginal dilators include an incrementally inflatable, optionally curved balloon mounted onto a flexible, elongated shaft having a soft rubber tip.

Description

VAGINAL DILATOR

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of and priority to U.S. Provisional Application Serial No. 62/049,702 filed September 12, 2014, the entire contents of which are incorporated herein by reference.

BACKGROUND

[0002] In medical practice, dilation of the cervix may be necessary prior to performing certain surgical techniques. One dilation technique involves the use of a series of solid, rodlike instruments of graduated diameter used in a serial fashion. This is usually accompanied by a distressing amount of pain and discomfort for the patient. Another, less painful dilation technique involves the use of an inflatable device. The inflatable device is positioned in the body opening and inflated. Upon inflation, the device expands into contact with, and exerts pressure against the walls of the vaginal canal causing dilation.

[0003] There remains room for improvement in inflatable dilation devices.

SUMMARY

[0004] The present disclosure relates to vaginal dilators and methods of utilizing same in a treatment program. The present vaginal dilators include a balloon mounted onto a flexible, elongated shaft. The balloon is incrementally inflatable. Inflation may be radially incremental, or incremental in the proximal to distal direction. In embodiments, the present vaginal dilators include a soft rubber tip to avoid unintended damage to internal body tissues. In embodiments the balloon of the present vaginal dilators is curved.

[0005] Further scope of applicability of the present disclosure will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating specific embodiments of the present disclosure, are given by way of illustration only, since various changes and modifications within the spirit and scope of the present disclosure will become apparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:

[0007] Fig. 1 is a side view of an exemplary dilation device in accordance with one embodiment of the present disclosure with the balloon collapsed for insertion into a body cavity;

[0008] Fig. 1A is a detail of the collapsed balloon of the exemplary dilation device of Fig.

1;

[0009] Fig. 2 is a side view of the exemplary dilation device of Fig. 1 with the balloon partially inflated;

[0010] Fig. 2A is a detail of the partially inflated balloon of the exemplary dilation device of Fig. 1;

[0011] Fig. 3 is a side view of the exemplary dilation device of Fig. 1 with the balloon fully inflated;

[0012] Fig. 3A is a detail of the fully inflated balloon of the exemplary dilation device of

Fig. 1;

[0013] Fig. 4A is a side view of an exemplary dilation device in accordance with one embodiment of the present disclosure with the balloon partially inflated; [0014] Fig. 4B is a side view of the exemplary dilation device of Fig. 4A with the balloon more inflated that in Fig. 4A;

[0015] Fig. 4C is a side view of the exemplary dilation device of Fig. 4A with the balloon more inflated that in Fig. 4B;

[0016] Fig. 5 is a side view of an exemplary embodiment of a curved balloon useful in connection with dilators in accordance with the present disclosure;

[0017] Fig. 6 is a side view of an exemplary dilation device in accordance with another embodiment of the present disclosure; and

[0018] Fig. 6A is a detail of the fully inflated balloon of the exemplary dilation device of

Fig. 6.

[0019] The figures depict specific embodiments of the present disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the present disclosure described herein.

DETAILED DESCRIPTION

[0020] Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary and may be embodied in various forms. Well- known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. [0021] Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term "proximal" refers to the end of the apparatus which is closer to the user and the term "distal" refers to the end of the apparatus which is farther away from the user. The term "clinician" refers to any medical professional (i.e., doctor, surgeon, nurse, or the like) performing a medical procedure involving the use of embodiments described herein.

[0022] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. The word "example" may be used interchangeably with the term "exemplary."

[0023] The exemplary embodiments of the present disclosure relate to a dilator that can be used to dilate portions of the vaginal canal by directly exerting pressure on the vaginal canal upon inflation. Those having ordinary skill in the art will understand that the exemplary embodiments of the present disclosure can be implemented in any cavity in the body of a patient (e.g., the rectum, the nose, the lungs, the GI track, vascular system, the esophagus, etc).

[0024] Figure 1 shows a side view of an exemplary dilator apparatus 100 according to an exemplary embodiment of the present disclosure in an uninflated form. Exemplary dilator 100 has a distal or treatment portion 105 configured to be inserted into the vaginal canal, a flexible elongated shaft 115, a proximal portion 125, and a hub 130 positioned between the proximal end of flexible elongated shaft 115 and proximal portion 125.

[0025] Distal portion 105 can include a tip 140 which can be configured to aid in the insertion of applicator 100 into the vaginal canal. For example, tip 140 can taper distally to a width smaller than the width of distal portion 105, and can increase in size proximally. In embodiments, tip 140 is made from a soft material (such as, for example, a soft rubber or a soft foam) that will not damage tissue upon insertion of dilator 100. In addition, tip 140 may also provide a marker that is visible to an imaging system (such as, for example, MRI, x-ray, fluoroscopy and/or ultrasound, not shown) to confirm accurate placement of the balloon 120 relative to tissue to be dilated. Optionally, a lubricant (e.g., liquid, gel or the like), may be used to aid insertion of tip 140 into the vaginal canal.

[0026] A balloon 120 is located on distal portion 105. The distal end of balloon 120 is mounted to shaft 115 such that the seal 122 is within balloon 120, while proximal end of balloon 120 is mounted on shaft 115 such that the seal 124 is outside balloon 120. Distal seal 122 is positioned within balloon 120 by inverting the distal end of balloon 120 and securing the inverted portion to shaft 115 by any conventional means (such as, for example, adhesive or welding). This attachment technique results in a configuration at the distal end of balloon 120 that is different from the configuration at the proximal end of balloon 120 upon inflation as seen in Fig. 3A. The configuration of the distal end of balloon advantageously allows the wall of balloon 120 to be positioned directly up against the cervix. Generally, the size of balloon 120 will be tailored to the size of the vaginal canal into which the dilator is being inserted. Generally, balloon 120 may be from 0.1 cm to 10 cm in diameter, in embodiments from 1 cm to 5 cm in diameter, and 5 to 20 cm long, in embodiments 8 to 12 cm long. In embodiments where the dilator is intended for insertion into the cervix, balloon 120 may be from 2 cm to 6 cm in diameter when inflated. Balloon 120 can be fabricated from any biocompatible material capable of inflation. In embodiments, the material from which balloon 120 is constructed is elastic. The material from which balloon 120 is constructed may be a single layer or may be a laminate material. Those skilled in the art will readily envision suitable materials for use in making balloon 120. [0027] There is no requirement that balloon 120 be of any particular shape only that it be capable of engaging and dilating the desired anatomical structure. Balloon 120 may incorporate various inflated configurations and may even be segmented, to provide differing shapes along its length. In the exemplary embodiments shown in Figs. 1-4, balloon 120 is generally cylindrical. In another exemplary embodiment shown in Fig. 5, balloon 320 is curved, having a shorter side 322 and a longer side 324. In yet another exemplary embodiment shown in Figs. 6 and 6A, balloon 420 includes a generally cylindrical proximal portion 426 and a bulbous distal portion 428. Those skilled in the art reading this disclosure will envision other suitable shapes for the balloon. As those skilled in the art will appreciate, the configuration of the balloon upon inflation may be tailored by either the physical shape of the balloon material or by altering the characteristics of the material from which the balloon is made (e.g., thickness, durometer, etc.), or both.

[0028] Elongated shaft 115 is sufficiently stiff to facilitate insertion into the vaginal canal, but flexible enough to permit easy navigation of the contours of the anatomy once inserted. Shaft 115 may include one or more markers 117 that are visible to an imaging system (such as, for example, MRI, x-ray, fluoroscopy and/or ultrasound, not shown) to confirm accurate placement of the dilator relative to tissue to be dilated. Elongated shaft 115 may also or instead include one or more numerical indicia (not shown) to indicate to the clinician the depth to which dilator 100 has been inserted into the vaginal canal. Generally, elongated shaft 115 may be from 10 cm to 70 cm in length, in embodiments from 20 cm to 50 cm in length.

[0029] To inflate balloon 120, an inflation lumen 126 is in fluid communication with the interior of balloon 120 for introduction of fluid into, and withdrawal of fluid out of balloon 120.

Inflation lumen 126 is provided with a stopcock valve 127 at the proximal end thereof. Inflation lumen 126 begins at stopcock valve 127, extends distally and is received within hub 130. Inflation lumen 126 extends through hub 130, and continues along the length of flexible elongated shaft 115 to distal portion 105 of dilator 100 where the distal end of inflation lumen 126 opens into balloon 120. Generally, from stopcock valve 127 to hub 130, lumen 126 may be from 10 cm to 70 cm in length, in embodiments from 25 cm to 50 cm in length.

[0030] Inflation fluid may be provided to inflation lumen 126 via supply line (not shown) attached at one end to stopcock valve 127 and at the other end to a source or reservoir of fluid (not shown). A conventional means for moving the inflation fluid (not shown) may also be provided, such as a syringe or an electric pump. Inflation fluid may be any suitable fluid, either a gas or a liquid, and is typically inert. Inflation fluid, where a gas, may be, e.g., air, nitrogen, carbon dioxide or other gas. Inflation fluid, where a liquid, may be water, saline, mineral oil, or other liquid.

[0031] In use, dilator 100 (with balloon 120 in a deflated state) is inserted into a patient's body until the balloon is within the anatomical structure to be dilated (e.g., the cervix). Once properly positioned, balloon 120 is inflated by the introduction of inflating fluid.

As balloon 120 is filled with fluid, it expands radially outwardly under pressure until it presses into contact the anatomical structure. The amount of pressure exerted against the anatomical structure depends upon the amount of fluid pumped into balloon 120. The amount of fluid pumped in should be sufficient to produce a predetermined pressure against the anatomical structure contacted. The amount of fluid pumped in and the time that the resultant inflated balloon 120 is permitted to remain in contact with the anatomical structure is selected such that a predetermined desired degree of dilation of the anatomical structure is obtained. This degree of dilation should be selected so that the vaginal tissues are gently stretched, preferably with minimal or no pain. By retaining the inflating pressure within balloon 120 via stopcock valve 127, the outer wall of balloon 120 retains its expanded position. Once the desired degree of dilation is achieved, balloon 120 is deflated by allowing the inflating fluid to flow out through stopcock valve 127, and dilator 100 is withdrawn from the patient's body.

[0032] In embodiments, balloon 120 is inflated in a manner that provides incremental expansion. As seen in Figs. 1A, 2A and 3A, incremental expansion may be radial incremental expansion, where initial inflation results in a first diameter (e.g., 2 cm) and continued supply of inflating fluid results in expansion to a second diameter (e.g., 4 cm). Inflation may be stopped and balloon 120 maintained at any desired diameter by closing stopcock valve 127 to maintain the inflating fluid within balloon 120, and thus maintain dilating pressure against the anatomical structure being dilated. After a period of time, additional inflating fluid may be provided to balloon 120, incrementally increasing the diameter of balloon 120. After dwelling at that second, larger diameter for a sufficient time to effectuate dilation, additional inflating fluid may be provided to balloon 120, again incrementally increasing the diameter of balloon 120. This process is repeated until balloon 120 reaches its maximum diameter, or until the desired degree of inflation is achieved.

[0033] As seen in Figs 4A, 4B and 4C, in embodiments expansion may be incremental in a proximal to distal sense. Thus, in Fig. 4A, initial inflation results in expansion of a proximal portion of balloon 220. Continued supply of inflating fluid results in expansion of the center portion and, ultimately the distal portion of balloon 220.

[0034] As those skilled in the art will appreciate, the manner in which the balloon inflates upon introduction of inflating fluid may be tailored by either the physical shape of the balloon material or by altering the characteristics of the material from which the balloon is made (e.g., thickness, durometer, etc.), or both. [0035] While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of presently disclosed embodiments. Thus the scope of the embodiments should be determined by the appended claims and their legal equivalents, rather than by the examples given.

Claims

What is claimed is:

1. A vaginal dilator comprising

an elongate flexible shaft having a soft distal tip;

an inflatable balloon positioned on a distal portion of the elongate flexible shaft proximal of the soft distal tip,

an inflation lumen extending through the elongate flexible shaft and into and in fluid communication with the inflatable balloon;

the inflatable balloon configured for incremental expansion.

2. A method of vaginal dilation comprising

inserting into the vaginal canal of a patient a vaginal dilator in accordance with claim 1; introducing a first amount of fluid into the balloon to expand the balloon to a first size; and

incrementally expanding the balloon to a second size by introducing additional fluid into the balloon.

3. The method of claim 2, wherein incrementally expanding the balloon comprises radially expanding the balloon incrementally.

4. The method of claim 2, wherein incrementally expanding the balloon comprises expanding the balloon incrementally from a proximal end to a distal end of the balloon.