Patent Description:
Surgical Gynecologycal procedures refer to medical surgery or interventions on the female reproductive system. A dilator, medical (surgical) device, is used to expand a closed, stenotic or otherwise small opening or passage such as cervix, urethra, esophagus, rectum or vaginal introitus during procedure(s) or for treatment(s). The Dilators available currently in the industry are essentially metallic or plastic and have encountered several limitations. They require (re)sterilization, a process that removes, kills r deactivates all forms of life. The dilators available need additional, skilled assistance for instrumentation, a trained and skilled medical assistant or nurse which can be quite costly and not time efficient. The dilators available come in increasing sizes and require multiple instrumentation to achieve a desired opening; therefore, increased risk for trauma ( require stabilization by uterine tenaculum), increased operating time and anesthetic dosage. Often times metallic dilators cannot open a closed cervix and procedures risk to be canceled after induction of anesthesia. The force exerted from the present dilators can cause trauma to cervical canal and even perforate uterus, which require additional medical treatments, hospitalization, increased cost. Other available dilators require complex and expensive methodology (eg. Balloon dilators) or and need long time to achieve a dilated state (eg. Osmotic cervical dilator or laminaria).

An exemplary prior art dilator is known from <CIT>, which comprises:a tubular member of a flexible material forming a channel when in an open state, a plurality of wires extending inwardly from an interior of the tubular member into the channel, a string attached, centred, passing through to the plurality of wires and extending through the channel; and a handle attached to the string, wherein pulling the handle applies force to the string and wherein the tubular member in a recoiled state provides for dilation of a canal.

An objective of the present invention is to provide a disposable dilator that allows a user to utilize it without need for re-sterilization, during gynecological but also related medical procedures that encounter a stenotic orifice that needs opening for passage of instruments or visualization. ( eg rectal instrumentation, urethra instrumentation). Another objective is to provide a dilator that has a soft expandable outer structure that poses no mechanical traumatic risk to anatomical structures. Another objective is to provide a dilator with an inner metallic core that comprises a plurality of elastic wires that are restricted to expand in neutral position by a centered metallic string. The user can releasethe elastic wires to expand into the softer external material by simply pulling the metallic string out. The metallic string is the center piece of the invention and when triggered can activate the present invention to dilate and open the cervix or similar anatomical structures as exemplified above( urethra, anal canal). Once the elastic wires are released from the central string, the present invention provides a through-hole that allows passageof hysteroscope or other medical devices not limited to curets, suction catheter, uterine measuring devices, polyp baskets or scissors (urethroscope, rectoscope). The proposed invention is simple in construction, relatively inexpensive to fabricate and exhibits increased utility compared to present dilators.

The novel features believed characteristic of the embodiments of the present application are set forth in the appended claims. However, the embodiments themselves, as well as a preferred mode of use, and further objectives and advantages thereof, will best be understood by reference to the following detailed description when read in conjunction with the accompanying drawings, wherein:.

While the dilator of the present application is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular embodiment disclosed, but on the contrary, the intention is to cover all modifications and alternatives falling within the scope of the appended claims.

Illustrative embodiments of the device and a non-claimed method of use of the present application are provided below. It will of course be appreciated that in the development of any actual embodiment, numerous implementation-specific decisions will be made to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

The device and the non-claimed method of its use will be understood, both as to its structure and operation, from the accompanying drawings, taken in conjunction with the accompanying description. Several embodiments of the device are presented herein. It should be understood that various components, parts, and features of the different embodiments may be combined together and/or interchanged with one another, all of which are within the scope of the present application, even though not all variations and particular embodiments are shown in the drawings. It should also be understood that the mixing and matching of features, elements, and/or functions between various embodiments is expressly contemplated herein so that one of ordinary skill in the art would appreciate from this disclosure that the features, elements, and/or functions of one embodiment may be incorporated into another embodiment as appropriate, unless described otherwise.

The preferred embodiment herein described is not intended to be exhaustive or to limit the invention to the precise form disclosed. It is chosen and described to explain the principles of the invention and its application and practical use to enable others skilled in the art to follow its teachings.

The present invention provides a disposable and pass-through anatomical (cervical) dilator. The present invention will allow users to dilate the uterine cervix (also anal canal and urethra) without trauma, without extraordinary skilled training, without need for re-sterilization, without requiring a complex operating surgical environment (hospital or ambulatory surgical center), in a time efficient and sterile medical office setting.

In the contemplated embodiment, as shown in <FIG>, the present invention includes a dilator <NUM> having the core components of a tubular member <NUM> that forms a channel <NUM> which is obstructed via a plurality of wires <NUM> when not in a dilated configuration (see <FIG>) and is unobstructed by the plurality of wires <NUM> when in a dilated/recoiled configuration (see <FIG>), a string <NUM>, and a handle <NUM>. As shown, the string <NUM> extends into the channel <NUM> and is engaged with the plurality of wires. This allows for the user to remove the string, such that the wires retract against the tubular member to provide dilation as discussed below.

In <FIG>, a flowchart <NUM> depicts a non-claimed method of use of the dilator <NUM>. During use, the tubular member <NUM> is inserted into a patient's cervix, cervical canal, or uterine opening (or anal canal or urethra) and provides a passageway (channel <NUM>) for other surgical devices such as hysteroscope, a curette, a rectoscope, a suctioning catheter, polyp scissors, basket, etc., as shown with boxes <NUM>, <NUM>. Next, the string <NUM> can be pulled out to trigger the expansion and opening of the tubular member, as shown with box <NUM>. The handle allows for the user to manipulate the string, such as to pull the string downward and out of the canal, such as to release inner metallic elastic wires <NUM> into expansion, as shown with box <NUM>. This causes the wires to exert force against the interior of the tubular member to create a predetermined dimension of the tubular member within the canal and thereby dilate the canal.

Depending on the needed use, the string <NUM>, which in the preferred embodiment is composed of reinforced blunt coil, can be first pushed up towards the uterine fundus to sound (measure the depth of) the uterine cavity, as shown with box <NUM>.

The string can be made of metallic material not limited to nitinol with a blunt tip and measuring lines along the length of it. The string is attached to the tubular member in neutral position with the help of a locking clip <NUM> situated at the distal posterior midline of the tubular member. By unlocking the string (simply pulling it out of the lock), it becomes free to move inside the tubular member up towards the inside of the uterine cavity (or rectum or bladder) or downward releasing the metallic elastic wires into expansion.

It should be appreciated that the dimensions of the various components can vary as determined according to the targeted anatomical orifice (stricture) to dilate. For uterine cervix suggested dimensions (which can be adjusted according to results from clinical trials) and design of invention are <NUM>-<NUM> diameter at the tip and <NUM>-<NUM> diameter at the distal base where the handle and the string are attached with a to be determined length. The conical design allows a smaller proximal end to open strictures or closed anatomical passages otherwise meant to be open, like the uterine cervix (but also anal canal or urethra) non traumatic. Also allows the distal larger base to be handled by the user with ease.

Referring to <FIG>, a cross sectional view taken from <FIG> at line <NUM>, of the tubular member <NUM> is shown. The tubular member <NUM> can include a metallic core <NUM> that accommodates the plurality of elastic wires <NUM>, which in some embodiments is composed of nitinol. The metallic core <NUM> and the elastic wires <NUM> can optional be made of any other materials (eg. Biodegradable) that fit the description of present embodiment, The wires <NUM> may be composed of very fine nitinol with a pre-determined tension strength and size such that when open, they release and expand at a pre-determined distance. (Young Modulus Factors). The tension strength can be progressively increased or decreased from tip of the invention to base such that in expanded position the invention assumes a cylindrical shape allowing free pass through of medical instruments.

In <FIG>, the plurality of wires <NUM> are shown and are centered and held together by the string, when the invention is in the closed, inactivated position. The wires are equal distributed across the radius and length of the tubular member and overlap. In open, dilated, active position the wires recoil into a stretched curvilinear position which form the tubular structure with a pass-through opening.

In the preferred embodiment, the outer surface of the tubular member is made of highly compressed absorbent material which has a natural resiliency, and which when wet with fluid will tend to expand in an attempt to regain its initial shape without a strong adherence to the body tissues (similar to a "vaginal tampon material" as for example described in this patent <CIT> / <CIT>/ <CIT>). The outer, external surface of the invention, that comes in contact with the cervix is soft and has a smooth surface and can be provided with a plurality of pleats disposed around its cross- section that are capable of opening in an external direction (towards the cervix, pushing the cervix out into an open position) by the plurality of metallic wires when triggered (when removing the central string down and out of the cervix). The plurality of smooth outer pleats can be inverted to match with the plurality of inner elastic metallic wires. When the elastic wires are released and stretched to a dilated position, they will push the inverted plurality of the soft resilient outer material expanding them towards the anatomical orifice e.g. uterine cervix. The softer external material of the invention can potentially be medicated as needed or desired or silicon coated. The softer part of the invention may encompass a composite or a combination of materials (not limited to cotton, rayon, regenerated cellulose, resilient foam).

In <FIG> and <FIG>, the mechanism of pulling on the string <NUM> is shown. As shown, by pulling on the string, by the handle <NUM>, the plurality of elastic wires <NUM> are released from inside of the tubular member and recoil to the outer surface expandable material to a predetermined dimension, dilating the cervical canal. The plurality of elastic wires, once released, pushes against the plurality of pleats of the expandable outer soft material with equally distributed forces. In the preferred embodiment, the string is made of metallic
materials, nitinol, or reinforced blunt coil, although any desired materials may be used. In the preferred embodiment, the handle107 is attached to one (distal) end of the string and provides a circular structure (to allow a finger position and manipulation of device), although any desired design may be used.

In <FIG>, a cross sectional view taken from line <NUM> of <FIG> shows the dilator in the dilated configuration, such that the channel <NUM> is open.

As stated above, when the dilator <NUM> is in an open configuration, it allows for the free insertion of surgical devices. As shown in <FIG>, the present invention can be twisted or crumpled from the base of the handle to <NUM>. (Un twisted )Activate the device and release the string out of the elastic wires or to <NUM>. (Twisted)Minimize size before insertion into cervix or before disposing and removal out of the cervical canal at the end of the procedure. Also, the invention can be extracted together with the hysteroscope or other medical device at the end of the procedure.

In <FIG>, the string <NUM> can also be a reinforced coil with a blunt proximal end <NUM>, towards the uterine cavity, that can serve as an instrument to sound (measure) the uterus as it is first (pushed up and) unhooked from the metallic core. Then the string in the present invention, after measuring the uterine cavity (if necessary) is pulled down and out of cervical canal to release the plurality of elastic wires into the outer softer material to the expanded hollow tubular configuration. Once pulled out of the inner metallic core the string can be attached via a locking clip <NUM> to the base of the tubular expanded configuration, towards the distal end facing the outer cervix to allow manual control of the invention inside the cervical canal and uterus. In present embodiment the blunt proximal tip of the string( facing the inside of uterine cavity) can be designed as a hook <NUM> attached to the very last coil of metallic elastic tubular material; once the invention is manually triggered to open by untwisting the base of the distal part of the tubular component (base) and or pushing the string up, the tip of the string disengages from the elastic coil, to a straight upward position ready to pass up towards the uterine cavity for measurements or down through the elastic coils releasing them to an expanded, open tubular pass through dilated position. The tip of the string can very well be straight when the string is attached to the base by the locking clip. The shape and consistency of the tip of the string can encompass a multitude of forms and materials and is not limited to the description of present embodiment. The twisting of the base, distal part of the present invention, will allow compressing of the expanded tubular dilator, if needed at the end of the surgical procedure for removal and disposal. In present embodiment the tubular structure can appear twisted around the string in inactive compressed state and untwisted once the string is ready to be removed or already released out of the metallic coils into an active dilated position. Twisting of the tubular member around the string it is just a variant and not a mandatory part of the invention.

In <FIG>, a front view depicts the dilator <NUM> having the string <NUM> supported by a locking clip <NUM>. In the preferred embodiment the locking clip <NUM> is composed of a plastic but any other material can be used. The locking clip can contain the string by pushing in or release the string by pulling out.

The size and shape of the invention can be as depicted in <FIG>, conical with one smaller end (minimal size <NUM>-<NUM> allowing passage through stenotic, closed cervix free of trauma) to be inserted into the cervix and an opposite larger base attached to the handle for hand instrumentation and advancement inside the cervix. (<NUM>-<NUM>).

In present embodiment of the invention the string can be marked down from the tip all the way to the handle in inches or cm to allow precise measurements of the uterine cavity if such need is intended for the use of the invention.

Claim 1:
A dilator (<NUM>), comprising:
a tubular member (<NUM>) composed of a flexible material, the tubular member (<NUM>) forming a channel (<NUM>) when in an open state;
a plurality of wires extending inwardly from an interior of the tubular member (<NUM>) into the channel (<NUM>);
a string (<NUM>) attached, centered, passing through to the plurality of wires and extending through the channel (<NUM>) ; and a handle (<NUM>) attached to the string;
wherein pulling the handle (<NUM>) applies force to the string;
wherein the tubular member (<NUM>) in a recoiled state of the wires provides for dilation of a canal,
characterized in that in use force applied to the string (<NUM>) causes the string (<NUM>) to disengage and release from the plurality of wires such that the plurality of wires recoils against the interior of the tubular member (<NUM>) such that the tubular member (<NUM>) takes on a diameter of a predetermined dimension.