Patent Description:
The present invention relates more generally to a device for inspecting an internal cavity of a patient, to be understood as a natural cavity, for example an anal and/or vaginal cavity, or an artificial cavity fashioned by a surgeon.

Hereinafter precise reference will be made to the field of coloproctology, i.e. to devices such as anoscopes, proctoscopes or rectoscopes, although the present invention can have other surgical applications.

The use of proctoscopes as instruments for investigating the mucosa of the anal canal of a patient is known. Such instruments generally comprise a hollow dilator body, insertable into the anal canal of the patient and provided with a front opening in order to visually access the mucosa of the anal canal. The dilator body is provided at the rear with a gripping handle and is further provided, on its rear flange, with suitable coupling members for an adaptor body which is configured to support a camera. During use, the camera takes images of the mucosa through the internal cavity of the dilator body and through the front opening.

Proctoscopes of a traditional type are designed for solely diagnostic purposes, i.e. for taking images of the mucosa, and are therefore not compatible with surgical applications that require a surgeon to access the internal cavity of the dilator body. Such access, in proctoscopes of the above-described type, is precluded by the fact that the camera and the adaptor body occlude the rear access opening, preventing the insertion of any type of surgical instrument (for example, an electrosurgical unit).

Therefore, in the event of surgical implications, the surgeon is obliged to remove the camera and the adaptor. Besides complicating the procedure and introducing risks of contaminating the surrounding environment with the patient's fluids (the camera is removed while the proctoscope is still inserted in the patient's anal canal), this precludes documenting the operation by capturing images or videos. A proctoscope that is designed for diagnostic and surgical purposes is disclosed in prior art document <CIT>. Said document teaches a protoscope according to the preamble of claim <NUM> which is compatible with surgical applications that require the surgeon to access the internal cavity of the dilator body in the presence of a camera coupled to the proctoscope.

The task of the present invention is thus to provide a proctoscope that is free of the above-mentioned drawbacks.

In particular, it is an object of the invention to provide a proctoscope that has a high flexibility of use.

This object is substantially achieved by a proctoscope having the features set forth in one or more of the appended claims.

A preferred, but not exclusive, embodiment of a proctoscope in accordance with the present invention will now be illustrated by way of non-limiting example.

With reference to the appended <FIG> denotes a proctoscope in its entirety. The present invention may also be extended in a more general form to a device for inspecting an internal cavity of a patient, without going outside the claimed scope of protection.

Internal cavity means a natural cavity, for example an anal and/or vaginal cavity, or an artificial cavity fashioned by a surgeon.

Hereinafter in the description, use will be made of the terms "distal" and "proximal". In this context, such terms mean relative to the user; therefore, the term "proximal" means turned toward the "rear" parts of the device, farther from the patient, whilst the term "distal" means at the "front" parts, closer to the patient.

The proctoscope <NUM> comprises a dilator body <NUM>, having a longitudinal axis of extension "X" and internally hollow so as to define an internal volume "V". The internal volume "V" is accessible from a front opening <NUM>, with a substantially circular edge and preferably centred on the axis "X", and is further accessible from the rear through a rear opening <NUM>, as may be seen in <FIG>.

The dilator body <NUM> has a distal portion 2a, defining the aforesaid front opening <NUM> at the front thereof and having a substantially tubular shape (a cylindrical or slightly truncated cone shape or tapered towards the distal end thereof) for defining an zone of dilation of a cavity of a patient, and a proximal portion 2b extending from the distal portion 2a in a diverging fashion and defining said rear opening <NUM>.

The proctoscope <NUM> further comprises at least one handle <NUM> applied to the dilator body <NUM>, in particular to a lower part of the rear edge of the proximal portion 2b.

Said diverging proximal portion 2b has, in the embodiment illustrated in the appended <FIG>, an anchorage means <NUM> for an adaptor body <NUM> (which can be seen in <FIG> and <FIG>) and suitable for connecting a detection device <NUM> (which can be seen in <FIG>), in particular a camera, to the proctoscope <NUM>. The anchorage means <NUM> (for example of the snap-fit type) and the adaptor body <NUM> may have, in their essential features, a structure of a known type. With regard to the adaptor body <NUM>, a particular feature according to the invention is that it has two opposing axial protrusions <NUM> configured to engage with corresponding regions of the diverging proximal portion 2b of the dilator body <NUM>, in particular in proximity to the handle <NUM> and a region opposite the longitudinal axis of extension "X", as may be seen in <FIG> and <FIG>.

In a further variant illustrated in <FIG>, the aforesaid anchorage means <NUM> is connected to the at least one handle <NUM> and comprises coupling protrusions 6a in the lower part and a curved adaptor body <NUM> in the upper part, the adaptor body <NUM> being suitable for supporting a detection device <NUM>, in particular a camera.

The dilator body <NUM> has, on the diverging proximal portion 2b, two auxiliary access openings <NUM> configured to enable the insertion of a means (not illustrated) for operating in the internal volume "V" through one or both of the auxiliary openings, also in a configuration wherein the proctoscope <NUM> is associated with the adaptor body <NUM> (<FIG> and <FIG>).

Preferably, the two auxiliary openings <NUM> are identical and define a symmetrical conformation of the proctoscope <NUM> (in particular relative to a vertical midplane in the view of <FIG>).

Preferably, each auxiliary opening <NUM> has a conformation of diverging away from the distal portion 2a of the dilator body <NUM>, in particular with a "U" or "V" shape with the concavity facing rearwards.

This diverging conformation of the auxiliary portion <NUM> is devoid of undercuts, since the auxiliary opening <NUM> is configured to fittingly receive a corresponding complementary lobe of an introducer body <NUM> (<FIG>) by reciprocal translation along the longitudinal axis of extension "X". Preferably, each auxiliary opening <NUM> extends along an entire axial extension of the diverging proximal portion 2b of the dilator body <NUM> along the longitudinal axis of extension "X".

Preferably, moreover, each auxiliary opening <NUM> extends only on the diverging proximal portion 2b, but not on the distal portion 2a of the dilator body <NUM>.

Each auxiliary opening <NUM> extends to the rear edge of the diverging proximal portion 2b of the dilator body <NUM>, thus defining a respective zone of perimetral interruption of the proximal portion 2b. The presence of two auxiliary openings <NUM> thus defines, in the embodiment illustrated in <FIG>, a subdivision of the diverging proximal portion 2a of the dilator body <NUM> into two portions, an upper one and a lower one (the latter connected to the handle <NUM>), each associated with a respective part of the anchorage means <NUM>.

The region of the diverging proximal portion 2b positioned between the two auxiliary openings <NUM> and opposite the handle <NUM> has a flattened shape, i.e. one having a radius of curvature greater than the distance from the longitudinal axis of extension "X" (the reason for this will be clarified below).

Preferably, each auxiliary opening <NUM> is angularly positioned, about the longitudinal axis of extension "X", at <NUM>° relative to the handle <NUM>.

Again making reference to the variant in <FIG>, the anchorage means <NUM> is angularly positioned, about the longitudinal axis of extension, substantially at <NUM>° relative to the auxiliary openings <NUM>.

In a preferred embodiment, as shown in the figures, the proctoscope <NUM> further comprises a light guide <NUM>, in the form of a relief inside the dilator body <NUM>, which extends along the longitudinal axis of extension "X" in a distal direction from the handle <NUM>.

<FIG> and <FIG> show in detail the proctoscope <NUM> in association with a respective introducer body <NUM>, respectively in a configuration in which they are ready to be coupled and in a coupled configuration.

The introducer body <NUM> has a distal portion <NUM> of a cylindrical or tubular shape, configured for insertion into the distal portion 2a of the dilator body <NUM> and having a rounded or pointed end <NUM> intended to come out of the front opening <NUM> of the proctoscope <NUM>.

The introducer body <NUM> further has a proximal portion <NUM> with a larger cross section, configured to be coupled in a complementary manner with the proximal portion 2b of the dilator body and having, in particular, two opposite lobes <NUM>, each configured to be fittingly inserted into a corresponding auxiliary opening <NUM> in such a manner that, in a configuration of coupling between the dilator body <NUM> and introducer body <NUM>, the proximal portion 2a of the dilator body <NUM> and the proximal portion <NUM> of the introducer body <NUM> define an outer continuous surface devoid of irregularities or steps between the two proximal portions 2a, <NUM>.

In order to achieve this, the rear opening <NUM> and the lateral auxiliary openings <NUM> define a single recess with the concavity facing rearward and configured to receive, in a complementary manner, the proximal portion <NUM> of the introducer body <NUM>.

Preferably, moreover, said continuous outer surface has, in a section transversal to the longitudinal axis of extension "X", an elliptical shape that is flattened in the horizontal direction. This explains why, as said previously, the region of the diverging proximal portion 2b positioned between the two auxiliary openings <NUM> and opposite the handle <NUM> has a "flattened" shape.

In the illustrated embodiment, the introducer body <NUM> is stably couplable to the proctoscope <NUM> via the anchorage means <NUM>, which is thus configured for connection to both the adaptor body <NUM> and the introducer body <NUM>.

<FIG> and <FIG> show the proctoscope <NUM> associated with the adaptor body <NUM> (<FIG>) and also with a camera <NUM> (<FIG>). In said figures it may be noted that the presence of the adaptor body <NUM> coupled to the proximal portion 2b of the dilator body <NUM> does not interfere with the accessibility to the internal volume "V" through the lateral auxiliary openings <NUM>, which are moreover delimited at the front, top and bottom by the diverging profile of the proximal portion 2b and at the rear by the profile the adaptor body <NUM>.

<FIG> illustrates a variant of the proctoscope <NUM>, in which the adaptor body <NUM> supports a camera <NUM> suitable for detecting the internal volume of the proctoscope itself.

In this variant the camera <NUM> does not particularly interfere with the inside of the dilator body <NUM>, but the auxiliary openings <NUM> allow the surgeon a greater freedom of movement of any surgical instrument inserted through the rear opening <NUM> and coming out of the front opening <NUM>.

A method for carrying out an investigation on a cavity of a patient using the above-described proctoscope, not forming part of the claimed invention, comprises the following steps:.

The embodiment illustrated and described above has a pair of auxiliary lateral openings <NUM> opposite each other. However, the disclosure can also be equally applied to an embodiment (not illustrated) in which it has only one of the two auxiliary openings <NUM>, either on the left side or the right side, in a configuration of the proctoscope with the handle turned downwards. The present invention achieves the proposed object, overcoming the aforementioned drawbacks in the prior art.

Claim 1:
A proctoscope, comprising a dilator body (<NUM>), having a longitudinal axis of extension (X) and internally hollow so as to define an internal volume (V), and at least one handle (<NUM>) applied to said dilator body (<NUM>), wherein the dilator body (<NUM>) has a distal portion (2a), having a substantially tubular shape and defining a zone of dilation of an internal cavity of a patient, and a proximal portion (2b) extending from the distal portion (2a) in a diverging fashion and defining a rear opening (<NUM>) for accessing said internal volume (V), wherein said distal portion (2a) of the dilator body (<NUM>) has at least one front opening (<NUM>) to enable access to the patient's mucosa or tissue from said internal volume (V), and wherein said diverging proximal portion (2b), or, alternatively, said at least one handle (<NUM>), has an anchorage means (<NUM>); said proctoscope further comprising an adaptor body (<NUM>) stably and removably coupled to said anchorage means (<NUM>) and a detection device (<NUM>), in particular a camera, stably applied to the adaptor body (<NUM>) on the opposite side relative to said diverging proximal portion (2b) of the dilator body (<NUM>) such as to detect the internal volume (V) of proctoscope (<NUM>);
characterized in that
said dilator body (<NUM>) has, on said diverging proximal portion (2b), two auxiliary access openings (<NUM>) configured to enable the insertion of a means for operating in the internal volume (V) through said auxiliary opening (<NUM>), each auxiliary opening (<NUM>) extending to the rear edge of the diverging proximal portion (2b) of the dilator body (<NUM>) defining a respective zone of perimetral interruption of the proximal portion (2b);
and
each auxiliary opening (<NUM>) being delimited at the front, top and bottom by the diverging profile of the proximal portion (2b) and at the rear by the profile of the adaptor body (<NUM>).