Patent Description:
Various prior art solutions provide for colonoscopy devices which set out to increase the adenoma detection rate (ADR) during endoscopic procedures, especially for endoscopic screening.

To this end, during endoscopic examination, there arises the need to thoroughly inspect colon in all its parts, checking behind each curve and each single mucous membrane fold.

The problem raises from the fact that such inspection is long and complex if carried out appropriately, it requires multiple maneuvers by the operator and these maneuvers do not always allow to stretch the colon in a sensitive, non-traumatic and efficient manner.

It is clear that the need to stretch fully is diametrically opposed to that of stretching in a non-traumatic fashion.

Therefore, there arises the need for providing devices that are simultaneously capable of obtaining a complete and non-traumatic screening.

Up to date, prior art solutions are not able to meet this need; as a matter of fact, they are complex, traumatic and make the procedure longer and more complicated.

Prior art documents <CIT> and <CIT> disclose each a similar device to the one claimed by the invention. However, they are structurally different.

Therefore, there is felt the need to overcome the drawbacks and limitations mentioned with reference to the prior art.

Such need is met by an endoscopic medical device according to claim <NUM>.

Further characteristics and advantages of present the invention will be more apparent from the description outlined below regarding the preferred and non-limiting examples thereof, wherein:.

The elements or components shared by the embodiments described below will be indicated using the same reference numerals.

With reference to the above-mentioned figures, an overall view of an endoscopic medical device, in particular for colonoscopy, is generally indicated with <NUM>.

In particular, the endoscopic medical device <NUM> comprises a main body <NUM>, cylindrical with respect to a main extension axis X-X, which extends from a proximal end <NUM> to a distal end <NUM>.

Said main body <NUM> is hollow so as to delimit a cavity <NUM> adapted to at least partially house a distal portion <NUM> of an endoscope <NUM> which can be associated therewith, on the side of said proximal end <NUM> of the main body <NUM>.

The main body <NUM>, at an outer side wall <NUM>, opposite to said cavity <NUM>, has a plurality of flexible fins <NUM> provided with arms <NUM> which, in a resting condition, extend along main directions Y-Y incident with said main extension axis X-X according to an opening angle α comprised between <NUM> and <NUM> degrees, measured from the side of the distal end <NUM>.

According to a possible embodiment, said opening angle α is comprised between <NUM> and <NUM> degrees, preferably it is comprised between <NUM> and <NUM> degrees, even preferably it is equal to <NUM> degrees.

Said arms <NUM> are engaged with the outer side wall <NUM> at fixing ends <NUM> for fixing to the main body <NUM> and, at cantilevered ends <NUM>, opposite to the fixing ends <NUM>, branch into pairs of arms <NUM>,<NUM> arranged symmetrically with respect to a centerline plane M-M passing through said arms <NUM> and through said main extension axis X-X.

According to a possible embodiment, said branches <NUM>,<NUM>, at free ends <NUM>, opposite to opposite to the cantilevered end <NUM> of the arm <NUM>, have rounded tips <NUM> having a determined radius of curvature R.

According to an embodiment, said radius of curvature R is comprised between <NUM> and <NUM>, preferably it is equal to <NUM>.

According to an embodiment, said rounded tips <NUM> may be cylindrical-shaped with circular cross-section or they may be spherical.

According to a possible embodiment, <NUM> to <NUM> flexible fins <NUM> are provided, preferably angularly equally spaced from each other, with respect to the main extension axis X-X, along the outer side wall <NUM>.

According to a possible embodiment, the arm <NUM> has a greater thickness than the thickness of said branches <NUM>,<NUM>.

According to a possible embodiment, the arm <NUM> has a greater width than the width of said branches <NUM>,<NUM>.

According to a possible embodiment, the arm <NUM> and the branches <NUM>,<NUM> have a quadrangular cross-section <NUM> with rounded edges <NUM>, wherein the section is oriented so as to have a lesser moment of inertia with respect to a bending along the main extension axis X-X.

According to a possible embodiment, the arm <NUM> and the branches <NUM>,<NUM> have a constant thickness with respect to a radial cross-sectional plane parallel with and passing through the main extension axis X-X.

According to an embodiment, said thickness of the arm <NUM> and of the branches <NUM>,<NUM> is preferably smaller than a diameter D of said rounded tips <NUM> of the branches <NUM>,<NUM>.

According to an embodiment, the width of the branches <NUM>,<NUM>, and preferably also of the arm <NUM>, is smaller than a diameter D of said rounded tips <NUM> of the branches <NUM>,<NUM>.

Advantageously, the main body <NUM> and the flexible fins <NUM> are made of medical grade silicone material or a thermoplastic elastomer. Advantageously, furthermore, said material has a hardness between <NUM> and <NUM> SHORE A, preferably equal to about <NUM> SHORE A.

Preferably, said flexible fins <NUM> have an increasing flexibility moving from the fixing ends <NUM> to the free ends <NUM>.

According to a possible embodiment, said arms <NUM> have a cantilevered length L, with respect to the fixing end <NUM>, which are smaller than the lengths of said branches <NUM>,<NUM>, equal to the distance between the cantilevered end <NUM> of the arm <NUM> and the free ends <NUM>.

According to a possible embodiment, the free ends <NUM> of the branches <NUM>,<NUM>, opposite to the cantilevered end <NUM> of the arm <NUM>, diverge with respect to each other for a transversal distance T which is greater than the length of the arms <NUM>.

Said transversal distance T is for example equal to a diameter of the main body <NUM>, measured perpendicularly to the main extension axis X-X.

According to a possible embodiment, the main body <NUM>, at the fixing ends <NUM> of the arms <NUM>, on the side of the distal end <NUM>, has bulges <NUM> which serve as upper stops in the rotation of the arms <NUM> towards the distal end <NUM> of the main body <NUM>.

According to a possible embodiment, the main body <NUM>, at the fixing ends <NUM> of the arms <NUM>, on the side of the proximal end <NUM>, has recesses <NUM> which serve as partial seats of the arms <NUM> when rotated bent towards the proximal end <NUM> of the main body <NUM>.

According to a possible embodiment, the main body <NUM>, at the distal end <NUM>, comprises a cap <NUM>. Said cap <NUM> is advantageously transparent, preferably having a height comprised between <NUM> and <NUM>, even more preferably equal to <NUM>, and it is particularly made of the same material as the endoscopic medical device <NUM>. According to a possible embodiment, the cap <NUM> has a hole <NUM> preferably arranged at the lens of the endoscope <NUM>. Said hole <NUM> advantageously allows the draining of the liquids cleaning the lens of the endoscope <NUM> from any dirt that could stop in the cap <NUM> during the endoscopic examination.

According to a possible embodiment, for a blocking ring <NUM> is provided, which is positioned on the tip or distal end <NUM> of the main body <NUM> and shaped so as to allow to correctly position the endoscopic medical device <NUM> on the tip of the endoscope <NUM>. Preferably, said blocking ring <NUM> is positioned below said hole <NUM>; preferably said blocking ring <NUM> forms an abutment or stop for the distal portion <NUM> of the endoscope <NUM> and it guarantees the correct and full insertion of the endoscopic medical device <NUM> on the endoscope <NUM>.

The blocking ring <NUM> further advantageously allows to prevent the endoscope <NUM> from being positioned erroneously at the area designed for the cap <NUM>, and therefore prevent the lens of the endoscope <NUM> from coming into contact with the mucous membrane.

According to a possible embodiment, the cap <NUM> has a flared top portion <NUM> having a flaring angle β greater than <NUM>°, measured with respect to a horizontal plane perpendicular to the main extension axis X-X. Said flared top portion <NUM> has the advantage of not interfering with the view angle of the video camera arranged on the distal portion <NUM> of the endoscope <NUM>. Furthermore, such flared top portion <NUM> advantageously allows to prevent the excessive bending of the cap <NUM> (for example if made of soft silicone material) both inwards and outwards with respect to the visual field of the endoscope <NUM>.

Below is the functional description of the endoscopic medical device according to the present invention.

As mentioned above, the main body <NUM> is fitted onto the tip or distal portion <NUM> of an endoscope <NUM> to enable the introduction thereof.

When introducing into the body cavity and during the endoscopic examination, the flexible fins <NUM> elastically bend towards the proximal end <NUM> of the main body <NUM>; in particular, the branches <NUM>,<NUM> bend more with respect to the arms <NUM> which are stiffer. Therefore, the branches <NUM>,<NUM> collapse flattening downwards on the endoscope. This characteristic is particularly advantageous should there be encountered stenosis or stricture of the colon, during an endoscopic examination.

This characteristic is particularly advantageous, even generally during the advancement of the endoscopic medical device <NUM> given that it makes the profile of the instrument narrower and therefore the instrument may advance without difficulty. The flexibility of the branches <NUM> and <NUM> also allows not to cause traumas to the patient, when retracting the endoscopic medical device <NUM>. The retraction of the endoscope is not always linear and continuous; at times one had to advance and then return backwards again. The distal flexibility of the fins, and in particular of the branches <NUM>,<NUM>, allows the tips <NUM> of the arms <NUM> not to pivot on the walls of the colon and therefore avoid micro traumas to the mucous membrane. Furthermore, when retracting the endoscopic medical device <NUM>, having flexible tips means being sure not to ever apply excessive forces to the colon, given that, encountering resistance, the endoscopic medical device <NUM> will yield elastically instead of the anatomy of the patient yielding.

The geometric conformation of the doubled branches <NUM>,<NUM> allows greater stability of the medical device. The double branches <NUM>,<NUM> support each other, mutually supporting the overall radial opening of the medical device, preventing it from losing grip on the tissue, like it happens in the case of systems with single fins. Should a branch <NUM>,<NUM> slip, the remaining part binds the branch <NUM>,<NUM> thereto without gripping, holding it in position for a resumption of the function thereof.

Therefore, the arm <NUM> on the one hand allows a certain bending independence of the branches <NUM>,<NUM> which may therefore better adapt to the morphological conformation of the cavity section to be explored and - on the other hand - it creates a constraint between the branches <NUM>,<NUM> in question.

Furthermore, the apex of the oval, that is the bulging <NUM> of the material above the fixing end <NUM> of each arm <NUM>,<NUM> serves as a block for the arms <NUM> when retracting the medical device <NUM>. In this manner, the arms <NUM> always remain in open position adapted to facilitate the gripping and the stretching of the colon folds, always in a non-traumatic manner.

Furthermore, the bulging <NUM> prevents the arms <NUM> of the medical device <NUM>, when retracting the instrument, from projecting excessively forward, therefore entering into the visual field of the video camera and interfering with the endoscopic examination.

As observable in the light of the above, the present invention allows to overcome the drawbacks observed in the prior art.

In particular, the present invention allows to stretch - effectively and in a non-traumatic fashion - the folds of the colon, so as to increase the adenoma detection rate (adr) during endoscopic procedures, especially endoscopic screening.

Advantageously, the enlarged and rounded tips are non-traumatic and, at the same time, they have an improved grip so as to grip the tissues better. Furthermore, the rounded shape allows to prevent lesions to the mucous membrane.

The central body with a thicker arched structure allows to effectively support the stem, and it also facilitates the insertion of the medical device into the endoscope.

Furthermore, the device of the present invention better adapts to the morphology of the colonoscope. A more adherent fitting of the medical device ensures a better fixing thereof and ensures that the latter never inadvertently detaches from the tip of the colonoscope like it happens in some prior art solutions. The embodiment of the endoscopic medical device made of silicone material, makes the device soft and adaptable to the colonoscope. The diameters of the colonoscope most commonly used for endoscopic screening procedures are <NUM> and <NUM>. The device is made smaller in diameter with respect to these dimensions, so that it can (for example thanks to the properties of silicone) be elastic and widen fitting into the colonoscope. Once inserted, between the smaller diameter, the inherent ultra-high anti-slip property of silicone, and the absence of a rigid structure on the body of the endoscopic medical device, ensure a perfect fitting and that the endoscopic medical device can never be inadvertently detached from the tip or distal portion of the endoscope.

There can be used any material other than silicone provided it has the same properties and/or the same advantages.

Furthermore, the device of the present invention advantageously has a smaller thickness with respect to the prior art solutions: therefore, such small thickness facilitates the step for inserting and advancing the instrument into the colon section, when the arms, and in particular the branches, collapse flattening downwards on the endoscope. This characteristic is particularly advantageous should there be encountered stenosis and stricture of the colon.

Furthermore, the number of fulcrums of the arms which branch from the central body are advantageously small with respect to the prior art solutions: this allows to widen the empty spaces between the bases of the arms, allowing a very easy and effortless through-passing of fluids and stool.

Furthermore, the blocking ring positioned on the tip of the medical device allows to correctly position the medical device on the tip of the endoscope.

Furthermore, the apex and the oval, that is the bulging of the material above the fulcrum of each arm, serves as a rotary block for the arms when retracting the medical device. In this manner, the arms remain in open position adapted to facilitate the gripping and the stretching of the colon folds, always in a non-traumatic manner.

The bulging of the material above the fulcrum of the arms further prevents the arms of the device, when retracting the instrument, from projecting excessively forward, therefore entering into the visual field of the video camera, interfering with the endoscopic examination.

The geometric conformation of the double branches allows greater stability of the medical device. As a matter of fact, the double branches support each other, mutually supporting the overall radial opening of the medical device, preventing it from losing grip on the tissue, like it happens in the case of systems with single fins. The Y-shaped system therefore ensures greater stability, a greater opening and a greater effectiveness of the device especially in terms of non-traumatic stretching of the colon folds. As a matter of fact, should a part or branch of the arm slip, the remaining part binds the branch thereto without gripping, holding it in position for a resumption of the function thereof.

According to the current endoscopic techniques, in order to obtain a progressive advancement of the colonoscope one has to carry out maneuvers which provide for - continuously and alternatively - pushing the instrument, anchoring to the colon, and retracting the instrument. Advantageously, the conformation of the arms and of the branches allows greater grip and anchoring on the intestinal folds and curves during the endoscopic examination, while ensuring non-traumatic maneuver at the same time. Therefore, this also allows a faster advancement of the instrument and makes the exam shorter and less painful for the patient.

The embodiment of the device provided with a cap prevents the lens of the instrument from directly resting on the mucous membrane therefore obstructing the endoscopic read-out when moving the endoscope. Experiments showed that - in the version of the endoscopic medical device provided with cap, the latter is not framed by the video camera, in particular due to its flared shape. Therefore, this offers the benefits of a cap but without the classic visibility limitation of the cap, visibility being crucial during screening examinations.

Furthermore, the device becomes a further arm of the operator and helps the latter both to maneuver the grip on the colon and move the tissues or folds of the colon out of the way.

With the aim of meeting contingent and specific needs, a person skilled in the art may subject the solutions described above to numerous modifications and variants.

Claim 1:
Endoscopic medical device (<NUM>) comprising a main body (<NUM>), cylindrical with respect to a main extension axis (X-X), which extends from a proximal end (<NUM>) to a distal end (<NUM>),
said main body (<NUM>) being hollow so as to delimit a cavity (<NUM>) adapted to at least partially house a distal portion (<NUM>) of an endoscope (<NUM>) which can be associated therewith, on the side of said proximal end (<NUM>) of the main body (<NUM>),
said main body (<NUM>), at an outer side wall (<NUM>), opposite to said cavity (<NUM>), having a plurality of flexible fins (<NUM>) provided with arms (<NUM>) which, in a resting condition, extend along main directions (Y-Y) incident with said main extension axis (X-X) according to an opening angle (α) comprised between <NUM> and <NUM> degrees, measured from the side of the distal end (<NUM>),
wherein said arms (<NUM>) are engaged with the outer side wall (<NUM>) at fixing ends (<NUM>) for fixing to the main body (<NUM>),
said endoscopic medical device (<NUM>) being characterized in that said arms (<NUM>), at cantilevered ends (<NUM>) opposite to the fixing ends (<NUM>), branch into pairs of branches (<NUM>,<NUM>), arranged symmetrically with respect to a centerline plane (M-M) passing through said arms (<NUM>) and through said main extension axis (X-X).