Device and kit for inspecting cavity

Abstract

To provide a device for inspecting a cavity and a kit for inspecting a cavity including the device.SOLUTION: A device (1) for inspecting a cavity includes a dilator body (2) and a gripping element (4) having an elongate shape, which is applied or applicable to an end of the dilator body (2), is arranged transversely to the dilator body (2) and is graspable by an operator. The device (1) includes a support element (5), which is configured to define a reversible connection with the test assembly (1000), is connected to the gripping element (4) and is movable along the gripping element (4) towards and / or away from the dilator body (2). The inspection assembly (1000) includes an imaging device and an illumination device.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a device for inspecting a recess and a kit for inspecting a recess including the device.

[0002] The present invention is advantageously applied to the field of diagnosis of pathologies related to human cavities or orifices obtained naturally or surgically, and the diagnosis is performed by visual inspection of the tissue defining the boundaries of the cavities and orifices.

[0003] Although not exclusive, in particular, the present invention is advantageously applied to the field of anorectal and vaginal examinations. As a result, the device which is the object of the present invention has, although not exclusive, preferably alternative embodiments of an anoscope, a proctoscope, or a rectoscope, and a vaginoscope.

[0004] In the prior art, inspection devices provided with a dilator body and an introducer body are known.

[0005] The dilator body is hollow and has a tubular extension between a distal opening that provides visual and manipulative access to the mucosa defining the boundaries of the recess and a proximal opening that is accessible to the operator during use.

[0006] Specifically, the introducer body also has a tubular extension between a distal end having a substantially pointed shape and a proximal end that can be grasped by the operator.

[0007] The introducer body is configured to be coupled to the dilator body by sliding the introducer body inside the dilator body until the pointed end of the introducer body protrudes from the distal end of the dilator body, and an outer wall of the device shaped to facilitate its insertion into the patient's recess is obtained.

[0008] During the examination, after coupling between the dilator body and the introducer body, the operator inserts the examination device into the patient's fossa, and then withdraws the introducer body from the dilator body, maintaining the dilator body inserted into the fossa, enabling visual access and thus examination of the mucosa through the distal opening of the dilator body (towards the operator).

[0009] Known dilator bodies may be coupled to detection facilities, such as cameras or illuminators, respectively configured to detect images and illuminate the fossa being examined.

[0010] Currently, it is known that once the dilator body is correctly positioned within the patient's fossa, such a coupling can be obtained directly at the proximal opening (towards the operator).

[0011] In addition to not being very functional for the operator, this procedure is uncomfortable for the patient.

[0012] To overcome these drawbacks, it is known to provide the examination device with a support coupled to an illuminator, disposed directly inside the volume portion defined by the dilator body.

[0013] In other words, the support is disposed between the dilator body and the introducer body, and the operator can perform the examination without the need to manually couple the dilator body to an external support once the examination device is inserted into the patient's fossa and the introducer body is withdrawn.

[0014] Disadvantageously, these solutions do not provide for the use of a camera, thus precluding the possibility of taking diagnostic images.

[0015] Furthermore, disadvantageously, known solutions are not very practical in many cases where the operator has to examine the entire mucosa facing the dilator body and the distal opening of the dilator body.

[0016] That is, disadvantageously, the above inspection procedure is not a very functional inspection procedure for the operator and is also a redundant inspection examination for the patient.

[0017] In addition, known solutions disadvantageously prevent the operator from having a panoramic view of the mucosa facing the distal opening of the dilator body and / or adjacent to the side wall of the dilator body. Therefore, known solutions make the inspection examination difficult.

[0018] In addition, disadvantageously, known solutions are not very sustainable. This is because the illuminator arranged inside the dilator body is inserted into the patient's fossa together with it and thus has to be replaced and, in particular, has to be discarded together with the inspection device after each use.

[0019] Therefore, known devices are not only not very practical, but are also costly and lack sustainability. SUMMARY OF THE INVENTION

[0020] Therefore, the technical problem of the present invention is to provide an inspection device and kit that can overcome the drawbacks emerging from the prior art.

[0021] One object of the present invention is to provide an inspection device and kit that are functional and practical for use by an operator.

[0022] Another object of the present invention is to provide an inspection device and kit with reduced costs.

[0023] Another object of the present invention is to provide a sustainable inspection device and kit.

[0024] The specific technical problems and specific objects are substantially achieved by an inspection device and kit comprising the technical features disclosed in one or more of the appended claims.

[0025] In particular, the device comprises a dilator body having a main extension along the longitudinal axis between a proximal end and a distal end.

[0026] The proximal end and the distal end are connected by a side wall and together with the side wall define an internal volume portion.

[0027] More specifically, the proximal end defines a proximal opening, and the distal end defines a distal opening for access to tissue that defines the boundary of the fossa from the internal volume portion.

[0028] The device comprises an introducer body that is removably applicable to the dilator body in use, and in particular, the introducer body is slidably insertable into the internal volume portion through the proximal opening and releasable from the internal volume portion.

[0029] The device comprises a gripping element having an elongated shape, which is applied to or applicable to the proximal end of the dilator body and is arranged to cross the longitudinal axis.

[0030] The gripping element is grippable by an operator.

[0031] The device comprises a support element which is arranged outside the internal volume portion defined by the dilator body in order to support the inspection assembly outside the internal volume portion, and is movable along the gripping element towards and / or away from the proximal end of the dilator body.

[0032] Specifically, the inspection assembly comprises at least one imaging device and at least one lighting device.

[0033] Advantageously, the device is suitable for multi-purpose use, since the operator has to connect the inspection assembly to the support element for performing an inspection examination, but does not have to connect an external support to the proximal opening of the inspection device.

[0034] Furthermore, thanks to the support element, the device enables the operator to have an overall view of the patient's mucosa.

[0035] Advantageously, the device is also suitable for multi-purpose use, since the operator can position the inspection assembly relative to the proximal opening by acting on the support element.

[0036] Advantageously, the device is sustainable and economical, since the inspection assembly is supported outside the internal volume portion defined by the dilator body, so at least the inspection assembly is reusable.

[0037] Preferably, the device comprises a guiding element which is defined on or applied removably to the gripping element and is configured to guide the movement of the support element along a predefined path extending along the gripping element itself.

[0038] Advantageously, the guiding element enables easy adjustment of the position of the inspection assembly relative to the proximal opening of the dilator body.

[0039] Preferably, the guiding element comprises a plurality of locking members, and the locking members define respective plurality of preset positions for holding the support element along the gripping element.

[0040] Preferably, the locking member comprises a protrusion defined on the guiding element.

[0041] Advantageously, the locking member enables rapid adjustment of the position of the inspection assembly relative to the proximal opening of the dilator body.

[0042] Preferably, the support element is slidable along the gripping element between an insertion position where the support element is disposed at a distal position relative to the proximal opening, a shooting position where the support element is disposed at a proximal position relative to the proximal opening, and an observation position where the support element is disposed between the insertion position and the shooting position.

[0043] Advantageously, the insertion position enables the dilator body to be inserted into the patient's fossa in an facilitated manner, because the support element is disposed at a position away therefrom.

[0044] Advantageously, the shooting position enables an image of the patient's fossa to be taken in an facilitated manner, because thanks to the support element supporting the inspection assembly, the operator can observe the taken image without worrying about the position of the inspection assembly, particularly the position of the shooting device.

[0045] Advantageously, the observation position enables the operator to observe the patient's fossa with the naked eye in an facilitated manner, because thanks to the support element supporting the inspection assembly, the operator can observe the fossa without worrying about the position of the inspection assembly, particularly the position of the lighting device.

[0046] Advantageously, the device enables the patient's popliteal fossa to be examined using different methods (naked eye, on the screen), thereby enabling a thorough examination.

[0047] The present invention also provides a kit for examining the popliteal fossa.

[0048] The kit comprises the above device, an inspection assembly, and a portable battery connected to or connectable to the inspection assembly.

[0049] Accordingly, the kit comprises the above device, at least one imaging device, at least one lighting device, and a portable battery connected to or connectable to the imaging device and the lighting device.

[0050] The dependent claims correspond to possible embodiments of the present invention.

[0051] Further features and advantageous aspects of the present invention will become more apparent from the exemplary and non-limiting description of embodiments of the inspection device and the inspection kit including the device.

[0052] Such a description is set forth below with reference to the accompanying drawings. The drawings are provided for illustrative purposes only and not for purposes of limitation.

Brief Description of the Drawings

[0053]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

[0054] Referring to the appended claims, reference numeral 1 as a whole refers to a device for examination, and for simplicity, this device for examination is shown herein as "Device 1".

[0055] Device 1 is preferably an anoscope or a proctoscope for examining the anal or rectal fossa of a patient.

[0056] Alternatively, Device 1 is a vaginoscope for examining the vaginal fossa of a patient.

[0057] However, devices suitable for examining different fossae, whether naturally or surgically obtained, within a patient are not excluded.

[0058] The terms "distal" and "proximal" are used herein. These words are intended to be with respect to the operator, unless otherwise specified. Thus, unless otherwise specified, the term "proximal" is intended to refer to the part furthest from the patient, while the term "distal" is intended to refer to the part closest to the patient.

[0059] Referring to Figures 1, 5, and 6, Device 1 according to the present invention comprises a dilator body 2 and an introducer body 3.

[0060] The dilator body 2 is shaped to be inserted into the fossa of the patient intended to perform the examination.

[0061] The dilator body 2 has an elongated extension along the longitudinal axis "X", particularly between the proximal end 21 and the distal end 22 connected by the side wall 23.

[0062] In other words, the dilator body 2 has a substantially tubular shape.

[0063] In a non-exclusive embodiment, the side wall 23 extends in a shape that widens from the distal end 22 towards the proximal end 21.

[0064] Advantageously, the widening extension of the side wall 23 facilitates the expansion of the fossa to be examined, and thus also facilitates the insertion of the dilator body 2 itself into the fossa.

[0065] The side wall 23 is preferably made of a transparent material, more preferably a plastic material.

[0066] Specifically, the side wall 23, together with the proximal end 21 and the distal end 22, defines and delimits the boundary of the internal volume portion "V".

[0067] The proximal end 21 of the dilator body 2 defines respective proximal openings "PO" that face the internal volume space "V" and are accessible by the operator.

[0068] In a non-exclusive embodiment, the proximal opening "PO" is coaxial with the longitudinal axis "X" along which the dilator body 2 extends.

[0069] Similarly, the distal end 22 defines respective distal openings "DO" that face the internal volume space "V" and are configured to enable access to the tissue and mucosa that define the boundary of the fossa from the internal volume space "V".

[0070] Preferably, the distal opening "DO" is coaxial with the longitudinal axis "X".

[0071] Preferably, the proximal opening "PO" and the distal opening "DO" have a substantially circular shape.

[0072] Referring to the introducer body 3, it includes a gripping portion 31 (as shown in FIGS. 5 and 6) and an insertion portion 32.

[0073] The gripping portion 31 is accessible or grippable by an operator. Specifically, the gripping portion 31 is shaped to enable the operator to grip and manipulate the introducer body 3.

[0074] The insertion portion 32 is connected to the gripping portion 31 and has an elongated extension along its respective axis of extension.

[0075] In particular, the insertion portion 32 extends between an insertion end 33, which has a substantially pointed shape and is distal to the gripping portion 31, and the gripping portion 31.

[0076] As shown in FIGS. 1 - 4, the insertion portion 32 is inserted into the internal volume space "V" defined by the dilator body 2 to obtain the assembled configuration of the device 1. In the above - mentioned assembled configuration, the device 1 can be easily inserted into the fossa to be inspected.

[0077] The dilator body 2 and the introducer body 3 are assembled to enable easy insertion of the dilator body 2 into the interior of the fossa to be inspected.

[0078] Specifically, the above - mentioned assembled configuration is obtained by inserting the introducer body 3 through the proximal opening "PO", preferably along the longitudinal axis "X", into the internal volume portion "V" of the dilator body 2.

[0079] Inserting the introducer body 3 into the internal volume portion "V" of the dilator body 2 occurs through sliding the insertion portion 32 within the dilator body 2, particularly along the internal surface 231 that defines the boundary of the side wall 23 of the dilator body 2 on the inside. In other words, the internal surface 231 is the surface that defines the boundary of the side wall 23 and faces the internal volume portion "V".

[0080] Although not exclusive, for example, the internal surface 231 may have one or more slide guide interiors (not shown in the accompanying drawings), and the insertion portion 32 may be coupled to the above slide guide interiors. Therefore, the slide guide interiors enable the insertion portion 32 to slide guided along the internal surface 231, and advantageously, ensure the facilitation of inserting the introducer body 3 into the internal volume "V".

[0081] In particular, the insertion portion 32 is introduced into the internal volume portion "V" of the dilator body 2 and reaches the movement end position, at which the insertion end 33 protrudes from the distal opening "DO" of the dilator body 2 as shown in FIGS. 1 and 2.

[0082] That is, in the assembled configuration, the device 1 has an elongated extension that extends from the insertion end 33 of the introducer body 3 towards the proximal end 21 of the dilator body 2.

[0083] In addition, the device 1 in the assembled configuration does not have an edge or discontinuous element outside the internal volume portion "V" that may cause discomfort or pain during the insertion and positioning of the device 1 into the patient's fossa.

[0084] According to a non-exclusive embodiment, the introducer body 3 may comprise a locking element (not shown in the accompanying drawings) that reversibly restrains the introducer body 3 with respect to the dilator body 2 when the introducer body 3 is fully inserted into the dilator body 2.

[0085] Thus, the above-described locking element of the type known in the art is such that during the insertion of the device 1, the introducer body 3 can maintain the restraint against the dilator body 2.

[0086] In other words, thanks to this locking element, the dilator body 2 can advantageously be inserted into the patient's fossa together with the introducer body 3 inserted into the internal volume portion "V" by the operator using only one hand. This can be done without risking the introducer body 3 being moved in a direction different from the insertion direction relative to the dilator body 2 as a result of the resistance exerted, for example, by the muscular structure around the patient's fossa during the insertion into the fossa.

[0087] When the insertion into the patient's fossa is completed, the introducer body 3 is removed from the dilator body 2 along the extraction path, which is in the opposite direction to the insertion path, as schematically shown in FIG. 2.

[0088] In other words, the insertion portion 32 of the introducer body 3 is moved parallel to the longitudinal axis "X" and is withdrawn from the internal volume portion "V" through the sliding of the introducer body 3, particularly the insertion portion 32.

[0089] The device 1 comprises a gripping element 4 that is applied or applicable to the proximal end "PO" of the dilator body 2.

[0090] In the non-exclusive embodiment shown in the accompanying drawings, the gripping element 4, together with the dilator body 2, defines a single monolithic body.

[0091] Alternatively, in other non-exclusive embodiments, the gripping element 4 is removably connected to the proximal end "PO" of the dilator body 2.

[0092] In particular, the gripping element 4 has an elongated shape extending along a main axis of extension "W" in a direction transverse to the longitudinal axis "X".

[0093] In other words, the gripping element 4 is arranged so as to cross the dilator body 2.

[0094] Also, the gripping element 4 can be gripped by an operator.

[0095] In other words, the gripping element 4 is a handle inclined by an angle ranging from 1 degree to 90 degrees with respect to the longitudinal axis "X".

[0096] According to an advantageous aspect of the invention, the device 1 is configured to define a reversible connection with an inspection assembly 1000, the inspection assembly 1000 comprising a support element 5 which in particular comprises at least one imaging device 100 and at least one lighting device 200.

[0097] The inspection assembly 1000 can be defined, for example, by a single body part comprising an imaging device 100 and a lighting device 200.

[0098] The support element 5 is arranged outside the internal volume part "V" and can move along the gripping element 4 towards and away from the dilator body 2.

[0099] Preferably, in order to facilitate the movement of the support element 5 along the gripping element 4, the support element 5 comprises an activation zone 50 which can be gripped by an operator.

[0100] For example, as shown in the attached drawings, the activation zone 50 can be obtained in the form of a slider 50', the slider 50' being configured such that an operator can activate the sliding of the support element 5 along the gripping element 4 through the action of a finger on the slider 50'.

[0101] Preferably, in order to define the connection with the imaging device 100, the support element 5 comprises an imaging sheet 53 (shown in FIGS. 2 to 5) configured to receive the imaging device 100 by insertion.

[0102] Preferably, in order to define the connection with the lighting device 200, the support element 5 comprises a lighting sheet 54 (shown in FIGS. 2 to 5) configured to receive the imaging device 100 by insertion.

[0103] More specifically, the support element 5 is arranged outside the internal volume portion "V" and supports the inspection assembly 1000 outside the internal volume portion "V".

[0104] That is, thanks to the support element 5, the inspection assembly 1000, i.e., the imaging device 100 and the lighting device 200, is arranged outside the fossa itself during the inspection examination, i.e., when the dilator body 2 is inserted into the patient's fossa.

[0105] In other words, thanks to the support element 5, the imaging device 100 and the lighting device 200 do not come into contact with the patient's mucosa or any secretions generated thereby.

[0106] Therefore, advantageously, the device 1 is sustainable as it does not require the replacement and disposal of the inspection assembly 1000 after each use.

[0107] Specifically, the support element 5 is connected to the gripping element 4 and can move along the gripping element 4 towards and / or away from the dilator body 2.

[0108] That is, once the dilator body 2 is inserted into the patient's fossa and the introducer body 3 is removed from the internal volume portion "V", although the operator needs to directly connect the inspection assembly 1000 to the support element 5, when the dilator body 2 is inserted into the patient's fossa, it is unnecessary for the operator to couple the proximal opening "PO" to an external support, which is difficult for the operator and involves discomfort and pain for the patient.

[0109] Furthermore, in order to more thoroughly inspect / image the patient's fossa, the operator can, for example, by applying an action to the slider 50', arrange the support device 5 (and thus the imaging device 100 and the lighting device 200) as desired with respect to the dilator body 2, particularly with respect to its proximal opening "PO".

[0110] Therefore, advantageously, thanks to the support element 5, the device 1 can be used for multiple purposes.

[0111] According to one aspect of the present invention, the above device comprises a guiding element 6 arranged on the gripping element 4.

[0112] In particular, the guiding element 6 is configured to guide the movement of the support element 5 along a preset path extending along the gripping element 4.

[0113] In other words, thanks to the guiding element 6, the operator can move the support element 5 in an facilitated manner during the execution of the patient's examination.

[0114] Preferably, the above preset path extends parallel to the main extension axis "W" of the gripping element 4.

[0115] According to one aspect of the present invention, the guiding element 6 is defined on the gripping element 4.

[0116] In other words, the guiding element 6 and the gripping element 4 define a single monolithic body.

[0117] For example, the guide element 6 is obtained in the form of at least one rail 6a (as shown in FIGS. 1 and 6) defined on the gripping element 5, in particular along its main extension axis "W".

[0118] Alternatively, the guide element 6 is applied or applicable in a removable form with respect to the gripping element 4, in other words, the guide element 6 and the gripping element 5 are connectable and disconnectable from each other.

[0119] For example, the guide element 6 is obtained in the form of at least one rail 6a that is applied in a removable form with respect to the gripping element 4, in particular along its main extension axis "W".

[0120] According to one aspect of the invention, the guide element 6 defines respective channels 61 that define the boundaries of a preset path.

[0121] For example, the guide element 6 is a recess obtained on the gripping element 5 along its main extension axis "W", or (in the non-exclusive embodiment shown in FIGS. 1 and 6), the channel 61 is a pair of rails 6a that are applied or applicable to the gripping element, face each other, and are parallel, and the boundaries are defined by the pair of rails 6a.

[0122] More specifically, the support element 5 includes an interconnecting portion 51 for connection with the gripping element 4, in particular for connection with the guide element 6, and a connection portion 52 for connection with the inspection assembly 1000.

[0123] The interconnecting portion 51 is in particular inserted into the channel 61, slides along the channel 61 itself, and / or is coupled to the rail 6a.

[0124] For example, the interconnecting portion 51 is obtained in the form of a pin and is intended to be inserted into the channel 61 and slide along the edge of the channel 61 itself, i.e., along the rail 6a.

[0125] Preferably, the interconnecting portion 51 is provided with a slider 50' accessible to the operator at a position facing, for example, the channel 61.

[0126] On the other hand, the connecting portion 52 is arranged outside the channel 61 and is configured to support the imaging device 100 and the lighting device 200 outside the channel 61.

[0127] For example, the connecting portion 52 may include a bracket intended to receive the inspection assembly 1000 and an upright portion connected to the interconnecting portion 51 and the connecting portion 52. Alternatively, the connecting portion 52 may include a first bracket suitable for supporting the imaging device 100 and a second bracket suitable for supporting the lighting device 200.

[0128] According to the embodiment shown in the accompanying drawings, the imaging sheet 53 and the lighting sheet 54 are defined on the connecting portion 52, and more specifically, they penetrate the connecting portion 52.

[0129] According to a non-exclusive embodiment, the support element 5 includes an adapter 55 configured to define a reversible connection with the inspection assembly 1000, that is, with the imaging device 100 and the lighting device 200.

[0130] Therefore, the adapter 55 includes the imaging sheet 53 and the lighting sheet 54.

[0131] According to a non-exclusive embodiment, the adapter 55 is removable from the support element 5. For example, the support element 5 may include an insertion sheet for the adapter 55 at its connecting portion 52.

[0132] According to a further variant, the adapter 55 is connectable to and removable from the interconnecting portion 51 of the support element 5.

[0133] According to a further variant, the connection part 52 defines the adapter 55.

[0134] According to an advantageous aspect of the invention, the guide element 6 comprises a locking member “B”, which is configured to define a plurality of preset positions for holding the support element 5 along the gripping element 4.

[0135] In other words, the support element 5 is configured to move “in jerks” between at least a first locking member “B” and a second locking member “B” directly consecutive to the first one, along the gripping element 4.

[0136] Therefore, the locking members “B” are distributed along the gripping element 4, i.e. along the guide element 6.

[0137] In other words, the support element 5 is configured to move in a “jerk-like” manner between consecutive locking members “B”.

[0138] For example, referring to FIGS. 2, 3, 4, and 6, the locking member “B” may comprise a plurality of protrusions 62, and the support element 5 is a tab “L” (shown in FIGS. 2, 3, 4, and 5), which is intended to seat on the protrusions 62 to define the preset positions of the support element 5 and to slide along the protrusions 62 during the sliding of the support element 5 along the gripping element 4 to define the transition between a first preset position and a second preset position.

[0139] In other words, thanks to the protrusions 62, the support element 5 can move “in jerks” between the preset positions.

[0140] Preferably, as shown in the attached drawings, the protrusions 62 are obtained in the form of teeth arranged inside the channel 61 or in the form of teeth obtained on the rail 6a.

[0141] Advantageously, the position of the protrusion 62 can be adjusted, and the operator can make minimal adjustments during the examination of the patient's fossa.

[0142] More specifically, the support element 5 slides along the gripping element 4 between the insertion position, the imaging position, and the observation position.

[0143] Accordingly, the locking member "B" is configured to define the insertion position, the imaging position, and the observation position for holding the support element 5 along the gripping element 4. In the insertion position, as shown in FIG. 2, the support element 5 is disposed at a distal position with respect to the dilator body 2, particularly with respect to the proximal opening "PO".

[0144] Advantageously, the insertion position enables an easy and facilitated insertion procedure of the dilator body 2 into the patient's fossa. In particular, the operator can insert the dilator body 2 (into the patient's fossa) without being obstructed by the support element 5 and can extract the introducer body 3 upon completion of the insertion of the dilator body 2.

[0145] In the imaging position shown in FIG. 4, the support element 5 is disposed at a proximal position with respect to the dilator body 2, particularly with respect to the proximal opening "PO".

[0146] Accordingly, once the dilator body 2 is inserted into the patient's fossa and once the introducer body 3 is disengaged from the internal volume portion "V", the operator can move the support 5 along the gripping element 4 to the imaging position, connect the inspection assembly 1000, i.e., the imaging device 100 and the lighting device 200, to the support element 5, and image the patient's fossa in an facilitated manner.

[0147] Accordingly, the device 1 advantageously enables an facilitated imaging of the patient's fossa.

[0148] Advantageously, the time associated with the examination of the patient's fossa is shorter.

[0149] At the observation position shown in FIG. 3, the support element 5 is arranged between the insertion position and the imaging position.

[0150] Thus, in order to observe the patient's popliteal fossa with the naked eye, i.e., without the aid of the imaging device 100, the operator can move the support element 5 from the insertion position to the observation position or from the imaging position to the observation position in an easy and facilitated manner.

[0151] Since the imaging device 100 and the lighting device 200 can be removably connected to the support element 5, the operator can remove the imaging device 100 when the support element 5 is in the observation position.

[0152] Advantageously, in addition to facilitating the imaging of the patient's popliteal fossa, the device 1 also enables its (naked-eye) directional observation.

[0153] Thanks to the ability to move the support element 5 between the imaging position and the observation position, the operator can advantageously alternate between a (naked-eye) visual inspection of the patient's popliteal fossa by placing the support element 5 in the observation position and an on-screen inspection (by the imaging device 100) by placing the support element 5 in the imaging position.

[0154] In other words, the device 1 enables a thorough inspection of the patient's popliteal fossa.

[0155] Putting it even more simply, the device 1 enables the patient's popliteal fossa to be inspected using different methods (using the naked eye and the screen).

[0156] To enable proper illumination of the patient's mucosa at both the illumination position and the imaging position, which is actuated by the lighting device 200 connected to the support element 5, the inner surface 231 is preferably embossed so as to deflect or disperse the light beam generated by the lighting device 200.

[0157] More specifically, in order to enable inspections using different methods, the imaging sheets 53 of the support element 5 extend along respective imaging axes "Y" (schematically indicated by arrows in FIG. 4), and the imaging axis "Y" passes through the distal opening "DO" of the dilator body 2 at the imaging position. On the other hand, the illumination sheet 54 extends along respective illumination axes "Z" (schematically indicated by arrows in FIGS. 3 and 4), and the illumination axis "Z" passes through at least the proximal opening "PO" of the dilator body 2 at both the imaging position and the illumination position.

[0158] Preferably, the illumination axis "Z" passes through the distal opening "DO" of the dilator body 2 at both the imaging position and the illumination position.

[0159] In particular, the imaging sheet 53 is configured to receive, by insertion, an imaging device 100 that is oriented along respective imaging directions shown in the same form as the imaging axis "Y" of FIG. 4.

[0160] Thus, according to the embodiment shown in the accompanying drawings, the imaging direction is parallel and coincident with the imaging axis "Y".

[0161] According to a further alternative embodiment not shown in the accompanying drawings, the imaging direction is parallel to but not coincident with the imaging axis "Y", or is incident on the imaging axis "Y".

[0162] The imaging sheet 53 is configured to receive, by insertion, an imaging device 100 that is oriented along respective imaging positions, and the imaging direction passes through the distal opening "DO" of the dilator body 2 and is incident on the longitudinal axis "X" at the imaging position.

[0163] In other words, the imaging direction passes, at least in part, through the interior of the internal volume portion "V" at the imaging position, thereby enabling the operator to image the internal volume portion "V" with the imaging device 100.

[0164] Further, the imaging sheet 53 is configured to receive, by insertion, the imaging device 100 that is oriented along each imaging direction, and the imaging direction does not pass through the distal opening "DO" of the dilator body 2 nor is it incident with respect to the longitudinal axis "X" at the insertion position.

[0165] Therefore, at the insertion position, the imaging direction is not completely related to the internal volume portion "V", because at that position the operator inserts the device 1 into the interior of the patient's fossa.

[0166] Preferably, the imaging sheet 53 is configured to receive, by insertion, the imaging device 100 that is oriented along each imaging direction, and the imaging direction does not pass through the distal opening "DO" of the dilator body 2 nor is it incident with respect to the longitudinal axis "X" even at the observation position.

[0167] Therefore, at the observation position, the imaging direction is preferably not completely related to the internal volume portion "V", because at that position the operator observes the internal volume portion "visually" (without the assistance of the imaging device 100).

[0168] Referring to the illumination sheet 54, it is configured to receive, by insertion, the illumination device 200 that is oriented along each illumination position, in the same manner as the illumination axis "Z" shown in FIGS. 3 and 4.

[0169] Therefore, according to the embodiment shown in the accompanying drawings, the illumination direction is parallel and coincident with the illumination axis "Z".

[0170] According to a further alternative embodiment shown in the accompanying drawings, the illumination direction is parallel to but not coincident with the illumination axis "Z", or is incident with respect to the illumination axis "Z".

[0171] The illumination sheet 54 is configured to receive by insertion an illumination device 200 that is oriented along each illumination direction, the illumination direction passing through the distal opening "DO" of the dilator body 2 and, at the imaging position and the illumination position, being incident with respect to the longitudinal axis "X".

[0172] In other words, the illumination direction passes at least partially through the interior of the internal volume portion "V" at the imaging position and the observation position, thereby enabling the operator to illuminate the internal volume portion "V" with the illumination device 200.

[0173] Also, the illumination sheet 54 is configured to receive by insertion an illumination device 200 that is oriented along each illumination direction, and the illumination direction, at the insertion position, either does not pass through the distal opening "DO" of the dilator body 2 or is not incident with respect to the longitudinal axis "X".

[0174] Accordingly, at the insertion position, the illumination direction is not completely related to the internal volume portion "V", because at that position the operator inserts the device 1 into the patient's fossa.

[0175] The term "completely extraneous" is intended to mean that the imaging / illumination direction does not pass through the interior of the internal volume portion "V".

[0176] The present invention also provides a kit for examining the fossa.

[0177] The kit includes the device 1 and an inspection assembly 1000, i.e., an imaging device 100 and an illumination device 200.

[0178] Preferably, the imaging device 100 is in the form of an optical fiber camera.

[0179] Preferably, the illumination device 200 is fabricated in the form of an optical fiber illuminator.

[0180] The kit further comprises a portable battery 300 that is connected to or connectable to the imaging device 100 and / or the illumination device 200, for example by a dedicated cable.

[0181] Preferably, the portable battery 300 is connected to or connectable to both the imaging device 100 and the illumination device 200.

[0182] For example, the battery 300 is the battery of a portable device such as a computer or a tablet, which enables the kit to be used for multiple purposes.

[0183] Advantageously, the portable battery 300 reduces the cost of the kit and enables it to be used easily.

[0184] Furthermore, since the portable battery 300 is external and separate from the internal volume portion "V" of the dilator body 2, it does not need to be discarded after each use, and thus the kit is sustainable.

[0185] According to one aspect of the present invention, thanks to the support element 5, in the use configuration where the imaging device 100 and the illumination device 200 are connected to the support element 5, the center of gravity of the kit is located proximal to the support element 5.

[0186] Thus, advantageously, the kit enables the operator to support and move the kit in an easy manner.

[0187] Advantageously, the present invention is capable of overcoming the drawbacks appearing in the prior art.

[0188] Advantageously, thanks to the support element 5 and the guide element 6, the device 1 enables easy examination of the patient's popliteal fossa, while at the same time making it possible to carry out the patient's examination in a form that is not very uncomfortable and with limited time.

[0189] In addition, advantageously, the device 1 enables easy adjustment of the positions of the imaging device 100 and the lighting device 200, which is, for example, thanks to the locking member "B" provided with the protrusion 62.

[0190] Furthermore, the device 1 and the above kit are sustainable.

Claims

1. A device (1) for examining the cavity, wherein the device (1) is A dilator body (2), wherein the dilator body (2) has a general extension along the longitudinal axis (X) between a proximal end (21) and a distal end (22), the proximal end (21) and the distal end (22) are connected by a side wall (23) and together with the side wall (23) define an internal volume portion (V), the proximal end (21) identifies a proximal opening (PO), and the distal end (22) identifies a distal opening (DO) for access from the internal volume portion (V) to the tissue defining the boundary of the cavity, An introducer body (3), wherein the introducer body (3) is removable and applicable to the dilator body (2) when in use, and in particular, the introducer body (3) is slidably inserted into the internal volume portion (V) through the proximal opening (PO) and disengaged from the internal volume portion (V), A gripping element (4) having an elongated shape, wherein the gripping element (4) is applied to or can be applied to the proximal end (21) of the dilator body (2), the gripping element (4) is positioned to be transverse to the longitudinal axis (X), and the gripping element (4) is grippable by an operator, In the device (1) comprising, The device (1) includes a support element (5) configured to establish a reversible connection with the inspection assembly (1000), The support element (5) is positioned outside the internal volume portion (V) defined by the dilator body (2) in order to support the inspection assembly (1000) from the outside of the internal volume portion (V). The support element (5) is connected to the gripping element (4) and is movable along the gripping element (4) toward and / or toward the proximal end (21). The device (1) is characterized in that the inspection assembly (1000) comprises at least one imaging device (100) and at least one illumination device (200).

2. The device (1) according to claim 1, further comprising a guide element (6) positioned on the gripping element (4), wherein the guide element (6) is configured to guide the movement of the support element (5) along a predetermined path extending along the gripping element (4).

3. The device (1) according to claim 2, wherein the guide element (6) is defined on the gripping element (4), and preferably the guide element (6) is in the form of at least one rail (6a) defined on the gripping element (4).

4. The device (1) according to claim 2, wherein the guide element (6) is applied to the gripping element (4) in a removable manner, and preferably the guide element (6) is in the form of at least one rail (6a) that is applied to or can be applied to the gripping element (4) in a removable manner.

5. The guide element (6) defines a channel (61) that defines the boundary of the pre-set path, and the support element (5) An interconnection portion (51) is inserted into the channel (61) and slides along the channel (61), The device (1) according to claim 2, comprising: a connecting portion (52) extending across the channel (61) or the interconnecting portion (51) and configured to support the inspection assembly (1000).

6. The device (1) according to claim 2, wherein the guide element (6) is provided with a locking member (B), the locking member (B) is configured to determine a plurality of preset positions for holding the support element (5) along the gripping element (4), and preferably the locking member (B) is provided with a plurality of protrusions (62).

7. The support element (5) is aligned with the gripping element (4), An insertion position in which the support element (5) is positioned distal to the proximal opening (PO) of the dilator body (2), A shooting position in which the support element (5) is positioned proximal to the proximal aperture (PO) of the dilator body (2), The device (1) according to claim 1, wherein the observation position is the observation position, and the support element (5) is positioned between the insertion position and the imaging position, and slides between the observation position and the imaging position.

8. The aforementioned support element (5) is A photographic sheet (53), which is configured to receive the photographic device (100) by insertion when in use, The device (1) according to claim 1, comprising: an illumination sheet (54) configured to receive the illumination device (200) by insertion when in use.

9. The device (1) comprises a guide element (6) positioned on the gripping element (4), wherein the guide element (6) is configured to guide the movement of the support element (5) along a predetermined path extending along the gripping element (4), The guide element (6) defines a channel (61) that defines the boundary of the pre-set path, and the support element (5) An interconnection portion (51) is inserted into the channel (61) and slides along the channel (61), A connecting portion (52) extends across the channel (61) or the interconnecting portion (51) and is configured to support the inspection assembly (1000), and, The device (1) according to claim 8, wherein the imaging sheet (53) and the illumination sheet (54) are located on the connecting portion (52) and penetrate the connecting portion (52).

10. The support element (5) is along the gripping element (4), An insertion position in which the support element (5) is positioned distal to the proximal opening (PO) of the dilator body (2), A shooting position in which the support element (5) is positioned proximal to the proximal aperture (PO) of the dilator body (2), The observation position, wherein the support element (5) is positioned between the insertion position and the imaging position, and slides between the observation position and the imaging position. The imaging sheet (53) extends along each imaging axis (Y), and the imaging axis (Y) passes through the distal opening (DO) of the dilator body (2) at the imaging position. The device (1) according to claim 8, wherein the illumination sheet (54) extends along each illumination axis (Z), and the illumination axis (Z) passes through at least the proximal aperture (PO) of the dilator body (2) at both the imaging position and the illumination position, preferably the illumination axis (Z) also passes through the distal aperture (DO) of the dilator body (2).

11. The imaging sheet (53) is configured to receive, by insertion, the imaging device (100) of the inspection assembly (1000), which is oriented along each of the imaging directions, when in use, and the imaging direction or the imaging axis (Y) is At the aforementioned imaging position, the light passes through the distal opening (DO) of the dilator body (2) and is incident with respect to the longitudinal axis (X), and The device (1) according to claim 10, wherein at the insertion position, the device (1) has not passed through the distal opening (DO) of the dilator body (2) and has not been incident on the longitudinal axis (X).

12. The illumination sheet (54) is configured to have an illumination direction that is parallel to or coincides with the illumination axis (Z) when in use, and is configured to receive the illumination devices (200) of the inspection assembly (1000), which are oriented along each of the illumination directions when in use, by insertion. The illumination direction or illumination axis (Z) is At the aforementioned imaging position and illumination position, the light passes through the distal aperture (DO) of the dilator body (2) and is incident on the longitudinal axis (X), and The device (1) according to claim 10, wherein at the insertion position, the device (1) has not passed through the distal opening (DO) of the dilator body (2) and has not been incident on the longitudinal axis (X).

13. The device (1) according to claim 1, wherein the support element (5) includes an adapter (55) configured to establish a reversible connection with the inspection assembly (1000), and the adapter (55) is removable from the support element (5).

14. A kit for examining the cavity, the kit is A device (1) according to any one of claims 1 to 13, A photographing device (100) and a lighting device (200) are reversibly connected to the support element (5) of the device (1), A kit comprising a portable battery (300) connected to or connectable to the aforementioned imaging device (100) and the aforementioned lighting device (200).

Images