Device for inspecting cavity

Abstract

A device for examining a cavity includes: a dilator body extending predominantly along a longitudinal axis between a proximal end and a distal end, the proximal end and the distal end being connected by a sidewall and defining an interior volume with the sidewall; a proximal end defining a proximal end opening and connected to the gripping element, the proximal end being couplable with a detection device; the distal end defines a distal end opening for contacting tissue defining an orifice from the interior volume; the side wall comprises at least one side opening connecting the internal volume with an external environment; a guide body having a gripping portion that can be contacted or gripped by an operator, the gripping portion being connected to the insertion portion; the insertion portion has an elongated extension extending along a longitudinal axis between the insertion end and the intermediate portion; the shape of the insertion part is suitable for being introduced into the internal volume through the side opening of the dilator body in the transverse direction; the shape of the insert portion is adapted to move within the interior volume parallel to the longitudinal axis between an initial stroke position and an end stroke position.

Description

Technical Field

[0001] The present invention relates to a device for examining a cavity. Background Art

[0002] The present invention is advantageously applied in the field of pathological diagnosis related to cavities or orifices of human, natural or surgically obtained origin, the diagnosis being carried out by visual inspection of the tissues delimiting said cavity and said orifice.

[0003] In particular, but not exclusively, the present invention is advantageously applied in the field of anorectal and vaginal examinations: thus, the object of the present invention preferably, but not exclusively, has alternative embodiments of anoscope, proctoscope, endoscope and vaginal speculum.

[0004] Inspection devices including a dilator body and a guide body are known in the prior art: the dilator body is hollow and has a tubular extension between a distal opening and a proximal opening, the distal opening being for visual and operative access to the mucosa delimiting the cavity, and the proximal opening being accessible to the operator during use; the guide body also has a tubular extension located between a generally pointed distal end and a proximal end graspable by the operator.

[0005] The guide body is configured to be coupled to the dilator body by sliding the guide body within the dilator body until the pointed end of the guide body projects from the distal end of the dilator body, obtaining an outer wall shaped to facilitate insertion of the inspection device into the patient's cavity.

[0006] During the examination, after the dilator body and the guide body are coupled, the operator inserts the inspection device into the patient's cavity and then withdraws the guide body from the dilator body, keeping the dilator body inserted into the cavity, thereby allowing visual observation and mucosal examination through the distal opening of the dilator body.

[0007] The dilator body in the prior art can be coupled to a detection instrument, such as a camera, in various ways, the detection instrument being configured to detect images from the cavity being examined: once the dilator body is correctly positioned in the patient's cavity, the operator makes the said coupling.

[0008] The patent application number EP3329834 of the same applicant shows a proctoscope including the said dilator body and the said guide body. Specifically, the guide body is configured to be inserted through the proximal opening of the dilator body until a fully inserted configuration is achieved, with the pointed distal end projecting from the distal opening of the dilator body.

[0009] In addition, the dilator body has a coupling device at the proximal opening, which is configured to couple an adapter body adapted to connect a detection device, such as the aforementioned camera for detecting images of the anorectal cavity: once positioned, the camera is substantially coaxial with the extension axis of the tubular body.

[0010] The patent application also describes a method of examining the anus, including the steps of: inserting a dilator body coupled to a guiding body; withdrawing the guiding body through the proximal opening of the dilator body; coupling the adapter body to the coupling device located at the proximal opening; and finally, connecting the detection device to the adapter body.

[0011] However, the shown rectoscope and the steps described above are necessarily subject to improvement.

[0012] Specifically, the shown rectoscope can be improved in terms of the assembly of the examination device to facilitate such assembly by the operator; in addition, the rectoscope can also be improved such that the step of coupling the rectoscope with the detection device is more comfortable for the patient. Summary of the Invention

[0013] The technical task of the present invention is to provide a device for examining a cavity that can overcome the limitations of the prior art.

[0014] Specifically, the object of the present invention is to provide a device for examining a cavity that is easier to use for the operator and can improve the comfort of the patient once inserted into the cavity.

[0015] Another object of the present invention is to provide a device for examining a cavity that is versatile and easy to use.

[0016] The set technical task and the indicated objects are substantially achieved by a device for examining a cavity, which comprises the technical features described in one or more of the appended claims.

[0017] The dependent claims correspond to possible embodiments of the present invention. Brief Description of the Drawings

[0018] Further features and advantages of the present invention will become more apparent from the following indicative but non-limiting description of a preferred but non-exclusive embodiment of the device for examining a cavity, as shown in the drawings, wherein:

[0019] Figure 1 A side view of the device for examining a cavity according to the present invention in a disassembled configuration is shown;

[0020] Figure 2 Shows Figure 1 an isometric rear view of the examination device

[0021] Figure 3 Shows an isometric view from below of the device for inspecting a cavity according to the present invention in an assembled configuration;

[0022] Figure 4 Shows Figure 3 a side view of the inspection device of Detailed Description

[0023] The object of the present invention is a device 1 for an operator to inspect a cavity. The device 1 is preferably an anoscope or endoscope for inspecting the anal or rectal cavity of a patient. Alternatively, the device 1 is a vaginal speculum for inspecting the vaginal cavity of a patient. However, devices suitable for inspecting different cavities, whether natural or surgically obtained, within a patient's body are not excluded.

[0024] The terms "distal" and "proximal" will be used in the description. These terms are herein intended with respect to the operator: 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.

[0025] The device 1 according to the present invention includes a dilator body 2 and a guide body 3.

[0026] The dilator body 2 is shaped to be insertable into the cavity of a patient to be inspected. The dilator body has an elongated extension along the longitudinal axis X, which is located between the proximal end 21 and the distal end 22 and is connected by a side wall 23; thus, the side wall 23 is substantially tubular; in a non-exclusive embodiment, the side wall 23 extends in an expanding manner from the distal end 22 to the proximal end 21 to facilitate the dilation of the cavity to be explored.

[0027] The side wall 23, together with the proximal end 21 and the distal end 22, defines and delimits an internal volume V.

[0028] The proximal end of the dilator body defines a proximal opening PO accessible to the operator, which is traversed by the longitudinal axis X; in a non-exclusive embodiment, the proximal opening PO is coaxial with the longitudinal axis X; similarly, the distal end 22 defines a distal opening DO, preferably coaxial with the longitudinal axis X and configured to allow access to the tissue and mucosa defining the cavity from the internal volume V.

[0029] The proximal opening PO and the distal opening DO have a generally circular shape.

[0030] In addition, the proximal end 21 can be coupled to a detection device (such as a camera) for detecting images from the cavity being explored. Specifically, the proximal end 21 includes one or more hooking portions configured to reversibly constrain the detection device: the detection device is positioned at the proximal opening PO and constrained to the hooking portions, and the detection device turns towards the internal volume V and is operable to detect images, video clips or other parameters of interest to the operator.

[0031] The proximal end 21 is also connected to a grasping element 24, which can be accessed by the operator and can be grasped directly or indirectly by the operator. Preferably, the grasping element 24 is a handle that is inclined at an angle between 0 and 90° relative to the longitudinal axis X in the vertical direction.

[0032] The grasping element 24 can also include one or more hooking portions 26 for coupling to diagnostic and surgical instruments or, in any case, for completing the examination; for example, the grasping element 24 can include a hooking portion 26 for sucking air or other substances from the internal volume V.

[0033] The side wall 23 has at least one side opening LO that connects the internal volume V to the external environment: the side opening LO is preferably located in the proximal portion of the dilator body 2.

[0034] The device 1 according to the present invention further includes a guiding body 3, which has a grasping portion 31 and an insertion portion 32.

[0035] The grasping portion 31 is located at the proximal end of the insertion portion 32 and can be accessed or grasped by the operator: specifically, the shape of the grasping portion 31 allows the operator to easily grasp and manipulate the guiding body 3.

[0036] The insertion portion 32 connected to the grasping portion has an elongated extension along the longitudinal axis X, which is located between a generally pointed insertion end 33 that is away from the grasping portion 31 and an intermediate portion 34 that is proximal to the grasping portion 31.

[0037] The insertion portion 32 is configured to be inserted into the internal volume V defined by the dilator body 2 to obtain an assembled configuration of the device 1, which can be easily inserted into the cavity to be explored.

[0038] In other words, the guiding body 3 is reversibly coupled to the dilator body 2 to introduce the insertion portion 32 into the internal volume V, thereby obtaining the assembled configuration of the device 1.

[0039] Figure 1 and Figure 2Figure 0 shows the device 1 in a disassembled configuration, which includes a dilator body 2 and a guide body 3. However, for the purpose of facilitating the insertion of the dilator body 2 into the cavity to be explored, the dilator body 2 and the guide body 3 are assembled together to form the device 1. Figure 3 and Figure 4 Figure 1 shows the device 1 in an assembled configuration, where the guide body 3 is inserted into the dilator body 2.

[0040] Specifically, the assembled configuration is obtained by inserting the guide body 3 along an insertion trajectory into the dilator body 2: First, the insertion portion 32 is introduced into the internal volume V of the dilator body 2 through the side opening LO along the transverse direction Y. Subsequently, the insertion portion 32 moves parallel to the longitudinal axis X between the starting position of the stroke (where the insertion end 33 is close to the side opening LO) and the ending position of the stroke (where the insertion end 33 extends out from the distal opening DO of the dilator body 2).

[0041] Specifically, the insertion trajectory of the guide body 3 into the dilator body 2 includes a first section, which has an extension along the transverse direction Y between a first position and a second position. In the first position, the guide body 3 and especially the insertion portion 32 are located outside the dilator body 2. In the second position, the guide body 3 and especially the insertion end 33 are inserted into the internal volume V defined by the dilator body 2.

[0042] When moving from the first position to the second position, that is, when traveling along the first section of the insertion trajectory, the dilator body and especially the insertion end 33 pass through the side opening LO obtained from the side wall 23. Thus, when reaching the second position, the insertion portion 32 is at least partially inserted into the dilator body 3.

[0043] When the operator moves the guide body 3 along the first section of the insertion trajectory, the guide body 3 changes from a separated configuration to a configuration where it is at least partially inserted into the internal volume V of the dilator body 2.

[0044] At the end of the first section of the insertion trajectory, the insertion end 33 is located near the side opening LO.

[0045] The insertion trajectory further includes a second section, which has an extension substantially parallel to the longitudinal axis X between the starting position of the stroke and the ending position of the stroke. At the starting position of the stroke, the insertion portion 32 is at least partially located inside the dilator body 2 and the insertion end 33 is close to the side opening LO. At the ending position of the stroke, the insertion end 33 extends out of the dilator body 2 through the distal opening DO.

[0046] In other words, by advancing the insertion portion 32 from the starting position of the stroke to the ending position of the stroke, the guide body 3 reaches the ending position of the stroke.

[0047] To obtain the assembled configuration of the device 1, the insertion part 32 has a counter-shaped relative shape with respect to the internal volume V delimited by the side wall 23.

[0048] For example, the substantially cylindrical insertion part 32 corresponds to the substantially cylindrical internal volume V.

[0049] Alternatively, the insertion part 32 with a similar conical shape corresponds to the conical internal volume V.

[0050] The movement of the insertion part 32 between the starting position and the ending position of the stroke preferably occurs by the sliding of the insertion part 32 inside the dilator body 2; specifically, once the inner surface 231 of the side wall 23 that internally delimits the dilator body is defined, the insertion part slides along the inner surface 231 or a part thereof.

[0051] For example but not exclusively, the inner surface 231 may have one or more sliding guides: the insertion part 32 configured to be coupled with the sliding guides is configured to slide between the starting position and the ending position of the stroke along the sliding guides.

[0052] In other words, when the guiding body 3 is inserted into the dilator body 2, the insertion part 32 reaches the ending position of the stroke, and the pointed insertion end 33 projects from the distal opening DO of the dilator body: thus, the device 1 in the assembled configuration has an elongated extension that expands from the insertion end 33 of the guiding body 3 towards the proximal end 21 of the dilator body 2; there are also no steps or discontinuous elements on the outside of the device 1 that may make the insertion and positioning of the device 1 in the patient's cavity unpleasant or cause pain.

[0053] Specifically, in fact, the insertion part 32 has a relative shape with respect to the volume V, which ensures that the device 1 in the assembled configuration does not have the above-mentioned steps or discontinuous elements on the outside. Therefore, the device 1 has a generally pointed and uniform profile on the outside to ensure easy insertion into the patient's cavity.

[0054] In addition, the device 1 according to the present invention may include a locking element for locking the guiding body 3, which reversibly constrains the guiding body 3 to the dilator body 2 when the insertion part 32 of the dilator body 3 reaches the ending position of the stroke: locking elements of known types in the art allow the guiding body to be kept constrained to the dilator body 2 during the insertion of the device 1; in other words, due to the constraint element, the operator can conveniently insert the device 1 with one hand without the risk of the guiding body 3 moving in the direction opposite to the insertion direction with respect to the dilator body 2 during the insertion of the device 1 into the cavity, which is caused by, for example, the resistance exerted by the muscle structure around the patient's cavity.

[0055] Once the operator inserts the device 1 into the patient's cavity, the guiding body 3 is removed from the dilator body 2 along a withdrawal path opposite to the insertion path: first, the insertion part 32 of the guiding body 3 moves from the stroke end position to the stroke start position near the longitudinal opening LO parallel to the longitudinal axis X; then, the insertion part 32 moves in the transverse direction Y through the side opening LO, determining the withdrawal of the insertion part 32 from the internal volume V, thereby removing the guiding body 3 from the dilator body 2.

[0056] Advantageously, the device 1 according to the invention comprises the dilator body 2 having the side opening LO and the guiding body 3, allowing the operator to assemble and disassemble the device 1 quickly, intuitively and easily according to the aforementioned insertion path and the aforementioned withdrawal path respectively.

[0057] Advantageously, the device 1 according to the invention allows the assembly and disassembly of the device 1 without having to remove any hooking parts and / or any detection devices connected to the dilator body 2 at the proximal opening PO before each assembly and disassembly operation and thus before each insertion of the device 1 into the cavity and before each withdrawal of the guiding body 3 from the dilator body 2.

[0058] Therefore, advantageously, the assembly operation of the device 1, the operation of inserting the device 1 into the cavity and the operation of removing the guiding body 3 from the dilator body 2 are faster and more effective for the operator and improve the patient's comfort.

[0059] Inside the device 1, the dilator body 2 and the guiding body 3 can adopt different configurations as long as these configurations allow the assembly to follow an insertion path having a first extension in the transverse direction Y and a second extension along the longitudinal axis X.

[0060] Specifically, the side opening LO and the insertion part 32 can adopt different configurations.

[0061] First, considering that the gripping element 24 is positioned vertically downward, the side opening LO can be located on the right or left side of the proximal opening PO; in addition, the side opening LO can be delimited by an edge 25 and have a generally oval shape or, in any case, be elongated along the longitudinal axis X.

[0062] In Figures 1 to 4 In the preferred embodiment of the device 1 according to the invention shown, the dilator body 2 has two elongated side openings LO obtained from the side wall 23, which are symmetrically arranged with respect to the longitudinal axis X and are arranged transversely with respect to the gripping element 24.

[0063] However, other configurations of the dilator body 2, in particular the side opening LO, are not excluded.

[0064] Similarly, the guiding body 3 may also have a grasping portion 31 and an insertion portion 32 with different three-dimensional shapes.

[0065] In a first embodiment of the guiding body 3, the grasping portion 31 includes a grasping end 311 and a connecting wall 312. The shape of the grasping end facilitates grasping and moving the guiding body 3, and the connecting wall is between the grasping end 311 and the insertion portion 32. Preferably, the connecting wall 312 is inclined at an angle α with respect to the longitudinal axis X, and the angle α is between 0° and 90°.

[0066] In Figures 1 to 4 In the preferred embodiment shown, the guiding body 3 has a grasping portion 31 with two loops 313, the shape of which is suitable for the operator's fingers to insert. Advantageously, the grasping portion 31 with two loops 313 facilitates both the operation of inserting the guiding body 3 into the dilator body 2 along the insertion trajectory and the operation of withdrawing the insertion body 3 from the dilator body 2 along the withdrawal trajectory.

[0067] Therefore, advantageously, Figures 1 to 4 the device 1 in the preferred embodiment is particularly easy to operate, whether in the disassembled configuration and the assembled configuration, or in the transition from the assembled configuration to the disassembled configuration, and vice versa.

[0068] In addition, the guiding body 3 may include at least one stop element 35 configured to signal to the operator that the end-of-travel position has been reached; the stop element 35 may have different configurations and may be located at different positions along the guiding body 3. Preferably, the stop element 35 is located in the middle portion 34.

[0069] In Figures 1 to 4 In the preferred embodiment of the device 1 shown, the guiding body 3 has a stop element 35 including a abutting surface 351 that extends in a substantially vertical plane parallel to the longitudinal axis X; the abutting surface 315 is configured to contact a part of the edge 25 of the side opening LO when the insertion body 3 reaches the end-of-travel position; in other words, the abutting surface 351 prevents the guiding body 3 from being further inserted into the dilator body 2 by contacting the edge 25.

[0070] Those skilled in the art can easily infer other configurations of the abutting surface 351 or the stop element 35, and these others are not excluded either.

[0071] Finally, in an alternative embodiment, the guiding body 3 has an observation opening at the middle portion 34, which is coaxial with the longitudinal axis X and is configured to be able to observe the mucosa and tissue defining the cavity even when the guiding body 3 is inserted into the dilator body 2. Therefore, preferably, both the dilator body and the guiding body are made of a transparent polymer material so as to be able to observe the tissue and the surrounding mucosa.

[0072] In another embodiment, the guiding body 3 may include magnification means at the middle part 34 or the insertion end 33 so as to be able to magnify the observation of the tissue and mucosa defining the cavity; advantageously, due to the presence of the magnification means, the operator can observe more details, thereby improving the inspection quality.

[0073] In summary, compared with the inspection device of the prior art, the device 1 in the said variant is assembled / disassembled faster and easier, and is easier to manage and use for the operator.

[0074] As described above, the inspection device 1 according to the present invention can be advantageously used to facilitate the introduction and inspection of the cavity. The method of using the device 1 may include the following steps:

[0075] - Prepare a dilator body 2 of the type described in the previous paragraph, which has a hooking part for the detection device;

[0076] - Prepare a guiding body 3 of the type described in the previous paragraph;

[0077] - Assemble the device 1 by introducing the guiding body 3 into the dilator body 2 according to the above insertion trajectory;

[0078] - Introduce the device 1 at least partially into the patient's cavity;

[0079] - Withdraw the guiding body 3 from the dilator body 2 according to the above withdrawal trajectory;

[0080] - Inspect the cavity to be probed.

[0081] In addition, the method may include the following steps:

[0082] - Before or after introducing the device 1 into the patient's cavity, connect the detection device to the hooking part at the dilator body 1; and

[0083] - Detect images or other parameters of interest related to the cavity to be explored.

[0084] The method allows to avoid removing any hooking part or other adapter body for the detection device located at the proximal opening PO of the dilator body 2 each time the guiding body 3 is inserted into the dilator body 2 and each time the guiding body 3 is withdrawn from the dilator body 2.

[0085] The hooking part and the possible detection device can be advantageously kept connected to the dilator body 2 during the entire inspection period, starting from the assembly of the device 1 and during the withdrawal of the guiding body 3 from the dilator body 2.

[0086] In summary, it is advantageous that the device 1 simplifies and speeds up the assembly operation and generally makes it more comfortable for the patient and easier for the operator to insert the device 1 into the cavity.

Claims

1. A device (1) for inspecting a cavity, comprising: An expander body (2), mainly extending between a proximal end (21) and a distal end (22) along a longitudinal axis (X), wherein 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 (V); Wherein the proximal end (21) defines a proximal opening (PO) intersecting the longitudinal axis (X), and the proximal end is connected to a grasping element (24), which can be contacted or grasped by an operator, and the proximal end (21) can be coupled to a detection device; Wherein the distal end (22) defines a distal opening (DO) for contacting tissue defining an orifice from the internal volume (V); and Wherein the side wall (23) includes at least one side opening (LO), which connects the internal volume (V) to the external environment, The device (1) further comprises: A guiding body (3), having a grasping portion (31) that can be contacted or grasped by an operator, and the grasping portion is connected to an insertion portion (32); Wherein the insertion portion (32) extends along the longitudinal axis (X) between a generally pointed insertion end (33) and an intermediate portion (34), the insertion end being away from the grasping portion (31), and the intermediate portion being proximal relative to the grasping portion (31), The detection device (1) is characterized in that: The shape of the insertion portion (32) is adapted to be introduced into the internal volume (V) through the side opening (LO) of the expander body (2) along a transverse direction (Y); and The shape of the insertion portion (32) is adapted to move parallel to the longitudinal axis (X) within the internal volume (V) between a stroke start position and a stroke end position, in the stroke start position, the insertion end (33) is close to the side opening (LO), and in the stroke end position, the insertion end (33) protrudes from the distal opening (DO) of the expander body (2).

2. The device (1) according to claim 1, comprising a locking element for locking the guiding body (3), which reversibly restricts the guiding body (3) on the expander body (2) when the insertion portion (32) of the expander body (3) reaches the stroke end position.

3. The device (1) according to claim 1, wherein, The side wall (23) of the expander body is internally defined by an inner surface (231) having a sliding guide portion, and wherein the insertion portion (32) of the guiding body (3) can slide along the sliding guide portion until reaching the stroke end position.

4. The device (1) according to claim 1, wherein, The guiding body (3) includes a stop element (35) for signaling to the operator that the stroke end position has been reached.

5. The device (1) according to claim 4, wherein, The stop element (35) is located at the intermediate portion (34).

6. The device (1) according to claim 4 or 5, wherein, The side opening (LO) of the dilator body is defined by an edge (25), and wherein the stop element (35) includes at least one abutment surface (351) configured to contact a part of the edge (25) when reaching the end-of-travel position, thereby preventing further insertion of the guide body (3) into the dilator body (2).

7. The device (1) according to any one of the preceding claims, wherein, The intermediate portion (34) defines an observation opening coaxial with the longitudinal axis (X).

8. The apparatus according to claim 7, wherein The guide body (3) includes magnification means located at the intermediate portion (34) or the insertion end (33), thereby allowing magnified observation of the tissue defining the cavity.

9. The apparatus according to any one of the preceding claims, wherein, The grasping portion (31) includes a grasping end (311) connected to a connecting wall (312), the grasping end (311) facilitating grasping and moving the guide body (3); and the connecting wall (312) is interposed between the grasping end (311) and the insertion portion (32) and is inclined at an angle (α) with respect to the longitudinal axis (X).

10. The apparatus according to claim 9, wherein The angle (α) is between 0 and 90°.

11. The device according to claim 9 or 10, wherein, The grasping end (311) includes a pair of loops (313) into which the operator's fingers can be inserted.

12. The apparatus according to any one of the preceding claims, wherein, The dilator body (2) and the guide body (3) are made of a transparent polymer material.

13. The device according to claim 1, wherein The grasping element (24) has a hooking portion (26) capable of being coupled to a suction device.

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