WO2025114739A1

WO2025114739A1 - Accessory for diagnostic hysteroscope

Info

Publication number: WO2025114739A1
Application number: PCT/IB2023/061905
Authority: WO
Inventors: Nicolò Morabito; Marco Monti
Original assignee: Ciucci Federica
Current assignee: Ciucci Federica
Priority date: 2023-11-27
Filing date: 2023-11-27
Publication date: 2025-06-05
Anticipated expiration: 2026-05-27

Abstract

A diagnostic hysteroscope accessory is suitable to create an operating channel external to a diagnostic hysteroscope. The accessory has an elongated element (1) having in transversal cross-section a convex profile configured for a sliding coupling with a diagnostic hysteroscope sheath (H). The elongated element (1) includes a distal section (10) suitable for providing a passageway (14) for an obturator or an operating instrument, and a central section (16) forming a duct suitable for continuing said passageway (14) through a distal port (21) and a proximal port (20). Furthermore, a connector assembly (3) is provided, capable of guaranteeing continuity of passage for said duct, and equipped, on the side opposite to said duct, with at least two tubular tracts (24, 25) angled with respect to each other, and a fastening device (4) equipped with removable connection means for attaching the elongated element (1) to the body of the diagnostic hysteroscope.

Description

Title of Invention: ACCESSORY FOR DIAGNOSTIC HYS- TEROSCOPE

Technical Field

[0001] The present invention concerns an accessory for diagnostic hysteroscope. Diagnostic hysteroscopy is an outpatient examination that allows the visualization of the uterine cavity and of the cervical canal, and therefore the diagnosis of any pathologies present such as polyps, myomas, synechiae, etc. A diagnostic hysteroscope essentially has a tubular sheath and a body including a distension liquid inflow valve and an optical system.

[0002] During a hysteroscopic examination, a thin optic is used, inserted into the sheath and connected to a camera which is introduced inside the uterine cavity dilated by the distension liquid. What the diagnostic hysteroscope captures, through its camera and with the help of light source, is visible to all the medical staff on a special external monitor.

[0003] If the diagnostic hysteroscopy reveals the presence of pathologies that require a biopsy, the diagnostic hysteroscope is no longer sufficient and the gynaecologist is forced to extract it and to insert an operating hysteroscope that allows the introduction of instruments such as a biopsy forceps, a resector. The operating hysteroscope has a sheath that contains various ducts useful for the operation in addition to the optical system. However, the gynaecologist has to find again the pathology requiring surgery by the operating hysteroscope.

Background Art

[0004] US 2019/133640 Al provides a simplified and efficient disposable resector that does not require special handling, cleaning and sterilization procedures and medical systems that use them.

[0005] RS 20181531 Al describes a disposable diagnostic surgical hysteroscope made of plastic material. It includes a speculum and a protective element with dilator into which the hysteroscope is inserted. The hysteroscope consists of an external tube associated with a handle and a resector lever with a control ring. At the end of the control ring, an electronic camera, LED lighting, appropriate electrical power supply equipment and interchangeable connections, curette or toothed forceps, used for interventions during surgical operations, are fixed via an internal silicone tube. RS 20181531 Al therefore describes a disposable operational hysteroscope.

[0006] AU 2011202811 relates to a surgical instrument having a sheath with a channel dimensioned to receive a viewing instrument and enable the viewing instrument to be moved to or from a position near an optically transparent portion of a blunt, enclosed distal end of the sheath to provide unobstructed viewing through the distal end, and a position to the proximal side of an enclosed working area to provide viewing of the enclosed working area.

[0007] CN 109303543 describes an electronic hysteroscope.

Summary of Invention

[0008] The purpose of the present invention is to provide a device that avoids the extraction of the diagnostic hysteroscope from the uterus of a patient for the subsequent insertion of an operating hysteroscope to replace the diagnostic hysteroscope.

[0009] In general, another purpose of the invention is to free a gynaecologist from operations that involve trauma for the patient, loss of time and often of accuracy in observing the pathology to be removed.

[0010] In order to achieve the abovementioned purpose, the invention provides an accessory for diagnostic hysteroscope suitable for creating an operating channel external to a sheath of a diagnostic hysteroscope having a body, the accessory comprising:

[0011] an elongated element having in a transversal cross-section a convex profile configured so as to allow the sliding coupling of the elongated element with the diagnostic hysteroscope sheath and including:

[0012] - a distal section capable of providing a passageway for an obturator or an operating instrument, and

[0013] - a central section forming a duct suitable for continuing said passageway through a distal port in said distal section of the elongated element, and a proximal port;

[0014] a connector assembly designed to ensure continuity of passage for said duct, and equipped, on the side opposite to said duct, with at least two tubular tracts angled with respect to each other, and

[0015] a fastening device, provided on said connector assembly and equipped with removable connection means for attaching the elongated element to the body of the diagnostic hysteroscope.

Brief Description of Drawings

[0016] Further features and advantages of the invention will be evident from the following detailed description of an accessory for diagnostic hysteroscope, in which:

[0017] [Fig.1] [Fig.1] is an exploded perspective view of the component parts of the accessory in an embodiment thereof;

[0018] [Fig.2] [Fig.2] is a greatly enlarged cross section obtained along the line A-A of an elongated element of the accessory in [Fig.l];

[0019] [Fig.3] [Fig.3] is a greatly enlarged cross section obtained along the line B-B of the elongated element of the accessory in [Fig.l]; [0020] [Fig.4] [Fig.4] is a side view of the assembled accessory of the present invention;

[0021] [Fig.5] [Fig.5] is a longitudinally cross-sectioned perspective view of the accessory in

[Fig.4];

[0022] [Fig.6] [Fig.6] is a top plan view of the accessory in [Fig.4];

[0023] [Fig.7] [Fig.7] is a bottom plan view of the accessory in [Fig.4];

[0024] [Fig.8] [Fig.8] is a perspective view of the accessory of the present invention and of a diagnostic hysteroscope shown with dotted lines;

[0025] [Fig.9] [Fig.9] shows a perspective view of the accessory of the present invention in a first coupling phase with the diagnostic hysteroscope shown with dotted lines;

[0026] [Fig.10] [Fig.10] shows a perspective view of the accessory of the present invention in a second coupling phase with the diagnostic hysteroscope shown with dotted lines;

[0027] [Fig.1 l][Fig.11] shows a side view of the accessory of the present invention coupled to the diagnostic hysteroscope shown with dotted lines; and

[0028] [Fig.12] [Fig.12] shows a perspective view of the accessory of the present invention coupled to the diagnostic hysteroscope shown with dotted lines, an instrument, also shown with dotted lines, being inserted into the accessory.

Description of an Embodiment of the Invention

[0029] Referring initially to [Fig.l], which is an exploded perspective view of the component parts of the accessory according to the invention, it can be seen that it includes an elongated element 1, a connector assembly 3, a fastening device 4 and an obturator 5.

[0030] Also referring to [Fig.2] which is an enlarged transversal cross-section obtained along the line A-A of the elongated element 1 in [Fig.l], it can be noted that the elongated element 1 has a distal section 10, a central section 16 and a proximal extension 22. At the bottom, the elongated element 1 must have a convex profile capable of surrounding the diagnostic hysteroscope sheath and being removably attached to it.

[0031] This convex profile of elongated element can be limited to at least one pair of fins configured so as to retain the elongated element to the diagnostic hysteroscope sheath. These fins are indicated as 6 in the distal section 10 of the elongated element 1.

[0032] More precisely in the embodiment shown, the distal section 10 of the elongated element 1 has in cross-section a hollow profile 11 comprising lower curved portions 12, with a radius close to that of a diagnostic hysteroscope sheath, and an upper curved portion 13 in continuation of the lower curved portions 12. The upper curved portion 13 has a smaller radius than that of the lower curved portions 12.

[0033] The lower curved portions 12 of the hollow profile 11 are configured in order to allow sliding coupling of the elongated element 1 with a diagnostic hysteroscope sheath H as shown in [Fig.8], which is a perspective view of the accessory of the present invention and of a diagnostic hysteroscope shown with dotted lines.

[0034] The lower curved portions 12 of the hollow profile 11 serve to connect the elongated element 1 to the diagnostic hysteroscope sheath H by sliding on the latter, as shown in Figs. 9 and 10, which are a perspective view of the accessory of the present invention and of a diagnostic hysteroscope shown with dotted lines, in a first phase and in a second coupling phase, respectively. It is known that diagnostic hysteroscope sheaths essentially all have the same diameter, around 4,3 mm. Therefore, the lower curved portions 12 must be such as to embrace such sheaths and hold onto them.

[0035] Again, with reference to [Fig.2], the upper curved portion 13 of the hollow profile 11 serves to create a passageway 14 for the obturator 5 or for an operating instrument, as will be seen later.

[0036] Therefore, the hollow profile 11 in the distal section 10 of the elongated element 1 has an oval shape open at the bottom and internally equipped with facing teeth 15, designed to delimit the passageway 14 at the bottom and to prevent the elongated element 1 from lowering onto the diagnostic hysteroscope sheath H.

[0037] Now also refer to [Fig.3] which is an enlarged transversal cross-section obtained along the line B-B in the central section 16 of the elongated element 1 in [Fig.l]. The central section 16 forms a duct suitable for continuing the passageway 14 through a distal port 21 in the distal section 10 of the elongated element 1, and a proximal port 20 as shown in [Fig.7], which is a bottom plan view of the accessory of the present invention.

[0038] The central section 16 has a closed profile 17 in transversal cross-section. The closed profile 17 includes at the bottom an open curved portion 18 having a radius equal to that of the lower curved portions 12 mentioned above, and an upper cylindrical portion 19, which also serves to continue, in the section central 16 of the elongated element 1, the passageway 14 for the obturator 5 or for an operating instrument. In the central section 16, the passageway 14 has a radius greater in the closed profile 17 than that of the upper curved portion 13 of the hollow profile 11. The cross-section area of the passageway 14 is decreasing starting from the proximal end 20 of the central section 16 up to the distal port 21, where the passageway 14 merges into the hollow profile 11 of the distal section 10.

[0039] Consequently, the central section 16 of the elongated element 1 is tapered in the distal direction because the passageway 14 has a decreasing section in that direction.

[0040] As shown in [Fig.l], the elongated element 1 has a proximal extension 22 starting from the central section 16. The proximal extension 22 has in transversal cross-section a profile equipped with an open curved portion like the one indicated as 18 in the closed profile 17 of the distal section 16, and for this reason not shown further. In addition to the open curved portion, configured so as to allow the sliding coupling of the elongated element 1 with the diagnostic hysteroscope sheath H, the proximal extension 22 is equipped at the top with a sliding guide, for example a dovetail guide, for the removable coupling of the connector assembly 3.

[0041] The connector assembly 3 is designed to guarantee continuity of passage with the duct of the central section 16. For this purpose, the connector assembly 3 is equipped with a distal tract 23, that is tapered, and, on the side opposite the duct of the central section 16, with two tubular tracts 24, 25 angled to each other.

[0042] The first tubular tract 24, angled with respect to the elongated element 1, constitutes an exit route for a distension liquid, while the second tubular tract 25 of the connector assembly 3, extending parallel to the elongated element 1, on the opposite side to the distal tract 23 of the same connector assembly 3, includes an access port 26 for introducing an operating instrument into the duct of the central section 16 and into the passageway 14.

[0043] The access port 26 has a lip check valve 27 to prevent the flow of the distension liquid when an operating instrument is introduced into said second tubular tract 25.

[0044] The connector assembly 3 has, at the bottom, a grooved profile, not shown in detail, suitable for combining with the dovetail sliding guide provided on the proximal extension 22 of the elongated element 1.

[0045] It should be evident that the removable coupling between the connector assembly 3 and the proximal extension 22 of the elongated element 1 is advantageous because it allows the replacement of the connector assembly 3 with a different one as needed. Alternatively, without enjoying this advantage, it is possible that the connector assembly

3 can be made in one piece with the central section 16, i. e. its distal tract 23 is permanently inserted into the proximal end 20 of the central section 16.

[0046] In the case of a rigid coupling of the connector assembly 3 with the central section 16, it may be superfluous to provide the removable connection between the connector assembly 3 and the proximal extension 22, and therefore this may not be present.

[0047] The fastening device 4 is provided on the connector assembly 3. The fastening device

4 is equipped with removable connection means for attaching the elongated element to the body of the diagnostic hysteroscope. These means must ensure that the accessory does not change its position with respect to the diagnostic hysteroscope to which it is connected. As shown in [Fig.l], the attachment means may comprise an adjustable strap 40 adapted to encircle and tighten around the diagnostic hysteroscope body, which usually includes an inflow liquid valve and an optical system. By way of example, the adjustable strap 40 has notches 41 which can be inserted into a projection 42. Alternatively, a hook and loop connection known as Velcro can be used.

[0048] Now refer to Figs. 4 to 7 which are a side view, a longitudinally cross-sectioned perspective view, a top plan view and, respectively, a bottom plan view of the assembled accessory of the present invention.

[0049] The same reference numerals are used for these figures. It can be noted that the obturator 5 is inserted in the passageway 14 not shown in the figures. It can be noted that in the assembled accessory in Figs. 4 to 6 the proximal extension 22 is absent. With particular reference to [Fig.5] in which the longitudinal section clearly shows the passageway 14 in the central section 16 with its proximal port 20 and its distal port 21 and the connector assembly 3 in which the tubular tract 25 is shown with access port 26 equipped with a lip check valve 27.

[0050] With reference to [Fig.7], the hollow profile is shown, seen from below, of the distal section 10 of the elongated element 1, hollow profile that is indicated as 11 in [Fig.2], and that, indicated as 17 in [Fig.3], of the central section 16.

[0051] Returning to Figs. 8 to 10, one can imagine that the commercial diagnostic hys- teroscope H, represented with dotted lines, is inserted into the patient's uterus. If the gynaecologist recognizes the need to introduce an operating instrument, without being obliged to remove the diagnostic hysteroscope, he/she can introduce the accessory according to the invention, sliding it onto the diagnostic hysteroscope sheath H as shown in Figs. 9 and 10.

[0052] When the accessory has been positioned correctly, as verified through the obturator 5, the accessory can be locked onto the diagnostic hysteroscope H as shown in [Fig.11] , which is a side view of the accessory of the present invention coupled to the diagnostic hysteroscope shown with dotted lines.

[0053] Subsequently, the gynaecologist can intervene by extracting the obturator 5 and inserting, for example, a forceps P, as shown in [Fig.12] which is a perspective view of the accessory of the present invention coupled to the diagnostic hysteroscope H shown with dotted lines. The P forceps is also represented with a dotted line in the part visible outside the accessory where it is inserted.

Claims

[Claim 1] 1. An accessory for diagnostic hysteroscope suitable for creating an operating channel external to a sheath (H) of a diagnostic hysteroscope having a body, characterized in that the accessory comprises: an elongated element (1) having in a transversal cross-section a convex profile configured so as to allow the sliding coupling of the elongated element (1) with the diagnostic hysteroscope sheath (H) and including:

- a distal section (10) capable of providing a passageway (14) for an obturator or an operating instrument, and

- a central section (16) forming a duct suitable for continuing said passageway (14) through a distal port (21) in said distal section (10) of the elongated element (1), and a proximal port (20); a connector assembly (3) designed to ensure continuity of passage for said duct, and equipped, on the side opposite to said duct, with at least two tubular tracts (24, 25) angled with respect to each other, and a fastening device (4), provided on said connector assembly (3) and equipped with removable connection means for attaching the elongated element (1) to the body of the diagnostic hysteroscope.

[Claim 2] 2. The accessory according to claim 1, wherein said duct has a decreasing section of passageway (14) from said proximal port (20) to said distal port (21).

[Claim 3] 3. The accessory according to claim 1, wherein said connector assembly (3) is in one piece with said central section (16).

[Claim 4] 4. The accessory according to claim 1, wherein said elongated element

(1) includes a proximal extension (22) starting from said central section (16), having in transversal cross-section a profile equipped at the bottom with an open curved portion configured in such a way to allow the sliding coupling of the elongated element (1) with the diagnostic hysteroscope sheath (H), and, above, of a sliding guide for the removable coupling of said connector assembly (3) with said central section (16).

[Claim 5] 5. The accessory according to claim 4, wherein said connector assembly (3) has a tapered distal tract (23) to be inserted into said proximal port (20) of said central section (16).

[Claim 6] 6. The accessory according to claim 1, wherein said convex profile of elongated element is limited to at least one pair of fins (6) configured so as to retain the elongated element (1) to said diagnostic hysteroscope sheath (H).

[Claim 7] 7. The accessory according to claim 4, wherein said connector assembly (3) is in one piece with said fastening device (4).

[Claim 8] 8. The accessory according to claim 1, wherein said removable connection means of the fastening device (4) comprises an adjustable strap (40) adapted to encircle and tighten around said diagnostic hys- teroscope body and to prevent sliding of the elongated element (1) with respect to said diagnostic hysteroscope sheath (H).

[Claim 9] 9. The accessory according to claim 1, in which a first tubular tract (24) of the connector assembly (3), angled with respect to the elongated element (1), constitutes an exit route for a distension liquid.

[Claim 10] 10. The accessory according to claim 1, wherein a second tubular tract

(25) of connector assembly (3), extending parallel to said elongated element (1), includes an access port (26) for introducing an operating instrument into said duct and in said passageway (14).

[Claim 11] 11. The accessory according to claim 10, wherein said second tubular tract (25) has a reduction in section towards said tapered distal tract (23).

[Claim 12] 12. The accessory according to claim 10, wherein said access port (26) has a lip check valve (27) to prevent the outflow of the distension liquid when an operating instrument is introduced into said second tubular tract (25).

[Claim 13] 13. A use of the accessory according to claim 1, characterized in that the accessory is applied in situ to any commercial diagnostic hys- teroscopy sheath without removing the diagnostic hysteroscope.