Accessories for diagnostic hysteroscopes

Abstract

A diagnostic hysteroscope accessory is suitable for creating a surgical channel outside the diagnostic hysteroscope. The accessory has an elongated element (1) having a convex profile configured for sliding engagement with the diagnostic hysteroscope sheath (H) in a cross section. The elongated element (1) includes a distal section (10) suitable for providing a passage (14) for a closure or surgical instrument, and a central section (16) forming a duct suitable for continuing the passage (14) through a distal port (21) and a proximal port (20). Additionally, a connector assembly (3) capable of ensuring the continuity of the passage to the duct is provided, and on the opposite side of the duct, a fastening device (4) is provided having at least two tubular tracts (24, 25) angled toward each other and a removable connection means for attaching the elongated element (1) to the main body of the diagnostic hysteroscope.

Description

Technology Field

[0001] The present invention relates to an accessory for a diagnostic hysteroscope. A diagnostic hysteroscope is an outpatient examination that can diagnose all existing pathologies, such as polyps, fibroids, and adhesions, by visualizing the uterine cavity and the hysteroscope tube. The diagnostic hysteroscope essentially has a main body comprising a tubular sheath, an inflatable fluid inlet valve, and an optical system.

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

[0003] When a diagnostic hysteroscopy reveals the presence of a pathology requiring a biopsy, the diagnostic hysteroscopy is no longer sufficient, and the gynaecologist is compelled to extract the tissue and insert a surgical hysteroscope that allows for the insertion of instruments such as biopsy forceps and resectors. The surgical hysteroscope features a sheath containing various ducts useful for operation, in addition to an optical system. However, the gynaecologist must use the operating hysteroscope to locate the pathology requiring surgery. Background Technology

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

[0005] RS 20181531 Al describes a disposable diagnostic surgical hysteroscope made of plastic material. It includes a protective element containing a speculum and a dilator into which the hysteroscope is inserted. The hysteroscope consists of an outer tube associated with a handle and a resection lever with a control ring. At the end of the control ring, an electronic camera, an LED light, an appropriate power supply, interchangeable connectors, and a curette or serrated forceps used for intervention during surgery are secured via an inner silicone tube. Thus, RS 20181531 Al describes a disposable operating hysteroscope.

[0006] AU 2011202811 relates to a surgical instrument, wherein the surgical instrument has a sheath, the sheath accommodates an observation instrument and has a channel dimensioned to be positioned near an optically transparent portion of the bluntly enclosed distal end of the sheath to provide unobstructed observation of the observation instrument through the distal end of the sheath, and to be positioned proximal to the enclosed working area or moved therefrom to provide observation of the enclosed working area.

[0007] CN 109303543 describes electronic hysteroscopy. The problem to be solved

[0008] The object of the present invention is to provide a device that avoids the extraction of a diagnostic hysteroscope from a patient's uterus for the subsequent insertion of a surgical hysteroscope to replace the diagnostic hysteroscope.

[0009] In general, another objective of the present invention is to free obstetricians from surgeries involving trauma to the patient, loss of time, and accuracy in observing pathologies that are often removed. means of solving the problem

[0010] To achieve the aforementioned objective, the present invention provides an accessory for a diagnostic hysteroscope suitable for creating a surgical channel outside the sheath of a diagnostic hysteroscope having a main body, and the accessory is,

[0011] Slender element - The slender element has a convex profile in the cross section configured to allow sliding engagement between the diagnostic hysteroscopic sheath and the slender element, and,

[0012] A distal section capable of providing a passage for an obturator or surgical instrument, and

[0013] Includes a central section forming a duct suitable for continuing a passage through a distal port and a proximal port within the distal section of an elongated element.

[0014] Connector assembly - the connector assembly is designed to ensure passage continuity for the duct and, on opposite sides of the duct, is provided with at least two tubular tracts angled to each other -; and

[0015] A fastening device - the fastening device is provided on a connector assembly and includes a removable connection means for attaching an elongated element to the body of a diagnostic hysteroscope - is included. Brief explanation of the drawing

[0016] Further features and advantages of the present invention will be apparent from the following detailed description of the accessory for a diagnostic hysteroscope. [Fig. 1] is an exploded perspective view of the component parts of an accessory in one embodiment. [Fig. 2] is a greatly enlarged cross-sectional view obtained along line AA of the slender element of the accessory of [Fig. 1]. [Fig. 3] is a greatly enlarged cross-sectional view obtained along the line BB of the slender element of the accessory of [Fig. 1]. [Fig. 4] is a side view of the assembled accessory of the present invention. [Fig. 5] is a longitudinal cross-sectional perspective view of the accessory of [Fig. 4]. [Fig. 6] is an upper plan view of the accessory of [Fig. 4]. [Fig. 7] is a bottom plan view of the accessory of [Fig. 4]. [Fig. 8] is a perspective view of the accessory of the present invention and a diagnostic hysteroscope shown in dotted lines. [Fig. 9] shows a perspective view of the accessory of the present invention in the first coupling step having a diagnostic hysteroscope drawn with a dotted line. [Fig. 10] shows a perspective view of the accessory of the present invention in the second coupling step having a diagnostic hysteroscope drawn with a dotted line. [Fig. 11] shows a side view of an accessory of the present invention coupled to a diagnostic hysteroscope, illustrated with a dotted line. [Fig. 12] shows a perspective view of an accessory of the present invention coupled to a diagnostic hysteroscope shown by a dotted line, and an instrument shown by a dotted line is also inserted into the accessory. Specific details for implementing the invention

[0017] Referring first to [Fig. 1], which is an exploded perspective view of the components of the accessory according to the present invention, it can be seen that it includes an elongated element (1), a connector assembly (3), a fastening device (4), and an obturator (5).

[0018] Additionally, referring to [Fig. 2], which is an enlarged cross-section obtained along line AA of the elongated element (1) in [Fig. 1], it can be seen 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 that surrounds a diagnostic hysteroscope sheath and can be removedly attached thereto.

[0019] This convex profile of the slender element may be limited to at least one pair of pins configured to hold the slender element in the diagnostic hysteroscopic sheath. These pins are indicated as (6) in the distal section (10) of the slender element (1).

[0020] In the illustrated embodiment, more precisely, the distal section (10) of the elongated element (1) has a hollow profile (11) comprising a lower curve (12) having a radius close to the radius of a diagnostic uterine endoscope sheath in cross-section and an upper curve (13) continuous with the lower curve (12). The upper curve (13) has a radius smaller than the radius of the lower curve (12).

[0021] The lower curved portion (12) of the hollow profile (11) is configured to allow sliding coupling of the elongated element (1) and the diagnostic hysteroscope sheath (H) as shown in [Fig. 8], and [Fig. 8] is a perspective view of the accessory of the present invention and the diagnostic hysteroscope shown in dotted lines.

[0022] The lower curve (12) of the hollow profile (11) serves to connect the slender element (1) to the diagnostic hysteroscope sheath (H) by sliding it over the diagnostic hysteroscope sheath (H), as shown in FIGS. 9 and 10. FIGS. 9 and 10 are perspective views of the accessory of the present invention and the diagnostic hysteroscope shown in dashed lines at the first and second joining steps, respectively. It is known that the diagnostic hysteroscope sheaths essentially all have the same diameter of about 4.3 mm. Therefore, the lower curve (12) must accommodate and hold such sheaths.

[0023] Again, referring to [Fig. 2], the upper curved portion (13) of the hollow profile (11) serves to create a passage (14) for a closure (5) or surgical instrument, as will be known later.

[0024] Accordingly, the hollow profile (11) in the distal section (10) of the elongated element (1) has an elliptical shape that is open at the bottom and has opposing tooth-shaped portions (15) on the inside, and is designed to delimit the passage (14) at the bottom and prevent the elongated element (1) from descending onto the diagnostic hysteroscopic sheath (H).

[0025] Now, referring also to [Fig. 3], this is an enlarged cross-sectional view obtained along line BB in the central section (16) of the elongated element (1) in [Fig. 1]. The central section (16) forms a duct suitable for continuing the passage (14) through the distal port (21) in the distal section (10) of the elongated element (1) and the proximal port (20) as shown in [Fig. 7], which is a lower plan view of the accessory of the present invention.

[0026] The central section (16) has a closed profile (17) in cross-section. The closed profile (17) includes an open curve (18) having the same radius as the radius of the lower curve (12) described above at the bottom, and an upper cylindrical section (19) that serves to continue the passage (14) for the closure (5) or surgical instrument at the section center (16) of the elongated element (1). In the central section (16), the passage (14) has a larger radius in the closed profile (17) than the radius of the upper curve (13) of the hollow profile (11). The cross-sectional area of ​​the passage (14) decreases from the proximal end (20) of the central section (16) to the distal port (21), where the passage (14) merges into the hollow profile (11) of the distal section (10).

[0027] Consequently, the central section (16) of the elongated element (1) tapers in the distal direction because the passage (14) has a section that decreases in that direction.

[0028] As illustrated in [Fig. 1], the elongated element (1) has a proximal extension (22) starting from the central section (16). The proximal extension (22) has a profile having an open curve, such as the one indicated by (18) on the closed profile (17) of the distal section (16) in the cross-section, and for this reason is not further illustrated. In addition to the open curve configured to allow sliding coupling of the diagnostic hysteroscope sheath (H) and the elongated element (1), the proximal extension (22) has a sliding guide, such as a dovetail guide, on top for removable coupling of the connector assembly (3).

[0029] The connector assembly (3) is designed to ensure passage continuity with the duct of the central section (16). For this purpose, the connector assembly (3) is provided with a tapered distal tract (23) and, on the opposite side of the duct of the central section (16), two tubular tracts (24, 25) angled toward each other.

[0030] A first tubular tract (24) angled to the elongated element (1) forms an outlet path for the expansion fluid, while a second tubular tract (25) of the connector assembly (3), extending parallel to the elongated element (1) on the opposite side of the distal tract (23) of the same connector assembly (3), includes an access port (26) for introducing a surgical instrument into the duct of the central section (16) and into the passage (14).

[0031] The access port (26) has a lip check valve (27) to prevent the flow of expansion fluid when the surgical instrument is introduced into the second tubular tract (25).

[0032] The connector assembly (3) has a grooved profile, not shown in detail, suitable for engaging with a dovetail sliding guide provided on the proximal extension (22) of the elongated element (1) at the bottom.

[0033] It should be evident that the removable connection between the connector assembly (3) and the proximal extension (22) of the elongated element (1) is advantageous because the connector assembly (3) can be replaced with a different one as needed. Alternatively, without enjoying this advantage, the connector assembly (3) can be manufactured as one piece with the central section (16), that is, its distal tract (23) is permanently inserted into the proximal end (20) of the central section (16).

[0034] In the case of a rigid connection between the central section (16) and the connector assembly (3), providing a removable connection between the connector assembly (3) and the proximal extension (22) may be unnecessary and therefore may not exist.

[0035] A fastening device (4) is provided on the connector assembly (3). The fastening device (4) is provided with a removable connection means for attaching an elongated element to the body of a diagnostic hysteroscope. Such means must ensure that the accessory does not change position relative to the diagnostic hysteroscope to which it is attached. As illustrated in [Fig. 1], the attachment means may include an adjustable strap (40) configured to wrap around and tighten around the body of the diagnostic hysteroscope, which generally includes an inlet fluid valve and an optical system. For example, the adjustable strap (40) has a notch (41) that can be inserted into a protrusion (42). Alternatively, a hook and loop connection known as Velcro may be used.

[0036] Now, refer to FIGS. 4 to 7, which are side views, longitudinal cross-sectional perspective views, top plans, and bottom plans of the assembled accessory of the present invention, respectively.

[0037] The same reference numerals are used for these drawings. It can be seen that the closure (5) is inserted into the passage (14) which is not shown in the drawings. It can be seen that in the assembled accessories of FIGS. 4 through 6, the proximal extension (22) is absent. Particular reference is made to FIG. 5, which clearly illustrates a connector assembly (3) in which a longitudinal section has a passage (14) within a central section (16) having a proximal port (20) and a distal port (21), and a tubular tract (25) having an access port (26) equipped with a lip check valve (27).

[0038] Referring to [Fig. 7], the hollow profile of the distal section (10) of the elongated element (1), the hollow profile indicated as (11) in [Fig. 2], and the hollow profile of the central section (16) indicated as (17) in [Fig. 3] are shown from below.

[0039] Returning to FIGS. 8 through 10, one can imagine a commercially available diagnostic hysteroscope (H), indicated by a dotted line, being inserted into the uterus of a patient. When a gynecologist recognizes the need to introduce a surgical instrument without removing the diagnostic hysteroscope, he / she can introduce an accessory according to the present invention and slide it onto the diagnostic hysteroscope sheath (H) as shown in FIGS. 9 and 10.

[0040] When the accessory is correctly positioned, as confirmed through the closure device (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 by the dotted line.

[0041] Next, the obstetrician can extract the closure device (5) and intervene, for example, by inserting 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) illustrated by the dotted line. The forceps (P) may also be indicated by the dotted line on the part visible from the outside of the accessory into which it is inserted.

Claims

Claim 1 An accessory for a diagnostic hysteroscope suitable for creating a surgical channel outside the sheath (H) of a diagnostic hysteroscope having a main body, said accessory comprising: an elongated element (1) - said elongated element (1) having a convex profile in its cross section configured to allow sliding engagement between the diagnostic hysteroscope sheath (H) and said elongated element (1), and, - a distal section (10) capable of providing a passage (14) for an obturator or surgical instrument, and - a central section (16) forming a duct suitable for continuing said passage (14) through a distal port (21) and a proximal port (20) within said distal section (10) of said elongated element (1); a connector assembly (3) - said connector assembly (3) is designed to ensure continuity of the passage to said duct, and on the opposite side of said duct, at least angled to each other An accessory characterized by comprising: two tubular tracts; and a fastening device (4) - the fastening device (4) is provided on the connector assembly (3) and has a removable connecting means for attaching the elongated element (1) to the main body of the diagnostic hysteroscope. Claim 2 In claim 1, the duct is an accessory having a reduced section of passage (14) from the proximal port (20) to the distal port (21). Claim 3 In claim 1, the connector assembly (3) is an accessory that is one piece with the central section (16). Claim 4 An accessory according to claim 1, wherein the elongated element (1) comprises a proximal extension (22) starting from the central section (16), and the proximal extension (22) has, in a cross-section, a profile having an open curve at the bottom configured to allow the sliding connection of the diagnostic uterine endoscope sheath (H) and the elongated element (1), and at the top a profile of a sliding guide for the removable connection of the central section (16) and the connector assembly (3). Claim 5 In paragraph 4, the connector assembly (3) is an accessory having a tapered distal tract (23) to be inserted into the proximal port (20) of the central section (16). Claim 6 An accessory according to claim 1, wherein the convex profile of the elongated element is limited to at least one pair of pins (6) configured to hold the elongated element (1) in the diagnostic uterine endoscope sheath (H). Claim 7 In paragraph 4, the connector assembly (3) is an accessory that is one piece with the fastening device (4). Claim 8 An accessory according to claim 1, wherein the removable connecting means of the fastening device (4) surrounds and tightens around the main body of the diagnostic hysteroscope and includes an adjustable strap (40) adapted to prevent sliding of the elongated element (1) relative to the sheath (H) of the diagnostic hysteroscope. Claim 9 In claim 1, the first tubular tract (24) of the connector assembly (3), which is angled with respect to the elongated element (1), forms an outlet path for the expansion fluid, an accessory. Claim 10 An accessory according to claim 1, wherein a second tubular tract (25) of a connector assembly (3) extending parallel to the elongated element (1) includes an access port (26) for introducing a surgical instrument into the duct and into the passage (14). Claim 11 In item 10, the second tubular tract (25) is an accessory having a reduction in cross-section toward the tapered distal tract (23). Claim 12 In item 10, the access port (26) is an accessory having a lip check valve (27) to prevent the expansion fluid from leaking out when a surgical instrument is introduced into the second tubular tract (25). Claim 13 The use of the accessory according to claim 1, wherein the accessory is applied in situ to any commercial diagnostic hysteroscope sheath without removing the diagnostic hysteroscope.

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