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Title:
A SYSTEM OF CURETTAGE OF THE UTERINE CAVITY AND DILATION OF THE CERVICAL CANAL
Document Type and Number:
WIPO Patent Application WO/2016/067233
Kind Code:
A1
Abstract:
A system of curettage of the uterine cavity (11) and dilation of the cervical canal (10), comprising: - a first device (1) for curettage of the uterine cavity, comprising a first elongated tubular body (2) having a head (3) suitable to be introduced into the uterine cavity (11); said head having a member (4) to perform said curettage operation, - and a second device (5) for dilation of the cervical canal (10), comprising a second elongated tubular body (6), having at one of its ends a member (7) for widening the cervical canal (10), - wherein said member (7) for widening the cervical canal (10) has at least one portion (8) which can be expanded at least: from a first idle position (PI), wherein said portion (8) is not expanded and has a first transverse dimension (Tl), to a second operating position (P2), wherein said portion (8) is expanded and has a second transverse dimension (T2), exceeding the first, - wherein the first elongated tubular body (2) and the head (3) of the first curettage device (1) have seats (12, 13) to allow the transit of at least one section of the second elongated tubular body (6) and of the widening member (7) of the second dilation device (5) inside said first elongated tubular body (2) and the head (3), when said expandable portion (8) is in idle position, - and wherein said head (3) of the first curettage device has an opening (31) for allowing at least said expandable portion (8) of the second widening device (5) to come out of said head (3) when said expandable portion (8) is in the idle position PI.

Inventors:
LAVAGNA AMEDEO (IT)
Application Number:
PCT/IB2015/058343
Publication Date:
May 06, 2016
Filing Date:
October 29, 2015
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
GLAM SNC (IT)
International Classes:
A61B17/42; A61B1/303; A61B1/32; A61B17/3207; A61M29/00; A61M29/02
Domestic Patent References:
WO2008027292A22008-03-06
Foreign References:
US5865729A1999-02-02
US3670732A1972-06-20
EP0419154A11991-03-27
US3848602A1974-11-19
US3670732A1972-06-20
US3491747A1970-01-27
US5865729A1999-02-02
US5807282A1998-09-15
US5951490A1999-09-14
Attorney, Agent or Firm:
KRATTER, Carlo (19/B, Milano, IT)
Download PDF:
Claims:
CLAIMS

1 A system of curettage of the uterine cavity (11) and dilation of the cervical canal (10), comprising:

a first device (1) for curettage of the uterine cavity, comprising a first elongated tubular body (2) having a head (3) suitable to be introduced into the uterine cavity (11); said head having a member (4) to perform said curettage operation, and

a second device (5) for dilation of the cervical canal (10), comprising a second elongated tubular body (6), having at one of its ends a member (7) for widening the cervical canal (10),

wherein said member (7) for widening the cervical canal (10) has at least one portion (8) which can be expanded at least: from a first idle position (PI), wherein said portion (8) is not expanded and has a first transverse dimension (Tl), to a second operating position (P2), wherein said portion (8) is expanded and has a second transverse dimension (T2), exceeding the first, characterised in that:

the first elongated tubular body (2) and the head (3) of the first curettage device (1) have seats (12, 13) to allow the transit of at least one section of the second elongated tubular body (6) and of the widening member (7) of the second dilation device (5) inside said first elongated tubular body (2) and the head (3), when said expandable portion (8) is in idle position, and

wherein said head (3) of the first curettage device has an opening (31) for allowing at least said expandable portion (8) of the second widening device (5) to come out of said head (3) when said expandable portion (8) is in the idle position (PI).

2 A system according to claim 1, characterised in that the seats (12, 13) of the first elongated tubular body (2) and of the head (3) of the first curettage device (1) are coaxial to each other.

3 A system according to one of the preceding claims, characterised in that the opening (31) of the head (3) of the first curettage device is provided in a distal end portion (23B) of said head (3).

4 A system according to one of the preceding claims, characterised in that it provides end means (46, 46 A, ) adapted to block the insertion of the second device (5) into the first (1) and make sure that in the end position of the second device (5) the expandable portion (8) of said second widening device (5) protrudes from the opening (31) of the head (3) of the first curettage device (1), so as to ease the correct positioning of the second device into the first.

5 A system according to one of the preceding claims, characterised in that the expandable portion (8) of the second device (5) consists of an inflatable element (8A) sealingly connected in correspondence with its two ends (8B) to the outer surface of the tubular body (6) of said second device (5), in correspondence with the distal end of said tubular body (6), and in that said tubular body (6) has at least one through opening (45) provided in correspondence with said inflatable element, suitable to allow the flow of an inflating fluid through a channel (42) of said elongated tubular body (6) up to said inflatable body, so that said inflatable element can be inflated/deflated by said fluid and its volume can be adjusted.

6 A system according to one of the preceding claims, characterised in that the head (3) of the curettage device (1) provides a proximal body (23A) and a distal body (23B), connected to each other by a plurality of elongated, elastically deformable elements (22),

in that said distal body (23B) comprises the opening (31) suitable to allow at least said expandable portion (8) of the second widening device (5) to come out of said head (3) when said expandable portion (8) is in the idle position (PI).

7 A system according to one of the preceding claims, characterised in that the head (3) of the curettage device (1) provides a through seat (13) which crosses it entirely to allow the transit of said expandable portion (8) when it is in the idle position (PI).

8 A system according to one of the preceding claims, characterised in that the head (3) of the curettage device (1) provides a proximal body (23A) and a distal body (23B), connected to each other by a plurality of elongated, elastically deformable elements (22), and in that said elongated elements (22) are adapted to bend outwards under the action of a force (F) applied coaxially to a longitudinal axis (M) of the head itself, acting on said distal body (23B) and directed towards said proximal body (23 A), and to return to their initial, unbent position when said force (F) is removed.

9 A system according to one of the preceding claims, characterised in that the head (3) of the curettage device (1) provides a plurality of elongated, elastically deformable elements (22), and in that at least one edge (27) of said elongated elements (22) is sharp towards the outside and is suitable to perform the curettage.

10 A system according to one of the preceding claims, characterised in that the head (3) of the curettage device (1) provides a plurality of elongated, elastically deformable elements (22), and in that, at least when bended, said elongated elements (22) delimit at least one opening (28) for the transit of the curetted biological material.

11 A system according to one of the preceding claims, characterised in that the first elongated tubular body (2) of the first device (1) for curettage of the uterine cavity consists of a body having a substantially cylindrical volume, extending from a proximal end (2 A) meant to be held by the gynaecologist during the curettage operations to a distal end (2B) providing the head (3) suitable to be introduced into the uterine cavity (11), in that, at least when the relevant member (4) to perform the curettage is not active, said head has a cylindrical volume having a diameter which is substantially equal to or less than the diameter of said tubular body (2), in that said tubular body (2) is internally hollow and defines the seat (12) for the transit of the second elongated tubular element (6), during the preliminary step and the step of widening the cervical canal and, when said operation is over and the second device (5) is extracted from the first, for the suction of the endometrial material removed during curettage.

12 A device (1) for curettage of the uterine cavity, comprising a first elongated tubular body (2) having a head (3) suitable to be introduced into the uterine cavity (11); said head comprising a member (4) to perform said curettage operation, characterised in that:

said first elongated tubular body (2), said head (3) and said member (4) to perform the curettage have seats (12, 13) to allow the transit of at least one further elongated tubular body (6) having a smaller diameter than said first elongated tubular body and being adapted to allow the flow of a fluid, and in that

said member (4) to perform the curettage has a through opening (31) suitable to allow at least one end portion of said further elongated tubular body (6) to come out of said member (4).

13 A device according to claim 11, characterised in that it has a single body comprising: the first elongated tubular body (2), the head (3) suitable to be introduced into the uterine cavity (11) and the member (4) to perform said curettage operation.

14 A device according to one of claims 11 to 12, characterised in that the seats (12, 13) of the first elongated tubular body (2) and of the head (3) are coaxial to each other.

15 A device according to one of claims 11 to 13, characterised in that the opening (31) of the head (3) of the first curettage device is provided in a distal end portion (23B) of the head (3).

16 A device according to one of claims 11 to 14, characterised in that the head (3) of the curettage device (1) provides a proximal body (23 A) and a distal body (23B), connected to each other by a plurality of elongated, elastically deformable elements (22).

17 A device according to one of claims 11 to 15, characterised in that the head (3) of the curettage device (1) provides a proximal body (23A) and a distal body (23B) connected to each other by a plurality of elongated, elastically deformable elements (22) and in that said elongated elements (22) are adapted to bend outwards under the action of a force (F) applied coaxially to a longitudinal axis (M) of the head itself, acting on said distal body (23B) and directed towards said proximal body (23A), and to return to their initial, unbent position when said force (F) is removed.

18 A device according to one of claims 11 to 16, characterised in that the head (3) of the curettage device (1) provides a plurality of elongated, elastically deformable elements (22) and in that at least one edge (27) of said elongated elements (22) is sharp towards the outside and is suitable to perform the curettage.

19 A device according to one of claims 11 to 17, characterised in that the head (3) of the curettage device (1) provides a plurality of elongated, elastically deformable elements (22) and in that, at least when bended, said elongated elements (22) delimit at least one opening (28) for the transit of the curetted biological material.

20 A device according to one of claims 11 to 18, characterised in that the first elongated tubular body (2) consists of a body having a substantially cylindrical volume, extending from a proximal end (2 A) meant to be held by the gynaecologist during the curettage operations to a distal end (2B) providing the head (3) suitable to be introduced into the uterine cavity (11), in that, at least when the relevant member (4) to perform the curettage is not active, said head has a cylindrical volume having a diameter which is substantially equal to or less than the diameter of said tubular body (2).

21 Method of assembling a system of curettage of the uterine cavity (11) and dilation of the cervical canal (10) according to one or more of claims 1 to 11, which provides:

assembling the system by introducing the second dilation device (5) into the first curettage device (1), so that the expandable portion (8) of the second device (5) protrudes for its entire length from the head (3) of the first device (1), through an opening (31) provided in said head of the first device.

22 Use of a system of curettage of the uterine cavity (11) and dilation of the cervical canal (10) according to one or more of claims 1 to 11, which provides:

assembling the system by introducing the second dilation device (5) into the first curettage device (1), so that the expandable portion (8) of the second device (5) protrudes for its entire length from the head (3) of the first device (1), through an opening (31) provided in said head of the first device,

introducing into the cervical canal the expandable portion (8) of the second device (5), laying on the outer neck (10 A) of the cervical canal a distal end portion (23B) of the head (3) of the first device (1),

inflating the expandable portion (8) and accordingly dilating the cervical canal to the desired dimensions,

deflating the expandable portion (8), so as to restore the initial, unexpanded shape of said expandable portion,

extracting the second device (5) from the first (1), keeping said first device (1) into the patient's body,

pushing the head (3) of the first device (1) through the dilated cervical canal inside the uterine cavity up to contact with the bottom of the uterus (11),

and/or exerting such a pressure as to allow the elongated elements (22) to open in the position provided for the curettage,

and performing the curettage by rotating the instrument.

23 Use of a system of curettage of the uterine cavity (11) and dilation of the cervical canal (10) according to one or more of claims 1 to 11, which provides:

introducing into the cervical canal an expandable portion (8) of a second dilation device (5), laying on the outer neck (10 A) of the cervical canal a distal end portion (23B) of a head (3) of a first curettage device (1),

inflating an expandable portion (8) and accordingly dilating the cervical canal to the desired dimensions,

deflating the expandable portion (8), so as to restore the initial, unexpanded shape of said expandable portion,

extracting the second dilation device (5) from the first curettage device (1), keeping said first device (1) into the patient's body.

24 Use of a system of curettage of the uterine cavity (11) and dilation of the cervical canal (10) according to the preceding claim, characterised in that:

it pushes the head (3) of the first curettage device (1) through the dilated cervical canal inside the uterine cavity up to contact with the bottom of the uterus (11), and in that it performs the curettage by rotating the instrument.

25 Use of a system of curettage of the uterine cavity (11) and dilation of the cervical canal (10) according to one or more of claims 22 to 23, characterised in that it exerts such a pressure as to allow the elongated elements to open in the position provided for the curettage, and in that it performs the curettage by rotating the instrument.

Description:
A SYSTEM OF CURETTAGE OF THE UTERINE CAVITY AND DILATION OF THE CERVICAL CANAL

The object of the present invention is a system of curettage of the uterine cavity and dilation of the cervical canal according to the pre-characterising part of the main claim. It is known that in order to clean the uterine cavity it is necessary to previously dilate the cervical canal and then accomplish the curettage of the endometrium and the suction of the removed material.

It is known how to perform this operation in successive stages, with a number of instruments ranging from six to ten and with a long procedure, involving the risk of lacerations and perforations of the anatomical structures concerned.

The current method to achieve the dilation of the uterine cervical canal is based on the use of a plurality of dilating instruments having an increasingly growing diameter, named Hegar dilators, consisting of chrome -plated steel sounds having a conical tip and a central curvature, with diameters ranging from 0.5 mm to 30 mm for a single dilator. Once the orifice of the cervical canal becomes visible by means of a vaginal speculum, before dilating said canal the gynaecologist assesses the uterine depth by means of an instrument named hysterometer. The gynaecologist then introduces the first Hegar dilator compatible with the diameter of the cervical canal and with the stretchiness of the uterine orifice. The transition to larger-sized sounds occurs gradually, leaving each dilator in place until it can be easily extracted. The possibility to remove the dilator effortlessly shows that the cervical canal is dilated.

A curettage surgical operation as a rule requires a dilation of about 10-12 mm, in particular cases up to 18 mm.

The known dilation methods have both immediate and secondary drawbacks, connected with the force which must be exerted by the operator on the dilating instruments and with the perception said operator must have of reaching the bottom area of the uterus. Ultimately, the success of the above method decisively depends on the operator's expertise and manual skill. In actual fact, if not handled properly, Hegar dilators may cause several troubles, the most frequent being: cervical laceration as a result of abrupt or excessive stretching of the cervical canal, wounds of the sphincter fibres at the level of the outer cervical orifice, perforation of the uterine wall due to the abrupt transit of the dilator through the cervical canal and its reaching the bottom wall of the uterus. Devices for the dilation of the cervical canal comprising an inflatable element to be introduced into the cervical canal are also known (see for example: WO2008/027292 or US3848602). Although they simplified the cervical canal dilation operations and reduced the risks involved in the dilation operation, such kinds of devices have drawbacks too and their use has not been widespread so far. At any rate, their use in combination with a following curettage operation is still complicated, since, once the dilation is performed, in order to accomplish the curettage it is however necessary to extract the dilation device from the patient's body and then position the curettage device in the cervical canal and introduce it into the uterine cavity: as explained above, these operations are delicate and require the utmost skill and at any rate involve a longer time and a more complicated procedure to perform the curettage.

Once the dilation is completed, the operator may proceed with the curettage and cleaning of the uterine cavity. For these operations the use of a cannula is known, also called curette or Karman cannula, which is introduced into the uterine cavity to perform the curettage of the endometrium and afterwards the suction of the curetted material or the uterine contents. This cannula is shaped as a cylindrical tube and is connected with a vacuum aspirator. The cannula's tip is cut diagonally relative to the cannula's axis. The edges of the ending portion of the cannula are sufficiently sharp to be able to curette the endometrium material. The outer diameter of the cannula and of its ending portion is reduced to about 8-12 mm, so as to avoid abrasions or lacerations of the cervical canal during the introduction of the cannula itself. Since the uterine cavity stretches towards the inside to a greater extent than the cannula diameter, the gynaecologist must rotate and swing the cannula so as to curette all the walls of uterine cavity. Said operation is delicate and complex and is extremely related to the operator's expertise and skill: indeed, if excessive pressure is exerted on the cannula, the tip of the latter might damage or even perforate the uterine wall. Conversely, if the operator fails to exert also a proper rotation on the cannula, parts of the endometrium or of the uterine contents which ought to be curetted and removed may remain inside the uterine cavity even after the operation, resulting in complications for the patient.

Curettage devices comprising a properly shaped head, suitable to ease the operation, wherein said head can be expanded once it is introduced in the uterine cavity, are also known (see for example US 3670732 or US3491747). Although they simplify the curettage operations, such kinds of devices have drawbacks too and their use has not been widespread so far. In particular, the known devices provide, inside the channel of the cylindrical body carrying said expandable head, members suitable to set said head to an expanded or unexpanded position, and said members significantly reduce the free cross-section of said channel.

US5865729 describes a system to make examinations and gynaecological procedures easier, wherein a device for dilating the cervical canal is arranged outside a device for curetting the uterine cavity.

US3670732 discloses a device for curetting the uterine cavity having a first tubular element open at its ends and suitable to be introduced through the cervical canal into the uterine cavity and a second tubular element, differing from the first and distinct therefrom, which is suitable to be housed and driven into the first tubular element and which can be rotated and shifted in said first tubular element. The second tubular element has at one of its ends flexible elements suitable to allow the curettage to be performed and shaped in such a way that they can be housed inside the first tubular element and that they can also come out of one end of the first tubular element when it is in the uterine cavity. The object of the present invention is to implement a system and a method of curettage of the uterine cavity and dilation of the cervical canal, allowing the above surgical acts to be performed with simple operations, rapidly and safely, which the currently used prior art would require a longer time to do, entailing risks of unintended anatomic lesions by the operator.

A further aim is to implement an easily manufactured, cost-effective system.

These and other purposes which will appear plain to see to a person skilled in the art are achieved by a system and a method according to the characterising part of the appended claims.

For a better understanding of the present invention, drawings are herewith enclosed by way of example but not by way of limitation, wherein:

fig. 1 shows a schematic perspective view of the system in a first possible operating condition,

fig. 2 shows a schematic perspective view of a first device of the system, represented in a scale differing from that of fig. 1

fig. 2A shows a view like fig. 2, but of a variation of the device of fig. 2,

fig. 3 shows a partially cross-sectional, schematic view of an end portion of a first condition of use, in a scale differing from that of fig. 2

fig. 4 shows a schematic perspective view of a second position of use and in a scale differing from that of fig. 3,

fig. 4A shows a view like fig. 4, but of the variation of the device shown in fig. 2A, fig. 5 shows a schematic perspective view of a second device of the system, represented in a scale differing from that of fig. 1,

fig. 5A shows a schematic perspective view of a variation of the second device of the system as in fig. 5.,

fig. 6 and fig. 7 show schematic cross-sectional views of an end portion of the second device as in fig. 5 in two different positions of use and in an enlarged scale compared to fig. 5,

figures 8-11 show partially cross-sectional, schematic views of a part of the system in different possible operating conditions and with the system associated to a cervical canal and a uterine cavity, also represented schematically,

fig. 12 shows a schematic perspective view of a variation of a head for a curettage device according to the invention,

fig. 13 shows a schematic perspective view of a further variation of a head for a curettage device according to the invention.

The above-mentioned figures 8-11 show a system of dilation of the cervical canal 10 (fig. 8) and curettage of the relevant uterine cavity 11, comprising:

- a first device 1 for the curettage of the uterine cavity, comprising a first elongated tubular body 2 having a head 3 suitable to be introduced into the uterine cavity 11 ; said head having a member 4 to perform said curettage operation,

- a second device 5 for the dilation of the cervical canal, comprising a second elongated tubular body 6, having at one of its ends a member 7 for widening the cervical canal 10. This member 7 for widening the cervical canal 10 has at least one portion 8 which can be expanded between at least: a first position PI (fig. 6) wherein said member is not expanded and a second position P2 (fig. 7) wherein said member 7 is expanded, wherein said expandable portion 8 in said two positions PI and P2 has transverse sizes Tl and T2 differing from each other.

According to the invention, the second device 5 is suitable to be housed inside the first device 1 and slide therein; to this end, the first elongated tubular body 2 of the first device 1 and the relevant head 3 have seats 12, 13 which are coaxial to each other to allow the second elongated tubular body 6 and the widening member 7 of the second device 2 to transit inside them, and said head 3 of the first device has at least one through opening 31 suitable to allow at least said expandable portion 8 of the second device to come out of said head 3 when said expandable portion 8 is in an unexpanded position PI.

As will be described in detail hereinafter, the system according to the invention allows the device 5 to be set to the operating position for widening the cervical canal by sliding the same in the seat 12 provided in the device 1 for the curettage of the uterine cavity and letting the member 7 for widening the cervical canal 10 come out of the head 3 through the through opening 31 of said curettage device. Once the required widening is accomplished, the second device is extracted from the first and the latter is pushed into the uterine cavity, where curettage is performed and the removed material is extracted through the same seat 12 of the first device which had previously been used for positioning the second dilation device.

More particularly, the first elongated tubular body 2 of the first device 1 for the curettage of the uterine cavity consists, for example, (fig. 2) of a substantially cylindrical body extending from a proximal end 2 A (fig. 2), meant to be hand-held by the gynaecologist during the curettage operations, to a distal end 2B provided with the head 3 suitable to be introduced into the uterine cavity 11. The tubular body 2 is hollow inside and defines the seat 12 (fig. 2) for the transit of the second elongated tubular element 6, both during the step preceding the widening of the cervical canal and when said operation is concluded and the second device 5 is extracted from the first, for the suction of the endometrium material removed during curettage.

The outer diameter of the tubular body 2 of the first device ranges, for example, from 6 mm to 18 mm, the width of the wall of said tubular body ranges, for example, from 0.5 mm to 3 mm, and preferably amounts to 1 mm, and the overall length LI (fig. 2) of the first device ranges, for example, from 200 to 250 mm. The above sizes are quoted by way of mere example and not by way of limitation of the invention.

The proximal end 2A of the body 2 of the first device is meant to be connected, during curettage, by a tube 20 (partially represented in fig. 2) to a conventional aspirator (not shown), in order to suck the material removed by the device, as provided in known curettage instruments. To this end, at this proximal end 2A the tubular body has an ordinary member 21 for constraining an end of said tube 20.

The distal end 2B of the tubular body 2 of the first device has the head 3 and the member 4 to perform the curettage.

The head 3 has a proximal body 23A and a distal body 23B connected to each other by a plurality of elastically deformable elongated elements or fins 22.

Preferably the head is implemented by machining a single plastic tubular body, namely the fins 22 are integral with the bodies 23 A and 23 B of the head.

The head 3 has a through hole 13 crossing it entirely, preferably longitudinally, and advantageously has the same transverse size Tl (fig. 3) of the seat 12 of the tubular body 2 of the first device, so that throughout said first device a preferably axial longitudinal tubular seat is available for the transit of the second device of the system and to allow a portion of said second device to come out of the head 3 through a through hole 31 provided at the end of the head 3.

As will be described in detail hereinafter, the fins 22 are suitable to bend outward, under the effect of the application of a longitudinal force F (fig. 10) when the distal body 23B rests against the bottom wall 11 A of the uterus 11, and to return to their initial position when said force is removed.

By way of example, the drawings represent fins 22 with a substantially rectangular cross-section; however, said fins might have fins with a differently shaped cross-section, for example prism-shaped or triangle-shaped.

The fins have at least one sharp edge 27 towards the outside. Figures 1-4 and 10-11 show a head having eight fins spaced equally from one another, however the number of said fins may be different and is preferably comprised between 2 and 12. Figures 2A and 4A show a head 203 with four fins 222 (the components shared with the head shown in figures 2 and 4 are designated with the same numbering used in these figures, but with the addition of 200, and they will not be further described). In the idle position (fig. 2 A) the fins 222 are in pairs longitudinally contacting each other (along a contact surface designated as J in fig. 2A), whereas in the operating position (fig. 4A) the fins of each of these pairs are separate from each other. In this idle position, the head 203 is no longer cylindrical, but still has at any rate a volume with a cylindrical profile advantageously having the same diameter as the elongated tubular body from which said head extends.

In an operating position, the fins can open symmetrically relative to a longitudinal axis M (fig. 4) of the head, or they can open in a "pear-like" manner, as shown in fig. 4. The thickness of the fins may be variable and preferably higher in proximity to the proximal body 23A of the head 3 and lower in proximity to the distal body 23B of the head, so as to offer a different flexibility along the body of the fins and favour a higher widening of the head in proximity to said distal body and hence provide the head in the operating position with a "pear-like" shape, that is such a shape that the maximum diameter G of the head in the operating position is closer to the distal body 23B of the head than to the proximal body 23 A.

However, it must be highlighted that the fins are preferably made of a flexible material able to adapt to the shape of the uterine cavity, in other words, once the head has been introduced into the uterine cavity, the flexible fins expand until they come into contact with the inner wall delimiting the uterine cavity, taking on substantially the same shape. The transverse thickness of each fin ranges from 0.2 mm to 1.5 mm.

Advantageously, when the blades 27 are in a closed position, the head 3 is substantially cylindrical and has an outer diameter D2 equalling the one Dl of the tubular body 2 of the curettage device 1. In other words, when the blades are closed, the curettage device 1 has preferably, as a whole, a substantially cylindrical outer shape and a constant diameter.

The proximal body 23A of the head 3 is, for example, a tubular body having an outer diameter D2 (fig. 4) equalling that of the tubular body 2 of the remaining part of the first device. Advantageously, the head 3 and the tubular body 2 can consist of two distinct parts, removably connected to each other through connecting members and relevant countermembers 26 A and 26B, such ad a thread and a counterthread at the contacting ends of said tubular body 2 and said head 3. However, the proximal body 23A and the head 3 may also be advantageously implemented in a single piece, that is be both an integral part of a single, properly shaped body. The distal and ending body 23B of the head 3 has a tubular or ring shape and has a basically flat annular ending wall 30 suitable to rest on the uterus bottom wall without hurting it (as represented in fig. 10). The distal and ending body 23B of the head 3 has a through hole 31, coaxial to the tubular seat of the proximal body 23A of the head and to the seat 12 of the tubular body 2 of the first device.

In addition to being implemented integrally with the distal and proximal bodies 23B and 23 A, the fins 22 can also be connected thereto in a way which is known to a person skilled in the art, for example by gluing or welding.

The length L3 of the fins 22 in an unbent idle position ranges, for example, from 20 to 50 mm.

In the starting use situation (with the fins in an unbent position), the fins 22 are all parallel to the longitudinal axis M of the first device and slits 28 are provided between them, through which the scraped biological material can later be sucked, when the fins are in an operating position.

The first device 1 is made of plastics, such as polyethylene (PE), ethylene vinyl acetate (EVA), polypropylene (PP), polyurethane (PU), PVC, and more preferably low density polyethylene (LDPE).

With reference now to the second device 5 of the system, as already specified, it comprises a second elongated tubular body 6, having at one end a member 7 for widening the cervical canal 10, comprising at least one portion 8 thereof which can be expanded between at least: one first position PI (fig. 6) wherein said member is not expanded and one second position P2 (fig. 7) wherein said member 7 is expanded and wherein said expandable portion 8 in said two positions PI and P2 has different transverse sizes Tl and T2.

More particularly, the elongated tubular body 6 has the shape of a substantially hollow cylindrical body and extends from one proximal end 40, meant to be hand-held by the gynaecologist, to a distal end 41, meant to be introduced into the cervical canal. This distal end 41 is closed and has a rounded bullet shape 41 A, to ease introduction into the cervical canal.

The tubular body 6 is hollow inside, so as to define an axial channel 42 (fig. 6) suitable for the transit of a fluid. The diameter of said channel 7 ranges, for example, from 1 to 3 mm and preferably amounts to about 2 mm and the thickness of the walls of the tubular body 6 ranges from 0.5 to 3 mm and preferably amounts to about 1 mm.

The proximal end 40 of the body 6 is open and has a conventional connector 43 (fig. 5) for connecting a conventional means (not represented) to introduce into the device a fluid for expanding the expandable portion 8 of the device, said means being for example an ordinary syringe with a Luer-lock fitting, suitable to introduce and extract a liquid for expanding the expandable portion 8. Advantageously the syringe is a screw- actuated syringe or a syringe with an end-of-travel limit stop, so that it is adapted to keep for a preset time a continuous inflation pressure on the expandable portion 8, sufficient to achieve the dilation of the cervical canal (this kind of syringe is ordinary for a person skilled in the art and shall not therefore be described in detail hereinafter). At this proximal end 40, an end of travel element 46 projects from the tubular body 6 (fig. 5), suitable to lock the tubular body 6 itself inside the tubular body 2 of the first device; said end of travel element 46 is provided in such a position that, when it stops against the proximal end 2A of the tubular body 2 of the first device, the expandable portion 8 of the body 6 of the second device projects from the hole 31 of the head 3 of the first device (as represented in figure 1); the end of travel element 46 is therefore suitable to allow the second device to correctly fit into the first, in a simple and rapid way.

It must be pointed out that, as shown in figure 5bis, the tubular body 6 could also be formed by a body 6C with a first part having a first diameter CI and a second part having a lower diameter C2, wherein both diameters are sized so as to allow anyway the body 6C to be introduced into the first device as discussed so far. In this way the body 6C (fig. 5A) has a step 46A suitable to stop against the inner face 30 A (fig. 8) of the distal part 30 of the head 3 of the first element 1. The step 46 A is provided in such a position that, when it comes into contact with the stop surface 30 A, the expandable portion 8 is all outside the hole 31 of the head 3 of the first device (as represented in fig. 1), so that said step is suitable to allow the second device to correctly fit into the first, in a simple and rapid way.

The expandable portion 8 consists of an inflatable element or sleeve 8A, sealingly constrained (for example through welding or gluing and through known techniques in the field of medical equipment), at its ends 8B, to the outer surface of the tubular body 6 of the second device, at its distal end provided with the point 41 A. The expandable portion 8 is suitable to create between the outer surface of the tubular body and the inner surface of the portion itself a chamber 44 having the size desired by the operator. The inflatable element or tubular sleeve 8A changes its size depending on whether it is filled with a fluid suitable to expand it or is without said fluid. Accordingly, when the inflatable element or sleeve is not filled by any fluid, its walls are crumpled on the relevant portion of the tubular body 6 and slightly project from the outer surface 6 A of said portion of the body (this situation is represented in figures 6, 5, 8); as the sleeve is filled with the expansion fluid, the bag gets inflated up to its position of maximum expansion, wherein it projects significantly from the outer surface of the body 6 (this situation is represented in figures 7 and 9). When the cervical canal has been dilated and the expansion fluid is sucked, the sleeve crumples up again on the outer surface 6A of the body 6 and basically returns to its initial position.

According to the invention, the expandable portion 8, namely the sleeve 8 A, when unexpanded (fig. 6), projects from the outer surface 6A of the tubular body 6 to which it is associated by a section VI (fig. 6) having a height ranging from 0.1 to 1.5 mm and preferably amounting to about 0.5 mm, whereas in its condition of maximum expansion it may reach a distance V2 from said outer surface 6 A ranging from 2 to 15 mm and preferably ranging from 5 to 8 mm. The total diameter V3 of the fully expanded sleeve hence ranges from 5 to 35 mm.

In correspondence with its section covered by the expandable portion 8, the tubular body 6 has one or more through holes 45 suitable to allow the expandable portion 8 to be inflated, namely to allow the chamber 44 to communicate with the axial channel 42.

The length G of the expandable portion ranges, for example, from 25 to 45 mm.

The tubular body 6 has, for example, an overall length L5 ranging from 200 to 400 mm, so that, when it is introduced into the device 1, it always has two end sections projecting from the tubular body of the device 1 (as represented in fig. 1). The above sizes are quoted by way of mere example and not by way of limitation of the invention.

The second device 2 is made of rigid, semi rigid or flexible plastics, whereas the expandable portion is in the form of a film made of deformable plastics.

Eligible plastics for this purpose comprise: low or high density polyethylene (PE), polypropylene (PP), DEHP-free PVC, polyurethane (PU), polyester PET, silicone.

The sleeve is preferably made of PU, silicone, DEHP-free PVC, whereas the tubular body is preferably made of PET, DEHP-free PVC, HDPE.

Sets of second devices can be advantageously provided, implemented with different sizes of the tubular body 6 and/or with expandable portions having different maximum expansion volumes, so as to cover the broadest range of diameters of the uterine cervical canal (differing in nulliparous or multiparous women) and dilation diameters required for the most varied gynaecological operations. Advantageously both the first and the second device are of a disposable type.

The operation of the system according to the invention is described in detail below. First of all, the system is assembled by introducing the second dilation device 5 into the first curettage device 1, in such a way that the portion of the second device having the expandable portion 8 projects from the opening 31 of the head 3 of the first device. In practical terms, the device 5 is introduced inside the tubular body 2 of the device 1 until it reaches its stop 46 . Once the outer orifice of the cervical canal 10 to be dilated has been detected in a manner known to a person skilled in the art, the expandable portion 8 of the second device 5 is introduced into said orifice throughout its length, until the ending portion 31 of the head 3 of the first device 1 contacts the external orifice (ostium of uterus) of the cervical canal (as shown in figure 8).

Now, connecting a customary means to inflate the expandable portion 8 at the proximal end 43 (fig. 5) of the second device 5, for example connecting a screw-actuated syringe with a Luer-Lock fitting, a preset amount of the expansion fluid, suitable to expand said portion 8 to the desired volume and consequently to dilate the cervical canal to the desired size (as represented in fig. 9), is introduced through the channel of the body 6 of the second device 5 into the chamber 44 (fig. 6 and 7) defined by said expandable portion 8. The expansion fluid can, for example, be a physiological solution, vaseline oil or air. Preferably the syringe to be used for inflating or expanding the portion 8 is provided with a device suitable to prevent the plunger from returning once its contents have been injected. Said device is preferably a screw-actuated plunger feeding device, which makes it easier to adjust the filling of the chamber 44 delimited by the portion 8 with the selected fluid. The syringe can contain a dosed amount of the fluid required for the partial or complete expansion of the chamber 44; or else said syringe can be filled completely with fluid properly injected in the desired dose after determining the correspondence between the volume of the injected fluid and the extent of the increase of the diameter of the expandable chamber 44. Once the portion 8 has reached the desired expansion volume, said portion determines the dilation of the cervical canal by the desired diameter, for example 6 to 15 mm, after the device has been left in place for a few minutes.

Now, again acting on the syringe, the previously injected fluid can be sucked, so that the bag 8A of the expandable portion 8 collapse and crumbles on the relevant portion of the tubular body 6 of the second device, which can hence be extracted from the channel 12 of the body 2 of the first device. Then, advantageously, while the second device is being extracted from the first, the head 3 of the first device can also be pushed through the cervical canal into the uterus 11. The head 3 is pushed into the uterus 11 until the flat end wall 30 of the head 3 stops against the bottom wall 11 A of the uterus (as shown in figure 10).

Now the curettage device is in the correct position to start said operation. It must be highlighted that the blades 22 of the head 3 of the curettage device have remained so far in their idle position, wherein their sharp edge 27 is not active, because the blades are all in a cylindrical pattern, wherein said edge is not turned outward.

Pushing the device again towards the wall 11 A of the uterus, an axial force F is exerted on the blades 22 (fig. 11) towards the end of the head 3 of the device, determining the opening of the blades, as shown in fig. 11.

In this position, the blades shift from a condition wherein they are arranged longitudinally relative to the head and to the tubular body 2 of the device to a working position wherein a central part of the fins (highlighted by the arrow G in fig. 4) bends outward to a higher extent relative to the original diameter of the head 3 and of the tubular body 2. In the working condition, preferably the central part G of the fins 22 bends outward to an extent defined by a closed line R, for example a circumference (fig. 4) having a diameter with a value ranging from 10 mm to 25 mm, compared to the diameter D2 (fig. 3) of the head 3 and of the tubular body 2 of the device.

Now the surgeon can rotate the head 3 with the open blades 22 around its longitudinal axis to perform the curettage of the inner wall of the uterus.

Generally a rotation of 60° is sufficient so that the sharp edge 27 of the fins 22 may glide on the endometrium, scraping the biological material to be removed. When the operation is repeated two or three times, it may be reckoned that all the material contained in the uterine cavity is removed. When the operator feels no more resistance against the rotation of the head 3 of the device, it is confirmed that the operation has been successfully accomplished.

The removed material transits through the space 28 between the blades 22 and then into the channel 12 of the tubular body 2 of the first device 1 and is sucked by aspirators connected to the proximal end 2 A (fig. 2) of the tubular body 2 of the device. At the end of this operation, the device is slightly withdrawn and the blades 22 elastically return to their original position and to their arrangement in the form of a cylinder. Now the device is extracted from the patient's body.

It must be pointed out that the system according to the invention allows both the dilation device and the curettage device to be immediately available and already introduced into the patient's body, so that the operations needed to accomplish said treatments are simplified and the time needed therefor is shorter.

Furthermore, the system drastically reduces problems relating to accidental lacerations, traumas and perforations, which is fully beneficial for patients.

It must be highlighted that the head 3 of the first curettage device 1 might also have a shape other than the one illustrated so far, at any rate known to a person skilled in the art, such as the shape of a spoon or a the shape of a bullet comprising one or more fixed blades (see for example patents US 5 807 282 or US 5 951 490), so long as it is provided at its distal end portion with a through hole or however with an opening for the transit of the portion of the second device 5 widening the cervical canal, having the expandable member 7 suitable to accomplish said widening. A head 103 of this kind is schematically represented in fig. 12 (wherein the parts shared with the former embodiment are designated by the same numbering as the one used previously, but increased by 100). The head 103 has a plurality of slits 128 delimited by edges 128 A, B, C, and in communication with the cavity 112 of the head itself and of the hollow cylindrical body 106 to which said head is connected, so as to create a passage for sucking and removing the scraped material. At least one edge (and preferably all edges 128A-C) is shaped so as to act as a sharp blade 127 to perform the curettage. The distal ending part 123B of the head 103 has a through hole 131, preferably coaxial to the longitudinal axis M of the head and of the cylindrical body 106 to which said head is associated, suitable to allow the second device 5 to transit for the dilation of the cervical canal and in particular to allow its distal portion with the expandable member 7 to transit to perform said dilation.

Figure 13 shows a further variation (wherein the parts shared with the form of embodiment shown in figures 1-11 are designated by the same numbering as the one used previously, but increased by 300) wherein the head 303 has a shape of the kind usually found in straight Karman cannulas. The head 303 has two openings 328 delimited by edges 328 A, B, C, D and in communication with the cavity 312 of the head itself and of the hollow cylindrical body 306 to which said head is connected, so as to create a passage for sucking and removing the scraped material. At least one edge (and preferably the edges arranged longitudinally 328A-D) is shaped so as to act as a sharp blade 327 to perform the curettage. The distal ending part 323B of the head 303 has a through hole 331, preferably coaxial to the longitudinal axis M of the head 303 and of the cylindrical body 306 to which said head is associated, suitable to allow the second device 5 (not represented in fig. 13) to transit for the dilation of the cervical canal and in particular to allow its distal portion with the expandable member 7 to transit to perform said dilation. The head 303 and the tubular body 302 are made of rigid or semi rigid plastics, of the kind normally used for Karman cannulas.