WO2016067233A1 - Système de curetage de la cavité utérine et de dilatation du canal du col de l'utérus - Google Patents

Système de curetage de la cavité utérine et de dilatation du canal du col de l'utérus Download PDF

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Publication number
WO2016067233A1
WO2016067233A1 PCT/IB2015/058343 IB2015058343W WO2016067233A1 WO 2016067233 A1 WO2016067233 A1 WO 2016067233A1 IB 2015058343 W IB2015058343 W IB 2015058343W WO 2016067233 A1 WO2016067233 A1 WO 2016067233A1
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WO
WIPO (PCT)
Prior art keywords
curettage
head
tubular body
cervical canal
elongated
Prior art date
Application number
PCT/IB2015/058343
Other languages
English (en)
Inventor
Amedeo LAVAGNA
Original Assignee
Glam Snc
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Filing date
Publication date
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Publication of WO2016067233A1 publication Critical patent/WO2016067233A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320708—Curettes, e.g. hollow scraping instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium
    • A61B2017/4225—Cervix uteri

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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,
  • FIGS. 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • a tube 20 partially represented in fig. 2
  • a conventional aspirator not shown
  • 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.
  • 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.
  • Tl transverse size
  • 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.
  • 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).
  • 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.
  • 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.
  • the fins 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.
  • 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.
  • the head 3 when the blades 27 are in a closed position, is substantially cylindrical and has an outer diameter D2 equalling the one Dl of the tubular body 2 of the curettage device 1.
  • the curettage device 1 when the blades are closed, 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • plastics such as polyethylene (PE), ethylene vinyl acetate (EVA), polypropylene (PP), polyurethane (PU), PVC, and more preferably low density polyethylene (LDPE).
  • the second device 5 of the system 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.
  • 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.
  • 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).
  • an end of travel element 46 projects from the tubular body 6 (fig.
  • 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.
  • 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.
  • 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.
  • the inflatable element or sleeve 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).
  • the sleeve crumples up again on the outer surface 6A of the body 6 and basically returns to its initial position.
  • 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.
  • 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.
  • both the first and the second device are of a disposable type.
  • 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.
  • the device 5 is introduced inside the tubular body 2 of the device 1 until it reaches its stop 46 .
  • 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).
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • a 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the system drastically reduces problems relating to accidental lacerations, traumas and perforations, which is fully beneficial for patients.
  • 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.

Abstract

L'invention concerne un système de curetage de la cavité utérine (11) et de dilatation du canal (10) du col de l'utérus, comprenant : - un premier dispositif (1) pour le curetage de la cavité utérine, comprenant un premier corps tubulaire allongé (2) présentant une tête (3) appropriée pour être introduite dans la cavité utérine (11) ; ladite tête présentant un élément (4) pour effectuer ladite opération de curetage,- et un deuxième dispositif (5) pour la dilatation du canal (10) du col de l'utérus, comprenant un deuxième corps tubulaire allongé (6), présentant, en l'une de ses extrémités, un élément (7) pour élargir le canal (10) du col de l'utérus, - ledit élément (7) pour élargir le canal (10) du col de l'utérus présentant au moins une partie (8) qui peut être dilatée au moins : à partir d'une première position de repos (PI), dans laquelle ladite partie (8) n'est pas dilatée et présente une première dimension transversale (Tl), dans une seconde position de fonctionnement (P2), dans laquelle ladite partie (8) est dilatée et présente une deuxième dimension transversale (T2), supérieure à la première, - le premier corps tubulaire allongé (2) et la tête (3) du premier dispositif de curetage (1) présentant des sièges (12, 13) pour permettre le passage d'au moins une section du deuxième corps tubulaire allongé (6) et de l'élément d'élargissement (7) du deuxième dispositif de dilatation (5) à l'intérieur dudit premier corps tubulaire allongé (2) et de la tête (3), lorsque ladite partie expansible (8) est dans la position de repos - et ladite tête (3) du premier dispositif de curetage présentant une ouverture (31) pour permettre la sortie au moins de ladite partie expansible (8) du deuxième dispositif d'élargissement (5) de ladite tête (3), lorsque ladite partie expansible (8) est dans la position de repos PI.
PCT/IB2015/058343 2014-10-31 2015-10-29 Système de curetage de la cavité utérine et de dilatation du canal du col de l'utérus WO2016067233A1 (fr)

Applications Claiming Priority (2)

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ITMI20141869 2014-10-31
ITMI2014A001869 2014-10-31

Publications (1)

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WO2016067233A1 true WO2016067233A1 (fr) 2016-05-06

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112294405A (zh) * 2019-07-31 2021-02-02 汤细巧 一种基于妇科疾病的刮宫装置用辅助机构
EP3648654A4 (fr) * 2017-07-03 2021-04-07 Krishna Kumar, Pathyil Damoderam Procédés, compositions et dispositifs destinés à des procédures gynécologiques
CN114176741A (zh) * 2022-01-19 2022-03-15 郑州大学第一附属医院 一种宫腔镜下可控式宫腔刮匙装置

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US3491747A (en) 1966-08-12 1970-01-27 Ralph R Robinson Curette device
US3670732A (en) 1970-05-11 1972-06-20 Ralph R Robinson Vacuum curette
US3848602A (en) 1972-04-19 1974-11-19 Gutnick Morton Abortion facilitating device and process
EP0419154A1 (fr) * 1989-09-14 1991-03-27 Robert E. Fischell Cathéter d'athérectomie intraluminaire dilatable
US5807282A (en) 1995-12-28 1998-09-15 Mayo Foundation For Medical Education And Research Endometrial tissue curette and method
US5865729A (en) 1997-10-10 1999-02-02 Olympus America, Inc. Apparatus for facilitating gynecological examinations and procedures
WO2008027292A2 (fr) 2006-08-28 2008-03-06 Femsuite Llc Dilatateur cervical et ses procédés d'utilisation

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3491747A (en) 1966-08-12 1970-01-27 Ralph R Robinson Curette device
US3670732A (en) 1970-05-11 1972-06-20 Ralph R Robinson Vacuum curette
US3848602A (en) 1972-04-19 1974-11-19 Gutnick Morton Abortion facilitating device and process
EP0419154A1 (fr) * 1989-09-14 1991-03-27 Robert E. Fischell Cathéter d'athérectomie intraluminaire dilatable
US5807282A (en) 1995-12-28 1998-09-15 Mayo Foundation For Medical Education And Research Endometrial tissue curette and method
US5951490A (en) 1995-12-28 1999-09-14 Mayo Foundation For Medical Education And Research Endometrial tissue curette
US5865729A (en) 1997-10-10 1999-02-02 Olympus America, Inc. Apparatus for facilitating gynecological examinations and procedures
WO2008027292A2 (fr) 2006-08-28 2008-03-06 Femsuite Llc Dilatateur cervical et ses procédés d'utilisation

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3648654A4 (fr) * 2017-07-03 2021-04-07 Krishna Kumar, Pathyil Damoderam Procédés, compositions et dispositifs destinés à des procédures gynécologiques
CN112294405A (zh) * 2019-07-31 2021-02-02 汤细巧 一种基于妇科疾病的刮宫装置用辅助机构
CN114176741A (zh) * 2022-01-19 2022-03-15 郑州大学第一附属医院 一种宫腔镜下可控式宫腔刮匙装置
CN114176741B (zh) * 2022-01-19 2023-05-26 郑州大学第一附属医院 一种宫腔镜下可控式宫腔刮匙装置

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