Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/42—Gynaecological or obstetrical instruments or methods
  • A61B17/425—Gynaecological or obstetrical instruments or methods for reproduction or fertilisation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/42—Gynaecological or obstetrical instruments or methods
  • A61B17/425—Gynaecological or obstetrical instruments or methods for reproduction or fertilisation
  • A61B17/43—Gynaecological or obstetrical instruments or methods for reproduction or fertilisation for artificial insemination
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/42—Gynaecological or obstetrical instruments or methods
  • A61B17/425—Gynaecological or obstetrical instruments or methods for reproduction or fertilisation
  • A61B17/435—Gynaecological or obstetrical instruments or methods for reproduction or fertilisation for embryo or ova transplantation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00867—Material properties shape memory effect
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/08—Accessories or related features not otherwise provided for
  • A61B2090/0801—Prevention of accidental cutting or pricking
  • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs

Definitions

• the present invention relates to a recoverable intrauterine system.
• Intrauterine systems implantable and recoverable by natural routes have been known for several years.
• IUDs in general, these systems can be classified into three major families according to their indication or mode of action.
• devices with an anti-conceptual indication such as IUDs
• the second category consists of capsules loaded with a therapeutic substance and placed in the uterine cavity for diffusion and action in the body.
• the third category consists of intrauterine devices indicated for in vivo assistance in medically assisted procreation processes.
• An intrauterine device is thus known, as described in particular in document WO 03/011200, intended to be placed in the uterine cavity for a period of between a few hours and a few days, and allowing preimplantation development of an in vivo embryo. .
• the devices concerned must meet a double constraint, a priori contradictory.
• these devices must be both thin and compact to be placed in the uterine cavity and extracted, by natural means, which requires crossing the isthmus cervical canal.
• they must be sufficiently cumbersome to stabilize in the uterine cavity by avoiding being expelled by the natural contractions of the uterus.
• the stabilization systems existing in the field of contraception, and in particular for maintaining in position of an IUD in the uterus are not satisfactory. Indeed, they can damage the endometrium, not only during the holding in position of the device in the uterine cavity, exerting a constant pressure against the endometrium (causing contractions phenomena, possibly with hormonal activation), but also during the removal of the device, the holding elements rubbing a long length of the endometrial wall, thus causing microlesions or inflammatory inductions, or bleeding.
• WO 03/011200 describes an intrauterine device carrying stabilizing fins at a distal end of the housing. These stabilizing fins are capable of damaging the endometrial wall, in particular during removal of the device and thereby reducing the chances of success of the subsequent implantation of the embryo.
• the present invention aims to provide a recoverable intrauterine system to solve the aforementioned drawbacks and in particular to ensure the positional retention in the uterine cavity of the system while preserving the integrity of the endometrium.
• the present invention relates to a recoverable intrauterine system comprising a housing adapted to contain one or more elements selected from the group comprising an embryo, male and / or female gametes, a fertilized oocyte, an unfertilized ovum and a combination of these elements, and a device for maintaining the intrauterine system recoverable in the uterus.
• the holding device comprises a deformable element adapted to take at least two positions:
• maintaining the housing position inserted into the uterus is performed inside the cervix to limit contact with the endometrial wall of the body of the uterus.
• the entire system can be introduced into a conventional transfer catheter used to introduce the recoverable intrauterine system into the uterine cavity beyond the cervix. .
• the introduction of the system can thus be carried out without the risk of damaging the cervix or the endometrial wall by friction using a transfer catheter of small internal and external diameter adapted to the passage of the cervix.
• the deformable element is an elongate element deformable spiral.
• the contact between the elongate spiral member against the wall of the cervix is limited and the holding device is not likely to obstruct the cervix and interfere with the flow of the uterus. fluid existing between the uterus and the vagina.
• the element of the holding device is deformable between an insertion position and a holding position under the action of an elastic restoring force.
• the holding device is automatically placed in a holding position inside the cervix when the recoverable intrauterine system is introduced into the uterine cavity, and after removal of the transfer catheter used for its introduction.
• the holding in position of the recoverable intrauterine system is thus achieved reliably and naturally without requiring additional manipulation on the part of the practitioner.
• the invention also provides a transfer catheter and intrauterine system assembly in which the system is housed within the catheter.
• the housing associated with the holding device can be placed in the uterus through the transfer catheter, without risk of tissue damage.
• FIG. 1 is a schematic view of a recoverable intrauterine system according to one embodiment of the invention.
• FIG. 2 is a view schematically illustrating the mounting of a recoverable intrauterine system of FIG. 1 in a transfer catheter; and
• FIG. 3 is a sectional view schematically illustrating the positioning of the recoverable intrauterine system in the uterine cavity.
• the recoverable intrauterine system firstly comprises a housing 10 to be placed in the uterus.
• This housing 10 is intended to be placed in the uterine cavity for a period of between a few hours and a few days for preimplantation development of an in vivo embryo.
• the housing 10 is adapted to contain an embryo, male and / or female gametes, a fertilized oocyte, an unfertilized ovum or a combination of these various elements.
• This housing 10 may be made of silicone and be provided in its wall with a series of perforations allowing interaction between the interior of the housing and the external environment in which the housing is located, that is to say the uterine medium .
• this housing 10 is of elongate shape along an axis X.
• the housing 10 is constituted by an elongated cylindrical tube of transparent silicone.
• the length of the housing in the direction X may be substantially equal to 10 mm, the inner diameter of the housing 10 being between 0.4 and 0.5 mm and the outer diameter of the cylindrical housing 10 being between 0, 7 and 0.8 mm.
• This elongated housing 10 thus has, along its insertion axis along the X axis in a uterine cavity, a distal end 12 and a proximal end 13.
• the housing 10 has at its distal end 12 a plug 14, for example titanium, fixed by adjustment to the end of the housing 10 and to seal it.
• a plug 14 for example titanium
• This plug 14 can be removed after use of the intrauterine system to extract embryos and / or elements that have been temporarily placed in the uterine cavity. These elements, particularly the embryo thus removed, can then be selected and reimplanted into the uterine cavity.
• the housing 10 has a proximal plug 15 at its proximal end 13.
• the housing 10 is also associated with a device 20 for maintaining the intrauterine system in the uterus.
• This holding device 20 is arranged at the proximal end 13 of the housing 10.
• this holding device 20 comprises a deformable element 21 adapted to be held by support in the cervix.
• the deformable element 21 is a spiral deformable elongated element.
• the holding device 20 is adapted to take an insertion position in which the deformable element 21 is adapted to be housed in a catheter 40.
• the deformable element 21 is disposed in the extension of the housing 10, that is to say substantially aligned in the longitudinal direction X of the housing 10.
• the holding device 20 is adapted to take a holding position as shown in Figure 3 in which the deformable element 21 is adapted to cooperate with a wall of the cervix.
• the deformable element is substantially in the form of a spiral.
• the deformable element 21 comprises a steel rod element 22 covered with a protective sleeve 23.
• the steel rod member may be made from a helical spring of steel and extend inside the protective sleeve 23.
• This protective sleeve 23 may be made of a biocompatible silicone tube.
• the sleeve 23 housing the spring 22 has in stretched configuration, that is to say when it is substantially aligned in the longitudinal direction X, a length of between 45 and 60 mm. When it is at rest, in the form of a spiral, this sleeve 23 extends substantially over a length of between 15 and 25 mm.
• the deformable element 21 of the holding device 20 is deformable between the insertion position as illustrated in FIG. 2 and a free rest position in which the deformable element takes the form of a spiral, under the action of an elastic restoring force.
• the deformable element 21 is forced, against the elastic restoring force, to occupy an extended position substantially rectilinear and, in the rest position, the deformable element 21 resumes a spiral elongate position under the action of the elastic restoring force.
• the rest position of the deformable element is limited by the dimensions of the cervix such that the elastic restoring force forces the deformable element 21 to come into contact with the walls of the cervix.
• the spring 22 is inserted inside the protective sleeve 23 and the assembly is secured to the proximal plug 15 at the proximal end 13 of the housing 10.
• the silicone protective sleeve 23 is mounted in force on a rod 15a of the proximal plug 15 of the housing 10.
• the assembly consisting of the steel spring 22 and the protective sleeve 23 is wound in a spiral around a rod in order to obtain a mechanical deformation of the element deformable.
• the recoverable intrauterine system includes a withdrawal wire 30 for pulling the device from the uterus by traction.
• This withdrawal wire 30 may be nylon and has a total length of 150 mm and a diameter of 0.1 mm.
• the withdrawal wire extends inside the protective sleeve 23 and opens at the end 23a of the protective sleeve to extend to the outside.
• the withdrawal wire 30 is inserted into the protective sleeve 23 at the same time as the spring steel element 22.
• the distal end portion 21a of the elongated member 21 is molded on the proximal plug 15 to reinforce the mounting of the protective sleeve 23 on the stem 15a of the proximal plug 15.
• the end 30a of the withdrawal wire 30 melts slightly inside the silicone protective sleeve 23 so as to fix this withdrawal wire 30 inside the protective sleeve 23 and to maintain in position the spring element 22.
• a molding operation is performed at the proximal end 21b of the elongate member 21 to secure at this proximal end 21b the withdrawal wire 30 over a portion of its length to the silicone protective sleeve 23.
• the housing 10 is assembled to the holding device 20 after the introduction of the elements into the housing, and for example male and female gametes.
• the distal plug 14 is in place at the distal end 12 of the housing 10.
• a catheter 40 (shown partially in FIG. 2) is conventionally used, which is generally in the form of an elongate cylindrical tube of appropriate length making it possible to accommodate the entire of the intrauterine system, that is to say successively the housing 10 and the holding device 20 and a part of the withdrawal wire 30.
• this withdrawal wire 30 extends beyond the transfer catheter 40.
• a conventional catheter has an internal diameter of between 0.9 and 1.1 mm, adapted to the passage of the cervix.
• the deformable element 21 is substantially rectilinear and adapted to be housed in the catheter.
• the elastic deformation force of this deformable element 21 must not be too high to allow the deformation of the holding device 20 to be inserted into the interior of the catheter 40 without undue effort and then the removal of the transfer catheter 40
• the system thus housed in the catheter is introduced into the uterine cavity until the housing 10 extends beyond the cervix.
• the deformable element 21 is adapted to take a holding position in which it cooperates with the wall of the cervix. As is diagrammatically illustrated in FIG. 3, the deformable element resumes a spiral shape inside the neck of the uterus so as to come into contact with the walls of the cervix and to be supported by the cervix. -this.
• the cervix With this spiral shape, the cervix is not closed by the holding device 20, the contact between the deformable element 21 and the cervix being made along a spiral curve against the walls of the cervix.
• the housing containing the gametes can be held in position in the uterus for the duration chosen by the obstetrician.
• the elastically deformable element 21 could be replaced by an elongate element with shape memory, adapted to deform by example under the effect of the heat released by the human body or through the presence of moisture.
• the deformable member could be made from an elongated steel rod disposed within the protective sleeve instead of the coil spring.

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• Health & Medical Sciences (AREA)
• Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Medical Informatics (AREA)
• Animal Behavior & Ethology (AREA)
• Reproductive Health (AREA)
• Pregnancy & Childbirth (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Gynecology & Obstetrics (AREA)
• Molecular Biology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Surgical Instruments (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Orthopedics, Nursing, And Contraception (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=39739528

Family Applications (1)

Country Status (8)

Families Citing this family (4)

Family Cites Families (9)

• 2008
  • 2008-02-20 FR FR0851086A patent/FR2927528B1/fr not_active Expired - Fee Related
• 2009
  • 2009-02-13 JP JP2010547268A patent/JP2011512219A/ja not_active Withdrawn
  • 2009-02-13 CN CN2009801059993A patent/CN101951846A/zh active Pending
  • 2009-02-13 EP EP09713407A patent/EP2242435A1/de not_active Withdrawn
  • 2009-02-13 WO PCT/IB2009/000482 patent/WO2009104093A1/fr not_active Ceased
  • 2009-02-13 US US12/735,811 patent/US20110275885A1/en not_active Abandoned
  • 2009-02-13 AU AU2009215360A patent/AU2009215360A1/en not_active Abandoned
  • 2009-02-13 CA CA2713220A patent/CA2713220A1/fr not_active Abandoned

Non-Patent Citations (2)

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