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
  • 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
  • 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
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
  • A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
  • A61L29/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
  • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
  • A61L29/141—Plasticizers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00526—Methods of manufacturing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00946—Material properties malleable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
  • A61D19/00—Instruments or methods for reproduction or fertilisation
  • A61D19/02—Instruments or methods for reproduction or fertilisation for artificial insemination
  • A61D19/027—Devices for injecting semen into animals, e.g. syringes, guns, probes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
  • A61D19/00—Instruments or methods for reproduction or fertilisation
  • A61D19/04—Instruments or methods for reproduction or fertilisation for embryo transplantation
• • 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0009—Making of catheters or other medical or surgical tubes

Definitions

• the invention relates to a medical device used in gynecology and more particularly to an embryo transfer device or artificial insemination provided with a catheter made of malleable material. (deformable) and able to keep the shape given after deformation. Such materials therefore have an ability to deform under stress imposed by the user, and to keep the shape imposed. The deformation is called inelastic or plastic.
• shape memory For convenience, these materials are called "shape memory”.
• Current transfer devices whether for sampling or injection / insemination, or embryo transfer generally comprise a catheter in the form of a hollow circular cylindrical tube open at both ends and of small diameter.
• this tube is connected or associated by one of its ends, for example by means of a coupling, to a device for creating a vacuum or an overpressure in order to respectively perform a sampling or an injection.
• certain devices comprise on the one hand a so-called introduction catheter and, on the other hand, a transfer catheter.
• This embodiment provides in the first place the installation in the uterine cavity of the introducer catheter.
• said catheter is inserted into the uterine cavity.
• the transfer catheter which is associated with the pressure relief device or depression.
• Such an embodiment is generally used to bring the transfer catheter directly into position without risk of contamination with the various parts of the body being passed through and to facilitate introduction of the catheter in the case of a cervix difficult to catheterize
• deformable flexible polymer catheters for example as described in US6027443A which have a high flexibility.
• Such a catheter avoids traumatizing the inner walls of the uterus while having a flexibility and texture allowing its insertion along complex paths, the catheter folding as soon as it meets a wall without damaging it.
• catheters that retain their shape before introduction into the uterus and are directed directly along the paths determined by the practitioner.
• the practitioner examines the patient to determine the path to be taken for the catheter and then gives the said catheter the desired shape to follow precisely this path without abutting against the inner walls of the patient.
• a mandrel forming a metal mesh or a metal alloy is generally incorporated in the catheter tube.
• This metal mesh gives said tube a rigidity and a shape memory capacity allowing the practitioner to modulate the shape of the tube according to his needs.
• this type of known catheter requires certain manipulations to ensure the maintenance of shape and often presents a risk of kinking when the mandrel is removed, thus rendering the catheter unusable.
• the integration of such a metal mandrel into the walls of the catheter substantially increases the diameter of said catheter thereby reducing the comfort of the patient and can generate uterine contractions.
• This method is most often used today but it requires, on the one hand the manufacture of an independent malleable metal mandrel and, on the other hand, additional manipulations to insert the metal mandrel and remove it before being able to use the transfer catheter which can generate aseptic mistakes.
• the problem raised by these techniques is to make a catheter both flexible enough to be deformed at will, without breaking or plicating, by the practitioner, and able to retain the shape thus given.
• the catheters of the prior art do not succeed in optimally filling these contradictory characteristics.
• the object of the invention is therefore to provide a malleable (deformable) and shape-memory catheter having non-elastic deformation properties and deforming at will while retaining in the uterus the shape given by the practitioner. This catheter must also remain simple to use and without additional manipulation or tedious installation or positioning.
• the subject of the invention is a malleable and shape-memory gynecological transfer device comprising a catheter comprising a polymer tube open at each of its ends, characterized in that said tube is composed of a medium density polymer associated with a mineral filler.
• a medium density polymer as used in the composition of the catheter tube according to the invention has features enabling a flexible and deformable catheter to be obtained in a simple and desired manner while not being too flexible such as the prior art polymer.
• Such a medium density polymer may be directly selected from medium density polymers or be obtained by a mixture of high density polymer and low density polymer, said mixture being produced beforehand in order to obtain a homogeneous material for use in the invention.
• the mixture making up the catheter tube comprises between 60% and 90% of medium density polymer and between 40% and 10% of mineral filler, respectively.
• the tube is composed of about 80% polymer and 20% mineral filler. The percentages are expressed by weight.
• the medium-density polymer In order to reduce and control the elasticity of the medium-density polymer, the latter is mixed with a mineral filler, the molecules of which are insinuated between the molecules of the medium-density polymer and reduce the elasticity thereof.
• This mineral filler mechanically reduces the elasticity and increases the malleable (deformable) nature of the plastic, the catheter thus comprising an amorphous tube deforming at will and keeping the given shape in use.
• the medium density polymer is a polyolefin.
• a polyolefin is easily convertible and allows the manufacture of a particularly malleable tube.
• this polyolefin is a polyethylene, the tube obtained from this polyethylene thus being more flexible and easier to process.
• the mineral filler may be titanium oxide giving a pearlescent appearance and good slip characteristics to the tube.
• the mineral filler is a barium sulfate, which improves the malleability of the tube.
• this inorganic filler can be bismuth salt, these mineral fillers making it possible to obtain a tube with satisfactory sliding properties.
• the polymer is mixed with different mineral fillers to form the tube.
• the invention also relates to a method for manufacturing a device according to the invention characterized in that it comprises a step of mixing a medium density polymer and a prior mineral filler, for example by melting or " compounding ", followed by a step of extruding the products obtained during the mixing or compounding process
• This manufacture of the tube is preferably carried out by extrusion but may also be made by molding or by any other means known to those skilled in the art.
• the step of mixing the medium density polymer with the inorganic filler by compounding makes it possible to obtain granules of homogeneous mixed materials from these components.
• the granules introduced into the extruder obtained by the preliminary mixing step are of homogeneous composition and make it possible to obtain an extrusion tube having the same characteristics of malleability, flexibility and shape retention regardless of the location of said tube.
• the mixture comprises 81.5% of medium-density polyethylene such as, for example, Lupolen® 3721 C, 15% of BaSo 4 , 3% of TiO 2 and 0.5% of dye, for example ultramarine blue dye.
• medium-density polyethylene such as, for example, Lupolen® 3721 C
• BaSo 4 15% of BaSo 4
• TiO 2 3% of TiO 2
• dye for example ultramarine blue dye.
• the percentages of medium-density polyethylene can vary from 75% to 85%; BaSO4 from 15 to 20%; 2-3% of ⁇ 02; and 0.2 to 0.5% dye. It is possible to use another medium density PE (or a mixture of HDPE high density polyethylene and LDPE LDPE) provided that the final product contains at least 20% mineral filler.
• the extrusion is done according to four heating zones at respectively 215 ° C., 226 ° C., 230 ° C. and 224 ° C. with a screw rotating at 27.1 rpm.
• the indicated temperatures may vary depending on the machine used, the desired flow rate and the diameters of the tube.
• the transformation temperature range of the material is generally between 180 and 240 ° C.
• Figure 1A is a schematic top view showing a catheter or transfer tube.
• Figure 1B is a schematic top view of a catheter or introducer tube, the catheter is provided with a valve mandrel which prevents mucus from entering the catheter
• Fig. 1C is a view of the introducer catheter of Fig. 1B (after removing the obturator mandrel), into which the transfer catheter of Fig. 1A is introduced.
• the transfer catheter 1 (FIG. 1A) consists of a cylindrical tube with a diameter of about 1 mm, and whose proximal end 2 has a gripping portion 3 known per se. In the tube 2 is disposed a metal cannula 4 known in itself.
• the introduction catheter according to FIG. 1B comprises, in a known manner, a tube 5 with a diameter of approximately 2.7 mm in which is inserted a shutter mandrel 7 consisting of a male element penetrating inside the tube 5 forming the introducer catheter.
• the proximal end 7A of the mandrel 7 bears on the proximal end 5A of the tube 5 and the distal end 7B of the mandrel 7 is about 2 mm in length from the open distal end 5B of the tube 5.
• Chuck shutter 7 is removed from the tube 5 to be replaced by the transfer catheter 1 to effect the transfer.
• the distal portion 5B of the tube 5, intended to be introduced into the body of the patient, has uniformly spaced graduations of the order of 10 mm, for example graduations from 1 to 6. These graduations are used by the practitioner to evaluate the length of catheter introduced into the uterus of the patient.
• FIG. 1C there is shown the transfer catheter 1 introduced into the catheter or introducer tube and protruding by about 50 mm from the open end 5B of the tube 5 forming the introducer catheter.
• the gripping portion 3 at the proximal end 2A of the transfer catheter 1 abuts on the proximal end 5A (remote from the patient) of the introducer catheter.
• the catheter In the context, for example, of an embryo transfer or insemination, the catheter must be inserted into the uterus of the patient so that a first end is accessible to the practitioner and therefore located outside of the uterus while the other end reaches the uterine cavity through the patient's cervix.
• the catheter has a diameter respectively between 0.7 mm and 1 60 mm or between 1.90 mm and 2.70 mm.
• the tube of the catheter (alone or introducer) must be flexible enough to take certain curvatures to reach the uterine cavity during its installation. That is, the tube must be able to follow a path from the outside of the uterus to the uterine cavity despite the change of axis imposed by the passage of the cervix.
• the catheter tube according to the invention is made from a medium density polymer.
• the choice of the medium density polymer is either directly in the polymers belonging to the family of medium density polymers, or by mixing a high density polymer and a low density polymer to obtain a mixture of polymers whose average density is that of a polymer with medium density, that is to say between 0.926 g / cm 3 and 0.940 g / cm 3 .
• Such a medium density polymer has a flexibility to fold the tube without risk of breakage or plication, without being too rigid which would impose a significant effort to bend the tube and would be possibly traumatic for the patient. Conversely, this polymer is not too flexible thus avoiding inadvertent and undesirable tube bends that would require additional maneuvers to correctly position the catheter.
• This medium density polymer retains an elasticity that does not allow it to reliably maintain a given shape when curved. Typically, its malleability properties are limited and in the absence of stress, it tends to return to its original shape, generally rectilinear.
• the tube is formed by a polymer to medium density associated with a mineral charge.
• a mineral filler enters the composition of the tube at a level of 10 to 40%, the medium density polymer representing between 90 and 60% of the composition of the tube.
• the molecules of the mineral filler insinuate between the molecules of the medium-density polymer and thus reduce or even cancel the natural elasticity of the medium-density polymer.
• the medium-density polymer is a polyolefin, the latter being easier to process and working for the manufacture of the tube than other polymers.
• the polyolefins have characteristics making it possible to obtain a very malleable tube thus ensuring comfort for the practitioner wanting to give the desired shape to the tube.
• This polyolefin is more particularly a polyethylene, the resulting tube thus being more flexible and easier to process.
• the mineral filler may be titanium oxide, for its gliding qualities, barium sulfate or bismuth salt for its malleability.
• the inorganic filler is a mixture composed of several mineral fillers with the desired properties, for example a mixture of barium sulfate and titanium oxide.
• the tube according to the invention is composed of 81.5% of lupolen 3721 C, medium density polymer of 0.9375 g / cm 3 , 3% of titanium oxide, 15% of barium sulfate and 0.5% blue dye.
• This composition has the advantage of having non-elastic properties giving an "amorphous" material deforming at will and maintaining in the uterus the form that was given to it by the practitioner after examination of the patient while having, thanks to the mixture with mineral fillers, good sliding properties and malleability.
• a catheter tube according to the invention is described below in the context of a tube manufactured by extrusion, but said tube could be manufactured by any other means known to those skilled in the art, by example by molding.
• the method according to the invention provides for mixing the components prior to extrusion. This mixing step is important, especially if the method of manufacturing the tube does not ensure the homogeneous mixing of the tube components. According to the invention, this mixing is carried out by compounding or melt blending and preparing a semi-finished product in the form of granules constituting a homogeneous mixture of the various components of the finished product.
• the semifinished product thus obtained comprising in the example given 81, 5% of Lupolen 3721 C, 15% of barium sulfate, 3% of TiO 2 titanium oxide and 0.5% of dye, for example blue ultramarine, is in the form of granules directly usable by an extruder for making catheter tubes.
• Such an extruder comprises for example four heating zones at respectively 215 ° C., 226 ° C., 230 ° C. and 224 ° C. with a screw rotating at 27.1 rpm.
• the indicated temperatures may vary depending on the machine used, the desired flow rate and the diameters of the tube.
• the transformation temperature range of the material is generally between 180 and 240.degree.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Gynecology & Obstetrics (AREA)
• Biomedical Technology (AREA)
• Molecular Biology (AREA)
• Medical Informatics (AREA)
• Heart & Thoracic Surgery (AREA)
• Pregnancy & Childbirth (AREA)
• Reproductive Health (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Epidemiology (AREA)
• Transplantation (AREA)
• Composite Materials (AREA)
• Chemical & Material Sciences (AREA)
• Materials Engineering (AREA)
• Materials For Medical Uses (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Extrusion Moulding Of Plastics Or The Like (AREA)
• Compositions Of Macromolecular Compounds (AREA)

Applications Claiming Priority (2)

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Citations (2)

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• 2012
  • 2012-02-01 FR FR1250941A patent/FR2986146B1/fr active Active
• 2013
  • 2013-01-30 BR BR112014019000A patent/BR112014019000A8/pt not_active IP Right Cessation
  • 2013-01-30 US US14/375,605 patent/US20150025307A1/en not_active Abandoned
  • 2013-01-30 CN CN201380012310.9A patent/CN104159540A/zh active Pending
  • 2013-01-30 RU RU2014131686A patent/RU2014131686A/ru not_active Application Discontinuation
  • 2013-01-30 CA CA2862677A patent/CA2862677A1/fr not_active Abandoned
  • 2013-01-30 EP EP13706590.0A patent/EP2809259A1/de not_active Withdrawn
  • 2013-01-30 WO PCT/FR2013/050185 patent/WO2013114039A1/fr not_active Ceased

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