EP3986316A1

EP3986316A1 - Protection device for medical device

Info

Publication number: EP3986316A1
Application number: EP20734686.7A
Authority: EP
Inventors: Mathieu ASTRANSKAS; Peter Christian SVALANDER; Alison VELASCO; Martin VELASCO
Original assignee: Anecova SA
Current assignee: Anecova SA
Priority date: 2019-06-24
Filing date: 2020-06-22
Publication date: 2022-04-27
Also published as: FR3097425A1; CN114051398A; WO2020260174A1; US20220265319A1; JP2022539033A

Abstract

Disclosed is a protection device for a medical device (1) comprising a substantially cylindrical body (3) and a tube (4), the body (3) and tube (4) being hollow and open at their ends, the body (3) comprising a thermally insulating distal part (32) and assembly means, the tube (4) comprising complementary assembly means, the body (3) being capable of sliding on the tube (4) in a longitudinal direction from a first position corresponding to a sampling configuration of the protection device (2) to a second position corresponding to a protection configuration of the protection device, the assembly means of the body (3) and the complementary assembly means being capable of immobilising the body (3) in longitudinal translation in the first position and the second position.

Description

Title of the invention: Protective device for a medical device The present invention relates to a protective device for a medical device.

It also relates to a medical transfer assembly comprising the protection device and a transfer device as a medical device.

Finally, it relates to a method of transferring an element to be removed by means of the medical transfer set.

During certain medical procedures, practitioners are required to handle medical devices. These are, for example, devices for the transfer of biological material, such as an embryo.

In this particular context, biological material is taken in the laboratory by means of the transfer device from a preparation arranged for example in medium in a petri dish. The sample is usually taken in a temperature-controlled environment, for example a temperature close to that of the human body, i.e. around 37 ° C. The sample is for example carried out in a heated and transparent box. The box may include two holes adapted to allow the arms of a practitioner to pass so as to allow the collection of biological material within the box. The transfer device is thus maintained at a predefined and controlled temperature throughout the sample.

Once the collection is complete, the transfer device is moved for use of the collected biological material. Thus, as part of a medically assisted fertilization process, biological material is transferred to be introduced into the uterine cavity of a patient for injection. Transporting the temperature-controlled environment transfer device as it exists in the chamber to the patient can take from a few seconds to a few minutes. A temperature drop in the transfer device, which can reach 20 ° C, then occurs during transport. This fall of temperature is detrimental to the transferred biological material. In the particular case of embryo transfer, several elements suggest that this may alter the correct implantation of the latter in the uterus, and thus reduce the chances of success of the fertilization process.

The present invention proposes a solution to this problem, namely a protection device configured to allow transport of the medical device while maintaining the temperature in said medical device at a predefined temperature, for example close to body temperature.

To this end, the invention relates to a protective device for a medical device comprising a substantially cylindrical body and a tube, the body and the tube being hollow and open at their ends, the body comprising a thermally insulating distal part and means for assembly, the tube comprising complementary assembly means, the body being adapted to slide on the tube in a longitudinal direction from a first position corresponding to a sampling configuration of the protection device to a second position corresponding to a protection configuration of the protection device, the assembly means of the body and the complementary assembly means of the tube being adapted to block the body in longitudinal translation in the first position and the second position.

The protective device thus formed allows the storage of a medical device until the moment of the medical intervention, for example until the moment of the injection or the introduction of a biological material into the body of a patient. . Once a medical device is inserted into the protective device, an operator can easily place the protective device in either of the sampling and protection configurations as needed.

In particular, the thermally insulating distal part allows the storage of at least a portion of the medical device in the distal part. In fact, the protection device can be brought into a configuration allowing the distal part of the body to cover a portion of the medical device to be maintained within a predefined temperature range. According to one characteristic, the length of the protection device in the protection configuration is greater than the length of the protection device in the sampling configuration.

By modifying the length of the protection device, and in particular by increasing the length, the protection device thus makes it possible to protect a portion of the medical device by sliding the body from the first position to the second position.

According to one characteristic, the distal part of the body is formed of a cylindrical double wall.

The thermal insulation properties are thus improved.

According to one characteristic, the protection device comprises a hollow cylinder arranged in the distal part of the body, the cylinder being made of a material having high thermal conductivity, in particular aluminum.

The realization of the cylinder in a material having a high thermal conductivity makes it possible to easily heat the cylinder by thermal conduction. The protection device can for example be heated before use, in particular by bringing the cylinder into contact with a heat source. For example, a preheated rod or plug can be introduced into the cylinder.

According to one characteristic, the cylinder can be made of a material having a high thermal capacity. The cylinder thus stores heat, which also helps to keep the distal part of the body at a preset temperature.

According to one characteristic, the cylinder has a length at least equal to a length of the distal part of the body.

The cylinder thus makes it possible to heat perfectly and evenly the entire distal part of the body.

According to one characteristic, the assembly means of the body and the complementary assembly means of the tube are adapted to block in longitudinal translation irreversibly the body in the second position. An operator using the protection device can therefore no longer position the body in the first position. The protection device is therefore disposable, which reduces the risk of contamination.

According to one characteristic, the assembly means of the body comprise a first housing and a second housing, the complementary assembly means of the tube comprising a lug, the lug being adapted to fit into the first housing when the protection device is in the sampling configuration and to fit into the second housing when the protection device is in the protection configuration.

The body is thus blocked in longitudinal translation when the body is in the first position or the second position.

According to one characteristic, the lug comprises a stop face bearing against stop faces respectively of the first and second housings when the body is respectively in the first and second positions, the stop face of the first housing being inclined with respect to to the stop face of the lug so as to allow the sliding of the body from the first position to the second position, the stop face of the second housing being parallel to the stop face of the lug so as to block irreversibly the body in the second position.

Thanks to the inclination of the stop face of the first housing, the lug can be released from the first housing to position the body in the second position. The stop face of the second housing parallel to the stop face of the lug, on the other hand, prevents the lug from coming out of the second housing, which ensures that the protection device is locked in the protection configuration. The stop face of the second housing is normal to the direction of sliding of the body or longitudinal translation.

According to one characteristic, the assembly means of the body comprise means for guiding in translation and for locking in rotation adapted to cooperate with means for guiding in translation and for locking in complementary rotation of the tube when the body is in the first position. or in the second position so as to block the body in rotation about a longitudinal axis and to guide the sliding of the body on the tube.

According to one characteristic, the tube comprises fixing means suitable for fixing the tube on the medical device.

The fixing means thus make it possible to block any movement of the tube relative to the medical device during handling of the protection device.

According to one characteristic, the body has a proximal part communicating with the distal part through an interface opening, the proximal part having an internal cross section that tapers towards the interface opening.

The narrowing of the internal cross section of the proximal portion towards the interface opening allows the medical device to be directed as it is inserted into the protective device. In particular, this facilitates the introduction of part of the transfer device into the distal portion of the protection device.

The invention also relates to a medical transfer assembly comprising a protection device having the above characteristics and a transfer device. The transfer device includes a catheter and a syringe mounted at a proximal end of the catheter, the transfer device being partially disposed within the tube of the shielding device, the catheter comprising a hollow conduit, a distal portion of the conduit extending across the tube. beyond the distal part of the body so as to be outside the protection device when the protection device is in the sampling configuration, the distal portion of the duct being disposed inside the distal part of the body when the protection device is in protection configuration.

It is thus possible to remove an element, for example biological material, when the protection device is in the sampling configuration since the distal portion is placed outside the protection device. In particular, said element can be withdrawn from the catheter by means of the syringe. More precisely, said removed element can be maintained in the distal portion of the catheter duct. In this way, the device shield may be disposed in the shield configuration in which the thermally insulating distal portion of the body covers the distal portion comprising the removed element.

Sampling of the element can be carried out in a heated box. The protective device placed in the protective configuration is taken out of the heated box to be transported to the place of the medical intervention. The distal portion of the medical device is thus maintained at a predefined temperature, and is therefore protected from temperature variations that may be detrimental to the element removed. The medical device is thus protected from temperature variations throughout its handling.

According to one characteristic, the transfer device comprises a safety sleeve, the safety sleeve comprising at a proximal end mounting means suitable for irreversibly fixing the syringe to the safety sleeve.

The safety sleeve secures the assembly of the syringe to the catheter and prevents them from coming loose during handling of the transfer device.

According to one feature, the safety sleeve is a screw sleeve comprising a reamed distal end, the catheter being adapted to be screwed and unscrewed from the distal end of the safety sleeve.

Unlike the syringe which is irreversibly mounted to the safety sleeve, the catheter can be mounted and removed from the sleeve by screwing and unscrewing. However, the catheter cannot be detached from the sleeve by simply pulling on the catheter.

According to one characteristic, the means for fixing the tube are adapted to fix the tube to the safety sleeve.

Attaching the tube to the transfer device blocks any movement of the tube relative to the transfer device while preventing damage to the catheter.

In addition, fixing the tube on the safety sleeve instead of fixing on the syringe, this prevents damage to the syringe. According to one characteristic, the distal portion of the duct is adapted to receive biological material, in particular an embryo.

Finally, the invention relates to a method of transferring an element to be taken by means of the medical transfer assembly having the characteristics described above and comprising the following steps:

- arrangement of the protection device in the sampling configuration;

- provision of a distal end of the catheter conduit in a box containing the element to be removed;

- sampling of said element to be taken from the transfer device by creating a vacuum in the transfer device by means of the syringe; and

- arrangement of the protection device in the protection configuration.

Other features and advantages of the invention will become apparent in the description below with reference to the appended drawings, given by way of non-limiting examples:

- Figure 1a is a perspective view of a transfer device adapted to be mounted to a protection device according to the invention;

- Figure 1b is an exploded view of a set of catheters of Figure 1a;

- Figure 1c is a sectional view of the transfer device of Figure 1a;

FIG. 2 is a perspective view of a protection device according to an embodiment according to the invention on which the transfer device of FIG. 1 a is mounted, the protection device being in the sampling configuration;

- Figure 3 is a sectional view along a first plane of Figure 2;

- Figure 4 is a sectional view along a second plane of Figure 2; - Figure 5 is a perspective view of the protection device of Figure 2 in the protection configuration;

- Figure 6 is a sectional view along the foreground of Figure 5; and

- Figure 7 is a sectional view along the second plane of Figure

5.

In the description, the term "proximal" refers to a situation close to an operator while the term "distal" refers to an opposite situation. In the example described below and relating to an embryo transfer, the distal part refers to the part of the transfer device intended to be introduced into the uterine cavity of a patient.

The terms internal surface and external surface refer to the side surfaces of an element defining between them the thickness of said element. The term internal volume is also understood to mean the volume defined or delimited between the internal surface. Finally, the internal diameter of a part refers to the diameter of the internal surface of said part.

Figures 1a, 1b and 1c show a medical device. The medical device is here a device 1 for transferring biological material, in particular an embryo, but can of course be any other type of medical device. Figure 1c is a sectional view along a median plane of Figure 1a.

The transfer device 1 comprises on the one hand a catheter or a set of catheters, and on the other hand a syringe 12 known per se. The transfer device 1 has the particular feature of further comprising a safety sleeve 13.

In this example, the transfer device 1 comprises a set of catheters composed of a first catheter 10 and a second catheter 11 intended to cooperate together. The first catheter 10 and the second catheter 1 1 are open at their ends.

The first catheter 10 comprises a first hollow conduit 100 and an introducer sleeve 101.

The first duct 100 is made here of a non-transparent material. The first duct 100 is made of a flexible material. A proximal end 100a of the first hollow duct 100 opens into the sleeve 101. The sleeve 101 has a substantially cylindrical shape. The sleeve 101 is intended to remain outside the natural cavity of the patient.

The second catheter 1 1 comprises a second duct 1 10 transparent, hollow and a handle 1 1 1.

The second duct 110 has a diameter smaller than the diameter of the first duct 100 of the first catheter 10. This allows the first duct 100 to house the second duct 110. The second duct 110 is also made of a flexible material. The second conduit 1 10 is made of a transparent material.

The second conduit 110 is intended to contain biological material, for example an embryo, intended to be introduced into the cervix of the patient.

The handle 1 1 1 extends a proximal end 1 1 a of the second conduit 1 10.

The second catheter 11 has a length greater than the length of the first catheter 10 so that when the second catheter 1 1 is introduced into the first catheter 10, the handle 1 11 and a distal portion 1 10b of the second duct 1 10 s 'extends beyond the first catheter 10.

The set of catheters is intended to be introduced into the uterine cavity of the patient to make it possible to reach the cervix via a distal end 1b of the catheter assembly and in particular of the second duct 1 10. The introduction of the catheter assembly into the cervix is facilitated by the flexibility of the first and second conduits 100, 110. The transparency of the second conduit, 110 allows an operator to view the biological material during collection.

In a different example and also known from the prior art, the transfer device 1 comprises a single catheter.

The safety sleeve 13 comprises a proximal end 13a to which the syringe 12 is mounted and a distal end 13b to which the catheter is mounted, in particular here the second catheter 11. In other words, the second catheter 11 and the syringe 12 are assembled together by means of the safety sleeve 13.

The safety sleeve 13 is here a hollow cylinder. The safety sleeve 13 includes a bore formed at the distal end 13b. In particular, the safety sleeve 13 is a screw sleeve or threaded sleeve. The bore includes rings 132 formed inside the safety socket 13. The rings 132 project from an inner wall 130 of the safety socket 13.

The safety sleeve 13 also comprises, at its proximal end 13a, mounting means 133. The mounting means 133 are formed in this example of an annular elastic element or annular clips projecting from the internal wall 130 of the safety sleeve. 13

The safety sleeve 13 comprises a window, called the first window 134, adapted to expose a part of the syringe 12 when the transfer device 1 is assembled.

The socket also comprises three fingers, called the first finger 135, second finger 136 and third finger (not visible in the figures), and protruding from an external wall 131 of the safety socket 13. The second finger 136 and the third finger are symmetrically formed with respect to the first finger 135.

Syringe 12 is a conventional syringe similar to those commonly used in medical laboratories for the collection and transfer of elements. The syringe 12 makes it possible to take a sample, an injection or an insemination of an element, for example biological material, by creating a depression or an overpressure in the set of catheters.

During the assembly of the transfer device 1, the syringe 12 is mounted at the proximal end 13a of the safety sleeve 13. In particular, part of the syringe 12 is fixed to the safety sleeve 13 by means of mounting 133. In the example described, the elastic element constituting the mounting means 133 is deformed by elasticity when the syringe 12 is introduced into the safety sleeve 13.

The fixing of the syringe 12 on the safety sleeve 13 is irreversible, that is to say that the mounting means 133 do not allow the removal of syringe 12 once it has been secured to safety sleeve 13.

The second catheter 1 1 is then mounted to the safety sleeve 1 3. The second catheter 1 1 is here screwed to the distal end 13b of the safety sleeve 13. The handle 1 1 1 is in particular screwed onto the rings 132. The second catheter 1 1 can be unscrewed from the safety sleeve 13. Thus, unlike the fixing of the syringe 12 on the safety sleeve, the fixing of the second catheter 1 1 on the safety sleeve is reversible. The second catheter 11, however, cannot be withdrawn from the safety sleeve 13 only by pulling on it.

The bore and in particular the rings 132 as well as the mounting means 133 formed in the safety sleeve 13 make it possible to prevent separation of the second catheter 11 from the syringe 12.

FIGS. 2 to 7 represent a protection device 2 for a medical device according to an embodiment according to the invention.

The protection device 2 comprises a body 3 and a tube 4. The body 3 and the tube 4 are hollow and open at their ends. The body 3 is adapted to slide on the tube 4 in a longitudinal direction between a first position and a second position. The first position and the second position are end positions also referred to herein as longitudinal translational end positions. The body 3 comprises a proximal opening 300a formed at a proximal end 3a and adapted to the introduction of the tube 4. The body 3 comprises a distal opening 300b formed at a distal end 3b opposite the proximal end 3a.

The body 3 comprises an external surface 31 and an internal surface 30. The internal surface 30 of the body 3 defines an internal space adapted to receive the tube 4.

The body 3 has a substantially cylindrical shape. In the description, the longitudinal direction refers to a direction parallel to a longitudinal axis or of revolution around which the body 3 extends. The body 3 comprises a proximal part 32 and a distal part 33. The proximal part 32 and the distal part 33 communicate with each other at an interface end 3c via an interface opening 300c.

The interface opening 300c has a diameter smaller than the internal diameter of the proximal portion 32. In particular, the interface opening 300c is smaller than the proximal opening 300a of the body 3. In the illustrated embodiment, the portion of the body 3 adjacent to the distal portion 33 has an internal cross section tapering towards the interface opening 300c.

The interface opening 300c also has a diameter at least equal to the diameter of the second catheter 1 1 of the transfer device 1, and in particular to the diameter of the distal portion 1 10b so as to allow the passage of the second duct 1 10 .

The distal part 33 is thermally insulating. In the example shown, the distal part 33 is formed of a double wall, which gives it thermal insulation properties.

The distal part 33 comprises receiving elements 330. The receiving elements 330 are here formed of a first hollow cylindrical projection extending from the interface end 3c towards the distal end 3a, and of a second projection cylindrical hollow from the distal end 3a to the interface end 3c.

The body 3 comprises assembly means 340, 341, 342.

The assembly means 340, 341, 342 of the body 3 comprise means adapted to block the longitudinal translation of the body. The body assembly means here comprise a first housing 340 and a second housing 341. The first housing 340 and the second housing 341 are provided in an internal surface 30 of the body 3. The first housing 340 comprises a stop face 343 and the second housing 341 comprises a stop face 344. The distance separating the first housing 340 from the second housing 341 is equal to the travel distance of the body 3 or distance traveled by the body 3 when it slides from the first position to the second position. The means for assembling the body 3 also comprise means for guiding in translation and for locking in rotation around the longitudinal direction. In this example, the assembly means comprise a groove 342 formed in the internal surface 30 of the body 3.

The body 3 comprises at least one window, called the second window 35.

The second window 35 is adapted to expose a part of the body 3 and / or of the tube 4. The second window 35 has a substantially rectangular shape.

The tube 4 is adapted to be disposed in the proximal part 32 of the body 3. In other words, the tube 4 does not extend here into the distal part 33 regardless of the position in which the body 3 is located.

The tube 4 comprises an internal surface 40 and an external surface 41. The internal surface 40 of the tube 4 defines an internal space or volume suitable for receiving the medical device.

The tube 4 includes a proximal end 4a and a distal end 4b. The tube 4 comprises a distal opening 400b formed at the distal end 4b of the tube 4 and opposite a proximal opening 400a formed at the proximal end 4a of the tube 4. The proximal opening 400a of the tube 4 is adapted to the introduction. of the medical device. The distal opening 400b of the tube 4 is narrow relative to the proximal opening 400a of the tube 4. A distal portion of the tube 4 has a cross section tapering towards the distal opening 400b. The distal portion of the tube 4 here has a substantially frustoconical shape, the distal opening 400b forming the smallest base of the truncated cone. The distal opening 400b of the tube 4 has a diameter at least equal to the diameter of the second catheter 11 of the transfer device 1, in particular the diameter of the distal portion 110b.

The tube 4 includes a chamfered front face 420 extending to the distal end 4b of the tube 4. The chamfered shape of the front face 420 facilitates the insertion of the tube 4 into the body 3 when mounting the protection device.

The tube 4 comprises complementary assembly means 440,

442. The complementary assembly means of the tube 4 are adapted to cooperate with the assembly means of the body 3 so as to block the longitudinal translation of the body 3 on the tube 4 as well as the rotation of the body 3 around the longitudinal direction. In the exemplary embodiment described, the means for assembling the body and the means for assembling the body by cooperating together also make it possible to guide the sliding of the body 3 on the tube 4.

The complementary assembly means comprise a lug 440 formed in the outer surface 41 of the tube 4. The lug 440 is formed so as to allow interlocking by complementarity of shapes in the first housing 340 and the second housing 341 of the body 3. The lug 440 comprises a stop face 441 adapted to be supported against the stop face 343 of the first housing 340 when the body 3 is in the first position, and to be supported against the stop face 344 of the second housing 341 when the body 3 is in the second position. The stop face 344 of the first housing 340 is inclined relative to the stop face 441 of the lug 440. The stop face 344 of the second housing 341 is parallel to the stop face 441 of the lug 440.

The complementary assembly means of the tube 4 also include two projections 442. The projections 442 are symmetrically formed with respect to the lug 440. The projections 442, cooperating with the groove 342 of the body 3, allow the guiding of the sliding of the body 3. on the tube 4 as well as the locking in rotation of the body 3 around the longitudinal direction. The protrusions 442 of the tube 4 are spaced a distance less than the length of the groove 342 of the body 3.

The cooperation between the groove 342 of the body 3 and the projections 442 of the tube 4 also makes it possible to place the second window 35 of the body 3 facing the third window 45 of the tube 4 when the body 3 is in the first position.

The tube 4 also includes a window, called the third window 45. The third window 45 of the tube 4 has the same shape and the same dimensions as the second window 35 of the body 3.

The body 3 and the tube 4 can be made of plastic material, for example by injection or molding. This allows them to easily be given the desired shape and dimensions. The use of plastic provides a lightweight protective device. The tube 4 comprises fixing means suitable for fixing the tube 4 on the medical device. The fixing means are adapted to prevent the rotation of the tube 4 around the longitudinal direction as well as the sliding in the longitudinal direction of the tube 4 on the transfer device 1. In this example, the tube 4 comprises a hollow 460 opening into the internal surface 40 and two buttons 461 formed symmetrically with respect to the hollow 460.

The protection device 2 comprises a hollow cylinder 5 arranged in the distal part 33 of the body 3. The cylinder 5 and the body 3 are thus integral. The cylinder 5 is housed between the receiving elements 330 of the body 3. The cylinder 5 is made of a material having high thermal conductivity. Preferably, the cylinder 5 is made of a material having a thermal conductivity at least equal to 150 Wm ¹ .K ¹ . The cylinder can be made of aluminum or even silver or gold.

In another embodiment, the cylinder 5 has a recess adapted to accommodate a lug formed in the distal part 33 of the body 3.

The cylinder 5 is open at its ends and comprises a passage suitable for housing, for example, a heating plug (not shown). The stopper may be in the form of a cylindrical rod which has been heated beforehand and which can be inserted into the cylinder 5 before the use of the protection device. This allows the cylinder 5 to be heated and thus the distal part 33 of the body 3 to be heated.

In another exemplary embodiment, at least a part of the cylinder 5 extends beyond the distal part 33 of the body, outside the body 3. The cylinder 5 then has a length greater than a length of the part. distal 33 of the body 3 so that a part of the cylinder 5 extends outside the body 3. The cylinder 5 can thus be heated by conduction by bringing it into contact with a heat source such as hotplate.

The passage formed in the cylinder 5 also makes it possible to accommodate a part of the transfer device 1. In particular, the passage has a cylindrical shape and has a diameter at least equal to the diameter of the second catheter 1 1, in particular the diameter of the distal portion 110b. The protection device 2 is configured to take a sampling configuration and a protection configuration.

Figures 2, 3, 4 show the protection device 2 in the sampling configuration in which the assembly means 340, 341, 342 of the body 3 cooperate with the complementary assembly means of the tube 4 so as to place the body 3 in the first position. FIG. 2 is a perspective view of the protection device in the sampling configuration. Figure 3 is a sectional view along a first median plane of the protection device of Figure 2, the first plane passing through the longitudinal axis. Figure 4 is a sectional view along a second median plane of the protection device of Figure 2, the second plane passing through the longitudinal axis and substantially orthogonal to the foreground. In the exemplary embodiment described, the projections 442 of the tube 4 cooperate with the groove 342 of the body 3 so as to position the second window 35 of the body 3 facing the third window 45 of the tube 4. The lug 440 of the tube 4 is fitted into the first housing of the body 3. The stop face 441 of the lug 440 is thus resting against the stop face 343 of the first housing 340. The distal end 4b of the tube 4 and the end of interface 3c extend substantially in the same transverse plane.

Figures 5, 6, 7 show the protection device 2 in a protection configuration in which the assembly means 340, 341, 342 of the body 3 cooperate with the complementary assembly means of the tube 4 so as to place the body 3 in second position. Figure 5 is a perspective view of the protection device in the protection configuration. FIG. 6 is a view in section along the first median plane of the protection device of FIG. 5. FIG. 7 is a view in section along the second median plane of the protection device of FIG. 5. In the exemplary embodiment described, the projections 442 cooperate with the groove 342 and the lug 440 of the tube 4 is fitted into the second housing 341 of the body 3. The stop face 441 of the lug 440 is thus resting against the stop face 344 of the second accommodation 341. The protection device 2 passes from the sampling configuration to the protective configuration by sliding the body 3 on the tube 4. In other words, an operator or practitioner pulls on the body 3 so as to cause the body 3 to pass through. the first position to the second position. In the example described, the operator pulls on the body 3 so as to release the lug 440 from the first housing 340 of the tube 4. The stop face 343 of the first housing 340 being inclined relative to the stop face 441 of the lug 440, the lug can in fact be released from the first housing 340 by applying a tensile force to the body 3.

The body 3 is therefore no longer blocked in longitudinal translation and can thus slide on the tube 4 to the second end position of longitudinal translation. The projections 442 of the tube 4 cooperating with the groove of the body 3 make it possible to guide the sliding of the body 3 on the tube 4. The lug 440 of the tube 4 is housed in the second housing 341 of the body 3. The stop face 344 of the second housing 341 being parallel to the stop face 441 of the lug

440, the lug 440 can no longer be disengaged from the second housing 341. The body 3 is thus locked in the second position and therefore the protection device is locked in the protection configuration.

The removal of an item takes place in the following steps.

The element to be taken contained in a petri dish is placed, for example, in a semi-closed heated box. The box is heated, for example, by means of a horizontal heating plate. The heated box includes two through holes adapted to allow the operator's arms to pass through so as to allow the handling of medical equipment. The heating plug can be heated beforehand, for example in an oven or by being placed on the heating plate of the box. The heating plug, once heated, can then be placed in the cylinder 5 so as to heat the distal part 33 of the body 3.

In the alternative embodiment (not shown) where a part of the cylinder protrudes from the distal part of the body, the protection device 2, alone not fitted to the transfer device 1, can be placed beforehand in the box so as to that the cylinder 5 of the protection device 2 is in contact with the hotplate. The protection device 2 can for this purpose be arranged vertically on the heating plate. The protection device can also be heated in an oven. The cylinder 5 of the protection device 2 having a high thermal conductivity, then heats by conduction.

The distal part 33 of the body 3 being thermally insulating, this allows heat to be stored in the distal part 33 of the protection device 2. The protection device 2 can be kept in the box while awaiting its use.

Of course, the element can be sampled in an environment other than that of the box.

Prior to the removal of an element, the transfer device 1 is assembled. In particular, the syringe 12 is assembled to the safety sleeve 13 by means of the mounting means 133. In the example described, the elastic element of the safety sleeve 13 allows the syringe 12 to be fixed irreversibly on the safety sleeve. 13. In other words, once the syringe

12 assembled to safety sleeve 13, syringe 12 and security sleeve

13 can no longer be separated. The second catheter 11 is then assembled to the safety sleeve 13. The handle 11 1 is in particular screwed onto the rings 132. The assembly of the second catheter 11 to the syringe 12 is thus secured by the safety sleeve 13.

The protection device 2 is then mounted on the transfer device 1. Figures 2 to 7 show the protection device 2 to which the transfer device is mounted 1. The transfer device 1 is introduced into the protection device 2. In the The exemplary embodiment described, the narrowed cross section of the portion of the body 3 adjacent to the distal portion 33 and of the distal portion of the tube 4 facilitates the introduction of the second duct 110 of the transfer device 1 into the protection device 2. This indeed allows the guidance of the catheter during its introduction into the protection device 2. Of course, the transfer device 1 is not fully inserted. At least a proximal part of a piston 120 of the syringe 12 extends beyond a proximal end of the protection device 2 so as to allow the removal and injection of the element, for example of the material organic. The protection device is then attached to the transfer device. The first finger 135 of the safety sleeve 13 is positioned in the hollow 460 of the tube 4 so as to block, on the one hand, the tube 4 in rotation around the longitudinal direction and, on the other hand, to position the first window 134 of the safety sleeve 13 facing the third window 45 of tube 4 and the buttons 461 of tube 4 facing the second finger 136 and third finger of the security sleeve 13. By applying pressure on the buttons 461 of tube 4, the buttons 461 are pushed in and clipped onto the second finger 136 and the third finger of the safety sleeve 13. The tube 4 is thus blocked in longitudinal translation.

The protection device 2 is dimensioned so that when the protection device 2 is in the sampling configuration, the distal portion 1 10b of the second catheter 1 1 extends beyond a distal end of the protection device 2. In other words, the distal portion 110b of the transfer device 1 extends outside the protection device 2. It is thus possible to remove the element to be taken from the catheter, in particular from the catheter. second catheter 1 1.

In practice, the medical assembly comprising the protection device 2 and the transfer device 1 is transferred to a container of the element to be taken, for example the petri dish. The protection device 2 is arranged in the sampling configuration. The distal end 1b of the second catheter 1 1 is disposed in the container. The plunger 120 of the syringe 12 is pulled so as to create a vacuum in the second catheter 11. The biological material is thus taken from the distal portion 110b of the second catheter 11.

The second window 35 of the body 3 being disposed opposite the third window 45 of the tube 4 and the first window 134 of the safety sleeve 13 when the protection device 2 is in the sampling configuration, the operator can thus view a part of syringe 12, for example graduations. The operator can therefore precisely take the desired amount of element.

Once the sampling is complete, the protection device 2 is brought into the protection configuration. Body 3 slides on tube 4 until the distal portion 33 of the body 3 completely covers the distal portion 110b of the second catheter 11. In other words, the distal portion 1 10b of the catheter is located entirely inside the protection device 2, in particular inside of the distal portion 33 of the body 3. Preferably, the stroke or sliding distance of the body 3 is at least equal to the length of the distal portion 110b of the transfer device 1. The term “stroke of the body 3” is understood to mean the distance , taken in the longitudinal direction, traversed by the body 3 from the first position to the second end position of longitudinal translation.

The medical assembly comprising the protection device 2 and the transfer device 1, can be extracted from the box to be routed to the body 3 of the patient. During transport, the protection device 2 is maintained in the protection configuration. The distal portion 110b of the transfer device 1 is thus disposed entirely in the distal portion 33 of the protection device 2. The distal portion 33 of the protection device 2 is thermally insulating, the distal portion 110b of the transfer device 1 comprising the The element taken is then protected from temperature variations.

In the particular case of transfer of biological material such as an embryo, the transfer device 1 is removed from the protection device 2 only at the time of introduction into the patient's body. To do this, the operator unlocks the tube 4 of the transfer device 1 by unlocking the fixing means. In particular, pressure is applied to the buttons 461 of the tube 4, thus pressing on the second finger 136 and third finger. The second finger 136 and the third finger then push the buttons 441 of the tube 4 by reaction. The transfer device can then be removed. The operator can in particular pull on the safety sleeve 13 so as to release the first finger 135 of the safety sleeve 13 from the hollow 460 of the tube 4.

Of course, the present invention is not limited to the embodiments described and illustrated.

The protection device has been described for use with a transfer device as a medical device. In particular, a device for transferring biological material such as an embryo has been given as an example. The protection device can be used for any other device medical, when it is a question of maintaining part of the medical device at a given or predefined temperature.

By way of example, the protection device can be used to protect a recoverable intrauterine device which may contain embryos or gametes, such as that described in patent application EP 336 79 37 filed in the name of the Applicant.

The protection device can be used to protect something other than biological material.

In addition, the protection device 2 can be used with a transfer device that does not include a safety sleeve 13.

In addition, the transfer device as described can be used independently of the protection device, for example in combination with other devices.

The means of assembling the body and the complementary means of assembling the tube may be different. For example, the interlocking direction of the assembly means and the additional assembly means can be reversed. In other words, in another embodiment the means for assembling the body may include lugs and protrusions, and the complementary means for assembling the tube may include a groove and housings.

The body assembly means and the complementary tube assembly means may also cooperate other than by interlocking.

In the exemplary embodiment described, the groove of the body 3 and the projections of the tube 4, by cooperating together, on the one hand, allow the sliding of the body 3 on the tube 4 to be guided and, on the other hand, block the rotation of the body 3. around the longitudinal direction. However, the means for blocking the body in rotation around the longitudinal direction and the means for guiding the sliding of the body on the tube can be separated. In this case, the body and the tube may comprise, on the one hand, first means cooperating together to allow the body to be locked in rotation, and on the other hand second means cooperating together to allow the guiding of the sliding of the body on the tube.

The proximal part 32 of the body 3 can thus for example comprise means for locking in rotation around the longitudinal direction, and at least one guide element adapted to facilitate the sliding of the body 3 on the tube 4. The guide element forms a protrusion inside the body. In other words, the cross section of the body 3 is narrowed at the level of the guide member. The guide element bears against the tube and may have an annular shape.

The means for fixing the tube 4 to the medical device may comprise a locking screw. The locking screw extends in a radial or transverse direction. The locking screw includes a head and a shank. The locking screw can be configured to take a locking position in which the locking screw passes through the tube 4 and an unlocking position in which the locking screw releases the internal space defined by the internal surface 40 of the tube 4. By in particular, the rod is adapted to pass through the tube 4 when the locking screw is in the locking position and conversely to free the internal space of the tube 4 when the locking screw is in the unlocking position.

The means for fixing the tube may include elastic clips projecting from the internal surface of the tube adapted to keep the tube fixed to the medical device. The clips can be of the type conventionally used in car cigarette lighters.

The protection device can be combined with Internet of Things technology, for example through the use of sensors connected to an external system such as a computer. The sensors can then send information to the computer to be used or processed, such as the temperature in the protection device or an alarm signaling a drop in temperature below a predefined threshold.

The present invention provides a protection device having an optimized structure allowing the protection of at least part of a device. medical device and thus avoiding temperature variations within said part of the medical device.

Claims

1. Protective device for a medical device (1) comprising a substantially cylindrical body (3) and a tube (4), said body (3) and tube (4) being hollow and open at their ends,

the body (3) comprising a thermally insulating distal part (32) and assembly means, the tube (4) comprising complementary assembly means, the body (3) being adapted to slide on the tube (4) according to a longitudinal direction from a first position corresponding to a sampling configuration of the protection device (2) to a second position corresponding to a protection configuration of the protection device, the means for assembling the body (3) and the means of assembly

complementary to the tube (4) being adapted to block the body (3) in longitudinal translation in the first position and the second position.

2. The protection device according to claim 1, wherein the length of the protection device (2) in the protection configuration is greater than the length of the protection device (2) in the sampling configuration.

3. Protective device according to one of claims 1 or 2, wherein the distal part (33) of the body (3) is formed of a double cylindrical wall.

4. Protective device according to one of the preceding claims, wherein the protective device (2) comprises a hollow cylinder (5) disposed in the distal part (33) of the body, said cylinder (5) being made of a material. having high thermal conductivity, especially aluminum.

5. Protective device according to one of the preceding claims, wherein the assembly means of the body (3) and the assembly means complementary to the tube (4) are adapted to block in longitudinal translation irreversibly the body (3) in the second position.

6. Protective device according to one of the preceding claims, wherein the body assembly means (3) comprise a first housing

(340) and a second housing (341), the complementary assembly means of the tube comprising a lug (440), said lug (440) being adapted to fit into the first housing (340) when the protection device ( 2) is in the sampling configuration and to fit into the second housing (341) when the protection device (2) is in the protection configuration.

7. Protective device according to claim 6, wherein said lug (440) comprises a stop face (441) bearing against stop faces (343; 344) respectively of the first and second housings (340, 341) when the body (3) is respectively in the first and second positions, the stop face (343) of the first housing (340) being inclined relative to the stop face (441) of the lug (440) so as to allow the body to slide from the first position to the second position, the stop face (344) of the second housing (341) being parallel to the stop face (441) of the lug (440) so as to block irreversibly the body (3) in the second position.

8. Protective device according to one of the preceding claims, wherein the body assembly means (3) comprise means for guiding in translation and for locking in rotation (342) adapted to cooperate with means for guiding in translation. and blocking in complementary rotation (442) of the tube (4) when said body (3) is in the first position or in the second position so as to block the body (3) in rotation about a longitudinal axis and to guide the sliding of the body (3) on the tube (4).

9. Protective device according to one of the preceding claims, wherein the tube (4) comprises fixing means adapted to fix the tube (4) on the medical device (1). 10. Protective device according to one of the preceding claims, wherein the body (3) comprises a proximal portion (32) communicating with the distal portion (33) through an interface opening (300c), said proximal portion (32). ) having an internal cross section tapering towards said interface opening (300c).

1 1. Medical transfer assembly comprising a protection device (2) according to one of the preceding claims and a transfer device (1), said transfer device (1) comprising a catheter (10; 1 1) and a syringe (12) mounted at a proximal end (1a) of the catheter (10; 11), said transfer device (1) being partially disposed in the tube (4) of the protection device (2), said catheter (10; 1) 1) comprising a hollow duct (100; 110), a distal portion (1 10b) of the duct extending beyond the distal portion (33) of the body (3) so as to lie outside the device protection (2) when the protection device (2) is in the sampling configuration, said distal portion (1 10b) of the duct (100; 110) being disposed inside the distal part (33) of the body ( 3) when the protection device (2) is in the protection configuration.

12. A medical transfer assembly according to claim 11, wherein the transfer device (1) further comprises a safety sleeve (13), the safety sleeve comprising at a proximal end (13a) mounting means (133 ) adapted to fix the syringe (12) irreversibly to the safety sleeve (13).

13. Medical transfer assembly according to claim 12, wherein the safety sleeve (13) is a screw sleeve comprising a distal end (13b) reamed, said catheter (10; 1 1) being adapted to be screwed and unscrewed from said distal end of the safety sleeve (13).

14. Medical transfer assembly according to one of claims 12 or 13 comprising a protection device (2) according to claim 9, wherein the means for fixing the tube (4) are suitable for fixing the tube (4) on the safety sleeve (13).

15. Medical transfer assembly according to one of claims 1 1 to 14, wherein the distal portion (1 10b) of the conduit (100; 1 10) is adapted to receive biological material, in particular an embryo.

16. A method of transferring an element to be taken by means of the medical transfer assembly according to one of claims 1 1 to 15, comprising the following steps:

- arrangement of the protection device (2) in the sampling configuration;

- provision of a distal end (1 b) of the conduit (100; 1 10) of the catheter (10; 1 1) in a box containing the element to be taken;

- sampling of said element to be taken from the transfer device (1) by creating a vacuum in the transfer device (1) by means of the syringe (12); and

- arrangement of the protection device (2) in the protection configuration.