Medical device, drug delivery system and associated manufacturing process

Abstract

Medical device comprising a first sheath 13 made by molding and having a longitudinal axis L, the first sheath 13 having at least one elastic tab 23, 29 deformable between a first configuration and a second configuration, the elastic tab 23, 29 being in the second configuration offset from the longitudinal axis L relative to the first configuration, characterized in that the elastic tab 23, 29 has a relief 51, 53 adapted to cooperate with a first molding member 59, 61 of the first sheath 13 so as to maintain the elastic tab 23, 29 in position during the movement of a second molding member 57 of the first sheath 13 along a radial direction R relative to the longitudinal axis L. Figure for the abbreviation: Figure 4

Description

Title of the invention: Medical device, drug delivery system and associated manufacturing process

[0001] The invention relates to a medical device comprising a sheath made by molding and having a deformable elastic tab between a first configuration and a second configuration, the elastic tab being in the second configuration away from the longitudinal axis of the sheath relative to the first configuration.

[0002] Such a medical device is in particular a medical device intended for parenteral application.

[0003] Such a medical device is for example used in cooperation with a syringe and forms for example an automatic system for protecting the syringe needle after an injection of medicine via said needle.

[0004] The syringe includes, for example, a syringe body, a needle, a piston stopper or piston and a piston rod.

[0005] FR 2830765, in particular, is known as such a medical device comprising a first sheath made by molding, having a deformable elastic tab between a first and a second configuration, the elastic tab being, in the second configuration, offset from the longitudinal axis of the sheath relative to the first configuration. This medical device further comprises a second sheath mounted to slide relative to the first sheath. Depending on its configuration, the elastic tab of the first sheath either prevents or allows the sliding of the second sheath relative to the first sheath. The second sheath is specifically designed to receive a syringe and to slide relative to the first sheath after the injection of medication so that the syringe needle ends up inside the first sheath and becomes inaccessible to the user.This mechanism prevents accidental contact with the needle after drug injection. However, manufacturing the first sheath with a deformable elastic tab by molding is not easy. Indeed, molding the elastic tab requires moving a molding element in a direction perpendicular to the longitudinal axis of the first sheath, which sometimes causes deformation of the elastic tab. The deformed elastic tab does not perform its function correctly within the medical device, and the first sheath thus manufactured is defective.

[0006] The invention is intended in particular to facilitate the manufacture of a medical device as described above.

[0007] To this end, the invention relates to a medical device comprising a first sheath made by molding and having a longitudinal axis, the first sheath carrying at least one deformable elastic tab between a first configuration and a second configuration, the elastic tab being in the second configuration offset from the longitudinal axis relative to the first configuration. According to the invention, the elastic tab has a relief adapted to cooperate with a first molding member of the first sheath so as to maintain the elastic tab in position during the movement of a second molding member of the first sheath in a radial direction relative to the longitudinal axis.

[0008] Thus, the raised area provides a gripping zone for the elastic tab, allowing it to be held in position during the radial movement of the second molding element. Without this raised area, the tab could easily be separated in the radial direction during demolding, a separation that could subsequently lead to a malfunction of the device. By holding the elastic tab in its initial configuration during such demolding, the risk of variability in the manufacturing of the first sheath is reduced, thereby ensuring the proper functioning of the medical device. The safety of the medical device is thus improved, and the productivity of the manufacturing process is increased.

[0009] Advantageously, at the end of the molding sequence of the first sheath, the demolding of the relief takes place naturally during the movement of the first molding member to demold the first sheath.

[0010] Depending on other optional features of the medical device, taken alone or in any of their technically permissible combinations:

[0011] - The first sheath generally has a tubular shape, with a circular cross-section, oval, square or convex polygon. It is thus suitable for receiving one or more elements of a generally tubular shape.

[0012] - The medical device includes a second sheath mounted to slide relative to at the first sheath between two operating positions of the medical device, the elastic tab being able, depending on its configuration, to prevent or allow the movement of the second sheath relative to the first sheath in a longitudinal direction.

[0013] Preferably, in its first configuration, the elastic tab of the first sheath prevents the second sheath from moving relative to the first sheath, and in its second configuration, the elastic tab of the first sheath allows the second sheath to move relative to the first sheath.

[0014] Preferably, the second sheath has a generally tubular shape, with a circular, oval, square or convex polygonal cross-section. It is thus suitable for receiving one or more elements of generally tubular shape, for example an injection syringe. According to one variant, the two sheaths are mounted coaxially.

[0015] - The elastic leg has an outer face and an inner face and the relief of the The elastic tab is positioned on the inner face. The inner face of the elastic leg is defined with reference to the inside of the first sheath. The outer face of the elastic leg is defined with reference to the outside of the first sheath.

[0016] More specifically, the first sheath comprises a wall or set of walls delimiting an internal space of the first sheath, also called the interior of the first sheath, said wall or set of walls separating the internal space from an external space of the first sheath, also called the exterior of the first sheath. The elastic tab separates the internal space from the external space and therefore comprises an inner face facing the internal space and an outer face facing the external space. In other words, the outer face of the elastic tab is opposite the inner face along a radial direction to the longitudinal axis and is in contact with the external space of the first sheath, while the inner face is in contact with the internal space of the first sheath.Since the first sheath and the elastic band each have a certain thickness, an inner face is more precisely defined as a surface molded by a mold part located inside the sheath, and an outer face as a surface molded by a mold part located outside the sheath. Generally speaking, "inner" refers to a face or surface of the first sheath or of a component of the first sheath molded by a mold part located inside the sheath, such as the first molding element, as opposed to "outer," which refers to a face or surface of the first sheath or of a component of the first sheath molded by a mold part located outside the sheath, such as the second molding element.

[0017] - The elastic leg comprises at least one main body and a radial projection extending in a radial direction relative to the longitudinal axis, the radial projection bearing: a buttress surface, and an axial protuberance, extending along the longitudinal axis, forming the relief. Thus, a particularly simple type of gripping zone is proposed: an axial protrusion formed on a radial projection of the elastic tab. This protrusion can act as a stop, so that when the second molding element is withdrawn radially outwards, the axial protrusion, through its interaction with the first molding element, resists the movement of the elastic tab in the direction of withdrawal of the second molding element. This easily prevents radial separation of the tab during demolding. Furthermore, adding the protrusion is a particularly inexpensive solution that does not significantly alter the complexity of the mold and, consequently, its cost. Generally speaking, "radial direction" means a direction extending in a plane perpendicular to the longitudinal axis of the first sheath.

[0018] Advantageously, the elastic leg is formed from the material along with the first sheath. The elastic leg, and in particular its main body, is, for example, attached to the rest of the first sheath at a connection point located at a distal or proximal end of the elastic leg. Preferably, the elastic leg comprises a proximal end, a distal end, and two opposing lateral sides. The lateral sides and one of the distal and proximal ends are separated from the rest of the first sheath by a notch, such as a slot or cutout in the first sheath, while the other distal and proximal ends are connected to the rest of the first sheath at the connection point. Such an arrangement of the elastic leg at the first sheath provides the leg with the elasticity necessary to deform it between its first and second configurations. Alternatively, the axial protrusion is replaced by an axial recess, for example an axial hollow formed on the radial projection of the elastic leg.

[0019] - The radial projection has an inner face and an opposite outer face, the the abutment surface being supported by the outer face and the axial protrusion by the inner face. Thus, the attachment area is made in an area inaccessible to the user and which, advantageously, does not interfere with the operation of the medical device.

[0020] - The radial projection of the elastic leg comprises an inner face, a section of which radial includes a dovetail-shaped portion. The dovetail-shaped portion is along the radial section, that is to say, along a section in a plane perpendicular to the longitudinal axis of the first sheath. Such a dovetail-shaped portion can advantageously form a dovetail joint with a complementary part of the first molding element or inner mold, and thus ensure, in addition to the attachment area, retention of the elastic tab during demolding in a radial direction outwards.

[0021] - The radial projection has a radial end adjacent to the main body and a opposite radial end free, the axial protuberance being located between these two ends, preferably on a median line between these two ends. The axial protrusion can easily be manufactured using pre-existing molds. Indeed, a simple modification of the mold, particularly the first molding element, by removing material allows the axial protrusion to be formed.

[0022] - The axial protuberance is located at a free end of the radial projection. This positioning of the axial protrusion improves the robustness of the mold. Indeed, this allows for a wider space between the axial protrusion and the main body, and therefore for a thicker and more robust steel blade thickness in the mold.

[0023] - The radial projection connects to a distal or proximal end of the body main of the elastic leg and comprises a wall extending in a substantially radial direction and bearing the abutment surface and the axial protuberance and two opposing lateral arms on either side of the wall extending in a substantially radial direction, oriented axially and attached to the main body, and the axial protuberance is a rib which extends from one arm to the other on the radial projection.

[0024] The term "distal" refers to the position of an element close to the site of drug administration, for example, skin, eye, nostril, mouth, etc., as opposed to "proximal," which refers to the position of an element close to the user, that is, the person using the medical device to administer the drug. More precisely, for the same element, a distal end of the element is closer to the site of administration of a medical product, particularly a drug, than a proximal end of the element. Similarly, for the same element, a proximal end of the element is closer to the person using the medical device, and in particular to their fingers used to operate the medical device, than a distal end of the element.

[0025] - The first sheath comprises a first part and a second part following the longitudinal axis, the first part being more proximal than the second part, and includes in the vicinity of its first part at least one elastic retaining tab corresponding to the elastic tab, said elastic tab forming a retaining tab of the second sheath in a first operating position of the medical device, this retaining tab being deformable so as to release the second sheath so that it moves axially under the effect of a return element and passes into a second operating position of the medical device. Thus, the attachment zone prevents damage, due to demolding, to a tab that holds the second sheath in a functional position, for example, in the position for injecting a medical product. Such damage could make it impossible to inject the product, hence the importance of the attachment zone.

[0026] In such an embodiment, the elastic tab preferably extends from the first part of the first sheath to the second part of the first sheath and has a distal end forming a radial projection oriented towards the inside of the first sheath. This radial projection has, on its so-called outer face, a stop surface for retaining the second sheath in the first operating position of the medical device.

[0027] - The first sheath has a first part and a second part along the long axis gitudinal, the first part being more proximal than the second part, and comprising in the vicinity of its second part at least one elastic locking tab corresponding to the elastic tab, said elastic locking tab being suitable for locking the second sheath in a second operating position of the medical device, and being capable of: + to be deformed from its first configuration to its second configuration so as to be crossed by a lug of the second sheath when the latter moves from a first to a second operating position of the medical device, then + to resume its first configuration so as to form a stop for this lug and thus lock the second sheath in the second operating position of the medical device. Thus, the attachment zone prevents damage, due to demolding, to an elastic tab that secures, or locks, the second sheath in an operating position, for example, in a safety position, after an injection of a medical product. Such damage could make it impossible to move the device into the safety position or allow the user to move the medical device from its second operating position back to its first operating position after the injection of the product / medication is complete—two events that could lead to accidents. In this embodiment, the elastic tab preferably extends from the second part of the first sheath to the first part of the first sheath and has a proximal end forming a radial projection oriented towards the inside of the first sheath. This radial projection has, on its outer face, a stop surface for locking the lug of the second sheath in the second operating position of the medical device.

[0028] The first operating position of the medical device is, for example, a position for injecting a medical product and the second operating position is, for example, a safety position in which the syringe needle is inaccessible to the user and is, for example, inside the first sheath.

[0029] - The medical device is a safety device for an injection syringe.

[0030] The invention also relates to a parenteral drug administration system, comprising a syringe attached to a medical device as described above.

[0031] The invention also relates to a method for manufacturing a medical device by molding as described above, the method comprising the following steps: - the injection of plastic material into a mold comprising the first and second molding elements to mold the first sheath, - the demolding of the first sheath, including, in order: • the movement of the second molding member along the radial direction relative to the longitudinal axis, for the formation of an outer face of the elastic tab, the first molding member cooperating with the relief of the elastic tab so as to maintain the elastic tab in position during said movement, and • the movement of the first molding element in a direction substantially parallel to the longitudinal axis. The relief defines a particularly relevant gripping area to prevent radial separation of the elastic tab when removing the second molding element to demold the first sheath.

[0032] Depending on other optional features of the manufacturing process taken alone or in combination:

[0033] - the radial projection of the elastic leg of the medical device comprises a face in external, a radial section of which includes a dovetail-shaped portion, and during the movement of the second molding member, the dovetail-shaped portion of the elastic leg interacts with the first molding member so as to maintain the elastic leg in position during said movement. Thus, the dovetail structure formed by the elastic leg prevents radial separation of the elastic leg.

[0034] - the first sheath has a first part and a second part along the long axis gitudinal, the first part being more proximal than the second part, and comprising in the vicinity of its second part at least one elastic locking tab corresponding to the elastic tab, said elastic locking tab being suitable for locking the second sheath in a second operating position of the medical device, and being able to be deformed from its first configuration to its second configuration so as to be crossed by a lug of the second sheath when it passes from a first to a second operating position of the medical device, and then to return to its first configuration so as to form a stop for this lug and thus lock the second sheath in the second operating position of the medical device;the first molding unit comprises a first element and a second molding element of the first sheath and the second molding unit comprises a third molding element of the first sheath, the demolding of the first sheath comprises in the following order: ; • the displacement of the second molding element a predetermined distance in a direction substantially parallel to the longitudinal axis, from a distal end to a proximal end of the medical device, to form the first part, • the movement of the third molding element for the formation of an ex- face external part of the retaining leg and the elastic leg during which:

[0035] • the dovetail-shaped portion of the retaining leg interacts with the second molding element so as to hold the retaining tab in position during said movement, • The first molding element cooperates with the relief of the elastic leg so as to maintain the elastic leg in position during said movement, • the movement of the first molding element in a direction from a proximal end to a distal end of the medical device to form the second part. Brief description of the figures

[0036] The invention will be better understood upon reading the following description, given solely by way of example and made with reference to the accompanying drawings in which:

[0037] [Fig-1] [Fig.1] is a schematic longitudinal cross-sectional view of a system parenteral drug administration comprising a syringe and a medical device according to the invention, in a first operating position;

[0038] [Fig.2] [Fig.2] is a set of front views, in transparency (figure 2a, 2b and 2c) of the medical device of [Fig.1] in distinct stages of operation of the medical device to reach a second operating position;

[0039] [Fig.3] [Fig.3] is a partial view of a longitudinal perspective section of a first sheath of a medical device according to a first embodiment of the invention, having two proximal elastic tabs and two distal elastic tabs;

[0040] [Fig.4] [Fig.4] is a view of an enlarged detail of a proximal elastic leg of the first sheath of the [Fig.3];

[0041] [Fig. 5] [Fig. 5] is a perspective view from inside an elastic leg proximal of the first sheath of the [Fig.3];

[0042] [Fig.6] [Fig.6] a view of an enlarged detail of a distal elastic leg of the first sheath of the [Fig.3];

[0043] [Fig.7] [Fig.7] is a perspective view from inside an elastic leg distal of the first sheath of the [Fig.3];

[0044] [Fig.8] [Fig.8] is a schematic view of the molding of a medical device according to an embodiment of the invention.

[0045] [Fig.9] [Fig.9] is a partial view of a longitudinal perspective section of a distal elastic leg of a first sheath of a medical device according to a second embodiment of the invention;

[0046] [Fig. 10] [Fig. 10] is a perspective view from inside the distal elastic leg of [Fig. 9].

[0047] [Fig. 11] [Fig. 11] is a perspective view from inside a proximal elastic leg of a first sheath of a medical device according to a third embodiment of the invention. Detailed description

[0048] Figures 1 and 2 show a parenteral drug delivery system, designated by general reference numeral 1. The delivery system 1 comprises a medical device 3 and a syringe 5 equipped with a needle. The medical device 3 is a safety device for an injection syringe. It has a distal end D, which is the end closest to the patient's skin, on the needle side, and an opposite end, which is the proximal end P.

[0049] The syringe 5 comprises a syringe body 7, a piston rod 9, a piston 11 or plunger stopper, and the needle 12. The syringe body 7 is designed to receive a substance, such as a medication, to be administered to a patient. The needle 12 is mounted at one end of the syringe body 7, and the plunger stopper 11 is received within the syringe body 7 and is adapted to be moved along the syringe body 7 when force is applied to the plunger stopper 11 via the piston rod 9.

[0050] Advantageously, the piston rod 9 comprises a first end in contact with the piston stopper 11 and a second end for pushing on the piston rod 9. The second end defines a support area suitable for receiving a finger of a user to control the administration of medication via the movement of the piston rod 9 which causes a movement of the piston stopper 11.

[0051] The medical device 3 comprises a first sheath 13, made by molding, and a second sheath 15 mounted to slide relative to the first sheath 13 between a first and a second operating position of the medical device 3 shown in Figures 1 and 2c. The syringe 5 is attached to the medical device 3, more precisely to the second sheath 15, and is disposed inside the second sheath 15. The first operating position is, for example, a medical product injection position, in which the medical device 3 is ready to be used in cooperation with the syringe 5 to inject said medical product into a patient. In the first operating position, the needle 12 protrudes relative to the first 13 and the second sheath 15 and is free to come into contact with the patient's body.The second operating position is, for example, a safety position, after an injection of a medical product, in which the needle 12 is in a retracted position relative to the first sheath 13 and is, for example, positioned inside the first sheath 13 so as to be inaccessible to any user of the administration system 1.

[0052] The first 13 and second 15 sheaths have a generally tubular shape, of circular section. They are coaxial. The medical device 3 also includes a helical spring 17 placed around the second sheath 15, between a shoulder 19 of the first sheath 13 and a collar 21 of the second sheath 15.

[0053] The first sheath 13 has a longitudinal axis (L). The first sheath 13 comprises a first part 13P and a second part 13D along the longitudinal axis, the first part 13P being more proximal than the second part 13D. In other words, the first part 13P is closer to a person using the medical device 3 to administer a medical product, and in particular to their fingers used to control the medical device 3, than the second part 13D.

[0054] The first part 13P has two elastic tabs 23 forming retaining tabs for the second sheath 15 in the first operating position of the medical device 3. Each retaining tab 23 has an outer face 24 and an inner face 26. Each retaining tab 23 comprises a main body 25 and a radial projection 27 extending in a radial direction (R) relative to the longitudinal axis (L). More precisely, the radial projection 27 extends at least in the radial direction; that is, it is capable of extending in addition to the radial direction in another direction, such as the longitudinal direction. The radial projection 27 has a stop surface 28. The radial projection 27 has an inner face 35 and an outer face 37. The stop surface 28 is supported by the outer face 37.

[0055] The second part 13D has two elastic tabs 29 forming locking tabs for the second sheath 15 in the second operating position of the medical device 3. Each locking tab 29 comprises a main body 31 and a radial projection 33 extending in a radial direction (R) relative to the longitudinal axis (L). More precisely, the radial projection 33 extends at least in the radial direction; that is, it is capable of extending in addition to the radial direction in another direction, such as the longitudinal direction. Each locking tab 29 has an outer face 30 and an inner face 32. The radial projection 33 has a stop surface 34. The radial projection 33 of the locking tab 29 has an inner face 41 and an outer face 43. The stop surface 34 is supported by the outer face 43.

[0056] The second sheath 15 comprises a first portion 15P and a second portion 15D along a longitudinal axis of the second sheath. The first portion 15P is more proximal than the second portion 15D. The first portion 15P has two arms 45, each with a notch 47 against which a retaining tab 23 of the first sheath 13 bears. The second portion 15D has two lugs 49.

[0057] Each retaining tab 23 of the first sleeve 13 is deformable between a first configuration and a second configuration so as to release the second sleeve 15 so that it slides axially under the effect of a return element (here the helical spring 17) and passes into the second operating position of the medical device 3. Each locking tab 29 of the first sleeve 13 is able to be deformed between a first configuration and a second configuration so as to be passed by the lug 49 of the second sleeve 15 when it passes from the first position ( [Fig.1]) to the second position (figure 2c) of operation of the medical device 3, then to return to its first configuration so as to form a stop 34 for this lug 49 and thus lock the second sleeve 15 in the second operating position of the medical device 3. In their second configuration, the elastic tabs 23, 29 are moved away from the longitudinal axis (L) relative to their first configuration.The elastic legs 23, 29 are capable, depending on their configuration, of preventing or allowing the movement of the second sheath 15 relative to the first sheath 13 in the longitudinal direction.

[0058] The administration system 1 works as follows. To inject the medication contained in the syringe 5, the user pushes on the piston rod 9 to depress the piston 11. At the end of the piston 11's stroke in the syringe body 7 (Figure 2a), the piston rod 9, and in particular one of its heads, causes the retaining tabs 23 of the first sleeve 13 to spread apart, thus releasing the second sleeve 15. The helical spring then causes the assembly consisting of the second sleeve 15 and the syringe 5 to retract towards the proximal end of the delivery system 1, as can be seen in Figures 2a and 2b, which show the delivery system 1 in intermediate positions where the retaining tabs 23 have been spread apart and are no longer bearing against the arms 45 of the second sleeve, and in particular the notches 47 of the arms 45 of the second sleeve 15, referenced on the [Fig.l].Each lug 49 of the second sheath 15 also retracts and passes through the radial projection 33 of the corresponding locking tab 29. At the end of their travel, as illustrated in Figure 2c, the lugs 49 come to rest against the stop surfaces 34, which prevent the second sheath 15 from moving towards the second part 13D of the first sheath 13, and in particular towards a distal end of the medical device 3. The needle 12 is retracted into the first sheath 13. The lugs 49, which are engaged above the radial projections 33, also prevent the second sheath 15 from moving towards the first part 13P of the first sheath 13, and in particular towards a proximal end of the medical device 3.More specifically, the first sheath 13 defines, along the longitudinal axis (L), between the locking tabs 29 and a proximal part of the first sheath 13, for example the first part 13P of the first sheath 13, a housing for receiving the lugs 49 when the medical device 3 is in its second operating position. Thus the lugs 49 are held locked in said housings. reception occurs when the medical device 3 is in its second operating position. This ensures that the medical device 3 is locked in its safety position after injection.

[0059] Figures 3 to 7 show in more detail a portion of a first sheath of a medical device according to a first embodiment of the invention. This portion is the upper part of the first sheath 13, that is, the part furthest from a distal injection end. The upper part includes, for example, the first 13P and second 13D portions of the first sheath 13 mentioned above.

[0060] In this embodiment, each elastic retaining tab 23 further comprises an axial protrusion 51 extending along the longitudinal axis (L), which constitutes a raised feature. Each elastic locking tab 29 also comprises an axial protrusion 53 extending along the longitudinal axis (L), which constitutes a raised feature. The axial protrusions 51, 53 are formed on the radial projection 27, 33 of the corresponding elastic tab 23, 29, more precisely on the inner face of the corresponding radial projection. The axial protrusions 51, 53 form a particularly simple raised feature / gripping area.This protrusion can serve as a radial stop, so that when a mold portion is withdrawn from the first sleeve 13 in an outward radial direction (R), the axial protrusion resists the movement of the elastic tab in the direction of withdrawal of that mold portion. This simply prevents the corresponding tab from spreading radially during demolding. The addition of the protrusion 51, 53 is a particularly inexpensive solution that does not significantly alter the complexity of the mold and therefore its cost. Furthermore, and advantageously, the inner face of each radial protrusion 27, 33 does not affect the operation of the medical device. Therefore, adding axial protrusions to this inner face has no impact on the functioning of the medical device.

[0061] Each radial projection 27, 33 connects to a distal end 69 or proximal end 71 of the main body 25, 31 of the corresponding elastic leg 23, 29 and comprises a wall 73 extending in a substantially radial direction and bearing the abutment surface 28, 34 and the axial protuberance 51, 53. The radial projection also comprises two opposing lateral arms 75 on either side of the wall 73, oriented axially and attached to the main body 25, 31. The axial protuberance 51, 53 is a rib extending from one arm 75 to the other 75 on the radial projection 27, 33. By axially oriented is meant oriented along the longitudinal axis.

[0062] Each radial projection 27, 33 has, according to the radial direction, a first radial end 65 and a second radial end 67 opposite to the first radial end 65.

[0063] Furthermore, in the medical device according to the first embodiment of In the invention, each axial protrusion 51, 53 is located between the two radial ends 65, 67 of the radial projection 27, 33, preferably on a midline between these two ends. The axial protrusion 51, 53 can easily be manufactured by modifying pre-existing molds. Therefore, it is not necessary to develop a specific mold to add the axial protrusion 51, 53.

[0064] Advantageously, and as shown in the figures, each elastic leg 23, 29 is formed from the material of the first sheath 13. The main body 25, 31 of each elastic leg 23, 29 is attached to the rest of the first sheath 13 at a connection zone 36 located at a distal 69 or proximal 71 end of the elastic leg 23, 29. Preferably, each elastic leg 23, 29 comprises a proximal end 71, a distal end 69, and two opposing lateral sides 38. The lateral sides 38 and one of the distal 69 and proximal 71 ends are separated from the rest of the first sheath 13 by an opening 40, such as a slot or cutout in the first sheath 13, while the other of the distal 69 and proximal 71 ends is connected to the rest of the first sheath 13 at the connection zone. link 36.

[0065] The linkage area 36 of each retaining leg 23 is located at a proximal end 71 of said retaining leg while the linkage area 36 of each locking leg 29 is located at a distal end 69 of said locking leg 29.

[0066] Such an arrangement of the retaining tabs 23 and locking tabs 29 at the level of the first sleeve 13 makes it possible to give each tab the necessary elasticity to deform it between its first and second configurations.

[0067] In the rest of the description the terms axial protuberance and relief are used interchangeably.

[0068] Figure 8 shows a schematic view of the molding of the first sheath 13 according to one embodiment of the invention. In the molding process of a medical device, and in particular of a first sheath according to the first embodiment of the invention, a mold 55 is used which comprises a first and a second molding element.

[0069] The first molding member comprises a first core 61 which constitutes a first molding element of the first sheath and in particular of a distal portion of the first sheath. The first core 61 is adapted to be displaced in a direction substantially parallel to the longitudinal axis, in particular in a direction from a proximal end to a distal end of the first sheath during the demolding of the first sheath.

[0070] The first organ also includes a second core 59 which constitutes a second molding element of the first sheath and in particular of a proximal part of the first sheath 13. The second core 59 is capable of being displaced in a direction substantially parallel to the longitudinal axis (L), in particular in a direction moving from a distal end to a proximal end of the first sheath 13 during the demolding of the first sheath.

[0071] The second molding member has two lateral drawers 57 for forming the outer faces 24 of the retaining tabs 23 and the outer faces 30 of the locking tabs 29. These lateral drawers 57, which can be moved radially outwards from the first sleeve 13 when it is demolded, constitute at least a third molding element of the first sleeve 13 in a direction (R) perpendicular to the longitudinal axis (L).

[0072] The relief 53 is able to cooperate with the first molding member and in particular the first molding element 61 of the first sleeve 13 so as to maintain the elastic tab 29 in position during the movement of the second molding member and in particular the third molding element 57 of the first sleeve 13 in the radial direction.

[0073] The relief 51 is able to cooperate with the first molding member and in particular the second molding member 59 so as to maintain the elastic tab 23 in position during the movement of the second molding member and in particular the third molding member 57 of the first sleeve 13 in a radial direction, that is to say substantially perpendicular to the longitudinal axis (L).

[0074] Thus, each elastic tab 23, 29 has a relief 51, 53 adapted to cooperate with a molding element 59, 61 of the first sleeve 13 so as to hold the elastic tab 23, 29 in position during the movement of a third molding element 57 of the first sleeve 13 in the radial direction. The relief 51, 53 thus constitutes an attachment zone for the elastic tab 23, 29 to retain it during the removal of a mold portion 57 55 delimiting the outer face of the first sleeve 13 and moving in the radial direction. Indeed, without this relief 51, 53, that is to say, when using an elastic tab whose demolding presents no obstacle, the tab could easily be separated in a direction perpendicular to the longitudinal axis of the first sleeve during demolding, a separation which could subsequently cause a malfunction of the device.By retaining the elastic tab in its initial configuration during demolding, the risk of variability in the manufacturing of the first sheath is reduced, thus ensuring the proper functioning of the medical device. The safety of the medical device is therefore improved.

[0075] Thus, the attachment zone 51 prevents damage, due to demolding, to a tab 23 which retains the second sleeve 15 in an operating position, for example in a position for injecting a medical product. Such damage could make it impossible to inject the product, hence the importance of the attachment zone 51.

[0076] The gripping area 53 helps prevent damage due to demolding, a tab 29 which secures, or locks, the second sheath 15 in an operating position, for example in a safety position, after an injection of a medical product. Such damage could make it impossible to move the device 3 into the safety position, hence the importance of the attachment area 53.

[0077] In one embodiment of the manufacturing process for the medical device 3 by molding, according to the first embodiment, the demolding of the first sheath 13 comprises the following steps: - the injection of plastic material into mold 55 comprising the first and second molding elements to mold the first sheath, - the demolding of the first sheath, including, in order: The movement of the second molding member, and in particular of the third molding element 57, in the radial direction relative to the longitudinal axis, for the formation of an outer face of the elastic tab, the first molding member cooperating with the reliefs of each elastic tab so as to maintain the elastic tabs 23, 29 in position during said movement. More specifically, during this step, the first molding element 61 cooperates with the reliefs of the locking tabs 29 and the second molding element 59 cooperates with the reliefs of the retaining tabs 23 and . the movement of the first molding element in a direction substantially parallel to the longitudinal axis. More specifically, during this step, the second molding element 59 moves in a direction from the distal end D to the proximal end P of the medical device and the first molding element 61 moves in a direction from a proximal end P to a distal end D of the medical device.

[0078] Advantageously, the radial projections 27 of each retaining lug 23 and / or locking lug 29 have an inner face of which a radial section includes a dovetail-shaped portion as shown in [Fig. 11] corresponding to the third embodiment.

[0079] The dovetail-shaped portion is for example formed by the lateral arms 75 and an inner face of the main body.

[0080] Such a dovetail-shaped portion 39 can advantageously form a dovetail assembly with a complementary mold part, and thus ensure, in addition to the gripping area, retention of the elastic leg during demolding in a radial direction outwards.

[0081] In an embodiment of the manufacturing process by molding a medical device according to this advantageous version, the demolding of the first sheath 13 further implies that during the movement of the third element 57 of molding, the dovetail-shaped portion of each retaining lug 23 and / or locking lug 29 interacts with the first molding member so as to improve the holding of the corresponding elastic lug in position during said movement.

[0082] Figures 9 and 10 show a locking tab of a medical device according to a second embodiment of the invention. In these figures 9 and 10, elements similar to those in the preceding figures are designated by identical reference numerals.

[0083] The device of the second embodiment is identical in every respect to the medical device according to the first embodiment.

[0084] It differs from this one, however, in that the axial protrusion 53 of the radial projection 33 of the locking tab 29 is located at a free end, preferably on a free edge 63 of the radial projection 33. This positioning of the axial protrusion improves the robustness of the mold.

[0085] In another embodiment not shown, the axial protrusion 51 of the radial projection 27 of the retaining tab is also located on a free edge of the radial projection 27.

[0086] Figure 11 shows an elastic retaining tab of a medical device according to a third embodiment of the invention. In this embodiment, each elastic retaining tab 23 is devoid of an axial protrusion, while the elastic locking tabs 29 are similar to those in the first or second embodiment.

[0087] As can be seen in [Fig. 11], the radial projection 27 has an inner face of which a radial section includes a dovetail-shaped portion.

[0088] Such a dovetail-shaped portion 39 advantageously forms a dovetail assembly with a complementary mold part, and thus ensures, instead of the attachment zone of the retaining tabs according to the first and second embodiments, retention of the retaining tab during demolding in a radial direction outwards.

[0089] A manufacturing process for the medical device 3 by molding, according to the third embodiment, comprises, in order: - the displacement of the second molding element 59 by a predetermined distance, for example on the order of a few millimeters, in a direction substantially parallel to the longitudinal axis in a direction going from a distal end to a proximal end of the medical device to form the first part 13P, - the movement of the third molding element 57 for the formation of an outer face of each retaining tab 23 and each locking tab 29 during which: The dovetail-shaped portion 39 of the retaining tab 23 interacts with the second molding element 59 so as to hold the retaining tab 23 in position during said movement, . the first molding element 61 cooperates with the relief 53 of the elastic leg 29 so as to maintain the elastic leg 29 in position during said movement, - the movement of the first molding element 61 in a direction from a proximal end to a distal end of the medical device to form the second part 13D.

[0090] Advantageously, following the step of moving the third molding element 57, the method also includes an additional step of moving the second molding element 59 in a direction from a distal end to a proximal end of the medical device to remove the second molding element from the first part 13P.

[0091] The invention is not limited to the embodiments shown and other embodiments will be obvious to a person skilled in the art. List of references

[0092] 1: Parenteral drug delivery system 3: medical device 5: syringe 7: syringe body 9: piston rod 11: piston 12: needle 13: first sheath 13P: Part One 13D: Part Two 15: second sheath 15P: first portion 15D: second portion 17: helical spring 19: shoulder of the first scabbard 21: collar of the second sheath 23: elastic tab near the proximal end of the first sheath, retaining tab of the second sheath 24: outer face of the retaining tab 25: Main body of the retaining leg 26: inner face of the retaining tab 27: radial projection of the retaining lug 28: abutment surface of the radial projection of the retaining lug 29: elastic leg near the distal end of the first sheath, leg of blocking the second sheath 30: outer face of the locking tab 31: Main body of the locking lug 32: Inner face of the locking tab 33: radial projection of the locking lug 34: abutment surface of the radial projection of the locking lug 35: inner face of the radial projection of the locking tab 36: Connection zone 37: outer face of the radial projection of the locking tab 38: side 39: Dovetail-shaped portion 40: obviously 41: inner face of the radial projection of the locking tab 43: outer face of the radial projection of the locking tab 45: arm of the second scabbard 47: notch for the arm of the second scabbard 49: spur of the second sheath 51: relief of the radial projection of the retaining lug 53: relief of the radial projection of the retaining lug 55: mold 57: Side drawer - third molding element 59: second core - second molding element 61: first core - first molding element 63: free edge of the radial projection 65: radial end of the radial projection adjacent to the main body 67: free radial end of the radial projection 69: distal end of the elastic leg 71: proximal end of the elastic leg 73: radial wall of the radial projection 75: Lateral arms of the radial projection (L) longitudinal axis of the first sheath (R) radial direction D: distal end P: proximal end SR: radial section

Claims

Demands

1. Medical device (3) comprising a first sheath (13) made by molding and having a longitudinal axis (L), the first sheath (13) having at least one elastic tab (23, 29) deformable between a first configuration and a second configuration, the elastic tab (23, 29) being in the second configuration away from the longitudinal axis (L) relative to the first configuration, characterized in that the elastic tab (23, 29) has a relief (51, 53) capable of cooperating with a first molding member (59, 61) of the first sheath (13) so as to maintain the elastic tab (23, 29) in position during the movement of a second molding member (57) of the first sheath (13) in a radial direction (R) relative to the longitudinal axis (L).

2. Medical device (3) according to claim 1, wherein the medical device (3) comprises a second sheath (15) mounted to slide relative to the first sheath (13) between two operating positions of the medical device (3), the elastic tab (23, 29) being able, depending on its configuration, to prevent or allow the movement of the second sheath (15) relative to the first sheath (13) in a given longitudinal direction.

3. Medical device (3) according to any one of the preceding claims, wherein the elastic tab (23, 29) has an outer face (24, 30) and an inner face (26, 32) and the relief (51, 53) of the elastic tab (23, 29) is disposed on the inner face (26, 32).

4. Medical device (3) according to any one of the preceding claims, wherein the elastic leg (23, 29) comprises at least one main body (25, 31) and a radial projection (27, 33) extending in a radial direction with respect to the longitudinal axis (L), the radial projection (27, 33) carrying: - a stop surface (28, 34), and - an axial protuberance (51, 53), extending along the longitudinal axis (L), forming the relief.

5. Medical device (3) according to the preceding claim, wherein the radial projection (27, 33) has an inner face (35, 41) and an opposite outer face (37, 43), the stop surface (28, 34) being carried by the outer face (37, 43) and the axial protrusion (51, 53) by the inner face (35, 39).

6. Medical device (3) according to claim 4 or 5, wherein the radial projection (27, 33) of the elastic leg (23, 29) comprises an inner face having a radial section comprising a dovetail-shaped portion (39).

7. Medical device (3) according to any one of claims 4 to 6, wherein the radial projection (27, 33) has a radial end (65) adjacent to the main body (25, 31) and a free opposite radial end (67), and the axial protrusion (51, 53) is located between these two ends (65, 67), preferably on a midline between these two ends (65, 67).

8. Medical device (3) according to any one of claims 4 to 6, wherein the axial protrusion (53) is located at a free end (63) of the radial projection (33).

9. A medical device (3) according to any one of claims 4 to 8, wherein the radial projection (27, 33) connects to a distal (69) or proximal (71) end of the main body (25, 31) of the elastic leg (23, 29) and comprises: - a wall (73) extending in a substantially radial direction and carrying the abutment surface (28, 34) and the axial protrusion (51, 53) and - two opposing lateral arms (75) on either side of the wall (73) extending in a substantially radial direction, oriented axially and attached to the main body (25, 31), and wherein the axial protrusion (51, 53) is a rib extending from one arm (75) to the other (75) on the radial projection (27, 33).

10. Medical device (3) according to claim 2, wherein the first sheath (13) has a first part (13P) and a second part (13D) along the longitudinal axis, the first part (13P) being more proximal than the second part (13D), and comprises in the vicinity of its first part (13P) at least one elastic retaining tab (23) corresponding to the elastic tab, said elastic retaining tab being capable of retaining the second sheath (15) in a first operating position of the medical device (3), and being deformable so as to release the second sheath (15) so that it moves axially under the effect of a return element (17) and passes into a second operating position of the medical device (3).

11. Medical device (3) according to claim 2 or 10, wherein the first sheath (13) has a first part (13P) and a second

12.

13.

14. part (13D) along the longitudinal axis (L), the first part (13P) being more proximal than the second part (13D), and comprising in the vicinity of its second part (13D) at least one elastic locking tab (29) corresponding to the elastic tab, said elastic locking tab (29) being suitable for locking the second sheath (15) in a second operating position of the medical device (3), and being capable of: - to be deformed from its first configuration to its second configuration so as to be passed by a lug (49) of the second sheath (15) when the latter passes from a first to a second operating position of the medical device (3), then - to resume its first configuration so as to form a stop (34) for this lug (49) and thus lock the second sleeve (15) in the second operating position of the medical device (3). Medical device (3) according to any one of the preceding claims, the medical device (3) being a safety device for an injection syringe (5). Parenteral drug delivery system (1), comprising a syringe (5) and a medical device (3) according to any one of the preceding claims, the syringe (5) being attached to the medical device (3). A method for manufacturing a medical device (3) by molding according to any one of claims 1 to 12, the method comprising the following steps: - the injection of plastic material into a mold (55) comprising the first (59, 61) and the second (57) molding elements for molding the first sheath, - the demolding of the first sheath comprising, in order: • the movement of the second molding member (57) in the radial direction relative to the longitudinal axis (L), for the formation of an outer face of the elastic tab, the first molding member (59, 61) cooperating with the relief of the elastic tab so as to maintain the elastic tab (23, 29) in position during said movement, and • the displacement of the first molding element (59, 61) along a direction substantially parallel to the longitudinal axis (L).

15. A manufacturing method according to claim 14, the medical device being according to claim 6, wherein during the movement of the second molding member (57), the dovetail-shaped portion (39) of the elastic tab (23, 29) interacts with the first molding member (59, 61) so as to maintain the elastic tab (23, 29) in position during said movement.

16. A method for manufacturing a medical device (3) according to claim 14 or 15, the medical device being according to claim 11, the first sheath (13) comprising in the vicinity of its first part (13P) at least one retaining tab (23) of the second sheath (15) in the first operating position of the medical device (3), this retaining tab (23) being deformable so as to release the second sheath (15) so that it moves axially under the effect of a return element (17) and passes into the second operating position of the medical device (3), the retaining tab (23) comprising an inner face having a radial section comprising a dovetail-shaped portion (39), in which the first molding member comprises a first molding element (61) and a second (59) molding element of the first sheath and the second molding member comprises a third molding element (57) of the first sheath,in which the demolding of the first sheath (13) comprises, in order: - the displacement of the second molding element (59) a predetermined distance along the direction substantially parallel to the longitudinal axis (L) in a direction from a distal end (D) to a proximal end (P) of the medical device to form the first part (13P), - the displacement of the third molding element (57) for the formation of an outer face of the retaining tab (23) and the elastic locking tab (29) during which: + the dovetail-shaped portion (39) of the retaining tab (23) interacts with the second molding element (59) so as to maintain the retaining tab (23) in position during said displacement, + the first molding element (61) cooperates with the relief (53) of the, elastic locking tab (29) so as to maintain the elastic locking tab (29) in position during said movement, - the movement of the first molding element (61) in a direction from a proximal end (P) to a distal end (D) of the medical device to form the second part (13D).

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