Device for holding injection-device tubes

Abstract

The invention relates to a holding device (10) intended to hold injection-device tubes (2) of the type comprising an upper flange (8) at one end of a body (4) and a lower flange (6) at the opposite end of the body (4), this device comprising orifices (12) each intended to accept one tube, each orifice being configured to allow the tube and each of its flanges to pass, and the device comprising a holding means (P) configured to hold the tube through the orifice via its upper flange, the holding means having at least one elastically deformable element (22), the said element comprising a holding end (18) situated in line with the orifice and configured to deform as the upper flange passes through the orifice, and to support the tube via the said flange when it is inserted in the orifice.

Description

[0001] DEVICE FOR RETAINING INJECTION TUBE

[0002] The present invention relates to a device for holding tubes of a drug injection device, as well as a method of implementing such a device for holding tubes of a drug injection device.

[0003] Syringes usually used for needle injection, comprising a piston pushed by an operator, generally have a tube with a collar at one end called the upper end.

[0004] In the following text, the terms "superior", "inferior", "horizontal", "vertical", "high", "low", etc. will be used as a non-limiting term and in reference to the device in the position of use.

[0005] Another type of injection device, described in particular by document FR-A1-3038232, performs needle-free intradermal, subcutaneous, or intramuscular injections of active ingredients contained in a fluid for therapeutic use in human or veterinary medicine. The fluid can be a gel or a liquid of varying viscosity. These devices are for single use only and contain an energy source, such as a pressurized gas generator, which delivers a sudden release of gas to a piston fitted within a cylinder formed by a glass tube with a flange at each end. This propels the fluid contained beneath the piston to an injection nozzle in contact with the skin, injecting it under the skin. The flanges generally have similar diameters.

[0006] Glass tubes for injection devices, especially those without needles, undergo a complete cycle during their preparation in a controlled air environment, successively including washing, drying, silicone deposition, depyrogenation and final sterilization.

[0007] For the preparation cycle of tubes with a single flange, they are inserted into circular retaining holes formed on a tray. The single flange forms rims that rest above the holes, holding the tubes vertically. In this way, a set of tubes arranged on the same tray is easily handled in different devices to perform the sequence of preparation operations. Tube handling is simple, quick, and safe.

[0008] This type of holding device can also be used for the preparation cycle of tubes having collars of different dimensions at each end, the collar at the upper end of the tube being larger than the lower collar.

[0009] However, for tubes, especially glass tubes, with a collar at each end of similar dimensions, such a tray cannot be used because the circular retaining holes, having a diameter sufficient to receive the tube collars, would not be able to retain the collar at the upper end.

[0010] For this purpose, it is known to have a tray comprising orifices designed to receive each the body of the tube, each orifice having a retaining part having dimensions smaller than the collars so as to allow the collar of the upper end of the tube to be blocked vertically, the retaining part extending laterally by an introduction part allowing the passage of the collars.

[0011] This type of holding device allows an operator to insert the lower end flange of each tube into the insertion section, then slide the tube vertically towards the holding section. The tube is then held vertically by its upper flange, which is held above the bore.

[0012] Such a platform, although satisfactory overall, is susceptible to improvements, particularly with the aim of increasing the number of tubes held per holding device, so as to increase the number of tubes prepared during a preparation cycle in order to increase production capacity.

[0013] The present invention aims in particular to avoid these drawbacks of the prior art.

[0014] For this purpose, it proposes a retaining device intended to hold injection device tubes of the type having an upper flange at one end of a body and a lower flange at the opposite end of the body, this device comprising orifices provided for each to receive a tube, the retaining device being notable in that each orifice is configured to allow passage of the tube and each of its flanges, and in that the retaining device includes a retaining means configured to hold the tube through the orifice by its upper flange, the retaining means having at least one elastically deformable element, said element having a retaining end located at the orifice and configured to deform when the upper flange passes through the orifice, and to support the tube by said flange when it is inserted into the orifice.

[0015] The support device is, for example, a platform. In the following description, the term "platform" will be understood to mean any support device.

[0016] It is understood that the retaining device includes several means of retention, each means of retention being configured to hold one of the tubes through one of the orifices by its upper flange.

[0017] It is understood that the retention device includes a retention means for each orifice. In other words, each retention means is associated with an orifice.

[0018] The element is elastically deformable so that it is configured to be mechanically constrained by the upper collar and to deform over its passage.

[0019] The retaining end is configured to support the tube by its upper flange when the mechanical stress is removed.

[0020] It advantageously defines a support surface.

[0021] The term "located at the orifice" means that the retaining end is located in the orifice or on the path of the tube when it is inserted into the orifice.

[0022] The retaining means is configured to hold a tube in a support position through the orifice.

[0023] More specifically, the retaining means is configured to hold the tube vertically, with the upper flange of the tube resting on the retaining end.

[0024] One advantage of this tray is that, in a simple, quick and efficient way, an operator can insert each tube into an orifice, the tube then being held vertically by its upper collar.

[0025] In addition, the openings in this tray are such that they allow for space savings on the tray, so as to allow for the storage of additional tubes, compared to the previous art.

[0026] The platform according to the invention may further comprise one or more of the following characteristics, which may be combined with each other.

[0027] For example, the retaining device includes a plate, preferably flat. The holes are then made in the plate.

[0028] In particular, the retaining means is configured to be at least partially in contact with the tube body when the tube is inserted into the orifice, thus providing additional tube retention. According to one characteristic, the retaining means is integral with the tray. More precisely, each of the retaining means is integral with the plate.

[0029] The retaining device and the plate are a single piece. More precisely, each of the retaining devices and the plate are made from a single piece of material.

[0030] In one embodiment, the retaining means protrudes upwards.

[0031] For example, each of the retaining devices protrudes from the plate.

[0032] According to one characteristic, the retaining means forms a wall for the orifice, the wall protruding from the tray. More precisely, the wall protrudes from the plate.

[0033] According to one aspect, each means of support forms a wall encircling one of the openings.

[0034] By wall, we mean a projecting element that surrounds the opening, said element being able to be perforated by having spaces.

[0035] The wall can be perforated.

[0036] This wall increases the stability of the tubes in the tray. In other words, the wall improves the stability of the tubes in the tray.

[0037] According to one feature, the wall has a proximal end in contact with the tray, and more specifically, in contact with the plate, and a distal end forming the retaining end located at the orifice, said retaining end forming an opening configured to deform when the upper flange of the tube passes through the orifice and to support the tube by said flange when it is inserted into the orifice.

[0038] The opening is smaller in size than the orifice and configured to be smaller in size than the upper flange of the tube.

[0039] The wall is elastically deformable so that it is configured to move apart when passing over the upper collar.

[0040] Advantageously, the elastically deformable element has at least two legs, preferably between three and ten legs, and preferably even six legs.

[0041] The legs form the wall advantageously.

[0042] In this way, the wall has spaces arranged between the legs, which allow the wall to move apart when the upper collar passes through the opening. According to one characteristic, the opening is configured to be complementary to the upper collar.

[0043] By "complementary" we mean that the shape of the orifice is essentially identical to that of the upper flange, but its dimensions are slightly larger to allow the flange to pass through when the tube is inserted into the orifice. In other words, the orifice and the upper flange of the tube are configured to cooperate through complementary shapes.

[0044] In this way, no space is wasted on the set, which allows for optimized production capacity.

[0045] Advantageously, the tray is made of a plastic material comprising liquid crystal polymers, produced by injection molding. This plastic material offers good rigidity, resistance to various chemical agents, and resistance to the high temperatures of dry sterilization.

[0046] It should be noted that the tray as described above is configured to hold tubes of the type having a single flange at one upper end of a body, and / or tubes of the type having an upper flange and a lower flange, the upper flange being of a dimension greater than or equal to the lower flange.

[0047] In some embodiments, the diameter of the orifice is between 15 and 20 mm and is for example 16 mm.

[0048] In some embodiments, the diameter of the opening is between 10 and 15 mm and is for example 12 mm.

[0049] The invention further relates to an assembly comprising a retaining device conforming to any one of the characteristics mentioned above,

[0050] tubes for injection device having an upper flange at one end of a body and a lower flange at the opposite end of the body, each tube being configured to be inserted into an orifice of the holding device.

[0051] The invention also relates to a method of implementing a tray as described above, for holding drug injection device tubes, in which a tube is inserted vertically into each orifice of the tray.

[0052] In the embodiment in which the retaining means protrudes upwards, the method for implementing the tray includes a step of inserting a tube into each orifice from the bottom of the tray. Other features and advantages of the invention will become apparent upon reading the detailed description that follows, for understanding which reference should be made to the accompanying drawings in which:

[0053] Figure 1 is a schematic side perspective view of a needle-free injection device tube of the type having a collar at each end of a body;

[0054] Figure 2 is a schematic perspective top view of a tray with orifices according to the invention, intended to receive tubes of Figure 1;

[0055] Figure 3 is a schematic perspective view of an opening in the plate of Figure 2;

[0056] Figure 4 is a schematic top view of the opening in Figure 3;

[0057] Figure 5 is a schematic side view of a detail of the tray in Figure 2, with tubes inserted into the orifices.

[0058] The terms "upper", "lower", "front", "rear", "top", "bottom" and their derivatives refer to the position or orientation of an element or component, this position or orientation being considered when the board is in use configuration.

[0059] Figure 1 represents a glass tube 2 of an injection device, comprising a cylindrical body 4 having a lower flange 6 at one end of the body 4 and an upper flange 8 at the opposite end of the body 4, each forming an external ridge of revolution around the main axis of the body.

[0060] The upper collars 8 and lower collars 6 are circular.

[0061] The glass tube 2 can be used in particular by the injection device shown above and illustrated by the prior art document FR-A1-3038232.

[0062] Figure 2 illustrates a rectangular-shaped plate 10.

[0063] Advantageously, the plate 10 is made by injection molding of a plastic material comprising liquid crystal polymers, called "LCP" (acronym for the English terms "Liquid Crystal Polymer"), which are high mechanical performance materials resistant to dry heat cycling at 240°C, as well as to various chemical agents.

[0064] The platform 10 comprises a flat plate 24 having, in the middle of two opposite sides, a notch 14 facilitating the handling of this platform. The platform 10 has eight identical rows, parallel to the sides having the notches 14, of seven circular holes 12.

[0065] Each orifice 12 is designed to receive a glass tube 2 which is held vertically, with its axis perpendicular to this plate (figure 5).

[0066] As illustrated in more detail in Figure 3, each orifice 12 has six tabs 22 projecting upwards from the plate, forming a wall P for the orifice, perforated by spaces 13 between the tabs 22.

[0067] The six legs 22 are oriented at 30°.

[0068] In variants not shown, the orifice has three or four legs.

[0069] The presence of the six legs is advantageous because it allows for better support of the tubes

[0070] This perforated wall P is configured to hold a tube 2 through the orifice 12, by its upper flange 8, as will be described in more detail with reference to figure 5.

[0071] The wall P is a means of holding a tube.

[0072] Each leg 22 has a proximal end 16 in contact with the plate 24 of the platform 10 at the contour of the orifice 12, and a distal end called the retaining end 18, located at the orifice 12.

[0073] Thus, each leg 22 is attached to the plate 10 and the retaining end 18 is located on the path of the tube 2 when it is inserted through the orifice.

[0074] Each leg 22 is elastically deformable so that it is adapted to deform during the passage of the upper collar 8 from the proximal end 16 to the retaining end 18, and to support the upper collar 8 when the tube 2 is inserted through the orifice 12, as illustrated in Figure 5.

[0075] Thus, each leg is configured to be mechanically constrained by the upper collar 8 and to deform over its passage.

[0076] The retaining end 18 is configured to support the tube 2 by its upper flange 8 when the mechanical stress is removed.

[0077] The retaining ends 18 of each leg 22 of an orifice 12 define a retaining surface located at the orifice.

[0078] The retaining surface forms an opening 20 (figure 4) located at the orifice 12, configured to deform during the passage of the upper flange 8 and to support the tube 2 by its upper flange 8 when it is inserted through the orifice 12, as shown in figure 5.

[0079] Furthermore, each leg 22 has a proximal portion 26 oblique upwards, starting from the proximal end 16 towards the inside of the orifice 12, and a distal portion 28 vertical upwards, starting from the proximal portion 26 towards the retaining end 18.

[0080] In addition, the height of each leg 22 is between 10 and 25 mm, preferably 18.5 mm in order to ensure vertical support of the tubes 2 inserted into the orifices 12.

[0081] The height of the proximal portion 26 is between 10 and 15 mm, and preferably 13 mm, while the height of the distal portion 28 is between 3 mm and 5 mm, and preferably 4 mm.

[0082] As shown in Figure 4, the diameter "d" of opening 20 is 12.2 mm, while the diameter "D" of orifice 12 is 16 mm.

[0083] Thus, the opening 20 is smaller in size than the orifice 12.

[0084] Furthermore, the upper collar 8 has a diameter of approximately 14 mm. It is therefore complementary in size to the orifice 12 but larger than the opening 20.

[0085] Figure 5 illustrates a part of the tray 10 having tubes 2 inserted into orifices 12 as described previously, the tray 10 being fitted in a standardized support 30 forming a contour, also called "Tub", allowing positioning in different devices for processing glass tubes 2.

[0086] The tray 10 has "keyhole" shaped lights 17 which are used to grip the tray when removing it from the support 30.

[0087] Each orifice 12 is configured to allow passage of a tube 2 and each of its flanges 6, 8.

[0088] The wall P of an orifice 12, formed by the lugs 22, is configured to hold the tube 2 in a support position through the orifice 12.

[0089] Thus, each tube 2 is held vertically, the upper collar 8 resting on the retaining end 8 of the legs 22.

[0090] The legs 22 are configured to be at least partially in contact with the body 4 of the tube 2 inserted into the orifice 12, which allows additional support for the tube.

[0091] It is the distal portion 28 of the legs 22 that is in contact with the body 4 of the tube 2 when it is inserted into an orifice 12. The distal portion 28 is substantially adjusted around the body 4 of a glass tube 2.

[0092] For the introduction of a tube 2 into an orifice 12, the tube 2 is inserted vertically into the orifice 12, from the bottom of the tray 10.

[0093] When the tubes 2 have been introduced into the orifices 12 of the tray 10, the complete tray 10 with its support 30 is then bagged and the bag sealed to sterilize the tubes.

[0094] We use plastic bags made of high-density polyethylene, which can in particular be a material marketed under the registered trademark "Tyvek", allowing reduced moisture transmission, good heat conduction, a strong microbial barrier, and high mechanical resistance, especially for resistance to perforation.

[0095] The final packaging is carried out according to the French standard "NF ISO 11040-7", specifying the packaging of systems to deliver sterilized tubes ready to be filled.

[0096] After washing the tubes 2, a silicone coating is applied, followed by sterilization using a pyrogen reduction process including dry heat heating to achieve a strong reduction of endotoxins, which are pyrogens.

[0097] In particular, a dry heat heating cycle at 240°C has the advantage of simultaneously cross-linking the silicone, thus preventing the release of this silicone into the medication after filling the glass tube 2 and during the final use of the injection device on the patient. Furthermore, this process avoids sterilization with ethylene oxide, which introduces toxic substances.

Claims

DEMANDS 1. A retaining device (10) for retaining tubes (2) of an injection device of the type having an upper flange (8) at one end of a body (4) and a lower flange (6) at the opposite end of the body (4), said retaining device (10) comprising orifices (12) each provided to receive a tube (2), each orifice (12) being configured to allow passage of the tube (2) and each of its flanges (6, 8), the retaining device (10) comprising retaining means (P), each retaining means being configured to retain one of the tubes (2) through one of the orifices (12) by its upper flange (8), each retaining means (P) having an elastically deformable element (22), said elastically deformable element (22) having a retaining end (18) located at the orifice (12), the retaining end (18) being configured to deform during the passage of the upper flange (8) through the opening (12),and to support the tube (2) by means of said collar (8) when the tube is inserted into the orifice (12).

2. Device according to the preceding claim, wherein the retaining means (P) is configured to be at least partially in contact with the body (4) of the tube (2) when the tube (2) is inserted into the orifice (12).

3. Device according to any one of the preceding claims, wherein the retaining means (P) is projecting upwards.

4. Device according to any one of the preceding claims, wherein the retaining means (P) forms a wall for the orifice (12), the wall being projecting from the retaining device (10).

5. Device according to the preceding claim, in which the wall (P) has a proximal end (16) in contact with the retaining device (10) and a distal end forming the retaining end (18) located at the orifice (12), said retaining end (18) forming an opening (20) configured to deform when the upper flange (8) of the tube (2) passes through the orifice (12) and to support the tube (2) by said flange (8) when it is inserted into the orifice (12).

6. Device according to any one of the preceding claims, wherein the elastically deformable element (22) has at least two legs (22), preferably between three and ten legs (22), and preferably even six legs (22).

7. Device according to the preceding claim in combination with any one of claims 4 to 5, wherein the legs (22) form the wall (P).

8. Device according to any one of the preceding claims, wherein the orifice (12) is configured to be complementary to the upper collar (8).

9. Holding device according to any one of the preceding claims, wherein the diameter of the orifice (12) is between 15 and 20 mm and is for example 16 mm.

10. Retaining device according to any one of claims 5 to 9, wherein the diameter of the opening (20) is between 10 and 15 mm and is for example 12 mm.

11. Set comprising: a retaining device (10) according to one of the preceding claims, tubes (2) for injection device having an upper flange (8) at one end of a body (4) and a lower flange (6) at the opposite end of the body (4), each tube being configured to be inserted into an orifice (12) of the retaining device (10).

12. Method of implementing a retaining device (10) according to any one of the preceding claims, for retaining tubes (2) of a drug injection device, in which a tube (2) is inserted vertically into each orifice (12) of the retaining device (10).

13. Method of implementing a holding device (10) according to any one of claims 3 to 10 in combination with claim 3, wherein a tube (2) is inserted vertically into each orifice (12) from the bottom of the device (10).

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