CN105617490B

CN105617490B - Needle shield with specific roughness

Info

Publication number: CN105617490B
Application number: CN201610103851.8A
Authority: CN
Inventors: J-C·蒂博; J·贝尔纳
Original assignee: Beckton Dickinson French Co
Current assignee: Beckton Dickinson French Co
Priority date: 2007-07-27
Filing date: 2007-07-27
Publication date: 2019-12-20
Anticipated expiration: 2027-07-27
Also published as: CN105617490A

Abstract

The present invention relates to a shield (10) for a distal tip of a drug delivery device (3) comprising a needle hub (2), said shield (10) being for removable engagement on said needle hub, said shield (10) having a wall (13) with an inner surface (14) defining an inner cavity (15) for receiving a tip of a drug delivery device (3), at least a portion (14a) of said inner surface (14) being for contacting said needle hub (2) when said shield (10) is engaged on a tip of said drug delivery device (3), wherein said portion (14a) has surface features (16, 17) distributed over a major part of said portion (14a), said surface features defining an amount of contact between said portion (14a) and said needle hub (2).

Description

Needle shield with specific roughness

The invention is a divisional application with the Chinese patent number of 200780100551.3(PCT/IB2007/003214, International application date 2007, 7-27) with the name of 'needle shield with specific roughness'.

Technical Field

The present invention relates to a shield for covering a distal tip of a drug delivery device at least before use of the drug delivery device.

Background

In this application, the term distal refers to the portion furthest from the user's hand, while the term distal refers to the portion closest to the user's hand. Likewise, in the present application, the term "distal direction" refers to the direction of administration, i.e. towards the patient, while the term "proximal direction" refers to the direction opposite to the direction of administration, i.e. away from the patient.

Administration devices are commonly used in several technical fields, such as, for example, the medical field, for example, for administering drugs to patients, either by spraying them through a spraying device or injecting them through an injection device. To this end, the distal tip of the administration device may be provided with a staked needle or nozzle or luer connection allowing for the provision of a component, such as a nozzle assembly or needle assembly.

In this application, "stake mounted needle" refers to a needle that is affixed to the tip of an injection device by gluing or other suitable means, such as, for example, shrinking the tip of the syringe around the needle after heating.

In the medical field, injection devices (such as syringes provided with or stake-mounted needles or needles of needle assemblies on luer syringes) are commonly provided with needle shields to the end user: in fact, the needle must remain sterile until use and must be protected from possible contamination from the environment. Furthermore, in the case of injection devices having a needle, the end user must also be protected from accidental needle stick injuries. Moreover, in the case of refilling the syringe, the needle shield ensures tightness, avoiding loss of the contents during storage.

Similarly, injection devices provided with a luer or nozzle or luer-lock fitting (such as syringes without needles) are typically provided to the end user with a tip cap that protects the tip of the luer or nozzle from possible contamination from the environment.

The invention applies to both needle shields and tip caps. In this application, the term "shield" is generally used for "needle shields" or for "tip caps" unless otherwise indicated.

These shields or at least parts of these shields are usually made of an elastic material, such as a thermoplastic elastomer, such as rubber, and are fastened to the distal end of the administration device, e.g. on the assembly line of an industrial pharmaceutical company. In this regard, the distal tip of the drug delivery device typically comprises a needle hub to which the needle may be secured, e.g. by gluing, and to which the shield is removably engaged, e.g. by friction.

One of the problems encountered when automatically fitting a needle shield on the distal tip of a drug delivery device on an assembly line is that the needle shield cannot always be placed sufficiently at the tip of the drug delivery device. In particular, it may occur that the needle shield is not oriented along the longitudinal axis of the drug delivery device when the needle shield is mounted on the end of the drug delivery device. As a result, the longitudinal axis of the needle shield does not overlap (collapsed) with the longitudinal axis of the administration device, and the needle shield is tilted with respect to the distal end of the administration device. Since the shield is typically made of rubber, which is a fairly sticky material under normal use conditions, the shield accidentally sticks in an improper position to the needle hub of the administration device. Furthermore, the administration device may be difficult to remove when it is used.

Another problem arising from the fact that the shield is poorly positioned is that it is difficult to position the shield in the hole of the operating disk, in particular with the use of automated means of the assembly line: this can lead to disruption and emergency shutdown of the manufacturing line.

Furthermore, where the administration device comprises a stake mounted needle, the tip of the needle may penetrate into the resilient material forming the shield: this phenomenon is very problematic for the subsequent use of needles that can be contaminated by particles from the elastomeric material. Furthermore, the tip of the needle may puncture the wall of the shield, which would cause significant sealing and sterility problems. Finally, the shield may be bent due to poor positioning of the shield and the needle itself may be damaged. Figures 1a-1d illustrate the problems of the prior art described above. These figures show the steps of fastening a prior art needle shield 1 to a needle hub 2 of a distal tip of an administration device, such as a syringe 3, according to automated industrial processes, such as for example those occurring in assembly lines of pharmaceutical companies.

Fig. 1a shows the start of the fastening operation of the needle shield 1 to the needle hub 2. As shown in the figure, the needle shield 1 is constituted by a wall 4 forming a cavity 5. In fig. 1a, the cavity 5 of the needle shield 1 is proximal to a needle 6 fixed at the distal tip of the syringe 3. As can be seen from fig. 1a, during the approach of the needle shield 1 to the needle 6, the longitudinal axis a of the needle shield 1 is not parallel to the longitudinal axis B of the syringe 3. Fig. 1b shows the step of positioning the needle shield 1 on the end of the syringe 3 by means of an oscillating device. After this step the longitudinal axes a and B of the needle shield and the administration device should be parallel, but due to the viscosity of the elastomer the needle shield 1 remains in an improper position, wherein the longitudinal axes a and B of the needle shield 1 and the administration device 3 are not parallel. As a result, the tip 7 of the needle 6 is in contact with the elastomeric wall 4 of the needle shield 1. As shown in fig. 1c, a distal force, indicated by arrow F in fig. 1c, is then exerted on the needle shield 1 to fit the needle shield on the tip of the administration device. In fig. 1c, the respective axes of the needle shield 1 and the drug delivery device 3 are now parallel under the influence of the distal force exerted on the needle shield 1, but this causes the needle 6 to bend. In fig. 1d, the assembly is shown when the distal force exerted on the needle shield 1 is released. The resilience of the needle 6 brings the longitudinal axis of the needle back substantially in the direction of the longitudinal axis of the syringe 3, but this force forces the needle shield 1 to tilt relative to the longitudinal axis of the syringe 3.

As is evident from fig. 1d, the elastomeric wall 4 of the needle shield 1 adheres to the needle hub 2 at an incorrect position. This phenomenon makes it difficult to remove the needle shield when using the syringe. Furthermore, as is evident from fig. 1d, the tip 7 of the needle 6 has penetrated the elastomeric wall 4 of the needle shield. The tip 7 of the needle 6 may be contaminated by elastomer particles from the wall 4.

There is therefore a need for a shield for covering the end of an administration device which allows correct mounting of the shield on the needle hub of the end of the administration device, in particular by means of automated devices such as those used in assembly lines. Such a shield should be easy to remove from the hub to which it is secured when it is decided to use the administration device, maintaining good sterility and sealing when the shield is in place.

Disclosure of Invention

The present invention fills this need by providing a shield having a specific inner surface, allowing for better mounting of the shield on the end of the administration device.

A first aspect of the present invention provides a shield for covering at least part of a distal tip of an administration device, the distal tip of the administration device comprising a needle hub, the shield being for removable fastening on the needle hub, the shield having an open proximal end, a closed distal end and a longitudinal wall extending from the proximal end to the distal end, an inner surface of the longitudinal wall forming an inner cavity for receiving at least part of the tip of the administration device, at least part of the inner surface of the longitudinal wall being for contact with the needle hub when the shield is fastened on the tip of the administration device, characterised in that the portion has surface features distributed over a major part of the portion, the surface features defining an amount of contact between the portion and the needle hub.

In one embodiment, the surface features of the portion are substantially longitudinal.

The shield of the present invention is easily mounted on the end of the administration device. In particular, the shield of the present invention can be mounted on the end of the administration device in such a way that the shield is parallel to the respective longitudinal axes a and B of the administration device. The shield of the present invention does not stick to the needle hub of the administration device to which the shield is fastened. In case the drug delivery device comprises a needle, the shield of the present invention has the advantage that the needle does not contact the wall of the shield, since the needle shield is easily and correctly mounted on the drug delivery device.

Furthermore, the shield of the present invention may be easily removed from the end of the administration device when one wishes to use the administration device. In particular, with the shield of the present invention, the extraction force required to remove the shield from the administration device is reduced.

In the present invention, the surface features have an average radial roughness of greater than 2 μm, preferably greater than 5 μm, more preferably greater than 10 μm.

In the present invention, the average radial roughness is measured according to the following method: the three roughness measurements were performed by scanning 370 μm × 240 μm in VSI (vertical scanning interferometry) mode using a Wyko NT 1100(Veeco observations inc. tucson USA) profiler. Calibration of the device was performed after the WI 7.6-20 procedure using a measurement instrument from international standards and technology (NIST).

In one embodiment of the invention, the average radial roughness is less than 100 μm, preferably less than 50 μm, more preferably less than 30 μm.

In one embodiment of the invention, the average radial roughness is about 25 μm.

For example, the surface features form a contact ratio between the portion of the inner surface and the hub of less than 90%, preferably less than 80%, when the shield is secured on the hub. Preferably, the contact ratio is greater than 10%, preferably greater than 20%. In one embodiment of the invention said portion of said inner surface is provided with micro-undulations forming said radial roughness.

The microrelief is selected from the group consisting of grooves, ridges, and combinations thereof.

In the case of a shield being a molded part, this roughness may be obtained by modifying the center pin on the mold: this modification may be achieved by any mechanical technique. In another embodiment of the invention, a portion of the inner surface of the longitudinal wall may have been surface treated to make it rough.

Preferably, said micro-undulations of said inner surface are regularly or randomly distributed along the circumference of said portion of said inner surface. The average radial roughness of said portion (such as the micro-undulations mentioned above) when said shield is fastened to said hub, creates a contact ratio between said portion of said inner surface and said hub of less than 90%: in particular, due to the roughness of the portion, a certain percentage (for example 10%) of the surface of the portion is not in contact with the hub when the shield is fastened on the hub. This allows air to flow between the portion and the hub, which reduces the viscous effects of the elastomer when positioning and mounting the shield on the hub or when removing the shield.

Moreover, the roughness of the portion (such as the microrelief mentioned above) may guide the shield over the hub as it is placed thereon, thereby facilitating proper mounting of the shield on the hub.

The contact ratio between said portion of said inner surface and said needle hub is preferably not less than 10%, otherwise the shield may not be well fastened to the administration device and some sudden ejection may occur, for example during sterilization of the administration device after the shield has been fastened to the administration device, wherein a small increase of the inner pressure of the administration device may eject the shield from the administration device.

In one embodiment of the invention, the value of the mean radial roughness varies from the proximal end of the portion to the distal end of the portion.

For example, the average radial roughness of the proximal end region of the portion is greater than the average radial roughness of the distal end region of the portion.

In one embodiment of the invention, the microrelief is in the form of a plurality of grooves parallel to the longitudinal axis a of the shroud.

In another embodiment of the invention, the microrelief is in the form of a plurality of grooves inclined relative to the longitudinal axis a of the shroud.

Another aspect of the invention is to provide a method for protecting a distal tip of an administration device, characterized in that the method comprises the step of fastening a shield as described above to the distal tip of the administration device.

Preferably, said step of fastening is carried out by automated means on an assembly line.

Drawings

Further advantages of the invention will now be explained in detail by means of the following description and the attached drawings, in which:

figures 1a-1d show the steps of fitting a prior art shield on the end of a drug delivery device;

figure 2 is a cross-sectional view of a shield according to the invention;

figure 3 is a cross-sectional view of a second embodiment of the shield of the present invention;

figure 4 is a cross-sectional view of a third embodiment of the shield of the present invention.

Detailed Description

Fig. 2 shows a shield 10 of the present invention. The shield 10 is used to cover the distal tip of an administration device such as a syringe 3 (partially shown in fig. 2). Alternatively, the administration device may be a needle assembly. The distal tip of the syringe 3 is provided with a needle hub 2 to which a needle 6 is fixed. The shield 10 has an open proximal end 11, a closed distal end 12 and a wall 13 extending from said proximal end 11 to said closed distal end 12. The inner surface 14 of the wall 13 forms a cavity 15 for receiving a portion of the distal tip of the syringe 3. When the shield 10 is fastened to the distal end of the syringe, a portion 14a of the inner surface 14 is intended to come into contact with the needle hub 2 of the distal end of the syringe 3 in order to protect said distal end, for example during transportation of the administration device before use.

In fig. 2, the average radial roughness of said portion 14a of the inner surface 14 of the wall 13 is greater than 2 μm and preferably less than 100 μm. Said average radial roughness results in a contact ratio between said portion 14a and the needle hub 2 of less than 90% and greater than 10% when the shield is fastened to the needle hub 2. For example, the roughness as measured above is about 25 μm.

Such average radial roughness may be obtained by modifying the center pin of the mold used to mold the shroud using any mechanical technique.

Preferably, the wall 13 is made of an elastomeric material, such as rubber.

Fig. 3 shows another embodiment of the shield of the present invention, wherein a portion 14a of the inner surface 14 of the wall 13 is provided with a plurality of grooves 16. The same reference numerals are retained for components as in fig. 2. The grooves 16 are regularly distributed along the circumference of said portion 14a and they are parallel to the longitudinal axis a of the shield 10. Which allow air flow during assembly of the shield on the needle hub 2. The adhesive surface of the shield is smaller, thereby facilitating assembly and facilitating keeping the respective longitudinal axes a and B of the shield 10 and the administration device 3 in overlap. Thus, the shield 10 of the present invention is perfectly and correctly fastened on the end of the administration device 3. Since the grooves are formed with a certain roughness of the portion 14a of the inner surface 14 of the wall 13, it is easier to remove the shield 10 from the end of the administration device 3 when using the administration device 3.

Fig. 4 shows another embodiment of the shield 10 of the present invention in which the portion 14a is provided with a plurality of inclined grooves 17. The grooves 17 are randomly distributed along the surface of the portion 14 a. The grooves 17 cover at least 10% of the surface of the portion 14 a. The same reference numerals are retained for components as in figures 2 and 3. The recess 17 is inclined relative to the longitudinal axis a of the shroud 10.

According to the method of the present invention, the shield 10 of the present invention can be fitted on the end of an administration device in a very simple and efficient manner. Due to the specific nature of the portion 14a of the inner surface 14 of the wall of the shield of the present invention, the shield 10 is guided in the direction of the longitudinal axis of the administration device. In particular, when the portion 14a is provided with the grooves 16, 17, the shield 10 is correctly mounted on the needle hub 2, while the respective longitudinal axes of the shield 10 on the one hand and the administration device 3 on the other hand remain overlapping. The shield 10 of the present invention is secured to the administration device 3 by automated means such as a robot in an industrial process using an assembly line.

The shield 10 of the present invention is also easy to remove during use when the shield 10 is fastened to the administration device 3, since the micro-undulations (such as grooves, ridges or ridges) created by the specific surface of the portion 14a of the shield 10 intended to be in contact with the needle hub 2 of the administration device 3 allow air to flow.

According to a variant of the invention, the grooves may be provided only on a limited surface closest to the proximal end of said portion 14 a.

According to another variant of the invention, the grooves may be provided with a variable radial roughness, for example a greater average radial roughness close to the proximal end of the portion 14 a.

The invention has been described with the use of grooves ensuring a contact ratio between said portion 14a and the needle hub 2 of less than 90%. The present invention also applies other geometries to the portion 14a, such as ridges, bumps, or any other geometry.

Claims

1. A shield for covering at least a portion of a distal tip of an administration device, the administration device including a needle hub, the shield being removably engaged on the needle hub, the shield comprising:

an open proximal end, a closed distal end, and a longitudinal wall extending from the proximal end to the distal end, the longitudinal wall being made of an elastic material, an inner surface of the longitudinal wall defining an inner cavity for receiving at least part of a distal tip of the administration device, the inner surface defining a fastening portion contacting the needle hub when the shield is fastened to the administration device,

wherein the fastening portion has an average radial roughness of more than 2 μm and less than 100 μm and wherein the fastening portion has surface features distributed thereon which define a contact ratio between the fastening portion and the needle hub of less than 90% and more than 10% when the shield is fastened on the needle hub, thereby making it easy to mount the shield on the distal tip of a drug delivery device and keeping the longitudinal axis (A) of the shield overlapping the longitudinal axis (B) of the drug delivery device and to remove the shield from the distal tip of the drug delivery device when the drug delivery device is in use;

wherein the value of the mean radial roughness varies from the proximal end of the fastening portion to the distal end of the fastening portion and such that the mean radial roughness of the proximal end region of the fastening portion is greater than the mean radial roughness of the distal end region of the fastening portion.

2. The shield of claim 1 wherein the ratio of contact between the securing portion and the hub when the shield is secured on the hub is less than 80%.

3. The shield of claim 1 wherein the ratio of contact between the securing portion and the hub when the shield is secured on the hub is greater than 20%.

4. The shroud of claim 1, wherein the surface features are distributed around a circumference of the securing portion.

5. The shroud of claim 1, wherein the surface features are a plurality of micro-undulations defining a contact ratio.

6. The shroud of claim 5, wherein the plurality of micro-undulations are distributed about a circumference of the fastening portion.

7. A patch according to claim 6, wherein the micro-undulations are regularly distributed around the circumference of the fastening portion.

8. The shroud of claim 6, wherein the micro-undulations are randomly distributed about a circumference of the fastening portion.

9. The shield of claim 1 wherein with the shield secured to the hub, air can pass from a space outside the shield through the surface feature into the interior cavity.

10. The shroud of claim 1, wherein the surface features comprise a plurality of grooves inclined relative to the longitudinal axis (a) of the shroud.

11. The shroud of claim 10, wherein the plurality of grooves are regularly distributed around a circumference of the securing portion.

12. The shroud of claim 10, wherein the plurality of grooves are randomly distributed about a circumference of the securing portion.

13. The shield of claim 10 wherein air may enter the lumen from a space external to the shield through the plurality of grooves with the shield secured to the hub.

14. The shroud of claim 1, wherein the surface features define a plurality of ridges extending radially therefrom and distributed about a circumference of the fastening portion.

15. The shroud of claim 14, wherein the plurality of protuberances are regularly distributed about a circumference of the securing portion.

16. The shroud of claim 14, wherein the plurality of ridges are randomly distributed about a circumference of the securing portion.

17. The shroud of claim 1, wherein the surface features define a plurality of ridges extending radially therefrom and distributed about a circumference of the fastening portion.

18. The shroud of claim 17, wherein the plurality of ridges are regularly distributed around a circumference of the securing portion.

19. The shroud of claim 17, wherein the plurality of ridges are randomly distributed about a circumference of the securing portion.