HK1106460B - Cap for drug delivery devices - Google Patents

Description

Cap for a drug delivery device

Technical Field

The present invention relates to a cap for a drug delivery device, in particular of the syringe type comprising a needle and a needle cover, wherein said cap is adapted to be used as a safety means for the needle by comprising a needle cover retaining portion. In particular, the invention relates to such devices which can be operated by the patient himself.

Background

Drug delivery devices which are self-administered by the patient and which allow individual administration of a desired amount of a drug are well known in the art. Generally, such devices have substantially the same purpose as a conventional syringe. Mechanical pen-type devices are known, for example, from US patent No.5,226,895. Typically in such devices, a needle assembly comprising a double-ended needle is attached to the distal end of the device. A medicament containing cartridge is mounted in the distal portion of the housing between the needle and a piston rod which is moved by the drive mechanism and drives the piston in the cartridge to dispense the liquid. A removable needle cover is mounted over the distal end of the needle to protect the needle from contamination and damage. In addition, a removable cap is mounted to the distal end of the housing of the device. The cap serves to cover and protect the needle and needle cover.

Prior to injection, the user (patient, caregiver, etc.) must remove the cap from the distal end of the housing and the needle cover from the distal end of the needle. After injection, the needle cover is fitted back over the needle and the cap is fitted back to the distal end of the housing.

Disclosure of Invention

The problem to be solved by the present invention is to reduce the risk of needle related injuries to the user, which injuries may lead to infections for users of drug delivery devices of the kind described above. Furthermore, the present invention may be used to prevent loss of the needle cover during drug delivery and thereby improve the operation of the drug delivery device.

The present invention provides a cap for a drug delivery device having a needle cover retaining portion for retaining a needle cover during injection and facilitating safe attachment/detachment of the needle cover to/from the needle before/after injection. Thus, a safety tool for retaining a needle cover is provided by the cap of the present invention.

The attachment/detachment of the needle cover to the needle, for example in the axial direction, is achieved in that the cap holds the needle cover with a needle cover holding section provided on the cap for attaching/detaching the needle cover.

Definition of

The term "drug delivery device" according to instant invention shall mean a single-dose or multi-dose, disposable or reusable device for dispensing selectable or fixed doses of medicinal products, such as insulin, growth hormone, low molecular weight heparin, their analogues and/or derivatives, and the like. The device may have any shape, for example a compact form or a pen type. Delivery of the dose may be achieved by a mechanical (optionally manual) or electrical drive mechanism or a stored energy drive mechanism such as a spring or the like. The selection of the dose may be achieved by a manual mechanism or an electrical mechanism. Further, the device may comprise means for monitoring physiological characteristics such as blood glucose levels and the like. Additionally, the device may include a needle or needle assembly. In particular, the term "drug delivery device" refers to a disposable multi-dose pen-type device having a mechanical or manual dose delivery and dose selection mechanism, which is designed to be routinely used by persons without formal medical training, such as patients. Preferably, the drug delivery device is of the injector type, in particular a pen-type injector.

The term "needle" according to instant invention refers to an elongated hollow device for introducing material into the body by intravenous, intramuscular or subcutaneous injection. In particular, the term "needle" refers to an elongated hollow device having sharp ends at its distal and proximal ends to facilitate engagement with a medicament containing cartridge and injection of medicament into a patient.

The term "proximal end" according to instant invention refers to the end of the device or the device component furthest from the dispensing end of the device.

The term "distal end" according to instant invention refers to the end of the device or the device component closest to the dispensing end of the device.

The term "needle cover" according to instant invention refers to any part of a drug delivery device that serves to protect the needle from physical damage and contamination by environmental factors such as dust, bacteria, etc. as well as to protect the user of the drug delivery device from needle stick injuries. The components may be of any shape and size and may be made of any suitable material known to those skilled in the art. In particular, the term "needle cover" refers to a substantially cylindrical tubular member having a closed distal end and an open proximal end, which is intended to be detachably mounted at the distal end of a needle of a drug delivery device.

The term "cap" according to instant invention refers to a component of a drug delivery device that is used to cover a needle assembly and needle cover of the device. The components may be of any shape and size and may be made of any suitable material known to those skilled in the art, such as plastic. Furthermore, the component is designed to be attached to the distal end of the drug delivery device by any suitable means known to the person skilled in the art. Additionally, the component may include a clip for securing the entire device in a pocket in a manner similar to a pen. In particular, the term "cap" refers to a tubular member of cylindrical shape having an open proximal end and a closed distal end, which is intended to be detachably mounted on the distal end of a drug delivery device and to close the needle assembly and the needle cover of said device.

The term "needle cover retaining portion" according to instant invention refers to one or more parts of the cap of the drug delivery device that serve to retain the needle cover during injection and to facilitate safe attachment/detachment of the needle cover to/from the needle before/after injection. In particular, the term "needle cover retaining portion" refers to one or more components of the cap of the drug delivery device that serve to retain the needle cover during injection and facilitate safe attachment/detachment of the needle cover to/from the needle before/after injection, said components:

formed between the cover portion of the device and the spring clip of the cover; or

Formed within a distal end of a cap of the device; or

Integrally molded with the cover; or

Molded as a separate component and subsequently attached to the lid portion.

According to the invention, the term "provided on the cap" means that a given functionality, such as a needle cover holder or a clip retainer or the like, is present on the cap.

The term "high friction material" according to instant invention refers to any material having elasticity, such as rubber or any other suitable material, which can adapt to the shape and size of the outer surface of the needle cover to ensure that the needle cover is retained in the needle cover retaining portion by friction during injection.

Such suitable materials may be made of any material selected from, for example, the following various elastic (or soft) materials, including, for example: natural rubber, synthetic rubbers such as isoprene rubber, silicone rubber, urethane rubber, styrene-butadiene rubber, fluorinated rubber and acrylic rubber, porous bodies of polytetrafluoroethylene, thermoplastic elastomers based on polyamides, polyesters and other materials, and porous bodies of polyurethane. The material may be applied to the inner surface of the needle cover retaining portion by adhesive, deposition or the like, or may be moulded integrally with the cap (insert moulding), two colour moulding (2-colour moulding) or the like), or moulded as a separate component and then attached to the cap by adhesive, fitting or the like. Furthermore, the material may be a unitary component or be composed of multiple components.

Detailed Description

Examples of the invention

The following examples illustrate embodiments of the cover of the present invention, but do not limit or define the basic inventive concept.

Example 1

The outer shape of a drug delivery device adapted to employ the cap of the present invention will be described with reference to fig. 1.

The device shown is of the pen type and comprises a housing 2 at the distal end of which a cartridge retaining portion 2a is integrally and concentrically engaged. A cartridge 3 containing a medicine is mounted in the cartridge holding portion 2 a. A needle 5 for injection is removably mounted at the distal end of the barrel 3 by a needle assembly 6.

The detachable needle cover 11 covers and protects the needle 5 from contamination and damage, for example.

A substantially cylindrical removable cap 12 covers the needle assembly 6 and the needle cover 11. The cover 12 includes a substantially cylindrical cover body portion 13 and a spring clip 14. The cap 12 and needle cover 11 are removed prior to dispensing the medicament.

Details of the needle cover retaining portion 31 are shown in figures 2 to 3.

A needle cover retaining portion 31 is formed between the cover body 13 of the cover 12 and the spring clip 14 of the cover (fig. 2).

A recess 32 is formed on the inner surface 14c of the clip 14. The high friction material 33 is applied on the inner surface of the recess 32 by adhesion. The high friction material 33 is made of an elastic material such as synthetic rubber. The inner diameter of the high friction material 33 is adapted to the outer diameter of the needle cover 11 to hold the needle cover.

The needle cover retaining portion 31 shown in figure 3 allows the needle cover 11 to be safely and easily attached/detached to/from the needle 5. When the needle cover 11 is removed from the needle 5, it is held in the needle cover retaining portion 31 by the pressing force of the clip 14 of the cap 12. Thus, the needle cover 11 can be held safely with the cap 12 and possible loss of the needle cover 11 can be prevented.

After injection and when the needle cover 11 has been reattached to the needle 5, in order to remove the needle cover 11 from the needle cover retaining portion 31, the user needs to apply a force to the distal end of the needle cover 11 to overcome the frictional resistance of the high friction material 33.

Example 2

A second embodiment of the lid of the present invention is illustrated in figures 4 to 5.

In this embodiment, the needle cover retaining portion 31 is formed along the longitudinal axis of the cap 12 and is positioned between the cap body 13 and the free end 14e of the clip 14.

The needle cover retaining portion 31 is formed of a pair of upper and lower recesses 37, 38 and a pair of upper and lower elastic high friction materials 39, 40 (hereinafter simply referred to as "high friction materials"). The high friction materials 39 and 40 are made of synthetic rubber and are applied by adhesion to the inner surfaces of said recesses 37 and 38. Recesses 37 and 38 are formed on the outer peripheral surface 13c of the lid portion 13 and the inner surface 14g of the free end 14e of the clip 14.

After injection and when the needle cover 11 has been reattached to the needle 5, to remove the needle cover 11 from the needle cover retaining portion 31, the user needs to apply a force to the free end 14a of the clip 14 so that the distal free end 14e of the clip 14 is lifted, allowing the needle cover 11 to overcome the frictional resistance of the high friction material 39, 40.

Example 3

A third embodiment of the lid of the present invention is illustrated in figures 6 to 7.

In this embodiment, the needle cover retaining portion 31 is formed on the distal outer peripheral surface 13c of the cap body 13 of the cap 12. The needle cover retaining portion 31 is formed of an elastic high friction material 43 (hereinafter simply referred to as "high friction material"), the high friction material 43 being made of synthetic rubber, said needle cover retaining portion 31 being either integrally moulded with the cap portion 13 or moulded as a separate component and subsequently attached to the cap portion 13 by gluing.

Thus, example 3 of the needle cover retaining portion 31 describes another alternative by which the needle cover 11 can be safely and easily attached/detached to/from the needle 5.

The cap for a drug delivery device of the present invention is not limited to the embodiments described in examples 1, 2 and 3 above, and various effective alternatives may be envisaged by a person skilled in the art.

Drawings

Fig. 1 is a longitudinal sectional side view of a whole pen type drug delivery device adapted to employ the cap of the present invention.

Fig. 2 is a side view (2A), a top view (2B) and a partial cutaway top view (2C) showing the needle cover retaining portion of the cap of example 1.

Fig. 3 is a top view showing the attaching/detaching operation of the needle cover to/from the needle when the needle cover is held by the needle cover holding portion of the cap of example 1.

Fig. 4 is a side view (4A), a partially cut side view (4B) and a distal end view (4C) showing the needle cover holding portion of the cap of example 2.

Figure 5 is a side view showing the attaching/detaching operation of the needle cover to/from the needle when the needle cover is held by the needle cover holding portion of the cap of example 2.

Fig. 6 is a side view (6A), a top view (6B) and a distal end view (6C) showing the needle cover holding portion of the cap of example 3.

Figure 7 is a top view showing the attaching/detaching operation of the needle cover to/from the needle when the needle cover is held by the needle cover holding portion of the cap of example 3.

Claims (7)

1. A cap (12) for a drug delivery device, the drug delivery device comprising:

a needle (5);

a needle cover (11) detachably mounted, wherein the cap (12) is detachably mounted on the drug delivery device to cover the needle cover (11),

the cap comprises a needle cover retaining portion (31) comprising a high friction material (33, 39, 40, 43) applied by gluing or moulding and capable of removably retaining the needle cover (11) in order to facilitate the coupling/uncoupling of the needle cover (11) to/from the needle (5).

2. The cap (12) according to claim 1, wherein said needle cover retaining portion is formed in

A) Between the cover body (13) of the cover (12) and the clamp (14) of the cover (12), or in

B) The cover body part (13) of the cover (12).

3. Cap (12) according to any one of claims 1 to 2, characterized in that said needle cover retaining portion (31) is or comprises an elastic member in order to retain said needle cover (11).

4. A drug delivery device comprising a cap (12) according to any one of claims 1 to 3.

5. The drug delivery device of claim 4, wherein the drug delivery device is a pen-type device.

6. Drug delivery device according to any of claims 4 to 5, characterized in that it comprises insulin, low molecular weight heparin, derivatives and/or analogues thereof.

7. Method for connecting/disconnecting a needle cover (11) of a drug delivery device to/from a needle (5) by using a cap (12) according to any of claims 1 to 3.