HK1111077B

HK1111077B - System and device for removing pharmaceutical products

Info

Publication number: HK1111077B
Application number: HK08101681.4A
Authority: HK
Inventors: Zihlmann Rudolf
Original assignee: F. Hoffmann-La Roche Ag
Priority date: 2006-02-16
Filing date: 2008-02-15
Publication date: 2012-11-09

Description

System and device for withdrawing a drug

Technical Field

The present invention relates to a system and a device for withdrawing a drug from a reservoir.

Background

In medicine, mostly liquid drugs are often filled into reservoirs or containers, e.g. into vials with a capacity of a few ml. Medical personnel may puncture the seal of the container with a cannula and fill the syringe with the desired amount of medication, for example, as desired.

To avoid handling of the exposed cannula, and the risk of injury associated therewith, an adapter is used between the container and the syringe. Various embodiments of adapters are known, for example, from US 6591876. Such an adapter has a first container connector for engaging a first container, a second container connector for engaging a second container, a central portion between the two connectors that protects the cannula from accidental contact with the interior of the adapter, and a cannula. The first container connector has elements in its side wall separated from each other by slots, enclosing a portion of the first container. The second container connector has two openings in its side walls to accommodate two lateral projections at the front of the second container, similar to a snap-fit connection. In one embodiment, the adapter has a locking mechanism that retains the adapter in a position in which the central portion is compressed after the adapter is coupled to the container. In another embodiment, such compression is not required. The central part is here rigid and has two opposite clamping surfaces.

In one application, the adapter is used to fill an ampoule for an insulin pump with insulin, such as Accu-An insulin pump. The insulin pump continuously dispenses insulin to the human body through a thin tube, the cannula of which is positioned subcutaneously. The microprocessor controls the electric motor which moves the stopper into the insulin ampoule, for example every three minutes, by means of a threaded rod. The patient can replace an empty ampoule with an ampoule that has been refilled with insulin itself or with an ampoule that is ready for use.

In summary, it is desirable to be able to easily and without great effort manipulate a device for automatically administering drugs in a manner that is easy for a user to use.

Disclosure of Invention

It is therefore an object of the present invention to provide a system and device for withdrawing a liquid drug from a container, enabling coupling between an adapter and an ampoule and between an adapter and a reservoir in a user-friendly manner. To achieve such an object, in embodiments of the systems and devices disclosed herein, the device may be designed with at least one locking mechanism comprising a resilient element.

Accordingly, one aspect relates to a system for withdrawing a drug from a reservoir. The system has an ampoule in which a piston is arranged that can be moved, and an adapter which has a reservoir connector and an ampoule connector for engaging the ampoule in the longitudinal direction. The ampoule connector has at least one locking mechanism comprising a resilient element in a side wall. The resilient member corresponds to a portion of the sidewall extending circumferentially along the sidewall and merges with the sidewall at opposite ends.

Another aspect relates to an adapter for a system for retrieving a drug from a reservoir. The adapter has a reservoir connector and an ampoule connector for engaging an ampoule in a longitudinal direction. The ampoule connector has at least one locking mechanism comprising a resilient element in a side wall. The resilient member corresponds to a portion of the sidewall extending circumferentially along the sidewall and merges with the sidewall at opposite ends.

Drawings

Further embodiments, advantages, novel features, and applications of the present invention will become apparent from the following detailed description of the invention when considered in conjunction with the drawings. Like elements in the drawings are represented by like reference numerals.

Figure 1 is a schematic view of an embodiment of a system for withdrawing a liquid drug,

figure 2 is a side view of an embodiment of the adapter,

figure 3 is a top view of the adapter shown in figure 2,

figure 4 is a perspective view of the adapter shown in figure 2,

figure 5 is a schematic view of a piston in an ampoule,

figures 6A-6B are schematic views of a piston with a piston rod and a piston stop,

fig. 6C-6D are schematic views of the piston rod.

Detailed Description

Various methods of practicing the invention are disclosed below, without limiting the scope of the invention, wherein reference is made to an insulin pump as the management device. However, an insulin pump is only one example of the present application, wherein in a preliminary step a drug, i.e. insulin for the treatment of diabetes, is taken out of a container in order to use it in another container in a management device. Among other applications, growth hormone may be used as a drug for growth abnormality, Erythropoietin (EPO) may be used as a drug for renal failure or erythrocyte deficiency, or interferon-alpha may be used as a drug for treatment of hepatitis or cancer.

In addition, the various methods of practicing the present invention are not limited to liquid drugs, although in medical applications it is common to remove liquid drugs from a reservoir. However, the invention is generally applicable to medicines of various viscosities (from liquids to powdered lyophiles that must be dissolved by a liquid).

Fig. 1 is a schematic diagram illustrating an embodiment of a system 1 for withdrawing a drug, e.g. a liquid drug, from a reservoir 4. The system 1 has an adapter 2 and an ampoule 6, the ampoule 6 having a piston 8 movable therein. In this case, the terms "reservoir" and "ampoule" generally denote a container suitable for containing a substance. The reservoir 4 and the ampoule 6 may be made of a rigid or hard material, such as plastic, glass, metal, or may be made of a flexible or elastic material, such as a film made of plastic or a different material.

The drug can be removed from the reservoir 4 via the adapter 2 and transferred into the ampoule 6. To remove the drug, ampoule 6 and reservoir 4 may be coupled to adapter 2. Thus, a connection between the interior of the reservoir 4 and the interior of the ampoule 6 is established by means of a hollow needle or cannula. For example, if the patient pulls the piston 8 out of the ampoule 6, the medicine flows into the ampoule 6. The filled ampoule 6 can then be inserted into an insulin pump, for example. In one embodiment, the piston rod is also removed from the piston 8 so that only one piston stopper is held in the ampoule 6 for sealing. The piston 8 is shown in more detail in figures 5 and 6A-6D.

Fig. 2 shows a side view of an embodiment of the adapter 2. The adapter 2 has a reservoir connector 10, a central portion 12 and an ampoule connector 14. The reservoir connector 10 is bonded to the reservoir 4 and is approximately hollow cylindrical in shape, having a plurality of recesses 16, for example three, along the circumference on its outer wall. The recess 16 creates a bulge on the inner wall as shown in fig. 3 and 4.

In the illustrated embodiment, the central portion 12 has a cylindrical portion that connects the reservoir connector 10 to the ampoule connector 14. In addition, the central part 12 has one or more, for example two ribs 11 or rib elements 11, which project radially outwards and extend outside the cylinder part between the reservoir connector 10 and the ampoule connector 14. The ribs 11 facilitate gripping and/or holding of the adapter 2. In the embodiment shown, the central portion 12 has two opposing openings 18 near the ampoule connector 14 through which a patient can see, for example, the front portion of the ampoule 6 (e.g., a portion of a Luer connector as shown in fig. 5) and thus see if air or medicine is located in the front portion. This makes it easier for the patient to remove unwanted air from the ampoule 6 at the end of the filling process in a known manner.

An ampoule connector 14 is coupled to ampoule 6 and is approximately hollow cylindrical in shape, in the illustrated embodiment increasing in diameter outwardly from central portion 12. In the system-engaged state, the ampoule connector 14 accommodates a part of a luer connector. In addition, in the embodiment shown, the ampoule connector 14 has two opposing locking mechanisms in its outer wall, which each comprise two grooves 22, 24 and a spring element 20, hereinafter also referred to as web 20. The slots 22, 24 each produce an opening and the spring element 20 can be elastically deformed in the radial direction. The ampoule connector 14, in particular the locking mechanism, is suitable for use in the front part of the ampoule 6 shown in fig. 5 (for example in the form of a luer connector).

In yet another embodiment, only one slot may be substituted for the two slots 22, 24. In this embodiment, both the resilient element 20 and the slot are part of the locking mechanism. Also in this embodiment, the elastic member 20 can be elastically deformed in the radial direction.

Fig. 3 shows a top view of the adapter 2 of fig. 2, from which the reservoir connector 10 and the hollow needle 26 or cannula 26 can be seen. In the illustrated embodiment, the outer wall shape of the reservoir connector 10 deviates from a circle. In another embodiment, the outer wall may be a different shape, such as circular. The shape shown in fig. 3 deviating from the circular shape can be formed, for example, by flattening the circular outer wall in the region of the three recesses 16, for example by means of a reshaping and shaping process. As shown in fig. 3, the recesses 16 are evenly distributed along the circumference of the outer wall and form bulges in the interior of the reservoir connector 10. The non-circular shape may accommodate reservoirs 4 of slightly different diameters. As the size of the reservoir 4 increases, the shape approaches the optimal circular shape. The difference between the non-circular shape and the optimal circular shape can be used to compensate for the deformation of different diameters. The protruding portion serves to retain the reservoir 4 in the adapter 2.

On the base of reservoir connector 10, a circular protrusion 28 encloses cannula 26. The diameter of the bulge 28 is adapted to the outer diameter of the front end of the reservoir. The bulge 28 serves for longitudinal compensation of the different reservoirs 4, since the bulge 28 can enter the elastic septum (pierceable membrane).

The mode of operation of the locking mechanism of the adapter 2 is disclosed hereinafter with reference to fig. 4 and 5. Fig. 4 shows a perspective view of the adapter 2, in which one of the three elements 11 and one of the two locking mechanisms can be seen. Fig. 5 shows a schematic view of the piston 8 arranged in the ampoule 6. Fig. 5 shows the ampoule 6 only in its front region.

The web 20 corresponds to an extension of the outer wall along its circumference and extending parallel to the slots 22, 24 and merges with the outer wall at its ends. The slot 22 is contiguous with one longitudinal side of the web 20 in the direction of the central portion 12 and the slot 24 is contiguous with the other longitudinal side of the web 20 in the direction of the ampoule 6. As shown in fig. 4, the web 20 may be bent into the interior of the ampoule connector 14. In one embodiment, the adapter 2 is made of polypropylene (PP) which is elastically deformable. Thus, the web 20 is also elastic, mainly in the radial direction.

In one embodiment, the front of the ampoule 6 is based on a (male) luer connector 30, said luer connector 30 having a collar portion 32. The collar portion 32 projects substantially perpendicular to the longitudinal axis of the luer connector 30. The collar portion 32 has two circular portions 36, 38 separated from each other by four legs 34 in the longitudinal axis direction. As a result, four empty spaces 40 are formed between the circular portions 36, 38, which are separated from each other.

To couple the ampoule 6 to the adapter 2, the front of the ampoule 6 is pushed into the ampoule connector 14 and the ampoule 6 and the adapter 2 are pressed against each other. The circular collar portion 36 initially presses the web 20 outwardly. When the opposite web 20 encounters an empty space 40, both webs 20 significantly engage in the respective empty space 40. Thus if the web 20 encounters the post 34, the web 20 may be positioned by rotating the ampoule 6 and/or adaptor 2 slightly about the axis so that they may encounter the empty space 40 and the web 20 may engage. In the engaged state, the circular collar portion 36 penetrates the opening 22 and the webs 20 are released to their original state and thus secure the bond.

To disengage, the patient may pull ampoule 6 and adapter 2 apart, preferably in conjunction with pivoting of ampoule 6 and/or adapter 2. During rotation, the struts 34 press the web 20 outwards, thus separating the ampoule 6 and the adapter 2 from each other with a relatively low force.

The schematic diagrams of fig. 6A and 6B show the piston 8 with the piston rod 46 and the piston stopper 42. Fig. 6B shows a longitudinal section through the piston 8. The piston stopper 42 may be connected by being screw-engaged to the front end of the piston rod 46, and has two seal rings 44. Each sealing ring 44 is located in a groove extending along the circumference of the piston stopper 42. The forward end of the piston rod 46 has a threaded portion 52 that is threadably engaged in the blind bore of the piston stop 42. The threaded portion 52 has an external thread adapted to correspond to the internal thread of the blind bore.

At the rear end, the piston rod 46 has an ergonomically shaped handle 48 by which the patient can grasp and pull the piston 8. An ergonomically shaped handle 48 is seamlessly connected to the remainder of the piston rod 46. The handle 48 is typically designed so that the patient can grasp it in a comfortable and natural manner with two fingers (e.g., thumb and forefinger) or three fingers (e.g., thumb, forefinger, and middle finger). In particular, it provides a relatively large gripping surface for the patient. Thus avoiding as much as possible the edges which may be uncomfortable or even painful for the patient.

Fig. 6C and 6D show schematic views of the piston rod 46 without the piston stopper 42. The threaded portion 52 has a gap 50 extending along the longitudinal axis and dividing the threaded portion 52 into two portions. The two parts are resilient and can be pressed towards each other, for example when the piston stopper 42 is screwed on.

The outer diameter of the threaded portion 52 is larger than the diameter of the internal thread of the piston stopper 42 by a fixed amount. The elasticity of the parts separated by the gap 50 compensates for the difference in the diameters and the possible manufacturing tolerances, i.e. the piston stop 42 presses the parts together by its internal thread. The parts also press against the internal thread of the piston stopper 42, resulting in a zero clearance connection and in an improved way holding the piston rod 46 and the piston stopper 42 together. The main advantage of this is that when the filling process is finished and the patient presses the wall of the ampoule 6 with one finger, air bubbles that may be present in the ampoule 6 rise to the top.

The screw connection is therefore designed such that the torque for releasing the piston rod 46 is lower than the torque for rotating the piston stop 42 in the ampoule 6. As a result, it is ensured that the piston rod 46 can be unscrewed without the piston stopper 42 rotating therewith.

The foregoing embodiments of systems and devices for withdrawing a drug from a reservoir 4 generally facilitate the withdrawal of the drug. In the illustrated embodiment, filling of the empty ampoule 6 is primarily convenient for the patient. The locking mechanism and the empty space distributed over the ampoule increase the probability that the web 20 engages in the empty space 40 when the ampoule 6 is coupled to the adapter 2. To disengage, the patient need only pull (possibly in conjunction with twisting) on the adapter 2 and/or ampoule 6. The elastic web 20 then releases the collar portion 32.

Other features that facilitate handling are openings 18 and grooved threaded portion 52. An opening 18 in the adapter 2 facilitates the removal of unwanted air from the ampoule 6 at the end of the filling process. When the patient may tap on ampoule 6 and/or piston rod 46 for this purpose, it is advantageous that grooved threaded portion 52 sits securely in piston stopper 42 without being accidentally disengaged.

Claims

1. A system (1) for removing a drug from a reservoir (4), with an ampoule (6) in which a piston (8) is arranged that can be moved, and with an adapter (2), the adapter (2) having in the longitudinal direction a reservoir connector (10) and an ampoule connector (14) for engaging the ampoule (6),

the ampoule connector (14) has at least one locking mechanism comprising a resilient element (20) in the side wall, which resilient element corresponds to a part of the side wall extending along the circumference of the side wall and merges with the side wall at opposite ends; and is

The at least one locking mechanism further comprises a slot (22, 24), the resilient element (20) extending parallel to the slot (22, 24).

2. System according to claim 1, wherein the adapter (2) has two opposite openings (18) through which the front of the ampoule (6) is visible, in a central part (12) between the reservoir connector (10) and the ampoule connector (14).

3. System according to claim 1, wherein the adapter (2) has, in a central part (12) between the reservoir connector (10) and the ampoule connector (14), at least one rib element (11) extending radially outwards between the reservoir connector (10) and the ampoule connector (14).

4. System according to claim 1, wherein the adapter (2) has two opposite openings (18) through which the front of the ampoule (6) is visible in a central portion (12) between the reservoir connector (10) and the ampoule connector (14), and wherein the adapter (2) has at least one rib element (11) extending radially outwards between the reservoir connector (10) and the ampoule connector (14) in the central portion (12) between the reservoir connector (10) and the ampoule connector (14).

5. System according to any one of claims 1 to 4, wherein the at least one locking mechanism further comprises two slots (22, 24), and wherein the resilient element (20) extends parallel to the slots (22, 24).

6. The system of claim 1, wherein the reservoir connector (10) has a non-circular cross-section.

7. The system of claim 1, wherein the reservoir connector (10) has at least one recess (16) in the sidewall that creates a bulge on the inner surface of the sidewall.

8. System according to claim 1, wherein the ampoule (6) has a luer connector (30) with a collar portion (32) having two circular portions (36, 38) separated from each other by four legs (34) in the direction of the longitudinal axis, thereby creating four empty spaces (40) separated from each other, which empty spaces (40) are adapted to the resilient element (20).

9. The system of claim 1, wherein the piston (8) has an ergonomically shaped handle (48).

10. The system of claim 1, wherein the piston (8) has a piston rod (46) and a piston stopper (42), the piston stopper (42) being threadably engaged to the piston rod (46).

11. The system of claim 10, wherein the piston rod (46) has a threaded portion (52) that is threadedly engaged into a blind bore of the piston stop (42).

12. The system of claim 11, wherein the threaded portion (52) has a gap (50) extending along a longitudinal axis of the piston (8) and bisecting the threaded portion (52).

13. The system of claim 12, wherein the outer diameter of the threaded portion (52) is greater than the diameter of the blind bore by a fixed amount.

14. An adapter (2) of a system (1) for taking a drug out of a reservoir (4) having in longitudinal direction a reservoir connector (10) and an ampoule connector (14) for engaging an ampoule (6), characterized in that,

15. The adapter (2) according to claim 14, wherein the central part (12) between the reservoir connector (10) and the ampoule connector (14) has two opposite openings (18) through which the front of the ampoule (6) is visible.

16. The adapter (2) according to claim 14, wherein a central portion (12) between the reservoir connector (10) and the ampoule connector (14) has at least one rib element (11) which extends radially outwards between the reservoir connector (10) and the ampoule connector (14).

17. The adapter (2) according to claim 14, wherein the central portion (12) between the reservoir connector (10) and the ampoule connector (14) has two opposite openings (18) through which the front of the ampoule (6) is visible, and the central portion (12) between the reservoir connector (10) and the ampoule connector (14) has at least one rib element (11) which extends radially outwards between the reservoir connector (10) and the ampoule connector (14).

18. The adapter (2) according to claim 14, wherein the at least one locking mechanism further comprises two slots (22, 24), and wherein the resilient element (20) extends parallel to the slots (22, 24).

19. The adapter (2) according to claim 14, wherein the reservoir connector (10) has a non-circular cross-section.

20. The adapter (2) according to claim 14, wherein the reservoir connector (10) has at least one recess (16) in the side wall, which recess creates a bulge on the inner surface of the side wall.