Device for subcutaneous administration of a medicament to a patient

[0001] This application is a continuation of International Application No. PCT/DK2003/000569, filed Sep. 1, 2003, which is a continuation of Danish Application No. PA 2002 01284, filed Sep. 2, 2002, these references are incorporated herein in their entirety.

[0002] The present invention relates to a device for subcutaneous administration of a medicament to a patient, comprising a cannula housing with an interior chamber, a cannula connected to said cannula housing and being in flow communication with the interior chamber, and a flexible tubing having a first end and a second end, wherein the tubing is, at the first end, coupled to the cannula housing such that the tubing is in flow communication with the interior chamber, and wherein, at its second end, the tubing carries a source coupling by which the tubing can be coupled to a source for said medicament; and wherein, between its first and its second end, the tubing is folded for forming a controlled configuration of the tubing with essentially parallel courses of tubing.

[0003] U.S. Pat. No. 5,522,803, being now as a reference deemed to constitute a part of the present text, shows in FIGS. 1 and 2 a cannula housing to be adhered to the skin of the patient so as to enable continuous administration of a drug to the patient via a plastics needle introduced into the skin of the patient. At its one end a tubing features a coupling that is releasably secured to the cannula housing, whereby the tubing can be released from the cannula housing, eg when the patient is in the bath. At its other end the tubing features a source coupling by which the tubing can be coupled to a source, such as a pump, thereby enabling the drug to be fed to the cannula housing through the tubing.

[0004] In some situations, eg when the patient is asleep it is necessary to have a relatively long distance between the cannula housing and the source of the drug to enable the source of drug to sit on a table next to the patient. Thus there is a need for a comparatively long tubing, eg a tubing having a length of about 1.1 m. Conversely, a short tubing is typically desired when the patient is up and about, ie when the source of drug is carried by the patient, eg in a pocket in his clothes. To overcome this problem, it is an option to change tubing as day turns into night. This, however, may lead to waste of the usually very expensive medicament located in the long tubing.

[0005] It is previously been attempted to solve this problem by providing the source of drug with a winder mechanism for the tubing, see international patent application No. WO 96/35472. The winder mechanism described therein, however, cannot be manufactured at low costs and there is a risk of the winder mechanism getting stuck.

[0006] U.S. Pat. No. 4,406,042 discloses a tubing clips where variation of the distance between the ends of the tubing is by changing the size of a tubing loop that projects from the clips.

[0007] It is the object of the present invention to provide a device for subcutaneous administration of a drug to a patient that can be manufactured at low costs and that enables variations in the distance between the source of drug and the cannula housing.

[0008] This is accomplished in that, the device comprises a first and a second holder and in order to secure the tubing in said configuration, it is received in guides in a first holder device arranged between the first and the second end of the tubing and in guides in a second holder device arranged at the first or second end of the tubing or between the first and the second end of the tubing with parallel courses running between the holder devices; and that the first holder device can be displaced along the tubing in a direction towards the second holder device by movement of the tubing along said guides in the first holder device. Hereby it is possible to vary the effective distance between the cannula housing and the source of drug between approximately the length of the tubing and a distance determined by the number of folds on the tubing and the position of the holder device; and to adequately control the courses of tubing and adequately support the tubing in the area around the folds. The second holder device may be an integral part of the cannula housing or the source coupling, or it may be configured in the same manner as the first holder device and may be arranged on the tubing as a separate component that is capable of being displaced along the tubing.

[0009] In the latter case, the effective distance between the cannula housing and the source of drug can be increased by manually displacing the holder devices towards each other along the tubing, ie along the respective courses of tubing, and then sort out the requisite length of tubing. Depending on the frictional resistance between the tubing and the holder device, said effective distance may alternatively be increased by merely applying a pull in the two ends of the tubing. The distance can subsequently be reduced by manually pulling the holder devices away from each other.

[0010] It is preferred that at least the first holder device is provided with guides for the tubing, preferably in the form of bores, ie closed channels, and these guides can be rectilinear or they can be curved and hence receive the fold(s) of the tubing and provide a certain protection of the tubing in these areas. Particular advantages from the point of view of mounting can be accomplished by configuring the one or both of the holder devices as a two-piece housing, thereby facilitating the mounting of the holder devices on the tubing.

[0011] In the present context, the term “parallel courses of tubing” is intended to designate one or two lengths of the tubing that has/have—apart from the folding area—courses that are mutually entirely parallel or converge towards each other within an angle interval of a very few degrees, eg 1-5°, so as to allow the courses of tubing to extend relatively close to each other irrespective of the position of the holder device along the tubing. Also, the term “folded” is intended to designate a state in which the tubing continues to be able to convey medicament from the one end of the tubing to the other.

[0012] The invention also relates to a medicament supply device as recited in claim 12 that is suitable for being mounted on an existing system for subcutaneous administration of a medicament.

[0019] FIG. 1 shows a part of a flexible tubing 4 having a first end 4′ and a second end 4″. At its first end 4′ the tubing 4 is provided with a coupling 3 configured for being, in a releasable manner, able to be secured to a cannula housing 1. The cannula housing 1 has an interior chamber that communicates with the tubing 4 and with a cannula 2 that protrudes from the cannula housing 1 which is preferably flexible and of plastics and intended for being introduced through the surface of the skin of a patient by means of a not shown insertion needle. The interior chamber is not shown, but its configuration may like the one shown in U.S. Pat. No. 5,522,803.

[0020] A source coupling 5 secured to the second end 4″ of the tubing 4 makes it possible to releasably couple the tubing to a source for a drug. The term ‘source’ in this context is intended to designate a receptacle for the drug, a pump preferably being introduced between the receptacle and, the coupling that, said pump supplying the drug to the patient via the tubing 4 in a predetermined dosage. The source coupling 5 is configured for being able to co-operate with a complementary coupling on said drug receptacle or on a tubing connected to the receptacle or pump. Preferably the tubing 4 is made of a plastics material and has such properties that, to a wide extent, the tubing 4 is able to prevent a local occlusion of the flow of the drug if the tubing 4 is folded sharply.

[0021] FIG. 2 shows an embodiment of the invention, wherein two holder devices 10, 20 are used for providing a desire controlled configuration with three courses, 14, 24, 34 of tubing that extend between the holder devices 10, 20. Alternatively, it is certainly an option to configure the holder devices 10, 20 to form five courses of tubing.

[0022] The holder devices 10, 20 are shown in FIG. 2 in a schematic sectional view and each of the holder devices 10, 20 comprises an internal semicircular guide 11 and an internal rectilinear guide 12, respectively. The semi-circular guide 11 serves to receive the fold 9, 9′ of the tubing, while the rectilinear guide 12 conveys the tubing 4 into the area between the two holder devices 10, 20. The width of the guides 11, 12 are adapted to the diameter of the tubing 4, such that the tubing 4 is able to slide in the guides 11, 12 with a desired minimum friction. In order to increase the distance between the cannula housing and the source coupling, a pull is merely exerted in the tubing 4 at its ends 4′, 4″, whereby the length of the individual courses of tubing is reduced, while simultaneously the holder devices 10, 20 move towards each other. Conversely, to increase the length of the courses 14, 24, 34 of tubings and thus to move the ends 4′, 4″ of the tubing 4 towards each other, a pull is merely exerted in the holder devices 10, 20 in a direction away from each other. In both situations the holder devices are displaced along the tubing 4, the tubing 4 sliding in the guides 11, 12.

[0023] FIG. 3a shows a variant of embodiment shown in FIG. 2, wherein the holder devices 10, 20 are split, the two parts 10′, 10″ being preferably articulated to each other and configured for being moved from an open state shown in FIG. 3b to a closed state shown in FIG. 3c, and to be secured in the latter state via a lock 15, such as a snap lock. Hereby the holder devices 10, 20 can be mounted in an existing system of the kind shown in FIG. 1. In this embodiment, the holder devices 10, 20 comprise three rectilinear guides 11, 12, 13 for the tubing 4.

[0024] A further embodiment is shown in FIG. 4, wherein the first holder device 10 is configured as described above with reference to FIG. 2, but wherein the second holder device 20 is arranged at the first end 4′ of the tubing 4 and is configured as an integral part of the cannula housing 1, said cannula housing 1 comprising an outer guide 11 for the fold 9 of the tubing 4. The guide 11 is preferably configured as a notch into which the tubing can be urged and that secures the tubing to the cannula housing 1. Like in the above-referenced embodiments, the guide 11 must be dimensioned such that the tubing 4 is able to slide in the notch when the first holder device 10 is pulled to the right in FIG. 4 to increase the length of the courses 14, 24, 34 of the tubings.

[0025] FIGS. 5a and 5b show alternative embodiments, wherein the second holder device 20 is arranged at the first end 4′ of the tubing 4 and is configured as an integral part of the coupling 3, whereby the tubing 4 is connected to the cannula housing 1. Thus, the coupling 3 secures, firstly, the end 4′ of the tubing and, secondly, it also comprises two guides in the form of bores 11, 12 that secure the tubing in the region at the fold 9. The first holder device 10 can be configured like the holder device 10 shown in FIG. 3c. An increase in the distance between the cannula housing 1 and the source coupling is accomplished merely by a pull in the tubing 4 at its ends 4′, 4″, whereby the length of the individual courses of tubing is reduced while simultaneously the first holder device 10 moves towards the second holder device 20. Conversely, an increase in the length of the courses 14, 24, 34 of the tubings, and hence movement of the ends 4′, 4″ of the tubing towards each other, is accomplished merely by a pull in the holder devices 10, 20 in a direction away from each other. In both situations the tubing 4 is displaced in the guides of the two holder devices 10, 20.

[0026] Finally FIG. 6 shows an embodiment that, in principle, corresponds to the one shown in FIG. 5a, but wherein the second holder device is configured as an integral part of the source coupling 5. The first holder device 10 can optionally be configured such that it can be locked releasably to the second holder device 20 and be separated there from, when the distance between the courses of tubing is to be increased as is shown at the bottom of FIG. 6.