DE29905072U1 - Subcutaneous infusion device - Google Patents

Description

TIEDTKE — BÜHLINÖ '.£-· :

PARTNERS «a*)

&rgr; Tiedtke - Bühling - Kinne, POB 20 19 18, D - 80019 Munich &eegr; Patent Attorneys / Representatives at the EPO '

Dipl.-Ing. Harro Tiedtke * Dipl.-Chem. Gerhard Bühling * Dipl.-Ing. Reinhard Kinne * Dipl.-Ing. Hans-Bernd Pellmann * Dipl.-Ing. Klaus Grams * Dipl.-Biol. Dr. Annette Link Dipl.-Ing. Aurel Vollnhals * Dipl.-Ing. Thomas J.A. Leson * Dipl.-Ing. Hans-Ludwig Trösch * Dipl.-Ing. Dr. Georgi Chivarov * Dipl.-Ing. Matthias Grill * Dipl.-Ing. Alexander Kühn * Dipl.-Chem. Dr. Andreas Oser * Dipl.-Ing. Rainer Böckelen *

Bavariaring 4, D-80336 Munich

15 June 1999

DE 23838 / case P199701455

MAERSK MEDICAL A/S

Lynge, Denmark

„Subcutaneous infusion device*

Telephone: 089 - 544690

Fax (G3): 089-532611 Fax (G4): 089 - 5329095 postoffice@tbk- patent.com Deutsche Bank (Munich) Account 286 1060 (bank code 700 700 10) Dresdner Bank (Munich) Account 3939 844 (bank code 700 800 00) Postbank (Munich) Account 670 - 43 - 804 (bank code 700 100 80) Dai-Ichi-Kangyo Bank (Munich) Account 51 042 (bank code 700 207 00) Sanwa Bank (Düsseldorf) Account 500 047 (bank code 301 307 00)

title

Subcutaneous infusion device 5

Background of the invention

The present invention relates to infusion devices for subcutaneous delivery of a drug or therapeutic fluid by means of an external infusion system, and more particularly relates to an infusion device having a releasably connected device for delivery of the drug or therapeutic fluid from the external infusion system.

Infusion devices are well known in the art for delivering a drug or therapeutic fluid to a subcutaneous site in a patient by means of a cannula that is inserted through the patient's skin to the subcutaneous site. Such devices typically comprise a tubular cannula extending from a housing adapted to receive the desired drug via a separable device for suitable connection to other components of the infusion system. The ability to separate the infusion set from the other parts of the infusion system is provided to improve user comfort. The user is able to perform activities that do not permit the presence of a pump or the like, or that are hindered by the presence of a pump or the like. In the separated state, only a portion of the infusion set is worn by the patient. This allows increased mobility. In order to provide such a separable device and further to maintain a fluid-tight seal to the interior of the housing and tubular cannula, preventing contamination of the infusion site, such devices are usually provided with a self-sealing septum

either on the housing or on the separable part and with a hollow needle on the other part adapted to penetrate the septum. Upon withdrawal of the needle from the septum, this provides a fluid-tight seal to the interior of the housing. The septum and needle further provide a fluid-tight seal between the housing and the connecting device when the drug or therapeutic fluid is delivered from the external infusion system to the patient. Subcutaneous infusion devices of this well-known type are known, for example, from US Patent 5522803 to Teissen-Simony and US Patent 5545143 to Fischeil.

In connection with such infusion devices which have different insertion points for the insertion needle and the needle of the connecting device, a self-sealing septum must be arranged at each insertion point. The manufacture of such devices is therefore rather cumbersome and time-consuming.
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The infusion devices known to date are relatively space-consuming due to their design, which requires a septum at each needle insertion point.

For these reasons, there is a need for improvements in infusion devices of the type described above and in particular with regard to the provision of an infusion device which is far less cumbersome from a manufacturing point of view in relation to a device which is a fluid-tight seal between the housing and the connecting device in a mutual fastening position for these elements. The infusion device according to the invention eliminates the disadvantages described above and provides further advantages which will become apparent from the description which follows.

3 Summary of the invention

According to the invention, a subcutaneous infusion device has been developed, the infusion device comprising: 5

a housing;

a flow channel in the housing;

a cannula fixed in the housing in flow communication with the flow channel;

a self-sealing septum that covers the flow channel;

a connecting device for discharging liquid into the flow channel;

a needle on the connecting device for penetrating the self-sealing septum covering the flow channel; 20

an opening in the housing for insertion of an insertion needle;

a self-sealing partition to cover the opening;

wherein the self-sealing partition covering the flow channel and the self-sealing partition covering the opening are a single element.

By providing the self-sealing partition for sealing both openings as a single element, both the material costs and the manufacturing costs can be reduced without affecting the function of the infusion device. Furthermore, it has been possible to create an infusion device which has smaller dimensions than those known hitherto.
35

In a preferred embodiment, the housing has a chamber-creating portion of the flow channel where the opening faces the chamber and where the self-sealing septum is placed in the chamber.
5

As a further advantage, the self-sealing septum has a surface that is inclined relative to both the axis of the flow channel and the axis through the opening and the cannula.

The infusion device is advantageously connected to the patient by means of an adhesive.

The invention is explained in more detail below with reference to the drawing.
15

Short description of the drawings

Figure 1 is a perspective view of another preferred embodiment of the subcutaneous infusion device according to the invention;

Figure 2 is a side view of the device shown in Figure 1;

Figure 4 is a plan view of the device shown in Figure 1; 25

Figure 3 is a sectional view taken along line 3-3 in Figure 4;

Figure 5 is a plan view of the housing of the device shown in Figure 1;
30

Figure 6 is a plan view of the connecting device of the apparatus shown in Figure 1;

Figure 7 is a rear view of the housing of the device shown in Figure 4;

Figure 8 is a front end view of the connector assembly of the apparatus shown in Figure 4;

Figure 9 is a plan view of a self-sealing septum;

Figure 10 is a front view of a self-sealing septum;

Figure 11 is a side view of a self-sealing septum; 10

Figure 12 is a side view of an introducer needle for use in

Connection to the device shown in Figure 1.

Description of the preferred embodiments

From Figure 1 it can be seen that the second embodiment of the infusion device comprises a housing 1 and a soft cannula 2 extending from the housing. A connector 3 is connected to the housing and a hose 4 extends from the connector to provide fluid communication between a pump (not shown) and the connector 3. Two locking arms 5 are provided on the connector 3 to provide a locking function with respect to the housing 1.

Figure 2 shows the device as seen from the side. It can be seen that an introducer device comprising a needle hub 9 and a needle 10 was mounted in the housing and through the lumen of the soft cannula 2.

From Figure 3 it can be seen that the housing 1 is provided with a bore, at one end of which the soft cannula is attached in flow connection with the bore. At the end of the bore, opposite the soft cannula 2, a self-sealing partition 16 is attached. The connecting device

·

· i

3 has a bore 13 where the hose 4 is connected in fluid communication with that bore at one end thereof and where at the end of the bore, opposite the hose, a hollow needle 12 is provided in fluid communication with the bore. The needle 12 is intended to penetrate the self-sealing septum 16 in the housing. The self-sealing septum 16 provides a fluid and air seal to the environment when the needle 12 of the connector 3 is withdrawn from the septum and it further provides an air and fluid seal around the needle 12 when it is inserted through the septum 16.

From Figure 4 it can be seen that the device has a substantially elliptical basic shape. However, the device could have any other basic shape which allows the provision of a bore, a self-sealing septum and a cannula in the housing and a bore, a tube and a needle in the connecting device and further the combined guiding and closing device 5, 6 in connection with the housing and the connecting device. The two locking arms 5 on the connecting device each have a barb 6 which cooperates with an edge in the housing 1. In order to release the connecting device 3, the locking arms 5 must be pressed towards each other at the surface 7 which has a reduced material thickness in order to release the barbs from the locking position while the connecting device 3 is withdrawn from the housing 1.

Figure 5 shows the housing after the connector has been released from the device. It can be seen that the housing 1 has a rearwardly extending platform intended to support the connector in the attached condition. Grooves are provided to facilitate movement of the locking arms towards each other during a release operation of the connector.

Figure 6 shows the connecting device 3 after it
was detached from the housing 1. It follows that the
flexible locking arms 5 extend beyond the needle 12, whereby
a protective shield against harmful injuries caused by the needle
Furthermore, projections 19 are provided on each arm. These serve as a guide device for the
Connecting device in relation to the housing and prevent
unintentional movements transverse to the needle axis.

Figure 7 shows the rear end of the housing. The conical
Entrance for the needle into the element 17 is shown, as well as the grooves for the flexible guide and locking arms 5, 19.

Figure 8 shows the front end of the connecting device 3
The needle 12 and the flexible guide and locking arms 5
are visible.

Figure 9, Figure 10 and Figure 11 show the self-sealing
Partition 16 in top view, front view and side view

The septum 16 has on the outer side the shape

of an oblique truncated cylinder. It follows that the septum, due to the oblique, truncated shape, has a surface that is beveled in relation to the flat top and the back. The inclined surface faces the interior of the housing and allows the insertion needle to penetrate into and
through the soft cannula and the use of the needle of the
Connecting device to introduce fluid into the cavity inside
of the housing. However, the partition may have any
Have a shape that conforms to the housing around the respective openings and at the same time allows the penetration of both the insertion needle and the needle of the connecting device
allows, for example, a partially spherical shape.

Figure 12 shows an insertion needle for use in conjunction with the device shown in Figure 10. The insertion needle has

a needle bushing 9 and a needle 10 which, in the insertion position shown in Figure 2, extends through the soft cannula 2 beyond the outer tip of the latter.

The invention relates to a subcutaneous infusion device comprising: a housing; a flow channel in the housing; a cannula mounted in the housing in flow communication with the flow channel; a self-sealing septum covering the flow channel; a connecting device for supplying a liquid into the flow channel; a needle on the connecting device for penetrating the self-sealing septum covering the flow channel; an opening in the housing for introducing an introduction needle; a self-sealing septum for covering the opening; wherein the self-sealing septum covering the flow channel and the self-sealing septum covering the opening are a single element.

By providing the self-sealing element to seal both

Openings as a single sealing element can seal both the

Both material costs and manufacturing costs can be reduced without affecting the function of the infusion device.

Claims (5)

1. A subcutaneous infusion device comprising:
a housing;
a flow channel in the housing;
a cannula mounted in the housing in flow communication with the flow channel;
a self-sealing septum that covers the flow channel;
a connecting device for supplying liquid into the flow channel;
a needle on the connector for penetrating the self-sealing septum covering the flow channel;
an opening in the housing for insertion of an insertion needle;
a self-sealing partition to cover the opening;
wherein the self-sealing partition covering the flow channel and the self-sealing partition covering the opening are a single element. 2. Subcutaneous infusion device according to claim 1, characterized in that the housing has a part of the flow channel creating a chamber, and that the opening is opposite the chamber and that the self-sealing septum is placed in the chamber. 3. A subcutaneous infusion device according to claim 1, characterized in that the self-sealing septum has a surface which is inclined relative to both the axis of the flow channel and the axis through the opening and the cannula. 4. Subcutaneous infusion device according to claim 1, characterized in that the self-sealing septum has a shape of a truncated cylinder with an oblique angle in relation to the central axis. 5. Subcutaneous infusion device according to claim 1, characterized in that the self-sealing septum has the shape of a truncated sphere, for example a hemisphere.