Septum for implantable devices releasing agents

p0001The invention relates to an arrangement of a septum in an implantable device for dispensing active ingredients, eg drugs to the patient's body, with a septum and a device for its fastening to the housing of a medicament chamber wherein the septum as a cover of the drug chamber corresponding to the opening the casing is tightly inserted through one or more clamping members. Such devices for example, the GB-A-2121690 or US-A-4193397.

p0002In known embodiments of this kind so far, a circular septum has been used, which is held at the edge by clamping bodies in the device. The center portion of the septum, the opening of the medication chamber free spans, so that the size of the septum so far there are limits to the range when the septum is very elastic, rubber-like body, which again must be closed tightly after each insertion of a hypodermic needle, thereby if too much span the septum occurs during penetration at the bottom of the chamber for the plant, thereby refilling the chamber is significantly impeded. Due to the only small in the known training area available for penetration by the injection needle each puncture site is very often used by the injection needle, so that the previous septa tend to leakage occurs soon.

p0003The invention has for its object to provide a septum of the aforementioned type, in which a larger area is available for penetration, without the free span of the septum is changed.

p0004This object is achieved in that the septum is annular, wherein along the inner edge of the septum acting clamping members cooperate with a fixedly connected to the rest of the housing part of the Vorrichtungswandung. It is thereby achieved that a substantially larger surface area for the insertion of the injection needle is not available, so that the septum is not occupied by the recesses of the injection needle. The inventive construction, although the device for delivery of active agents is diametrically slightly larger, however, this disadvantage is offset by the much longer shelf life of the septum by far.

p0005In a particularly advantageous manner, the septum inventive implantable device for the metered delivery of a substance such as drug is, the apparatus two separate exhibits by a flexible membrane separate chambers, of which the one chamber containing the substance to be dispensed, with a with a delivery catheter associated discharge opening and a filling hole is provided, and the other chamber is filled with a propellant which expands the output of the dispensed substance under evaporation isobar. With such a design of the invention can septum to seal the chamber containing the substance to be dispensed, serve. This also can be achieved in that the refilling of the chamber can be carried out more often without the septum is leaking.

p0006Furthermore, according to the application septum is also connected to an implantable device for the dosed dispensing of a substance, such as medicament, preferably wherein the apparatus has two each other, comprising by a flexible membrane separate chambers, of which the one chamber containing the substance to be dispensed, with a with a delivery catheter associated discharge opening and a filling hole is provided, and the other chamber is filled with a propellant which expands the output of the dispensed substance under evaporation isobar, wherein between the output port of the chamber and the delivery catheter means for an additional inputting medications od is provided. like. in the outlet catheter. In such a device the annular septum can serve to seal the chamber for the additional input of drugs, the septum around the replenishing opening is arranged around. Characterized in addition to the magnification is the surface which is to penetrate from the injection needle, ensures that the septum can be easily found. This finding, moreover, the annular chamber may also be greatly facilitated by a template, which is placed on the skin of the patient, wherein the position of the template by approximately the tactile edge of the implanted device is determined. Finally, the filling aperture can be provided centrally at the device and the annular septum be arranged concentrically to the replenishing opening. This can also be placed onto the implanted device that the center of the template coincides with the central, outwardly projecting filling hole for locating the annular septum the template. The template then has in a corresponding radius of the annular chamber from the center a continuous opening, which indicates the location of the annular chamber. If the position of the mask by the palpable edge of the implanted device is determined, then the refill must be located exactly centrally in the device. To determine the location of the annular chamber and the edge of the template could be used when its diameter corresponds to that of the annular chamber.

p0007Such implantable devices for the metered delivery of a substance are usually used directly introduce insulin or other medications duration in the body, these devices via replenishing apertures which are sealed by a septum, be refilled with a syringe. Now, it is often necessary that to the continuous dosage of the drug and additional drug must be given. For this purpose it is known to provide an additional chamber, which communicates with the outlet catheter, and can be injected through which additional drug directly into the outlet catheter. This chamber is provided in the known design on the outer periphery of the device, and as well as the refill opening closed with a circular septum through which an injection needle by means of the additional injection of the medicament is allows to pass. This known construction has the disadvantage that the doctor who injects the additional medication must seek this additionally sealed with a septum opening of the chamber only, which is not easy in an implanted device. In addition, the location for the additional introduction of the drug from the injection needle is often pierced, which can then subsequently lead to lead the septum. All these mentioned disadvantages are avoided by the inventive construction described above.

p0008In the drawings, some embodiments of the subject invention are shown.<ul><li>Fig. 1 shows a vertical section through a septum according to the invention provided with a device for the metered delivery of a medicament, namely according to line II of FIG. 2.</li><li>Fig. Figure 2 illustrates a plan view of the inventive apparatus according to claim 1.</li><li>Fig. 3 shows a vertical section through a provided with the septum according to the invention Zuspritzeinrichtung medicine. </li><li>Fig. 4 shows a section along line IV-IV of FIG. 5 another embodiment of a Zuspritzeinrichtung, which is likewise provided with the septum according to the invention.</li><li>FIG. 5 shows a section along line VV of Fig. 4.</li></ul>

p0009The device comprises a composite of two parts 1, 2 housing, whose interior is divided by a flexible diaphragm 3 into two chambers 4; 5. The chamber 4 is intended to receive the dispensed medicament, the chamber 5 will contain a propellant which expands isobaric by the body heat. By the expansion of the blowing agent, the membrane 3 is exposed in the sense of displacement of the drug from the chamber 4, wherein the medicament through the outlet port 6, an outlet reducing means 7, and an outlet catheter 8 is released into the patient's body. Before the drug reaches the outlet catheter 8, it is introduced into a chamber 9, which is provided annularly on the part 1 of the housing. This chamber 9 is at its top by a ring 10 which can be pierced by a hypodermic needle and automatically reseals after withdrawing the injection needle, thus, completed by a septum. This ring 10 is held by an annular fastening device 11 in its position. The chamber 4 is connected via a further septum 12, which is held by a fastening member 13, refillable.

p0010In the present case, the implantable device is designed as a rotation body, wherein the refill port 12 is disposed in the device centric and the annular chamber 9 concentrically thereto. not shown - - template so be placed on the patient's skin such that the center of the template corresponds to the refilling opening for locating the annular chamber 9 a is. The template has a, the radius of the annular chamber corresponding distance from the center a hole, which is then located by appropriate placement of the template over the annular chamber so that reliable through the hole, the annular chamber is found in insertion of the injection needle.

p0011The outlet reducing means 7 is formed in this case by a tube winding, which is repeatedly wound in a recess of part 1 of the housing. This recess is sealed by a lid 14 so that a smooth outer contour of the implantable device is achieved.

p0012As is apparent from Fig. 2, the chamber 9, and thus the sealing ring 10 is arranged concentrically around the refilling opening 12.

p0013The device is about the outlet catheter 8 continuously from the left in the chamber 4 drug to the patient's body. Should now be delivered more of this medication or another additional drug to the patient's body for health reasons, then the ring by means of a syringe, which is pointed to the area of ​​injection of the attached template, 10 pierced and the drug to be delivered into the chamber 9 injected, from which it is discharged directly via the outlet catheter 8 to the body. The flow resistance in the outlet reducing means 7 is so great that a pushing back of the drug is prevented in the chamber 4 of the implantable device. It must not necessarily be the same drug that is output from the chamber 4, but may be 8 or heparin-like substance also be injected to the franking of the catheter, for example.

p0014In the embodiment of FIG. 3, an annular chamber 21 is provided in a housing 20 which is open at the top, ie in the direction towards the end face of the housing 20. There, the chamber 21 is closed by an annular septum 22, which is fixed by means of annular clamping members 23, 24 in the housing 20th With 25 the lead for a period medication with 26 of the delivery catheter is indicated.

p0015In the embodiment of FIG. 4 likewise a disc-shaped housing is provided, which consists of two parts, namely the base 30 and an upper part 31. In this upper part 31 a circular opening is provided, into which the center a middle piece 32 is used, which is defined by arms 33, 34, 35 on the upper part. Between the upper part 31 and the central portion 32, an annular space is left free, which is complete with a likewise annular septum 36th The annular septum 36 is again attached with the annular clamping members 37, 38 at the upper part or on the center piece. The center piece 32 in this case has smaller thickness than the top 31 is high so that a chamber is released inside the case, in which the injected drug is. At 39, the supply line and designated 40 of the outlet catheter. The shape of the chamber is not critical and can be selected according to the application.

p0016In the embodiments according to FIGS. 3 to 5 is merely Zuspritzstellen of drug, whereas the embodiment of FIG. 1 and 2, a device for the metered delivery of drugs duration is, additionally comprising means for Zuspritzung of drugs. All the embodiments have in common that the septum or one of the septa is annular, whereby the advantages set forth above are achieved.

p0017In a modification shown in FIGS. 3 to 5 embodiments shown, which can be used as an additive for an infusion pump, the formation of the present invention may also serve as a mere injection point for drugs that are to be brought to specific organs, said in this regard hollow organ, such as the zubringende vein, is impossible or very difficult to access. In this case, then be omitted, the leads 25 and 39, respectively, so that 26 or 40 leading from the implanted device, only the outlet catheter.