Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-03-17
2003-09-16
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S110000
Reexamination Certificate
active
06620138
ABSTRACT:
BACKGROUND OF THE INVENTION
This application claims the priority of German patent application no. 199 12 434.5, filed Mar. 19, 1999, which is incorporated herein by reference.
FIELD OF THE INVENTION
The invention relates to an infusor for the dosed administration of a product fluid as well as a catheter means and a catheter head used, more particularly, together with the infusor.
The object of the invention is to facilitate administering a product fluid, especially for the case of a user himself administering the product.
SUMMARY
An infusor of the kind relating to the invention comprises a housing accommodating a reservoir for at least one product fluid to be administered and a delivery means accommodated in the housing for dosed delivery of the product fluid from the reservoir. The product fluid is a solution of an active substance; preferably being a solution effective in medicine or in cosmetics. More particularly, it may involve insulin administered in the scope of diabetes therapy. Accordingly, the invention is described in the following by way of insulin therapy as an example.
In accordance with the invention, the product fluid is contained in at least two separate fluid spaces having separate fluid outlets. The reservoir is thus formed by at least these two fluid spaces or comprises at least two such fluid spaces separate from each other. Separating the fluid spaces makes it possible, more particularly, to automatically administer different product fluids, for example normal insulin, so-called pump insulin, and a quick-acting insulin as compared to the latter, more particularly insulin analog, using a single infusor. This results in the therapy being improved and simplified since the user administering himself no longer needs to implement injections manually, for example at unscheduled mealtimes or sports activities, thus eliminating the awkwardness and uncertainty involved in administration.
The infusor facilitates, in principle, not only the administration of different product fluids. When the at least two separate fluid spaces constitute conventional ampules, such those as employed many applications, by preparing the infusor so as to accommodate at least two such ampules, the amount of fluid which can be administered is increased by easily changing both ampules, preferably simultaneously. However, a primary use of the invention is regarded as administering different product fluids by a single infusor.
The delivery means is preferably configured so that each product fluid contained in the at least two separate fluid spaces can be alternatively delivered, i.e. both singly and together with the other. The two differing product fluids may be administered in a coordinated manner with each other, depending on the particular requirements of the treatment and of the user. Administration can thus be adapted as regards both quantity and time to at least two differing product fluids as ensured by a controller for the delivery means, preferably a programmable controller.
Connectable to the infusor is a catheter means comprising preferably at least one separate fluid conduit for each of the at least two separate fluid spaces. In this way, differing product fluids can be conducted—without becoming mixed—directly to an outlet or at least in the vicinity of an outlet forming an outlet common to the product fluids in the at least two separate fluid spaces.
In one catheter means, the separate fluid conduits form together an integral multilumen catheter body. The catheter body is prepared at one end for connection to the at least two separate fluid spaces. The other end of the catheter body is prepared for connection to a catheter head or is already commercially available with a catheter head.
In principle, each of the separate fluid conduits may be connected to a separate catheter head, a catheter head in accordance with the invention being preferred, however. Such a catheter head comprises a catheter head housing including a substantially flat underside suitable for direct skin contact and prepared for being attached to the skin. Furthermore, the catheter head comprises a piercing needle protruding from the underside of the catheter head housing. The catheter head is characterized by a fluid guide means being formed therein comprising an outlet and at least two inlets. The outlet is connected to the piercing needle, and the at least two inlets are each connectable to a product administering device. Two or more fluid conduits may be simply brought together in the catheter head. Preferably, the fluid guide means comprises a fluid chamber in the sense of an expanded fluid space into which a plurality of fluid conduits port.
In one embodiment, at least one inlet of the fluid guide means of the catheter head is closed off by a septum, which needs to be punctured by a connecting needle to connect to the product administering device whereby a hermetic seal forms around the connecting needle at the puncture site.
The connecting needle may be configured at a needle holder of a two-part catheter head, such a needle holder forming a removable part of the catheter head.
In one embodiment, the inlet of the fluid guide means of the catheter head hermetically sealed off by means of the septum is arranged in the catheter head such that it is suitable for connecting an injector, more particularly an injector pen. In this case, the injector forms one of the product administering devices. In this further development of the invention, the catheter head may serve as the catheter head for the infusor, as well as for an injector connected from time to time as required by the user and which makes use of the piercing needle or one of the piercing needles of the catheter head for administering its product fluid. In this configuration, in which a possibility for connecting an injector is provided, different product fluids may also be administered by means of the catheter head in accordance with the invention, even when the connected infusor comprises one fluid space only. With the then conventional infusor normal pump insulin, for example, may be administered and with the injector a quick-acting insulin or also a delayed-action insulin may be administered.
Exemplary embodiments will now be described with reference to the Figures.
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Marrgi Rolf
Michel Willi
Steck Jürg
Disetronic Licensing AG
Mendez Manuel
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