Device for introducing a substance into a body cavity of a patie

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

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Details

604 68, 604192, 604199, 604239, 604263, 604279, 2225916, 425441, 425443, 249 63, A61M 524, A61M 528

Patent

active

055317073

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD OF THE INVENTION

The present invention relates to a prefilled, disposable device for introducing a pharmacologically active substance, preferably in the form of a jelly, into a body cavity of a patient, for instance into the urethra, comprising a container for the substance and a tubular part communicating with the container and intended to be inserted into said cavity, said tubular part ending in an opening having a frangible seal with an inner side facing the inside of said device and an outer side facing the outside, said seal being located a slight distance within said opening and preferably being in the form of a membrane, the outer side of said seal further being provided with an integrally formed actuating rod projecting through said opening to the outside of the device, said actuating rod being arranged to rupture and remove said seal upon actuation and before the insertion of said tubular part into said body cavity, the parts of the walls of the tubular part being located on the outer side of said seal further being provided with rounded edges in order to alleviate any discomfort which may be experienced by the patient when the tubular part is inserted into said body cavity.
The invention also relates to method and a mould apparatus for manufacturing the invention.


BACKGROUND OF THE INVENTION

It is sometimes necessary to introduce pharmacologically active substances into body cavities, such as the urethra or the rectum of a patient. One instance of this is the introduction of a local anesthetic into the urethra prior to the insertion of a catheter or similar into the urethra in order to alleviate the discomfort and pain experienced by the patient during this operation. The local anesthetic may for instance be introduced through a tubular part inserted into the body cavity in question.
In order that the patient may not experience the same discomfort during the introduction of the anesthetic as during the actual insertion of the catheter, very high demands have to be made on the shape and smoothness of the tubular part and particularly on the tip thereof.
These demands easily can be met if a reusable, tubular part made of a permanent material without an integral seal is used in accordance with the long-established prior art. However, such a tubular part normally would have to be sterilized before a renewed use which is one reason why they no longer are much in use.
Instead prefilled, disposable devices are nowadays used extensively in hospitals, medical practices etc. These devices are normally delivered in a sterile condition in the form of sealed containers normally having a frangible seal in or on a dispensing outlet. In a device of the kind mentioned above in the introduction, the dispensing outlet of course would be the opening in the tubular part. When designing the frangible seal, the fact that this opening may not have any sharp edges after removal of the frangible seal must be taken into consideration, since such sharp edges would cause the patient pain or other discomfort when the tubular part is inserted into the body cavity.
One solution to this problem is disclosed in AT-B-386 123. This document discloses a device for introducing a lubricating substance into the urethra in order to facilitate a subsequent insertion of a catheter. The device comprises two parts, namely a bellow-shaped container and a funnel-shaped part ending in a tubular part. The free end of the tubular part is sealed by means of a frangible seal. The container and the funnel-shaped part are ultrasonically welded together. The opening at the free end of the tubular part has rounded edges and the frangible seal is located a slight distance within the tubular part. The frangible seal is provided with an integrally formed actuating rod projecting outside the opening and the frangible seal is broken upon actuation of the rod.
CH-A-608 373 discloses another device of the same general kind as the prior art device described above, the main difference being the field of application, which in this case is th

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