Patent Application
20070299405
This application claims priority to Swiss Application No. 816/06, filed on May 19, 2006, which is hereby incorporated herein by reference in its entirety.
The present invention relates to devices for dispensing, injecting, administering, infusing or delivering substances, and to methods of making and using such devices. More particularly, the present invention relates to securing an infusion device or a portion of an infusion device to a patient's skin, whereby the device may be reliably secured in a suitable position. The term “infusion device” is used herein interchangeably with and to refer to any device for dispensing, injecting, administering, infusing or delivering substances, including infusion pumps, administration devices, appliances, metering devices, etc.
Infusion devices, including miniaturized infusion devices, e.g., infusion pumps, that are applied directly to the surface of the skin and permit discrete and comfortable wearing are used, for example, for outpatient treatment of diabetes patients. In some instances, after such an infusion device has been secured to the surface of the skin, it generally adheres to the body for 4-5 days and may then be removed and reattached, or completely or partially disposed of. In many instances, the use of such infusion devices involves the initial application or use of an infusion set, catheter head or the like to the surface of the skin and the insertion of a cannula carried by the infusion set or catheter head into the body tissue. This procedure may be carried out by patients or care-givers.
In daily use by the patient, it is desirable that the infusion device, or at least part of it, can be temporarily removed, for example to allow the patient to freely pursue a sporting activity, or so as not to expose the precision parts or electronic components of a metering device, which may be associated with the infusion device, to undesired contact with water during bathing or showering.
To allow the infusion device to be temporarily removed without removing the cannula and thereafter requiring the cannula to be pushed through the skin again, infusion devices that may be detached from the catheter head are known. The catheter head and the cannula form an indwelling fixture and, being provided with suitable sealing means, remain in or on the body tissue during the disconnection.
Patent specification DE 199 12 459 C2 describes an indwelling fixture in the form of an adapter which can be applied to the surface of the skin by an adhesive skin plaster and which permits connection of a metering device for continuous administration of a medical liquid, or connection of an injection pen, or fluidic connection to a syringe needle.
If an infusion or metering device, e.g., a pump, is mechanically coupled to an indwelling fixture, the static imbalance of the infusion device, which cannot be entirely eliminated because of its construction, results in forces or tilting moments that are dependent on and/or variable with the orientation of the infusion device. Such forces may limit or effect the wearing comfort experienced by the person wearing the device. For a person wearing a device, such as an infusion pump, it is desirable to permit individual orientation of the pump such that it can be worn in a suitable, comfortable position on the body.
An object of the present invention is to provide that an infusion device coupled to an indwelling fixture via a releasable plug-in connection and fluidic connection can be affixed comfortably and in a suitable position to the surface of the skin and, after disconnection, can be safely and comfortably secured again.
An arrangement and method for administering a medicinal substance to a patient, the arrangement including a catheter head with an underside for securing to the patients' body, a cannula extending from the underside of the catheter head for insertion into the patient's body, a connector carried on the catheter head for establishing a releasable fluidic connection to an administration device, the administration device at least initially rotatably coupled to the connector, wherein the administration device carries, on peripheral areas of the underside thereof, at least one adhesive suitable for fixing the administration device in a selected position relative to the patient's body.
In one embodiment, the present invention comprises an infusion device which is worn on the surface of the skin and administers a medical liquid, the infusion device being releaseably connected to a catheter head rotatably about a guide element associated with or carried by the catheter head. The catheter head is secured to the surface of the skin by an adhesive, as is known in the prior art.
When the infusion device is connected on or to the catheter head, it initially remains free to rotate about the guide element. In this way, the person wearing the device is able to orient the device individually with respect to, for example, wearing comfort, discreetness, convenience of use, etc. As soon as the device is located in the desired position, the device can be fixed and secured by adhesives that are located on a peripheral area or areas of the underside. In some embodiments, a second securing area, which may be formed and/or located similarly, permits a double introduction of forces, either redundant or different forces, with an overall better fixing to the surface of the skin. The reliability can be further improved by using several adhesives, which may be similar or different.
To disconnect the infusion device temporarily, for example to protect the it from undesired contact with water and moisture during bathing or showering, the adhesive attachment in the peripheral area is first removed. The infusion device is then released from the catheter head.
To ensure a satisfactory adhesive connection or reconnection, new adhesives or adhesives with characteristics facilitating reuse may be used on the peripheral areas after a temporary disconnection.
In one embodiment, the present invention comprises an infusion device for administering a liquid medical substance into human or animal body tissue, said device comprising a catheter head with an underside for securing to the body tissue, a cannula which is mounted on the catheter head, protrudes from the underside thereof and is inserted into the body tissue, a guide element and connector arranged on the top face of the catheter head and designed to establish a releasable plug-in connection and fluidic connection to an administration device, the administration device mounted, at least initially, so as to be able to rotate about the guide element and establish a releasable connection to the catheter head, wherein the administration device is prepared, on the peripheral areas, with at least one adhesive suitable for fixing the administration device onto the body such that the latter can be suitably worn on the body.
In one preferred embodiment of the present invention, plaster-like adhesives are provided on the underside of an infusion device, the active adhesive surface covered initially by a protective film. When the plaster-like adhesive is to be activated, the protective cover is removed. An ergonomically designed tear-off tab on the protective film makes it easier for the person using the device to grip the film and pull it off.
In another embodiment, separately stored adhesives provided as auxiliaries are not activated until directly before use on the infusion device, and are applied at a suitable location on the underside of the device.
In another preferred embodiment, adhesives are secured on the underside of the device via one or more independent backing films. In this way, used adhesives can be removed as and when required.
The arrangement of a suitable protective film 4, a suitable adhesive in the form of a skin-compatible plaster 3, and a suitable backing film 5 can be seen exploded at the left side of
Embodiments of the present invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms and steps disclosed. Modifications or variations are possible in light of the above teachings. The embodiments were chosen and described to provide the best illustration of the principles of the invention and the practical application thereof, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.
| Number | Date | Country | Kind |
|---|---|---|---|
| 816/06 | May 2006 | CH | national |
