Patent Application
20080004573
This application claims priority to Swiss Application No. 815/06, 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, including medicinal substances, and to methods of making and using such devices. More particularly, the present invention relates to an adapter or auxiliary device with which a medical appliance or device provided with or carrying an adhesive can be applied to the skin of a patient securely and ergonomically, and with precise positioning.
By virtue of the technical advances in microelectronics and micromechanics, it is possible to produce portable medical appliances with ever smaller structural volumes and lower inherent weights. This means that, with the advantages of enhanced wearing comfort and improved discreetness, it is possible to secure them directly to the skin surface of a human or animal body.
Portable medical appliances or devices in the form of infusion devices, e.g., pumps, that are secured directly on the skin surface and thus permit discreet and comfortable wearing, are used, for example, for treating diabetes patients. Ideally, an infusion device of this kind worn on the body adheres for 4 to 5 days to the body and is water-tight. In many instances, the infusion device is exchanged, and the location of the cannula insertion site altered, by the actual patient.
Other appliances that can be secured on the skin are known, for example, in the field of continuous recording of blood sugar measurement values in the human body. A glucose measurement sensor, mounted on a housing part remaining on the outside of the body, is introduced subcutaneously into the body tissue to determine the blood sugar value.
The securing of such medical appliances to the body has to meet a number of basic requirements to optimize a secure hold, good wearing comfort and positionally accurate placement.
For securing to the skin surface, a firm connection should be provided between the body and the medical appliance throughout the period of use. Self-adhesive plaster materials permit sufficient adherence during the period of placement of the medical appliance on the skin surface, provided that the adhesive face of the medical appliance has been contacted with and/or connected to the skin surface with sufficient surface pressure. For this purpose, an appliance that is to be affixed should be easy to handle during the application procedure. In miniaturized appliances, this requirement is often difficult to satisfy.
For secure attachment and comfortable wear, the tilting moments caused by clothing and by gravity should be kept as low as possible. This requirement can be met by a construction having the smallest possible overall height, i.e., by a device that is as thin as possible. For the manipulation and application of the medical device, however, such a configuration, which provides a reduced grip, may prove to be disadvantageous. A thicker structure or ergonomically shaped gripping features and structures, permitting secure handling of the medical appliance during the application procedure, would likely be inconvenient during the time the appliance is in use on the body.
The generally thin, flat, plate-like shape of a medical appliance designed to be secured to the skin, for example an insulin pump, means that the patient's required view of the insertion cannula, and of the sensor that is to be introduced, is obstructed during the application procedure. This makes it difficult, or even impossible, to provide for secure and positionally accurate fixing of the medical appliance to the skin surface.
In the prior art, infusion pumps that can be secured on the body are known which have a modular structure. A modular configuration of such an infusion pump is described in patent specification DE 198 21 723 C2.
Moreover, the prior art includes embodiments that disclose application or adapter devices with adhesives between medical appliance and skin surface. Patent specification WO 2004/060436 A2 shows an adapter plate with which a disposable infusion pump can be applied to the skin surface by way of differently configured adhesive surfaces. US 2004/0116866 A1 describes an infusion pump which can be adhesively affixed to the human or animal body and which has multi-part adhesive fields that permit optimal force-fit conditions at different loads. In the area of the infusion site, the use of several adhesive segments with different adhesion properties and strengths are disclosed.
An object of the present invention is to ensure that a medical appliance or device to be secured on the skin surface of a human or animal body can be applied or placed on the body manually by using an adapter device, securely and ergonomically, and with precise positioning.
In one embodiment, the present invention comprises an auxiliary adapter with which a medical appliance provided with an adhesive can be applied to the skin of a human or animal body, wherein the adapter may be connected to or integral with the medical appliance and, in some embodiments, includes a fixing portion generally correlative with a pivot mechanism associated with the appliance. Using the adapter, the medical appliance may be applied to the skin surface ergonomically and comfortably, and as precisely and securely as possible.
In one embodiment, the present invention comprises an adapter for aiding placing a medical appliance on a patient's body, the adapter comprising a gripping portion for connection to an attachment portion of the medical appliance, whereby the gripping portion facilitates placing the appliance on the body. In some embodiments, the appliance further comprises a pivot part flexibly coupled to the attachment portion, and the adapter further comprises another portion flexibly coupled to the gripping portion for connection to the pivot part, the another portion and gripping portion coupled by a fixing portion and, in some embodiments, the fixing portion is generally correlative with and/or located generally adjacent to the flexible coupling between the attachment portion and the pivot part.
In one embodiment, the present invention comprises an adapter device or auxiliary device with which a medical appliance provided with an adhesive arrangement can be applied manually to the skin surface of a human or animal body, wherein the adapter device, forming a unit with the medical appliance, is provided with a pivot mechanism and with a releasable fixing structure. The adapter device allows a medical appliance to be applied to the skin surface securely and ergonomically, and with precise positioning.
In the starting state, the adapter device is fixedly or, in some embodiments, releaseably connected to the medical appliance and is equipped with an ergonomically shaped gripping structure or portion to ensure that the miniaturized appliance can easily be held with a secure grip in the user's hand. The fixed connection between adapter device and medical appliance can be achieved both with a force fit and with a form fit. The starting state refers to the state from which the medical appliance is applied to the skin surface and in which a pivot part associated with the medical device is secured by a fixing means at a defined angle with respect to the attachment part.
The pivot mechanism divides the adapter device and the now fixedly connected medical appliance into an attachment part and a pivot part. In some embodiments, the pivot mechanism reflects that the medical device and adapter have two portions. The attachment part is that part that is first applied and affixed to the skin surface. In the starting state, the pivot part extends at an angle, in a deflected position, from the attachment part, in such a way that the adhesive on underside of the pivot part does not come into contact with the skin surface. The pivot mechanism located between attachment part and pivot part permits a movement from the deflection position to the use position. In the use position, the attachment part and pivot part lie approximately planar on the body surface and provide a secure attachment of the medical appliance via the adhesive surface connections.
One embodiment of the present invention assumes a deformability of the medical appliance. If this is not provided, for example in appliances with a rigid or flexurally stiff housing, the required flexibility has to be provided structurally, for example by an articulated connection or link between attachment part and pivot part.
The grip structure, which is situated distally on the attachment part, permits ergonomic and firm handling of the medical appliance. Its ergonomic design means that the adhesive surface can be better pressed onto the skin surface, and the necessary surface pressure for a secure adhesive connection can be maximized.
In one preferred embodiment, the pivot mechanism is in the form of an articulated connection which can be locked in a deflected position and can be released manually via a release mechanism. In this way, the adapter can be packed and sold in a space-saving manner. Before application to the skin tissue, the pivot part is bought to the deflection position, in which it locks. The pivoting to the use position is achieved by actuating the manual release mechanism or, in the case of a predetermined breaking point, by exceeding an ultimate moment generated manually on the pivot mechanism.
In another preferred embodiment, the pivot is designed as an articulated fixing connection generally between the application part and pivot part of the medical device with which the adapter is being used. The fixing connection, comprising a suitable linking structure, is constructed as or includes a predetermined breaking point or fracture threshold which permits the desired pivoting movement after a sufficient manually generated ultimate moment has been generated.
In another preferred embodiment, the predetermined breaking point can be realized in the form of a connection that is easy to release manually, for example a transverse web or bracket between the pivot part and the application part.
Another preferred embodiment, in which the articulated connection can be fixed in a locked position and is released after a moment is exceeded, permits folding or movement from any desired starting position to the in use position.
The grip section or structure associated with, connected to or integral with the adapter allows, during the securing procedure, a small pump to be held firmly in the hand, thus facilitating the insertion of a needle or cannula associated with the pump.
To provide the medical appliance with a shape that is as flat as possible, the grip section or portion may be removed from the medical appliance after application (i.e., after the appliance is placed on the body) or is designed such that the grip section or portion can be detached or removed, in whole or in part, from the housing of the appliance after use.
In another preferred embodiment, a medical appliance or medical device with a sensor device, with which a sensor element is introduced into the body tissue, is secured on the body.
With regard to making, attaching or connecting components of the present invention and/or making the invention as a whole, unless specifically described as otherwise, conventional mechanical fasteners and methods may be used. Other appropriate fastening or attachment methods include adhesives, welding and soldering, the latter particularly with regard to the electrical system of the device, if any. In embodiments with electrical features or components, suitable electrical components and circuitry, wires, chips, boards, microprocessors, inputs, outputs, displays, control components, etc. may be used. Generally, unless otherwise indicated, the materials for making the adapter and/or the medical appliance or device of the present invention and/or their components may be selected from appropriate materials such as metal, suitable adhesives, metallic alloys, plastics, etc.
It should be understood that any embodiment of a medical appliance in accordance with the present invention, e.g., the embodiments depicted in
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. Obvious 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 |
|---|---|---|---|
| 815/06 | May 2006 | CH | national |
