Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-10-04
2001-08-14
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S177000, C604S180000, C604S001000
Reexamination Certificate
active
06273873
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a device for fixating an epidural catheter or a similar drainage catheter to a skin surface part of a patient or person.
The present invention generally relates to the technique of applying and fixating a catheter, such as an epidural catheter, relative to a skin surface part of a patient or person, and more precisely a device for fixating such a catheter relative to a skin surface part of a patient or person.
It is a well-known technique to enter a catheter through the skin of a patient or person, e.g. after a surgical operation.
In certain applications, tiny catheters are to be used which have to be applied to e.g. the back of the person or patient. The size of the catheter itself makes the catheter extremely susceptible to blockings in case the catheter is not properly mounted and in case the patient or person lies on the catheter. The small size of the catheter, e.g. of an epidural catheter also renders it highly likely that the catheter is withdrawn from its intentional position as the patient or person shifts his or her position sitting or lying in the bed or is moved to and from a bed, a chair or moves around as the catheter is very easily caught by the patient or person or caught by a person helping the patient or person.
Furthermore, the technique of applying and fixating a catheter, in particular an epidural catheter, is a complex and time-consuming operation which requires skill and which further often turns out to be inadequate and inappropriate as the epidural catheter is easily pulled out and removed from its intentional position.
Various devices for fixating a catheter have recently been developed as disclosed in eg. GB patent No. 2,115,290, U.S. pat. No. 4,419,094, U.S. pat. No. 4,645,492, U.S. pat. No. 5,282,791, U.S. pat. No. 5,370,627, U.S. pat. No. 5,372,589, WO 91/07204, WO 91/17738, WO 95/33508, WO 93/25264 and WO 93/17738. Reference is made to the above patents and patent applications, and the above U.S. patents are hereby incorporated in the present specification by reference.
The above-mentioned U.S. Pat. No. 5,372,589 discloses a transparent self-adhesive film dressing with a special aerating fenestra, which substantially covers and secures an intravenous catheter to the skin of the patient, for visual inspection, without encouraging growth of bacteria. Although the above-mentioned film dressing is advantageous from the point of view of its extremely simple construction, it can only be used in connection with catheters for percutaneous intubations, which catheters are introduced practically tangentially to the patient's skin, and not in connection with catheters which are introduced perpendicularly to the patient's skin, such as epidural catheters. Application of the self-adhesive film dressing according to U.S. Pat. No. 5,372,589 in connection with an epidural catheter would cause the epidural catheter to bend brusquely at the exit from the puncture point, provoking thus a constriction of the catheter flow channel and impeding an uninterrupted epidural collection and would not prevent the epidural catheter from being pulled out from the position.
The above mentioned published international patent application, publication No. WO 93/25264 discloses a device for fixating a drainage tube, and a drainage tube assembly introduced perpendicularly to the patient's skin, which device comprises a support component including a flange part and a tubular part which are integrally connected through a conical part. The tubular part has a through-going passage for receiving the drainage tube, and the flange part has a surface part to be arranged in surface contact with the skin surface part of the patient. The device also comprises a locking component for locking the drainage tube relative to the tubular part of the support component. The particular assembly of the flange part, the conical part and the tubular part eliminates the risk that the drainage tube may bend at the entrance of the patient's skin and the risk of creation of kinks in the drainage tube. However, the device according to publication No. WO 93/25264 has appreciable dimensions in all three coordinates, making it uncomfortable for the patient if he/she will make a move and squeeze the tube assembly between his/her skin and the bed, at the same time provoking also the interruption of flow in the tube or even the breaking thereof.
Consequently, none of the existing types of fixation devices have been found to meet the requirement of being able to ensure a reliable fixation of a catheter, in particular an epidural catheter, inserted substantially perpendicularly relative to the patient's skin.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a device for fixating an epidural catheter or similar catheter, which device eliminates the risk that the catheter may bend abruptly at the perforation site in the patient's skin or create kinks, and further prevent the catheter from being pulled out in case the catheter is unintentionally squeezed, pressed or in any other way removed from a resting position.
A particular advantage of the device according to the present invention resides in that a single unitary structure is provided which renders it possible, in a single and easily performable operation, to accomplish a secure fixation of the epidural catheter and also make the catheter and the catheter flow less sensitive to the patient's moves or to external pull, squeeze, press or jerk factors.
A particular feature of the device according to the present invention is the provision of a pad which by its curved shape ensures that the epidural catheter by bending over said pad and following the outer contour thereof will form a loop with the same large radius of curvature as the above-mentioned pad, and by its thickness and softness ensures that the epidural catheter will not bend abruptly when exiting the puncture point in the patient's skin.
A further particular feature of the device according to the present invention lies in that the device according to the present invention constitutes a disposable unitary structure which has been presterilized and is applied in a simple manner as a plaster structure to the patient's skin.
The above object, the above advantage and the above features together with numerous other objects, advantages and features which will be evident from the description below are obtained by means of a device for fixating an epidural catheter to the skin surface part of a patient, comprising in accordance with the present invention:
a pad element to be arranged adjacent to the perforation site and defining a convex marginal surface having a radius of curvature of at least one order of magnitude larger than the outer diameter of the catheter, the marginal surface providing a support surface in relation to the catheter positioned in facial contact therewith for arranging the catheter in a loop and turning the catheter from an orientation substantially perpendicularly relative to the skin surface part to an orientation substantially parallelly with the skin surface part and for preventing the catheter from sliding along the marginal surface,
a cover foil of a foil material having opposite first and second surfaces and defining a first end,
an adhesive material applied to the first surface of the cover foil, and
a connecting foil being connected to the cover foil at the first end thereof and constituting an extension thereof, the pad element being connected to and supported by the connecting foil, the connecting foil defining a transition area between the supporting element and the cover foil, a folding line being defined within the transition area, the cover foil being foldable onto the pad element along the folding line for arranging the first surface of the cover foil facing towards the pad element for adhering to the skin surface part, for fixating the catheter relative to the pad element and for covering the perforation site.
The pad element of the fixation device
Klein & Szekeres LLP
Maersk Medical A/S
Seidel Richard K.
Sirmons Kevin C.
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