Surgery – Miscellaneous – Methods
Reexamination Certificate
1999-01-21
2001-06-12
Lacyk, John P. (Department: 3736)
Surgery
Miscellaneous
Methods
C128S845000
Reexamination Certificate
active
06244272
ABSTRACT:
The present invention essentially relates to a multi-layer product having an electrically conductive central layer that can be used as an inductive sensor element. More particularly, the invention relates to a multi-layer product including an electrically conductive central layer that can be used as an inductive sensor element in the context of a method and a device for improving support of a patient, in particular for treating or preventing bedsores.
Documents U.S. Pat. Nos. 4,886,152; 4,009,312; 4,734,303; GB-A-2,103,999 and GB-A-1,495,659 all relate to multi-layers metallic foils as packaging materials.
Document EP-A-0 218 301 discloses a method and a device for improving support of a patient, which support comprises a mattress provided with one or more closed chambers filled with a fluid under a controlled filling pressure, and uses a measurement device based on a combination of two induction coils
24
,
25
shown in FIG.
4
. That device is not very satisfactory because it requires provision to be made to power both induction coils, i.e. including the moving induction coil which is disposed close to the patient, and that always poses a safety problem.
In Document FR-A-2 718 347 =EP-A-676 158, which corresponds to U.S. Pat. No. 5,560,374, the applicant discloses a method and apparatus for supporting an element to be supported, in particular the body of a patient, making it possible to support the element at an essentially constant controlled penetration depth by means of a measurement device comprising an induction system combined with a piece of metal foil situated under the body being supported. Displacement of the metal foil modifies the self-induction coefficient of the induction coil, shifting the resonant frequency of the LC circuit away from the tuning frequency of the oscillator, thereby damping the signal delivered to an amplifier by the oscillator, so as to ensure that the signal is correctly processed and appropriately monitored.
It should be noted that the piece of metal foil situated under the body being supported is generally arranged in the vicinity of that region of the element being supported which has the largest mass or which is most protuberant, generally the sacral region which constitutes the lowest position of the element being supported, e.g. the body of a patient.
In the context of the applicant's prior solution, the metal foil is situated very close to the element being supported, e.g. a patient, and it suffers from the drawback of being noticeable to the element being supported.
Furthermore, the metal foil must not give rise to any adverse physical phenomenon on the element being supported, especially when said element is a patient. Likewise the metal foil must not disturb the treatment of the patient.
Therefore, a main object of the present invention is to solve the new technical problem consisting in providing a solution making it possible to support an element to be supported, in particular the body of a patient, while using a measurement device for measuring the penetration depth to which the element being supported penetrates into the support element, without it being noticed by the element being supported, in particular by a patient, and without giving rise to disturbances or physical phenomena that might have adverse effects on the element being supported, in particular a patient, since any adverse effect on the treatment of a patient is unacceptable.
Another main object of the present invention is to solve the new technical problem consisting in providing a solution making it possible to support an element to be supported, such as the body of a patient, while using a measurement device for measuring the penetration depth to which the element being supported penetrates into the support element, which measurement device is flexible enough to change shape to fit the morphology of the element being supported, in particular the morphology of the body of a patient.
Yet another main object of the present invention is to solve the new technical problem consisting in providing a solution that makes it possible to support an element to be supported while using a measurement device for measuring the penetration depth to which the element being supported penetrates into the support element, which measurement device uses a piece of metal foil designed so as to have very good flexibility as well as very good mechanical strength, and in particular resistance to degradation of its electrical characteristics.
All of these technical problems are solved for the first time by the present invention in a way that is simple, cheap, safe and reliable, and that can be used on an industrial and medical scale.
In a first aspect, the present invention provides the use of a multi-layer film product, characterized in that it comprises an electrically conductive flexible active central layer comprising two main faces of large area, a first face glued onto at least one “support” layer of a synthetic material that is advantageously electrically insulating, and that has a coefficient of elasticity substantially similar to that of the active central layer, and a second face glued onto at least one “protective” second layer, in particular for protecting against abrasion, and made of a synthetic material that is advantageously electrically insulating, the total thickness of the multi-layer film product being chosen so that the flexibility of the active central layer is retained substantially completely, as an inductive sensor element or in a measurement device for measuring the penetration depth of an element being supported, in particular the body of a patient, which penetrates in a support device, for instance a mattress or the like, preferably the protective layer being located in front of said element being supported, for instance the body of a patient. The invention also relates to a multi-layer film product as previously defined but wherein the active central layer is of a size smaller than the support layer and the protective layer. Therefore, the central layer does not have any edge liable to be apparent or in contact with the outside. For instance, the size of the central layer is of the order of 600 mm fold 600 mm and the size of the support layer is in the order of 725 to 975 mm fold 1100 to 1400 mm and the size of the protective layer is of the order of 700 mm fold 1000 mm.
In the context of the present description and of the claims, the term “flexible active central layer” indicates that the central layer has a folding flexibility in a direction perpendicular to the layer over its main faces of large area, thereby enabling it to change shape to fit the morphology of the element being supported, in particular the morphology of the body of a patient. Likewise, in the present description and in the claims, it is to be understood by the term “electrically conductive active central layer” that the central layer conducts electricity regardless of how it is implemented. Advantageously, the thickness of the electrically conductive flexible central layer is at least 15 &mgr;m.
In an advantageous embodiment, the thickness of the electrically conductive flexible central layer lies in the range 20 &mgr;m to 40 &mgr;m approximately, or better still in the range 25 &mgr;m to 35 &mgr;m approximately, in particular approximately 30 &mgr;m.
In another advantageous embodiment of the invention, the thickness of the support layer lies in the range 10 &mgr;m to 15 &mgr;m approximately. Preferably, the support layer contains or is made of polyester.
In an advantageous embodiment, the support layer is metal plated over at least one face that is to be arranged facing the electrically conductive central layer. Preferably, the metal plating of the support layer is implemented using a metal or a metal alloy compatible with a metal or metal alloy making the active central layer electrically conductive.
In a currently preferred embodiment, the electrically conductive active central layer contains or is constituted by at least one piece of aluminum foil which may be about 30 &m
Caminade Jean-Luc
Montant Jean-Marc
Lacyk John P.
Support Systems International Industries
Wolf Greenfield & Sacks P.C.
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