Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-05-18
2001-04-24
Kamm, William E. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S070000
Reexamination Certificate
active
06223084
ABSTRACT:
The present invention relates to an apparatus for the correction of the non-malforming alterations of the foot such as flat, sunken, valgus and varus foot of various degrees, by means of electrostimulations.
The most common foot alteration occurs when the arch supporting the foot subsides. This defect is called by the specialists flat foot and is ranked at the second place only behind scoliosis in the score of orthopaedic troubles most worrying in the children growth, since it effects about 20% of the whole population. It involves not only aesthetic problems but causes also the loss of the foot regular function and this is a more serious problem. The methods for its solution are often inefficient. Half of the flat foots found during infancy heals up spontaneously because they are indeed slack foots. In this case the too elastic tissues subside under the infant's weight and simulate the flat foot. During growth however the foot becomes stronger and the trouble decreases until it disappears.
True flat foot is very different: the plantar vault, generally curved so as not to touch the ground on stepping, is flattened so that the entire sole leans on the ground. It is a defect involving bones, muscles and tendons, that does not improve in time. On the contrary this problem that is only aesthetic at the beginning, in the course of years causes even serious troubles of orthopaedic kind. Tendinitis, foot and ankle pain are the first consequences of flat foot. Moreover in time, incorrect stepping and running in view of flat foot, cause negative effects on knee, pelvis and even spine. Thus an ascending syndrome is generated, namely a trouble that starting from the extremities goes up to skeleton with a cascade effect with general articular and muscular consequences. Hence the importance of detecting true flat foots, namely those that improve only if they are treated.
Currently the methods used for the correction of the alterations of the plantar vault are mainly of two kinds: treatment with mobile orthoses or corrective shoes and surgical treatment.
The first method actually is only a prosthesis, namely it supports the relaxed arch of the foot without attaining any real improvement. Indeed most children undergoing this therapy, after some months having noticed no improvement, grow tired thereof and in agreement with the parents discontinue the treatment. The mobile prostheses generally consist of arch supports, and as such they should be worn for the lifetime. The same consideration apply to the black heavy orthopaedic shoe, hated by generations of children, which fortunately seems now to be obsolete. Also the mobile arch support and the recent American shell do not show any rehabilitative action. Such a first method is still today proven not to cause any corrective effect, but only a prosthetic effect so that it works until it is used, but when it is discontinued, the foot returns to its previous condition and therefore it is only a provisional support of the relaxed plantar vault.
In addition to that, one has to take into account the non-negligible cost, that often is borne by the National Health Service but many times by the family too.
The second method is certainly decisive in comparison with the first one. It is however a surgical operation and as such it has the risks connected with anaesthesia and complications arising during or after surgery, and therefore it may cause after effects such as ankylosis.
A great number of techniques were devised, but as it results also in the literature, there is no standard operation, thus tested and 100% or slightly less fail-safe because there is still uncertainty of the pathogenetic frame of the various kinds of flat foot.
In summary flat foot and all the other alterations of the foot rest are manifestations existing in a great number of children and adults.
The bloodless and non-invasive corrections, still used today, seem not to attain an actual correction of the foot alterations since they are simple prostheses only with a support function. Therefore, they neither cause the foot to do any active movement nor do they carry out a rehabilitative action.
On the other hand the surgical techniques resulted to be usable only in the few cases of serious deformity, being largely not advisable for the most common alterations such as the flexible pes planus.
A third conservative method is that of physiotherapy whose purpose is to give the patient, through a suitable program of exercises, the sensorial information needed to feel and maintain the correct position of the foot and to strengthen possible weakened muscles. This kind of physiotherapy, called proprioceptive, is advisable only for children of cooperative age, about from eight years onwards, but it is not exhaustive giving poor results. Moreover it is almost useless for adults.
As to the correction of other types of vault alteration such as varus valgus and sunken foot, there is no updated discussion in the literature with reference to resolutive non surgical therapies. For a general information of the known state of the art one should refer to the following publications: “Historical Review of flat foot surgery” by Prof. Bagliani of Alessandria, Italy and “Treatment of flat foot with orthesis and footwear” by Prof. Riccio of Naples, Italy.
The poor results obtained by the above mentioned methods pressed to test out innovative approaches in order to treat alterations of the arch of the foot. The resulting target of the intense research activity of the Applicant is the subject matter of the present invention. More particularly the considerable results obtained with the new method based on the use of electrostimulations supplied by the apparatus of the invention are described hereinafter. This innovative technique is absolutely bloodless and non-invasive, and on the basis of long and documented tests showed to give quick and irreversible results in the vast majority of treated cases.
Moreover this technique showed to overcome the limits of the mentioned conventional therapeutic methods, by giving quick and irreversible results in more than 90% of the cases affected by alterations that cannot be treated with the above mentioned methods.
Therefore Applicant started testing the apparatus of the present invention on the most common case, the flat foot, obtaining more than 90% of success for non structured cases, and in the structured cases normally intended for surgery, success was attained in at least 60% of the treated cases. Thereafter this method was extended to other types of alterations such as the pronated vagus foot, the sunken foot in all their degrees. This method resulted to be useful and operative also for adults and for all those conditions which in the meantime became a true pathology with a specific symptomatology, as for instance pain, easy trend to become tired and also lumbago and discopathy as a consequence of such alterations. It was now highlighted that these symptoms tend to disappear with great facility.
Object of the present invention is now an apparatus for the correction of the non-malforming alterations of the foot (flat, sunken, valgus and varus foot of various degrees) by means of electrostimulations. The method applied through the above-mentioned apparatus is based on its emissions of electrostimulations with stepwave shape at pulsed rate of variable duration and amplitude.
More particularly the present invention relates to an apparatus for the bloodless and non-invasive correction of the non-malforming alterations of the foot characterized by comprising:
a) a source of electrical currents with multiple step wave shapes at pulsed rate of variable duration and amplitude;
b) that source being connected to electrodes to be placed on the body of the patient to be treated;
c) detector means of the electric resistance existing at the ends of those electrodes during use of the apparatus;
d) means for measuring and transducing data supplied by the detectors; and
e) means for processing the data supplied by said detectors c) through said means (d) for the self regulation of
Lepore Antonio
Pettrone Francesco
Rendina Ivo
Vozza Antonio
Cookfair Arthur S.
Correctionpes S.R.L.
Kamm William E.
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