Surgery: splint – brace – or bandage – Bandage structure – Support covering
Reexamination Certificate
1999-04-19
2001-09-11
Lee, Kim M. (Department: 3761)
Surgery: splint, brace, or bandage
Bandage structure
Support covering
C602S061000, C602S063000
Reexamination Certificate
active
06287269
ABSTRACT:
BACKGROUND OF THE INVENTION
The orthesis device according to the invention is specifically designed for the conservative treatment of patellofemoral instability of the knee.
Patellar instability is in fact characterized by a gradual loss of patellofemoral articular alignment, with gradual lateral displacement of the patellar position with respect to the position of the femoral trochlea, which can be classified, depending on the severity of the condition, as follows:
(i) external patellar hyperpressure (the patellar tangential axis is dislocated outward with respect to the axis of the femoral trochlea);
(ii) patellar subluxation (partial loss of articular relationships); and
(iii) full luxation (with complete loss of articular relationships and consequent absolute functional disability).
The cause of the disorder can be found in static alterations, such as a decrease in patellar dysplasia and condylar displasia convexity and/or in the concavity of the femoral trochlea, and in dynamic ones, such as alterations to trophic conditions and to the insertion (lever arm) of the muscles that have a medializing action. The altered patellofemoral alignment is accompanied by an imbalance in the distribution of articular loads, with early wear of the cartilage (covering of the joint surfaces) and becomes clinically manifest with symptoms such as pain, effusions and articulation failures (patellar pseudoseizures). The condition reaches its peak in patellar luxations, where complete loss of articular relationships causes the functional locking of the articulation.
Indications for treatment, defined in relation to an extensive review of the literature, entail:
(1) surgical treatment, electively recommended for recurrent luxations and for minor instabilities which show symptoms despite conservative treatment; and
(2) conservative treatment, including physical therapy, elective strengthening of muscles having a medializing action and stretching of the posterior muscles of the thigh and of the lateral capsular and tendon structures, associated with the use of ortheses.
Conservative treatment can therefore include the use of patellar stabilization ortheses, all of which have the common purpose of restoring normal articular alignment by acting with various methods:
1) patellar centering hole;
2) stabilization system with crossing bands centered on the patella;
3) stabilization system using bands which produce a medializing pressure using traction belts or a presser support.
The drawbacks shown by the ortheses produced so far can be summarized as follows:
1) insufficient medializing action, which fails to produce sufficient alignment of the patellofemoral articulation through flexing and extension;
2) low compliance and limitation of the articulation;
3) pressure due to tangential action which induces an excessive articular load and sustains the associated synovial-capsular inflammation;
4) excessive compressive forces induced on the soft tissues of the posterior region of the knee (muscle and tendon insertions and vascular-nerve structures running in the popliteal area).
The above shortcomings become clinically manifest as:
1) failed reduction of “patellar snapping” occurring on flexing and extension of the knee and produced by contact of the patellar surface with the external “side” surface of the trochlea;
2) difficulty in maintaining an adequate ratio between alignment of the orthesis and the possibility to obtain functional range of motion of the joint for everyday and sports activity of the femur;
3) increase in anterior knee pain, particularly evident in the case of activities which entail marked flexing of the knee;
4) compressive action, which can cause the latency and aggravation of vascular or muscle and tendon disorders in the posterior region of the knee and of the popliteal canal.
SUMMARY OF THE INVENTION
The design of the orthesis hereinafter described arises, therefore, from a biomechanical and functional analysis of currently produced orthesis models and proposes a conceptual and substantial improvement obviating the described limitations.
The conceptual and structural improvements that have been applied can be summarized as follows:
I) The provision of an anatomical pressure support which can be customized as for the traction direction (T). At this level, the improvement introduced can be divided into three elements:
1) the shape of the lateral patellar containment supporting element or support (A), which reflects the anatomical shape of the patella and has a sloping contact surface which is effective in limiting, during continuous contact, the stimulation and irritation of the peripatellar synovial tissue that is often observed;
2) the presence of two traction belts or arms (E), which are directly connected to the support and integrated therein so as to allow the correct and most effective transmission of patellofemoral medializing/aligning forces;
3) the possibility to direct the traction forces (T) of the belts (E) with a particular possibility of selectable angular orientation through an angle of approximately 45°, so as to allow customized adjustment of the corrective forces that medialize and align the patellofemoral articulation also in relation to other variables, such as for example the different height of the patella with respect to the center of the femoral trochlea (high patella or low patella).
II) An anatomical centering hole (B), which by reproducing the true shape of the patella reduces tangential compression forces.
III) A butterfly-shaped anatomical posterior opening (C), which eliminates compressive forces acting on the soft tissues of the posterior region of the knee. The posterior opening does not compromise structural integrity because it is integrated with an elastic stabilization bar band (F), which is required in order to maintain the structural stability of the orthesis and alignment whilst the orthesis is being worn.
IV) An anchoring system in order to avoid the brace slipping during sports activity (entire knee brace-patellar support).
V) Ventilation holes (G) in order to improve compliance, reducing overheating and skin perspiration.
This model of orthesis for the conservative treatment of patellofemoral instability, by virtue of the particular patellar centering system, allows to modulate and customize, according to the degree of the disorder, the traction/pressure forces required to improve the patellofemoral articular alignment in static conditions and the proper function of the joint during activities.
REFERENCES:
patent: 4296744 (1981-10-01), Palumbo
patent: 4532921 (1985-08-01), Von Torklus et al.
patent: 5139015 (1992-08-01), Morneau
patent: 5417646 (1995-05-01), Gauvry
patent: 5417647 (1995-05-01), Down
patent: 5613943 (1997-03-01), Palumbo
patent: 5695452 (1997-12-01), Grim et al.
patent: 5800491 (1998-09-01), Kolen et al.
patent: 5807298 (1998-09-01), Palumbo
Smith and Nephew Donjoy, Donjoy Products Catalog, pp. 48-49, 1994.
Osti Leonardo
Saveri Luciano
Josif Albert
Lee Kim M.
Modiano Guido
O'Byrne Daniel
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