WO2010127822A1

WO2010127822A1 - Assembly of an orthopaedic ferula and soft means suitable for maintaining a human leg in horizontal position

Info

Publication number: WO2010127822A1
Application number: PCT/EP2010/002696
Authority: WO
Inventors: Arturo Caniglia
Original assignee: Arturo Caniglia
Priority date: 2009-05-08
Filing date: 2010-05-04
Publication date: 2010-11-11
Also published as: IT1394058B1; ITMI20090786A1

Abstract

The longitudinal impression defined in an orthopaedic ferula (2) comprises cavities (3, 4, 5) of different depths which receive soft means (7, 8) for supporting and holding still the foot, heel, calf, popitleal muscle and part of the thigh of a harmed leg.

Description

Title: Assembly of an orthopaedic ferula and soft means suitable for maintaining a human leg in horizontal position.

Field of the invention

This invention refers to an assembly made of an orthopaedic ferula and soft means suitable for maintaining a human leg in horizontal position, in particular the assembly is suitable for maintaining in the correct position a leg of a person who suffered a trauma, a fracture, is in post-operation conditions due to a thighbone fracture and comes out of operations of hip or knee arthroprosthesis, is in the endoprosthesys, in triple twist as well as for a person having to maintain the setting of thigh bone dyaphisary fractures in stand by in view of an operation or after an operation and is in any leg trauma requiring leg immobilization along short or medium/long periods.

In the continuation of this specification, a leg laid down into the ferula because of any of the above referred reasons will be referred to as - harmed leg - for shortness.

The prior art

Some orthopaedic ferulas are known and documents disclosing ferulas appearing as the most close to the assembly according to the present application are cited herein: FR2161704(A5); CH693841 (A5); US5716334 (A); US5603692 (A); US 3843979 (A).

All ferulas cited in the above documents have a cavity suitable for containing a leg part and a verticall wall adjacent to the plant foot position. Some of said ferulas face the problem to reduce the risk of skin sores as, for instance, in the document FR 2161704(A5) where the inner surface receiving the laying leg comprises ribs right-angled with the ferula longitudinal axis so as to allow air to pass below the leg; document US 3843979(A) provides for a continuous covering material in the ferula cavity suitable for a soft contact with the skin.

Prior art drawbacks

The main drawback in all known ferulas is that the leg weight is not well spread into the ferula cavity which entails risk of skin sores and pains in the popliteus external sciatic nerve.

A second drawback is due to ferula outer outline preventing the harmed leg and the other leg to lay abducted correctly, the harmed leg into the ferula and the contralateral limb out. Moreover, some of the known ferulas prevent the harmed leg and the foot from being hold correctly into the cavity which causes harmful foot extra-rotations.

Also, searches carried out in some hospitals showed that ferulas in use cause skin ulcers on the fifth foot finger, in the heel and in the malleoluses.

A further drawback in some of the known feralas is that they have no cavity covering and are consequently prone to blood, urine, and feces dirty .

Summary of the invention

The main problems that the invention solves are to embody an assembly of ferula and soft means wherein the weight of a harmed leg or the weight of part of the harmed leg is distributed as much as possible on the ferula bottom so as to reduce the risk of skin sores and pains in the popliteus external sciatic nerve, to immobilize the leg conveniently into the ferula and to keep abducted conveniently the harmed leg and the contralateral limb.

The ferula in the invented assembly presents a longitudinal impression similar in shape to the rear part of a leg and comprises at least three cavities of different depth adapted to receive, once soft means contained in a bag have been placed in a corresponding cavity, the heel, the calf, the popitleal muscle and part of the thigh of a leg Said soft means have at least three sections, each adapted to be received in a corresponding cavity in the ferula. In the continuation of this description, the ferula is considered to lie in horizontal position. Said ferula cavities will be referred to in the continuation of the description, respectively: closed cavity, central cavity and open cavity, while the ferula extremity adjacent to the closed cavity will be referred to as closed extremity and the extremity adjacent to the open cavity will be referred to as open extremity The different depths of the cavities are suitable for receiving the relevant soft means which, in turn, have a thickness proportional with the weight of the leg part to be supported. Said depths and thicknesses are also so defined that the upper surfaces of the soft means substantially fit the outline of the supported harmed leg part. The soft means are made of silicone panels having preferably a thickness ranging from 0 5 to 0 9 mm and from 13 to 18 mm, respectively in the open cavity and closed cavity. Indeed, said impression is defined taking into account the medium sizes and medium weight of the human leg and in the areas where a leg particularly weighs upon, the cavities are defined for receiving soft means of suitable thickness

The ferula closed extremity ends with a vertical wall that is right-angled with the longitudinal axis of the ferula. On the outer surface of said vertical wall a vertical plate is associated which is provided with gripping means for moving the ferula. The ferula has a longitudinal outer outline substantially conical and is narrow in the proximity of the open extremity and progressively increases to become wide in the proximity of the closed extremity

Advantages of the invention The main advantage of the invented assembly resides in that the association of the differently made cavities with the relevant soft means gives a leg a position more confortable than the positions granted by the known ferulas and improves the weight distribution of a leg set therein, saves from or reduces the risk of skin sores and pains in the popliteus external sciatic nerve. A second advantage of the invented assembly comes from the ferula outer outline, substantially conical, makes it easy to position the harmed and the other leg abducted correctly making them spaced one from the other in the appropriate position.

Also, the shape imparted the ferula provides for a wide base which makes the assembly more stable than known ferulas. Finally, said bag containing the soft material is made of transpiring and waterproof material which allows to clean the bag after use and to protect the ferula from blood, urine, and feces dirty .

Detailed description of the invention

The invention will be described in detail herebelow by an embodiment example and the help of a drawing wherein:

- Fig. 1 is a vertical cross section showing the assembly ferula-soft means,

- Fig. 2 is a first axonornεtric view,

- Fig. 3 is a second axonometric view from bottom and

- Fig. 4 is a view from above of soft means. Figure 1 shows an assembly 1 comprising a ferula 2 which defines an impression made of three cavities 3, 4, 5 of depths different one from the others, a soft bag 6 made of three sections 7, 8, 9 , seven aeration holes 10, a vertical wall 11, a vertical plate 12 and a hole 13 passing through the wall 11 and the plate 12.

As it can be seen in the figure, the three cavities 3, 4, 5 receive the bag 6 which presents the sections 7, 8 filled in with silicone panels respectively of about 0.7 mm and 15 mm thickness so as to fit the different depths of the respective cavity s 3 and 5 and the upper surfaces of the soft means coincide substantially with the profile of the rear part of a harmed leg set therein. A third section 9 of the bag is silicone free and is suitable for connecting in a flexible manner section 7 with section 8 of the bag 6. In the embodiment shown in this figure, section 9 is silicone free since this section corresponds to the cavity which receives the calf, a leg portion of low risk of skin sores and nerve pains also due to its notable muscular mass. The different thicknesses of sections 7 and 8 enable the weight of the harmed leg to be distributed uniformly into the impression so making the leg lie still therein. Said section thicknesses save the harmed leg from detrimental compressions in the bearing points and maintain the leg still into the ferula. The aeration holes 10 are spaced along the bottom surface of the ferula impression in order to ventilate uniformely the rear part of the harmed leg; the vertical plate 12 is intergral with the vertical wall 11 and is provided with holes, not visible in this figure, as gripping means for moving the ferula. The hole 13 passes through the wall 11 and the plate 12 and is suitable for a possible conventional foot skin traction of the harmed leg. Figure 2 shows the same assembly as shown in Fig. 1 and corresponding parts in the figures are referred to with same reference numbers.

Fig. 2 shows the assembly 1, ferula 2, cavities 3, 4, 5, soft bag 6 received into the ferula impression, sections 7, 8 and 9 of the soft bag, two aeration holes 10, vertical wall 11, vertical plate 12 and the through hole 13. The figure also shows the gripping holes 14 for moving the assembly. As shown in the figure, the longitudinal outer outline 15 of ferula 2 is of substantially conical shape and the ferula is narrow outside in the proximity of the open extremity 16 and, progressively, becomes wide in the proximity of the closed extremity 17. Such a shape forces to the abducted position both legs of a patient.

As it may be seen in the figure, each section of the bag 6 covers completely the surface of the relevant cavity and section 8 is so shaped as to protect from possible skin sores the malleoluses, heels and foot fingers which lie in the proximity of the extremity 18 af the part bag 8.

Fig. 3 shows an assembly 30 comprising a ferula 31, a soft bag 32, aeration holes 33, a vertical wall 34 and a vertical plate 35. Moreover, the figure shows that bag 32 is provided with opposite side flaps 36 which, connected one to the other, define a sort of cap 37 that fits the ferula open extremity 38 in order to keep in position the bag into the ferula. The bag 32 and cap 37 protect the ferula from blood, urine, feces and other organic fluids dirty.

Fig. 4 shows a soft bag 50 with its three sections 51, 52, 53. The shape of section 53 is suitable for protectiong the foot fingers thanks to its opposite extremities 54. The broken lines Ll, L2 ideally separate three longitudinal sections 55, 56, 57 in the bag 50. This separation is made to make clear that section 56 is the one lying on the impression bottom and the two sections 55 and 57 lie on the side walls of the impression so as to cover it completely.

The assembly shown in the above figures may be provided with soft wedges and spacers adapted to be put between the side walls of the impression and the soft bag in order to reduce the space wherein a harmed leg is set and grant a satisfactory blocking thereof as well as, when necessary, for holding the foot in intra- rotated position.

The soft bag may be provided with extentions in the form of ribbons for improving the holding of a leg into a ferula. The assembly shown in the figures 1-4 is made of materials adapted to medical use and all of them are hypoallergenic, transpiring, fireproof, autoestinguishable and antidecubitus and the parts which may contact the skin are all washable and disinfectable.

As far as ferula 2 is concerned, it is made by cold moulding of TDI based polyurethane, foamed in water completely. The components of said polyurethane are known by the commercial names "VORALUX HM 681" Polyol and "VORALUX HE

131" Isocyanate and the ferula is coated with an atoxic paint suitable for contact with human skin.

As far as soft bags 6, 32, 50 are concerned, they comprise a thermoplastic cover, high frequency welded, transpiring, waterproof and suitable for contact with human skin and known by the commercial name "SOLTANE F/B4".

The filling material for the soft sections is made of polyaddition silicone catalyzed with platinum of the type with low viscosity biocomponents, which silicone has excellent shocks absorption capacity, vibration damping capacity and is particularly suitable for all uses where antidecubitus properties are required. Such a silicone has no term once it has been vulcanized.

Claims

1. Assembly (1) of an orthopaedic ferula (2, 31) and soft means (6, 50) suitable for maintaining a human leg in horizontal position wherein the ferula (2, 31) comprises an impression suitable for receiving the rear part of the leg, characterized in that three cavities (5, 4, 3) are defined in such impression, one closed, one central and one open, that receive in supporting condition, respectively, the heel, the calf, the poplite and a section of the thigh, that each of the three cavities (5, 4, 3) has a depth different one from the other in order to make the upper surfaces of the soft means (6, 50) in their cavities substantially coincide with the rear profile of the part of the leg received therein and that the soft means are in the form of a bag (6, 50) that comprises at least two sections (7, 8 - 51, 53) of different thickness that fit, respectively, the closed cavity (5) and the open cavity (3).

2. Assembly (1) according to claim 1 characterized in that the ferula (2, 31) has a substantially longitudinal conical shape, is narrow outside in the proximity of the open extremity (16) and, progressively, becomes wide in the proximity of the closed extremity (17) for maintaining both the harmed leg and the contralateral limb correctly abducted.

3. Assembly (1) according to claims 1 and 2 characterized in that the bag (6, 50) comprises three sections (7, 8, 9 - 51, 52, 53) of different thickness, each fitting one of the three cavities of different depth.

4. Assembly (1) according to claims 1 and 2 characterized in that the sections (7, 8 - 51, 53) of the bag (6, 50) corresponding to the open and closed cavities are filled in with polyaddition silicone catalyzed with platinum of the type with low viscosity biocomponents and have respectively a thickness ranging from 0,5 to 0,9 millimeters and from 13 to 18 millimeters.

5. Assembly (1) according to claims 1 to 4 characterized in that the bag (6, 50) is removable from the cavities.

6. Assembly (1) according to each of the previous claims characterized in that the section of the bag (32) corresponding to the open cavity comprises a cap (36, 37) covering said open cavity (3).

7. Assembly (1) according to each of the previous claims characterized in that the bag (6, 50) comprises extensions in the form of ribbons making easy the fixing of the leg into the ferula (2, 30).

8. Assembly (1) according to each of the previous claims characterized in that it comprises a plurality of auxiliary stoppers for better blocking the leg and foot and for maintaining the latter in intra-rotated position when necessary.

9. Assembly (1) according to each of the previous claims characterized in that it comprises a vertical plate (12, 35), associated with the ferula vertical walls (11 - 34), that extends upwardly in order to exceed the height of any foot received in the ferula (2, 30).