FR2560518A1 - Device for immobilising with retention a part of the human or animal body and an external rigid envelope - Google Patents

Abstract

This device is of the type comprising an internal envelope 2 in contact with the skin of the patient and an external rigid envelope 3 enclosing the internal envelope. According to the invention the internal envelope 2 is flexible and associated with means allowing its volume to be varied during the whole period of use, so as to adapt it to the volume of the limb to the immobilised. Application to the immobilisation of fractured limbs.

Description

"IMMOBILIZATION DEVICE WITH CONTAINMENT OF A PART OF
HUMAN OR ANIMAL BODY AND A RIGID OUTER SHELL "
The present invention relates to an immobilization device with restraint of a part of the human or animal body, and of a rigid outer envelope.

 In many cases, such as fractures, sprains, or malformations, it is necessary to immobilize a part of a human or animal body having this defect, for a period of several days to several weeks.

 In the case of a limb fracture, the immobilization of the limb is carried out using plaster of Paris or using more recent materials, such as heat-polymerizable materials (thermoplastics), under the 'action of certain wavelengths (UV for example) or even using materials obtained by chemical reaction between two components.

 The improvement of these products in recent years has focused on increased resistance to water and perspiration, greater resistance to shear or wear forces, greater lightness of the apparatus and greater ease of modeling.

 At the same time, some of these improvements have been accompanied by drawbacks, the improvement in water resistance resulting in intolerances of the product in contact with the skin, the lightness of the device resulting in either modeling difficulties. , either by taking too quickly, or by handling at high temperature (in the case of thermoplastic products), or by the texture of the material used which is difficult to depress.

 At the same time, a diversification was made of the materials constituting the internal envelope, that is to say of the layer interposed between the skin and the compression device proper.

 We have gone from simple carded cotton to synthetic substances put in place either by simple winding, or by injection into an envelope with progressive and variable hardening going from a soft consistency to a hard consistency.

 These interposition layers have various drawbacks: progressive compaction with the perspiration of the skin for cotton, good comfort but no effective compression for the foam fleece, good molding but too hardness or too much compression due to its expansion for polyurethane foam.

 Whatever the process used in making long-term fixed assets, that is to say exceeding 48 hours, it is practically impossible to ensure satisfactory containment and comfort because the volume of the apparatus around of the body part to be immobilized remains constant, while the body part varies in volume.

 Indeed, a body part to be immobilized is susceptible to volume variations either in the short term (edema, pulsations. Arterial) or in the medium and long term (reduction of edema following a trauma, amyotrophy due to immobilization).

 The only device allowing volume variations concerns inflatable splints. However, they cannot be considered as restraint devices, but rather as first aid devices, which can only be used for a few hours before intervention on the injured member.

 The constant volume of the apparatus and the variations in volume of which the limb to be immobilized is likely to result in discomfort for the patient, in risks of displacement if the compression is insufficient, and in risks of friction of the limb when inside the device, which can cause bedsores.

 In addition, when the variations in the volume of the limb are too great, it is advisable to modify or replace the initial apparatus, necessitating additional intervention costs and, possibly, hospitalization costs.

 Finally, certain devices, such as the ribs intended to carry out the maintenance of a patient after a fracture of the cervical vertebrae, for example, are made to measure by specialists requiring hospitalization of the patient for the duration of production of the device.

 The present invention aims to remedy these drawbacks by providing an immobilization and restraint device whose volume adapts to the volume of the member to be immobilized, and which satisfies a sufficiently simple design to be capable of standardization, thus limiting current requirements for a specific device, limiting the intervention times of practitioners as well as the length of hospital stay for patients.

 To this end, in the device which it relates, surrounding the limb to be immobilized and of the type comprising an internal envelope in contact with the patient's skin and a rigid external envelope surrounding the internal envelope, the internal envelope is flexible and associated. to means making it possible to vary its volume throughout the duration of use, in order to adapt it to the volume of the member to be immobilized.

 The outer envelope being rigid, forms a bearing surface for the inner envelope which, by increase in volume comes to bear against the body part to be immobilized. Depending on the volume variations of the body part, it is possible to vary the volume of the inner envelope to ensure constant pressure on the integuments, sufficient to effectively contain the underlying bony framework, without compressing the systems venous, arterial, linphatic, superficial and deep.

 The outer envelope requires only the production of a rigid wall, and can be obtained with conventional means such as Paris plaster, thermoplastic materials or materials which can be polymerized under certain wavelengths.

 According to one embodiment of this device, the inner envelope is constituted by two parallel sheets of fabric whose edges are closed so as to delimit a reservoir which, intended to be filled with a viscous liquid giving it a certain thickness, is fitted with a valve. Once filled, the envelope is applied against the body part to be immobilized. The valve, advantageously arranged in the upper part, allows the filling as well as the emptying of the envelope.

 It is advantageous to equip this valve with a three-way valve putting it in communication, on the one hand, with a filling and emptying orifice and, on the other hand, with an expansion balloon serving as a shock absorber pressure when the switchgear is in operating conditions.

This balloon makes it possible to compensate for small variations in volume of the limb to be immobilized, the large variations being compensated for by introduction or withdrawal of liquid as the case may be.

 In the case of certain specific restraints, requiring the creation of extra thickness at specific points such as nervous pathway, arterial or bony protuberance, it is possible to locally superimpose two inner envelopes, the second inner envelope not necessarily being connected to a balloon expansion.

 According to a characteristic of the invention, the two layers of fabric constituting the inner envelope are made of a non-allergenic material on the skin, capable of being bonded using a hot-melt adhesive, or of undergoing thermal assembly of the made of a pre-coating of hot-melt adhesive, or because of its nature if it is a synthetic textile. This fabric is preferably cellulose-based, which allows it in the current state of research, to be treated as a bio-textile.

 Advantageously, the two layers of fabric constituting the inner envelope are assembled by points by gluing or welding. These connection points are of a sufficiently large area to allow the management of a central perforation.

 These connection points first of all make it possible to avoid the sliding of the two plies with respect to one another, to limit the spacing of the two plies during filling with fluid, to ensure good retention of the fluid by creating labyrinths preventing rapid transfer of fluid from one end to the other of the envelope, and creating a network of channels between the various connection points ensuring ventilation of the surface of the immobilized member, favored by the existing perforations at the connection points, allowing rapid drying of the immobilized member after a bath or a shower for example.

 Advantageously, to ensure good retention of the fluid inside the envelope, the connection points are staggered. It should be noted that it is possible to carry out local complementary assemblies between the two layers of fabric, in order to locally limit the expansion of the envelope during the introduction of fluid into it.

 The fluid introduced into the inner envelope is a high viscosity fluid between 30 and 15,000 centipoise, non-polymerizable, thermostable between -30 and + 800C, transparent to X-rays, and biocompatible in order to avoid any damage to the skin of the patient in case of accidental leakage of the envelope.

 The role of this fluid is to separate the two layers of the envelope, in order to fill the space between the tegu ment and the outer envelope. The deformations on one side will depress the thickness of the envelope ~ the fluid being incompressible, there will be a transfer thereof where it can be accommodated, and an expansion on the opposite side to the maximum point of inflation authorized by the spacing of the bonding points, which results in automatic centering of the part to be immobilized, allowing the realization of a device which can be considered as a "floating plaster.

 From a practical point of view, depending on the size of the body part to be immobilized, the practitioner chooses a sheet of tissue surface of sufficient size, then envelops the member using this envelope. After making a trace on the fabric, it cuts at least one of the two edges of the envelope, so that the edges of the latter are roughly contiguous, or even can slightly overlap.

The two longitudinal edges of the envelope are then closed by gluing or welding, then the two longitudinal edges are assembled by welding, gluing, or even using an adhesive tape, in order to form a sleeve.

 Prior to this operation, after opening an opening, the upper part of the casing of a valve was fixed by welding or gluing.

After injection into the interior envelope, of a small quantity of fluid, realizing a light uniform mattress, it is proceeded to the confection of the rigid exterior envelope by taking the same precautions as for a traditional plaster, and taking care of let the valve emerge out of this plaster
When the outer envelope is taken, an additional filling of the inner envelope is carried out with fluid, until the patient feels a uniform pressure over the entire limb. The filling cartridge is then disconnected and the volume of the inner envelope is placed in communication with the expansion balloon.

Anyway, the invention will be clearly understood with the aid of the description which follows, with reference to the appended schematic drawing representing, by way of nonlimiting example, an embodiment of this device as well as several applications including that -this is likely
Figure 1 is a flat view of an inner envelope constituting this device
Figure 2 is a perspective view of the envelope of Figure 1 being placed on the limb of a patient
Figure 3 is a perspective view of the envelope of Figures 1 and 2 after installation
Figure 4 is a partial top view and on an enlarged scale of the inner casing under conditions of use
Figure 5 is a cross-sectional view along line 5-5 of Figure 4, of this inner envelope
Figure 6 is a cross-sectional view of a member equipped with an immobilization device according to the invention
Figure 7 is a partial view, in cross section and on an enlarged scale of the immobilization device and its associated members
Figures 8 to 11 show four applications of the immobilization device according to the invention.

 The immobilization device according to the invention comprises an inner envelope (2) surrounding the member to be immobilized and a rigid outer envelope (3) surrounding the inner envelope.

 The inner envelope (2) is, as shown in FIG. 1, in the form of two sheets of fabric (4) and (5) of the same surface, joined to one another on two of their edges ( 6) as well as according to a certain number of points (7) arranged in staggered rows and distributed regularly over the entire surface of the envelope. These edge and point connections can be made by gluing or welding depending on the material of the fabric or according to the treatment that this fabric has undergone.

 The connection points (7) have a sufficient surface for a perforation (8) to be formed in the central part of each of them.

 From a practical point of view, the operator chooses a sufficient surface envelope to allow surrounding the member to be immobilized. One of the two open edges of the envelope is cut out, after identification, so that the two open edges (9) of the envelope are substantially contiguous. The two edges (9) are then closed by gluing using hot-melt glue or by heat-bonding if the fabrics are pre-coated with hot-melt glue, or by hot assembly by heat-sealing in the case of certain synthetic materials.

 After an opening has been made in the upper part of the envelope, a valve (10) with a flange, of known type, is fixed by welding or gluing, as shown in FIG. 2.

 After carrying out these various operations, the envelope (2) is placed around the member to be immobilized and then closed thereon by gluing or welding the two edges (9) or using adhesive tapes, as shown in Figure 3.

 A light filling of the envelope (2) is then carried out using a high viscosity fluid defined above, before traditional positioning and modeling of the rigid envelope (3). After taking it, it is completed with the additional filling of the inner envelope, so that it is supported, on the one hand, on the outer envelope and, on the other hand, on the member whose immobilization is to be carried out.

 It should be noted that the points of attachment of the two plies (4) and (5) of the inner envelope limit the spacing of these and provide the channels (12) allowing aeration of the surface of the immobilized member. .

 It should be noted that, if it is desired to limit the spacing between. two plies (4) and (5), it is possible to produce complementary bonding zones (13) between two securing points (7), which results in the configuration shown in FIGS. 4 and 5.

 If, on the contrary, it is desirable to create extra thicknesses at certain points, it is possible, as shown in FIG. 6, to locally interpose a secondary envelope (14) between the external envelope (3) and the internal envelope main (2).

 FIG. 6 shows that the limb to be immobilized, whose bone bears the reference (15) and the muscles the reference (16), is automatically centered inside the apparatus, when the envelope is filled ( 2) in fluid.

 FIG. 7 shows a detail of the device for filling and emptying the inner envelope (2). On the valve (10) is mounted a three-way valve (17) capable of communicating the valve and, consequently, the casing (2), on the one hand with a cartridge (18) for filling with fluid or withdrawal thereof and, on the other hand, with a balloon (19) capable of compensating for small variations in pressure inside the envelope (2).

 This balloon (19) can either have a structure of the type of that of expansion vessels with a chamber in communication with the interior of the envelope, separated by an elastic membrane from a chamber filled with air, or more simply be constituted by a pocket made of a deformable material opposing an elastic resistance to filling with the fluid coming from the envelope.

 From a practical point of view, the liquid is filled or drawn off during large variations in the volume of the immobilized member, while under normal conditions, the inner envelope is in communication with the balloon, which provides compensation pressure variations.

 Such a device is capable of numerous applications, some of which are shown in FIGS. 8 to 11.

 Figure 8 shows a device (20) for simple immobilization of a leg.

 FIG. 9 represents a system (22) for articulated immobilization of a leg in which the apparatus comprises three devices (23, 24 and 25) connected to each other by articulated connections (26) and (27).

 FIG. 10 represents a neck brace (28) obtained in accordance with the device according to the invention. This neck brace does not require the production of a device made to measure by a specialist, comprising two parts, respectively, upper (29) and lower (30 ) standard and adaptable to the patient's morphology by modifying the volume of the inner envelope, the two parts (29) and (30) being connected by screw jacks (32) allowing perfect adaptation to the immobilization to be carried out.

 FIG. 11 represents a thoraco-pelvic device (33) usable in the case of fractures of the spine or of kyphoscoliosis corrections comprising two respectively upper (34) and lower (35) parts which are standard and adaptable to the morphology of the patients thanks to the inner casing (2) and connected to each other by screw jacks (36).

 Many other applications are conceivable requiring total immobilization or with freedom of the joints.

 Thus, in particular, the rigid outer envelope may be constituted by a prosthesis intended to be engaged on a stump of leg or arm, or on a complete limb, which is atrophied and which requires an appliance.

The inner envelope ensures immediate adaptation of the prosthesis to the patient, with good comfort for the latter, without having to resort to custom molded elements, intended to be interposed between the limb, or the stump, and the prosthesis.

As is apparent from the above, the invention brings a great improvement to the existing technique by providing the following advantages
- solution of the problem of adapting a body part of variable volume to a rigid apparatus
- permanent compensation for variations in the volume of the body part avoiding the multiplication of the number of devices for the same treatment
- possibility of greater use of articulated devices deemed hitherto very uncomfortable because of friction between the member and the device, and insufficient in their containment; such use eliminates or reduces rehabilitation times
- possibility of more frequent use for trophic or vasomotor disorders, without risk of restriction, or hindrance of mobility
- treatment better accepted by patients due to improved comfort, the possibility for him to compensate for variations in the volume of the immobilized limb without requiring the intervention of a specialist
- standardization of the immobilization system lowering the cost of the apparatus, including taking into account the possibility of recovering the fluid from the inner envelope
- rapid production of a single device for a subject throughout the immobilization period
- almost total elimination of accidents due, with known devices, to the risks of compression, necking or bedsores; this reduction in risks allows the manufacture of equipment by less qualified people, which is particularly interesting in developing countries.

 It goes without saying that the invention is not limited to the sole embodiment of this device, nor to its only applications described above by way of example; on the contrary, it embraces all of the variant embodiments and applications.

Claims (8)

 1. Immobilization device containing a part of the human and animal body, and of a rigid external envelope, of the type comprising an internal envelope (2) in contact with the patient's skin and a rigid external envelope (3) surrounding the inner envelope, characterized in that the inner envelope (2) is flexible and associated with means making it possible to vary its volume throughout the duration of use, in order to adapt it to the volume of the member to be immobilized.  2. Device according to claim 1, characterized in that the inner envelope (2) is constituted by two parallel sheets of fabric (4,5) whose edges are closed so as to delimit a reservoir which, intended to be filled with 'a viscous liquid giving it a certain thickness, is equipped with a valve (10).  3. Device according to claim 2, characterized in that the valve (10) is equipped with a three-way tap (17) putting it in communication, on the one hand, with a filling and emptying orifice and, d 'on the other hand, with an expansion balloon (19) serving as a pressure damper when the apparatus is in conditions of use.  4. Device according to any one of claims 1 and 2, characterized in that the two layers (4,5) of fabric constituting the inner envelope (2) are made of a non-allergenic material on the skin, capable of '' be glued using a hot melt glue, or undergo a thermal assembly because of a pre-coating of hot melt glue, or because of its nature if it is a synthetic textile.  5. Device according to any one of claims 2 to 4, characterized in that the two sheets of fabric (4,5) constituting the inner envelope (2) are assembled by points by gluing or welding.  6. Device according to claim 5, characterized in that the connecting points 17) between the two layers of fabric (4,5) are staggered.  7. - Device according to any one of claims 5 and 6, characterized in that the connection points (7) between the two sheets of fabric (4, 5) each have a central perforation.  8. - Device according to any one of claims 2 to 7, characterized in that the fluid intended to fill the inner envelope (2) is non-polymerizable, has a viscosity between 30 and 15,000 centipoise, and is stable for temperatures between -30 and + 800C, transparent to X-rays.