The invention relates to the field of compressive orthoses for use in the immediate postoperative period after surgery of veins in the lower limbs.
Surgery of superficial veins comprises two main operations, both of which involve surgical removal of the diseased vein.
The first operation is known as “stripping” which comprises tearing out the vein axis of the inner or outer saphena on a wire. This operation is performed under an anesthetic which can be general, loco-regional, peridural, or under neuroleptanalgesia. It gives rise to significant damage to the collateral branches of the saphena which consequently bleed, giving rise to hematomas, which are painful and uncomfortable for patients in the hours and days following surgery.
The other technique in common use is outpatient phlebectomy, which is a surgical act that is less traumatizing than stripping (but which can also be performed in the context of stripping). This technique involves thorough exeresis of the superficial veins under outpatient conditions. The hematomas are smaller than with stripping, but the risk of immediate bleeding exists when the patient gets up, such risks being inherent to outpatient surgery.
In both cases, in order to reduce bleeding and attenuate the consequences thereof, immediately after surgery the surgeon applies compression very strongly to the operated limb so as to limit postoperative inflammation and bleeding.
In nearly all cases, such compression is applied at present using dry or adhesive bands.
That technique presents several drawbacks:
In practice, during the period immediately following surgery, it is found that patients generally suffer far more from bands that have been poorly put into place than they do from the operation itself.
Other methods of vascular surgery give rise to discomfort of the same kind, for example methods referred to as “conservative surgery” derived from conservative hemodynamic outpatient treatment for vein insufficiency (known in French under the initials CHIVA).
One of the objects of the invention is to propose an orthosis which, on being put into place immediately after an operation, serves to provide controlled and regular compression over the entire lower limb in a manner that does not depend on the skill of the person applying the orthosis, and that compresses sufficiently to limit postoperative inflammation and bleeding.
The bands that are currently in widespread use constitute the orthosis that is easiest to put into place, but as mentioned above, that is least suited to the purpose of applying compression.
It is possible, instead, to use some other existing type of orthosis, in particular medical elastic stockings. However such stockings apply pressure degressively, and in particular they apply little pressure to the thigh, whereas under postoperative conditions, it is specifically on the thigh where the pressure needs to be applied most strongly. Furthermore, such stockings are difficult to put on a patient who is unconscious because of general anesthesia and also because of the dressings that have been applied to the leg and that increase its volume.
The orthosis of the invention serves to mitigate all of those drawbacks.
Thus, the invention provides a tubular compressive orthosis for compressing a lower limb after vein surgery, in particular after outpatient phlebectomy or vein stripping, which orthosis comprises a compressive tubular portion of knitted or woven fabric, and of varying section matching the profile of the lower limb, and in which the structure of the knit or the weave is selected as a function of the peripheral dimensions of the lower limb so as to apply compression at a pressure which is substantially constant along the length of the limb.
According to various advantageous secondary characteristics:
The invention is described below in greater detail with reference to the accompanying drawings.
This orthosis is for covering the lower limb, as shown in
It must be capable of exerting constant compressive pressure on the lower limb from the ankle to the thigh (unlike traditional elastic stockings which produce pressure that decreases going away from the ankle), and this pressure should be about 30 mmHg to 40 mmHg (40.0 hectopascals (hPa) to 53.2 hPa), thus enabling a regular and constant hemostatic effect to be exerted all along the lower limb.
The tubular orthosis 10 comprises two substantially semicylindrical portions 12 and 14 which extend along the entire length of the orthosis and which are connected together along two generator lines 16, 18 situated at opposite ends of a diameter 20.
The semicylindrical portion 12 that is situated on the inside of the leg is constituted by a reinforced elastic stitch, e.g. of the same type as that used on the seat face of pantyhose.
The semicylindrical portion 14 situated on the outside of the leg is knitted using a stitch that stretches little, i.e. a stitch with short elongation, so as to apply greater compression on the outer face.
The term “elasticity” is used herein in the sense that is conventional for textiles, i.e. to denote the ability of a textile material that has been stretched to return to its initial shape and dimensions once the deforming forces have been removed; this elasticity is expressed in percentage elongation relative to one meter at rest.
Elongation is said to be “short” (for a stitch that stretches little, such as that used in the portion 14) when maximum elongation is less than 70% (see in particular C. Gardon-Mollard and A.-A. Ramelet in “La Contention Médicale” [Medical compression], published by Masson, Paris, 1999, pp. 51-54) and elongation is said to be “medium” (an “elastic” stitch such as that used in the portion 12) when the maximum elongation lies in the range 70% to 140%.
Advantageously, the orthosis is manufactured in several sizes, typically three or four sizes of different diameters but having a single length, with the orthosis being fitted to the length of the patient's leg by cutting off excess length at each end. The orthosis should then be knitted, at least at both ends, with a stitch of the run-resistant type so as to avoid unraveling after it has been cut to length.
The stitch can be of the same type as is used in a conventional elastic stocking, e.g. the Varisma (registered trademark) stocking produced by Innothéra Topic. It can be of the wefted, plain, pinched or floated micromesh, etc. type, all of which stitches are known per se to specialists in knitting techniques.
The yarn used for knitting the orthosis can be an elastane covered in cotton and polyamide, an elastane covered in polyamide without any cotton, or indeed a mixture of elastane and elastodiene (synthetic rubber latex). Nevertheless, the material advantageously includes a large fraction of cotton so as to be more effective in absorbing serosites and bleeding; it can also be selected so as to be washable and optionally reusable.
The orthosis of the invention is advantageously put into place using an accessory of the kind described in WO-A-99/44558 (Innothéra Topic International) which makes putting on and adjusting the orthosis simple, quick, and accurate, even in the presence of thick dressings and on a limb that is still anesthetized.
Naturally, a variety of variants can be envisaged.
In a first variant shown in
Another variant consists not in knitting the orthosis but in making it up from two kinds of woven fabric presenting the same deformation characteristics as those described above, i.e. both a fabric having small elongation for the outer face 14 and an elastic fabric for the inner face 12. To avoid the drawbacks associated with lines of stitching, the two semicylindrical portions can be connected together using textile heat-sealing or high frequency methods, which are known per se.
An improvement shown in FIGS. 5 to 7 consists in providing the top portion of the orthosis in the form of a thigh sleeve that is not elastic but that is adjustable, e.g. made of woven fabric.
To make it easy to put on, this sleeve is open along a generator line as shown in
Number | Date | Country | Kind |
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00/11240 | Sep 2000 | FR | national |
Number | Date | Country | |
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Parent | 10111553 | Sep 2002 | US |
Child | 11124378 | May 2005 | US |