COMPRESSION PRODUCT FOR THE TREATMENT OF OSAHS
20210290445 · 2021-09-23
Inventors
- Nicolas Patrikeeff (Saint Vallier, FR)
- Dominico Demontis (Frouard, FR)
- François CROS (Ivry Sur Seine, FR)
- Amina OUCHENE (Creteil, FR)
Cpc classification
International classification
Abstract
An elastic compression product for a wearer's lower limbs, intended for the treatment of obstructive sleep apnoea-hypopnea syndrome, the product having a pressure profile defining textile pressures P.sub.B, P.sub.B1, P.sub.C, P.sub.D, P.sub.E, P.sub.F, P.sub.G, P.sub.H, P.sub.I, P.sub.D′, P.sub.E′, P.sub.F′ and P.sub.G′ at altitudes B, B1, C, D, E, F, G, H, I defined in section 4.1.2 of standard NF_S_97_114, and at altitudes D′, E′, F′ and G′ located respectively at 92% of altitude D, at 110% of altitude E, at 126% of altitude E and at 92% of altitude G, respectively, the pressures being measured as the compression pressures of compression stockings according to French standard NF G 30-102 part B, the pressure profile being such that 30 mmHg>P.sub.C>10 mmHg, 30 mmHg>P.sub.F>10 mmHg and P.sub.C>(P.sub.B+10 mmHg).
Claims
1. An elastic compression product for a wearer's lower limbs, intended for the treatment of obstructive sleep apnoea/hypopnea syndrome, said product having a pressure profile defining textile pressures P.sub.B, P.sub.B1, P.sub.C, P.sub.D, P.sub.E, P.sub.F, P.sub.G, P.sub.H, P.sub.I, P.sub.D′, P.sub.E′, P.sub.F′ and P.sub.G′ at altitudes B, B1, C, D, E, F, G, H, I, defined in section 4.1.2 of standard NF_S_97_114, and at altitudes D′, E′, F′ and G′ located respectively at 92% of altitude D, at 110% of altitude E, at 126% of altitude E and at 92% of altitude G, respectively, the pressures being measured as the compression pressures of compression stockings according to French standard NF G 30-102 part B, the pressure profile being such that 35 mmHg>P.sub.C>10 mmHg, 30 mmHg>P.sub.F>0 mmHg and P.sub.C>(P.sub.B+10 mmHg).
2. An elastic compression product for a wearer's lower limbs for use in the treatment of obstructive sleep apnoea/hypopnea syndrome, said product having a pressure profile defining textile pressures P.sub.B, P.sub.B1, P.sub.C, P.sub.D, P.sub.E, P.sub.F, P.sub.G, P.sub.H, P.sub.I, P.sub.D′, P.sub.E′, P.sub.F′ and P.sub.G′ at altitudes B, B1, C, D, E, F, G, H, I defined in section 4.1.2 of standard NF_S_97_114, and at altitudes D′, E′, F′ and G′ located respectively at 92% of altitude D, at 110% of altitude E, at 126% of altitude E and at 92% of altitude G, respectively, the pressures being measured as the compression pressures of compression stockings according to French standard NF G 30-102 part B, the pressure profile being such that 35 mmHg>P.sub.C>10 mmHg, 30 mmHg>P.sub.F>10 mmHg, and P.sub.C>(P.sub.B+10 mmHg).
3. The product according to claim 1, the pressure profile having a local minimum pressure at altitude B, and/or a local maximum pressure between altitudes B1 and D′, and/or a local maximum pressure between altitudes F′ and G′, and/or a local minimum pressure between altitudes D and E′, and/or a local minimum pressure between altitudes H and I.
4. The product according to claim 1, wherein P.sub.C>(P.sub.F+8 mmHg).
5. The product according to claim 1, wherein 3 mmHg<P.sub.B<15 mmHg, and P.sub.E<13 mmHg, and P.sub.H<10 mmHg.
6. The product according to claim 1, wherein P.sub.C>20 mmHg, and 30 mmHg>P.sub.F>10 mmHg.
7. The product according to claim 1, wherein P.sub.B>2 mmHg, and/or 15 mmHg>P.sub.D>5 mmHg, and/or 13 mmHg>P.sub.F>5 mmHg, and/or 15 mmHg>P.sub.E′>5 mmHg, and/or 10 mmHg>P.sub.I>2 mmHg.
8. The product according to claim 1, wherein P.sub.B1>15 mmHg, and/or P.sub.D′>15 mmHg, and/or 25 mmHg>P.sub.F′>10 mmHg, and/or 25 mmHg>P.sub.G′>10 mmHg.
9. The product according to claim 8, wherein 28 mmHg>P.sub.B1>20 mmHg, and/or 28 mmHg>P.sub.D′>20 mmHg, and/or 23 mmHg>P.sub.F′>13 mmHg, and/or 23 mmHg>P.sub.G′>13 mmHg.
10. The product according to claim 1, not extending beyond altitude I.
11. The product according to claim 1, in the form of a kit including a pair of socks and a pair of shorts.
12. The product according to claim 11, wherein 15 mmHg>P.sub.B>3 mmHg, and/or 35 mmHg>P.sub.B1>20 mmHg, and/or 35 mmHg>P.sub.C>20 mmHg, and/or 15 mmHg>P.sub.D>5 mmHg, and/or 23 mmHg>P.sub.F>15 mmHg, and/or 20 mmHg>P.sub.G>10 mmHg, and/or 10 mmHg>P.sub.H>2 mmHg, and/or 10 mmHg>P.sub.I>2 mmHg.
13. The product according to claim 12, wherein 35 mmHg>P.sub.D′>25 mmHg, and/or 15 mmHg>P.sub.E′>5 mmHg, and/or 23 mmHg>P.sub.F′>15 mmHg, and/or 23 mmHg>P.sub.G′>15 mmHg.
14. The product according to claim 1 wherein 33 mmHg>P.sub.C>25 mmHg.
15. The product according to claim 1, wherein 30 mmHg>P.sub.B1, and/or 30 mmHg>P.sub.D′.
16. The product according to claim 1, wherein 10 mmHg>P.sub.B.
17. A process for treating obstructive sleep apnoea/hypopnea syndrome wherein a product according to claim 1 is worn for more than 5 hours.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0160] Other features and advantages of the invention will also appear upon reading the detailed description which follows, and upon examining the appended drawing wherein:
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[0167]
DEFINITIONS
[0168] “Altitude” corresponds to a level in the vertical direction z when the compression product is worn by a wearer standing upright, as represented in
TABLE-US-00001 TABLE 1 B B1 C D′ D E′ F′ F G′ G H I Δ 29 71 92 59 54 66 63 63 69 73 78 82
TABLE-US-00002 TABLE 2 B B1 C D′ D E E′ F′ F G′ G H I Δ 29 71 92 59 54 60 66 63 63 69 73 78 82 [0190] The standard uses a “Hohenstein-type” leg model made of cone trunks, which is a standard in the field of support stockings. [0191] When a product does not extend to an altitude, it is considered to exert zero textile pressure at that altitude. For example, a product according to the invention does not necessarily extend to altitude I. [0192] The mmHg is commonly used as a textile pressure measuring unit in the field of medical compression. It can be easily converted to hPa: [0193] 2 mmHg: roughly 2.66 hPa; [0194] 4 mmHg: roughly 5.33 hPa; [0195] 5 mmHg: roughly 6.66 hPa; [0196] 8 mmHg: roughly 10.66 hPa; [0197] 10 mmHg: roughly 13.3 hPa; [0198] 12 mmHg: 16 hPa; [0199] 15 mmHg: 20 hPa; [0200] 20 mmHg: roughly 26.66 hPa; [0201] 23 mmHg: roughly 30.66 hPa; [0202] 25 mmHg: roughly 33.33 hPa; [0203] 28 mmHg: roughly 37.33 hPa; [0204] 30 mmHg: or 40 hPa.
[0205] Unless otherwise specified, a “pressure” is a textile pressure.
DETAILED DESCRIPTION
[0206] The textile pressure profile of the compression product is decisive for its efficacy in treating OSAHS. The study of the pressure profile alone is however insufficient and wear tests are essential to verify that the compression product is comfortable. Failure to do so will result in poor compliance and reduced efficacy.
[0207] Numerous pressure profiles were thus tested and led to the selection of the products according to the invention.
[0208] The preferred pressure profile features of these products are listed below: [0209] the pressure profile has a local maximum pressure, preferably an absolute maximum pressure, between altitudes B1 and D′, preferably at altitude C; [0210] the pressure profile has a local maximum pressure between altitudes F′ and G′, preferably at altitude F; [0211] the pressure profile has a minimum pressure (absolute minimum) between altitudes D and E′, preferably at altitude E; [0212] the pressure profile has a local minimum pressure between altitudes D and E′, preferably at altitude E and/or at altitude E′; [0213] the pressure profile has a local minimum pressure between altitudes H and 1; [0214] the pressure profile has a local minimum pressure between altitudes B and B1, preferably at altitude B; [0215] the pressure profile increases from altitude B to altitude B3; [0216] the pressure profile increases from altitude E′ to altitude F′; [0217] the pressure profile decreases from altitude D′ to altitude D; [0218] the pressure profile decreases from altitude G′ to altitude G; [0219] the pressure profile has a plateau from altitude B1 to altitude D′; [0220] the pressure profile has a plateau from altitude F′ to altitude G′; [0221] the pressure profile has a plateau from altitude H to altitude I; [0222] the pressure profile has two pressure peaks, at the calf and at the thigh; [0223] P.sub.B<15 mmHg, preferably P.sub.B<12 mmHg, preferably P.sub.B<10 mmHg, preferably P.sub.B<8 mmHg, and/or P.sub.B>2 mmHg, preferably P.sub.B>4 mmHg; [0224] P.sub.B1<30 mmHg, preferably P.sub.B1<28 mmHg and/or P.sub.B1>15 mmHg, preferably P.sub.B1>20 mmHg; [0225] P.sub.C<30 mmHg, preferably P.sub.C<28 mmHg and/or P.sub.C>15 mmHg, preferably P.sub.C>20 mmHg; [0226] P.sub.D′<30 mmHg, preferably P.sub.D′<28 mmHg and/or P.sub.D′>15 mmHg, preferably P.sub.D′>20 mmHg; [0227] P.sub.D<15 mmHg, preferably P.sub.D<12 mmHg, and/or preferably P.sub.D>5 mmHg, preferably P.sub.D>8 mmHg; [0228] P.sub.E>1 mmHg and/or P.sub.E<25 mmHg, preferably P.sub.E<20 mmHg, preferably P.sub.E<15 mmHg, preferably P.sub.E<10 mmHg, preferably P.sub.E<5 mmHg; [0229] preferably, P.sub.E=0; [0230] in particular for the kit of a product according to the invention including a sock and a pair of shorts, preferably P.sub.E′>1 mmHg, preferably P.sub.E′>5 mmHg and/or P.sub.E′<25 mmHg, preferably P.sub.E′<20 mmHg, preferably P.sub.E′<15 mmHg; [0231] P.sub.F′<30 mmHg, preferably P.sub.F′<25 mmHg, preferably P.sub.F′<20 mmHg, and/or P.sub.F′>10 mmHg, preferably P.sub.F′>13 mmHg, or even P.sub.F′>15 mmHg; [0232] P.sub.F<30 mmHg, preferably P.sub.F<25 mmHg, preferably P.sub.F<20 mmHg, and/or P.sub.F>10 mmHg, preferably P.sub.F>13 mmHg, or even P.sub.F>15 mmHg; [0233] P.sub.G′<30 mmHg, preferably P.sub.G′<25 mmHg, preferably P.sub.G′<20 mmHg, and/or P.sub.G′>10 mmHg, preferably P.sub.G′>13 mmHg, or even P.sub.G′>15 mmHg; [0234] P.sub.G<25 mmHg, preferably P.sub.G<20 mmHg, preferably P.sub.G<15 mmHg, and/or P.sub.G>5 mmHg, preferably P.sub.G>8 mmHg, preferably P.sub.G>10 mmHg; [0235] P.sub.H<10 mmHg, preferably P.sub.H<8 mmHg, and/or P.sub.H>2 mmHg, preferably P.sub.H>4 mmHg; [0236] P.sub.I<10 mmHg, preferably P.sub.I<8 mmHg, and/or P.sub.I>2 mmHg, preferably P.sub.I>4 mmHg; [0237] P.sub.C>P.sub.F, preferably P.sub.C>(P.sub.F+5 mmHg), preferably P.sub.C≥(P.sub.F+8 mmHg); [0238] P.sub.E<P.sub.C, preferably P.sub.E<P.sub.C−5 mmHg, preferably P.sub.E<P.sub.C−10 mmHg, or even P.sub.E<P.sub.C−15 mmHg, or even P.sub.E<P.sub.C−20 mmHg, or even P.sub.E<P.sub.C−25 mmHg, provided that P.sub.E≥0 mmHg; [0239] |P.sub.D−P.sub.E|<5 mmHg, preferably |P.sub.D−P.sub.E|<2 mmHg; [0240] |P.sub.C−P.sub.B1|<5 mmHg, preferably |P.sub.C−P.sub.B1|<2 mmHg; [0241] P.sub.E<P.sub.F, preferably P.sub.E<P.sub.F−5 mmHg, preferably P.sub.E<P.sub.F−10 mmHg, or even P.sub.E<P.sub.F−15 mmHg, or even P.sub.E<P.sub.F−20 mmHg, or even P.sub.E<P.sub.F−25 mmHg, provided that P.sub.E≥0 mmHg; [0242] P.sub.B<15 mmHg and (15 mmHg<P.sub.C<30 mmHg) and P.sub.E<15 mmHg and (10 mmHg<P.sub.F<25 mmHg) and P.sub.H<10 mmHg; [0243] P.sub.B<10 mmHg and (20 mmHg<P.sub.C<30 mmHg) and P.sub.E<10 mmHg and (12 mmHg<P.sub.F<23 mmHg) and P.sub.H<7 mmHg; [0244] P.sub.B<7 mmHg and (23 mmHg<P.sub.C<27 mmHg) and P.sub.E<5 mmHg and (12 mmHg<P.sub.F<23 mmHg) and P.sub.H<7 mmHg.
[0245] In general, the pressure profile of these products is irregular, with low pressure in the ankle, knee and pelvis, and moderate pressure in the calf and thigh.
[0246] In an embodiment, the product is open-footed, i.e., it does not cover the wearer's feet.
[0247] Preferably, the product is closed-footed.
[0248] A low pressure at the ankle makes it easier to put the product on, without affecting the product's efficacy. Preferably, 2 mmHg<P.sub.B<15 mmHg.
[0249] A low pressure P.sub.H at the pelvis, preferentially comprised between 2 mmHg and 8 mmHg, improves the comfort of wearing the product, without affecting its efficacy.
[0250] In an embodiment, the product is a legging.
[0251] In an embodiment, which is not preferred, in particular when the product is a legging, P.sub.E′>P.sub.F. Particularly for a legging, P.sub.E′ and/or P.sub.E and/or P.sub.D can be greater than 10 mmHg, greater than 15 mmHg, and preferably less than 25 mmHg.
[0252] For a legging, preferably P.sub.E can be greater than 5 mmHg or even greater than 8 mmHg.
[0253] However, unexpectedly, the inventors discovered in particular that a low pressure at the knee does not significantly impair efficiency, while providing remarkable comfort. In particular, wear tests have shown, surprisingly, that no oedema forms at the knee.
[0254] In a preferred embodiment, the product is a kit composed of a pair of socks and a pair of shorts. The pressure at the knee P.sub.E is advantageously zero, which ensures maximum comfort.
[0255] Preferably, the socks extend at least from altitude B to altitude D and/or the shorts extend at least from altitude E′, to altitude G, preferably to altitude H, preferably to altitude I.
[0256] The pressure profile for a sock is preferably such that the pressure decreases from altitude D′ to altitude D and such that P.sub.D>8 mmHg and P.sub.D′>23 mmHg.
[0257] The pressure profile for the shorts is preferably such that the pressure is maximum between the altitudes F′ and G′ and preferably such that P.sub.G<P.sub.G′.
[0258] According to a preferred embodiment, the compression product includes: [0259] a sock extending from altitude B to altitude D, said sock having a pressure profile increasing from altitude B to altitude B1 and decreasing from altitude D′ to altitude D, the pressure profile of the sock having a maximum between altitudes B1 and D′, preferably a plateau between altitudes B1 and D′, the pressure P.sub.B preferably being such that P.sub.B≤10 mmHg, or even P.sub.B≤5 mmHg, the pressure P.sub.C preferably being between 20 mmHg and 35 mmHg, the pressure P.sub.D preferably being such that P.sub.D<15 mmHg, or even P.sub.D≤10 mmHg, preferably (P.sub.D+5 mmHg)<P.sub.C, and [0260] a pair of shorts extending from altitude E′ to altitude I, said shorts having a pressure profile increasing from altitude E′ to altitude F′ and decreasing from altitude G′ to altitude H, the pressure profile of the shorts having a maximum between altitudes F and G′, preferably a plateau between altitudes F′ and G′, and a minimum between altitudes H and I, preferably a plateau between altitudes H and 1, the pressure P.sub.E′ being preferentially such that P.sub.E′<15 mmHg, or even P.sub.E′≤10 mmHg, the pressure P.sub.F being preferably comprised between 10 mmHg and 25 mmHg, again preferably between 10 mmHg and 20 mmHg, the pressure P.sub.H being such that P.sub.H<10 mmHg, or even P.sub.H≤5 mmHg. (P.sub.E′+5 mmHg)<P.sub.F, preferably (P.sub.E′+10 mmHg)≤P.sub.F.
[0261] The manufacture of a product according to the invention does not pose any particular difficulty. In particular, the techniques usually used for the manufacture of elastic venous compression orthoses can be used.
[0262] The structure of a product according to the invention preferably comprises a network of stitches made by means of a knitting yarn, a weft yarn being interlaced between said stitches. The dimensioning and nature of the knitting and weft yarns as well as the stitch structure are chosen in such a way as to exert in the circumferential direction, after the product has been placed on the lower limb, an elastic restoring force capable of producing the desired textile pressure.
[0263] The different parts of the product according to the invention are preferably knitted continuously on a circular loom, with a single knitting yarn along the entire length of the product and with different weft yarns according to the zones considered and/or by varying the tightness of the knitted stitch.
[0264] The product can alternatively be made on a straight loom or a “cut-and-sew” loom.
[0265] In a preferred embodiment, all parts of the product are compressive.
[0266] Preferably, the went yarn is elastic, preferably is a double-covered elastane yarn.
[0267] In the case where the product is a legging, preferably: [0268] the panty is made with two alternating knitting yarns C1 and C2, preferably C1 being in Lycra 44DT DG 1/44/34 and C2 being in Lycra 44DT DG 1/44/12, [0269] the panty-thigh transition zone is made from a 1×3 weft and an alternating 1×3 bare Lycra, the bare Lycra advantageously producing a gripping zone and thus ensuring that the legging doesn't fall; the knitting being done preferentially on a covered 1×3 weft and on the bare Lycra with a knitted needle and three floating needles; the alternation between covered weft and bare Lycra advantageously modulates the gripping; the greater the bare Lycra surface in contact with the skin, the greater the gripping effect; the alternation as well as the number of knitted/floated needles being possible with many configurations. [0270] the thigh/knee transition zone is made from a 1×3 weft and an alternating 1×3 bare Lycra, [0271] the knee is made from a 2-weft comfort zone, the comfort zone being a zone where the stitch height is increased to provide great extensibility. In this case, the comfort zone has been extended to the back of the knee. [0272] the knee/calf, calf and calf/ankle transition zones are made from two wefts, [0273] the ankle is made from one weft, [0274] the belt is made with a “boxer”-type elastic: but other alternatives are also possible, the reinforcement of the belt seam being preferentially made with a Text 1/44/34 thread. [0275] the leg is made of two alternating weft threads J1 and J2, preferably J1 being in Lycra 570DT DG 1/22/7 and J2 being in Lycra 570DT Nu, [0276] the knitting of the leg is in Lycra 17DT SG 1/85/92, and [0277] the heel is made of Lycra 44DT DG 1/44/34 (800).
[0278] In the case where the product is a thigh/sock kit, preferably: [0279] the panty is made of two alternating knitting yarns C1 and C2, preferably C1 being in Lycra 44DT DG 1/44/34 and C2 being in Lycra 44DT DG 1/44/12, [0280] the panty/thigh transition zone is made from a 1×1 weft and a 1×3 bare Lycra, the bare Lycra advantageously producing a gripping zone and thus ensuring that the product doesn't fall at the level of the thigh; the knitting being done preferentially on a covered 1×1 wet and on 1×3 bare Lycra so as to ensure a maximum gripping effect, with a knitted needle and three floating needles; the greater the bare Lycra surface in contact with the skin, the greater the gripping effect; the alternation and the number of knitted/floated needles being possible with many configurations, [0281] the thigh/knee transition zone is made from a 1×1 weft and a 1×3 bare Lycra, [0282] the BC (side edge)/calf transition zones, the calf and the calf/ankle transition zone are made from two wefts, [0283] the ankle and the foot are made from one weft, [0284] the ends are made with “boxer”-type elastics; but other alternatives are also possible, the reinforcement of the belt seam being preferentially made with Text 1/44/34 yarn, [0285] the leg for the shorts is made of two alternating weft yarns J1 and J2, preferably J1 being in Lycra 475DT DG 1/22/7 and J2 being in Lycra 475DT Nu, [0286] the leg knit for the shorts is in Lycra 17DT SG 1/85/92, [0287] the weft of the sock is made of Lycra 570DT DG 1/22/7, [0288] the leg knit for the sock is in Lycra 17DT SG 1/85/92, [0289] the heel is made of Lycra 44DT DG 1/78/23 Tex, and [0290] the reinforcement of the seam of the side edge is in Tex 1/44/34. [0291] Alternatively, other polyamide (PA) and/or polyester (P.sub.E) yarns can be used for the manufacture of the shorts or the sock. [0292] Each end of the shorts/thigh kit can be made according to different modes of construction to achieve the desired pressure, comfort and support objective. For example, wide “boxer”-type elastics, weft yarns of different cross-sections, and/or constructions combining more or fewer weft yarns per row on the outside or inside of the ends can be used.
Examples
[0293] The graphs in
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[0298] To form a kit according to the invention, the sock having the profile illustrated in
[0299] Of course, the invention is not limited to the embodiments described and represented, provided for illustrative purposes only.