SURGICAL SWAB COMPOSED OF NON-WOVEN FABRIC AND TEXTILE POLYMER NET

Abstract

The present application describes a surgical swab composed of two or more outer layers made of non-woven fabric and an inner layer of a textile polymer net, with or without x-ray detectable thread, which can be obtained, for example, by a process of knitting or weaving. The textile net can present in its composition materials with high elasticity such as elastane or alternatively combinations of materials that allow shrinking after heat treatment such as the polyamide or polyamide and polyester or even polyamide and cotton. In the present application, it is also described the production process of this surgical swab which, after the junction and overlapping of the non-woven fabric layers and the inner layer of textile polymer net, comprises ultrasound welding of the layers. The surgical swabs of this application present improved performance features and the production process involved is simple, economical and automated.

Claims

1. A surgical swab that comprises: a) Two or more outer layers of non-woven fabric; and b) an inner layer of textile polymer net comprising a polymer selected from: i. elastane; ii. polyamide; iii. polyamide and polyester; and iv. polyamide and cotton.

2. The surgical swab, according to claim 1, wherein the textile polymer net comprises elastane.

3. The surgical swab, according to claim 1, wherein the textile polymer net comprises polyamide or polyamide and polyester or polyamide and cotton.

4. A production process of the surgical swab described in claim 1, comprising: junctioning and overlapping two layers of non-woven fabric and an inner layer of textile polymer net comprising a polymer selected from: i. elastane; ii. polyamide; iii. polyamide and polyester; and iv. polyamide and cotton; ultrasound welding the layers forming a laminate; and cutting the laminate.

5. The production process, according to claim 4, wherein the textile polymer net comprises elastane.

6. The production process, according to claim 4, wherein the textile polymer net comprises polyamide, or polyamide and polyester or even polyamide and cotton.

7. The production process according to claim 4, wherein the textile polymer net is obtained through weaving or knitting.

8. The production process according to claim 5, wherein the junctioning, overlapping and welding is carried out under tension.

9. The production process according to claim 6, further comprising a heat treatment, after cutting, which generates a shrink-wrapping of the surgical swab, between 40 and 80° C.

10. The production process according to claim 4, wherein the overlapping of the layers is carried out by pressure rollers.

11. The production process according to claim 4, wherein the cutting is carried out through a blade system.

12. The production process according to claim 4, further comprising applying a security strip.

13. The production process according to claim 4, further comprising a folding step of the surgical swab.

14. The production process according to claim 4, further comprising applying a thread or strip detectable by X-rays.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0024] For easier understanding of the art, find enclosed the figures that represent preferred embodiments that, however, are not intended to limit the subject matter of this application.

[0025] FIG. 1 illustrates a scheme of the surgical non-woven fabric swab with pre-washed aspect (1) in its final presentation.

[0026] FIG. 2 illustrates, in the case of the textile net comprising a material with high elasticity such as elastane, the swab (1) production process, that passes through the junction of two outer layers of non-woven fabric (2) and an inner layer of elastic textile net, and placed under tension (3) to stay stretched. The three layers are overlapped by pressure rollers (11) and welded together by ultrasound (12), forming the laminate (4) still under tension. Subsequently, the laminate (4) is cut through a blade system (13) to the required dimension. The cutting of the laminate (4) causes relaxation of the textile net, causing it to return to its initial shape, and thus creating a wrinkled effect on the non-woven fabric surfaces to which it has been welded while stretched. Thus, it is obtained the retracted open swab (5) that shifts to an application table of security strips and folds (14) giving rise to the finished article.

[0027] FIG. 3 illustrates a productive scheme for swabs (1) with a textile net comprising polyamide or polyamide and polyester or even polyamide and cotton. The polyamide or polyamide and polyester or cotton textile net (6) is used without applying any tension. The overlapping of non-woven fabric layers (2) and polyamide, polyamide and polyester or polyamide and cotton textile net (6) is carried out by pressure rollers (11). Thereafter the weld is performed by ultrasound (12) giving rise to the laminate (7). The cutting of the laminate into the desired dimension is performed in the blade system (13), thereby obtaining the open swab without shrinking (8). This swab is then subjected to a heat treatment (15) originating the retracted open swab (9). The last step of applying security strips and fold is identical to that described above and performed on the table (14).

[0028] In both situations presented in FIGS. 2 and 3, it is also possible to apply either by welding or by another process a thread or strip, detectable by X-rays (10).

[0029] FIG. 4 illustrates the application of ultrasound welding (12) at the ends (15 and 16) and inside (17) the swab simultaneously and through a single roll.

[0030] FIG. 5 illustrates the application of ultrasound welding (12) though two different rolls.

DESCRIPTION OF EMBODIMENTS

[0031] Referring to the figures, some embodiments will now be described in more detail, which however are not intended to limit the scope of the present application.

[0032] In an embodiment and in the case of textile net comprising elastane, the production process of the swab (1) involves the junction of two outer layers of non-woven fabric (2) and an inner layer of elastic textile net, placed under tension (3) to stay stretched. The three layers are overlapped by pressure rollers (11) and welded together by ultrasound (12), forming the laminate (4), still under tension. Subsequently, the laminate (4) is cut to the required dimension through a blade system (13). The cutting of the laminate (4) causes relaxation of the textile net, causing it to return to its initial shape, and thus creating a wrinkled effect on the non-woven fabric surfaces to which it has been welded while stretched. Thus, it is obtained the retracted open swab (5) that shifts to an application table of security strips and folds (14) giving rise to the finished article.

[0033] In an embodiment and in the case of textile net comprising polyamide or polyamide and polyester or even polyamide and cotton, the production process of the swab involves the junction and overlapping of two outer layers of non-woven fabric (2) and one inner layer of polyamide or polyamide and polyester or even polyamide and cotton textile net, performed by pressure rollers (11). Thereafter, the welding is performed by ultrasound (12) giving rise to the laminate (7). The cutting of the laminate into the desired dimension is performed in the blade system (13), thereby obtaining the open swab without shrinking (8). This swab is then subjected to a heat treatment (15) originating the retracted open swab (9). The last step of applying security strip(s) and fold is identical to that described above and carried out on the table (14).

[0034] In a preferred embodiment, the heat treatment is performed at a temperature between 40 and 80° C. At this temperature range also the sterilization by Ethylene Oxide will cause the desired shrinking effect therefore requiring no heat station in the production machine.

[0035] In a preferred embodiment, regardless of the type of textile net used, the overlapping of the layers is carried out by pressure rollers.

[0036] In a preferred embodiment, regardless the type of textile net used, the cut is made through a blade system.

[0037] In one embodiment, applying the security strip is performed so that it becomes fixed at one end. The security strips are kept outside the surgical incision while the swabs are on the inside, to ensure that none swabs is forgotten inside the patient after surgery.

[0038] In one embodiment, it is also possible to apply a thread or strip, detectable by X-rays (10). In one embodiment, this application is carried out by welding.

[0039] As illustrated in FIGS. 4 and 5, there are two alternative methods for the application of ultrasound welding (12) on the non-woven fabric laminate and elastane textiles net (4) or on the laminate with non-woven fabric and polyamide or polyamide and polyester or even polyamide and cotton textile net (7).

[0040] In the first roll of FIG. 5, it is performed the outer welding parallel to the roll (16) as well as the internal welding (17), while in the second roll is performed the outer welding perpendicular to the roll (15).

[0041] Test Results Carried Out to Swabs

[0042] In the following tables are presented the results obtained in the tests carried out to a representative sample of the surgical swab in non-woven fabric, with pre-washed effect, when used in a elastane, polyamide, polyamide and polyester or polyamide and cotton textile net on the inside compared to other options currently available:

[0043] Absorption Capacity:

[0044] The absorption capacity of the non-woven fabric swab with elastane, polyamide, polyamide and polyester or polyamide and cotton net is considerably higher than the absorption capacity of different types of available swabs.

TABLE-US-00001 TABLE 1 Absorption capacity values of the surgical non-woven fabric swab with elastane, polyamide, polyamide and polyester or polyamide and cotton net as compared with other products currently on the market. Absorption Absorption Absorption Method cap. (%) cap. (g/g) cap. (g/cm.sup.2) Standard EN1644-1 EN1644-2 13726-1 Non-woven fabric swab 1048 16.5 17.7 with elastane net Non-woven fabric swab 1236 20.6 18.7 with polyamide net Non-woven fabric swab with 1170 15.8 28.3 polyamide/polyester net Non-woven fabric swab with 951 15.7 17.6 polyamide/cotton net Abdominal swab 966 11.3 12.0 Non-woven 2 layers Gauze swab 17 threads/ 472 6.9 7.2 cm.sup.2 4 layers Gauze swab 17 threads/ 629 9.5 14.9 cm.sup.2 4 pre-washed layers Gauze swab 20 threads/ 447 7.5 7.9 cm.sup.2 4 layers Gauze swab 20 threads/ 640 8.8 18.3 cm.sup.2 4 pre-washed layers

[0045] Absorption Rate:

[0046] The surgical non-woven fabric swab with elastane, polyamide, polyamide and polyester or polyamide and cotton net presents higher percentage of water retention than the surgical pre-washed gauze swab, after 5 and 10 seconds from the beginning of the test.

[0047] Tables 2 and 3—Absorption rate values obtained from a pre-washed gauze surgical swab and for a surgical non-woven fabric swab with elastane, polyamide, polyester and polyamide or polyamide and cotton net at the end of 10 seconds, and 5 seconds, respectively.

TABLE-US-00002 TABLE 2 Test time - 10 seconds Initial Final Amount of water weight (g) weight (g) retained in the swab % swab swab + water after 10 seconds (g) retained Pre-washed gauze swab 20.72 59.76 39.04 188 21.83 60.73 38.9 178 Non-woven fabric swab with elastane net 16.59 58.43 41.84 252 17.4 53.28 35.88 206 Non-woven fabric swab with polyamide net 16 61.93 45.93 287 14.6 62.95 48.35 331 Non-woven fabric swab with polyamide/polyester net 19.54 74.48 54.94 281 20.06 65.21 45.15 225 Non-woven fabric swab with polyamide/cotton net 14.26 44.43 30.17 212 14.28 43.82 29.54 207

TABLE-US-00003 TABLE 3 Test time - 5 seconds Initial Final Amount of water weight (g) weight (g) retained in the swab % swab swab + water after 5 seconds (g) retained Pre-washed gauze swab 20.813 57.809 37 178 20.714 66.21 45.5 220 27.81 93.62 65.81 237 27.082 69.41 42 156 Non-woven fabric swab with elastane net 16.13 55.41 39.28 244 17.02 62.55 45.53 268 Non-woven fabric swab with polyamide net 14.7 71.64 56.94 387 14.71 66.53 51.82 352 Non-woven fabric swab with polyamide/polyester net 20.05 68.66 48.61 242 19.57 69.25 49.68 254 Non-woven fabric swab with polyamide/cotton net 13.91 44.5 30.59 220 14.27 42.85 26.58 200

[0048] Release of Fibres and Particles:

[0049] The surgical non-woven fabric swab with elastane, polyamide, polyamide and polyester or polyamide and cotton net presents lower amounts of released particles than the surgical pre-washed gauze swab.

TABLE-US-00004 TABLE 4 Release values of fibres and particles obtained from a surgical pre-washed gauze swab and for a surgical non-woven fabric swab with elastane, polyamide, polyamide and polyester or polyamide and cotton net. ISO 9073-10 No. Particles ≧0.5 μm Pre-washed gauze swab approx. 1000000 Non-woven fabric swab with elastane, <5000 polyamide, polyamide and polyester or polyamide and cotton net.

[0050] Chemical Properties:

[0051] The values obtained in the chemical properties tests for the surgical non-woven fabric swab with elastane, polyamide, polyamide and polyester or polyamide and cotton net are within the parameters defined by applicable standards.

TABLE-US-00005 TABLE 5 Values obtained for the different chemical properties tests for a surgical pre-washed gauze swab and for a surgical non-woven fabric swab with elastane, polyamide, polyamide and polyester or polyamide and cotton net. Substances Water- soluble soluble Optic in nonpolar substances (%) White pH solvents (%) Pre-washed gauze ≦0.5 Absent 6.0-8.0 ≦0.5 swab Non-woven fabric ≦0.5 Absent 6.0-8.0 ≦0.5 swab with elastane net Non-woven fabric ≦0.5 Absent 6.0-8.0 ≦0.5 swab with polyamide net Non-woven fabric ≦0.5 Absent 6.0-8.0 ≦0.5 swab with polyamide/ polyester net Non-woven fabric ≦0.5 Absent 6.0-8.0 ≦0.5 swab with polyamide/ cotton net

[0052] The present embodiment is not, naturally, in any way restricted to the embodiments described herein and a person of ordinary skills in the area can provide many modification possibilities thereof without departing from the general idea, as defined in the claims.

[0053] All embodiments described above are obviously combinable with each other. The following claims further define preferred embodiments.