Device and method for simulating mechanical stresses on protective gloves and / or a flexible material

Abstract

Device for simulating mechanical stresses on protective gloves and / or a flexible material (7), device comprising a. a slide (1), and a sliding rail (2) on which the slide (1) is movably mounted, b. a first holding device (3) which has a first force direction converter (5), and wherein the first holding device (3) is arranged on the slide (1), c. and a second holding device (4) which has a second force direction converter (6), wherein the first and the second holding devices (3,4) with the force direction converters (5,6) are arranged opposite each other, d. a flexible material (7) which is stretched between the first and the second force direction converter (5,6), e. a fixing assembly (8) having a resistance, wherein the slide (1) is fixed on one side by means of the fixing assembly (8) such that when a tensile force occurs on the first holding device (3) the slide (1) is moved against the resistance, f. a force measuring device (9) which is arranged on the first and / or the second force direction converter (5,6) and / or on the slide (1) and / or on the first and / or on the second holding device (3,4).

Description

[0001] The invention relates to a device and a method for simulating mechanical loads on protective gloves and / or a flexible material, in particular a device and a method for simulating superimposed tensile, crushing and tribological stresses.

[0002] The invention particularly relates to a device for simulating mechanical tensile and tribological friction loads on medical gloves caused by surgical suture material.

[0003] The increasing number of surgical procedures, coupled with a consistently low infection rate, is leading to an increase in surgical site infections (SSIs). Reducing the SSI rate requires coordinated optimization of all influencing factors. Sterile surgical gloves play a key role here; they protect the patient under the concept of asepsis and serve as a protective barrier for operating room staff against pathogens.

[0004] The ISO DIN EN 455 standard for surgical gloves specifies only low, particularly minimal, mechanical demands on latex and latex-free surgical gloves. DIN EN 455-1 describes a leak test with 1000 ml (water retention test for 2-3 minutes at 230 °C, i.e., 140 °C below body temperature). DIN EN 455-2 includes standardized dimensions and a tear strength of 9 N for the entire glove. DIN EN 455-3 and -4 relate to biocompatibility and aging / durability. Information on a minimum material thickness is missing, and mechanical stresses occurring during surgery are not considered. These cannot yet be simulated in vitro under laboratory conditions. Therefore, mechanical stress has not yet been considered in the further development of surgical gloves.

[0005] The state of the art only includes methods for detecting damage or devices for testing the tightness of surgical gloves.

[0006] For example, DE 20 2012 013 099 U1 discloses a test disk and a test system with a test disk for testing the tightness of gloves installed in the ports of an isolator. The glove and the isolator form a spatially separated area from the surroundings.

[0007] DE 199 54 581 A1 discloses a device for detecting micro-defects in a liquid-tight sheet material, comprising a pressure generating arrangement for producing a pressure difference between the first side and the second side of the sheet material, so that a gas flow can pass through the micro-defects, and comprising at least one sensor for detecting the gas flow through the micro-defects.

[0008] DE 44 00 226 A1 discloses a material testing device, in particular for determining the permeation and degradation behavior, preferably of chemical protection materials, for example, gloves, under certain chemical and / or physical influences, comprising a test cell and a permeation test cell. A material sample can be clamped tightly between the test cell and the permeation test cell, such that it can be directly exposed to a test chemical introduced into the test cell on one side, and the permeation test cell is separated from the test cell by the sample. A detection device for detecting the chemical that has penetrated or diffused through the sample toward the permeation test cell is provided, and an expansion device for cyclical mechanical stressing of the sample is provided on the permeation test cell side.

[0009] DE 10 2006 042 857 A1 describes a measuring device and a method for determining the clamping force of cloth-like or film-like materials, preferably for use in gloves. A tensile bar, coated with the material on both sides, is clamped between two clamping jaws and pulled out of the clamping jaws with a measurable tensile force. The force required for this is referred to as the clamping force.

[0010] The publication DE 10 2014 016 482 A1 discloses a test and / or inspection device, in particular for determining the resistance of surfaces or objects to abrasion, impact sensitivity, or scratch resistance. The test device consists of an adaptive holding device, at least one means for attaching a test object in front of or above the object to be tested, a device for moving the test object as it strikes the object to be tested, as well as a control, monitoring, and / or display device for controlling and monitoring the speed and force with which the test object comes into contact with the object to be tested. The test and / or inspection device is equipped with a torsion-proof push and / or pull device for moving the test object.However, the proposed device is not suitable for testing a glove itself, but rather the surface of hands or special gloves can be simulated on the test object by means of appropriate roughness and it can be tested how often the test object can be loaded with which load by the test object under these conditions.

[0011] The document DE 10 2012 219 235 A1 relates to a device for testing the fracture behavior of material strips, in particular flexible leather-like material strips, preferably artificial leather strips, wherein the device is designed to subject a material strip to be tested, which has at least two end sections, to a first type of stress and a second type of stress alternately with the aid of at least two holding elements, so that a distance between the end sections of the material strip to be tested is increased in the case of the first type of stress and is reduced in the case of the second type of stress.

[0012] The patent specification DE 102 60 216 B3 relates to a device for the reproducible testing of the extensibility of elastic, band-shaped textile materials, comprising a supporting structure for receiving at least one first, fixed and one second, movable holding device with a clamping area for the material to be tested, wherein the movable holding device slides displaceably on a guide.

[0013] The patent specification US 2005 / 0 234 511 A1 discloses a testing device and associated methods for evaluating the surface durability with regard to the fraying resistance or tear behavior of a suture material when rubbed against itself or against a solid surface material.

[0014] The publication by Walsh, Donna L. [et al.]: “Abrasion Resistance of Medical Glove Materials.” (In: Journal of Biomedical Materials Research Part B: Applied Biomaterials. Vol. 68, 2004 No. 1, A. 81-87) discloses a device for determining the abrasion resistance of medical protective gloves, wherein the glove is mechanically loaded with a roller and then the glove is subjected to a leak test.

[0015] There are currently no devices available to simulate glove damage, particularly during surgery, and particularly during the tying of sutures. Description of the invention

[0016] It is therefore an object of the invention to eliminate the disadvantages of the prior art and to provide a device and a method for simulating mechanical loads on protective gloves and / or a flexible material, which enable the cause and location of damage to protective gloves to be determined, whereby tensile and friction values ​​arising during the mechanical load can be recorded in order to develop protective gloves with load-adapted areas.

[0017] It is a further object of the invention to provide a device for simulating mechanical loads on sterile surgical protective gloves, with which intraoperatively occurring mechanical loads can be simulated and evaluated under standardized laboratory conditions in order to develop protective gloves with load-adapted areas.

[0018] This problem is solved by the features listed in the claims.

[0019] This object is achieved by means of a device for simulating mechanical loads on protective gloves and / or a flexible material. The device has a carriage and a slide rail on which the carriage is movably mounted. Furthermore, the device has a first holding device comprising a first force direction converter. The first holding device is arranged on the carriage. A second holding device, which has a second force direction converter, is arranged opposite the first holding device. This results in an opposing arrangement of the first and second force direction converters. A flexible material is stretched between the force direction converters.By means of a fixing assembly having a resistance, the carriage is movably fixed on one side in such a way that when a tensile force occurs on the first holding device, the carriage is moved against the resistance, wherein the resistance is a resistance over a distance of the carriage.

[0020] Furthermore, the device comprises a force measuring device which is arranged on the first and / or second force transducer and / or on the carriage and / or on the first and / or second holding device.

[0021] According to various embodiments, the fixing assembly comprises spring, damping, and / or friction elements. The spring, damping, and / or friction elements can be adjustable.

[0022] According to various embodiments, the first and / or second force direction converter is / are a deflection pulley(s). The deflection pulleys are preferably formed with grooves, wherein the grooves have a defined surface roughness to enable guidance of the thread and generate different frictional resistances.

[0023] According to various embodiments, the flexible material is tensioned between the force direction converters such that the flexible material of the first deflection pulley and the second deflection pulley is wrapped at least once.

[0024] Furthermore, the first and / or the second holding devices can have torsion-resistant cantilever beams.

[0025] Preferably, the flexible and / or elastic material is a surgical suture material.

[0026] According to various embodiments, the device for simulating mechanical loads on protective gloves has a second carriage, wherein the second holding device can be arranged on the second carriage.

[0027] Preferably, the carriage(s) is / are arranged on the slide rail in a low-friction, sliding, rail-mounted and / or ball-bearing manner.

[0028] According to various embodiments, the first force converter is / are pivotally mounted on the first holding device and / or the second force converter is pivotally mounted on the second holding device.

[0029] The resistance over a travel distance of the slide is preferably adjustable by means of the fixation assembly. Furthermore, the set resistance preferably corresponds to the resistance of a knot being tied during a surgery, with the increasing resistance corresponding, for example, to the resistance of a fascial gap or tendon lesion that needs to be closed. The resistance can preferably be adjusted variably.

[0030] According to various embodiments, the device according to the invention comprises an RFID transponder for transmitting data.

[0031] The device is designed to ensure operation even under humid conditions (e.g., serum or artificial blood plasma). To enable testing of the protective glove or the flexible material in a humid or wet environment, the device according to the invention, according to various embodiments, comprises a container in which the device is arranged. The container can be filled with liquid.

[0032] Furthermore, according to various embodiments, the device can comprise a displacement sensor, for example an incremental displacement sensor, which can be arranged in the carriage and / or on the slide rail.

[0033] The object is further achieved by means of a method for simulating mechanical loads on protective gloves and / or a flexible material by means of the device according to claim 1, wherein the method has the following method claims: a) threading a flexible material into the first and second force direction converters, thereby forming two ends, or threading a flexible material into the first and second force direction converters, thereby forming two ends, and putting on a protective glove, b) Simulating the tying of knots at the ends, whereby the carriage approaches the second holding device against a resistance, c) Recording the resulting forces and / or length changes using the force measuring device and d) Assessment of the flexible material and / or assessment of any damage to the protective glove and / or testing of the protective glove for damage, for example in accordance with current state-of-the-art methods.

[0034] In order to assess a protective glove and / or the suture material according to the extent of use, the process steps b) and) can be carried out several times, whereby the resistance can be determined according to the duration of use.

[0035] According to ISO DIN 455-2, only a total mechanical load for surgical gloves has been prescribed so far. Therefore, testing for mechanical point loads is not performed on surgical gloves. The proposed device allows for the simulation and evaluation of intraoperative, point-load mechanical loads on surgical gloves under standardized laboratory conditions. This is an essential prerequisite for developing medical gloves with load-adapted areas.

[0036] The proposed device allows for the standardized simulation of mechanical influences and loads on surgical gloves when tying surgical knots. The resulting forces and length changes as well as the knot fixation can be recorded and subsequently analyzed.

[0037] The invention simulates the intraoperative tying of surgical knots, such as the closure of muscle fascia, as occurs in hip or knee endoprostheses or in the suturing of muscle tendons. The mechanical stress on the glove material under specific tensile and friction forces is simulated and analyzed in a standardized manner. The resulting forces are recorded using a load cell. Any resulting damage can be examined and evaluated under laboratory conditions. Suture material can be tested for its tensile strength and / or knot security during tying procedures.

[0038] The device according to the invention makes it possible to determine the cause and location of damage caused by mechanical stress.

[0039] Furthermore, the device according to the invention enables simulation of damage to surgical gloves caused by the intraoperative tying of surgical knots. The resulting tensile and friction forces can be recorded and evaluated. Based on the results, protective gloves with stress-adapted areas can be developed. Implementation of the invention

[0040] The invention will be explained in more detail using one or more exemplary embodiments. Fig. 1 Embodiment of a device according to the invention for simulating mechanical loads on protective gloves and / or a flexible material

[0041] In the description, reference is made to the accompanying drawings, which show, by way of illustration, specific embodiments in which the arrangement according to the invention may be practiced. In this regard, directional terminology such as "top," "bottom," "right," "left," etc., is used with reference to the orientation of the described drawings. The directional terminology is for illustrative purposes and is in no way limiting.

[0042] It is understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. It is understood that the features of the various exemplary embodiments described herein may be combined with one another unless specifically stated otherwise. The following detailed description is therefore not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

[0043] In the figures, identical or similar elements are provided with identical reference numerals where appropriate.

[0044] In Fig. 1 shows an embodiment of a device according to the invention for simulating mechanical loads on protective gloves and / or a flexible material. The device comprises a carriage 1 and a slide rail 2 on which the carriage 1 is movably mounted. Furthermore, the device comprises a first holding device 3, which has a first force direction converter 5. The first holding device 3 is arranged on the carriage 1. A second holding device 4, which has a second force direction converter 6, is preferably mounted immovably. The first and second holding devices 3, 4 with the force direction converters 5, 6 are arranged opposite one another. A flexible material 7 is stretched between the first and second force direction converters 5, 6. A fixing assembly 8 comprising a resistor fixes the carriage 1 on one side (In Fig. 1 (the illustrated left side of the carriage 1) such that when a tensile force occurs on the first holding device 5, the carriage 1 is moved against the resistance. Furthermore, the device comprises a force measuring device 9, which is arranged on the first and / or second force direction converter 5, 6 and / or on the carriage 1 and / or on the first and / or second holding device 3, 4.

[0045] As in Fig. As shown in Figure 1, the force direction converters 5,6 can be designed as deflection pulleys.

[0046] The holding devices 3,4 can be designed as torsion-resistant cantilever beams or can have these (not shown here).

[0047] The fixing assembly is preferably a combination of spring, damping, and / or friction elements. The use of other or additional fixing elements with the same effect is conceivable.

[0048] Particularly preferably, the fixing assembly and / or the spring, damping and / or friction elements are designed to be adjustable.

[0049] The elastic / flexible material 7 is surgical suture material, which is particularly suitable for simulating the stresses on protective gloves under real-life conditions. Furthermore, the device can also be used to test various types of suture material, such as polyfilament, pseudopolyfilament, or monofilament suture material, under real-life conditions.

[0050] Alternatively, the device may comprise a second carriage on which, for example, the second holding device 4 is arranged (not shown here).

[0051] In order to achieve the best possible results and to be able to simulate real conditions, the carriage 1 should be arranged on the slide rail 2 in a low-friction, sliding, rail-mounted and / or ball-bearing manner.

[0052] The force direction converters 5,6 can be pivotally mounted on the respective holding devices 3,4.

[0053] The fixation assembly 8 is designed such that the resistance against which the slide 1 is moved by tension can be adjusted. Using various resistance settings, knot tying during a surgical procedure, such as the closure of muscle fascia, as occurs in hip or knee endoprostheses or the suturing of muscle tendons, can be simulated.

[0054] According to various embodiments, the device according to the invention preferably comprises a data transmission device. This can, for example, be an RFID transponder, which transmits the recorded force and / or displacement data to a computer and / or an evaluation unit.

[0055] Furthermore, the device according to the invention (as in Fig. 1) have a container 10 in which the device is arranged.

[0056] Using a displacement sensor, such as an incremental displacement transducer, the distance traveled by the carriage 1 when the tensile force is applied can be measured. The incremental displacement transducer can be arranged, for example, in the carriage 1 and / or on the slide rail 2.

[0057] To Fig.1, the method according to the invention can also be explained using the device according to the invention. First, a flexible material 7 is threaded once into the first and second force direction converters 5 / 6, thereby forming two ends of the flexible material 7. To test protective gloves, a test person should put on protective gloves. If only the flexible material 7 is to be tested for mechanical stress, putting on protective gloves is not absolutely necessary. In a next method step, the mechanical stress on the suture material 7 and / or the protective glove is simulated, for example by tying knots using the ends of the elastic material 7. Triggered by the application of force, the carriage 1 approaches the second holding device 6 against the resistance exhibited by the fixing assembly 8.The resulting forces and length changes during the application of force are recorded using the force measuring device 9 and / or the incremental displacement sensor. Subsequently, the flexible material 7 is assessed and / or any damage to the protective glove is assessed and / or the protective glove is tested for damage using common state-of-the-art methods, such as leak testing. The recorded data on the applied forces and distances traveled can be transmitted via an RFID transponder, for example, to a computer and / or an evaluation unit. These can be improved in conjunction with the detected damage to the protective glove and / or the suture material 7. Reference symbol 1 sled 2 slide rails 3 First holding device 4 Second holding device 5 First force direction converter / first pulley 6 Second force direction converter / second pulley 7 Flexible material / surgical suture material 8 Fixing assembly 9 Force gauge 10 containers

Claims

[1] Device for simulating mechanical loads on protective gloves and / or a flexible material (7), comprising a carriage (1) and a slide rail (2) on which the carriage (1) is movably mounted, b. a first holding device (3) which has a first force direction converter (5), and wherein the first holding device (3) is arranged on the carriage (1), c. and a second holding device (4) which has a second force direction converter (6), wherein the first and the second holding device (3, 4) with the force direction converters (5, 6) are arranged opposite one another, d. a flexible material (7) which is stretched between the first and the second force direction converter (5,6), e. a fixing assembly (8) having a resistance, wherein the carriage (1) is fixed on one side by means of the fixing assembly (8) in such a way that when a tensile force occurs on the first holding device (3), the carriage (1) is moved against the resistance, f. a force measuring device (9) which is arranged on the first and / or the second force direction converter (5, 6) and / or on the carriage (1) and / or on the first and / or on the second holding device (3, 4). [2] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to claim 1, characterized by that the first force direction converter (5) is a deflection pulley and / or that the second force direction converter (6) is a deflection pulley. [3] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to claim 1, characterized bythat the holding devices (3,4) have torsion-resistant cantilever beams. [4] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to claim 1, characterized by that the fixing assembly (8) has spring, damping and / or friction elements, wherein the spring, damping and / or friction elements are adjustable. [5] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to one of the preceding claims, characterized by that the flexible material (7) is surgical suture material. [6] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to one of the preceding claims, further comprising a second carriage. [7] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to claim 6, characterized by that the second holding device (4) is arranged on the second carriage. [8] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to one of the preceding claims, characterized by that the carriage (1) is arranged on the slide rail (2) in a low-friction, sliding, rail-mounted and / or ball-bearing manner. [9] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to one of the preceding claims, characterized by that the first force direction converter (5) is pivotally mounted on the first holding device (3) and / or the second force direction converter (6) is pivotally mounted on the second holding device (4). [10] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to one of the preceding claims, characterized by that the resistance can be adjusted over a distance of the slide (1) by means of the fixing assembly (8). [11] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to one of the preceding claims, characterized by that the resistance set by means of the fixing assembly (8) corresponds to a resistance of a knot tie during an operation. [12] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to one of the preceding claims, further comprising an RFID transponder for transmitting data from the force measuring device (9). [13] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to one of the preceding claims, further comprising a container (10) in which the device is arranged. [14] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to one of the preceding claims, further comprising a displacement sensor. [15] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to claim 14, characterized by that the displacement sensor is arranged in the carriage (1). [16] Device for simulating mechanical loads on protective gloves and / or a flexible material (7) according to claim 14, characterized by that the displacement sensor is arranged on the slide rail (2). [17] Method for simulating mechanical loads on protective gloves and / or a flexible material (7) by means of the device according to claim 1, method comprising the following method claims: a. Threading a flexible material (7) into the first and second force direction converters (5, 6), thereby forming two ends, or threading a flexible material (7) into the first and second force direction converters (5, 6), thereby forming two ends and putting on a protective glove, b. exerting force at the two ends, whereby the carriage (1) approaches the second holding device (4) against the resistance of the fixing assembly (8), and whereby a mechanical load on the flexible material (7) and / or the protective glove is simulated, c. Recording the resulting forces and / or length changes by means of the force measuring device (9) and / or by means of a displacement sensor, d. Assessment of the flexible material (7) and / or assessment of any damage to the protective glove and / or testing of the protective glove for damage. [18] Method according to claim 17, characterized by that process steps b) and c) are carried out several times.

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