Compression bandage

文档序号:1590334 发布日期:2020-01-03 浏览:16次 中文

阅读说明:本技术 压迫绷带 (Compression bandage ) 是由 圭多·希奇曼 于 2018-04-30 设计创作,主要内容包括:一种用于人类小腿的压迫绷带,该压缩绷带具有:a)第一主表面上的第一接合区域,其包括机械接合装置;b)第一主表面上的第二接合区域,其包括机械接合装置;c)位于第一接合区域和第二接合区域之间的软区段,其在长度方向上具有减小的弹性模量;以及d)硬区段,其在长度方向具有升高的弹性模量,并且其长度大于软区段的长度。硬区段包括第二主表面上的第三接合区域,该第三接合区域包括用于与第一接合区域和与第二接合区域接合的机械接合装置。当围绕小腿包裹绷带时,第三接合区域可在后续圈中与第一接合区域以及与第二接合区域接合,以使得硬区段桥接软区段。(A compression bandage for a human lower leg, the compression bandage having: a) a first engagement region on the first major surface comprising a mechanical engagement means; b) a second bonding region on the first major surface comprising mechanical bonding means; c) a soft segment located between the first joining region and the second joining region, having a decreasing modulus of elasticity in the length direction; and d) a hard segment having an elevated modulus of elasticity in the length direction and a length greater than the length of the soft segment. The hard segment includes a third engagement region on the second major surface, the third engagement region including a mechanical engagement means for engaging with the first engagement region and with the second engagement region. When wrapping the bandage around the lower leg, the third joining region may be joined with the first joining region and with the second joining region in subsequent loops such that the hard segment bridges the soft segment.)

1. An elongated elastic compression bandage (1, 2) for application in a circumferential loop (179, 180) around a human lower leg (160) for applying a therapeutic pressure thereon for treating venous leg ulcers,

the bandage has a first main surface (10) and an opposite second main surface (20), wherein the long extension of the bandage defines a length direction (100) when arranged flat, and

wherein the bandage disposed in a lengthwise direction thereof comprises,

a) a first bonding region (30, 31) arranged on the first main surface and comprising mechanical bonding means (50),

b) a second bonding region (40, 41) arranged on the first main surface and comprising mechanical bonding means (60),

c) a soft segment (70, 70a, 70b, 71a),

-the soft segment is arranged between the first joining area and the second joining area in the length direction of the bandage,

-the soft segment has a decreasing modulus of elasticity in the length direction,

d) hard segment (80, 80a, 80b, 81)

-the hard segment has an elevated modulus of elasticity in the length direction higher than the reduced modulus,

-the length (90) of the hard segment is greater than the length (130) of the soft segment, wherein the length of a segment is determined by the longest extension of the segment in the length direction of the unrolled bandage,

-the hard section comprises a third joining region (140, 141) arranged on the second main surface, the third joining region comprising mechanical joining means for joining with the first joining region and the second joining region,

wherein the segments (70, 70a, 70b, 71a, 80a, 80b, 81) and the joining regions (30, 31, 40, 41, 140, 141) are arranged such that a first portion of the third joining region is engageable with the first joining region in a subsequent turn and a second portion of the third joining region is engageable with the second joining region when the bandage is applied in a circumferential turn, such that the hard segments bridge the soft segments.

2. A compression bandage (1, 2) according to claim 1, wherein the bandage extends in the width direction (110) between a first side edge (200) and a second side edge (210), and wherein each hard segment and each soft segment extends from the first side edge to the second side edge.

3. Compression bandage (1, 2) according to any one of the preceding claims, wherein the bandage extends in width between a first side edge (200) and a second side edge (210), wherein each stiff section (80, 80a, 80b, 81) has a rectangular or trapezoidal shape and extends from the first side edge (200) to the second side edge (210), and wherein each soft section (70, 70a, 70b, 71a) has a rectangular shape and extends from the first side edge (200) to the second side edge (210).

4. A compression bandage according to any one of the preceding claims, wherein at least one hard segment (80, 80a, 80b, 81) has an elastic modulus in the length direction (100) of greater than 0.03N/cm/% at 5% elongation relative to the unstretched length.

5. A compression bandage according to any one of the preceding claims, wherein each soft segment (70, 70a, 70b, 71a) has an elastic modulus in the length direction (100) of less than 0.1N/cm/% at 5% elongation relative to the unstretched length.

6. A compression bandage (1, 2) according to any one of the preceding claims, wherein the first and/or second engagement region comprises engagement means (50, 60) in the form of a plurality of hooks, and wherein the third engagement region comprises engagement means (160) in the form of a plurality of loops suitably shaped for mechanical engagement with the same hooks as the hooks of the first and/or second engagement region.

7. A compression bandage according to any one of the preceding claims wherein the first and/or second engagement regions comprise engagement means in the form of a plurality of loops, and wherein the third engagement region comprises engagement means in the form of a plurality of hooks suitably shaped to mechanically engage with the same loops as the loops of the first and/or second engagement regions.

8. A compression bandage according to any one of the preceding claims, wherein the first and/or second engagement regions (30, 31, 40, 41) comprise engagement means (50, 60) in the form of a plurality of mushroom-shaped fastening elements, and wherein the third engagement region (140, 141) comprises engagement means (160) in the form of a plurality of mushroom-shaped fastening elements adapted to mechanically engage with the same mushroom-shaped fastening elements of the first and/or second engagement regions.

9. A compression bandage according to any one of the preceding claims, wherein the first joining region (30, 31) and/or the second joining region (40, 41) comprises joining means (50, 60) in the form of an exposed friction enhancing layer adapted to mechanically engage with the same exposed surface as that of the third joining region (140, 141), or wherein the third joining region (140, 141) comprises joining means (160) in the form of an exposed friction enhancing layer adapted to mechanically engage with the same exposed surface as that of the first joining region (30, 31) or the second joining region (40, 41).

10. A compression bandage according to any one of the preceding claims, wherein at least one hard segment (80, 80a, 80b, 81) comprises apertures for facilitating the transfer of air between the second main surface (20) and the first main surface (10).

11. A compression bandage (1, 2) according to any one of the preceding claims, wherein the bandage, when unrolled and arranged flat, covers a geometric bandage area, and wherein a plurality of hard segments (80, 80a, 80b, 81) occupy at least 50% of the geometric bandage area.

12. Compression bandage (1, 2) according to claim 1, comprising

a) A plurality of soft segments (70, 70a, 70b, 71a), each soft segment having a decreasing modulus of elasticity in the length direction (100), an

b) A plurality of hard segments (80, 80a, 80b, 81) each having an elevated modulus of elasticity in the length direction, the plurality of hard segments being arranged alternately with the plurality of soft segments in the length direction of the bandage,

wherein each hard segment of the plurality of hard segments comprises a first joining region (30, 31) and a second joining region (40, 41) on the first main surface (10) and a third joining region (140, 141) on the second main surface, each joining region (30, 31, 40, 41, 140, 141) comprising a mechanical joining means (50, 60, 160),

the third joining region is arranged such that a first portion of the third joining region is engageable with the first joining region of a first other hard segment of the plurality of hard segments and a second portion of the third joining region is engageable with the second joining region of a second other hard segment of the plurality of hard segments such that the hard segment bridges the soft segment between the first other hard segment and the second other hard segment.

13. Compression bandage (2) according to claim 12, wherein the third joining regions (30, 31, 40, 41) of at least two consecutive hard segments (80, 80a, 80b, 81) have a uniform "herringbone" shape, said herringbone shapes being oriented parallel to each other and pointing in the same length direction (100) of the bandage, wherein the at least two herringbone shapes are spaced apart from each other in length direction by one or more respective herringbone soft segments.

14. A compression bandage (2) according to claim 13, wherein the length (130) of each of the chevron soft segments (71, 71a) is less than 80% of the minimum length (90) of each of the at least two chevron hard segments (81).

15. A kit of parts for forming a compression system for application around a human lower leg (160) for applying a therapeutic pressure on the lower leg for treating venous leg ulcers, the kit comprising

a) An elastic compression sock (240) for wearing as an inner layer on a human lower leg for applying a therapeutic pressure on the lower leg for treating venous leg ulcers,

wherein the sock comprises a calf section (280) arranged to compress the calf when the sock is worn, the calf section having an inner major surface for facing the skin and an opposed outer major surface, the calf section comprising,

i) a first joining region (32) arranged on the outer main surface and comprising mechanical joining means,

ii) a second joining region (32) arranged on the outer main surface and comprising mechanical joining means,

iii) a soft segment (72) arranged between the first joining region and the second joining region and having a decreasing modulus of elasticity in the circumferential direction, and

b) a reinforcement wrap (300) applied circumferentially around the compression sock (240) as an outer layer when the compression sock is in use, the reinforcement wrap having an inner major surface (320) for facing the compression sock,

and comprises

i) Two hard portions (310) of linear shape, oriented in parallel and spaced apart from each other, having an elevated modulus of elasticity in the circumferential direction, each hard portion (310) comprising on its inner main surface (320) a respective wrap engaging area comprising mechanical engaging means for engaging with the first and second engaging areas of the sock, and

ii) a soft portion (370) arranged between the two hard portions (310) and having a reduced modulus of elasticity in the circumferential direction (290) which is lower than the elevated modulus,

wherein the wrap engagement area is arranged such that the reinforcement wrap (300) is capable of being circumferentially applied around the compression sock (240) such that the wrap engagement area is capable of engaging with the first engagement area (32) and the second engagement area (32) such that at least a portion of the hard portion (310) of the reinforcement wrap bridges the soft section (72) of the compression sock.

Technical Field

The present invention relates to an elastic compression bandage and a compression sock for compression treatment of venous leg ulcers on the lower leg of a human body. In particular, the present invention relates to such compression bandages that are designed to be wrapped around the lower leg in multiple wraps.

Background

The use of compression bandages in the treatment of, for example, edematous diseases of the lower extremities and other venous and lymphatic diseases is known. An area where compression bandages are considered particularly useful is in the management and treatment of chronic wounds such as venous leg ulcers. Compression bandages are one of the common compression devices used in compression therapy. Due to the elasticity of the elastic compression bandage, it can conform well to the contours of the lower leg of the patient. Compression treatment of venous leg ulcers involves providing high pressure to veins in the patient's lower leg while the patient is standing. Only a sufficiently high pressure can sufficiently support the so-called muscle pump to support healing. Lower stress levels are not considered therapeutic stress levels.

Generally, the unstretched, loose portions of the bandage do not provide therapeutic pressure. However, the compression bandage should conform sufficiently to the contour of the lower leg to provide therapeutic compression also to those portions of the lower leg having a smaller diameter. Thus, compression bandages are generally elastically stretchable in the length direction of the bandage so that they can be easily stretched with a small force before application to the lower leg. In the case where the same loop of bandage covers both the larger diameter portion and the smaller diameter portion of the lower leg, the bandage is stretched sufficiently prior to application so that even the smaller diameter portion remains covered by the stretched portion of the bandage and does not loosen or form a loose encapsulation. "Soft" easy stretch bandages have a relatively low modulus of elasticity.

On the other hand, an effective compression bandage should provide substantial resistance against small increases in the diameter of the lower leg, for example when the patient moves from a resting position to a standing position. Bandages that provide such resistance are commonly referred to as "inelastic" and will be referred to as "hard" in this disclosure. Hard bandages have a higher modulus of elasticity in the elongated state than soft bandages when they are applied. The hard bandage can provide more effective compression by low resting pressure and high standing or walking pressure. In other words, a hard bandage results in a higher static stiffness index, with a difference between static pressure and resting pressure of greater than about 10mm Hg. The use of a non-elastic "hard" compression bandage is particularly advantageous for patients with venous insufficiency, because the low resting pressure provides comfort when the patient is repositioned, while also preventing the expansion of the muscle diameter when the patient stands or walks, thereby increasing the return of the veins and lymph when the muscles of the legs contract. International patent application WO 2013/048755a1 describes such non-elastic hard bandages.

Disclosure of Invention

The resting pressure of the resulting soft (e.g., long stretch) compression bandage can be well controlled, but the sub-bandage standing pressure of such systems is not much higher than the resting pressure, resulting in less effective compression. On the other hand, hard (inelastic, e.g., short stretch) compression bandages are designed to provide standing pressure well above resting pressure, resulting in higher compression efficacy. Traditional bandages are designed to balance hardness and softness, often compromising both.

The present disclosure attempts to solve this problem. The present disclosure provides an elongated elastic compression bandage for application in a circumferential loop around a human lower leg for applying sufficient therapeutic pressure to the lower leg to treat venous leg ulcers, the bandage having a first major surface and an opposing second major surface, wherein a long extension of the bandage, when laid flat, defines a length direction, and wherein the bandage, arranged in its length direction, comprises: a) a first joining region arranged on the first main surface and comprising mechanical joining means, b) a second joining region arranged on the first main surface and comprising mechanical joining means, c) a soft segment arranged between the first joining region and the second joining region in the length direction of the bandage and having a decreasing modulus of elasticity in the length direction, d) a hard segment having an increasing modulus of elasticity in the length direction which is higher than the decreasing modulus and having a length which is greater than the length of the soft segment, wherein the length of the segment is determined by the longest extension of the segment in the length direction of the unrolled bandage and comprising a third joining region arranged on the second main surface, the third joining region comprising mechanical joining means for joining the first joining region and the second joining region, wherein the segment and the joining region are arranged such that, such that when the bandage is applied in a circumferential loop around the lower leg, a first portion of the third joining region can be joined with the first joining region in a subsequent loop and a second portion of the third joining region can be joined with the second joining region such that the hard segment bridges the soft segment.

The present disclosure also provides a kit of parts for forming a compression system for application around a lower leg of a human for applying a therapeutic pressure on the lower leg for treating venous leg ulcers, the kit comprising

a) An elastic compression sock for wearing as an inner layer on a human lower leg for applying a therapeutic pressure on the lower leg for treating venous leg ulcers, wherein the sock comprises a lower leg section arranged to compress the lower leg when the sock is worn, the lower leg section having an inner major surface for facing the skin and an opposed outer major surface, the elastic compression sock comprising,

i) a first joining region arranged on the outer main surface and comprising mechanical joining means,

ii) a second joining region arranged on the outer main surface and comprising mechanical joining means,

iii) a soft segment arranged between the first joining region and the second joining region and having a decreasing modulus of elasticity in the circumferential direction, an

b) A reinforcement wrap applied circumferentially around the compression sock as an outer layer when the compression sock is in use, the reinforcement wrap having an inner major surface for facing the compression sock and comprising,

i) two hard parts of linear shape, oriented in parallel and spaced from each other, having an elevated modulus of elasticity in the circumferential direction, each hard part comprising on its inner main surface a respective wrap engaging area comprising mechanical engaging means for engaging with a first engaging area and a second engaging area of the sock, and

ii) a soft portion arranged between the two hard portions and having a reduced modulus of elasticity in the circumferential direction, the reduced modulus of elasticity being lower than the elevated modulus,

wherein the wrap engagement region is arranged such that the reinforcement wrap is circumferentially applicable around the compression sock such that the wrap engagement region is engageable with the first engagement region and the second engagement region such that at least a portion of the hard portion of the reinforcement wrap bridges the soft section of the compression sock.

Drawings

Fig. 1 is a perspective view of a first compression bandage according to the present disclosure;

FIG. 2 is a side view of a first compression bandage applied for two turns;

fig. 3 is a top view of a second compression bandage according to the present disclosure;

fig. 4 is a bottom view of the second compression bandage;

FIG. 5 is a top view of a second compression bandage with two layers applied;

FIG. 6 is a perspective view of a compression sock according to the present disclosure;

FIG. 7 is a plan view of a reinforcement wrap according to the present disclosure;

FIG. 8 is a perspective view of the compression sock in use with a reinforcement wrap applied thereto; and is

Fig. 9 is a cross-sectional view of a flexible material for use in a bandage according to the present disclosure.

Detailed Description

The present disclosure provides an elongated elastic compression bandage for application in a circumferential loop around a human lower leg for applying sufficient therapeutic pressure to the lower leg to treat venous leg ulcers, the bandage having a first major surface and an opposing second major surface, wherein a long extension of the bandage, when laid flat, defines a length direction, and wherein the bandage, arranged in its length direction, comprises: a) a first joining region arranged on the first main surface and comprising mechanical joining means, b) a second joining region arranged on the first main surface and comprising mechanical joining means, c) a soft segment arranged between the first joining region and the second joining region in the length direction of the bandage and having a decreasing modulus of elasticity in the length direction, d) a hard segment having an increasing modulus of elasticity in the length direction which is higher than the decreasing modulus and having a length which is greater than the length of the soft segment, wherein the length of the segment is determined by the longest extension of the segment in the length direction of the unrolled bandage and comprising a third joining region arranged on the second main surface, the third joining region comprising mechanical joining means for joining the first joining region and the second joining region, wherein the segment and the joining region are arranged such that, such that when the bandage is applied in a circumferential loop around the lower leg, a first portion of the third joining region can be joined with the first joining region in a subsequent loop and a second portion of the third joining region can be joined with the second joining region such that the hard segment bridges the soft segment.

In the first circumferential loop (and possibly further loops, depending on the position of the hard segment in the length direction) of the bandage around the lower leg, the soft segment is not yet bridged and remains easy to stretch. Thus, the entire bandage is softer than the hard sections alone, and is able to conform to the components of the lower leg having a smaller diameter without forming loose parts.

In the second circumferential loop (or later loops depending on the position of the hard segment in the length direction), after the joining area is joined, the soft segment is bridged by the hard segment. The lower elastic modulus characteristic of the soft segment is covered by the higher elastic modulus of the hard segment, whereby the entire bandage becomes stiffer and presents a higher resistance to an increase in the calf diameter.

The joining of the third joining region of the hard segment with the respective first and second joining regions of the two hard segments adjacent to the soft segment, and the resulting bridging of the soft segment by the hard segment, changes the properties of the bandage as a whole to a higher stiffness than before the joining. This is desirable for effective compression therapy of venous leg ulcers.

Bandages according to the present disclosure have a common geometry: it is elongate and its long extension defines the length direction of the bandage when laid flat. The bandage is long enough for winding in at least two complete circumferential turns around a typical human calf. The circumferential ring is the ring that follows the circumference of the lower leg. The bandage extends between a first side edge and a second side edge in a direction orthogonal to the length direction ("width direction"). The sides may be parallel to each other. The thickness direction of the bandage is a direction orthogonal to both the length direction and the width direction. Bandages according to the present disclosure may have a length of between 15 centimeters (cm) and 500cm, preferably between 70cm and 300cm, when unexpanded. A bandage according to the present disclosure may have a width of between 5cm and 20cm, preferably between 7cm and 15cm, when not unfolded.

A section of a bandage refers to a longitudinal portion of the bandage, for example as a result of subdivision of the bandage in its length direction. The segment may extend from the first side edge to the second side edge.

The bandage may extend widthwise between a first side edge and a second side edge. The second side edge may be parallel to the first side edge. The hard and soft sections may extend from the first side edge to the second side edge. In a bandage having a plurality of hard segments according to the present disclosure, each hard segment may extend from a first side edge to a second side edge. In a bandage having a plurality of soft segments according to the present disclosure, each soft segment may extend from a first side edge to a second side edge.

Bandages comprising rectangular sections may be particularly cost effective to manufacture. Thus, each reinforcement section may have a rectangular shape and may extend from the first side edge to the second side edge. Each soft segment may have a rectangular shape and may extend from a first side edge to a second side edge.

Alternatively, each reinforcement section may have a trapezoidal shape and may extend from the first side edge to the second side edge. Each soft segment may have a trapezoidal shape and may extend from the first side edge to the second side edge.

In general, any section of the bandage may have a length. In the context of the present disclosure, the length of a segment refers to the maximum extension of the segment in the length direction of the bandage when the bandage is not unfolded and flattened.

In the present disclosure, the modulus of elasticity is referred to as a measure of the resistance of a segment of the bandage or the entire bandage to (further) extension in the length direction. For elastic fabrics commonly used for compression bandages, the modulus is expressed in newtons/(additional) centimeters of extension, per cm width of the test sample, and per cm thickness of the sample. However, in the present disclosure, the thickness of the sample is not considered, and the "elastic modulus" is independent of the thickness of the sample. As used herein, elastic modulus refers to the force per percent of width elongation, i.e., its elastic modulus in the conventional sense multiplied by the thickness of the sample.

Generally, the modulus of elasticity of the hard sections of the bandage according to the present disclosure must be higher than the modulus of elasticity of the soft sections. The modulus of elasticity of the hard segment may be, for example, more than 10%, more than 30%, or even more than 50% higher than the modulus of elasticity of the soft segment. This ensures that a stiffening effect on the bridging of the bandage is obtained. The absolute values of the modulus of elasticity of the hard and soft segments are less relevant for effective bridging. A material having a modulus of elasticity may be used to form the hard segments in one type of bandage, while the same material may be used to form the soft segments in another type of bandage.

The material used in the hard segment ("hard material") of the compression bandage according to the present disclosure has an elevated elastic modulus, i.e., an elastic modulus of greater than 0.03N/cm/% measured at an elongation of 5% relative to the unstretched length, regardless of the thickness of the material. "N/cm/%" refers to the elastic force in newtons divided by the width of the material (in centimeters) and divided by the percent additional elongation at 5% elongation. Percent elongation is determined by dividing the elongation length by the unstretched length and multiplying by 100. Preferred hard materials have an elastic modulus of greater than 0.30N/cm/% measured at 5% elongation relative to the unstretched length. The typical modulus of elasticity of a hard material is 0.40N/cm/%, measured at 5% elongation relative to the unstretched length.

The material used in the soft segment ("soft material") of the compression bandage according to the present disclosure has a reduced elastic modulus, i.e., an elastic modulus of less than 0.10N/cm/% measured at 5% elongation relative to the unstretched length. The modulus of elasticity can be measured on a number of commercially available tensile elongation test machines. The modulus of elasticity of a section of the bandage can be determined, for example, by measuring the modulus of elasticity of a 5cm wide sample of material, wherein the section is measured in the direction of stretch, i.e. the length of the bandage on a tensile elongator, at room temperature (22 ℃) at an elongation of 5% relative to the unstretched length.

The modulus of elasticity in the length direction may be different at different elongations of the bandage. In the context of the present disclosure, elastic modulus generally refers to the modulus at the elongation at which the bandage is wrapped around the lower leg of a patient. In the context of the present disclosure, the elastic modulus is measured at an elongation of 5% relative to the unstretched length.

Once the hard segment bridges the soft segment, its elasticity determines the stiffness of the bandage in the area of the bandage where the hard segment joins. For effective therapeutic compression, the elastic modulus is advantageously relatively high. The hard segment may have an elastic modulus in the length direction of greater than 0.03N/cm/% measured at an elongation of 5% relative to the unstretched length. In particular, the hard segment may have an elastic modulus in the length direction of greater than 0.10N/cm/% measured at an elongation of 5% relative to the unstretched length. Hard segments can be rendered hard by a very high modulus of elasticity. In a bandage according to the present disclosure having a plurality of hard segments, each hard segment may have an elastic modulus in the length direction of greater than 0.03N/cm/% measured at an elongation of 5% relative to the unstretched length.

In order to conform the bandage to the contour of the lower leg, the soft section advantageously has a relatively low modulus of elasticity in the length direction of the bandage. The soft segment may have an elastic modulus in the length direction, measured at an elongation of 5% relative to the unstretched length, of less than 0.10N/cm/%, preferably less than 0.05N/cm/%. In a bandage according to the present disclosure having a plurality of soft segments, each soft segment may have an elastic modulus in the length direction of less than 0.10N/cm/% measured at an elongation of 5% relative to the unstretched length. Preferred soft materials have an elastic modulus of less than 0.05N/cm/% measured at 5% elongation relative to the unstretched length. The typical modulus of elasticity of the soft material, measured at 5% elongation relative to the unstretched length, is 0.04N/cm/%.

The segments of a bandage according to the present disclosure may be elastic. In particular, they may be elastic in the length direction of the bandage. Generally, when stretched or stretched in the lengthwise direction by the force typically used when applying a compression bandage, the elastic segments attempt to return to their original, un-stretched length. When applied in an expanded state around the lower leg, the expanded elastic segments and the expanded elastic bandage attempt to return to their original unexpanded length, and the resulting contractive force exerts a therapeutic compression on the lower leg.

Any portion may be made of or contain an elastic material, such as an elastic fabric. Such fabrics are known and fabrics with different elastic moduli, such as Spandex, Lycra or fabrics comprising elasticity, are commercially available under the trade name such as Lycra, Elaspan, Acepora, Creora, Inviya, ROICA, Dorlastan, line or ESPA from fabric.

The soft segment, any soft segment, or all soft segments may have a reduced modulus of elasticity. The hard segments, any hard segments, or all hard segments may have an elevated modulus of elasticity. Any section may extend over at least a portion of its length from the first side edge to the second side edge of the bandage.

The joining areas of the segments of the bandage refer to the parts of the segments that comprise the mechanical joining means or are collectively referred to as those parts. The joining area may thus be composed of one or two or more parts each comprising mechanical joining means. The engagement area may comprise different types of engagement means. A portion of the engagement region may comprise different engagement means. Due to the presence of the mechanical engagement means, the engagement area is adapted to mechanically engage with another engagement area. In the context of the present disclosure, the expression "positively engaging" or "engaging" refers to establishing a mechanical connection between two elements which prevents relative movement of the engaging elements in the length direction of the bandage. In a bandage according to the present disclosure, a first portion of the third joining region may be joined with the first joining region, and a second portion of the third joining region may be joined with the second joining region.

In the context of the present disclosure, the mechanical engagement means may be, for example, an adhesive bearing surface. This surface can be mechanically joined to another surface (adhesive coated or uncoated) via an adhesive by bringing the surfaces into mechanical contact with each other. The adhesive provides a mechanical bond between the surfaces that prevents relative movement of the surfaces, for example in a direction parallel to the surfaces.

Alternatively or additionally, the mechanical engagement may be obtained by magnetic means. The mechanical engagement means may thus comprise a magnet. With the magnetic means, the surface of the magnetising element may contact the surface of the opposing magnetising element. Properly oriented magnets will attract each other such that their surfaces contact each other. The magnetic force may increase friction between the contacting surfaces, which in turn prevents relative movement of the surfaces in a direction parallel to the surfaces.

In certain embodiments, the engagement device comprises a first component of a two-component connection system (such as, for example, a two-component mechanical fastening system). The first component is engageable with the second component of the two-component connection system to establish a mechanical connection and prevent relative movement of the engagement elements in the length direction of the bandage. Examples of two-part attachment systems are hook-and-loop type fastening systems, mechanical fastener type attachment systems such as those comprising a surface bearing mushroom-shaped microstructures that can engage with an opposing surface also bearing such mushroom-shaped microstructures.

Hook-and-loop type engagement can be achieved by having one engagement area with a surface covered with engagement means in the form of small hooks and having a corresponding opposite engagement area with an engagement yellow-faithful surface covered with a number of small loops of filaments. The hooks or surfaces provided with hooks are components of a two-component connection system. The ring or surface with the ring is a component of a two-component connection system. When the regions are brought into contact, the loops entangle with the hooks, thereby engaging the engagement regions. Thus, relative movement between the surfaces of the joining area, in particular in a direction parallel to the surfaces and/or if suitably arranged in the length direction of the bandage, is prevented. One example of a hook and loop type engagement is the well known velcro (r) fastening system. A material that may be used as an engagement means in a bandage, sock or wrap according to the present disclosure is "Loop 001", available from Velcro or "Hook 088", also available from Velcro. These materials are hard such that they can be used to form hard segments in bandages according to the present disclosure. Alternatively, they may be attached to the surface of a hard material, thereby forming a hard segment. An alternative hook material is available from Gotelley's Binder limit formula (Gottlieb Binder GmbH & Co. KG of Holzerlingen, Germany) from Holelin, Germany.

The engagement area may thus comprise an engagement means in the form of a fabric, or a fabric surface adapted to engage with a hook surface or a mushroom structured surface, such as the surface of a nonwoven fabric. The engagement region may comprise engagement means in the form of a hook-type surface adapted to engage with a loop-type surface. The engagement region may comprise engagement means in the form of a loop-type surface adapted to engage with a hook-type surface. In certain embodiments, the first and/or second engagement regions comprise engagement means in the form of a plurality of hooks and the third engagement region comprises engagement means in the form of a plurality of loops suitably shaped to mechanically engage the same hooks as the hooks of the first and/or second engagement regions. In certain other embodiments, the first and/or second engagement regions comprise engagement means in the form of a plurality of loops and the third engagement region comprises engagement means in the form of a plurality of hooks suitably shaped to mechanically engage the same loops as the loops of the first and/or second engagement regions.

So-called mechanical fastening systems are known fastening systems. They provide a joint between two opposite joining areas, the surfaces of which are covered with a large number of mushroom-shaped elements. When the areas are brought into contact with each other under a certain moderate pressure, the "tops" of the mushroom elements hook into each other and prevent relative movement, especially in a direction parallel to the surface and/or the length direction of the bandage (if properly arranged). An engagement means in the form of a mechanical fastening system may be used in a compression bandage according to the present disclosure to engage the third engagement region with the first and second engagement regions. In such embodiments of the bandage, the first and/or second engagement region comprises engagement means in the form of a plurality of mushroom-shaped fastening elements, and the third engagement region, or at least a portion thereof, comprises engagement means in the form of a plurality of mushroom-shaped fastening elements adapted to mechanically engage with the same mushroom-shaped fastening elements as the mushroom-shaped fastening elements of the first and/or second engagement region.

Alternatively or additionally, the mechanical engagement may be achieved via one or more friction enhancing layers. Where the bond region includes a bonding means in the form of an exposed friction enhancing layer (e.g., a tacky adhesive layer), the bond region may be in contact with an opposing bond region having a bonding means in the form of a "landing zone" for contacting the opposing friction enhancing layer. Under moderate pressure, the friction enhancing layer on one joint area will adhere to the landing zone on the corresponding opposite joint area and prevent relative movement in a direction parallel to the contact surface of the joint area and/or in the length direction of the bandage.

Thus, in certain embodiments of the bandage according to the present disclosure, the first joining region and/or the second joining region comprise joining means in the form of an exposed friction enhancing layer adapted to mechanically bond with the same exposed surface as the exposed surface of the third joining region. In certain embodiments, the third joining region comprises joining means in the form of an exposed friction enhancing layer adapted to mechanically engage the same exposed surface as the first joining region or the second joining region.

For a stronger joining effect, the two opposing joining regions may comprise joining means in the form of respective friction-enhancing layers. Thus, in certain embodiments of the bandage according to the present disclosure, the first joining region and/or the second joining region comprise joining means in the form of an exposed friction enhancing layer, and the third joining region comprises joining means in the form of an exposed friction enhancing layer adapted to mechanically engage with the same friction enhancing layer as the first joining region and/or the second joining region.

Alternatively or additionally, mechanical bonding may be achieved via one or more exposed adhesive layers. Where the joining region has a joining means in the form of an exposed adhesive layer (e.g. a tacky adhesive layer), the joining region may be in contact with an opposing joining region having a joining means in the form of a "landing zone" for contacting the opposing adhesive layer. Under moderate pressure, the adhesive layer on one joining region will adhere to the landing zone on the corresponding opposing joining region and prevent relative movement in a direction parallel to the contact surface of the joining region and/or in the length direction of the bandage. Thus, in certain embodiments of the bandage according to the present disclosure, the first joining region and/or the second joining region comprises joining means in the form of an exposed adhesive layer, and the third joining region comprises joining means in the form of an exposed landing zone adapted to mechanically join with the same adhesive layer as the adhesive layer of the first joining region and/or the second joining region.

For a stronger joining effect, the two opposite joining regions may comprise joining means in the form of respective adhesive layers. Thus, in certain embodiments of the bandage according to the present disclosure, the first joining region and/or the second joining region comprises joining means in the form of an exposed adhesive layer, and the third joining region comprises joining means in the form of an exposed adhesive layer adapted to mechanically join the same adhesive layer as the adhesive layer of the first joining region and/or the second joining region.

The joining region may be arranged on a main surface of the segment contained therein. In particular, the first joining region may be arranged on a main surface of the first pressing section. Preferably, it is arranged on a main surface of the first compression area, which main surface is oriented radially outwards when the bandage is applied around the lower leg.

The second joining region may be arranged on a main surface of the second pressing section. Preferably, it is arranged on a main surface of the second compression area, which main surface is oriented radially outwards when the bandage is applied around the lower leg.

The third joining region may be arranged on a main surface of the hard section. Preferably, it is arranged on a main surface of the hard section, which main surface is oriented radially inwards when the bandage is applied around the lower leg.

The joining region may cover a certain area of the main surface of the segment contained therein. For example, it may cover 2 square centimeters (cm)2) And 200cm2The area in between. However, for ease of application, it is preferred that the coaptation area cover 10cm2And 100cm2The area in between.

The material of the segments (e.g., the first urging segment, the second urging segment, or the hard segment) may be selected such that one of its major surfaces is adapted to be mechanically engaged by the engagement region. In such cases, the entire major surface of the segment may form the joint region.

As defined above, the soft segments of the bandage according to the present disclosure have a decreasing modulus of elasticity in the length direction of the bandage. The soft segment may extend from the first side edge to the second side edge of the bandage. Which may extend over at least a portion of its length from the first side edge to the second side edge of the bandage.

For a given length of bandage, the length of the soft segment affects the stiffness of the bandage. If the soft segments occupy a large percentage of the bandage length, the bandage will conform better to the contours of the patient's lower leg. However, a shorter soft segment may make the bandage stiffer and thereby allow a higher degree of therapeutic compression. The length of the soft segment should be less than the circumference of the lower leg. The soft section may have a length between 1cm and 20cm when the bandage is not unrolled and laid flat. Preferably, the soft segment may have a length between 3cm and 10cm when the bandage is not unrolled and arranged flat. Preferably, the length of the soft segments and the length of the hard segments are selected such that there are three to six soft segments between each turn of the bandage around a typical human lower leg.

Where a bandage according to the present disclosure has additional soft segments, the lengths of the multiple soft segments may be equal. In this case, the length of each soft segment may be, for example, between 1cm and 20 cm.

A suitable material for forming the soft segments in a bandage according to the present disclosure is "Coban LF," available from 3M Company of saint paul, Minnesota, usa (3M Company, st.

As defined above, the hard segments of the bandage according to the present disclosure have an elevated modulus of elasticity in the length direction of the bandage. The hard segment may extend from the first side edge to the second side edge of the bandage. Which may extend over at least a portion of its length from the first side edge to the second side edge of the bandage.

For a given length of bandage, the length of the hard segment may affect the stiffness of the bandage before the bandage is applied around the lower leg. If the hard segments occupy a greater percentage of the bandage length, the bandage is generally stiffer and therefore may allow a higher degree of therapeutic compression. The or each hard segment may have a length of between 1cm and 20 cm. Preferably, the or each hard segment may have a length of between 3cm and 10 cm.

Where a bandage according to the present disclosure has additional hard segments, the lengths of the multiple hard segments may be equal. In this case, the length of each hard segment may be, for example, between 1cm and 20 cm.

The hard segment may have a first end and an opposite second end in a length direction of the bandage. The first end portion may comprise a first portion of the third engagement region. The second end portion may comprise a second portion of the third joining region.

In other words, the first end of the hard segment may be located at one longitudinal end of the hard segment and the second end may be located at the opposite longitudinal end of the hard segment. The first portion of the third joining region of stiff strength may be arranged at one longitudinal end, e.g. the edge of the third joining region is located within 2cm or 5cm from one longitudinal end of the stiff section. The second portion of the third joining region of the hard segment may be disposed at the opposite longitudinal ends, e.g., the edge of the second portion of the third joining region is located within 2cm or 5cm from the opposite longitudinal ends of the hard segment.

Stiff elastic fabrics are generally quite dense and do not allow a sufficient amount of air to pass through. This can cause skin irritation under the hard segment. To avoid such irritation, the hard segment may include apertures for facilitating the transfer of air between the lower and upper major surfaces. Where the compression bandage comprises a plurality of hard segments, at least one of the hard segments may comprise apertures for facilitating the transfer of air between the lower major surface and the upper major surface.

A compression bandage according to the present disclosure is adapted to be wrapped around a human calf in multiple turns. This means that the bandage is flexible, i.e. it can be deformed so as to follow the contour of the lower leg. In the context of the present disclosure, flexibility is considered to be independent of elasticity. In order for the bandage to be flexible, all sections of the bandage are preferably flexible. The first pressing section and/or the second pressing section may be flexible. The soft segment may be flexible. The hard section may be flexible.

Alternatively, however, one or more of the segments may be inflexible, i.e. rigid. In particular, the hard section may be rigid. If the hard segment is rigid, its modulus of elasticity in the length direction is very high and can have typical values for solid nonelastomers.

The hard segment bridges the soft segment when the engagement region of the hard segment engages with the respective engagement regions of the first and second compression segments. When bridged, the hard segments may extend parallel to the soft segments, i.e., the major surfaces of the hard and soft segments may be parallel to each other, both conforming to the lower leg of the patient. When the bandage is not unrolled and laid flat, the hard segment has a length as defined herein that is greater than the length of the soft segment.

Certain bandages according to the present disclosure will be applied sequentially around the lower leg with subsequent loops overlapping the previous loop by about half the bandage width. In these bandages, the hard segment will bridge the soft segment below it, but it may only overlap the soft segment with half of its width. Bridging is believed to exist where 100% overlap of the width between the hard segment and the underlying soft segment is down to about 10% width overlap.

Bridging the soft region by the hard region results in a bandage that is stiffer in the region of the soft region because the hard region has an elevated modulus of elasticity compared to the modulus of the soft region. When the diameter of the lower leg is slightly increased, the bandage in the area of the soft area can be unfolded against the (higher) resistance of the hard area only, whereas it can be unfolded against the (lower) resistance of the soft area before bridging.

The soft segment is adapted to be deployed prior to application of the bandage around the lower leg. In order to make it easier for the third joining area on the hard segment to join with the first joining area and with the second joining area, the first part and the second part are preferably spaced apart from each other in the length direction by a distance which is greater than the length of the soft segment when the bandage is not unrolled and laid flat. Thus, when the bandage is not unrolled and arranged flat, the first and second portions of the third joining region may be spaced apart from each other in the length direction of the bandage by a longitudinal distance that is greater than the length of the soft segment.

In order that a bandage according to the present disclosure may be used to treat a number of different circumferences of the lower leg, the bandage advantageously comprises more than one soft segment and more than one hard segment. A bandage according to the present disclosure may therefore include,

a) a plurality of soft segments, each soft segment having a decreasing modulus of elasticity in the length direction, an

b) A plurality of hard segments, each hard segment having an elevated modulus of elasticity in the length direction, the plurality of hard segments being arranged alternately with the plurality of soft segments in the length direction of the bandage.

Each hard segment of the plurality of hard segments comprises a first joining region and a second joining region on the first major surface and a third joining region on the second major surface, the third joining region being arranged such that a first portion of the third joining region is engageable with a first joining region of a first other hard segment of the plurality of hard segments and a second portion of the third joining region is engageable with a second joining region of a second other hard segment of the plurality of hard segments such that the hard segment bridges the soft segment between the first other hard segment and the second other hard segment.

The bandage may consist of a sequence of "soft-hard-soft-hard" segments, with no other segments between the soft region and the adjacent hard region. Such bandages may be particularly cost effective to manufacture.

The arrangement of the first and second joining regions on the first major surface of each hard segment facilitates their joining with the third or fourth joining region of the other hard segment, which can be positioned on the hard segment in a subsequent turn of the bandage as it is wrapped around the lower leg.

The arrangement of the third joining region on the second major surface of each hard segment facilitates its joining with the first or second joining region of the other hard segment, which may be positioned underneath the hard segment in the previous turn of the bandage when the bandage is wrapped around the lower leg.

In bandages having multiple hard segments and multiple soft segments, the area occupied by the hard segments has an effect on the overall stiffness of the entire bandage. "area" refers to the geometric surface area covered by the bandage when laid flat in an unstretched state. When typical commercially available elastically stretchable materials with elevated elastic moduli are used for the hard segments, it has been found to be advantageous if the hard segments occupy more than half of the geometric bandage area when the bandage is not unrolled and laid flat. Such bandages have suitable overall stiffness for effective compression treatment of venous leg ulcers. Thus, in certain embodiments of the bandage according to the present disclosure, the bandage, when unrolled and arranged flat, covers the geometric bandage area, and wherein the plurality of hard segments occupy at least 50% of the geometric bandage area. In particular, the plurality of hard segments may occupy at least 70% of the geometric bandage area.

In the case of soft areas which are not bridged by successive hard areas, the bandage remains easily stretchable in the area of the soft areas. In this region, it may not provide sufficient therapeutic pressure on the lower leg. It is therefore desirable to avoid such "unbridged" soft regions.

Since many bandages according to the present disclosure may be applied to a lower leg with an overlap of about 50% of the width between the lower and subsequent upper loops, the right hand side (when looking at the length direction of the bandage towards its not yet applied end) will be covered by the left hand side of the subsequent upper loop, and vice versa. Thus, if the right side of each hard segment is provided with a joining region extending linearly in a first diagonal direction (such as forming an angle of + 45% with the length direction of the bandage in the plane of the bandage in the case of a flat arrangement) and a joining region extending linearly in a second diagonal direction (such as forming an angle of-45% with the length direction of the bandage in the plane of the bandage in the case of a flat arrangement), then the unbridged soft regions can be reduced or avoided. When a first turn of the bandage is covered in width by a subsequent turn with a 50% overlap, the joint area on the upper major surface of the hard segment in the first turn and the joint area on the lower major surface of the hard segment in the subsequent turn form an "X" pattern with intersecting diagonals. In this geometry, bonding and bridging are likely to occur. The "herringbone" shape combines two diagonal corners in different directions arranged side by side in the width direction. Therefore, the joining region in this herringbone shape seems to be advantageous.

Thus, in certain embodiments of bandages according to the present disclosure, the third joining regions of at least two consecutive hard segments may have a consistent "herringbone" shape and points in the same length direction of the bandage. At least two chevron shapes may be spaced apart from one another in the length direction by one or more respective chevron soft sections.

When the hard segments have a chevron shape extending from one side to the opposite side and the soft segments have a chevron shape extending from one side to the opposite side, at least one hard segment must be of sufficient length to bridge at least one soft segment. In some embodiments, the length of each chevron soft segment may be less than the length of any of the chevron hard segments. In embodiments in which at least two consecutive hard segments each have a uniform chevron shape, are oriented parallel to each other and are directed in the same length direction of the bandage, being spaced apart from each other in the length direction by one or more respective chevron soft segments, the length of each of the chevron soft segments may be less than 80% of the minimum length of each of the at least two chevron hard segments.

A compression bandage as described herein may be used in a single layer compression bandage system or alternatively in a two layer compression bandage system, where an outer bandage is wrapped around an inner bandage. They can be used, for example, as an external bandage, applied over an internal bandage forming a cushioning or comfort layer. In yet another alternative use, a bandage as described herein may be used as an inner layer in a two layer compression system, wherein the elastic sock forms an outer layer. This stacking may improve the visual appearance of the compression system when worn and/or may prevent the inner compression bandage from loosening or sliding on the lower leg.

Embodiments of the present disclosure include, but are not limited to, compression bandages. Additionally, compression socks may benefit from the present disclosure:

a kit of parts for forming a compression system according to the present disclosure includes a sock having one or more soft, easily stretchable circumferential sections arranged circumferentially between two respective engagement regions. Due to the soft segment, the sock is easy to put on and does not require a large amount of force to be exerted on the patient's leg. Once the sock is applied, a separate reinforcement wrap is applied as a second layer around the sock. In certain embodiments, the reinforcement wrap has one or more hard portions that are linearly shaped and arranged parallel to each other. The hard portion has a corresponding wrap engaging region on its inner surface. The soft segments are arranged between the hard portions of the reinforcement wrap such that the reinforcement wrap can conform to the contours of the lower leg. With the joining areas suitably spaced apart, the joining area on the inner side of the reinforcement wrap can be joined with two corresponding joining areas on the outer part of the sock, so that the hard part of the reinforcement wrap bridges the soft section between the two joining parts of the sock.

Bridging the soft sections of the sock with the hard sections of the reinforcement wrap results in the entire compression system being stiffer in the area of the soft sections than before bridging and provides a higher resistance to small increases in the diameter of the lower leg of the patient. This in turn increases the efficacy of the treatment of compression. Preferably, the plurality of hard portions of the reinforcement wrap bridge the plurality of soft sections of the sock.

Accordingly, the present disclosure also provides a kit of parts for forming a compression system for application around a lower leg of a human for applying a therapeutic pressure on the lower leg for treating venous leg ulcers, the kit comprising

a) An elastic compression sock for wearing as an inner layer on a human lower leg for applying a therapeutic pressure on the lower leg to treat a venous leg ulcer,

wherein the sock comprises a calf section arranged to compress a calf when the sock is worn, the calf section having an inner major surface for facing the skin and an opposed outer major surface, comprising,

i) a first joining region arranged on the outer main surface and comprising mechanical joining means,

ii) a second joining region arranged on the outer main surface and comprising mechanical joining means,

iii) a soft segment arranged between the first joining region and the second joining region and having a decreasing modulus of elasticity in the circumferential direction, an

b) A reinforcement wrap applied circumferentially around the compression sock as an outer layer when the compression sock is in use, the reinforcement wrap having an inner major surface for facing the compression sock and comprising

i) Two hard parts of linear shape, oriented in parallel and spaced from each other, having an elevated modulus of elasticity in the circumferential direction, each hard part comprising on its inner main surface a respective wrap engaging area comprising mechanical engaging means for engaging with a first engaging area and a second engaging area of the sock, and

ii) a soft portion arranged between the two hard portions and having a reduced modulus of elasticity in the circumferential direction, the reduced modulus of elasticity being lower than the elevated modulus,

wherein the wrap engagement region is arranged such that the reinforcement wrap is circumferentially applicable around the compression sock such that the wrap engagement region is engageable with the first engagement region and the second engagement region such that at least a portion of the hard portion of the reinforcement wrap bridges the soft section of the compression sock.

Generally, the hard portion of the reinforcement wrap according to the present disclosure must have a modulus of elasticity that is higher than the modulus of elasticity of the soft section of the sock that it bridges in use. The modulus of elasticity of the hard portion may be, for example, more than 10%, more than 30%, or even more than 50% higher than the modulus of elasticity of the soft section of the sock. This ensures that a stiffening effect on the bridge of the sock is obtained. The absolute values of the elastic moduli of the hard and soft segments are less relevant for effective bridging. The different values of the modulus of elasticity of the hard and soft segments cited above for the compression bandage according to the present disclosure are equally applicable to the hard and soft segments of the sock and the hard and soft portions of the reinforcement wrap described herein.

The size and arrangement of the splicing area on the sock can be suitably selected to ensure that the splicing area on the reinforcement wrap has a splicing area on the sock to splice. For example, all the joined areas of the sock can be made very large. However, this can result in the entire sock being rather stiff and difficult to don, even before the reinforcement wrap is applied. It is believed that the stiff portion on the reinforcement wrap is made large-which can make the reinforcement wrap quite stiff so that it does not conform well to the contours of the patient's leg and form a loose package. Alternatively, it may be considered to make the hard portion of the reinforcement wrap smaller and the soft portion larger, in order to make the reinforcement wrap softer so that it does better conform to the contours of the patient's legs and has less risk of forming a loose package.

The sock as described herein may be made of a material known as "indianapolis", for example, which is available from MITI of ulluna, italy (manicattura italian tissue analysis indemegliti s.p.a.). "Indianapolis" has 83% polyester and 17% elastomer. Alternatively, a material labeled "dragonfly" also available from MITI may be used, comprising 95% polyester and 5% elastomer. The strips of Velcro hook material described above can be sewn to the Indianapolis or Dradonfly material to form the engagement regions.

The following arrangement of the hard segments and the joint region has been found to be advantageous: the joining region of the sock may have a linear elongate shape. The hard section of the sock may have a linear elongate shape. The linear shape may be, for example, a linearly curved shape or a linearly straight shape. The hard segments (or all of the hard segments) may extend longitudinally in a direction that forms an angle of between 20 ° and 70 ° (e.g., 45 °) with the circumferential direction of the sock. The circumferential direction of the sock refers to the circumferential direction when the sock is used on a leg. When the sock is worn, the circumferential direction of the sock is parallel to the circumferential direction of the leg.

The wrap engagement area on the reinforcing wrap may also have a linear elongated shape. The stiff portion of the reinforcement wrap may have a linear elongated shape, such as a linear straight shape or a linear curved shape. If the reinforcement wrap is applied around the compression sock, it may be advantageous to apply it such that the lengthwise direction of the engagement area of the wrap forms an angle of about 90 ° with the lengthwise direction of the engagement area of the sock. This may facilitate the engagement between more engagement areas of the sock and more wrap engagement areas of the reinforcement wrap.

The reinforcement wrap as described herein may also be made of, for example, "indianapolis" material or "Dragonfly" material. The strips of Velcro loop material described above may be sewn to indianapolis or Dragonfly material to form the wrapper engagement regions.

In some embodiments, the sock includes soft and hard segments in alternating order along a circumferential direction of the sock. Then, a first and second joining region that facilitate bridging the soft section of the sock may be included in the hard section on opposite ends of the soft section. Alternatively, they may be arranged within the soft segment, for example at opposite ends of the soft segment. In this case, only the portion of the soft zone located between the first joining zone and the second joining zone may be bridged by the corresponding hard portion of the reinforcement wrap.

In certain embodiments, the reinforcing wrap comprises soft segments and hard segments in alternating sequence along one direction of the wrap. The wrap-engaging regions of the reinforcing wrap may then be included in two different soft sections adjacent opposite ends of the hard section. Alternatively, the wrap-engaging regions of the reinforcing wrap may be included in the/one hard portion, for example at opposite ends of the hard portion. In the latter case, only a part of the hard part is available for bridging.

The present disclosure will now be described in more detail with reference to the accompanying drawings, which illustrate specific embodiments of the disclosure.

Fig. 1 is a perspective view of an illustration of a first compression bandage according to the present disclosure. The compression bandage 1 is shown laid flat and not unfolded. Having a first major surface 10 and an opposite second major surface 20. The long extension of the bandage 1 defines the length direction of the bandage 1, indicated by arrow 100. The width of bandage 1 defines a width direction 110 and the thickness of the bandage defines a thickness direction 120.

The bandage 1 is arranged in sequence along its length 100 and includes a plurality of soft segments 70 and a plurality of hard segments 80 in alternating sequence. The soft segments 70 have a reduced modulus of elasticity, i.e., they can be stretched with relatively little force along the length direction 100. The hard segments 80 have an elevated modulus of elasticity, i.e., they require more force in the length direction 100 to stretch at the same distance as the distance required for the soft segment sections 70. The soft segments 70 all have the same length 130. In addition, the hard segments 80 all have the same length 90, which is greater than the length 130 of the soft segments 70. Each hard segment 80 and each soft segment 70 extend from a first side edge 200 to an opposite second side edge 210 of the bandage 1.

The bandage 1 arranged in its longitudinal direction 100 comprises a first joining region 30 and a second joining region 40, which are each arranged on the first main surface 10 of the bandage 1 and on the respective hard segment 80. Both engagement areas 30, 40 comprise respective engagement means 50, 60 in the form of a plurality of small hooks. The first and second joining regions 30, 40 are arranged adjacent to opposite longitudinal ends of the leftmost soft segment 70a such that the soft segment 70a is arranged between the first and second joining regions 30, 40 in the length direction 100.

The hard segment 80 includes a third bonding region 140 on its second major surface 20. The third engagement region 140 of each hard segment 80 comprises engagement means 160 in the form of a plurality of loops suitably shaped to mechanically engage the same hooks as those of the first or second engagement regions 30, 40. Once the bandage is applied to the lower leg of the patient, a first portion of the third joint region 140 will be joined with the first joint region 30 of the hard segment 80, which is different from the hard segment 80 on which the third joint region 140 is disposed. A second portion of the third joining region 140 will join with the second joining region 40 of the hard segment 80, which is different from the hard segment 80 on which the third joining region 140 is arranged.

Fig. 2 is a side view of the first compression bandage 1 shown in fig. 1 applied around a lower leg 160 shown in cross-section. The bandage 1 is applied in two loops around the lower leg 160, resulting in a previous inner loop 179 and a subsequent outer loop 180 of the same bandage 1. The outer ring 180 is applied over the inner ring 179 with a 50% overlap in the width direction, and fig. 2 is a side view of the rings 179, 180 where they overlap. The rightmost hard section 80a, 80b of the inner loop 179 comprises on the first main surface 10 of the bandage 1a respective first 30 and second 40 engagement area with mechanical engagement means 50, 60 in the form of hooks. The soft segments 70a are arranged in the length direction 100 between the respective first joining zones 30 and the respective second joining zones 40.

It can be seen that the right hand portion of the third engagement region 140 of the rightmost hard segment 80c of the outer loop 180 engages with the first engagement region 30 on the first major surface 10 of the first hard segment 80a of the previous inner loop 179. In addition, the left hand portion of the third engagement region 140 of the rightmost hard segment 80c of the outer collar 180 engages with the second engagement region 40 on the first major surface 10 of the second hard segment 80b of the previous inner collar 179. In this arrangement, the hard segment 80c bridges the soft segment 70 a.

Thus, the hard segments 80a and 80a are connected to each other in two ways: first, via the soft zone end 70a between them, and second, via the hard zone 80c of the subsequent turn 180. Since the joining of the joining regions 30, 40, 140 prevents relative movement of the hard segments 80a, 80b, 80c in the length direction 100 of the bandage 1, the bandage 1 is significantly stiffer (i.e., resists a slight increase in the diameter of the lower leg 160) in the region bridging the soft segment 70 a. Prior to bridging, only the soft segment 70a presents a (lower) resistance to the increase in diameter of the lower leg 160, while in the case of bridging, the soft segment 70a and bridging hard segment 80c present a significantly higher resistance to such increase in diameter.

The pattern of longitudinally alternating hard and soft regions 80, 70 of the bandage 1 indicates that the joining means 50, 60 on the first major surface 10 of the hard segment 80 may form either the first joining region 30 or the second joining region 40, depending on whether they are joined with the first or second part of the third joining region 140 of the hard segment 80 of the subsequent turn 180. However, this is only a naming problem.

In the left part of fig. 2, one of the soft segments 70 of the inner circle 179 (i.e., the soft segment 70b) is not bridged by an overlying hard segment 80 in the upper circle 180. This is due to the longitudinal registration mismatch between the inner 179 and outer 180 rings, which themselves vary in circumference from calf to calf. In the region of this unbridged soft section 70b, the bandage 1 remains soft, i.e. easy to unfold longitudinally, and there is no high resistance to a slight increase in the diameter of the lower leg 160. To reduce the likelihood of such a mismatch in longitudinal registration, the pattern of rectangular hard segments 80 and rectangular soft segments 70 used in the first compression bandage 1 may be replaced with a pattern of chevron hard segments and soft segments.

This is illustrated in fig. 3, which shows the second compression bandage 2 according to the present disclosure in a top view, laid flat and not unfolded. Similar to the first bandage 1, the second bandage 2 has a plurality of soft segments 71 and a plurality of hard segments 81 arranged one after the other in an alternating sequence along its length direction 100. The hard segments 81 have a "chevron" shape that is symmetrical with respect to the central axis 190 of the bandage, all of which have the same dimensions, the same length 90 and the same orientation, i.e., toward the right (in fig. 3) along the central axis 190. The soft segments 71 also have a symmetrical chevron shape relative to the central axis 190, all of which have the same size, the same length 130, and the same orientation as the orientation of the hard segments 81. Each hard segment 81 and each soft segment 71 extend from a first side edge 200 to an opposite second side edge 210 of the bandage 2.

When arranged in its longitudinal direction 100, the second bandage 2 comprises a first joining region 31 and a second joining region 41, both arranged on the first main surface 10 of the bandage 2 and on the respective hard segment 81. Both engagement areas 31, 41 comprise respective engagement means 50, 60 in the form of a plurality of small hooks. Unlike the first bandage 1, the joining regions 31, 41 are smaller than the hard segment 81 on which they are arranged and do not extend to the edge of the hard segment 81. The first and second bonding regions 31, 41 are arranged adjacent to opposite longitudinal ends of the intermediate soft segment 71a such that the intermediate soft segment 71a is arranged between the first and second bonding regions 31, 41 in the length direction 100. Soft segment 71a and all soft segments 71 do not contain hooks and any engagement means.

The second bandage 2 is identical to the first bandage 1 of fig. 1 and 2, except for the chevron shape of the soft segment 71, the hard segment 81 and the joint regions 31, 41 arranged on the main surface of the hard segment 81.

Fig. 4 shows the second main surface 20 of the second compression bandage 2 in a bottom view. The hard segments 81 include respective third bonding regions 141 on the second major surface 20. Each third engagement zone 141 comprises mechanical engagement means 160 in the form of a plurality of loops suitably shaped for mechanical engagement with the same hooks as the hooks 50 of the first engagement zone 31 or the second engagement zone 41. The third bonding region 141 extends from the first side 200 to the opposing second side 210.

Fig. 5 is a top view of two parts of a second bandage 2 arranged on top of each other to show how the inner circle 179 and the subsequent outer circle 180 interact once the bandage 2 is applied around the lower leg 160 in a two-circumference turn in the width direction 110 of the bandage 2 with an overlap of about 50%. For simplicity, the lower portion will be referred to as the inner loop 179 and the upper portion as the outer loop 180, reflecting the order of the loops when the bandage 2 is applied around the lower leg 160. For greater clarity, the engagement means are not drawn in fig. 5. A first portion 220 of the third engagement region 141 underlying the hard section 81c of the outer ring 180 engages the first engagement region 31 on the first major surface 10 of the first hard section 81a of the previous inner ring 179. In addition, the second portion 230 of the third engagement zone 141 on the underside of the hard section 81c of the outer ring 180 engages with the second engagement region 41 on the first major surface 10 of the second hard section 81b of the previous inner ring 179. In this arrangement, the hard segment 81c bridges the soft segment 71 a.

It is evident that the other hard section 81 of the outer ring 180 bridges the other soft section 71 of the inner ring 179 via the same mechanism, making the entire bandage 2 harder after being applied around the lower leg. It will also be apparent that a subsequent third turn (not shown) will bridge the soft segment 71 of the second turn 180.

Where the joint regions 31, 41, 141 have a chevron shape, a 50% overlap results in the right "arm" of the chevron of the lower ring 179 being oriented at an angle to the left "arm" of the chevron of the upper ring 180, forming an X-pattern. With the chevron angle and the length 130 of the soft segment 71 appropriately selected, this configuration reduces the likelihood of longitudinal registration mismatch between the inner and outer rings 179, 180, and thus reduces the likelihood of the occurrence of an unbridged soft segment 71.

Fig. 6 is a perspective view showing how the concepts of the present disclosure can be used to provide a compression sock that is easy to don and then stiffen by applying a reinforcing wrap around the sock.

The compression sock 240 is shown laid flat and not deployed. The foot section 270 is for application on a patient's foot and the lower leg section 280 is for application on a patient's lower leg. The sock 240 is elastic and includes, on its outer surface and around its circumference, in alternating sequence, a plurality of hard segments carrying the joining regions 32 and a plurality of soft segments 72 arranged between the joining regions 32. As mentioned above, each of the engagement regions 32 of the sock 240 includes a respective mechanical engagement means (not shown) on the outer surface. The soft segment 72 has a linear straight elongated shape. They are arranged between the hard segments carrying the joined areas 32, parallel to each other in a direction 245, forming an angle 250 of about 45 ° to the longitudinal axis 260 of the sock 240. The soft segment 72 has a decreasing modulus of elasticity in the circumferential direction 290. Thus, they are easily stretchable in the circumferential direction 290, so that when pulled over the foot and lower leg, the sock 240 is easily unfolded and thus easily pulled apart. However, only the sock 240 is not sufficiently stiff, i.e., it is too easily stretched circumferentially to provide sufficient therapeutic pressure to treat a leg ulcer.

Once the sock 240 is pulled apart, a separate element, a so-called reinforcement wrap 300, may be applied circumferentially around the lower leg over the lower leg section 280 of the sock 240. In fig. 7, the reinforcement wrap 300 is shown in plan view as being laid flat and not deployed. The reinforcement wrap 300 is a sheet-like flexible member made of a deployable material, which includes soft sections having a reduced modulus of elasticity and hard sections having an elevated modulus of elasticity higher than the reduced modulus of elasticity.

The reinforcement wrap 300 includes a linear pattern of a plurality of parallel engagement regions 310 on one of its major surfaces that face the patient's skin when wrapped around the lower leg portion 280 of the sock 240. These joining areas are arranged on the hard part. The major surface of the reinforcement wrap 300 that faces the skin of the patient in use (referred to as the "inner" major surface 320) is shown in fig. 7. Its upper edge 330 is longer than its lower edge 340 because it is intended to wrap around the upper part of the lower leg, closer to the knee, with the circumference of the lower leg being greater than it is at the point closer to the foot. The length of the edges 330, 340 is selected so that the reinforcement wrap 300 can be wrapped around a typical lower leg slightly more than once. The height of the reinforcement wrap 300 (i.e., its extension between the lower edge 340 and the upper edge 330) is selected such that it fits over the lower leg portion 280 of the compression sock 240 between the knee and foot of a typical lower leg. A soft material, i.e. a material having a reduced modulus of elasticity in the circumferential direction 290 (when the reinforcement wrap is arranged around the lower leg 160) is arranged between the hard segments of the load-bearing joint region 310 and forms a soft segment 370, such that the soft segment 370 is arranged between adjacent hard segments of the load-bearing joint region 310.

The engagement region 310 of the reinforcement wrap 300 includes an engagement means engageable with an engagement means on the engagement region 32 on the outer surface of the sock 240. Such an engagement means may be, for example, a hook and loop system, wherein the engagement means on the sock 240 is a loop and the engagement means on the reinforcement wrap 300 is a hook engageable with the loop. In the context of compression bandages according to the present disclosure, alternative mechanical engagements have been discussed, such as mechanical fasteners based on small mushrooms, friction enhancing layers, magnetic or adhesive engagement means. They may be used on the sock 240 and the reinforcement wrap 300 as described herein.

The direction 345 of the straight, linear and parallel engagement area 310 forms an angle 350 of about 45 ° with the central axis 360 of the reinforcement wrap 300. The central axis 360 passes through the midpoint of the upper edge 330 and the midpoint of the lower edge 340. In use, the central axis 360 is substantially parallel to the longitudinal axis 260 of the sock 240 when the reinforcement wrap 300 is wrapped around the sock 240 and lower leg.

Fig. 8 shows in perspective view the human lower leg 160 wearing the compression sock 240 of fig. 6 with the reinforcement wrap 300 of fig. 7 wrapped around the lower leg portion 280 of the sock 240. To enhance transparency, reinforcement wrap 300 has been drawn as if it were transparent between joining regions 310. Thus, it can be seen that, in use, the linear engagement region 310 of the reinforcement wrap 300 and the linear engagement region 32 of the sock 240 cross each other and form a cross-hair pattern. The pattern is formed by the joined areas 32 of the sock 240 and the joined areas of the reinforcement wrap 300 forming angles 250, 350 with their respective central axes 260, 360. The cross-hair pattern has the advantage that the risk of any soft section 72 of the sock 240 not being bridged by the hard section 370 of the reinforcing wrap 300 is reduced.

The reinforcement wrap 300 is applied to the sock 240 with a longitudinal tension wherein its inner surface 320 contacts the outer surface of the sock 240 whereby the engagement region 310 of the reinforcement wrap engages the engagement region 32 of the sock 240. By this engagement, the hard section 370 of the reinforcement wrap 300 bridges the soft section 72 of the sock 240 such that the soft section 72 cannot be easily deployed in the circumferential direction 290. Accordingly, the sock 240 is stiffened by applying the reinforcement wrap 300. The combination of the sock 240 and the reinforcement wrap 300 provides a higher resistance to small increases in the diameter of the lower leg 160 (e.g., while the patient is walking), which in turn provides a more effective therapeutic compression of the lower leg and a more effective treatment of leg ulcers.

Fig. 9 is a cross-sectional view of an exemplary flexible material for bandages 1, 2, bandages 1, 2 being expandable in a length direction 100 and including a soft segment 70 disposed between joined regions on a hard segment 30. The base is a soft, deployable material 380 having a reduced modulus of elasticity. In the area of each hard segment 80, a patch of hard material 390 is secured to the first major surface 10 of the soft material 380 either adhesively or by welding or stitching. Suitable soft materials and suitable hard materials are commercially available from companies such as MITI and others mentioned above. The upper surface (in fig. 9) of each hard segment 80 carries an engagement region 30 comprising mechanical engagement means in the form of a small hook element 50.

Also in the region of each rigid section 80, a patch of hard material 400 is secured to the second major surface 20 of the soft material 380 either adhesively or by welding or stitching. The opposite lower surface (in fig. 9) of each patch 400 in the hard segment 80 carries a further engagement region 40 comprising mechanical engagement means in the form of loops formed of thin filaments and adapted to mechanically engage with hooks of the engagement portions 30 on the upper major surface 10.

The stiffness of the hard materials 390, 400 stiffens the portions of the soft material 380 on which the hard materials 390, 400 are applied and provides them with an elevated modulus of elasticity, transforming them into hard portions 80. The modulus of elasticity of the section between the hard portions 80 remains low so that after applying patches of hard material 390, 400 on the soft material 380, these sections remain as soft sections 70.

The result is a material that includes bonding areas 30, 40 on opposing major surfaces 10, 20 and an alternating sequence of hard segments 80 and soft segments 70. This material can be used to make compression bandages according to the present disclosure.

An alternative method of stiffening or even making rigid a portion of an initially soft, easily stretchable material may be to coat the portion with a liquid or viscous curable resin and let the resin penetrate into the material at least to some extent. By curing the resin and thereby hardening it, the resin hardens the material. Suitable resins are, for example, UV curable resins as described in US patent application US 2013/01791.

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