ES1058214U - Inflatable compression sleeve (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

A disposable sleeve for compression therapy that includes a predetermined number of inflation and deflation cycles that define a use of the sleeve, the sleeve having at least one air-inflatable chamber or cell, defined between a first air-tight wall, which it is to be placed adjacent to the body of the patient to be treated, and a second air-tight wall, in which each of said first and second walls comprises an inner hermetic layer including polyethylene (pe) and an adjacent outer porous layer to the inner layer, the inner layers of the two walls being facing one another, the walls being joined along joining joints by welding said internal layers together and having penetrated and placed molten portions of the same. Said pe in the adjacent external porous layers in said joints, the joint and the walls being designed to support said predetermined number of cycles of inflates do and deflated. 2.the disposable sleeve according to claim 1, wherein said predetermined number of inflation and deflation cycles is at least 250. 3. The disposable sleeve according to claim 2, wherein said predetermined number of inflation and deflation cycles is approximately 30,000. 4. The disposable sleeve according to claim 1, wherein said inner layer is made of reinforced pe (polyethylene). 5. The disposable sleeve according to claim 4, wherein the inner layer of reinforced pe is composed of an intermediate sub-layer of reinforcing nylon, laminated between two sub-layers of pe. 6. The disposable sleeve according to claim 1, wherein said outer porous layer is of a textile material. 7. The disposable sleeve according to claim 6, wherein said textile material is non-woven. 8. The disposable sleeve according to claim 6, wherein said outer porous layer is polyester. 9. The disposable sleeve according to claim 1, further comprising a lug for inflating said air cell, said lug having a collar welded to said inner layer of said first wall. 10. The disposable sleeve according to claim 9, wherein said collar is made of pe. 11. The disposable sleeve according to claim 1, further comprising a flange for securing said sleeve to the body of a patient, said flange being formed as an extension or extension of said first and said second walls beyond said cell. Air, and having means to attach to another part of said sleeve. 12. The disposable sleeve according to claim 11, wherein said means for fastening comprise a male velcro pad (hooked) with a rear face laminated with pe, and are joined by said rear face to said outer porous layer of said flange, in such a way that the molten portion of said pe, which constitutes the unión, penetrates and is placed in said outer porous layer. 13. The disposable sleeve according to claim 12, wherein said fastening means comprises a female pad that includes a layer of hook retaining material that is capable of retaining or holding the hooks of a male velcro pad, and a layer of carrier material or porous support, joined together, such that said female pad is disposed between said first and said second walls of said flange, and is attached to said inner layer of pe of the walls, penetrating and positioning the molten material from said inner layer of pe, which constitutes the joint, in the porous materials of the female pad, and one of the walls having a cutout that exposes said hook retaining material. (Machine-translation by Google Translate, not legally binding)

Description

Inflatable compression sleeve

Field of the Invention

This invention relates to inflatable sleeves. for use in pneumatic compression therapy.

Background of the invention

Thrombosis of the deep veins, too known as DVT ("Deep Vein Thrombosis"), it is a condition serious and that potentially can constitute a threat to the lifetime. The physiological cause of this condition is the lack of adequate blood circulation in the lower extremities. Lack of venous blood movement can cause formation of clots or thrombi, which can cause obstructions in local blood vessels, or in more situations serious, can be deposited in the lungs or in the heart and cause critical obstructions that can be dangerous for lifetime.

A large number of research studies doctor has shown that deep vein thrombosis can avoid improving or accelerating the return of venous blood from the lower extremities. A common and accepted method for accelerate the return of venous blood from the limbs Lower is the pneumatic compression applied to the sole of the foot and / or the twin leg muscle. This form of treatment is it is usually called "compression therapy" and it leads to out using a compression device, which supplies compressed air to a garment or "cuff" that It contains one or more cells that inflate and deflate by applying and releasing a pressure, alternatively, to the extremities lower patient.

There are many devices in hospitals this type, and there are use procedures for therapy of compression that apply to patients who are hospitalized for operative treatments or suffering from other risk factors of the development of deep vein thrombosis. The compression therapy devices can be used 24 hours a day throughout the hospitalization period. Studies clinicians have shown that the effectiveness of such devices comes determined primarily by the compliance of the patient and the staff, which, in turn, is affected by its ease of use and for the comfort of the patient. The employment of such devices is also determined by economic factors, such  as the cost of the device and the garments, as opposed to Pharmaceutical interventions, such as heparin.

US 4,013,069 describes sleeves of compression made of sheets or waterproof inner layers  and one or more sheets or layers of soft flexible material intended to cover the outside of the waterproof layers, adjacent to the patient's leg. Outer layers they can be made of any suitable material, such as TYVEK?, And provide an aesthetically exterior surface Nice and comfortable for the cuff. Outer layers they can be fixed to the inner layers by suitable means, such as sewing stitches located along the edges lateral and extreme The sleeves may have a plurality of hook and loop closure strips, in order to securely releasable sleeves around the patient's legs.

US 4,066,084 describes a piece of fist turn comprising a piece of cloth or plastic material stable of soft qualities, but not elastic, and that has the shape of a trapezoid whose two non-parallel sides have the same length. The two non-parallel sides are provided with a closure of divisible zipper, by means of which the fist turn piece It can take the form of a cylinder that gradually narrows or converges slightly so that it fits on a limb of a patient. On one of the sides of the material stably, it has provided a certain number of elongated inflatable sections, which have been arranged parallel to the parallel sides of the trapezoid. These sections are made of an elastic and plastic material resistant, rubber or other air impermeable material. The sections may also consist of balloons inserted in pockets arranged in the back piece of fist.

US 4,338,923 describes a sleeve liable to wrap around the part of the body to be be treated, and that is manufactured in the form of a band inflatable and substantially flat, divided into a plurality of internal inflatable cells that extend in annular arrangement around the sleeve, in partially overlapping positions. The band is made of three strips of sheet or layer material resistant, joined together along joining lines separated, in order to define the inflatable cells that partially overlap or overlap.

The sleeves described above for compression therapy are of a durable construction or structure and constitute a constant part of the massage device that used multiple times with different patients, the largest part of the time as physical therapy for venous conditions and chronic lymphatic

When these devices are used as prophylaxis for deep vein thrombosis, either in the operating room or during the period of convalescence, the needs Specific to the hospital market are those referring to sleeves disposable for use only once or in a single patient. The Made of PVC fabric are manufactured by Kendall Co. (Tyco), as well as by other major manufacturers. However the cost of these sleeves is still high, and hospitals are have been forced to recycle and reuse these sleeves called "disposables" in an attempt to cut expenses. In addition, PVC is currently considered a harmful material from an environmental point of view, and its use has been restricted in many countries due to carcinogenic considerations. The layer External PVC also prevents evaporation or perspiration normal, which causes patient discomfort.

Summary of the invention

The present invention is directed to a more hygienic disposable sleeve, intended to be used only once, which is comfortable, reliable and inexpensive, and which is particularly suitable for use in large quantities of said devices in the
hospitals

\hbox{primera}

pared hermética al aire, destinada a colocarse adyacente al cuerpo del paciente que se ha de tratar, y una segunda pared hermética al aire. Cada una de las dos paredes comprende una capa porosa externa y una capa interna hermética al aire, que comprende polietileno (PE) adyacentemente a la capa externa, de tal manera que las capas internas están situadas una de cara a la otra. Las paredes se unen a lo largo de juntas de unión, mediante soldadura de las capas internas una con otra, y por porciones fundidas del PE, que han penetrado y se han colocado en las capas porosas externas, en dichas juntas. La unión y las paredes han sido diseñadas para soportar el número predeterminado de ciclos de inflado y desinflado. Preferiblemente, este número es al menos 250 ciclos. Para algunas aplicaciones, la unión y las paredes están destinadas a durar aproximadamente 30.000 ciclos.In accordance with the present invention, a disposable sleeve for compression therapy is provided that includes a predetermined number of inflation and deflation cycles defining a use of the sleeve. The sleeve has at least one chamber or inflatable cell with air, defined between a

 \ hbox {first} 

air tight wall, intended to be placed adjacent to the body of the patient to be treated, and a second air tight wall. Each of the two walls comprises an outer porous layer and an air-tight inner layer, comprising polyethylene (PE) adjacent to the outer layer, such that the inner layers are facing each other. The walls are joined along joint joints, by welding the inner layers with each other, and by molten portions of the PE, which have penetrated and been placed in the outer porous layers, in said joints. The joint and the walls have been designed to withstand the predetermined number of inflation and deflation cycles. Preferably, this number is at least 250 cycles. For some applications, the joint and the walls are intended to last approximately 30,000 cycles.

The inner layer can be made of reinforced PE, for example, made of a sub-layer reinforcement intermediate with nylon, stratified between two PE sub-layers.

The outer porous layer can be made of cloth, preferably non-woven, and can be made of polyester or Polypropylene.

The disposable sleeve comprises a stud for the Inflated air cell, with a collar welded to the layer internal of the first wall and attached to the porous layer. The necklace It can be made of PE.

The disposable sleeve may comprise means of  fastening such as a flange to fix the sleeve to the body of a patient. The tab is preferably formed as a extension or extension of the first and second walls, beyond of the air cell. The tab preferably has means for be attached to another part of the sleeve, such as a pad of Male Velcro (hooks with its back side stratified with PE. The pad joins on the back side to the porous layer outer flange, penetrating and placing the molten portion belonging to the PE stratified and constituting the union, in the outer porous layer, such that it preferably reaches the PE inner layer and welded to it.

The fixing means may comprise additionally a female pad that includes a layer of material for hook retention, capable of retaining or hold the hooks of the male Velcro pad, as well as a layer of porous carrier or support material, joined together. The female pad is disposed between the first and said second flange walls, and is attached to the inner layer of the walls, such that the PE coming from the inner layer, cast and that constitutes the union, penetrates and is placed in the porous materials of the female pad. One of the walls it has a cutout that exposes the retention material of the hooks

The disposable sleeve according to the invention provides a very hygienic device, adaptable to the human body, comfortable and easy to use, intended for the prevention and treatment of DVT, as well as for massage therapy in general. The sleeve can be manufactured cheaply in large quantities from common plastic materials, cheap and more environmentally friendly, with the use of reliable technology with wide application
industrial.

The use of PE for welding or bonding air tight is known, for example, from US documents 6,500,200, US 5,443,488 and US 3,867,939. However, none of These publications suggest multiple and cyclic loading, such as the cycles for inflation and deflation therapy.

Brief description of the drawings

In order to understand the invention and appreciate how it can be implemented, will be described below embodiments thereof, by way of examples only limiting and with reference to the accompanying drawings, in the which:

Figure 1 is a view of a sleeve for compression therapy according to an embodiment of the present invention, fixed, in operative state, to a limb bottom of a patient.

Figure 2 is a plan view of the sleeve of Figure 1 in a flat state.

Figure 3A is a side view of the sleeve of Figure 1 in a folded or folded state.

Figure 3B is a cross-sectional view. of the lower section of the sleeve of Figure 3A.

Figure 4 is a schematic cross section, taken through an air cell of the sleeve of the Figure one.

Figure 5 is an enlarged cross section of a welding zone of the sleeve of Figure 4.

Figure 6 is a schematic cross-section, taken through an air cell of a sleeve according to another embodiment of the present
invention.

Detailed description of achievements

Referring to Figures 1, 2 and 3, a disposable compression sleeve 10 according to one embodiment of the present invention, which has been designed for prevention of the DVT, comprises a top section 12, provided with cells of upper air 14 intended to compress the twin 16 of the patient, and having upper lashes 18 and 20, formed on the left and right sides of the air cells 14; a lower section 24, provided with an air cell bottom 26 intended to compress the 28th floor of the foot of the patient, and having lower lashes 38 and 40; So as air inlets (studs) 41, located in cells 14 and 16 and mounted to connect the air cells, by means of hoses, to an inflation device, such as a compress with its distribution valve (not shown).

In the upper section 12, the size of the air cells 14 is designed to cover only the muscle twin 16, instead of the entire circumference of the member. The rest of the circumference is enclosed or covered by the tabs of clamping 18 and 20, as explained below. 18 tabs and 20 may be formed of the same material as the cells of air 14, or they can be fixed thereto along junction joints 68 and 70.

In the lower section 24, the air cell bottom 26 has a left part 32 and a right part 34, divided by junction joints 33 in upper lobes 32a and 34a, and in lower lobes 32b and 34b, respectively. The cell of air 26 has a lower left edge 35 and a lower edge right 36, shown .. disassembled in Figure 2. In the assembled state, edges 35 and: 36 are joined together, so the lower lobes 32b and 34b form an inflatable sole, such as It is shown in cross section in Figure 3B. The eyelashes of lower fasteners 38 and 40 are fixed to the same edges 35 and 36. Clamping tabs can be formed integrally with the lower section, starting from the sleeve foil material. In such case, the edges 35 and 36 will be only joints between the air cell 26 and the tabs 38 and 40.

The upper section 12 and the lower section 24 of the sleeve 10 can be manufactured in the form of a one-piece garment, although they can also be independent and used as two units
independent.

In its operational position, sleeve 10 is placed against the patient's foot, with the upper section 12 behind of the twin and the lower section 24 below the heel and of the sole of the foot. The air cells 14 are wrapped around the twin and are fastened by means of tabs 18 and 20. The section bottom 24 is wrapped around the foot and is held above of the instep by means of fins 38 and 40. Lobes 32b and 34b they remain adjacent to the sole of the foot, while the lobes 32a and 34a are adjacent to the sides and to the instep of the foot.

Clamping tabs 18, 20, 38 and 40 provide closure and clamping of the sleeve around a wide range of circumferential portions of the limb, without that interrupt or affect the air cells, eliminating form the need for a wide variety of sizes or Sizes for this sleeve. Eyelash fastening can be done by various means, for example, by adding or Velcro patches of hooks and loops, 42, 44, 46 and 48. Also, the eyelash fastening can be done by means of a layer self-adhesive arranged on the eyelashes, with the side of the adhesive protected by a tape that can be withdrawal. Alternatively, it is possible to use a patch self-adhesive independent on both sides, which can be placed on the cuff by the patient or by the staff of treatment for closure according to the exact size of the patient's limb

In another embodiment of the sleeve, the section lower 24 of the sleeve 10 may also contain a material rigid 50, installed inside tabs 38 and 40, adjacent to joint joints 35 and 36, such that it supports the lobes 32b and 34b that are in contact with the sole 28 of the foot. Said rigid material may consist of a plastic plate rigid, such as a board made of PVC or other materials. The rigid material located on the sole of the foot applies a surface resistant to the air cell, which improves the effectiveness of the application of pressure on the sole of the foot. From optionally, the rigid material can be in the form of two plates that can be inserted into pockets formed in the lower clamping tabs 38 and 40, adjacent to the lobes lower right and left 32b and 34b of the air cell bottom 26.

Referring to the cross section that is shown in Figure 4, an air cell 14 or 26 located in the inside of the sleeve 10 has been formed with an upper wall 54 and a bottom wall 56, such that the bottom wall 56 is adjacent to the patient member when the sleeve. The walls 54 and 56 comprise, each of them, a respective inner sheet 58, 58 'and a respective outer sheet 60, 60 ', joined together along lines 64, 68, 70, 33, 35, 36, etc., which define the contours of the air cells (so only one line 64 is seen in the cross section in the Figure 4). The internal sheets 58 and 58 'are made of polyethylene, for example, the PE (polyethylene) metallocene from Dow Chemicals, which is relatively cheap. The material is susceptible to weld easily and air tight, although not particularly resistant However, the inventors have tried and demonstrated that, for example, a sheet between 100 and 150 p.m of This material has sufficient tensile strength and durability for a guaranteed limited number of cycles of Inflated and deflated. This number is typically 30,000 for a few days of preoperative or postoperative treatment of a patient. The number can be considerably smaller, than approximately 250 for one or two therapy procedures of compression, which allows the use of even thinner PE sheets. Resistance requirements for cell walls can be further reduced if the cells do not hug the entire contour of the limb, but about two thirds of it or less. This is the reason why this material is very suitable in the manufacture of disposable items for use in the prevention of DVT in the extremities. The outer sheets 60 and 60 'are made of a porous material such as a textile fabric. Preferably, a nonwoven textile material is used, for example, polypropylene or polyester fabric.

The union of the constituent sheets is done in a special way shown in Figure 5. The two PE sheets 58 and 58 'are welded together by an area of welding 66, for example, by heating with radiation of radio frequency (RF). At the same time, the molten portions 72 of the PE located in the welding zone 66 penetrate the pores of the porous material 60 and solidify there, blocking the outer sheets 60 and 60 'against PE sheets 58 and 58' and a with other. As can be seen, it is not necessary that the material Porous be weldable with PE layer. The inventors have discovered that said union can be reliable enough and provides the required durability for the same number of inflated and deflated cyclic exposed above.

As shown in Figure 6, the sleeve 10 of compression therapy can be made of internal sheets reinforced 158, 158 'of a more complex structure. Plate 158 or 158 'may comprise, for example, a reinforcing layer 160 not woven or nylon, sandwiched between two layers of polyethylene 162 and 164, formed as an integral sheet, for example, by stratified Such materials are manufactured for the purpose of be used in the food packaging industry and are relatively cheap The total thickness of the inner sheets, in this case, it can be even smaller than that of an inner sheet PE only. It will be appreciated that it is possible to apply the same method of union that has been exposed in the above

While a description of a specific realization, the possibility of carrying out various changes without departing from the scope of the present invention. For example, the present invention could be modified and Used for the manufacture of others. compression devices for the treatment of DVT or lymphedema (lymphatic edema).

Claims (13)

1. A disposable sleeve for compression therapy that includes a predetermined number of inflation and deflation cycles defining a use of the sleeve, the sleeve having at least one chamber or cell inflatable with air, defined between a first air-tight wall, which It must be placed adjacent to the body of the patient to be treated, and a second air-tight wall, in which each of said first and second walls comprises an inner hermetic layer that includes polyethylene (PE) and an adjacent outer porous layer to the inner layer, the inner layers of the two walls being placed facing each other, the walls being joined along weld joint joints of said inner layers to each other and having penetrated and having molten portions placed of said PE in adjacent external porous layers in said joints, the joint and walls being designed to withstand said predetermined number of inflation cycles I give
deflated. 2. The disposable sleeve according to the claim 1 wherein said predetermined number of cycles Inflation and deflation is at least 250. 3. The disposable sleeve according to the claim 2 wherein said predetermined number of cycles Inflation and deflation is approximately 30,000. 4. The disposable sleeve according to the claim 1 wherein said inner layer is made of PE (polyethylene) reinforced. 5. The disposable sleeve according to the claim 4, wherein the inner reinforced PE layer is composed of an intermediate sub-layer of reinforcement nylon, stratified between two sub-layers of PE. 6. The disposable sleeve according to the claim 1, wherein said outer porous layer is of a Textile material. 7. The disposable sleeve according to the claim 6, wherein said textile material is not tissue. 8. The disposable sleeve according to claim 6, wherein said outer porous layer is of polyester. 9. The disposable sleeve according to the claim 1, further comprising a stud for the inflated of said air cell, said stud having a collar welded to said inner layer of said first wall. 10. The disposable sleeve according to the claim 9, wherein said collar is made of PE. 11. The disposable sleeve according to claim 1, further comprising a flange for fixing said sleeve to a patient's body, said flange being formed as an extension or extension of said first and said second walls beyond said cell of air, and having means to be fixed to another part of said
sleeve. 12. The disposable sleeve according to the claim 11, wherein said means for fixing comprise a male Velcro pad (hooks) with a back side stratified with PE, and are joined by said face subsequent to said outer porous layer gives said tab, such so that the molten portion of said PE, which constitutes the joint, penetrates and is placed in said outer porous layer. 13. The disposable sleeve according to the claim 12, wherein said fixing means comprise a female pad that includes a layer of material hook retention that is able to retain or hold the hooks of a male Velcro pad, and a layer of carrier material or of porous support, joined together, in such a way that said female pad is disposed between said first and said second walls of said flange, and is attached to said inner layer PE of the walls, penetrating and placing the molten material from said inner layer of PE constituting the joint, in the porous materials of the female pad, and having one of the walls a cut that exposes said material of hook retention.