KR0145083B1 - Support system to reduce the formation of bedsores - Google Patents

Abstract

A support system such as a clinical mattress comprises two sheets of flexible material bonded together to provide a plurality of separate cells (1) that are capable of being alternately and repeatedly inflated and deflated by means of a fluid contained in the cells (1). The flexible material is impermeable to the fluid. The cells (1) are of a size and shape and with an intercellular spacing such that in the width or length, or both, of the system, the distance between centres of adjacent inflated cells (1) is less than the human two-point discrimination threshold and the clinical support system is capable of supporting a human body with bottoming out either of or between the inflated cells (1).

Description

A support system for reducing the formation of bedsores.

1 is a schematic of a portion of a single row of cells of a clinical support system, the whole being seen in an expanded state.

FIG. 2 is a schematic view of the cell of FIG. 1, some of which are seen in the contracted state.

3 is a schematic representation of an embodiment of a support system of the present invention.

4 is a computer simulation diagram of a cell.

5 is a bar graph of the data obtained in Example I.

6 is a graph of the data obtained in Example II.

7 is a graph of the data obtained in Example III.

8 is a graph of the pressure profile measured in Example IV.

9A and 9B are cross-sectional schematic diagrams of a support stem having an elongated expandable tubular cell and use of the support system of the present invention.

FIG. 10 is a graph of temperature versus recovery time measured in Example V.

FIG. 11 is a graph of thermal response of tissue to time measured in Example VI.

* Description of the symbols for the main parts of the drawings *

1,27 Cell 2

3: space 4 (d): distance between cell centers

11, 41, 47: expansion cell 12, 48: shrink cell

20 matrix system 21 closed cell layer

22: heating component layer 23, 25, 51: fiber layer

24: high friction layer 26: fine porous layer

28, 29: heating and cooling means 40: human fuselage

41: cushion system 43: area

44: sciatic 45: arrow

46: monolayer cell 49: flexible thermoelectric layer

50: heating and cooling circuit

The present invention is a clinical support system used to reduce breakage of human skin and in particular to reduce the likelihood of bedsore formation in a person who must be on a bed, wheelchair or the like for a long period or otherwise cannot move in whole or in part And related apparatus.

As used herein: support systems include support devices for mattresses, cushions, pads or trains, including support systems that can be used for treatment or other purposes. Bottoming out means both sides of the cell of the clinical support system where the top of the cell is in contact with the bottom or bottom of the cell by weight, such as the weight of a person, and the clinical support system between the cells is contacted by the person with the bottom part. Say collapse. The two-point identification limit of a human is the minimum distance at which two objects can be distinguished by contact when placed on the skin, that is, the distance understood in the field of anatomy, which is approximately 30 mm in the back of a person and is measured in the back of a person.

People may be on a support surface, such as a bed, a wheelchair, or other device, for a variety of reasons, such as for example due to injury or illness or as a need for work function. Older people may stay on beds or other devices for long periods of time.

Pressure sores, also known as pressure ulcers, pressure wounds, and bed wounds, are a widespread problem in the field of health care, which costs a lot both for the duration of individual suffering and for the financial costs to society. The frequency of bedsores in hospitalized patients ranges from about 30% to about 17%, and in older hospitalized patients increases to 20-30% (Ref .: Study of Geriatric Nursing Problems at Dinoton's Hospital, Churchill Livingston Edinburgh (1962). The frequency for neurologically impaired patients may range from 30 to 60% of patients. (Ref .: Richardson and Mayer, Gerontol 19 235-247 (1981; Taylor J. Gerontol. Nurs 6 689-391 (1980)). It is a local necrosis of cells that can appear when compressed between hard surfaces.External pressure affects by blocking the flow of blood and damages ischemia. If not, a series of intracellular phenomena that occur in an irreversible stage occurs: Ischemia injury results in cell death, ie necrosis and accumulation of cell debris in tissue.

The most decisive factor in the development of pressure sores is the strength and duration of the applied pressure, and the relationship between these factors is generally believed to be a parabolic intensity period curve.

If the patient remains stationary in the same position for less than about 2 hours, ischemia is reversible and generally no long-term or irreversible damage occurs in soft tissues, ie skin, subcutaneous tissue and muscle, on the ridges of the bone. However, if it does not move for about 2 hours, pressure sores begin to develop, sometimes referred to as the formation of a first stage pressure wound. This is especially the case for many hospitals and institutions that change their location every two hours. However, these implementations are not completely efficient. Moreover, there is a tendency to care for patients at home rather than in a hospital, and 24 hours / day is not possible in this environment.

External and internal factors are considered to act to reduce tissue tolerance to pressure. External factors affecting soft tissue include shear friction, moisture, and temperature. Internal factors that determine the ease of tissue destruction include sensory loss, impaired mobility, aging, lack of nutrition, vascular disease, anemia, incontinence, and infection.

Among age-related skin changes that facilitate pressure sores in older people, flattened epidermal folds (Montagna and Carlisle, Research Journal of Dermatology 73 47-53 (1979)), Langerhans Cell Reduced number of cells (Ref .: Kripke, magazine of the American Academy of Dermatology 14 149-155 (1986)), and reduced skin densities that are relatively blood and non-vascular (Ref .: Motagna and Carlisle, Modulation in collagen and elastic fibers (Ref .: Schuster party, British magazine of dermatology 93 639-643 (1975)), reduced function of sweat glands and sebaceous glands (Ref .: Foster party, age and aging 5 91 -101 (1976) and Planning and Krigman, Magazine of Dermatological Research, 70 314-317 (1978), and Impaired Immune Response (Ref. Barrett's Party, Clinical Immunology and Immune Pathology 17 203-211 (1980) There is). Bursluissen (Clin. Res. ₂₉₂ 1311-1313 (1985)) reported that pressure sores progress in 90% of patients with hip fractures older than 70 years. Failure of bed sores is associated with mortality rates of nearly six times in older adults (Reid. MD State Med. J. 30 45-50 (1981)). Complications of pressure sores include osteomyelitis and sepsis, and the mortality rate of sepsis is close to 50% (Ref .: American Magazine of Galpinian Medicine 61 346-350 (1976); Collection only group, Arch. Phys. Med. Rehabil 66 177-179 (1985); Briman et al., Arch.Intern, Med. 143 2093-2095 (1983)). So bedsores are a potentially very serious problem in health care.

There are a variety of systems useful for reducing the formation of bedsores. Most of these work by functioning by shifting support pressure in two principles: a bubble matrix, an air mattress, a water bed and a static device that redistributes the support away from the raised areas of the bone such as sheepskin, and alternating air mattresses. Function of the device, either. Although such a device is an improvement on the use of conventional mattresses, further improvements are required in terms of effectiveness and / or use rate. Many static devices have only a limited service life because they cannot be cleaned in an efficient way that can be reused by the same or different patients. The decisive problem with dynamic devices and some static devices is that they cannot support the weight of the body in the raised areas of the bone. Under these circumstances, the support system collapses under the weight of the ridges of the bones, and the ridges of the bones are placed on the mattress floor, ie they adhere to the floor. This occurs because the device consists of one or more air-filled chambers of plastic material that can be expanded regardless of the arrangement of the yarns. Since the remaining chambers only have minimal expansion to equalize the chamber pressure, the force applied by the ridges of the bone in a relatively small area of the support device causes the collapse of the relevant part of the chambers. Another cause involved is the arrangement of air chambers. Most seals are tubular or diamond ground bump patterns or other shaped parts or cells such that when one part is filled with air, the air in the adjacent part is released. However, a typical support system of cell size of 5 cm or larger cannot lift the patient sufficiently out of contact with the mattress under the device, in particular to provide efficient alternating pressure on the ridges of the bone. Larger cell-sized devices have sufficient excursion, ie height, to overcome the problem of sticking to the floor (see Bliss et al., British medical journal 394-397 (1967)), while other problems, such as Large areas of the body are not supported, resulting in patient discomfort. The 5 cm cell size is also unable to prevent ridges of small bones on the body to stop, ie, adhere to the floor, on the dropping mattress between inflated cells. Higher pressures in these tubes can be used to prevent the floor from sticking, but as a result problems arise for the patient's comfort and problems in which the effective alternating pressure cannot be achieved. Another limiting oscillation period for these devices, in particular the time required to inflate the support cells and to contract adjacent cells. The prolonged expansion and contraction periods hinder a sufficient period of pressure relief, ie interfacial pressure below internal capillary pressure, to allow normal blood flow and tissue recovery.

A support system has now been found to reduce the formation of bedsores. The invention thus consists of a sheet of two flexible materials which are in planar and superimposed relation therebetween, which are joined in selected areas to provide a plurality of separate cells of a selected size and shape in a single layer therebetween. As a clinical support system; The material is sufficiently impermeable to the fluid contained within the cells such that they can expand and contract each cell repeatedly; The cell has a size and shape and a space between the cells such that the distance between the centers of adjacent expansion cells at one or more of the width and length of the clinical support system is less than a human two-point identification limit, between or between the expansion cells It provides a clinical support system that can support the human body without sticking to the bottom.

In an embodiment of the support system of the present invention, the cell is shaped and sized so as not to cause sticking to the bottom of a 2.5 kg additional support system having a spherical surface of 2.67 cm diameter overlying the support system.

The present invention also relates to a sheet of two flexible materials that are (a) in a plane and in a superimposed relationship therebetween, joined in selected areas to provide a plurality of separate cells of a selected size and shape in a single layer therebetween. A clinical scaffold system consisting of; The material is sufficiently impermeable to the fluid contained within the cells such that they can expand and contract each cell repeatedly; The cell has a size and shape and a space between the cells such that the distance between the centers of adjacent expansion cells at one or more of the width and length of the clinical support system is less than a human two-point identification limit, between or between the expansion cells A clinical support system capable of supporting the human body without sticking to the bottom of the body; And (b) a means of expansion and contraction of the cells.

In a preferred embodiment of the support system of the present invention, the cells are shaped and sized so as not to cause noise at the bottom of a 2.5 kg additional support system of 2.67 cm diameter overlying the support system.

In another embodiment of the support system, the means for inflating the cell is adjusted so that the adjacent cell contracts when one cell is inflated. In another embodiment of the support system, the cells can be expanded and contracted independently.

In another embodiment of the support system, the expansion means of the cell is a compressor or liquid which can be vaporized to expand the cell, in particular vaporized by the use of an electrical heating component or thermoelectric means.

In another embodiment of the support system, each cell has a geometry that precludes complete collapse of the cell upon contraction.

Additionally, the present invention relates to (a) a planar and superimposed relationship thereon, wherein two flexible materials are joined in selected areas to provide a plurality of separate cells of a selected size and shape in a single layer therebetween. As a clinical support system consisting of a sheet of; The material is sufficiently impermeable to the fluid contained within the cells such that they can expand and contract each cell repeatedly; The cell has a size and shape and a space between the cells such that the distance between the centers of adjacent expansion cells at one or more of the width and length of the clinical support system is less than the human identification threshold, and between or between the expansion cells A clinical support system capable of supporting the human body without sticking to the bottom of the body;

(b) means for expansion and contraction of cells;

(c) a cushion material layer; And

(d) Provide a support system composed in order of a layer of material having a high coefficient of friction. In a preferred embodiment of the support system of the present invention, the cell is shaped and sized so as not to cause noise at the bottom of a 2.5 kg additional support system having a spherical surface of 2.67 cm diameter overlying the support system.

In another embodiment of the support system of the present invention, with a fibrous layer, in particular a removable fibrous layer, the fibrous layer between the moisture absorbing layer and the flexible material layer overlies the flexible material layer. The moisture absorbing layer is preferably a microporous film layer, preferably a disposable layer.

The present invention additionally comprises means for heating and / or cooling the liquid, which can be expanded and contracted alternately, contains an inert liquid having a boiling point of 0 to 50 ° C., is made of a flexible impermeable thermoplastic and In addition, it provides a cell having.

In a preferred embodiment of the cell of the invention, the liquid is of at least one fluorocarbon, or at least one liquid form developed for replacing fluorocarbons for environmental reasons, in particular from 10 to 40 ° C., in particular from 20 to 34 ° C. Fluorocarbons and liquids having boiling points.

The invention is described herein in particular with respect to clinical support systems and mattress support systems, but in particular for some purpose applications the system is to be understood in the form of seats or other supports as described below, rather than in the form commonly referred to as clinical supports or mattresses. do.

The invention will be described in more detail with reference to the following figures.

In FIG. 1 a single column of cells 1 is shown; The outer surface and the substrate surface 2 of the cells 1 are sheets of flexible material forming the outer and substrate surfaces of the cell. The cells 1 are separated by a space 3 substantially smaller than the distance d between the cell centers indicated by 4.

Although cell 1 is shown as being extended, it is understood that the cell can be any convenient shape; However, it must be of a size and shape that prevents the floor from blowing out, i.e., preventing the collapse of the cell in contact with the top of the cell and the top of the cell under the influence of the weight, eg the weight of the patient. An example of a cell is shown in the computer simulation diagram in FIG. In use, the cell 1 is connected with means for expanding and contracting the cell in a controlled manner.

The cells may be formed to have single or multiple compartments containing foam, provided they can expand and contract.

The cell 1 of FIG. 1 can be expanded and contracted as shown in FIG. In the embodiment shown, the expansion cells 11 are separated by the shrink cells 12. The distance between the expanded cell centers is below the human head identification limit, so that a person placed on a cell cannot identify by contact whether the cells are alternately expanded and contracted. Moreover, the patient generally cannot detect the contraction of the cell 11 and the expansion of the cell 12.

In FIG. 3, the mattress system, generally shown at 20, consists of a closed cell layer 21, a fibrous layer 23, and a high friction layer 24 over the heating component layer 22. Above the top of the closed cell layer 21 is a fibrous layer 25 and an outer microporous layer 26. The closed cell layer 21 has a plurality of cells 27 in the form shown in FIG. The cell 27 is shown extending and aligned in the axial and transverse directions of the cell. However, the cells may be in alternating form and / or more arbitrary patterns.

A cell is referred to herein as an isolated cell. However, it should be understood that one cell may be connected to one or more other cells due to the expansion and contraction of the cell even though the cells have a separate physical appearance.

Cell 27 can be expanded and contracted. Various means can be used to inflate and deflate the cell. For example, with a pressure sufficient to expand the cell 27 when in use, it applies alternating vacuum to the cell 27 to the extent necessary to supply compressed gas, such as compressed air, and subsequently to shrink the cell 27. The cells can be attached by tubes to the system. The amount of vacuum applied may be a small amount sufficient to retract the cell 27 such that the cell 27 can no longer support the patient on the mattress system 20. Since the compressor supplying the compressed air is noisy, the supply of compressed gas may alternatively be from the source of use of the mattress system, such as from a source away from the compressor or from another supply of compressed gas at a remote location. Alternatively, the alternating pressure of the cell can be applied by hydraulic means in the liquid phase in the cell. Examples of such liquids include water and silicone oils.

A preferred way to inflate and deflate cell 27 is to incorporate liquid into the cell. In the use of such liquids, the liquids are heated by thermoelectric means to form vapors and thus expand the cell 27. This heating increases the temperature of the liquid above its boiling point. This is not necessary if enough pressure is created to inflate the cell. With cooling the pressure in the cell 27 decreases and the cell shrinks. The liquid should be selected to produce sufficient vapor to expand the cell while maintaining at the desired or preselected temperature. In addition, the liquid must be selected for a particular purpose-temperature position. For example, in some stomachs the patient ambient temperature may be as low as about 18 ° C, while in other locations the ambient temperature may be as high as about 40 ° C.

The liquid placed in the cell 27 is preferably inert, non-toxic and non-flammable and does not participate in the health rights of the patient and the caregiver, such as both doctors and nurses. In addition, the cell 27 needs to be constructed from a material that has adequate disturbance properties for the liquid so that the supply of liquid is retained in the cell at least for the life of the mattress system. Such materials are referred to herein as being impermeable. As discussed herein, the material may be a multi-layered structure that includes a coated structure to obtain acceptable levels of impermeability. The duration of use of the clinical support system may be six months or two years or more.

Examples of liquids embedded in the cell include fluorocarbons, in particular chlorofluorocarbon mixtures which exhibit a change in vapor pressure over the temperature range used in the expansion and contraction of the cell 27 and, for environmental reasons, Fluids of the type developed for replacement, such as mixtures of hydrochlorofluorocarbons. Fluorocarbons and chlorofluorocarbons are commercially available from DuPont Canada Inc. under the trade names Freon sold under the trademark designations 114, 113, 22, 11, 123 and 141B, for example.

The boiling point of the liquid should be 0 to 50 ° C, preferably 10 to 40 ° C. Liquids having a low boiling range can be used, for example, for cooling the limbs or other parts of the body. In certain embodiments, the acte has a boiling point at a comfortable range, in particular 20-34 ° C., for patients except for normal human sweating limits.

The cell 27 shown in FIG. 3 is in a form containing a liquid. Although the liquid can only be heated by the body heat of the patient, it is preferred that electrical or in particular thermoelectric means be provided for heating and cooling the liquid. The heating and cooling layer (thermoelectric stack) 22 placed under the closed cell layer 21 in FIG. 3 provides heating and cooling means 28 and 29 which can be used to vaporize or compress the liquid. Have Although the disclosure refers to heating and cooling layers, in some embodiments the layers may be solely heating or cooling layers.

Heating and cooling means 28 and 29 are separate electrical circuits and heat and cool adjacent cells 27, heating and cooling means 28 and adjacent cells used to heat and cool one cell. It is connected to the heating and cooling means 29 used for this purpose. One of the heating and cooling means 28 and 29 is generally associated with each cell to tightly control the expansion and contraction of the cell. Only two heating and cooling means 28 and 29 are used to adjust the entire mattress system. Several heating and cooling means can be used to control different parts of the matrix system in different ways, such as using a microprocessor. It is preferable to operate the heating and cooling means at a low voltage which is not dangerous, i.e. substantially lower than that normally used for heating and cooling devices.

As noted above, the flexible material should be sufficiently impermeable to permit use of the clinical support system for the duration of use. The nature of the flexible material to meet these impermeability requirements will depend in particular on the fluid contained in the cells of the clinical support system. For example, flexible materials suitable for use with inert gas fluids such as hydrochlorofluorocarbons are not suitable for use as would be understood by one skilled in the art if water is used as the fluid. The flexible material is preferably a polymeric material, and in particular will be a polymeric material that is loaded, thermally bonded or coated. In an embodiment, the flexible material is a thermoplastic polymer laminated or coated with a polymeric material in which the clinical support system exhibits barrier properties to the liquid to be contained in the cell. In some embodiments, the polymeric material is linear low density polyethylene coated or laminated with polyvinylidene chloride (PVDC). Such flexible materials exhibit both disturbing and flexible and toughness properties that are important for the useful life of the clinical support system. In train embodiments, the flexible material may be polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, polyester, polyamide, chlorosulfonated polyethylene, vinylidene fluoride / hexafluoropropylene copolymer, polyurethane, ethylene / Propylene / diene terpolymers, copolymerized etherester polymers, silicone rubbers, butyl rubbers and leading edge rubbers, and may be coated if necessary to achieve the desired failure properties.

The closed cell layer 21 and the thermoelectric layer 22 are shown in FIG. 3 as being located above the fibrous layer 23. Layer 23 provides more comfort to the patient by providing comfort and good pressure distribution to the mattress system. The steam 23 is formed from a variety of fibers or foam materials including synthetic fibers, such as polyamides, polyesters and / or polypropylenes, natural fibers such as woolen fibers, including cotton, cellulose fibers or sheepskin, etc. Can be. In most cases, the fibrous layer will be formed from synthetic fibers that are bulky enough to provide a cushioning effect. Examples of preferred fibers are Kualofil ^R polyester fibers used to make pillows. In another embodiment, layer 23 may be an air mattress.

In FIG. 3, the fibrous layer 23 is shown above the friction layer 24. The friction layer is provided for the safety and safety of the patient, in particular to prevent slipping of the bed or other structure used in the mattress system. Various friction layer materials are known, including foamed thermoplastic polymers such as polystyrene, interwoven fabric structures, Velcro ^R , materials and the like.

The mattress system shown in FIG. 3 has two layers accumulated over a closed cell layer. The layer immediately adjacent to the closed cell layer is a fibrous layer 25 which is mainly used as a cover sheet or a sheet surrounding the mattress system of the present invention for aesthetic reasons as well as to maintain integrity of the mattress system and to prevent infection. The outer layer is a microporous layer 26 for comforting the patient. In particular, the microporous layer 26 improves patient comfort by removing sweat or other moisture associated with the patient from the patient's location. The microporous layer is intended to be a disposable layer. The fibrous layer 25 and the microporous layer 26 should be formed of such a material with a thickness that allows to obtain an advantageous effect of the operation of the closed cell layer 22. In an embodiment, the outer layer can be a non-hard layer, in particular a layer used in burn patients or in some therapeutic end uses.

In operation of the mattress system of FIG. 3, the patient is placed in contact with the microporous layer and placed on a mattress system or a sheet or similar layer on the microporous layer. The mattress system is preferably configured such that the cells are aligned at an angle to the axis of the patient's body, and in an embodiment are arranged to cross the body. The cells of the closed cell layer are then alternately expanded and shrunk by applying heat, for example using a heating component layer, and then allowing the liquid to cool or actively cooling the liquid.

The period of expansion and contraction can vary from one minute to one hour or more. But the cycle should be more frequent than every two hours. Different cycles are available for different regions of the body, for example, a body region exerting greater pressure may be a shorter cycle than an area exerting less pressure, or different cycles may be used for therapeutic or other reasons. It is expected that there may be different optimal cycles depending on the intended use of the mattress system or clinical support system.

Reference is made herein to the cycle for expansion and contraction of the cell. The cycle time depends not only on the transition of the fluid into or out of the cell to actually affect the expansion and contraction of the cell, but also on the compression or vaporization of the fluid contained entirely within the cell, as well as the period during which the cell is expanded or contracted. For the period required. The period for the transfer of such fluids is limited and can be several minutes.

The beneficial effect of the contraction of the cell, in particular the restoration of normal microcirculation in the skin layer adjacent to the contracted cell, is mainly limited to the period in which the cell does not support the patient, which may be shorter than the cycle time. The period for fluid transition in cycle time is more important in short cycles and needs to be considered in the operation of the system of the present invention.

Expansion and contraction of a cell is generally described herein as the adjacent cell contracts as the cell expands. This expansion and contraction occurs simultaneously or successively, in the latter case it is understood that adjacent cells contract after one cell is expanded. Moreover, expansion and contraction may be performed in the manner of a wave passing across the included clinical support system along the peristaltic cycle, in which case the patient detects a wave or peristaltic action. Such action may have an advantageous therapeutic effect, for example, and may be used for this or other reasons. In an embodiment of the invention, the cells to be expanded may be surrounded by the cells to be shrunk, conversely the rows of cells are expanded and immediately adjacent rows of cells are shrunk, or the arrangement of cells being expanded and shrunk is described herein. Other inflated and retracted arrangements of cells can be used if the patient can be supported as such.

The mattress system of the present invention is alternately supported and supported such that the patient has little or no sense of the stirring support provided by the mattress system, that is, little or no sense of movement in the bed in which a part of the patient's body is lying. A stir support is provided to the patient in a manner that is not. Any such sensation is very embarrassing to the patient. However, at a distance below the human two-point identification limit in at least one direction, the space of the expanded cell substantially eliminates or overcomes any sense and allows the mattress system to perform its function. Moreover, the pressure exerted on the body of the patient lying side by side in the constricted cell is less than the human capillary threshold, such as 20 to 32 mmHg, otherwise blood circulation to a specific area of the patient's skin over the constricted cell occurs. Pressure bedsore. Internal capillary pressure will vary from patient to patient, and will usually change in some areas of the patient and other areas. The capillary pressure limit, such as the surface pressure at which the capillary tube is expected to collapse, is about 20 to 32 mmHg depending on the patient and the area of the patient in contact with the mattress system. Therefore, in an embodiment, the pressure exerted on the patient by the constricted cell is less than about 20 mm Hg and the pressure exerted on the constricted cell is generally required to be below the capillary pressure limit.

As pointed out above, the clinical support system can support the body without sticking to the bottom of one or between expanded cells. In an embodiment, the body is simulated by a spherical surface. In particular, the following procedure can be used to determine if the clinical support system can support the body without sticking to the floor. The process uses a jig with a spherical manifestation with a diameter of 2.67 cm and a head with an actual diameter of 7.5 cm. The jig also has a rod axially attached to the head opposite the spherical surface and adapted to receive the weight. In the course of the test, the jig is placed on the surface of the cell so that it is centered over the contracted cell and supported by two adjacent expanded cells. A weight having an axial hole is then added to the jig using the rod until the surface of the jig contacts the bottom surface of the contracted cell. The total weight of the jig should be at least 2.5 kg. Under these circumstances, the clinical support system cell will have a shape and size such that it will not cause adhesion to the bottom of a 2.5 kg additional clinical support system with a spherical surface of 2.67 cm in diameter placed on the clinical support system.

In FIG. 9A, a portion of the human fuselage, generally indicated by 40, is shown on a mattress or cushion system 41 having a large expandable cell 42 shown in cross section. The expandable cell 42 has gas in the expanded cell 42, which is shown to be forced out of the cell area 43 attached to the bottom in the direction of the arrow 45, and the sciatic 44 of the fuselage 45. It is seen that it is attached to the bottom in the area 43, which is the cell area immediately below. Conversely, in FIG. 9B the fuselage 40 is shown on the mattress system of the present invention. The mattress system consists of a single cell layer 46, shown as alternatingly inflated cells 47 and retracted cells 48. The cell layer is attached to the flexible thermoelectric layer 46. The flexible thermoelectric layer 49 includes heating and cooling circuits 50 placed under expansion cells 47 or shrink cells 48, respectively. In the embodiment shown, the heating and cooling circuit 50 under the shrink cell 48 cools the steam in the cell, while the heating and cooling circuit 50 under the expansion cell 47 heats the gas in the cell. The flexible layer 49 is shown above the fibrous layer 51. As illustrated in FIG. 9B, the fuselage lies on the expansion cell 47 and does not stick to the bottom or contact the surface of the shrink cell 48. Therefore, the fuselage located above the shrink cell 48 does not exert pressure thereon. Activation of the heating circuit under the shrink cell 48 and activation of the cooling circuit immediately below the expansion cell 47 will cause the part of the fuselage currently shown to be in contact with the expansion cell to be out of contact with the cell.

The mattress system of the present invention functions as both the capillary pressure threshold and the head discrimination threshold, thereby providing the patient with the benefit of enhanced blood circulation and the tendency to reduce bedsores, while at the same time making the patient comfortable. The mattress system is easy to use and can be easily cleaned and operated in a secure manner, especially when liquids that can cause phase changes are used to provide for the expansion and contraction of the sal. Can be operated and transported. Ie suitable for transportable use in, for example, wheelchairs and other transportable systems, including limbs and other parts of the body that enable the patient to move. Moreover, the liquid in the cells can be cooled to allow cooling of all or part of the body, for example as a cooling wrap, for use in surgical operations and for therapeutic reasons.

While the support system of the present invention is generally described herein as a medical use, i.e. a mattress system, the support system can be used in a variety of forms and for a variety of purposes, and in many of these purposes, the system can be used to support a support system, a seat, a chair, or the like. It is to be understood that it may be commonly referred to by other names including. For example, the systems described herein can be used in health care, transportation, and recreational businesses and include, for example, aircraft, automobiles, offices, homes, trucks, and other seats.

The invention is illustrated by the following examples.

Example 1

Holes of circular cross sections of different diameters were cut into a series of metal plates of different thicknesses. The diameters of the holes were as follows: 31.5 mm, 39.0 mm, 45.0 mm and 51.3 mm. The plates were 4.2 mm, 5.4 mm, 6.6 mm and 7.8 mm thick.

A healthy male 46-year-old, 173 cm tall, approximately 84 kg in weight, and an average sciatic human sciatic bump were placed on each hole in turn. The pressure sensing device was placed in the hole or on its opposite side to achieve the desired knitting movement. The sensing device was placed on a wooden surface to measure the pressure exerted by a human at the opposite surface of the device, the hole. The results obtained are shown in FIG. In only three cases, the human sciatic container exerts pressure, i.e. a 31.5 mm hole (measured by the distance of the pressure sensing device located in the hole from the surface of the plate) and a 7.8 mm knitting movement A 39.0 mm hole with knitting movement was not attached to the floor. Therefore, for this combination of hole diameter and knitting movement, no sticking occurred to the bottom. Cells of this size and small diameter did not show the result of attaching the sciatic bump of the patient used in this example to the floor.

In a series of related tests, the cell size was determined for supporting the human body at various positions, such as the sciaticus in sitting position, the sacral and scapula in larger electronic and angular position lying on the side. This test provides guidance on the cell size required to prevent sticking to the floor in the clinical support system of the present invention. The results obtained depend on the location of the human body.

Example 2

Using a method similar to that described in Example 1 except the hole was a rectangular hole, a series of tests were performed to determine the effect of cell geometry on pressure due to osteoblastic nodules. In all experiments, the thickness of the sheet, ie the knitting motion, was 8 mm. The holes were lined up in the forward / rear direction and were 18 to 34 mm wide and 20 to 100 mm long. The results obtained are shown in FIG. A capillary pressure limit of 32 mm is also shown in the figure.

Example 3

Example II was repeated using crosswise aligned holes. The results obtained are shown in FIG.

The results of Example II show that only 18-34 mm wide and 20-36 mm short cell lengths impose pressure below the capillary pressure limit where the long axis of the hole is aligned in the forward / rear direction. In contrast, the results of Example III show that much longer cells can withstand.

Example 4

The pressure exerted by the man lying in a flat position on the synthetic fibrous layer on the mattress and the mattress used in the hospital was measured at multiple locations on the mattress and the floor to illustrate the patient's pressure profile.

The results obtained are shown in FIG. The three regions of high pressure exerted by humans were the ass, shoulders and head in descending order. The use of a synthetic fibrous layer in the mattress resulted in a substantial reduction in the pressure exerted on the three spirits, such as about a 60% reduction in the area of the shoulder, but the pressure was above the capillary threshold per all three positions.

Example 5

Restoration of the normal (preliminary) skin temperature of the human hip in the sitting position during the following various periods was monitored using a therapeutic camera.

The man is a 46 year old healthy male, 173 cm tall, approximately 84 kg in weight and average physique. A person sits on a mattress system or fluffy cushion of the present invention operating at a cycle time of 10 minutes for various periods of time, and then agema infrared thermal graph camera, motel 870 (Agema Infra-), having a phase analysis of the time at which skin temperature returns to normal rea Thermogaraphic camera, Model 870).

The results obtained are shown in FIG. Since skin temperature is directly proportional to the blood flow in the skin, the recovery of skin temperature to normal indicates the blood circulation in the skin.

The results show that the recovery time increases exponentially with the length of the sitting period. Furthermore, recovery from sitting on the mattress system of the present invention for 30 minutes was as fast as sitting on a soft cushion for 5 minutes, much faster than sitting on a cushion for 7 minutes, and a regression line for the data on the long term cushion. While pointing to this inherently longer recovery, the regression line through the cushion and data for the mattress system of the present invention for 3 and 5 minutes tends to converge for about 6 minutes.

For proper operation, the recovery time from the pressure relief on the contraction cell in the mattress system of the present invention to the normal blood flow circulation must be compatible with the durability on the expansion cell.

The results show that the appropriate periodic vibration of the mattress system of the present invention used by the person described above in the sitting position is approximately 10 minutes.

Example 6

After 2 hours at the supine position, the recovery of the skin temperature in the human sacrum region was monitored by infrared thermal graph. The man is a 46 year old healthy male, 173 cm tall, approximately 84 kg in weight and average physique. The person was placed in the supine position on the matrix system of the present invention operating on a standard hospital bed or 10 minute cycle time. After 2 hours on the bed or mattress, the person was repositioned to the right for immediate monitoring of the sacral area using the thermal graph camera of Example V. FIG. Temperature control time and average temperature change for humans were measured. The results obtained are shown in FIG.

The thermal response after 2 hours on the hospital bed indicates skin inflammation, which is shown by a constant increase in temperature for regulation. Skin inflammation is characterized by an immediate skin redness and an increase in temperature after a pause above the pressure point. In contrast, after 2 hours on the mattress system of the present invention, the thermal response reaches normal temperature after 15 minutes without inducing skin inflammation.

Claims (40)

A clinical support system consisting of a sheet of two flexible materials joined in a selected area to provide a plurality of separate cells of a selected size and shape in a planar and superimposed relationship therebetween; The material is sufficiently impermeable to the fluid contained within the cell such that each cell can alternately expand and contract in turn; The cell has a size and shape and a space between the cells such that the distance between the centers of adjacent expansion cells at one or more of the width and length of the clinical support system is less than a human two-point identification limit, between or between the expansion cells A clinical support system that can support the human body without sticking to the bottom of the patient. The clinical scaffold system of claim 1, wherein the distance between the centers of adjacent expansion cells is less than 25 mm, including the distance across the contraction cells. The clinical scaffold system of claim 2, wherein when the scaffold system supports the human body, the contracting cell exerts a pressure below the human capillary threshold of the human. The clinical support system of claim 2, wherein the addition of 2.5 kg having a diameter of 2.67 cm placed on the clinical support system does not cause adhesion to the bottom of the clinical support system. The clinical scaffold system of claim 2, wherein the cells can independently expand and contract. The clinical scaffold system of claim 2, wherein the fluid is a mixture of fluorocarbons or fluorocarbons. The clinical scaffold system of claim 6, wherein the fluid is a fluorocarbon substitute that is acceptable to the environment. (a) a clinical scaffold system consisting of a sheet of two soluble materials joined together in a selected area to provide a plurality of discrete cells of a selected size and shape in a plane and a superimposed relationship therebetween. As; The material is sufficiently impermeable to the fluid contained within the cell such that each cell can alternately expand and contract in turn; The cell has a size and shape and a space between the cells such that the distance between the centers of adjacent expansion cells at one or more of the width and length of the clinical support system is less than a human two-point identification limit, between or between the expansion cells A clinical scaffold system capable of supporting the human body without the bottom of the body; And (b) a support system comprising means for expansion and contraction of the cell. The support system of claim 8, wherein the distance between the centers of adjacent expansion cells is less than 25 mm, including the distance across the contraction cell. The support system of claim 9, wherein when the clinical support system supports the body, the contracting cell exerts pressure on the body below the human capillary threshold of the human being. 10. The support system of claim 9, wherein an additional 2.5 kg with a diameter of 2.67 cm placed on the clinical support system does not cause adhesion to the bottom of the clinical support system. The support system of claim 9, wherein the cells can independently expand and contract. 10. The support system of claim 9, wherein the fluid is a liquid capable of vaporizing to expand the cell. The support system of claim 13, wherein the expansion and contraction means of the cell are heating and cooling means. 10. The support system of claim 9, wherein the fluid is a gas. 10. The support system of claim 9, wherein the fluid is a liquid. The support system of claim 15, wherein the expansion means of the cell is a compressor. 17. The support system of claim 16, wherein the expansion and contraction means of the cell are hydraulic means. 15. The support system of claim 14, comprising electrical heating means or thermomagnetic means, wherein the liquid is controlled to vaporize by the heating means or thermoelectric means. 10. The support system of claim 9, wherein each cell has a geometry that prevents complete collapse of the cell upon contraction. 21. The support system of claim 20, wherein the means for expansion of the cell is adapted to retract adjacent cells upon expansion of the cell. The support system of claim 16, wherein the fluid is adjusted to heat and cool. The support system of claim 16, wherein the fluid is adjusted to heat or cool. 6. The support system of claim 5, wherein the cell is adjusted to expand and contract in a period of less than 2 hours. 25. The support system of claim 24, wherein the cells are expanded and contracted using a simulated wave on the support system. The support system of claim 24, wherein the cell is expanded and contracted using a simulated peristaltic motion on the support system. 10. The system of claim 9, wherein the means for expansion and contraction of the cell has a cycle that promotes recovery of normal microcirculation of the human skin while the cell is contracted. (a) a clinical scaffold system consisting of two sheets of flexible material bonded in a selected area to provide a plurality of discrete cells of a selected size and shape in a plane and superimposed thereon in a single layer; ; The material is sufficiently impermeable to the fluid contained within the cell to alternately inflate and deflate each cell alternately, the cell between the centers of adjacent expansion cells at one or more of the width and length of the clinical support system. (B) A clinical support system having a size and shape and a space between cells that allows the distance to be less than a human two-point identification limit, and capable of supporting the human body without sticking between the expansion cells or the bottom of one of them. Expansion and contraction means; (c) a cushion material layer; And (d) an order of layers of material having a high coefficient of friction. 29. The support system of claim 28, wherein the distance between the perimeters of adjacent expansion cells is less than 25 mm, including the distance across the contraction cell. 29. The support system of claim 28, wherein when the clinical support system supports the human body, the contracting cells exert pressure on the human body below the capillary threshold within the human body. The support system of claim 29, wherein the addition of 2.5 kg with a diameter of 2.67 cm placed on the clinical support system does not cause adhesion to the bottom of the clinical support system. 30. The support system of claim 29, wherein a fibrous layer present between the moisture absorbing layer and the flexible material layer is positioned over the flexible material layer. 33. The support system of claim 32, wherein the fibrous layer is a removable fibrous layer. 33. The support system of claim 32, wherein the moisture absorbing layer is a microporous film layer. 33. The support system of claim 32, wherein the moisture absorbing layer is a disposable layer. 33. The support system of claim 32, wherein the fluid is fluorocarbon or a mixture of fluorocarbons. 37. The support system of claim 36, wherein the fluid is a fluorocarbon substitute for the environment. 33. The support system of claim 32, wherein the fluid is a gas. 33. The support system of claim 32, wherein the fluid is a liquid. 30. The support system of claim 29, wherein the means for expansion and contraction of the cell has a period of promoting recovery of normal microcirculation of the human skin upon contraction of the cell.

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