A method for selecting a pre-determined kit of products for a patient at risk of developing pressure ulcers

Abstract

The present disclosure generally relates to a method for selecting a pre-determined kit of products for a patient at risk of developing pressure ulcers comprising: a) determining a plurality of risk parameters associated with the patient, wherein the plurality of risk parameters are selected from sensory perception, exposure to moisture, degree of physical activity, mobility, friction and / or shear, skin condition, medication, trauma, fluid and / or food intake pattern, time of hospitalization, perfusion and / or medical condition, b) evaluating, based on the risk parameters, a risk score associated with the patient, c) selecting a pre-determined kit of products, based on the risk score, wherein the pre-determined kit of products is selected from at least a standard-risk kit of products and high-risk kit of products, and wherein the standard-risk kit of products comprises a first, a second and a third prophylactic dressing; the first prophylactic dressing being a sacral dressing (200); the second and third prophylactic dressings being heel dressings (300), and wherein the high-risk kit of products comprises the first, second and third prophylactic dressings and at least one additional prophylactic dressing or prophylactic product. The present disclosure also relates to an array of products comprising the standard-risk and high-risk kits of products.

Description

[0001] A METHOD FOR SELECTING A PRE-DETERMINED KIT OF PRODUCTS FOR A

[0002] PATIENT AT RISK OF DEVELOPING PRESSURE ULCERS

[0003] TECHNICAL FIELD

[0004] The present disclosure generally relates to a method for selecting a predetermined kit of products for a patient at risk of developing pressure ulcers. The present disclosure also relates to an array of products comprising at least a high-risk kit of products and a standard-risk kit of products.

[0005] BACKGROUND

[0006] A pressure ulcer is a localized injury to the skin and / or underlying tissue over a bony prominence that results from sustained pressure, often in combination with friction and shear. The major factors leading to pressure ulcers are pressure, shear, friction, and unfavorable microclimate. Other factors, intrinsic to patients, may also increase the likelihood of pressure ulcer development, e.g. poor perfusion, reduced sensation, reduced mobility level, and inadequate nutrition.

[0007] A pressure ulcer typically does not start at the skin surface. Pressure ulcers often develop in soft tissue under the skin which covers bony areas of the body (so called “bony prominences”), for example the heels, ankles, elbows, the hips or the sacrum. Pressure and shear forces cause blood vessels to become squeezed between the skin surface and bone. Hence, muscles and tissue under the skin near the bone surface typically suffer the greatest damage. Accordingly, any pressure ulcer as apparent on the skin, regardless of how small, should be regarded as critical because of the probable damage below the skin surface.

[0008] A pressure ulcer can be classified into four categories: in the first category, the skin appears pink, reddened, or discolored, and may feel hard and warm to touch. In the second category, the skin breaks open and an ulcer that may look like a blister is formed. In this stage, the skin may be damaged beyond repair or may die. A category three pressure ulcer is an ulcer that extends into the tissue beneath the skin, forming a small crater. In category four, the pressure sore is very deep, reaching into the muscle and bone and causing extensive damage to deeper tissue and tendons. Serious complications, such as infection of the bone or blood, can occur if the pressure ulcer progresses.

[0009] Pressure ulcers are a global problem and the possibility to prevent these is desirable both to reduce human suffering but also to avoid unnecessary costs. The average cost for a category three or four pressure ulcer is estimated to be from 75000 to 125000 US dollars per patient.

[0010] Pressure ulcers often arise among persons being bedridden for various reasons, e.g. due to hospitalization or other causes of immobility.

[0011] In many hospitals and care facilities, the routines applied to prevent the formation of pressure ulcer are inadequate, and sometimes non-existent. While the medical personnel are often aware of the risks associated with pressure ulcer development, the applied prevention regimen typically only involves regular turning and re-positioning of the patient. However, for most of the patients, regular turning and re-positioning is not sufficient, and pressure ulcers still arise. Furthermore, many times, potential actions applied to prevent pressure ulcers are applied too late, i.e. at a stage where a pressure ulcer has already developed.

[0012] There is consequently a need to provide improvements in preventing pressure ulcers from occurring in the first place, and to provide for a proactive and cost-efficient means to minimize the burden for the patients at risk of developing pressure ulcers, as well as for the caregivers and staff dealing with pressure ulcers.

[0013] SUMMARY

[0014] In view of the above mentioned and other drawbacks of the prior art, it is an object of the present disclosure to provide improvements in preventing pressure ulcers, and in the overall preventative regimen in a hospital or in a care facility.

[0015] According to a first aspect of the present disclosure, there is provided a method for selecting a pre-determined kit of products for a patient at risk of developing pressure ulcers comprising: a) determining a plurality of risk parameters associated with the patient, wherein the plurality of risk parameters are selected from sensory perception, exposure to moisture, degree of physical activity, mobility, friction and / or shear, skin condition, medication, trauma, fluid and / or food intake pattern, time of hospitalization, perfusion and / or medical condition, b) evaluating, based on the risk parameters, a risk score associated with the patient, c) selecting a pre-determined kit of products, based on the risk score, wherein the pre-determined kit of products is selected from at least a standard-risk kit of products and high-risk kit of products, and wherein the standard-risk kit of products comprises a first, a second and a third prophylactic dressing; the first prophylactic dressing being a sacral dressing; the second and third prophylactic dressings being heel dressings, and wherein the high-risk kit of products comprises the first, second and third prophylactic dressings and at least one additional prophylactic dressing or prophylactic product.

[0016] The method of the present disclosure significantly alleviates the burden for caregivers, and facilitates the selection of products to be used in a specific care scenario and for a specific patient.

[0017] Each patient is individually analyzed based on the plurality of risk parameters, and the risk score associated with a specific patient allows for a selection of the appropriate products for that patient.

[0018] The medical personnel may, after an individual risk assessment, retrieve a score indicating that the patient is in need of a standard-risk kit of products or a high-risk kit of products. Accordingly, significant time and effort is saved for each care scenario and each patient being assessed.

[0019] The method of the present disclosure offers a proactive approach in preventing pressure ulcers. Instead of waiting until the first symptoms of pressure ulcers arise, a predetermined kit of products aiming at preventing and / or alleviating pressure ulcers is provided. Accordingly, the risk for developing pressure ulcers is minimized. Furthermore, the staff is guided with respect to what products to utilize in a specific care scenario and for a specific patient.

[0020] For example, if the assessment of the risk factors associated with a specific patient reveals that the patient has a poor sensory perception; i.e. ability to respond meaningfully to pressure-related discomfort, an enhanced level of moisture exposure, e.g. due to incontinence or high levels of sweating, a low degree of physical activity, e.g. inability to walk an being confined to bed, a poor fluid or food intake pattern and / or a high degree of friction and shear; i.e. requires assistance in moving, then the risk score associated with that patient will be high. In this regard, the medical personnel may select a high-risk kit of products to be used for the specific patient.

[0021] The method of the present disclosure offers a possibility to reduce the overall cost for the hospital, clinic or home care facility, and each patient may get a tailored and individualized preventative treatment strategy, that in the end may reduce the treatment needed for that patient.

[0022] The standard-risk kit of products comprises a first prophylactic dressing being a sacral dressing, and a second and third prophylactic dressing being heel dressings. The sacrum and the heels are areas that have a higher risk of developing pressure ulcers than other areas. The anatomy and physiology of the heels and sacrum make the tissue very vulnerable to pressure.

[0023] In general, any patient being bedridden suffers a risk of developing sacral pressure ulcers.

[0024] Patients at risk of developing heel pressure ulcers are generally those with a reduced ability to move their legs.

[0025] The risk score may be a qualitative score or a quantitative score. The risk score may e.g. be based on the number of risk factors associated with a specific patient.

[0026] In exemplary embodiments, the risk parameter may be associated with at least three levels of sub-scores and wherein the risk score associated with the patient is the sum of each sub-score associated with each risk parameter.

[0027] For example, at least some of the risk parameters utilized may correspond to those of the Braden scale. The Braden scale is a standardized assessment tool to assess a patient’s risk of developing pressure ulcers, and comprises the following risk parameters: sensory perception, degree of moisture, degree of physical activity, mobility level, food intake pattern (nutrition), friction and shear.

[0028] Each of the risk parameters mentioned hereinbefore may be associated with an individual sub-score.

[0029] For example, the risk parameter “exposure to moisture” may be divided into the four levels: constantly moist, very moist, occasionally moist or rarely moist. Each of these levels may be individually scored between 1 and 4, where 4 denotes the worst scenario; i.e constantly moist (skin is kept moist constantly by perspiration, urine etc.).

[0030] Furthermore, the risk parameter “degree of activity” may be divided into the four levels: bedfast, chairfast, walks occasionally and walks frequently. Each of these levels may be individually scored between 1 and 4, where 4 denotes the worst scenario; i.e. bedfast (patient being confined to bed).

[0031] In exemplary embodiments, the first, second and third prophylactic dressing is a dressing having anisotropic stiffness properties.

[0032] The prophylactic sacral and / or heel dressing is preferably “stiffer” in one direction than the other.

[0033] The prophylactic dressing generally has a lateral (x) extension and a longitudinal (y) extension. The dressing is preferably stiffer; i.e. has a higher tensile force in the longitudinal (y) direction of extension than in the lateral (x) direction of extension. In use, the prophylactic dressing is to be applied such that its longitudinal (y) direction corresponds to the direction of which the patient is exposed to most shear forces; i.e. in the direction in which the patient slides in bed. This is normally along the length of the patient. This way, the pressure and shear forces inflicted on a bed-ridden patient are significantly reduced.

[0034] The lateral (x) direction of the dressing is preferably more pliable and may have a lower tensile force. This is beneficial since the lateral (x) direction of the dressing corresponds to the direction in which the patient, wearing such dressing, will be turned and re-positioned by nursing personnel. A bedridden patient at risk of developing pressure ulcers must be turned and repositioned at regular intervals. It is therefore advantageous that the dressing conforms to this lateral movement and stays on the skin. Furthermore, the skin and is prevented from becoming “over constrained” which could otherwise be the case when the dressing is stiff in both the lateral (x) and longitudinal (y) directions.

[0035] In exemplary embodiments, the additional prophylactic dressing of the high- risk kit of products is selected from an elbow dressing, a shoulder dressing, and / or a dressing for use in conjunction with a medical device.

[0036] The elbows and shoulders represent bony prominences that are also prone to pressure ulcer development.

[0037] The various prophylactic dressings may thus be arranged on the most vulnerable parts of the skin of a patient; i.e. the areas overlying the bony prominences of the body.

[0038] Pressure ulcers may also develop underneath medical devices. Such pressure ulcers are referred to as medical device related pressure ulcers (MDRPU). Medical devices, such as feeding tubes, oxygen delivery devices, intravenous catheters, orthopedic devices, tracheostomy tubes and nasogastric tubes are examples of medical devices commonly used in a hospital or medical setting. These devices are designed to be in continuous and close contact with the body, particularly the facial areas of a patient. If a patient is in need of any such medical device, the high-risk kit of products may also include a dressing for use underneath a medical device.

[0039] In exemplary embodiments, the prophylactic dressings of the standard-risk and high-risk kits of products may comprise a pressure-relieving material.

[0040] For example, the pressure-relieving material may be a gel or a foam.

[0041] Preferably, the pressure- relieving material may comprise a polyurethane foam. A polyurethane foam has a pressure relieving and offloading effect and can absorb large amounts of fluids. A bed-ridden patient may have a high degree of perspiration and may also be incontinent. Fluids, such as sweat and urine (and potentially also blood) are efficiently handled by the absorbent and pressure-offloading polyurethane foam material.

[0042] In exemplary embodiments, the prophylactic dressings of the standard-risk and high-risk kits of products comprise a backing layer, an adhesive skin contact layer and a pad arranged between the backing layer and the adhesive skin contact layer; the pad comprising one or a plurality of pad-forming layers, wherein at least one of the pad-forming layers comprises the pressure-relieving material.

[0043] At least one of the pad-forming layers may be a layer having anisotropic stiffness properties. Such a pad-construction is suitable for use for the first, second and third prophylactic dressings; i.e. the sacral and heel dressings.

[0044] In exemplary embodiments, the additional prophylactic dressing of the high- risk kit of products is an elbow dressing, and wherein the elbow dressing may comprise at least one pad-forming layer provided with a plurality of incisions.

[0045] The mode of movement of the elbows of a bed-ridden patient is typically different from that of e.g. the sacrum. The sacral region is subject to shear forces as the patient slides in bed. In contrast, the elbows may move and chafe against the bed surface in multiple directions. Hence, the elbow dressing preferably comprises a pad provided with a plurality of incisions which render the dressing flexible in all directions. In this regard, the wear time of the dressing is improved.

[0046] In exemplary embodiments, the additional prophylactic product of the high-risk kit of products may be at least one pressure offloading pad; the pressure offloading pad being a moldable pad comprising a fluidized medium.

[0047] Such a pressure-offloading pad may offload bony prominences on patients at risk of developing pressure ulcers. In use, the pad may be arranged directly underneath a body part of a patient in a hospital bed to offload the pressure exerted on that body part. Alternatively, it may be used in conjunction with a pressure offloading mattress to angle a patient and hold the patient in a specific position for the purpose of pressure offloading.

[0048] The fluidized medium preferably has no or limited shape memory such that the pad can conform to the skin of a patient in various positions.

[0049] A pressure-offloading pad may also be arranged underneath the head of a patient. The back head of the patient is susceptible to pressure ulcers. The same applies to the ears. The pressure-offloading pad is moldable and conformable, and may e.g. be molded and conformed to a patient’s head such that a “cradle” is formed around the head and ears of the patient. The pressure-offloading pad may also be arranged in the sacral region and or on the back of a patient.

[0050] In exemplary embodiments, the additional prophylactic product of the high- risk kit of products may be a pressure-offloading mattress.

[0051] Such a pressure-offloading mattress may comprise a gel, a foam or air to redistribute pressure under the body. The mattress may also be utilized to turn and re-position the patient.

[0052] In exemplary embodiments, the additional prophylactic product of the high-risk kit of products is a pressure-offloading heel boot.

[0053] The risk assessment performed by the caregiver may reveal a high risk for heel pressure ulcer development, in which case a heel dressing may not be sufficient.

[0054] Accordingly, the high-risk kit of products may comprise a heel boot for use in conjunction with the heel dressing to offload the pressure and optimize healing of a heel pressure ulcer.

[0055] In exemplary embodiments, the high-risk kit of products comprises at least a first, second, third, fourth and a fifth prophylactic dressing; the first prophylactic dressing being a sacral dressing; the second and third prophylactic dressings being heel dressings; the fourth and fifth prophylactic dressings being elbow dressings, and at least one prophylactic product selected from a pressure-offloading pad and / or a pressure-offloading mattress.

[0056] Such a kit of products significantly reduces the overall risk for developing pressure ulcers.

[0057] In exemplary embodiments, the method of the present disclosure further comprises evaluating at least one patient-specific parameter, wherein the patient-specific parameter is the weight, body mass index (BMI), gender, size, and / or weight-height relationship of the patient.

[0058] Each of these patient-specific parameters may affect the strategy to prevent pressure ulcers from occurring in the first place.

[0059] The step c) of selecting a kit of products may further be based on the patientspecific parameter, and wherein the high-risk and standard-risk kit of products is categorized into at least a first size category and a second size category.

[0060] Hence, the various prophylactic dressings and products of the kits may come in a small size and a large size. A larger patient will benefit from a larger sized prophylactic dressing and / or product, e.g. pressure-offloading pad. For a smaller patient, the smaller sized dressings and / or pressure offloading pad may be sufficient. In exemplary embodiments, the method is a computer implemented method performed by a processing unit.

[0061] The processing unit may in some embodiments form part of a computer system, further comprising a database. The computer system may be implemented as a server. It may be possible to make use of more than a single processing unit, such as for example including FPGAs, ASICs, etc., software systems and applications, software packages, mechanical and electrical parts, etc. Software packages may be part of the server, the database, and / or a network.

[0062] According to another aspect, there is provided an array of products comprising at least:

[0063] - a standard-risk kit of products comprising a first, a second and a third prophylactic dressing; the first prophylactic dressing being a sacral dressing; the second and third prophylactic dressings being heel dressings,

[0064] - a high-risk kit of products comprising the first, second and third prophylactic dressings and at least one additional prophylactic dressing or prophylactic product.

[0065] The standard-risk kit of products and high-risk kit of products may be divided into at least a first and a second size category.

[0066] The products associated with a pre-determined kit of products may be contained in separate packages, and wherein the packages comprise at least a first printed marking indicating a risk category, and optionally, at least a second marking indicating a size of the product(s) comprised in the package.

[0067] Hence, each category of prophylactic dressings or products may be packaged individually, but the package is provided with a marking that indicates to a caregiver that the product belongs to a specific pre-determined kit. This way, a clear and communicative means to guide the medical staff and caregivers to a correct product (and pre-determined kit) selection and its use is provided.

[0068] Alternatively, or in addition, the products associated with the standard-risk kit may be comprised in a first package, and wherein the products associated with the high-risk kit are comprised in a second package.

[0069] Hence, all products belonging to a specific kit (standard-risk or high-risk) of components are packaged together. Accordingly, considerable time and effort is saved in each care scenario.

[0070] Further features of, and advantages with, the present disclosure will become apparent when studying the appended claims and the following description. The skilled addressee realizes that different features of the present disclosure may be combined to create embodiments other than those described in the following, without departing from the scope of the present disclosure.

[0071] BRIEF DESCRIPTION OF THE DRAWINGS

[0072] The various aspects of the present disclosure, including its particular features and advantages, will be readily understood from the following detailed description and the accompanying drawings, in which:

[0073] Figure 1 schematically outlines the steps of the method of the present disclosure.

[0074] Figure 2 schematically illustrates a prophylactic sacral dressing of the standard-risk and high-risk kits of products.

[0075] Figure 3 schematically illustrates a prophylactic heel dressing of the standardrisk and high-risk kits of products.

[0076] Figure 4 schematically illustrates an elbow and / or shoulder dressing of the high-risk kit of products.

[0077] Figure 5 schematically illustrates a prophylactic dressing for use in conjunction with a medical device of the high-risk kit of products.

[0078] Figure 6 schematically illustrates a patient wearing the cut out dressing pieces when the medical dressing of figure 5 has been cut along the printed cutting guide lines.

[0079] Figure 7 schematically illustrates a pressure offloading pad of the high-risk kit of products.

[0080] Figure 8 schematically illustrates a care scenario where a patient is turned and positioned by means of a pressure offloading mattress and a pressure offloading pad of the high risk kit of products.

[0081] +Figure 9 illustrates a package containing prophylactic sacral dressings, wherein the package comprises printing markings indicating the risk category and the size of the dressings in the package.

[0082] DETAILED DESCRIPTION

[0083] The present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which currently preferred embodiments of the present disclosure are shown. The present disclosure may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided for thoroughness and completeness, and fully convey the scope of the present disclosure to the skilled person.

[0084] With reference to figure 1, the steps of the method of the present disclosure are schematically outlined. The method 100 for selecting a kit of products for a patient at risk of developing pressure ulcers comprises: a) determining a plurality of risk parameters associated with the patient, wherein the plurality of risk parameters is selected from sensory perception, exposure to moisture, degree of physical activity, mobility, friction and / or shear, skin condition, medication, trauma, fluid and / or food intake pattern, time of hospitalization, perfusion and / or medical condition (step 101), b) evaluating, based on the risk parameters, a risk score associated with the patient (step 102), c) selecting a pre-determined kit of products, based on the risk score (step 103), wherein the pre-determined kit of products is selected from at least a standard-risk kit of products (104) and high-risk kit of products (105), and wherein the standard-risk kit of products comprises a first, a second and a third prophylactic dressing; the first prophylactic dressing being a sacral dressing; the second and third prophylactic dressings being heel dressings, and wherein the high-risk kit of products comprises the first, second and third prophylactic dressings and at least one additional prophylactic dressing or prophylactic product.

[0085] As used herein, the term “risk parameter” means a parameter or factor that contributes to the risk of developing pressure ulcers.

[0086] As used herein, the term “sensory perception” means the degree to which a patient can respond meaningfully to pressure-related discomfort.

[0087] As used herein, “exposure to moisture” means the degree to which the skin is exposed to moisture, such as urine or perspiration.

[0088] As used herein, the term “degree of physical activity” means whether the patient is confined to bed or whether he / she is able to walk.

[0089] As used herein, the term “mobility” means the degree to which a patient can change or control body position with or without assistance.

[0090] As used herein, the term “friction and shear” means the degree of sliding in bed, e.g. due to agitation or having sufficient muscle strength to e.g. lift up during moving.

[0091] The “skin condition” means the color, temperature, or status of the skin, and whether the skin is intact or if a pressure ulcer has already been formed or is about to develop. One of the first signs that a pressure ulcer has developed or is about to develop is a reddened, discolored or darkened skin area.

[0092] The skin condition may be evaluated with the so called “blanching test”, wherein one finger is used to press the darkened or reddened area. The area should go white, and when pressure is removed, the area should return to the red or darkened color within a few seconds, which is an indication of good blood flow. If the area stays white, the blood flow has been impaired, and damage has begun.

[0093] The term “perfusion” means blood flow to the extremities. A poor perfusion may e.g. be indicated by the blanching test.

[0094] The term “determining a plurality of risk parameters” typically means determining at least three, preferably at least four risk parameters, more preferably at least five risk parameters.

[0095] The term “risk score” means a score obtained by evaluating the risk parameters associated with a patient. The risk score may be a predetermined risk score. The risk score may be a qualitative risk score or a quantitative risk score. A qualitative risk score may correspond to the number of risk parameters associated with a patient.

[0096] The risk-score may also be obtained by an individual assessment of each risk parameter (quantitative risk-score).

[0097] For example, the risk parameter may be associated with at least three levels of sub-scores and wherein the risk score associated with the patient is the sum of each sub-score associated with the risk parameter.

[0098] At least some of the individual sub-scores may be based on the Braden scale.

[0099] For example, the risk parameter sensory perception may be divided into the four levels: completely limited, very limited, slightly limited, and no impairment. Each of these levels may be individually scored between 1 and 4, where 4 denotes the worst scenario; i.e. completely limited sensory perception (patient being unresponsive to painful stimuli or has a limited ability to feel pain over the most part of the body).

[0100] The exposure to moisture may be divided into the four levels: constantly moist, very moist, occasionally moist or rarely moist. Each of these levels may be individually scored between 1 and 4, where 4 denotes the worst scenario; i.e constantly moist (skin is kept moist constantly by perspiration, urine etc.).

[0101] The degree of activity may be divided into the four levels: bedfast, chairfast, walks occasionally and walks frequently. Each of these levels may be individually scored between 1 and 4, where 4 denotes the worst scenario; i.e. bedfast (patient being confined to bed).

[0102] The mobility may be divided into the four levels: completely immobile, very limited, slightly limited, and no limitation. Each of these levels may be individually scored between 1 and 4, where 4 denotes the worst scenario; i.e. completely immobile (patient does not make any changes in body or extremity position without assistance).

[0103] The food intake pattern (nutrition) may be divided into the four levels: very poor, probably inadequate, adequate and excellent. Each of these levels may be individually scored between 1 and 4, where 4 denotes the worst scenario; i.e. very poor nutrition (the patient never eats a complete meal or is maintained on clear liquids or IVs for more than 5 days).

[0104] Friction and shear may be divided into the three levels: problem, potential problem, no apparent problem. Each of these levels may be individually scored between 1 and 3, where 3 denotes the worst scenario; i.e. problem (patient requires moderate to maximum assistance in moving and complete lifting without sliding against the sheets is impossible, spasticity, contractures or agitation leads to constant friction).

[0105] A “standard-risk kit or products” comprises a first prophylactic sacral dressing, and a second and a third prophylactic heel dressing.

[0106] A “high-risk kit of products” comprises the first prophylactic sacral dressing, and a second and a third prophylactic heel dressing and at least one additional prophylactic dressing and / or prophylactic product. Preferably, the high-risk kit of products comprises at least three additional prophylactic dressings and / or prophylactic products than the standardrisk kit of products.

[0107] As used herein, the term “prophylactic dressing” means a dressing aimed at mitigating or preventing the onset of a pressure ulcer.

[0108] A “sacral dressing” is a dressing adapted for application onto the sacral region of a patient. The sacral dressing preferably has a shape configured for application onto the sacral region. For example, the sacral dressing 200 may have the shape illustrated in figure 2.

[0109] A “heel dressing” is a dressing adapted for application onto the heel of a patient. The heel dressing preferably has a shape configured for application onto the heel. For example, the heel dressing(s) 300 may have the shape illustrated in figure 3.

[0110] Preferably, the first, second and third prophylactic dressing is a dressing having anisotropic stiffness properties. The prophylactic dressing(s) may comprise one or several layers that have anisotropic stiffness properties.

[0111] The term “anisotropic stiffness properties” means that the stiffness is different in the lateral (x) and longitudinal (y) direction of the dressing or dressing layer.

[0112] The dressing may have a lateral (x) extension and a longitudinal (y) extension. The dressing may have a tensile force at 15% strain that is higher in the longitudinal (y) direction than in the lateral (x) direction. The tensile force may e.g. be measured with ASTM D882-12.

[0113] Typically, the first, second and third prophylactic dressing has a tensile force at 15% strain that is at least four, preferably at least six times higher in the longitudinal (y) direction than in the lateral (x) direction.

[0114] The prophylactic dressing is preferably “stiffer”, i.e. has a higher tensile force in the direction in which the patient slides. This way, harmful compression and shear forces arising in the soft tissue due to patient sliding are minimized. On the other hand, the lateral (x) direction of the dressing is preferably more pliable and stretchable, and may consequently have a lower tensile force. A bedridden patient at risk of developing pressure ulcers must be turned and repositioned at regular intervals. It is therefore advantageous that the dressing conforms to this lateral movement and stays on the skin.

[0115] The high-risk kit of products comprises a larger number of prophylactic dressings and / or prophylactic products that the standard-risk kit of products. As mentioned hereinbefore, the high-risk kit of products may comprise at least two, preferably at least three additional prophylactic dressings or prophylactic products.

[0116] The additional prophylactic dressing of the high-risk kit of products may be selected from an elbow dressing, a shoulder dressing, and / or a dressing for use in conjunction with a medical device.

[0117] The elbow dressing may have a shape adapted to fit with the elbow. A suitable elbow dressing is illustrated in figure 4. Such a shaped dressing is also suitable for use with the shoulder(s).

[0118] As illustrated in figure 4, the prophylactic elbow and / or shoulder dressing 400 comprises a plurality of incisions 401, which enhance the flexibility of the dressing.

[0119] A suitable prophylactic dressing for use in conjunction with a medical device is illustrated in figure 5.

[0120] Such a prophylactic dressing 500 may be referred to as a MDRPU (medical device related pressure ulcer) prophylactic dressing. As illustrated in figure 5, the MDRPU prophylactic dressing 500 is provided with a plurality of guiding lines 501 indicating how to cut the dressing into a plurality of shaped dressing pieces. The dressing pieces are adapted to fit and to be used in conjunction with a variety of medical devices. In figure 6, the shaped dressing pieces 601a-d are designed to fit underneath a CPAP mask.

[0121] The prophylactic dressings of the standard-risk and high-risk kits of products may comprise a pressure-relieving material.

[0122] The pressure-relieving material may be a foam or a gel.

[0123] Preferably, the pressure-relieving material may comprise a polyurethane foam. Typically, the prophylactic dressings of the standard-risk and high-risk kits of products comprise a backing layer, an adhesive skin contact layer and a pad arranged between the backing layer and the adhesive skin contact layer; the pad comprising one or a plurality of pad-forming layers, wherein at least one of the pad-forming layers comprises the pressure-relieving material.

[0124] The “backing layer” is the top layer of the dressing. The backing layer may e.g. comprise a polymeric film, e.g. a polyethylene film, a polypropylene film or a polyurethane film. Typically, the backing layer comprises a polyurethane film. The thickness of the backing layer may be in the range of from 10 to 50 pm, e.g. from 15 to 40 pm.

[0125] As used herein, the term “adhesive skin contact layer” means a layer configured to detachably adhere the dressing to a dermal surface. In other words, the adhesive skin contact layer is configured to contact the skin of patient.

[0126] Preferably, the adhesive skin contact layer comprises a silicone-based adhesive. A silicone-based adhesive is gentle to the skin and may be removed and applied to the skin in a gentle manner, without causing any trauma. For example, the adhesive skin contact layer may comprise a silicone gel.

[0127] The silicone gel may be provided as a coating on the pad-forming layer. Alternatively, the adhesive skin contact layer may comprise one or more sub-layers. For example, the adhesive skin contact layer may comprise a polymeric film and an adhesive silicone gel layer, wherein the adhesive silicone gel layer is arranged to contact the skin.

[0128] The adhesive skin contact layer preferably comprises a plurality of perforations. The perforations facilitate the entry of body fluids exudate into the dressing.

[0129] One of the pad-forming layers may be a polyurethane foam layer.

[0130] The prophylactic dressing may further comprise additional pad-forming layers, such as an absorbent layer and a liquid distribution layer. For example, the pad may comprise, from top-to-bottom, an absorbent layer, a liquid distribution layer, and a polyurethane foam layer.

[0131] Alternatively, the pad may comprise, from top-to-bottom, a liquid distribution layer, an absorbent layer and a polyurethane foam layer.

[0132] The polyurethane foam layer is preferably arranged close to the skin to improve the pressure offloading effect.

[0133] This pad construction is beneficial from a microclimate point of view.

[0134] Moisture absorbed into the dressing is quickly transported away from the layer in closest contact with the skin. Also, heat energy generated may be wicked away from the skin. Since heat increases the metabolism of the already stressed cells under pressure and shear, this could otherwise add to the deterioration of skin cells. The layered pad construction prevents accumulation of body liquids close to the skin.

[0135] The absorbent layer may comprise a superabsorbent material, such as superabsorbent polymer (SAP) particles or superabsorbent fibers (SAF).

[0136] The liquid distribution layer may comprise a nonwoven material.

[0137] As mentioned hereinbefore, the sacral and heel dressings preferably have anisotropic stiffness properties. Hence, at least one of the pad-forming layers, typically the liquid distribution layer may be a layer having anisotropic stiffness properties.

[0138] A nonwoven layer is preferably used since many nonwoven materials can be manufactured with directional stiffness, e.g. by orienting the fibers in the longitudinal direction such that reinforcement will be provided in this direction. Also a nonwoven may improve the spreading of moisture entering the dressing leading to a better transport of moist into the dressing and away from the skin.

[0139] As mentioned hereinbefore, the additional prophylactic dressing of the high- risk kit of products may be an elbow dressing 400, and wherein the elbow dressing 400 may comprise at least one pad-forming layer provided with a plurality of incisions 401.

[0140] The elbow dressing is preferably flexible in all directions (in contrast to the anisotropic heel and sacral dressings).

[0141] As illustrated in figure 7, the additional prophylactic product of the high-risk kit of products may be at least one pressure offloading pad 700; the pressure offloading pad 700 being a moldable pad comprising a fluidized medium 701.

[0142] As used herein, the term “moldable pad” means that the pad may be molded into any shape upon the application of a force. Preferably, the moldable pad has no shape memory. In other words, after the moldable pad has adopted a specific shape upon the application of a force, that shape is retained when the force is removed.

[0143] The moldable pad comprises a fluidized medium 701. As used herein, the term “fluidized medium” means a medium which flows under an applied shear force. The fluidized medium does not flow due to gravity. The fluidized medium is preferably shape retaining and may be pushed into a shape with very little force, but retains that shape when the force is removed.

[0144] The fluidized medium may comprise a viscous fluid, e.g. a viscous oil, such as a silicone oil or a mineral oil. The fluidized medium may further comprise microparticles 702 having an average diameter less than 500 pm, e.g. an average diameter of from 10 to 300 pm.

[0145] The viscous fluid lubricates and coats the exterior surface of the microparticles and reduces the friction between the microparticles. A compact and firm medium, which does not flow in the absence of a shear force, is thus accomplished.

[0146] Preferably, the microparticles are microspheres. The microspheres may be hollow phenolic, glass or plastic particles. Typically, the microspheres are hollow spherical particles with plastic walls. The fluidized medium may further comprise an additional lightweight material, such as foam beads. The foam beads may e.g. comprise polyethylene or polystyrene.

[0147] The moldable pad may e.g. be formed by filling an outer shell with a mixture of the viscous fluid and microspheres and subsequently removing gas, e.g. air by vacuum.

[0148] The outer shell 703 may be any bladder or chamber in which the fluidized material may be enclosed. For example, the outer shell may be formed by two films or layers welded together along the peripheral edges of the films or layers.

[0149] The moldable pad 700 may be provided with a protective cover layer 704, as illustrated in figure 7.

[0150] The high-risk kit of products may comprise a plurality of moldable pads 700. For example, high-risk kit of products may comprise a moldable pad adapted for the back of a patient’s head. Furthermore, the high-risk kit of products may comprise one or more moldable pads adapted to offload the sacrum or support patient re-positioning.

[0151] The high-risk kit of products may further comprise a pressure-offloading mattress. A pressure-offloading mattress is schematically illustrated in figure 8, where a moldable pad 700 and a pressure-offloading mattress 800 are used for turning- and repositioning a patient 801. The pressure-offloading mattress 800 may comprise a pressure-offloading material, such as air, a gel or a foam. The pressure off-loading mattress may be configured to support patient turning and re-positioning.

[0152] The additional prophylactic product of the high-risk kit of products may be a pressure-offloading heel boot (not shown).

[0153] In cases where a heel dressing is not sufficient for use, the high-risk kit of products may comprise a heel boot comprising a pressure-offloading material.

[0154] The pressure-offloading material may be selected from air, a gel, a foam and / or a fluidized medium.

[0155] The high-risk kit of products may comprise at least a first, second, third, fourth and a fifth prophylactic dressing; the first prophylactic dressing being a sacral dressing; the second and third prophylactic dressings being heel dressings; the fourth and fifth prophylactic dressings being elbow dressings, and at least one prophylactic product selected from a pressure-offloading pad and / or a pressure-offloading mattress.

[0156] It is also conceivable that the high-risk kit of products comprises prophylactic dressings adapted for offloading each bony prominence of a patient’s body.

[0157] Also, the high-risk kit of products may comprise an ointment suitable for promoting skin damage or skin rash.

[0158] In exemplary embodiments, the method of the present disclosure further comprises evaluating at least one patient-specific parameter, wherein the patient-specific parameter is the weight, body mass index (BMI), gender, size, and / or weight-height relationship of the patient.

[0159] Each of these patient-specific parameters may affect the strategy to prevent pressure ulcers from occurring in the first place.

[0160] The step c) of selecting a kit of products may further be based on the patientspecific parameter, and wherein the high-risk kit of products, standard-risk kit of is categorized into at least a first size category and a second size category.

[0161] Hence, the various prophylactic dressings and products of the kits may come in a small size and a large size.

[0162] In exemplary embodiments, the method is a computer implemented method performed by a processing unit.

[0163] The computer implemented method may be arranged in communication with a database for selecting the prophylactic dressings and products for a specific patent.

[0164] The computer implemented method may comprise the steps of: - receiving, at the processing unit, the plurality of risk parameters associated with the patient, wherein the plurality of risk parameters are selected from sensory perception, exposure to moisture, degree of physical activity, mobility, friction and / or shear, skin condition, medication, trauma, fluid and / or food intake pattern, time of hospitalization, perfusion and / or medical condition,

[0165] - evaluating, using the processing unit, a risk score associated with the patient,

[0166] - selecting, using the processing unit, a pre-determined kit of products, based on the risk score, wherein the pre-determined kit of products is selected from at least a standardrisk kit of products and high-risk kit of products, and wherein the standard-risk kit of products comprises a first, a second and a third prophylactic dressing; the first prophylactic dressing being a sacral dressing; the second and third prophylactic dressings being heel dressings, and wherein the high-risk kit of products comprises the first, second and third prophylactic dressings and at least one additional prophylactic dressing or prophylactic product.

[0167] The control functionality of the present disclosure may be implemented using existing computer processors, or by a special purpose computer processor for an appropriate system, incorporated for this or another purpose, or by a hardwire system. Embodiments within the scope of the present disclosure include program products comprising machine- readable medium for carrying or having machine-executable instructions or data structures stored thereon. Such machine-readable media can be any available media that can be accessed by a general purpose or special purpose computer or other machine with a processor. By way of example, such machine-readable media can comprise RAM, ROM, EPROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of machine-executable instructions or data structures and which can be accessed by a general purpose or special purpose computer or other machine with a processor.

[0168] According to another aspect, there is provided an array of products comprising at least:

[0169] - a standard-risk kit of products comprising a first, a second and a third prophylactic dressing; the first prophylactic dressing being a sacral dressing 200; the second and third prophylactic dressings being heel dressings 300,

[0170] - a high-risk kit of products comprising the first, second and third prophylactic dressings and at least one additional prophylactic dressing or prophylactic product. As used herein, the term “array of products” means a display or line-up of products associated with a kit belonging to a specific pressure ulcer risk category. The products of the array prevent the formation of pressure ulcers. The array of products may belong to the same brand, but may differ with respect to the sub-brand.

[0171] The standard-risk kit of products and high-risk kit of products may be divided into at least a first and a second size category.

[0172] The products associated with a pre-determined kit of products may be contained in separate packages, wherein the packages comprise at least a first printed marking indicating a risk category and at least a second marking indicating a size of the product(s) comprised in the package.

[0173] A package 900 comprising prophylactic sacral dressings is schematically illustrated in figure 9. Since the sacral dressings belong to both the standard-risk kit of products and the high-risk kit of products, printed markings 901, 901’ indicating both risk categories may be present on the package.

[0174] It is also conceivable that the packages containing the products comprise a color-coded portion indicative of a specific risk-category. In figure 9, the color-coded portion is denoted 903a and 903b.

[0175] For example, the color-coded portion for packages containing products belonging to the high-risk kit of products may differ from the color-coded portion for packages containing products belonging to the standard-risk kit of products.

[0176] Accordingly, the recognition of the prophylactic dressings and products to utilize for a patient is improved. The selection of the correct products in a specific predetermined kit is significantly facilitated.

[0177] The printed markings may be printed on the front panel 904 and / or the side panels 905 of the package 900.

[0178] The printed markings may comprise additional product-identifying markings, e.g. to indicate the ability of the dressing and / or product to deal with moisture, pressure, shear, friction and / or microclimate (see e.g. 906a-b). As illustrated in figure 9, the printed marking may also be an image or a picture 907 of the product contained in the package.

[0179] The package 900 may further comprise a printed machine readable tag 908, e.g. a bar code or a QR code.

[0180] The bar code or QR code may encode an internet or web address containing technical and / or usage-specific information related to the prophylactic dressing or product and to the additional products and dressings belonging to a specific kit. Furthermore, the package may also comprise a printed marking 902 indicating the size of the product(s) comprised in the package.

[0181] Alternatively, or in addition, the products associated with the standard-risk kit may be comprised in a first package, and wherein the products associated with the high-risk kit are comprised in a second package.

[0182] Hence, all products belonging to a specific kit (standard-risk or high-risk) of components are packaged together. This allows for considerable time and effort to be saved for the medical personnel.

[0183] The first and the second packages may comprise at least a first printed marking indicating a risk category and at least a second marking indicating a size category of the products comprised in the package.

[0184] Terms, definitions, and embodiments of all aspects of the present disclosure apply mutatis mutandis to the other aspects of the present disclosure.

[0185] Even though the present disclosure has been described with reference to specific exemplifying embodiments thereof, many different alterations, modifications and the like will become apparent for those skilled in the art.

[0186] Variations to the disclosed embodiments can be understood and effected by the skilled addressee in practicing the present disclosure, from a study of the drawings, the disclosure, and the appended claims. Furthermore, in the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality.

Claims

CLAIMS1. A method for selecting a pre-determined kit of products for a patient at risk of developing pressure ulcers comprising: a) determining a plurality of risk parameters associated with said patient, wherein said plurality of risk parameters are selected from sensory perception, exposure to moisture, degree of physical activity, mobility, friction and / or shear, skin condition, medication, trauma, fluid and / or food intake pattern, time of hospitalization, perfusion and / or medical condition, b) evaluating, based on said risk parameters, a risk score associated with said patient, c) selecting a pre-determined kit of products, based on said risk score, wherein said predetermined kit of products is selected from at least a standard-risk kit of products and high- risk kit of products, and wherein said standard-risk kit of products comprises a first, a second and a third prophylactic dressing; said first prophylactic dressing being a sacral dressing (200); said second and third prophylactic dressings being heel dressings (300), and wherein said high-risk kit of products comprises said first, second and third prophylactic dressings and at least one additional prophylactic dressing or prophylactic product.

2. The method according to claim 1, wherein said risk parameter is associated with at least three levels of sub-scores and wherein said risk score associated with said patient is the sum of each sub-score associated with said risk parameter.

3. The method according to claim 1 or claim 2, wherein said first, second and third prophylactic dressing is a dressing having anisotropic stiffness properties.

4. The method according to any one of the preceding claims, wherein said additional prophylactic dressing of said high-risk kit of products is selected from an elbow dressing (400), a shoulder dressing, and / or a dressing for use in conjunction with a medical device (500).

5. The method according to any one of the preceding claims, wherein said prophylactic dressings of said standard-risk and high-risk kits of products comprise a pressure-relieving material.

6. The method according to claim 5, wherein said pressure-relieving material comprises a polyurethane foam.

7. The method according to claim 5 or claim 6, wherein said prophylactic dressings of said standard-risk and high-risk kits of products comprise a backing layer, an adhesive skin contact layer and a pad arranged between said backing layer and said adhesive skin contact layer; said pad comprising one or a plurality of pad-forming layers, wherein one of said padforming layers comprises said pressure-relieving material.

8. The method according to any one of the preceding claims, wherein said additional prophylactic dressing of said high-risk kit of products is an elbow dressing (400), and wherein said elbow dressing comprises at least one pad-forming layer provided with a plurality of incisions (401).

9. The method according to any one of the preceding claims, wherein said additional prophylactic product of said high-risk kit of products is at least one pressure offloading pad (700); said pressure offloading pad (700) being a moldable pad comprising a fluidized medium (701).

10. The method according to any one of the preceding claims, wherein said additional prophylactic product of said high-risk kit of products is a pressure-offloading mattress (800).

11. The method according to any one of the preceding claims, wherein said additional prophylactic product of said high-risk kit of products is a pressure-offloading heel boot.

12. The method according to any one of the preceding claims, wherein said high-risk kit of products comprises at least a first, second, third, fourth and a fifth prophylactic dressing; said first prophylactic dressing being a sacral dressing (200); said second and third prophylactic dressings being heel dressings (300); said fourth and fifth prophylactic dressings being elbow dressings (400), and at least one prophylactic product selected from a pressure-offloading pad (700) and / or a pressure-offloading mattress (800).

13. The method according to any one of the preceding claims, further comprising evaluating at least one patient-specific parameter, wherein said patient-specific parameter is the weight, body mass index (BMI), gender, size, and / or weight-height relationship of said patient.

14. The method according to claim 13, wherein said step c) of selecting a kit of products is further based on said patient-specific parameter, and wherein said high-risk kit of products, standard-risk kit of products, and optionally, said medium-risk kit of products is categorized into at least a first size category and a second size category.

15. The method according to any one of claims 1-14, wherein said method is a computer implemented method performed by a processing unit.

16. An array of products comprising at least:- a standard-risk kit of products comprising a first, a second and a third prophylactic dressing; said first prophylactic dressing being a sacral dressing (200); said second and third prophylactic dressings being heel dressings (300),- a high-risk kit of products comprising said first, second and third prophylactic dressings and at least one additional prophylactic dressing or prophylactic product.

17. The array of products according to claim 16, wherein said standard-risk kit of products and high-risk kit of products are divided into at least a first and a second size category.

18. The array of products according to claim 16 or claim 17, wherein the products associated with a pre-determined kit of products are contained in separate packages (900), and wherein the packages comprise at least a first printed marking (901) indicating a risk category, and, optionally, at least a second marking (902) indicating a size of the product(s) comprised in said package.

19. The array of products according to any one of claims 16-18, wherein the products associated with said standard-risk kit are comprised in a first package, and wherein the products associated with said high-risk kit are comprised in a second package.

20. The array of products according to claim 19, wherein said first and second packages comprises at least a first printed marking (901) indicating a risk category and, optionally a second marking (902) indicating a size category of the products comprised in said package.

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