A POSITIONING SYSTEM

The present invention relates to a positioning system for positioning a person on an operating table, in a hospital bed or in an institutional bed, comprising at least one positioning pad having a waterproof and breathable cover enclosing one or more layers of foam.

During surgery, a patient may spend a great deal of time lying on a surgical table where the patient is positioned by various devices, pads and cushions. Until recently, hospitals have provided fairly crude positioning devices for this positioning process. For example, patients may be propped into a selected operative position by rolled-up sections of bath blankets, disposable foam and surgical towels. However, these fairly crude positioning devices do not provide an acceptable degree of stability and do not facilitate appropriate safety.

When a patient is positioned in a position which is improper such a position can create peak pressure points that may cause capillary occlusion. A restriction of blood flow or capillary occlusion can cause post-operative decubitus ulcers and hence can require a long term costly physical therapy regimen. In addition, high interface pressure can lead to localized nerve damage, tissue damage or damage to muscles and bones.

The most common post-operative injuries are decubitus ulcers, also known as bed sores or pressure sores. Decubitus ulcers are wounds that form due to prolonged pressure on a particular point on the body, which constricts blood flow. Such pressure sores may result from a positioning device that creates high pressure (over 32 mmHg) against the skin. Once formed, pressure sores can take months to heal and can actually become life-threatening. Decubitus can develop already after 30 min -1½ hour bedding within vulnerable patient groups.

It is estimated that 23-25% of post-operative decubitus ulcers arise from damage that initially occurs due to high interface pressure on a specific area of the skin that occurs during surgery. In 75 % of the cases, the damaged caused in the internal tissue is not visible on the outer layer of skin until several days later. The risk of decubitus ulcer development increases in patients that are prone to reduced circulation such as diabetics and the elderly. Decubitus ulcers lead to increased costs for medical care as well as increased costs that arise from potential medical malpractice claims.

Pressure ulcers may be a complication of immobility. The major cause of pressure ulcers is generally accepted to be an external pressure that occludes blood vessels (capillary occlusion). Two distinct mechanical forces that contribute to pressure ulcers are direct downward pressure and shear pressure. Tissue Interface Pressure (TIP) is a direct downward vertical pressure, can occlude blood capillaries and cause ischemia to the area supplied by the affected vessels.

Prolonged ischemia leads to cell and tissue death. Shear pressure is a horizontal force that occurs when the skin and underlying subcutaneous tissues are pulled taut and over-stretched, causing tissue deformity, obstructing blood flow and tissue necrosis. Horizontal and shear pressure will be higher in areas where soft tissue lies over bony surfaces. Forces over bony prominences should be reduced whenever possible.

Surgical procedures longer than two hours and procedures that involve the cardiovascular system may cause an otherwise low risk patient to be at risk for harm. Patient positioning in surgery in general needs to be assessed carefully and surfaces used in positioning should meet recommended standards for positioning.

Consequently, various pads or pillows have been developed for use in the medical field to alleviate dangers caused by rolled bath blankets, for example. Typical pillows or pads are designed to provide support for a particular body part and have most often been produced for the following specific body parts: neck, head, foot and heels, sacral, trochanter, brachial plexus, and major surgical positions (supine, prone, lateral, Fowler and lithotomy). To provide such support, these pads are sometimes constructed and designed to conform to the shape of the body part to be supported.

Better position systems including pads with special designs and shapes have been developed to improve the situation where a patient is lying on a surgical table. The pads may be delivered with different stiffness and hardness depending of the desired use. The pads are designed with these different properties for providing the best possible positioning for a large range of patients that all have different size and weight. Consequently, a modern position system including the special designed pads offers solutions which can be adapted to an individual patient with a specific size and weight.

For example, US 4 840 362 A discloses a kit of resilient blocks and an assemblage thereof for positioning and supporting a patient for spinal surgery.

However, the modern position system may sometimes cause difficulties in operating rooms, in which the staff may be under great stress. Thus, it has been realised that a frequent error in operating rooms is that the pads used to position a patient have been wrongly identified by the operating personal, which may have the consequence that the pads does not fit with the particular patient and may cause post-operative complications. A more serious complication caused by improper pads for positioning may be decubitus ulcer.

Consequently, there is a need for an improved position system where the correct pad can be easy and fast identified.

An object of the present invention as claimed is to provide a position system for positioning a person, e.g. a patient on an operating table which position system comprises one or more pads, where each individual pad easily can be identified, and in which the history of each pad can be tracked, i.e. how many times have the pad been used.

Moreover, the present invention provides a positioning system comprising pads with different properties in which system each pad includes a data storage device providing information about how the pad should be used, e.g. such as an electronic user manual.

Consequently, the present invention relates to positioning system for positioning a person on a surgical table inhibiting decubitus ulcer, comprising at least one positioning pad having a water proof and breathable cover enclosing one or more layers of foam wherein the cover or a layer of foam comprises a data storage device adapted for providing individual identification of the positioning pad and capable of communicating with a data processing unit , whereby said data storage device is adapted to contain information about the use of said at least one positioning pad, thus allowing a staff at a hospital, care home or the like to always get updated information about said positioning pad, said information relating to the history of said positioning pad in terms of how and where and when said positioning pad has been used.

The positioning system according to the invention is highly suitable for positioning a person, such as a patient, on an operating table or surgical bed table during sedation and surgery. However, the position system may also be used in beds or chairs, in particular for persons who for some reason are fully or partly immobilised.

A mattress set may be designed to cover the surgical table and provide support for the patients body. The mattress set may comprise one or more parts which can be placed on the surgical table to form the support.

The positioning pad is a specially designed pad that comprises one or more layers of foam. In case the pad comprises more than one layer the layers may have different hardness and density, whereby the layers can be used to build in desired properties in the pad, e.g. properties in respect of supporting specific body parts.

The invention also provides embodiments wherein the mattress set is used without the positioning pads and embodiments wherein the positioning is used alone without the mattress set. Thus, the system offers great flexibility for use in an operating theatre.

Moreover, the mattress set and the positioning pad comprises a water proof and breathable cover. The cover prevents that body fluids like blood and sweat may enter the foam inside the mattress or pad while at the same time allowing the material to breath.

The covers of the positioning system may comprise water proof zippers, which will make the system more convenient to use and easier to clean.

As a unique feature the mattress set and the positioning pad comprise a data storage device capable of communicating with a data processing unit. Thus, it is possible to store data in the data storage device integrated in mattress set and the positioning pad. The data may comprise information about correct use of the positioning pad, how many times the pad has been used and for what purposes etc. A positioning pad for surgery should be properly cleaned after each usage, e.g. by use of an autoclave. All these details can be stored in the data storage device and transferred to and from a data processing unit, which may simply be a computer or a smart phone with a display screen that can display the data from the data storage device. Thus, all required data about the positioning pad can easily be stored and retrieved from the data storage device.

The data storage device may be integrated in the cover or alternatively in a layer of foam inside the pad. That last solution may be chosen if there is a risk that data storage device integrated in the cover may have a negative impact on a patient positioned by the positioning pad.

To achieve all the advantages of the positioning system according to the invention it is preferred that the data storage device comprise at least one sender and at least one receiver. Thus, the data storage device is capable of sending and receiving data and information to and from the data processing unit. Although, the data storage device and the data processing device may be connected via a contact and wires during exchange of data it is, however, preferred that the data storage device communicates with the data processing unit using wireless communication. Wireless communication is fast and easy to establish and also reliable. Moreover, contacts in the surface of the cover may be avoided.

Consequently, in preferred embodiments of the positioning system according to present invention the data storage device is selected among microprocessors, RFID and intelligent chips. At present RFID is particular preferred.

The data storage device allows individual identification of the positioning pad, which is particular advantageously when several different positioning pads are used, e.g. to positioning a patient on an operating table. Thus, the positioning system according to the invention comprises embodiments with two or more pads and where each pad comprises a data storage device for individual identification.

As mentioned the data storage device may be integrated in the cover of the positioning pad, and preferably the data storage device is attached on the inner side of the cover, e.g. by gluing or welding. Alternatively the data storage device is integrated in a layer of foam in the positioning pad, which will ensure that the data storage device will not be able to press against a patient's skin and optionally cause damage.

In preferred embodiments the positioning system is adapted for use with a surgical table. However, it may be possible to use the positioning system in a bed or a wheel chair. Thus, the positioning system can be used not only for a patient on a surgical or operating table, but also for a patient laying in a bed such as a hospital bed or a bed in a hospice. The positioning system may highly reduce the risk of bed sores and decubitus ulcer.

Although, the data storage device offers great safety and serves to ensure that a correct mattress set or positioning pad is selected in a specific situation, the safety may be improved by the embodiments of the present invention where the cover of the mattress or positioning pad has a colour indicating the properties of the mattress or the positioning pad. Thus, positioning pads with different properties have covers with different colours. This may e.g. be a specific colour for positions pads for children and a different colour for patients suffering from obesity. Moreover, a specific colour may be used for pads in a position system for positioning patients on the side and another specific colour may be used for a system for positioning patients on the back.

The use of bar codes for the different types of positioning pads is also possible. However, bar codes do not allow for additional information to be stored subsequently, e.g. information about how many times the positioning pad has been used and cleaned. Moreover, bar codes have to be printed on the outer surface of the cover and may be worn off during use.

Consequently, the present invention provides a positioning pad comprising a data storage device, such as a RFID chip. The positioning pad according to the present invention may be designed as e.g. a positioning pad, operating theatre, hospital mattress or pads for wheel chairs and have several advantages.

The positioning pad may advise the users, i.e. the professional users such as surgeons, nurses, and porters (not the patient) of how to best utilize the positioning pad in order to prevent Decubitus.

The positioning pad will provide information about the range of the body weight for which it is suitable and the recommended length of time the positioning pad should be used to achieve optimal pressure distribution and prevent Decubitus ulcer.

The possibility to scan a positioning pad to obtain instant information about correct usage presented as text, pictures or video will reduce cases of incorrect usage. Moreover some patients are placed on mattresses before, during and after surgery that does not offer optimal pressure distribution based on their body weight. Since it is difficult to see from a mattress which body weight it is optimal for, the data storage could instantly provide that information.

Moreover, the positioning pad will allow the hospital to document which pads and/or mattresses were used on a patient in case of injuries. Furthermore, the positioning pad according to the invention will allow the hospital to scan the pads and mattresses each time they have been cleaned or washed and ready for reuse. Such safety documentation may serve to prevent spreading of infections.

The positioning pads according to the invention normally comprises a combination of viscoelastic foam with a specific density, HR foam with a specific density, and specific distribution between the different foam constitutes the design for optimal pressure distribution for the actual operating procedure undertaken by the hospital. The main purpose of the positioning pads is to prevent the risk of pressure sores, which can easily occur during long-lasting surgery or lying in a hospital bed.

The cover for the positioning pads, which may be shaped as pads or mattresses, is made of a waterproof and breathing material such as Decu-Tex©, which may optional be combined with other types of proprietary cover materials, with urethane as the main ingredient. For optimal hygiene all covers are full-welded. However, some covers are fitted with a plastic zipper which makes it easy to remove the cover for cleaning. The cover is folded over the zipper to avoid skin injury to the patient or staff before, during and after the operation.

At present it is preferred to use RFID chips as data storage device in the positioning pads according to the invention. RFID (radio frequency identification) is a technology that incorporates the use of electromagnetic or electrostatic coupling in the radio frequency (RF) portion of the electromagnetic spectrum to uniquely identify an object. The advantage of RFID is that it does not require direct contact or line-of-sight scanning. A RFID system consists of an antenna and transceiver (often combined into one reader) and a transponder (the tag).

The antenna uses radio frequency waves to transmit a signal that activates the transponder. When activated, the tag transmits data back to the antenna. The data is used to notify a programmable logic controller that an action should occur. High-frequency RFID systems (850 MHz to 950 MHz and 2.4 GHz to 2.5 GHz) offer longer transmission ranges (more than 30 meter).

As explained above the positioning system according to the invention provides several advantages. The positioning system is easy and fast to use, and ensures great safety for the patient.

The positioning pads may be shaped as pads, wedges, mattresses and shapes may vary according to the desired use. The pads may be designed to specific purposes such as use for children weighing between 10 and 50 kilo and the cover may have a specific color indicating this use. Other colors may indicate that the pads are for use in situations where the patient is positioned on the back, the side or prone. Thus, the invention also presents a coloring system that facilitates the use of the positioning system.

To achieve the desired properties, the positioning pads or pads may comprise several layers of foam, in which each layer of foam has different properties. Thus, it is possible to design a pad suitable for supporting specific body parts and that will adapt in respect of a patients weight and size. Consequently, it is possible to design position pads with a wide range of properties, from pads suitable for children to pads suitable for person suffering from obesity.

In addition to the coloring system indicating the use of the positioning pads, each positioning pad also comprises a data storage device, e.g. a RFID chip that contains information about the use of the positioning pad. The information may include an instruction video and, furthermore, information about weight ranges for patients, how and when the positioning pad was cleaned. Information about how the positioning pad has been used and how and when it has been cleaned can be stored continuously during the life time of the positioning pad. Thus, the staff at the hospital, care home etc. will always get updated information about the positioning pad, which further improves the use and safety of the positioning pad. The information stored in the data storage device may be retrieved by scanning the position pad with a scanner connected to a computer, PDA or smart phone. Thus, the complete story of the positioning pad, inclusive prior use, is available for the staff, which then fast and easy may determine whether or not a specific positioning pad should be used in a specific situation, e.g. such as an operation.

Consequently, the positioning system according to the present invention provides a system for positioning a patient in a safe and reliable manner and with significant reduced risk of post operation complications such as decubitus ulcer.

The unique properties of the positioning system according to the invention are achieved by the incorporation of a data storage device, such as a RFID chip in each positioning pad of the system. The data storage device provides the option of storing information about correct use of the positioning pad, e.g. including an instruction video. Moreover, additional information may be stored during the life time of the positioning pad, whereby it is possible to track how and where and when the positioning pad has been used. This may be important in case of post operation complications with a patient, such as infections or decubitus.

As mentioned the safety and convenience of the positioning system according to the invention may be further improved by using covers with different colors for positioning pads with different properties.

Thus, the present invention provides a positioning system that improves safety for the patients and a system that is very easy and convenient to use for the staff. A wide range of positioning systems and positioning pads may be realized within the scope of the present invention as defined in the claims.