Patent Publication Number: US-10758442-B2

Title: Device for positioning a bedridden patient

Description:
This application is a National Stage Application of PCT/IB2016/051052, filed 26 Feb. 2016, which claims benefit of Ser. No. MI2015A000395, filed 16 Mar. 2015 in Italy and which applications are incorporated herein by reference. To the extent appropriate, a claim of priority is made to each of the above disclosed applications. 
     The present invention relates to a device for positioning a bedridden patient, in particular for keeping the lateral Trendelenburg position or another safety position. 
     BACKGROUND ART 
     So-called VAP (Ventilator-Associated Pneumonia) is the complication most frequently associated with tracheal intubation and mechanical ventilation in patients hospitalized in intensive care. 
     Preliminary studies on animal models have shown that the orientation of the trachea and the tracheal tube under the horizontal plane prevents the onset of VAP with respect to the currently recommended orientation by at least 30°. In adults, the trachea and the endotracheal tube may be kept under the horizontal plane by means of the lateral Trendelenburg position. 
     At least four pillows are normally used by nursing staff in order to keep the lateral Trendelenburg position. Such a position is difficult to be kept because the sedated patient with muscular relaxation tends to spontaneously take the supine position. This requires continuous assistance by nurses to reposition the patient. Furthermore, the tailoring of the pillows to the needs of different patients, in particular to their body size, requires particular attention and considerable experience of the health care staff. 
     A further difficulty arises from the need to turn the patient onto the other side at regular intervals, which requires a complete rearrangement of all pillows. 
     A problem addressed by the present invention is thus that of providing a medical device which simplifies the operations of positioning and repositioning a bedridden patient and keeping him/her in the Trendelenburg position or in a similar safety position. 
     SUMMARY OF THE INVENTION 
     These and other problems are solved by a medical device as set forth in the appended claims, the definitions of which form an integral part of the present description. 
     Therefore, a subject of the invention is a medical device comprising at least one shaped pillow adapted to keep a patient in a lateral position with a predetermined inclination angle and characterized in that it can be extended laterally in width so as to tailor it to the patient&#39;s body size. 
     A second subject of the invention is a medical device comprising a back supporting pillow as and at least one pillow chosen from a pillow for the patient&#39;s head and a pillow for the patient&#39;s legs, where said pillows are joined together by removable connection means. 
     Another subject of the invention is a kit comprising at least two pillows, and the at least one other pillow is a leg pillow or a head pillow. 
     A yet further subject of the invention is a kit comprising pillows and removable connection strips to keep said pillows joined together when used on the patient. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further features and advantages of the present invention will become apparent from the description of some embodiments, given below by way of non-limiting example, with reference to the following figures: 
         FIG. 1  is a perspective view of a shaped pillow according to the invention; 
         FIG. 2  is a side phantom view of the pillow in  FIG. 1 ; 
         FIG. 3  is a perspective view of a kit comprising the pillow of the invention; 
         FIG. 4  is a perspective view of the kit of the invention in use on a patient; 
         FIG. 5  is a perspective view of the kit of the invention in use on a patient according to a different embodiment; 
         FIG. 6  is a perspective view of a pillow for legs and arms according to a further embodiment. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     With reference to the figures, the shaped pillow of the invention, indicated by reference numeral  1  as a whole, comprises a shaped portion  2  and an expandable portion  3 . 
     Pillow  1  develops along three directions:
         a first longitudinal direction L 1  (length), substantially parallel to the patient&#39;s body;   a second lateral direction L 2  (width), substantially traversal to the patient&#39;s body, and   a third vertical direction L 3  (height).       

     The shaped portion  2  is shaped so that the width L 2 ′ at the level of the upper surface of pillow  1  is less than the width L 2  at its base. 
     The shaped portion  2  consists of a body  4  having a rectangular base  5  and a substantially right-angled triangle shaped cross section. Therefore, body  4  has an inclined surface  6 . Surface  6  forms the support surface for the patient&#39;s back. 
     In preferred embodiments, the inclination of surface  6  with respect to base  5  (angle α in the figures) is from 20° to 40°, or from 25° to 35°, or about 30°. It has been noted that such an inclination angle ensures a better position for the patient. 
     The shaped portion  2  is made of a flexible material so as to be soft and accommodating and not to create abrasions for the patient. 
     In preferred embodiments, the material of the shaped portion  2  of pillow  1  is an elastomer, in particular a foam elastomer. For example, natural or synthetic rubber or a viscoelastic foam, in particular of the bedsore-prevention type, may be used. In certain embodiments, such a material may be a latex, e.g. of the memory shape type. 
     At least the shaped portion  2 , or only the support surface  6  thereof, is preferably covered with a breathable fabric, such as cotton, flax or other fabric used in the medical field. In some embodiments, a synthetic fabric will be used, such as an acrylic fiber fabric or a knitted pile fabric of the “Spandex” type. 
     In some embodiments, at least the shaped portion of pillow  1  or, if used, the fabric coating thereof, comprises an antibacterial compound, such as for example an antibacterial active compound either absorbed, adhered or bound to the surface thereof by means of covalent bonds. 
     Examples of antibacterial active compounds are penicillins, aminoglycosides, quinolone antibiotics, tetracyclines, chloramphenicol, sulfacetamide, sulfamethazine, sulfadiazine, sulfamerazine, sulfamethizole, erythromycin, clarithromycin, rifamycin, rifampicin, ceftazidime, amoxicillin, amoxicillin trihydrate, clavulanic acid, vancomycin hydrochloride, teicoplanin, linezolid, colistin and chlorhexidine. For example, such compounds may be bound to the surface to be treated by means of cyclodextrins, according to technologies known to those skilled in art. 
     In other embodiments, the antibacterial compound either comprises or consists of Ag +  ions. For example, a silver yarn or an organometallic complex may be used, in which Ag +  is coordinated. Examples of complexes of this type are described in EP 2 024 117 B1 to NM TECH LTD NANOMATERIALS. 
     In some embodiments, the antibacterial compound is based on bioactive synthetic polymers and natural protein substances with positive charges. 
     The expandable portion  3  of pillow  1  comprises one or more sections  7  (four sections  7  in the figure). When the sections  7  are more than one, they are separated from one another so as to create a series of expandable modules, each being able to be expanded by a suitable inflation fluid, so as to adjust the thickness of pillow  1  along the lateral direction L 2  according to needs. Indeed, it is known that according to the patient&#39;s body size and the size of the bed on which the patient is laying, it may be necessary to modify the size, in particular the lateral dimensions, of pillow  1  in order to obtain an appropriate support. Indeed, the pillow must be arranged so as to be supported between the patient&#39;s back and the bed containment barriers, so as to remain fixed in place, whereby the void may vary as a function of the indicated parameters. 
     For this purpose, each section  7  internally comprises a chamber  8 ,  8 ′,  8 ″,  8 ′″, connected to the outside by a spout  9 , for the inflation fluid to enter. A check valve is preferably arranged at spout  9 . The chambers  8 ,  8 ′,  8 ″,  8 ′″ may also comprise a second valve (not shown) for draining the inflation fluid, or the valve associated with spout  9  may be a charging/discharging valve actuatable on command. 
       FIG. 3  shows a kit comprising the pillow  1  according to the invention, a second pillow  11  to be placed between the patient&#39;s legs, and a third pillow  10  for the patient&#39;s head. 
     The shape of the third pillow  10  is such as to ensure an adequate support to the patient&#39;s head, in particular in the Trendelenburg position which involves a downward inclination (negative inclination) of about 5°. Therefore, pillow  10  has a double hump shape  13 ,  13 ′ which has a middle depression  12  such as to allow the desired negative inclination ( FIG. 4 ). 
     As shown on the drawing, the second pillow  11  may have a classic parallelepiped shape, but in other embodiments it may be circular, elliptical or have a different shape. Pillow  11  is placed between the patient&#39;s legs as shown in  FIG. 4  or under the knee and the upper elbow as shown in  FIG. 5 , so as to support the knee and the upper elbow. For this purpose, the size of pillow  11  may be different according to different needs: wider and shorter in the case shown in  FIG. 4 , narrower and longer in the case shown in  FIG. 5 . Furthermore, in the latter case, pillow  11  may have a wider first portion  11   a  to support the leg and a narrower second portion  11   b  to support the arm without interfering with the patient&#39;s torso ( FIG. 6 ). 
     In some embodiments, as shown in the figures, pillow  11  may also comprise at least one support portion  14 ,  14 ′ and at least one expandable portion  15 . Two support portions  14 ,  14 ′ sandwiching the expandable portion  15  on the two sides thereof are shown in the figures, but in other embodiments a single support portion  14  may be provided. 
     The expandable portion  15  is similar to the expandable portion  3  of the first pillow  1 , but will preferably consist of a single section  7  in which the chamber  8  for the inflation fluid is housed. 
     A spout  9  with check valve and charging/discharging valve is also included for the second pillow  11 . In the first case, a valve (not shown) for discharging the fluid will be obviously included. 
     In some embodiments, the support portion(s)  14 ,  14 ′ are made of the same material as the support portion  2  of the first pillow  1  and may be similarly coated with a breathable fabric like those described above, possibly comprising an antibacterial compound as defined above. 
     The inflation fluid may be a gas or a liquid, preferably sterile and non-flammable. 
     In the case of a gas, any means may be included for inflating the chambers  8 , such as a manual pump, a compressed air generator or a compressed air line, or a line of another fluid, having a pressure higher than atmospheric pressure. 
     An inert, non-flammable gas will be preferably used, such as for example nitrogen. 
     If the inflation fluid is a liquid, typically water, an appropriate pump will be used, which will both introduce the fluid and remove it at the end of use. Typically, the inflation liquid will be recycled. In such a case, it will preferably contain sanitizing substances. 
     The kit in  FIG. 3  may further comprise a first connection strip  16  between the first pillow  1  and the second pillow  11  and a second connection strip  17  between the first pillow  1  and the third pillow  10 . 
     The connection strips  16 ,  17  may be made of natural, artificial or synthetic fabric and are preferably removable (as shown in the figures). For this purpose, the strips  16 ,  17  comprise removable connection means  18  at the two ends, in particular the male portion or the female portion of a hook and loop system (known as Velcro® system), the complementary female or male portion being arranged on the lower surface of the pillows  1 ,  10 ,  11 . With regard to the second pillow  11  for the patient&#39;s legs, such a complementary portion of the connections means will be positioned in a point to prevent the interference with the patient&#39;s body so as to ensure maximum comfort. 
     It is worth noting that the above-described hook and loop system is only one example of removable connection means  18 . Other examples may be hook and eyelet systems, automatic buttons, magnetic coupling systems or the like. 
     The advantages of the pillows according to the invention and of the corresponding kit are apparent and already highlighted in part. 
     The first pillow  1  and the second pillow  11  comprise expandable modular portions, so as to adjust the width or thickness of the pillow, respectively, according to needs, i.e. as a function of the bed size and of the patient&#39;s body. 
     The removable connection means between the three pillows of the kit allow to keep them joined, making it easier to position them on the patient and keep him/her in the desired position. Indeed, the connection means avoid the leg pillow  11  from being inadvertently moved by the patient, thus altering the correct support position, for example. On the other hand, the fact that such connection means are removable facilitates the later storage of the kit in a cabinet or other container, by limiting the dimensions thereof. 
     As apparent from the shape of the pillows, the pillow kit according to the invention may be used for the patient resting either on the left or on the right side, which operation must be performed at regular intervals for a bedridden patient in the described conditions. 
     It is apparent that only some particular embodiments of the present invention have been described, to which those skilled in the art will be able to make all the changes required to adapt it to particular applications, without thereby departing from the scope of protection of the present invention.