EP4125766B1

EP4125766B1 - Support device in form of a pad, mainly for use upon an operating table

Info

Publication number: EP4125766B1
Application number: EP21712909.7A
Authority: EP
Inventors: Carlambrogio Bianchi; Diego CASATI; Cristiano BETTINELLI
Original assignee: AB Medica SpA
Current assignee: AB Medica SpA
Priority date: 2020-03-23
Filing date: 2021-03-17
Publication date: 2024-01-31
Anticipated expiration: 2041-03-17
Also published as: IT202000006058A1; WO2021191745A1; EP4125766A1

Description

Technical field of the invention

The present invention relates to a support device, in particular substantially in the form of a pad element, mainly for use on a support structure in the form, for example, of a medical operating bed.

Background

Many support devices in the form of a pad are known in the art, which are typically placed on a medical bed, or on a different bearing structure, for example during surgery.
Such devices typically provide a deformable main body, just in the form of a pad element, which is fixed to the medical bed by means of bands or straps. Similar locking elements are also provided to hold the patient's body in the desired posture during the medical intervention.
Despite their wide use, the known support devices are still perfectible, especially in relation to the ability of the main body to withstand the stresses associated with the traction on the aforesaid straps or bands, the simplicity of construction and the cost of production.
Another essential requirement to which an improvement solution can be provided is the simplicity of connection to the medical table or to a bearing structure in general.
EP3207912 discloses a pad assembly and system for securing a patient onto an operating table in the Trendelenburg position.

Summary of the invention

The technical problem posed and solved by the present invention is therefore that of providing a support device that allows overcoming the drawbacks mentioned above with reference to the known art.
This problem is solved by a device according to claim 1.
Preferred features of the present invention are the subject of the dependent claims.
According to a preferred embodiment of the invention, the support device includes the three main components listed below, structurally distinct or integrated or connected to each other.

▪ A pad element, or pad, configured to receive the body of a subject, typically a patient, in a completely or partially extended position (prone or supine) on it. To this end, this element generally has a flat shape that is elongated in a longitudinal direction with a prevailing dimension with respect to the dimension in a transverse direction, both such dimensions being widely greater than the thickness of the element itself.
▪ Fixing means to a bearing structure underlying the pad element, typically a medical bed or a transport stretcher, which fixing means generally includes straps, strips or in any case oblong elements.
▪ A pair of longitudinal stress distribution elements, interposed between the pad element and the fixing means and each typically made in the form of a strip or band.

Advantageously, the pad element can be configured to prevent the subject from slipping, even in longitudinally and/or transversely inclined positions typical of some surgical procedures, for example of a gynecological type.
In addition, the pad element can exhibit a viscoelastic behavior to perform a more uniform distribution of loads on the subject, avoiding concentrated stresses due to the prolonged stay in contact with the support structure and which could cause damage to the skin.
Advantageously, the pad element can be made, at least in part, of an expanded polymer with open cells, which allows the skin of the subject lying on it to breathe, avoiding localized irritation.
Preferably, the pad element is made entirely or partially in Polyurethane (PU), in particular expanded polyurethane, or in a material with similar physical-mechanical characteristics.
In preferred embodiments, the pad element has properties of biocompatibility and/or is fireproof.
According to a first aspect of the invention, each of the stress distribution elements is configured to uniformly distribute the forces involved between the straps and the pad element, both during the connection operation of the device to the bearing structure and in the subsequent use, even in procedures that require an inclined posture of the patient.
To this end, advantageously, each distribution element is made of an elastic material, preferably having a stiffness of the same order of magnitude as that of the pad element, with a difference of ≤ 20%.
In a specific embodiment, the stiffness of each distribution element is in a range of about 1.1×10^-2 ÷ 1.7x10^-2 N/mm and preferably equal to 1.4×10^-2 N/mm.
Preferably, each distribution element is made, completely or in part, of fabric, for example based on natural and/or synthetic fibers. In variant embodiments, each element has a coating, for example made of polymeric material such as polyurethane, polyvinyl chloride or other. Other solutions may consist, for example, in a coupled Polyester/Polyurethane foam/Polyester, or in a simple sheet of polymeric material.
In one embodiment, each distribution element is bound to the pad element through a continuous junction area, arranged over the entire longitudinal extension of a long edge of the pad element itself. In this way, the entire longitudinal portion involved contributes to the transfer of forces.
This constraint, or mechanical connection, can be achieved by one or more of the following techniques: bonding with adhesive; welding, for example by ultrasound or heat sealing; melting using solvents; seam.
In advantageous embodiments, each distribution element is constrained to the pad for a portion of its width comprised within a range of 50-75%, the remaining part being dedicated to the connection with the fixing means.
In specific embodiments, each distribution element is, as mentioned, in the form of a strip or band, advantageously with a substantially rectangular or quadrangular plan, for example with a width of 150 mm.
Distribution elements can also be fireproof.
On the basis of a second aspect of the invention, which can be used synergistically or independently of the first aspect mentioned above, the fixing means are also made of a material having an elastic modulus of the same order of magnitude as the pad element, which helps to distribute the forces between the latter and the distribution elements.
The fixing means can be made of the same materials and structures already mentioned in relation to the distribution elements.
It is also possible, for example, to use a non-woven fabric (TNT) belt.
As mentioned, the fixing means typically comprises straps at both longitudinal sides of the pad element, preferably three per side.
Preferably, the fixing means also include hooking elements, for example in the form of Velcro, buckle, clip and/or button, provided at one or both ends of each strap.
Also the fixing means can be fireproof.
The fixing elements made on the basis of this second aspect of the invention can be provided, as mentioned, even independently of the presence of the distribution elements as introduced above.
In a first preferred configuration, the three main components mentioned above are provided already mechanically connected to each other.
In an alternative configuration, they can be supplied mechanically separated from each other or only partially connected. For example, the distribution elements may already be connected to the fixing means, but not to the pad element. Advantageously, in this case the elements of distribution can be prepared with a pre-applied adhesive layer protected by a removable coating, or liner, to be mechanically connected to the pad by the user at the time of use.
In this configuration, therefore, the device is supplied in the form of a kit.
In one embodiment, the device can comprise one or more pressure sensors or transducers, which, on the basis of the measured values, can transmit the detected data to a local or remote acquisition and/or control unit. Transmission can take place in wireless mode (e.g., via Bluetooth and/or Wifi). These data, suitably processed, can provide a signal to operators regarding any critical areas, in order to act accordingly for the (re) positioning of the patient.
In a further variant, on the basis of the processing of the acquired data, commands (possibly arranged automatically) can be sent to a second device, arranged under the first, which selectively activates compensatory measures. For example, the second device could be divided into inflatable sectors, which can also be activated separately from each other, to optimally redistribute the loads, thus avoiding the physical intervention of the operator.
The aforementioned sensors or transducers can be integrated into one or more of the device components introduced above or applied to the surface of this/these, for example printed on one face of the pad element.
Also or only detectors other than pressure sensors or transducers can be provided, for example suitable for measuring any vital parameter such as temperature.
Other advantages, characteristics and methods of use of the present invention will become evident from the following detailed description of some embodiments, presented by way of example and not limiting.

Brief description of the figures

Reference will be made to the figures of the attached drawings, in which:

▪ Figures 1, 1A and 1B refer to a first embodiment of a support device according to the invention, showing respectively a perspective view from above, the same view also exploded and an enlarged detail of the latter;
▪ Figure 2 shows an exploded perspective view of fixing means of the device of Figure 1;
▪ Figure 2A shows a perspective view of a component of the fixing means of Figure 2;
▪ Figure 2B shows an enlarged view of a detail of the fixing means of Figure 2A;
▪ Figure 3 shows a plan view of locking means of a subject which can be used in association with the device of Figure 1;
▪ Figure 4A shows an exploded perspective view of the locking means of Figure 3;
▪ Figure 4B shows a perspective view of a component of the locking means of Figure 3;
▪ Figure 4C shows an enlarged view of a detail of the locking means of Figure 4B;
▪ Figures 5 and 5A refer to a support device according to an embodiment of another aspect of the invention, showing respectively a perspective view from above and the same view also exploded;
▪ Figures 6 and 6A refer to a support device according to another embodiment, showing respectively a perspective view from above and the same view also exploded;
▪ Figures 7 and 7A refer to a support device according to a further embodiment, showing respectively a perspective view from above and the same view also exploded;
▪ Figures 8 and 8A refer to a support device according to a different embodiment, showing respectively a perspective view from above and the same view also exploded.

In the figures introduced above, the dimensions are intended as purely exemplary and not necessarily with components shown in proportion. Figures 5, 5A to 8, 8A do not disclose embodiments according to the present invention.

Detailed description of preferred embodiments

Below different embodiments and variants of the invention and its parts will be described, based upon different aspects of it that can be used separately or in combination and this will be done with reference to the figures introduced above. Similar components are denoted in the various figures with the same or corresponding numerical reference.
In the detailed description that follows, further embodiments and variants with respect to embodiments and variants already treated in the same description will be illustrated limitedly to the differences with what has already been disclosed.
Furthermore, as mentioned, the various embodiments and variants described below are capable of being used in combination, where compatible.
Referring initially to Figures 1 and 1A, a support device according to a preferred embodiment of the invention it is generally denoted with 1.
The support device 1 is primarily intended for use on a bearing structure, in particular a fixed or mobile medical bed, subjected to the device itself.
The support device 1 comprises a pad element, or pad, 2, configured to receive the body of a subject in a lying position on it. To this end, the pad element 2 generally has a planar or flat conformation, in particular quadrangular, with a longitudinal dimension L prevalent with respect to a transverse dimension T, and both prevailing with respect to the thickness s.
The pad element 2 is configured to support the subject, preventing it from slipping even in longitudinally and/or transversely inclined postures.
The pad element 2, advantageously, has a viscoelastic behavior to perform a more uniform distribution of loads on the patient, avoiding concentrated stresses.
Preferably, the pad element is made entirely in part in Polyurethane (PU), in particular expanded polyurethane, or in a material with similar mechanical characteristics of elasticity and / or deformability.
The support device 1 also comprises means 3 for fixing the pad element 2 to the support structure.
The support device 1 then comprises a first and a second stress distribution element, denoted respectively by 10 and 11. Each distribution element 10, 11 is substantially configured in the form of a strip or longitudinal band.
Each of these distribution elements is arranged, during use, at a respective portion of the longitudinal margin 20, 21 of the pad element 2 and interposed between the latter and the fixing means 3 to connect one to the other.
In particular, each distribution element 10, 11 is connected to the respective portion of the longitudinal margin 20, 21 of the pad element 2 preferably at a lower face of the element 2 itself. This connection is made at a respective first longitudinal portion thereof 101, 111 of each distribution element 10, 11. Each element 10, 11 protrudes externally with respect to the pad element 2 with its own second longitudinal portion 102, 112 at which the fixing means 3 are connected.
Advantageously, each distribution element 10, 11 has stiffness of the same order of magnitude, in particular with a percentage difference ≤ 15 20%, of the pad element 2 and / or of the longitudinal margin portions 20, 21 of the latter.
The fixing means 3 comprise one or more oblong fixing elements, each preferably in the form of a strap or strip. In the present example, three fixing elements are provided for each longitudinal margin portion 20, 21 of the pad element 2. In particular, in Figure 1A, by way of example, the fixing elements provided on the right margin are denoted with 31, 32 and 33, respectively.
Preferably, also each fixing element 31, 32, 33 has stiffnesses of the same order of magnitude, in particular with a percentage difference ≤ 20%, of the pad element 2 and/or of the longitudinal margin portions 20, 21 of the latter.
In the present embodiment, each fastening element, for example the one denoted by 31, comprises a first branch 311 and a second branch 312 which extend outwards of the pad element 2 from a common longitudinal end 310 fixed on the respective element distribution 11.
As better visible in Figure 1B, in the present example each fastening element 31-33 is obtained through the union of a first and a second oblong component, also denoted by 311 and 312, performed at a single respective longitudinal end 310 of each of them.
With reference to the more detailed Figures 2, 2A and 2B, each fixing element, for example the one denoted by 31, is configured to form, during use, a ring, or loop, for connection to the bearing structure. To this end, for the closure of the loop, dedicated means can be provided, for example in form of one or more Velcro^® strips, one of which is denoted by way of example with 313 in Figures 1B and 2.
As shown in Figure 2B, each fixing element, for example element 31, has, in cross section, a multilayer structure, in particular a sandwich, which includes an intermediate layer of polyurethane foam and two external layers of polyester.
The same structure can also be provided for each of the elements of distribution 10 and 11.
With reference to Figures 3 to 4C, the support device 1 described above can be provided in association with one or more locking components of the patient's body, one of which denoted by 5. As shown, the component 5 is in the form of strap or locking band and includes three oblong parts, respectively denoted by 51, 52 and 53 in Figure 4A, mutually connected in correspondence of respective longitudinal end portions.
The belt 5 is equipped with buckles 50, or other mechanical connection elements, at at least one longitudinal end thereof.
As shown in Figure 4C, the cross-sectional structure of the strap 5 can be similar to that already described in relation to the fixing means 3.
With reference now to Figures 5 and 5A, a support device made in accordance with another aspect is generally denoted with 500. The device 500 also comprises a pad element, here denoted with 502, made in two equal parts 551 and 552 mutually associated according to the vertical direction.
The pad element 502 is equipped with seats, in the form of through openings 530, each advantageously with an oblong profile. The seats 530 are arranged in correspondence with their own longitudinal margin portions 520 and 521 and obtained therefore on both parts 551 and 552. The openings 530, on each portion of the margin 520 and 521, are aligned precisely according to the longitudinal direction of the pad element 502.
The support device then comprises stiffening or reinforcing elements, denoted by 510 and 511, each in the form of a strip or band and interposed between the two parts 551 and 552 in correspondence with a respective portion of the longitudinal margin 520, 521. Each stiffening element 510, 511 has respective seats, in particular openings 553, 554, corresponding to those of the element pad 502.
The elements 510, 511 define a structural stiffening in correspondence to the perforated areas of the device 500.
The support device 500 then comprises fixing means 503, which also in the present example are in the form of a plurality of oblong elements, or straps, one of which denoted by way of example with 531, preferably equipped with end buckles 513. The straps are arranged at the longitudinal margin portions 520, 521 of the pad element 502 and are inserted within the aforementioned seats, according to a desired configuration that can be defined during the assembly phase.
For example, the strap 531 fits into a seat 530 of the lower part 552 of the pad element 502 and into a seat 553 of the stiffening element 510.
The strap 531 advantageously have, in correspondence with their own oblong main body, stiffness of the same order of magnitude, in particular with a percentage difference ≤ 20%, of the pad element 502 and/or of the portions of the longitudinal margin 520, 521 of the latter.
Figures 6 and 6A refer to another example of a device support, here generally denoted with 600. The device 600 also comprises a pad element, here denoted with 602, preferably made in one piece.
The pad element 602 is equipped with seats, in the form of through openings 630, for example each with a substantially circular profile, in correspondence with its longitudinal margin portions 620 and 621. The openings 630 are aligned precisely according to the longitudinal direction of the pad element 602 and, in the present example, there are three for each margin portion 620, 621. Within each seat 630 a reinforcing or stabilizing element 632 can be arranged, for example in the form of a ring, possibly made in two parts that can be vertically juxtaposed and engageable with each other.
The support device 600 then comprises fixing means 603, which also in the present example are in the form of a plurality of oblong elements, or straps, one of which denoted by way of example with 631. Preferably, each strap 631 is equipped with means end closure, to form a ring or loop, for example in the form of one or more elements of Velcro ^® 613.
The straps 631 are arranged in correspondence with the longitudinal margin portions 621, 622 of the pad element 602 and are inserted within the seats 630 mentioned above to create the aforementioned loop or ring.
The straps advantageously have stiffness of the same order of magnitude, in particular with a percentage difference ≤ 20%, of the pad element 602 and/or of the longitudinal margin portions 620, 621 of the latter.
With reference to Figures 7 and 7A, a support device made in accordance with another aspect is generally denoted by 700. The device 700 comprises, similarly to the device 500, a pad element, here denoted 702, made in two equal parts 751 and 752 mutually associated in the vertical direction.
The pad element 702 is equipped with sites, in the form of through recesses 730, each advantageously with a semicircular profile, in correspondence with its own longitudinal margin portions 720 and 721 and thus obtained on both parts 751 and 752. The recesses 730 are they open precisely at their respective edges of the pad element 702, which therefore has a profile with notches.
Between the two parts 751, 752 of the pad element 702 a stiffening body 710 is interposed, substantially shaped according to the same planar profile as the pad element 702 and made from a plurality of bar elements 711. The profile of the longer bars external is accessible through the aforementioned recesses, in order to create, together with the edge of the pad element 702, a plurality of ring sites, also denoted with 730.
The stiffening body 710 can be made of metal.
The support device 700 then comprises fixing means 703, made similarly to the means 603 described above, in particular comprising oblong elements in the form of belts 731.
The straps 731 are arranged at the longitudinal margin portions 720, 721 of the pad element 702 and are inserted through the aforementioned structure 710 to create the aforementioned loop or ring.
The straps 731 advantageously have stiffness of the same order of magnitude, in particular with a percentage difference ≤ 20%, of the pad element 702 and/or of the longitudinal margin portions 720, 721 of the latter.
With reference to Figures 8 and 8A, a support device according to another example 10 is generally denoted with 800. The device 800 also comprises a pad element, here denoted by 802, made in two equal parts 851 and 852 mutually associated, similar to the configuration of Figure 5. In this case, openings on the upper part 851, to the advantage of the comfort of the subject.
Furthermore, the reinforcing elements 510, 511 of the previous embodiment are replaced, or integrated, with an anti-deformation grid 810, or for reinforcement or stiffening, with the same planar extension of the parts 851 and 852.
The pad element 802 is equipped with seats, in the form of through openings 830, advantageously each with an oblong profile, corresponding to its longitudinal margin portions 820 and 821, obtained on the lower part 852 and on the grid 810. The openings 830, for each margin portion, are aligned precisely according to the longitudinal direction of the pad element 802. Advantageously, two rows of seats side by side are provided.
The support device 800 then comprises fixing means 803, similar to those described with reference to the configuration of Figure 5.
The present invention has been described up to now with reference to preferred embodiments. It is to be understood that other embodiments may exist which pertain to the same inventive core, as defined by the scope of protection of the claims set out below.

Claims

A support device (1), mainly for use upon a bearing structure, in particular a fixed or mobile medical bed, which support device (1) comprises:
▪ a pad element (2), configured to receive on it the body of a subject in a distended position and to this aim generally having a flat shape with a longitudinal dimension (L) prevailing with respect to a transverse dimension (T);

▪ fixing means (3) of the pad element (2) to the bearing structure; and

▪ a first (10) and a second (11) stress distribution element, each arranged, in use, at a respective longitudinal edge portion (20, 21) of said pad element (2) and interposed between the latter and said fixing means (3) for connecting the one (2) to the other (3),
characterized in that, in use, each of said first (10) and second (11) distribution element is connected to the respective longitudinal edge portion (20, 21) of said pad element (2) at a first longitudinal portion thereof (101, 111) and protrudes externally with respect to said pad element (2) with a second longitudinal portion thereof (102, 112) at which said fixing means (3) are connected or connectable.
The support device (1) according to claim 1, wherein each of said first (10) and second (11) distribution elements has stiffness of the same order of magnitude, in particular with a percentage difference ≤ 20%, of said pad element (2) and/or said longitudinal edge portions (20, 21).
The support device (1) according to claim 1 or 2, wherein said fixing means (3) have stiffness of the same order of magnitude, in particular with a percentage difference ≤ 20%, of said pad element (2) and/or said longitudinal edge portions (20, 21).
The support device (1) according to any one of the preceding claims, wherein each of said first (10) and second (11) distribution element is configured substantially in the form of a longitudinal band or strip.
The support device (1) according to any one of the preceding claims, wherein, in use, each of said first (10) and second (11) distribution element is constrained to said pad element (2) by means of a continuous joining region, preferably corresponding substantially to the entire longitudinal extension of the respective longitudinal edge portion (20, 21) of the pad element (2) itself.
The support device (1) according to any one of the preceding claims, wherein, in use, each of said first (10) and second (11) distribution element is constrained to said pad element (2) by one or more of the following techniques: gluing with adhesive; welding, for example ultrasound or heat welding; solvent melting; seam.
The support device (1) according to any one of the preceding claims, wherein said fixing means (3) comprises one or more oblong fixing elements (31-33), each for example in the form of a belt or strip.
The support device (1) according to any one of the preceding claims, wherein said fixing means (3) comprises at least one fixing element (31) obtained by joining a first (311) and a second (312) oblong component at a respective longitudinal end (310) of each of them.
The support device (1) according to any one of the preceding claims, wherein said fixing means (3) comprises at least one fixing element (31) having a first (311) and a second (312) branch extending from a common longitudinal end (310).
The support device (1) according to any one of the preceding claims, wherein said fixing means (3) comprises at least one fixing element (31) configured to form, in use, a ring, or loop, for connection to the bearing structure.
The support device (1) according to any one of the preceding claims, wherein said fixing means (3) comprises at least one fastening element (31) carrying closing means of a Velcro^® (313), buckle, clip and/or button type.
The support device (1) according to any one of the preceding claims, wherein each of said first (10) and second (11) distribution elements and/or said fixing means (3) are made, completely or in part, in one or more materials selected in the following group: fabric; polymeric material; Polyurethane; Polyurethane foam; Polyvinyl chloride.
The support device (1) according to any one of the preceding claims, wherein each of said first (10) and second (11) distribution element and/or said fixing means (3) have, in cross section, a multilayer structure which includes an intermediate layer of polyurethane foam and two external layers in polyester.
The support device (1) according to any one of the preceding claims, which is supplied in the form of a kit.
The support device (1) according to any of the preceding claims, comprising sensor or transducer means, in particular of pressure or temperature, in communication with a control unit.