DESCRIPTION

Field of the invention

The present invention relates to a positioning device, in particular for the positioning of an arm of a patient to allow the execution of radial vascular access procedures needed during percutaneous interventional operations.

Background

Percutaneous interventional operations have had in recent years an exponential growth in number and complexity of the interventions made. During these procedures both the operator and the patient are often forced to take on and maintain for long time unnatural positions. The need to assume unnatural positions as well as compromising patient comfort hinders the work operator in handling medical devices. More difficulties are encountered in some types of percutaneous accesses (e.g. access from left upper limb) which for this reason have poor diffusion although they constitute an alternative, sometimes, crucial for the success of the procedure. Most of the operators prefer to perform the vascular access from the upper limbs with the patient's arm in abducted position, i.e. away from the body of the patient. To perform the interventional procedure is however necessary, once performed the vascular access, to reposition the arm near the patient's body.

The positioning devices of the prior art are typically simple devices for supporting arm, or devices designed to be used in different types of intervention, but without any technical feature that makes them particularly suitable to be employed in procedures that require the issuance of radiation. Also, they are not customizable according to the specific needs neither of the patient, nor of the medical staff. Summary of the invention

Therefore, the technical problem posed and solved by the present invention is that of providing a positioning device, in particular apt to position and support a patient arm above a base surface with an orientation such as to allow the execution of vascular accesses procedures during percutaneous interventional operations, allowing overcoming the drawbacks mentioned above with reference to the known art.

This problem is solved by a positioning device according to claim 1.

Preferred features of the present invention are provided in the dependent claims.

The present invention provides some relevant advantages. The main advantage lies in the fact that the positioning device according to the invention allows the operator to position the limb in the manner most favorable to the execution of the procedure, in particular in a position of closure to the patient body. Furthermore, the invention allows the patient to comfortably maintain this position.

The positioning of the upper limb close to the patient body is highly advantageous for several reasons.

First, it enables the doctor and the staff can easily perform all the maneuvers potentially necessary during surgery, with particular regard to the need to execute vascular accesses from the lower limbs, such as the femoral vascular accesses.

Moreover, such positioning is particularly advantageous in the case of operations in which is required the use of radiation, such as X-rays.

Under this circumstance, the positioning of the upper limb next to the patient body is essential to allow the shield of protection by X-rays, generally located below the surface of the surgical bed and with dimensions equal to the surface of the bed itself, protect the operator from radiation coming from below, throughout the course of the intervention.

Therefore, the device according to the invention, while being preferably made of radiolucent material, allows to reduce the radiological exposure of the operator thanks to the special positioning of the arm of the patient and the consequent position assumed by the operator. The invention also allows easy modification of the conditions of support of the arm to allow the execution of bilateral vascular accesses. Advantageously, such a device is adjustable in a plurality of directions and is adjustable in function of the different anatomical features of the patient.

Other advantages, features and use modes of the present invention will result evident from the following detailed description of some embodiments, shown by way of example and not with limitative purpose.

Brief description of the drawings

Reference to the figures of the enclosed drawings will be made, wherein:

^■ Figure 1 shows a prospective view of a first preferred embodiment of the positioning device according to the present invention, in particular in a use configuration;

^■ Figure 2 shows a further prospective view of a first preferred embodiment of the positioning device according to the present invention;

^■ Figure 3 shows a prospective view of a second preferred embodiment of the positioning device according to the present invention;

^■ Figure 4 shows an exploded view of a detail of Figure 1 and 2;

^■ Figure 5 shows a prospective view of a third preferred embodiment of the positioning device according to the present invention;

^■ Figure 6 shows a detail of Figure 5; ■ Figure 7 shows an exploded view of a fourth embodiment of the positioning device according to the present invention;

^■ Figure 8 shows a prospective view of the device of Figure 7 in an assembled configuration;

^■ Figure 9 shows a prospective view of the device of Figure 7 during use; and ■ Figure 10 shows a prospective view of the device of Figure 7 in another operating configuration. Detailed description of preferred embodiments

In the follow, various embodiments and variations of the invention will be described, and this with reference to the figures introduced above.

In the detailed description that follows, embodiments and further variants with respect to embodiments and variations already dealt with in the description thereof will be illustrated limited to the differences with what has already been exposed.

Moreover, the different embodiments and variants described to follow are likely to be employed in combination, if compatible.

By firstly referring to Figure 1 , a positioning device according to a first preferred embodiment of the invention is designated as a whole with 1.

As shown in Figure 1 , the positioning device 1 is apt to position and support a patient arm above a base surface 2 with an orientation such as to allow the execution of vascular accesses procedures during percutaneous interventional operations.

Advantageously, the base surface 2 can be substantially entirely comprised within a supporting surface of a surgical bed or table, or for example superimposed to it. In particular orientation and positioning configurations, it is possible that no portion of the positioning device 1 protrudes outside the surface of the surgical table.

In Figures 2 and 4 the positioning device 1 is best shown, which device comprises a supporting element 3 for the arm, shaped in such a way as to maintain the arm in the desired position during said operations. The device further comprises connecting means apt to connect the supporting element 3 to the base surface 2 in an assembly configuration of the device. The supporting element 3 has a supporting surface 5 for the arm, for example having an ergonomic conformation.

Adjusting means of the relative positioning and orientation of the supporting element 3 with respect to the base surface 2 is provided, in particular in the aforesaid assembly configuration.

It is also represented an oblong spacer element 4 positioned in a manner substantially perpendicular to the base surface 2 for spacing the supporting element 3 from the base surface 2.

Preferably, the spacer element 4 presents a joint portion which divides the element substantially into two portions and which enables the movement of a first portion respect to the other. In the preferred embodiment, the joint is a fork junction 17. As shown for example in Figure 4, the junction involves the coupling of a first fork shaped element 44 and of a second ring shaped element 44' apt to be inserted in the fork.

In particular, the fork is perforated to allow the insertion of a locking pin 15 of the junction.

The junction 17 therefore allows a relative rotation, with respect to a main axis of the locking pin, of a first portion of the spacer element 4 with respect to the other. The locking pin 15, preferably having a knob-shaped end, is inserted in the coupling between the first 44 and second 44' element for locking the relative rotation of a portion of the element with respect to the other.

Alternative embodiments include junctions of known type, apt to provide more degrees of freedom in the relative movement of a portion of the element with respect to the other.

In particular, the spacer element 4 has a first threaded end 14 apt to be connected to the base surface 2 at a receiving seat, for example a through hole, provided on the base surface, as will be better described below. The threaded connection between the spacer element 4 and the base surface 2 is for example ensured by the application of a fixing ring 34.

Advantageously, the threaded connection allows to adjust a vertical spacing between the support element 3 and the base surface 2 according to the degree of screwing of the first threaded end 14 inside the respective seat.

Equally advantageously, the threaded connection allows a rotation of the arm supporting surface 5 in such a way as to orient said surface along a desired direction.

It also foreseen the presence of an adjusting nut 24 couplable to the threaded end to adjust the spacing of the supporting element 3 with respect to the base surface 2 in an assembly configuration.

In the preferred embodiment described here, the first portion of the spacer element 4 has the second ring-shaped element 44' at its end, and it is coupled with a supporting plate 16 at a further end. The supporting plate 16 is dimensioned in such a way as to support the supporting surface 5.

Alternative embodiments may provide that the spacer element 4 has a variable height, for example telescopic.

In particular, guide elements 1 1 positioned at a lower surface of the supporting surface 5 are also provided to allow relative sliding of the supporting surface 5 with respect to the supporting plate 16. Said guide elements 1 1 may comprise sliding guide elements as, for example, rails.

In this way, in an assembly configuration of the positioning device, it is possible to move the positioning surface along the sliding axis of the rails towards the outside and the inside of the angiographic table. Advantageously, it becomes possible to adjust the distance of the supporting surface 5 from the angiographic table according to the specific physical conformation of the patient.

Preferably, as shown in Figure 4, the guide elements 11 extend along a main direction B-B, substantially orthogonal to a main development direction A-A of the supporting surface 5.

In the preferred embodiment, brake elements are provided at the guide elements 11 apt to lock the relative sliding of the supporting surface 5 with respect to the supporting plate 16.

As shown in the Figures, the supporting surface 5 has two containment flaps 6 apt to contain undesirable lateral movements of patient arm.

Furthermore, the supporting surface 5 comprises a recliner portion 7, for example apt to support the patient wrist and maintain it in a position of optimal extension for the radial access from both right and left direction.

A hinge element 8 positioned at a lower surface of said supporting surface 5 is also provided to connect said supporting surface 5 with the recliner portion 7.

The hinge 8 also allows an inclination of the portion 7 with respect to the supporting surface 5.

In particular, a further pin element 17, apt to be coupled to said hinge element 8, is positioned to block the inclination of the portion 7 with respect to the support surface 5 at a desired position.

To adjust the width of the supporting surface 5 according to the specific conformation of patient arm, a divider element 9 is provided, positioned or positionable at an upper surface of the supporting element 3.

Preferably, the divider element 9 has a "L" shaped section and is coupled to the supporting surface 5 by means of a still further pin element 13.

On the supporting surface 5 and on the face of the divider element that can be coupled together seats for receiving the pin 13 are provided.

In particular, the divider element 9 has a seat shaped substantially as a step, in such a way as to allow a displacement of the divider element along the main development direction A-A of the support surface 5 and along the main direction B-B. A variant of alternative embodiment not shown in the figures provides the use of a pillow of ergonomic shape connected or connectable to the divider element 9 apt to improve the comfort of the patient in maintaining, without effort, the appropriate position of the arm. A locking element 23 of said pin 13 is also provided to lock the coupling between said divider element 9 and said supporting element 3 in a desired position, in particular depending on the specific conformation of the patient.

In the first preferred embodiment of the present invention the base surface 2 is shaped to be positioned, in particular between the angiographic table and the mattress, under the back of a patient in a supine position.

As shown in the figures, the base surface 2 can be shaped to support a positioning device on one side (Figure 2) or on two sides (Figure 3).

Preferably, at a lateral edge of the base surface, a receiving seat 50 of the first threaded end 14 of the spacer element 4 is provided. In particular, said seat 50 is preferably slot shaped and extends along the edge of the base surface. The shape of a slot allows a greater freedom of adjustment of the device and the possibility of fixing the supporting element 3 to the base surface 2 at the best position for both the patient and the operating staff.

Preferably, said receiving seat 50 is raised with respect to the base surface 2 to allow that the base surface 2 is substantially entirely comprised inside the support surface of a surgical bed or table, or for example superimposed to it, while ensuring the sliding of the spacer element 4 by means of the adjustment of the fixing ring 34, which remains housed in the space comprised between said supporting surface and the same elevated slot. At the same time, this configuration allows to maintain the support element 3 substantially completely above and within the surgical table.

A further embodiment of the present invention provides the use of a base surface 2, for example for supporting the right supporting element, slidable with respect to a further base surface, for example for supporting the left supporting element, as shown in Figure 3.

In a second preferred embodiment, as shown in Figures 5 and 6, the base surface 20 is supported by a movable carriage.

Advantageously, the use of a movable carriage allows to support the limb in abducted position during the vascular access while providing a supporting surface for the materials needed to the access. Once vascular access is obtained the arm is repositioned in a position alongside the patient body on the interventional supporting element of the angiographic table.

The use of a mobile carriage is useful for vascular access also outside of the interventional room. The carriage is easily transportable in corridors and quickly positioned at the desired area.

Figures 7 and 8 show a further embodiment of the positioning device according to the present invention, in this case designated as a whole with 100.

In particular, this embodiment differs from those previously described for the presence of some changes in design and additional technical elements that increase the functionality and comfort during use. The elements common to the previous embodiments will be designated with the same numeral reference.

As is shown in Figure 7, the positioning device 100 first of all comprises an arm supporting element 3, having a supporting surface 5, and connection means apt to connect the supporting element 3 to a base surface 2, as described in the embodiments previously discussed.

In particular, the supporting element 3 has at least one containment flap 106, apt to the containment of the patient arm positioned on the device 100, in order to avoid unwanted lateral movements of the arm. Said containment flap 106 develops preferably in a direction substantially perpendicular to the supporting surface 5, for example on a side of the supporting element 3 that is farthest from the patient, i.e. external.

In this configuration, the absence of a further containment flap positioned opposite to said flap, that is in a position on an inner side of the supporting element 3, allows a maximum approach of the arm to the body of the patient.

The flap 106 preferably has a configuration which follows the anatomical profile of the patient arm, in said flap 106 has a height decreasing along a longitudinal direction of the device, going from the forearm to the hand. This configuration allows to easily access to the patient wrist for performing interventional procedures.

Adjusting means of the positioning and the relative orientation of the supporting element 3 with respect to the base surface 2 are also provided, as in the embodiments already described.

Furthermore, in the considering embodiment an optimized version of the recliner portion 7 is provided. The latter recliner portion comprises a movable portion 101 of the supporting element 3, on which supporting surface the housing of the patient hand is provided. As shown in Figure 8, the movable portion 101 can rotate around a longitudinal axis C of the device 100. Also, the location of the portion 101 can be changed in a transverse direction, denoted by an arrow T, by means of dedicated adjusting means, such as screws.

By virtue of said mobility along the axis C and the T direction - which preferably is added to the rotatability around an axis parallel to the transverse direction T, already provided in other embodiments - the movable portion 101 allows to orient correctly and in an optimal manner the patient hand during a percutaneous interventional, ensuring the doctors operating a lower radiological exposure as well as greater comfort and freedom of action. At the same time, said position of the hand is easily taken and maintained by the patient operated. To increase the positioning stability of the patient limb, the positioning device 100 can additionally comprise locking means 102 apt to maintain the limb immobile and firmly secured to the device, in a particular preferred position for the execution of the operation. Said arm locking means 102 has an extension preferably adjustable in function of the particular shape of the arm of the patient and may be for example realized by means of straps or velcro bands. By way of example, such locking means 102 may be provided at the movable portion 101 , for fixing the patient hand, and/or at the surface 5, in a position of maximum distance from said movable portion 101.

Figures 9 and 10 show different use configurations of the positioning device 100, in particular two main possible orientations of the movable portion 101 with respect to the rest of the device 100.

Preferably, the positioning device according to the present invention is made of plastic material with appropriate characteristics of strength, lightness and radio transparency.

Advantageously, the device according to the invention allows to orient the supporting element in a plurality of spatial directions so as to provide the need versatility to adapt to the different physical-somatic characteristics of patients.

In addition, the adjustment and the orientation of the supporting element can be realized at any stage of the intervention to improve the position of patient or operators. The device is designed to work with any cardiology or radiology work table, it is quickly installable and adjustable.

It will be appreciated that the positioning device according to the invention, comprising a plurality of interconnected parts, may also be provided in the form of an assembly kit.

The present invention has been sofar described with reference to preferred embodiments. It is to be meant that other embodiments may exist, belonging to the same inventive core, as defined by the protection scope of the here-below reported claims.