Patent Description:
Performing a pacemaker or defibrillator implantation in a patient exhibits post-operative risks including the formation of a hematoma in the shoulder, especially in patients who undergo therapies with the use of anticoagulants or antiplatelet agents.

The formation of a hematoma close to the pocket of the pacemaker or defibrillator can lead to the development of an infection with possible damage to the cardiac tissue.

Another complication is the displacement of the implanted leads as a result of early or accidental patient mobilization.

To combat the aforementioned complications, the patient's shoulder is currently subjected to compression bandage, which must be carried out by skilled personnel in order to be performed correctly.

A medical apparatus for the containment of hematomas comprising a support unit enveloping at least a part of the patient's body and an inflatable cushion held in place by the support unit is currently known from patent application <CIT>.

<CIT> describes an orthopaedic device for treating bone fracture.

<CIT> describes orthopaedic devices for treating limb injury by reducing or milking edema.

However, the position of the cushion directly in contact with the patient's body is not comfortable for the patient and does not allow a uniform distribution of pressure over the whole part where the hematoma is present.

In view of the background art, it is the object of the present invention to provide a medical apparatus for the containment of hematomas which overcomes the aforementioned drawbacks.

According to the present invention, said object is achieved by a medical apparatus for the containment of hematomas for treatment following operations for implanting cardiac devices, said apparatus comprising a support unit externally enveloping at least a part of the patient's body and adapted to resist efforts aimed to detach said unit from said patient, at least one inflatable cushion held in place over or close to the patient's shoulder by said support unit, characterized in that it comprises a material arranged between said inflatable cushion and the patient's shoulder, said material being configured to distribute the pressure of said cushion, once inflated, on the patient's shoulder, said support unit comprising at least one pocket arranged to contain said material, said inflatable cushion being shaped so that, once inflated, it takes a wavy shape.

The features and advantages of the present invention will become apparent from the following detailed description of a practical embodiment thereof, shown by way of non-limiting example in the accompanying drawings, in which:.

With reference to <FIG> and <FIG>, a medical apparatus <NUM> for the containment of hematomas according to a first embodiment of the present invention is described.

The apparatus comprises a support unit <NUM> adapted to cover and externally envelop the patient's shoulder; preferably the support unit <NUM> is in the form of a jacket. The support unit <NUM> is provided in particular for treatments following operations for implanting a pacemaker or a defibrillator, i.e., when hematomas are possible at the shoulder.

The apparatus comprises at least one bag or cushion <NUM> preferably inflatable with air, substantially flattened and arranged at or straddling the shoulder; the inflatable bag or cushion is held in place on the shoulder by the support unit <NUM>.

The apparatus comprises manually activatable inflation devices <NUM>, such as manual inflation means, and means <NUM> for detecting the pressure in the cushion, such as a pressure gauge.

The support unit comprises at least one pocket <NUM> configured to house the inflatable cushion <NUM>. Preferably, the pressure of the inflatable cushion <NUM> is between <NUM> and <NUM> millimetres of mercury and the support unit <NUM> must bear said pressure without deforming in order to transmit said pressure to the patient's shoulder.

The support unit <NUM> in the form of a jacket comprises a plurality of portions <NUM> which are stably mutually engageable by means of connections, for example with Velcro; the portions are arranged so as to firmly grip at least one inflatable cushion <NUM> arranged in the pocket <NUM> over a shoulder.

The jacket-shaped support unit <NUM> comprises anchoring means <NUM>, for example strips, adapted to support and hold a patient's arm substantially immobile.

Advantageously, the support unit <NUM> comprises, at the pocket <NUM> and in the inner part of the jacket, another pocket <NUM> for the containment of a material <NUM>, for example memory foam, adapted to uniformly distribute the pressure of the inflatable cushion <NUM> on the shoulder <NUM>; the pressure of the inflated cushion <NUM> is thus uniformly distributed over the part where the hematoma is present so as to ensure certain compression values on the entire part of the patient's body affected by the hematoma.

The support unit <NUM> is applied to the patient so that the same unit adheres to the patient's body, in particular in the area where the inflatable cushion <NUM> is placed. The latter is initially deflated and is inflated immediately after the application of the support unit <NUM> to the patient.

Generally, the pressure to be reached is between <NUM> and <NUM> millimetres of mercury so as to apply local compression to the patient. The material <NUM> allows to uniformly distribute said compression exerted by the now inflated cushion <NUM>; moreover, the presence of the material <NUM> allows the patient to obtain greater comfort.

The pressure in the cushion <NUM> may be monitored and controlled by the pressure gauge.

With reference to <FIG>, a medical apparatus <NUM> for the containment of hematomas according to a second embodiment of the present invention is described. The medical apparatus <NUM> of the second embodiment of the invention differs from the medical apparatus <NUM> of the first embodiment of the invention in the different shape of the inflatable cushion <NUM> with respect to the inflatable cushion <NUM> and in the presence of some additional elements <NUM> and <NUM>.

The apparatus <NUM> comprises a support unit <NUM>, seen in <FIG> and <FIG>, adapted to externally cover and envelop the patient's shoulder; preferably the support unit <NUM> is in the form of a jacket. The support unit <NUM> is provided in particular for treatments following operations for implanting a pacemaker or a defibrillator, i.e., when hematomas are possible at the shoulder.

The apparatus comprises at least one bag or cushion <NUM> preferably inflatable with air, substantially flattened and arranged at or straddling the shoulder, as better seen in <FIG>; the inflatable bag or cushion is held in place on the shoulder by the support unit <NUM>. The inflatable cushion <NUM> is rectangular in shape and has size such as to cover the entire wound caused by the implantation of the pacemaker or defibrillator; the inflatable cushion <NUM> is designed so as to take a wavy shape when inflated.

In particular, the inflatable cushion <NUM> comprises a sequence of three sectors <NUM> having the same dimensions which are normally flattened but when inflated take the top hat-like or -type shape each. The sectors <NUM> are adjacent to one another and are joined together by long side thereof, i.e., by the cylindrical side surface when the sectors <NUM> are inflated, by means of junction areas <NUM> having the same length as the sectors <NUM>; the inflatable cushion <NUM> has three sectors <NUM> alternated with two junction areas <NUM> so as to take the wavy shape once inflated. The sectors <NUM> are simultaneously inflatable and deflatable by a tube <NUM> connected to the inflation device <NUM> while another tube <NUM> is connected to the pressure detection means <NUM>.

The particular shape of the cushion <NUM>, once inflated, allows the pressure to be well distributed over the entire wound or hematoma of the shoulder <NUM>, however the presence of the junction areas <NUM> between the sectors <NUM> allows the formation of areas <NUM> on the patient's shoulder, i.e., the areas at the junction areas <NUM>, where the pressure exerted by the inflatable cushion is slightly lower than the areas <NUM> below the sectors <NUM>, as better seen in <FIG>; the cushion <NUM> thus allows a better circulation of the blood in the areas <NUM> of the patient's shoulder corresponding to the junction areas <NUM> as compared to the areas <NUM> of the patient's shoulder, corresponding to the sectors <NUM>, subjected to greater pressure. Preferably, the sectors <NUM> are <NUM> wide and <NUM> long while the junction areas are <NUM> wide and <NUM> long.

The apparatus comprises manually activatable inflation devices <NUM> (not seen in <FIG> and <FIG>), such as manual inflation means, and means <NUM> for detecting the pressure in the cushion, such as a pressure gauge.

The support unit <NUM> in the form of a jacket comprises a plurality of portions <NUM> which are stably mutually engageable by means of connections, for example with Velcro; the portions are arranged so as to firmly grip at least one inflatable cushion <NUM> arranged in the pocket <NUM> over a shoulder. The Velcro engageable portions <NUM> allow a continuous monitoring of the wound of the patient who has undergone an operation for implanting a pacemaker or defibrillator.

The jacket-shaped support unit <NUM> comprises means adapted to support and hold a patient's arm substantially immobile. In particular, said means comprise a lateral band <NUM> with Velcro fastening, which band serves for the immobilization of the limb, thus reducing the complications related to the dislocation of the leads from the cardiac muscle, considering that a pacemaker or defibrillator rests on the pectoral muscle, and any unusual movement of the limb would result in the complication described above, thus making the operation of the implanted devices null.

Advantageously, the support unit <NUM> comprises, at the pocket <NUM> and in the inner part of the jacket, another pocket <NUM> for the containment of the material <NUM>, for example memory foam, for a better patient comfort or ease when the cushion <NUM> is inflated and exerts compression on the shoulder <NUM>.

Generally, the pressure to be reached is between <NUM> and <NUM> millimetres of mercury so as to apply local compression to the patient. The material <NUM> allows the patient to obtain greater comfort.

The pressure in the cushion <NUM> may be monitored and controlled by the pressure gauge <NUM>. The support unit <NUM> also comprises a central support <NUM> for hand housing. This support has been added to prevent and counteract stasis edemas of the affected limb and hand due to the medical contraindication of limb mobility and the operation itself. This support allows to put the limb and hand in relief, preventing edema.

Furthermore, the medical apparatus <NUM> and components thereof and therefore the inflatable cushion <NUM> as well are made of radiolucent materials which allow clinical and instrumental investigations on the patient without the need to remove the apparatus itself from the patient; for example, the jacket can be made of cotton.

<FIG> and <FIG> show that the apparatus <NUM> is made to adapt to whether the patient undergoes an implantation on the left or right shoulder, since the pocket <NUM> for the containment of the inflatable cushion <NUM> and the pocket <NUM> for the containment of the material <NUM> can be placed on the patient's right or left shoulder and always held in place by the support unit <NUM>. Likewise, the band <NUM> can allow the immobilization of the left or right limb.

Claim 1:
Medical apparatus (<NUM>, <NUM>) for the containment of hematomas for treatment following operations for implanting cardiac devices, said apparatus comprising a support unit (<NUM>) in the shape of a jacket, externally enveloping at least a part of the patient's body and adapted to resist efforts aimed to detach said unit from said patient, at least one inflatable cushion (<NUM>, <NUM>) held in place over or close to the patient's shoulder by said support unit, characterized in that it comprises a material (<NUM>) arranged between said inflatable cushion and the patient's shoulder, said material being configured to distribute the pressure of said cushion, once inflated, on the patient's shoulder, said support unit comprising at least one pocket (<NUM>) arranged to contain said material (<NUM>), said inflatable cushion (<NUM>) comprising a sequence of three sectors (<NUM>) adjacent to one another and joined together by long side thereof, the inflatable cushion (<NUM>) having three sectors (<NUM>) alternated with two junction areas (<NUM>), so that, once inflated it takes a wavy shape, said three sectors being simultaneously inflatable and deflectable by a tube (<NUM>) connected to an inflation device (<NUM>) while another tube (<NUM>) is connected to a pressure detection means (<NUM>), wherein said sectors (<NUM>) are <NUM> wide and <NUM> long and said junction area (<NUM>) are <NUM> wide and <NUM> long.