WO2016001802A1

WO2016001802A1 - Medical apparatus for the containment of haematomas

Info

Publication number: WO2016001802A1
Application number: PCT/IB2015/054768
Authority: WO
Inventors: Ciro ANGELORO
Original assignee: Angeloro Ciro
Priority date: 2014-07-01
Filing date: 2015-06-25
Publication date: 2016-01-07

Abstract

A medical apparatus (1) for the containment of haematomas is provided for, comprising a support unit (2) externally enveloping a body part of a patient and suitable to resist efforts to detach it at least partly by the patient, and at least one inflatable cushion (4) held in position by the support unit (2) and associated with activation and control members (5) including inflating means (6) which can be activated manually and detection elements (7) suitable to show the air pressure inside the inflatable cushion (4).

Description

DESCRIPTION

MEDICAL APPARATUS FOR THE CONTAINMENT OF HAEMATOMAS

The invention relates to a medical apparatus for the containment and reduction of haematomas, for example haematomas of a shoulder or in the vicinity of a shoulder that may form in patients who have had an operation to implant a pacemaker or defibrillator.

As is known, in particular after implantation of a pacemaker or a defibrillator, a patient presents surgical risks related to age, clinical history and the physical conformation of the patient himself.

Such complications may be significant and determine a longer hospital stay and a considerable increase in health care spending.

Among the complications in question the possible formation of a haematoma in the shoulder is of particular significance and occurs mainly in patients for whom the therapeutic use of anticoagulants or anti-platelet agents is provided.

As a result of the haematoma, the risk exists of developing an infection, for example, at the pocket of the pacemaker or defibrillator, in addition to possible implications of the heart tissue.

In extreme cases, the infection can be life-threatening. The risk of developing an infection in the case of a haematoma being formed is due to the fact that the same determines a "pabulum" or nourishment for germs responsible for the infection.

In practice, the formation of haematomas is particularly negative and requires a renewed and prompt surgical intervention to remove the same.

Another complication which may occur, in particular after the implantation of a pacemaker or defibrillator, is the possible displacement or change of position of the implanted pacing leads. This complication occurs in the presence of early and/or accidental mobilization of the patient and of the limb involved.

In fact, based on current practice, mobilization should take place after a relatively long time - approximately 24 hours after surgery - and before such time substantial immobility is required.

Currently, to counter both these complications, bandaging or compression bandaging of the patient is performed, in particular of the shoulder and surrounding areas, and also with the application of cryotherapy, as well as the required immobility of the limb.

An appropriately compressive bandage has the drawback of requiring the intervention of expert staff to be properly performed.

Furthermore, compressive bandaging has the drawback of varying unpredictably in effectiveness and functionality.

In fact, even with careful intervention, the degree of compression and the position of the bandage may vary considerably because it is not easy to apply and manually calibrate the compression of said bandage.

Among other things, the specific needs and situations of patients vary greatly from one case to another, making broad margins of error possible.

Another drawback of the bandaging or compressive bandaging is related to the fact of having to tightly wrap a relatively large portion of the patient's body, even when only a very limited area, such as a shoulder, needs to be compressed.

This results in significant discomfort and inconvenience for the person bandaged.

Such discomfort is then increased by said extended period of substantial immobility which a patient must undergo following an operation of the type mentioned. In this situation the technical purpose of the present invention is to devise a medical apparatus for containing haematomas able to substantially overcome the inconveniences mentioned above.

Within the sphere of said technical purpose one important aim of the invention is to devise a reliable apparatus able to ensure certain compression values, and also appropriate values precisely calibrated to specific needs.

Another important object of the invention is to devise an apparatus which does not require the intervention of particularly expert staff.

A further object of the invention is to devise an apparatus able to intervene selectively and accurately on the areas to compress, leaving the surrounding areas free.

Another object of the invention is to make available an apparatus which allows a patient greater comfort.

Yet a further object is to provide an apparatus which limits the immobilization time of a patient to a minimum.

A further object of no less importance is to devise an apparatus which allows hospitals and care centres to minimise expenditure as regards specialized staff and length of hospitalization and to reduce operations due to complications to a minimum.

The technical purpose and specified aims are achieved by a medical apparatus for containing haematomas as claimed in the appended Claim 1.

Preferred embodiments are evident from the dependent claims.

The characteristics and advantages of the invention are clearly evident from the following detailed description of preferred embodiments thereof, with reference to the accompanying drawings, in which: -Fig. 1 highlights an operative portion of the medical apparatus according to the invention;

-Fig. 2 shows a simplified embodiment of the apparatus; and- Fig. 3 shows a preferred and substantially complete embodiment of the apparatus.

With reference to said drawings, reference numeral 1 globally denotes the medical apparatus according to the invention.

It comprises a support unit 2 suitable to clothe and/or envelop a body part of a patient and suitable to resist efforts directed at detaching, lifting or at least partially spacing the unit 2 from said body part.

In particular, the body part in question is a shoulder 3 and the support unit 2 is provided especially for treatment following implant operations of cardiac devices such as a pacemaker or defibrillator, when haematomas are possible on a shoulder 3, as specified in the introduction.

The unit 2 can be variously predisposed and may consist of a piece of fabric held in place by a partial bandage, as in Figure 2, or in a more complete garment, which for example envelops both shoulders, as specified below.

In combination with the unit 2 at least an operative portion of the apparatus 1 is provided, consisting at least of an inflatable bag or mattress or cushion, for example, a single cushion 4 inflatable with air, and placed, for example at or in the vicinity of or to straddle at least one shoulder 3.

Structurally, the cushion 4 preferably has a substantially flattened shape, when deflated, and square or rectangular, so as to increase, when inflated, its thickness and to press, in contrast to the support unit 2, the portion of the patient's shoulder. The cushion 4 preferably acts from only one side of the shoulder 4, in particular from the front side, but can, alternatively, also be positioned on both sides, front and rear, and, in particular to straddle said shoulder 3.

Alternatively, several cushions 4 may be provided placed at both shoulders and/or other body parts needing compression and containment treatment.

Each inflatable cushion 4 is held in the working position by the support unit 2, whatever the structure of the latter.

More particularly, said cushion 4 is associated with activation and control members 5 including both inflating means 6 which can be activated manually and detection elements 7 suitable to show the air pressure in the cushion or bag 4. Appropriately, the activation and control members 5 are permanently joined to the cushion 4.

The inflating means 6 comprise at least a simple pear pump 6a and a check or non-return valve 6b, which can be manually deactivated.

The detection elements 7 comprise for example a simple pressure gauge 7a. Advantageously, the support unit 2 has a pocket 8, or several pockets 8, each suitable to house a cushion or bag 4.

It is also possible for the unit 2 to be permanently joined to one or more cushions 4, so as to offer an apparatus immediately ready for use.

One important feature of each cushion 4 and of the activation and control members 5 is the ability thereof to easily reach a pressure of between 80 and 100 mmHg (millimetres of mercury), or other pressures, where necessary.

Similarly, the support unit 2 must withstand this pressure without significant deformation, to transmit this pressure for example to a shoulder 3 of a patient. In the preferred embodiment, in addition, the support unit 2 is made in the form of a jacket 2a enveloping the chest and shoulders of a patient 3 (figure 3). It is made of quilted cotton or synthetic or other materials.

In particular, the jacket 2a has a plurality of component portions stably engageable together by means of large areas of velcro 2b and these portions are arranged so as to firmly grip at least one cushion 4, placed in a said pocket 8 over a shoulder

3.

The jacket also presents an opening 8a adjacent to the pocket 8 and suitable to allow the passage towards the outside of said pear pump 6a with the valve 6b and said pressure gauge 7a, for an immediate control and activation thereof.

Preferably there are two inner pockets 8 at the two shoulders 3 and two openings 8a for the passage towards the outside of the pear pump 6a and the pressure gauge 7a.

Moreover, advantageously, the jacket 2a has anchoring means 9 suitable to hold an arm substantially still.

These anchoring means 9 may consist for example in strips or slots through which to make the arm pass, and/or in sleeves or portions of sleeves (not shown) suitable to restrain an arm.

They may, in addition, comprise a band 9b suitable to block the upper part of the patient's arm in a position adjacent to the body.

The use of the medical apparatus 1 according to the invention, described above in a structural sense, is as follows.

The apparatus is applied to a patient typically after the implantation of a pacemaker or a defibrillator and the application may be performed directly in the Electrophysiology room. This application may be performed by nursing staff who will carry out the following procedure.

Firstly a substantially deflated cushion or bag 4 and the attached activation and control members 5 are inserted in a pocket 8 of the support unit 2 and are positioned so as to be immediately reached-even by the patient himself- when the medical apparatus 1 is in use.

The pocket 8 is selected from among those available in such a way that the cushion 4 overlaps the part of the patient subject or potentially subject to a postoperative haematoma.

This operation is not performed when the support unit 2 is joined permanently or innate with a cushion or bag 4 or to several cushions 4, arranged at chosen points of the said unit 2.

The support unit 2 is then applied to the patient so that he can wear it comfortably but snugly, in particular in the area where the cushion is situated.

In the case of the jacket 2a the various portions of the vest are tightened and fixed using the velcro 2b. This also makes it easy to inspect the shoulder.

Subsequently the activation and control members 5 are used, in particular the inflating means 6, such as for example, the pear pump 6a to inflate the cushion 4.

The valve 6b prevents backflow of the air.

The inflation is simple and spontaneous and the detection elements 7, in particular said gauge 7a shows how the air pressure increases in the cushion 4 and on the shoulder 3.

Generally it is useful to reach the said pressure of 80 and 100 millimetres of mercury, or another pressure established by a doctor. The cushion 4, in contrast with the support unit 2, thus presses on the portion of the human body, in particular on a shoulder 3, which is beside it or which is located close to it.

At this point all that is needed is to periodically check the pressure gauge 7a, to make sure that there is no pressure loss. Optionally it is possible to graduate the inflation pressure upwards or downwards, to obtain combined maximum effectiveness and minimum stress of the patient.

In short, a procedure is performed which consists of applying a local compression only on a patient by inflating a cushion kept in a suitable position by a garment. The procedure also provides for constant monitoring of the inflation pressure, possibly by constant adjustment thereof.

The patient can thus hold his arm immobile even resorting to the anchoring means 9, when these are provided.

At the end of the treatment the cushion 4 can be completely deflated by simply acting on the valve 6b.

When removed, the medical apparatus 1 can be washed and used again for another patient.

The invention achieves the proposed objectives and permits important advantages.

In fact, the apparatus is reliable and able to guarantee reliable and optimal compression values, by intervening selectively and accurately on the areas to compress and leaving the surrounding areas substantially free.

It can also be adjusted according to the precise and specific needs of each patient and the setting can be varied over time, upwards or downwards, depending on the evolution of the situation. Once the specific needs have been defined it does not require the intervention of highly-skilled staff and even the patient himself can effectively cooperate in the management of the apparatus.

Thanks also to the extremely localised intervention the comfort of a patient is also greatly increased.

One significant advantage obtained thanks to the effectiveness of the medical apparatus according to the invention is therefore the possibility of an early mobilization of patients, which in many cases is achievable immediately after the first twelve hours from the operation to implant a pacemaker or a defibrillator. This period is very low compared to the current 24-48 hours.

This is positive both for patients and for hospitals and care centres, which can minimise the expense of hospitalization.

Variations may be made to the invention without departing from the scope of the inventive concept defined in the independent claim and by its technical equivalents.

All details may be replaced with equivalent elements and the materials, shapes and dimensions may be any within the scope of protection defined by the independent claims and by the technical equivalents.

Claims

1. Medical apparatus (1) for the containment of haematomas for treatment following implant operations of cardiac devices, characterised in that it comprises, in combination, a support unit (2) externally enveloping a part of the patient's body and suitable to resist efforts to detach at least partly said unit (2) from said patient, at least one inflatable cushion (4) held in place by said support unit (2) and placed for example at or in the vicinity of at least a shoulder (3) of said patient.

2. Medical apparatus (1) according to the previous claim, wherein said inflatable cushion (4) is placed exclusively on the front side of said shoulder (3).

3. Medical apparatus (1) according to the previous claim, wherein said inflatable cushion (4) is placed on both sides, front and back, of said shoulder (3).

4. Medical apparatus (1) according to one or more of the previous claims, comprising activation and control members (5) of said cushion (4), including means for inflating (6) said cushion.

5. Medical apparatus (1) according to the previous claim, wherein said activation and control members (5) comprise detection elements (7) suitable to show the air pressure inside said cushion (4).

6. Medical apparatus (1) according to one or more of the previous claims, wherein said activation and control members (5) are permanently joined to said inflatable cushion (4).

7. Medical apparatus (1) according to one or more of the previous claims, wherein said inflatable cushion (4) is held in position by said support unit (2).

8. Medical apparatus (1) according to one or more of the previous claims, wherein said support unit (2) has at least one pocket (8) suitable to house said inflatable cushion (4).

9. Medical apparatus (1 ) according to one or more of the previous claims, wherein said support unit (2) is in the shape of a jacket (2a).

10. Medical apparatus (1 ) according to one or more of the previous claims, wherein said jacket (2a) has anchorage means (9) suitable to keep at least one arm substantially motionless.