WO2018010797A1

WO2018010797A1 - Automatic heart massager for use in catheterization rooms

Info

Publication number: WO2018010797A1
Application number: PCT/EP2016/066766
Authority: WO
Inventors: Daniele NICOLIS; Igor Sergio Laerte STEFANINI; Agatino Christian TAVILLA; Saul Matteo FIORI; Gianluca Stefano MONTU'; Fabio Angelo Giuseppe REZZONICO; Dante Luigi Davide MOCCETTI; Tiziano Cristoforo Pietro MOCCETTI; Daniel Christoph SÜRDER
Original assignee: Fondazione Cardiocentro Ticino (FCCT)
Priority date: 2016-07-14
Filing date: 2016-07-14
Publication date: 2018-01-18

Abstract

There is described an automatic heart massager (1) for use in a catheterization room. The heart massager (1, 110) comprises a support platform (2) for the back of the patient undergoing heart massage and at least two uprights (4, 40) which rise laterally from said support platform (2). The two uprights (4, 40) each contain an actuator for moving a transverse bridge (5, 50) with a pad (6) for compressing the patient's chest, perpendicularly to the support platform (2). At least the transverse bridge (5, 50) and the support platform (2) are made of a radiolucent material.

Description

AUTOMATIC HEART MASSAGER FOR USE IN CATHETERIZATION ROOMS

DESCRIPTION

The present invention relates to an automatic heart massager for use in catheterization rooms. Heart massage is typically an emergency manoeuvre for supporting blood circulation in patients suffering from cardiac arrest and ensuring a blood supply to the brain that is sufficient for survival.

There are known automatic heart massagers designed to perform uninterrupted compressions at a constant frequency and depth with the aim of facilitating the return to spontaneous circulation and avoiding operator fatigue, which can result in an inadequate frequency or depth of the massage.

For example, a type of automatic heart massager 100 with a compression system with lateral belts is known (FIG. 1). In this device a single-use chest strap 101 is fixed to the lateral belts 102 of a platform 103 supporting the patient's back; the chest strap 101 is then automatically adapted to the patient's chest and can start a massage cycle. The strap system wraps around the patient and exerts pressure in such a way as to make only the lateral parts of the chest work, thereby avoiding the risk of crushing the sternum.

Other types of automatic heart massagers make it possible to have a more precise action on the cardiac region and are more effective in terms of the stimulating effect of the massage. For example, there are known heart massagers 200, 300 comprising a functional body 201, 301 which must be positioned in contact with the patient's chest by means of belts 202 (FIG.2) or by means of a structure comprising two support arms 302 which rise laterally from a support plate 303 (FIG. 3). Once started, by acting on a series of function keys, each of these devices develops chest compressions according to the set and/or default parameters. The compression is applied on the sternum through the action of a piston, with the functional body 201, 301 in a position corresponding to the axis passing through the heart.

These known devices are used to administer automatic chest compressions in different settings, from first aid on the site, in an ambulance or in any hospital department. Specifically, they are widely used in catheterization rooms in which, while the heart massage is being performed, it is necessary to be able to observe the area undergoing intervention via an X-ray unit in order to operate with the required precision. For example, in the case of a cardiac arrest caused by refractory ventricular fibrillation or in the presence of a rhythm that is not treatable with a shock, automatic heart massagers enable the intervention to continue by administering constant chest compressions that facilitate blood circulation and the supply of oxygen to vital organs.

Therefore, in addition to optimally supporting blood circulation, heart massagers contribute to reducing the operator's level of stress, facilitating more pondered decisions and keeping personnel at a safe distance from the X-rays.

However, the use of the known heart massagers in catheterization rooms poses some problems. In fact, the structural nature of such devices constitutes a serious obstacle to a clear view of the work area, due particularly to the high opacity of the materials used (metals in particular) to X- rays and to the architecture of the heart massager itself, which imposes a position interfering with the X-rays path. The visual field of the X-ray unit, i.e. the area represented in the reconstructed image, will thus show a series of more or less dark, irregular shadows that make the surgeon's work arduous, if not impossible.

In particular, the massaging device 100, though it is relatively thin and occupies little space vertically, has its active part in the platform 103 below the patient's chest and thus along the trajectory of the X-rays, something that makes the heart massager 100 subject to a masking effect.

Analogously, in the other types of heart massagers 200, 300 described above, since the compression on the sternum takes places by means of a piston, practically the whole device is located on the axis passing through the heart and in this case as well, therefore, it is not possible to avoid the effect of masking the X-rays.

A further known heart massager 400 features a pneumatic compressor 401 with actuation from only one side. This solution makes it possible to have the opposite side substantially free of objects that could interfere with the X-ray unit; however this device is suitable only for panoramic views that are inclined to the vertical. The problem of masking the X-rays is thus not wholly eliminated.

In view of the prior art, the object of the present invention is to provide a heart massager that is as transparent as possible to X-rays, in relation to the work area, and such as to enable vertical panoramic views of the work area and ones that are inclined at larger angles to the vertical.

In accordance with the present invention, said object is achieved by means of an automatic heart massager adapted for use in a catheterization room, characterized in that it comprises a transverse bridge, to which a silicone pad for compressing a patient's chest is fixed, a support platform for the patient's back and at least two uprights which rise laterally from said support platform, said at least two uprights each containing an actuator for moving said transverse bridge perpendicularly to the support platform, at least said transverse bridge and support platform being made of carbon fibre.

Preferably, said pad has a suction-cup configuration so that, during the step of raising said transverse bridge, it will remain adherent to the patient's chest, thus contributing to expanding the chest upward and generating, as a consequence, a significant increase in the volume of the cardiac cavities.

Preferably, the angle having as its vertex the point of intersection, with the support platform, of the straight line orthogonal to the support platform passing through the centre of the pad, a side coinciding with said straight line orthogonal to the support platform, and a side tangent to an upright, is no less than about 30 degrees.

The characteristics and advantages of the present invention will become more apparent from the following detailed description of two of its practical embodiments, illustrated by way of non- limiting example in the appended drawings, in which:

figure 1 shows a known automatic heart massager with a compression system with lateral belts; figure 2 shows a known heart massager comprising a functional body to be positioned on the patient's chest by means of belts;

figure 3 shows a known heart massager comprising a functional body to be positioned on the patient's chest by means of a structure comprising support arms which rise laterally from a support plate;

figure 4 shows a known heart massager with a pneumatic compressor with actuation from only one side;

figure S shows an axonometric view of a first embodiment of a heart massager according to the present invention;

figure 6 shows a front view of the heart massager of figure S;

figure 7 shows an axonometric view of a second embodiment of a heart massager according to the present invention;

figure 8 shows a front view of the heart massager of figure 7;

figure 9 shows a cutaway view of a first detail of the heart massager of figure 7; figure 10 shows a second detail of the heart massager of figure 7.

FIG. 5 shows an automatic heart massager 1, according to a first embodiment of the present invention, for use in catheterization rooms.

The automatic heart massager 1 is used for the purpose of performing compressions of the chest region of a patient with a constant frequency and depth in order to support blood circulation and facilitate the return to spontaneous circulation.

The heart massager 1 has broad application in catheterization rooms in which, while the heart massage is being performed, it is necessary to be able to observe the area undergoing intervention via an X-ray unit in order to operate with the required precision.

The heart massager 1 comprises a support platform 2 for the patient's back which is substantially rectangular in shape and has a certain thickness that is reduced at least on one of the long sides according to a ramp 3, suitably shaped so as to facilitate the placement and positioning of the patient to undergo heart massage.

By way of example, the long side of the support platform 2 has dimensions of about 69 cm.

The support platform 2 is made of carbon fibre, i.e. an epoxy-resin based composite and carbon fibre fabrics, precisely, arranged in duly oriented layers. Carbon fibre, in particular, besides offering high mechanical strength, is the ideal material for having structures that are rigid, resistant, lightweight, and for the specific application concerned, radiolucent, i.e. transparent to the X-rays produced by the X-ray unit.

The heart massager 1 comprises at least two uprights 4, 40 which rise laterally from said support platform 2. Specifically, there is a master upright 4 and a slave upright 40 fixed at the short sides of the support platform 2 by means of a hinge system with a spring-loaded anchorage coupling 22. By way of example the master upright 4 and the slave upright 40 are substantially conformed as rectangular parallelepipeds about 31 cm high and have a distance of about 45 cm between their opposite surfaces.

Internally, each upright 4, 40 contains an actuator 13 configured for moving a transverse bridge 5 adapted to transfer the forces generated by said actuators to the sternum (compression of the chest region) by means of a pad 6 fixed centrally and underneath the transverse bridge 5.

In particular, the transverse bridge 5 is a bar with a polygonal (e.g. hexagonal) cross section which centrally has a lower projection (e.g. truncated pyramid-shaped) on which the pad 6 is located.

The transverse bridge 5 is likewise made of carbon fibre. The pad 6, by contrast, is made of silicone and is advantageously shaped like a suction cup, so that, during the step of raising the bridge 5, the effect of adherence that occurs between the suction cup and the patient's chest contributes to expanding the chest upward and generating, as a consequence, a significant increase in the volume of the cardiac cavities. In this manner the heart, albeit passively, increases its capacity, fully to the advantage of the movement of blood and hence the oxygenation thereof. The use of carbon fibre ensures that the heart massager 1 will offer an excellent level of transparency to X-rays across wide angles.

In particular, the angle having as it vertex O the point of intersection, with the support platform 2, of the straight line orthogonal to the support platform 2 passing through the centre of the pad 6, a side A coinciding with said straight line orthogonal to the support platform 2, and a side B tangent to the top part of an upright 4, 40, is no less than about 30 degrees.

This angle represents the semi-aperture of the field of vision of the X-ray unit (FIG. 6). The overall field of vision of the X-ray unit will thus have a conical shape (cone of vision), with a semi-aperture AOB and axis OA (FIG. 5).

Thanks also to the lowered configuration of the upright 4, 40, the surgeon can therefore operate with a broad, clear view of the work area.

The two actuators 13 positioned in the master 4 and slave 40 uprights are electromechanical actuators suitably controlled and synchronized by an onboard electronic circuit of the master upright 4, and which, as noted, enable the transverse bridge 5 to be raised and lowered according to parameters set from a control panel 10 likewise mounted on the master upright 4, on an outer side surface as shown in FIG. 5. The control panel 10 comprises a keypad and a display and is adapted to set the massage parameters, or, essentially, the depth of the chest compression and the compression frequency.

Each actuator 13 (FIG. 9) comprises an electric motor 14 which, via a transmission system 15, transfers a linear movement to the transverse bridge 5, 50 in a direction perpendicular to the support platform 2 and thus to the pad 6 which will go into contact with the chest region of the patient For example, the transmission system 15 comprises a first pulley 16 integral with the motor shaft, a second pulley 17 integral with a drive screw 18 and a belt 19 adapted to place said motor shaft and said drive screw 18 in connection with each other.

The drive screw 18 is coupled with a nut 180 made of self-lubricating plastic material and fixed to a slider 29 in such a way as to convert the rotational motion of the electric motor 14 into a translational motion of the slider 29, which is adapted to be coupled with the transverse bridge 5. The slider 29 slides by means of a pair of sliding shoes 20, likewise made of self-lubricating plastic material, along two vertical rods 21 fixed to the frame of the upright 4, 40.

The onboard electronic circuit of the master upright 4 comprises at least one microcontroller configured to send, simultaneously, appropriate commands to a control unit of each motor 14, so that the latter act accordingly and in a perfectly synchronized manner. Said onboard electronic circuit is likewise configured to check the distance of the ends of the transverse bridge 5, 50 from the support platform and, in the event that a difference occurs in the distance of the ends of the transverse bridge 5, 50 from the support platform, to interrupt the massage and, optionally, to indicate an error situation (audible signal and message on the display of the control panel 10). Therefore, the two actuators 13 work in a synchronous manner and thus function as a single actuator in order to ensure the symmetry and balance of the structure of the heart massager 1 and of the application of forces.

Furthermore, the actuators can be activated (or deactivated) by means of a floor switch (not shown in the figures) connected to a suitable first bayonet connector 12, with which the support platform 2 is provided; the foot switch enables the operator to more easily activate (or deactivate) the heart massager 1 without needing to use his or her hands, which are usually engaged in other activities. In fact, the foot switch works in parallel with a pause-start button on the keypad and moreover constitutes a safety stop system, since in terms of size and accessibility, is it easier to actuate.

The heart massager 1 further comprises an adjustment means 7, 70 for adjusting the position of coupling the transverse bridge 5, 50 to the uprights in order to adjust the height of the transverse bridge S 50 relative to the support platform 2 depending on the size of the patient

Specifically, the adjustment means 7 comprises two linear blocks 8, each integral with one of said sliders 29 and positioned on opposite side surfaces of the two uprights 4, 40. Moreover, the adjustment means 7 comprises a pair of coupling (or release) 9 handles present on the ends of the transverse bridge S; the handles are adapted to couple with the linear blocks 8 in such a way as to slide along them and lock at given heights of the transverse bridge S from the support platform 2. In the support platform there is also provided a second connector 11 for the power supply of the heart massager 1.

FIG. 7 shows an automatic heart massager 110, according to a second embodiment of the present invention, for use in catheterization rooms.

The heart massager 110 shown in FIG. 7 differs from the previous embodiment in that it comprises a substantially arch-shaped transverse bridge 50 with linear sliding blocks 80 present at ends of the transverse bridge 50; centrally, the transverse bridge 50 has a lower projecting part (e.g. truncated pyramid-shaped) on which the pad 6 is located. Thanks to this configuration of the transverse bridge 50, the semi-aperture AOB of the field of vision of the X-ray unit is increased and is here equal to about 40 degrees (FIG. 8).

Furthermore, in this case the heart massager 110 comprises an adjustment means 70 with a comb-like fixing system (FIG. 10). In particular, the adjustment means 70 comprises a pair of hinges 28, fixed to said sliders 29 of the actuators 13, adapted to be coupled with the two sliding blocks 80 of the transverse bridge 50. Each of said hinges 28 is provided with a lever 23 for the translational movement of a key 27 adapted to enmesh with a plurality of teeth 26 present in the linear block 80.

The two linear blocks 80 enable pitches of 6 mm and are adapted to slide along said hinges 28 until the levers 23 are in a release position (keys 27 disengaged from the teeth); otherwise, the two linear blocks 80 lock when the levers 23 are in a coupling position (keys enmeshed with the teeth 26), constraining the transverse bridge 50 to the actuators 13.

The power supply unit and floor switch are connected, respectively, to the massager by means of two bayonet connectors 25, 24, this time positioned on the master upright 4, whilst the slave upright 40 is powered and controlled via the support platform 2 and spring-loaded electrical contacts positioned on the lower part of the uprights themselves.

The heart massager 1, 110 according to the present invention performs compressions of the chest region to a depth of about 20% of the distance between the sternum and vertebral column of the patient (i.e. 50-70 mm, with reference to an adult patient with a chest thickness of between 170 and 260 mm) with a compression frequency of between 60 and 100 compressions per minute. The heart massager 1, 110, disassembled into its components, can be stored and transported in a suitable carrying case. At the time of use in the catheterization room, the heart massager 1, 110 requires only a few operations in order to be assembled and made operational:

- positioning the support platform 2 on a table;

- coupling the uprights 4, 40 to the sides of the support platform 2 (in a horizontal position) by inserting the uprights 4, 40 into the hinges 22 provided (keeping the same at an angle of about 20-25° relative to the support platform 2);

- positioning the patient on the support platform 2;

- rotating the uprights 4, 40 into a vertical position and anchorage by means of the couplings of the hinges 22;

- connecting the power supply unit and of the floor switch to the master upright 4 (connecting the switch is indispensable as it performs a safety function, which, if not detected by the onboard electronic circuit will not enable the massage);

- connecting the power supply unit to the electricity mains and switching on the same.

In the use and operation of the heart massager 1, 110 according to the present invention, the following steps are envisaged:

- searching for references and activating the control over the actuators 13 in such a way that the sliders 29 are aligned and the onboard electronic circuit enables them to remain so during the introduction of the transverse bridge 50 and the positioning thereof on the patient;

- introducing and fixing the transverse bridge 50 by raising the levers 23 present on the sliders 29 in such a way as to align the keys 27 in a suitable manner;

- positioning the transverse bridge 50 with the pad 6 in contact with the patient's chest;

- positioning the levers 23 in a coupling position to constrain the transverse bridge 50 to the actuators 13;

- setting the massage parameters from the keypad and display of the control panel 10;

- activating the massage by acting on the button on the keypad of the control panel 10 or on the floor switch;

- interrupting the massage by acting on the button on the keypad of the control panel 10 or on the floor switch; the actuators 13 complete the compression cycle underway and return to the initial position.

With the heart massager 1, 110 according to the present invention, the semi-aperture of the field of vision can reach about 40 degrees, and presently represents the maximum aperture of the cone of vision. The lateral actuation resolves, in fact, the problem typical of the known devices, namely, that of having metal parts in front of or behind the work area and thus in line with the X- ray unit.

Ultimately, thanks to the use of radiolucent materials, such as carbon fibre, and an external positioning of the active part, the heart massager 1, 110 according to the present invention is capable of offering high, extensive transparency to X-rays, in relation to the work area, enabling vertical panoramic views of the work area and ones that are inclined at larger angles to the vertical.

Claims

1. An automatic heart massager (1, 110) adapted for use in a catheterization room, characterized in that it comprises a transverse bridge (5, 50), to which a silicone pad (6) for compressing a patient's chest is fixed, a support platform (2) for the patient's back and at least two uprights (4, 40) which rise laterally from said support platform (2), said at least two uprights (4, 40) each containing an actuator (13) for moving said transverse bridge (5, 50) perpendicularly to the support platform (2), at least said transverse bridge (5, 50) and support platform (2) being made of carbon fibre.

2. The heart massager (1, 110) according to claim 1, characterized in that said pad (6) has a suction-cup configuration so that, during the step of raising said transverse bridge (5), it will remain adherent to the patient's chest, thus contributing to expanding the chest upward and generating, as a consequence, a significant increase in the volume of the cardiac cavities.

3. The heart massager (1, 110) according to any one of the preceding claims, characterized in that the angle having as its vertex (O) the point of intersection, with the support platform (2), of the straight line orthogonal to the support platform (2) passing through the centre of the pad (6), a side (A) coinciding with said straight line orthogonal to the support platform (2), and a side (B) tangent to an upright (4, 40), is no less than about 30 degrees.

4. The heart massager (1, 110) according to claim 1, characterized in that said uprights (4, 40) comprise an adjustment means (7, 70) for adjusting the position of coupling of the transverse bridge (5, 50) to said uprights in order to adjust the height of the transverse bridge (5, 50) relative to the support platform (2) depending on the size of the patient.

5. The heart massager (1) according to claim 4, characterized in that said adjustment means (7) comprises linear blocks (8), positioned on opposite side surfaces of the two uprights

(4) , and a pair of coupling handles (9), present on the ends of the transverse bridge (S), said coupling handles (9) being adapted to couple with the linear blocks (8) in such a way as to slide along them and lock at given heights of the transverse bridge (5) from the support platform (2).

6. The heart massager (1) according to claim 1, characterized in that said transverse bridge

(5) is a bar with a polygonal cross section which centrally has a lower projecting part on which the pad (6) is located.

7. The heart massager (110) according to claim 4, characterized in that said adjustment means (70) comprises a pair of hinges (28) fixed to the actuators (13) and adapted to be coupled with linear sliding blocks (80) present at ends of the transverse bridge (50), said hinges (28) each being provided with a lever (23) for the translational movement of a key (27) adapted to enmesh with a plurality of teeth (26) present in the linear block (80)

8. The heart massager (110) according to claim 1, characterized in that said transverse bridge (50) is substantially arch-shaped and centrally has a lower projecting part on which the pad (6) is located.

9. The heart massager (1, 110) according to claim 1, characterized in that said actuators (13) are electromechanical actuators, each comprising an electric motor (14) which, via a transmission system (15) transfers a linear movement to the transverse bridge (5, 50) in a direction perpendicular to the support platform (2) and thus to the pad (6) which will go into contact with the chest region of the patient.

10. The heart massager (1, 110) according to claim 9, characterized in that said transmission system (15) comprises a first pulley (16) integral with the motor shaft, a second pulley (17) integral with a drive screw (18) and a belt (19) adapted to place said motor shaft and said drive screw (18) in connection with each other, said drive screw (18) being coupled with a nut (180) made of self-lubricating plastic material and fixed to a slider (29) which is adapted to be coupled with the transverse bridge (5, 50).

11. The heart massager (1, 110) according to claim 10, characterized in that said slider (29) slides by means of a pair of sliding shoes (20) made of self-lubricating plastic material along two vertical rods (21) fixed to the frame of the upright (4, 40).

12. The heart massager (1, 110) according to claim 1 or 8, characterized in that said actuators can be activated by means of a floor switch connected to a suitable first connector (11, 25) with which the support platform (2) or one of the uprights (4) is provided.

13. The heart massager (1, 110) according to claim 1 or 8, characterized in that the actuators (13) are controlled and synchronized by an onboard electronic circuit of one of the uprights (4) in order to enable the transverse bridge (5, 50) to be raised and lowered according to parameters set from a control panel (10) likewise mounted on the upright (4), said control panel (10) comprising a keypad and a display and being suitable for setting the parameters of massage.

14. The heart massager (1, 110) according to claim 13, characterized in that said onboard electronic circuit comprises a microcontroller configured to send, simultaneously, appropriate commands to a control unit of each motor (14) so that the latter act in a synchronized manner, said onboard electronic circuit likewise being configured to check the distance of the ends of the transverse bridge (5, 50) from the support platform and, in the event that a difference occurs in the distance of the ends of the transverse bridge (5, 50) from the support platform, to interrupt the massage.

15. The heart massager (1, 110) according to any one of the preceding claims, characterized in that said actuator (13) is programmed to cause said pad (6) to perform compressions of the chest region to a depth of about 20% of the distance between the sternum and vertebral column of the patient with a compression frequency of between 60 and 100 compressions per minute.