WO2018177654A1

WO2018177654A1 - Thoracic restraint and safety device for patients and tensioning element associated thereto

Info

Publication number: WO2018177654A1
Application number: PCT/EP2018/054087
Authority: WO
Inventors: Javier Jose PÉREZ ACEBO
Original assignee: Corporació Sanitària Parc Taulí
Priority date: 2017-03-31
Filing date: 2018-02-20
Publication date: 2018-10-04
Also published as: ES2620985B1; EP3600204A1; ES2620985A1

Abstract

A thoracic restraint and safety device, comprising a restraint harness (2) configured to adjust to the upper part of the back of a patient (P); a first fastening strap (3) extending laterally from the restraint harness (2), and having a first joining end (31); and a second fastening strap (4) extending laterally from the restraint harness (2) in the opposite direction to the first fastening strap (3), and having a second joining end (41). Both joining ends (31, 41) are configured to join together around a bed or stretcher (C). Wherein the second fastening strap (4) comprises an auxiliary end (5) for connecting a tensioning element (6), joined in turn to the first joining end (31), enabling gradual tightening of the fastening straps (3, 4) around the bed or stretcher (C).

Description

THORACIC RESTRAINT AND SAFETY DEVICE FOR PATIENTS AND

TENSIONING ELEMENT ASSOCIATED THERETO

DESCRIPTION

Field of the invention

The present invention relates to a thoracic restraint and safety device for agitated and/or aggressive patients, as well as a tensioning element associated thereto, especially applicable in the sectors of emergency and/or mental health. Background of the invention

Thoracic restraint devices must be used as a last resort during the mechanical containment of agitated and/or aggressive patients according to hospital protocols, ensuring at all times the safety of the patient, of healthcare personnel and third parties. Furthermore, they should always take into account continuous patient supervision, correct positioning of the patient on the bed or stretcher on which the containment is carried out, as well as proper use of the device during the agitation episode and/or while awaiting pharmacological containment. Once the agitation has disappeared, the device should be removed as quickly as possible.

Currently, different devices are known for mechanical containment of this type of patients. One of the most representative is SALVAFIX®. It consists of a "¥" shaped thoracic harness that is joined to an abdominal belt at the patient's back by means of Velcro® through a fabric buckle. It then ascends the dorsal area to a transverse strap, previously fastened to the bed frame by means of magnetic fastening elements. Said straps surround the patient at each clavicular area joining together in front of the neck in the shape of a "cross", by means of a magnetic fastening element, to another strap that serves as an extension piece and which extends towards the neck from the ventral area of the abdominal belt. This "¥" shaped strap also has two straps sewn to "Y" for the purpose of encircling the patient's thorax at the height of the floating ribs and joining to the extension piece that extends from the ventral area of the abdominal restraint at another fastening point by means of a magnetic fastening element, located below, to which one of the straps in the shape of a "cross" is joined. Once said magnetic elements are closed, these cannot be opened manually, but require the use of specific tools. This type of devices has various drawbacks both for the patient and for healthcare personnel.

As far as the patient is concerned, it should be noted that thoracic restraint is carried out by means of the use of two restraint straps, in a crossed manner, each of them extending from the patient's abdominal area to the clavicular area near the patient's neck. Such that, said restraint straps may end up passing very close to the softest parts of the neck, putting the patient at risk. Furthermore, all the bands and/or straps used by this type of devices have flat and rigid surfaces that may be uncomfortable for the patient.

As far as the healthcare personnel are concerned, it should be noted that the most important problems arise when placing the device, and more specifically when the fastening straps have to be tightened and this is not possible because the type of stretcher does not allow access to the frame, and the ends thereof must be joined. This is due to the great diversity of widths, shapes and sizes of said support bases (beds, stretchers, etc.), as well as the thickness and sponginess of the mattresses used thereon. As an example, those used in ambulances can be between 50 and 60 cm wide, hospital stretchers can be between 70 and 80 cm wide and beds can be more than 90 cm wide. As a result, when tightening the fastening straps, healthcare personnel must pull them manually with force so that the device is firmly attached to said support base, often in rather uncomfortable positions due to lack of space (especially in ambulances and boxes with beds attached to the wall) and with the patient acting against them. It often occurs that once the magnetic fastening element is arranged, the fastening straps are not sufficiently tightened to the bed or stretcher, granting certain mobility to the patient, who put its own safety and/or that of third parties at risk, for example, by banging its head against the handrails, the wall or the sanitary personnel.

Another complication that can be added to the existing ones is the difficulty in placing the thoracic harness due to the different parts that make it up and the risk of injury perceived by healthcare personnel by having straps that pass very close to soft neck areas when the patient wants to sit up violently, in addition to the need for having magnetic keys and sufficient restraint material available at all times in order to be able to quickly release the patient, in case of life-threatening risk.

The present invention solves the aforementioned problems by means of a thoracic restraint and safety device for agitated and/or aggressive patients as well as a tensioning element associated thereto, the configuration of which enables the connection of a tensioning element to first of all carry out a quick joining of both fastening straps and secondly, a progressive or gradual adjusting of the tension thereof on the bed or stretcher until reaching the desired tension, subsequently allowing the ends thereof to be joined, in order to release said tensioning element and reuse it in another device. In turn, the configuration of the harness incorporated in the device of the present invention also favors proper arrangement thereof on the patient, avoiding risks for the patient and ensuring adequate containment and release thereof in case of life-threatening emergency in a more comfortable, quicker and safer way, using a single magnetic fastening element that does not interfere with the rapid release of the agitated/aggressive patient. Description of the invention

The present invention relates to a thoracic restraint and safety device for patients of the present invention comprising:

a restraint harness configured to adjust to the upper part of the back of a patient;

- a first fastening strap that extends laterally from the restraint harness and that has a first joining end; and

a second fastening strap that extends laterally from the restraint harness in the opposite direction to the first fastening strap, and has a second joining end;

wherein both joining ends are configured to join together around a bed or stretcher on which the patient is arranged.

Said device is characterized in that the second fastening strap comprises an auxiliary end for connecting a tensioning element, joined in turn to the first joining end of the first fastening strap, enabling gradual tightening of the fastening straps around the bed or stretcher.

The device of the present invention has certain ergonomics, which enable it to adapt to the morphology of various patients. The shape itself and the dimensions of the components thereof facilitate said adaptation. Furthermore, all the components thereof are integrated into the device in order to avoid loss and thus prevent it from becoming inoperative Preferably, the auxiliary end enables releasing the tensioning element once the fastening straps have been tightened, after joining both joining ends. This enables using the tensioning element in other patients.

Preferably, the restraint harness comprises a rear band configured to adjust on the back of the patient, having:

a first side from which a first fastening strap extends laterally; and a second side, opposite the first side, from which the second fastening strap and the auxiliary end extend laterally.

Preferably, the restraint harness comprises a first restraint strap and a second restraint strap arranged in parallel, configured to adjust around the acromioclavicular joints of the patient. Similarly, the first restraint strap comprises a first adjusting end to which a first quick adjusting element is joined by means of a first swivel joint; while the second restraint strap comprises a second adjusting end to which a second quick adjusting element is joined by means of a second swivel joint. Said swivel joints enable the restraint straps to better adapt to the pseudo circular shape of the acromioclavicular area. Velcro®-type quick adjusting elements, for example, also help to improve said adaptation.

Preferably, the first restraint strap extends perpendicularly from the rear band, from a first fixed joint integral to said rear band and opposite the first quick adjusting element; while the second restraint strap extends perpendicularly from the rear band, from a second fixed joint integral to said rear band and opposite the second quick adjusting element. Similarly, the rear band comprises a first securing strip enabled to allow the passage of the first adjusting end between said first securing strip and the rear band; and a second securing strip enabled to allow the passage of the second adjusting end between said second securing strip and the rear band.

Preferably, the first restraint strap and the second restraint strap respectively comprise a first padded lining and a second padded lining for protecting the patient. Thus, since the restraint straps are lined with foam, they provide the patient greater safety and comfort.

Preferably, the first fastening strap and the second fastening strap respectively have a first length and a second length, wherein the second length is smaller than the first length. For example, the first length could be in the order of about 120 cm, while the second length could be in the order of about 20 cm. This enables that the joining point is not right under the bed or stretcher but rather on a side thereof on top of the mattress. Such that the time and effort required by healthcare personnel for placing the patient on the stretcher is improved, since the former do not have to get under the stretcher in order to join both straps.

Preferably, the first joining end and the second joining end respectively comprise first adjusting holes and second adjusting holes configured to coincide with each other, allowing the passage of a fastening element between two coinciding adjusting holes in order to join both joining ends.

Preferably, the fastening element is magnetic, made up of two magnetized pivots that join to each other, and the separation of which requires a specific tool. Nevertheless, said fastening elements can also consist of flanges, clip-on elements or the like.

Preferably, the auxiliary end comprises an auxiliary strap section, the end of which has a first quick coupling and uncoupling element, such as for example a buckle with a male or female clasp.

Preferably, the device comprises a tensioning element that has a connecting end for connection thereof to the auxiliary end and an adjusting end for connection thereof to the first joining end. Said connecting end is made up of a strap section, of about 10 to 30 cm, for example, which extends from the tensioning element to a second quick coupling and uncoupling element, such as for example a buckle with a male or female clasp, complementary to the first quick coupling and uncoupling element. Preferably, said tensioning element is a ratchet-type tensioning element.

The present invention also relates to a tensioning element for thoracic restraint and safety devices for patients, comprising:

- an adjusting end configured to join to a first joining end of a first fastening strap of a thoracic restraint and safety device for patients; and

- a connecting end configured for connection thereof to an auxiliary end of a second fastening strap of said device, which has a second joining end;

wherein said tensioning element enables gradual tightening of the fastening straps around a bed or stretcher on which the patient is arranged.

Preferably, the connecting end is made up of a strap section, of about 10 to 30 cm, for example, which extends from the tensioning element to a second quick coupling and uncoupling element, such as for example a buckle with a male or female clasp, complementary to a first quick coupling and uncoupling element of the auxiliary end. Preferably, said tensioning element is a ratchet- type tensioning element. Brief description of the drawings

What follows is a very brief description of a series of drawings that aid in better understanding the invention, and which are expressly related to an embodiment of said invention that is presented by way of a non-limiting example thereof.

Figure 1 shows a view of the thoracic restraint and safety device for agitated and/or aggressive patients of the present invention arranged on a bed or stretcher.

Figure 2 shows a first rear elevation view of the device of Figure 1 , with the restraint straps deployed.

Figure 3 shows a second rear elevation view of the device of Figure 1 , with the restraint straps gathered up forming two loops for restraining the patient.

Figure 4 shows an elevation view of the tensioning element.

Figure 5 shows a way of implementing the device of the present invention, before joining the joining ends of the fastening straps.

Figure 6 shows a view of the "Y" detail of Figure 5.

Figure 7 shows a way of implementing the device of the present invention, after releasing the tensioning element.

Figure 8 shows a view of the "Z" detail of Figure 7.

Detailed description of the invention

Figure 1 shows a view of the thoracic restraint and safety device (1 ) for agitated and/or aggressive patients of the present invention arranged on a bed or stretcher (C).

As can be seen, said device (1 ) comprises:

a restraint harness (2) configured to adjust to the upper part of the back of a patient (P);

a first fastening strap (3) that extends laterally from the restraint harness (2) and that has a first joining end (31 ); and

- a second fastening strap (4) that extends laterally from the restraint harness (2) in the opposite direction to the first fastening strap (3), and has a second joining end (41 );

wherein both joining ends (31 , 41 ) are configured to join together around a bed or stretcher (C) on which the patient (P) is arranged.

Said device (1 ) is characterized in that the second fastening strap (4) comprises an auxiliary end (5) for connecting a tensioning element (6), Figure 4, joined in turn to the first joining end (31 ), of the first fastening strap (3), enabling gradual tightening of the fastening straps (3, 4) around the bed or stretcher (C), Figures 5 and 7.

In turn, the restraint harness (2) comprises a rear band or base (21 ) configured to adjust on the back of the patient (P), having:

a first side (21 a) from which a first fastening strap (3) extends laterally; and

a second side (21 b), opposite the first side (21 a), from which the second fastening strap (4) and the auxiliary end (5) extend laterally.

As can be seen in Figures 2 and 3, the restraint harness (2) comprises a first restraint strap (22a) and a second restraint strap (22b) arranged in parallel, for example spaced between 15 and 25 cm apart, configured to adjust around the acromioclavicular joints of the patient (P), Figures 5 and 7. Similarly, the first restraint strap (22a) comprises a first adjusting end (23a) to which a first quick adjusting element (25a) is joined by means of a first swivel joint (24a); while the second restraint strap (22b) comprises a second adjusting end (23b) to which a second quick adjusting element (25b) is joined by means of a second swivel joint (24b). Said swivel joints (24a, 24b) enable the restraint straps (22a, 22b) to better adapt to the pseudo circular shape of the acromioclavicular area.

As an example, each of the restraint straps (22a, 22b) can approximately have a length of 80 cm and a width of 2.5 cm. In turn, the quick adjusting elements (25a, 25b) can be Velcro®-type male elements of approximately 15 cm in length, also helping to improve said adaptation.

In turn, the first restraint strap (22a) extends perpendicularly from the rear band (21 ), from a first fixed joint (26a), Figure 1 , integral to said rear band (21 ) and opposite the first quick adjusting element (25a); while the second restraint strap (22b) extends perpendicularly from the rear band (21 ), from a second fixed joint (26b), Figure 1 , integral to said rear band (21 ) and opposite the second quick adjusting element (25b). Similarly, the rear band (21 ) comprises a first securing strip (27a) enabled to allow the passage of the first adjusting end (23a) between said first securing strip (27a) and the rear band (21 ); and a second securing strip (27b) enabled to allow the passage of the second adjusting end (23b) between said second securing strip (27b) and the rear band (21 ).

The first restraint strap (22a) and the second restraint strap (22b) respectively comprise a first padded lining (28a) and a second padded lining (28b) for protecting the patient (P). Thus, since the restraint straps (22a, 22b) are lined with foam, they provide the patient greater safety and comfort and also facilitate fastening of the Velcro®-type quick adjusting elements (25a, 25b), Figures 5 and 7. As an example, the padded linings (28a, 28b) can each have a length of approximately 70 cm of foam "fabric".

The first fastening strap (3) and the second fastening strap (4) respectively have a first length (3L) and a second length (4L), wherein the second length (4L) is smaller than the first length (3L). For example, the first length (3L) could be in the order of about 120 cm, while the second length (4L) could be in the order of about 20 cm. This enables that the joining point is not right under the bed or stretcher (C), but rather on a side thereof on top of the mattress, Figures 5 and 7. Such that the time and effort required by healthcare personnel for placing the patient on the stretcher (C) is improved, since the former do not have to get under the stretcher in order to join both straps (3, 4). In turn, the width of each strap (3, 4) can, as an example, be about 2.5 cm.

The first joining end (31 ) and the second joining end (41 ) respectively comprise first adjusting holes or eyelets (32) and second adjusting holes or eyelets (42) configured to coincide with each other, allowing the passage of a fastening element (7) between two coinciding adjusting holes (32, 42) in order to join both joining ends (31 , 41 ).

The holes (32, 42) can be distributed at various points along the fastening straps (3, 4) in order to adapt to the different types of beds or stretchers (C). For example, the first fastening strap (3) can have a first group of first adjusting holes (32), not shown, at about 60 cm from the first side (21 a) of the rear band (21 ) for use thereof in ambulance stretchers y and a second group of first adjusting holes (32) at about 80 cm from the first side (21 a) of the rear band (21 ) for use thereof in hospital beds. The adjusting holes (32, 42) can be arranged in line along the fastening straps (3, 4), for example, every 4 cm. According to this example, the auxiliary end (5) comprises an auxiliary strap (51 ) section, about 5 cm long by 2.5 cm wide, the end of which has a first quick coupling and uncoupling element (52), such as a buckle with a female clasp, sewn to said auxiliary strap (51 ).

As can be seen in figure 4, the device (1 ) comprises a ratchet-type tensioning element (6) that has a connecting end (61 ) for connection thereof to the auxiliary end (5) and an adjusting end (62) for connection thereof to the first joining end (31 ). Said connecting end (61 ) is made up of a strap section (63), of about 20 cm, which extends from the tensioning element (6) to a second quick coupling and uncoupling element (64) such as a buckle with a male clasp, complementary to the first quick coupling and uncoupling element (52). These quick coupling and uncoupling elements (52, 64) enable releasing the tensioning element (6) once the fastening straps (3, 4) have been tightened, after joining both joining ends (31 , 41 ), in order to be able to use the tensioning element (6) in other patients.

The tensioning element (6) allows the device (1 ) to be adjusted to the bed or stretcher (C) in order to overcome the sponginess of the mattress, adjusting the patient (P) - bed or stretcher (C) assembly more firmly.

Figures 5 and 6 respectively show a way of implementing the device (1 ) of the present invention and a detail thereof, before joining the joining ends (31 , 41 ) of the fastening straps (3, 4).

As can be seen, the auxiliary end (5) is connected to the tensioning element (6), which in turn is joined to the first joining end (31 ) of the first fastening strap (3). This allows the fastening straps (3, 4) to be gradually tightened around the bed or stretcher (C). When the desired tension is reached, it is automatically maintained due to the securing exerted by the tensioning element (6). At that time, healthcare personnel can easily and effortlessly join the joining ends (31 , 41 ) of both fastening straps (3, 4). For this purpose, they can use a single magnetic fastening element (7) made up of two magnetized pivots that join to each other through the coinciding adjusting holes (32, 42).

Figures 7 and 8 respectively show a way of implementing the device of the present invention and a detail thereof, after releasing the tensioning element (6). Said process is carried out easily and conveniently by simply uncoupling the first quick coupling and uncoupling element (52) of the type of buckle with a female clasp from the second quick coupling and uncoupling element (64) of the type of buckle with a male clasp.

It should be added that, in light of the mode of implementation shown in figures 5 - 8, with regard to the safety of the patient (P), exposure of the patient's (P) thorax is improved with respect to known devices, enabling access thereto both for medical examination and for monitoring purposes. This also represents a vital safety element, as it does not interfere with normal breathing, since there are no straps around the thorax of the patient (P), thus making it impossible to suffocate the patient due to over tightening.

On the other hand, as mentioned previously, monitoring the restrained patient (P) is mandatory according to hospital protocols due to the possibility of lethal arrhythmias because of sustained increase in heart rate and the cardiotoxic or depressant substances of the respiratory system that the patient may have consumed prior to the agitated/violent episode, as well as due to adverse pharmacological effects of iatrogenic origin.

Profuse sweating produced by the intense physical effort during agitation, ambient temperature and drugs that raise body temperature play against the electrodes used to monitor the patient because they detach from the thorax of the patient or cause errors. In this sense, the thoracic restraint and safety device (1 ) of the present invention considers the possibility of implementing sensors (100) in contact with the skin, secured to the same device (1 ), that enable sending information, without the need for cables, to a receiver (101 ) which would display it in real time on a monitor located at the nursing control area.

Furthermore, according to hospital protocols, a person under mechanical restraint must be supervised at least every 15 minutes. During that time, since the thoracic restraint and safety device (1 ) of the present invention, is held in place by the acromioclavicular area of the patient (P), it allows placing an accelerometer in order to quantify the number of scapular movements and thus be able to determine the level of psychomotor agitation, in order to be able to justify withdrawal thereof when the agitation ceases, or to ask the doctor to assess the need for administering relaxing rescue drugs.

Claims

1 . A thoracic restraint and safety device for patients, comprising:

a first fastening strap (3) extending laterally from the restraint harness (2) and having a first joining end (31 ); and

a second fastening strap (4) extending laterally from the restraint harness (2) in the opposite direction to the first fastening strap (3), and having a second joining end (41 );

wherein both joining ends (31 , 41 ) are configured to join together around a bed or stretcher (C) on which the patient (P) is arranged, said device (1 ) characterized in that the second fastening strap (4) comprises an auxiliary end (5) for connecting a tensioning element (6), joined in turn to the first joining end (31 ) of the first fastening strap (3), enabling gradual tightening of the fastening straps (3, 4) around the bed or stretcher (C).

2. The thoracic restraint and safety device for patients according to claim 1 , characterized in that the auxiliary end (5) enables releasing the tensioning element (6) once the fastening straps (3, 4), have been tightened, after joining both joining ends (31 , 41 ).

3. The thoracic restraint and safety device for patients according to any of claims 1 to 2, characterized in that the restraint harness (2) comprises a rear band (21 ) configured to adjust on the back of the patient, having:

4. The thoracic restraint and safety device for patients according to any of claims 1 to 3, characterized in that the restraint harness (2) comprises a first restraint strap (22a) and a second restraint strap (22b) arranged in parallel, configured to adjust around the acromioclavicular joints of the patient (P).

5. The thoracic restraint and safety device for patients according to claim 4, characterized in that the first restraint strap (22a) comprises a first adjusting end (23a) to which a first quick adjusting element (25a) is joined by means of a first swivel joint (24a); and in that the second restraint strap (22b) comprises a second adjusting end (23b) to which a second quick adjusting element (25b) is joined by means of a second swivel joint (24b).

6. The thoracic restraint and safety device for patients according to claims 3 and 5, characterized in that the first restraint strap (22a) extends perpendicularly from the rear band (21 ), from a first fixed joint (26a) integral to said rear band (21 ) and opposite the first quick adjusting element (25a); and in that the second restraint strap (22b) extends perpendicularly from the rear band (21 ), from a second fixed joint (26b) integral to said rear band (21 ) and opposite the second quick adjusting element (25b).

7. The thoracic restraint and safety device for patients according to claim 6, characterized in that the rear band (21 ) comprises a first securing strip (27a) enabled to allow the passage of the first adjusting end (23a) between said first securing strip (27a) and the rear band (21 ); and a second securing strip (27b) enabled to allow the passage of the second adjusting end (23b) between said second securing strip (27b) and the rear band (21 ).

8. The thoracic restraint and safety device for patients according to any of claims 4 to 7, characterized in that the first restraint strap (22a) and the second restraint strap (22b) respectively comprise a first padded lining (28a) and a second padded lining (28b) for protecting the patient (P).

9. The thoracic restraint and safety device for patients according to any of claims 1 to 8, characterized in that the first fastening strap (3) and the second fastening strap (4) respectively have a first length (3L) and a second length (4L), wherein the second length (4L) is smaller than the first length (3L).

10. The thoracic restraint and safety device for patients according to any of claims 1 to 9, characterized in that the first joining end (31 ) and the second joining end (41 ) respectively comprise first adjusting holes (32) and second adjusting holes (42) configured to coincide with each other, allowing the passage of a fastening element (7) between two coinciding adjusting holes (32, 42) in order to join both joining ends (31 , 41 ).

1 1 . The thoracic restraint and safety device for patients according to claim 10, characterized in that the fastening element (7) is magnetic.

12. The thoracic restraint and safety device for patients according to any of claims 1 to 1 1 , characterized in that the auxiliary end (5) comprises an auxiliary strap (51 ) section, the end of which has a first quick coupling and uncoupling element (52).

13. The thoracic restraint and safety device for patients according to any of claims 1 to 12, characterized in that it comprises a tensioning element (6) that has a connecting end (61 ) for connection thereof to the auxiliary end (5) and an adjusting end (62) for connection thereof to the first joining end (31 ).

14. The thoracic restraint and safety device for patients according to claims 12 and 13, characterized in that the connecting end (61 ) is made up of a strap section (63), which extends from the tensioning element (6) to a second quick coupling and uncoupling element (64), complementary to the first quick coupling and uncoupling element (52).

15. The thoracic restraint and safety device for patients according to any of claims 1 to 14, characterized in that it comprises a ratchet-type tensioning element (6).

16. A tensioning element for thoracic restraint and safety devices for patients, said tensioning element (6) characterized in that it comprises:

- an adjusting end (62) configured to join to a first joining end (31 ) of a first fastening strap (3) of a thoracic restraint and safety device for patients; and - a connecting end (61 ) configured for connection thereof to an auxiliary end (5) of a second fastening strap (4) of said device, which has a second joining end (41 );

wherein said tensioning element (6) enables gradual tightening of the fastening straps (3, 4) around a bed or stretcher (C) on which the patient (P) is arranged.

17. The tensioning element for thoracic restraint and safety devices for patients according to claim 16, characterized in that the connecting end (61 ) is made up of a strap section (63), which extends from the tensioning element (6) to a second quick coupling and uncoupling element (64), complementary to a first quick coupling and uncoupling element (52) of the auxiliary end (5).

18. The tensioning element for thoracic restraint and safety devices for patients according to any of claims 16 to 17, characterized in that said tensioning element (6) is a ratchet-type tensioning element.