GB2362321A - Medical restraint - Google Patents

Abstract

A device to restrain the upper limbs of an unconscious patient against inadvertent movement from a safe position during medical procedures has an elongate flexible component 10, which is substantially planar when relaxed, but which is flexible in the direction normal to its relaxed plane. This component supports a pair of adjustable wrist or forearm straps 13,14 each of which is readily releasable from a secured position encircling a patient's wrist or forearm, and each of which is of an easily adjustable length, to permit each strap 13,14 to encircle and securely hold a respective arm of a patient, in order to limit the movement thereof The position of each strap 13,14 on the support 10, is also adjustable. Further, the support 10 may be in two parts 11,12 the relative angular position of which is adjustable.

Description

2362321 MEDICAL RESTRAINT This invention relates to a medical restraint -

and in particular to a device suitable for limiting the movement of a heavily sedated or unconscious (e.g. anaesthetised) patient's arms before, during andlor after a diagnostic or operative procedure.

A heavily sedated or unconscious patient has little or no control over the movement of his or her limbs. Serious nerve damage can therefore occur if any limb is allowed to fall (for example, from an operating table) or is over extended or compressed in any other way. In addition, if a limb, or any other part of the body, is allowed to come into contact with metal (for example, whilst diathermy is being used) serious burns can result.

A particular problem arises in the case of the 'brachial plexus' - a complicated arrangement of nerves in the neck, that originate in the uppermost section of the spinal cord. On both sides of the body the brachial plexus is significantly responsible for the nerve supply to each arm- If the brachial plexus is damaged in any way grave problems can result - for instance, drop wrist or paralysis of the whole arm.

The brachial plexus can be damaged in conscious people - for example, by pulling too hard on a child's arm or by using badly adjusted crutches.

However, unconscious (e.g. anaesthetised) people are especially at risk because they are unable to protect themselves by, for instance, reacting to pressure on the brachial plexus by moving or changing the position of their arms. It must also be remembered that involuntary movements can lead to other injuries - for example, if a patient's arm hits (or gets caught on) other equipment etc.

The majority of operative procedures require the patient to be positioned I ! 1 1 on a relatively narrow operating table, trolley or chair - because this enables the surgeon, the anaesthetist (and their assistants) to do their. work more easily and efficiently.

However, the width of the operating table, trolley or chair means that an adult patient's arms usually need continual support (before, during and after the procedure) to ensure that the arms do not drop from the operating table, trolley or dental chair. Currently, patient's arms are dealt with'by either (a) pulling the patient's gown up and tucking it under his or her shoulders andlor (b) pushing 'arm supports' (i.e. U shaped upstanding boards) under the mattress - in order to keep the patient's upper limbs close to his or her trunk and out of the 'operative field'.

However, although these techniques have been used for many years, they are not without problems - because both methods can restrict access to the patient and the former method also exposes the patient unnecessarily. In addition, bad positioning or handling can cause nerve damage (e.g. due to pressure or stretching) and unsuitable procedures can also cause problems.

All professionals are aware of the problem and some practitioners use additional or alternative methods (e.g. sticky tape) to secure the arms but, until now, the problem has not perhaps been given the attention that it deserves.

Despite care being taken to keep upper limbs on the operating table the potential problem of a limb dropping (or nerves being Compressed) during a surgical procedure still persists and is well documented in medical literature e.g. the standard work Synopsis of Anaesthesia warns about damage to the nerves of the arm, viz..

"The radial nerve can be injured due to stretching if the arm is allowed to sag over the edge of the operating table... wrist-drop can result".

"The ulna nerve can be damaged if the elbow is allowed to sag over the 13U1 W sharp edge of the table so that the nerve is compressed against the medical epicondyle of the humerus."

Despite universal recognition of the problem - and the consequences if a patient's arm should accidentally drop. from an operating table or chair, or be compressed too much, or be allowed to touch metal whilst electrical and other equipment is being used - there has been no standard device for solving the problem. In addition, major changes in patient care, anaesthetics and surgery all mean that the above rather 'old-fashioned' techniques should be improved.

An aim of this invention is therefore to provide a device to restrain the upper limbs of an unconscious patient against movement (especially downward) and also gently restrict upper limb movement in patients who are heavily sedated andlor moving in an unintentional way - for instance, during the induction of anaesthesia.

According to this invention, there is provided a device to restrain the upper limbs of an unconscious patient against movement from a safe position, which device comprises an elongate flexible component, optionally in two sections, provided with spaced-apart first and second wrist or forearm straps, each of which straps is readily releasable from a secured position encircling a patient's wrist or forearm and each is of an adjustable length to permit each strap to encircle and securely hold respective arm in order to limit movement thereof.

As will be appreciated, the device in question has an elongate flexible component with two wrist or forearm straps. The wrist straps are spacedapart and each strap may be adjustable to move towards and away from the mid-line of the component. Each strap is also adjustable in length to permit it to encircle and securely hold a wrist or forearm, as required, and therefore to hold each @I"? qA upper limb, against involuntary movement.

It is very important to stress that the device does not perform the same role as a 'hand-cuff because it is designed to separate as soon as voluntary movement is possible. In addition, the device is designed to keep the patient's arms in a number of operative positions - and, if the device is intentionally disconnected, each arm is then free to be used and/or positioned by the patient and/or the carer.

It will be appreciated that the device of the present invention may be used to secure together the two wrists and/or forearms of a patient - with the 10 upper limbs resting an or near the patient's head, chest, abdomen or sides.

The device allows maximum access to the operative field and other parts of the patient's body - for example, for intravenous infusions and monitoring devices etc. The risk of a limb failing from the operating table, trolley or chair, on which the patient is lying or sitting, is minimal - even if the patient moves (or needs to be moved) during the course of the procedure. Shoufd there be a tendency for one arm to fall from the operating table, its descent is prevented by the other arm - and consequently the likelihood of damage to the brachial plexus is greatly reduced. In addition, the method used to secure the arms reduces the risk of nerve damage resulting from pressure. The device is also designed to remain in situ whilst the patient is being moved to and from an operating table - so the patient benefits from an increased level of safety. Also, staff are protected from unexpected involuntary movement during induction and transfer.

In the event that the placement of the upper limbs on the chest of the patient restricts access to the 'operative field' (or in cases of reduced respiratory function), the device of this invention may be used to hold the upper limbs in another position - for example, with the forearms on the abdomen, or lit4W4 by the side, or above the head - for example, in a 'sun-bathing' position. In any of these positions the device will still serve to prevent the arms failing off the table andlor table attachments and, by doing so, greatly reduce the risk of damage to the brachial plexus.

The elongate flexible component (when not in use) is essentially planar but it exhibits flexibility in the direction normal to the plane thereof, whilst being substantially rigid in all directions in its relaxed plane. Therefore, in its nondisposable form, this component may be formed of sheet material. This allows the component to bend to some extent over the chest or abdomen when in use, whilst still restraining the wrists or forearms of a patient in the desired position i.e. adjacent to one another. In most cases, one hand will be positioned over the other.

Advantageously, the flexible elongate component is in two sections, with one end portion of one section adjustably connected to the corresponding end portion of the other section. This may conveniently be achieved by having said one end portion provided with one part of a two-part hook-and-loop fastener (such as VelcroC) and the one end portion of the other section provided with the other part of the fastener. In this way, the two sections can be joined together, merely by pressing the two fastener parts together so as to engage 20 one another.

Prior to doing this the two sections may be arranged, with respect to each other, at any convenient angle, having regard to the way in which the device is to be used. Typically, the included angle between the two sections e) 0 will be in the range of 60 and 180.

Each wrist or forearm strap should have a sufficient width so as to prevent the risk of damage to the patient's arms. However, the wrists are relatively resilient and are unlikely to suffer trauma if the pliable wrist or 11162 q.

forearm straps are applied and removed at the'right'time and with care.

Each wrist or forearm strap will be made of a soft and pliable material and may also be especially lined to minimise the possibility of damage to the skin whilst allowing optimum circulation - the latter point being important for hypotensive and geriatric cases. For example, a soft lining (utilising air pockets or bubbles) may be employed, to ensure that an acceptable pressure is distributed around each wrist. In this way properly applied wrist or forearm straps will allow normal blood flow and radial pulses etc.

The outwardly-directed surface at one end portion of each wrist or forearm strap may b rovided with one part of a two-part hook-and-loop fastener (such as Velcro@) 'and the inwardiy-directed surface, at the other end portion of the wrist or forearm strap may then be provided with the other part of the fastener. In this way, the strap may be rapidly and easily adjusted to an appropriate length - merely by releasing the fastener and then re- engaging the two fasteners parts with the strap adjusted to the required length.

The position of each strap on the flexible elongate component may also be adjustable along the length of the component. This may be achieved by providing a pair of elongate parallel slots along the length of a single flexible elongate component, or along each section of the flexible elongate component if the component has two relatively adjustable sections. Each strap may then pass through the two slots and the position of the strap adjusted by a sliding movement along the length of the elongate flexible component. However, it may be advantageous temporarily to secure a strap to the elongate flexible component in an adjusted position and - for a case where a two-part hook- andloop fastener system is used for adjustment of the length of a strap - a further piece of the fastener may be provided on the strap in order to connect with an additional strip of fastener provided on the underside of the flexible elongate - epe CV 9f:z,.

c " <- 0 -01,07 r Ccajo ct+2 >o -L t &To L 1 B"? 'W4 + V L? 4nnj.K -7rlvem - ed19 TA component, between the two slots.

In this way, once the new position of a wrist or forearm strap has been selected (with regard to its position on the flexible elongate component) gentle pressure on the part of the strap between the two slots, below the component, will engage the two parts of the fastener so as to secure the strap in the new selected position.

In order to enhance the usefulness of the device an alternative form of wrist or forearm strap may be employed to the strap that has been previously described. The alternative version may be of a slimmer design to allow more forearm area to be exposed - i.e. to be used when a patient needs more 'skin area' for intravenous infusions, patient controlled analgesia, additional cannulae, electrodes andlor invasive monitoring etc.

In addition, two further alternative forms of 'arm' straps may be connected to each end of the flexible elongate component, so as to extend generally away from the elongate component. Each such strap should be provided with suitable means to permit it to be secured around an upper limb of the patient - for example, by means of areas of two-part fasteners (engageable one with the other) or by the strap defining a pre-formed loop through which the arm may be passed.

Some of the alternative straps may be interchangeable so that, if necessary, it may be possible to use two different strap designs on the same patient - using one flexible elongate component.

Each strap may be releasably attached to the flexible elongate component by means of further areas of two-part fasteners. These alternative configurations may be useful, for example, to secure the arms of a patient closely adjacent to the sides of his or her body. For example, if an average adult patient is laid on the flexible elongate component it will extend to.either 91142 -m side of his or her body and, if specialised arm straps are then applied to each end of the component and secured around the forearms or elbows of the patient, the patient can then be operated upon in the prone or supine position.

By way of example only one specific embodiment of device of this invention will now be described in detail, reference being made to the accompanying drawings in which Figure 1 is a general perspective view of the device, with a first form of strap and with the various parts set in selected positions; Figure 2 is a plan view on one section of the flexible elongate component,

used in the device of Figure 1; Figure 3 is a plan view of a strap used in the embodiment of Figure 1 Figure 4 is a cross-section through the strap of Figure 3.

Figure 6 is a plan view of a first alternative form of strap; Figures 6 and 7 are plan views respectively of second and third alternative and forms of strap, Figures 8, 9, 10 and 11 illustrate alternative ways of using the device.

Referring initially to Figures 1 to 4, the device comprises an elongate flexible component 10 assembled from two sections 11 and 12. Each section provides a base for an adjustable wrist or forearm strap 13 and 14. In this example each section 11 and 12 is of a flexible plastic sheet material and has a pair of slots 15 and 16 extending along the length of each section of the flexible elongate component. Each strap is threaded through the two slots so as to be secured to the respective section.

Figure 2 illustrates section 11 - i.e. half of the flexible elongate component 10. It is easy to see that this section has a medial 'head' poffion (area 17) which is provided on one side with one part 18 of a Velcrog fastener. The other section 12 is symmetrical with section 11 but the underside of its 6 1 1.MI " -g- medial 'head' portion (area 17) is provided with the other part of the Velcro(E) fastener, so that the two medial 'head' areas may be secured together merely by pressing into engagement the two parts of the Velcro@ fastener.

The large area devoted to the fastener ensures a strong bond between the two sections. However, this bond can be easily broken by a conscious patient or a carer. The angle between the two sections 11 and 12 may be set 0 as required and typically will be within the range of 60 to 180. The angle 0 shown in Figure 1 shows the sections set at approximately 120 - A further pad 19 of Velero(E) is provided an each section 11 and 12. The additional fastener extends between the slots 15 and 16 and also under the other (distal) end region of the section, remote from the medial 'head' portion i.e. area 17.

A cover (not shown) for the distal 'other end' region may be provided for each section. The cover may have the other part of the fastener to permit the cover to be secured to the distal 'other end' region and thus to protect the patient's body (and blankets etc) from contact with the Velcro(R) at the distal end when the latter is not in use.

Figures 3 and 4 show one of the straps 13 and 14 used in the device of Figure 1. This strap may be of a flexible plastic material or of a fabric and is fined over areas 20 and 21 with a bubbfe-like material - the latter being somewhat similar to 'bubble wrap packaging' but having significantly smaller air pockets. Such material is known per se and is useful for minimising pressure on localised areas during use of the device.

It is also possible that another version of the flexible elongate component and the wrist or forearm straps may be made of a padded 'nappylike' material (using adjustable straps) and that the whole de-vice, in the latter case, may be disposable.

91M2-M Between areas 20 and 21 a pad of Velcro(D (marked 22) may be provided. The latter pad is designed to link with pad 19 on each of the sections 11 and 12. In this way pad 22 may be secured to pad 19 by pressing the two parts together, where the strap extends between slots 15 and 16 in the respective section. Therefore, using the aforementioned system it is possible to adjust the straps for each individual patient.

In order to permit the ends of each strap to be joined together at an appropriate position for the patient's wrist or forearm, the strap carries a first securing pad 23 overlying bubble lining area 21 (on the other side of the strap) and also a second securing pad 24 at the end portion of the strap adjacent and on the same side of the strap as bubble fining area 20.

In this way, the strap may be wrapped round to form a loop surrounding a patient's wrist or forearm, and secured by inter-engaging pad 24 to a suitable portion of pad 23. Once again, maximum fastening area is available for optimum strength and adjustability.

As shown in Figure 4, the edges of the strap may be rounded in order to prevent the edges of the strap cutting into the skin. In the case of a plastic material strap this may be easily achieved during manufacture of the strap - for example, by an extrusion process.

Figure 5 shows an alternative form of strap, although it is generally similar to that illustrated in Figure 4. It will be noted that like parts are given like reference characters and those parts will not be described again here. The strap has a relatively narrow central section, when compared to the strap of Figure 4, but in all other respects the strap shown in Figure 5 is used in exactly the same way. The main advantages of this strap are greater adjustability along the length of sections 11 or 12, and an increased area for electrodes, cannulae and monitoring devices etc.

115421P4 Figures 6 and 7 illustrate two other variations of strap which may be used instead of the straps shown in Figures 3 to 5. The straps shown in Figures 6 and 7 both utilise the Velcroo pad under the distal (other end) region of the sections 11 and 12. The strap of Figure 6 is of a pre- formed shape that is intended to loop around the patient's arm or elbow, and then tuck in under the patient's body.

This strap may have a projecting end that may have a Velcrog pad 26 the same shape as pad 19 that may be found at the distal (other end)'region of each of the sections, so that the strap may be secured to the section in alignment with the length of the section and flexible elongate component. The strap enlarges in width, as shown, and is provided with a bubble lining (27) over the enlarged area of the loop, to offer maximum hold and comfort. This type of strap would ensure that the patient's elbows would be well protected and padded.

The strap of Figure 7 has two strap portions 28 joined by a bridging portion 29 provided with a Velero@ pad 30 of a similar shape and the latter pad is also engageable with pad 19 on either section 11 or 12- Each of the strap portions 28 has, at one end and on one face, one part 31 of a Velcro@ fastener and at the other end and on the other face, the other part 32 of the Velcro(D fastener. In this way, each of the two portions 28 may be formed into a loop to encircle the patient's arm (rather than be tucked under his or her body) and the length of each strap is adjustable to individual patients.

If required, bubble lining material (not shown) may be provided over the appropriate areas of the strap portions 28. This strap would leave the actual elbow exposed during the course of an operation, so additional padding may be needed, but the arm would be held more firmly than with the strap shown in Figure 6.

1 IM? WA - 12 Figures 8 to 11 illustrate various uses for the device. In Figure 8 the device is set generally as shown in Figure 1 and is then used to hold the two arms of the patient, with the hands placed together on the chest. This position is extremely common and it is used for a wide range of abdominal, perineal and lower limb operations, using the supine and lithotomy positions, for instance, 1 aparotomy/s copy, gynaecological and rectal operations.

In Figure 9 the device has simply been inverted, so that the two sections 11 and 12 are now pointing towards the feet, as opposed to towards the head. The hands and forearms of the patient are therefore now on her abdomen.

This is another position that is regularly used and it is suitable for ear, nose and throat surgery, dentistry and general surgery to the head and neck. Dentists have a particular problem because most dental chairs are primarily designed for conscious patients, so an unconscious patient can be difficult to position, especially if the procedure is quite quick. This device will immediately solve the problem.

In Figure 10 the two sections are set at exactly the same angle but this time the device is used to hold the two arms above the patient's head. The patient in Figure 10 is in the prone position and the device can also be used with the patient in, for instance, the jack-knife position. The prone position is used for some operations on the spine and other operations that require a view of the posterior surface of the body - e.g. wiricose veins and pilonidal sinus.

Alternatively, it may be necessary for the patient to be positioned supine (i.e. on his or her back) for various procedures on the anterior chest wall - e.g. mastectomy. In this case the patient's arms can be secured above her head using exactly the same configuration.

Figure 11 shows use of the device with straps as shown in either Figures 31562-04 6 or 7, after removal of straps 13 and 14. Here, the two sections 11 and 12 are set essentially in a straight line and positioned under the supine (or prone) body of the patient. The elbow regions of the arms are then secured by appropriate straps, i.e. either those shown in Figure 6 or Figure 7.

The device described above, together with the various alternative strap designs, is able to limit arm movement by gently restraining the arms of many patients - before, during and after the majority of operative procedures that require a general anaesthetic or deep sedation.

The device can be used for all of the most common operating positions and the degree of adjustability, made possible by having two sections 11 and 12 that can be linked together at various angles, in addition to a variety of different straps that adjust to suit a wide age and size range. This allows the device to be used on male and female patients. The device is suitable for children aged seven years old or more up to 125kg adults! 0 It is probably true to say that, sometimes, more thought goes into protecting patients who are having major surgical procedures than those who need relatively quick intermediate and minor operations. In recent years there have been major changes in surgery, and an ever increasing number of patients are now undergoing surgical procedures as 'day case' patients- It could also be argued that staffing levels are generally decreasing and that litigation for medical negligence is on the increase.

The primary objective of the device is to protect patients against nerve and soft tissue damage that can be prevented. However, the device has a number of additional benefits including the following. The device:

- will allow many patients, to retain their dignity during procedures that can be carried out without exposing parts of the body that do not need to be exposed, i.e. the patients gown need not be pulled up any more.

adjusts to the contour of the patient's body.

a 1 -43 IA permits good access to common cannulation sites, including the dorsum and ACF.

allows for non-invasive (e.g. blood pressure, pulse oximetry and ECG) and invasive (e,g. CVP and arterial line) monitoring, - permits normal perfusion to the hands with normal radial pulses.

allows an unobstructed flow for intravenous infusions.

allows ample skin area for the placement of electrodes etc.

can be adjusted, applied and removed very rapidly and easily. is flexible. For instance, if a preliminary procedure (e.g. an epidural) is required before a main procedure it is extremely easy to separate the two sections of the elongate component, and then rejoin the sections on completion of the preliminary procedure. will ease patient handling problems, especially in situations (e.g. dental surgeries) where staff levels are minimal and/or the surgical list involves a number of quick procedures.

may be manufactured as a disposable (single use) item and/or as a permanent (multi-use) device that may be autoclavable, to withstand a 0 temperature of 134 C for up to 20 minutes.

11 -42 "

Claims (14)

1 A device to restrain the upper limbs of an unconscious patient against movement from a safe position, which device comprises an elongate flexible component, optionally in two sections, provided with spaced- apart first and second wrist or forearm straps, each of which straps is readily reieasable from a secured position encircling a patient's wrist or forearm and each is of an adjustable length to permit each strap to encircle and securely hold respective arm in order to limit movement thereof.

2. A device as claimed in claim 1, wherein the flexible component or each section thereof (when relaxed) is substantially planar and exhibits flexibility in the direction normal to the plane thereof, but is substantially rigid in all directions in its relaxed plane.

3. A device as claimed in claim 1 or claim 2, wherein the flexible component 15 is in two sections, with one (media]) end portion of one section adjustably connected to the corresponding (medial) end portion of the other section.

4. A device as claimed in claim 3, wherein the said one (medial) end portion is provided with one part of a two-part hook-and-loop fastener, such as VelcroC, and the (medial) end portion of the other section is provided with the other part of the fastener.

5. A device as claimed in any of the preceding claims, wherein each wrist or forearm strap is of a soft and pliable material carrying an inward lydi rected lining.

6. A device as claimed in claim 5, wherein each strap has a lining which 25 includes pockets or air bubbles.

7. A device as claimed in any of the preceding claims, wherein the outward ly-directed face at one end portion of each strap is provided with one limlq" part of a two-part hook-and-loop fastener, and the inward ly-di rected face, at the other end portion of the strap, is provided with the other part of the fastener.

8. A device as claimed in any of the preceding claims, wherein the position of each strap is adjustable along the length of the flexible elongate component, or along the associated section thereof, as appropriate.

9. A device as claimed in claim 8, wherein the elongate flexible component or section thereof has 2 pair of elongate parallel slots extending therealong, each wrist or forearm strap passing through the two slots in order to link the strap to the component or section.

10. A device as claimed in claim 9, wherein means are provided to permit a strap to be secured in an adjusted position with respect to the elongate component.

11. A device as claimed in claim 10, wherein a piece of a two-part hookand loop fastener is provided on the strap to link with a corresponding length of fastener provided on the underside of the flexible elongate component, between the two slots.

12. A device as claimed in any of claims I to 7, wherein each strap is connected one to each end respectively of the elongate component, so as to extend generally away from the flexible elongate component.

13. A device as claimed in claim 12, wherein each strap is releasably attached to the flexible elongate component, by means of further areas of twopart hook-and-loop fasteners, with one part provided on each strap and the parts provided on the two ends of the flexible elongate component.

14. A device to limit and/or restrain the upper limb movements of an 25 unconscious and/or sedated patient and substantially as hereinbefore described, with reference to and as illustrated in the accompanying drawings.