AU2015316601A1

AU2015316601A1 - Device for retaining healthcare apparatus relative to a patient's body

Info

Publication number: AU2015316601A1
Application number: AU2015316601A
Authority: AU
Inventors: Paul Eakin
Original assignee: Pelispec Ltd
Current assignee: Pelispec Ltd
Priority date: 2014-09-19
Filing date: 2015-09-16
Publication date: 2017-05-04
Also published as: GB2530315A; WO2016042322A1; GB201416597D0; EP3194004A1

Abstract

The invention provides a device for retaining at least one item of healthcare equipment in a desired position relative to a user's body, the device comprising a strap-like device body having at least two end portions each provided with a quantity of adhesive for securing the respective end portions to the user's body; and an intermediary portion separating the at least two of the end portions and configured to facilitate retention of the apparatus in the desired position. In some embodiments, the device is provided with means for engaging with and/or attaching to the healthcare equipment. In other embodiments, the equipment may be provided as an integral part of the retention device. The healthcare equipment may be a monitoring device, cannula, wound dressing etc. The device may be used many times. The adhesive may comprise one or more holes, gaps or indentations to facilitate pooling of perspiration or moisture during use. The intermediary portion may be provided with an aperture through which a portion of the healthcare equipment can be passed to engage the equipment with the device.

Description

PCT/GB2015/052677 WO 2016/042322 -1-

Device for Retaining Healthcare Apparatus Relative to A Patient’s Body

This invention relates generally to healthcare devices, and more particularly to a solution for retaining a healthcare device at a desired location relative to a patient’s body. The invention is particularly suited for, but not limited to, use in retaining a monitor against a woman’s stomach so as to monitor foetal condition or contraction patterns during pregnancy and child birth. The invention may also be used for holding other healthcare related apparatus in situ relative to the body, such as cannula, wound dressings and the like.

Various types of healthcare related devices, such as monitoring devices, cannula, dressings, needles etc need to be held against a patient’s body while a procedure or process is carried out. Some procedures may take a considerable length of time. Therefore, device retention arrangements have been devised for holding the healthcare device in the desired position.

In one known arrangement, a belt or strap is wound around the patient’s body. The strap engages with loops, clips or other engaging means provided on the healthcare device. However, these can be uncomfortable for the patient to wear and difficult to put into place. For example, it can be problematic trying to wrap a strap around the torso of a pregnant woman to hold a foetal monitoring transducer in place, and in an emergency situation time may be of the essence. PCT/DK2010/000005 discloses a device for positioning and securing foetal monitoring transducers and the like against the stomach of a pregnant woman. The device comprises two separate straps each having two ends, one end of each strap having an adhesive provided thereon for adhering to the skin of the patient. The separate straps engage the monitoring device to hold it in place. However, because this arrangement comprises separate straps which have to be manipulated independently and then combined and adjusted as required, the arrangement can be time consuming and difficult to use. This can be a disadvantage in an emergency. PCT/GB2015/052677 WO 2016/042322 -2-

Thus, it is desirable to provide a solution which overcomes or at least alleviates the problems associated with known arrangements.

Such an improved solution has now been devised. The present invention is defined in the appended claims.

In accordance with the invention there is provided a device for retaining at least one item of healthcare equipment in a desired position relative to a user’s body, the device comprising a device body having: at least two end portions each provided with a quantity of adhesive for securing the respective end portions to the user’s body; and an intermediary portion separating the at least two end portions and configured to facilitate retention of the apparatus in the desired position relative to the user’s body.

The device holds the healthcare equipment in the desired position on or against the user’s body. The user may be referred to as a ‘patient’. The device body may comprise a nylon and polyurethane fabric strap. The device may be hypoallergenic.

Preferably, the end portions and the intermediary portion are integrally formed. This results in a device which is simpler in construction than prior art arrangements comprising multiple straps, and is easier to use.

Preferably, the intermediary portion is elongate and at least one, some or all of the end portions are enlarged relative to the width of the intermediary portion. The end portions may be referred to as ‘paddles’ or ‘pads’. The device may be substantially dumb-bell shaped.

At least one of the end portions may be at least partially curved or rounded. However, the invention is not intended to be limited with regard to the shape or contour of the end portion(s).

The adhesive may be a silicone adhesive. WO 2016/042322 PCT/GB2015/052677 -3-

At least one recess, aperture or gap may be provided in the adhesive. A pattern of recesses, apertures or gaps may be provided in the adhesive. It may be a repeating pattern. The adhesive may be provided with a ‘dimpled’ effect. Perspiration or other fluids may be able to pool in the recesses, gaps or apertures, thus enhancing the effectiveness of the adhesive. The plurality of gaps, apertures or indents may extended across the entire area of adhesive on one or more end portions, or only part of the area.

An adhesive-free margin is provided at or towards the edge of at least one end portion. It may extend around the entire edge of an end portion or only part of it. The adhesive free margin facilitates gripping of the end portion when removing the device from the user’s skin and/or when removing a protective layer from the adhesive.

The at least one of the end portion may be provided with a removable layer. The removable layer may be a film or sheet which serves to protect the adhesive when not in use on a user’s body.

The intermediary portion may be provided with equipment attaching means for attaching the at least one item of healthcare equipment to the device. The equipment attaching means may be an aperture. However, other forms of attachment means may be provided for securing the healthcare equipment to the device. The equipment attaching means may be provided at or towards the middle of the intermediary portion.

The at least one item of healthcare equipment may be a monitoring device, wound care equipment, a cannula or any other type of device used for clinical, medical, surgical or other healthcare related tasks. The invention is not intended to be limited with regard to the type of device which it retains.

The at least one item of healthcare equipment may be attached to the device in a removable or non-removable manner. The healthcare equipment may be formed integrally with the device body. PCT/GB2015/052677 WO 2016/042322 -4-

Also according to the invention there is provided a kit of parts comprising: at least one device according to any preceding claim; and a container for housing the at least one device.

The container may be a pouch or bag. The container may have a transparent portion such that the at least once device can be observed through the container. The container may be re-sealable.

Also according to the invention there is provided a method of retaining at least one item of healthcare equipment in a desired position relative to a user’s body, the method comprising the steps: positioning a device as described above in the desired position relative to the user’s body such that at least a portion of the healthcare equipment is retained between the device and the user’s body.

The method may further comprise the step of: drying a portion of the user’s skin at the desired position.

The method may further comprise the step of: removing a removable layer from at least one of the end portions prior to positioning the device in the desired position.

The method may further comprise the step of: removing the device from a container prior to positioning the device in the desired position.

The method may further comprise the step of: attaching the at least one item of healthcare equipment to the device.

The method may further comprise the step of: pressing the device against the user’s body to facilitate adhesion of the device to the user’s body. WO 2016/042322 PCT/GB2015/052677 -5-

Also according to the invention there is provided a device for retaining at least one item of healthcare equipment in a desired position relative to a user’s body, the device comprising a device body provided with adhesive for securing the respective end portions to the user’s body; wherein a pattern of recesses, apertures or gaps is formed in the adhesive.

Thus, the invention provides a solution which can be used to hold an item of healthcare equipment against a patient’s body in a secure and comfortable manner. The invention is simple, quick and easy to use. It is simple and inexpensive to manufacture. It is re-usable. It is adaptable for use with patients of various sizes, for example obese patients. It is hygienic. It is able to maintain the position of the healthcare device relative to the patient’s body even when the patient moves or is mobile.

These and other aspects of the present invention will be apparent from and elucidated with reference to, the embodiment described herein.

An embodiment of the present invention will now be described, by way of example only, and with reference to the accompany drawings, in which:

Figure 1 illustrates an embodiment of the invention showing adhesive covering the pads at the end of the retention device.

Figure 2 illustrates two devices according to the invention with healthcare devices attached to the device body.

Figure 3 illustrates two devices according to the invention being used to hold two healthcare devices against a patient’s body.

The invention provides a solution which enables a piece of healthcare equipment such as a monitoring device, cannula, wound care apparatus, dressing, needle etc to be held in a particular position relative to a patient (user) body. The invention is not intended to be PCT/GB2015/052677 WO 2016/042322 -6- limited with regard to the type of healthcare device or equipment with which it is used. For the sake of convenience, the equipment will be referred to hereafter as a ‘monitor’. A preferred embodiment is shown in Figure 1. The invention comprises a device body 1 which may be referred to as a ‘strap’. In a preferred embodiment, the strap is formed as a unitary (integrally formed) item. This distinguishes it from prior art arrangements which are made up of multiple straps or elements which are then connected or assembled during use. As a result, the invention provides an arrangement which is simpler to use. It is also simpler and less costly to manufacture.

The strap has an elongate middle 2 or intermediary part 2 provided between two enlarged, bulbous end portions 3a, 3b. In a preferred embodiment the device is dumb-bell shaped. This has been found to provide an ergonomically and aesthetically advantageous form. However, other shaped profiles may be used instead of rounded end portions. The shape and size of the intermediary part which bridges the end portions may vary. For example, the edges of the intermediary part 2 may not be straight or parallel.

In some embodiments, the device is provided with a hole 4 to enable the healthcare equipment eg monitor to be attached to the device, as shown in the lower device of figure 2. The hole is provided in the middle of the intermediary portion. Some monitoring devices are provided with a button or projection on the back of the monitor. This button can be pushed through the hole in the strap to secure the monitor to the strap in a releasable fashion. Other monitors a provided with a hinged clip in place of the button. The clip is biased against the back of the monitoring device. This allows the hinged clip to be lifted so that the intermediary portion can be inserted between the clip and the back of the monitor housing. When the clip is moved back to its starting position the strap is clamped between the clip and the monitor 5.

One side of the end rounded portions 3a, 3b are provided with an adhesive to enable the ends of the strap 1 to be secured to the patient’s body 6. The adhesive is provided on the same side of the strap at both ends, as shown in figure 1. The adhesive may cover all or most of the ends, or just a portion thereof. Preferably, though, the adhesive covers most of PCT/GB2015/052677 WO 2016/042322 -7- the end with an adhesive-free margin 7a, 7b provided at the tip of the pad to facilitate removal of a protective film or layer during use.

In the preferred embodiment of Figure 1, the intermediary portion between the ends is free of adhesive. However, the amount and exact location of the adhesive portion(s) may vary in other embodiments.

The preferred embodiment of figure 1 shows perforations 8 provided in the adhesive 9.

This enables perspiration or other moisture to pool within the holes, indentations or gaps, thus enhancing the device’s ability to remain adhered to the patient’s body during use. Recesses or indentations may be formed in the adhesive instead of (or in addition to) holes, thus providing a dimpled effect. The invention is not limited in regard to the number or size of the holes or dimples. The perforations and/or indentations may be provided such that they form a pattern across the area of adhesive on the pad.

The strap may have content such as text, images etc printed on it. The content may comprise branding such as a company logo, or may comprise instructions for using the device. The strap is flexible and may be formed using a nylon material which is washable. While some degree of elasticity may be present, it is preferred that this is avoided because a stretchable strap may pose difficulties when applying the adhesive.

The adhesive 9 is a silicon adhesive. An acrylic backing is provided to enable the adhesive to bond to the nylon strap. The adhesive is selected such that its adhesive properties are sufficient to hold the device and healthcare equipment in situ during use, but not to cause harm to the user’s skin upon removal of the device.

The device is provided in a paper and/or polyethylene pouch or bag (not shown in figures) which has at least one clear window or face. This enables the user to view the device while it is in the bag. The bag can be provided with content such as text or images. This can be useful for providing instructions for correct use. The bag is re-sealable so that it may be used more than once after the strap has been removed from the patient’s body. PCT/GB2015/052677 WO 2016/042322 -8-

In addition, the ends of the strap are provided with protective layers (not shown) which shield the adhesive from damage and dirt when the device is not in use. Therefore, the device may be a ‘single patient’ device rather than ‘single use’ device. The patient or practitioner may retain the strap and use it multiple times.

The device and/or the bag may be provided with an identifier, code or label which can be recorded in the patient’s medical notes so that the device can be associated with the patient. This ensures that the same strap is used with the same patient each time. Using the same strap with different patients would be undesirable and may cause hygiene concerns.

In use, a practitioner such as a nurse or healthcare worker removes a strap from its bag. An identifier printed on the bag and/or strap may be recorded in the patient’s notes. The user’s name or other identifier may be written on the bag and/or pouch so that the strap now ‘belongs’ to the patient.

The patient’s body may be prepared by cleaning and drying the area where the strap is to be secured. This may help the adhesive to adhere to the skin. A monitoring device 5 is attached to the strap 1 either by pushing a portion of the monitor through the aperture or by clipping the monitor to the intermediate portion, depending on the type of monitor being used as described above (see figure 2). The monitor is attached to the side of the strap which will face the patient’s body in use - ie the same side as the adhesive.

The protective shields are peeled back and removed to reveal the adhesive at each end of the device. The device is positioned against the patient’s body at the desired location, and the adhesive brought into contact with the skin. Gentle pressure is applied to the ends of the strap so that a secure connection is formed.

When the monitor is to be removed, each end of the strap is removed from the patient’s skin. The adhesive-free tips of the strap ends are gripped so that the end can be peeled off the skin. The adhesive free margin 7a, 7b at the edge of the strap end facilitates this PCT/GB2015/052677 WO 2016/042322 -9- process because it provides a flap which is not attached to the skin and can be easily gripped.

The protective shields are placed back onto the adhesive areas at the ends of the strap. The 5 monitor is then removed from the strap and the strap is replaced into its bag for storage until next use.

It should be noted that the above-mentioned embodiments illustrate rather than limit the invention, and that those skilled in the art will be capable of designing many alternative 10 embodiments without departing from the scope of the invention as defined by the appended claims. In the claims, any reference signs placed in parentheses shall not be construed as limiting the claims. The word "comprising" and "comprises", and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, “comprises” means “includes or 15 consists of’ and “comprising” means “including or consisting of’. The singular reference of an element does not exclude the plural reference of such elements and vice-versa. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot 20 be used to advantage.

Claims

CLAIMS:

1. A device for retaining at least one item of healthcare equipment in a desired position relative to a user’s body, the device comprising a device body having: at least two end portions each provided with a quantity of adhesive for securing the respective end portions to the user’s body; and an intermediary portion separating the at least two end portions and configured to facilitate retention of the apparatus in the desired position relative to the user’s body.
2. A device according to claim 1 wherein the end portions and the intermediary portion are integrally formed.
3. A device according to claim 1 or 2 wherein the intermediary portion is elongate and at least one, some or all of the end portions are enlarged relative to the width of the intermediary portion.
4. A device according to any preceding claim wherein at least one of the end portions is at least partially curved or rounded.
5. A device according to any preceding claim wherein at least one recess, aperture or gap is provided in the adhesive.
6. A device according to any preceding claim wherein a pattern of recesses, apertures or gaps are provided in the adhesive.
7. A device according to any preceding claim wherein an adhesive-free margin is provided at or towards the edge of at least one end portion.
8. A device according to any preceding claim wherein the at least one of the end portions is provided with a removable layer.
9. A device according to any preceding claim wherein the intermediary portion is provided with equipment attaching means for attaching the at least one item of healthcare equipment to the device.
10. A device according to claim 9 wherein the equipment attaching means is an aperture.
11. A device according to any preceding claim wherein the at least one item of healthcare equipment is a monitoring device, wound care equipment, a cannula or any other type of device used for clinical, medical, surgical or other healthcare related tasks.
12. A device according to any preceding claim wherein the at least one item of healthcare equipment is attached to the device in a removable or non-removable manner.
13. A kit of parts comprising: at least one device according to any preceding claim; and a container for housing the at least one device.
14. A kit of parts according to claim 13 wherein the container is a pouch or bag.
15. A kit of parts according to claims 13 or 14 wherein the container has a transparent portion such that the at least once device can be observed through the container.
16. A kit of parts according to claims 13 to 15 wherein the container is re-sealable.
17. A method of retaining at least one item of healthcare equipment in a desired position relative to a user’s body, the method comprising the steps: positioning a device according to any of claims 1 to 11 in the desired position relative to the user’s body such that at least a portion of the healthcare equipment is retained between the device and the user’s body.
18. A method according to claim 17 and further comprising the step of: removing a removable layer from at least one of the end portions prior to positioning the device in the desired position.
19. A method according to claim 17 or 18 and further comprising the step of: removing the device from a container prior to positioning the device in the desired position.
20. A method according to claims 17 to 19 and further comprising the step of: attaching the at least one item of healthcare equipment to the device.
21. A method according to claims 17 to 20 and further comprising the step of: pressing the device against the user’s body to facilitate adhesion of the device to the user’s body.
22. A device for retaining at least one item of healthcare equipment in a desired position relative to a user’s body, the device comprising a device body provided with adhesive for securing the respective end portions to the user’s body; wherein a pattern of recesses, apertures or gaps is formed in the adhesive.