GB2510599A - Ostomy alarm with magnetic sensor - Google Patents

Abstract

An ostomy alarm comprising a magnet 3, a magnetic sensor (not shown) and means to generate an alarm signal (not shown) when the relative proximity of the magnet 3 and the magnetic sensor exceeds a predetermined threshold, wherein the ostomy alarm is removably attachable to an ostomy pouch by at least one magnetic attachment element 7,8 e.g. magnetic clamp. The magnet 3 may be mounted on arm 4 which is pivotally connected to housing 2. The attachment element may comprise one or more magnets 7,8. The means to generate an alarm signal may comprises a magnetically responsive switch. The signal generating device can be an audible, visual, or vibratory signal generating device.

Description

Ostomy Device and Alarm

Field of the Invention

The invention relates to an ostomy alarm. In particular) the invention relates to an S ostomy alarm in which the alarm signal is indicative of an inflated condition of an osLomy pouch. The invenlion also relaLes Lo an osLomy pouch or bag comprising an alarm and a method of alerting an ostomy pouch user.

Background to the Invention

The term stoma is commonly used to refer to an opening that is surgically constructed in the body as a tube) which allows waste from the gastrointestinal tract to be collected externally of the body. Surgical procedures that create an artificial stoma end in the suffix "ostomy" and a prefix referring to the location in the body. Common procedures involve creating a stoma to drain waste from the small intestine [ileum), large intestine [colon) and urinary bladder.

Following surgery, a user may be fitted with an ostomy device, which may be in the form of a bag or pouch -a "stoma pouch" which covers the stoma. Waste passes via the stoma and is collected in the pouch, which then needs to be emptied or replaced.

In the UK, around 60,000 colostomy patients and around 40,000 ileostomy patients presently use such a device to collect solid waste from the colon and ileum. A further 20,000 urostomy patients use a similar device to collect liquid waste from the bladder.

In addition to these numbers, many patients are fitted with such a device as a temporary measure after surgery to allow the healing process to complete, before reversing the fitment Conventional ostomy devices comprise a pouch having a self-adhesive backing, which adheres to the skin surrounding the surgically constructed opening.

During the day, the wearer can generally feel that the pouch is filling and will be alerted to the need for disposal of waste collected in the pouch. However, for overnight use, a sleeping user is often unaware of any increase in volume and/or pressure that could indicate the need to empty or replace the pouch. Further as pressure within the pouch increases, the seal between pouch and skin can be broken, resulting in messy leaks occurring.

This is a common problem and is addressed by users avoiding foods that may result in S gas build up or liquid stools, or simply avoiding all foods after 6pm.

One product designed to address this need is marketed under the brand "Full Bag Alert" and comprises a magnetic disc that locks onto an ostomy pouch via a locking hinge mechanism.

It would be desirable to provide an improved ostomy device.

Summary of the Invention

One aspect of the invention provides ostomy alarm as claimed in Claim 1.

Another aspect of the invention provides an ostomy device as claimed in Claim 11.

The invention provides an ostomy alarm comprising a magnet, a magnetic sensor and means to generate an alarm signal when the relative proximity of the magnet and the magnetic sensor exceeds a predetermined threshold, wherein the ostomy alarm is removably attachable to an ostomy pouch by at least one magnetic attachment element Preferably, the ostomy alarm is arranged to attach to an ostomy pouch such that the magnet and the magnetic sensor are positioned on opposing sides of the pouch.

Advantageously, the alarm signal is indicative of a substantially inflated condition of the ostomy pouch.

This provides the advantage of alerting the user to a pressure build-up occurring in the pouch, with increased volume or indeed simply caused by turning over in bed while asleep, and then to alert the user to the problem ideally before a leak occurs.

The at least one magnetic attachment element may comprise one or more magnets.

In a preferred embodiment, the magnetic attachment element may comprise at least one pair of magnets having opposing poles.

In yet further embodiments of the invention, the magnetic attachment element may comprise at least one magnet and at least one ferromagnetic material. In such embodimenis, Lhe aLLracLion of Lhe magneL Lo Ihe ferromagneLic maLerial mainLains Lhe alarm in position on the ostomy pouch until the magnetic force therebetween is insufficient to maintain the magnet and the ferromagnetic material in proximity with one another.

In certain embodiments, the magnet and a, or the, magnet of the magnetic attachment element are one and the same.

Preferably the magnetic attachment element is configured to attach to an ostomy pouch such that it is locatable on opposing sides of the pouch. More specifically, in embodiments wherein the at least one magnetic attachment element comprises a pair of magnets having opposing poles, the first magnet and the second magnet are preferably locatable on opposing sides of the ostomy pouch. In alternative embodiments wherein the at Least one magnetic attachment element comprises a magnet and a ferromagnetic material, the magnet and the ferromagnetic material are preferably locatable on opposing sides of the ostomy pouch.

Advantageously the strength of the attraction between the portions of the magnetic attachment element may determine the level of pressure (within the ostomy pouch) at which the alarm signal will be generated by the magnet and magnetic sensor moving apart More specifically, the magnetic force between the pair of magnets or, alternatively, between a magnet and the opposing ferromagnetic material may determine the level of pressure (within the ostomy pouch) at which the alarm signal will be generated by the magnet and magnetic sensor moving apart Advantageously, the ostomy alarm detaches from the ostomy bag when the relative proximity of the magnet and magnetic sensor exceeds the predetermined threshold.

This provides the advantage that the ostomy alarm may be automatically detachable from an ostomy pouch as the force between the portions of the magnetic attachment element is no longer sufficient to maintain them in magnetic proximity with one another. Thus the alarm device will automatically detach, thereby alerting the user to a full pouch requiring attention.

The means to generate an alarm signal may comprise a magnetically responsive switch.

Advantageously, the magnetically responsive switch is electrically connected to a signal generating device.

The signal generating device may be an audible, visual or vibratory generating device.

In a preferred embodiment, the magnetically responsive switch triggers an alarm signal when the relative proximity of the magnet and magnetic sensor exceeds a predetermined threshold.

The alarm signal may be generated by an electrical circuit) which is closed when the magnet and magnetic sensor are in close proximity and interrupted when the magnet and magnetic sensor move apart, or an electrical circuit, which is open when the magnet and magnetic sensor are in close proximity and closed when the magnet and magnetic sensor move apart.

The means to generate an alarm signal may further comprise a power source.

Preferably the power source comprises at least one battery.

This provides the advantage that there need be no wires attached to the device and the battery may be changed when necessary.

Advantageously, the ostomy alarm is arranged to be mountable to the external surfaces of the ostomy pouch.

This provides the advantage that pressure building up inside the ostomy pouch can be detected outside the pouch, whilst protecting the magnetic attachment element from the internal environment in the pouch.

In one embodiment, the ostomy alarm comprises a substantially V-shaped clamping arrangemenL.

This maybe manufactured by scoring or bending a plastic strip.

The clamping arrangement may further comprise an uneven surface for improving grip on the ostomy pouch.

The ostomy alarm is very easy to attach and use and is reliable, such that it will always be triggered as pressure rises.

It is also inexpensive, small and unobtrusive and comfortable to wear -even when sleeping.

Brief Description of the Drawings

In the drawings, which illustrate embodiments of the invention by way of example only: Figure 1 shows a schematic representation, in rear perspective view, one embodiment of the ostomy alarm of the invention in an open position; Figure 2 shows a schematic representation of the ostomy alarm of Figure 1 with the arm removed; Figure 3 shows a schematic representation, in rear perspective view, of an alternative embodiment of the ostomy alarm of the invention; Figure 4 shows a front perspective view the ostomy alarm of Figure 1 or Figure 3; and Figure 5 shows an ostomy pouch having an ostomy alarm according to an embodiment of the invention attached thereto.

Detailed Description of the Preferred Embodiments

Like reference numerals will he used throughout the figures to depict similar features.

As shown in Figure 1, an ostomy alarm 1 comprises a plastic housing 2 containing a battery, an electrical circuit and alarm generator (not shown].

The housing 2 may comprise a small slot for accessing and replacing the battery. In the embodiment of Figure 4, for example) the housing 2 has two portions separable about a join 12 in order that the internal battery, electrical circuit and alarm generator may be accessed.

In the embodiment of Figure 1, a first magnet 3 is mounted on an arm 4, which is pivotally connected to the main body of the housing 2. Thus, the magnet 3 is moveable in a direction away from the main body of the housing 2. A magnetic sensor (not shown), which acts as a magnetic switch, is located in the housing 2 and is sensitive to the magnet 3, such that movement of the magnet 3 away from the magnetic sensor triggers a magnetic switch that results in an alarm that alerts a user.

The housing 2 further comprises a user interface (not shown) which allows a user to control the ostomy alarm 1 in a simple manner, using a sing'e push button (11, see Figure 4] to arm and disarm the device and select alarm settings.

As is best seen in Figure 5, the arm 4 also facilitates clamping of the ostomy alarm 1 to an ostomy pouch 20. The ostomy alarm 1 simply clamps onto the outside surface 21 of the flexible ostomy pouch 20, where it can sense a change in pressure inside the pouch by detecting inflation of the pouch 20.

In the embodiment shown in Figure 1, the arm 4 forms one half of a V-shaped clamp 5.

Another arm 6, completes the clamping arrangement. In an alternative embodiment, the arm 6 could be absent or formed integrally with the housing 2 to clamp an ostomy pouch directly between the housing 2 and arm 4. Arm 4 may be formed of a plastic coated ferromagnetic material. Magnet 9 is provided on arm 6 in order to facilitate closure of the clamp 5 when the ferromagnetic material of arm 4 is brought into proximity with the magnet 9.

S

In Lhe alLernaLive embodimenL depicled in Figure 3, aLLachmenl magneLs 7 and 8 are located on opposing arms 4,6 of the ostomy alarm 10. These magnets have unlike poles and the attraction between them means that the clamp 5 is biased towards a closed position when the magnets 7 and 8 are in close proximity.

The attraction between the magnets 7 and 8 provides the effect of holding the plastic strip S in place on an ostomy pouch. The ostomy alarm 10 is thus configured to clamp onto an ostomy pouch and be retained on the pouch by the magnetic attraction between clamping magnets 7 and 8. The inner surfaces of the clamp S maybe provided with a non slip coating to improve grip on the pouch.

When the pressure in the pouch exceeds the magnetic attraction between the magnets 7 and 8, the arms 4 and 6 will pivot apart, opening the clamp S. In other words, the V-shaped clamp 5 thus stays in place on the ostomy pouch when closed) and pops open' when pressure builds up inside the ostomy pouch.

In a preferred embodiment, the magnets 7 and 8 are bar magnets with length and breadth dimensions of around 10mm by 3mm and having a thickness dimension oft to 2mm. The magnet may be formed of a Neodymium material. These magnets are mounted on the clamp 5 at corresponding positions and arranged to have opposing north and south poles, which attract It will be appreciated by the skilled reader that in an alternative embodiment, such as the one depicted in Figure 1, one of the magnets 7 or 8 may be substituted with a ferromagnetic material that attracts a magnet The magnet 3 is suitably positioned on arm 4 so as to be adjacent to the magnetic sensor, itself located internally of the housing 2, when the clamp 5 is in the closed position. In the depicted embodiments, the magnet 3 is a disc shaped magnet, located near the centre of the moveable arm 4 at a sufficient distance from the magnets 7 and 8 so as not to be interfered with by their magnetic field. It will be understood that the magneL may be provided in any suiLable shape.

There may be suitable additional attachment means to prevent the ostomy alarm 1 from detaching completely from the ostomy pouch in the open position. However, since the ostomy alarm 1 should be removed once the alarm has tripped, so as not to be dropped when emptying the pouch, it may be desirable for the ostomy alarm 1 to automatically detach from the ostomy pouch on activation of the alarm.

In one embodiment, the main body of the ostomy alarm housing 2 has a size of approximately 45mm x 20mm x 10mm and the arm 4 is around 35 mm in length.

As shown in Figure 5, to attach the ostomy alarm 1 to an ostomy pouch 20, a user may simply slip the opened clamp S over the flexible part of an ostomy pouch 20, and allow it to substantially close under the attraction of the magnets 7 and 8, which hold it in place on the ostomy pouch 20.

The user may then press a button 11 to arm' the unit and there may be an audible or visiNe signal to indicate to the user that the unit is armed. Once armed, pressing the button 11 will have no further effect whilst the ostomy alarm 1 is clamped shut If the pouch 20 inflates by accumulation of solid, liquid or gas, a trip point or threshold point will be reached and the clamp 5 will be opened against the force of the magnets 7 and 8, by inflation of the ostomy pouch 20.

In a preferred embodiment, the alarm will be an audible warning. The audible warning may be provided as a suitably pulsed tone such as, for examp'e, a pulsed telephone ring or a warbling sound. By pulsing the tone as opposed to providing a continuous tone, battery consumption in generating the tone is suitably reduced. Pressing the button when armed causes the alarm to stop and the unit to be disarmed -accompanied by a sound indicating that the unit has been disabled.

When the ostomy alarm 1 is idle or in "sleep mode" it consumes very little power from S the battery. It detects when the user presses the button and becomes active. When it is filled and aimed, IL is also "asleep" bul consumes slighLly more power because Lhe magnetic switch is also enabled.

Claims (12)

1. Claims 1. An ostomy alarm comprising a magnet, a magnetic sensor and means to generate an alarm signal when the relative proximity of the magnet and the magnetic sensor exceeds a predetermined threshold, wherein the ostomy alarm is removably attachable to an ostomy pouch by at least one magnetic attachment element.
2. 2. An ostomy alarm as claimed in Claim 1, wherein the ostomy alarm detaches from the ostomy bag when the relative proximity of the magnet and magnetic sensor exceeds the predetermined threshold.
3. 3. An ostomy alarm as claimed in Claim 1 or 2, wherein the at least one magnetic attachment element comprises one or more magnets.
4. 4. An ostomy alarm as claimed in any of Claims 1 to 3, wherein the means to generate an alarm signal comprises a magnetically responsive switch.
5. 5. An ostomy alarm as claimed in Claim 4, wherein the magnetically responsive switch is electrically connected to a signal generating device.
6. 6. An ostomy alarm as claimed in Claim 5, wherein the signal generating device is an audible, visual or vibratory signal generating device.
7. 7. An ostomy alarm as claimed in any of claims 4 to 6, wherein the magnetically responsive switch triggers an alarm signal when the relative proximity of the magnet and magnetic sensor exceeds a predetermined threshold.
8. 8. An ostomy alarm as claimed in any preceding claim, wherein the means to generate an alarm signal further comprises a power source.
9. 9. An ostomy alarm as claimed in any preceding claim wherein the ostomy alarm comprises a substantially V-shaped clamping arrangement.
10. 10. An ostomy alarm as claimed in Claim 9, wherein the clamping arrangement comprises an uneven gripping surface.
11. 11. An ostomy device comprising the ostomy alarm of any preceding claim.
12. 12. An ostomy alarm or ostomy device substantially as shown in and described with S reference to the drawings.