GB2527611A

GB2527611A - Flexible treatment chamber

Info

Publication number: GB2527611A
Application number: GB1412700.5A
Authority: GB
Inventors: Edward Louis Palmer; Shaun Nightingale
Original assignee: Thesis Tech Products and Services Ltd
Current assignee: Thesis Tech Products and Services Ltd
Priority date: 2014-06-26
Filing date: 2014-07-17
Publication date: 2015-12-30
Also published as: GB201411421D0; GB201412700D0

Abstract

A flexible treatment chamber 16 features a fluid impermeable sleeve 12 and one or more seals 14, 15. In use, commonly liquid or gas medicament is introduced into the chamber 16, in order to closely treat an injured limb contained within the chamber 16, without external leakage of fluid. A number of alternate arrangements are possible, with different numbers of seals, and various means, such as valves, tubes and pumps, to introduce the medicament into the chamber 16. Other significant variants include the addition of a plenum (26, fig.4) for low medicament release, and a variant in which an end of the limb can be free of the internal treatment chamber by the positioning of a seal (14, fig.10).

Description

Flexible Treatment Chamber The present invention relates to administering medicine to a injured limb and more particularly to the containment of a medicine containing liguid around the limb of a patient.

Devices exist for receiving a limb for the purposes of excluding water while washing or bathing. These are of particular use when the limb has been broken and is set in a plaster cast or is bandaged. Typically such devices are in the form of a water proof flexible plastics tube sealed at one end and open at the other. The open end may typically contain a waterproof seal that conforms to the shape of the is limb at a point remote from the wounded area, containing the water sensitive area within the tube or sleeve. Such a device is described in GB2287194.

Developments in the field of medicine have determined that in the case of certain ailments, it is beneficial for medicines to be administered to directly wounds by means of partial or full submersion within a medicated fluid, including both liguids and gases. Typically, this means submerging the limb within a bath of the fluid or in some cases a bucket. This can prove to be messy and also expensive as much of the medical fluid is wasted due to the volume required to fill the bucket. Diluting the fluid in order to increase its volume results in weakening the concentration of the active medical ingredient and so is undesirable.

With a view to mitigating the foregoing disadvantage, the present invention provides, in a first aspect, a device for exposing the outer surface of a limb to a treatment fluid, comprising a fluid impermeable sleeve for fitting over the limb and at least one seal for preventing egress of fluid from the sleeve to define a sealed annular chamber surrounding the limb, wherein each seal comprises an annular disc to fit over the limb, the two discs being spaced from one another along the limb, the outer periphery the annular disc being welded to the sleeve and each disc being deformable to enable the inner periphery of the disc to make sealing contact with the limb, such that the weight of the fluid inside the annular chamber serves to apply pressure to the radially outer surface of the seal, increasing the integrity of the seal against the limb.

According to a second aspect of the present invention there is further provided a device for exposing the outer surface of a limb to a treatment fluid, comprising a fluid impermeable sleeve to fit over the limb and at least one seal for preventing egress of fluid from the sleeve to define an annular chamber surrounding the limb, wherein at least one fluid connector communicating with the annular chamber is provided on the sleeve to permit the annular chamber to be filled with fluid and to permit fluid to be drained from the annular chamber.

Advantageously, two connectors are provided on the sleeve, each located near a respective end of the sleeve.

Preferably the device further includes a valve to allow venting of air as the device is filled with liguid.

According to a third aspect of the present invention there is further provided a device for exposing the outer surface of a limb tc a treatment fluid, comprising a fluid impermeable sleeve to fit over the limb and at least one seal for preventing egress of fluid from the sleeve so as to define an annular charter surrounding the limb, wherein at least one plenum is provided within the sleeve and a connector is provided in the sleeve to enable fluid to be introduced into the plenum, the plenum having a perforated wall to permit fluid introduced therein to be expelled into the annular chamber and to be directed onto the limb, the sleeve having a second connector communicating with the annular chamber to allow fluid to be drained from the annular chamber after having come into contact with the limb.

Preferably, each disc is formed of a multi-layered flexible and elastic material, the layer forming one surface of the disc being of an elastomeric material and the layer forming the opposite surface of the disc being of a plastics material capable of being welded to the material of the sleeve, the annular disc being welded to the sleeve with the layer of plastics material facing toward the interior of the sealed annular chamber.

The sleeve is formed of a flexible plastics material.

According to a fourth aspect of the present invention, there is further provided a treatment system comprising a device as claimed in any preceding claim in combination with a pump for circulating fluid through the annular chamber of the device.

According to a fifth aspect of the present invention there is further provided a device in the form of a fluid impermeable sleeve for exposing the outer surface of a limb to a treatment fluid, the sleeve having a first end that is open for receiving the limb; at least one proximal seal located near the open end for preventing egress of fluid from the sleeve, and an intermediate seal located axially further from the open end than the primary seal to define an annular treatment chamber surrounding the limb, wherein the opposite end of the sleeve is either closed or provided with a distal seal for sealing against the limb, so as to define a post-treatment chamber into which treatment fluid can be discharged from the treatment chamber.

Additionally, the device includes at least one connector associated with each of the treatment chamber and the post-treatment chamber for allowing the introduction or removal of treatment fluid.

The treatment fluid may be a liquid.

According to a sixth aspect of the present invention there is further provided a method of applying a treatment fluid to a limb which comprises placing a sleeve over the limb to define a sealed chamber surrounding the limb, with the limb forming one wall of the sealed chamber, and introducing the treatment fluid into the sealed chamber to make contact with the outer surface of the limb.

The method may further comprise placing a sleeve as described above over the limb to define a sealed chamber surrounding the limb, with the limb forming one wall of the sealed chamber, introducing the treatment fluid into the sealed treatment chamber to make contact with the surface of the limb, and after treatment is complete disturbing the intermediate seal between the treatment and post-treatment chambers to cause the used treatment fluid to drain into the post-treatment chamber.

The applicants have recognised that devices formerly used to keep affected limbs dry during bathing can, with adaption be used to provide a watertight volume directly around the wounded area. By filling or partially filling the device or sleeve with a desired medicated fluid, it is possible to treat the area without creating mess and also with the minimum amount of wastage of the medicated fluid and without reducing its concentration.

The invention will now be described further by way of example, with reference to the accompanying drawings in which: Figure la shows a perspective view of a single seal sleeve surrounding a limb, according to one aspect of the present invention, Figure lb shows a perspective view of a double seal sleeve surrounding a limb, according to a second aspect of the present invention, Figure 2 shows a similar view to that of figure lb of a third embodiment of the present invention, Figure 3 shows a similar view to that of figure lb of a fourth embodiment of the present invention, Figure 4 shows a similar view to that of figure lb of a fifth embodiment of the present invention, Figure 5 shows a seal component of the present invention, Figure 6 shows a plan view of the seal of figure 5, Figure 7 shows a cross section along the line AA of figure 6, Figure 8 shows a similar view to that of figure lb of a sixth embodiment of the present invention, Figure 9 shows a similar view to that of figure lb of a seventh embodiment of the present invention including an additional intermediate seal, Figure 10 shows a similar view of the embodiment of figure 9, modified to Include an open distal end with an additional distal seal, and Figure 11 shows a still further embodiment based on the embodiment of figure 10.

Turning now to the figures in which features common to different embodiments are given the same reference numerals.

Figure la shows an arm 10 of a patient oontained within a waterproof and watertight sleeve 12 according to a first embodiment of the present invention. It may similarly applied to any limb including a foot or a leg. The sleeve is of known construction, and is as described in but not limited to the disclosure of G32287194. It may be made of a plastics material but may be made of any suitable material having the appropriate properties, namely that it is lightweight, flexible and may be plastic welded, whilst being waterproof and for the purposes of the present invention, watertight and gastight. Typically the sleeve is in the form of a tube constructed by plastic welding a flat sheet along adjoined edges and then along one of its open ends. It may also be made from tubular sheet plastic, also known as lay flat tubing' The sleeve 12 benefits from a single inwardly pointing seal 14, preferably made from neoprene, which is welded to the interior face of the watertight plastics tube at weld 15. The purpose of the seal is to separate the annular chamber 16 bounded by the skin of the limb 10 and the interior face of the sleeve 12. By providing a seal 14, the chamber can be filled with a fluid for the benefit of the wounded limb 10. This may be oxygen gas or a medicated solution for delivering medicine into an open wound, or any other suitable treatment mechanism.

The seal 14 is arranged to point inwardly, away from the opening that receives the limb 10. As a result, the weight of medicated liguid contained within the sleeve serves to push the seal towards the limb to improve the integrity of the seal against the patient's skin. Similarly, the gas pressure fortifies the seal if the chamber 16 is filled with a gas at higher than ambient pressure.

The components of the seal will be described further in more detail with reference to Figures 5, 6 and 7.

Figure lb shows a similar embodiment to that of figure la, but with the provision of a double seal 14. Both seals 14 are physically the same but are axially spaced from one another. This serves to significantly reduce leakage from the sleeve, particularly when the chamber 16 contains liquid.

In both figures la and lb, gases or liquids may be introduced and removed from the annular charter by simply distorting the seal to break contaot with the limb and introducing the fluid past the seal and into the annular chamber 16.

Figure 2 shows an alternative embodiment, based on the embodiment of figure lb, in which the sleeve is further provided with a filler nozzle 18 and supply tube 20. The nozzle 18 allows the annular charter 16 to be more easily filled and emptied. The arrows shown at the end of the supply tube 20 indicate that fluid can flow in either direction along the tube. To facilitate easier filling and emptying, the sleeve 12 is further provided with a valve 22 which allows egress of air displaced as the annular chamber 16 is filled with fluid through the supply tube 20 from an external source. The valve 22 may be manually operated by a user or automatically close when sufficient fluid is present. It may be, for example, a gas pressurised valve or a ball float valve for liquid use.

Figure 3 is a further development of the embodiment of figure 2 but has a dedicated fluid-in tube 20 and fluid-out tube 24. In this embodiment there is no need for a valve 22 as the fluid-out tube 24 allows for the escape of displaced air. By having a dedicated feed for draining the fluid or gas from the annular chamber, it is possible, where applicable, to more easily recycle the fluid back to the fluid-in tube 20. If permitted, re-use of the fluid can allow the use of less overall medicated fluid to treat the limb, thereby reducing the cost of treatment. If desired it also allows removed fluid to be filtered by an external filter (not shown) prior to re-use or disposal.

Figure 4 shows a further development of the embodiment shown in figure 3 further including a plenum chamber 26. The plenum chamber is formed by joining to the inner surface of the plastics tube by welding or other means an additional perforated layer 28. The perforated layer 28 divides the annular chamber 16 in two between the limb 10 and the fluid in-tube 20 creating the plenum chamber 26. The perforations in the perforated layer 28 impede the flow of fluid (preferably liquid) , causing the plenum chamber 26 to fill up in a similar way to the annular chamber 16 in previous embodiments, whilst allowing the fluid to slowly escape through the perforations. This has the effect of "showering" the limb with medicated fluid. Medically, this has been shown to be of benefits to certain conditions, but also additionally, it serves to reduce the amount of treatment fluid required to effectively treat the limb. Additionally, by using a reduced amount of treatment fluid, the weight of the device when in use is significantly reduced which is again beneficial when being supported by a potentially weakened limb.

Figures 5, 6 and 7 show an individual seal 14 in more detail. Each seal 14 is annular in shape as shown in figure 6. The outer circumference is bonded to the inner circumference of the plastics tube that forms the body of the sleeve, while the inner circumference is sized to receive the limb 10.

As shown in figures 5 and 7, the seal is made from two distinct layers of differing materials, bonded together during manufacture. The resulting seal remains flexible and extensible and confirms to the surface shape of the limb at -10 -its inner circumference to create a band rather than a line contact surface. The two layers are an elastomeric layer 30 such as neoprene and a plastic weldable layer 32 such as nylon. The elastomeric layer 30 is required to create a waterproof seal and the plastic weldable layer 32 as its name suggests allows the seal to be joined to the plastics tube. Figure 7 shows a section of figure 6 along the line AA to emphasize the position of the layers relative to the annular shape of the seal 14.

Figure 8 shows a similar embodiment to that of figure 4 but further shows an external pump 34. The pumps can determine a specific throuqh put of fresh or recycled treatment fluid into the annular chamber. Additionally it may serve to regulate the temperature of the fluid. In addition it may include an inline filter (not shown) to remove any impurities from the fluid as a result of coming into contact with the limb prior to recycling.

Figure 9 shows an embodiment similar to that of figure lb having a further intermediate seal 14' which divides that annular chamber into a treatment chamber l6a and a post treatment chamber 16b. This provides the advantage of sub dividing the limb into smaller sections to allow the use of far less treatment fluid to submerge the affected area of the limb. To effectively seal between the treatment and post treatment chambers, the intermediate seal 14' has a slightly smaller internal aperture for receiving the limb 10. When the limb has been submerged for a sufficient period of time, the intermediate seal 14' can be distorted to break its seal against the limb 10 and allow the treatment fluid to escape into the post treat chamber 16b, most likely under the effect of gravity. This ensures full capture of the fluid -11 -when removing the limb from the sleeve reducing the risk of accidental spillage of the used treatment fluid.

Figure 10 shows an alternative to the embodiment of figure 9 but using a further distal seal 14'' to enable both axial ends of the sleeve 12 to receive a limb. This embodiment provides the same advantages as that shown in figure 8 but caters for longer limbs, and for treating an affected area on the limb further from the distal end of the limb than closed ended sleeves previous embodiments would allow.

Figure 11 shows the embodiment of figure 10 but further includes two supply tubes 20, one communicating with each of the treatment chamber 16a and the post treatment chamber l6b. As shown by the arrows in the diagram, the supply tubes can be used, preferably with an external pump (not shown) to allow treatment fluid to flow into or out of each chamber independently. This enables different areas of the limb enclosed within each respective chamber to be treated differently at the same time. For example, the two chambers may be operated with different fluids at different temperatures in order to produce a combined effect on the limb.

While it is appreciated that the seals 14' and 14'' are shown in a specific orientation, depending on the application of fluid within the treatment chambers 16a and 16b, it may be preferable for either or both the intermediate and distal seals to be oriented in the opposite direct with respect to the seals 14.

Claims

-12 -CLAIMS1. A device for exposing the outer surface of a limb to a treatment fluid, comprising a fluid impermeable sleeve for fitting over the limb and at least one seal for preventing egress of fluid from the sleeve to define a sealed annular chamber surrounding the limb, wherein each seal comprises an annular disc to fit over the limb, the two discs being spaced from one another along the limb, the outer periphery of the annular disc being welded to the sleeve and each disc being deformable to enable the inner periphery of the disc to make sealing contact with the limb, such that the weight of the fluid inside the annular chamber serves to apply pressure to the radially outer surface of the seal, increasing the integrity of the seal against the limb.
2. A device for exposing the outer surface of a limb to a treatment fluid, comprising a fluid impermeable sleeve to fit over the limb and at least one seal for preventing egress of fluid from the sleeve to define an annular chamber surrounding the limb, wherein at least one fluid connector communicating with the annular chamber is provided on the sleeve to permit the annular chamber to be filled with fluid and to permit fluid to be drained from the annular chamber.
3. A device as claimed in claim 2, wherein two connectors are provided on the sleeve each located near a respective end of the sleeve.
4. A device as claimed in claims 1 to 3, further comprising a valve to allow venting of air as the device is filled with fluid.-13 -
5. A device for exposing the outer surface of a limb to a treatment fluid, comprising a fluid impermeable sleeve to fit over the limb and at least one seal for preventing egress of fluid from the sleeve so as to define an annular chamber surrounding the limb, wherein at least one plenum is provided within the sleeve and a connector is provided in the sleeve to enable fluid to be introdilced into the plenum, the plenum having a perforated wall to permit fluid introduced therein to be expelled into the annular chamber and to be directed onto the limb, the sleeve having a second connector communicating with the annular chamber to allow fluid to be drained from the annular chamber after having come into contact with the limb.is
6. A device as claimed in any preceding claim, wherein each disc is formed of a multi-layered flexible and elastic material, the layer forming one surface of the disc being of an elastomeric material and the layer forming the opposite surface of the disc being of a plastics material capable of being welded to the material of the sleeve, the annular disc being welded to the sleeve with the layer of plastics material facing toward the interior of the sealed annular chamber.
7. A device as claimed in any preceding claim, wherein the sleeve is formed of a flexible plastics material.
8. A treatment system comprising a device as claimed in any preceding claim in combination with a pump for circulating fluid through the annular chamber of the device.
9. A method of applying a treatment fluid to a limb which comprises placing a sleeve over the limb to define a sealed -14 -chamber surrounding the limb, with the limb forming one wall of the sealed chamber, and introducing the treatment fluid into the sealed chamber to make contact with the cuter surface of the limb.
10. A device in the form of a fluid impermeable sleeve for exposing the cuter surface of a limb to a treatment fluid, the sleeve having a first end that is open for receiving the limb; at least one proximal seal located near the open end for preventing egress of fluid from the sleeve, and an intermediate seal located axially further from the open end than the primary seal to define an annular treatment chamber surrounding the limb, wherein the opposite end of the sleeve is either closed or provided with a distal seal for sealing against the limb, so as to define a post-treatment chamber into which treatment fluid can be discharged from the treatment chamber.
11. A device as claimed in claim 10, further comprising at least one connector associated with each of the treatment chamber and the post-treatment chamber for allowing theintroduction or removal of treatment fluid.
12. A device as claimed in any preceding claim wherein the treatment fluid is a liquid.
13. A method of applying a treatment fluid to a limb which comprises placing a sleeve as claimed in claims 10 to 12, over the limb to define a sealed chamber surrounding the limb, with the limb forming one wall of the sealed chamber, introducing the treatment fluid into the sealed treatment chamber to make contact with the surface of the limb, and -15 -after treatment is complete disturbing the intermediate seal between the treatment and post-treatment chambers to cause the used treatment fluid to drain into the post-treatment chamber.