WO2011135078A1 - An inflatable and / or vaccumizable medical device - Google Patents
An inflatable and / or vaccumizable medical device Download PDFInfo
- Publication number
- WO2011135078A1 WO2011135078A1 PCT/EP2011/056847 EP2011056847W WO2011135078A1 WO 2011135078 A1 WO2011135078 A1 WO 2011135078A1 EP 2011056847 W EP2011056847 W EP 2011056847W WO 2011135078 A1 WO2011135078 A1 WO 2011135078A1
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- WIPO (PCT)
- Prior art keywords
- valve
- inflatable
- heel
- vaccumizable
- rim
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
- A61F5/0102—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
- A61F5/012—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations inflatable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/4404—Details or parts
- A61F5/4405—Valves or valve arrangements specially adapted therefor ; Fluid inlets or outlets
Definitions
- the present invention relates to an inflatable and / or vaccumizable medical device defining an inflatable and / or vaccumizable compartment and a self sealing valve.
- the present invention relates to a medical device forming a heel lifter for lifting the heel of a patient above the surface which supports the heel lifter.
- the present invention relates to an inflatable and / or vaccumizable medical device comprising at least two sheets of compartment foil which are attached to each other so as to form an inflatable and / or vaccumizable compartment, the inflatable and / or vaccumizable medical device comprising a self sealing valve which is defined by two sheets of valve foil; the two sheets of valve foil extending into the inflatable and / or vaccumizable compartment and being arranged with respect to each other such that when a predetermined pressure is established in the inflatable and / or vaccumizable compartment, the two sheets of valve foil are forced towards each other whereby the valve is sealed; the two sheets of valve foil being fastened to each other such that a first and second fastening rim is defined and such that a valve passage is defined between the two sheets of valve foil and the first and second fastening rims, the valve passage defining a valve inlet and a valve outlet;
- a rim-passage ratio defined as - the distance from the valve inlet to the valve outlet along either of first or second fastening rims
- the inventors of the present invention have made the unexpected discovery that leaks from self sealing valves made from two sheets of foil emanates from air flowing along the fastening rim, i.e. the rim along which the two sheets of foil are fastened to each other.
- the reason is that the two sheets of foil are spaced apart slightly due to the welding seam forming the fastening rim or due to an adhesive by means of which the two sheets are fastened to each other.
- the inventors have also found that the longer the fastening rim is, the larger the likelihood is that at some point the two sheets of foil are not spaced apart. Such a point will cause the valve to be air tight as the air inside the compartment is prevented from flowing along the fastening rim due to the point(s) where the sheets are not spaced a part.
- the medical device may be a medical device for preventing pressure ulcers (bedsores); or a gastric balloon ; or a device for the fixation of a broken limb or bone; or a splint; or a device for the fixation of the neck of people who are suspected to suffer from a broken neck; or a device for helping people with a problem with impotency; or a device for elevating parts of a patients body, for instance during an operational procedure; or a device for helping patient positioning; or a device for the distribution of pressure against the body of patients; or a device for compression or vacuum therapy; or a medical purpose pillow; or a massage cushion; or a tissue expander or implant; or a cuff for a tracheal tube.
- the inflatable and / or vaccumizable medical device may form one or more inflatable and / or vaccumizable compartments, such as one, such as two, such as three, such as four, such as five etc. Each compartment may define one or more sub-compartments which may be fluidly connected to each other.
- the compartment may be adapted to withstand pressure of at least 0.001 bars above or below the surrounding atmospheric pressure without rupturing, such as a pressure of at least 0.05 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.1 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.2 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.3 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.4 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.5 bar above or below the surrounding atmospheric pressure.
- a pressure of at least 0.05 bar above or below the surrounding atmospheric pressure such as a pressure of at least 0.1 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.2 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.3 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.4 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.5 bar above or below the surrounding atmospheric
- the valve is self sealing when the predetermined pressure inside the compartment is at least 0.05 bars above or below the surrounding atmospheric pressure without rupturing, such as a pressure of at least 0.1 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.2 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.3 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.4 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.5 bar above or below the surrounding atmospheric pressure.
- the two sheets of compartment foil and/or the two sheets of valve foil may comprise a plastic material such as Polyamid or Nylon, or Polyethylene or PE, or Polypropylene or PP or organic plastic/bioplastic.
- the sheets of foil may be fastened to each other by means of welding such as laser welding, or ultrasonic welding or impulse welding or heat welding, and/or by means of an adhesive.
- the term 'self sealing' shall be understood such that the pressure inside the compartment is at least 90 percent of the pressure 24 hours earlier, such as 92 percent of the pressure 24 hours earlier, such as 94 percent, such as 96 percent, such as 98 percent, such as 99 percent.
- the valve passage may be straight or be shaped such that a straight line may extend through the passage without coinciding with any of the fastening rims.
- the valve inlet and the valve outlet may be positioned relative to the passage such that the line may extend through the valve inlet and the valve outlet.
- the rim-passage ratio is defined as the distance from the valve inlet to the valve outlet along either of first or second fastening rims divided by the shortest distance between the valve inlet and the valve outlet inside the valve passage.
- the shortest distance shall be measured as the shortest line that may be drawn, which passes through the passage without crossing or coinciding with one of the fastening rims.
- the rim-passage ratio is at least 10, such as at least 25, such as at least 50, such as at least 75, such as at least 100, such as at least 150, such as at least 200, such as at least 300, such as at least 400, such as at least 500.
- At least a part of the passage is shaped so as to allow an elongated element to pass through the passage without touching either of the first and the second fastening rim.
- This element may be hollow to allow the air to flow through the passage defined in the hollow element.
- the element may be solid but shaped such that it forces the walls of the valve passage (i.e. the two sheets of valve foil) away from each other whereby an air passage is defined through which the air may flow.
- At least a part of the first and/or the second fastening rim may be curved such that at least a part of the first or the second fastening rim extends in a direction transverse to a line extending between the valve inlet and the valve outlet.
- This curved part may from one or more S-curves or form one or more spiral-lines such as double-spiral lines.
- at least a part of the first and/or second fastening rim may form a zig-zag shape.
- At least one of the first and the second fastening rims defines one or more rim projections each of which extends in a direction transverse to a line extending between the valve inlet and the valve outlet, such as in a direction which is orthogonal relative to said line. In one embodiment, this line may follow a line defining the shortest distance between the valve inlet and the valve outlet inside the valve passage.
- At least one of the rim projections may define a projection length along the first or second fastening rims, which is at least a third of the length of the line extending between the valve inlet and the valve outlet, such as at least half the length of the line extending between the valve inlet and the valve outlet.
- the sum of all the projection lengths i.e. when more than one rim projection is defined
- each rim projection is U-shaped thus defining two straight parts which are joined by a curved portion. The two straight parts may be parallel or substantially parallel.
- each rim projection defines two parallel rim portions which extend towards the line extending between the valve inlet and the valve outlet and which are connected to each other by means of a curved rim portion.
- at least one rim projection is V-shaped i.e. forming two straight lines which meet in one single point.
- One or more of the straight parts of the U- and/or V-shaped rim projections may extend in a direction transverse to the longitudinal direction of the valve passage.
- At least one of the rim projections is arranged so as to guide the elongated element towards the valve outlet during insertion of the elongated element into the valve passage through the valve inlet.
- the latter may be achieved by designing any part of the fastening rim which the elongated element may come into contact with during insertion, such that the elongated element is forced/guided towards the center of the valve passage.
- these parts of the fastening rim may be inclined with respect to the longitudinal direction of the valve passage. It will be appreciated that the larger the number rim projections is, the higher the rim- passage ratio will be.
- each of the first and the second fastening rims may comprise a plurality of rim projections, such as two, such as three, such as four, such as five, such as six, such as seven, such as eight, such as nine or such as ten.
- the inflatable and / or vaccumizable medical device is an inflatable heel lifting device which is adapted to lift a heel of a user from a surface onto which the heel lifting device rests.
- Such a device may comprise any combination of features and elements of the invention according to the second aspect.
- the present invention relates to a heel lifter (or a heel lifting device) for lifting a user's heel from a surface while the user rests on his back, thus relieving the heel, said heel lifter being made from a material that allows moisture and water passing therethrough and which is air tight so that the heel lifter in it's air filled state forms two sides between which the lower leg is positioned during use to relieve the lower leg, said heel lifter including a valve through which the cells can be filled with air, which can be closed, whereby air can not get out again.
- the heel lifter is designed so that it forms two elongated cells, which, when they are inflated, create a space between the two cells, thereby providing space for the Achilles tendon, so that this during the use will not be damaged or too affected by pressure and thus is spared.
- the gap between the two cells forms a V shape.
- the large cells in the first end - behind up towards the knee - are tapered in such a way as not to create an edge to the calf.
- the large cells are designed so that they do not support the user's heel, so that it during use hovers freely and is not exposed to pressure.
- the heel lifter at the other end, opposite to the first end forms two vertical cells between which a piece of plastic prevents the foot from falling forward during use.
- the plastic piece between the two vertical cells is non-inflatable, so that a flat piece of plastic is formed under the user's foot during use.
- the heel lifter at the sides of the user's foot forms two elongated channels with air that prevent the malleoluses from being damaged.
- the upper part of each of the two sides can be fastened to each other.
- the invention according to the second aspect relates to a single patient use only or disposable relief aid for the prevention of decubitus or pressure ulcers on a heel, a heel lifter.
- the heel lifter helps lifting the heel of people from a surface while they are for instance lying on their back, whereby the heel or the heels are relieved, thereby avoiding pressure on the heel or the skin on the heel.
- the heel lifter is made of a material that is not permeable to air and can therefore be inflated with air and keep the air inside the product for a long time.
- the heel lifter is made of a material that allows the passing of moisture or water while it is at the same time airtight. The moisture comes e.g. from the patients secretion, sweat, perspiration, and this moisture can lead to skin lesions and burns and skin injuries similar to burns and that the skin breaks and sores and skin injuries form, therefore there must be no moisture.
- the material that lets moisture pass may for instance work in a way where the moisture passes through the material or the material may work in a way where the material first absorbs the moisture from one side and thereafter lets it evaporate on the other side.
- the heel lifter is inflated with air and thus has a perfect or near perfect or good pressure distribution of the weight lying on top because the air distributes inside the heel lifter automatically and thus does not press more on one spot of the user than on another spot of the user. This is an advantage since the disorder, which must be remedied may have occurred exactly because of pressure and because the patient may very well suffer from weak skin that is easily affected or damaged by pressure or for example suffer from poor circulation of the blood, which may also increase the risk of being harmed.
- the heel lifter is designed so that there are two large oblong cells, which lift, carry and support the calf and by the gap between the two cells gives space for the Achilles tendon, so that the Achilles tendon is not damaged or pressure influenced too much and thus the Achilles tendon is spared.
- the two cells are in their bloated state, seen in a section, two cylinders lying side by side, thereby leaving a v-shaped space on top of the inflated shape.
- the two large oblong cells can simultaneously remain stable against the underlying surface and keep the leg in a good position.
- the two large cells are tapered, so that there is not an edge against the calf, which would have pressure affected the patient unreasonably with possible damage or nuisance as a consequence.
- the cells shape and restraint in relation to each other are designed to enclose and gently hold the foot so that the heel lifter remains in the same place regardless of the user for example turning in bed or turning the leg or foot.
- the retaining and closure of the product is made by a non bloated part of the product made from some kind of material passing over the foot so that the not closed heel lifter gives very easy access to the loading of the foot or leg and so that you can easily use the loose part to attach to the other side of the product, thereby positioning the product in relation to the user in the most advantageous way and in a manner, so that you can be sure that the heel lifter does not shift in a disadvantageous way.
- the securing between the two sides can be done by for example laces, self-adhesive, velcro, buttons, magnets or clamping.
- the heel lifter is produced by putting two pieces of plastic film together, and this can be done favorably by for example welding the layers together or by gluing them together, and by not putting all of the surface together, but instead leave some spaces unjoined, the opportunity arises to fill air between the two layers and thus to obtain a cushion-like structure.
- the air can get into the cavities for example through a valve or through a kind of tube or long cell in the material, and these can be closed or close themselves as with a valve, so that the air can not get out again. In some cases, it is desirable to let out the air again, so the closing arrangement (-s) can be made so that you can to let air out, thus adjusting the air pressure to the benefit of the intended effect of the product.
- a self-closing valve can be designed as a part of the two previously mentioned plastic film layers or as a separate part and be inserted between the layers and be welded or glued.
- the internal pressure in the product can then help closing the valve system so that air does not escape.
- the material which the heel lifter is made of is of a type which is not harmful to humans and which by the end of its use can be disposed of without special measures and which does not take up a lot of space if the air is let out or if punctured by for instance cutting off a corner.
- oblong channels On the side of the product off the foot sides are two oblong channels with air placed so that they prevent the malleoluses from being harmed. These channels also provide a good relief or pressure distribution when the user is lying so that the leg or foot rest on the side.
- a closing device On the upper surface of the product, a closing device is placed, that can be designed with self-adhesive closures, so there for example is a kind of strip that can be placed over the product around the leg, so the product sits fairly firmly on the foot and thereby is not moved to such an extent that it may cause inconvenience, and thus the user can e.g. turn over in bed and be confident that the product still sits in a good way, and turn back on his back again and still have the product sitting in a good way.
- Fig. 1 discloses a first embodiment of the invention according to the first aspect
- Fig. 2 discloses a second embodiment of the invention according to the first aspect
- Fig. 3 discloses a third embodiment of the invention according to the first aspect
- Fig. 4 discloses a fourth embodiment of the invention according to the first aspect
- Fig. 5 discloses a cross-section through a fastening rim
- Fig. 6 discloses a cross-section through a fastening rim
- Fig. 7 discloses a side elevational view of the invention according to the second aspect
- Fig. 8 discloses a cross-sectional end elevational view of the invention according to the second aspect. DETAILED DESCRIPTION OF THE FIGURES
- Figs. 1-4 discloses four different embodiments of the self sealing valve 100 each of which are defined by a first and a second sheet of valve foil 102,104, which are fastened to each other such that a first fastening rim 106 and a second fastening rim 108 is defined.
- the two sheets of valve foil extend into the inflatable and / or vaccumizable compartment of a medical device and are arranged on top of each other such that when a predetermined pressure is established in the compartment, the valve is self sealing.
- the self sealing valve 100 defines a valve passage 110 which extends from a valve inlet 112 to a valve outlet 114.
- the distance from the valve inlet 112 to the valve outlet 114 along either of the first and the second fastening rim 106,108 are substantially longer than the shortest distance between the valve inlet 112 and the valve outlet 114.
- the relationship between these two distances is designated the rim-passage ratio in the present invention and is at least two.
- first fastening rim 106 and the second fastening rim 108 are both shaped with the aim of providing very long fastening rims 106,108.
- first and the second fastening rims 106,108 define rim projections 116, each of which extends in a direction transverse to a line 118 extending between the valve inlet and the valve outlet.
- the rim projections extend from a sidewall part 119 of the fastening rims 106,108. and each define a first and a second straight part 120,122 which are parallel or substantially parallel and which are joined together by means of a U-shaped part 124.
- the combined length of the first and the second straight parts 120,122 may be called the projection length, which may be at least a third of the length of the line 118 extending between the valve inlet 112 and the valve outlet 114.
- the rim projections 116 are arranged so as to guide an elongated element not illustrated towards the valve outlet during insertion of the elongated element into the valve passage through the valve inlet. This causes an air passage to be defined along the elongated element or inside the elongated element in cases where the latter is hollow.
- Figs. 5 and 6 disclose a cross-section through a fastening rim 106,108. Due to the thickness of the adhesive 126 in the embodiment of Fig. 5 a small air escape passage 128 is defined between the adhesive 126, and the first and a second sheet of valve foil 102,104. By providing long fastening rims 106,108 the likelihood of this passage 128 being blocked at some point is increased. In the embodiment of Fig. 6, the two sheets of valve foil 102,104 are welded together. Again a small air escape passage 128 is defined due to the deformation of the sheets of valve foil during the welding process.
- FIG. 7 and 8 discloses the invention according to the second aspect.
- the heel lifter being made from a material that allows moisture and water passing therethrough and which is air tight so that the heel lifter in it's air filled state forms a medial side 204 and a lateral side 206 between which the lower leg (the lower limb) is positioned during use to relieve the lower leg.
- the heel lifter includes a valve (e.g. the one described in Figs. 1- 6) through which cells can be filled with air.
- the heel lifter is designed so that it forms two lower elongated cells - a lower medial elongated cell 208 and a lower lateral elongated cell 210 - , which, when they are inflated, create a space 212 between the two cells 208,210, thereby providing space for the Achilles tendon (not visible in the figures), so that this during the use will not be damaged or too affected by pressure and thus is spared.
- the large cells 208,210 in a first end 214 - behind up towards the knee 216 - are tapered in such a way as not to create an edge to the calf.
- the large cells 208,210 are designed so that they do not support the user's heel 218, so that the heel 218 during use hovers freely above the surface 202 and is not exposed to pressure.
- the plastic piece between the two vertical cells 222 is non-inflatable, so that a flat piece of plastic is formed under the user's foot 224 during use.
- the heel lifter at the sides of the user's foot forms two upper elongated channels cells - a upper medial elongated cell 226 and a upper lateral elongated cell 228 - with air that prevent the malleoluses 230 from being damaged.
- each of the two sides 204,206 can be fastened to each other by means of a fastening means 232.
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Abstract
An inflatable medical device made from two sheets of compartment foil which are attached to each other so as to form an inflatable compartment. The inflatable medical device comprising a self sealing valve which is defined by two sheets of valve foil which are fastened to each other such that a first and second fastening rim is defined and such that a valve passage is defined between the two sheets of valve foil and the first and second fastening rims, the valve passage defining a valve inlet and a valve outlet wherein a rim-passage ratio defined as the distance from the valve inlet to the valve outlet along either of first or second fastening rims divided by the shortest distance between the valve inlet and the valve outlet inside the valve passage, is at least two. Moreover the present invention relates to an inflatable heel lifting device.
Description
AN INFLATABLE AND / OR VACCUMIZABLE MEDICAL DEVICE FIELD OF THE INVENTION
The present invention relates to an inflatable and / or vaccumizable medical device defining an inflatable and / or vaccumizable compartment and a self sealing valve. In particular the present invention relates to a medical device forming a heel lifter for lifting the heel of a patient above the surface which supports the heel lifter.
BACKGROUND OF THE INVENTION
In connection with inflatable and / or vaccumizable medical devices it is critical that the devices maintain the pressure of the air inside the inflatable and / or vaccumizable compartment and that air leaks are prevented.
It is an object of one or more embodiments of the present invention to provide an inflatable and / or vaccumizable medical device with a self sealing valve which does not leak air.
It is an object of one or more embodiments of the present invention to provide an inflatable and / or vaccumizable medical device which is air tight even at relatively low pressures. DESCRIPTION OF THE INVENTION
In a FIRST aspect the present invention relates to an inflatable and / or vaccumizable medical device comprising at least two sheets of compartment foil which are attached to each other so as to form an inflatable and / or vaccumizable compartment, the inflatable and / or vaccumizable medical device comprising a self sealing valve which is defined by two sheets of valve foil; the two sheets of valve foil extending into the inflatable and / or vaccumizable compartment and being arranged with respect to each other such that when a predetermined pressure is established in the inflatable and / or vaccumizable compartment, the two sheets of valve foil are forced towards each other whereby the valve is sealed; the two sheets of valve foil being fastened to each other such that a first and second fastening rim is defined and such that a valve passage is defined between the two sheets of valve foil and the first and second fastening rims, the valve passage defining a valve inlet and a valve outlet;
wherein
a rim-passage ratio defined as
- the distance from the valve inlet to the valve outlet along either of first or second fastening rims
divided by
- the shortest distance between the valve inlet and the valve outlet inside the valve passage,
is at least two.
The inventors of the present invention have made the unexpected discovery that leaks from self sealing valves made from two sheets of foil emanates from air flowing along the fastening rim, i.e. the rim along which the two sheets of foil are fastened to each other. The reason is that the two sheets of foil are spaced apart slightly due to the welding seam forming the fastening rim or due to an adhesive by means of which the two sheets are fastened to each other. However, the inventors have also found that the longer the fastening rim is, the larger the likelihood is that at some point the two sheets of foil are not spaced apart. Such a point will cause the valve to be air tight as the air inside the compartment is prevented from flowing along the fastening rim due to the point(s) where the sheets are not spaced a part.
Thus it will be appreciated that the higher the rim-passage ratio is, the lower the pressure in the compartment can be while at the same time ensuring that the valve is air tight.
In one embodiment, the medical device may be a medical device for preventing pressure ulcers (bedsores); or a gastric balloon ; or a device for the fixation of a broken limb or bone; or a splint; or a device for the fixation of the neck of people who are suspected to suffer from a broken neck; or a device for helping people with a problem with impotency; or a device for elevating parts of a patients body, for instance during an operational procedure; or a device for helping patient positioning; or a device for the distribution of pressure against the body of patients; or a device for compression or vacuum therapy; or a medical purpose pillow; or a massage cushion; or a tissue expander or implant; or a cuff for a tracheal tube.
The inflatable and / or vaccumizable medical device may form one or more inflatable and / or vaccumizable compartments, such as one, such as two, such as three, such as four, such as five etc. Each compartment may define one or more sub-compartments which may be fluidly connected to each other. The compartment may be adapted to withstand pressure of at least 0.001 bars above or below the surrounding atmospheric pressure without rupturing, such as a pressure of at least 0.05 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.1 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.2 bar above or below the surrounding atmospheric pressure, such as
a pressure of at least 0.3 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.4 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.5 bar above or below the surrounding atmospheric pressure.
In one embodiment, the valve is self sealing when the predetermined pressure inside the compartment is at least 0.05 bars above or below the surrounding atmospheric pressure without rupturing, such as a pressure of at least 0.1 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.2 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.3 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.4 bar above or below the surrounding atmospheric pressure, such as a pressure of at least 0.5 bar above or below the surrounding atmospheric pressure.
The two sheets of compartment foil and/or the two sheets of valve foil may comprise a plastic material such as Polyamid or Nylon, or Polyethylene or PE, or Polypropylene or PP or organic plastic/bioplastic. The sheets of foil may be fastened to each other by means of welding such as laser welding, or ultrasonic welding or impulse welding or heat welding, and/or by means of an adhesive.
In the context of the present invention, the term 'self sealing' shall be understood such that the pressure inside the compartment is at least 90 percent of the pressure 24 hours earlier, such as 92 percent of the pressure 24 hours earlier, such as 94 percent, such as 96 percent, such as 98 percent, such as 99 percent.
The valve passage may be straight or be shaped such that a straight line may extend through the passage without coinciding with any of the fastening rims. The valve inlet and the valve outlet may be positioned relative to the passage such that the line may extend through the valve inlet and the valve outlet. The rim-passage ratio is defined as the distance from the valve inlet to the valve outlet along either of first or second fastening rims divided by the shortest distance between the valve inlet and the valve outlet inside the valve passage. Thus if the valve passage is curved, the shortest distance shall be measured as the shortest line that may be drawn, which passes through the passage without crossing or coinciding with one of the fastening rims. In one embodiment, the rim-passage ratio is at least 10, such as at least 25, such as at least 50, such as at least 75, such as at least 100, such as at least 150, such as at least 200, such as at least 300, such as at least 400, such as at least 500.
It will be appreciated that in some embodiments, it will be desirable to be able to remove a part of the air in the compartment i.e. to deflate the compartment slightly. As an example this may be desirable when the medical device is a heel lifting device as removal or addition of air to the compartment may cause the heel to be elevated or lowered relative to the surface onto which the device rests. Thus, a desired lifting height may be achieved.
Accordingly in one embodiment, at least a part of the passage is shaped so as to allow an elongated element to pass through the passage without touching either of the first and the second fastening rim. This element may be hollow to allow the air to flow through the passage defined in the hollow element. Alternatively, the element may be solid but shaped such that it forces the walls of the valve passage (i.e. the two sheets of valve foil) away from each other whereby an air passage is defined through which the air may flow.
In order to achieve a high rim-passage ratio, at least a part of the first and/or the second fastening rim may be curved such that at least a part of the first or the second fastening rim extends in a direction transverse to a line extending between the valve inlet and the valve outlet. This curved part may from one or more S-curves or form one or more spiral-lines such as double-spiral lines. Alternatively, or as a supplement, at least a part of the first and/or second fastening rim may form a zig-zag shape.
In one embodiment, at least one of the first and the second fastening rims defines one or more rim projections each of which extends in a direction transverse to a line extending between the valve inlet and the valve outlet, such as in a direction which is orthogonal relative to said line. In one embodiment, this line may follow a line defining the shortest distance between the valve inlet and the valve outlet inside the valve passage.
Again, in order to achieve the high rim-passage ratio at least one of the rim projections may define a projection length along the first or second fastening rims, which is at least a third of the length of the line extending between the valve inlet and the valve outlet, such as at least half the length of the line extending between the valve inlet and the valve outlet. In one embodiment, the sum of all the projection lengths (i.e. when more than one rim projection is defined) is at least 20 times the length of the line extending between the valve inlet and the valve outlet. In one embodiment, each rim projection is U-shaped thus defining two straight parts which are joined by a curved portion. The two straight parts may be parallel or substantially parallel. In one embodiment, each rim projection defines two parallel rim portions which extend towards the line extending between the valve inlet and the valve outlet and which are connected to each other by means of a curved rim portion. In one embodiment, at least one rim projection is V-shaped i.e. forming two straight lines which meet in one single point. One
or more of the straight parts of the U- and/or V-shaped rim projections may extend in a direction transverse to the longitudinal direction of the valve passage.
In one embodiment, at least one of the rim projections is arranged so as to guide the elongated element towards the valve outlet during insertion of the elongated element into the valve passage through the valve inlet. The latter may be achieved by designing any part of the fastening rim which the elongated element may come into contact with during insertion, such that the elongated element is forced/guided towards the center of the valve passage. As an example these parts of the fastening rim may be inclined with respect to the longitudinal direction of the valve passage. It will be appreciated that the larger the number rim projections is, the higher the rim- passage ratio will be. Thus each of the first and the second fastening rims may comprise a plurality of rim projections, such as two, such as three, such as four, such as five, such as six, such as seven, such as eight, such as nine or such as ten.
In one embodiment, the inflatable and / or vaccumizable medical device is an inflatable heel lifting device which is adapted to lift a heel of a user from a surface onto which the heel lifting device rests. Such a device may comprise any combination of features and elements of the invention according to the second aspect.
In a SECOND aspect the present invention relates to a heel lifter (or a heel lifting device) for lifting a user's heel from a surface while the user rests on his back, thus relieving the heel, said heel lifter being made from a material that allows moisture and water passing therethrough and which is air tight so that the heel lifter in it's air filled state forms two sides between which the lower leg is positioned during use to relieve the lower leg, said heel lifter including a valve through which the cells can be filled with air, which can be closed, whereby air can not get out again. In one embodiment, the heel lifter is designed so that it forms two elongated cells, which, when they are inflated, create a space between the two cells, thereby providing space for the Achilles tendon, so that this during the use will not be damaged or too affected by pressure and thus is spared.
In one embodiment, the gap between the two cells forms a V shape. In one embodiment, the large cells in the first end - behind up towards the knee - are tapered in such a way as not to create an edge to the calf.
In one embodiment, the large cells are designed so that they do not support the user's heel, so that it during use hovers freely and is not exposed to pressure.
In one embodiment, the heel lifter at the other end, opposite to the first end, forms two vertical cells between which a piece of plastic prevents the foot from falling forward during use.
In one embodiment, the plastic piece between the two vertical cells is non-inflatable, so that a flat piece of plastic is formed under the user's foot during use.
In one embodiment, the heel lifter at the sides of the user's foot forms two elongated channels with air that prevent the malleoluses from being damaged. In one embodiment, the upper part of each of the two sides can be fastened to each other.
The invention according to the second aspect relates to a single patient use only or disposable relief aid for the prevention of decubitus or pressure ulcers on a heel, a heel lifter. The heel lifter helps lifting the heel of people from a surface while they are for instance lying on their back, whereby the heel or the heels are relieved, thereby avoiding pressure on the heel or the skin on the heel.
This is especially good if the user is a patient with heel wound(s), pressure ulcers, decubitus on the heel or by it, or if the user is in danger of developing these disorders or at risk for it. The heel lifter is made of a material that is not permeable to air and can therefore be inflated with air and keep the air inside the product for a long time. The heel lifter is made of a material that allows the passing of moisture or water while it is at the same time airtight. The moisture comes e.g. from the patients secretion, sweat, perspiration, and this moisture can lead to skin lesions and burns and skin injuries similar to burns and that the skin breaks and sores and skin injuries form, therefore there must be no moisture.
The material that lets moisture pass may for instance work in a way where the moisture passes through the material or the material may work in a way where the material first absorbs the moisture from one side and thereafter lets it evaporate on the other side.
In some cases, moisture will get into an air-filled cavity in the product, but it can then get out through the next layer of material facing the outside, e.g. not toward skin.
The heel lifter is inflated with air and thus has a perfect or near perfect or good pressure distribution of the weight lying on top because the air distributes inside the heel lifter automatically and thus does not press more on one spot of the user than on another spot of the user. This is an advantage since the disorder, which must be remedied may have occurred exactly because of pressure and because the patient may very well suffer from weak skin that is easily affected or damaged by pressure or for example suffer from poor circulation of the blood, which may also increase the risk of being harmed.
With the good pressure distribution follows that where the patient rests on the heel lifter, there is an even pressure all over and thus there are no specific points where more pressure is applied to the body than elsewhere, and thus the risk of new damage minimized or diminished.
The heel lifter is designed so that there are two large oblong cells, which lift, carry and support the calf and by the gap between the two cells gives space for the Achilles tendon, so that the Achilles tendon is not damaged or pressure influenced too much and thus the Achilles tendon is spared.
The two cells are in their bloated state, seen in a section, two cylinders lying side by side, thereby leaving a v-shaped space on top of the inflated shape. The two large oblong cells can simultaneously remain stable against the underlying surface and keep the leg in a good position.
Behind up towards the knee, the two large cells are tapered, so that there is not an edge against the calf, which would have pressure affected the patient unreasonably with possible damage or nuisance as a consequence.
Where the user's heel is placed in the product, it is ensured that there is no support, and this is achieved by designing the cells' shape and restraint in relation to each other in a way so that there are no cells under the heel, whereby it can hover freely and not be exposed to pressure.
At the same time, the cells shape and restraint in relation to each other are designed to enclose and gently hold the foot so that the heel lifter remains in the same place regardless of the user for example turning in bed or turning the leg or foot.
The retaining and closure of the product is made by a non bloated part of the product made from some kind of material passing over the foot so that the not closed heel lifter gives very easy access to the loading of the foot or leg and so that you can easily use the loose part to attach to the other side of the product, thereby positioning the product in relation to the user in the most advantageous way and in a manner, so that you can be sure that the heel lifter does not shift in a disadvantageous way.
The securing between the two sides can be done by for example laces, self-adhesive, velcro, buttons, magnets or clamping.
At the foot there is on two sides vertical cells, which keep a piece of plastic between them up, air pressure inside the cells ensures that the cells cannot collapse and so the plastic is kept up, whereby the foot on the lying person can not fall forward and cause problems such as the diseases equine foot or foot drop, as the foot is prevented from falling forward and instead is supported in a position that is closer to a vertical position than the foot would have otherwise assumed. At the foot there is on the sides two vertical cells which keep a piece of plastic between them up, and this piece of plastic has no built-in cells and thus can not inflate like a pillow, and thereby an entirely flat piece of plastic is created under the user's foot, this causes that walking is not bothered and that the user therefore is in a smaller danger of for example tripping, falling, distorting the foot or the like, if it is attempted to stand or walk while wearing the heel lifter.
The heel lifter is produced by putting two pieces of plastic film together, and this can be done favorably by for example welding the layers together or by gluing them together, and by not putting all of the surface together, but instead leave some spaces unjoined, the opportunity arises to fill air between the two layers and thus to obtain a cushion-like structure. The air can get into the cavities for example through a valve or through a kind of tube or long cell in the material, and these can be closed or close themselves as with a valve, so that the air can not get out again. In some cases, it is desirable to let out the air again, so the closing arrangement (-s) can be made so that you can to let air out, thus adjusting the air pressure to the benefit of the intended effect of the product. For example, a self-closing valve can be designed as a part of the two previously mentioned plastic film layers or as a separate part and be inserted between the layers and be welded or glued. The internal pressure in the product can then help closing the valve system so that air does not escape.
The material which the heel lifter is made of is of a type which is not harmful to humans and which by the end of its use can be disposed of without special measures and which does not take up a lot of space if the air is let out or if punctured by for instance cutting off a corner.
In this way, a very hygienic product is achieved, as a soiled product is simply replaced by a new clean one. This saves big costs for logistics and cleaning and minimizes the possibility of errors and sources of infection.
On the side of the product off the foot sides are two oblong channels with air placed so that they prevent the malleoluses from being harmed. These channels also provide a good relief or pressure distribution when the user is lying so that the leg or foot rest on the side. On the upper surface of the product, a closing device is placed, that can be designed with self-adhesive closures, so there for example is a kind of strip that can be placed over the product around the leg, so the product sits fairly firmly on the foot and thereby is not moved to such an extent that it may cause inconvenience, and thus the user can e.g. turn over in bed and be confident that the product still sits in a good way, and turn back on his back again and still have the product sitting in a good way.
BRIEF DESCRIPTION OF THE FIGURES
Fig. 1 discloses a first embodiment of the invention according to the first aspect, Fig. 2 discloses a second embodiment of the invention according to the first aspect, Fig. 3 discloses a third embodiment of the invention according to the first aspect, Fig. 4 discloses a fourth embodiment of the invention according to the first aspect, Fig. 5 discloses a cross-section through a fastening rim, Fig. 6 discloses a cross-section through a fastening rim,
Fig. 7 discloses a side elevational view of the invention according to the second aspect, and
Fig. 8 discloses a cross-sectional end elevational view of the invention according to the second aspect.
DETAILED DESCRIPTION OF THE FIGURES
Figs. 1-4 discloses four different embodiments of the self sealing valve 100 each of which are defined by a first and a second sheet of valve foil 102,104, which are fastened to each other such that a first fastening rim 106 and a second fastening rim 108 is defined. The two sheets of valve foil extend into the inflatable and / or vaccumizable compartment of a medical device and are arranged on top of each other such that when a predetermined pressure is established in the compartment, the valve is self sealing.
The self sealing valve 100 defines a valve passage 110 which extends from a valve inlet 112 to a valve outlet 114. In all the drawings the distance from the valve inlet 112 to the valve outlet 114 along either of the first and the second fastening rim 106,108 are substantially longer than the shortest distance between the valve inlet 112 and the valve outlet 114. The relationship between these two distances is designated the rim-passage ratio in the present invention and is at least two.
It will be appreciated that the first fastening rim 106 and the second fastening rim 108 are both shaped with the aim of providing very long fastening rims 106,108. In the embodiments of Figs. 1-3, the first and the second fastening rims 106,108 define rim projections 116, each of which extends in a direction transverse to a line 118 extending between the valve inlet and the valve outlet. The rim projections extend from a sidewall part 119 of the fastening rims 106,108. and each define a first and a second straight part 120,122 which are parallel or substantially parallel and which are joined together by means of a U-shaped part 124. The combined length of the first and the second straight parts 120,122 may be called the projection length, which may be at least a third of the length of the line 118 extending between the valve inlet 112 and the valve outlet 114.
In the embodiments of the figures, the rim projections 116 are arranged so as to guide an elongated element not illustrated towards the valve outlet during insertion of the elongated element into the valve passage through the valve inlet. This causes an air passage to be defined along the elongated element or inside the elongated element in cases where the latter is hollow.
Figs. 5 and 6 disclose a cross-section through a fastening rim 106,108. Due to the thickness of the adhesive 126 in the embodiment of Fig. 5 a small air escape passage 128 is defined between the adhesive 126, and the first and a second sheet of valve foil 102,104. By providing long fastening rims 106,108 the likelihood of this passage 128 being blocked at some point is increased. In the embodiment of Fig. 6, the two sheets of valve foil 102,104
are welded together. Again a small air escape passage 128 is defined due to the deformation of the sheets of valve foil during the welding process.
Fig. 7 and 8 discloses the invention according to the second aspect. A heel lifter 200 for lifting the a user's heel from a surface 202 while the user rests on his back and/or when the legs of the user is resting on its dorsal side.
The heel lifter being made from a material that allows moisture and water passing therethrough and which is air tight so that the heel lifter in it's air filled state forms a medial side 204 and a lateral side 206 between which the lower leg (the lower limb) is positioned during use to relieve the lower leg. The heel lifter includes a valve (e.g. the one described in Figs. 1- 6) through which cells can be filled with air.
The heel lifter is designed so that it forms two lower elongated cells - a lower medial elongated cell 208 and a lower lateral elongated cell 210 - , which, when they are inflated, create a space 212 between the two cells 208,210, thereby providing space for the Achilles tendon (not visible in the figures), so that this during the use will not be damaged or too affected by pressure and thus is spared.
The large cells 208,210 in a first end 214 - behind up towards the knee 216 - are tapered in such a way as not to create an edge to the calf. The large cells 208,210 are designed so that they do not support the user's heel 218, so that the heel 218 during use hovers freely above the surface 202 and is not exposed to pressure. The heel lifter at an other/second end 220, opposite to the first end 214, forms two vertical cells 222 between which a piece of plastic (not visible in the figures but extending in a direction into and out off the figure) prevents the foot from falling forward (i.e. to the right in the figure) during use.
The plastic piece between the two vertical cells 222 is non-inflatable, so that a flat piece of plastic is formed under the user's foot 224 during use.
The heel lifter at the sides of the user's foot forms two upper elongated channels cells - a upper medial elongated cell 226 and a upper lateral elongated cell 228 - with air that prevent the malleoluses 230 from being damaged.
The upper part of each of the two sides 204,206 can be fastened to each other by means of a fastening means 232.
Claims
1. An inflatable and / or vaccumizable medical device comprising at least two sheets of compartment foil which are attached to each other so as to form an inflatable and / or vaccumizable compartment, the inflatable and / or vaccumizable medical device comprising a self sealing valve which is defined by two sheets of valve foil; the two sheets of valve foil extending into the inflatable and / or vaccumizable compartment and being arranged with respect to each other such that when a predetermined pressure is established in the inflatable and / or vaccumizable compartment, the two sheets of valve foil are forced towards each other whereby the valve is sealed; the two sheets of valve foil being fastened to each other such that a first and second fastening rim is defined and such that a valve passage is defined between the two sheets of valve foil and the first and second fastening rims, the valve passage defining a valve inlet and a valve outlet;
wherein
a rim-passage ratio defined as
- the distance from the valve inlet to the valve outlet along either of first or second fastening rims
divided by
- the shortest distance between the valve inlet and the valve outlet inside the valve passage,
is at least two.
2. An inflatable and / or vaccumizable medical device according to claim 1, wherein the rim- passage ratio is at least 10.
3. An inflatable and / or vaccumizable medical device according to any of claims 1 or 2, wherein the rim-passage ratio is at least 50.
4. An inflatable and / or vaccumizable medical device according to any of the preceding claims, wherein at least a part of the passage is shaped so as to allow an elongated element to pass through the passage without touching either of the first and the second fastening rim.
5. An inflatable and / or vaccumizable medical device according to any of the preceding claims, wherein at least a part of the first and/or the second fastening rim is curved such that at least a part of the first or the second fastening rim extends in a direction transverse to a line extending between the valve inlet and the valve outlet.
6. An inflatable and / or vaccumizable medical device according to any of the preceding claims, wherein at least one of the first and the second fastening rims defines one or more rim projections each of which extends in a direction transverse to a line extending between the valve inlet and the valve outlet.
7. An inflatable and / or vaccumizable medical device according to claim 6, wherein at least one of the rim projections defines a projection length along the first or second fastening rims, which is at least a third of the length of the line extending between the valve inlet and the valve outlet.
8. An inflatable and / or vaccumizable medical device according to claim 6 or 7, wherein at least one of the rim projections is arranged so as to guide the elongated element towards the valve outlet during insertion of the elongated element into the valve passage through the valve inlet.
9. An inflatable and / or vaccumizable medical device according to any of the preceding claims, wherein each rim projection defines two parallel rim portions which extend towards the line extending between the valve inlet and the valve outlet and which are connected to each other by means of a curved rim portion.
10. An inflatable and / or vaccumizable medical device according to any of the preceding claims, wherein each of the first and the second fastening rims comprises a plurality of rim projections.
11. An inflatable and / or vaccumizable medical device according to any of the preceding claims, wherein the inflatable and / or vaccumizable medical device is an inflatable heel lifting device which is adapted to lift a heel of a user from a surface onto which the heel lifting device rests.
12. A heel lifter for lifting a user's heel from a surface while the user rests on his back, thus relieving the heel, said heel lifter being made from a material that allows moisture and water passing there-through and which is air tight so that the heel lifter in it's air filled state forms two sides between which the lower leg is positioned during use to relieve the lower leg, said heel lifter including a valve through which the cells can be filled with air, which can be closed, whereby air can not get out again.
13. Heel lifter according to claims 12, wherein the heel lifter is designed so that it forms two elongated cells, which, when they are inflated, create a space between the two cells, thereby providing space for the Achilles tendon, so that this during the use will not be damaged or too affected by pressure and thus is spared.
14. Heel lifter according to claim 13, where the gap between the two cells forms a V shape.
15. Heel lifter according to claim 13 or 14, wherein the large cells in the first end - behind up towards the knee - are tapered in such a way as not to create an edge to the calf.
16. Heel lifter according to any of the claims 13-15, wherein the large cells are designed so that they do not support the user's heel, so that it during use hovers freely and is not exposed to pressure.
17. Heel lifter according to any of claims 12-16, wherein the heel lifter at the other end, opposite to the first end, forms two vertical cells between which a piece of plastic prevents the foot from falling forward during use.
18. Heel lifter according to claim 17, where the plastic piece between the two vertical cells is non-inflatable, so that a flat piece of plastic is formed under the user's foot during use.
19. Heel lifter according to any of claims 12-18, wherein the heel lifter at the sides of the user's foot forms two elongated channels with air that prevent the malleoluses from being damaged.
20. Heel lifter according to any of claims 12-19, wherein the upper part of each of the two sides can be fastened to each other.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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DKPA201000383 | 2010-04-29 | ||
DKPA201000383 | 2010-04-29 |
Publications (1)
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WO2011135078A1 true WO2011135078A1 (en) | 2011-11-03 |
Family
ID=44583634
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/EP2011/056847 WO2011135078A1 (en) | 2010-04-29 | 2011-04-29 | An inflatable and / or vaccumizable medical device |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2016139445A1 (en) * | 2015-03-03 | 2016-09-09 | Frontier Therapeutics Limited | Limb support and limb support fastening arrangement |
WO2016142650A1 (en) * | 2015-03-11 | 2016-09-15 | Jake Timothy | Graduated pressure applicator |
Citations (3)
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US4266298A (en) * | 1980-01-31 | 1981-05-12 | Marlene S. Mindey | Inflatable heel protector |
US4949756A (en) * | 1988-08-31 | 1990-08-21 | Uresil Corporation | One-way valve |
WO1999011204A1 (en) * | 1997-09-04 | 1999-03-11 | Gaymar Industries, Inc. | Heel care device and method |
-
2011
- 2011-04-29 WO PCT/EP2011/056847 patent/WO2011135078A1/en active Application Filing
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4266298A (en) * | 1980-01-31 | 1981-05-12 | Marlene S. Mindey | Inflatable heel protector |
US4266298B1 (en) * | 1980-01-31 | 1996-05-21 | Mindey Marlene S | Inflatable heel protector |
US4949756A (en) * | 1988-08-31 | 1990-08-21 | Uresil Corporation | One-way valve |
WO1999011204A1 (en) * | 1997-09-04 | 1999-03-11 | Gaymar Industries, Inc. | Heel care device and method |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2016139445A1 (en) * | 2015-03-03 | 2016-09-09 | Frontier Therapeutics Limited | Limb support and limb support fastening arrangement |
WO2016142650A1 (en) * | 2015-03-11 | 2016-09-15 | Jake Timothy | Graduated pressure applicator |
US11266536B2 (en) | 2015-03-11 | 2022-03-08 | Jacob Timothy | Graduated pressure applicator |
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