Patent Application
20240164916
The technical field generally relates to limb-prosthesis interfaces, and more particularly to adjustable overlaying liner-prosthesis interfaces, and to corresponding methods.
Prosthetic liners are commonly used to act as a barrier or interface between an amputated or residual limb (or stump) and a socket of a prosthesis, for the purpose of increasing comfort and maintaining a consistent fit of the prosthesis onto the residual limb. Nevertheless, most liners do not account for the variation in volume, decrease in blood flow in the limb, increased temperature of the limb, and/or any pain and injury commonly related to the prolonged use of a prosthesis. Moreover, some users find known liners to be uncomfortable due to a poor pressure distribution resulting from the limb-liner-socket interface. When using a prosthetic socket, normal and shear forces are generated upon the skin of the residual limb. Many known liners fail to distribute pressure evenly about the residual limb, causing areas of the limb to be subject to pressure greater than others. The concentrated pressure areas can cause discomfort, pain, and pressure marks. To overcome these concerns, the prosthesis would normally need to be removed multiple times a day or multiple layers of socks or liners would need to be applied. Nevertheless, this only temporarily treats the discomfort and is not an effective solution.
U.S. Pat. No. 10,806,606 discloses a liner system for reducing motion between a socket of a prosthesis and a limb inserted therein. The liner system teaches using shims placed around the limb to compensate for variation in limb volume. One drawback of such liner system is that it forces the user to purchase a complete new system including a new liner to benefit from the advantages promised by such liner system.
In view of the above, there is a need for a limb-prosthesis interface which would be able to overcome or at least minimize some of the above-discussed prior art concerns.
It is an object of the present invention to provide an adjustable overlaying interface for adjusting a prosthesis to a liner worn over a residual limb of a user that overcomes or mitigates one or more disadvantages of known such adjusting systems, or at least provides a useful alternative. The invention provides the advantage of being compatible with standard liners and prosthesis that a user likely already owns. Moreover, the invention provides the advantage of being adapted to locally compensate where the limb volume varies rather than generally all around the limb.
In accordance with an embodiment of the present invention, there is provided an adjustable overlaying interface for adjusting a prosthesis to a liner worn over a residual limb of a user. The adjustable overlaying interface comprises a sleeve, an inflatable bladder and a fluid-providing device. The sleeve is pullable on an outer surface of the liner, thereby being adapted to be worn over the liner and at least partially inside a socket of the prosthesis. The inflatable bladder is attached to or integrally formed with the sleeve. The fluid-providing device is fluidly connected to the inflatable bladder and is operative to inflate the inflatable bladder with a fluid. The variations in volume of the residual limb may therefore be compensated by using the fluid-providing device to inflate and/or deflate the inflatable bladder.
Optionally, the adjustable overlaying interface may further comprise a valve fluidly connected to the inflatable bladder in order to selectively let the fluid out of the inflatable bladder.
Optionally, the sleeve is at least partially made of a stretchable material so as to snugly fit over the liner. At least a portion of the sleeve may have a stretchability of at least 10% and may have a tensile module of less than substantially 100 kPa. The sleeve material may at least partially be made of an antibacterial material and may at least partially made of a fabric. Optionally, the sleeve may at least be partially made of a material selected from the list consisting of: nylon, polyester, elastane, aramid fibers, cotton, wool, silk, thermoplastic polyurethane, polyurethane and polyvinyl chloride or a combination thereof.
Optionally, at least a portion of an inner surface of the sleeve may have a sleeve friction coefficient against human skin of less than substantially 1. The inner surface of the sleeve may have a first zone and a second zone, in which case the first zone represents at least 60% of a total inner surface area of the sleeve and may have a friction coefficient against human skin of less than 0.5. The second zone may have a friction coefficient against human skin greater than the friction coefficient of the first zone and less than 1. The second zone may be arranged at at least one of distal and proximal end portions of the sleeve.
Optionally, the inflatable bladder may be permanently attached to the sleeve. The inflatable bladder may be secured to an outer surface of the sleeve whereas at least a portion of the outer surface of the sleeve is adapted to face an inner surface of the socket. The inflatable bladder may extend over less than 270 degrees of a circumference of the sleeve or even less than 180 degrees of the circumference of the sleeve, but more than 90 degrees of the circumference of the sleeve.
The inflatable bladder comprises two walls sealed together on a periphery thereof. Optionally, the two walls are further attached together locally and within their periphery so as to define relief zones where the inflatable bladder is uninflatable and a plurality of inflatable cells where the inflatable bladder can be inflated. The inflatable cells create a visible pattern on at least a portion of an outer surface of the adjustable overlaying interface, the outer surface being adapted to face at least a portion of the inner surface of the socket. The pattern is indicative of an adjustable zone to be aligned over a predetermined muscular portion of the residual limb of the user that is prone to varying in volume. At least one of the plurality of inflatable cells may be smaller than a circle of 60 mm of diameter. The pattern may extend along a longitudinal axis of the sleeve.
Optionally, the inflatable bladder may be made, at least partially, of a stretchable material. The material also be the same material as used for the sleeve. The inflatable bladder may use a film made of a bladder material impervious to the fluid. This bladder material may be selected from the list consisting of: thermoplastic polyurethane, thermoplastic elastomer, polyurethane, polyvinyl chloride or a combination thereof.
Optionally, the thickness of the adjustable overlaying interface may be less than 3 mm, or even less than 2 mm, along substantially an entirety of a periphery thereof when the inflatable bladder is fully deflated. It may even be less than that, for example, less than 1.5 mm.
Optionally, the fluid-providing device may be adapted to pressurize and pump a compressible fluid. Both the fluid-providing device and the valve may be located proximate a longitudinal extremity of the sleeve so as to be outside the socket when in use. The fluid-providing device may be longitudinally spaced apart from the inflatable bladder. The fluid-providing device may be one of a pump and a cartridge of pressurized compressible fluid such as a CO2 cartridge.
In accordance with another embodiment of the present invention, there is provided a prosthetic liner-recovering sheath for use with a prosthetic socket and an associated liner. The prosthetic liner-recovering sheath comprises a sheath body and a thickness-adjusting system. The sheath body is substantially tubular along at least a longitudinal portion thereof and has a liner-superposing inner surface at least partially defining a liner-receiving cavity. The thickness-adjusting system is secured to or is integrally formed with the sheath body and comprises at least one variable-volume pad arranged to be pressurized so as to adjust a thickness of the sheath along at least a portion of a periphery thereof.
Optionally, the thickness-adjusting system further comprises a fluid-providing device in fluid communication with the at least one variable-volume pad to respectively inflate and deflate the at least one variable-volume pad. The thickness-adjusting system may further comprises a valve which is fluidly connected to the at least one variable-volume pad in order to selectively let the fluid out of the at least one variable-volume pad.
Optionally, the sheath body is at least partially made of a stretchable material so as to snugly fit over the liner. At least a portion of the sheath body may have a stretchability of at least 10% and may have a tensile module of less than substantially 100 kPa. The sheath may at least partially be made of an antibacterial material and may at least partially made of a fabric. Optionally, the sheath body may at least be partially made of a material selected from the list consisting of: nylon, polyester, elastane, aramid fibers, cotton, wool, silk, thermoplastic polyurethane, polyurethane and polyvinyl chloride.
Optionally, at least a portion of an inner surface of the sheath body may have a sheath body friction coefficient against human skin of less than substantially 1. The inner surface of the sheath body may have a first zone and a second zone, in which case the first zone represents at least 60% of a total inner surface area of the sheath body and may have a friction coefficient against human skin of less than 0.5. The second zone may have a friction coefficient against human skin greater than the friction coefficient of the first zone and less than 1. The second zone may be arranged at at least one of distal and proximal end portions of the sheath body.
Optionally, the variable-volume pad may be permanently attached to the sheath body. The variable-volume pad may be secured to an outer surface of the sheath body whereas at least a portion of the outer surface of the sheath body is adapted to face the inner surface of the socket. The variable-volume pad may extend over less than 270 degrees of a circumference of the sheath body or even less than 180 degrees of the circumference of the sheath body, but more than 90 degrees of the circumference of the sheath body.
The variable-volume pad comprises two walls sealed together on a periphery thereof. Optionally, the two walls are further attached together locally and within their periphery so as to define relief zones where the variable-volume pad is uninflatable and a plurality of inflatable cells where the variable-volume pad can be inflated. The inflatable cells create a visible pattern on at least a portion of an outer surface of the adjustable overlaying interface, the outer surface being adapted to face at least a portion of the inner surface of the socket. The pattern is indicative of an adjustable zone to be aligned over a predetermined muscular portion of the residual limb of the user that is prone to varying in volume. At least one of the plurality of inflatable cells may be smaller than a circle of 60 mm of diameter. The pattern may extend along a longitudinal axis of the sheath body.
Optionally, the variable-volume pad may at least partially be made of a stretchable material. The material also be the same material as used for the sheath body. The variable-volume pad may use a film made of a bladder material impervious to the fluid. This bladder material may be selected from the list consisting of: thermoplastic polyurethane, thermoplastic elastomer, polyurethane, polyvinyl chloride.
Optionally, the thickness of the adjustable overlaying interface may be less than 3 mm, or even less than 2 mm, along substantially an entirety of a periphery thereof when the variable-volume pad is fully deflated. It may even be less than that, for example, less than 1.5 mm.
Optionally, the fluid-providing device may be adapted to pressurize a compressible fluid. Both the fluid-providing device and the valve may be located proximate a longitudinal extremity of the sheath body so as to be outside the socket when in use. The fluid-providing device may be longitudinally spaced apart from the variable-volume pad. The fluid-providing device may be one of a pump and a cartridge of pressurized compressible fluid such as a CO2 cartridge.
In accordance with another embodiment of the present invention, there is provided a prosthetic liner-recovering sheath for use with a prosthetic socket and an associated liner. The prosthetic liner-recovering sheath comprises a sheath body and a thickness-adjusting system. The sheath body is substantially tubular along at least a longitudinal portion thereof and has a liner-superposing inner surface at least partially defining a liner-receiving cavity. The thickness-adjusting system is secured to or is integrally formed with the sheath body and comprising at least one variable-volume pad arranged to be pressurized so as to adjust a thickness of the sheath along at least a portion of a periphery thereof.
In accordance with another embodiment of the present invention, there is provided a kit for adjusting a prosthesis to a residual limb of a user. The kit comprises an inner member and an adjustable outer sheath. The inner member has a limb-facing surface at least partially delimiting a limb-receiving cavity and being superposable onto the residual limb of the user. The inner member also has an opposed outer surface. The adjustable outer sheath comprises a sheath body and a thickness-adjusting system. The sheath body overlays at least partially the outer surface of the inner member. The thickness-adjusting system is secured to or is formed integral with the sheath body. The thickness-adjusting system comprises at least one variable-volume bladder arranged to be pressurised so as to adjust a thickness of the adjustable outer sheath along at least a portion of a periphery thereof.
In accordance with another embodiment of the present invention, there is provided a kit for adjusting a prosthesis to a residual limb of a user. The kit comprises 1) an inner member having a limb-facing surface at least partially delimiting a limb-receiving cavity and being superposable onto the residual limb of the user and an opposed outer surface; and 2) the prosthetic liner-recovering sheath as previously described and overlaying at least partially the outer surface of the inner member.
In accordance with another embodiment of the present invention, there is provided a method for mounting a prosthesis to a residual limb of a user. The method comprises:
Optionally, the action of b) installing the adjustable overlaying interface may comprise pulling the sleeve of the adjustable overlaying interface over the residual limb. The method may further comprise the action of e) aligning the inflatable bladder of the adjustable overlaying interface over a predetermined muscular portion of the residual limb that is prone to varying in volume. The method may also comprise the action of f) inflating the inflatable bladder via the fluid-providing device. The inflatable bladder may be inflated to a predetermined inner pressure. The method may further comprise deflating the inflatable bladder to the predetermined pressure using the valve.
In accordance with another embodiment of the present invention, there is provided an adjustable residual limb-prosthesis interface, comprising: a residual limb-engaging sleeve engageable with a residual limb of a user; and a thickness-adjusting system comprising: at least one inflatable air bladder being part of or being mounted to the residual limb-engaging sleeve; and an air pump and a valve both being in fluid communication with said at least one inflatable air bladder to respectively inflate and deflate said at least one inflatable air bladder so as to adjust a thickness of the adjustable residual limb-prosthesis interface.
In accordance with another embodiment of the present invention, there is provided a prosthetic liner device for forming an interface between a residual limb and a prosthesis socket, comprising: a) a liner adapted for at least partially engaging said residual limb; b) an air pump system affixed to or being part of said liner and comprising a pump, at least one inflatable air bladder, and a valve; wherein dimensions of a gap between an outer surface of said liner and an inner surface of the prosthesis socket are adjusted by inflating and/or deflating said at least one inflatable air bladder.
In accordance with another embodiment of the present invention, there is provided a kit comprising the prosthetic liner device described herein, and at least one of a prosthesis and a prosthesis socket.
In accordance with another embodiment of the present invention, there is provided a limb prosthesis interface cushioning device for forming at least partially an interface between a residual limb and a prosthesis, the cushioning device defining a limb-receiving cavity and comprising at least one bone-contacting area at least partially made of silicone and delimiting at least partially the limb-receiving cavity.
In accordance with another embodiment of the present invention, there is provided a method for reducing discomfort, pain, heat accumulation, and/or risk of injury caused by a prolonged used of a prosthesis equipping a residual limb, said method comprising: providing a prosthetic liner device described herein; engaging the liner with the residual limb; engaging a prosthesis socket of said prosthesis with the prosthetic liner device; and actuating at least one of the pump and the valve to inflate and/or deflate said at least one inflatable air bladder to modify dimensions of a gap defined between an outer surface of the liner and an inner surface of a prosthesis socket.
In accordance with another embodiment of the present invention, there is provided a method for adjusting a cooperation between a residual limb and a prosthesis, comprising: providing an adjustable residual limb-prosthesis interface described herein; engaging the residual limb-engaging sleeve with the residual limb; engaging a prosthesis socket of said prosthesis with the adjustable residual limb-prosthesis interface; if a thickness of the residual limb-engaging sleeve is smaller than a space between the residual limb and an inner surface of the prosthesis socket, actuating the air pump to inflate said at least one inflatable air bladder; and if a pressure within the at least one inflatable air bladder is greater than a predetermined pressure, actuating the valve to deflate said at least one inflatable air bladder.
In accordance with another embodiment of the present invention, there is provided a method for adjusting a cooperation between a residual limb and a prosthesis, comprising: providing an adjustable residual limb-prosthesis interface described herein; engaging the residual limb-engaging sleeve with an existing prosthetic liner or sock that is applied on the residual limb; engaging a prosthesis socket of said prosthesis with the adjustable residual limb-prosthesis interface; if a thickness of the residual limb-engaging sleeve is smaller than a space between the residual limb and an inner surface of the prosthesis socket, actuating the air pump to inflate said at least one inflatable air bladder; and if a pressure within the at least one inflatable air bladder is greater than a predetermined pressure, actuating the valve to deflate said at least one inflatable air bladder.
For a better understanding of the embodiments described herein and to show more clearly how they may be carried into effect, reference will now be made, by way of example only, to the accompanying drawings which show at least one exemplary embodiment, and in which:
It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Nevertheless, for disclosure purposes, it should be understood that the relative proportions of the various elements as shown in the figures are disclosed.
It will be appreciated that, for simplicity and clarity of illustration, where considered appropriate, reference numerals may be repeated among the Figures to indicate corresponding or analogous elements or steps. In addition, numerous specific details are set forth in order to provide a thorough understanding of the exemplary embodiments described herein. However, it will be understood by those of ordinary skill in the art, that the embodiments described herein may be practiced without these specific details. In other instances, well-known methods, procedures and components have not been described in detail so as not to obscure the embodiments described herein. Furthermore, this description is not to be considered as limiting the scope of the embodiments described herein in any way but rather as merely describing the embodiment of the various embodiments described herein. The embodiments, geometrical configurations, materials mentioned and/or dimensions shown in the figures are optional, and are given for exemplification purposes only.
Moreover, it will be appreciated that positional descriptions such as “above”, “below”, “forward”, “rearward”, “left”, “right” and the like should, unless otherwise indicated, be taken in the context of the figures only and should not be considered limiting. Moreover, the figures are meant to be illustrative of certain characteristics of the adjustable residual limb-prosthesis interface and are not necessarily to scale.
The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one” but it is also consistent with the meaning of “one or more”, “at least one”, and “one or more than one”.
As used in this specification and claim(s), the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.
In the following description, the expression “prosthesis socket” refers to a device forming at least partially a junction between a residual limb and a prosthesis. The prosthesis socket might be part of the socket or be mountable thereto.
In the following description, the expression “prosthetic liner” usually refers to a liner acting as an interface between the user's skin and their prosthesis. The prosthetic liner is thus engageable, either directly or indirectly, with the prosthesis socket and the residual limb of the user.
Other objects, advantages and features of the present description will become more apparent upon reading of the following non-restrictive description of specific embodiments thereof, given by way of example only with reference to the accompanying drawings.
Liners typically require to be unrolled on the residual limb 14 because they are designed to provide a high level of adhesion against the skin of the residual limb 14. Liners 18 achieve such high adhesion by using a combination of factors such as a pressure against the residual limb 14, which pressure may be dependent on an elasticity (defined for instance by the material's Young's modulus), thickness of the liner 18 and on a friction coefficient. Liners 18 generally have a high friction coefficient. The liners are usually at least partially made of silicone, polyurethanes, TPE and the like, which are known to be materials with a high friction coefficient. For example, the friction coefficient between silicone and skin ranges between 1.0 and 3.0, the friction coefficient between polyurethanes and skin ranges from 0.5 to 0.7 while the friction coefficient between TPE and skin ranges between 0.8 and 3.0. Moreover, the use of a relatively large wall thickness of the liners typically ranging from 3 mm to more than 9 mm and a relatively high Young's modulus (silicones liners typically ranging from 150 kPa to 3500 kPa, polyurethane liners typically ranging from 100 kPa to 250 kPa, and TPE liners typically ranging from 100 kPa to 2500 kPa) all contribute to achieve this desired high level of adhesion between the liner 18 and the residual limb 14. Liners are used traditionally to provide cushioning to the residual limb by distributing pressure on the limb caused by a prosthetic device. The liner also protects the limb from irritation that might be caused by movement of the prosthesis against the limb. Since such liners 18 are well known in art, they will not be further described.
The adjustable overlaying interface 16 (or prosthetic liner-recovering sheath) is used to more precisely adjust the prosthesis 10 to the liner 18 worn over the residual limb 14 of the user. More precisely, the adjustable overlaying interface is designed to compensate a variation of volume of the residual limb 14. This variation of volume occurs especially where there is muscular mass. For example, on a leg, the calf region would be more prone to volume variation than the front of the leg. The adjustable overlaying interface 16 may be shaped and dimensioned to be engaged with an amputated leg or an amputated arm. The leg amputation may be at any location of the leg, such as a knee disarticulation, tibial or femoral amputation. Similarly, the arm amputation could be, without being limitative, a transhumeral or transradial amputation, a wrist disarticulation and the like.
The adjustable overlaying interface 16 comprises a sleeve 20 (also referred to as a sheath body), an inflatable bladder 22 (also referred to as a variable-volume pad) and a fluid-providing device 24 fluidly connected to the inflatable bladder 22 for pressurizing, or pumping, a fluid into it and thereby inflate the inflatable bladder 22 (i.e., increase a volume thereof). As detailed below, the inflatable bladder and the fluid-providing device at least partially form together a thickness-adjusting system which is mounted to or formed integral with the sleeve 20. The sleeve 20 is designed to be pulled on and/or superposed onto an outer surface of the liner 18 and is thereby adapted to be worn over the liner 18 and at least partially inside the socket 12 of the prosthesis 10. For instance, the sleeve (or sheath body) is substantially tubular along at least a longitudinal portion thereof. The tubular sheath body (or sleeve) has an inner surface defining a cavity which is adapted to receive the liner 18. The variations in volume of the residual limb 14 may therefore be compensated by using the fluid-providing device 24 to inflate and/or deflate the inflatable bladder 22. If the fluid-providing device 24 is not of a model capable of pumping the fluid out of the inflatable bladder 22, the adjustable overlaying interface 16 may be further equipped with a valve 25, which is also fluidly connected to the inflatable bladder 22 in order to selectively let the fluid out of the inflatable bladder 22, in order to decrease the volume thereof.
In the embodiment shown, the sleeve 20 is basically a tubular chassis—or comprises at least a substantially tubular portion—to which the inflatable bladder 22 is attached. The sleeve 20 depicted in
The inner surface 26 of the sleeve 20 may be provided with at least two distinct zones having two different friction coefficients. For example, a first zone 30, typically representing at least about 30%, for instance at least about 45%, for instance at least about 60% of a total inner surface area of the sleeve 20 may have a friction coefficient against human skin of less than 0.5 while the second zone 32 may have a friction coefficient against human skin greater than the friction coefficient of the first zone 30 yet still less than 1. The second zone 32 may be arranged at at least one of the distal end portion 34 and a proximal end portion 36 of the sleeve 20. The second zone 32 can, for example, be defined by a zone of the sleeve inner surface 26 which is provided with a material increasing the friction coefficient, or stickiness, such as a strip 38 of silicone or of a rubberized material.
Suitable fabrics may be used for manufacturing the sleeve 20. Conveniently, the sleeve material may also have antibacterial properties. By way of example, the following materials may be used for the sleeve 20: nylon, polyester, elastane, aramid fibers, cotton, wool, silk, thermoplastic polyurethane, polyurethane, polyvinyl chloride, natural fibers, or any combination thereof (such as for instance and without being limitative a micro-fiber base with a PU film lamination, knitted poly-spandex with PU film lamination or PU coating and the like). This list is not exhaustive as other materials may also be suitable. The material might be woven or non-woven.
For instance, the inflatable bladder 22 is attached to the sleeve 20. It may be permanently attached, thereby providing a thin assembly of the adjustable overlaying interface 16, or removably. The inflatable bladder 22 is secured to a sleeve outer surface 40 or within it. This sleeve outer surface 40 is adapted to at least partially face an inner surface 51 of the socket 12 and is preferably made of a wear resistant material, such as nylon or aramid fiber, or any other suitable material.
As best shown in
In the embodiment shown, the inflatable bladder 22 comprises two walls 42 (
By at least partially inflating the inflatable bladder 22, the adjustable overlaying interface 16 is at least partially expanded in a direction substantially transversal to the longitudinal axis 41 (i.e., substantially radially in an outward direction, when the overlaying interface has a substantially cylindrical shape when in use and with reference to a liner-receiving cavity at least partially delimited by the inner surface of the overlaying interface), and the outer surface 50 of the adjustable overlaying interface 16, or at least portions thereof formed by the inflatable bladder 22, is displaced towards the inner surface 51 of the socket 12. Conversely, by at least partially deflating the inflatable bladder 22, the adjustable overlaying interface 16 is at least partially compacted in a direction substantially transversal to the longitudinal axis 41 (i.e., substantially radially in an inward direction, when the overlaying interface has a substantially cylindrical shape when in use and with reference to the liner-receiving cavity at least partially delimited by the inner surface of the overlaying interface), and the outer surface 50 of the adjustable overlaying interface 16, or at least the portions thereof formed by the inflatable bladder 22, are displaced away from the inner surface 51 of the socket 12. For instance, the inflatable bladder is shaped and dimensioned to have an inflated thickness greater than about 5 mm, for instance greater than about 10 mm, for instance greater that about 20 mm, for instance greater than about 30 mm, for instance greater than about 40 mm. The inflatable bladder might be shaped and dimensioned so that at least some of the inflatable cells thereof have different inflated thicknesses, in order to increase an adjustment of the prosthetic liner-recovering sheath to the morphology of the user. This is illustrated in
The inflatable bladder 22 may be made, at least partially, of either stretchable or non-stretchable materials that are impervious to the fluid being used. The inflatable bladder 22 may be constructed of a thin material such as a film, typically made of thermoplastic polyurethane, thermoplastic elastomer, polyurethane, silicone, rubber or polyvinyl chloride or a combination thereof. This is not an exhaustive list and other suitable materials may be used. Conveniently, especially if the inflatable bladder 22 is made of a stretchable material, the sleeve 20 and the inflatable bladder 22 may be made of the same material such that the sleeve 20 constitutes one of the walls 42 of the inflatable bladder 22. In any case, it is preferable to select materials so that the thickness of the adjustable overlaying interface 16 along substantially an entirety of the periphery thereof remains less than 3 mm, or even less than 2 mm, when the inflatable bladder 22 is fully deflated. It may even be less than that, for example, less than 1.5 mm.
According to some example embodiments, the inflatable bladder 22 may be aligned with a muscle and/or bone of the residual limb for increased blood flow and comfort. For example, the inflatable bladder 22 may be aligned, at least partially, with a triceps sural, tibialis anterior, fibularis longus, extensor hallucis longus, medial gastrocnemius, lateral gastrocnemius, soleus, flexor hallucis longus, fibularis brevis (peroneus brevis), biceps femoris, and/or plantaris muscle(s) of the user. Furthermore, the inflatable bladder 22 may be aligned with a back of the leg, over an area that may extend from the intercondylar eminence or popliteal fossa to the calcaneal (Achilles) tendon, the calcaneus, or to the medial and lateral malleolus.
The fluid-providing device 24 is typically one of a pump, either manual or electric, and a pressurized cartridge of compressed fluid, for example air or CO2. If used, the cartridge could be stored in a storage pouch affixed to the sleeve 20. In the present
An assembly of the fluid-providing device 24 and the inflatable bladder 22 constitutes a thickness-adjusting system 56. Optionally, the thickness-adjusting system 56 may include the valve 25. The thickness-adjusting system 56 is best shown in
For instance, the thickness-adjusting system is permanently secured to the sheath body. Unless otherwise stated, the term permanent implies that the thickness-adjusting system can not be separated from the sheath body without at least partially damaging at least one of the thickness-adjusting system and the sheath body. For instance, the thickness-adjusting system is secured to the sheath body (for instance to an outer surface thereof) via a permanent adhesive layer, High Frequency welding (HF Welding), Radio-frequency welding (RF Welding), heat press bonding, heat welding, ultrasonic welding, or could be arranged with a closed pocket at least partially formed by the sheath body. The thickness-adjusting system could also be arranged between two layers or two components at least partially forming the sheath body. The thickness-adjusting system could also be formed at least partially integral with the sheath body: for instance, it could be conceived that the sheath body be formed at least partially of a material impervious to the fluid (for instance at least partially formed of poly-spandex with a laminated TPU layer forming one of the walls of the thickness-adjusting system, the second wall of the thickness-adjusting system being welded and/or glued to the sheath body). In another embodiment, the thickness-adjusting system is removably mounted to the sheath body, for instance removably engageable in a pocked or bladder-receiving cavity formed in the sheath body.
In more details, the action of installing 302 the adjustable overlaying interface further comprises pulling the sleeve 20 of the adjustable overlaying interface 16 over the residual limb 14. Also, the user may find it beneficial to e) align 308 the inflatable bladder 22 of the adjustable overlaying interface 16 over a predetermined muscular portion of the residual limb 14, which is typically more prone to varying in volume. In particular, and if the adjustable overlaying interface is so equipped, the user may activate the pump of the fluid-providing device 24 to do the inflating 306. Such inflating 306 can be inflating to a predetermined pressure inside the inflatable bladder 22. If the user has exceeded the predetermined pressure, or if the user overinflated the inflatable bladder 22 to a point where it is not comfortable, the user may deflate the inflatable bladder 22 to the predetermined pressure or below using the valve 25.
Several alternative embodiments and examples have been described and illustrated herein. The embodiments of the invention described above are intended to be exemplary only. A person of ordinary skill in the art would appreciate the features of the individual embodiments, and the possible combinations and variations of the components. A person of ordinary skill in the art would further appreciate that any of the embodiments could be provided in any combination with the other embodiments disclosed herein. It is understood that the invention may be embodied in other specific forms without departing from the central characteristics thereof. The present examples and embodiments, therefore, are to be considered in all respects as illustrative and not restrictive, and the invention is not to be limited to the details given herein. Accordingly, while the specific embodiments have been illustrated and described, numerous modifications come to mind. The scope of the invention is therefore intended to be limited by the scope of the appended claims.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/CA2022/050305 | 3/3/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63155930 | Mar 2021 | US |
