Ventilated prosthetic liner

Abstract

A prosthetic cushion (300) having a ventilation structure (312) that connects an interior space (305) of the prosthetic cushion (300) with an exterior (E1), thereby allowing air and moisture to transfer therebetween. The prosthetic cushion (300) includes a facing layer (316) that defines at least a portion of the perimeter of the interior space (305) of the cushion (300) and forms a perforated pattern (326) including a plurality of holes extending therethrough. A cushioning layer (312) is juxtaposed with the facing layer (316) and forms a lattice structure that includes a plurality of voids that communicate with the perforated pattern (326) of the facing layer (316).

Description

Technical Field

[0001] The present disclosure relates to medical devices, such as prosthetic or orthopedic devices. An exemplary embodiment is a pad, sleeve or foot pad, which are collectively referred to herein as a "pad", for suspension comfort in a prosthetic device system. The exemplary embodiment is formed of an elastic lattice structure and a solid layer, which creates a ventilated structure that allows air and moisture to transfer from the interior space of the pad to the exterior or surrounding pad. Background Art

[0002] Pads are well known and serve as an interface between a residual limb and a prosthetic socket, allowing a user to comfortably and safely wear the prosthetic socket and a prosthesis attached thereto, such as a prosthetic limb. Pads can, for example, provide a cushion between the end of a residual limb and the prosthetic socket, thereby avoiding pressure points on the limb when the user's weight is applied to the hard components of the prosthetic socket during use. Pads can also provide improved pressure distribution along the residual limb and within the prosthetic socket. In vacuum suspended prosthetic systems, pads can also protect the residual limb from prolonged exposure to a high vacuum.

[0003] Polymeric materials, particularly elastomeric materials, are often used to construct the pads. For example, medical grade silicones may be used that are naturally compatible with human tissue and resistant to fluids and bacteria, thereby reducing the risk of infection. Despite limited breathability, these pads generally remain fresh and odor-free after each use, and have lasting strength and thickness even with repeated use. However, many pads may not perform as well as expected after repeated use, depending on the characteristics of the user.

[0004] An elastic material may be preferred for constructing the liner because it has an inherent elasticity that conforms to the residual limb, however this is not limiting. The elasticity of the liner can be tailored to inhibit elasticity in different directions (e.g., axial) but enhance elasticity in one direction (e.g., radial) relative to another direction (e.g., axial).

[0005] Typically, the liner is constructed by molding an elastomeric material between male and female molds, thereby forming a solid layer of elastomeric material that tightly wraps around the residual limb. The elastomeric material may be extruded into a predetermined shape. The liner is molded or extruded to have a fixed cross-sectional profile, eliminating the need to adjust the profile of the molded or extruded piece.

[0006] The fixed cross-sectional profile is typically a solid piece of resilient material that is impermeable to both air and liquid, with the solid layers cohesively forming a unitary body. To provide adequate cushioning and protection for the residual limb, the pad typically includes a relatively thick layer of fluid-impermeable resilient material. The thickness may be increased at the distal end of the pad to provide additional cushioning at the point of the pad where the weight of the user is most pronounced against the prosthetic socket.

[0007] Because the cushion is comprised of a single wall or solid layer of elastomeric material, typically formed or cured from a liquid resin poured into a mold or extruded, the material can have uniform properties throughout the cushion body, or simplified properties (e.g., a tapered thickness) between the various components of the cushion. Examples of methods for making cushions can be found in U.S. Pat. No. 6,626,952, issued Sept. 30, 2003, while examples of cushions having multiple components or properties can be found in U.S. Pat. No. 6,136,039, issued Oct. 24, 2000.

[0008] A common practice is to attach a textile material to the outer surface of the cushion, the textile material having defined properties that may provide customized or desired features at specific locations. A solid elastic layer may be cured on the textile material, which requires pre-processing steps, such as sewing and forming, in order to have the desired properties. An example of such a time-consuming and costly pre-processing step is sewing the distal seam in the fabric tube to form the fabric tube into the cushion shape. Other components may be provided in the cushion, such as a hard distal cap.

[0009] Sewing and securing fabric to the cushion body and additional cushion components of elastic material may create pressure points when the cushion is worn by the user and pressed against the hard socket. Research has been conducted to minimize such effects, as described in U.S. Patent 9,770,891, issued on September 26, 2017. Nevertheless, there is still a need to simplify the process for providing such fabric or other components to the cushion body, thereby further minimizing pressure points.

[0010] A known problem with pads is moisture and heat build-up between the residual limb and the pad, which can lead to discomfort, unpleasant odor, "milking," "pistoning," and tissue breakdown. For example, medical-grade silicone is hydrophobic, which is because it is impermeable to both air and liquid. Sweat can build up between the residual limb and the pad, which can cause the pad to slide off the residual limb and become uncomfortable, affect suspension, and make the skin more susceptible to breakdown. These drawbacks can lead to unsatisfactory use of the prosthetic system, or even the risk of catastrophic failure of the prosthetic system during use.

[0011] Up to 72% of amputees experience reduced health-related quality of life due to heat and sweating. Therefore, the impact of sweat and heat on the quality of life of transfemoral amputees is significant. Sweating and heating while wearing a liner are the most common complaints reported by amputees. Traditional solid wall liners compromise the closure properties of the natural skin regulation mechanism for moisture and heat management.

[0012] There is a balance between providing a liner with sufficient cushioning and thickness to protect the residual limb from harmful long-term contact with hard or rigid surfaces and providing a breathable liner to mitigate heat and moisture buildup. One question is whether the liner can maintain the same strength, thickness, compressibility and general functionality as a traditional solid wall liner in a liner with a ventilated structure. Likewise, it is desirable to maintain the liner as being constructed of an approved and acceptable medical grade elastomeric material (e.g., silicone).

[0013] Research to bridge this gap includes providing wicking layers or absorbent materials within the silicone layer or between the silicone and textile material, which can increase the cost and complexity of constructing the liner. An example of such research is provided in U.S. Patent 9,629,732, issued on April 25, 2017. Efforts to provide holes or wicking layers and absorbent materials may compromise the functionality of the liner or result in the mechanical properties of the liner being inferior relative to conventional solid wall liners. Such existing ventilated liners may prevent or preclude other desired features in the liner, such as the outer surface perimeter profile disclosed in U.S. Patent 7,118,602, issued on October 10, 2006, and the sealing system in U.S. Patent 9,066,821, issued on June 30, 2015.

[0014] Despite these studies in the patent literature, few commercially available pads have a breathable structure that can control sweat. Other interventions to prevent sweating are tap water iontophoresis, talcum powder, wiping the stump, and exhausting gas from the stump. Injections of botulinum toxin have also been reported to be effective, but this involves a greater clinical intervention and provides only temporary relief.

[0015] There remains a need for a pad that provides the structural and cushioning benefits of traditional solid wall pads while mitigating heat and moisture buildup, while retaining the structure of medical grade materials and incorporating the features commonly found in traditional pads.

[0016] Another problem with existing systems and methods for producing pads is the difficulty and cost of providing a customized prosthetic system with features that correspond to the needs at different portions of the residual limb. Each residual limb has a unique size and shape, and a trained prosthetist must assess the needs of the user if the user's needs exceed the normal pad shape and size. Depending on how the residual limb was formed, individuals may have different bone mass structures and soft tissues, making it difficult to accommodate the unique limb shape and needs of an individual residual limb, especially as the size and needs of a particular user may be dynamic and changing due to swelling or weight changes.

[0017] Because it is difficult to achieve the structural and functional needs of every residual limb, it is desirable to provide a liner that can meet the needs of each user, whether the liner is for the lower or upper limb and whether the user requires a high vacuum, sealed exhaust, and a locking suspension system. Customized liners can be provided to amputees of various lifestyles and activity levels, but it is difficult to meet the needs of all of them using standard regular sized liners. Individuals may require material additives for easier donning and doffing, skin treatment additives, and features of traditional liners that are desired in custom liners.

[0018] Because many medical devices with elastic materials (e.g., medical grade silicone) are formed by injection molding, where silicone is injected into a space defined by a negative mold of the medical device, most medical devices do not have customized properties based on the desired degree of functionality for different areas of the user's body, but rather have uniform properties across the entire area. In the example of a pad, however, more elasticity may be desired at and behind the knee than is required above, below, and to the sides, or a different degree of breathability may be required near active muscle groups that generate more heat and fluid. A medical device is needed that provides customized properties at desired locations around the medical device rather than uniform properties.

[0019] There is a need for a cushion that can be tailored to the needs of an individual user while accommodating the features of conventional cushions. More generally, there is a need for a medical device constructed of an elastic material that provides an ideal balance of breathability and mechanical properties to withstand daily use of the device. Such a desired cushion should reduce moisture on the skin, increase perceived improvements in stability and suspension over commercially available cushions, provide comparable comfort to known cushions, and provide overall improved skin health despite prior research and alternative treatments. Summary of the invention

[0020] In some embodiments of the present disclosure, the balance between strength, comfort, breathability and other desired properties of elastomers and other polymer-based (especially elastomer-based medical grade) materials in medical devices (e.g., prosthetic and orthotic devices) is addressed. These embodiments illustrate such pads that include discretely and continuously deposited layers of medical grade elastomeric materials (e.g., silicone) used in traditional pads while maintaining mechanical strength and other mechanical properties at least comparable to such traditional pads.

[0021] While such pads may be constructed of the same medical grade elastomeric materials and have the same mechanical and chemical properties as conventional pads, the structures of the embodiments of the present disclosure provide improved cushioning, moisture removal, and / or breathability than known conventional pads. These embodiments may be provided in combination with fabric coverings, reinforcement layers, material additives, and other desired features found in conventional pads, while having the improved features described above. Although medical grade elastomeric materials are discussed, it should be understood that the present disclosure is by no means limited to medical grade materials, and any suitable material may be used.

[0022] Exemplary embodiments provide reduced moisture during increased perspiration, resulting in perceived improvements in stability and suspension, improved or at least equivalent comfort compared to conventional pads, and improved skin health.

[0023] Exemplary embodiments have features that can be extended to a wide range of medical devices, including prosthetic or orthopedic components, medical implants, medical tubes, prostheses, and other components or devices. These features can be adjusted according to the desired characteristics or needs and can be customized to meet the needs of the user. For example, features of the embodiments can be used in devices made from known medical grade elastomeric materials, eliminating the need for material approval and simplifying regulatory approval.

[0024] Embodiments of exemplary pads are configured to effectively manage sweat formed by a limb, prevent the pad from sliding on the limb, and provide suitable cushioning for the limb. The described exemplary embodiments are discussed and shown in the context of pads used with a hard socket in a prosthetic system. However, the present disclosure is not limited to the embodiments or exact uses of such prostheses described, but includes applications requiring sweat management, anti-slip, limb cushioning, or any other structural and / or functional benefits (which are derived in whole or in part from the principles of the present disclosure). The principles described herein can be extended to any prosthesis, orthopedic, or medical device, and are by no means limited to pads.

[0025] In one exemplary embodiment, the liner advantageously bridges the gap between the strength of a solid wall liner and the need for breathability when using medical grade materials. The liner can be customized to have features at specific locations corresponding to the needs of an individual user, minimizing the cost and complexity of manufacturing and providing physical structures and functions that are beneficial to different needs. The liner is just one example of different structures that can be manufactured and configured according to the principles described herein.

[0026] According to an exemplary embodiment, the pad has a first or proximal end, a second or distal end, and a tubular pad body defined between the first and second ends. The pad body preferably includes a facing layer or base layer formed of an elastic material (e.g., silicone) and has an inner surface extending along the interior of the tubular pad and defining its periphery. The facing layer defines a plurality of openings that preferably extend through the thickness of the facing layer. Since the facing layer is used to be secured to the skin of the user around the residual limb, the facing layer may have a combined solid surface area that is larger than the combined area of ​​the plurality of openings to provide an effective skin interface. The inner surface of the facing layer is preferably smooth in that it has a generally uniform surface height except for the openings.

[0027] The facing layer can include multiple filaments, which are integrally adjacent to each other and / or chemically bonded together (preferably without adhesive) to form a continuous solid layer. The filaments are aligned with each other and chemically bonded to adjacent filaments along their length without gaps. Such a structure can be formed to constitute a film that is both airtight and liquid-tight. A filament can be formed continuously against an adjacent filament, and the adjacent filament can be formed with gaps along its length, but another filament is also provided on the opposite side of the adjacent filament to form a perforated or ventilated layer; however, this perforated or ventilated layer has a real hole formed, without mechanically or chemically perforating the solid layer to form such a hole. In certain embodiments, a solid or continuous film or layer can be formed, and then the material can be removed in any suitable manner to define the hole.

[0028] A first layer formed of an elastic material is fixed to the outer surface of the facing layer (so that the facing layer is fixed to the inner side of the first layer) and includes a first set of voids having an axis corresponding to the axis of the opening of the facing layer. The first layer includes a first sublayer and a second sublayer, wherein the first sublayer includes a plurality of first filaments arranged in a first direction, and the second sublayer includes a plurality of second filaments arranged in a second direction. The second sublayer overlaps the first sublayer and forms a plurality of voids therebetween. The material properties of the elastic material forming the facing layer may be different from the material properties of the elastic material forming the first layer. The facing layer may include skin care additives, such as moisturizers, antimicrobial compositions, aloe vera, etc., while the first layer may not include them, and vice versa.

[0029] In a preferred embodiment, each long filament may have a uniform cross section extending in a predetermined shape along its length. Each long filament is formed discretely and extends continuously relative to adjacent long filaments. These discretely formed long filaments can constitute the basic unit of a pad or medical device structure. Although the preferred embodiment shows that the long filaments are arranged in a lattice network, they can be arranged at different distances and orientations relative to each other. The lattice network defines a plurality of gaps between the long filaments, resulting in a channel for transferring air and moisture through the lattice network. The long filaments can be arranged relative to each other with uncertain coordinates in x, y, z planes and / or coordinates. The cross section of the long filament can be modified so as to be similar to any desired geometric shape, such as a square, rectangle, triangle or circle, and an exemplary shape is a roughly circular structure. The cross section can be asymmetric and is different at different lengths or positions of continuous long filaments.

[0030] The first sublayer and the second sublayer of the first layer are preferably chemically and integrally bonded to each other and may be formed of the same elastic material, but still compatible materials to ensure bonding. Similarly, the facing layer and the first sublayer are chemically bonded to each other by compatible materials. In this way, the sublayers integrally form an inseparable and continuous structure that is bonded together so as to function mechanically as an integral structure. Through chemical and integral bonding, a preferred embodiment is to bond the filaments together without using an adhesive, because the elastic material that defines the filaments is a solidified material and has sufficient fluidity to allow the layers to at least slightly mix with each other at their interfaces; however, the use of an adhesive, a primer or any other suitable means does not exceed the scope of this disclosure.

[0031] Additional layers may be fixed to the second side or outside of the first layer (i.e., a second layer formed similarly to the first layer and fixed to the first layer). These additional layers are preferably formed together as an inseparable and continuous structure so as to function mechanically as an integral structure. The second layer may be chemically bonded to the second sublayer of the first layer and include a plurality of gaps whose axes correspond to the axes of the gaps of the first layer. The textile or fabric layer may be fixed to the periphery of the first layer or the additional layer. It may be breathable to allow air and moisture passage through the entire thickness of the first layer and the additional layer from the inner surface of the facing layer or the internal space of the pad. Thus, the axis extends through each gap of the first layer, the corresponding gap of the additional layer, and each or corresponding opening of the facing layer. Breathability is not limited to passing only through the wall thickness, but air and moisture may be transferred in all directions within the lattice network of the gaps (which defines the lattice structure). For example, air and moisture may be guided to be transmitted through the gaps and flow out from the proximal end of the pad leading to the external environment.

[0032] The openings of the facing layer and the gaps of the first layer and the additional layer are arranged in a controlled manner into a predetermined shape and pattern. Although the materials of the base layer, the first layer and the additional layer can be elastic, they can be formed by the same material or different materials. The base layer, the first layer and the additional layer can have different or similar mechanical properties. Depending on the position of the layer relative to the liner, these layers can be customized to have different mechanical properties. For example, the facing layer can have a lower hardness than the first layer as a whole.

[0033] In some embodiments, areas corresponding to joints such as the knee may be formed of a material that imparts greater elasticity or breathability than adjacent areas. For example, the facing layer may have a non-porous area that includes a substantial surface area of ​​the facing layer that only extends beyond the spaces between the holes, as discussed below. The non-porous area may include a solid patch area corresponding to the user's anatomy, such as the groin area, to avoid possible abrasions and skin irritation at sensitive areas of the user.

[0034] These materials are preferably compatible materials that allow chemical bonding so they are permanently attached to each other and may share at least one blending region where the materials of the various layers blend or interlock to form a permanent chemical bond. Other features, such as seals, volume control pads, cushions, distal caps, etc., may be formed of compatible materials and chemically bonded to the bulk of the pad or within its thickness.

[0035] By arranging discretely deposited filaments and material layers with different properties, the cushion advantageously provides greater precision in achieving desired mechanical properties, structure and functionality than existing cushions. For example, an inner layer may provide greater comfort by having a lower hardness, while an outer layer may have a greater thickness and greater elasticity to provide mechanical strength and desired functional properties. In some embodiments, the discretely deposited material layers may include multiple layers of deposits, dots or filaments of different materials with different properties.

[0036] According to a variation, the filaments can be arranged together with the co-extruded material, so the two materials are coaxial, and the outer layer is formed by a material having a hardness (or other characteristics) different from the material forming the inner layer. Some of the reasons are that the outer layer can protect the soft inner layer and form a firm chemical bond with the adjacent filaments. In some embodiments, the elastomer can be co-extruded with a fabric such as a yarn. In other embodiments, the elastomer can be extruded into continuous filaments with different characteristics at different positions, which can be provided by the online quantitative distribution of additives (for example, adding at certain positions to obtain a lower hardness). The stretchability of the inner layer can be controlled by the outer layer while allowing the compressibility of the soft inner layer. This embodiment allows the filaments formed discretely to have the advantage of providing multiple types of materials at the same time. For example, the liner can have the characteristics and advantages of a hard and durable material, as well as the characteristics and advantages of a soft cushioning material.

[0037] The combination or combination of adjacent filaments can be extended to the solid wall portion of the pad, which is a solid wall pad that is airtight and liquidtight, or other medical devices that have a solid wall portion or are completely solid. Preferably, the solid wall portion can be formed by a plurality of adjacent and abutting filaments, which are also discrete and continuous. In a sense, the resulting structure is preferably smooth and continuous, and the naked eye cannot identify each filament in the plurality of discrete filaments, whether mechanical, tactile or functional. The resulting structure of adjacent filaments is other filaments that have a mixed chemical bond with adjacent and abutting filaments in the x, y, z plane and / or coordinates.

[0038] In one embodiment, a fabric is provided on the outer surface of the elastic cushion body, and the elastic material is used to seal and secure the fabric to the cushion body. The fabric can be placed on the cushion body and mechanically interlocked therein, so that the elastic material of the cushion body impregnates the fabric, and discrete portions of the elastic material are used to close the fabric material around the cushion body, eliminating any stitching. This feature is advantageous because this embodiment can avoid uncomfortable pressure points by eliminating seams and stitching. This feature is also advantageous because the fabric can be connected to the cushion body at many points on the fabric, ensuring a strong, durable bond. The manufacturing process is also simplified by eliminating a separate stitching procedure.

[0039] Due to the controllability of forming a liner according to the above structure, versatility is provided in forming a customized liner with various features (which are integrally formed or fixed to each other). The liner can be custom formed from a stack of compatible materials with different but compatible properties to accommodate uniquely shaped residual limbs.

[0040] As the present disclosure is not limited to pads, other medical devices may also be formed from medical grade elastomeric materials (e.g., silicone) from discretely and continuously deposited elastomeric materials according to the principles described herein. These medical devices may be prosthetic or orthopedic components, medical implants, medical tubing, prostheses, and other components or devices that utilize such medical grade elastomeric materials.

[0041] These and other features of the present disclosure will become better understood with regard to the following description, appended claims and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 is a schematic front view of one embodiment of a cushion.

[0043] Figure 2 is along Figure 1 A cross-sectional view taken along line II-II at the interface between the main body region and the distal end of the pad.

[0044] Figure 3 is along Figure 1 A cross-sectional view taken through the inner surface of the liner is shown.

[0045] Figure 4 is a schematic half-section view showing thickness variation of the main body region.

[0046] Figure 5A is a schematic front view of another embodiment of a cushion.

[0047] Figure 5B yes Figure 5A Schematic half-section view of the thickness of the body region in the pad shown.

[0048] Figure 5C is along Figure 5A A radial cross-sectional view of the thickness of the main body region taken along line VC-VC.

[0049] Figure 5D is along Figure 5A An axial cross-sectional view of the thickness of the main body region taken along line VD-VD in FIG.

[0050] Figure 6 is a schematic cross-sectional view of the distal end of the pad.

[0051] Figure 7 is a front view of the other distal end of the pad.

[0052] Figure 8 is along Figure 7 A cross-sectional view taken along line VIII-VIII in FIG.

[0053] Fig. 9 is used in Figure 1 Schematic cross-sectional view of the manufacturing process for forming a seal on a gasket is shown.

[0054] Fig.10 yes Figure 2 Detail view of the details in X.

[0055] Fig.11 yes Figure 5A Detailed view of the details in XI.

[0056] Fig.12 yes Fig.10 Schematic cross section of a variant of a gasket.

[0057] Fig.13 is a schematic cross-sectional view of a gasket having multiple sealing bands.

[0058] Fig.14 is a perspective view of another embodiment of a cushion.

[0059] Fig.15 is along Fig.14A first cross-sectional elevation view of the illustrated gasket taken along line XV-XV.

[0060] Fig.16 It is taken from Fig.15 Detail view of detail XVI showing the perforated surface of the facing layer.

[0061] Fig.17 yes Fig.14 A proximal to distal plan view of the pad showing the interior space of the pad.

[0062] Fig.18 is along Fig.14 A second cross-sectional elevation view of the illustrated gasket is taken along line XVIII-XVIII.

[0063] Fig.19 It is taken from Fig.18 Detail view of Detail XIX showing the stacking of mesh layers in the pad along a cross section of the main body of the pad.

[0064] Fig. 20 It is taken from Fig.18 Detail view of detail XX showing the stacked layers at the distal cup.

[0065] Fig.21 It is taken from Fig.18 Detail XXI is a detailed view of FIG. 5 showing the stacking of mesh layers at the sealing recess in the sealing area.

[0066] These drawings are not drawn to scale. Instead, they are drawn to provide a better understanding of the components and are not intended to limit the scope, but rather to provide exemplary illustrations. These figures show exemplary configurations of the pads and are not intended to limit the structure or configuration of the pads and components according to the present disclosure. DETAILED DESCRIPTION

[0067] Embodiments of the pad overcome the limitations of prior pads by providing a pad structure that advantageously allows breathability, minimizes heat and moisture buildup, without sacrificing firmness, cushioning, strength, and other advantageous features of solid wall pads. The pad provides discrete areas of varying characteristics to better suit the needs of individual users and the shapes and needs of varying residual limbs.

[0068] Embodiments according to the present disclosure are not limited to pads, but pads are provided only as exemplary medical devices created according to the principles of the present disclosure. Methods and apparatuses that can make devices according to the principles of the present disclosure are described in co-pending U.S. Application Nos. 16 / 681,096 and 16 / 680,959, both filed on November 12, 2019.

[0069] According to the methods and systems of the co-pending applications, partially cured or uncured medical grade elastic materials (e.g., silicone) are sequentially deposited onto a substrate in a controlled manner from a material source through a nozzle or similar device under computer control to define a defined shape, such as an elongated or continuous filament. The deposited elastic material can be a thermosetting material, such as silicone or thermosetting polyurethane, which solidifies after being deposited from the nozzle. The additive manufacturing system of the co-pending application can deposit the elastic material together with a preferred elastic material blend to obtain the desired properties at a desired location along or within a medical device, so that the continuous filament can have different properties, composition, and shape at different locations along its length.

[0070] Examples of medical grade silicone are available from NuSil Technology, Inc. of Carpinteria, California, U.S.A., under the product names CF13-2188, MED-4901, MED-6340, or MED-6345. Other silicone compositions may be used, and the embodiments herein are not limited to these exemplary silicone materials, but may be formed from other suitable polymer or elastomeric compositions, such as polyurethanes, block copolymers, and the like.

[0071] The cushion layer or different structures of multiple layers can be formed according to the co-pending U.S. application 16 / 680,959 disclosed, especially those lattice structures or solid structures formed by filaments of elastic material. Any layer of the following pad can be made according to the co-pending application associated with the lattice or solid structure defined by multiple discretely formed filaments, or have its structure.

[0072] refer to Figure 1 , an exemplary pad 100 for prosthetic use defines a proximal end 102 and a distal end 104. The pad 100 has a main body region 106 extending distally from the proximal end 102 toward a closed distal region 110 at the distal end 104 along an axis AA. The pad includes a cushioning layer 112 located at least within the main body region 106 and is formed of a lattice structure. The lattice structure defines a plurality of voids or cavities between the structural filaments or components forming the lattice structure, which voids are inherent in the lattice structure, allowing air and moisture to be transferred through the lattice structure. In this embodiment, the cushioning layer 112 defines an outer surface O of the pad, but an outer fabric covering may also be provided as described below.

[0073] The liner 100 includes a fabric layer 114 having a first surface positioned along a second surface opposite the first surface of the liner layer 112. A facing layer 116 is positioned along the second surface opposite the first surface of the fabric layer 114. The fabric layer 114 may be porous so that it is air and liquid permeable.

[0074] The cushion includes a sealing region 108 between the body region 106 and the distal region 110. The sealing region 108 has a seal 118 extending radially from the axis AA relative to the body region 106. The seal may be formed and arranged in the same manner as the seal disclosed in US Pat. No. 9,066,821.

[0075] refer to Figure 2 and 3 , the facing layer 116 may form a predetermined pattern 126 on the second surface of the fabric layer 114. The predetermined pattern 126 preferably forms a plurality of openings 120 on the second surface of the fabric layer 114. The size of the plurality of openings 120 may be determined according to the degree of balance between providing ventilation and the adhesion of the facing layer 116 to the user's skin as required. The fabric layer 114 has a certain porosity, wherein the openings 120 of the facing layer 116 are greater than the porosity or openings of the fabric layer 114.

[0076] The facing layer 116 may be formed of a plurality of filaments 129 of elastic material, and thus the facing layer 116 is continuously formed of the plurality of filaments 129. The plurality of filaments 129 may define a mesh-like structure that extends continuously around a portion or all of the second surface of the fabric layer 114. Figure 2 As shown, the facing layer 116 secures the distal end 104 of the liner.

[0077] The distal end 104 has a thickness 124 formed of an elastic polymer. The elastic polymer forms the inner surface I of the distal end 104 of the pad. The interface 122 is preferably bonded to the elastic polymer of the distal end 104. Since the fabric layer can be sewn into a tubular shape, the facing layer 116 has a strip portion 130 extending and covering the sewing line 128 of the fabric layer 114.

[0078] like Figure 2 As shown, the fabric layer 114 may extend over the outer surface O of the distal end 104 of the cushion. The fabric layer 114 may also extend over the sealing area 108, and the seal 118 in turn extends over the fabric layer 114. Since the fabric layer 114 may be formed between the cushion layer 112 and the facing layer 116, it may extend between the cushion layer 112 and the facing layer 116 at the distal end 104 of the cushion.

[0079] Come and see Figure 2 and 10, the thickness of the cushioning layer 112 can be gradually narrowed toward the distal end by a tapered profile 113, and is fixed to a corresponding tapered profile 125 that gradually narrows at the proximal end of the thickness 124 of the distal end 104. The thickness 124 of the distal end 104 forms a recess 127 along the outer surface O, which is suitable for accommodating the seal 118. The base 131 of the seal 118 extends within the recess 127 so as not to protrude beyond the periphery of the cushion body. In this embodiment, the tapered profile 113 extends distally along the outer surface O, while the tapered profile 125 preferably extends proximally substantially along the inner surface I.

[0080] exist Fig.12 In one variation of the illustrated embodiment, the cushion 200 has a cushioning layer 202 defining a tapered region 212 that extends distally generally along the inner surface I of the cushion 200. The tapered region 214 of the thickness 210 of the elastomeric polymer at the distal end 208 of the cushion 200 corresponds to the tapered region 212 of the cushioning layer 202. In this embodiment, the cushioning layer 202 and the facing layer 206 extend distally further relative to the inner surface I than relative to the outer surface O. According to the depicted embodiment, the fabric layer 204 may be located between the cushioning layer 202 and the facing layer 206.

[0081] The cushioning layer 202 and the facing layer 206 extend in the distal region 207 of the liner 200, and may extend more distally to provide a ventilated distal end. When the outer surface of the distal end is covered by the thickness 210 of the distal end, the cushioning layer 202 may extend a distance into the entire inner surface I of the distal region 207, or extend along the entire inner surface I of the distal region 207, while the facing layer 206 is positioned along at least a portion of the inner surface I of the liner 200 and defines at least a portion of the inner surface I of the liner 200.

[0082] refer to Figure 4 In an embodiment of the present invention, a variation of the main body portion 140 includes a facing layer 142 formed by an elastomer and defines a perforated structure 148. The facing layer 142 extends along a first side of a buffer layer 144 formed by a lattice structure, and a fabric layer 146 extends along a second side of the buffer layer 144. As shown, the buffer layer 144 can be thicker than the facing layer 142, and the fabric layer can be thicker than the facing layer 142. The facing layer 142 can be formed by an elastic material having a softer or lower hardness than the buffer layer, because the facing layer 142 is used to be arranged near the user's skin. Since the main body portion needs to be ventilated, the fabric layer 146 is preferably breathable and liquid-permeable, but it can also be airtight and liquid-impermeable, and ventilation is formed through the proximal end of the buffer layer.

[0083] The lattice structure of the buffer layer 144 is preferably formed of at least one elastomer. The facing layer 142 may be formed of an elastomer having different properties from the at least one elastomer of the lattice structure of the buffer layer 144, such as having a lower hardness to form improved skin contact properties. The facing layer 142 may be formed of a plurality of filaments arranged in a pattern of a first series of filaments extending in a first direction D1 and a second series of filaments extending in a second direction D2 different from the first direction. The facing layer may be formed continuously, wherein the filaments extend in the same direction but are interrupted in a pattern of openings, such as Figure 3 shown.

[0084] The apertured structure 148 may be formed by voids between the first and second series of filaments extending in a first direction D1 and a second direction D2. The first direction D1 and the second direction D2 are generally perpendicular with respect to each other.

[0085] exist Figures 5A-5D In another embodiment shown, the main body portion 141 includes a facing layer 143 having a ventilation feature 159 formed by a plurality of openings 161 extending through its thickness. The facing layer 143 may include at least a first sublayer 143a of a first elastic material and a second sublayer 143b of a second elastic material. The first and second elastic materials may have different properties from each other, or may have the same properties, such as hardness.

[0086] The first sublayer 143a and the second sublayer 143b may be formed of filaments bonded to each other to form a generally structurally inconspicuous adhesive layer; however, a layer such as the first sublayer 143a may be defined by a plurality of filaments directly adjacent to each other in a single plane, some of which may be interrupted with respect to other filaments to form openings 161. The first sublayer 143a, which is intended to be directly adjacent to the user's skin, may be formed of a soft inner silicone elastomer, while the second sublayer 143b may be formed of a relatively hard silicone to provide structural rigidity to the facing layer to withstand the movement of the user on the facing layer 143. The opening 161 may extend through the second sublayer 143b. One advantage of this arrangement is that the first and second layers may be formed of different elastomers, such as disclosed in U.S. Patent No. 6,136,039 issued on October 24, 2000. However, the final structure of the layer 143 is formed of filaments that can provide greater control over the ventilation features 159, as opposed to the injection molding process taught in U.S. Patent No. 6,136,039.

[0087] When the ventilation feature 159 is customized to a predetermined pattern, the size of each of the plurality of openings 161 may gradually increase from the first side of the facing layer 143 or the inner surface of the main body portion toward the second side of the facing layer 143. The first sub-layer 143a and the second sub-layer 143b of the filaments may further include a supplementary layer 145, and such filaments may extend continuously to each other, intermingling with each other to define the facing layer 143 as continuous and interrupted only at the opening 161.

[0088] The supplementary layer 145 of long filament is bonded to at least one of the first sublayer 143a and the second sublayer 143b of long filament.Supplementary layer 145 may include filaments spaced apart and oriented along the third direction D3.Supplementary layer 145 of long filament may be provided to enhance the structural integrity of the facing layer, or to form an interface between the facing layer and other long filaments, particularly when there is a mismatch between the characteristics of the long filament.Supplementary layer 145 of this long filament may be used as an adhesive layer between different long filaments, so that the supplementary layer of long filament is complementary to the material for adjacent long filament layers.

[0089] The third filament layer 147 may extend along the second side of the facing layer 143 or the complementary layer 145 of filaments. The third filament layers 147 are spaced apart from each other and extend parallel to each other in the fourth direction D4. Since the fourth direction D4 generally extends axially, the third filament layer 147 can provide improved axial extension control for the pad and promote moisture release toward the proximal end of the pad.

[0090] The size of the filaments can vary depending on the desired mechanical properties associated therewith. For example, the diameter or thickness of the third filament layer 147 can be greater than the diameter or thickness of the supplementary layer 145 of the filaments, because the third filament layer 147 can control axial elongation, and the supplementary layer of the filaments can provide ventilation or bonding between the facing layer 143 and the third filament layer 147. Another example is that the diameter or thickness of the first sublayer 143a and the second sublayer 143b of the filaments can be greater than the diameter or thickness of the supplementary layer 145 of the filaments.

[0091] The main body portion 141 includes a buffer layer 165 defined by the lattice structure disclosed in the above-mentioned reference. For example, the buffer layer 165 includes at least a fourth filament layer 149 and a fifth filament layer 151. The fourth filament layer 149 and the fifth filament layer 151 extend transversely relative to each other. The fourth filament layer 149 and the fifth filament layer 151 can extend obliquely relative to the third filament layer 147. The arrangement of the fourth filament layer 149 and the fifth filament layer 151 provides compressibility and can suppress the radial extension of the main body portion 141.

[0092] The sixth layer of filaments 153 can extend with the fifth layer of filaments 151. Similar to the third layer of filaments 147, the sixth layer of filaments 153 can be spaced apart and oriented in the fourth direction D4.

[0093] The interface layer 155 may be disposed between the sixth filament layer 153 and the fabric layer 157. The interface layer 155 may be selected from materials that can provide chemical bonding or adhesion with the sixth filament layer 153 and the fabric layer 157. For example, the material of the interface layer 155 may be an elastic material that is arranged to impregnate at least a portion of the fabric layer 157.

[0094] Reference Figure 6 The distal end 150 of any of the above-described pads or those disclosed in the above-described references may have a thickness 152 that is greatest along the axis AA of the pad. The thickness 152 may taper proximally toward a tapered region 154. The distal end 150 may be preformed onto the pad body and may be formed of an elastic material.

[0095] like Figure 7 and 8 As shown, the distal end 160 of the above-mentioned cushion or those cushions disclosed in the above-mentioned references may include a fabric layer 162 extending over the distal end 160, and an outer surface O of the cushion. The distal end 160 includes a distal cover 164 having a cover body 166 formed integrally with the thickness 152 of the distal end 160. The cover body 166 may include a pin seat 168 extending at least partially into the thickness 152 of the distal end. As shown in other embodiments of the present disclosure, the distal end 160 may be formed to provide a groove for sealing.

[0096] Fig. 9 A seal 118 is shown, which can be formed from a plurality of filaments that are continuous with each other without interruption to form an air-tight and liquid-tight structure. When manufacturing the seal 118, a mold 182 can be disposed anywhere on the cushion body, such as at the distal end 104. According to the methods disclosed in the references cited above, a plurality of filaments can be deposited on the mold 182 by a dispensing head 180 to form the seal 118.

[0097] Fig.13 It is shown how the cushion body 190 can include a plurality of sealing strips 198 extending through the thickness T2 of the lattice structure 192. A plurality of filaments can form each sealing strip. The sealing strips can be formed by continuous filaments arranged without interruption. Each sealing strip can have a tip 199 that protrudes from the lattice structure or the outer surface O of the cushion body by a protruding length L1. The sealing strip can have a length equal to the sum of the protruding length L1 and the thickness T2.

[0098] Fig.14 Another embodiment of a prosthetic liner 300 according to the present disclosure is shown. Figure 1Like the exemplary liner 100 of the present invention, the liner 300 has a main body region 306 extending distally from the proximal end 302 along the axis BB toward the closed distal end 304. The liner 300 defines an interior space 305 suitable for receiving a residual limb. The liner 300 includes a cushioning layer 312 located at least within the main body region 306, and is preferably formed of a lattice or mesh combination structure, and the lattice and mesh combination structures can be used interchangeably. The cushioning layer 312 can be formed as described herein and in any of the embodiments mentioned in the above references. For example, the cushioning layer 312 can be formed of a plurality of filaments forming a lattice structure, with gaps formed between the filaments.

[0099] The lattice structure defines the size and configuration of the voids to allow air and moisture to transfer across the thickness of the cushioning layer. As in other embodiments, the liner 300 can be provided with a seal region 308 having a seal 318, and a distal region 310 below or distal to the seal region 308 and including a distal cup 320. The seal 318 is considered to extend from the outer surface E1 of the liner because it is located above the fabric layer 314.

[0100] In this embodiment, the fabric layer 314 extends along the outer surface O1 of the pad 300 between the proximal end 302 and the distal end 304. The fabric layer 314 preferably extends along the entire outer surface O1. The fabric layer 314 can be a continuous tube with or without seams, or can be segmented and positioned along the entire outer surface O1 or only a portion of the entire outer surface O1. As described above, the fabric layer 314 can be porous so that it is permeable to air and liquids and communicates with the interior space 305 through the perforated cushioning layer 312 extending between the perforated facing layer 316 and the fabric layer 314.

[0101] The facing layer 316 extends around the interior space 305 in the main body region 306. According to a preferred embodiment, the facing layer 316 is formed of a material (e.g., silicone) that is lower in hardness than the filaments or sublayers forming the buffer layer. The lower hardness material of the facing layer, while preferably thinner than the total thickness of the buffer layer, provides a skin-friendly interface for the user's skin. The facing layer 316 typically terminates at the sealing area 308, which is demarcated by the boundary 322.

[0102] like Fig.16As shown, the aperture pattern 326 of the facing layer 316 includes a plurality of apertures 330 spaced apart from one another, and solid or non-porous areas 328, which are generally smooth and non-porous and include solid portions of the material forming the facing layer. The apertures 330 may be formed according to any of the methods and materials disclosed in the above-cited references. The solid non-porous areas 328 are generally formed of a non-porous layer of silicone or other polymeric material forming the facing layer, preferably impermeable to air, however the cushioning layer 312 may be retained between these solid areas and the fabric layer, such as Fig.19 The apertures 330 of the aperture pattern 326 extend through the entire thickness of the facing layer and are configured and sized to communicate with the lattice structure (particularly the interstices thereof) to transfer air and moisture from the interior space of the cushion to its exterior.

[0103] Although in Fig.16 The aperture pattern 326 in a preferred embodiment of the invention is illustrated as having apertures 330 spaced evenly apart at 90 degrees relative to one another, however, the apertures may be arranged in any configuration and corresponding orientation to enable transfer of air and moisture between the interior space and the external environment of the pad and / or fabric layer. The configuration and orientation of the apertures may be balanced by providing sufficient solid area 330 to enable secure contact with the user's skin and provide the support required by the pad.

[0104] The size of the hole can be adjusted according to the balance of air and moisture transmission and skin adhesion, and in a preferred embodiment, the hole is significantly smaller than the distance between them. An example of the hole spacing defined as the distance D6 between two holes can be preferably set to 0.8 to 1.2mm, more preferably 1.0mm, and the diameter D5 of the hole can be preferably set to 0.16 to 0.24mm, more preferably 0.2mm, and the ratio of spacing to diameter can be the preferred ratio of about 5:1 thus. Therefore, the surface area of ​​the non-porous part of the facing layer is about 5:1 with the ratio of the surface area comprising the hole, thereby providing the facing layer that can realize ventilation but does not sacrifice the safety surface close to the user's skin, thereby providing the excellent fit and comfort with ventilation, avoiding scratches and skin irritation simultaneously. Of course, the disclosure is not limited to such size, scope and ratio. However, it has been unexpectedly found that above-mentioned size, scope and ratio provide outstanding balance between skin adhesion and ventilation.

[0105] exist Fig.17 and 18 In one example more clearly shown in FIG. 3 , the facing layer 316 may have a solid patch area 332 without holes, wherein holes are adjacent to or around at least a portion of the periphery of the solid patch area 332. The solid patch area 332 substantially includes the non-porous area 328 of the facing layer without holes, such as Fig.16In a preferred embodiment, about 35-45%, more preferably 40%, of the facing layer 316 comprises a solid patch, whereby the facing layer is defined as the solid thickness of the silicone or other polymeric material forming the facing layer. In a preferred arrangement, the solid patch area may correspond to the user's groin area.

[0106] The solid patch area 332 can have a variety of configurations. In a preferred example, the solid patch area 332 extends from the open proximal end relative to the axis BB to a distance short of the boundary 322 of the sealing area 308, while gradually narrowing relative to the radius 366 of the cushion. The extension of the solid patch area provides for customizing the cushion to areas where improved skin contact and reduced skin irritation are desired.

[0107] like Fig.18 As shown, in the distance 362 between the solid patch area 332 and the border 322, the facing layer 316 may have a breathable or ventilated area 334, such as a portion of the facing layer 316 surrounding the radial and / or circumferential periphery of the solid patch area 332. The ventilated area 334 may allow sweat or moisture collected in the solid patch area to drip into the ventilated area 334, from which the sweat may be transferred through the cushioning layer 312 and discharged to the external environment of the pad through the fabric layer 314.

[0108] Although Fig.17 Small portions of the pattern 326 and non-porous areas 328 are shown as well as the facing layer, however these small portions are only intended to represent the entire area (i.e., a solid patch area with a surface having completely non-porous areas 328). It should be noted that the holes can take any desired shape and are not limited to Fig.16 The holes may be arranged in different patterns depending on their relative axial and radial positions and positions of the facing layers. For example, some holes in one area may be larger relative to those in another area, such as the holes in the facing layer around the perimeter of the solid patch area relative to those in the ventilation area 334.

[0109] The solid patch regions may be configured in a single region or in segmented regions, thereby including multiple solid patch regions above the boundary 322. The solid patch regions may be modified circumferentially, axially, and in shape.

[0110] Fig.19The relationship between the facing layer 316 and the cushioning layer 312 and the fabric layer 314 in the main body region 306 is shown. A matching layer 376 with holes can be disposed between the facing layer 316 and the cushioning layer 312 to secure the facing layer 316 to the cushioning layer 312, because the facing layer 316 can be formed of a different material or have different properties than the cushioning layer 312, and the matching layer 376 is compatible with both the facing layer 316 and the cushioning layer 312 to ensure proper adhesion to each other. The matching layer 376 can have a predetermined pattern of holes that corresponds to and matches the predetermined pattern of holes of the facing layer, or have a predetermined pattern of holes thereof while still corresponding to the holes of the facing layer to allow air and moisture to transfer to the cushioning layer through the facing layer and the matching layer. The matching layer 376 is preferably thinner than the facing layer, and can also be thinner than each sub-layer of the cushioning layer so as not to hinder the performance of the facing layer or the cushioning layer.

[0111] The matching layer is preferably composed of a material having a higher hardness than the relatively lower hardness material forming the facing layer. According to the methods described herein and in the above-mentioned references, the matching layer can be formed of the same material as the sub-layer forming the buffer layer to provide adhesive compatibility between the facing layer and the buffer layer for manufacturing the cushion. By including the matching layer, the facing layer can be reinforced and resist failure due to friction with the skin due to its lower hardness relative to the hardness of the buffer layer.

[0112] The cushioning layer 312 is preferred in any of the above embodiments and includes a plurality of sub-layers 378 that can be formed into a lattice structure, or any arrangement of the above structures discussed herein. The cushioning layer 312 and the corresponding sub-layers 378 can be customized with different properties relative to each other or at key portions of the pad to change the compressibility and cushioning, as well as the fit of the pad to the user. For example, different layers or regions of the cushioning layer 312 can have different hardnesses, as discussed in at least the above-cited references.

[0113] like Fig.19 As shown, the facing layer 316 has a relatively thinner thickness than the aggregate of the sub-layers 378 or the thickness of the buffer layer 312. This structure of the facing layer 316 being formed of a lower hardness material balances the stiffness of the facing layer 316 relative to the user's skin, while the higher hardness material of the buffer layer 312 provides cushioning. The higher hardness material has sufficient rigidity to avoid clogging of the gaps formed by the lattice structure of the buffer layer exhibited by the sub-layers.

[0114] In an alternative, the facing layer 316 may have a thicker construction and may obviate the need for an entire cushioning layer or at least a portion thereof, but rather the composition and properties of the facing layer may function as a cushioning layer. The fabric layer 314 is secured to the cushioning layer 312 by an adhesive arranged so as not to obstruct the ventilation features of the pad. Depending on the arrangement of the cross sections, the transfer of ventilation air and moisture VA may flow from the fabric layer 314 from the interior space 305 to the environment outside the pad.

[0115] The disclosed cushion embodiments are adaptable in terms of their different layers and structures. Unlike conventional cushions that typically include a single material or injection molded structure of at least two layers, these layers are adjacent to each other over a large portion of the cushion, if not the entire cushion. The variability of the mechanical properties of such layers is limited by the inherent material properties of the layers.

[0116] Embodiments of the present disclosure are constructed from discrete layers of material that may or may not be similar in construction and material composition, but are arranged in segments with respect to the circumferential, axial, and radial directions to better customize the cushion for its intended purpose. The construction may involve thickness differences achieved through terminating layers, extended or overlapping layers, and structural features such as open or non-porous areas. In fact, because the methods used and disclosed in the above-mentioned references achieve a cushion that provides extremely high variability and adaptability, the structural variations in the specific locations of the cushion are endless, which has not been seen in previous prosthetic cushions.

[0117] Fig. 20 310 can be constructed with multiple layers, including a first layer 368, a second layer 370, and a third layer 372, wherein an adhesive layer 374 can be applied to the third layer 372 to secure the fabric layer 314. The first, second, and third layers are arranged to extend axially and terminate at different positions relative to the axis, particularly in the sealing area, such as Fig.21 By using different layers terminating at different axial positions, a balance of axial stiffness can be achieved at the distal region and the seal region, particularly in view of the effect of the seal on the liner as the seal becomes wedged between the outer surface of the bushing from which it protrudes and the wall of the receiving cavity, thereby maintaining a vacuum distal to the seal in the receiving cavity.

[0118] Each of the layers 368, 370, 372 may have different properties, such as a different durometer, but each layer is integrally secured to one another according to the methods and structural arrangements discussed herein and in the references cited above. For example, in the distal cup 320, the first or innermost layer 368 may provide a softer durometer to accommodate the sensitive distal end of the residual limb. In the silicone or other polymeric material used, the first layer 368 may also provide a skin conditioning agent, such as aloe vera, silicone oil, and menthol, as is understood in conventional pads. The second layer 370 may serve as a cushioning layer having properties including increased compressibility relative to the third layer 372, which may have a harder durometer and be more able to withstand pressure and movement relative to the prosthetic socket at its distal end. Of course, none of these properties of these layers are limiting, and one skilled in the art may adjust the multiple distal region layers and their corresponding properties accordingly.

[0119] The challenge of providing the distal region 310 is to increase the axial stiffness and durability to withstand the pressure exerted by the sealing interface between the receiving cavity and the liner without making the stiffness uncomfortable for the user. In one example, the third layer of the distal region 310 may be adapted to include a thin layer of a higher hardness elastic material, or the third layer itself may be adapted to be a thin layer of a higher hardness material at least relative to the first layer. In this case, a thin layer typically in the range of 0.5 to 1.5 mm is applied to the distal region and terminates in a sealing notch or groove 324. The disadvantage is that the thin layer must be adjusted to avoid creating an axial stiffness that is greater than that of the other layers. In order to avoid the stiffness becoming too great, in addition to the thickness and material selection, if it is considered too great, the axis can be cut through or into the depth of the thin layer to reduce the stiffness.

[0120] Another option for increasing the axial stiffness of the distal region is to provide an additional fabric layer over the fabric layer 314. Such additional fabric layers can be cut to size for the distal region and provided to the user as a kit if the user wishes to increase the axial stiffness without changing the overall pad. In practice, multiple additional fabric layers can be provided, each with a different stiffness or adapted to be secured to one another to increase stiffness.

[0121] Another option may be to fix an additional matrix on the distal end, which may be done during and / or after the manufacture of the pad. The additional matrix may be formed of a hard and thin plastic material so as not to interfere with the comfort of the user. The additional matrix may be formed with gaps or spaces in the structure to enable stretching by the user putting on the pad while maintaining high axial stiffness.

[0122] Yet another option is to print or provide additional filaments on the third layer rather than just coating and subsequently forming the threads. The additional filaments may be provided by a compatible material adhered to the third layer but by a high durometer material to enhance the relative axial stiffness of the distal region of the pad.

[0123] Fig.18 and 21 The ability to tailor thickness and structural features by using different layers that partially overlap each other at selected locations relative to axis BB is illustrated. In this example, the focus is on the groove 324 provided for the seal 318. Although past developments have produced grooves formed by molding processes, such as disclosed in U.S. Patent No. 9,066,821, however Fig.14 , 15 and 18 provide a layered configuration similar to Fig.10 and 11 The distal end 310 of the liner has a layered structure, such as Fig. 20 As shown, however, when the layers 368, 370, 372 terminate in the sealing area 308, each layer terminates at a different position relative to the axis BB.

[0124] The seal 318 may be provided with a low friction coating 338 together with the inner seal, such as Fig.18 The low friction coating 338 may be selected to enable the seal 318 to slide easily along the fabric layer without significant resistance, while the outer side of the seal 339 has greater friction properties than the low friction coating 338 to promote frictional engagement with the socket wall, thereby creating a vacuum between the liner and the socket wall distal to the sealing area.

[0125] As for the first or innermost layer 368, this layer extends beyond the groove 324 to provide a consistent inner surface for placement adjacent to the residual limb at the distal end 304 of the pad. This extension allows for secure adhesion to the user's skin without creating pressure points on the pad itself at the transition from the first layer 368 to the facing layer 316. This extension of the first layer 368 past the groove 324 provides a thicker wall than the facing layer 316 and can better withstand the weight of the residual limb at the distal end and the irregular shape of such a residual limb. As mentioned, the first layer 368 can be provided with additives to better conform to the skin and, due to its intended purpose adjacent to the residual limb, particularly at the distal end where greater pressure is applied by the user to the intended prosthetic socket, the first layer 368 can have a softer construction than the other layers.

[0126] The first layer 368 may extend more past the seal 318, and the entire innermost or first layer extends completely along the interior space in at least the distal region 310 and all (or at least most) of the seal region 308, thereby isolating the solid surface along the interior space before the breathable facing layer contacts the user. Due to the additional pressure applied to the cushion by the presence of the seal 318, according to this embodiment, it is preferred that the seal 308 and the distal region 310 lack breathability to avoid damaging the seal, and above the seal, the cushion may include breathability characteristics, the same as the facing layer.

[0127] The second layer 370 is defined to extend to the base 319 of the seal 318, and the third layer 372 extends axially beyond the base 319. The first layer 368, the second layer 370, and the third layer 372 extend to the vicinity of the base 319, at the location 336, thereby defining the proximal end of the distal cup 320, and the thickness of the cushion at the base 319 can better withstand the pressure and vacuum generated at least at the distal end of the base 319 when the seal 318 is engaged with the socket wall. The third layer 372 can be configured to form the groove 324 required for the seal 318, while the first layer 368 and the second layer 370 can remain unchanged except for the axial location at which they terminate.

[0128] As in the previous embodiments, the buffer layer 312 is preferably composed of at least two layers that can provide a ventilation structure. In order to adapt to the axial termination of the first layer 368, the second layer 370 and the third layer 372 of the distal region 310, each layer of the buffer layer 312 is axially terminated at different positions adjacent to the first layer 368, the second layer 370 and the third layer 372, and when terminating and adapting to the thickness of the first layer 368, the second layer 370 and the third layer 372, the corresponding layer of the buffer layer 312 is also terminated.

[0129] For example, in region 380 where the second layer 370 terminates between the axial extensions of the first layer 368 and the third layer 372, the buffer layer 312 terminates as two overlapping sub-layers sandwiched between the first layer 368 and the third layer 372 to accommodate the thickness lost by the termination of the second layer 370. As the buffer layer 312 extends proximally from region 380, additional sub-layers are introduced as the buffer layer 312 extends to the termination point of the third layer 370, where additional sub-layers are introduced to accommodate the thickness loss of the third layer 370. To form a portion of the groove 324, a sub-layer 390 of the buffer layer 312 may be deflected over other sub-layers of the buffer layer 312 in region 384, thereby providing a portion of the outer surface groove of the cushion at the proximal end of the seal 318.

[0130] Starting from the proximal end, the cushioning layer 312 has a sublayer adjacent to the first layer 368 and the fabric layer 314 in the region 386. The fabric layer 314 can extend beyond and include the outer surface E of the cushion, which passes through the cushion body, the seal and the distal region. Once the first layer 368 is axially terminated, the facing layer 316 extends along the interior space 305 and defines the inner surface I around the interior space 305 of the cushion in the region 388, while introducing additional sublayers of the cushioning layer 312 to make up for the thickness lost by the termination of the first layer 368.

[0131] like Fig.21 As shown, the profile of the cushioning layer and its ventilation and cushioning properties taper towards the sealing area. Fig.21 As is evident from the previous embodiments, the taper is achieved by intermittently staggered sub-layers that terminate axially according to designated areas of the layers of the distal end and sealing area. These sub-layers may include filaments oriented at an angle relative to the axis BB, providing ventilation and compressibility that vary according to their position relative to the axis BB and the axial termination of the layers of the distal end and sealing area (including their proximity relative to the seal, including the base 319 and the groove 324 or the notch along the outer surface of the liner).

[0132] and Fig. 20 and 21 Same, Fig.18 Illustrated are multiple thickness variations of the liner 300 that can be achieved by varying any of the layers and sublayers described herein, such as their axial termination at location 336 at the end of the distal cup 320. The thickness 342 of the distal end 310 tapers as it extends proximally toward the sealing area 308, having a maximum thickness 354 at the distal end at axis BB, thereby providing more cushioning at a location generally perpendicular to axis BB where it is generally necessary to support the greatest weight of the residual limb. The distal end 310 may also have a thinnest thickness at its radial maximum 364 (generally corresponding to the boundary of the sealing area). The thickness 342 tapers to a thinner thickness 344 corresponding to the base of the seal 318, yet further decreases in the sealing area 308, as shown. Fig.21 More clearly shown in .

[0133] From the seal area 308, the thickness of the body region 306 tapers as it extends toward the proximal end 302. For example, at a first height 356 extending proximally relative to the boundary 322, the body region 306 has a greater thickness 348 than the thickness 350 at a height 358 extending therefrom. The thickness 352 at the proximal edge of the proximal end is the minimum of the body region 306. This minimum thickness and the corresponding increase in thickness from the proximal end 302 to the seal area 308 enables a better donning of the pad because it provides for easier rolling of the body region 306. Likewise, the gradual thinning of the body region 306 toward the proximal end provides a more comfortable pad because the pad receives more support as it extends distally, particularly because less cushioning is required toward the proximal end.

[0134] The thickness of the body region, seal, and distal region can be adjusted according to the axial height. Fig.21 As more clearly shown in FIG. 3 , the thickness of the sealing region 308 is generally consistent with its height 360 , except for the grooves in the third layer 372 , based on the axial termination of the layers in the distal region and the addition of a corresponding sub-layer of the buffer layer.

[0135] The thickness of the bulk region is adapted by varying the thickness of the buffer layer, since the facing layer and fabric layer are generally of uniform thickness, which is mostly if not completely uniform. Alternatively, although variations are less likely since the thickness of the facing layer is preferably much thinner than that of the buffer layer, the facing layer may be varied, particularly since it is generally constructed as a solid layer, as opposed to the multiple filaments that make up the buffer layer. This is typically achieved by modifying the axial termination of the sub-layers and the relative directions in which the thickness variations occur, at least in the bulk region.

[0136] By providing a medical device according to the described embodiments, problems with medical devices, such as the poor balance of mechanical strength required for cushioning and protecting a body part (e.g., a residual limb) and the need for breathability to mitigate the accumulation of fluids and heat are solved. The formation layer, the structure of multiple layers of filaments and the openings, and the defined structure, advantageously provide the cushion with permeability to fluids and heat while maintaining the required structural strength to cushion the residual limb. The cushion further provides a simplified manufacturing process by incorporating stitching or sewing of the fabric covering in the material of the formation layer or cushion body.

[0137] Embodiments of the pad also provide a multi-layer pad structure whose layers and sub-layers include different materials and / or properties for providing a pad with appropriately arranged portions having mechanical strength, elasticity, comfort characteristics, friction characteristics and rigidity.

[0138] It should be understood that not all objects or advantages can be achieved in one embodiment of the present disclosure. Those skilled in the art will recognize that the medical device may be embodied or implemented as it achieves or optimizes one advantage or a group of advantages as taught herein, but does not achieve other objects or advantages as taught or suggested herein.

[0139] Those skilled in the art will recognize the interchangeability of the various disclosed features. In addition to the described variations, those skilled in the art can mix and match other known equivalents of each feature to construct medical devices according to the principles of the present disclosure. Those skilled in the art will understand that the described features can be applied to other types of orthopedic, prosthetic or medical devices.

[0140] Although the present disclosure describes certain exemplary embodiments and examples of medical devices or pads, it will be understood by those skilled in the art that the present disclosure extends from the specifically disclosed embodiments of the prosthetic socket to other alternative embodiments and / or users, as well as obvious modifications and equivalents thereof. The present disclosure should not be limited to the above specifically disclosed embodiments, and may be extended to medical devices and stents, as well as other applications that may employ the described features.

Claims

1. A prosthetic liner, defining a proximal end and a distal end and forming an internal space, the liner having a main body region extending along an axis from the proximal end to the distal end, the prosthetic liner comprising: a buffer layer, which is located at least in the main body region and forms a predetermined lattice structure, wherein the lattice structure defines a plurality of gaps or cavities between structural filaments or components forming the lattice structure, wherein the lattice structure includes a plurality of sub-layers, wherein the sub-layers include filaments extending in different directions relative to each other and a plurality of gaps are formed between the sub-layers, and wherein the buffer layer defines a first surface facing the inner space and a second surface opposite to the first surface; a facing layer positioned along a first surface of the cushioning layer, the facing layer being formed of a plurality of filaments arranged in a pattern, the pattern comprising a first series of filaments extending in a first direction and a second series of filaments extending in a second direction different from the first direction, the facing layer defining a plurality of apertures extending through a thickness of the facing layer, the plurality of apertures being in communication with the plurality of voids to permit transfer of air and moisture from an interior space of the prosthetic cushion through the facing layer and the cushioning layer; a distal cup located at a distal region of the prosthetic liner and distal to the facing layer and the cushioning layer, the distal region being secured to the body region such that the distal cup is formed from at least one layer chemically bonded to the cushioning layer and the facing layer, the cushioning layer, facing layer and distal cup sharing at least one blending region in which materials of the layers blend or interlock to form a permanent chemical bond without an adhesive; The distal cup is air and liquid impermeable and is formed from a solid body of elastomeric material located at the interior volume of the distal end and extending through its thickness.

2. The prosthetic liner according to claim 1, characterized in that The buffer layer has a thickness greater than that of the facing layer.

3. The prosthetic liner according to claim 1, characterized in that The facing layer is formed of an elastic material having a lower hardness than at least one material forming the buffer layer.

4. The prosthetic liner according to claim 1, characterized in that The facing layer typically has a non-porous region with a surface area ratio of non-porous region to pores of typically 5:

1.

5. The prosthetic liner according to claim 1, characterized in that A matching layer is disposed between the facing layer and the buffer layer, the matching layer having a predetermined pattern of holes corresponding to the predetermined pattern of holes of the facing layer, the matching layer being formed of a material having a higher hardness than the facing layer, wherein the buffer layer, the facing layer and the matching layer share at least one mixed region in which the materials of the layers are blended or interlocked to form a permanent chemical bond without an adhesive.

6. The prosthetic liner according to claim 1, characterized in that The plurality of sub-layers includes a first sub-layer formed of a first plurality of filaments oriented along a first direction forming a portion of a thickness of the buffer layer, each filament of the first plurality of filaments being spaced apart from one another.

7. The prosthetic liner according to claim 6, characterized in that The plurality of sub-layers includes a second sub-layer formed of a second plurality of filaments oriented along a second direction forming a portion of the thickness of the buffer layer but different from the first direction, each filament in the second plurality of filaments being spaced apart from one another.

8. The prosthetic liner according to claim 7, characterized in that The first and second pluralities of filaments are chemically and integrally bonded to one another without a binder and are directly adjacent to one another such that interstices between each filament in the first and second pluralities of filaments form the void.

9. The prosthetic liner according to claim 7, characterized in that The predetermined lattice structure is determined by at least the first plurality of filaments and the second plurality of filaments.

10. The prosthetic liner according to claim 1, characterized in that The buffer layer defines a tapered thickness extending from a distal end to a proximal end of the body region.

11. The prosthetic liner according to claim 10, characterized in that The cushioning layer includes at least a first layer and a second layer of a plurality of filaments, and the tapered thickness includes omitting the first layer of the plurality of filaments at a location relative to an axis of the prosthetic liner.

12. The prosthetic liner according to claim 10, characterized in that The facing layer has a substantially uniform thickness in the bulk region of the prosthetic cushion.

13. The prosthetic liner according to claim 1, characterized in that The at least one layer of the distal region includes a first layer and a second layer, wherein at least one of the first layer and the second layer overlaps with at least one sub-layer of the buffer layer.

14. The prosthetic liner according to claim 1, characterized in that Also included is a sealing region located on the distal side of the main body region, the sealing region comprising at least one sublayer of the buffer layer and at least one layer of the distal cup.

15. The prosthetic liner according to claim 14, characterized in that The facing layer terminates at the sealing region, and the innermost layer of the distal region is chemically bonded to the facing layer and forms a perimeter of the interior space of the prosthetic cushion within the sealing region and the distal region.

16. The prosthetic liner according to claim 14, characterized in that Also included is a porous fabric layer secured to the second surface of the cushioning layer, the fabric layer defining the entire outer surface of the prosthetic cushion within the body region.

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