Prosthetic lining

Abstract

A prosthetic liner defines a proximal end and a distal end, and a liner body defined between the proximal end and the distal end. The liner body has a tubular shape and includes a lattice-shaped structure defined as a structure in which a plurality of layers are integrally formed inseparable and continuous. The lattice structure includes a first layer of first filaments discretely formed from a first elastic material, and a second layer of second filaments discretely formed from a second elastic material. The first filaments and the second filaments overlap each other and form a first set of voids therebetween in a predetermined pattern. Wherein the first filaments are spaced apart from each other and extend in a first direction, and the second filaments extend in a second, different direction. The first layer and the second layer are permanently chemically bonded to each other and are at least partially mixed with each other in the mixing region. The first filament and the second filament extend continuously around the tubular shape of the liner body. The first layer and the second layer are concentric with respect to each other.

Description

[0001] This application is a divisional application of the Chinese patent application with the application date of November 12, 2019, application number 201980074196.X, and invention name “Medical device comprising a filament-based structure”. Technical Field

[0002] The present invention relates to medical devices such as prosthetic or orthotic devices, and an exemplary embodiment is a liner, sleeve or sock, which is generally referred to herein as a "liner", for providing suspension and comfort in a prosthetic device system. The exemplary embodiment is formed of a lattice-like honeycomb or solid structure defined by a plurality of discretely formed filaments. Background Art

[0003] The use of liners in prostheses is well known and they can be used as an interface between the residual limb and the prosthetic base, allowing the user to comfortably and safely wear the prosthetic base and the prosthesis connected thereto, such as a prosthetic limb. For example, the liner can provide a cushion between the end of the residual limb and the prosthetic base, thereby protecting the limb from pressure points caused by the user's weight being applied to the rigid components of the prosthetic base during use. In addition, the liner can provide improved pressure distribution along the residual limb and within the prosthetic base. In vacuum-suspended prosthetic systems, the liner can also protect the residual limb from prolonged exposure to a high vacuum.

[0004] Liners are often constructed using polymeric materials, especially elastomeric materials. For example, medical-grade silicones that are naturally compatible with human tissue and resistant to fluids and bacteria can be used to reduce the risk of infection. Such liners, while limited in breathability, are often designed to remain fresh and odor-free after each use, and to have lasting strength and thickness even with repeated use. However, depending on the characteristics of the user, many liners may not perform as expected after repeated use.

[0005] Although not limiting, an elastic material is preferably used to construct the liner because it has an inherent elasticity that conforms to the residual limb. The elasticity of the liner can be tailored to suppress elasticity in different directions (e.g., axial), but enhance elasticity in one direction (radial) relative to another direction (axial).

[0006] Typically, the liner is constructed by molding an elastomeric material between male and female molds to form a solid layer of elastomeric material that can tightly wrap around the residual limb. The elastomeric material can also be extruded into a predetermined shape. Whether molded or extruded, the liner is formed with a fixed cross-sectional profile and does not need to be controlled to adapt to the contours of the molded or extruded component.

[0007] The fixed cross-sectional profile is usually a solid body of air- and water-impermeable elastic material, which is bonded together to form a whole. In order to provide adequate cushioning and protection for the residual limb, such a liner usually includes a relatively thick layer of water-impermeable elastic material. The thickness can be increased at the distal end of the liner to provide additional cushioning at the liner location where the user's weight most prominently acts on the prosthesis base.

[0008] Because the liner is composed of a unitary wall or solid layer of elastomeric material, typically formed or cured from a liquid resin injected into a mold, or extruded, the material can have uniform properties throughout the body of the liner, or simplified properties (e.g., tapered thickness) between various components of the liner. An embodiment of a method for making a liner is set forth in U.S. Pat. No. 6,626,952, issued Sept. 30, 2003, and an embodiment of a liner having multiple components and / or properties is set forth in U.S. Pat. No. 6,136,039, issued Oct. 24, 2000.

[0009] A common implementation is to attach a fabric material to the outer surface of the liner, the fabric material having defined properties that can provide customized or desired features at specific locations. A solid elastic layer can be cured against the fabric material, which requires pre-processing steps, such as stitching and shaping, to have the desired properties. An example of such a time-consuming and costly pre-processing step is stitching the distal seam in the fabric tube to shape the fabric tube into the shape of the liner. Other components can be provided in the liner, such as a rigid distal cap.

[0010] Sewing and securing fabric to the liner body of elastic material and other components of the liner may result in pressure points when the user wears the liner and presses it against a hard seat. Some efforts have been made to alleviate this effect, such as U.S. Patent 9,770,891 issued on September 26, 2017. However, there remains a need to simplify the method for providing such fabric or other components to the liner body and further reduce pressure points.

[0011] A known problem with liners is that moisture and heat can accumulate between the residual limb and the liner, which can cause discomfort, unpleasant odor, "milking," "pistoning," and tissue breakdown. For example, medical grade silicone is hydrophobic in that it is impermeable to air and water. Sweat can accumulate between the residual limb and the liner, which can cause the liner to slip relative to the residual limb and cause discomfort. This can lead to the risk of improper use of the prosthetic system and even catastrophic failure of the prosthetic system during use.

[0012] There is a balance between providing a liner with sufficient cushioning and thickness to protect the residual limb from harmful extensive contact with hard or rigid surfaces and providing a breathable liner to mitigate heat and moisture buildup. There is concern as to whether the liner can maintain the same strength, thickness, compressibility, and general functionality as a conventional solid wall liner in a liner with a breathable structure. Similarly, it is desirable to maintain the liner constructed of approved and accepted medical grade elastomeric materials such as silicone.

[0013] Efforts to bridge this gap include providing a wicking layer or absorbent material within the silicone layer or between the silicone layer and the fabric material, steps that may increase the cost and complexity of constructing the liner. One embodiment of such an effort is set forth in U.S. Patent 9,629,732, issued April 25, 2017. Efforts to provide holes, or wicking layers and absorbent materials may impair the functionality of the liner or result in the liner having mechanical properties that are inferior to conventional solid wall liners. Such existing breathable liners may hinder or preclude other desired features in the liner, such as outer surface edge contours (such as U.S. Patent 7,118,602, issued October 10, 2006) and sealing systems (such as U.S. Patent 9,066,821, issued June 30, 2015).

[0014] There remains a need for a liner that can achieve the structural and cushioning advantages of solid wall conventional liners and can also mitigate the buildup of heat and moisture while remaining constructed of medical grade materials and accommodating many of the features commonly found in traditional liners.

[0015] Another problem with existing systems and methods for producing liners is the difficulty and cost of providing a custom-fitted prosthetic system that features features that correspond to the needs of different parts of the residual limb. Each residual limb has a unique size and shape, and if a liner of a normal shape and size does not meet the needs of the user, then a trained prosthetist must expend a lot of effort to meet the needs of the user. Individuals may have different bone structures and soft tissues depending on how the residual limb was formed, and because the size and needs of a particular user may be dynamic and change due to swelling or weight changes, it is difficult to meet the unique limb shape and needs of an individual with a residual limb.

[0016] Because the structural and functional needs of every residual limb are difficult to achieve, 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. Custom liners can be provided for amputees of all lifestyles and activity levels, and it is difficult to meet the needs of all such individuals using a standard regular sized liner. An individual may require material additions for ease of donning and doffing, as well as skin care additions, and want the features of a regular liner in a custom fit liner.

[0017] Because many medical devices with elastic materials (e.g., medical grade silicone) are formed by injection molding, where silicone resin is injected into a space defined by a negative mold of the medical device, most medical devices do not have the desired customized properties based on the functionality of different areas of the user's body, but rather have uniform properties. However, in the example of a liner, it may be desirable to have more elasticity at and behind the knee compared to the upper, lower, and lateral sides of the knee, or to have different levels of breathability in areas near active muscle groups where more heat and fluid are generated. Therefore, there is a need for a medical device that can provide customized properties at desired locations around the medical device, rather than uniform properties.

[0018] There is a need for a liner that can be customized to the needs of an individual user while possessing the features of conventional liners. More generally, there is a need for a medical device constructed from an elastomeric material that provides a desired balance between breathability and mechanical properties so that the device can withstand daily use. Summary of the invention

[0019] The problem of balancing strength, comfort, breathability, and other desirable properties of elastomer-based and other polymer-based materials (preferably elastomer-based medical-grade materials) in medical devices such as prosthetics and orthotics is addressed in embodiments of the present invention. These embodiments illustratively provide a liner that includes discretely attached and continuously attached layers of filaments based on polymer materials (e.g., silicone or other elastomers) used in conventional liners, while maintaining at least the same mechanical strength and other mechanical properties of these conventional liners. Although such liners can be made of the same medical-grade elastomeric material and have the same mechanical and chemical properties as conventional liners, the lattice structure in the embodiments provides improved cushioning, moisture removal, and / or breathability compared to known conventional liners.

[0020] These embodiments may be configured to combine with fabric covers, reinforcement layers, material additives and other desired features in conventional liners and have improved features. Although medical grade elastic materials are discussed, it should be understood that the present invention is not limited to medical grade materials, but any suitable material may be used.

[0021] The features of the exemplary embodiments can be extended to a wide range of medical devices, including prosthetic or orthotic components, medical implants, medical tubes, prostheses, and other components or devices. The features can be adjusted according to the desired characteristics or requirements and customized to meet the needs of the user. For example, the features of the embodiments can be used in devices made of known medical grade elastomeric materials, thereby eliminating the need for material approval and simplifying the regulatory approval process.

[0022] Exemplary liner embodiments are configured to effectively manage perspiration generated by a limb, prevent the liner from sliding on the limb, and provide suitable cushioning for the limb. The described exemplary embodiments are described and shown for use with a liner in a prosthetic system with a rigid prosthetic base. However, the present invention is not limited to this prosthetic embodiment or the exact use described, but rather encompasses any use requiring perspiration management, anti-slipping, limb cushioning, or any other structural and / or functional advantage that may be derived in whole or in part from the principles of the present invention. The principles described herein can be extended to any prosthetic, orthotic, or medical device, and are by no means limited to liners.

[0023] In an exemplary embodiment, the liner advantageously bridges the gap between the strength and breathability requirements of a solid wall liner when using medical grade materials. The liner can be customized to have features at specific locations corresponding to the needs of an individual user, thereby reducing 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 constructed according to the principles described herein.

[0024] According to the above exemplary embodiment, the liner has a first end or proximal end, a second end or distal end, and a liner body having a tubular shape defined between the first end and the second end. The liner body preferably includes a base layer formed of an elastic material (e.g., silicone) having an inner surface extending along the tubular liner and defining its edge. The base layer defines a plurality of openings that preferably extend through its thickness. Since the base layer should be in close contact with the user's skin around the residual limb, the combined solid surface area of ​​the base layer is larger than the combined surface area of ​​the plurality of openings to provide effective skin engagement. The inner surface of the base layer is preferably smooth in that, except for the openings, the inner surface of the base layer has a substantially uniform height.

[0025] The base layer may include multiple filaments that are integrally adjacent and / or chemically bonded to each other to form a continuous solid layer. The filaments are aligned with each other and chemically bonded to adjacent filaments along their length without gaps or interruptions. This structure may be formed to form an airtight and watertight film. A filament may be continuously formed on an adjacent filament, and the adjacent filament may form a gap along its length, and another filament may be formed on the opposite side of the adjacent filament to form a porous or breathable layer. However, this porous or breathable layer has a hole formed in a forward direction, rather than mechanically or chemically perforating a solid layer to form such a hole, thereby providing control of the shape and size of such a hole. A solid or continuous film or layer may be formed, and then material may be removed in any suitable manner to define the hole.

[0026] The first layer formed by the elastic material is fixed on the outer surface of the base layer (therefore, the base layer is fixed to the inner side of the first layer) and includes a first group of gaps, the axis of which corresponds to the axis of the opening of the base layer. The first layer includes a first sublayer and a second sublayer, 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 gaps between them. The material properties of the elastic material forming the base layer may be different from the material properties of the elastic material forming the first layer, for example, having different hardnesses, for example, skin-friendly hardnesses. The base layer may include skin care additives, such as moisturizers, antimicrobial compositions, aloe vera, etc., while the first layer may not be provided with skin care additives, and vice versa.

[0027] Each filament can have a uniform cross section extending in a predetermined shape along its length. Each filament is formed discretely and extends continuously relative to adjacent filaments. These discretely formed filaments can constitute the basic components of a lining or medical device structure. Although the preferred embodiment shows the filaments as being arranged into a lattice network to form a lattice structure, they can be arranged to have different distances and directions relative to each other. The filaments can be arranged relative to each other in an infinite number of coordinates relative to each other in X, Y, Z planes and / or coordinates. The cross section of the filament can be modified to be similar to any desired geometric shape, such as a square, rectangle, triangle or circle, and exemplary shapes are generally circular structures. The cross section can be asymmetric and can be different at various lengths or positions of continuous filaments.

[0028] The first sublayer and the second sublayer of the first layer are preferably chemically bonded to each other and may be formed of the same elastic material, but still compatible materials to ensure bonding. Similarly, the base layer and the first sublayer may be chemically bonded to each other from compatible materials. In this way, the sublayers are integrally formed into an inseparable structure and a continuous structure that is bonded together so as to function mechanically as a unitary structure. By chemical bonding, a preferred embodiment does not require an adhesive, wherein the filaments are bonded together in the following manner: the elastic material defining the filaments is a solidified material and has sufficient fluidity to allow the layers to be at least slightly mixed at the interface; however, the use of an adhesive, a primer or any other appropriate means is not excluded from the scope of the present invention.

[0029] Additional layers may be secured to a second or outer side of the first layer (i.e., a second layer formed similarly to the first layer and secured to the first layer). These additional layers are also preferably formed together as an inseparable and continuous structure so as to function mechanically as one unitary 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 gaps of the first layer.

[0030] The fabric or fiber layer may be secured to the periphery of the first layer or the additional layer and may be breathable to allow air to pass from the inner surface of the base layer through the entire thickness of the first layer and the additional layer, so that the shaft extends through each interstices of the first layer and corresponding interstices of the additional layer, and corresponding openings of the base layer. The breathability is not limited to passing through the wall thickness, but air can be transported in all directions within the lattice network of interstices defining the lattice structure. At least one layer of filaments may be arranged to impregnate at least a portion of the fabric layer, for example, depending on size or material properties.

[0031] The openings of the base layer and the voids of the first layer and the additional layer are arranged in a controlled manner into a predetermined shape and pattern to form a lattice structure. Although the materials of the base layer, the first layer and the additional layer can be elastic, they can be formed of the same material or different materials. The base layer, the first layer and the additional layer can have different or similar mechanical properties. Regarding mechanical properties, the layers can have different mechanical properties depending on their position relative to the liner. For example, the base layer can have a lower hardness as a whole compared to the first layer. The material forming the area corresponding to the joint such as the knee can have greater elasticity or air permeability than the material forming the adjacent area.

[0032] The materials are preferably compatible materials to allow chemical bonding so they can permanently bond to each other and can share at least one blending region where the materials of the layers blend or interlock with each other to form a permanent chemical bond. Other features (e.g., seals, volume control pads, cushioning pads, distal caps, etc.) can be formed of compatible materials and chemically bonded to the liner body or chemically bonded into the thickness of the liner body. Intermediate layers can be provided between layers to improve adhesion between chemically bonded or mechanically interlocked layers, fabrics, or other elements.

[0033] By providing discretely attached filaments and material layers having different properties, the liner advantageously provides enhanced precision to achieve desired mechanical properties, structure and functionality relative to existing liners. The inner layer may, for example, provide greater comfort by having a lower hardness, while the outer layer may have a greater thickness and greater elasticity to provide mechanical strength and desired functional properties. In some embodiments, the discretely attached material layers may include multiple layers of attachments, dots or filaments of different materials having different properties.

[0034] According to a variation, the filaments can be arranged by co-extruding the material, so that the two materials are coaxial, wherein the hardness (or other characteristics) of the material forming the outer layer is different from the material forming the inner layer. In some reasons, the outer layer can protect the soft inner layer and form a strong chemical bond with the adjacent filaments. In other variations, the elastic material can be co-extruded with a fabric such as a yarn. In other embodiments, the elastic material can be extruded into continuous filaments with different characteristics at different positions, which are provided by additives metered online, such as adding oil at certain positions to achieve a lower hardness. The filaments can be hollow to allow the use of higher hardness, higher durability materials while maintaining the buffer associated with the material of lower hardness. The stretchability of the inner layer can be controlled by the outer layer while allowing the soft inner layer to have compressibility. This makes the filaments formed discretely have the advantage of being able to provide multiple types of materials at the same time. For example, the lining can have the characteristics and advantages of a hard, durable material, as well as the characteristics and advantages of a flexible buffer material.

[0035] The combination or combination of adjacent filaments can extend to the solid wall portion of the liner, which is an airtight and watertight solid wall liner, or other medical equipment with a solid wall portion, or other medical equipment that is solid as a whole. Preferably, the solid wall portion can be formed by discrete and continuous multiple adjacent and abutting filaments. The resulting structure is preferably smooth and continuous, so that each filament in a plurality of discrete filaments cannot be identified due to direct adjacent proximity, whether mechanically, tactilely, or functionally. The resulting structure of adjacent filaments is achieved by mixed chemical bonding of other filaments with adjacent and abutting filaments in X, Y, Z planes and / or coordinates.

[0036] A plurality of filaments may define a layer of a medical device, wherein each of the plurality of filaments extends a distance in the Z axis to define the thickness of the layer. Each filament may define a coiled structure utilizing a liquid rope effect. A plurality of filaments may define a lattice structure. The filaments may interlock with adjacent filaments to provide desired properties in the X and Y axes, wherein the layer may maintain uniform properties as per manufacturing parameters regardless of the plurality of filaments defining the layer. Such a constructed layer may advantageously be simple to manufacture while having desired and predictable properties.

[0037] A fabric is disposed on an outer or inner surface or intermediate layer of an elastic lining body, and an elastic material is used to seal and secure the fabric to the lining body. For example, the fabric may be placed on the lining body and mechanically interlocked with the elastic material of the lining body impregnated with the fabric, and discrete portions of the elastic material are used to close the fabric material around the lining body, thereby eliminating any stitching. This feature is advantageous in that this embodiment can avoid uncomfortable pressure points by eliminating seams and stitches. This feature is also advantageous in that the fabric can be connected to the lining body at many points of the fabric, thereby ensuring a strong, durable bond. The manufacturing process can also be simplified by eliminating a separate stitching process.

[0038] Due to the controllability of forming a liner according to the above structure, versatility is provided in forming a custom-fit liner with various features (these features are integrally formed or fixed to each other). The liner can be custom formed by laminating compatible materials with different but compatible properties to accommodate uniquely shaped residual limbs.

[0039] Since the present invention is not limited to liners, other medical devices may be formed from medical grade elastic materials such as silicone according to the principles described by discrete and continuously attached elastic materials. These medical devices may be prosthetic or orthotic parts, medical implants, medical tubes, prostheses, and other parts or devices using such medical grade elastic materials.

[0040] The above and other features of the present invention will become more apparent from a reading of the following description, claims and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 A front view of a liner according to one embodiment is shown.

[0042] Figure 2A Shows along Figure 1 A three-dimensional cross-sectional view of the lining along line II-II.

[0043] Figure 2B Shows Figure 1 A plan view of the base layer of the lining.

[0044] Figure 2C Shows Figure 2A A perspective cross-sectional view of a variation of the lining in FIG.

[0045] Figure 2D Shows Figure 2C Plan view of the base layer in the cross-sectional view.

[0046] Figure 2E Shows Figure 2C Plan view of the central part of the cross-section diagram.

[0047] Figure 2F Shows Figure 2C Plan view of the fabric layer in the cross-section view.

[0048] Figure 2G Shows Figure 2C A plan view of a variation of the central portion in the cross-section.

[0049] Figure 3A Shows along Figure 1 A three-dimensional cross-sectional view of the lining along line III-III.

[0050] Figure 3B Shows the Figure 3A Enlarged cross-sectional view of .

[0051] Figure 4 Shows Figure 1 A plan view of one layer of the lining.

[0052] Figure 5 Shows along Figure 4 A three-dimensional cross-sectional view of the layers along line VV in FIG.

[0053] Figure 6 A plan view of the layers of a liner according to one embodiment is shown.

[0054] Fig. 7A A schematic diagram of a first line block pattern with an angle of 20° is shown.

[0055] Figure 7B A schematic diagram of a second line block pattern with an angle of 30° is shown.

[0056] Figure 7C A schematic diagram of a second line block pattern with an angle of 45° is shown.

[0057] Fig.7D A schematic diagram of a second line block pattern with an angle of 60° is shown.

[0058] Fig. 7E A graph of angle and stiffness is shown for a first line block pattern, a second line block pattern, a third line block pattern, and a fourth line block pattern.

[0059] Fig. 8A The lining (e.g. Figure 1 A schematic cross-sectional view of a liner in FIG. 1 showing the cushioning effect associated with a limb to a prosthetic seat.

[0060] Figure 8B The lining (e.g. Figure 1 Schematic cross-sectional view of the lining in the figure) showing the volume compensation of the bony prominence of the limb to the prosthetic base.

[0061] Figure 8C A schematic plan view of a lattice structure according to one embodiment is shown.

[0062] Fig. 9 Shows Figure 1 Schematic diagram of a layer offset variation of the lining in.

[0063] Fig. 10A A front view of a liner according to another embodiment is shown.

[0064] Fig. 10B Shows Fig. 10A Detailed view of the portion in area 10B of the lining.

[0065] Fig. 10C Shows Fig. 10B A cross-sectional view of the filaments in the lining along line 10C-10C.

[0066] Fig.11A A cross-sectional view of a variation of a liner is shown.

[0067] Fig. 11B Shows Fig.11A A schematic plan view of a central layer or multiple layers in a cross-sectional view.

[0068] Fig. 11C Shows Fig.11A A plan view of the outer layer formed by the elastic material in a cross-sectional view.

[0069] Fig. 12A A schematic plan view of another embodiment of a layer formed of an elastic material is shown.

[0070] Fig. 12B An elevation view of another embodiment of a plurality of any of the foregoing layers is shown.

[0071] Fig. 12C A schematic plan view of another embodiment of a layer formed of an elastic material is shown.

[0072] Fig.13A A plan view of another embodiment of a layer formed from an elastic material is shown.

[0073] Fig. 13B Shows Fig.13A A front view of the layers in .

[0074] Fig. 13C Shows Fig.13A Detail view of detail 13C.

[0075] Fig.13D Shows Fig. 13B Detail 13D detailed view.

[0076] Fig.14 A schematic cross-sectional view of a liner according to one embodiment is shown.

[0077] Fig.15 Shows Figure 1 Schematic cross-sectional view of the interface between at least one layer of the liner and the distal cup portion.

[0078] Fig.16 A perspective view of another liner embodiment is shown. DETAILED DESCRIPTION

[0079] Embodiments of the liner overcome the limitations of prior art liners by providing a liner structure that advantageously achieves breathability and reduces heat and moisture buildup without sacrificing the stability, cushioning, strength, and other advantageous features of a solid wall liner. The liner provides discrete areas with different features to better meet the needs of individual users, as well as the shapes and needs of different residual limbs.

[0080] Embodiments according to the present invention are not limited to liners, which are merely exemplary medical devices formed according to the principles of the present invention. Methods and apparatus that can be used to manufacture devices according to the principles of the present invention are described in a co-pending U.S. patent application entitled "Additive Manufacturing Systems, Methods, and Corresponding Components for Elastic Materials" filed on November 12, 2019 by the specific inventors of the present invention.

[0081] According to the method and system of the co-pending application, partially cured or uncured medical grade elastic material (e.g., silicone) is sequentially attached to a substrate from a material source in a controlled manner according to computer control through a nozzle or similar device to define a determined shape, such as a narrow or continuous filament. The attached elastic material can be a thermosetting material, such as silicone or thermosetting polyurethane, so that it can be cured after it has been deposited from the nozzle. The additive manufacturing system of the co-pending application can attach elastic materials and a preferred mixture of elastic materials together to obtain preferred properties along or at desired locations in a medical device, so that a continuous filament can have different properties, compositions and shapes at different locations along its length.

[0082] exist Figure 1 and Figure 3A An exemplary liner 100 is shown in FIG. 1 , which has a ventilation structure formed by a plurality of discretely attached elastic materials in the form of filaments. The term "discrete" and variations thereof are intended to convey its usual meaning, namely: independently separated and distinct. The liner 100 includes: a proximal end P or an open first end 104, into which a residual limb can be inserted; and a distal end D or a closed second end 106 disposed near the distal end D or the end of the residual limb. The first end 104 and the second end 106 define the ends of a liner body 102, and the diameter of the liner body can gradually taper to a solid wall structure 112 toward the second end or distal end. The liner body 102 and the solid wall structure 112 define an inner cavity 114, which is contoured to accommodate a residual limb. The surface of the outer E of the liner 100 can be configured to engage or interact with a prosthetic seat, and the inner I surface of the liner 100 can be configured to abut against and cushion the residual limb.

[0083] The elastic material according to the embodiments of the present invention is discretely attached as filaments so that each filament is independent, separate and differently formed. Although the adjacent layers or filaments can form a solid overall structure, this structure includes such discretely attached elastic material that is different from the elastic material body injected into the mold and is no different from discretely composed filaments or similar structures, and can obtain the desired properties at specific locations.

[0084] According to some embodiments, the elastic material is continuously attached to achieve uninterrupted formation of layers or filaments until it reaches a single length. In a structure (e.g., a porous structure or a breathable structure), the lengths of filaments adjacent to or adjacent to each other may be different. The length of the filaments may be shorter (e.g., but not limited to, 0.1 mm) or longer (e.g., 1 m).

[0085] In either case, the elastic material is continuously formed into filaments of discrete material having a predetermined solid cross-section and a predetermined continuous length, which filaments are combined with other filaments to form a defined structure of a liner or other medical device. This feature is advantageous because it allows a high level of customization of these structures. The characteristics of the filaments can be varied and selected to obtain any suitable final product. In some embodiments, the size, diameter and other characteristics can be varied to achieve a film-like layer; in other embodiments, the properties of the filaments can achieve a thick and / or textured layer of contiguous, identifiable discrete filaments.

[0086] In certain embodiments, the liner body 102 may have a tubular or tapered configuration and advantageously defines a breathable structure 110 that makes the liner 100 breathable and fluid (including moisture) permeable, and thereby heat permeable. The advantageous components and configuration of the breathable structure 110 allow breathability and fluid permeability to be achieved without sacrificing the robustness, mechanical strength, and cushioning provided by a solid wall liner, as will be described in greater detail below.

[0087] The solid wall structure 112 may be constructed to have additional thickness relative to the liner body 102 at the distal end 106 as compared to the breathable structure 110. The additional thickness of the distal end 106 having a closed configuration may provide additional cushioning at the distal end of the residual limb to support the weight of the user. The solid wall structure 112 also maintains an area of ​​the liner 100 that may generate suction to the residual limb, thereby eliminating any suction loss with existing breathable liners; the solid wall structure 112 advantageously provides a secure connection between the liner 100 and the limb, although mechanical adhesion to the skin may otherwise be relied upon. Although "solid", the solid wall structure 112 includes a plurality of discrete filaments that are directly adjacent and bonded to each other without gaps to form a "solid" wall structure, as opposed to a lattice-type construction forming a plurality of grids or meshes, as described below. Fig. 12C As shown, the filaments are adjacent on the X-axis and are roughly aligned on the Y-axis. In some embodiments, the solid wall structure 112 can have a Shore OO hardness between about 30 and about 60, preferably between about 39 and about 50. The solid wall structure 112 may also include a thixotropic agent for stabilizing the structure during manufacturing.

[0088] exist Figure 1 In the embodiment of the present invention, the distal portion 106 defines a solid and impermeable wall thickness along the entire solid wall structure 112. The "solid" structure can be considered a membrane, and its thickness can be modified according to the desired material properties. Although the solid wall structure 112 is defined as a plurality of filaments directly adjacent to each other and bonded in one plane (due to the closeness of their proximity), the solid wall structure 112 can define a plurality of layers stacked adjacent to each other in the Z axis, such as Fig. 12B The solid wall structure 112 may also provide additional strength and rigidity to the pin connection, for example allowing pin structures used to connect the liner 100 and a corresponding prosthetic base to remain firmly engaged with each other without risk of damage to the liner 100 .

[0089] The breathable structure 110 and the solid wall structure 112 are preferably formed as a unitary structure by a plurality of discretely attached layers of elastic material filaments chemically bonded to each other. In this way, the liner 100 is integrally formed and mechanically used as a single object that is firmly indivisible. This arrangement can ensure a lasting bond between the liner body 102 and the distal end 106. Although both may preferably be integral structures, the breathable structure 110 and the solid wall structure 112 preferably have different mechanical properties, such as tensile strength, elasticity (radially and axially) and hardness. This provides the ability to achieve a product that meets the individual needs of the patient. The breathable structure 110 and the solid wall structure 112 can be formed separately and mechanically and / or chemically fixed together (e.g., by an adhesive), and production flexibility can be achieved, and different materials and processes can be used.

[0090] The liner body 102 and the solid wall portion 112 can be formed by one or more elastic materials. Either or both of the liner body 102 and the solid wall portion 112 are preferably formed by medical grade elastomers. Such medical grade elastic materials preferably include silicone, polyurethane or other elastic materials. For the present invention, the embodiment will be described as being formed by medical grade silicone. Examples of medical grade silicone and other elastic materials can be obtained from NuSil Technology, Carpinteria, California, USA, with product models CF13-2188, MED-4901, MED-6340 or MED-6345. Other silicone components can be used, and the embodiments herein are not limited to exemplary silicone materials, but can be formed by other suitable polymers or elastic components (e.g., polyurethane, block copolymers, etc.).

[0091] The liner body 102 may be formed of a different material or material having different properties than the solid wall portion 112, and the various layers (including the first layer 122 of the liner body 102) may have a different material than the second end portion 106. The materials forming the first layer 122, the liner body 102, the second end portion 106, or a combination thereof may include the same material, but may be configured to have different structural and functional properties.

[0092] The interface 108 can provide a secure connection between the air-permeable structure 110 of the liner body 102 and the solid wall structure 112 of the distal end portion 106. The interface 108 can include an additional elastic layer bonded between the solid wall structure 112 and the components of the air-permeable structure 110. The liner body 102 and the distal end portion 106 are preferably formed integrally with each other and chemically bonded to each other. The liner body 102 is fixed to the solid wall structure 112 along the interface 108 by chemical bonding between the material forming the liner body 102 and the material forming the solid wall structure 112. The materials of the air-permeable structure 110 and the solid wall structure 112 can be mixed at the interface 108, the thickness or extension of the interface can be minimized, and only the portions of the air-permeable structure 110 and the solid wall structure 112 can be included. The degree of mixing that occurs at the interface can be minimized so that the shape of the filament is not changed, but it is sufficient to ensure the bonding of adjacent portions of the filament.

[0093] See also Figure 2A , wall thickness 120 extends between base layer 121 and layer 136. Layer 136 is disposed on the outwardly facing surface of liner 100 and is configured to engage with a corresponding prosthetic base. Layer 136 may be formed of a fabric or a fabric substitute. Layer 136 may be formed of a plurality of filaments defining a fine pattern to mimic, for example, a semi-enclosed surface in a fabric. The fine pattern layer of filaments may be formed of an elastic material having a friction reducing coating. In addition, the fine layer of filaments may have a composition mixed with an elastomer, such as polyparadichlorotoluene, which is a chemical vapor attached as polyparadichlorotoluene polymer, which acts as a moisture barrier and a dielectric barrier. Base layer 121 is disposed on the inwardly facing surface of liner 100 and is configured to engage with a residual limb. Multiple layers 122, 124, 126 may extend between base layer 121 and fabric 136. Each layer 121, 122, 124, 126, 136 has unique properties and characteristics, which allows for a high degree of customization corresponding to the size and needs of the user.

[0094] In one embodiment, the base layer 121 can be constructed as a generally solid film of elastic material formed by the joined filaments and extending over and around the residual limb. The advantage of this arrangement is that an optimized frictional engagement with the skin is achieved at the inner surface 123 of the base layer 121 to avoid a "piston effect", "milking effect" or catastrophic failure of the orthotic system due to poor engagement between the residual limb and the liner 100.

[0095] The base layer 121 may include holes or openings 129 arranged in a fixed manner, a predetermined pattern and a predetermined shape as described below, see Figure 2B. The opening 129 is fixedly arranged to ensure that the opening 129 intersects or corresponds with other layers and corresponding openings in the thickness of the liner body 102. The opening 129 can advantageously extend through the entire thickness Tb of the base layer 121. In one embodiment, the opening 129 can be aligned with a portion of the void axis 128 extending through the thickness 120 of the liner body 102 and define a portion of the void axis 128 to provide a substantially straight-through channel or passage through which fluid and heat can pass from the residual limb through each layer 121, 122, 124, 126, 136 to the exterior E of the liner 100.

[0096] The inner surface 123 of the base layer 121 defines the inner cavity 114 of the liner 100 and includes a solid surface area that is larger than the cumulative surface area of ​​the opening 129 to provide effective and reliable skin engagement. The solid surface should be smooth because it has a generally uniform height except for the opening 129. The smooth surface can avoid the creation of pressure points on the user's skin and ensure uniform adhesion to the skin of the residual limb, thereby achieving effective frictional engagement. Because the base layer 121 conforms to and defines the tubular shape of the liner body 102, it defines a generally uniform curved and / or rounded profile. If the inner surface 123 is set to a planar configuration, then due to the characteristics of the smooth surface, the inner surface can be flat. The curved and / or rounded profile can mitigate pressure peaks or pressure points during use and absorb shear forces, thereby protecting the skin of the residual limb and possible scar tissue.

[0097] In addition, the inner surface 123 may be provided with active skin care additives for enhanced comfort and skin care, and easy to put on and take off. The skin care additives may be silicone oil, Menthol, antimicrobial ingredients, aloe vera, or any other suitable skin care additives to alleviate irritation, skin problems or mechanical problems. For example, the base layer 121 may include a composite material including a silicone elastomer and silicone oil dispersed in the silicone elastomer, and / or the base layer 121 may include a plurality of hollow microspheres of silicone oil or other additives dispersed in the silicone elastomer.

[0098] The base layer 121 is preferably formed of a plurality of discretely attached filaments or material attachments to form its structure. In addition to the openings 129, the base layer 121 is preferably a solid wall, and the filaments are adjacent to each other to form such a solid wall structure. The attachment of the filaments is controlled, wherein some of the filaments can be interrupted during attachment to form a predetermined shape of the opening 129. This advantageously provides a plurality of controlled and smooth-edged openings 129, and also simplifies the manufacturing process by reducing the need to remove or "punch out" material to form the openings after forming the base layer.

[0099] In the embodiments herein, the filaments can have different sizes and shapes relative to each other. According to certain embodiments, the filaments have a circular cross-section, but may also have other shapes and cross-sections depending on the attachment device used to attach the filaments. Such cross-sections may include predetermined shapes, such as squares, rectangles, triangles, ovals, etc., because these shapes are only limited by the devices used to attach the filaments. An embodiment or certain layers do not necessarily have filaments that are uniformly identical in shape, but may have variable shapes depending on the desired properties and form of the embodiment or layer. The cross-sections do not necessarily have to be symmetrical and may vary along the length of the filaments.

[0100] The size of the filaments can be appropriately varied depending on the desired properties of the layer. For example, the filaments can have an exemplary precise diameter of 0.1 mm, or be arranged in a rectangular form of 1 cm x 2 cm. The ability to precisely control the size results in structural variability in the liner, and to a wider extent in the medical device. The filaments can have different predetermined lengths relative to each other to form precise surface features (i.e., openings) in a layer, or the filaments can be stacked along other layers to form precise surface protrusions or protrusions. For example, a volume-controlled liner can be formed by attaching filament segments one by one along the inner surface of the liner and stacking them one after another with different lengths to form a liner. Fig.14 The predetermined convex shape in .

[0101] The hardness of the base layer 121 may be in the range of about 40 Shore OO to about 50 Shore OO, and may vary from the top to the bottom; in some embodiments, the hardness may be about 45 Shore OO at the bottom end close to the user's skin, and the hardness may be higher at the top end opposite to the bottom end, preferably about 50 Shore OO. The tensile strength of the base layer 121 at the top end is between 2N and 6N at 100% elongation, preferably about 4N at 100% elongation. The tensile strength of the bottom end is between 0.5N and 4N at 100% elongation, preferably about 2N at 100% elongation.

[0102] In some embodiments, the base layer 121 can be a fabric layer. The fabric layer can be provided with an elastic material on its surface (e.g., inner surface) to promote skin adhesion by providing friction characteristics and other properties. The elastic material on the inner surface of the fabric layer can interlock with the fabric material (e.g., by penetrating the fabric material and solidifying relative to the fabric material) and can define any appropriate pattern. For example, the pattern can be a grid pattern, a grid pattern, a repeating shape, a dot, or other form that can define friction and skin engagement characteristics. The pattern defined on the surface by the elastic material can cumulatively include approximately half of the surface area of ​​the base layer 121. The illustrated embodiments are exemplary only and not restrictive.

[0103] The first layer 122 may be formed of silicone and disposed adjacent and concentric to the base layer 121 and may be connected to the base layer 121 by chemical bonding, adhesives, or any other suitable connection mechanism. In an exemplary embodiment, the innermost portion or surface of the first layer 122 is chemically bonded to the base layer 121 at the joint 125, and the integral formation of the base layer 121 and the first layer 122 allows the layers 121, 122 to have different properties and structures, but to be reliably and permanently fixed to each other to avoid separation under load and retain the mechanical advantages of a solid elastic liner.

[0104] Although the first layer 122 may be configured differently relative to the base layer 121, the first layer 122 may be formed of a material having different or the same mechanical properties as the base layer 121. For example, while the filaments defining the base layer 121 may define a substantially layered or solid soft silicone membrane perforated or interrupted by openings 129, the first layer 122 may be formed of filaments, strands, ribs, or other structures that allow a plurality of substantial openings 130 to be defined within and through the thickness of the first layer 122. The hardness of the first layer 122 may be greater than the hardness of the base layer 121. In certain arrangements, the stiffness of the first layer 122 is greater than the stiffness of the base layer 121. The greater stiffness enables the first layer 122 to provide stability, such as through circumferential and axial resilience, while the softer base layer 121 provides vibration damping, comfort, and frictional engagement with the residual limb.

[0105] The openings 130 preferably define a predetermined pattern and a predetermined shape. The openings 130 correspond to the openings 129 of the base layer 121 and are coaxially aligned or overlapped therewith and coincide with the void axis 128. The openings 130 may extend through the entire thickness T1 of the first layer 122. The thickness T1 of the first layer 122 may be greater than the thickness Tb of the base layer 121, wherein the larger thickness T1 provides strength and mechanical support for the liner 100, while the openings 130 reduce the overall weight and volume. The openings 130 may include a different shape than the openings 129 and may have a different surface area. For example, the openings 130 may be larger or smaller than the openings 129, and the combined solid surface area of ​​the first layer 122 may be less than the combined surface area of ​​the openings 130, as opposed to the case of the base layer 121.

[0106] In some embodiments, base layer 121 may include between about 5% and about 15% of its surface area in an unstretched state as defined, for example, by openings 129. First layer 122, second layer 124, and third layer 126 may be formed such that between about 30% and about 70% of the surface area of ​​first layer 122, second layer 124, and third layer 126 is open area, preferably between 40% and 60% is open area. These percentages are exemplary only and may vary based on the load applied to liner 100 or based on the size of the user wearing and using liner 100.

[0107] Additionally, the filaments, strands, ribs, or other structures forming the first layer 122 may be formed of a material having different properties than the material forming the base layer 121. While the base layer 121 may define a friction material, for example, the first layer 122 may include a material having a lower hardness, greater elasticity, anisotropic elasticity, or higher heat transfer properties than the base layer 121. These properties are exemplary, and the material forming the first layer 122 may include any number of other advantageous properties or combinations thereof.

[0108] The second layer 124 may be formed of silicone or another elastic material and is disposed adjacent and concentric to the first layer 122. The second layer 124 may have the same or different properties and structure as the base layer 121 and the first layer 122. As between the first layer 122 and the base layer 121, the innermost portion of the second layer 124 may be integrally formed with the outermost portion of the first layer 122, and / or intermixed, preferably by chemical bonding. The integral formation of the materials of the first layer 122 and the second layer 124 allows for reliable connection of the layers in the liner 100, which provides the advantages of a solid wall structure and also maintains unique properties and structure.

[0109] The second layer 124 may define a structure 127 having a thickness T2, such as a filament, strand, rib or other structure, and a plurality of holes or openings 132 may be defined through the entire structure. The holes 132 are formed by interrupted segments of the filaments in the continuous direction of the second layer 124 and the filaments defining them. The openings 132 may advantageously be arranged coaxially or overlapping with the openings 129 of the base layer 121 and the openings 130 of the first layer 122, and may have the same predetermined shape and predetermined pattern as in the base layer 121 and the first layer 122.

[0110] The openings 132 further define and extend along the interstitial axis 128 and form substantially straight through passages for moisture and heat to escape from the interior I of the liner 100. In some embodiments, the openings 132 may be staggered relative to the openings 130 of the first layer 122. The staggered relationship of the structures 127 and the openings 132 relative to the openings 130 and structures of the first layer 122 advantageously allows columns 131 of solid structure to extend continuously from the interior surface 123 of the base layer 121 to the exterior surface 137 of the fabric 136. The columns 131 are formed because at least some of the filaments from the layers 121, 122, 124, 126, and 136 overlap along an axis from the surface of the interior I to the surface of the exterior E. The columns 131 provide mechanical strength and cushioning when the exterior surface 137 of the fabric 136 contacts and receives loads from a corresponding prosthetic base.

[0111] Similar to the first layer 122, the second layer 124 may also have different properties from the base layer 121 and the first layer 122. For example, the second layer 124 may have greater stiffness, greater elasticity, anisotropic elasticity, or any other properties to complement the cushioning effect of the base layer 121 and the properties of the first layer 122. Another consideration is that because the breathable structure 110 enlarges and expands the openings of the various layers 121, 122, 124, 126, 136, the liner 100 may become more breathable when the liner 100 expands.

[0112] The exemplary third layer 126 may be formed of an elastic material and disposed adjacent to and concentric with the second layer 124. Similar to the base layer 121, the first layer 122, and the second layer 124, the third layer 126 may be attached to the second layer 124 by chemical bonding, adhesives, or any other suitable connection method. In a preferred chemical bonding, the innermost portion of the third layer 126 is blended with the outermost portion of the second layer 124, so that the second layer 124 and the third layer 126 are formed as one body and fixedly joined, but maintain unique properties.

[0113] The third layer 126 can define a structure 133 including filaments, strands, ribs, or any other structure that can define a plurality of openings 134 extending through the thickness T3 of the third layer 126. Similar to the other layers, the openings 134 can have a predetermined shape and can be arranged in a predetermined pattern. The openings 134 can be arranged to correspond at least partially to the openings 132, 130, 129 of the other layers and extend along the gap axis 128. Similar to the second layer 124, the structure 133 of the third layer 126 can be arranged in size and shape to at least partially overlap and abut the structure 127 of the second layer 124 so as to extend and define the columnar body 131 for radial strength and stability.

[0114] The first layer 122, the second layer 124, and / or the third layer 126 may define, individually or in combination, a central portion of the liner body 102, and may be configured to have a hardness between about 20 Shore A and about 60 Shore A, preferably about 40 Shore A. The central portion may have a tensile strength between about 1000 psi and about 1600 psi, preferably about 1350 psi, and may be thixotropic to maintain a desired or predetermined shape.

[0115] It should be understood that additional layers may be disposed adjacent to and concentric with the base layer 121, the first layer 122, the second layer 124, and the third layer 126, and that other structures or layers may discretize one or more of the base layer 121, the first layer 122, the second layer 124, and the third layer 126 relative to the other layers. For example, a matrix of reinforcing material extending longitudinally from the distal end 106 may extend between the first layer 122 and the second layer 124. The matrix may provide additional mechanical strength in the axial or radial directions. The layers 121, 122, 124, 126 may extend completely to the distal end 106 of the liner 100 without being interrupted by the solid wall portion 112. The distal end 106 may include structures such as an umbrella connector, additional layers with additional cushioning, spacer material, wicking material, or other components.

[0116] In some embodiments, a second base layer or skin-facing layer may be disposed adjacent to the base layer 121 and between the base layer 121 and the first layer 122. The second base layer may include the same material as the first layer 122, the second layer 124, and / or the third layer 126, and may preferably be defined by thinner filaments. The second base layer may provide support and strength to the base layer 121.

[0117] Each layer may have different mechanical properties and may be formed of different materials, yet the materials are compatible to allow chemical bonding. For example, the second or third layer 122, 124, 126 may have greater stiffness or hardness, while the more inward layers (e.g., layers 121, 124) have lower hardness and greater compressibility. It should be understood that the arrangement of the structure and openings of each layer 121, 122, 124, and 126 may vary appropriately along the circumference and may also vary along the axial direction. For example, the arrangement shown with columns and void axes may be well suited to a particular portion of a liner or medical device; while another embodiment (e.g., in which a greater or lesser number of openings may be provided and the openings may be aligned differently with the structure and openings of adjacent layers) may be suitable for different regions. In some embodiments, the structure of some layers may be arranged adjacent to the openings of adjacent layers, rather than defining columns.

[0118] Each layer 121, 122, 124, 126, 136 can have a different thickness suitable for a specific user, a specific application, etc. In some embodiments, the thickness of the base layer 121 is in the range of 0.1mm to 1mm, and preferably the thickness can be about 0.5mm. The second base layer can have a thickness similar to the base layer 121, such as 0.5mm. The first layer 122, the second layer 124, and the third layer 126 can have a thickness of 0.1 to more than 1mm, and preferably can have a greater thickness than the base layer 121. In some embodiments, the first layer 122, the second layer 124, and the third layer 126 can have a thickness of about 0.7mm. The fabric layer 136 can have a thickness of 0.1 to 1mm, preferably a thickness of about 0.5mm, and can be connected to adjacent layers by an adhesive having a thickness between 0.05 and 0.2mm, preferably about 0.1mm. The total thickness of the lining body 102 can be between about 3mm and about 6mm, preferably between about 4mm and 5mm. The dimensions described are not limiting but merely exemplary.

[0119] The lattice structure formed by the gaps 129, 130, 132, 134 may vary between different layers, in different coordinates of the layer itself, or in correspondence with other layers. For example, a rib may be formed by the layer at a predetermined position in the circumference of the liner 100 and extend generally axially between the first end 104 and the second end 106 of the liner 100. The lattice structure at the rib may include smaller gaps than other gaps, or may be free of gaps, wherein the filaments of each sub-layer abut each other to form the rib, but are spaced apart from each other outside the rib.

[0120] The fiber or fabric material may form a fabric layer 136 at the outward portion or periphery E of the liner 100. The fabric layer 136 may be secured to the third layer 126 by impregnating the material of the fabric layer 136 with the elastomer of the immediately adjacent layer (e.g., the third layer 126). The third layer 126 may be connected to the fabric layer 136 by an adhesive or any other suitable connection mechanism. The third layer 126 may impregnate the fabric layer 136 at a portion corresponding to and adjacent to the structure 133, while leaving the portion of the fabric layer 136 corresponding to and adjacent to the opening 134 unimpregnated with the elastic material.

[0121] The fabric layer 136 can be configured to engage with a corresponding prosthetic base to resist wear and tear, provide desired properties with respect to anisotropy or moisture wicking, absorb moisture, provide a desired level of stiffness in a specific axis, such as controlling a piston effect or facilitating donning and doffing of the liner 100. The fabric material can modify the stretch of the liner body 102, such as by increasing the radial stretch of the liner body 102, and provide a neutral elasticity relative to the liner body 102 by having a different elasticity than one or more layers 121, 122, 124, 126. In addition, the fabric material can facilitate breathability. The fabric layer 136 can include functional areas defined by different portions of the weave pattern to give the liner 100 a specific shape, elasticity, stiffness, or tendency.

[0122] The fabric layer 136 may be formed of a breathable material, so that fluid and heat flowing through the channel defining the void axis 128 may diffuse or seep out to the outside of the liner 100 through the fabric layer 136. Since the material of the third layer 126 impregnates the fabric layer 136 only at the portion of the fabric layer 136 corresponding to and adjacent to the structure 133, the portion of the fabric layer 136 corresponding to the void axis 128 remains breathable and allows fluid and heat to penetrate, while the fabric layer 136 remains firmly connected to the liner body 102. The thickness Tt of the fabric layer 136 may be less than the thicknesses T1, T2, and T3 of the first layer 122, the second layer 124, and the third layer 126.

[0123] Due to the elasticity of the elastomer (e.g., silicone or other material) forming the layers 121, 122, 124, 126, the openings 129, 130, 132, 134 defined through the layers 121, 122, 124, 126 can expand when the liner 100 is worn because the residual limb forces the layers 121, 122, 124, 126 to have a larger circumference and cover a larger surface area than in the contracted, resting state of the liner 100. As the openings 129, 130, 132, 134 expand and enlarge when worn due to the diffusion of the material forming the layers 121, 122, 124, 126, the permeability of the liner 100 to fluids and heat can be increased, while the solid structure defining the layers 121, 122, 124, 126 can continue to provide structural and mechanical strength and comfort to the residual limb from pressure points, contact with the prosthetic base, etc. The thicknesses Tb, T1 , T2, T3, Tt of the layers may decrease as the liner 100 expands and swells, and the structure may continue to define the columns 131 , providing strength and support.

[0124] The layers 121 , 122 , 124 , 126 and the fabric layer 136 together define a thickness 120 of the liner body 102 . Figure 3AA perspective cross-sectional view of the liner 100 is shown. The interior cavity 114 is surrounded by concentric layers 121, 122, 124, 126, 136. The concentric layers 121, 122, 124, 126, 136 extend through the entire liner body 102 and include different materials and / or different properties to define a comfortable, stable, and breathable liner 100. It should be understood that the liner body 102 may include discrete or tapered portions that include different layers and different materials relative to the illustrated embodiment, which is exemplary and not limiting.

[0125] Figure 2B 1 is a detailed view of the base layer 121. The base layer 121 defines an inner surface 123 of the liner 100 and a plurality of openings 129. The shape of the openings 129 is not limited and may be formed in a variety of geometric shapes suitable for promoting the flow of air and sweat. The openings 129 may be distributed in a non-uniform pattern, with a greater density of openings 129 in areas where more flexibility and / or breathability is desired, and a lower density of openings 129 in areas where less flexibility or breathability is desired.

[0126] Figure 2C to Figure 2G Shows Figure 2A Variations of the lining structure in. Figure 2C The lining structure 430 may include a base layer 432 having a Figure 2D The central portion 434 may include at least two layers 438, 440, 442, and 444, which are arranged in a grid configuration and stacked on each other alternately in the X direction and the Y direction, as shown. Figure 2E For example, at least two layers have filaments 456 extending relative to each other on the X-axis, which are spaced apart from filaments 458 extending on the Y-axis on the Z-axis. It has been found that stacking filaments parallel to each other on the Z-axis forms a significantly cushioned center portion 434. Stacked filaments staggered relative to each other on the Z-axis ( Figure 6 exemplarily shown in FIG. 4 ) can provide less buffering. Figure 2F An outer layer 436 is shown having a breathable structure 460, thereby enabling transport of air and other fluids from the base layer 432 through the central portion 434 and the outer layer 436. The outer layer 436 may be a resilient layer formed of filaments, a fabric layer, or any other suitably formed structure.

[0127] refer to Figure 2C, the thickness 446 of the base layer 432 can be much thinner than the thickness 448 of the central portion 434. The base layer 432 can be formed by a single layer of filaments or multiple filaments. The central portion 434 includes a plurality of filaments, and each filament can be selected to have a thickness greater than or less than the total thickness 446 of the base layer 432. At least in the illustrated embodiment, the total thickness 448 of the central portion 434 is defined as the combination of each layer of filaments, and is significantly greater than the thickness of the base layer 432. For example, "significantly" means that the thickness 448 of the central portion can be at least twice the thickness 446 of the base layer 432. The thickness 450 of the outer layer 436 is preferably greater than the thickness 446 of the base layer 432, but less than the thickness 448 of the central portion 434, because the central portion 434 is provided to be used as the main cushioning feature of the lining structure 430.

[0128] Figure 2G yes Figure 2E A variation of , wherein the first filament layer 462 extends in a first direction and the second filament layer 464 extends in a second direction different from and relative to the first direction. For example, the first filament layer 462 and the second filament layer 464 extend at an oblique angle relative to the X-axis and the Y-axis, thereby forming a vertex 468. The vertex 468 can have a desired angle of any value, such as FIG. 7A to FIG. 7D In the illustrated embodiment, the first and second layers may be tilted relative to the x-axis and y-axis and extend at right angles or perpendicularly relative to each other. The third layer 466 of filaments may be arranged perpendicularly along the Y-axis and may intersect or be offset relative to the vertex 468. By arranging a layer of filaments 466 relative to the first filament layer 462 and the second filament layer 464, the third layer 466 of filaments may be arranged to promote or inhibit extension in a direction relative to the XY axes.

[0129] In a variation, the third layer or layers of filaments may comprise a composite of filaments adjacent to and combined with each other. For example, each filament comprised by the third layer of filaments may be formed by two filaments having different material properties to inhibit or promote extension along its length.

[0130] Figure 3BIllustrated are vertical flow paths or channels 135 defined as passing through the longitudinal length of the layers 121, 122, 124, 126. The vertical flow paths or channels 135 define openings between the solid structures used to form the layers 121, 122, 124, 126 that allow breathability or permeability to fluid and heat, thereby allowing fluid and heat to escape from the residual limb in both radial and vertical directions. Fluid and heat can be discharged in the distal or proximal direction through the vertical flow paths 135. The vertical flow paths 135 are shown as extending in an alternating manner between the multiple layers 121, 122, 124, 126, but it should be understood that the vertical flow paths 135 can extend through all layers, selected multiple layers, or a single layer, and uniformly or non-uniformly through the layers and liner body 102.

[0131] exist Figure 4 In the illustrated embodiment, the first layer 122 includes a structural sublayer as a filament layer, which together form the first layer 122. As an example of the arrangement of the first filaments 140, in the first sublayer 140, a plurality of first filaments 140 extend in a direction D1, wherein the separated first filaments 141, 143 extend parallel to each other and are spaced apart by a distance d1. The second sublayer 142 adjacent to the first sublayer 140 includes a plurality of second filaments 142 that define the second sublayer 142 and extend in a second direction D2. The second direction D2 may be perpendicular to the direction D1, or may extend in any direction relative to the first direction D1. The second filaments 142 may also include separated second filaments 145, 147, which are spaced apart by a distance d2 and extend parallel to each other.

[0132] The second sublayer 142 is arranged to overlap above or below the first sublayer 140 and define openings 130 corresponding to predetermined positions of the interstitial axes 128 between the first filaments 140 and the second filaments 142. The first sublayer 140 and the second sublayer 142 define a lattice structure. Each opening or interstitial axis 130 can be arranged to define an interstitial axis 128 extending vertically or orthogonally through the thickness T1 of the first layer 122. The distances D1, D2 define the size of the opening 130, which is determined by the gaps between the separated filaments 141, 143, 145, 147.

[0133] The first sub-layer 140 including separate filaments 141, 143 can be arranged within the first layer 122 to be closer to the interior I of the liner 100 than the second sub-layer 142, wherein the first sub-layer 140 and the second sub-layer 142 include different material properties suitable for their respective locations. For example, the first sub-layer 140 may have a lower hardness, a lower tensile strength, a greater extensibility, or a greater tear strength, or may include different skin additives, any of which may provide greater comfort at the residual limb and / or provide a better frictional engagement between the liner 100 and the residual limb, particularly due to the first sub-layer 140 being closer to the user's skin. The properties of the first sub-layer 140 and the second sub-layer 142 may vary over the entire length and circumference of the liner 100.

[0134] Figure 5 Shows along Figure 4 14. A perspective cross-sectional view of the intersection between the first filament 140 and the second filament 142 of the first layer 122 taken along line VV in FIG. The first filament 140 is configured to overlap and extend on the second filament 142, wherein discrete intersections 149 of the first filament 140 and the second filament 142 are formed in a predetermined pattern throughout the first layer 122 according to the first direction D1 and the second direction D2 in which the first filament 140 and the second filament 142 extend continuously relative to each other. The first sub-layer 140 and the second sub-layer 142 may be fixed to each other at the mixed portion 148 at one or more intersections 149, so that the filaments of the first sub-layer 140 and the second sub-layer 142 are continuous and in contact with each other at the intersection 149. If the first filament 140 and the second filament 142 are made of silicone or other elastic materials, the mixed portion 148 may include a chemical material located at the edge or outermost portion of the first filament 140 and the second filament 142 to achieve an integrally formed intersection of the first sub-layer 140 and the second sub-layer 142. In one exemplary embodiment, the first filament or sub-layer 140 and the second filament or sub-layer 142 are formed of medical grade silicone. The bonding or connection of the filaments 140, 142 at the intersection 149 can ensure that the layer 122 maintains structural integrity and desired mechanical properties.

[0135] Figure 6An embodiment of a second layer 124 is shown, which is adhered and adjacent to the first layer 122 and the first and second sublayers 140, 142, so that the first and second layers 122, 124 arranged in a lattice structure are juxtaposed. The second layer 124 includes a third sublayer 144 and a fourth sublayer 146 relative to the first and second sublayers 140, 142, and is arranged in a pattern that defines openings and intersections between the third and fourth sublayers 144, 146. As with the first and second sublayers 140, 142, the third sublayer 144 defines distinct and separate filaments 151, 153 that extend parallel to each other and are spaced apart by a distance d3, while the fourth sublayer 146 defines distinct and separate filaments 155, 157 that extend parallel to each other and are spaced apart by a distance d4. The distances d3, d4 define the size of the openings 132 extending through the thickness of the second layer 124.

[0136] The openings 132 are arranged to correspond at least partially with the openings 130 of the first layer 122, thereby defining a void axis 128 that extends through the thickness of the first layer 122 and the second layer 124. The filaments 141, 143, 145, 147 can be interlaced within the first layer 122, and the filaments 151, 153, 155, 157 can be interlaced within the second layer 124 and between the filaments of the first layer 122 and the second layer 124. This arrangement advantageously provides a channel along the void axis 128, which can allow fluid and heat to flow from the residual limb to the exterior E of the liner 100. It should be understood that although only the first layer 122 and the second layer 124 are described, the filaments or other structures can also be arranged in other layers such as the third layer 126 in a similar manner or in an alternative configuration.

[0137] The interlacing of the filaments 141, 143, 145, 147 of the first layer 122 and the filaments 151, 153, 155, 157 of the second layer 124 may also provide a beneficial cushioning effect and mechanical strength to the liner body 102. When the liner 100 is donned and used, the liner 100 is loaded due to the weight of the user being applied to the prosthesis seat system, thereby pressing the liner 100 into and against the corresponding prosthesis seat. As the liner 100 is pressed downwardly and outwardly into and against the prosthesis seat, the layers 121, 122, 124, 126 and the fabric layer 136 may be radially compressed between the prosthesis seat and the residual limb. The column of solid material 131 including portions of layers 121, 122, 124, 126 and fabric layer 136 advantageously resists compression and provides cushioning for the residual limb, thereby reducing pressure points on the residual limb and maintaining the void shaft 128 for fluid and heat transport.

[0138] When layers 121, 122, 124, 126 and fabric layer 136 are compressed, columns 131 can further provide relief through the staggered arrangement of filaments 141, 143, 145, 147, 151, 153, 155, 157 because columns 131 can press against adjacent columns 131, forming a reinforcing or cushioning arrangement of the layer of columns 131. When liner 100 is compressed, each filament extending parallel to each other (e.g., sub-layers 155 and 157) will lean to one side of the filament sub-layer below it, so that columns 131 can lean into adjacent columns 131. The ease with which the filaments can be compressed (because the staggered arrangement does not force two or more filaments to press directly on top of each other) is advantageous because it creates a cushioning effect. The proximity of each column 131 to another column 131 will provide support because a compressed column pressed down will lean into an adjacent column, distributing the compressive pressure over a larger area, thereby reducing the pressure felt by the wearer.

[0139] The filaments of the first layer 122 and the second layer 124 can be formed of different but compatible materials according to their material properties. Even within the first layer 122 and the second layer 124, the sub-layers 140, 142, 144, 146 can have different mechanical properties, which can vary along the length of any filament, and all are permanently bonded to each other by chemical bonding.

[0140] FIG. 7A to FIG. 7D Different patterns of filament layers are illustrated which may vary the stiffness or other properties of the combination of overlapping layers of filaments, such as Fig. 7E It has been found that as the angle of the apex increases, the corresponding tubular lining (such as Figure 1 The radial stiffness of the liner 100 is also increased. The stiffness can be adjusted in local areas of the liner or over the entire circumference. For example, in a liner, these advantages can be applied to a trans-tibial liner, where the local elastic stiffness in the knee area can be reduced, making it easier to bend the knee. Another example can be to gradually reduce the stiffness towards the proximal opening of the liner to improve comfort and ease of donning and doffing of the liner 100.

[0141] Fig. 7A A layer 300 is shown having a first layer 316 of filaments and a second layer 318 with apexes 308 oriented 20° toward the Y-axis. Figure 7B A layer 302 is shown having a first layer 320 of filaments and a second layer 322 having apexes 310 oriented at 30° toward the Y-axis. Figure 7C Layer 304 is shown having a first layer 324 of filaments and a second layer 326 of filaments having apexes 312 oriented 45° toward the Y-axis. Fig.7DLayer 306 is shown having a first layer 328 of filaments and a second layer 330 of filaments with apexes 314 oriented at 60° toward the Y-axis.

[0142] Fig. 8A The lattice structure 340 of the liner in the embodiment is illustrated to create a cushioning effect on the opposite sides of the liner or multiple filament layers 348 between the inner layer 342 and the outer layer 344. It has been found that when using such a liner, there is a "cushioning" effect at the thickness 346 between the opposite sides 342, 344 of the lattice structure 340, and it has been described as "walking on grass" (e.g. Figure 1 Examples and Fig. 8A The difference between a concrete lining (shown schematically in ) and "walking on concrete" (e.g. a conventional solid wall lining).

[0143] In conventional solid elastic liners of the prior art, the lattice structure provides a buffer for the axial and torsional forces that are usually transmitted directly from the hard prosthesis base to the residual limb. The inner and outer layers of the liner can be fixed to the residual limb L and the prosthesis base S, respectively. The central portion 340 allows the inner layer 342 and the outer layer 344 to be respectively moved in the direction M I 、M O Move independently of each other to a certain extent without exerting high or significant shear forces on the skin. Such forces are associated with skin irritation and discomfort.

[0144] from Figure 8B It can be seen that during the stance phase of gait, the limb L can move axially downward from the neutral position relative to or with respect to the prosthesis seat S. L , which can have a positive "vibration absorption" effect. However, during the swing phase of gait, the axial downward movement M from the neutral position L This may cause the prosthetic base to pull away from the limb. Figure 8C The schematic diagram shows how multiple filament layers 352, 354, 356, 358 arranged in a lattice structure 350 are aligned to move downwardly through the M L Inhibit movement to promote movement only in the desired direction.

[0145] Fig. 9 It is shown how the lattice structure 340, unlike conventional liners, has air grooves 341 which may allow the lattice structure 340 to be more easily compressed without displacing solid material and transferring pressure to another location. Fluctuation in the volume of the residual limb is one of the main problems faced by amputees and may cause the fit of the prosthetic base to become too loose or too tight. The lattice structure 340 addresses this shortcoming in known liners.

[0146] Bony prominences B on the residual limb L may cause uncomfortable pressure points. The volume compensation characteristics of the lattice structure 340 can accommodate these bony prominences to a local degree, thereby easily deforming around the bony prominences B with local deformation D, thereby alleviating the local pressure points. A solid liner that normally has a solid construction can also be similarly customized by including multiple filaments, which are customized to a local area of ​​the lattice structure to provide pressure relief for a specific residual limb with bony prominences or other irregularities that may form pressure points.

[0147] Another advantage of this arrangement is that it alleviates the challenges posed by changes in user needs or size and reduced liner effectiveness. Liners according to some embodiments can better accommodate users whose limbs change in size due to swelling or weight changes, without requiring additional pads, notches or other features to accommodate the size of the user. Instead, the lattice structure 340 provides improved accommodation for bony prominences, bulges, swelling, bone reduction, and other changes in user size due to improved volume compensation properties.

[0148] Fig. 10A A front view of another embodiment of a liner 200 is shown. The liner 200 may be formed of silicone or other elastic materials having a variety of hardnesses. The liner 200 includes a distal portion 204 and a proximal portion 202, wherein the proximal portion 202 is open to receive the residual limb. The liner body 203 may be formed of multiple layers of material, wherein the outer layer 206 has a higher hardness and the inner layer 208 has a lower hardness than the outer layer 206. Figure 1 Similar to the embodiment in , the inner layer 206 and the outer layer 208 may define at least partially aligned voids 210 to allow fluid and heat to be transported away from the interior of the liner 200 .

[0149] Similar to the previous embodiments, the liner 200 includes a solid wall portion 205 that provides additional strength and cushioning to the distal end portion 204, where a connecting pin or other component may be connected. The solid wall portion 205 may define a gradient 212 that increases toward the distal opening 214, with the area immediately surrounding the distal opening 214 having greater stiffness. The greater stiffness may be due to a change in material properties proximate the distal opening 214, a material change or material selection proximate the distal opening 214, an additive, or an embedded structure proximate the distal opening 214, or other suitable measures.

[0150] The interface 216 can connect the solid wall portion 205 of the distal end portion 204 with the liner body 203. The liner body 203 can include an outer layer 206 and an inner layer 208. A ledge, ridge, or thickness 218 can be formed at the interface 216. The thickness 218 can provide additional mechanical strength and an engagement feature with a corresponding prosthetic base.

[0151] Fig. 10A and Fig. 10B The outer layer 206 is shown as including a sublayer including a first filament 220 and a second filament 222. The inner layer 208 may similarly include a first filament 224 and a second filament 226. The first filaments 220, 224 may extend parallel to each other and perpendicular to the second filaments 222, 226, which may extend parallel to each other. The distance at which the filaments are spaced apart from each other may define the size of the voids 210, thereby enabling breathability without sacrificing the mechanical advantages of a solid wall lining.

[0152] The liner 200 may also include a base layer connected to and adjacent to the inner layer 208. As described in the previous embodiment, the base layer includes a substantially solid silicone layer that is perforated with a hole pattern that at least partially corresponds to the voids 210.

[0153] If targeted Figure 1 As described in the embodiment of FIG. 1 , the inner layer 206 and the outer layer 208 may advantageously include different properties, materials or configurations. Various stiffnesses may be obtained by providing filaments comprising multiple material layers having different properties. The inner layer 206 and the outer layer 208 need not have uniform properties throughout, but may have different properties at different locations.

[0154] exist Fig. 10C In an embodiment of the present invention, a cross-sectional view of a multilayer filament 220 is shown. The filament 220 has an inner layer 228 and an outer layer 227 that is concentric with and adjacent to the inner layer 228. The outer layer 227 and the inner layer 228 may have different properties relative to each other. For example, the inner layer 228 may be softer or have a lower hardness than the outer layer 227. The outer layer 227 and the inner layer 228 may have different solidification rates to facilitate chemical bonding to adjacent sublayers or filaments. Preferably, the outer layer 227 and the inner layer 228 are co-extruded or co-attached and chemically bonded to each other to form a fixed and permanently integrated structure of the multilayer filament 220.

[0155] The inner layer 228 of the multi-layer filaments 220 may advantageously have a different stiffness relative to the filaments 224, 226 of the inner layer 208. The color profile of the material forming the outer layer 227 may be different from the color profile or clear color of the material forming the inner layer 228. The colorant or other material mixed with the material of the outer layer 227 to define its color profile may additionally provide the outer layer 227 with different properties than the inner layer 228, including a higher stiffness, greater elasticity, or other properties at different locations of the liner. Fig. 10C As examples of additional embodiments of multi-layer filaments, additional layers can be provided adjacent to the outer layer 227, or the outer layer 227 and the inner layer 228 can be provided adjacent to each other in a layered manner. Any number of layers having any suitable properties can be provided in any suitable shape and at any location along the length of the filament.

[0156] According to one variation, the multi-layer filament 220 may be modified such that the diameter of the cross section of the inner layer 228 varies along the length of the filament 220. The outer diameter of the outer layer 227 may remain constant or vary, and the inner diameter of the outer layer 227 may vary depending on the diameter of the inner layer 228. With this variation, the multi-layer filament 220 may have varying properties depending on its length due to the different properties of the outer layer 227 and the inner layer 228.

[0157] The liner 200 may include additional layers or structures to facilitate breathability, improve mechanical characteristics, or provide other functionality to the liner.

[0158] FIG. 11A to FIG. 11C Schematically illustrated is another embodiment of a medical device such as a liner 370. In this embodiment, a base layer 372 is defined on a first side of a lattice structure 374 and a fabric layer 378 is defined on a second side of the lattice structure 374. Fig. 11B It is shown how the lattice structure 374 has a grid-like structure of layers of filaments 380, 382 along the X-axis and Y-axis, respectively, with interstices or meshes 378 defined between or among the generally vertically arranged filaments 380, 382. Each layer 380, 382 can be stacked on top of each other and aligned on the X-axis and Y-axis, or they can be staggered relative to each other so that the layers can be located directly above or below each mesh 378, and adjacent layers can include filaments that overlap the mesh 378.

[0159] Fig. 11C A base layer 372 is shown having a perforated layer 384, wherein the holes are much finer than the lattice structure 374. The base layer 372 may be formed from a plurality of filaments to form a substantially solid thickness except for the holes 386, or may be formed from filament segments adjacent to continuous filaments in one of the X and Y directions. The base layer 372 may have different material properties than the lattice structure 374, such as for a much softer surface facing the residual limb skin. The surface area of ​​the holes 386 may be less than the surface area of ​​the grid 378, such that the combined surface area of ​​the base layer 372 is greater than the combined surface area of ​​the holes 386.

[0160] Fig. 12A A variation of the lattice structure 390 is shown. In this variation, the portions 392a, 392b of the lattice have generally uniformly spaced grids 397, however the spacing between the filaments in one direction (e.g., the Y direction) may be different relative to the spacing in the X direction. FIG. 7A to FIG. 7DAs mentioned in the embodiments of the present invention, this relative spacing can be modified according to the desired elasticity. The lattice structure 390 can have some localized areas where there are gradually changing spacings in different filament layers and directions, such as areas 394a, 394b. The gradually changing spacing can cause the local elasticity of the lattice structure 390 to increase or decrease, and can make the lattice structure 390 transition from the parts 392a, 392b to a second area or other areas with different characteristics.

[0161] Fig. 12B The schematic diagram shows how the filaments 385, 387, 389 are arranged to have different thicknesses in the Z axis. For example, the thickness 391 of the first filament layer 385 extending in the first direction D5 is less than the thickness 393 of the second filament layer 387 extending in the second direction D6, where the second direction D6 can be orthogonal to the direction D5. The third filament layer 389 extending in the first direction D5 may have a greater thickness 395 than the second filament layer 387; however, these layers may have the same thickness as another layer. In some embodiments, the filaments 385, 387, 389 may have dynamic thicknesses and diameters that vary throughout the lattice structure 390. The overlap and mixing of layers (for example, at the intersections between filaments in different layers or sub-layers) can be appropriately varied. Areas where filaments 385, 387, 389 have larger diameters and / or more overlap and intermixing at the intersections of adjacent layers may have lower air permeability than areas where filaments 385, 387, 389 have smaller diameters and / or less overlap between filaments in adjacent layers.

[0162] Fig. 12C Schematically shows a film 396 formed by a plurality of filaments 398 arranged in the same direction (e.g., along the Y axis). A plurality of filaments 398 are arranged to be directly adjacent to each other so that they each have a continuous and contacting boundary 399 that is mixed with each other. Although shown between each filament 398 by a line, in an actual sample, due to the mixing of the boundary 399, the boundary 399 between each filament 398 is indistinguishable and visually inconspicuous. A plurality of filaments 398 may include a single layer or multiple layers, wherein the boundary of the filament and other filaments on the Z axis may be mixed as continuous and contacting as well. Different filament layers may be combined with adjacent filament layers in any suitable manner. For example, the connection between the layers may be continuous, or may be connected in a specific portion.

[0163] FIG. 13A to FIG. 13DAnother embodiment of a liner 400 is shown, which has a plurality of filaments 402 defining a vertically coiled lattice structure in the direction of the Z axis and in the X and Y axes. The filaments 402 are arranged adjacent to each other in the X and Y directions in a layer. Each filament 402a, 402b, 402c, 402d extends along the height of the thickness of the layer in the Z axis, and interlocks with adjacent filaments 402 in the X and Y axes, and forms a grid 403 between them in a certain pattern along the X, Y and Z axes.

[0164] It has been found that vertically coiled filaments exhibit a generally uniform shape when certain parameters are maintained. The shape of the grid 403 may vary depending on the shape of the coiled lattice structure. Medical devices according to some embodiments of the present invention may use one or more layers having a plurality of filaments 402 extending along the Z axis depending on the height or length of the filaments. For example, Figure 1 One or more of the base layer 121 , the first layer 122 , the second layer 124 , and the third layer 126 in the embodiment of FIG. 1 may be formed by a plurality of filaments 402 .

[0165] The filaments 402 may be configured to utilize a phenomenon known as the "liquid rope effect," whereby the filaments 402 may each be attached as a linear, straight, or otherwise non-curled filament of an uncurled elastomeric material in a liquid phase. When the uncurled linear filament contacts the surface of a layer to be built, the liquid rope effect may cause and propagate a curling or twisting effect in the filaments 402. The curled shape may be maintained as the filaments 402 solidify, solidify, and interact with adjacent filaments and the build surface.

[0166] It has been found that using the liquid rope effect to form a layer defined by a plurality of filaments 402 can simplify the manufacturing process because relatively short and linear filaments of uncured elastic material can be attached at specific locations to form filaments 402, rather than attaching long and uninterrupted filaments in the X and Y directions and without precise attachment for any of the plurality of filaments 402, while maintaining the desired properties over a portion of the layer. Over a portion of the layer defined within a specific length in the X and Y directions, although the properties of the individual filaments 402 vary, the properties of the filaments (e.g., elasticity) can be averaged to a desired value, and thus the properties of the layer can also be averaged to a desired value.

[0167] When the filaments 402 are attached to form a layer, each filament 402 can be attached to interlock with adjacent filaments 402 at intersections 406, 408, wherein the coils of adjacent filaments 402 are twisted together. The interlocking of the filaments 402 at the intersections 406, 408 can advantageously provide properties in terms of elasticity, anisotropy, or other properties in the X and Y directions and toward the Z axis. The interlocking of the filaments 402 at the intersections 406, 408 advantageously allows the layers to be defined by the filaments 402 without a backing layer or solid layer for attaching or linking the filaments 402.

[0168] Depending on the properties of the individual filaments 402, for example, the interlocking at the intersections 406, 408 can increase the stiffness of the medical device, can promote extension in a desired direction, or can provide desired cushioning at a specific area. As described in the previous embodiments, adjacent filaments 402a, 402b, 402c, 402d can be chemically bonded to each other at the intersections 406, 408. Like the properties of the individual filaments 402, the intersections 406, 408 can have respective variations throughout the layer while still achieving desired average properties at a specific portion of the layer.

[0169] exist Fig.14 In an alternative embodiment of a portion of a liner 230 shown, the liner 230 may include a first layer 232, a second layer 234 adjacent and concentric with the first layer 232, and a third layer 236 adjacent and concentric with the second layer 234. A volume control pad or raised feature 238 extends over a portion of an inner surface 246 of the liner body and is formed integrally with the first layer 232. An uneven surface 248 (e.g., for vacuum sealing applications) may extend over an outer surface of the third layer 236.

[0170] The non-uniform opening 240 may be defined by the thickness of the first layer 232, wherein an outlet 242 leading to the non-uniform opening 240 and defined by a portion of the second layer 245 may be aligned with the non-uniform opening 240 and define a vertical channel to facilitate enhanced axial transport of fluid and heat, and to replace, for example, along Figure 2A 128. It should be understood that the configurations, sizes, patterns, materials, properties, and numbers of openings, channels, layers, and other features in the illustrated embodiments are exemplary, and that other features and configurations may also be used to implement medical devices according to the present invention.

[0171] Fig.15 Schematically illustrates how the thickness of the lattice structure 412 according to some embodiments of the present invention may have a tapered or stepped profile to match the thickness of the lattice structure 412. Figure 1The distal end portion 410 of the liner is shown interlocked. The distal end portion 410 can be a solid wall structure formed by discrete filaments and can be formed of a different elastic material or polymer material than the lattice structure 412. According to the embodiment shown, the interface 414 between the stepped end portion 416 of the lattice structure 412 and the corresponding stepped end portion 418 of the distal end portion 410 can be continuous and in contact with the end portions 416, 418, the two ends intermixing to form a chemical bond.

[0172] In one embodiment, Figure 1 The air-permeable structure 110 and the solid wall structure 112 in the embodiment may form an inverted cone at the interface 108. Fig.15 An embodiment is shown in . The solid wall structure 418 defining the stepped end portion of the distal end portion 410 is reduced in thickness at the interface 414. The solid wall structure 418 at the interface 414 is configured to be close to the surface of the interior I of the liner. The thickness of the breathable structure 416 defining the stepped end portion of the lattice structure 412 increases at the interface 414 until the desired thickness is reached. The breathable structure 416 at the interface 414 is configured to be close to the surface of the exterior E of the liner. This feature is advantageous because it reduces the pressure points at the interface 414 between the breathable structure 416 and the solid wall structure 418. This embodiment provides a larger surface area for the interface 414, which ensures a stronger and more durable bond between the breathable structure 416 and the solid wall structure 418.

[0173] In one variation, as described above, the solid wall structure 418 and the breathable structure 416 taper at the interface 414. However, in this embodiment, the solid wall structure 418 is configured to be close to the surface of the exterior E of the liner at the interface 414. Conversely, the breathable structure 416 is configured to be close to the surface of the interior I of the liner at the interface 414. This feature is advantageous because it allows the breathable structure 416 to extend further down into the distal portion 410, thereby enabling better wicking of heat and fluid from the distal portion 410. The taper of the interface 414 may be relative to Fig.15 The taper shown in FIG. 4 is increased or decreased to increase or decrease the extent to which the breathable structure 416 extends into the distal end 410. Due to the characteristics of the lattice structure described herein, this can also provide cushioning for the limb at pressure points.

[0174] The stepped interface 414 between the solid wall structure 418 and the breathable structure 416 advantageously provides a gradually changing compression. As the solid wall structure 418 gradually transitions into the breathable structure 416 via the stepped interface 414, the compression profile is smoother and reduced.

[0175] exist Fig.16In another embodiment of the liner 250 shown, the liner 250 includes a liner body 252 at a distal end of the liner 250, wherein a fabric 254 covers a portion of the liner body 252 proximal to the distal end and is connected at a seam or seal 256. The fabric 254 can be discrete relative to the distal end by a distal seam 262, where the fabric 254 is reinforcedly joined to the liner body 252. The first side 258 and the second side 260 of the fabric covering 254 are advantageously joined using the material forming the liner body 252.

[0176] Unlike existing orthopedic liners, in which the fabric covering must be connected at the seams using stitching, sewing or other connecting means, which increases the cost and complexity of manufacturing the liner, the connection of the fabric 254 can be achieved at the first side 258 and the second side 260 by connecting or impregnating the fabric 254 with an elastic material that forms the liner body 252.

[0177] The liner 250 may include a matrix throughout the liner body 252, which is configured to limit axial extension while allowing circumferential or radial extension, which advantageously mitigates the "piston effect", "milking effect" and other undesirable effects between the liner and the residual limb. The liner body 252 may include a filament layer or other material layer configured to receive the matrix.

[0178] By providing a medical device according to the described embodiments, the following problems with medical devices such as liners, namely, the inability to adjust the tension between the mechanical strength required to provide cushioning and protection to a body part (e.g., a residual limb) and the need for a breathable device to mitigate the accumulation of fluids and heat, can be solved. The formation layer, the structure of multiple layers of filaments and openings, and the defined structure advantageously provide the liner with permeability to fluids and heat while maintaining the structural strength required to provide cushioning to the residual limb. The manufacturing process of the liner is also simplified by incorporating stitching or sewing of the fabric covering into the material of the formation layer or liner body.

[0179] Embodiments of the liner also provide a multi-layer liner structure having layers and sub-layers comprising different materials and / or properties so that the liner has appropriately arranged portions having mechanical strength, elasticity, comfort, friction properties and rigidity.

Claims

1. A prosthetic liner (100) defining a proximal end portion (104) and a distal end portion (106), the prosthetic liner (100) having a liner body (102) defined between the proximal end portion and the distal end portion, the liner body having a tubular shape, the liner (100) comprising: Lattice structures, which are defined as structures integrally formed of multiple layers into an inseparable and continuous structure; The lattice structure comprises a first layer (122) of first filaments (140) discretely formed of a first elastic material, and a second layer of second filaments (142) discretely formed of a second elastic material, the first filaments (140) of the first layer (122) and the second filaments (142) of the second layer (124) overlap respectively and form a first group of gaps (130) therebetween in a predetermined pattern, wherein the first filaments (140) are spaced apart from each other and extend in a first direction, the second filaments (142) extend in a second direction, the first direction and the second direction are oriented differently, The first layer of the first filaments and the second layer of the second filaments are permanently chemically bonded to each other, the first layer and the second layer being at least partially mixed with each other in a mixing region; The first and second filaments extend continuously around the tubular shape of the liner body, and the first and second layers are concentric with respect to each other.

2. The prosthetic lining (100) according to claim 1, characterized in that The first layer (122) of the first filaments (140) is disposed at an angle relative to the second layer (124) of the second filaments (142), the angle being greater than or equal to 0° and less than or equal to 90°.

3. The prosthetic lining (100) according to claim 1, characterized in that The lattice structure includes a third layer (126) of third filaments (144) discretely formed by an elastic material, and the third layer (126) of the third filaments (144) is located on the opposite side of the second layer (124) of the second filaments (142) relative to the first layer (122) of the first filaments (140), and is offset at a certain angle relative to the first layer (122) of the first filaments (140), and the angle is greater than or equal to 0° and less than or equal to 90°.

4. The prosthetic lining (100) according to claim 1, characterized in that It also includes a base layer (121), which is formed of a third elastic material and is permanently fixed on the inner side of the lattice structure.

5. The prosthetic lining (100) according to claim 4, characterized in that The base layer (121) defines a plurality of apertures (129).

6. The prosthetic lining (100) according to claim 5, characterized in that The hole size of the plurality of holes (129) of the base layer (121) is different from the size of the first group of gaps (130) of the lattice structure, and the plurality of holes corresponds to the first group of gaps (130) of the lattice structure.

7. The prosthetic lining (100) according to claim 5, characterized in that The pores occupy 5% to 15% of the surface area of ​​the substrate, and the surface area of ​​the lattice structure includes at least 30% open area.

8. The prosthetic lining (100) according to claim 4, characterized in that The base layer (121) is concentric with the first layer (122).

9. The prosthetic lining (100) according to claim 4, characterized in that The thickness of the first layer (122) is greater than the thickness of the base layer (121).

10. The prosthetic liner (100) according to claim 1, characterized in that The second elastic material has different properties than the first elastic material.

11. The prosthetic liner (100) according to claim 1, characterized in that The first elastic material is selected from the group consisting of silicone and polyurethane.

12. The prosthetic liner (100) according to claim 1, characterized in that The second elastic material is selected from the group consisting of silicone and polyurethane.

13. The prosthetic liner (100) according to claim 1, characterized in that The distal portion (106) has a closed structure including a solid wall structure (112), and the proximal portion (104) has an open structure, wherein the solid wall structure is fixed to the liner body (102) along an interface (108), and at the interface, the lattice structure is chemically bonded to the distal portion.

14. The prosthesis lining (100) according to claim 13, characterized in that The lattice structure has a tapered profile at the distal end, and the solid wall structure (112) has a tapered profile corresponding to the tapered profile of the lattice structure at a location where the lattice structure is chemically bonded to the distal end.

15. The prosthetic liner (100) according to claim 1, characterized in that It also includes a fabric layer (136) fixed to the outside of the lattice structure, the fabric layer (136) is integrally fixed to the lattice structure, and one of the first layer (122) and the second layer (124) is mechanically interlocked with the fabric layer (136).

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