CN117255666A

CN117255666A - Custom knitted wearables with reactive material to enhance rigidity

Info

Publication number: CN117255666A
Application number: CN202280028406.3A
Authority: CN
Inventors: H·D·小罗莫; F·埃尔南德斯; J·佩雷斯
Original assignee: Aspen Pharmaceutical Products Co ltd
Current assignee: Aspen Pharmaceutical Products Co ltd
Priority date: 2021-02-17
Filing date: 2022-02-17
Publication date: 2023-12-19

Abstract

One embodiment relates to an orthopedic preform that includes a knitted shell portion and a knitted flexible portion. Heat or other hardening agent is used to harden the housing portion while maintaining the flexibility of the flexible portion. Contemplated hardeners include light, heat and chemical polymerization agents. In some embodiments, the housing portion comprises thermoplastic threads or yarns that are hardened by heating the thermoplastic material sufficiently to at least partially melt, thereby fusing some of the threads or yarns together, and then cooling to ambient temperature to increase rigidity. In other embodiments, the preform is contained in a bag or other airtight container with a self-heating composition that is triggered to release heat upon contact with oxygen. In other embodiments, the preform comprises a prepolymer of other polymerizable composition that is polymerized by the effective application of light, heat, and/or chemical agents, or is used as a wearable.

Description

Custom knitted wearables with reactive material to enhance rigidity

Citation of related application

The present application claims the benefit of U.S. patent application Ser. No. 17/673716, filed on month 2, 2022, and 17, which is a continuation-in-part application of U.S. patent application Ser. No. 17/178,071, filed on month 2, 2021, which is incorporated herein by reference in its entirety.

Technical Field

The field of the invention is braces (orthotics).

Background

The following description contains information that may be helpful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

An brace (orthosis) generally needs to be adjusted or customized in some way to conform to the body part being supported before it can be positioned correctly. Typical orthoses generally have at least two parts, a rigid part that supports a body part and a flexible part that secures the orthosis to the body. The flexible portion is typically a strap and, in many orthoses, multiple straps are required to adequately secure the orthosis. It can be time consuming for the patient to adjust the different bands repeatedly.

Us patent 8480604 to Messer describes an Ankle Foot Orthosis (AFO) having straps arranged around the calf region. Unfortunately, for some people, a single strap may not be sufficient to secure the orthosis in view of the complex ankle movements that occur during walking, including dorsiflexion, plantarflexion, varus, and valgus. Thus, AFO may be misplaced during walking, giving the patient a painful walking experience, and may even deteriorate the patient's medical condition.

U.S. patent 9572703 to Matthews describes an orthopedic sock that utilizes an elastic material to limit movement of a patient's foot. Since this orthosis is a sock, it is easier to wear than a typical AFO. However, the elasticity of the material may not be sufficient to provide adequate support.

It is known to produce custom AFO by creating a negative mold of a patient's calf, ankle and foot, using the negative mold to create a positive mold, wrapping a preheated flexible and hardenable material on different parts of the positive mold, then applying a vacuum to the material-wrapped positive mold, and subsequently cooling the material to the shape of the positive mold. After the material cools, the material must be carefully cut from the mold and then all the trim edges must be sanded/smoothed into the final shape. The production of such custom AFOs is extremely labor intensive and inefficient. Production is time consuming, requires considerable skill and is therefore expensive.

All publications identified herein are incorporated herein by reference as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein should be used and the definition of that term in the reference should not be used.

Accordingly, there remains a need for a system and method for efficiently producing custom orthotics.

Disclosure of Invention

The present subject matter provides a system and method in which a knitted wearable, such as an orthopedic preform/orthosis (hereinafter "preform") or garment, is described. According to one embodiment of the present disclosure, the orthopedic preform is characterized by: (i) A first knitted portion comprising at least one or more knitted strands of a first thermoplastic material, the first knitted portion mechanically coupled to (ii) a second knitted portion comprising knitted strands of less thermoplastic material (or a different thermoplastic material) and/or comprising a non-thermoplastic material. The first knitted portion and the second knitted portion may be attached as part of a single layer preform construction, wherein the portions of the orthopedic preform utilize different materials and/or different knitting techniques to provide greater rigidity, maintain a flexible and/or elastic construction, and the like.

Upon being heated to a prescribed temperature at which the first thermoplastic material melts, the first knitted portion undergoes a phase change, becoming more rigid than its previous configuration. This first knitted portion, sometimes referred to as the "shell portion", may occupy different areas of the orthopedic preform. Whether the second knitted portion undergoes a phase change depends on its material composition and structure. However, as described herein, the degree of phase change is different, providing different levels of rigidity (e.g., stiffness, flexibility, semi-stiffness, etc.) to the region of the orthosis.

As an illustrative example, where the second knitted portion includes the same thermoplastic material as the first knitted portion but in a smaller quantity (e.g., fewer strands due to the knitting/stitching pattern, finer thermoplastic strands, smaller thermoplastic strand volumes, etc.), the second knitted portion may remain flexible (or at least be less rigid) than the first knitted portion. Similarly, where the second knitted portion comprises a second thermoplastic material that is different from the first thermoplastic material and has a higher melting temperature than the first thermoplastic material, the second knitted portion may remain flexible when the heating temperature is below the melting temperature of the second thermoplastic material. Finally, in the case of the second knitted portion comprising a non-thermoplastic material, the second knitted portion may remain in its flexible and possibly elastic state after the heating process for converting the orthopedic preform into an orthosis worn by the patient.

The term "knit" as used herein with respect to a portion of an object (e.g., an orthopedic preform) is generally defined to include essentially any arrangement of material (e.g., threads, yarns, etc.) used to create one or more strands of that portion of the object. Such "knitting" may constitute an attachment means that attaches one or more materials together as a single continuous material or multiple layers (two or more layers) of material by stitching (e.g., a "V" stitch), weaving (interweaving multiple strands of material), crocheting (knotting stitches), stitchbonding (knotting stitches in a geometric pattern), or another attachment scheme. In addition, the knitting may be performed in a two-dimensional (2D) knitting process or a three-dimensional (3D) knitting process. The two-dimensional knitting process allows for the manufacture of thin orthotics in which the shell portion and the flexible portion are knitted on a single layer of knitted material. The three-dimensional knitting process may be used to create a multi-layer knitted orthosis, for example additional padding and/or additional layers of the same or different types of thermoplastic materials may be added to the shell portion to increase its rigidity.

The term "rigid" as used herein with respect to an object (e.g., preform) or a portion of an object refers to a rigid object or rigid portion of an object that resists bending or deformation. According to this definition, a given structure and composition of different lengths may be rigid over a shorter length and flexible over a longer length. As an illustrative example, in some cases a "rigid" object or "rigid" portion of an object may mean that the object or portion of the object may deform if bent or twisted at least 20 ° end-to-end, in some cases permanently.

The term "elastic" as used herein with respect to an object or a portion of an object refers to the fact that upon bending or stretching the portion will automatically return to its shape prior to being substantially bent or stretched. The term "bending" as used herein may be interpreted to include twisting.

The term "flexible" as used herein with respect to an object or a portion of an object means that the object or portion of an object is not permanently deformed by bending. For example, the knitted portion of the preform may be flexible in nature even after the heating and cooling process. The term "permanent deformation" as used herein means that the deformation remains unchanged unless the deformation is actively repaired. According to this definition, an object or a part of an object may be rigid in one direction and flexible in another direction. Unless otherwise indicated in this context, the object or object portion is considered rigid.

The term "elastic" as used herein with respect to an object or a portion of an object means that the elastic portion will return to its resting length when stretched or compressed longitudinally by at least 10% without the application of external forces and without permanent deformation.

The term "shell" as used herein refers to a structure configured to impart rigidity that limits movement of a portion of a patient's body, wherein the structure is either (i) rigid upon application of prescribed heating and cooling phases, or (ii) becomes rigid upon completion of the heating and cooling phases. In particular, the knitted portion of the preform, which is present in a non-rigid form, may constitute the shell portion by having characteristics that allow the knitted portion to be transformed from its non-rigid form into a rigid form in response to heating and subsequent cooling at or above a prescribed melting temperature. In some embodiments, the housing may include a structure having a cavity, hollow, or lumen.

The term "patient" as used herein includes humans and animals, irrespective of whether the patient is under the care of a medical or veterinary professional.

The term "strand" as used herein is generally defined as an elongated length of one or more natural, artificial, or a combination of natural and artificial substances. According to one embodiment of the present disclosure, each strand may be a fiber no more than 3 millimeters (mm) thick over a length of at least one centimeter (cm), although other dimensional specifications are also contemplated. Examples of "strands" may include threads, yarns, strings, ropes, or any flexible material that may be organized (e.g., stitched, interwoven, etc.) into a structure to create the object (e.g., an orthopedic preform). Where strands represent thermoplastic material, the strands may be elongated fibers of thermoplastic material, or the strands may be another substance coated with or impregnated with thermoplastic material.

In some embodiments, the orthopedic preform/orthosis can be configured to have a tubular structure including a shell and a flexible portion. In some embodiments, the orthopedic preform/orthosis can be configured to have a tubular structure including shell portions of different stiffness levels.

In some embodiments, the housing portion is in a longitudinal orientation along the tube. For example, the shell and flexible portion of the preform may correspond to the front and rear portions of the calf, respectively, and these portions may be directly connected to one another. For such preforms, the shell portion would be considered to be in a longitudinal orientation along the tube. Alternatively, the housing portions may be in a cross-orientation relative to the tube. For example, a preform capable of receiving a torso portion of a patient may have a shell portion extending over the entire front of the patient, and a flexible portion also extending over the entire front of the patient, the flexible portion being connected to the shell portion above and below. For such an orthopedic preform, the shell portions would be considered to be in a cross-orientation along the tube.

The term "intersecting" as used herein includes diagonal angles of varying degrees.

The thermoplastic material used for the knitted (housing) portion may be different or the same as the thermoplastic material used for the additional knitted (housing) portion. For example, the thermoplastic material for the wrist of the full arm wrist brace may be the same as or different from the thermoplastic material for the elbow. In a preferred embodiment, the melting temperatures of the different thermoplastic materials used for the same preform differ by 10-20 ℃, 10-30 ℃, 30-50 ℃, even 50-150 ℃.

In some embodiments, the thermoplastic portion may comprise at least 30% by weight of the preform. In a preferred embodiment, the thermoplastic portion may comprise from 5% to 90% by weight of the preform, more preferably from 50% to 90% by weight of the preform, and even more preferably from 80% to 90% by weight of the preform.

Similarly, in some embodiments, the shell portion may comprise at least 30% by weight of the preform. In a preferred embodiment, the shell portion may comprise from 5% to 90% by weight of the preform, more preferably from 50% to 90% by weight of the preform, and even more preferably from 80% to 90% by weight of the preform.

In some embodiments, the nominal thickness of the shell portion of the preform may vary by at least 50%. Similarly, the nominal thickness of the flexible portion of the preform may vary by at least 50%.

In some embodiments, the flexible portion may be resilient. Elasticity may be achieved by the material itself having elastic characteristics or by knitting techniques that are capable of having elastic characteristics.

In some embodiments, the housing and the flexible portion may be multi-layered. For example, the flexible portion may be disposed adjacent to (e.g., laminated together with) at least one layer of the housing portion to provide structural reinforcement. Alternatively, the housing portions may be arranged adjacent to (e.g., laminated together) at least one layer of the flexible portion to enhance skin comfort.

In some embodiments, the preform may include at least one shaped aperture (eyelet) and a mating band.

The inventive subject matter also includes a method of producing a custom orthosis, the method comprising the operations of:

1) Placing an orthopedic preform around a male mold, the preform comprising: (a) A first knitted portion as a housing portion comprising knitted strands of at least a first thermoplastic material melted at a first melting point, and (b) a second knitted portion as a flexible portion comprising elastic knitted strands that do not melt below the first melting point; and

2) The preform is heated to at least 140 ℃ to partially melt, thereby melting and hardening the shell portion. Other expected minimum heating temperatures are listed in the table below for thermoplastics. It will be appreciated by those of ordinary skill in the art that increasing the temperature to completely melt the thermoplastic material will result in a loss of functional shape of the housing portion, and therefore the processing temperature should only be increased to the lower portion of the melting range. Furthermore, the processing temperature should be increased at a rate at which the surface of the thermoplastic material has begun to melt but the core of the thermoplastic material still retains its shape. It is also conceivable that in case of different layers of thermoplastic material in the housing part, temperature parameters may be utilized such that the thermoplastic material in some layers melts more than in other layers. Experiments have shown that one successful way of practicing the inventive subject matter is to provide a male mold with a through hole and steam-treat the orthopedic preform internally through the male mold.

The male mold of the body part may be produced in accordance with well known techniques, including (a) using plaster or other material to produce a female mold of the body part, removing the female mold from the body part, filling the casting with a hardenable casting material, and then removing the female mold from the immediate vicinity of the male mold. It is also known to cut material from a male die or add material to a male die. The male mold may be made of any body part or combination of adjacent parts, for example, a male mold that mimics the hand, wrist and forearm may be made. There are many advantages to placing the preform on a male mold of a patient's body part, where the preform can be heated to create the orthosis, rather than on the patient's body part. One advantage is that the mold can be reshaped from the patient's anatomy to add or remove certain contours that may create relief on the patient's bone processes, or to direct additional loads to certain soft tissue areas that can withstand the additional loads to improve patient comfort when wearing the orthosis.

In a preferred method, the preform may be slightly tubular, having one or two open ends, so that the preform may be slipped over the body part. In some embodiments, the knitted portion operating as the shell portion may comprise multiple types of thermoplastic materials, where the second or third thermoplastic material may have a different melting point than the first thermoplastic material.

As used herein, unless the context indicates otherwise, the term "coupled to" is intended to include both direct coupling (wherein two elements coupled to each other are in contact with each other) and indirect coupling (wherein at least one additional element is located between the two elements). Thus, the terms "coupled to" and "coupled with" are used synonymously.

The terms "a," "an," and "the" as used in the description herein and in the following claims, are inclusive of the plural referents unless the context clearly dictates otherwise. Further, unless the context clearly indicates otherwise, the meaning of the words "within" and "within" as used in the description herein includes "within" and "on.

All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided with respect to certain embodiments herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention claimed unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

Various objects, features, aspects and advantages of the present subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawings in which like numerals represent like parts.

Drawings

FIG. 1 is a perspective view of an exemplary embodiment of a torso orthosis preform.

Fig. 2 is a perspective view of a first exemplary embodiment of a leg-ankle-foot orthosis preform in accordance with the principles of the present invention.

Fig. 3A is a perspective view of a second exemplary embodiment of a prefabricated leg-ankle-foot orthosis in accordance with the principles of the present invention.

Fig. 3B is a vertical cross-sectional view of the preform of fig. 3A.

Fig. 4 is a perspective view of a third exemplary embodiment of a leg-ankle-foot orthosis preform in accordance with the principles of the present invention.

Fig. 5 is a perspective view of an exemplary embodiment of the back and palm of a left hand wearing a wrist brace in accordance with the principles of the present invention.

FIG. 6 illustrates a heating process of one embodiment of a preform according to the principles of the present invention.

Fig. 7A is a schematic diagram of an exemplary embodiment of an orthopedic preform in the preform as in fig. 1, 2, 4, 5 or 6.

FIG. 7B is a schematic view of a portion of the exemplary orthopedic preform of FIG. 7A wherein the thermoplastic material is heated.

FIG. 8A is a schematic view of an exemplary embodiment of a portion of an orthopedic preform having a first knitted portion and a second knitted portion, the first knitted portion having a higher content of thermoplastic material than the second knitted portion.

FIG. 8B is a schematic view of an exemplary embodiment of a portion of an orthopedic preform having a first knitted portion and a second knitted portion, the knit stitch of the first knitted portion being tighter than the knit stitch of the second knitted portion.

FIG. 8C is a schematic view of an exemplary embodiment of a portion of an orthopedic preform having a first knitted portion and a second knitted portion, the thermoplastic strands of the first knitted portion being thicker than the thermoplastic strands of the second knitted portion.

FIG. 8D is a schematic view of an exemplary embodiment of a portion of an orthopedic preform having a first knitted portion and a second knitted portion, the first knitted portion having a greater number of layers of thermoplastic filaments than the second knitted portion.

FIG. 9 is a schematic view of an exemplary embodiment of a portion of an orthopedic preform having a band.

FIG. 10A is a schematic view of an exemplary embodiment of a portion of an orthopedic preform wherein a first knitted portion is stitched or knitted to a second portion.

Fig. 10B is a schematic view of an exemplary embodiment of a portion of an orthopedic preform in which a first knitted portion is laminated to a second portion.

Fig. 10C is a schematic view of an exemplary embodiment of a portion of an orthopedic preform wherein a first knitted portion is chemically bonded to a second portion.

FIG. 10D is a schematic view of an exemplary embodiment of a portion of an orthopedic preform in which a first knitted portion is partially melted to fuse to a second portion.

FIG. 11 is a perspective view of an exemplary embodiment of a portion of an orthopedic preform wherein a first knitted portion is coupled with a second elastic portion.

Fig. 12A is a perspective view of an exemplary embodiment of an orthopedic prepit wherein a first knitted portion is layered with a second knitted portion.

Fig. 12B is a perspective view of the preform of fig. 12A, wherein a top edge portion of the second knitted portion of the preform sheath has been folded down over at least a portion of the first knitted portion.

Fig. 13 is a perspective view of a portion of an orthopedic preform having a band extending through an aperture formed in a first knitted portion.

Fig. 14A is a perspective view of an exemplary embodiment of an orthopedic preform disposed about an inanimate mold.

Fig. 14B is a perspective view of the orthopedic preform of fig. 14A disposed about the calf, ankle and foot of a patient mold to create an ankle-foot orthosis (AFO) derived from the orthopedic preform.

FIG. 15 is a perspective view of an exemplary embodiment of a self-heating orthopedic preform having embedded self-heating material disposed in a non-oxygenated bag to cause an exothermic reaction.

Fig. 16 is a perspective exploded view of an alternative embodiment of a self-heating orthopedic preform having self-heating material in a jacket disposed in a nitrogen-filled bag.

FIG. 17 is a perspective view of one exemplary embodiment of an alternative preform comprising a polymerizable material, the preform stored in a bag without a polymerizing agent.

Fig. 18 is a perspective view of an exemplary embodiment of a shoulder orthosis created from a preform having one or more first knitted portions of thermoplastic material.

Fig. 19 is a perspective view of an exemplary embodiment of a post-operative shoe configured with a first knitted portion disposed along a foot plate and a selected area surrounding an ankle area.

FIG. 20 is a perspective view of an exemplary embodiment of a garment in which a thermoplastic material scaffold is knitted to form one or more channels within the garment.

Detailed Description

The following discussion provides many exemplary embodiments of the inventive subject matter. While each embodiment represents one combination of innovative elements, the inventive subject matter is to be considered to include all possible combinations of the elements disclosed. Thus, if one embodiment includes elements A, B and C, while a second embodiment includes elements B and D, then the inventive subject matter is also considered to include the remaining combinations of A, B, C or D, even if not explicitly disclosed.

In some embodiments, the numbers expressing quantities of ingredients, properties (e.g., concentration, reaction conditions, etc.) used to describe and declare certain embodiments of the present invention are to be understood as still maintaining the spirit and scope of the disclosed invention when modified. Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are exemplary approximations that may vary depending upon the desired properties sought to be obtained by the particular embodiment.

Unless the context dictates otherwise, all ranges described herein should be interpreted to include their endpoints, and open ranges should be interpreted to include only the commercially practical value. Similarly, all numerical lists should be considered to include intermediate values unless the context indicates otherwise.

The grouping of alternative elements or embodiments of the invention disclosed herein should not be construed as limiting. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements presented herein. For convenience and/or patentability reasons, one or more members of a group may be included in or deleted from the group. In the event of any such inclusion or deletion, the specification is considered herein to contain groups that have been modified so as to satisfy the written description of all markush groups used in the appended claims.

I. Exemplary orthosis architecture

Fig. 1 generally illustrates an orthosis 100 produced from a preform sized and dimensioned to be wrapped around a patient's torso and used as part of a lumbosacral orthosis (LSO) or thoracolumbosacral orthosis (TLSO). The orthosis 100 can be configured as a first portion 110 knitted from one or more strands comprising thermoplastic material, the first portion 110 having a rigid structure (referred to as a "shell portion") after a prescribed amount of heat is applied to the first portion 110. Above and below the housing portion 110 are upper 120 and lower 122 portions (each referred to as a "flexible portion") that may be knitted from one or more strands comprising non-thermoplastic materials. As shown, for this embodiment of the present disclosure, the housing portion 110 and flexible portions 120, 122 generally form a tube (e.g., a band) 130 having two open ends. In this particular example, the housing portion 110 and the flexible portions 120, 122 are both in a cross-orientation relative to the tube 130.

As shown in fig. 1, the flexible portions 120, 122 are located at the outer edges of the band 130 to create a transition region between the rigid housing portions 110. This transition region enables a more comfortable fit of the orthosis 100, while at the same time creating a higher anatomical stability by placing the shell portion 110 within the orthosis 100. Furthermore, the integration of the non-thermoplastic material of the flexible portions 120, 122 (disposed along the edges of the orthosis 100) and the thermoplastic material forming the shell portion 110 (interposed therebetween) allows for the construction of a thin (single layer) orthosis, rather than a multi-layer orthosis having stiffening plates attached at different sections of the band 130.

Herein, each of the one or more strands forming the housing portion 110 may include at least one thermoplastic material according to one embodiment of the present disclosure. For example, the strands forming the housing portion 110 may comprise a single thermoplastic material. Alternatively, the strands forming the shell portion may form a shell portion composed of a composite material, which may comprise at least two different thermoplastic materials, wherein the thermoplastic materials may have the same or different melting temperatures. As another alternative embodiment of the present disclosure, the strands may also be a composite of one or more thermoplastic materials and one or more non-thermoplastic materials, so long as the stiffness of the housing portion 110 changes after the application of heat of selected temperature and duration and cooling of the housing portion 110. The strands may be formed of thermoplastic materials, or strands of different materials may be coated and/or impregnated with one or more thermoplastic materials (by the application process). In this context, "thermoplastic" may refer to a collection of materials comprising one or more strands of thermoplastic that change the overall material stiffness upon heating and cooling, while "non-thermoplastic" does not have a thermoplastic that affects such stiffness.

According to one embodiment of the present disclosure, the thermoplastic material may be configured to form flexible strands at room temperature, be non-toxic, melt at a temperature of 140 ℃ to 350 ℃, and become rigid when the strands are partially melted together into a sheet or mat having a thickness of 0.5 millimeters to 6 millimeters. Examples of contemplated thermoplastic materials may include, but are not limited to, the following: polyethylene terephthalate (PET), polyetheretherketone (PEEK), polyphenylene oxide (PPO), polypropylene (PP), polyethylene (PE), polyvinylchloride (PVC) and Polystyrene (PS), polymethyl methacrylate (PMMA), acrylonitrile Butadiene Styrene (ABS), polylactic acid (PLA), polybenzimidazole (PBI), polycarbonate (PC), polyethersulfone (PEs), polyoxymethylene (POM), polyphenylene Sulfide (PPs), polystyrene, polyvinylchloride (PVC), polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), polyamide 6 (PA 6), polybutylene terephthalate (PBT), polyetherimide (PEI), and the like.

The thermoplastic and non-thermoplastic materials may be selected using any combination of natural and synthetic materials to achieve desired characteristics, such as a desired degree of stiffness, compressibility, flexibility, bendability, stretchability, and elasticity. As described above, one or more strands associated with the rigid shell portion 110 of the orthosis 100 can include thermoplastic and non-thermoplastic materials. For example, the non-thermoplastic material may include Kevlar ^TM To improve the durability/toughness of the orthosis 100, as one or more other non-thermoplastic materials (e.g., cotton fibers, non-carbon fibers, nanotubes, glass fibers, ceramic, and/or metal fibers) may be used. Similarly, the one or more strands of material forming flexible portions 120 and/or 122 may also comprise thermoplastic and/or non-thermoplastic materials. However, according to this embodiment of the present disclosure, the lowest melting point of the thermoplastic material of flexible portions 120 and/or 122 may be significantly higher than the lowest melting point of the thermoplastic material used in housing portion 110.

Thus, one of the concepts of the present invention is that the preform forming orthosis 100 will have (1) one or more knit strands of a first (thermoplastic) material or group of materials that partially melt when heated, and thus fuse together to form rigid shell portion 110, and (2) one or more knit strands of a second (non-thermoplastic) material or group of materials that remain flexible when cooled because they do not melt, or they melt an insubstantial amount at the temperature used to melt the thermoplastic material forming shell portion 110, and that together form flexible portions 120 and 122. Thus, the terms "non-substantial" and "substantial" are used in this context to refer to the amount of thermoplastic material that melts to change a portion of the preform of the orthosis to a rigid state.

It is understood that one or more knitted strands of one or more different materials that remain flexible after cooling may or may not include thermoplastic materials. Preferably, however, the one or more knitted strands of one or more different materials that remain flexible after cooling may comprise primarily or entirely natural fibers, such as cotton or wool. To avoid oxidation of such non-thermoplastic materials, the heating may be performed in an anoxic or hypoxic environment.

In production, a preform associated with orthosis 100 can be placed on a male mold and heated such that at least some of the thermoplastic material melts into a rigid shell. This allows the housing portion 110 to closely conform to any portion of the patient where movement is to be restricted. Alternatively, the preform may be placed on a first male mold, inverted from inside to outside, to provide a different (opposite) layering scheme for the inverted preform, then placed on a second male mold, heated, and then cooled to form an orthosis having a rigid shell portion, or to form an orthosis having multiple layers when the inverted preform is placed with another preform.

The preform of orthosis 100 has a tubular configuration with an upper open end and a lower open end. However, as shown in FIG. 1, fasteners that can be installed at the prefabrication stage (e.g., velcro ^TM Or similar shacklesFastener 151) laterally opens and closes orthosis 100. Any suitable fastener is contemplated, including buttons, toggles, studs, snaps, buckles, zippers, spindle-shaped buttons, eyes, magnets, grommets, brooches, safety pins, fabric strips, and belts.

In fig. 1, the flexible portions 120, 122 may advantageously be elastic, and in particularly preferred embodiments, the portions 120, 122 may be knitted such that flexibility and/or elasticity increases toward the outer edge. This change in flexibility and elasticity can improve patient comfort by shifting the pressure on the body.

The flexible portions 120 and 122 are preferably resilient even after the heating and cooling process. Elasticity is advantageous because it allows the orthosis 100 to conform to different body shapes. Furthermore, because the shell portion 110 of the orthosis 100 has limited extensibility (e.g., extends partially around the preform), the portion 124 is flexible enough to allow a user to pull the orthosis 100 around the waist as an alternative to placement.

The orthosis 100 includes a strap or tether 140 to further secure the orthosis 100 to the patient's body, such as by a cinching mechanism (not shown) positioned along the back of the preform 100.

Exemplary preset architecture

The following illustrations and description are directed to prefabricated architectures that can be used to produce a final orthosis having the same architecture. The exemplary architecture is not limiting, but is selected to highlight the functions that may be implemented in any orthosis architecture.

Fig. 2 generally illustrates an orthopedic preform 200 that can be heated and cooled to produce a first type of ankle-foot orthosis (AFO) configured to limit movement of a patient's lower leg relative to a foot. The preform 200 generally includes a first knitted portion 210 and a second knitted portion 220, the second knitted portion 220 generally configured as a stocking featuring a tube 230 with an open upper calf section end and a closed toe end. The second knitted portion 220 may be formed of an elastic, non-thermoplastic material as a flexible portion of the preform 200 (and final orthosis), while the first knitted portion 210 may be formed of a thermoplastic material as a shell portion of the preform (and final orthosis). The preform 200 may also be provided in a preformed state in an average shape of a given anatomical dimension. Thus, various sizes may be provided. Such preforms may be sold as "off-the-shelf" products that, due to their size, may be provided to patients having an average profile without modification. The opportunity for profile optimization may also be provided by heating and reshaping the shell material at strategic locations.

In the corresponding preform 200, the first knitted portion 210 and the second knitted portion 220 cooperate to support the rear and front portions of the calf respectively. The first knitted portion 210 and the second knitted portion 220 are in a longitudinal orientation along the tube 230. In this configuration, the second knitted (flexible) portion 220 allows for ease of donning and doffing of the corresponding orthosis, while the first knitted (shell) portion 210 provides dorsiflexion, plantarflexion, varus and valgus stability at the ankle.

Strategically using elastic regions can enhance functionality. For example, in fig. 2, the second knitted (flexible) portion 220 may be elastic, and such elasticity may be used to press the first knitted (shell) portion 210 against the back of the leg, and may help lift the foot during the swing phase of walking. In some embodiments, the orthosis derived from the preform 200 may have a slightly dorsiflexed configuration such that the weight of the foot pulls the foot to neutral (neither dorsiflexion nor plantarflexion) or other desired configuration when worn.

Fig. 3A generally shows a second AFO-type preform 300. The first knitted (shell) portion 310 of the preform 300 is wider (including a larger circumference) and possibly thicker than the first knitted (shell) portion 210 of fig. 2. This provides greater (sagittal and coronal) stability to the ankle than the AFO preform 200 of fig. 2, which helps to stabilize the patient's knee.

The relative dimensions of the housing portion 310 and the flexible portion 320, the knitting pattern used for each of these portions 310/320, and the areas of different thickness are readily customized during the knitting process to provide reinforcement at the desired locations. For example, similar to preform 300, different preforms may be configured with shell portions (e.g., shell portion 310) having different attachment patterns (e.g., knitting, weaving, etc., including stitching) that alter their rigidity, e.g., different regions of shell portion 310 have different levels of rigidity, because these regions use different knitting patterns or different thermoplastic strand thicknesses, as described below. Thus, the preform 300 may feature a shell portion 310 having a certain level of stiffness, while the shell portion of another preform may be configured to have more or less stiffness after heating and cooling.

For example, in fig. 3B, region 351 is knitted thicker than region 350. The thickness may be tailored by using different thermoplastic materials, different types or thicknesses of strands, and/or varying knitting techniques. Here, the housing portion and the flexible portion may be coupled in any suitable manner, including laterally juxtaposed and overlapping (e.g., flexible portion 351 is inside housing portion 352 and laminated or laminated over an area of housing portion 352).

Fig. 4 generally illustrates a preform 400 corresponding to a hinged AFO. The brace produced by the preform 400 accommodates greater ankle movement, greater medial lateral stability, and greater movement along the sagittal plane relative to the brace produced from the preforms 200, 300 of fig. 2-3.

Here, according to this embodiment of the present disclosure, preform 400 includes a plurality of knitted portions; that is, in this example, the first knitted portion 410 acts as a lower shell portion (foot plate section) and the second knitted portion 412 acts as an upper shell portion (calf section). These housing portions 410 and 412 are coupled at least in part by a third knitted portion 420 that is a first flexible portion and/or a fourth knitted portion 450 that is a second flexible portion. The second flexible portion 450 is arranged to separate the lower shell portion 410 from the upper shell portion 412 within the final orthosis. The second flexible portion 450 may be woven in as part of the preform 400 or may constitute a post-production element for attachment at a connection point 460 (and optionally a second connection point (not shown) located on the opposite side of the ankle). The attachment may be achieved, for example, by fasteners arranged at each connection point.

According to one embodiment of the present disclosure, the second flexible portion 450 may be resilient to provide varying degrees of tension to the patient's achilles tendon. Alternatively, the second flexible portion 450 may be flexible, but may be inelastic, or may have one or more inelastic connection points 460 at which the second flexible portion 450 is attached to the first flexible portion 420.

Fig. 5 generally shows a view of the back of the hand and palm of the left hand of a preform 500 with a wrist orthosis worn. The shell portion appears as two physically separated regions 511, 512 on the dorsal side, but as a single region 513 on the palmar side. The flexible portion 520 extends entirely around the housing portions 511, 512 and 513. On the orthosis for each hand, there are three openings, one for the thumb, one for the wrist and one for the finger/distal metacarpal region. In this particular example, thumb sleeve 530 includes a housing portion 532 and a flexible portion 534.

The wrist brace corresponding to preform 500 effectively reduces bending, stretching, abduction, adduction and rotational movements of the wrist while still being easier to wear due to flexible portion 520. The stiffness of the housing portions 511, 512 and 513 may be the same or the stiffness of the housing portions 511, 512 and 513 may differ based on the type of thermoplastic material used, the number and/or content of strands of thermoplastic material within the housing portions, the knitting pattern used, etc.

One advantage associated with this type of wrist brace is that the patient can wear the brace like a glove without the need for a fastening strap. With the integrated rigid region, the wrist brace is configured to stabilize the wrist and/or thumb without requiring additional locking using straps or other fasteners.

Fig. 6 generally illustrates a stage in the production of a prefabricated orthosis from a knitted prefabricated member 600. As shown, the preform 600 is directed to a foot orthosis designed to protect a forefoot region of a patient, although the preform orthosis may be developed for any portion of the patient's body. Here, preform 600 includes a knitted strand having at least two different materials 610 and 620. For example, the different materials 610 and 620 may include thermoplastic materials and non-thermoplastic materials, respectively. Alternatively, the different material may include a first thermoplastic material 610 having a lower melting temperature than a second thermoplastic material 620.

Here, the preform 600 may be placed on a male mold 670 of a target body part and heated to a first temperature 660 (e.g., a lower melting temperature) that partially melts the thermoplastic material 610. After cooling, this provides sufficient rigidity to enable the preform 600 to retain its shape when removed from the male mold (or patient). After removal, the hardened preform 630 may be provided as a prefabricated orthosis or sold to a clinician.

Thereafter, upon receipt of the hardened preform 630, the clinician may place it on a mold associated with the body part of the patient, manually mold it as needed, and heat it to a second temperature 662. The second temperature 662 may be greater than the first temperature 660 to allow for reshaping of the first thermoplastic material 610. After cooling, the preform 650 becomes a custom orthosis, with the now hardened shell portion 610A being located in a first region of the orthosis.

Although not shown, where preform 600 includes knitted strands of first thermoplastic material 610 having a lower melting temperature than second thermoplastic material 620, hardened preform 630 may be placed on a patient's mold, manually molded as needed, and heated to second temperature 662. The second temperature 662 may be greater than the first temperature 660 to allow the first thermoplastic material 610 to reshape and to allow at least a portion of the second thermoplastic material 620 to melt. Upon cooling, the preform 650 becomes a customized orthotic with the hardened shell portion 610A located in a second zone (e.g., ankle-heel zone) along with another hardened shell portion.

As an alternative embodiment, the preform 600 may be placed on a body part of the patient instead of the male mold. Here, the first temperature 660 may be within a temperature range that does not harm the patient, within which a series of heating processes may occur to allow the clinician to adjust and shape during the hardening phase of the preform 630 until the preform 650 becomes a custom orthosis.

An embodiment of a preform having multiple layers of knitted material is now described with reference to fig. 7A-8D. According to these embodiments, each preform may comprise a plurality of layers of knitted material. Preforms having multiple layers of material may be achieved by a variety of techniques including complex multi-layer knitting processes, separately knitted sections that overlie and attach to each other, or preforms having a single layer of knitted material folded upon itself or with another preform to form a multi-layer knitted section. As an illustrative example, for a preform formed for a body part (e.g., a foot, leg, hand, or arm), a first knitted portion may be directed toward a first body part (e.g., a right foot) and a second knitted portion may be directed toward a complementary second body part (e.g., a left foot) disposed opposite and co-linearly with the first body part. The knitting process is performed using a first sock piece knitted from a first material (e.g., starting from an open tubular region and ending at a closed tubular region knitted for a right foot facing a first direction), followed by a second sock piece knitted from a second material (e.g., continuing from a closed tubular region knitted for a left foot facing a second direction opposite the first direction to the open tubular region). The second sock piece is then folded about itself to wrap the first sock piece, thereby creating a sock orthosis preform comprising multiple layers of an inner first material and an outer second material.

Fig. 7A generally illustrates a schematic view of one embodiment of an orthopedic preform 700, the orthopedic preform 700 including a second knitted portion 720, the second knitted portion 720 characterized by one or more strands of a second material 725 having a melting point lower than a melting point of one or more strands of a first material 715 associated with the first knitted portion 710. For this exemplary embodiment, different materials 715 and 725 may be layered when forming preform 700. For example, upon application of a specified temperature to provide rigidity upon cooling, the second material 725 may partially melt, while the first material 715 may not undergo a phase change (e.g., no change from a solid state to a partially liquid phase that is cooled to resolidify), but rather act as an inner barrier to provide a cushioning effect and airflow.

As with all examples herein, where the second material 725 associated with the second knitted portion 720 is composed of a thermoplastic material having a lower melting point than the first material 715 associated with the first knitted portion 710, it is contemplated that a melting point differential may occur because the first material 715 has no melting point or a melting point that is significantly higher than the melting point of the second material 725. For example, the first material 715 may be nylon or Kevlar ^TM 。

Fig. 7B generally illustrates a schematic view of a portion of the orthopedic preform 700 shown in fig. 7A after heating above a lower limit of the melting point of the thermoplastic material 725 of the second knitted portion 720. When heat is applied above the lower limit of the melting point of thermoplastic material 725, one or more portions 740 of thermoplastic material 725 partially melt and spread, thereby contacting and engaging first material 715. Heat may be provided by a heat source 730, which heat source 730 is understood to be any suitable heat source, including but not limited to a heat generator or a steam generator. Upon cooling, the thermoplastic material 725 solidifies, the second knitted portion 720 becomes stiff, while the first material 715 remains in the same phase and acts as a soft interface between the stiff second portion 720 and the patient's skin.

Fig. 8A generally shows a schematic view of a portion of an orthopedic preform 800, the preform 800 having a second knitted portion 822, the second knitted portion 822 being provided with a higher content of thermoplastic material 821 than the first knitted portion 810. According to this embodiment of the present disclosure, upon application of heat above the lower limit of the melting point of thermoplastic material 821, both first knitted portion 810 and second knitted portion 822 may undergo a partial phase change caused by partial melting of thermoplastic material 821. As shown, the second knitted portion 822 may present a greater amount of molten thermoplastic material 821 due to its higher content level. Thus, after cooling, both the first knitted portion 810 and the second knitted portion 822 may solidify, the second knitted portion 822 becoming stiffer than the first knitted portion 810.

Accordingly, the orthosis created by the preform 800 can have different layers, with the outer layer associated with the second knitted portion 822 having a higher stiffness than the inner layer associated with the first knitted portion 810.

Fig. 8B generally shows a schematic view of a portion of an orthopedic preform 804, the preform 804 having a first knitted portion 814 configured with a first knitted pattern 815 and a second knitted portion 824 configured with a second knitted pattern 825 different from the first knitted portion 814. Here, for this illustrative example, the second knitted pattern 825 of thermoplastic material is more compact than the first knitted pattern 815 of thermoplastic material. According to this preform architecture, when heat is applied above the lower limit of the melting point of the thermoplastic material, both the first knitted portion 814 and the second knitted portion 824 experience a partial phase change caused by the partial melting of the thermoplastic material. However, given that the second knitted pattern 825 has a greater amount of thermoplastic material over a prescribed distance or area than the first knitted pattern 815, a greater amount of melted thermoplastic material may be present in the second knitted portion 824. Thus, after cooling, the second knitted portion 824 may be formed as a housing portion having a higher rigidity, and the first knitted portion 814 may also be formed as a housing portion. Thus, different types of knitting patterns can be used to influence the stiffness of the final shell portion of the orthosis.

Fig. 8C generally shows a schematic view of a portion of an orthopedic preform 806, the preform 806 having a first knitted portion 816, the first knitted portion 816 configured with strands 817 of thermoplastic material that are finer than the second knitted portion 826. In other words, the second knitted portion 826 is provided with thicker thermoplastic material strands 827 than the thermoplastic material strands 817 in the first knitted portion 816.

According to this preform structure, in the case where the same thermoplastic material is used in the first knitted portion 816 and the second knitted portion 826, when heat is applied above the lower limit of the melting point of the thermoplastic material, both the first knitted portion 816 and the second knitted portion 826 undergo a partial phase change caused by partial melting of the thermoplastic material. However, given that strands 827 of thermoplastic material within second knit pattern 826 are thicker than strands 817 of thermoplastic material within first knit pattern 816, a greater amount of thermoplastic material within second knit portion 826 may be melted during the melting process.

Thus, after cooling, the second knitted portion 826 will form into a shell portion having a greater stiffness than the shell portion formed by the first knitted portion 816. Thus, different types of strand thicknesses can be used to influence the stiffness of the final shell portion of the orthosis.

Fig. 8D is a schematic view of a portion of an orthopedic preform 808, the preform 808 having a second knitted portion 828, the second knitted portion 828 configured with a plurality of layers comprising filaments of thermoplastic material, wherein the number of layers of the second knitted portion 828 exceeds the first knitted portion 818. According to this preform architecture, the second knitted portion 828 will undergo a phase change caused by partial melting of the thermoplastic material when heat is applied above the lower limit of the thermoplastic material melting point. However, given that the second knitted portion 828 has a greater amount of thermoplastic material than the first knitted portion 818 over a prescribed distance or area, and that heat transfer will decrease as heat is transferred into the first knitted portion 818 via the second knitted portion 828, a greater amount of molten thermoplastic material will be present in the second knitted portion 828. Thus, after cooling, the second knitted portion 828 will form a shell portion having a higher rigidity than the first knitted portion 818. Thus, multiple layers of thermoplastic material may be used to affect the stiffness of the final shell portion of the orthosis.

Fig. 9 generally illustrates a schematic view of a portion of an orthopedic preform 900 having a second knitted portion 920 comprising a thermoplastic material having a lower melting point than the first knitted portion 910. Here, the second knitted portion 920 further includes a material other than a thermoplastic material, which increases rigidity. Contemplated rigidity-enhancing materials include carbon, glass, or other rigid fibers. The first portion 910 includes Kevlar ^TM Or other materials having high strength and high flexibility. The band 940, which is knitted in conjunction with the first knitted portion 910 and the second knitted portion 920, is used to help retain the orthopedic preform 900 on the lower limb and foot of a patient (not shown).

Fig. 10A generally illustrates a schematic view of a portion of an orthopedic preform 1000 having a second knitted portion 1020, the second knitted portion 1020 comprising a thermoplastic material having a lower melting point than the first knitted portion 1010, wherein the second portion 1020 is stitched or knitted 1050 to the first knitted portion 1010. This preform layering scheme may be used in cases where the material associated with the second knitted portion 1020 does not adhere to the material associated with the first knitted portion 1010 after heating and cooling. Knit 1050 attaches first knitted portion 1010 and second knitted portion 1020, wherein thermoplastic material within first knitted portion 1010 or second knitted portion 1020 does not provide sufficient adhesion when heat is applied within the lower limit of the melting point of thermoplastic material within second knitted portion 1020 to melt and harden after cooling.

Fig. 10B generally illustrates a schematic view of a portion of the orthopedic preform 1002, the orthopedic preform 1002 having a second knitted portion 1022, the second knitted portion 1022 comprising a thermoplastic material having a lower melting point than the first knitted portion 1012, wherein the second knitted portion 1022 can be laminated to the second knitted portion 1012 at a lamination area 1052. This preform layering scheme may be utilized where the material associated with the second knitted portion 1022 is unable to adhere to the material associated with the first knitted portion 1012 after heating to melt the thermoplastic material and subsequent cooling.

Fig. 10C generally illustrates a schematic view of a portion of an orthopedic preform 1004 having a second knitted portion 1024 comprising a thermoplastic material having a lower melting point than the first knitted portion 1014, wherein the second knitted portion 1024 is chemically bonded to the first knitted portion 1014 at a chemical bonding region 1054. This preform layering scheme may be used where the material associated with the second knitted portion 1024 cannot adhere to the material associated with the first knitted portion 1014 after application of heat to melt the thermoplastic material of the second knitted portion 1024 and subsequent cooling.

Fig. 10D generally illustrates a schematic view of a portion of an orthopedic preform 1006 having a second knitted portion 1026 comprising a thermoplastic material having a lower melting point than the first knitted portion 1016, wherein the second knitted portion 1026 is melted onto the first portion 1016 at a melting region 1056 using heat provided by a heat source 1030. This preform layering scheme may be used where the material associated with the second knitted portion 1026 generally adheres to the material associated with the first knitted portion 1016 after application of heat to melt the thermoplastic material and subsequent cooling. For example, the first knitted portion 1016 may comprise a first type of thermoplastic material (e.g., polyethylene (PE)), while the second knitted portion 1026 may comprise a second type of thermoplastic material (e.g., polypropylene (PP)). The melted region 1056 between the first knitted portion 1016 and the second knitted portion 1026 is formed where the PE will adhere to the PP.

Fig. 11 generally illustrates a perspective view of a portion of an orthopedic preform 1100 having a first knitted portion 1110, the first knitted portion 1110 comprising a thermoplastic material having a lower melting point than material within a second knitted portion 1120. Here, the second knitted portion 1120 is elastic. Elasticity may be achieved by using elastic threads and/or by using one or more knitting patterns that impart elasticity. Thus, while the first knitted portion 1110 and the second knitted portion 1120 are formed simultaneously, the material forming the first knitted portion 1110 is different from the material forming the second knitted portion 1120.

Here, after preform 1100 is placed on the male mold (or patient's leg), it can be heated above the lower limit of the melting point of the thermoplastic material within first knitted portion 1110. Then, after cooling, the first knitted portion 1110 is rigid to provide stability to the patient's rear leg when worn, while the second knitted portion 1120 remains elastic to provide comfort and greater mobility to the patient.

Fig. 12A generally illustrates a perspective view of an orthopedic pre-cast sheath 1200 having a first knitted portion 1220, the first knitted portion 1220 comprising a thermoplastic material having a lower melting point than a material forming the second knitted portion 1210. Here, the first knitted portion 1220 may be integrated at selected areas of a single knitted composite layer including the first knitted portion 1220 and the second knitted portion 1210. As shown, the first knitted portion 1220 may be located in one or more desired areas, such as the patella area.

As a result, after a prescribed amount of heat is applied above the lower melting point limit of the thermoplastic material within the first knitted portion 1220 of the preformed armor and then cooled, the first knitted portion 1220 converts to a rigid shell portion that prevents dislocation of the patella and protects the patella from blunt forces. For this example, the sheath preform 1200 can be converted into a custom brace and brace having a protective shell portion integrated as part of a single knitted composite layer.

Fig. 12B generally shows a perspective view of the orthopedic preformed sheath 1200 shown in fig. 12A, wherein a top edge section 1230 of the preformed sheath 1200 has been folded down over at least a portion of the first knitted portion 1220. According to this embodiment of the present disclosure, the top edge segment 1230 may partially or completely cover the first knitted portion 1220. This folding occurs prior to the heating process to convert the preformed sheath 1200 into an orthosis for use by the patient having a thicker top region 1240 to assist in donning and/or removal of the orthosis as desired. In addition, where the second knitted portion 1210 comprises a thermoplastic material, higher heat may be applied to convert this section of the preformed jacket 1200 into a thicker rigid shell portion to provide further patella protection.

Fig. 13 generally illustrates a perspective view of an orthopedic preform 1300 having at least a first knitted portion 1310, a second knitted portion 1320, and a third knitted portion (not shown) located at a selected location of the first knitted portion 1310. Here, the melting point of the material of the third knitted portion is lower than the melting point of the thermoplastic material contained in the first knitted portion 1310. The first knitted portion 1310 includes a thermoplastic material having a lower melting point than the material within the second knitted portion 1320.

Based on this preform structure, heating the orthopedic preform 1300 to a temperature at or above the lower melting point limit of the thermoplastic material contained within the first knitted portion 1310 can result in the following: (a) The thermoplastic material within the first knitted portion 1310 is at least partially melted, and (b) the third knitted portion is completely melted (or incinerated) to create an aperture 1350. As a result, a frame for a removable knee/elbow protection orthosis is created from the preform 1300, wherein the first knitted portion 1310 transitions to a rigid shell portion, while the second knitted portion 1320 may remain flexible or even remain in an elastic configuration.

Thereafter, strap 1330 may be used as a fourth knitted portion that is anchored to foot region 1340 at first knitted portion 1310, or a first end of strap 1330 may be coupled to foot region 1340 and looped around second end 1360 of strap 1330 for insertion through aperture 1350, thereby serving as an attachment element for strap 1330 as a post-production element. The second end of the strap 1360 may include fasteners (e.g., hook fasteners of a hook and loop fastening mechanism), while the outer surface 1370 of the strap 1330 may include complementary fasteners (e.g., complete loop (UBL) material for a hook and loop fastening mechanism).

Fig. 14A generally shows a perspective view of an orthopedic preform 1400 having a first knitted portion 1420, the first knitted portion 1420 comprising a thermoplastic material having a lower (first) melting point than the second portion 1410. Preform 1400 is placed around a mold 1450 of a patient's body part (e.g., foot and ankle region) to show that first knitted portion 1420 is placed along the posterior side to cover the heel, ankle, and achilles tendon regions of the patient. As described above, there are many advantages to using the mold 1450 in manufacturing the orthosis 1480 of FIG. 14B. The orthosis 1480 can be better adapted to the patient by having the mold 1450 with certain undulating regions to assume the patient's anatomy (e.g., adding or removing contours to relieve stress caused by bone processes, adding or removing contours to better direct additional loads to soft tissue regions to improve comfort, etc.).

As shown in more detail in fig. 14B, preform 1400 is disposed about a mold 1460 (similar to mold 1450) of a body part of a patient (e.g., foot and ankle region), and preform 1400 is heated using a heat source 1430 (e.g., heat, steam heat, etc.) to a temperature above the lower melting point limit of the thermoplastic material within first knitted portion 1420. According to one embodiment, heating occurs across preform 1400. According to another embodiment, the heating may be "spot" heating to heat the target area of the preform 1400 more than other areas. After the heating process, preform 1400 is cooled, at least first knitted portion 1420 is partially hardened into a shell portion, while second portion 1410 retains its elastic (or at least non-rigid nature). As a result, AFO orthosis 1480 is produced.

Fig. 15 generally illustrates a perspective view of a self-heating orthopedic preform 1500 disposed in a nitrogen-filled bag 1550. Preform 1500 has a shell portion 1520 with thermoplastic material that can include thermoplastic threads or yarns 1522, non-thermoplastic fibers 1524, and an amount of embedded self-heating composition 1526. The embedded self-heating composition 1526 should be interpreted as any one or more of a loose powder or other particles of self-heating composition 1526, particles bonded to one or both of thermoplastic thread or yarn 1522 and non-thermoplastic thread or yarn 1524. This particular example orthopedic preform 1500 is an AFO, wherein the shell portion 1520 is knitted to the second flexible portion 1510.

Any suitable functional material may be employed as the embedded self-heating composition 1526, including magnesium metal powder alloyed with small amounts of iron, and the like, such as materials used to heat ready-to-eat foods (MREs). Typically, this material generates heat during an exothermic chemical reaction when triggered by atmospheric oxygen and, in fig. 15, prevents heat generation by storing an embedded self-heating composition 1526 in a nitrogen filled bag. In other contemplated embodiments, the appropriate exothermic chemical reaction may be triggered by some other means, such as by ambient heat or other light.

When the preform 1500 is removed from the pouch 1550, the preform 1500 is placed on a person's limb or other mold, wherein the embedded self-heating composition 1526 is contacted with oxygen in the air and the chemical reaction heats the thermoplastic filaments or yarns 1522 to about the melting point. Upon cooling, the thermoplastic thread or yarn 1522 partially melts together, thereby transitioning from the portion 1520 to a hardened shell.

Fig. 16 generally shows a perspective exploded view of an alternative self-heating orthopedic preform 1600 that is similar to the orthopedic preform of fig. 15, except that the self-heating composition described herein is contained in a jacket or cladding 1670 that can be removed from the preform 1600.

Fig. 17 generally shows a perspective exploded view of another alternative orthopedic preform 1700 that generally has a shell portion 1720 and a flexible portion 1710. The housing portion 1720 contains an amount of a polymerizable composition 1726, the polymerizable composition 1726 being construed as any one or more of loose powder or other particles 1726, threads or yarns 1722 containing a polymerizable material, or particles of a polymerizable material bonded to any other thread or yarn 1724.

Preform 1700 is stored in bag 1750 which does not contain a polymerizer. Contemplated polymerizers include Ultraviolet (UV) or other light, one or more chemicals, or other suitable energy sources. Upon opening the bag 1750, the preform 1700 is placed on a person's limb or other mold and a polymerization agent is applied to polymerize the polymerizable material 1726, forming a hardened shell from the portion 1720.

Additional exemplary applications

The above-described construction of the preform is exemplary, as the invention extends to a variety of orthotics. Here, the orthopedic preform includes (i) a first knitted (shell) portion having one or more strands of a first thermoplastic material; and (ii) a second knitted portion mechanically coupled to the first knitted portion such that the first knitted portion and the second knitted portion are formed on a single knitted layer. The melting point of the first thermoplastic material is lower than the melting point of the material used for the second knitted portion. Here, when heat is applied to the orthopedic preform above the lower limit of the melting point of the first thermoplastic material, the first knitted portion transforms into a rigid shell portion, while the second knitted portion remains flexible and, in some cases, elastic.

Referring to fig. 18, an orthopedic preform (as described above) can be applied to a shoulder orthosis 1800 comprising a first knitted (shell) portion and a second knitted (flexible) portion. Here, the shoulder orthosis 1800 can be provided as an arm suspension 1810 and a shoulder adjustment member 1820, which shoulder adjustment member 1820 retains the patient's arm 1830 within the arm suspension 1810 at a prescribed distance from a side 1840 of the patient 1850. The shoulder adjustment member 1820 is disposed generally perpendicular to the inner forearm region 1812 of the arm suspension 1810 to position the elbow and forearm region to position the shoulder 1860 of the patient 1850. Abduction and rotation control of shoulder 1860 occurs when hip housing 1825 and the rigid structure with the first knitted (housing) portion at the forearm are joined.

According to one embodiment of shoulder orthosis 1800, as shown in fig. 18, a first end (not shown) of shoulder adjustment member 1820 is mechanically coupled to inner forearm region 1812 of arm suspension 1810, while a second end 1822 of shoulder adjustment member 1820 includes at least one first attachment member 1824 for coupling to strap 1870 extending around the waist of patient 1850. First attachment member 1824 may include a loop-shaped fastener for mating with a complete loop (UBL) connector located on top surface 1872 of strap 1870.

Arm suspension 1810 includes a first knitted portion 1814 disposed around forearm/elbow region 1812/1815 and around both sides of the patient's forearm to secure arm 1830 and create abduction and rotation control of shoulder 1860. Arm suspension 1810 also includes a second knitted portion 1816 that surrounds a portion of the perimeter of arm suspension 1810 to provide a soft transition to protect the patient from being cut or pinched by slight movement of first knitted portion 1814. When heated, the first knitted portion 1814 becomes rigid, similar to a casting, while the second knitted portion 1816 retains its flexibility. Here, the first knitted portion 1814 includes an amount of thermoplastic material that substantially exceeds the amount of any thermoplastic material (if any) that is part of the second knitted portion 1816. Similarly, the shoulder adjustment member 1820 includes at least one first attachment member 1824, the first attachment member 1824 including a first knitted portion 1825 disposed along a mid-section of the first attachment member 1824 and a second knitted portion 1826 disposed along a perimeter of the first knitted portion 1825. As previously described, this amount provides sufficient force to limit lateral movement of the arm slings 1810.

As further shown in fig. 18, the shoulder pad 1880 is formed from a second material that may include a flexible, smooth, and/or resilient material to avoid irritation of the neck and/or shoulder regions of the patient from use. For example, the second material may be a soft thermoplastic material, such as Polyethylene (PE). Here, the shoulder pad 1880 may maintain its flexible and/or elastic structure in the event that the second material has a higher melting point range than the material associated with the first knitted portion 1814/1825. Shoulder pad 1880 has an annular rim 1882 to allow straps 1890 to pass therethrough to vertically support arm straps 1810.

As another alternative, although not shown, the shoulder pad 1880 may be molded and hardened to provide greater support for the arm suspension 1810 by the straps 1890.

Similar structures may be used for garments outside of the orthosis design. For example, as shown in fig. 19, a shoe 1900 (e.g., slipper, post-operative shoe shown, etc.) can be configured with a first knitted (shell) portion disposed along a foot plate 1910 and around a selected area of an ankle area 1920. When heated, portions of the foot plate 1910 and ankle region become rigid to secure and protect the patient's foot. The remainder of the footwear (e.g., second knitted portion 1930) features soft fabric, padding, and/or other materials (e.g., straps 1940) to achieve lateral fastening of footwear 1900. The post-operative footwear 1900 may be used in combination with a rear leg stabilizer 1950, shown shaped around the rear of the patient's leg, made from a preform of a first knit (shell) material (or one form thereof), a leg-ankle-foot orthosis (AFO) 200 as shown in fig. 2, or may be used separately.

With respect to garments, although not shown, various embodiments may utilize the conversion of strands of flexible material in a non-heated state into rigid regions. For example, a glove may be provided in which certain areas of the glove develop increased rigidity when heated to protect the wearer's hand, such as a bicycle glove. A sock may be provided in which certain areas of the sock (e.g. the shin-covering areas) comprise a first knitted portion (thermoplastic strands) and the remainder of the sock comprises a second knitted portion (cotton strands) such that when heated and cooled, the first knitted portion becomes rigid to protect the shin of the wearer during a sporting event.

Furthermore, the garment may constitute a shirt having thereon (i) an inner pocket surface having a first knitted portion that, when hardened, protects the wearer from cellular radiation and/or radiant heat emanating from the cellular telephone, and/or (ii) a collar having a first knitted portion (with thermoplastic material) to orient the collar shape as desired to maintain the shape even after a laundry cycle conducted in a washing machine and dryer (i.e., the melting point of the thermoplastic material is substantially higher than the maximum temperature of an electric or gas dryer).

Further, in the alternative, as shown in fig. 20, the garment may constitute a pair of pants 2000 having rigid zones 2010 along the buttocks 2020, leg tendons 2030 and/or lower legs 2040, as shown. In addition to using a thermoplastic material scaffold having a first knitted portion to provide rigidity to relieve external forces applied to certain body parts (e.g., buttocks, leg tendon regions, calf regions, etc.), as shown in fig. 20, the thermoplastic material scaffold may be knitted to form one or more channels 2050 within an object (e.g., orthosis, garment, etc.). These passageways 2050 may be sized for the propagation of wires, ropes and/or interconnects (e.g., cables, elastic cords, etc.) 2060 within an object (e.g., pants 2000).

For example, according to one embodiment, the elastic tension of the interconnect 2060 is applied by routing the interconnect 2060 behind the knee joint, which may create a bending moment for the knee joint 2070. Similarly, where the path of the interconnect 2060 is located in front of the knee joint 2070, knee extension may be facilitated. In other words, the interconnect 2060 may be included within the channel 2050 between two regions, and directional forces may be generated between the two rigid regions. As shown in fig. 20, one rigid region is disposed to cover the thigh region of the patient and one rigid region is disposed to cover the calf of the patient, the interconnect 2060 may facilitate flexion or extension of the knee joint depending on the position of the strands relative to the anatomical joint and the tension and elasticity of the interconnect 2060. The interconnect 2060 may be a cable having elastic segments in series or at either end, which can be pulled taut with a spool or other device.

It is envisaged that such an architecture may be used in many places: shoulder, elbow, hip and ankle. This has the advantage that a single layer of material can control the course of the cable to tension/control the movement over the joint. Additionally or alternatively, one or more interconnects 2060 may be mounted within the channel 2050 to limit movement across the joint, or the interconnects 2060 may constitute wires located within the channel 2050 to apply electromagnetic therapeutic pulses to stimulate tissue healing at various parts of the body.

These and other products can be formulated according to the selected positioning, heating, and subsequent cooling of the knitted portions with thermoplastic materials to achieve rigidity of the knitted portions.

It is also contemplated that instead of thermoplastic strands (e.g., threads, yarns, etc.) that are heated and then cooled to form the shell portion, materials may be used in strands that harden by polymerization from ambient or artificial light, an oxidizing or reducing agent, or any other suitable source of energy.

It will be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where in the description and claims reference is made to "at least one item selected from the group consisting of A, B, c.i. and N, this text should be interpreted as requiring only one element of the group, not a+n or b+n etc.

Claim (modification according to treaty 19)

1. A knitted wearable, comprising:

a first knitted portion comprising a knitted strand comprising at least one thermoplastic material that is at least partially melted at a first melting point; and

a second knitted portion mechanically coupled to the first knitted portion,

wherein the first knitted portion is configured such that after heating the knitted product to at least the first melting point and subsequently cooling, the first knitted portion is stiffer than the second knitted portion in at least one dimension.

2. The knitted wearable recited in claim 1, formed into an orthosis, wherein (i) the first knitted portion, after being heated and cooled, operates as a hardened shell to locate along a rear portion of a leg to provide stability at an ankle portion of the orthosis when worn, and (ii) the second knitted portion is oriented to support the front portion of the leg.

3. The knitted wearable recited in claim 1, wherein the second knitted portion has resiliency that presses the first knitted portion against a rear portion of a leg and assists in lifting a foot of a wearer during a swing phase.

4. The knitted wearable recited in claim 1, wherein the first knitted portion is comprised of thicker thermoplastic filaments than thermoplastic filaments in the second knitted portion or has a tighter knit stitch than second knitted portion.

5. The knitted wearable recited in claim 1, wherein the first knitted portion is configured to have a greater number of layers of material than a number of layers of material used by the second knitted portion.

6. The knitted wearable recited in claim 2, wherein the first knitted portion is configured with a plurality of different types of thermoplastic materials to increase rigidity of different portions of a shell forming portion of an orthosis.

7. The knitted wearable recited in claim 2, wherein the second knitted portion includes non-thermoplastic strands to provide elasticity of the second knitted portion while the first knitted portion remains rigid.

8. The knitted wearable recited in claim 1, wherein the first knitted portion is stitched or knitted to a second knitted portion.

9. The knitted wearable recited in claim 1, wherein the first knitted portion is laminated to a second knitted portion.

10. The knitted wearable recited in claim 1, wherein the first knitted portion is chemically bonded or fused to a second knitted portion.

11. The knitted wearable recited in claim 1, wherein the first knitted portion has a first knitted pattern that is different from a second knitted pattern, wherein the knitted strands of thermoplastic material knitted in accordance with the first knitted pattern are more rigid than the knitted strands of thermoplastic material knitted in accordance with the second knitted pattern.

12. The knitted wearable of claim 1 further comprising a tube comprising a first knitted portion and a second knitted portion.

13. The knitted wearable recited in claim 1, wherein the thermoplastic material comprises at least 8 weight percent of the first knitted portion.

14. The knitted wearable recited in claim 13, wherein the first knitted portion is at least eight percent of a total weight of the preform.

15. The knitted wearable recited in claim 1, wherein the thermoplastic material is resilient to bending after being partially melted and cooled to room temperature.

16. The knitted wearable recited in claim 1, wherein the second knitted portion includes at least a second thermoplastic material having a higher melting temperature than the first melting point and being physically separate from the first knitted portion.

17. The knitted wearable recited in claim 16, wherein the second knitted portion includes a non-thermoplastic material that is bonded with a second thermoplastic material.

18. The knitted wearable recited in claim 1, wherein the knitted strands of the first knitted portion are a composite material including at least strands of thermoplastic material and strands of another type of material.

19. The knitted wearable recited in claim 18, wherein another type of material strand comprising a non-thermoplastic material has a melting point that differs from the thermoplastic material by at least 50 ℃ and a volume of the thermoplastic material is greater than a volume of the non-thermoplastic material.

20. The knitted wearable recited in claim 1, wherein the first knitted portion and the second knitted portion are located within a same layer of knitted material forming the preform.

21. The knitted wearable recited in claim 1, wherein the second knitted portion is layered with the first knitted portion and is placed in a different layer of knitted material than the first knitted portion.

22. The knitted wearable recited in claim 1, further comprising a third knitted material having a melting point that is lower than the first melting point, such that when the preform is heated to the first melting point, the third knitted material is removed, leaving at least one eyelet or foot for a band located within the first knitted portion.

23. The knitted wearable recited in claim 1, formed as an orthosis, wherein the second knitted portion includes a first portion that is coplanar with and positioned along a first outer edge of the first knitted portion, and a second elastic portion that is coplanar with and positioned along a second outer edge of the first knitted portion, as a single layer, and upon heating and cooling operates as a hardened shell to be positioned along a rear portion of a leg to provide dorsiflexion, plantarflexion, varus, and valgus stability at an ankle of the orthosis when worn, and (ii) the second knitted portion is oriented to support a front portion of the leg.

24. The knitted wearable recited in claim 1, wherein the first knitted portion includes one or more channels sized for passage of a wire, rope, or other interconnect.

25. A method of producing a customized orthosis for a patient, comprising:

placing an orthopedic preform around a mold, the preform comprising a shell portion and a second portion, the shell portion comprising a first knit strand comprising a first thermoplastic material that at least partially melts at a first melting point, the second portion comprising a second knit strand having a second melting point that is substantially greater than the first melting point such that the first knit strand can phase change and melt without changing the phase of the second knit strand; and

the preform is heated and then cooled to at least a first melting point to at least partially melt and harden the shell portion.

26. The method of claim 25, wherein the preform comprises a tube comprising the shell portion and the second portion, and the method further comprises pulling the tube onto the mold.

27. The method of claim 25, wherein the mold is a male mold.

28. The method of claim 25, wherein

Placing the orthopedic preform includes forming the preform, wherein the shell portion further includes a third braided strand formed from a second thermoplastic material having a melting point lower than the melting point of the first thermoplastic material;

heating and then cooling the preform includes applying a temperature to the preform that melts at least some of the second thermoplastic material, but prevents melting of the first thermoplastic material.

29. The method of claim 25, further comprising selecting the first thermoplastic material such that the housing portion has a flexural elasticity.

30. A method of producing an orthosis, comprising:

removing an orthopedic preform from a container, the preform comprising (i) a first knitted portion comprising a material configured to harden upon application of a hardening agent; and (ii) a second knitted portion that remains flexible when the hardener is applied;

placing the preform around a person's limb or other mold;

applying a hardener to the preform to form an orthotic device having a hardened portion formed by deformation of the first knitted portion and a flexible portion formed by deformation of the second knitted portion; and

The orthosis produced from the orthopedic preform is removed from the mold.

31. The method of claim 30, wherein the material configured to rigidify comprises thermoplastic strands and the rigidizer comprises application of heat.

32. The method of claim 30, wherein the material configured to harden comprises a self-heating composition comprising strands of thermoplastic material that, when exposed to ambient oxygen, cause the self-heating composition to at least partially melt.

33. The method of claim 30, wherein the material configured to harden comprises a polymerizable composition, the hardener comprises a polymerization agent, and the method further comprises applying a polymerization agent sufficient to polymerize the polymerizable composition.

Claims

1. A knitted wearable, comprising:

a second knitted portion mechanically coupled to the first knitted portion,

2. The knitted wearable recited in claim 1, wherein the first knitted portion is configured to have a higher content of thermoplastic material than the second knitted portion.

3. The knitted wearable recited in claim 1, wherein the first knitted portion is configured to have a tighter knit stitch than the second knitted portion.

4. The knitted wearable recited in claim 1, wherein the first knitted portion is comprised of thicker thermoplastic material filaments than thermoplastic material filaments in the second knitted portion.

6. The knitted wearable recited in claim 1, wherein the first knitted portion is configured with a plurality of different types of thermoplastic materials to increase rigidity, rather than using only a single type of thermoplastic material.

7. The knitted wearable recited in claim 1, wherein the second knitted portion includes non-thermoplastic strands to provide elasticity of the second knitted portion while the first knitted portion remains rigid.

23. The knitted wearable recited in claim 1, the knitted wearable being an orthopedic preform.

24. The knitted wearable recited in claim 1, which is a garment, such as a sock.

25. A method of producing a customized orthosis for a patient, comprising:

27. The method of claim 25, wherein the mold is a male mold.

28. The method of claim 25, wherein

30. A method of producing an orthosis, comprising:

Placing the preform around a person's limb or other mold;

the orthosis produced from the orthopedic preform is removed from the mold.