This present disclosure relates generally to a prosthetic device configured for creating and enabling better joint contouring at the site of an amputation and prosthetic component. In another aspect, the present disclosure relates to method of forming a prosthetic device to better contour to an amputation site of a patient to enable same day delivery of a prosthetic product.
In the pedorthic, orthotic, prosthetic, and podiatric industries, it is known to create customized devices in the management and treatment of the foot and particularly amputations of the foot and/or toes. Generally, these devices are referred as toe prosthesis or partial foot prosthesis or as they are more commonly known as toe fillers. These devices are generally formed and constructed from universal materials, such as plastics, woods, foams, rubbers (natural and synthetic), and composites of these material types. Typically, production of these devices is outsourced to third parties that will mill, 3D print, or hand craft from a molded impression or images of the anatomical features and constructed by hand.
Accordingly, these customized devices can be time consuming to make, expensive, and may need to be further customized depending upon the type or style of footwear the device is used for. The third-party nature of fabrication also creates room for error in communication and device specifications. Additionally, as the patient is waiting for these customized devices, they are still having to utilize the damaged/amputate body part without or with an ill-fitting temporary device that can result in additional damage and/or infection to the amputation site. This can result in additional delays in healing and potentially additional adverse health effects.
Therefore, there exists a need for a better prosthetic device for placement within footwear to compensate for a missing toe(s) and a more efficient way to create these types of prosthetic devices, along with an improved method to create a more accurate contour of the prosthetic with the amputation site, as well as allow for same day fabrication of the prosthetic for the patient to utilize.
In one aspect, this disclosure is related to a prosthetic device that utilizes a series of critical interfaces that together streamline the manufacturing process and result in a more adjustable prosthetic. These interfaces can each be customized for a universal method that reduces the need for multiple sizes of kits. Customization of each interface can also be related to patient needs, such as offloading methods.
In another aspect, this disclosure is related to a prosthetic device that can utilize a moldable material that includes a moldable putty and activator combined together to form a body safe and hardened material configured for placement on a specifically adapted footbed for placement within footwear, in combination with a light weight section made of foam or a comparable material that can reduce weight in the forefoot and reduces the amount of putty material needed.
In another aspect, this disclosure is related to a prosthetic device that utilizes a moldable putty and activator combined together to form a body safe and hardened material configured for placement on a specifically adapted footbed for placement within footwear, shaped by using prefabricated, adjustable molds to shape the prosthetic device to the desired shape.
In another aspect, this disclosure is related to method and apparatus for creating a contoured prosthetic component to an amputation site that includes a generally in the form of a putty and activator combined together to form a body safe and hardened material configured for placement on a specifically adapted footbed for placement within footwear.
In another aspect, this disclosure is related to an improved method for constructing a customized and durable toe/partial foot prosthetic formed from multiple materials and/or layers in an assembled condition.
In another aspect, this disclosure is related to a prosthetic device that utilizes a putty in combination with a hollow form and footplate to form a durable and resilient prosthetic for use in footwear.
The invention now will be described more fully hereinafter with reference to the accompanying drawings, which are intended to be read in conjunction with both this summary, the detailed description and any preferred and/or particular embodiments specifically discussed or otherwise disclosed. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of illustration only and so that this disclosure will be thorough, complete and will fully convey the full scope of the invention to those skilled in the art.
The following detailed description includes references to the accompanying drawings, which forms a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments, which are also referred to herein as “examples,” are described in enough detail to enable those skilled in the art to practice the invention. The embodiments may be combined, other embodiments may be utilized, or structural, and logical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.
Before the present invention of this disclosure is described in such detail, however, it is to be understood that this invention is not limited to particular variations set forth and may, of course, vary. Various changes may be made to the invention described and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s), to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the disclosure made herein.
Unless otherwise indicated, the words and phrases presented in this document have their ordinary meanings to one of skill in the art. Such ordinary meanings can be obtained by reference to their use in the art and by reference to general and scientific dictionaries.
References in the specification to “one embodiment” indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.
The following explanations of certain terms are meant to be illustrative rather than exhaustive. These terms have their ordinary meanings given by usage in the art and in addition include the following explanations.
As used herein, the term “and/or” refers to any one of the items, any combination of the items, or all of the items with which this term is associated.
As used herein, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise.
As used herein, the terms “include,” “for example,” “such as,” and the like are used illustratively and are not intended to limit the present invention.
As used herein, the terms “preferred” and “preferably” refer to embodiments of the invention that may afford certain benefits, under certain circumstances. However, other embodiments may also be preferred, under the same or other circumstances.
Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful and is not intended to exclude other embodiments from the scope of the invention.
As used herein, the terms “front,” “back,” “rear,” “upper,” “lower,” “right,” and “left” in this description are merely used to identify the various elements as they are oriented in the FIGS, with “front,” “back,” and “rear” being relative to the apparatus. These terms are not meant to limit the elements that they describe, as the various elements may be oriented differently in various applications.
As used herein, the term “coupled” means the joining of two members directly or indirectly to one another. Such joining may be stationary in nature or movable in nature. Such joining may be achieved with the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or with the two members or the two members and any additional intermediate members being attached to one another. Such joining may be permanent in nature or alternatively may be removable or releasable in nature. Similarly, coupled can refer to a two member or elements being in communicatively coupled, wherein the two elements may be electronically, through various means, such as a metallic wire, wireless network, optical fiber, or other medium and methods.
It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element without departing from the teachings of the disclosure.
The present disclosure most generally relates to a material and method to provide a comfortable extension of a patient's residual limb that is less time consuming to manufacture when compared to the traditional solutions. Accordingly, the present disclosure most generally relates to prosthetic device that utilizes at least a moldable material 103 for use in the manufacture of a prosthetic device for placement within footwear. In an exemplary embodiment of the present disclosure, a two-part system comprises, but is not limited to, a putty, clay, or any other suitable moldable material that can be mixed together to form a cured substance. In one exemplary embodiment, the moldable material can be a siliconized mold putty provided in a pair of separate materials. Alternate to a siliconized mold putty, the moldable material 103 may be comprised of, but not limited to, a vinyl polysiloxane material that is provided in a pair of separate materials that is mixed together to form a cured substance. These siliconized based materials can be preferred for their material properties as the durometer (hardness/softness) of the material can be customized and utilized for different applications.
In some exemplary embodiments, the moldable material 103 can be beneficial for creating an intimate fit “socket” that creates total contact around the patients residual limb and contours to the amputated area of the residual limb. This total contact contour can better disperse pressure and reduce the risk of wound complications. The remaining aspects of the device can vary based on patient's needs. For example, under layer interfaces for cushioning or off-loading can be optionally included as needed on a case by case basis. Additionally, varying interfaces can be used in the forefoot to reduce the total weight of the prosthetic device based upon the desired use and type of prosthetic needed.
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An enclosure system 150 can be utilized to help with forming around the exterior edge of the footplate 100 and the patient's foot 120. In some exemplary embodiments, the enclosure system 150 can be adjustable in nature to accommodate a wide variety of appendages sizes. In some embodiments, the enclosure system 150 can take the form of a snap together fastening means 152 that can couple a first portion 153a of the enclosure system to a second portion 153b as shown in
In some exemplary embodiments, the prosthetic cap component 102 can be a universal appendage mold 102 that can be used to reduce weight in the forefoot. In one exemplary embodiment, appendage mold 102 can be a trimmable appendage mold 102 and composed from any suitable trimmable composition including but not limited to a foam material. A patient's appendage can be placed onto the footplate 100 and measured in relation to the appendage mold 102 to determine how much of the appendage mold needs to be trimmed in order to contour to the patient and/or to the apparatus which the mold 102 will be placed within, such as a shoe. In some exemplary embodiments, the mold 102 can have pre-defined standard cut guides 170 on the surface of the mold 102 as shown in
Once the mold 102 is trimmed and generally fills the majority of the negative space resulting from the amputation, the moldable material 103 can be placed and/or coupled on the back end of the mold 102 and then contoured to the contouring surface 122 of the patient's appendage. Once the moldable material 103 is contoured and fitted to a patient/user's residual limb 120, the enclosure system 150 can then be adjusted to provide an outer mold that can be used to contain the moldable material 103 to fit in the user's shoe while creating structure for the outer walls of the moldable material 103 as it is contoured to the interfacing portion 122 of the appendage. When a uniform and contoured joint between the moldable material 103 and the contouring surface 122 is achieved, the moldable material can be allowed to harden as well as fully coupled to the mold 102. In some exemplary embodiments, a fully formed prosthetic mold assembly can include both the mold 102 and the moldable material, which can then be coupled to the footplate 100. Alternatively, the fully formed prosthetic mold assembly can be coupled to a brace or any other suitable means to provide support for the user/patient.
The enclosure system 150 can be removed and additional material 160 can be optionally added to a top of the appendage mold 102 and the moldable material 103 to enclose and secure the interface between the mold 102 and the material 103. The additional material 160 can be any suitable material. In some exemplary embodiments, the additional material 160 can be a heat moldable film, film, canvas, or any other suitable material that can be coupled to the mold 102 and moldable material 103. In an exemplary embodiment, a padded film 160 having a pre-applied adhesive can be used to easily couple the various components together. The additional material 160 can allow for a final prosthetic component assembly to be formed while also providing additional padding for the user's anatomy. It should be understood that while this present disclosure primarily relates to molds for foot appendages, the method and apparatus of the present disclosure can be applied to other appendages as well.
While the invention has been described above in terms of specific embodiments, it is to be understood that the invention is not limited to these disclosed embodiments. Upon reading the teachings of this disclosure many modifications and other embodiments of the invention will come to mind of those skilled in the art to which this invention pertains, and which are intended to be and are covered by both this disclosure and the appended claims. It is indeed intended that the scope of the invention should be determined by proper interpretation and construction of the appended claims and their legal equivalents, as understood by those of skill in the art relying upon the disclosure in this specification and the attached drawings.
This application claims priority to U.S. Provisional Patent Application No. 63/331,468 filed 15 Apr. 2022, to the above-named inventor, and is herein incorporated by reference in its entirety.
Number | Date | Country | |
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63331468 | Apr 2022 | US |