Prosthetic socket and methods of manufacture and use

Abstract

The present disclosure relates to a prosthetic socket for coupling a prosthetic to a stump. The socket includes a tapered cup dimensioned to engage and couple to the stump and a base to secure the socket to the prosthetic limb. The socket may be thermoformed directly onto the stump such that the socket may be heated and formed when secured to the stump.

Description

[0001] This application is a divisional application of Chinese invention patent application No. 201980017614.1, whose application date is March 4, 2019 and whose invention name is "Prosthetic Socket and Manufacturing and Use Methods". Technical Field

[0002] The present disclosure relates generally to sockets for prosthetic limbs and, more particularly, to prosthetic sockets having improved conformability to a residual limb. Background Art

[0003] Prosthetic sockets for amputated limbs are usually precisely and tightly fitted to the residual limb to support the patient's weight previously placed on the now lost limb, dispersing the forces from the severed bone ends and bony prominences and distributing them to the soft parts of the residual limb. Fitting the prosthetic socket to the residual limb is performed by an experienced prosthetist (as prosthetists are called), and usually requires a high degree of training and experience. The conventional process for making such a socket requires casting the residual limb, making a negative form by wrapping it with casting plaster (similar to making a fracture cast), and then filling the form with plaster to make an accurate positive model of the residual limb.

[0004] The orthotist must carefully assess the residual limb, alignment, stance, and sensitivity, and determine the appropriate load-bearing characteristics of the socket. Typically, the circumference of the entire model must be reduced to some extent to achieve a properly tight fit. In some areas, the model is enlarged or material is added to create capsules that reduce contact with sensitive areas of the residual limb. Using abrasive files, sandpaper, and scraping tools, the orthotist manually adjusts the diameter and shape of the model in an imprecise manner to approximate a shape that is assumed to be appropriate for the expected outcome. Some orthotists use computer scanning and manipulation to achieve this, but the process is still based on experience and is imprecise.

[0005] After the model shaping process is completed, the socket is created by heating high temperature thermoplastics and shaping them onto the model using complex and time-consuming techniques. Typically, more than half of the required material becomes debris and must be disposed of. In many cases, the socket is made of fiberglass and a toxic two-part resin. The resin must be cured and forms a very hard socket that can only be modified by grinding away material. These sockets are finished on the edges and surfaces using time-consuming and tricky methods and then trial-fitted to the residual limb. Because the model shaping process is imprecise and based on estimation, the socket often has to be adjusted several times in a time-consuming manner for a proper fit, requiring several visits to the orthotist and time-consuming techniques to make the adjustments.

[0006] This entire complex process requires a large workshop with expensive machinery, ventilation equipment, and extensive raw material inventory, making it impractical to manufacture the socket in a hospital or off-site. Many orthotists only perform the initial casting and final fitting process because they do not have adequate workshop space and must dispatch to a socket fabrication service, further complicating the process and increasing costs. Often, it is determined that the socket was not fabricated properly, and the entire process must then be started over again.

[0007] In the case of recent amputees, the residual limb is very sensitive and, over a period of several months, can significantly shrink and contract, change shape and form callus. During this time, a temporary "trial" socket is made using the above process, however, often using less durable materials because the socket will only be worn for a short period of time before a subsequent one made from scratch is needed. This process can be repeated three to five times, depending on the amputation and the condition of the amputee, thereby significantly increasing the time, effort, waste, office visits, travel and overall required effort involved.

[0008] The process is very stressful for the amputee. It is painful, time consuming and often requires long distance travel. Waiting for adjustments to be made can take hours and days. The amputee must often make several trips to the orthotist and wait days or weeks for the socket to be completed. The process of making adjustments is limited, and therefore if the orthotist is unable to adequately adjust the socket to achieve the desired result, the entire process must be repeated. The amputee must then get used to wearing the new socket, which can involve weeks of pain, and the ultimate prognosis is unknown until comfort is achieved.

[0009] Cost is another serious consideration. Insurance that will cover a prosthesis can be extremely limited and will not pay for another prosthesis for several years, even if the current one does not work well. For orthotists, insurance reimbursement is often based on the approved amputation and a one-time fee for the device. There is no reimbursement for the number of times the prosthesis must be made and adjusted, and therefore the orthotist loses profit each time the patient returns. The process is so laborious that amputees often endure months or even years of awkward fitting, chronic pain, and use / walking challenges before undergoing the process again.

[0010] To improve upon the challenges of conventionally fabricating sockets described previously, attempts have been made in the past to mold low temperature thermoplastic sockets directly onto the residual limb. These methods have not been widely accepted or used by orthotists. Low temperature thermoplastic materials such as polycaprolactone have been used. Such materials can be formed at conditions between 120°F and 180°F (50°C to 80°C). They are typically heated in hot water and can be applied directly to the skin. These materials do not have sufficient strength and rigidity to withstand the rigors of weight bearing and the abuse of walking. These materials also tend to become very difficult to work with because they become clay-like, extremely sticky, and very difficult to mold tightly to the limb when heated. Therefore, sockets made from these materials are inadequate and inappropriate. Although these sockets are occasionally used as temporary sockets, they are not generally used as permanent sockets.

[0011] Other currently used sockets have a hard, supportive outer shell made in a conventional manner and a softer, low-temperature, direct-on-body thermoformed liner. Although these sockets can be fully functional, they still require the same time-consuming steps necessary to make a rigid, outer socket made of high-temperature thermoplastics or fiberglass, and must be customized using molds and models as described above. Additional steps are required to mold the inner soft, non-supportive liner using a direct-on-body thermoforming process. If the outer hard socket is not properly formed and assembled, the inner soft liner will not be able to fully accommodate residual limb adjustment.

[0012] The readily available low temperature thermoplastics used in the above methods are typically polycaprolactone or derivatives. This is because the plastics industry has only recently developed thermoplastics that can be easily thermoformed at temperatures between 200°F and 300°F (between about 93°C and 150°C) and have adequate physical properties. Temperatures above 300°F are impractical because even with an insulating liner, the residual limb would be burned by the hot material applied to the body. It should be noted that physical properties for the prosthetic socket with respect to durability, elongation, crack resistance and stiffness have until recently only been achieved using materials thermoformed above 350°F (about 176°C) or using glass fibers and / or carbon fibers impregnated with resin.

[0013] Previously described methods of thermoforming a socket directly to a residual limb have been largely unsuccessful and therefore have not gained popularity in the marketplace. Summary of the invention

[0014] The present disclosure describes a prosthetic socket for a severed limb that is formed directly to the patient's residual limb using a patented material that is made flexible and retractable by dry heat. This eliminates the process of casting the residual limb along with the model making, and significantly reduces the number of steps required to make the socket. Direct forming also reduces the current imprecise hand grinding and shaping methods used to adjust the model in addition to forming the final high temperature plastic or fiberglass / resin socket to the model. The socket according to the present disclosure utilizes the residual limb to shape the socket and create a precise, tight fit. The present disclosure describes innovative features, materials and methods that will allow orthotists to quickly and efficiently heat form a prosthetic socket directly to a residual limb, the prosthetic socket having a precise, tight fit, durability, lightweight, reshapeability, and saving time, materials and costs.

[0015] The receiving cavity according to the present disclosure is formed of a patented thermoplastic material that allows the receiving cavity to be thermoformed at higher temperatures than previously used. During the forming of the receiving cavity, a prosthetic liner is worn on the limb, and the prosthetic liner is thick enough and insulated to protect the residual limb from the higher temperatures. The amputee basically wears such a liner to protect the residual limb and to keep the receiving cavity firmly held to the residual limb. The liner may, for example, include a retractable colloid with an outer elastic fabric lining. The colloid may include silicone, polyurethane, or other similar materials that are compatible with the skin and will be firmly held to the limb with circumferential tightness. Various attachment members can be used to hold the liner to the receiving cavity, and the receiving cavity according to the present disclosure can be compatible with such attachment members. Other suitable types of insulation may include cotton-containing fabric linings, various foams, and other sufficiently insulating materials.

[0016] Thermoplastic materials formed under higher temperature conditions can be chemically engineered to have improved physical properties over those used in previous lower temperature methods (e.g., such as those previously described herein). Prosthetic legs, for example, will be subjected to thousands of steps, high body weight, running, jumping, and other movements that exert considerable forces on the socket and on the attachment of the socket to the replacement prosthetic leg. Prosthetic arms, although not weight-bearing, will also require a very strong structure. A viable socket must have excellent stiffness, elongation, impact resistance, crack growth resistance, and creep resistance in order to be durable enough for these stringent requirements. Polymer Science currently provides plastics that can be thermoformed under temperature conditions far higher than previously attempted, but the temperatures are lower than those used for conventional prosthetic sockets.

[0017] The present disclosure describes methods of making a socket using a thermoplastic that becomes ductile, stretchable and formable under conditions of a higher temperature range, such as, for example, between about 225°F and 275°F (between 107°C and 135°C) (target heating range). This temperature range is new and desirable because it is the highest range that can be comfortably and safely formed to a residual limb with an insulating gel as previously described. This temperature range is also significantly higher than previously attempted and therefore, the thermoplastic can have sufficient stiffness, elongation, impact resistance, crack growth resistance and creep resistance to be sufficiently durable. Various additives can be included in the higher temperature thermoplastic to increase strength, including but not limited to carbon fibers, aramid fibers, glass fibers, glass microbeads, carbon nanotube beads, and others.

[0018] The receiving cavity according to the present disclosure is formed by injection molding. A variety of suitable sizes and shapes are provided, which correspond to various common residual limb sizes. When the receiving cavity is sized by the orthotist, the circumference of the receiving cavity will be smaller than the circumference of the residual limb, so that the receiving cavity can be stretched for a tight fit. In various embodiments, the receiving cavity can be obtained by injection molding of a single polymer type, or a secondary overmolding process can be used to combine (co-join) two different polymers to provide features that vary in different places. For example, the upper portion of the receiving cavity can be made of such a polymer that the polymer becomes more formable within the target temperature range, so that the polymer can be easily formed to the details of the limb.

[0019] In various embodiments, the lower portion of the receiving cavity includes a polymer that is not as formable as the upper portion within the target thermal range. When the upper portion is stretched to attach to the limb and the limb is forced downward into the receiving cavity, the lower portion can provide a more supportive area for the base of the receiving cavity when heated. However, the lower portion will also conform to the residual limb to a certain extent. The lower portion can also be such a material that has a higher forming temperature and therefore can have even better physical properties to adapt to the higher forces applied to the base of the receiving cavity and to the attachment portion to the prosthesis. The lower portion is also required to maintain its shape when heated so that the connection portion to the prosthesis and other key features will not deform during the heating and forming process. In addition, the receiving cavity may include a third polymer section at the base that does not become ductile under the target temperature range conditions, thereby maintaining its characteristics just during heating and forming. This part can also be overmolded or attached to the upper receiving cavity section by fasteners.

[0020] In various embodiments, complex and detailed features can be molded into the receiving cavity by, for example, injection molding to achieve various effects. The composition or thickness of the polymer material can be varied to precisely provide increased support or stronger formability as desired. Three-dimensional elements can be used to provide support and strength, such as ribs, tapered sections, wrinkles, mesh reinforcements, etc. For below-knee amputations, for example, additional attention may be paid to the areas near the ends of the tibia and fibula during shaping so that the receiving cavity provides additional space in these areas. These areas can be made thinner and therefore easier to expand and shape. Adjacent areas may have ribs to provide more support and strength.

[0021] After the socket is formed to the amputee, the top must be trimmed and smoothed. This can be efficiently performed by heating the top portion with a heat gun and using shears to cut the top to the preferred height and shape. A hand-cranked electric grinder can be used to smooth the top edge. Spot heat can be applied to adjust the top edge to flair outwards and tighten other parts to the limb. These tools can be portable and can produce only a small amount of grit and dust that can be easily contained and cleaned.

[0022] At any time, due to the low temperature formability of the polymer, a forced air heat gun can be used to locally heat the socket, which is often when the socket is worn by the amputee. Pressure can be applied and adjustments can be made quickly in a precise manner. In addition, if the shape of the socket proves to be dysfunctional, the entire socket can be reheated and quickly and accurately reshaped. This can prove to be particularly valuable in situations where muscles atrophy or change over time. Unlike starting the traditional process again by discarding the socket and molding a new one (socket), the reheating and reshaping process saves a lot of time, materials and expenses. The time required for shaping and finishing the socket of the present invention will be, for example, less than two hours and can be completed while the person is sitting. Compare this with the many hours, steps, drying and curing time, finishing and adjustment time required for traditional sockets that can take days or weeks. The benefits to orthotists and amputees are considerable.

[0023] Conventional processes for making sockets require a great deal of attention to the base of the socket, where the locking mechanism for the socket is connected to the gel liner. In addition, the metal connection to the leg extension or arm extension must be built into the base in a sturdy manner. Typically, a large inventory of various locking mechanisms and attachment components must be maintained to meet the various needs of the prosthesis. It takes a great deal of skill, knowledge, and time for the orthotist to manually build these devices into the base of the socket. In various embodiments, injection molding of the socket allows elements or physical features to be added to the socket, such as the base, adjustment portion, and locking mechanism. For example, the elements used by the locking mechanism of the prosthesis can be modular, interchangeable, and able to be quickly inserted into the base of the socket, so that the orthotist can simply pick the type of locking mechanism and attach any number of connectors for the leg extensions in minutes.

[0024] The precision injection molding process can also allow the base of the socket to include an adjustment mechanism for attaching the prosthesis. Typically, the prosthesis must be offset horizontally from the center of the bottom of the socket so that the socket is properly aligned for optimal use, gait and balance. The socket may, for example, include an attachment member for the prosthesis, which uses four ordinary flat head bolts that are conventionally used to attach a metal base plate. The base plate is attached to the prosthesis in an angularly adjustable manner. By loosening the four bolts, the base plate can be slid and adjusted in a flat horizontal manner to offset the prosthesis as desired. Tightening the four bolts locks it in place. This feature supplements the easy adjustability of the thermoformable socket by providing immediate alignment, thereby saving time, material and cost for amputees and orthotists. In addition, angular adjustment can be achieved by a ball-and-socket type connection to the lower base, which can be loosened, rotated and tightened.

[0025] The disclosed method of forming a socket can significantly reduce the equipment required to assemble and finish the socket. For example, a heating pack smaller than 2' x 1' x 6" is simply plugged in and can be securely held due to its insulating properties. In addition, a handheld heat gun is small, inexpensive, and convenient. The tools required by the disclosed method may include gloves, elastic bands, vacuum bags, etc., which are relatively small and portable. The equipment required to cut and finish the top of the socket is also handheld, plug-in, and portable. All of the tools required to assemble and finish the exemplary embodiment of the invention can be assembled into a suitcase, making the system portable, non-toxic, and relatively clutter-free. This allows orthotists in small offices, hospitals, and clinics to assemble and finish the socket themselves in less than two hours. The system can also be mobile, allowing orthotists to visit homes and hospitals to provide finished sockets. The potential in rural areas and developing countries is enormous.

[0026] Sockets made in accordance with the present disclosure can significantly improve the efficiency and outcome of making prosthetic sockets for amputees and allow for rapid adjustment and reshaping to achieve the best possible fit, comfort, and function.

[0027] A prosthetic socket according to the present disclosure may include: a conical cup body, the conical cup body comprising a material having a first flexibility under conditions between about 160°F and about 302°F (between about 70°C and about 150°C) to be attached to a residual limb and stretched circumferentially; a lower portion, the lower portion being connected to a lower surface of the conical cup body in the form of an enclosure, having a second flexibility, the second flexibility being less than the first flexibility; and a base connected to the lower portion, wherein the conical cup body and the lower portion are injection molded from a thermoplastic polymer, wherein the conical cup body and the lower portion when heated to between about 160°F and about 302°F (between about 70°C and about 150°C) have a working time between about five minutes and about 15 minutes before hardening close to room temperature, and wherein the conical cup body and the lower portion each include a hardness exceeding 50D Shore hardness of ASTM D2240, a tensile strength exceeding 5,000 psi of ASTM D638, and a tensile strength exceeding ASTM D638. D5023 has a flexural modulus of 150,000 PSI.

[0028] The conical cup body and the lower part may be integral. In addition, at least one of the conical cup body and the lower part may be injection molded, and the other of the conical cup body and the lower part may be overmolded. The thermoplastic polymer of the conical cup body may include at least one additive from the group of glass fibers, carbon fibers, aramid fibers, glass beads and carbon nanotubes. The base may include a fixing element.

[0029] The receiving cavity may also include an inlay, which includes rubber, polyurethane, estan (estan polyurethane elastic fiber), spandex, and long chain polymers. The inlay can be insert-molded into the conical cup body and can cause the heated conical cup body to become elastic and attached to the residual limb and tightened circumferentially when it is applied and formed. The receiving cavity may also include a thin outer layer surrounding at least a portion of the conical cup body, and the outer layer can be co-molded or adhered to the outer surface of the receiving cavity. Such an outer layer can provide body and support for the heated receiving cavity and can be colored, printed or decorated. The receiving cavity may also include an insulating layer, which is attached to the residual limb and fixed in the conical cup body. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The features and advantages of the present disclosure will become more apparent from the detailed description set forth below when taken in conjunction with the accompanying drawings, in which:

[0031] Figure 1 illustrates a side view of a prosthetic socket according to the present disclosure;

[0032] Figure 2 The diagram according to the present disclosure Figure 1 A stereoscopic view of the prosthetic socket;

[0033] Figure 3 The diagram according to the present disclosure Figure 1 and Figure 2 An exploded view of the prosthetic socket;

[0034] Figure 4 The diagram according to the present disclosure Figure 1-3 Another stereoscopic view of the prosthetic socket;

[0035] Figure 5 FIG. 1 shows an offset configuration according to the present disclosure. Figure 1-4 A stereoscopic view of the prosthetic socket;

[0036] Figure 6 The diagram according to the present disclosure Figure 1-5 A cut-away side view of a prosthetic socket;

[0037] Figure 7 FIG. 1 is a side cutaway view of another prosthetic socket according to the present disclosure;

[0038] Figure 8 illustrates a side cutaway view of still another prosthetic socket according to the present disclosure;

[0039] Fig. 9 illustrates a side view of a prosthetic socket according to the present disclosure;

[0040] Fig.10 The diagram according to the present disclosure Fig. 9An exploded view of the prosthetic socket;

[0041] Fig.11 FIG. 1 shows an offset configuration according to the present disclosure. Fig. 9 and Fig.10 Side view of the prosthetic socket;

[0042] Fig.12 FIG. 1 shows an offset configuration according to the present disclosure. Fig. 9 and Fig.10 A stereoscopic view of the prosthetic socket;

[0043] Fig.13 FIG. 1 shows an offset configuration according to the present disclosure. Fig. 9 and Fig.10 a side cross-sectional view of a prosthetic socket; and

[0044] Fig.14 A perspective view of a prosthetic socket and an insulating cover according to the present disclosure is shown. DETAILED DESCRIPTION

[0045] It will be readily understood by those skilled in the art that the various aspects of the present disclosure may be implemented by any number of methods and articles configured to perform the intended functions. In other words, other methods and articles may also be incorporated herein to perform the intended functions. It should also be noted that the drawings mentioned herein are not all drawn to scale, but are exaggerated to illustrate different aspects of the present disclosure, and in this regard, the drawings should not be interpreted as limiting. Finally, although the present disclosure may be described in conjunction with various principles and viewpoints, the present disclosure should not be defined by theory.

[0046] A prosthetic socket according to the present disclosure is used to secure a prosthesis to a patient's residual limb. In many cases, the orthotist and the patient select a suitable liner to be applied to the residual limb. The liner reduces discomfort (such as chafing or tenderness) between the skin of the residual limb and the socket. The liner also has a very high friction interior that adheres / attaches to the skin to keep it in place during movement, and the liner has a variable connection device to the socket. The socket is applied to the liner, and the socket is used to support and suspend the prosthesis to the patient's residual limb. In other words, the liner is positioned between the residual limb and the socket, and the actual prosthesis is connected to the socket.

[0047] In various embodiments, the receiving cavity includes an upper portion and a lower portion. In some embodiments, the upper portion has a first flexibility within a given temperature range, which is greater than the flexibility of the lower portion within the same temperature range. The lower portion is used to support the receiving cavity during thermoforming but will still conform when heated. The lower portion also has an appliance for attaching the prosthesis in an adjustable manner, and the lower portion has attachment members for various mechanisms for locking the gel liner to the receiving cavity. In this case, the lowermost portion that performs this function is not heated, so the lowermost portion retains its shape and mechanical properties.

[0048] In still other embodiments, the lower portion includes a middle portion and a base, the base including a polymer that does not become ductile at all within the same temperature range in which the upper portion and the middle portion become ductile. The upper portion interacts with and surrounds the residual limb (including a substrate in most cases). The middle portion is co-molded to the upper portion and is used to support the receiving cavity during thermoforming, but will still conform when heated and be mechanically attached to the base. The alignment of the base is adjustable, and the base acts as an attachment portion for the prosthesis that connects the prosthesis to the receiving cavity (and then to the patient's residual limb). The receiving cavity according to the present disclosure includes an upper portion (referred to as a conical cup) having improved flexibility, comfort and / or engagement with the residual limb. In still other embodiments, the receiving cavity is made of a single material that is flexible when heated, similar to the upper portion previously described. The receiving cavity is heated in a manner that causes the upper portion to be heated more than the lower portion. In this way, the upper portion will be more flexible, the middle portion will be moderately flexible, and the base will still be rigid during the forming process, maintaining its mechanical shape and properties.

[0049] Initial reference Figure 1 and Figure 2 , a prosthetic socket 100 according to the present disclosure is illustrated. In various embodiments, an upper portion of the socket 100 includes a conical cup 102. The conical cup 102 is coupled to a lower portion 105.

[0050] The conical cup 102 is sized and configured to engage the residual limb, securing the socket 100 to the limb. Basically, the liner is positioned around the outside of the residual limb. In such embodiments, the conical cup 102 of the socket 100 surrounds the liner. As noted, the liner can help reduce chafing and discomfort between the residual limb and the conical cup 102 and secure them together. After the conical cup 102 is positioned around the residual limb and secured to the residual limb, the prosthesis can be attached to the socket 100.

[0051] In various embodiments, the conical cup 102 comprises a polymer material. For example, the conical cup 102 can be injection molded from a polymer material. The conical cup 102 can, for example, include a polymer material having a hardness exceeding 70D Shore hardness of ASTM D2240, a tensile strength exceeding 7,000 psi of ASTM D638, and / or a flexural modulus exceeding 250,000 PSI of ASTM D5023. Although described with reference to specific materials and methods of forming the materials, any type of polymer material and method of making a suitable conical cup is within the scope of the present disclosure.

[0052] The conical cup 102 may also include, for example, a polymer material having a pliability between about 160°F and about 302°F (between about 70°C and about 150°C), and further between about 225°F and about 275°F (between about 107°C and about 135°C). In various embodiments, the pliability of the conical cup 102 provides a working time of between about five minutes and about 15 minutes before hardening when heated to between about 160°F and about 302°F (between about 70°C and 150°C). The pliability and working time allow the conical cup 102 to be attached to the residual limb and stretched circumferentially before the conical cup 102 cools and re-hardens.

[0053] In various embodiments, the cone 102 may include one or more additives that may be added to the polymer material to impart one or more desired physical and / or chemical properties to the polymer material. For example, the polymer material of the cone 102 may include one or more of the following: glass fibers, carbon fibers, aramid fibers, glass beads, carbon nanotubes, or other additives. Any additive that imparts or improves desired physical or chemical properties to the polymer material of the cone 102 is within the scope of the present disclosure.

[0054] The lower portion 105 includes a middle portion 104 and a base 106, which is positioned at the opposite end of the receiving cavity 100 from the conical cup 102. In various embodiments, the lower portion 105 is integral and made of a single material, so that the middle portion 104 and the base 106 are integral and complete. In other embodiments, the components of the lower portion 105, namely the middle portion 104 and the base 106, are separate and distinct from each other.

[0055] In various embodiments, the middle portion 104 of the lower portion 105 is coupled to the conical cup 102 and the base 106. Additionally, a prosthetic device, such as a prosthetic arm or leg, is attached and secured to the base 106.

[0056] In various embodiments, the lower portion 105 (which is coupled to the cone 102) can include, for example, a polymer material. In various embodiments, the lower portion 105 includes the same polymer material as the cone 102. In other embodiments, the lower portion 105 includes a different polymer material than the cone 102. For example, the lower portion 105 can include a polymer material having a second flexibility that is less than the flexibility of the polymer material of the cone 102. However, the lower portion 105 can include any suitable polymer material.

[0057] Similar to the cone 102, the lower portion 105 may comprise a polymer material having one or more additives added to the polymer material to impart one or more desired physical and / or chemical properties to the polymer material. For example, the polymer material of the lower portion 105 may include one or more of the following: glass fibers, carbon fibers, aramid fibers, glass beads, carbon nanotubes, or other additives. Any additive that imparts or improves desired physical or chemical properties to the polymer material of the lower portion 105 is within the scope of the present disclosure.

[0058] In various embodiments, the lower portion 105 is injection molded from a polymer material. For example, the lower portion 105 can be injection molded from the same material as the conical cup 102. Additionally, the lower portion 105 can be injection molded together with the conical cup 102, creating a one-piece polymeric receptacle 100. In other words, the polymeric receptacle 100 can include a "one-piece" design, wherein the conical cup 102 and the lower portion 105 (including its component parts; the middle portion 104 and the base 106) are all made together and at the same time, and are essentially a single piece.

[0059] In other embodiments, the lower portion 105 (including one or both of the middle portion 104 and the base 106) can be injection molded separately from the cone 102 and secured to the cone 102 via any suitable means of coupling the two components, including mechanical means, adhesives, or any other suitable means of coupling the two components. In other embodiments, the lower portion 105 can be overmolded such that the lower portion is formed in two parts in contact with the cone 102 after the cone 102 is injection molded.

[0060] In various embodiments, the base 106 is injection molded from a polymer material, which may or may not include the same polymer material as the polymer material forming the conical cup 102 and / or the lower portion 105 .

[0061] Initial reference Figure 3 , Figure 6 and Figure 7, the socket 100 includes a means for securing the prosthesis to the lower portion 105, and more specifically, the prosthesis to the base 106 of the socket 100. In various embodiments, the socket 100 includes a base plate 116 coupled to a locking plate 118. For example, the base plate 116 can be secured to the locking plate 118 by one or more threaded screws.

[0062] In various embodiments, the attachment member 114 can be secured to the base plate 116. The attachment member 114 can include, for example, a receptacle 138 that engages with and secures the prosthesis to the socket 100. For example, the receptacle 138 can include one of a ball or a socket configured to engage with a corresponding element in the prosthesis to secure the limb to the socket 100 in a "ball and socket" arrangement. Although described with reference to specific physical components, any physical configuration of the base plate 116 and the attachment member 114 that is capable of coupling the prosthesis to the socket 100 is within the scope of the present disclosure.

[0063] In various embodiments, the locking plate 118 can slide along the base plate 116. For example, by loosening the screws that secure the base plate 116 to the locking plate 118, the locking plate 118 can slide and change orientation relative to the base plate 116, allowing the attachment member 114 to change orientation relative to the socket 100. Figure 4 , a receiving cavity 100 is illustrated with the attachment member 114 oriented normally. In this case, "normal orientation" means perpendicular to the receiving cavity 100. In other words, the base plate 116 and the locking plate 118 are oriented in plane with respect to each other so that the attachment member 114 is perpendicular to the receiving cavity 100. Initial Reference Figure 5 , a socket 100 is illustrated having an offset attachment member 114. In other words, the base plate 116 and the locking plate 118 are oriented offset from each other (or non-planar with each other) such that the attachment member 114 is not perpendicular to (i.e., offset from) the socket 100. Such adjustment allows a prosthesis coupled to the attachment member 114 to be properly oriented relative to the patient's residual limb.

[0064] The receptacle 100 may also include, for example, a cover 124 positioned adjacent the base 106. For example, the cover 124 may be positioned at or near the bottom of the base 106 and may prevent dust or other contaminants from entering the base 106 and the receptacle 100.

[0065] In various embodiments, the receiving cavity 100 may further include a conventional locking pin 134 that couples the liner to the receiving cavity 100. In various embodiments, the locking pin 134 is secured to the receiving cavity 100 by a pin plate 130. For example, the pin plate 130 may be laterally moved about the locking pin 134 by, for example, a button 126 that engages and disengages the pin plate 130 from the locking pin 134. The locking pin 134 may, for example, include a ridge that engages the pin plate 130 so that when the locking pin 134 of the liner is inserted into the locking mechanism of the base 106, the locking pin of the liner progressively clicks lock, securing the liner to the base 106 and the receiving cavity 100. In various embodiments, the button 126 is housed within a button housing 128. Additionally, a housing cover 132 may be positioned on a side of the button housing 128 opposite the button 126. The pin plate 130 may further include a spring 136.

[0066] Initial reference Figure 8 , another embodiment of a socket 100 is illustrated. For example, the socket 100 may include a vacuum port 140 configured to apply a vacuum to a gel liner attached to the patient through a vacuum outlet 142. The vacuum port 140 may be positioned in the housing 128 (previously referred to as a button housing 128 in connection with other embodiments) and may be quickly and easily accessed by the patient and orthotist to apply or reduce suction to the socket 100, allowing the socket 100 to be secured or removed from the liner. Although described with reference to a particular physical configuration, any manner of coupling the socket 100 to a prosthetic liner is within the scope of the present disclosure.

[0067] A variety of methods of securing the socket 100 to the liner (and thus the residual limb) may be employed. For example, the following methods are also within the scope of the present disclosure;

[0068] The liner has a soft annular ridge near the bottom (not shown) that creates an airtight seal to the interior of the socket 100 and the conical cup 102. When the residual limb is pushed into the conical cup 102, air is expelled through a valve at the base 106. The liner is held tightly to the socket 100 by suction. To remove the socket 100 from the residual limb, a button is pressed, allowing air to enter the socket 100 and break the suction;

[0069] A sleeve (not shown) is placed over the top of the conical cup 102 of the socket 100, extending upward over at least a portion of the residual limb. The sleeve fits tightly to form an airtight seal between the socket 100 and the skin of the residual limb. This creates a suction force that holds the liner to the socket 100. The sleeve is rolled down the residual limb and socket 100 to break the seal, allowing the socket 100 to be removed; and

[0070] The sleeve can be used to seal the socket 100 to the residual limb in cooperation with a vacuum pump that creates a negative pressure that draws the liner into the conical cup 102 of the socket 100. These pumps can be activated manually, by walking, or by using an electromechanical pump to create suction.

[0071] The socket 100 may also include, for example, a coupling member for coupling and securing the socket 100 to a liner of the residual limb. In various embodiments, the coupling member attaches the base 106 to the liner. Such coupling members may include, for example: a clamp (e.g., a spring clamp) that engages a locking post of the gel liner; an airtight button seal that allows air to escape, is sealed, and is released for use with a suction socket retention system; and / or a hose attachment that is coupled to a vacuum source that applies negative pressure between the base 106 and the gel liner. Although described with reference to specific mechanical members, any manner of coupling the socket 100 to a prosthesis is within the scope of the present disclosure.

[0072] Initial reference Figure 9-13 In various embodiments, the base 106 is secured to the middle portion 104 via a fastening member 112. For example, the fastening member 112 may be formed into or otherwise secured to the bottom surface of the middle portion 105 or the cone 102. In various embodiments, the fastening member 112 passes through a portion of the base 106 and is secured by a corresponding member 110, holding the base 106 in place relative to the middle portion 104. For example, the fastening member 112 may include a threaded portion protruding from the middle portion 104 into the base 106. The washer 108 and the nut 110 are coupled to the fastening member 112 that secures the base 106 to the middle portion 104. Although described with reference to a particular arrangement, any manner of coupling the base 106 to the middle portion 104 or the cone 102 is within the scope of the present disclosure.

[0073] In various embodiments, the attachment member 114 can be secured to the base 106 by the fastening member 112 and the corresponding member 110. For example, the attachment member 114 can be positioned along the fastening member 112 (e.g., a threaded portion) and secured via the member 110 (e.g., a nut). Although described with reference to the various figures and specific embodiments, any manner of securing the attachment member 114 to the receiving cavity 100 is within the scope of the present disclosure.

[0074] For example, the base 106 may include a mechanical attachment member 114 for coupling components of a prosthetic arm or leg to the socket 100. In various embodiments, the attachment member 114 includes a base plate that is attached to the prosthesis by, for example, screws.

[0075] In various embodiments, the attachment member 114 can be adjusted along one or more planes or directions. Figure 6-8 , the attachment member 114 of the base 106 allows for adjustment of the positioning of the socket 100 and the prosthesis relative to each other. For example, the prosthesis can be horizontally offset from the central axis of the socket 100 so as to properly orient and position the socket 100 and the prosthesis for optimal use, gait and / or balance. In various embodiments, the attachment member 114 includes a base plate that is attached to the prosthesis in a manner that allows for angular adjustment between the base plate 106 and the prosthesis. For example, the adjustment member 114 can be bolted to the prosthesis, and loosening the bolts can allow the base plate to be slid and adjusted in a flat, horizontal manner to offset the prosthesis as desired. Tightening the bolts locks the base 106 and the prosthesis in place relative to each other.

[0076] In various embodiments, the receiving cavity 100 further comprises an inlay. In such embodiments, the inlay may be positioned within the conical cup 102 and include a material that causes the conical cup 102 to circumferentially tighten about the residual limb as it is heated and formed about the limb. In various embodiments, the inlay may include one or more of: a knitted fabric composed of elastic rubber, polyurethane, estan (estan polyurethane elastic fiber), spandex, or a long chain polymer, a mesh and / or a sheet or a perforated material. Although described with reference to specific materials, the inlay may include any material suitable for circumferentially tightening a portion of the receiving cavity 100 (such as the conical cup 102) when heated.

[0077] Additionally, the inlay may include a projection extending upwardly from the opening of the conical cup 102. In such embodiments, for example, the projection may include one or more handles that may be used to assist in pulling the socket 100 onto the residual limb during shaping.

[0078] In various embodiments, the receiving cavity 100 may further include an outer layer that surrounds at least a portion of the receiving cavity 100. The outer layer may provide a durable, smooth outer surface for the receiving cavity 100, and may be printable and / or textured for aesthetic purposes. For example, the outer layer may be co-molded or adhered to an outer surface of the receiving cavity 100 (such as, for example, an outer surface of the conical cup body 102). In various embodiments, the outer layer includes a sheet material, such as vinyl plastic, PVC, or other plastic that becomes flexible and stretchable under conditions between about 160℉ and about 302℉ (70℃ and about 150℃, and further between about 225℉ and 275℉ (107℃ to 135℃). In addition, the outer layer may have a thickness, for example, between about 0.0050" and about 0.025" (0.127mm and 0.3157mm).

[0079] In various embodiments, the method of forming the socket 100 to the residual limb includes selecting an appropriate socket size. For example, the conical cup 102 of the socket 100 may include a circumference that is smaller than the circumference of the residual limb. In such embodiments, when the socket 100 and the conical cup 102 are heated, the material of the socket 100 becomes sufficiently flexible and retractable to allow the conical cup 102 to stretch while attached to the residual limb. As the socket 100 cools, the conical cup 102 shrinks to its pre-heated circumference, providing a circumferentially tight fit to the residual limb.

[0080] The socket 100 and the cone cup 102 may be sized using pre-sized plastic or foam cups that are used to measure the residual limb with the liner in place. For example, the cups of different sizes may include labels with corresponding suggested socket sizes having a smaller circumference than the circumference of the cup being sized so that the correct reduction ratio of the circumference of the socket 100 and the cone cup 102 is achieved after heating to produce a suitable tight fit.

[0081] In various embodiments, a space or void may be created within socket 100 to correspond to a sensitive portion of the residual limb. For example, padding such as a foam sheet, tapered gel pad, batting, or other structural form may be applied directly to the skin and placed beneath a gel liner worn by the amputee, creating additional space within socket 100 during the thermoforming process. After socket 100 cools and hardens, the padding may be removed.

[0082] The socket 100 according to the present disclosure is assembled to the residual limb by heating a portion of the socket 100 to a predetermined temperature, allowing the portion of the socket 100 to plastically deform to conform to the residual limb. In various embodiments, the socket 100 is differentially heated so that the conical cup 102 is heated to a temperature between 225°F and 275°F (107°C to 135°C), while the base 106 is still at or near room temperature. For example, referring to Fig.14 , the insulating cup 152 can be assembled to a portion of the lower section 105 (e.g., the base 106) to reduce the heat transferred to the portion of the lower section 105 and prevent any change in the shape of the portion. Suitable insulating cups 152 may include, for example, molded foam, fabric insulation padding, silicone, or any material that can sufficiently insulate a portion of the lower section 105 and withstand repeated heating cycles without degradation. After the receiving cavity 100 is sufficiently heated, the insulating cup 152 can be removed from the receiving cavity 100.

[0083] In various embodiments, the method for applying the socket 100 may further include applying an insulating covering (not shown) to an outer surface of a portion of the socket 100. For example, the insulating covering may be applied before or after heating and may apply circumferential compression to the heated section of the socket 100, such as, for example, the conical cup 102. The insulating covering may prevent heat loss from the socket 100, extend the working time of the socket 100, and allow more time to fit the socket 100 to the residual limb.

[0084] For example, the insulating cover may include a tubular or cup-shaped cover that includes a stretch insulating material (such as neoprene foam) with a stretch fabric cover (such as wetsuit material, closed-cell foam, knitted stretch fabric, spandex fabric, etc.). In addition, the insulating cover may include strappings that are applied vertically and extend above the top of the cover to provide a handle for pulling the socket onto the residual limb. After the socket 100 is properly installed on the residual limb, the insulating cover can be removed from the socket 100.

[0085] The method for applying the receiving cavity 100 may also include applying an outer sleeve around a portion of the receiving cavity 100. For example, a woven or knitted outer sleeve may be assembled around a portion of the receiving cavity 100 before or after heating. In various embodiments, the outer sleeve may apply pressure to the receiving cavity 100 so that the circumference of a portion of the receiving cavity 100 (such as, for example, the conical cup 102) decreases as the outer sleeve is vertically stretched. In such embodiments, the outer sleeve operates similarly to a Chinese finger trap. The outer sleeve may include a material woven in a diagonal pattern.

[0086] Additionally, the outer sleeve may be suspended above the socket 100 by the frame. For example, the frame may include a hoop from which the outer sleeve is suspended, in a configuration similar to a basketball hoop and net. The opposite end (e.g., the bottom end) of the outer sleeve may include a rigid ring attached to the base 106, thereby locking it to the outer sleeve. In such embodiments, after the socket 100 is heated to operating temperature, the residual limb is inserted into the socket 100, and the downward pressure applied by the residual limb causes the outer sleeve to extend vertically, causing it to compress the flexible socket 100 circumferentially around the residual limb.

[0087] In the present disclosure, the word "a", "an" or "the" is understood to include both the singular and the plural. Conversely, any reference to plural items should include the singular as the case may be.

[0088] Many features and advantages have been set forth in the previous description, including various alternatives together with details of the structure and function of the device and / or method. This disclosure is intended to be illustrative only and is therefore not intended to be exhaustive. It will be apparent to those skilled in the art that various modifications may be made, particularly with respect to the arrangement of structures, materials, elements, components, shapes, sizes, and parts, including various combinations within the principles of the present invention, within the full range indicated by the broad general meaning of the clauses to which the appended claims are expressed. These various modifications are also intended to be included herein without departing from the spirit and scope of the appended claims.

Claims

1. A prosthetic socket, comprising: The conical cup body comprises: opening for residual limb insertion, an end portion opposite to the opening for enclosing the residual limb, The conical cup is configured to stretch circumferentially around the residual limb, The conical cup body has a first flexibility that is flexible under a temperature condition between 70° C. and 150° C., The cone has a work time of between five and 15 minutes when heated to said temperature, allowing the cone to be thermoformed; and A lower part, the lower part comprising: A base has a cylindrical shape and has a second flexibility, the second flexibility being less than the first flexibility.

2. The prosthetic socket according to claim 1, wherein: The conical cup and lower portion each include a hardness exceeding 50D Shore hardness of ASTM D2240, a tensile strength exceeding 5,000 psi of ASTM D638, and a flexural modulus exceeding 150,000 PSI of ASTM D5023 at room temperature.

3. The prosthetic socket according to claim 1, wherein: The conical cup body and the lower part are integral.

4. The prosthetic socket according to claim 1, wherein: The lower portion is overmolded to the conical cup.

5. The prosthetic socket according to claim 1, wherein: The conical cup body comprises a thermoplastic polymer further comprising at least one additive from the group consisting of glass fibers, carbon fibers, aramid fibers, glass beads and carbon nanotubes.

6. The prosthetic receiving cavity as described in claim 1 further includes an embedding layer, wherein the embedding layer includes one of rubber, polyurethane, elastane, spandex, and a long-chain polymer.

7. The prosthetic socket according to claim 6, wherein: The inlay is molded into the conical cup and wherein the inlay causes the conical cup to be circumferentially tightened about the residual limb as it is applied and shaped.

8. The prosthetic socket of claim 1 further comprising an outer layer surrounding at least a portion of the conical cup.

9. The prosthetic socket of claim 8, wherein: The outer layer is coformed or adhered to the outer surface of the receptacle.

10. The prosthetic socket of claim 1, further comprising an insulating layer configured to be attached to a residual limb and secured within the conical cup.

11. The prosthetic socket of claim 1, wherein: The lower portion includes a base, and wherein an attachment member having a receptacle is coupled to the base.

12. A method for securing a prosthetic socket to a residual limb, comprising: Provided is a prosthetic receiving cavity, the prosthetic receiving cavity comprising: a conical cup body, the conical cup body comprising an opening for residual limb insertion, an end opposite to the opening for enclosing the residual limb, the conical cup body having a first flexibility that is flexible under a temperature condition between 70°C and 150°C, and the conical cup body having an operating time between five minutes and 15 minutes when heated to the temperature; and a lower part, the lower part comprising a base, the base having a cylindrical shape and having a second flexibility, the second flexibility being less than the first flexibility; heating a socket, the socket comprising a conical cup and a lower portion coupled to the conical cup, the conical cup having a first flexibility between about 70° C. and 150° C., and the lower portion being connected to the prosthesis, wherein the lower portion has a second flexibility less than the first flexibility; and The conical cup body is formed.

13. The method of claim 12, wherein: The lower portion includes a base.

14. The method of claim 13, wherein a thermally insulating cover is positioned attached to a portion of the base, wherein: The insulating cover prevents heating of the base during heating of the receptacle.

15. The method of claim 12, wherein: Prior to heating the socket, the conical cup includes a circumference that is smaller than a circumference of the residual limb.

16. The method of claim 12, further comprising sizing the conical cup of the socket by identifying the circumference of the residual limb using a sizing aid and calculating the circumference of the conical cup using a reduction factor associated with the sizing aid.

17. The method of claim 12, wherein: At least one of foam, gel or fabric is placed into the liner of the residual limb at a location that creates a corresponding void during formation of the conical cup.

18. The method of claim 12, further comprising applying an outer sleeve around a portion of the conical cup, wherein: The outer sleeve is configured to reduce the circumference of the conical cup.

19. The method of claim 18, further comprising, after heating the tapered cup, inserting the residual limb into the socket and applying downward weight, thereby extending the outer sleeve and causing it to circumferentially compress a portion of the socket onto the residual limb.

20. A prefabricated thermoplastic prosthesis receiving cavity, comprising: a conical cup body, the conical cup body comprising a pre-heating circumference that is smaller than a circumference of the residual limb; and a lower portion positioned below the cone and coupled to the cone, wherein the lower portion includes a base positioned at an end of the lower portion opposite the cone; The conical cup body and the lower part are integrally formed by injection molding. The conical cup body has a first flexibility that is flexible under a temperature condition between 70° C. and 150° C., wherein the base comprises an attachment mechanism for coupling the base to the prosthesis, wherein the conical cup has a working time of between 5 minutes and 15 minutes when heated to a temperature between 70°C and 150°C, and wherein at least one of the conical cup and the lower portion comprises, at room temperature, a hardness exceeding 50D Shore hardness of ASTM D2240, a tensile strength exceeding 5,000 psi of ASTM D638, and a flexural modulus exceeding 150,000 psi of ASTM D5023.

Images