CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit U.S. Provisional Patent Application Serial No. 62/575,810, filed October 23, 2017 which is hereby incorporated in its entirety herein by reference.

FIELD

[0002] The invention relates to manufacturing methods for three dimensional parts and in particular to three dimensional printing methods and parts produced by the manufacturing method.

BACKGROUND

[0003] The statements in this section merely provide background information related to the present disclosure and may or may not constitute prior art.

[0004] Prosthetic limbs typically include a residual limb socket and a distal prosthetic component. The prosthetic socket is the portion of the prosthesis designed to fit on the residual limb, retain the residual limb securely, and mount the distal prosthetic component. If the prosthetic socket does not fit to the residual limb properly, the patients comfort will inevitably be compromised thus resulting in an unusable prosthetic.

[0005] Recent improvements in the manufacture of prosthetic sockets have greatly enhanced the comfort and fit of the socket to the residual limb. However, most of the improvements have come at a high cost by using expensive materials and time consuming manufacturing techniques. For example, many high quality prosthetics include carbon fiber for greatly improved strength. A carbon fiber socket uses manufacturing techniques that includes taking a cast of the residual limb, making a mold from the casting, and combining the carbon fiber and resin around the mold. This technique is not only time consuming but it is also very expensive as the result of the materials used to provide strength and rigidity. The cost and complexity of this manufacturing process easily puts such a high quality prosthetic out of reach for many of those patients that may benefit from such an improved prosthetic.

[0006] Even more recently, three dimensional printing or additive printing technology has evolved into providing very accurate printed parts in a quick and efficient manner at a low cost. A three dimensional print of a prosthetic socket starts with only a dimensional scan of the residual limb and a conversion to a CAD model of the socket. A "hard copy" of the CAD model is reproduced by the three dimensional printing device and fit with the distal prosthetic component for a near perfect fit to the residual limb. However, while the comfortable fit is one requirement for the socket, high strength is another. The current state of three dimensional printing of lightweight thermoplastic parts does not provide the high strength required by prosthetic sockets in heavy or medium duty applications. Furthermore, if a high strength socket is provided, the socket design required thicker materials and is much heavier and less comfortable for the patient. Thus there is a trade-off between strength and weight. Eventually, even in light duty application, three dimensional printed prosthetic sockets fail at much quicker in service. Therefore, the technique fails to provide as large of a benefit as possible.

[0007] While current viable prosthetic manufacturing techniques provide high quality prosthetic limbs, there is a need for a method that provides a prosthetic socket having improved strength, comfort, cost, and timing.

SUMMARY

[0008] The present disclosure provides a prosthetic socket for a prosthetic limb, the prosthetic socket comprising a socket body and a first structural member. The socket body comprises a distal end and a top edge opposite the distal end. The distal end comprises a prosthetic component attachment mechanism. The first structural member comprises a first straight portion, a second straight portion, and a first arch portion. The first structural member is disposed on an exterior surface of the socket body.

[0009] In one example of the present disclosure, the first straight portion of the first structural member comprises a first end fixed to a second end of the second straight portion of the first structural member. A third end of the first arch portion is fixed to a fourth end of the first straight portion. A fifth end of the first arch portion is fixed to a sixth end of the second straight portion of the first structural member.

[0010] In another example of the present disclosure, the socket body further comprises a medial fin disposed on the top edge of the socket body. The first arch member of the first structural member is disposed on the medial fin of the top edge of the socket body.

[0011] In yet another example of the present disclosure, the socket body further comprises a second structural member having a third straight portion, a fourth straight portion, and a second arch portion. The second structural member is disposed on a lateral exterior surface of the socket body.

[0012] In yet another example of the present disclosure, the third straight portion of the second structural member comprises a seventh end fixed to an eighth end of the fourth straight portion of the second structural member. A ninth end of the second arch portion is fixed to a tenth end of the third straight portion. An eleventh end of the first arch portion is fixed to a twelfth end of the fourth straight portion of the second structural member.

[0013] In yet another example of the present disclosure, the socket body further comprises a lateral fin disposed on the top edge of the socket body. The second arch member of the second structural member is disposed on the lateral fin of the top edge of the socket body.

[0014] In yet another example of the present disclosure, a first cross section of the socket body includes a first wall thickness from about 0.1 mm to about 20mm.

[0015] In yet another example of the present disclosure, a second cross section of the first structural member includes a second wall thickness from about .25mm to about 100mm.

[0016] In yet another example of the present disclosure, the socket body further comprises a posterior edge and an anterior edge, the posterior edge is disposed on the top edge connecting the medial fin with the lateral fin, the anterior edge is disposed on the top edge opposite the posterior edge connecting the medial fin to the lateral fin, and the posterior edge and anterior edge have a scalloped shape.

[0017] In yet another example of the present disclosure, the socket body further comprises an interior surface having a negative shape of a residual limb of a wearer.

[0018] The present disclosure also provides a method of manufacturing a prosthetic socket for a wearer. The method includes a first step of creating a CAD model of surface data of a surface of a residual limb of the wearer. A second step includes converting the CAD model of surface data into a CAD model of volume data of the socket body by adding wall thickness to the CAD model of surface data. A third step includes adding a CAD model of volume data of a medial structural member and a lateral structural member to the CAD model of volume data of the socket body resulting in a CAD model of volume data of the prosthetic socket. A fourth step includes converting the CAD model of volume data of the prosthetic socket to a three dimensional print path file. A fifth step includes printing the three dimensional print path file using a three dimensional printer.

[0019] In one example of the present disclosure, another step of the method includes adding a CAD model of volume data of a distal end to the CAD model of volume data of the prosthetic socket.

[0020] Other examples and advantages of the invention will be explained in further detail by reference to the following description and appended drawings. DRAWINGS

[0021] The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.

[0022] FIG. 1 is a lateral view of a prosthetic socket for use in a prosthetic limb according to the principles of the present invention;

[0023] FIG. 2 is a perspective view of a prosthetic socket for use in a prosthetic limb according to the principles of the present invention;

[0024] FIG. 3 is a perspective view of a prosthetic socket for use in a prosthetic limb according to the principles of the present invention;

[0025] FIG. 4 is a front cross section of the prosthetic socket, as shown in FIG. 2, for use in a prosthetic limb according to the principles of the present invention;

[0026] FIG. 5 is a top cross section of a prosthetic socket, as shown in FIG. 3, for use in a prosthetic limb according to the principles of the present invention;

[0027] FIG. 6 is a front view of a structural member of a prosthetic socket according to the principles of the present invention;

[0028] FIG. 7 is a perspective view of a structural member of a prosthetic socket according to the principles of the present invention;

[0029] FIG. 8 is a top view of a structural member of a prosthetic socket according to the principles of the present invention; and [0030] FIG. 9 is a flowchart containing the steps of a method of manufacturing a prosthetic socket according to the principles of the present invention.

DETAILED DESCRIPTION

[0031] The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses.

[0032] Referring to FIGS. 1 -3, a prosthetic socket of a prosthetic limb is illustrated and will now be described. Generally indicated by the reference number 10, the prosthetic socket 10 includes a medial fin 12, a lateral fin 14 (shown more clearly in FIG. 2), a posterior edge 16, an anterior edge 18, a socket body 20, a distal end 22, a medial structural member 24, a lateral structural member 26, an interior surface 28, and an exterior surface 30. More particularly, the medial fin 12, lateral fin 14, posterior edge 16, and anterior edge 18 combine to form a circumferential top edge 32 of the prosthetic socket. The height of the medial fin 12 and lateral fin 14 extends beyond the posterior and anterior edges 16, 18 which have a convex or scalloped shape. The medial 12 and lateral fins 14 have a top edge that generally follows a radius R curvature. The distal end 22 of the prosthetic socket 10 includes and attachment mechanism 25 for fixing a distal prosthetic component (not shown) to the prosthetic socket 10.

[0033] The shape of the interior surface 28 of the prosthetic socket 10 is generally a negative impression of a residual limb of a patient. Thus the interior surface 28 is tailored to the shape of the residual limb. There are several methods available to provide an interior surface 28 that is fitted to the particular patient's residual limb. One method in particular that is contemplated by this invention is to create a CAD model based on a scan of the residual limb. The scan is completed using a laser based scanning device, however, other types of devices made for taking measurements of objects have been considered by the present invention. Once the CAD model is generated from the scan of the residual limb, the interior surface 28 is created from the CAD model.

[0034] Regarding the design of the exterior surface 30 of the prosthetic socket 10, two major design considerations are weight and strength. As in most cases, when contemplating a particular material there is an inverse relationship between weight and strength. While the interior surface 28 of the prosthetic socket 10 is tailored to the shape of the residual limb, the shape of the exterior surface 30 is partially based on the shaped of the interior surface 28 and partially based on the forces applied to the prosthetic socket 10. In general, the forces that act on the prosthetic socket 10 are from two sources; the residual limb and the distal prosthetic component (not shown).

[0035] As stated above, the prosthetic socket 10 also includes a medial structural member 24, a lateral structural member 26. The structural members 24, 26 are defined by a raised portion of the outer surface 30 having a distinctive shape of a triangle 32 with two straight members 34 and an arch member 36. The arch member 36 of the medial structural member 24 is disposed on the prosthetic socket 10 such that the arch member 36 is co-located with the medial fin 12. Likewise, the arch member 36 of the lateral structural member 26 is disposed on the prosthetic socket 10 such that the arch member 36 is co-located with the lateral fin 14. The two straight members 34 of each of the structural members 24, 26 connect with the arch member 36 at the anterior and posterior ends 38, 40 of the arch members 36.

[0036] Turning now to FIGS. 4 and 5, cross sections of the prosthetic socket 10 of FIGS. 2 and 3 are illustrated and will now be described. As stated above, the design of the exterior surface 30 of the prosthetic socket 10 is based on minimizing the weight of the prosthetic socket 10 while also meeting specific strength requirements. In order to minimize weight, the wall thickness Ti between the interior surface 28 and exterior surface 30 in areas that do not include the medial and lateral structural members 24, 26 range from about 0.1 mm to about 20mm. Alternatively, the wall thickness T2 of the structural members 24, 26 between the interior surface 28 and exterior surface 30 range from about .25mm to about 100mm.

[0037] Referring now to FIGS. 6-8, an example of the medial and lateral structural members 24, 26 are illustrated and will now be described. The structural members 24, 26 include a pair of straight members or sides 34 and an arch member 36. The arch member 36 includes a posterior end 38 and an anterior end 40. The pair of straight members 34 each include a distal end 42 and a proximal end 44. The distal ends 42 of the straight members 34 are fixedly connected. The proximal end 44 of one of the straight members 34 is fixedly connected to the posterior end 38 of the arch member and the proximal end of the other of the straight members 34 is fixedly connected to the anterior end 40 of the arch member 36. The depth or thickness T2 of the structural member 24, 26 range from about .25mm to about 100mm. In one example of the present invention, the structural members 24, 26 are a continuous one-piece member. However, other examples may consider several separate members of the structural members 24, 26 without being outside the scope of the present invention.

[0038] Turning now to FIG. 9, a flowchart is shown illustrating the steps of a method 100 of manufacturing the prosthetic socket 10 previously described. The method includes a first step 102 of making a CAD model of the surface of a residual limb of a patient that is being fitted with a prosthetic limb. The CAD model can be created by using a surface scanning tool that uses a laser measuring device to convert the surface of the residual limb into digital surface data. A second step 104 converts the CAD model of the surface data into a volume model by adding wall thickness data. A third step 106 adds a scaled digital version of the medial structure member 24 and the lateral structured member 26 to the volume model through adding additional wall thickness in the portions of the volume model that represent the structural members 24, 26. A fourth step 108 checks the resulting volume model for voids or other inconsistencies. A fifth step 1 10 converts the volume model to a three dimensional printing path file. A sixth step 1 12 commands a three dimensional printer to print a prosthetic socket 10 using the three dimensional printing path file. [0039] The description of the invention is merely exemplary in nature and variations that do not depart from the spirit of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.