Method of digitally constructing a prosthesis

Abstract

A prosthetic limb and process to digitally construct a prosthetic limb which includes first, digitally producing a modified mold of a residual limb via 3d scanners and software known to the industry; constructing a test socket from the digitally modified mold and be equipped with an alignable system; for example, a pylon, along with the desired prosthetic foot; accurately scanning the test socket, preferably with a 3D scanner, along with finalized alignment that has been recorded and adjusted by a certified practitioner to provide a 3-D Image of the finalized prosthetic alignment; transferring the finalized digital alignment of the test socket to the finalized digitally modified mold; once the modified model has received the transferred alignment, fabricating the type of hookup in the socket; i.e., plug fit, four hole, support drop lock, or any other type of industry standard connection or accommodation via basic 3D software; and once the desired prosthetic attachment is finalized, the next step is to send the finished file to a 3-D printer to produce the definitive prosthetic device. The 3-D printed socket would then be placed in a vibratory finishing system to smooth out the interior and exterior surfaces of the printed socket; and the walls of the 3-D printed socket would be sealed by applying a mixture of epoxy sealant, for example, TC-1614, to the inside and outside walls of the socket, and placing the socket into an oven for a sufficient amount of time to seal the walls of the socket. Preferably, the prosthesis would be printed out of Nylon 12 material or of a strong plastic, such as ULTEM, or carbon fiber, or other material of equivalent or greater strength that may be known or developed in the future.

Claims

1. A process to digitally construct a prosthetic limb, comprising the following steps: a) digitally producing a modified mold of a residual limb via 3d scanners and software; b) constructing a test socket from the digitally modified mold of the residual limb; c) equipping the test socket with an alignable system; d) aligning the test socket equipped with the alignable system and determining a finalized prosthetic alignment of the test socket; e) scanning the test socket in the finalized prosthetic alignment to provide an image of the finalized prosthetic alignment; f) transferring the finalized prosthetic alignment of the test socket to the modified mold to produce a finalized digitally modified mold; and g) printing an aligned socket based on the finalized digitally modified mold.

2. The process in claim 1, wherein the test socket is scanned with a 3D scanner in step e.

3. The process in claim 1, wherein the printed socket is constructed of Nylon 12 material, or ULTEM plastic, or carbon fiber.

4. The process in claim 1, further comprising the step, once the modified mold has received the transferred finalized prosthetic alignment, of fabricating a hookup on the finalized digitally modified mold via 3D software.

5. The process in claim 1, further comprising placing the printed socket in a vibratory finishing system to smooth the printed socket and wherein the vibratory finishing system smooths interior and exterior surfaces of the printed socket.

6. The process in claim 5, further comprising cleaning the printed socket after smoothing the printed socket.

7. The process in claim 6, further comprising the step of sealing the printed socket.

8. The process in claim 5, wherein the vibratory finishing system is a batch vibratory unit.

9. The process of claim 4 wherein the hookup provided is a plug fit, a four hole fit, or a support drop lock hook up.

10. The process in claim 7 wherein the printed socket is sealed with a high solids content epoxy penetrating sealing and coating resin.

11. The process in claim 10 wherein the high solids content epoxy penetrating sealing and coating resin is applied to inner and outer surfaces of the printed socket.

12. The process in claim 11 wherein the high solids content epoxy penetrating sealing and coating resin on the printed socket is heated to complete the sealing process.

13. The process in claim 12 wherein the high solids content epoxy penetrating sealing and coating resin is heated at 120 F for at least 10 minutes.

14. The process in claim 1, wherein after the modified mold has received the transferred finalized prosthetic alignment, further comprising a step of adjusting one or more Z lines of the finalized digitally modified mold to set desired trim lines.

15. A method of constructing a prosthesis, comprising the steps of: a) providing a digital file of a digitally modified mold of a socket in alignment; b) adjusting the digital file to ensure proper trim lines; c) sending the digital file to a 3D printer; d) printing out a socket for a prosthesis based on the digital file; and e) sealing the printed socket, wherein the printed socket undergoes a sealing process including a high solids content epoxy penetrating sealing and coating resin system, and wherein the printed socket is placed in an oven set at 120 F for 10 minutes during the sealing process.

16. The method of claim 15 wherein residual epoxy is removed after the printed socket is in the oven for 10 minutes.

17. The method of claim 16 wherein the printed socket is placed back in the oven for at least 2 hours after removal of the residual epoxy.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

(1) For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein:

(2) FIG. 1 illustrates a modified mold of a residual limb digitally produced via 3D scanners and software;

(3) FIG. 2 illustrates a carving of the modified model before it goes with the test socket to be fabricated;

(4) FIGS. 3A and 3B illustrate two views of a fabricated test socket which is hooked up to an alignment or an alignable system respectively;

(5) FIGS. 4A through 4B illustrate steps in the scanning of the test socket and the alignment, with FIG. 4C illustrating the captured alignment;

(6) FIGS. 5A and 5B illustrate the modified mold and the beginning stages of transferring alignment, illustrating the addition of the pylon;

(7) FIG. 6 illustrates the process of cross-referencing of the modified mold with the alignment attachment with the test socket with the correct alignment;

(8) FIG. 7 is the completed merge of the process illustrated in FIG. 6 to assure the correct alignment;

(9) FIG. 8 is an image of the socket after alignment has been captured and with the use of CAD software showing a four hole hookup adapted to the socket;

(10) FIG. 9 is an actual printout of the image in FIG. 8 showing the four hole hookup;

(11) FIG. 10 is a printout of the prosthesis which has a plug fit adaptor;

(12) FIG. 11 is a printout of the prosthesis which has a plug fit where a pylon or adaptor can be engaged; and

(13) FIG. 12 is a Flow Chart illustrating a preferred embodiment of the method or process of constructing a prosthetic limb through a digital format; and

(14) FIGS. 13 and 14 illustrate in Flow Chart format the steps of Smoothing the prosthetic limb (3D socket) and Sealing the prosthetic limb (3D socket) respectively.

DETAILED DESCRIPTION OF THE INVENTION

(15) FIGS. 1 through 12 illustrate a preferred embodiment of the method or process of constructing a prosthetic limb through a digital format, while FIGS. 13 and 14 illustrate in Flow Chart format the steps of Smoothing the prosthetic limb (3D socket) and Sealing the prosthetic limb (3D socket) respectively.

(16) Before reference is made to the Figures, in general, this technique of achieving a positive mold for a test socket in a digital format is by scanning the residual limb. The first step would be to choose the materials and tools needed for measuring a patient. Again, one would need to prepare suspension of the prosthesis (silicone liner, foam or other types of socket designs); a scanner; a laptop; reflective dots; measuring tools such as a length stick M/L gauge tape measure, etc. The method may vary by which Distal Device used.

(17) After preparing oneself with the items one would need to take a digital image of a residual limb, the individual would use a scanner to capture the digital image of the limb. After the limb is captured, the individual would use a prosthetic software which is already known in the art, to modify the 3-D image or positive mold to achieve its relief and pressure points in precise locations. In essence one would modify the residual limb with the same basic techniques that are taught and used in the pre-scanner era or plastic molds.

(18) After modifying the mold in the desired manner via CAD, the positive mold is designed, and the final stages of a test socket is near. Before one would vacuum pull a test socket, a trained individual would determine the proper plastic material, and certain mechanical attachments were needed. Also required is the technique discussed earlier of forming the plastic over the mold (drape or bubble pull). Finally, after the plastic has cooled to a workable form, one would clean the proper trim lines, make final mechanical preparations and finalize the test socket before fitting the patient.

(19) During the fitting of the test socket, one would observe pressure points and proper fit of the test socket. Next, one would make adjustments if needed and fabricate a second socket if need be. At this time, alignment can be observed and obtained.

(20) When the fabrication of the definitive sockets materials have cured, the socket is removed from the mold and trimmed out. It is then applied to the desired prosthetic components in the final delivery, i.e., during the fit/walk, the prosthetist is looking for the proper fit of socket and the correct alignment that correspond to the patient's gait.

(21) In the process of the present invention, the individual would receive the aligned test socket, then one would capture the alignment and achieve a digital alignment via scanners and CAD systems along with the final test socket, the images can be merged to create a positive mold in an alignment.

(22) Once the digital prosthetic design is complete and approved, it is then sent to a 3-D printer where it is then printed or fabricated as a wearable prosthetic limb. As stated earlier, one such printer is sold under the trademark of Fortus which would be utilized in this process designed by Stratasys, although there may be other such printers available for use.

(23) During this process the preferred material to provide a prosthesis and a method to fabricate a prosthesis constructed of a material, preferably Nylon 12, but other suitable materials may include ULTEM, carbon fiber, or other material of equal or greater strength that may be known or developed in the future, while the printers are a product of Stratasys Corporation or other such types of printers. After the print is complete, the prosthetic limb is then shipped to the prosthetist. Upon delivery, the prosthetist will have an aligned prosthesis and would have the ability to finish the proper trim lines. During fit/walk the prosthetist is looking for the proper fit of socket and the correct alignment that corresponds to the patient's gait.

(24) Turning now to FIGS. 1 through 11, there is illustrated the various steps involved in the method of the present invention. In FIG. 1 there is illustrated a modified mold 10 of a residual limb which has been digitally produced via 3D scanners and software known in the industry. As illustrated, the modified mold 10 would include the relief and pressure points 11 of a test socket which would be actually molded. In FIG. 2, there is illustrated a carving 13 of a modified model before it is matched with the test socket to be fabricated. Turning to FIG. 3A there is illustrated an actual test socket 12 which has been constructed from the digitally modified mold 10, which is hooked up to an alignment system 15, having a pylon 16 and a prosthetic foot 17. In FIG. 3B, the test socket 12 has been equipped with an alignable system 21, including a pylon 16, together with base 23 of the alignable system 21, rather than the prosthetic foot 17 as seen in FIG. 3A. It should be noted that the actual test socket 12, as seen in FIGS. 3A and 3B, has also been equipped with a plurality of dots 20 so as to allow the socket 12 to be accurately scanned, as covered by the next step in the process.

(25) FIGS. 4A and 4B illustrate the images which appear of the test socket 12 as the test socket 12 is being accurately scanned, preferably with a 3D scanner, along with finalized alignment that has been recorded and adjusted by a certified practitioner to provide a 3-D Image of the finalized captured prosthetic alignment, or the completed image of the aligned prosthetic limb 22 which is illustrated in FIG. 4C.

(26) In FIGS. 5A and 5B there is illustrated examples of the modified mold and the beginning stages of transferring the alignment. It should be noted that in FIG. 5A, there has been placed a 30 mm adaption (pylon 16), while in FIG. 5B there is a shorter adaption (pylon 16) adapted to the modified mold. The next step would be to transfer the finalized digital alignment of the test socket 12 to the finalized digitally modified mold 10, as is illustrated in FIG. 6. In FIG. 6, the image on the left is the modified mold 10 with the alignment attachment that can be manipulated, on the right is the test socket 12 with the correct alignment. In this step, one is merging the alignment of a test socket (inner portion 24 of a prosthesis) with the final manipulated model (outer fit 26 of the prosthesis) as one. This is done by using techniques in the software that allows one to overlap the images to cross reference the objects at hand. But first using a certain cylindrical tool in the software to simulate the appearance of a pylon 16 (normally 30 mm) needs to be added to the distal portion of the final manipulated model (inner model). This will give the individual the option of lining up the alignment or changing it at this time. When cross-referenced, both models should line up exactly using the alignment model as reference. In FIG. 7, there is illustrated the final merged image 27 of both to assure there is correct alignment which does not have to be modified or corrected. In the process described above, it is foreseen that in the future this process as described herein will be accomplished through software to be developed.

(27) In FIG. 8, after the alignment has been captured, as described above, the next step is to use CAD software to proceed to fabricate the type of hookup in the definitive socket 28; i.e., plug fit, four hole (the type illustrated in FIG. 8), support drop lock, or any other type of industry standard connection or accommodation via basic 3D software. Prior to sending to the printer, it is important that each Z line in the file is adjusted to insure the strongest build of the socket with proper trim lines.

(28) In FIG. 9, there is illustrated the actual printout of the prosthesis, also referred to as definitive socket 28, that was illustrated in FIG. 8, showing the four hole hookup 30 mounted on the definitive prosthetic socket 28. One such printer is sold under the trademark of Fortus which would be utilized in this process designed by Stratasys, although other such printers are available. Preferably, the definitive socket 28 prosthesis would be printed out of a plastic material such as ULTEM, or carbon fiber, or other material of equal or greater strength that may be known or developed in the future.

(29) In addition to the four hole hookup 30 as illustrated in FIG. 9, FIG. 10 illustrates a printout of the prosthesis 28 which has a plug fit adaptor 32, while in FIG. 11, the prosthesis 28 is adapted with a plug fit 34 for receiving a pylon 16 or other type of adaptor.

(30) As stated earlier, by utilizing this process, the prosthetist is allowed to construct the prosthesis with prosthetic techniques for attachments such as: Four hole hook up with vacuum Four hole hook up that will support a drop lock Fitting of pylon or adapters Custom attachments (for certain feet/attachment)

(31) In the preferred method of the present invention it is foreseen that the socket will undergo sealing. In order to seal the socket the step will include adding a layer of epoxy to the exterior of the socket, which would help to add strength to the entire socket. The preferred type of epoxy is described as TC-1614 A/B epoxy, manufactured by BJB Enterprises, or an equivalent type of high solids content epoxy penetrating sealing and coating resin, or some other equivalent epoxy sealing product, which will be laminated over the socket. This will seal the socket in order to be able to use vacuum for proper fitting, if required.

(32) In addition to the Drawing Figures as discussed above, reference is made to FIG. 12, a Flow Chart which succinctly depicts the steps in the process of the present invention making reference to the appropriated drawing Figures as discussed herein.

(33) Reference is now made to FIGS. 13 and 14 which provide the new methods of smoothing the 3D Printed Socket, as set forth in the Flow Chart of FIG. 13, and the process of sealing the 3D Printed Socket following fabrication, as set forth in the Flow Chart of FIG. 14.

(34) As seen in FIG. 13, entitled The Smoothing Process, the method involves the steps that after trimming the fabricated 3D printed socket, the 3D printed socket will be placed in the Almco Model VB-2034 End Discharge Vibratory Finishing System, or an equivalent system on the market or to be invented. The 3D Printed Socket will then will vibrate for preferably 2 hours in the Alamo Finished System tumbler with the rpm's preferably between 1400-1600 with 2 different types of ceramics, preferable Star and Cone, and also wear rods, which are known in the industry, for smoothing the Socket.

(35) FIG. 14 is a flow chart which sets forth the sealing process after the 3-D Socket Has Been Smoothed in the manner described above. First, the 3D printed socket is cleaned of any leftover ceramic residue and dried. Next, an epoxy is applied to the socket, such as TC-1614, which is a high solids content epoxy penetrating sealing and coating resin system, manufactured by BJB Enterprises, or some other equivalent epoxy sealing product. If TC-1614 is used, Parts A & B of TC-1614 would be placed in an oven separately, together with the 3D printed socket, preferably at 120 F degrees, and preferably for 10 minutes. Next there is the step of mixing both parts A & B of TC-1614, then applying it to the 3D printed socket with a foam brush inside and outside of the socket. The 3D printed socket is then placed back into the oven for preferably 10 minutes. Next the 3D printed socket will then be removed from the oven and wiped down inside and outside to remove residual epoxy with a fabric, such as a lint free paper towel. The 3D printed socket is then placed back into oven for preferably 2 hours, with the temperature remaining at preferably 120 F degrees at all times during the process. Following these steps, the 3D Printed socket can then be removed for assembly.

(36) All measurements disclosed herein are at standard temperature and pressure, at sea level on Earth, unless indicated otherwise. All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise.

PARTS LIST

(37) Description Number Modified mold 10 Pressure points 11 Test socket 12 Carving 13 Alignment system 15 Pylon 16 Prosthetic foot 17 Dots 20 Alignable system 21 Aligned prosthetic limb 22 Base 23 Inner portion 24 Outer fit 26 Merged image 27 Definitive socket 28 Four hole hookup 30 Plug Fit Adaptor 32 Plug fit 34

(38) All measurements disclosed herein are at standard temperature and pressure, at sea level on Earth, unless indicated otherwise. All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise.

(39) The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.