US20100332197A1 - System for biomedical implant creation and procurement - Google Patents

Abstract

Automated systems and methods for creating and obtaining devices, including biomedical implants. Systems can have a surgeon's device, an automated platform, and a server. The surgeon's device can send a request for a template of a biomedical implant, and can access tools to edit the template. The automated platform can receive the edited template, and can generate a response. The response can include translating the edited template into a design for a biomedical implant. The response can further include generating a notice if the edited template falls outside of an acceptable range, or if the edited template is similar to the design of a standard biomedical implant. There can also be provided a manufacturing facility that can manufacture the implant and send the implant to the surgeon.

Description

RELATED APPLICATIONS
• This invention claims priority to U.S. provisional patent application No. 60/709,979, entitled “SYSTEM FOR BIOMEDICAL DEVICE CREATION AND PROCUREMENT,” filed on Aug. 19, 2005, the entirety of which is hereby incorporated by reference.
RELATED FIELDS
• This invention relates to a system that can be used to create and order devices, such as biomedical implants.
BACKGROUND OF THE INVENTION
• Surgeons routinely implant biomedical implants, including but not limited to intramedullary nails or hip stems, into patients. For example, a patient might have fractured his or her leg after falling. Another patient might have conditions typically associated with old age, for example, a weakened hip. A surgeon might decide that the patient's condition requires treatment with one or more biomedical implants. There are companies that manufacture and sell biomedical implants in standard sizes and designs. Sometimes, these standard implants are appropriate for the patient's condition. The surgeon could simply purchase the standard implant to treat the patient's condition. But oftentimes, these standard biomedical implants are not appropriate for treatment of the patient's condition. For example, if a patient has a fractured leg, the fracture might be larger, wider, or otherwise differently shaped than is appropriate for a standard biomedical implant. The standard biomedical implant might not fit into the fracture, might not make contact at the required points, or might otherwise inhibit the treatment of the patient's condition.
• When a standard biomedical implant is not appropriate for treatment, the surgeon can order a customized biomedical implant. Customized implants provide the flexibility of selecting an implant with the appropriate design to treat the patient's condition. Traditionally, biomedical implant manufacturers collaborate with a surgeon to design a customized implant. In this traditional method, all communication between the requesting surgeon and the biomedical implant manufacturer is either oral or written and delivered through the postal service. If the communication is oral, then the surgeon must schedule an appointment with the implant manufacturer, either by telephone or in person. Accordingly, communication can only occur when the manufacturer and surgeon are available at the same time. Waiting on concurrent availability takes a long time, and the delay might affect the patient's condition. Collaboration in these traditional methods of design also occurs in writing and is delivered through the postal service. For example, a surgeon might send X-rays and order forms through the mail, and the implant manufacturer will mail the design proposals back to the surgeon. Sending communication through the mail is time consuming, and the delay might affect the patient's condition. Accordingly, traditional systems and methods that depend on oral communication, or written communication delivered by the postal service, is undesirable.
• Other traditional methods, such as the methods taught by Bradbury et al. in U.S. Pat. No. 6,772,026, Funderund in U.S. Patent Application Publication No. 2005/0216305, or Baker in U.S. Patent Application Publication No. 2002/0072821 utilize a networked system that allows a surgeon's device to communicate electronically with a biomedical implant manufacturer's server and processor. In the systems taught by these references, the surgeon transmits to the manufacturer general patient data, such as gender, age, or name. The surgeon also transmits diagnostic data of the patient's condition, such as a digital X-ray image, a magnetic resonance image (“MRI”), or a computer tomography (“CT”) image. The biomedical implant manufacturer receives this information on a server and or processor. In these traditional systems, the manufacturer's processor typically uses computer aided design (“CAD”) systems to design a customized biomedical implant based on the received diagnostic data. In Bradbury et al., the design of the customized device is defined by edges of the patient's living tissue as shown in the patient's diagnostic data. So for example, if a patient has a fractured leg, the surgeon might transmit to the manufacturer a digital X-ray image that shows the two edges of the fractured leg. The system in Bradbury et al. receives the digital X-ray and uses a CAD system to design the customized device. The CAD system defines the edges of the customized device by the edges of the fractured leg as shown in the X-ray. These systems depend on the receipt of the diagnostic data, and the surgeon is not involved in the design of the customized device because the design is defined exclusively by the diagnostic data.
• There are several drawbacks associated with traditional systems and methods such as those taught by Bradbury et al. and Funderund. Often the diagnostic data required by the systems is unreliable and inconsistent. The MRI or CT files can have errors that prohibit use by the manufacturer's CAD system. The submitting surgeon could make a mistake in the diagnostic data, or could submit the wrong type of diagnostic data. The transmission of diagnostic data through the network and servers of traditional systems also presents a problem. One acceptable framework for transmitting electronic diagnostic data is the Digital Imaging Communications in Medicine (“DICOM”) standard, which is developed by the American College of Radiology (“ACR”). It is often difficult and costly, if not impossible, to convert diagnostic data to DICOM formats. The diagnostic data that is converted into DICOM formats is often unusable, and it is not reliable or verifiable for accuracy. Accordingly, it is not desirable to rely exclusively on diagnostic data to design the customized biomedical implant.
• A second problem associated with traditional systems such as taught by Bradbury et al. and Funderund is the lack of collaboration between the surgeon and the device manufacturer in the design process. In traditional systems such as Funderud and Bradbury et al., the design is defined exclusively by the device manufacturer, and is based solely on the diagnostic data. In some cases, however, it might be desirable for the surgeon to contribute to the design independently of the diagnostic data. For example, the diagnostic data might indicate that a device should have a length of 3 mm, but the surgeon might want a length of 5 mm. Systems such as in Funderud and Bradbury et al. do not allow the surgeon to alter the design. Moreover, it would be difficult and costly to allow the surgeon to contribute to the design. These traditional systems use complicated CAD and CAM software of which the surgeon is most likely unaware. Even if the systems did allow the surgeon to alter the design, he or she could not effectively do so because of inexperience with the CAD and CAM software.
• In other traditional systems such as in Baker, the design is defined exclusively by the user, and the device manufacturer cannot contribute to the design. In some situations, input might be required by the device manufacturer, for example if the proposed design is outside of acceptable ranges. Alternatively, the manufacturer might be aware of a standard device that could be substituted for the proposed design. It might be helpful for the manufacturer to be able to suggest the substitution. Systems such as in Baker do not allow the manufacturer to contribute to the design.
• Yet another problem is that these traditional systems do not provide a method to trace design iterations. An originally submitted design might differ significantly from the final design. Oftentimes it is desirable to identify what changes were made to the design, when they were made, and who made them. These traditional systems and methods do not provide a way to track design changes.
SUMMARY OF THE INVENTION
• Embodiments of the invention provide for systems and methods of creating and obtaining biomedical implants. Certain embodiments can be provided with a device for a surgeon, which can be embodied as a computer, fascimilie machine, handheld computing device, or a telephone system, if desired. Other embodiments can have an automated platform for an implant manufacturer, which can also be embodied as a computer, fascimilie machine, handheld computing device, or a telephone system, if desired. Embodiments include a server to allow the surgeon's device and the automated platform to transmit information over a network. In some embodiments, the network can be the Internet while in others, the network could be an Intranet. Certain embodiments further include a manufacturing facility. The manufacturing facility can receive instructions to manufacture the implant, and can then send the implant to the surgeon.
• The surgeon's device can be provided with tools, or can have access to tools, to enable the surgeon to practice certain methods of the invention. The tools can be embodied as software loaded on a computer, if the surgeon's device is embodied as a computer. In an alternative embodiment, the tools can be provided on the automated platform or on a server, and can be accessible by the surgeon's device. If desired, the tools can be other known embodiments such as menu selections on a telephone system. One tool can allow a surgeon to transmit a request for a biomedical implant. Tools of other embodiments can enable the surgeon to edit templates that represent biomedical implants. Embodiments further enable the surgeon to upload or input information into the surgeon's device, such as diagnostic data and patient information, if desired. Certain embodiments enable the surgeon's device to either send or receive information.
• Embodiments can include a server to receive and transmit information between the surgeon's device and the automated platform, if provided in the embodiment. If desired, the server can transmit information over the Internet. The server and the automated platform can be housed in the same location, or can be housed in different locations. In some embodiments, the server and the automated platform can be members of the same element, or the server and the automated platform can be separate elements.
• Embodiments of the invention may include an automated platform that can be accessed by a biomedical implant manufacturer. The automated platform can be embodied as a computer, if desired, and can also be embodied as a fascimilie machine, handheld computing device, or a telephone system. In certain embodiments there are tools associated with the automated platform, and the tools can include computer aided design (“CAD”) systems. The CAD systems can be enabled to translate edits received from the surgeon's device into a design for an implant. In some embodiments, memory can be provided. The automated platform can access the memory, but the automated platform and the memory need not be members of the same element. The memory can include multiple types of information, including a collection of templates, ranges of acceptable design parameters for implants, or designs of standard implants.
• In some embodiments, there is provided a manufacturing facility. The manufacturing facility can receive manufacturing instructions from the automated platform. The manufacturing facility and the automated platform can communicate through the server, or by other means including the postal service or telephone system. The manufacturing facility can have known manufacturing tools, and can manufacture the implant. If desired, the manufacturing facility can send the implant to the surgeon.
• It is accordingly an aspect of some embodiments of the invention to provide systems and methods for creating and obtaining devices, including biomedical implants.
• It is an additional aspect of some embodiments of the invention to provide systems and methods that quickly and efficiently create implants.
• It is an additional aspect of some embodiments of the invention to provide systems and methods that create implants without the need for diagnostic data.
• It is an additional aspect of some embodiments of the invention to provide systems and methods that allow a surgeon and an implant manufacturer to collaborate on a proposed implant design.
• It is an additional aspect of some embodiments of the invention to provide systems and methods that allow a surgeon who is unskilled in CAD systems to contribute to a proposed implant design.
• It is an additional aspect of some embodiments of the invention to provide systems and methods that record pertinent information about design iterations.
• Other aspects, features, and advantages of embodiments of the invention will become apparent with respect to the remainder of this document.
GENERAL DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates an embodiment of a system that can be used to practice an embodiment of a method of this invention.
• FIG. 2 illustrates an embodiment of the method inFIG. 1.
• FIG. 3 is another illustration of the method inFIG. 2.
• FIG. 4 illustrates a portion of a method of certain embodiments of the invention.
• FIG. 5 illustrates another portion of a method of certain embodiments of the invention.
• FIG. 6 illustrates an embodiment of a tool to send a request for a biomedical implant.
• FIG. 7 illustrates an embodiment of a tool for editing a hip stem template, where the tool comprises at least one slideable bar.
• FIG. 8 illustrates an embodiment of a tool for editing a hip stem template, where the tool comprises at least one form to input design parameters.
• FIG. 9 illustrates an embodiment of a tool for editing an intramedullary nail, where the tool comprises at least one form to input design parameters.
• FIG. 10 illustrates another embodiment of the tool inFIG. 9.
• FIG. 11 illustrates an embodiment of a tool to compare diagnostic data with a design for a biomedical implant.
DETAILED DESCRIPTION OF THE DRAWINGS
• Embodiments of the invention provide systems and methods for creating and obtaining devices, including biomedical implants. Referring now toFIGS. 1-3,systems10 of certain embodiments can be provided with a surgeon'sdevice12. InFIG. 1, the surgeon'sdevice12 is embodied as a computer, but other embodiments can include a facsimile machine, a telephone, a handheld computing device, or a pager. The surgeon'sdevice12 can access atool16 to inputinformation14. Thetool16 can be provided on the surgeon'sdevice12, or can be provided on theautomatic platform22 or theserver20 and can be accessible by the surgeon'sdevice12.Information14 can include identifying information for the surgeon and/or the patient, including names, case numbers, and insurance information, if desired. In certain embodiments,information14 can include diagnostic data, such as a digital X-ray image, a magnetic resonance image (“MRI”), or a computer tomography (“CT”) image.
• The surgeon'sdevice12 can accessother tools16 to practice other methods of the invention. Thetools16 can be provided on the surgeon'sdevice12, or can be provided on theautomatic platform22 or theserver20 and can be accessible by the surgeon'sdevice12. Onetool16 can enable the surgeon to send arequest28 for atemplate32 that represents a biomedical implant, or for an accessory to a biomedical implant.FIG. 6 illustrates one embodiment of atool16 to send arequest28 fortemplate32 of an intramedullary nail. Thetool16 provides a choice of four types of nails: a knee fusion nail, a trochanteric antegrade nail, a femoral antegrade nail, and a tibial/retrograde femoral nail. Other types of implants are also included in embodiments of the invention. For example, embodiments can provide implants for different types of hip stems, or for cosmetic implants such as breast implants. Embodiments can also provide accessories or customized instruments to implant the implants. For example, sometimes when a surgeon installs a custom-designed implant, the surgeon requires special tools. Accordingly, embodiments ofsystems10 can provide accessories to help the surgeon install the biomedical implant. For example, there can be provided drills, drill guides, broaches, nail guide drops, nail guide handles, proximal entry reamers, reamer drills, hexdrivers, drill sleeves, guide bolts, targeters, or other accessories known in the art. Further, embodiments of the invention can provide templates for trays in which to house accessories and/or biomedical implants. Accordingly, the surgeon'srequest28 can include multiple types of implants, or accessories for implants, or trays for implants.
• Certain embodiments also providetools16 for editing at least one design parameter of atemplate32. Thetools16 can be provided on the surgeon'sdevice12, or can be provided on theautomatic platform22 or theserver20 and can be accessible by the surgeon'sdevice12. There can be many design parameters associated withvarious templates32. For example, if the implant is for an intramedullary nail, as inFIG. 9, examples of design parameters can include length, outside diameter, bow radius, hole size, hole location, hole angle, the number of holes, slot size, slot location, material, surface finish, or surface coating. If the implant is for a hip stem, as inFIG. 8, examples of design parameters can include the profile, stem size, length, head offset, neck height, neck angle, medial and lateral fill, posterior and anterior fill, shoulder height, beam thickness, material, surface finish, or surface coating.
• One embodiment oftool16 for editing is illustrated inFIG. 7 and can include at least oneslideable bar110 associated with an edge of thetemplate32. The surgeon can click and drag theslideable bar110 to adjust design parameters of thetemplate32. As illustrated inFIG. 7, theslideable bars110 can adjust the width and depth of thetemplate32. In other embodiments, theslideable bars110 can adjust the height or other design parameters of thetemplate32. The invention is not limited to aslideable bar110, but can also include slideable points, or any other shaped sliding element.
• In the embodiment illustrated inFIGS. 8-10, thetool16 can include a form to input at least one design parameter. There can be at least three types of forms: amenu112, ablank field114, or aselector116. If the form is embodied as amenu112, the surgeon can click on the down arrow to obtain a list of design parameters, and can click on the desired design parameter of his/her choice. InFIG. 9, there is provided threemenus112, two of which are consecutive. In certain embodiments,menus112 can be interrelated such that their design parameters depend on one another. In these embodiments, the design parameters presented for selection in thesecond menu112 depend on the design parameters that the surgeon selected in thefirst menu112. For example, if in thefirst menu112 the surgeon selected an outside diameter of 10 mm, then the choices for an inside diameter provided in thesecond menu112 would be less than 10 mm. If the form is embodied as ablank field114, the surgeon can type in the desired design parameter into theblank field114. Still another embodiment of atool16 is aselector116 for the surgeon to select design parameters. InFIG. 10, there are twoselectors116 and eachselector116 only provides two choices. In other embodiments, there can bemultiple selectors116 and eachselector116 can provide multiple choices. Accordingly, thetool16 for editing can include at least one of aslideable bar110, amenu112, ablank field114, aselector116, or a combination of any of these.
• The embodiments inFIGS. 8-10 illustrate adimensional reference122, which can serve as a guide while the surgeon is editing thetemplate32. For example, thedimensional reference122 shown inFIG. 8 illustrates design parameters including head offset, neck height, neck angle, length, and stem size. Thedimensional reference122 helps the surgeon to identify design parameters while he/she is editing thetemplate32.
• Other embodiments of the surgeon'sdevice12 alsoaccess tools16 for creating a design based ondiagnostic data14. As discussed above,diagnostic data14 can include X-rays, MRI images, or CT images. In some embodiments, thetools16 can enable the surgeon to select certain points or elements associated with thediagnostic data14. Theautomated platform22 can be provided withtools26 to translate the selected points into a design. For example, there could be an X-ray showing a fractured leg, and the surgeon can select two points on one side of the fracture, and one point on the other side of the fracture. Theautomated platform22 could translate those points into a design for an intramedullary nail.
• In some embodiments a workingmodel118 can be provided on the surgeon'sdevice12 to allow the surgeon to view the progress of the design, and to catch any potential mistakes. The surgeon can enter edits, and can select aregeneration button120 to update the workingmodel118. Alternatively, the workingmodel118 can be regenerated automatically whenever the surgeon edits thetemplate32. For example, inFIG. 8 the standard length is 130 mm, and the edited length is 140 mm. When theregeneration button120 is selected, the workingmodel118 will grow 10 mm in length. If the surgeon made a mistake while entering edits, then the mistake can be illustrated on the workingmodel118. For example, if the length was 130 mm, and the surgeon mistakenly entered 1300 mm, then the surgeon can catch the mistake by viewing the workingmodel118.
• In addition, some embodiments of the surgeon'sdevice12 can include acomparison tool124 to allow the surgeon to compare the design to diagnostic data (not shown), such as an X-ray of the patient, to the design for the implant. Thiscomparison tool124 is helpful because it allows the surgeon to determine whether the design is appropriate for treatment of the patient's condition. The embodiment of thecomparison tool124 illustrated inFIG. 11 is a printable illustration of the design scaled to fit the diagnostic data. Other embodiments of thecomparison tool124 are within embodiments of the invention. InFIG. 11, there is one printable illustration for the medial and lateral side of the implant, and another printable illustration for the anterior and posterior side of the implant. The surgeon can print out the illustrations and compare them to the diagnostic data. If the design on the illustrations does not fit the diagnostic data, then the surgeon can use thetools16 for editing and redesign the implant.
• Certain embodiments can include aserver20. Theserver20 can be embodied as a computer, if desired. Theserver20 can be enabled to receive and transmit information between at least the surgeon'sdevice12 and theautomated platform22. Theserver20 can transmit information over anetwork18, which can be embodied as the Internet, or as an Intranet.
• Other embodiments can include anautomated platform22. Theautomated platform22 can be accessed by a biomedical implant manufacturer to practice methods of the invention. InFIG. 1, theautomated platform22 is embodied as a computer, but other embodiments are also within the scope of the invention. Theserver20 and theautomated platform22 can be housed in the same location, or can be housed in different locations, if desired. In the embodiment shown inFIG. 1, theserver20 and theautomated platform22 are two separate elements, but in other embodiments, theserver20 and theautomated platform22 can be members of the same element. In some embodiments,memory24 can be provided. Thememory24 can be a hard drive of a computer, if desired, but other embodiments are within the scope of the invention. Theautomated platform22 can access thememory24, but theautomated platform22 and thememory24 need not be members of the same element. Thememory24 can store multiple types of information, including a collection oftemplates42, ranges of acceptable design parameters forimplants44, or designs ofstandard implants46.
• Embodiments of theautomated platform22 can be provided withtools26 to automatically generate certain responses to theedits30 received from the surgeon'sdevice12. In some embodiments thetools26 can include computer aided design (“CAD”) systems. Common CAD systems known in the art can include SolidWorks®, produced by SolidWorks Corporation, 300 Baker Avenue, Concord, Mass. 01742, or Pro Engineer®, produced by Parametric Technology Corporation, 140 Kendrick Street, Needham, Mass. 02494. The CAD systems can be enabled to translateedits30 of thetemplate32 received from the surgeon'sdevice12 into a design for animplant34.
• In some embodiments, theautomated platform22 can havetools26 to ensure that the design is acceptable for treatment of a patient's condition. Not every type of biomedical implant is appropriate for insertion into the human body, and sometimes the surgeon might not be aware of whether a particular design is acceptable. For example, a regulatory agency, such as the Food and Drug Administration, might have determined that a hip stem cannot exceed a certain weight. The surgeon might not be aware of the ranges of acceptable weights, and might have designed an implant with an unacceptable weight. Accordingly,tools26 can be provided to practice a method, illustrated inFIG. 4, to ensure that the design is acceptable for treatment of a patient's condition. In some embodiments there can be ranges ofacceptable design parameters44 to identify whether anedit30 is acceptable. Instep80 of the illustrated embodiment, theautomated platform22 can accessmemory24 to obtain the ranges ofacceptable design parameters44. Next, instep82 of certain embodiments, theautomated platform22 can compare theedit30 to the ranges ofacceptable design parameters44 to determine if theedit30 is acceptable. If theedit30 is not acceptable, then instep84 theautomated platform22 can generate a notice, and instep86 theautomated platform22 can send the notice to theserver20, and in turn to the surgeon'sdevice12. The notice informs the surgeon that theedit30 is not acceptable, and can provide the surgeon with an opportunity to enter another edit. In some embodiments theautomated platform22 is further enabled to repeat the process as needed by comparing any successive edits to the ranges ofacceptable design parameters44. If theedit30 is acceptable, then in some embodiments theautomated platform22 can create a final design for the biomedical implant, or can provide the surgeon with an opportunity to enter another edit. Accordingly, in some embodiments theautomated platform22 can compare anedit30 to ranges ofacceptable design parameters44.
• Alternatively, in some embodiments, theautomated platform22 can havetools26 to compare anedit30 to the design of a standardbiomedical implant46. Biomedical implant manufacturers have available a wide variety of standard biomedical implants. Sometimes the surgeon might not be aware that a standard implant is suitable for his/her application. The surgeon might find it desirable to obtain a standard implant because a standard implant is less expensive and more readily available than a customized implant. Accordingly,tools26 can be provided to practice a method, illustrated inFIG. 5, to notify the surgeon that a standard implant might be acceptable for the application. Instep100 of certain embodiments, theautomated platform22 can accessmemory24 to obtain designs ofstandard implants46. Next, instep102 of certain embodiments, theautomated platform22 can compare theedit30 to the designs ofstandard implants46. If theedit30 is substantially similar to a design of astandard implant46, then instep104 theautomated platform22 can generate a notice, and instep106 theautomated platform22 can send the notice to theserver20, and in turn to the surgeon'sdevice12. The notice can inform the surgeon that a standard implant is similar to theedit30, and can provide the surgeon with an opportunity to obtain the standard implant. If theedit30 is not substantially similar to the design of astandard implant46, then instep108 of certain embodiments theautomated platform22 can create a final design, or can provide the surgeon with an opportunity to enter another. Accordingly, in some embodiments the automated platform can compare theedit30 to the designs ofstandard implants46.
• In certain embodiments theautomated platform22 is further enabled to generatemanufacturing instructions36 to manufacture theimplant40. Themanufacturing instructions36 can include computer aided manufacturing (“CAM”) instructions. Themanufacturing instructions36 can be sent to amanufacturing facility38. In certain embodiments theserver20 and thenetwork18 can send themanufacturing instructions36 to themanufacturing facility38, while in other embodiments themanufacturing instructions36 can be sent by other means, such as by mail or courier. Themanufacturing facility38 can include standard machine equipment to manufacture implants. When thebiomedical implant40 is completed, themanufacturing facility38 can send theimplant40 to the surgeon. In some embodiments, thebiomedical implant40 can be sent by the mail.
• Referring now toFIGS. 1-2, certain methods of the invention will now be discussed. Instep50 of the illustrated embodiment the surgeon uses the surgeon'sdevice12 to enterinformation14, such as patient data or diagnostic data, and forms arequest28 for atemplate32 that represents a biomedical implant. In some embodiments, there can be memory associated with the surgeon'sdevice12, and the memory can be provided with multiple typesbiomedical implant templates42. The surgeon'sdevice12 can access the memory, and can retrieve thespecific template32 that corresponds to therequest28. In other embodiments such as illustrated instep52, the surgeon'sdevice12 transmits theinformation14 and therequest28 for atemplate32 to theserver20, which in turn transmits to theautomated platform22. Instep54 of some embodiments, theautomated platform22 can then accessesmemory24. Theinformation14 can be stored inmemory24 to keep a record of the surgeon's order for abiomedical implant40. In this manner, theinformation14 can be recalled if the surgeon needed to temporarily pause the order, or if the surgeon needed to reopen the order once completed. In certain embodiments thememory24 can store multiple typesbiomedical implant templates42, and can obtain thetemplate32 that corresponds to the surgeon'srequest28. Instep56 of some embodiments, thememory24 can then deliver thetemplate32 to theautomated platform22, which in turn can transmit thetemplate32 to theserver20, which in turn can transmit thetemplate32 to the surgeon'sdevice12.
• Instep58 of certain embodiments, the surgeon can usetools16 for editing that are accessible by the surgeon'sdevice12 to create at least afirst edit30 to thetemplate32. Thetools16 can be provided on the surgeon'sdevice12, or can be provided on theautomatic platform22 or theserver20 and can be accessible by the surgeon'sdevice12. As discussed above, embodiments of the invention can providetools16 for editing comprising at least one of aslideable bar110, amenu112, ablank field114, aselector116, or a combination of any of these. Whatever embodiment of thetool16 for editing is provided, instep58 the surgeon can use thetool16 to generate at least afirst edit30 on thetemplate32. Instep60 of certain embodiments, the at least afirst edit30 can be transmitted to theserver20, which in turn can transmit the at least afirst edit30 to theautomated platform22.
• Instep62 of certain embodiments, theautomated platform22 can usetools26 to generate at least afirst response34. As discussed above, in some embodiments the at least afirst response34 can be to translate the at least afirst edit30 into an at least a first design (not shown). In the embodiment illustrated inFIG. 4, the at least afirst response34 can be to ensure that the design is acceptable for treatment of a patient's condition. Instep84 ofFIG. 4, theautomated platform22 can generate a notice if the at least afirst edit30 falls outside of the ranges ofacceptable design parameters44. Alternatively, in the embodiment illustrated inFIG. 5, the at least afirst response34 can be to compare the at least afirst design30 to the designs ofstandard implants46. Theautomated platform22 can generate a notice if the at least afirst edit30 is substantially similar to the design parameters ofstandard implants46. In still other embodiments, the at least afirst response34 can be a combination of any of these responses. Still other responses are within the scope of the invention. Instep64 of certain embodiments, the at least afirst response34 can be transmitted to theserver20, which in turn can transmit the at least afirst response34 to the surgeon'sdevice12.
• Instep66 of certain embodiments, the surgeon'sdevice12 can either use thetools16 for editing to generate at least a second edit (not shown), or can generate approval of the design (not shown). If the at least afirst response34 was to generate at least a first design, then the surgeon could give approval of the design. Alternatively, the surgeon might not be satisfied with the at least a first design, and can use thetools16 for editing to generate at least a second edit. If the at least afirst response34 was to generate notice that at least afirst edit30 falls outside of the ranges ofacceptable design parameters44, then the surgeon can use thetools16 for editing to generate at least a second edit. Finally, if the at least afirst response34 was to generate notice that the at least afirst edit30 is substantially similar to the design of astandard implant46, then the surgeon can give approval for the standard implant. Instep68 of certain embodiments, the approval or the second edit can be transmitted to theserver20, which in turn can transmit the approval or the second edit to theautomated platform22. As indicated inFIG. 3, embodiments of the invention allow for repetition ofsteps62 through68 on successive edits by the surgeon'sdevice12.
• Instep70 of certain embodiments, theautomated platform22 can create a final design (not shown). The final design is the product of the collaboration of the surgeon and the biomedical implant manufacturer. The surgeon contributed the at least afirst edit30, and theautomated platform22 of the biomedical implant manufacturer contributed at least afirst response34. Instep72 of certain embodiments, theautomated platform22 can createmanufacturing instructions36 to enable amanufacturing facility38 to manufacture the implant, if desired. Instep74 of some embodiments, theautomated platform22 can send themanufacturing instructions36 to amanufacturing facility38. In certain embodiments theserver20 can send themanufacturing instructions36 to themanufacturing facility38, while in other embodiments themanufacturing instructions36 can be sent by other means, such as by mail or courier. Instep76 of some embodiments, themanufacturing facility38 can make theimplant40, and instep78 of some embodiments, themanufacturing facility38 can send theimplant40 to the surgeon. Theimplant40 can be sent to the surgeon by many means, including for example through the mail or courier.
• The foregoing is provided for purposes of illustration and disclosure of a preferred embodiment of the invention. Changes, deletions, additions, and modifications may be made to the structures disclosed above without departing from the scope or spirit of the present invention.

Claims (25)

1-49. (canceled)

50. A method for the design of a biomedical device, the method comprising:

receiving a request for a biomedical device from a surgeon's device, wherein the surgeon's device is communicatively linked with an automated platform;

receiving from the surgeon's device at least a first edit to a pre-existing template corresponding to the biomedical device;

automatically generating at least a first response to the first edit;

automatically transmitting the first response to the surgeon's device;

receiving approval from the surgeon's device; and

automatically creating a final design for the biomedical device.

51. The method as inclaim 50, further comprising:

accessing a memory of the automated platform to obtain the pre-existing template corresponding to the request; and

automatically transmitting the pre-existing template to the surgeon's device.

52. The method as inclaim 50, wherein generating the first response comprises automatically translating the first edit into a first design.

53. The method as inclaim 50, wherein generating the first response comprises accessing the memory of the automated platform to obtain an acceptable range of design parameters and automatically generating a notice if the first edit falls outside of the acceptable range.

54. The method as inclaim 50, wherein generating the first response comprises accessing the memory of the automated platform to obtain a standard design of a biomedical device, and automatically generating a notice if the final design is substantially similar to the standard design.

55. The method as inclaim 50, further comprising providing a tool for editing the pre-existing template using the surgeon's device.

56. The method as inclaim 55, wherein providing the tool further comprises providing the tool on at least one of the surgeon's device or the automated platform.

57. The method as inclaim 55, wherein providing the tool comprises providing at least one of a slideable bar associated with an edge of the template, or a form to input design parameters.

58. The method as inclaim 55, wherein the method is a method of design for an intramedullary nail, and wherein providing the tool further comprises providing a tool for editing at least one of a shape, a length, an outside diameter, a bow radius, a hole size, a hole location, a hole angle, a number of holes, a slot size, a slot location, a material, a surface finish, or a surface coating of the template.

59. The method as inclaim 55, wherein the method is a method of design for a hip stem, and wherein providing the tool further comprises providing a tool for editing at least one of a profile, a stem size, a length, a head offset, a neck height, a neck angle, a medial and lateral fill, a posterior and anterior fill, a shoulder height, a beam thickness, a material, a surface finish, or a surface coating of the template.

60. The method as inclaim 50, further comprising: receiving at least a second edit from the surgeon's device; automatically generating at least a second response to the second edit; and automatically transmitting the second response to the surgeon's device.

61. The method as inclaim 50, further comprising generating a set of machine instructions for the final design.

62. The method as inclaim 50, wherein the method is a method of design for at least one of an intramedullary nail, a hip stem, a cosmetic implant, a breast implant, a drill, a drill guide, a broach, a nail guide drop, a nail guide handle, a proximal entry reamer, a reamer drills, a hexdriver, a drill sleeve, a guide bolt, a targeter, or a tray.

63. A method for the design of a biomedical device, the method comprising:

receiving a request for a biomedical device from a surgeon's device, wherein the request comprises at least one diagnostic data point, and wherein the surgeon's device is communicatively linked with an automated platform;

providing a tool for selecting points associated with the diagnostic data point using the surgeon's device;

receiving a selection of points from the surgeon's device;

automatically translating the selection of points into a first design for the biomedical device;

automatically transmitting the first design to the surgeon's device;

providing a tool for editing the first design using the surgeon's device;

receiving approval from the surgeon's device; and

automatically creating a final design for the biomedical device.

64. The method as inclaim 63, further comprising providing a comparison tool for comparing the final design to the at least one diagnostic data point.

65. The method as inclaim 64, wherein providing the comparison tool comprises providing an illustration of the final design scaled to fit the at least one diagnostic data point.

66. The method as inclaim 63, wherein receiving the request comprises receiving the at least one diagnostic data point, the at least one diagnostic data point corresponding to a digital X-ray image, a magnetic resonance image, or a computer tomography image.

67. The method as inclaim 63, further comprising receiving an edit of the first design from the surgeons device, and automatically translating the edit into a second design.

68. A system for the design of a biomedical device, the system comprising:

a template for a biomedical device;

a tool for editing the template;

an automated platform comprising a tool to automatically translate an edit of the template into a design for the biomedical device; and

a server to communicatively link the automated platform with a surgeon's device, and to transmit the template to the surgeon's device, to receive the edit of the template from the surgeon's device, and to transmit the design for the biomedical device to the surgeon's device.

69. The system as inclaim 68, where the tool comprises at least one of a slideable bar associated with an edge of the template, or a form to input design parameters.

70. The system as inclaim 68, wherein the automated platform automatically generates a notice if the edit of the template falls outside of an acceptable range of design parameters.

71. The system as inclaim 68, wherein the automated platform automatically generates a notice if the design for the biomedical device is substantially similar to a standard design for the biomedical device.

72. The system as inclaim 68, wherein the biomedical device comprises a biomedical implant.

73. The system as inclaim 68, wherein the biomedical device comprises at least one of a drill, a drill guide, a broach, a nail guide drop, a nail guide handle, a proximal entry reamer, a reamer drills, a hexdriver, a drill sleeve, a guide bolt, a targeter, or a tray.

Images