Methods and devices for validating the position of patient-specific devices

Abstract

The present invention relates to methods for validating the correct position of a patient-specific device on a chosen anatomy of the human body as well as such patient-specific devices. More specifically, the devices are provided with a fitting tool which allows in alignment of the patient-specific device with one or more predetermined patient-specific landmarks.

What is claimed is: 
     
         1 . A patient-specific device configured to be positioned on an anatomical part of a patient, comprising:
 a patient-specific surface configured to be complementary with at least a portion of the anatomical part;   a functional alignment element configured for optically aligning the patient-specific device; and   a patient-specific landmarking element configured to align with a predetermined anatomical landmark on the anatomical part when the patient-specific device is in a correct position,   wherein the predetermined anatomical landmark comprises a visible, physical feature of the anatomical part when the patient-specific device is in the correct position, and   wherein the patient-specific landmarking element defines a curve configured to align with a portion of a contour of the predetermined anatomical landmark and to validate the correct position of the patient-specific device on the anatomical part.   
     
     
         2 . The patient-specific device of  claim 1 , wherein the functional alignment element comprises one of a pin, a rod, a wire, or a cone. 
     
     
         3 . The patient-specific device of  claim 1 , wherein the anatomical part comprises a bone, and the visible, physical feature comprises one of a crest, a concavity, a convexity, a peak, or a tuberosity on a surface of the bone. 
     
     
         4 . The patient-specific device of  claim 1 , the functional alignment element is configured to be aligned using a medical imaging apparatus. 
     
     
         5 . The patient-specific device of  claim 4 , wherein the medical imaging apparatus comprises one of a CT scan apparatus, an X-ray scan apparatus, an ultrasound apparatus, or an MRI apparatus. 
     
     
         6 . The patient-specific device of  claim 1 , wherein the patient-specific device further comprises: a fitting tool configured to attach to the patent-specific device and to support the functional alignment element and the patient-specific landmarking element. 
     
     
         7 . The patient-specific device of  claim 1 , wherein the patient-specific surface was additively manufactured. 
     
     
         8 . A patient-specific device configured to be positioned on an anatomical part of a patient, comprising:
 a patient-specific surface configured to be complementary with at least a portion of the anatomical part;   a functional alignment element configured for optically aligning the patient-specific device; and   a patient-specific landmarking element configured to align with a predetermined anatomical landmark on the anatomical part when the patient-specific device is in a correct position,   wherein the predetermined anatomical landmark comprises a visible, physical feature of the anatomical part when the patient-specific device is in the correct position, and   wherein the patient-specific landmarking element comprises a beam configured to correlate with a width of the predetermined anatomical landmark.   
     
     
         9 . The patient-specific device of  claim 8 , wherein the functional alignment element comprises one of a pin, a rod, a wire, or a cone. 
     
     
         10 . The patient-specific device of  claim 8 , wherein the anatomical part comprises a bone, and the visible, physical feature comprises one of a crest, a concavity, a convexity, a peak, or a tuberosity on a surface of the bone. 
     
     
         11 . The patient-specific device of  claim 8 , the functional alignment element is configured to be aligned using a medical imaging apparatus. 
     
     
         12 . The patient-specific device of  claim 11 , wherein the medical imaging apparatus comprises one of a CT scan apparatus, an X-ray scan apparatus, an ultrasound apparatus, or an MRI apparatus. 
     
     
         13 . The patient-specific device of  claim 8 , wherein the patient-specific device further comprises: a fitting tool configured to attach to the patent-specific device and to support the functional alignment element and the patient-specific landmarking element. 
     
     
         14 . The patient-specific device of  claim 8 , wherein the patient-specific surface was additively manufactured. 
     
     
         15 . A patient-specific device configured to be positioned on an anatomical part of a patient, comprising:
 a patient-specific surface configured to be complementary with at least a portion of the anatomical part;   a functional alignment element configured for optically aligning the patient-specific device; and   a patient-specific landmarking element configured to align with a predetermined anatomical landmark on the anatomical part when the patient-specific device is in a correct position,   wherein the predetermined anatomical landmark is a visible, physical feature of the anatomical part when the patient-specific device is in the correct position, and   wherein the patient-specific landmarking element is a ring configured to correlate with an outline of the predetermined anatomical landmark.   
     
     
         16 . The patient-specific device of  claim 15 , wherein the functional alignment element comprises one of a pin, a rod, a wire, or a cone. 
     
     
         17 . The patient-specific device of  claim 15 , wherein the anatomical part comprises a bone, and the visible, physical feature comprises one of a crest, a concavity, a convexity, a peak, or a tuberosity on a surface of the bone. 
     
     
         18 . The patient-specific device of  claim 15 , the functional alignment element is configured to be aligned using a medical imaging apparatus. 
     
     
         19 . The patient-specific device of  claim 15 , wherein the patient-specific device further comprises: a fitting tool configured to attach to the patent-specific device and to support the functional alignment element and the patient-specific landmarking element. 
     
     
         20 . The patient-specific device of  claim 15 , wherein the patient-specific surface was additively manufactured.