Methods and instruments for assessing bone fracture risk

Abstract

Methods and instruments for assessing bone, for example fracture risk, in a subject in which a test probe is inserted through the skin of the subject so that the test probe contacts the subject's bone and the resistance of the test bone to microscopic fracture by the test probe is determined. Macroscopic bone fracture risk is assessed by measuring the resistance of the bone to microscopic fractures caused by the test probe. The microscopic fractures are so small that they pose negligible health risks. The instrument may also be useful in characterizing other materials, especially if it is necessary to penetrate a layer to get to the material to be characterized.

1 . A method for assessing bone, comprising:
 inserting a test probe through the periosteum and/or soft tissue on a bone of the subject so that the test probe contacts the subject's bone; and   evaluating a material property of the bone through said contact with the test probe.   
     
     
         2 - 68 . (canceled) 
     
     
         69 . A method for assessing bone fracture risk in a subject without surgically exposing the bone surface, the method comprising:
 inserting a probe assembly through the skin and soft tissue down to a bone, the probe assembly comprising a reference probe having a tubular section and a test probe slidably disposed within the tubular section;   inserting the test probe a microscopic distance into the bone to create one or more microscopic fractures in the bone; and   determining one or more of the following parameters:
 the extent of insertion of the penetrating end of the test probe into the bone; 
 the resistance of the bone to penetration of the test probe; 
 the resistance of bone to removal of the test probe after it penetrates the bone; 
   thereby assessing bone fracture risk in the subject.   
     
     
         70 . The method according to  claim 69 , wherein the microscopic fractures are on the order of 0.01 cubic millimeters or smaller. 
     
     
         71 . The method according to  claim 69 , wherein the test probe is a single use test probe, and wherein the test probe is discarded after use. 
     
     
         72 . The method according to  claim 69 , wherein determination of one or more parameters further comprises determining a distance the test probe inserts into the bone under a predetermined force. 
     
     
         73 . The method according to  claim 69 , wherein the method does not comprise exposing or visualizing the bone surface. 
     
     
         73 . The method according to  claim 69 , wherein the method is applied to a volume of bone allowing the one or more parameters to be determined over at least several osteons. 
     
     
         74 . The method according to  claim 69 , wherein the test probe is symmetrically sharpened. 
     
     
         75 . The method according to  claim 69 , wherein the microscopic fractures are on the order of 0.01 cubic millimeters or smaller, and wherein the test probe is a single use test probe discarded after use, and wherein determination of the one or more parameters further comprises determining a distance the test probe inserts into the bone under a predetermined force, and wherein the method does not comprise exposing or visualizing the bone surface, and wherein the method is applied to a volume of bone allowing the one or more parameters to be determined over at least several osteons.