Surgical instrument to assess tissue characteristics

Abstract

A surgical instrument for assessing tissue characteristics such as tissue density and volume is disclosed. The surgical instrument is hand-held and includes transducers adapted for emitting and/or receiving acoustic signals. The surgical instrument utilizes pulse-echo to determine tissue characteristics. The surgical instrument may be utilized to determine such things as the size of a lesion and whether the lesion has been completely removed or filled with graft material.

1 . A surgical instrument for use in the treatment of a lesion in a tissue, comprising: 
 a housing having an external gripping portion and a sensor portion having a conductive surface, the sensor portion adapted to be in conductive contact with a lesion in a tissue;    an energy source adapted for emitting an energy signal into the lesion, the energy signal configured to pass through the lesion and at least partially reflect off a boundary between the lesion and the tissue;    a sensor adapted for detecting the reflected signal; and    a processor for determining the volume of the lesion based on the reflected signal.    
   
   
       2 . The surgical instrument of  claim 1 , wherein the energy source and the sensor are components of an ultrasonic transducer.  
   
   
       3 . The surgical instrument of  claim 1 , wherein the energy source is configured to emit acoustic signals at a plurality of frequencies.  
   
   
       4 . The surgical instrument of  claim 3 , wherein the plurality of frequencies include frequencies in a range between 15 KHz and 100 MHz.  
   
   
       5 . The surgical instrument of  claim 4 , wherein the plurality of frequencies include frequencies in a range between 20 KHz to approximately 20 MHz.  
   
   
       6 . The surgical instrument of  claim 1 , wherein the energy source uses RF energy.  
   
   
       7 . The surgical instrument of  claim 1  wherein the energy source uses light energy.  
   
   
       8 . The surgical instrument of  claim 1 , further including a longitudinal axis extending substantially between the gripping portion and the sensor portion, wherein at least the sensor portion is adapted to be rotated about the longitudinal axis.  
   
   
       9 . The surgical instrument of  claim 8 , further including an accelerometer adapted to monitor the relative rotation of the sensor portion about the longitudinal axis.  
   
   
       10 . The surgical instrument of  claim 8 , further including a gyroscope adapted to monitor the relative rotation of the sensor portion about the longitudinal axis.  
   
   
       11 . The surgical instrument of  claim 1 , further including fiducial markers adapted to provide data for producing a three-dimensional image of the lesion and the three-dimensional location of the lesion.  
   
   
       12 . The surgical instrument of  claim 1 , further including a plurality of energy sources.  
   
   
       13 . The surgical instrument of  claim 12 , wherein each of the plurality of energy sources are adapted to emit acoustic signals at a different frequency.  
   
   
       14 . The surgical instrument of  claim 12 , wherein the plurality of energy sources are adapted to emit acoustic signals as a phased array.  
   
   
       15 . The surgical instrument of  claim 1 , further including an output mechanism adapted to produce an indicator of the volume of the lesion in human intelligible form.  
   
   
       16 . The surgical instrument of  claim 15 , wherein the output mechanism is a visual display.  
   
   
       17 . The surgical instrument of  claim 15 , wherein the indicator is an audible signal.  
   
   
       18 . The surgical instrument of  claim 15 , wherein the processor is controlled to determine the volume of the lesion in a bone based upon at least a first volume threshold and a second volume threshold, the second volume threshold being greater than the first volume threshold.  
   
   
       19 . The surgical instrument of  claim 18 , wherein a lesion volume less than the first volume threshold corresponds with a first container of bone void filler, a lesion volume greater than the first volume threshold and less than the second volume threshold corresponds to a second container of bone void filler larger than the first container, and a lesion volume greater than the second volume threshold corresponds to a third container of bone void filler larger than the second container.  
   
   
       20 . The surgical instrument of  claim 19 , wherein the output mechanism is adapted to produce an indicator of the first, second, or third container corresponding to the lesion volume.  
   
   
       21 . The surgical instrument of  claim 20 , wherein the bone void filler is one of an osteoinductive material, an osteoconductive material, an allograft, or an autograft.  
   
   
       22 . The surgical instrument of  claim 1 , wherein at least one of the housing, energy source, sensor, or processor is adapted to degrade during sterilization to limit the surgical instrument to single use applications.  
   
   
       23 . A method of determining the size of a lesion of a tissue, comprising: 
 placing an acoustic transducer and a sensor in conductive contact with the lesion, the acoustic transducer adapted to emit acoustic signals and the sensor adapted to receive reflected acoustic signals;    emitting an acoustic signal into the lesion, the acoustic signal adapted to pass through the lesion and at least partially reflect off a boundary of the lesion adjacent the tissue;    receiving at least a portion of the reflected signal at the sensor; and    determining the volume of the lesion based on the portion of the reflected signal received.    
   
   
       24 . The method of  claim 23 , further including emitting a plurality of acoustic signals into the lesion and receiving a plurality of reflected signals.  
   
   
       25 . The method of  claim 24 , wherein the acoustic transducer is associated with a housing having a longitudinal axis and further including rotating the ultrasonic transducer about the longitudinal axis.  
   
   
       26 . The method of  claim 25 , wherein rotating the ultrasonic transducer about the longitudinal axis includes a 360 degree rotation.  
   
   
       27 . The method of  claim 26 , further including providing an accelerometer to determine when the 360 degree rotation is complete and notifying the user of a complete revolution.  
   
   
       28 . The method of  claim 26 , wherein the plurality of acoustic signals are sent and the plurality of reflected signals are received at a plurality of points of rotation.  
   
   
       29 . The method of  claim 28 , wherein at least 3 reflected signals are received at different points of rotation.  
   
   
       30 . The method of  claim 29 , wherein at least 5 reflected signals are received at different points of rotation.  
   
   
       31 . The method of  claim 24 , wherein the plurality of acoustic signals are emitted by an array of acoustic transducers.  
   
   
       32 . The method of  claim 31 , wherein the array of acoustic transducers are a phased array.  
   
   
       33 . The method of  claim 24 , further including: 
 calculating a plurality of first points identifying a boundary of the lesion based on the reflected signals;    moving the acoustic transducer with respect to the lesion;    emitting a second plurality of acoustic signals into the lesion;    receiving a second plurality of reflected signals; and    calculating a plurality of second points identifying the boundary of the lesion based on the second plurality of reflected signals.    
   
   
       34 . The method of  claim 33 , wherein said determining includes selecting at least one three-dimensional geometric shape as the best fit for the plurality of first and second points.  
   
   
       35 . The method of  claim 34 , wherein the three-dimensional geometric shape is selected from the group of sphere, pyramid, cylinder, cube or cone.  
   
   
       36 . A method of removing of a lesion of a bone, comprising: 
 determining the volume of the lesion void by placing a hand-held ultrasonic device within the lesion void; and    debriding the lesion to produce a cavity in the bone substantially free of lesion.    
   
   
       37 . The method of  claim 33 , further including after said debriding, detecting any remaining lesion with the ultrasonic device.  
   
   
       38 . The method of  claim 34 , further including removing any remaining lesion from the bone.  
   
   
       39 . The method of  claim 35 , further including filling the void with a bone void filler corresponding to the volume determined by the ultrasonic device.  
   
   
       40 . The method of  claim 34 , further including at least partially filling the void with a conductive substance after said debriding and before said detecting.  
   
   
       41 . The method of  claim 37 , wherein said conductive substance is a saline solution.  
   
   
       42 . The method of  claim 37 , wherein the conductive substance is a flowable material packed into the bone cavity.  
   
   
       43 . The method of  claim 39 , wherein the flowable material is a bone growth promoting substance.  
   
   
       44 . The method of  claim 37 , wherein said determining includes alerting the user to presence of materials other than bone and the conductive substance.  
   
   
       45 . The method of  claim 33 , further including filling the void with a bone void filler.  
   
   
       46 . The method of  claim 42 , wherein the bone void filler is an osteoinductive material.  
   
   
       47 . The method of  claim 42 , wherein the bone void filler is an osteoconductive material.  
   
   
       48 . The method of  claim 42 , wherein the bone void filler includes autograft bone.  
   
   
       49 . The method of  claim 42 , wherein the bone void filler includes allograft bone.  
   
   
       50 . A surgical instrument for sensing and manipulation, comprising: 
 a tissue manipulation device having a proximal end adapted for engaging tissue;    an energy source disposed on said tissue manipulation device adjacent said proximal end and adapted for emitting an energy signal into the tissue, the energy signal configured to pass through the tissue and at least partially reflect off a boundary between the tissue and a substance different than the tissue;    a sensor adapted for detecting the reflected signal; and    a processor for determining the presence of the substance different than the tissue based on the reflected signal.    
   
   
       51 . The surgical instrument of  claim 47 , wherein said tissue manipulation device is a tamp.  
   
   
       52 . The surgical instrument of  claim 47 , wherein said tissue manipulation device is a tissue removal device.  
   
   
       53 . The surgical instrument of  claim 47 , wherein said tissue manipulation device is a grasper.  
   
   
       54 . The surgical instrument of  claim 47 , further including an optic lens disposed adjacent said tissue manipulation device and configured at least in part for viewing said proximal end.  
   
   
       55 . A kit for treatment of a lesion of a bone, comprising: 
 a first container adapted for holding a first volume of bone void filler;    a second container adapted for holding a second volume of bone void filler, the second volume being greater than the first volume; and    a hand-held ultrasonic device adapted for determining the volume of a lesion of a bone and indicating which of the first container or the second container corresponds to the volume of the lesion.    
   
   
       56 . The kit of  claim 55 , further including a third container adapted for holding a third volume of bone void filler, the third volume being greater than the second volume, wherein the hand-held ultrasonic device is adapted for determining the volume of a lesion of a bone and indicating which of the first container, second container, or third container corresponds to the volume of the lesion.  
   
   
       57 . A system for detection and removal of a lesion in a tissue, comprising: 
 an energy source adapted for emitting an energy signal into the lesion, the energy signal configured to pass through the lesion and at least partially return a reflected signal off a boundary between the lesion and the tissue;    a sensor adapted for detecting the reflected signal;    a processor adapted for determining the three-dimensional location and approximate volume of the lesion based on the reflected signal and providing a control signal; and    an automated lesion removal tool, said automated lesion removal tool guided by said control signal to remove the lesion from the tissue.    
   
   
       58 . A handheld surgical instrument for use in detecting a foreign body within a tissue, comprising: 
 a housing having an external gripping portion and a sensor portion having a conductive surface, the sensor portion adapted to be in conductive contact with a surface of the tissue;    an energy source adapted for emitting an energy signal into the tissue, the energy signal configured to pass through the tissue and at least partially reflect off a boundary between the foreign body and the tissue;    a sensor adapted for detecting the reflected signal; and    a processor for determining a characteristic of the foreign body based on the reflected signal.    
   
   
       59 . The surgical instrument of  claim 58 , wherein the energy source and the sensor are components of an ultrasonic transducer.  
   
   
       60 . The surgical instrument of  claim 58 , wherein the energy source is configured to emit acoustic signals at a plurality of frequencies.  
   
   
       61 . The surgical instrument of  claim 60 , wherein the plurality of frequencies include frequencies in a range between 15 KHz and 100 MHz.  
   
   
       62 . The surgical instrument of  claim 61 , wherein the plurality of frequencies include frequencies in a range between 20 KHz to approximately 20 MHz.  
   
   
       63 . The surgical instrument of  claim 58 , wherein the energy source uses RF energy.  
   
   
       64 . The surgical instrument of  claim 58 , wherein the energy source uses light energy.  
   
   
       65 . The surgical instrument of  claim 58 , wherein the energy source uses electromagnetic energy.  
   
   
       66 . The surgical instrument of  claim 58 , further including an accelerometer adapted to monitor the relative position of the surgical instrument with respect to an initial reference point.  
   
   
       67 . The surgical instrument of  claim 58 , further including a gyroscope adapted to monitor the relative position of the surgical instrument with respect to an initial reference point.  
   
   
       68 . The surgical instrument of  claim 58 , further including fiducial markers adapted to provide data for producing a three-dimensional image of the foreign body within the tissue.  
   
   
       69 . The surgical instrument of  claim 58 , further including a plurality of energy sources.  
   
   
       70 . The surgical instrument of  claim 69 , wherein each of the plurality of energy sources are adapted to emit acoustic signals at a different frequency.  
   
   
       71 . The surgical instrument of  claim 69 , wherein the plurality of energy sources are adapted to emit acoustic signals as a phased array.  
   
   
       72 . The surgical instrument of  claim 58 , further including an output mechanism adapted to produce an indicator of the presence of the foreign body.  
   
   
       73 . The surgical instrument of  claim 72 , wherein the output mechanism is a visual display.  
   
   
       74 . The surgical instrument of  claim 72 , wherein the indicator is an audible signal.  
   
   
       75 . The surgical instrument of  claim 72 , wherein the characteristic of the foreign body determined by the signal process is a volume of the foreign body.  
   
   
       76 . The surgical instrument of  claim 58 , wherein at least one of the housing, energy source, sensor, or processor is adapted to degrade during sterilization to limit the surgical instrument to single use applications.  
   
   
       77 . A method of detecting a foreign body within a tissue, comprising: 
 placing an energy transducer and a sensor in conductive contact with the tissue, the energy transducer adapted to emit energy signals and the sensor adapted to receive reflected energy signals, the energy transducer and the sensor positioned within a portable handheld device;    emitting an energy signal into the tissue, the energy signal adapted to pass through the tissue and at least partially reflect off a boundary of the foreign body within the tissue;    receiving at least a portion of the reflected signal at the sensor; and    determining a characteristic of the foreign body based on the portion of the reflected signal received.    
   
   
       78 . The method of  claim 77 , further including emitting a plurality of energy signals into the lesion and receiving a plurality of reflected signals.  
   
   
       79 . The method of  claim 78 , further comprising moving the portable handheld device about surface of the tissue while emitting the plurality of energy signals and receiving the plurality of reflected signals.  
   
   
       80 . The method of  claim 79 , further comprising utilizing an accelerometer to determine the position of the handheld device relative to an initial point.  
   
   
       81 . A method of removing a foreign body from a tissue, comprising: 
 detecting the presence of the foreign body within the tissue by placing a hand-held device in conductive contact with the tissue, the hand-held device comprising 
 an energy source adapted for emitting an energy signal into the tissue, the energy signal configured to pass through the tissue and at least partially reflect off a boundary between the foreign body and the tissue;  
 a sensor adapted for detecting the reflected signal; and  
 a processor for determining a characteristic of the foreign body based on the reflected signal;  
   determining the location and volume of the foreign body using the hand-held device;    utilizing the location and volume of the foreign body to guide a surgical instrument to the foreign body; and    removing the foreign body with the surgical instrument.    
   
   
       82 . The method of  claim 81 , wherein the surgical instrument is electronically guided to the foreign body using the location and volume information of the foreign body.  
   
   
       83 . The method of  claim 81 , further comprising coupling the hand-held device to the surgical instrument prior to removing the foreign body with the surgical instrument.