What is claimed is:
1. A gravity dependent pedicle screw tap hole guide, comprising:
a guide shaft having a proximal end, a distal end, and a longitudinal axis, the guide shaft being maintainable parallel to a drill bit during the drilling of a pedicle screw tap hole with the drill bit;
an accelerometer associated with a reference direction and being responsive to gravity to determine an angular difference between an acting direction of gravity and the reference direction; and
a mounting by which the accelerometer is attached to the guide shaft, the mounting establishing a positional relationship between the reference direction and the longitudinal axis of the guide shaft.
2. The gravity dependent pedicle screw tap hole guide of claim 1, wherein the guide shaft is fixed to the accelerometer by the mounting such that the longitudinal axis of the guide shaft is parallel to the reference direction.
3. The gravity dependent pedicle screw tap hole guide of claim 1, wherein the mounting is adjustable such that the longitudinal axis of the guide shaft is angulatable with respect to the reference direction.
4. The gravity dependent pedicle screw tap hole guide of claim 3, wherein the mounting has at least one indicator that is viewable to determine an angular difference between the longitudinal axis of the guide shaft and the reference direction.
5. The gravity dependent pedicle screw tap hole guide of claim 3, wherein the mounting comprises at least one rotational mounting between the guide shaft and the accelerometer, the rotational mounting being engageable and disengageable at a plurality of positions including a parallel position and a plurality of rotated positions, the parallel position being a position at which the longitudinal axis of the guide shaft is parallel to the reference direction, each of the rotated positions being a respective position at which the longitudinal axis of the guide shaft is rotated with respect to the reference direction.
6. The gravity dependent pedicle screw tap hole guide of claim 5, wherein the mounting comprises first and second rotational mountings between the guide shaft and the accelerometer, the first rotational mounting providing rotation of the longitudinal axis of the guide shaft relative to the reference direction in a first plane, the second rotational mounting providing rotation of the longitudinal axis of the guide shaft relative to the reference direction in a second plane, the second plane being perpendicular to the first plane, such that the parallel position of the first rotational mounting is a position at which the longitudinal axis of the guide shaft is parallel to the reference direction in the first plane, and the parallel position of the second rotational mounting is a position at which the longitudinal axis of the guide shaft is parallel to the reference direction in the second plane, each of the rotated positions of the first rotational mounting being a respective position at which the longitudinal axis of the guide shaft is rotated with respect to the reference direction in the first plane, and each of the rotated positions of the second rotational mounting being a respective position at which the longitudinal axis of the guide shaft is rotated with respect to the reference direction in the second plane.
7. The gravity dependent pedicle screw tap hole guide of claim 6, wherein each of the first and second rotational mountings has angle markers associated therewith that are viewable to determine an angular difference between the longitudinal axis of the guide shaft and the reference direction.
8. The gravity dependent pedicle screw tap hole guide of claim 1, further comprising a data processing device in communication with the accelerometer.
9. The gravity dependent pedicle screw tap hole guide of claim 8, wherein the data processing device presents an indication of the angular difference.
10. The gravity dependent pedicle screw tap hole guide of claim 8, wherein the data processing device receives signals from the accelerometer, interprets the signals, determines data from the signals, and presents the data.
11. The gravity dependent pedicle screw tap hole guide of claim 8, wherein the data processing device receives signals from the accelerometer, interprets the signals, determines data from the signals, and directs a second device using the data.
12. The gravity dependent pedicle screw tap hole guide of claim 8, wherein the data processing device uses signals received from the accelerometer to perform an action.
13. The gravity dependent pedicle screw tap hole guide of claim 8, wherein the accelerometer uses signals received from the data processing system to perform an action.
14. A method of drilling a pedicle screw tap hole, comprising:
determining a trajectory angle as an angle of a pedicle in a reference plane relative to an acting direction of gravity;
positioning at least one of a distal end of a drill bit and a distal end of a guide shaft of a gravity dependent pedicle screw tap hole guide at a position adjacent the pedicle in a vicinity of a base of a superior articular process of the pedicle and a base and a middle of a transverse process of the pedicle, the guide having the guide shaft and an accelerometer associated with a reference direction, the accelerometer being responsive to gravity to determine an angular difference between an acting direction of gravity and the reference direction, the guide having a mounting by which the accelerometer is attached to the guide shaft, the mounting establishing a positional relationship between the reference direction and the longitudinal axis of the guide shaft;
angulating the guide shaft about the distal end of the guide shaft until the gravity dependent pedicle screw tap hole guide indicates that an angle between the longitudinal axis of the guide shaft in the reference plane and the acting direction of gravity matches the trajectory angle; and
rotating the drill bit into the pedicle along a trajectory extending into the pedicle from the position at the trajectory angle.
15. The method of drilling a pedicle screw tap hole of claim 14, wherein the trajectory angle is a first trajectory angle and the reference plane is a first reference plane, the method comprising:
determining the first trajectory angle as the angle of the pedicle in the first reference plane relative to the acting direction of gravity;
determining a second trajectory angle as an angle of the pedicle in a second reference plane relative to the acting direction of gravity;
positioning at least one of the distal end of the drill bit and the distal end of the guide shaft at the position;
angulating the guide shaft about the distal end of the guide shaft until the gravity dependent pedicle screw tap hole guide indicates that the angle between the longitudinal axis of the guide shaft in the first reference plane and the acting direction of gravity matches the first trajectory angle, and that an angle between the longitudinal axis of the guide shaft in the second reference plane and the acting direction of gravity matches the second trajectory angle; and
rotating the drill bit into the pedicle along a trajectory extending into the pedicle from the position at the first trajectory angle and the second trajectory angle.
16. The method of drilling a pedicle screw tap hole of claim 15, wherein the first reference plane is a cephalad-caudad plane defined by a vertebral body comprising the pedicle, and the second reference plane is a medial plane defined by the vertebral body.
17. The method of drilling a pedicle screw tap hole of claim 14, comprising:
determining the trajectory angle as the angle of the pedicle in the reference plane relative to the acting direction of gravity;
positioning the distal end of the guide shaft at the position;
angulating the guide shaft about the distal end of the guide shaft until the gravity dependent pedicle screw tap hole guide indicates that the angle between the longitudinal axis of the guide shaft in the reference plane and the acting direction of gravity matches the trajectory angle;
positioning the drill bit coaxial with the longitudinal axis of the guide shaft; and
rotating the drill bit into the pedicle along the trajectory extending into the pedicle from the position at the trajectory angle.
18. The method of drilling a pedicle screw tap hole of claim 14, comprising:
determining the trajectory angle as the angle of the pedicle in the reference plane relative to the acting direction of gravity;
positioning the distal end of the drill bit at the position;
maintaining the longitudinal axis of the guide shaft parallel to the drill bit while angulating the guide shaft about the distal end of the guide shaft until the gravity dependent pedicle screw tap hole guide indicates that the angle between the longitudinal axis of the guide shaft in the reference plane and the acting direction of gravity matches the trajectory angle; and
rotating the drill bit into the pedicle along the trajectory extending into the pedicle from the position at the trajectory angle.
19. The method of drilling a pedicle screw tap hole of claim 14, wherein determining the trajectory angle comprises:
establishing a vertical orientation of a clamp having a longitudinal axis by maintaining the longitudinal axis of the guide shaft parallel to the longitudinal axis of the clamp while angulating the guide shaft about the distal end of the guide shaft until the gravity dependent pedicle screw tap hole guide indicates that the longitudinal axis of the guide shaft is parallel to the acting direction of gravity;
attaching the clamp in the vertical orientation to a spinous process of a vertebral body comprising the pedicle;
generating an image including the vertebral body while the clamp is attached; and
determining from the image an angular difference between the orientation of the pedicle and the orientation of the clamp.
20. The method of drilling a pedicle screw tap hole of claim 19, wherein determining the trajectory angle further comprises obtaining at least one of an MRI image of the vertebral body, a CAT image of the vertebral body, and a radiograph image of the vertebral body.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A biosensor, comprising:
a first base material having an insulating surface;
an adhesive layer located on the insulating surface of the first base material; and
an electrode system and wiring sections fixed to the first base material via the adhesive layer;
wherein:
the electrode system includes top electrode layers and bottom electrode layers, and the bottom electrode layers are formed of a material having a higher conductivity than that of the top electrode layers;
the electrode system includes a working electrode and a counter electrode, and also includes an enzyme reaction section located on the working electrode, the enzyme reaction section containing an enzyme and an electron acceptor; and
the bottom electrode layers and the wiring sections are integral with each other.
2. A biosensor according to claim 1, wherein the bottom electrode layers and the wiring sections are formed of the same material.
3. A biosensor according to claim 1, wherein:
the electrode system includes at least one reference electrode; and
the reference electrode includes a top electrode layer and a bottom electrode layer, and the bottom electrode layer is formed of a material having a higher conductivity than that of the top electrode layer.
4. A biosensor according to claim 3, wherein the working electrode, the counter electrode and the reference electrode are each formed by covering at least a part of the bottom electrode layer with the top electrode layer.
5. A biosensor according to claim 1, wherein:
the top electrode layers contain carbon; and
the bottom electrode layers and the wiring sections contain either one of aluminum, copper and iron, or an alloy containing at least one of aluminum, copper and iron.
6. A biosensor according to claim 1, wherein:
the top electrode layers contain a carbon pigment and an organic binder; and
the top electrode layers have a thickness of 0.3 \u03bcm or greater and 30 \u03bcm or less.
7. A biosensor according to claim 1, wherein:
the second base material and the third base material are stacked sequentially above the first base material;
the second base material has a sample supply path leading to an outer edge of the second base material and the working electrode; and
the third base material is fixed to the first base material so as to cover the second base material.
8. A biosensor according to claim 1, further comprising a flow path communicated to the sample supply path and leading to an outer edge of the second base material.
9. A method for producing a biosensor, comprising:
forming an adhesive layer on an insulating surface of a first base material;
bonding a metal foil to the adhesive layer and patterning the metal foil to form bottom electrode layers and wiring sections integral with the bottom electrode layers; and
forming top electrode layers containing carbon on top surfaces of the bottom electrode layers to form an electrode system including a working electrode and a counter electrode.
10. A method for producing a biosensor according to claim 9, wherein the top electrode layers are formed by partially covering the bottom electrode layers with carbon by printing.
11. A method for producing a biosensor according to claim 9, wherein:
a second base material having a sample supply path and an air discharge flow path is formed by forming the adhesive layer is on each of a top surface and a bottom surface of a base material;
the second base material and a third base material are bonded together; and
the surface of the first base material on which the electrode system is formed is bonded to the second base material and the third base material.