• SIGNIFICANCE

    To promote principals of process improvement for the patient, surgeon and hospital

  • The Baby Boomers are the largest population segment that are putting stresses on the health care system. Needing more intensive surgical intervention, They are the single most marke

  • Affordable health care act of 2013 (Obama Care) will add 30% increase to patient population into the healthcare system

  • Pay for performance vs pay for service payment modal will cause surgeons to take greater care which translates into greater times.

  • Accuracy in the performance in the procedures will be a measurable component of all surgeries.

  • INOVATION

    Using geometry, radiopaque markers and laser light to calculate, plot and navigate surgical introducers, guide pins and instrumentation into the human body.

  • USE OF THE GRANT

    To identify needed tools and people to insure proof of concept is sound.

  • REDUCE RADIATION EXPOSURE

    The total time the patient, surgeon and staff are exposed to radiation

  • REDUCE RADIATION DOSE

    The radiation intensity or technique used to acquire adequate imaging to preform the procedure

  • REDUCE PROCEDURE TIME

    The time it takes to do a specific part of the surgery

  • REDUCE PROCEDURE REPETE RATE

    The number of times it takes to do procedure right

  • Hip FX

  • Vertebral Compression FX

  • Spondilotisis of Spine

  • Hand, Wrist and Arm FX

  • Foot, Ankle and leg FX

  • Knee Ligiments

  • Tumor and biopsies

  • Hardware Removal

  • Current surgical capacity can not handle the increase in procedural requests that will be a result in this increase.

  • Need process improvements to streamline current infrastructure to handle increase in patient population.

  • Revision rates will be forced down and reported via PQRS and HQA reporting. If Surgeons fail to report they will be penalized monitaraly.

  • MORBIDITY

    The complexity that certain surgeries can take due to inefficiencies contribute to longer surgical times.

  • PROCESS

    Pre operative

    Review of an Axial view of area of interest.

  • Pre surgery

    Position patient on surgical table in the prone position. sterile prep and drape technique applied to patients area of interest.

  • Device alignment

    Attach SLaTS to the II and calibrate to 0”/ 0º and place over patient. turn on laser and center over center of spine using visual landmarks

  • SKIN PORT

    Prepare guide wire for incursion into pedicel of interest.
    Using a diamond tip guide wire, pierce the skin to gain initial purchase of a few mm. Align guide wire to the laser light. Using Pre Operative angel information, tilt guide wire later/medial to desired angel.

  • We can introduce a guide wire holder at this point to reduce surgeons direct exposure to primary beam of x ray.

  • Once x, y planes are established, the guide wire can be advanced. Advance until guide wire contacts bone. Take a snap shot in the lateral view and verify trajectory and depth.

    Turn off Laser.

  • Once “y” plane is established, move C Arm into AP view. Verify the tip of guide wire is over pre established land mark.

  • BONE PORT

    Once guide wire is in correct position, advance 1 cm through cortical bone. And position C Arm into lateral view. Take a snapshot and verify guide wire is advancing half or less the distance than in the lateral view.

    Position C Arm back to AP view

  • Tap guide wire through softer cancellous bone a few more cm. this should be less effort if a center pedicel trajectory is desired.

  • Take a snapshot in the AP view and verify guide wire is advancing half or less the distance than in the lateral view until the guide pin reaches the inside of the last 1/3 of the medial wall of the pedicle.

    Position C Arm back to Lateral view.

  • Take a snapshot in the lateral view and verify guide wire is passing or through the posterior wall of the vertebral body. Once through the posterior wall has been breached the guide wire can safely be advanced in the lateral view to its proper depth.

  • Product concept
    Evaluation of concept of surgeons is necessary for relevance and need.

  • Design and engineering of device is essential in creating an effective and versatile unit that can accommodate for multiple angles and wide distances across the face of the image intensifier.

  • Cadaver lab evaluation to prove concept is necessary for function and design to be tested.

  • Research papers to document the effectiveness of SLaTS would add to the overall benefit of the project and keep our progress relevant.

  • Energy consumption

    • Reducing the SID by moving II in
      computer algorithms
  • Laser light identifies the skin starting point in AP & Lateral

    Lateral Laser also gives you lateral Angle

  • Build out more facility, equipment and hire more personnel with less reimbursement per procedure.

  • Surgeon and Hospital have financial responsibility for revision surgeries.

  • longer an incision is open to the air the more likely the patient will acquire an infection or other complication.

  • Draw a center line through body of vertebra, spines process and skin.

  • Determine the path through the pedicle that establishes appropriate placement in the body of vertebra, med. lat.

  • Draw a plumb line on the Axial image down through the anatomy till it intersects a bony landmark.

  • Preserve the kyphosis

    Break table and open disc spaces

  • Slide marker left or right 5cm - 9cm off center and take a snap shot of fluoro/x ray to visualize AP landmark under marker. Make adjustments if necessary and repeat.

    Draw a line over laser light with skin marker.

    Turn laser light off.

  • Position C Arm to the lateral position and center over area interest. Slide marker north or south and match angle of marker to the kyphosis of patient. Turn laser light on and take snap shot of fluoro/x ray to visualize pedicel behind marker. Make adjustment if necessary and repeat.

    Draw a line and cross sect the AP line to establish SKIN PORT

    leave laser light on.

    • Manual

      Long forceps can be clamped onto guide wire and stabilized by hand in the x, y planes.

    • Robotic

      Using a bed rail mounted robotic guide wire poisoner (iSYS), place sterile arms into device over SKIN PORT. Using joystick control angle guide wire in the x, y planes.

    • Only make small adjustments superior or inferior at this point. pull guide wire back in the same trajectory it was inserted. 1 cm for every 1 degree of angel change.

    • Only make small adjustments medial or lateral at this point. Pull guide wire back in the same trajectory as it was inserted. 1 cm for every half degree of angle change.

    • Depending on desired END POINT in the vertebral body, the guide pin should not appear to advance faster in the AP than in the lateral. This insures the guide wire is positioned well and unlikely to violate the medial wall of the pedicel. If it appears to be coming across too quickly, swop out the stilet to a beveled tip and use the natural directional nature of the bevel tip to steer the guide wire back into safe parameters.

    • In some cases an off or cross angle, approach through the pedicel is desired to make contact points within the pedicel structure to create anti torc points within the construct. In these cases the advancement may be a bit more resistance throughout the placement.

    • Never cross the medial wall of the pedicle in the AP until you verify in the lateral view that guide wire is through the posterior wall of the vertebral body.

    • You may wish to obtain a bone biopsy or drill instead of advancing the guide wire through the vertebral body.

    • To build a prototype snap on laser device to facilitate positioning of radiopaque marker and laser line light.

    • If no bony landmark measure distance from exit point of midline marking at skin level to the exit point of the line through the pedicle at skin level.

    {"cards":[{"_id":"416ede9140c9b63b7d000012","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":0.5,"parentId":null,"content":"SIGNIFICANCE\n\nTo promote principals of process improvement for the patient, surgeon and hospital\n\n\n\n"},{"_id":"416ee59e40c9b63b7d000014","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":"416ede9140c9b63b7d000012","content":"REDUCE RADIATION EXPOSURE\n\nThe total time the patient, surgeon and staff are exposed to radiation"},{"_id":"416ef14840c9b63b7d000018","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416ee59e40c9b63b7d000014","content":"Energy consumption\n"},{"_id":"416ee67740c9b63b7d000015","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":3,"parentId":"416ede9140c9b63b7d000012","content":"REDUCE RADIATION DOSE\n\nThe radiation intensity or technique used to acquire adequate imaging to preform the procedure"},{"_id":"417f5f4c03d7855aa0000029","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416ee67740c9b63b7d000015","content":"* Reducing the SID by moving II in\ncomputer algorithms"},{"_id":"416ee6f340c9b63b7d000016","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":4,"parentId":"416ede9140c9b63b7d000012","content":"REDUCE PROCEDURE TIME\n\nThe time it takes to do a specific part of the surgery"},{"_id":"417f608903d7855aa000002a","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416ee6f340c9b63b7d000016","content":"Laser light identifies the skin starting point in AP & Lateral \n\nLateral Laser also gives you lateral Angle"},{"_id":"416ee86c40c9b63b7d000017","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":5,"parentId":"416ede9140c9b63b7d000012","content":"REDUCE PROCEDURE REPETE RATE\n\nThe number of times it takes to do procedure right"},{"_id":"416f1c58f8cf2dbd88000014","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":0.75,"parentId":null,"content":"The Baby Boomers are the largest population segment that are putting stresses on the health care system. Needing more intensive surgical intervention, They are the single most marke"},{"_id":"416f1c96f8cf2dbd88000015","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416f1c58f8cf2dbd88000014","content":"Hip FX"},{"_id":"416f1cf0f8cf2dbd88000016","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":"416f1c58f8cf2dbd88000014","content":"Vertebral Compression FX"},{"_id":"416f1d70f8cf2dbd88000017","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":3,"parentId":"416f1c58f8cf2dbd88000014","content":"Spondilotisis of Spine"},{"_id":"416f1e67f8cf2dbd88000018","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":4,"parentId":"416f1c58f8cf2dbd88000014","content":"Hand, Wrist and Arm FX"},{"_id":"416f1ee4f8cf2dbd88000019","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":5,"parentId":"416f1c58f8cf2dbd88000014","content":"Foot, Ankle and leg FX"},{"_id":"416f1f86f8cf2dbd8800001a","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":6,"parentId":"416f1c58f8cf2dbd88000014","content":"Knee Ligiments"},{"_id":"416f20bff8cf2dbd8800001b","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":7,"parentId":"416f1c58f8cf2dbd88000014","content":"Tumor and biopsies\n"},{"_id":"416f24e2f8cf2dbd8800001c","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":8,"parentId":"416f1c58f8cf2dbd88000014","content":"Hardware Removal"},{"_id":"416f26fef8cf2dbd8800001d","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":0.875,"parentId":null,"content":"Affordable health care act of 2013 (Obama Care) will add 30% increase to patient population into the healthcare system"},{"_id":"416f293cf8cf2dbd8800001e","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416f26fef8cf2dbd8800001d","content":"Current surgical capacity can not handle the increase in procedural requests that will be a result in this increase.\n"},{"_id":"4181fcee03d7855aa0000048","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416f293cf8cf2dbd8800001e","content":"Build out more facility, equipment and hire more personnel with less reimbursement per procedure."},{"_id":"418200b803d7855aa0000049","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":"416f26fef8cf2dbd8800001d","content":"Need process improvements to streamline current infrastructure to handle increase in patient population."},{"_id":"416f2e2ef8cf2dbd8800001f","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":0.9375,"parentId":null,"content":"Pay for performance vs pay for service payment modal will cause surgeons to take greater care which translates into greater times."},{"_id":"416f32f3f8cf2dbd88000020","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":0.96875,"parentId":null,"content":"Accuracy in the performance in the procedures will be a measurable component of all surgeries."},{"_id":"416f3590f8cf2dbd88000021","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416f32f3f8cf2dbd88000020","content":"Revision rates will be forced down and reported via PQRS and HQA reporting. If Surgeons fail to report they will be penalized monitaraly."},{"_id":"416f3fdcf8cf2dbd88000022","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416f3590f8cf2dbd88000021","content":"Surgeon and Hospital have financial responsibility for revision surgeries.\n"},{"_id":"416f8563f8cf2dbd88000023","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":"416f32f3f8cf2dbd88000020","content":"MORBIDITY\n\nThe complexity that certain surgeries can take due to inefficiencies contribute to longer surgical times. "},{"_id":"416f8a4cf8cf2dbd88000024","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416f8563f8cf2dbd88000023","content":"longer an incision is open to the air the more likely the patient will acquire an infection or other complication."},{"_id":"416ed18040c9b63b7d00000f","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":null,"content":"INOVATION\n\nUsing geometry, radiopaque markers and laser light to calculate, plot and navigate surgical introducers, guide pins and instrumentation into the human body."},{"_id":"416f9903f8cf2dbd88000027","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416ed18040c9b63b7d00000f","content":"PROCESS\n\nPre operative \n\nReview of an Axial view of area of interest. "},{"_id":"41700cf2f8cf2dbd88000028","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"416f9903f8cf2dbd88000027","content":"Draw a center line through body of vertebra, spines process and skin."},{"_id":"417016e7f8cf2dbd88000029","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":"416f9903f8cf2dbd88000027","content":"Determine the path through the pedicle that establishes appropriate placement in the body of vertebra, med. lat. "},{"_id":"4170295ff8cf2dbd8800002a","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":3,"parentId":"416f9903f8cf2dbd88000027","content":"Draw a plumb line on the Axial image down through the anatomy till it intersects a bony landmark."},{"_id":"41703c2df8cf2dbd8800002b","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"4170295ff8cf2dbd8800002a","content":"If no bony landmark measure distance from exit point of midline marking at skin level to the exit point of the line through the pedicle at skin level.\n"},{"_id":"417f686b03d7855aa000002b","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":"416ed18040c9b63b7d00000f","content":"Pre surgery\n\nPosition patient on surgical table in the prone position. sterile prep and drape technique applied to patients area of interest.\n"},{"_id":"417f8b4f03d7855aa000002c","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"417f686b03d7855aa000002b","content":"Preserve the kyphosis \n\nBreak table and open disc spaces\n\n"},{"_id":"417f99d003d7855aa000002d","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":3,"parentId":"416ed18040c9b63b7d00000f","content":"Device alignment\n\nAttach SLaTS to the II and calibrate to 0\"/ 0º and place over patient. turn on laser and center over center of spine using visual landmarks "},{"_id":"417fb87103d7855aa000002e","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"417f99d003d7855aa000002d","content":"Slide marker left or right 5cm - 9cm off center and take a snap shot of fluoro/x ray to visualize AP landmark under marker. Make adjustments if necessary and repeat.\n\nDraw a line over laser light with skin marker.\n\nTurn laser light off."},{"_id":"417fcd2903d7855aa000002f","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":"417f99d003d7855aa000002d","content":"Position C Arm to the lateral position and center over area interest. Slide marker north or south and match angle of marker to the kyphosis of patient. Turn laser light on and take snap shot of fluoro/x ray to visualize pedicel behind marker. Make adjustment if necessary and repeat. \n\nDraw a line and cross sect the AP line to establish SKIN PORT\n\nleave laser light on."},{"_id":"417fe6a103d7855aa0000031","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":3.5,"parentId":"416ed18040c9b63b7d00000f","content":"SKIN PORT\n\nPrepare guide wire for incursion into pedicel of interest. \nUsing a diamond tip guide wire, pierce the skin to gain initial purchase of a few mm. Align guide wire to the laser light. Using Pre Operative angel information, tilt guide wire later/medial to desired angel."},{"_id":"417fe12303d7855aa0000030","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":4,"parentId":"416ed18040c9b63b7d00000f","content":"We can introduce a guide wire holder at this point to reduce surgeons direct exposure to primary beam of x ray."},{"_id":"418006c303d7855aa0000033","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"417fe12303d7855aa0000030","content":"Manual\n\nLong forceps can be clamped onto guide wire and stabilized by hand in the x, y planes.\n"},{"_id":"41800a0803d7855aa0000034","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":"417fe12303d7855aa0000030","content":"Robotic\n\nUsing a bed rail mounted robotic guide wire poisoner (iSYS), place sterile arms into device over SKIN PORT. Using joystick control angle guide wire in the x, y planes. \n"},{"_id":"4180184a03d7855aa0000035","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":5,"parentId":"416ed18040c9b63b7d00000f","content":"Once x, y planes are established, the guide wire can be advanced. Advance until guide wire contacts bone. Take a snap shot in the lateral view and verify trajectory and depth.\n\nTurn off Laser."},{"_id":"41801d1903d7855aa0000036","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"4180184a03d7855aa0000035","content":"Only make small adjustments superior or inferior at this point. pull guide wire back in the same trajectory it was inserted. 1 cm for every 1 degree of angel change."},{"_id":"4180238f03d7855aa0000037","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":6,"parentId":"416ed18040c9b63b7d00000f","content":"Once \"y\" plane is established, move C Arm into AP view. Verify the tip of guide wire is over pre established land mark. "},{"_id":"41802de603d7855aa0000038","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"4180238f03d7855aa0000037","content":"Only make small adjustments medial or lateral at this point. Pull guide wire back in the same trajectory as it was inserted. 1 cm for every half degree of angle change."},{"_id":"4180341603d7855aa0000039","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":7,"parentId":"416ed18040c9b63b7d00000f","content":"BONE PORT\n\nOnce guide wire is in correct position, advance 1 cm through cortical bone. And position C Arm into lateral view. Take a snapshot and verify guide wire is advancing half or less the distance than in the lateral view.\n\nPosition C Arm back to AP view"},{"_id":"418048d203d7855aa000003a","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"4180341603d7855aa0000039","content":"Depending on desired END POINT in the vertebral body, the guide pin should not appear to advance faster in the AP than in the lateral. This insures the guide wire is positioned well and unlikely to violate the medial wall of the pedicel. If it appears to be coming across too quickly, swop out the stilet to a beveled tip and use the natural directional nature of the bevel tip to steer the guide wire back into safe parameters."},{"_id":"418055b303d7855aa000003b","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":8,"parentId":"416ed18040c9b63b7d00000f","content":"Tap guide wire through softer cancellous bone a few more cm. this should be less effort if a center pedicel trajectory is desired."},{"_id":"41805e2a03d7855aa000003c","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"418055b303d7855aa000003b","content":"In some cases an off or cross angle, approach through the pedicel is desired to make contact points within the pedicel structure to create anti torc points within the construct. In these cases the advancement may be a bit more resistance throughout the placement."},{"_id":"4180733203d7855aa000003d","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":9,"parentId":"416ed18040c9b63b7d00000f","content":"Take a snapshot in the AP view and verify guide wire is advancing half or less the distance than in the lateral view until the guide pin reaches the inside of the last 1/3 of the medial wall of the pedicle.\n\nPosition C Arm back to Lateral view."},{"_id":"418080b603d7855aa000003e","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"4180733203d7855aa000003d","content":"Never cross the medial wall of the pedicle in the AP until you verify in the lateral view that guide wire is through the posterior wall of the vertebral body."},{"_id":"418084fe03d7855aa000003f","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":10,"parentId":"416ed18040c9b63b7d00000f","content":"Take a snapshot in the lateral view and verify guide wire is passing or through the posterior wall of the vertebral body. Once through the posterior wall has been breached the guide wire can safely be advanced in the lateral view to its proper depth."},{"_id":"41808a7d03d7855aa0000040","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"418084fe03d7855aa000003f","content":"You may wish to obtain a bone biopsy or drill instead of advancing the guide wire through the vertebral body."},{"_id":"416ed72e40c9b63b7d000010","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":null,"content":"USE OF THE GRANT\n\nTo identify needed tools and people to insure proof of concept is sound."},{"_id":"4180c0f503d7855aa0000045","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1.5,"parentId":"416ed72e40c9b63b7d000010","content":"Product concept \nEvaluation of concept of surgeons is necessary for relevance and need."},{"_id":"4180b60903d7855aa0000042","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":2,"parentId":"416ed72e40c9b63b7d000010","content":"Design and engineering of device is essential in creating an effective and versatile unit that can accommodate for multiple angles and wide distances across the face of the image intensifier.\n"},{"_id":"4180bd8a03d7855aa0000043","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":1,"parentId":"4180b60903d7855aa0000042","content":"To build a prototype snap on laser device to facilitate positioning of radiopaque marker and laser line light."},{"_id":"4180be2603d7855aa0000044","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":3,"parentId":"416ed72e40c9b63b7d000010","content":"Cadaver lab evaluation to prove concept is necessary for function and design to be tested."},{"_id":"4180c77003d7855aa0000046","treeId":"416ed11f40c9b63b7d00000d","seq":1,"position":4,"parentId":"416ed72e40c9b63b7d000010","content":"Research papers to document the effectiveness of SLaTS would add to the overall benefit of the project and keep our progress relevant."}],"tree":{"_id":"416ed11f40c9b63b7d00000d","name":"SCOPE LASER TARGETING SYSTEM","publicUrl":"scope-laser-targeting-system"}}