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1
Laboratoire AmpèreUMR CNRS 5005
Electrical Engineering, Electromagnetism, Control, E nvironmental Microbiology and Applications
Design of a Design of a medicalmedical simulator for simulator for subcutaneoussubcutaneous contraceptive contraceptive
implant insertionimplant insertion
A.Jardin *, R.Moreau*, M.T.Pham*, A.Mallet*, T.Redarce* and O.Dupuis**
* Laboratoire Ampère** Centre Hospitalier Universitaire de Lyon
2
Table of contentsTable of contents
2
Table of contentsTable of contents
1. Introduction
2
Table of contentsTable of contents
1. Introduction
2. Task description: details on implant insertion
2
Table of contentsTable of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods3.1. Simulator components3.2. Criteria of the gesture evaluation
2
Table of contentsTable of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods3.1. Simulator components3.2. Criteria of the gesture evaluation
4. Experimental results4.1. Protocol4.2. Results
2
Table of contentsTable of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods3.1. Simulator components3.2. Criteria of the gesture evaluation
4. Experimental results4.1. Protocol4.2. Results
5. Conclusion and perspectives
3
Table of contentsTable of contents
1. Introduction
2. Task description: details on implant insertion
5. Conclusion and perspectives
3. Materials and methods3.1. Simulator components3.2. Criteria of the gesture evaluation
4. Experimental results4.1. Protocol4.2. Results
4
1. Introduction1. Introduction
� Context
+ Improvement of contraceptive methods for bringing more comfort
���� Development of implants
4
1. Introduction1. Introduction
� Context
+ Improvement of contraceptive methods for bringing more comfort
���� Development of implants
- Lack of practice before the first insertion
����"77 % of unintended pregnancies under contraceptive i mplants are due to a bad insertion " (L.Bensouda-Grimaldi et al., 2005)
4
1. Introduction1. Introduction
� Context
+ Improvement of contraceptive methods for bringing more comfort
���� Development of implants
- Lack of practice before the first insertion
����"77 % of unintended pregnancies under contraceptive i mplants are due to a bad insertion " (L.Bensouda-Grimaldi et al., 2005)
� ObjectiveDesign a suitable training and certification tool for doctors
���� new medical simulator
5
1. Introduction1. Introduction
� Advantages of a simulator
- Train novices without putting the well-being of patients in danger
5
1. Introduction1. Introduction
� Advantages of a simulator
- Train novices without putting the well-being of patients in danger
- Make easier the gesture learning by bypassing the constraints during an actual insertion
5
1. Introduction1. Introduction
� Advantages of a simulator
- Train novices without putting the well-being of patients in danger
- Make easier the gesture learning by bypassing the constraints during an actual insertion
� Learning constraints in an actual insertion
1. The gesture occurs in the arm���� the novice can not see the instructor gesture
5
1. Introduction1. Introduction
� Advantages of a simulator
- Train novices without putting the well-being of patients in danger
- Make easier the gesture learning by bypassing the constraints during an actual insertion
� Learning constraints in an actual insertion
1. The gesture occurs in the arm���� the novice can not see the instructor gesture
���� the experienced doctor can not validate the novice inse rtion
5
1. Introduction1. Introduction
� Advantages of a simulator
- Train novices without putting the well-being of patients in danger
- Make easier the gesture learning by bypassing the constraints during an actual insertion
� Learning constraints in an actual insertion
1. The gesture occurs in the arm���� the novice can not see the instructor gesture
���� the experienced doctor can not validate the novice inse rtion
2. First insertions are often akward because of stress
6
Table of contentsTable of contents
1. Introduction
2. Task description: details on implant insertion
5. Conclusion and perspectives
3. Materials and methods3.1. Simulator components3.2. Criteria of the gesture evaluation
4. Experimental results4.1. Protocol4.2. Results
7
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant type– Single-rod of 40mm long and 2mm in diameter– Containing etonogestrel– Duration of three years– As effective as a contraceptive pill
� The tool for insertion
Applicator
Implant
Obturator
Complete device
http://hcp.organon.com
8
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant insertion
http://hcp.organon.com
8
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant insertion
http://hcp.organon.com
Step 1
- Introduce the needle under the skin, in the upper-arm, 60-80 mm above the elbow
http:// hcp .organon. com
8
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant insertion
http://hcp.organon.com
Step 1
- Introduce the needle under the skin, in the upper-arm, 60-80 mm above the elbow
http:// hcp .organon. com
Step 2
- Lower the applicator to a position parallel to the skin
8
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant insertion
http://hcp.organon.com
Step 1
- Introduce the needle under the skin, in the upper-arm, 60-80 mm above the elbow
http:// hcp .organon. com
Step 2
- Lower the applicator to a position parallel to the skin
Step 3
- Lift the skin- Insert the full length of the needle
http:// hcp .organon. com
8
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant insertion
http://hcp.organon.com
Step 1
- Introduce the needle under the skin, in the upper-arm, 60-80 mm above the elbow
http:// hcp .organon. com
Step 2
- Lower the applicator to a position parallel to the skin
Step 3
- Lift the skin- Insert the full length of the needle
http:// hcp .organon. com
Step 4
- Press down the obturatorsupport - Turn the obturator 90°
8
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant insertion
http://hcp.organon.com
Step 1
- Introduce the needle under the skin, in the upper-arm, 60-80 mm above the elbow
http:// hcp .organon. com
Step 2
- Lower the applicator to a position parallel to the skin
Step 3
- Lift the skin- Insert the full length of the needle
http:// hcp .organon. com
Step 4
- Press down the obturatorsupport - Turn the obturator 90°
8
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant insertion
http://hcp.organon.com
Step 1
- Introduce the needle under the skin, in the upper-arm, 60-80 mm above the elbow
http:// hcp .organon. com
Step 2
- Lower the applicator to a position parallel to the skin
Step 3
- Lift the skin- Insert the full length of the needle
http:// hcp .organon. com
Step 4
- Press down the obturatorsupport - Turn the obturator 90°
Step 5
- Keep the obturator fixed- Pull out the canula
8
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant insertion
http://hcp.organon.com
Step 1
- Introduce the needle under the skin, in the upper-arm, 60-80 mm above the elbow
http:// hcp .organon. com
Step 2
- Lower the applicator to a position parallel to the skin
Step 3
- Lift the skin- Insert the full length of the needle
http:// hcp .organon. com
Step 4
- Press down the obturatorsupport - Turn the obturator 90°
Step 5
- Keep the obturator fixed- Pull out the canula
8
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� The implant insertion
http://hcp.organon.com
Step 1
- Introduce the needle under the skin, in the upper-arm, 60-80 mm above the elbow
http:// hcp .organon. com
Step 2
- Lower the applicator to a position parallel to the skin
Step 3
- Lift the skin- Insert the full length of the needle
http:// hcp .organon. com
Step 4
- Press down the obturatorsupport - Turn the obturator 90°
Step 5
- Keep the obturator fixed- Pull out the canula
Step 6
- Check the correctness of the insertion by palpating the implant
9
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� Good insertion- Palpable implant- No pain- Easy removal
Diagram of the different skin layers� Bad insertion
- Impalpable implant- Pain- Lower efficiency- Surgical intervention
�The implant must be placedat a limited depth !
(~3 or 4 mm)
9
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� Good insertion- Palpable implant- No pain- Easy removal
Diagram of the different skin layers� Bad insertion
- Impalpable implant- Pain- Lower efficiency- Surgical intervention
�The implant must be placedat a limited depth !
(~3 or 4 mm)
9
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� Good insertion- Palpable implant- No pain- Easy removal
Diagram of the different skin layers� Bad insertion
- Impalpable implant- Pain- Lower efficiency- Surgical intervention
�The implant must be placedat a limited depth !
(~3 or 4 mm)
9
2. 2. TaskTask descriptiondescriptionMedicalMedical detailsdetails on implant insertionon implant insertion
� Good insertion- Palpable implant- No pain- Easy removal
Diagram of the different skin layers� Bad insertion
- Impalpable implant- Pain- Lower efficiency- Surgical intervention
�The implant must be placedat a limited depth !
(~3 or 4 mm)
10
Table of contentsTable of contents
1. Introduction
2. Task description: details on implant insertion
5. Conclusion and perspectives
3. Materials and methods3.1. Simulator components3.2. Criteria of the gesture evaluation
4. Experimental results4.1. Protocol4.2. Results
11
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Principle: 2 components
11
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Principle: 2 components
- Mechanical component:- arm, insertion tool, sensors- PC
11
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Principle: 2 components
- Mechanical component:- arm, insertion tool, sensors- PC
- Software component:- programming- data acquisition- visual interfacing
11
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Principle: 2 components
- Mechanical component:- arm, insertion tool, sensors- PC
- Software component:- programming- data acquisition- visual interfacing
� 2 operating modes
11
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Principle: 2 components
- Mechanical component:- arm, insertion tool, sensors- PC
- Software component:- programming- data acquisition- visual interfacing
� 2 operating modes
- ‘Training’ mode
11
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Principle: 2 components
- Mechanical component:- arm, insertion tool, sensors- PC
- Software component:- programming- data acquisition- visual interfacing
� 2 operating modes
- ‘Training’ mode
- ‘Certification’ mode
12
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Mechanical componentIndexing
pivot joint
Global view of the simulator
Sensor
TransmitterArm
Bracelet
Sensor
Support
12
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Mechanical componentIndexing
pivot joint
Global view of the simulator
Sensor
TransmitterArm
Bracelet
Sensor
Support
The bracelet of the wristIndexing pivot joint at the shoulder
- 5 orientations (3 are correct)
12
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Mechanical componentIndexing
pivot joint
Global view of the simulator
Sensor
TransmitterArm
Bracelet
Sensor
Support
The bracelet of the wristIndexing pivot joint at the shoulder
- 5 orientations (3 are correct)
- Improve the arm stiffness
12
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Mechanical componentIndexing
pivot joint
Global view of the simulator
Sensor
TransmitterArm
Bracelet
Sensor
Support
The bracelet of the wristIndexing pivot joint at the shoulder
- 5 orientations (3 are correct)
- Improve the arm stiffness
- Indexing system
12
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Mechanical componentIndexing
pivot joint
Global view of the simulator
Sensor
TransmitterArm
Bracelet
Sensor
Support
The bracelet of the wristIndexing pivot joint at the shoulder
- 5 orientations (3 are correct)
- Improve the arm stiffness
- Indexing system
- Repeatable orientations
13
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Instrumentation
- MiniBird® (6 DOF electromagneticsensors) for:
- the arm- the obturator- the applicator
13
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Instrumentation
- MiniBird® (6 DOF electromagneticsensors) for:
- the arm- the obturator- the applicator
- Adaptation pieces:���� ABS���� small
Adaptation pieces
14
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Software component
- ControlDesk���� data treatment
14
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Software component
- ControlDesk���� data treatment
- Matlab/Simulink���� programming���� trajectories analysis
14
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Software component
- ControlDesk���� data treatment
- Matlab/Simulink���� programming���� trajectories analysis
- MotionDesk���� 3D visualization
14
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Software component
- ControlDesk���� data treatment
- Matlab/Simulink���� programming���� trajectories analysis
- MotionDesk���� 3D visualization
Arm profile
Visual guide
14
3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components
� Software component
- ControlDesk���� data treatment
- Matlab/Simulink���� programming���� trajectories analysis
- MotionDesk���� 3D visualization
Arm profile
Visual guide
15
3. 3. MaterialsMaterials and methodsand methods3.2. 3.2. CriteriaCriteria of the of the gesturegesture evaluationevaluation
� Three selected criteria
1. The arm orientation� In supination
15
3. 3. MaterialsMaterials and methodsand methods3.2. 3.2. CriteriaCriteria of the of the gesturegesture evaluationevaluation
� Three selected criteria
1. The arm orientation� In supination
2. The location of the impact point���� In the groove between the biceps and the triceps���� Target zone: ~ 5cm x 3.5 cm
15
3. 3. MaterialsMaterials and methodsand methods3.2. 3.2. CriteriaCriteria of the of the gesturegesture evaluationevaluation
� Three selected criteria
1. The arm orientation� In supination
2. The location of the impact point���� In the groove between the biceps and the triceps���� Target zone: ~ 5cm x 3.5 cm
3. The maximum depth���� Limit fixed to 4 mm
15
3. 3. MaterialsMaterials and methodsand methods3.2. 3.2. CriteriaCriteria of the of the gesturegesture evaluationevaluation
� Three selected criteria
1. The arm orientation� In supination
2. The location of the impact point���� In the groove between the biceps and the triceps���� Target zone: ~ 5cm x 3.5 cm
3. The maximum depth���� Limit fixed to 4 mm
� Difficulties
15
3. 3. MaterialsMaterials and methodsand methods3.2. 3.2. CriteriaCriteria of the of the gesturegesture evaluationevaluation
� Three selected criteria
1. The arm orientation� In supination
2. The location of the impact point���� In the groove between the biceps and the triceps���� Target zone: ~ 5cm x 3.5 cm
3. The maximum depth���� Limit fixed to 4 mm
� Difficulties � Detect the impact point
15
3. 3. MaterialsMaterials and methodsand methods3.2. 3.2. CriteriaCriteria of the of the gesturegesture evaluationevaluation
� Three selected criteria
1. The arm orientation� In supination
2. The location of the impact point���� In the groove between the biceps and the triceps���� Target zone: ~ 5cm x 3.5 cm
3. The maximum depth���� Limit fixed to 4 mm
� Difficulties � Detect the impact point
� Evaluate the tool depth
16
3. 3. MaterialsMaterials and methodsand methods3.2. 3.2. CriteriaCriteria of the of the gesturegesture evaluationevaluation
� Impact point detection
- Meshing of the target skin area (measures)
- Comparison between the altitudes
ε≤− SkinTipApplicator ZZ
17
3. 3. MaterialsMaterials and methodsand methods3.2. 3.2. CriteriaCriteria of the of the gesturegesture evaluationevaluation
� Depth evaluation
Arm
NeedleTangent plane
Impact point
Arm profile ~ plane tangent to the skin at the impact point:
- Meshing
- Polynomial approximation
17
3. 3. MaterialsMaterials and methodsand methods3.2. 3.2. CriteriaCriteria of the of the gesturegesture evaluationevaluation
� Depth evaluation
Arm
NeedleTangent plane
Impact point
Arm profile ~ plane tangent to the skin at the impact point:
- Meshing
- Polynomial approximation
Depth ~ altitude in the plane:- orthogonal to the tangent plane- parallel to the arm axis
Z axis
18
Table of contentsTable of contents
1. Introduction
2. Task description: details on implant insertion
5. Conclusion and perspectives
3. Materials and methods3.1. Simulator components3.2. Criteria of the gesture evaluation
4. Experimental results4.1. Protocol4.2. Results
19
4. 4. ExperimentalExperimental resultsresults4.1. Protocol4.1. Protocol
� Operators- One experienced doctor- Seven novices
� Experimental protocol
1. Position the arm
2. Palpate the arm and point out the intended location for insertion
3. Insert the implant (data recording)
20
4. 4. ExperimentalExperimental resultsresults4.2. 4.2. ResultsResults
Axis XTool progressalong the arm
Axis ZAltitude of the instrument tip
xOz planeOrthogonal to the tangent plane atthe impact point
21
Table of contentsTable of contents
1. Introduction
2. Task description: details on implant insertion
5. Conclusion and perspectives
3. Materials and methods3.1. Simulator components3.2. Criteria of the gesture evaluation
4. Experimental results4.1. Protocol4.2. Results
22
5. Conclusion5. Conclusion
� The prototype- Visual interface coupled with a mechanical component- Gesture learning (on-line)- Trajectories analysis (off-line)- First experiments validate simulator principles
22
5. Conclusion5. Conclusion
� The prototype- Visual interface coupled with a mechanical component- Gesture learning (on-line)- Trajectories analysis (off-line)- First experiments validate simulator principles
� Perspectives- Purchase a new arm- Refine the graphical interface- Carry out a new study with a larger population of novices