1. Laboratoire Ampère
UMR CNRS 5005
Electrical Engineering, Electromagnetism, Control, Environmental Microbiology and Applications
Design of a medical simulator for
subcutaneous contraceptive
implant insertion
A.Jardin*, R.Moreau*, M.T.Pham*, A.Mallet*,
T.Redarce* and O.Dupuis**
* Laboratoire Ampère
** Centre Hospitalier Universitaire de Lyon
1

2. Table of contents
2

3. Table of contents
1. Introduction
2

4. Table of contents
1. Introduction
2. Task description: details on implant insertion
2

5. Table of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods
3.1. Simulator components
3.2. Criteria of the gesture evaluation
2

6. Table of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods
3.1. Simulator components
3.2. Criteria of the gesture evaluation
4. Experimental results
4.1. Protocol
4.2. Results
2

7. Table of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods
3.1. Simulator components
3.2. Criteria of the gesture evaluation
4. Experimental results
4.1. Protocol
4.2. Results
5. Conclusion and perspectives
2

8. Table of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods
3.1. Simulator components
3.2. Criteria of the gesture evaluation
4. Experimental results
4.1. Protocol
4.2. Results
5. Conclusion and perspectives
3

9. 1. Introduction
Context
+ Improvement of contraceptive methods for bringing more comfort
Development of implants
4

10. 1. Introduction
Context
+ Improvement of contraceptive methods for bringing more comfort
Development of implants
- Lack of practice before the first insertion
quot;77 % of unintended pregnancies under contraceptive implants
are due to a bad insertionquot; (L.Bensouda-Grimaldi et al., 2005)
4

11. 1. Introduction
Context
+ Improvement of contraceptive methods for bringing more comfort
Development of implants
- Lack of practice before the first insertion
quot;77 % of unintended pregnancies under contraceptive implants
are due to a bad insertionquot; (L.Bensouda-Grimaldi et al., 2005)
Objective
Design a suitable training and certification tool for doctors
new medical simulator
4

12. 1. Introduction
Advantages of a simulator
- Train novices without putting the well-being of patients in danger
5

13. 1. 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

14. 1. 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

15. 1. 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 insertion
5

16. 1. 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 insertion
2. First insertions are often akward because of stress
5

17. Table of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods
3.1. Simulator components
3.2. Criteria of the gesture evaluation
4. Experimental results
4.1. Protocol
4.2. Results
5. Conclusion and perspectives
6

18. 2. Task description
Medical details on 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
Complete
device Implant
Obturator
http://hcp.organon.com
7

19. 2. Task description
Medical details on implant insertion
The implant insertion
http://hcp.organon.com
8

20. 2. Task description
Medical details on implant insertion
The implant insertion
Step 1
- Introduce the needle under the
skin, in the upper-arm, 60-80 mm
above the elbow
http://hcp.organon.com
8

21. 2. Task description
Medical details on implant insertion
The implant insertion
1
Step 2
- Lower the the needle to a the
- Introduce applicator under
positionthe upper-arm, skin mm
skin, in parallel to the 60-80
above the elbow
http://hcp.organon.com
8

22. 2. Task description
Medical details on implant insertion
The implant insertion
1
Step 2
3
- Lift thethe the needle to a the
- Lower skin
Introduce applicator under
- Insert the full length of the mm
positionthe upper-arm, skin
skin, in parallel to the 60-80
needle the elbow
above
http://hcp.organon.com
8

23. 2. Task description
Medical details on implant insertion
The implant insertion
1
Step 2
4
3
- Lift thethe the needle to a the
- Lower down the obturator
Introduce applicator under
Press skin
- Insert the full length of the mm
support parallel to the 60-80
positionthe upper-arm, skin
skin, in
needle the elbow
above
- Turn the obturator 90°
http://hcp.organon.com
8

24. 2. Task description
Medical details on implant insertion
The implant insertion
1
Step 2
4
3
- Lift thethe the needle to a the
- Lower down the obturator
Introduce applicator under
Press skin
- Insert the full length of the mm
support parallel to the 60-80
positionthe upper-arm, skin
skin, in
needle the elbow
above
- Turn the obturator 90°
http://hcp.organon.com
8

25. 2. Task description
Medical details on implant insertion
The implant insertion
1
Step 2
5
4
3
- Lift thethe the needle to a the
- Lower down the obturator
Introduce applicator under
Keep skin
Pressthe obturator fixed
- Insert the full length of the mm
support parallel to the 60-80
positionthe upper-arm, skin
skin, in the canula
Pull out
needle the elbow
above
- Turn the obturator 90°
http://hcp.organon.com
8

26. 2. Task description
Medical details on implant insertion
The implant insertion
1
Step 2
5
4
3
- Lift thethe the needle to a the
- Lower down the obturator
Introduce applicator under
Keep skin
Pressthe obturator fixed
- Insert the full length of the mm
support parallel to the 60-80
positionthe upper-arm, skin
skin, in the canula
Pull out
needle the elbow
above
- Turn the obturator 90°
http://hcp.organon.com
8

27. 2. Task description
Medical details on implant insertion
The implant insertion
1
Step 2
5
4
3
6
- Lift thethe the needle toof the
- Lower down the obturator the
Introduce applicator under
Keep skin
Pressthe obturator fixed
correctness a
Check
- Insert the full length of the mm
positionthe upper-arm,the implant
insertion by palpating 60-80
skin, in the canula
support parallel to the skin
Pull out
needle the elbow
above
- Turn the obturator 90°
http://hcp.organon.com
8

28. 2. Task description
Medical details on implant insertion
Good insertion
- Palpable implant
- No pain
- Easy removal
Bad insertion
Diagram of the different skin layers
- Impalpable implant
- Pain
The implant must be placed
- Lower efficiency
at a limited depth !
- Surgical intervention
(~3 or 4 mm)
9

29. 2. Task description
Medical details on implant insertion
Good insertion
- Palpable implant
- No pain
- Easy removal
Bad insertion
Diagram of the different skin layers
- Impalpable implant
- Pain
The implant must be placed
- Lower efficiency
at a limited depth !
- Surgical intervention
(~3 or 4 mm)
9

30. 2. Task description
Medical details on implant insertion
Good insertion
- Palpable implant
- No pain
- Easy removal
Bad insertion
Diagram of the different skin layers
- Impalpable implant
- Pain
The implant must be placed
- Lower efficiency
at a limited depth !
- Surgical intervention
(~3 or 4 mm)
9

31. 2. Task description
Medical details on implant insertion
Good insertion
- Palpable implant
- No pain
- Easy removal
Bad insertion
Diagram of the different skin layers
- Impalpable implant
- Pain
The implant must be placed
- Lower efficiency
at a limited depth !
- Surgical intervention
(~3 or 4 mm)
9

32. Table of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods
3.1. Simulator components
3.2. Criteria of the gesture evaluation
4. Experimental results
4.1. Protocol
4.2. Results
5. Conclusion and perspectives
10

33. 3. Materials and methods
3.1. Simulator components
Principle: 2 components
11

34. 3. Materials and methods
3.1. Simulator components
Principle: 2 components
- Mechanical component:
- arm, insertion tool, sensors
- PC
11

35. 3. Materials and methods
3.1. Simulator components
Principle: 2 components
- Mechanical component:
- arm, insertion tool, sensors
- PC
- Software component:
- programming
- data acquisition
- visual interfacing
11

36. 3. Materials and methods
3.1. Simulator components
Principle: 2 components
- Mechanical component:
- arm, insertion tool, sensors
- PC
- Software component:
- programming
- data acquisition
- visual interfacing
2 operating modes
11

37. 3. Materials and methods
3.1. 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

38. 3. Materials and methods
3.1. 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
11

39. 3. Materials and methods
3.1. Simulator components
Mechanical component
Indexing
Sensor
pivot joint
Sensor
Arm
Transmitter
Support
Bracelet
Global view of the simulator
12

40. 3. Materials and methods
3.1. Simulator components
Mechanical component
Indexing
Sensor
- 5 orientations (3 are correct) pivot joint
Sensor
Arm
Transmitter
Support
Bracelet
Indexing pivot joint at the shoulder Global view of the simulator
The bracelet of the wrist
12

41. 3. Materials and methods
3.1. Simulator components
Mechanical component
Indexing
Sensor
- 5 orientations (3 are correct) pivot joint
Sensor - Improve the arm stiffness
Arm
Transmitter
Support
Bracelet
Indexing pivot joint at the shoulder Global view of the simulator
The bracelet of the wrist
12

42. 3. Materials and methods
3.1. Simulator components
Mechanical component
Indexing
Sensor
- 5 orientations (3 are correct) pivot joint
Sensor - Improve the arm stiffness
Arm
Transmitter
- Indexing system
Support
Bracelet
Indexing pivot joint at the shoulder Global view of the simulator
The bracelet of the wrist
12

43. 3. Materials and methods
3.1. Simulator components
Mechanical component
Indexing
Sensor
- 5 orientations (3 are correct) pivot joint
Sensor - Improve the arm stiffness
Arm
Transmitter
- Indexing system
- Repeatable orientations
Support
Bracelet
Indexing pivot joint at the shoulder Global view of the simulator
The bracelet of the wrist
12

44. 3. Materials and methods
3.1. Simulator components
Instrumentation
- MiniBird® (6 DOF electromagnetic
sensors) for:
- the arm
- the obturator
- the applicator
13

45. 3. Materials and methods
3.1. Simulator components
Instrumentation
- MiniBird® (6 DOF electromagnetic
sensors) for:
- the arm Adaptation
pieces
- the obturator
- the applicator
- Adaptation pieces:
ABS
small
13

46. 3. Materials and methods
3.1. Simulator components
Software component
- ControlDesk
data treatment
14

47. 3. Materials and methods
3.1. Simulator components
Software component
- ControlDesk
data treatment
- Matlab/Simulink
programming
trajectories analysis
14

48. 3. Materials and methods
3.1. Simulator components
Software component
- ControlDesk
data treatment
- Matlab/Simulink
programming
trajectories analysis
- MotionDesk
3D visualization
14

49. 3. Materials and methods
3.1. Simulator components
Software component
- ControlDesk
data treatment
- Matlab/Simulink
programming
Visual guide
trajectories analysis
- MotionDesk
3D visualization
Arm profile
14

50. 3. Materials and methods
3.1. Simulator components
Software component
- ControlDesk
data treatment
- Matlab/Simulink
programming
Visual guide
trajectories analysis
- MotionDesk
3D visualization
Arm profile
14

51. 3. Materials and methods
3.2. Criteria of the gesture evaluation
Three selected criteria
1. The arm orientation
In supination
15

52. 3. Materials and methods
3.2. Criteria of the gesture evaluation
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

53. 3. Materials and methods
3.2. Criteria of the gesture evaluation
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

54. 3. Materials and methods
3.2. Criteria of the gesture evaluation
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

55. 3. Materials and methods
3.2. Criteria of the gesture evaluation
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

56. 3. Materials and methods
3.2. Criteria of the gesture evaluation
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
15

57. 3. Materials and methods
3.2. Criteria of the gesture evaluation
Impact point detection
- Meshing of the target skin area
(measures)
- Comparison between the altitudes
Z ApplicatorTip − Z Skin ≤ ε
16

58. 3. Materials and methods
3.2. Criteria of the gesture evaluation
Depth evaluation
Needle
Tangent plane
Arm profile ~ plane tangent
to the skin at the impact
point:
- Meshing
Impact point
Arm
- Polynomial approximation
17

59. 3. Materials and methods
3.2. Criteria of the gesture evaluation
Depth evaluation
Needle Z axis
Tangent plane
Arm profile ~ plane tangent
to the skin at the impact
point:
- Meshing
Impact point
Arm
- Polynomial approximation
Depth ~ altitude in the plane:
- orthogonal to the tangent plane
- parallel to the arm axis
17

60. Table of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods
3.1. Simulator components
3.2. Criteria of the gesture evaluation
4. Experimental results
4.1. Protocol
4.2. Results
5. Conclusion and perspectives
18

61. 4. Experimental results
4.1. 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)
19

62. 4. Experimental results
4.2. Results
xOz plane
Orthogonal to the
tangent plane at
the impact point
Axis X
Tool progress
along the arm
Axis Z
Altitude of the
instrument tip
20

63. Table of contents
1. Introduction
2. Task description: details on implant insertion
3. Materials and methods
3.1. Simulator components
3.2. Criteria of the gesture evaluation
4. Experimental results
4.1. Protocol
4.2. Results
5. Conclusion and perspectives
21

64. 5. Conclusion
The prototype
- Visual interface coupled with a mechanical component
- Gesture learning (on-line)
- Trajectories analysis (off-line)
- First experiments validate simulator principles
22

65. 5. 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
22

66. Thank you for your attention…
…any questions ?
Contact: audrey.jardin@insa-lyon.fr
23