design of a medical simulator for subcutaneous contraceptive implant insertion design of a medical...

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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

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Table of contentsTable of contents

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1. Introduction

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1. Introduction

2. Task description: details on implant insertion

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1. Introduction


3. Materials and methods3.1. Simulator components3.2. Criteria of the gesture evaluation

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1. Introduction



4. Experimental results4.1. Protocol4.2. Results

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1. Introduction




5. Conclusion and perspectives

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1. Introduction





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1. Introduction1. Introduction

� Context

+ Improvement of contraceptive methods for bringing more comfort

�� Development of implants

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� Context



- 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)

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� Context



- 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

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� Advantages of a simulator

- Train novices without putting the well-being of patients in danger

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- Make easier the gesture learning by bypassing the constraints during an actual insertion

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� Learning constraints in an actual insertion

1. The gesture occurs in the arm�� the novice can not see the instructor gesture

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�� the experienced doctor can not validate the novice inse rtion

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�� the experienced doctor can not validate the novice inse rtion

2. First insertions are often akward because of stress

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1. Introduction





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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

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� The implant insertion


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Step 1

- Introduce the needle under the skin, in the upper-arm, 60-80 mm above the elbow

http:// hcp .organon. com

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Step 1



Step 2

- Lower the applicator to a position parallel to the skin

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Step 1



Step 2


Step 3

- Lift the skin- Insert the full length of the needle


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Step 1



Step 2


Step 3



Step 4

- Press down the obturatorsupport - Turn the obturator 90°

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Step 1



Step 2


Step 3



Step 4


Step 5

- Keep the obturator fixed- Pull out the canula

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Step 1



Step 2


Step 3



Step 4


Step 5

- Keep the obturator fixed- Pull out the canula

Step 6

- Check the correctness of the insertion by palpating the implant

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� 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)

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1. Introduction





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3. 3. MaterialsMaterials and methodsand methods3.1. Simulator components3.1. Simulator components

� Principle: 2 components

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- Mechanical component:- arm, insertion tool, sensors- PC

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- Software component:- programming- data acquisition- visual interfacing

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� 2 operating modes

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- ‘Training’ mode

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- ‘Training’ mode

- ‘Certification’ mode

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� Mechanical componentIndexing

pivot joint

Global view of the simulator

Sensor

TransmitterArm

Bracelet

Sensor

Support

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pivot joint


Sensor

TransmitterArm

Bracelet

Sensor

Support

The bracelet of the wristIndexing pivot joint at the shoulder

- 5 orientations (3 are correct)

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pivot joint


Sensor

TransmitterArm

Bracelet

Sensor

Support



- Improve the arm stiffness

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pivot joint


Sensor

TransmitterArm

Bracelet

Sensor

Support




- Indexing system

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pivot joint


Sensor

TransmitterArm

Bracelet

Sensor

Support




- Indexing system

- Repeatable orientations

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� Instrumentation

- MiniBird® (6 DOF electromagneticsensors) for:

- the arm- the obturator- the applicator

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� Instrumentation

- MiniBird® (6 DOF electromagneticsensors) for:

- the arm- the obturator- the applicator

- Adaptation pieces:�� ABS�� small

Adaptation pieces

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� Software component

- ControlDesk�� data treatment

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- Matlab/Simulink�� programming�� trajectories analysis

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- MotionDesk�� 3D visualization

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- MotionDesk�� 3D visualization

Arm profile

Visual guide

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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

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2. The location of the impact point�� In the groove between the biceps and the triceps�� Target zone: ~ 5cm x 3.5 cm

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3. The maximum depth�� Limit fixed to 4 mm

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� Difficulties

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� Difficulties � Detect the impact point

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� Difficulties � Detect the impact point

� Evaluate the tool depth

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� Impact point detection

- Meshing of the target skin area (measures)

- Comparison between the altitudes

ε≤− SkinTipApplicator ZZ

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� Depth evaluation

Arm

NeedleTangent plane

Impact point

Arm profile ~ plane tangent to the skin at the impact point:

- Meshing

- Polynomial approximation

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� 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

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1. Introduction





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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)

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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

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1. Introduction





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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

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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

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Thank you for your attention…

…any questions ?

Contact: [email protected]

design of a medical simulator for subcutaneous contraceptive implant insertion design of a medical...

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