Commercial presentation 3D custom-made implants 20/04/2016 1 For - - PowerPoint PPT Presentation

Commercial presentation

3D custom-made implants

1 20/04/2016 For internal use only

AnatomikModeling is the result of 10 years of research and development with T

• ulouse University Hospital,

to develop a particularly innovative computer-aided design (CAD) technology for 3D custom-made implants, as well as a mini-invasive surgical method to implant them. Sebbin has been manufacturing and marketing implants, particularly breast implants, for plastic and reconstructive surgery all over the world for 30 years. AnatomikModeling and Sebbin partnered to develop an innovative product and market this new solution in Europe. Design through computer-aided designing (CAD) and manufacturing of silicone custom-made implants. These implants are perfectly fitting each patient’s anatomy to compensate for a congenital deformity or trauma Medical care of pathologies such as Pectus Excavatum (funnel chest), Poland syndrome (complete or partial absence of the pectoralis muscle) or other muscle deficiency (calf atrophy).

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PATHOLOGIES

Pectus Excavatum

• Malformation of the thorax characterised by a median or lateral depression of the sternum.
• Pectus Excavatum occurs in 1 to 2% of the population.This is the most common congenital

thoracic deformity with an incidence of 1 in 300 births. 1 woman for 5 men.

• Only 15% of those with a Pectus Excavatum are being operated on.
• Very rare functional impact, but strong psychological one.
• Pectus often affects the breast shape in women : high and low convergence, and asymmetry

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Poland Syndrome

• Complete or partial absence of the pectoral muscle. Poland cases are thus very different from one to

another.

• 1 case out of 30000 births. Can be associated with a malformation of the ipsilateral hand
• The defect often takes the form of a depression under the clavicle and in women by a breast asymmetry.
• Can be associated with a deformation of the rib cage

PATHOLOGIES

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Muscle deficiency

• Congenital or acquired muscular hypotrophy or agenesis : calf atrophy in particular
• Talipes equinovarus, sequelae of polyomyelitis, degenerative diseases, traumatic and/or

surgical sequelae

PATHOLOGIES

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Design

• Creation of a 3D virtual copy of each patient’s

body from hospital patient CT scan with millimetric precision (1 to 1,2)

• 3D reconstruction requiring complex

mathematical algorithms for medical imaging processing.

• Segmentation of each tissue : bones, muscles,

skin, cartilages

• Design of the virtual implant on each patient’s

3D digital body : based on 2 planes (anterior anatomical plane and posterior surgical plane.

• Control and optimisation of the result with the

direct participation of the surgeon in charge.

TECHNOLOGY

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Manufacturing

• Manufacturing of an Elastomer Prototype to get a perfect

silicone anatomical copy, which will be the future implant.

• Manufacturing of a mould from the prototype.
• Casting of the medical polymerised silicone also called

silicone rubber (long-life implant, no risk of rupture).

• Quality control, sterilisation, identification (serial number

and patient codification), packaging and shipping to the relevant hospital or clinic.

TECHNOLOGY

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Surgery

• Surgery under general anaesthesia, around 1 hour.
• 3-day hospitalisation maximum
• 7 cm vertical median incision, preparation of the locus

to the size of the implant. Implant deeply placed into the locus under the muscle. Closing in 3 planes.

Surgical Outcomes

• Surgical outcomes with little pain: simple analgesics.
• Little post-operative care: resorbable stitches, no drain,

a dressing for only 8 days and a compression bra to wear from discharge for1 month.

• Follow-up consultation after 8 days with possible

puncture of seroma

• Sick leave for 15 days and sports restriction for 3 months.

SURGERY

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3D custom-made implant Nuss procedure

SURGERY

• Fit perfectly to each patient anatomy, refined aesthetic

result, invisible implant.

• Easy setting up of the implant, excellent stability
• Comfort due to material’s flexibility and smooth implant’s

edges

• Simple surgery : only one surgery of 1 hour, 3-day

hospitalisation maximum

• Good post-operative outcomes, with mild pain (analgesics

during 15 days), control after 8 days

• Rapid resumption of activity (15 days to work and 3

months for sport)

• Low risk of complications, no manipulation of ribs
• Risk of malformation persists after bar removal
• Risk of bar displacement (urgent additional surgery)
• 2 surgeries of 2 hours, 7-day hospitalisation
• Pain treated with epidural during 4 days and analgesics

during minimum 1 month, physiotherapy sessions during 1 or 2 months

• Back to normal activity after 1 month and sport after 3

months (progressive, contact sports prohibited)

• Risks of lesions and complications : pneumothorax,

pericarditis, bar displacement, heart and lung damage, hematoma…

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PECTUS EXCAVATUM RESULTS

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POLAND SYNDROME RESULTS

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Surgeon AnatomikModeling Consultation / scan Send quotation to surgeon Send patient data/ scan (CD) + prescription to Sebbin

W

Launch design, send specifications to surgeon

W+1

Validate design to AnatomikModeling

W+2

Manufacture prototype

W+3

Manufacture by cast of silicone / package implant Send implant to sterilisation Receive implant and prototype in hospital

W+5 W 6+7 W+8

Perform surgery Validate data and feasability Confirm quotation to Sebbin Sebbin Manufacture mould

W+4

GLOBAL PROCESS

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2 months needed from the quotation confirmation and half

• f the payment to

implant delivery

Chavoin J.P., Grolleau J.L. , Moreno B., Brunello J., André A. , Dahan M., Garrido I. Chaput B. Correction of pectus excavatum by custom-made silicone implants : Contribution of computer-aided design reconstruction. A 20-year experience and 401 cases. Plast Reconstr Surg. 2016 May;137(5).

• JP. Chavoin, A. André, B. Chaput, I. Garrido, B. Moreno, M. Dahan , JL. Grolleau

Chirurgie des malformations congénitales et techniques de reconstructions assistées par l’informatique. Chirurgie Plastique de l’Enfant et de l’Adolescent, SAURAMPS MEDICAL; 2015 sept 15; p. 252-256 Ho Quoc Ch, Chaput B, Garrido I, André A, Grolleau JL, Chavoin JP. Management of breast asymmetry associated with primary funnel chest Ann Chir Plast Esthet. Elsevier Masson SAS; 2012 Aug 8:1–6. J-P. Chavoin, A.André, E.Bozonnet, A.Teisseyre, J..Arrue, B. Moreno, D. Glangloff, J-L. Grolleau, I.Garrido. Mammary implant selection or chest implants fabrication with computer help; Ann.de chirurgie plastique esthétique (2010) 55,471-480. André, M. Dahan, E. Bozonnet, I. Garrido, J.-L. Grolleau, J.-P. Chavoin Pectus excavatum : correction par la technique de comblement avec mise en place d’une prothèse en silicone sur mesure en position rétromusculaire profonde Encycl Méd Chir, Elsevier Masson SAS - Techniques chirurgicales - Chirurgie plastique reconstructrice et esthétique, 45-671, Techniques chirurgicales - Thorax, 42-480, 2010. Chavoin JP, Dahan M, Grolleau JL, Soubirac L, Wagner A, Foucras L, Darbas D, Pomar P. Funnel chest : filling technique with deep custom made implant. Ann Chir Plast Esthet. 2003 Apr 48(2) : 67-76. Chavoin JP, Grolleau JL, Lavigne B, Darbas D, Dahan M et Pomard P. Chirurgie des malformations du thorax. Encycl Méd Chir (Elsevier, Paris), Techniques chirurgicales Chirurgie plastique reconstructrice et esthétique, 45-671, 1998, 12 p. Umuroglu T, Bostancı K, Thomas DT, Yuksel M, Gogus FY. Perioperative anesthetic and surgical complications of the Nuss procedure. J Cardiothorac Vasc Anesth. 2013 Jun; 27(3):436–40. Guntheroth WG, Spiers PS. Cardiac function before and after surgery for pectus excavatum. Am J Cardiol. 2007 Jun 15; 99(12):1762–4. Malek MH, Berger DE, Marelich WD, Coburn JW, Beck TW, Housh TJ. Pulmonary function following surgical repair of pectus excavatum: a meta-analysis. Eur J Cardiothorac Surg. 2006 Oct; 30(4):637–43. Chichery A., Jalbert F., Foucras L., Grolleau J.-L., Chavoin J.-P. Syndrome de Poland. EMC (Elsevier SAS, Paris), Techniques chirurgicales - Chirurgie plastique reconstructrice et esthétique, 45-667-E, 2006.

BIBLIOGRAPHY

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CONTACT US

AnatomikModeling

Postal: 19 rue Jean Mermoz, 31100 Toulouse, France Email : contact@anatomikmodeling.com Phone: +33 5 62 83 31 04 Website: www.anatomikmodeling.com

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