title: Percutaneous steerable robotic tool delivery platform and metal microelectromechanical systems device for tissue manipulation and approximation: closure of patent foramen ovale in an animal model.
abstract: BACKGROUND
  Beating-heart image-guided intracardiac interventions have been evolving rapidly. To extend the domain of catheter-based and transcardiac interventions into reconstructive surgery, a new robotic tool delivery platform and a tissue approximation device have been developed. Initial results using these tools to perform patent foramen ovale closure are described.
  
  
  RESULTS
  A robotic tool delivery platform comprising superelastic metal tubes provides the capability of delivering and manipulating tools and devices inside the beating heart. A new device technology is also presented that uses a metal-based microelectromechanical systems-manufacturing process to produce fully assembled and fully functional millimeter-scale tools. As a demonstration of both technologies, patent foramen ovale creation and closure was performed in a swine model. In the first group of animals (n=10), a preliminary study was performed. The procedural technique was validated with a transcardiac hand-held delivery platform and epicardial echocardiography, video-assisted cardioscopy, and fluoroscopy. In the second group (n=9), the procedure was performed percutaneously using the robotic tool delivery platform under epicardial echocardiography and fluoroscopy imaging. All patent foramen ovales were completely closed in the first group. In the second group, the patent foramen ovale was not successfully created in 1 animal, and the defects were completely closed in 6 of the 8 remaining animals.
  
  
  CONCLUSIONS
  In contrast to existing robotic catheter technologies, the robotic tool delivery platform uses a combination of stiffness and active steerability along its length to provide the positioning accuracy and force-application capability necessary for tissue manipulation. In combination with a microelectromechanical systems tool technology, it can enable reconstructive procedures inside the beating heart.
authors.affiliation: Department of Cardiac Surgery, Boston Children’s Hospital, Harvard Medical School, 300 Longwood Avenue, Boston, MA 02115, USA. nikolay.vasilyev@childrens.harvard.edu
authors.forename: Nikolay V
authors.initials: NV
authors.lastname: Vasilyev
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Gosline
authors.forename: Evan
authors.initials: E
authors.lastname: Butler
authors.forename: Nora
authors.initials: N
authors.lastname: Lang
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Codd
authors.forename: Haruo
authors.initials: H
authors.lastname: Yamauchi
authors.forename: Eric N
authors.initials: EN
authors.lastname: Feins
authors.forename: Chris R
authors.initials: CR
authors.lastname: Folk
authors.forename: Adam L
authors.initials: AL
authors.lastname: Cohen
authors.forename: Richard
authors.initials: R
authors.lastname: Chen
authors.forename: David
authors.initials: D
authors.lastname: Zurakowski
authors.forename: Pedro J
authors.initials: PJ
authors.lastname: del Nido
authors.forename: Pierre E
authors.initials: PE
authors.lastname: Dupont
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization; D004195:Disease Models, Animal; D005471:Fluoroscopy; D054092:Foramen Ovale, Patent / Q000601:surgery*; D008670:Metals; D019651:Plastic Surgery Procedures; D012371:Robotics / Q000295:instrumentation*; D013552:Swine
chemical_list: D008670:Metals
keywords: catheters; heart septal defects; robotics; surgery
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