Velano Vascular, Inc.
Director, Quality Assurance
Philips Aug 2016 - May 2017
Qa and Qe Manager
St. Jude Medical Feb 2015 - Dec 2015
Principal Engineer, Customer Quality Support
St. Jude Medical Dec 2012 - Jan 2015
Director, Capa and Reliability
St. Jude Medical Oct 2010 - Nov 2012
Principal Engineer, Quality Assurance
Education:
California Polytechnic State University - San Luis Obispo Jan 1, 2003 - Dec 31, 2007
Master of Science, Masters, Biomedical Engineering
California Polytechnic State University - San Luis Obispo Jan 1, 1998 - 2003
Bachelors, Bachelor of Science, Engineering
Skills:
Failure Analysis Quality System Capa Design Control Fda Quality Assurance Medical Devices R&D Iso 13485 Validation V&V Biomedical Engineering Manufacturing Research and Development U.s. Food and Drug Administration Cross Functional Team Leadership
Yougandh Chitre - Valencia CA, US Cheuk Tang - Pasadena CA, US
Assignee:
Pacesetter, Inc. - Sylmar CA
International Classification:
A61N 1/05
US Classification:
607116, 607119, 600373
Abstract:
An implantable electrical medical lead for a pulse generator includes a distal electrode, a connector for electrical connection with the pulse generator, an electrical conductor within the lead extending between the connector and the distal electrode, and an insulating sheath of flexible resilient material normally covering the electrical conductor having self sealing properties to re-insulate the electrical conductor in the event a rupture of the sheath should occur which exposes the electrical conductor. The insulating sheath includes an outer insulative layer, an inner insulative layer, and an intermediate plasticized layer to seal any occurring rupture in the insulating sheath and re-insulate the electrical conductor which has been exposed.
Self-Sealing Insulation Employed On A Catheter Or Lead
Yougandh Chitre - Valencia CA, US Cheuk Tang - Pasadena CA, US
Assignee:
Pacesetter, Inc. - Sylmar CA
International Classification:
A61N 1/05
US Classification:
607116, 607119, 600373
Abstract:
An implantable electrical medical lead for a pulse generator includes a distal electrode, a connector for electrical connection with the pulse generator, an electrical conductor within the lead extending between the connector and the distal electrode, and an insulating sheath of flexible resilient material normally covering the electrical conductor having self sealing properties to re-insulate the electrical conductor in the event a rupture of the sheath should occur which exposes the electrical conductor. The insulating sheath is of polymeric material embedded with a plurality of pellets, each pellet having a frangible shell containing a liquid sealing material that solidifies when the frangible shell is broken and thereby filling in any voids in the polymeric material.
Active Fixation Medical Lead And Related Method And System
Shimul Sengupta - Chatsworth CA, US Yougandh Chitre - Valencia CA, US Cheuk Tang - Pasadena CA, US
Assignee:
Pacesetter, Inc. - Sylmar CA
International Classification:
A61N 1/37
US Classification:
607127, 607126
Abstract:
An implantable medical lead of the invention comprises an electrically active helix electrode extendable and retractable relative to a distal tip of the lead, an electrically conductive mapping collar disposed at the lead's distal tip and a proximal end carrying an electrical connector assembly. The electrical connector assembly comprises a first terminal connected to the helix electrode and a second terminal separately connected to the mapping collar. An advantage of the independent helix electrode and mapping collar circuits is that the implanting physician can confirm from separate electrode impedance readings that the helix is in fact extended and fully embedded within the myocardium. Further, the independent mapping collar and helix electrode circuits may be used, in conjunction with a configurable or programmable switch network, to provide the implanting physician with a choice of electrode impedances.
Active Fixation Medical Lead And Related Method And System
Shimul Sengupta - Chatsworth CA, US Yougandh Chitre - Santa Clara CA, US Cheuk Tang - Pasadena CA, US
Assignee:
Pacestter, Inc. - Sylmar CA
International Classification:
A61N 1/37
US Classification:
607127, 607126, 607116
Abstract:
An implantable medical lead of the invention comprises an electrically active helix electrode extendable and retractable relative to a distal tip of the lead, an electrically conductive mapping collar disposed at the lead's distal tip and a proximal end carrying an electrical connector assembly. The electrical connector assembly comprises a first terminal connected to the helix electrode and a second terminal separately connected to the mapping collar. An advantage of the independent helix electrode and mapping collar circuits is that the implanting physician can confirm from separate electrode impedance readings that the helix is in fact extended and fully embedded within the myocardium. Further, the independent mapping collar and helix electrode circuits may be used, in conjunction with a configurable or programmable switch network, to provide the implanting physician with a choice of electrode impedances.
Self-Sealing Insulation Employed On A Catheter Or Lead
Yougandh Chitre - Valencia CA, US Cheuk Tang - Pasadena CA, US
Assignee:
Pacesetter, Inc. - Sylmar CA
International Classification:
A61N 1/05
US Classification:
607116, 607119, 600373
Abstract:
An implantable electrical medical lead for a pulse generator includes a distal electrode, a connector for electrical connection with the pulse generator, an electrical conductor within the lead extending between the connector and the distal electrode, and an insulating sheath of flexible resilient material normally covering the electrical conductor having self sealing properties to re-insulate the electrical conductor in the event a rupture of the sheath should occur which exposes the electrical conductor. In one instance, the insulating sheath is of polymeric material embedded with a plurality of pellets, each pellet having a frangible shell containing a liquid sealing material that solidifies when the frangible shell is broken and thereby filling in any voids in the polymeric material. In another instance, the insulating sheath includes an outer insulative layer, an inner insulative layer, and an intermediate plasticized layer to seal any occurring rupture in the insulating sheath and re-insulate the electrical conductor which has been exposed.