Jarden Corporation Jul 2013 - May 2017
Quality Assurance Manager
Philips Jul 2013 - May 2017
Quality and Regulatory Manager
Actuated Medical, Inc. Oct 2008 - Jul 2013
Director, Qa and Ra
Avail Medical Products Oct 2000 - Sep 2008
Corporate Director, Quality Assurance and Compliance
Skills:
Capa Quality System Design Control Validation Spc Fda Medical Devices Six Sigma Quality Auditing Contract Manufacturing V&V Iso 13485 Quality Assurance Process Improvement Leadership Iso 14971 21 Cfr Dmaic Cqa Cqe Gmp Iso Regulatory Affairs Quality Control Biomedical Engineering Design of Experiments
Roger B. Bagwell - Bellefonte PA, US Paul L. Frankhouser - Miami Beach FL, US Maureen L. Mulvihill - Bellefonte PA, US Josue R. Crespo - Cabo Rojo, USA Brian M. Park - Bellefonte PA, US Dana B. Mallen - Yardley PA, US Gabriela Hernandez Meza - Philadelphia PA, US Debora L. Demers - State College PA, US
Assignee:
Actuated Medical, Inc. - Bellefonte PA
International Classification:
B08B 9/027 B08B 1/00
US Classification:
134166R, 134166 C, 1510403, 1510405, 15 931
Abstract:
A device for the breaking-apart of occlusions includes a stationary fitting, a hollow tube and a second fitting configured to reciprocate so as to cause the hollow tube to be compressed and expanded. The hollow tube is coupled on one side to the stationary fitting, and the stationary fitting provides access to a hollow portion of the hollow tube.
Methods For Clearing Blockages In In-Situ Artificial Lumens
Roger B. Bagwell - Bellefonte PA, US Paul L. Frankhouser - Miami Beach FL, US Maureen L. Mulvihill - Bellefonte PA, US Josue R. Crespo - Cabo Rojo PR, US Brian M. Park - Bellefonte PA, US Dana B. Mallen - Yardley PA, US Gabriela Hernandez Meza - Philadelphia PA, US Debora L. Demers - State College PA, US
Assignee:
Actuated Medical, Inc. - Bellefonte PA
International Classification:
B08B 9/027 B08B 9/04 B08B 1/00
US Classification:
134 8, 134 2211
Abstract:
A method for the in situ clearing of blockages in artificial tubes completely or partially disposed within a living being is described. The method includes coupling a first end of a releasably-securable flexible clearing member to a controller, inserting a second working end of the flexible clearing member into an opening in the artificial tube, energizing the controller such that said flexible clearing member experiences repetitive motion, and positioning the flexible clearing member such that the second working end of the flexible clearing member comes into repetitive contact with the blockage for clearing the blockage therein. The controller remains outside of the living being and the flexible clearing member clears the blockage when positioned within a straight portion or within a curved portion of the artificial tube.
Devices For Clearing Blockages In In-Situ Artificial Lumens
Roger B. Bagwell - Bellefonte PA, US Paul L. Frankhouser - Miami Beach FL, US Maureen L. Mulvihill - Bellefonte PA, US Josue Crespo - University Park PA, US Brian M. Park - Bellefonte PA, US Dana B. Mallen - State College PA, US Gabriela Hernandez Meza - State College PA, US Debora L. Demers - State College PA, US
Assignee:
PIEZO RESONANCE INNOVATIONS, INC. - Bellefonte PA
International Classification:
A61M 39/00
US Classification:
604267
Abstract:
Devices and methods for the effective clearing of artificial tubes, especially in-situ clearing of artificial tubes in a living being are covered in this disclosure. The devices and methods provide an elongated clearing member having a first end that is coupled to a driving mechanism and having a second working end that is subjected to repetitive motion for clearing blockages within the artificial tube. The elongated clearing member includes either a fixed or an adjustable element that selectively defines the portion of the elongated clearing member that is insertable within the artificial tube. The proximal end of the clearing member is releasably secured to the driving mechanism and the driving mechanisms may comprise a wide variety of repetitive motion drivers such as voice coil motors, piezoelectric actuators, pneumatic actuators, DC motors, etc. These devices/methods may comprise a free-standing console for hands-free operation or may comprise hand-held versions. The distal working end of the clearing member may comprise tips of differing functions, including an irrigation/aspiration feature.
Devices For Clearing Blockages In In-Situ Artificial Lumens
Roger B. Bagwell - Bellefonte PA, US Paul L. Frankhouser - Miami Beach FL, US Maureen L. Mulvihill - Bellefonte PA, US Josue Crespo - Cabo Rojo PR, US Brian M. Park - Bellefonte PA, US Dana B. Mallen - Yardley PA, US Gabriela Hernandez Meza - Philadelphia PA, US Debora L. Demers - Philadelphia PA, US
Assignee:
Actuated Medical, Inc. - Bellefonte PA
International Classification:
A61M 25/092
US Classification:
604 9501
Abstract:
A device for the in situ clearing of blockages in a tube includes a controller and a clearing member. The controller can have a housing and an actuator for generating repetitive motion. The clearing member can be releasably coupled to the controller and suitable for insertion in the tube. The tube can be at least partially disposed within a living being. The controller can be located external to the living being. The clearing member can have a first end releasably coupled to the actuator, at least one flexible section which permits axial displacement of the clearing member, and a second end suitable for repetitively engaging and disrupting the blockage. The flexible section permits the clearing member to repetitively engage and disrupt the blockage within one of a straight and a curved portion of the artificial tube.
Method For Clearing Blockages In In-Situ Artificial Lumens
Paul L. Frankhouser - Miami Beach FL, US Maureen Mulvihill - Bellefonte PA, US Josue R. Crespo - Cabo Rojo PR, US Brian M. Park - Bellefonte PA, US Dana B. Mallen - Yardley PA, US Gabriela Hernandez Meza - Philadelphia PA, US Debora L. Demers - State College PA, US
Assignee:
Actuated Medical, Inc. - Bellefonte PA
International Classification:
A61J 15/00 A61M 1/00
US Classification:
604500
Abstract:
Devices and methods for the effective clearing of artificial tubes, especially in-situ clearing of artificial tubes in a living being are covered in this disclosure. An elongated clearing member includes either a fixed or an adjustable element that selectively defines the portion of the elongated clearing member that is insertable within the artificial tube. The proximal end of the clearing member is releasably secured to the driving mechanism and the driving mechanisms may comprise a wide variety of repetitive motion drivers such as voice coil motors, piezoelectric actuators, pneumatic actuators, DC motors, etc. These devices/methods may comprise a free-standing console for hands-free operation or may comprise hand-held versions. The distal working end of the clearing member may comprise tips of differing functions, including an irrigation/aspiration feature.
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