Design Control Medical Devices Iso 13485 Fda V&V Capa Iso 14971 Validation Biomedical Engineering Inventor Creative Designs Problem Solving Design of Experiments Problem Analysis R&D Quality System Commercialization Product Development Catheters Gmp Manufacturing Cross Functional Team Leadership Biotechnology Regulatory Affairs Manufacturing Engineering Quality Assurance Clinical Trials Biomaterials 21 Cfr Design For Manufacturing Dmaic Fmea Injection Molding 21 Cfr Part 11 Change Control Root Cause Analysis Iso Electrophysiology Testing Engineering Technology Transfer Management Leadership Research and Development Verification and Validation
Hien Nguyen - Fountain Valley CA Jeffrey P. Wall - Hunnington Beach CA Suresh K. Wadhwani - Mission Viejo CA Payam Adlparvar - Lake Forest CA Bruce Stambaugh - Anaheim CA Tony R. Brown - Anaheim Hills CA 92807
Assignee:
Tony R. Brown - Anaheim CA
International Classification:
A61M 100
US Classification:
604542, 604540, 604902, 606170
Abstract:
A fat removal device includes a screen which includes passages through which fat can be extruded, to be cut or melted away from the surface of an internal organ. The device includes a blade to cut the fat or radiofrequency monopolar or bipolar electrodes to melt the fat, aspiration to remove the fat away from the screen and blade, irrigation to irrigate the screen and blade, and an electrocautery member to cauterize the capillary bed of the fat. Methods of using removing the fat layer from the surface of an internal body organ are also described.
Richard C. Ewers - Fullerton CA, US John R. Brustad - Dana Point CA, US Edward D. Pingleton - Laguna Niguel CA, US Nabil Hilal - Laguna Niguel CA, US Payam Adlparvar - Lake Forest CA, US Scott Taylor - Mission Viejo CA, US Gary R. Dulak - Newport Beach CA, US Michael J. Dunn - Santa Ana CA, US Norman L. Morales - San Jose CA, US Charles C. Hart - Summerville SC, US Robert R. Bowes - Aliso Viejo CA, US
Assignee:
Applied Medical Resources Corporation - Rancho Santa Margarita CA
International Classification:
A61B017/02
US Classification:
600208
Abstract:
A surgical wound retractor is adapted to dilate a wound stretchable to a desired diameter, the retractor includes a first ring having a diameter greater than that desired for the wound and being adapted for disposition interiorly of the wound. A second ring has a diameter greater than that desired for the wound and is adapted for disposition exteriorly of the wound. A plurality of retraction elements are disposed in a generally cylindrical relationship to each other, between the first ring and the second ring. These elements extend through the wound to exert a radial retraction force on the wound which is dependent on the distance separating the first ring and the second ring. Retraction elements, both distensible and non-distensible are contemplated with appropriate attachment elements at the rings to provide for variations in the retraction force. With a suitable retraction sleeve, a third ring can be provided to form a circumferential retainer to vary the retraction force. Rings can also be made inflatable or self-expanding to vary the retraction force.
Kink-Resistant Access Sheath And Method Of Making Same
John R Brustad - Dana Point CA, US Payam Adlparvar - Lake Forest CA, US Wassim R. Aliahmad - Irvine CA, US Canh T. Tran - Garden Grove CA, US Nabil Hilal - Laguna Niguel CA, US Boun Pravong - Corona CA, US Raffi S. Pinedjian - Fountain Valley CA, US Charles C Hart - Summerville SC, US
Assignee:
Applied Medical Resources Corporation - Rancho Santa Margarita CA
International Classification:
B65H 81/00
US Classification:
156175, 156169, 156173, 1563082, 1563096
Abstract:
A releasable mechanism such as a cap is adapted for use with an access sheath having an elongate tube and a handle structure disposed at a proximal end of the tube. The releasable mechanism is sized and configured to fit the handle structure, which is shaped like the bell of a horn, to further facilitate use with surgical instrumentation. The releasable mechanism may operate as a separate cap that snaps onto the handle structure to provide access pathways to the sheath. The releasable mechanism may also be disposed at a proximal end of a surgical instrument to be introduced into the access sheath such that it may be interlocked with the sheath. In a method of manufacturing a kink-resistant sheath, a wire is initially coated with a plastic material, the coated wire is then wrapped around a mandrel forming a plurality of windings, and the wound coated wire is heated until the plastic material melts and bonds the windings to form a wire-reinforced sheath. The plastic material is preferably polyurethane but may be a thermoplastic, a thermoset or any plastic material having hard and/or soft durometer. The wound coated wire may be heated by capturing the windings within a shrink tube or compressing the windings in a mold and heating the windings until the sheath is formed.
Device For Shaping Infarcted Heart Tissue And Method Of Using The Device
Michael D. Laufer - Menlo Park CA, US Suresh K. Wadhwani - Mission Viejo CA, US Edward J. Nance - Corona CA, US Payam Adlparvar - Lake Forest CA, US Thomas F. Kordis - Rancho Santa Fe CA, US
International Classification:
A61F 7/00
US Classification:
607102, 607 96, 607 99
Abstract:
A device and method for treating an infarct scar on a heart comprising an electric cable with proximal and distal ends; a handle with proximal and distal ends with the proximal end connected to the distal end of the cable; a stem with proximal and distal ends with the proximal end of the stem connected to the distal end of the handle; a heating element with a first surface for contacting infarct scar tissue connected to the distal end of the stem wherein the heating element comprises at least two electrodes and at least one temperature sensor positioned on the first surface for sensing a temperature of infarct scar tissue adjacent to the sensor; an energy source connected to the electrodes via the electric cable; and a regulator connected to the energy source and the temperature sensor of the infarct scar tissue, for controlling the temperature of the infarct scar tissue from about 60 degrees C. to about 99 degrees C. Once the heart has been treated, a restraint is disclosed that allows for the shrinkage to be maintained over time.
Henry Kahle - Trabuco Canyon CA, US Payam Adlparvar - Lake Forest CA, US Gary M. Johnson - Mission Viejo CA, US
Assignee:
Applied Medical Resources Corporation - Rancho Santa Margarita CA
International Classification:
A61B 1/32
US Classification:
600208, 6041672
Abstract:
A surgical access device includes a single valve that forms a seal with a body wall and provides an access channel into a body cavity. The valve has properties for creating a zero seal in the absence of an instrument as well as an instrument seal for an instrument having a diameter up to about 37 mm. The valve can include a gel material and the access channel can include a protective sleeve to provide for wound protection during insertion and withdrawal of a sharp surgical instrument. The valve further comprises a cap ring which may be inserted or molded with the gel material. The protective sleeve may be bonded or molded around an inner diameter of the cap ring. The protective sleeve may be a single tubular member, or may comprise a plurality of axially extending sleeve members having a plurality of axial slits. The protective sleeve and the cap ring may comprise of the same or different materials. The surgical access device further comprises at least one support ring disposed circumferentially of the valve forming a hollow space, and a wound retractor operatively placed in the hollow space.
Richard C. Ewers - Fullerton CA, US John R. Brustad - Dana Point CA, US Edward D. Pingleton - Laguna Niguel CA, US Nabil Hilal - Laguna Niguel CA, US Payam Adlparvar - Lake Forest CA, US Scott Taylor - Mission Viejo CA, US Gary R. Dulak - Newport Beach CA, US Michael J. Dunn - Santa Ana CA, US Norman L. Morales - Fremont CA, US Charles C. Hart - Summerville CA, US Robert R. Bowes - Aliso Viejo CA, US
Assignee:
Applied Medical Resources Corporation - Rancho Santa Margarita CA
International Classification:
A61B 17/02
US Classification:
600208
Abstract:
A surgical wound retractor is adapted to dilate a wound to a desired diameter. The retractor includes first and second rings, each having a diameter greater than that desired for the wound. The first and second rings are adapted for disposition interiorly and exteriorly of the wound, respectively. A plurality of retraction elements is disposed in a generally cylindrical relationship between the first and second rings and extends through the wound to exert a radial retraction force on the wound that is dependent on the distance separating the first and second rings. Retraction elements, both distensible and non-distensible, are contemplated with appropriate attachment elements at the rings to provide for variations in the retraction force. With a suitable retraction sleeve, a third ring can be provided to form a circumferential retainer to vary the retraction force. Rings can also be made inflatable or self-expanding to vary the retraction force.
Richard C Ewers - Fullerton CA, US John R Brustad - Dana Point CA, US Edward D Pingleton - San Juan Capistrano CA, US Nabil Hilal - Laguna Niguel CA, US Payam Adlparvar - Lake Forest CA, US Scott V Taylor - Mission Viejo CA, US Gary R Dulak - Valencia CA, US Michael J Dunn - Santa Ana CA, US Norman L Morales - Daly City CA, US Charles C Hart - Summerville SC, US Robert R Bowes - Laguna Hills CA, US
Assignee:
Applied Medical Resources Corporation - Rancho Santa Margarita CA
International Classification:
A61B 1/32
US Classification:
600208
Abstract:
A surgical wound retractor is adapted to dilate a wound stretchable to a desired diameter, the retractor includes a first ring having a diameter greater than that desired for the wound and being adapted for disposition interiorly of the wound. A second ring has a diameter greater than that desired for the wound and is adapted for disposition exteriorly of the wound. A plurality of retraction elements are disposed in a generally cylindrical relationship to each other, between the first ring and the second ring. These elements extend through the wound to exert a radial retraction force on the wound which is dependent on the distance separating the first ring and the second ring Retraction elements, both distensible and non-distensible are contemplated with appropriate attachment means at the rings to provide for variations in the retraction force. With a suitable retraction sleeve, a third ring can be provided to form a circumferential retainer to vary the retraction force. Rings can also be made inflatable or self-expanding to vary the retraction force.
Richard C. Ewers - Fullerton CA, US John R. Brustad - Dana Point CA, US Edward D. Pingleton - Laguna Niguel CA, US Nabil Hilal - Laguna Niguel CA, US Gary R. Dulak - Newport Beach CA, US Payam Adlparvar - Lake Forest CA, US Robert R. Bowes - Aliso Viejo CA, US
Assignee:
Applied Medical Resources Corporation - Rancho Santa Margarita CA
International Classification:
A61B 1/32
US Classification:
600208
Abstract:
A surgical access device includes a single valve forming a seal with the body wall and providing an access channel into a body cavity. The valve has properties for creating a zero-seal in the absence of an instrument and an instrument seal with instruments. The valve can include a gel comprised of an elastomer and oil providing elongation greater than 1000 percent and durometer less than 5 Shore A. The single valve can be used as a hand port where the instrument comprises the arm of a surgeon. A method for making the surgical access device includes combining a gelling agent with oil, preferably in a molding process. A method for using the device includes creating an opening with the instrument. An organ can be removed from the body cavity through the single valve to create an organ seal while the organ is addressed externally of the body cavity.