Rubicor Medical, Inc.

Manoa Medical, Inc.

Rubicon Medical, Inc.

Roberta Lee

James William Vetter

Ary S Chernomorsky

Natalie N Hyland

Don Alden

Scott Clinton Anderson

Ronald Kenichi Yamamoto

Stanley R Conston

Mark J Clifford

Huddee Jacob Ho

Samuel E Zuckswert

Jacob Ho Huddee

A method of marking an orientation of a cut specimen of tissue prior to excision thereof from a body includes steps of disposing a tissue-marking probe in the body adjacent the cut specimen, the tissue-marking probe including a tissue-marking tool configured to selectively mark the cut specimen. A surface of the cut specimen is then marked with the tissue-marking tool such that the orientation of the cut specimen within the body is discernable after the cut specimen is excised from the body. The tissue-marking tool may be configured to selectively bow out of and back into a window defined near a distal tip of the probe and the marking step may include a step of selectively bowing the tissue-marking tool out of the window and following the surface of the cut specimen while rotating the probe. The tissue-marking tool may include an RF cutting tool and the marking step may include a step of coagulating or cauterizing a selected portion of the surface of the cut specimen with the RF cutting tool. Alternatively, the marking step may include a step of delivering dye onto selected portions of the surface of the cut specimen.

Methods and systems for in situ tissue marking and orientation stabilization

An excisional biopsy device includes a tubular member having a window near a distal tip thereof; a cutting tool, a distal end of the cutting tool being attached near the distal tip of the tubular member, at least a distal portion of the cutting tool being configured to selectively bow out of the window and to retract within the window; and a tissue collection device externally attached at least to the tubular member, the tissue collection device collecting tissue excised by the cutting tool as the biopsy device is rotated and the cutting tool is bowed. An excision al biopsy method for soft tissue includes the steps of inserting a generally tubular member into the tissue, the tubular member including a cutting tool adapted to selectively bow away from the tubular member and an external tissue collection device near a distal tip of the tubular member; rotating the tubular member; selectively varying a degree of bowing of the cutting tool; collecting tissue severed by the cutting tool in the tissue collection device; and retracting the tubular member from the soft tissue. The tubular member may include an imaging transducer and the method may include the step of displaying information received from the transducer on a display device and the step of varying the degree of bowing of the cutting tool based upon the displayed information from the imaging transducer. Alternatively, the imaging transducer may be disposed within a removable transducer core adapted to fit within the tubular member.

Excisional biopsy devices and methods

Devices and methods for a minimally invasive procedure for cutting tissue are disclosed. The device generally includes a probe with a distal exit at an exit angle relative to the probe, a cutting loop with shape memory having a preconfigured shape, and a loop securing mechanism to secure the cutting loop in a penetrating configuration and to release the cutting loop into a cutting configuration. The cutting loop is generally within a profile of the probe in the penetrating configuration. In the cutting configuration, the cutting loop extends through the cutting loop exit and generally returns to the preconfigured shape at a cutting angle generally defined by the exit angle. The cutting loop securing mechanism may be, for example, a cover slidable over the probe, a slidable member extending from a distal tip of the probe, or a groove defined in the probe proximal to the cutting loop exit.

Bendable cutting device

An electrically activated surgical device includes a probe body, an active element and a structure for selectively electrically insulating and/or physically isolating the active element from the patient's tissue when the device is in use. The probe body defines an outer surface, a proximal end, a distal end and a window defined within the outer surface near or at the distal end. The active element is electrically connected to a power source and is configured to selectively assume a non-deployed configuration and a variable deployed configuration in which the active element at least partially emerges from the window out of the probe body. The insulating structure selectively insulates the active element from the patient's tissue when the device is inserted therein. In operation, a physician inserts the probe into the tissue, insulates the active element from the tissue (either before, during or after insertion of the probe), energizes the insulated active element using for example, radiofrequency (RF) power from the power source, and only then exposes the energized active element to the tissue. By insulating the active element during the energizing thereof, little or no current applied to the active element is dissipated in the patient's tissue, thus decreasing the time required to energize the active element and enabling lower and safer power levels to be applied to the active element during the energizing thereof.

Methods and devices for radiofrequency electrosurgery

Systems and methods for the orientation of soft tissue such as breast tissue for enhanced accuracy of imaging and/or procedures such as a biopsy or excision are disclosed. The system for orientating and maintaining the orientation of soft tissue generally includes a frame defining an opening, the frame being configured to orient and immobilize an area of soft tissue positioned on one side of the opening, an attachment mechanism to secure the frame to an attachment region defined by the area of soft tissue or by a skin surface overlying the area of soft tissue, to facilitate orienting and immobilizing the area of soft tissue, and an imaging device to image the area of soft tissue. The opening may allow a probe of the imaging device or imaging energy transmitted by the imaging device to be movable therein for image scanning of the soft tissue. The probe, e.g., an ultrasound transducer can be rotated within the frame such that the probe scans at least either of two perpendicular directions within the frame. The frame may be adjustable in at least one dimension in order to adjust the size of the frame opening so as to facilitate the scanning and positioning of the probe within the frame opening. The frame may be attached and secured to the soft tissue with vacuum, adhesive, and/or clips or hooks. The soft tissue may be stretched into a desire orientation prior to attachment of the frame. An anchored lift member may be connected to the frame so as to slightly lift the frame and thus position and immobilize the soft tissue to which the frame is attached. Lifting of the soft tissue improves and enhances a tissue separation process using a tissue separation device. A connector may connect the imaging device to the tissue separation device to maintain a portion of the tissue separation device within the image plane of the probe to further improve and enhance the tissue separation process.

Soft tissue orientation and imaging guide systems and methods

An excisional biopsy system includes a tubular member that has a proximal end and a distal end in which one or more windows are defined. A first removable probe has a proximal portion that includes a cutting tool extender and a distal portion that includes a cutting tool. The first removable probe may be configured to fit at least partially within the tubular member to enable the cutting tool to selectively bow out of and to retract within one of the windows when the cutting tool extender is activated. A second removable probe has a proximal section that includes a tissue collection device extender and a distal section that includes a tissue collection device. The second removable probe may also be configured to fit at least partially within the tubular member to enable the tissue collection device to extend out of and to retract within one of the windows when the tissue collection device extender is activated. A third removable probe may also be provided. The third removable probe may also be configured to fit at least partially within the tubular member and may include an imaging device, such as an ultrasound transducer, mounted therein. By selectively activating the cutting tool and the tissue collection device while rotating the excisional device, a tissue specimen may be cut from the surrounding tissue and collected for later analysis.

An excisional biopsy device includes a tubular member having a window near a distal tip thereof; a cutting tool, a distal end of the cutting tool being attached near the distal tip of the tubular member, at least a distal portion of the cutting tool being configured to selectively bow out of the window and to retract within the window; and a tissue collection device externally attached at least to the tubular member, the tissue collection device collecting tissue excised by the cutting tool as the biopsy device is rotated and the cutting tool is bowed. An excisional biopsy method for soft tissue includes the steps of inserting a generally tubular member into the tissue, the tubular member including a cutting tool adapted to selectively bow away from the tubular member and an external tissue collection device near a distal tip of the tubular member; rotating the tubular member; selectively varying a degree of bowing of the cutting tool; collecting tissue severed by the cutting tool in the tissue collection device; and retracting the tubular member from the soft tissue. The tubular member may include an imaging transducer and the method may include the step of displaying information received from the transducer on a display device and the step of varying the degree of bowing of the cutting tool based upon the displayed information from the imaging transducer. Alternatively, the imaging transducer may be disposed within a removable transducer core adapted to fit within the tubular member.

Excisional biopsy device and methods

The present invention relates to devices and methods that enhance the accuracy of lesion excision, through severing, capturing and removal of a lesion within soft tissue. Furthermore, the present invention relates to devices and methods for the excision of breast tissue based on the internal anatomy of the breast gland. A tissue severing device generally comprises a guide having at least one lumen and a cutting tool contained within the lumen. The cutting tool is capable of extending from the lumen and forming an adjustable cutting loop. The cutting loop may be widened or narrowed and the angle between the loop extension axis and the guide axis may be varied. Optional tissue marker and tissue collector may additionally be provided. A method for excising a mass of tissue from a patient is also provided. The device and method are particularly useful for excising a lesion from a human breast, e.g., through the excision and removal of a part of a breast lobe, an entire breast lobe or a breast lobe plus surrounding adjacent tissue.

Devices and methods for tissue severing and removal

A system and method for ultrasound imaging of breast tissue by injecting an ultrasound contrast agent into a duct lumen of a patient's breast to enhance the imaging of one or more ducts within a specified lobe of the breast to improve characterization of a lesion or lesions within the duct system of the specified lobe are disclosed. The ultrasound contrast agent used to improve breast imaging may be injected into the duct lumen through an orifice on the nipple and/or a duct wall into the duct lumen. The ultrasound contrast agent may be injected prior to and/or during ultrasound imaging. The ultrasound contrast agent may be an acoustically detectable gas such as a halogenated hydrocarbon, halogenated alkane gases, nitrogen, helium, argon and/or xenon. The halogenated alkane gas may be a perfluorinated hydrocarbon such as saturated perfluorocarbon, unsaturated perfluorocarbon, and/or cyclic perfluorocarbon. The acoustically detectable gas may alternatively be mixed in a liquid solution.

Growing community of inventors

Redwood City, CA, United States of America

Roberta Lee