Assurance Medical, Inc.

Sherwood Services Ag

Radionics, Inc.

Uromed Corporation

Michael A Cundari

Eric R Cosman, Sr

Robert A Daniels

Troy William Roberts

Alan Irving West

David Raymond Widder

Brian D Noble

Christophe P Mauge

Barton L Guthrie

Eric R Cosman

William Rittman

Lutz T Kynast

Richard H Theriault

Robert J Ledoux

Jeffrey Labuz

James P O'Connor

Timothy Last

A probe is connected to a probe carrier that is positioned with respect to the body of a patient. The probe is moved into or out of the body incrementally by means of a driver mechanism and flexible coupler. The flexible coupler in one embodiment comprises a flexible sheath with a flexible driver shaft that can be passed within the flexible sheath and can be rotated or pushed forward and backward with respect to the sheath by a driver element thereby causing translational movement of probe. Several forms of probes, flexible coupling elements, and driver apparatus as well as methods of applications accommodate specific objectives.

Microdrive for probes

This invention involves apparatus and methods for relating image scan data of a patient's anatomy from an imaging scanner to a device attached to said patient's anatomy or to an apparatus located nearby said patient's anatomy. In one embodiment it includes identification of fiducial points or markers on or near the patient's anatomy in the image scan data, and subsequently relating these fiducial points to reference points or structures connected to an apparatus attached to or nearby the patient's body. Such an apparatus might be a surgical head clamp or stereotactic frame or arc which has been attached to the patient's head at the time of surgery. A mapping is made between the coordinate frame data of the scan image to the coordinate reference frame of the patient attachment means or external apparatus by physically referencing the fiducial points to the patient attachment means or external apparatus. In one embodiment, such registration can be in the form of distance or coordinate measurements between the fiducial points on the patient's body and the reference points on the external apparatus. Applications are given in the field of frameless stereotaxy, radiosurgery, and stereotactic frame application.

Frameless to frame-based registration system

A skin-based band is fixed to a patient's skin in a repeatable position and includes reference markers which, attached to the skin band, can be visualized in tomographic image scanning. The reference markers appear as reference marker images in the image scan data from the image scan and correspond to coordinate positions in the image scan coordinate system. The reference markers also provide corresponding reference marker positions in the physical space of the patient's anatomy, which may correspond to a stereotactic coordinate system associated with a digitized navigator or frameless stereotactic reference system near the patient. The band can also be placed on the patient again at the time of surgical intervention, and the reference markers can be touched or referenced by the surgical navigator in the stereotactic coordinate system. A computer system assimilates the image scan data and calibration data and enables a mapping from the image scan coordinate system to the stereotactic coordinate system so that surgical instruments can be tracked by a surgical navigator so that their position can be referenced to the image scan data.

Head band for frameless stereotactic registration

A layer of material is provided for covering a plurality of sensors when using those sensors to examine tissue. The layer material is used with a tissue examination device that has a plurality of pressure sensors that produce signals in response to pressure imposed on the sensor as the sensors are pressed against tissue. The device also has a processor for processing those signals to detect whether an underlying tissue structure is present in the tissue being examined. The layer of material is configured to be disposed over the sensors and to distribute the imposed pressure in a selected manner. The processor can also process the signals to generate an image representative of the underlying tissue structure and a display then can display that image.

Layer of material for use with tissue examination device

This invention concerns performing clinical tissue examination with a device that includes sensors which produces signals in response to pressure imposed on the sensors as the sensors are pressed against the tissue. The sensors generate signals in response to pressure imposed on the sensors when pressed against a selected region of tissue. That pressure varies in accordance with properties of underlying tissue structures. An image of the region of tissue is generated based on the signals generated by the sensors. The image is then displayed. The image represents the pressure imposed on the sensors. The image that is displayed may be a three dimensional image of the region of tissue. The signals produced by the sensors can also be processed to detect an underlying tissue structure in the region of tissue. A location or a map of the detected underlying tissue structure relative to a reference point is generated and displayed. The results of a current examination are compared to those of a previous examination.

Clinical tissue examination

A device is provided for diagnosis and treatment of tissue with instruments, specifically locating a tissue structure and positioning an instrument relative to that tissue structure. The device which includes a plurality of sensors for generating signals in response to pressure imposed on the sensors as the sensors are pressed against the tissue. The device which includes a member which is configured to be pressed against tissue and the sensors are disposed on the member, for detection of an underlying tissue structure in the tissue. The device also includes a locating device, arranged at a selected position with respect to the sensors, for indicating a location of the underlying tissue structure. An image based on the sensors may be displayed. The method of using the device includes positioning the locating device, which may be an instrument guide, over an underlying tissue structure based on the image. The method further includes using the locating device to direct an instrument for treating or diagnosing a tissue structure towards that tissue structure.

Diagnosis and treatment of tissue with instruments

A tissue examination device includes a plurality of sensors, each of which produces a signal in response to pressure imposed on the sensor in accordance with the properties of different types of underlying tissue structures as the sensor is pressed against the tissue. A plurality of processing tests are performed on the signals, and the different types of the underlying tissue structures are discriminated from each other based on the results of the tests.

Tissue examination

This invention relates to apparatus for calibrating and recalibrating a digitized navigator or so-called frameless stereotactic instrument or device during a surgical operation. The apparatus enables calibration for the stereotactic digitizer to be recovered after sterile draping of the patient, movement of the patient's head during operation, relative movement of the patient's head and reference apparatus associated with the stereotactic digitizer, power failures, or other events which could compromise calibration of the stereotactic digitizer during the operation which would otherwise preclude continuations using the digitizer. It also provides convenient means for initial calibration or repeat calibration, should that be necessary. The apparatus is, in one embodiment, cooperatively coupled to, or coupled so as to move with, the portion of the patient's body which is being operated upon and enables the repositioning of the recalibration means after sterile draping. In exemplary embodiments, the apparatus would include a reference point structure or a reference holding structure that can be attached to, for example, a surgical head clamp in a neurosurgical operation and can be accessed for calibration positioning or calibration locationing by the digitizer during the operation. The apparatus could be removed, sterilized, and repositioned in an identical position relative to the head clamp, and therefore the patient's head during the operation, assuring that sterility and loss of calibration would not be compromised.

Intraoperative recalibration apparatus for stereotactic navigators

Methods and devices are described for calibrating the pressure sensors of a tissue examination device to enable the sensors to produce signals that accurately indicate whether an underlying tissue structure is present in tissue being examined. In general, the calibration is performed using a substance configured to apply a selected amount of pressure to the sensors when engaged in a selected way by the tissue examination device. The sensors are calibrated based on levels of the signals produced in response to the selected amount of pressure imposed by the substance. The tissue examination device may be pressed against the substance, or the substance may be pressed against the sensors. Preferably, the substance applies the selected amount of pressure substantially uniformly to the sensors. A wide variety of substances can be used, such as a foam pad, a rubber pad, a gel, a fluid-containing balloon, and pressurized air. The calibration methods and devices are simple to perform--and in fact are preferably performed during device power up so as to be transparent to the user--while accurately compensating for variations in the signals produced by the sensors as a group, as well as for individual (i.e., sensor to sensor) variations.

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Hingham, MA, United States of America

Michael A Cundari