Abstract: A labyrinth package for sutures. The package has a base member with a top and a bottom. A labyrinth wall member extends from the top of the base member upwardly to form a labyrinth channel. The channel has an open end and a closed end. There is a vacuum opening in the bottom of the channel adjacent to the closed end. A lid is placed on top of the package. The package is loaded with sutures by using a combination of a vacuum source applied to the vacuum opening and a venturi air stream feed.

Abstract: This invention relates to a three-dimensional digitizer and a probe means associated with said digitizer that enables a virtual target point to be visualized and depth and range measurements to that target to be determined. In one embodiment, a mechanical articulated arm or other type of 3-D digitizer is used in conjunction with a graphics workstation which displays images from CT, MR, or other scanning means of the anatomy. By registration of the digitizer to the patient's physical anatomy, a representation of the digitizer on the display means of the graphics workstation is possible. The position of the digitizer will be displayed in its quantitative relationship to the patient's anatomy, including internal pathologies such as tumors. The end means of the 3-D digitizer could be a holder or fixation device which can accept a sliding probe. The probe, for example, could be a shaft which slides in a spring-loaded or non-spring-loaded fashion within the fixation means of the digitizer.

Abstract: 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.

Abstract: 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.

Abstract: A machine for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, a suture package unloading arrangement and package unloading method employed in an automated machine for the high-speed individualized packaging of single or individual surgical needles each having an attached suture into a tray and detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures.

Abstract: A semi-automated machine and method for singulating individual surgical needles from an bulk supply and attaching a suture to the surgical needle is described. Each of the surgical needles has a suture receiving opening formed therein for receiving a suture. The machine includes a singulation station having a sliding surface that assists an operator in singulating needles and depositing them in a pair of drop locations for subsequent automatic handling. Indexing conveyors, an articulated robot and a precision conveyor are used with a precise positioning station for orienting each needle for automatic handling. A universal gripper mounted on a rotary indexing device automatically receives each individual needle in a predetermined orientation and conveys the needle for sequential processing from station to station to form the needle-suture assembly.

Abstract: This invention relates to a three-dimensional digitizer and a probe means associated with said digitizer that enables a virtual target point to be visualized and depth and range measurements to that target to be determined. In one embodiment, a mechanical articulated arm or other type of 3-D digitizer is used in conjunction with a graphics workstation which displays images from CT, MR, or other scanning means of the anatomy. By registration of the digitizer to the patient's physical anatomy, a representation of the digitizer on the display means of the graphics workstation is possible. The position of the digitizer will be displayed in its quantitative relationship to the patient's anatomy, including internal pathologies such as tumors. The end means of the 3-D digitizer could be a holder or fixation device which can accept a sliding probe. The probe, for example, could be a shaft which slides in a spring-loaded or non-spring-loaded fashion within the fixation means of the digitizer.

Abstract: 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.

Abstract: A method for automatically forming armed surgical needles and for automatically packaging the same in a packaging tray, the automatic forming and packaging operating under control of a control computer, each armed surgical needle including a surgical needle having a suture receiving opening formed therein for attachment of a definite length suture material thereof.

Abstract: The present invention is directed to improvements in an Automated Swage Wind and Packaging Machine that is particularly adapted to assist in the automated singulation of surgical needles to enable subsequent automated handling of the needle, automatic swaging of the suture into a receiving end of the needle, automatic pull testing of the combined needle and suture, and automated packaging of the pull tested combined needle and suture into a tray having a cover.

Abstract: A process for applying a biobarrier member to a vent opening in a foil member used for medical device packaging. The process provides for cutting a biobarrier member from a roll of stock and sealing the biobarrier member about the vent opening in the foil member. The seal is tested for integrity and the biobarrier member is tested for porosity.

Abstract: A machine for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, a package feed arrangement in an automated machine including a package tray supplying carousel arrangement and robotic pivot arm mechanism for the high-speed feed of package trays for the individualized packaging of single or individual surgical needles each having an attached suture into a tray and detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures.

Abstract: A semi-automated machine for singulating individual surgical needles from an bulk supply and attaching a suture to the surgical needle is described. Each of the surgical needles has a suture receiving opening formed therein for receiving a suture. The machine includes a singulation station having a sliding surface that assists an operator in singulating needles and depositing them in a pair of drop locations for subsequent automatic handling. Indexing conveyors, an articulated robot and a precision conveyor are used with a precise positioning station for orienting each needle for automatic handling. A universal gripper mounted on a rotary indexing device automatically receives each individual needle in a predetermined orientation and conveys the needle for sequential processing from station to station to form the needle-suture assembly.

Abstract: A machine for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, a needle gripper and transfer arrangement in an automated machine for the high-speed individualized packaging into trays of single or individual surgical needles each having an attached suture and a detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures. The machine includes vertically adjustable frame structure so as to adjust the elevation thereof relative to the needle transfer arrangement to facilitate the packaging of differently sized needles in a single size of packaging tray.

Abstract: A machine and a method for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, an automated machine for the high-speed individualized packaging of single or individual surgical needles each having an attached suture into a tray and detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures. Additionally, the automated packaging machine incorporates operative mechanism adapted to wind the sutures into a peripheral channel of the tray and facilitating the attachment of the cover to the tray which contains the single needle and attached wound suture, and which cover concurrently constitutes a product-identifying label as a component of the tray, and upon removal of the cover enables a user to gain access to the contents of the tray; in essence, the armed suture.

Abstract: A machine for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, a suture winding arrangement in an automated machine for the high-speed individualized packaging of single or individual surgical needles each having an attached suture into a tray and detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures.

Abstract: 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.

Abstract: A machine for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, an arrangement and a method for applying covers to package trays in an automated machine for the highspeed individualized packaging of single or individual surgical needles each having an attached suture into a tray and detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures.

Abstract: A machine for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, a suture capture and tensioning arrangement in an automated machine for the high-speed individualized packaging of single or individual surgical needles each having an attached suture into a tray and detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures.

Abstract: A semi-automated machine for singulating individual surgical needles from an bulk supply and attaching a suture to the surgical needle is described. Each of the surgical needles has a suture receiving opening formed therein for receiving a suture. The machine includes a needle singulation station, a precise positioning station, a suture feeding station, a swage station, a pull-test station and an off-load station. A universal gripper mounted on a rotary indexing device automatically receives each individual needle in a predetermined orientation and conveys the needle for sequential processing from station to station to form the needle-suture assembly. The rotary indexing device includes two coaxial cam dials that provide rotation and reciprocation of the universal gripper, and an off-set drive is provided at two locations for laterally off setting the radial reciprocation of the universal gripper.