Abstract: A device for administering brachytherapy to a patient includes a vessel that may be in the form of a hollow cylindrical cup, for fleshing into and substantially filling the open-ended cavity. The vessel has a closed outer end, which may be a removable cover, and a source guide penetrates the closed outer end so as to extend deep into the vessel, to receive a radiation source in the source guide. A manipulator can be connected to the radiation source, and also to the source guide, for allowing several different types of manipulation of the source orientation and position within the vessel during the brachytherapy procedure.

Abstract: A needle device which is manufactured from shape memory or pseudo-elastic materials, such as Nickel Titanium alloys, is provided which may be formed and used repeatedly without adverse effects, such as permanent deformation or fatigue failure. The device in accordance with the present disclosure may be provided having an initial shape which a doctor may bend to a desired shape. The device may be easily returned to its initial shape after use by heating the device above a predetermined sterilization temperature. This cycle may be repeated during subsequent uses, substantially extending the life of the instrument, due to the reduced work hardening and enhanced fatigue properties of the Nickel Titanium device.

Abstract: An apparatus for applying a blood vessel clip includes a grip assembly having a handle, an applicator barrel attached to the grip assembly, a magazine connected to the applicator barrel, and a plunger connected to the grip assembly. The magazine has a plunger space and a magazine passage separated by a divider shim. A distal end of the magazine defines an exit aperture. The magazine passage is adapted for storing at least one blood vessel clip therein. The magazine includes a constricted region narrower than a head of the blood vessel clip. The constricted region is spaced apart from the exit aperture and has a narrowest point narrower than the exit aperture. The plunger extends into the plunger space. The plunger moves the at least one blood vessel clip distally through the constricted region and the exit aperture.

Abstract: A vaginal brachytherapy applicator has an insertable tip section, preferably rigid or at least firm enough to retain its shape when inserted, and a tubular handle section extending proximally from the tip section. A common lumen extends from the handle into and through most of the length of the tip section. In one embodiment the tip section is made of a flexible open-celled foam material with a substantially impermeable outer skin, and in this case the tip section can be contracted, or stretched lengthwise to reduce its diameter, for ease of insertion, then re-expanded to its nominal and working configuration prior to insertion of a radiation source into the lumen and irradiation of tissue surrounding the tip section.

Abstract: Methods and applicator apparatus are disclosed for brachytherapy treatment of tissue surrounding a cavity in a patient, particularly a resection cavity. In treatment regimes requiring recovery time between successive radiation treatments, applicators of the invention are retained under the skin, with the skin allowed to at least partially heal, and are re-accessed later for one or more subsequent treatments. To reduce patient discomfort an anesthetic agent can be infused through the applicator to patient tissue, for insertion, balloon inflation or removal of the applicator.

Abstract: Brachytherapy treatment of a patient's lung tissue following resection is effected using a balloon applicator which is inserted, normally through the same opening used for the surgery, through the chest wall and into the cavity. The lung and chest openings are closed around the applicator and generally sealed around the applicator. A suction port is provided, in a suction circuit of the applicator, to withdraw fluid from the pleural cavity, at intervals as needed, to assure that the lung can be inflated. Different embodiments of suction circuits are disclosed. A bronchial applicator and method are also disclosed.

Abstract: A blood vessel clip applicator preferably includes two twist pins at one end, between which a blood vessel is placed before occlusion. A magazine in the blood vessel clip applicator preferably holds a plurality of blood vessel clips and can be rotated independently from a grip assembly, whereby the twist pins can be rotated to compress a blood vessel held between them. A blood vessel clip is preferably placed on the blood vessel after it has been flattened. A blood vessel clip preferably comprises spring quality material, and preferably has a head connected to a first leg and a second leg. The magazine preferably has a constricted region adjacent to an exit aperture. As the head enters the constricted region, the compressive force exerted on the head by the constricted region opens the blood vessel clip to an open position. In an alternate embodiment, a plunger applies a blood vessel clip with a direct stroke.

Abstract: A balloon brachytherapy applicator has either a single or double chambers, with the capability of “blistering” outwardly at a specified area on one side of the balloon. This is useful to move sensitive tissue, such as skin or bone, farther away from a radiation source within a source guide inside the balloon. In one case a secondary balloon or secondary compartment is formed on the primary balloon, and is separately inflatable so as to allow blistering as desired when needed.

Abstract: An everting applicator for brachytherapy of body cavities such as the vagina has a flexible sleeve secured to a distal mandrel, both the sleeve and the mandrel having internal lumens. The flexible sleeve has a diverging opening at its distal end, preferably bell-shaped or cone-shaped, such that when the open end is pushed against the mouth of a vagina, the sleeve will evert back upon itself, progressively unrolling to an inside out configuration wherein, fully inserted, the sleeve is fully everted back over the exterior surface of the mandrel. A radiation source, isotopic or electronic, is then inserted into the mandrel lumen to commence a therapeutic irradiation procedure of tissues of the vagina.

Abstract: An everting applicator for brachytherapy of body cavities such as the vagina has a flexible sleeve secured to a distal mandrel, both the sleeve and the mandrel having internal lumens. The flexible sleeve has a diverging opening at its distal end, preferably bell-shaped or cone-shaped, such that when the open end is pushed against the mouth of a vagina, the sleeve will evert back upon itself, progressively unrolling to an inside out configuration wherein, fully inserted, the sleeve is fully everted back over the exterior surface of the mandrel. A radiation source, isotopic or electronic, is then inserted into the mandrel lumen to commence a therapeutic irradiation procedure of tissues of the vagina.

Abstract: A brachytherapy applicator and method of use involve source guides that assume a desired curving, non-linear configuration. A flexible source catheter follows the shape of the source guides when inserted therein. Radiation dose received in various tissue areas can be better controlled using the invention, and the ratio of cavity surface dose to prescription depth dose can be lowered. With sequential manipulation of the source via movement of the catheter, the applicator can deliver radiotherapy to a treatment plan with local variation to prevent overdose, through either stepped or continuous movement of the source. Source guides can be fixed in position and arranged in bowed configuration around a generally central balloon axis, either attached to the balloon wall or not, and the series of off-center guides can be used to shape the dose delivered.

Abstract: A stent and catheter for implanting or removing a helical-shaped stent within a body passageway; the catheter having an elongate sheath with a socket for securing one end of the stent at a distal region of the sheath and an inner member extending from the sheath, and also having a socket at a distal region of the inner member for securing the other end of the stent. The inner member is rotatable relative to the sheath to transmit torque to the stent to permit unwinding of the helical stent at its limiting strain to expand the stent. Also discussed are methods for performing procedures for implanting or removing a helical stent from a body passageway.

Abstract: Radiation treatment methods for breast cancer following resection, both intraoperative and post operative, involve mapping preferably using an electronic x-ray source, and can include rotation of a direction source. By using a very rapid, near-instantaneous method of pathology of tissue margins following resection, the invention carries out intraoperative radiation treatment, preferably with the patient remaining anesthetized. Whether or not radiation is intraoperative, the invention preferably includes a mapping procedure using an electronic source that is progressed through the resection cavity while radiation dose is sensed at one or more points, to determine the shape of the resection cavity.

Abstract: An expansible tunneling apparatus and associated methods for creating an anatomic working space for a surgical procedure. Various embodiments of one and two piece apparatus that permit laparoscopic observation both during tunneling and during subsequent balloon dissection are disclosed. In a disclosed one piece embodiment, a tubular member has a bore extending therethrough and an open distal end. A lip is formed in the distal end of the tubular member to capture the distal tip of a laparoscope that is inserted into the tubular member to permit observation of the procedure both during tunneling to a desired location and during subsequent balloon inflation. An elongated neck of the balloon is secured to the tunneling member. The elongated neck permits the tubular member to be withdrawn slightly from the balloon after inflation to facilitate observation.

Abstract: A laparoscopic apparatus for tunneling dissection including a hollow tunneling member and an inflatable balloon disposed at the distal end of the tunneling member to form together a blunt tipped obturator. The tunneling member has a bore sized allow the insertion of a conventional laparoscope therein to provide observation during surgical procedures. After the anatomic space has been created, the device and laparoscope are withdrawn through the incision. The anatomic working space may be insufflated with an insufflation gas if required for the particular procedure. The apparatus is prepared for use by inserting the tunneling member into the interior of the balloon, forming the balloon into a generally cylindrical roll about the tunneling member, and preferably, through the use of an integral balloon cover, securing the balloon roll to the tunneling member to form a semi-rigid blunt tipped obturator.

Abstract: The invention provides a method of using an apparatus for manipulating matter in a confined or inaccessible space, comprising providing an apparatus having manipulator means at least partly constructed of one or more bent or twisted elongate shape memory alloy members having pseudoelasticity at the intended manipulation temperature, and a hollow housing or cannula capable of holding at least the shape memory alloy member(s) in a relatively straightened state, and actuating means for extending the shape memory alloy member(s) from the housing to manipulate matter within the space and for withdrawing the shape memory alloy member(s) into the housing, the arrangement being such that the shape-memory alloy member(s) bend(s) or twist(s) pseudoelastically in a lateral or helical sense to manipulate the matter on extending from the housing at the manipulation temperature, and become(s) relatively straightened on withdrawal into the housing at the temperature.

Abstract: A method and apparatus for dissecting a first layer of tissue from a second layer of tissue and thereafter holding open an anatomic space for the performance of a surgical procedure. The method includes steps of making an incision in a body, introducing a deflated balloon dissector into the incision, inflating the balloon dissector to effect dissection of the first layer of tissue from the second layer of tissue, deploying a retractor within the anatomic space in order to hold open the anatomic space, and optionally deflating or evacuating the balloon dissector to open a cavity for surgical manipulations. The apparatus includes a combined dissector-retractor having a balloon retractor disposed upon the surface of the balloon dissector and integrated therewith.

Abstract: An expansible tunneling apparatus and associated methods for creating an anatomic working space for a surgical procedure. Various embodiments of one and two piece apparatus that permit laparoscopic observation both during tunneling and during subsequent balloon dissection are disclosed. In a disclosed one piece embodiment, a tubular member has a bore extending therethrough and an open distal end. A lip is formed in the distal end of the tubular member to capture the distal tip of a laparoscope that is inserted into the tubular member to permit observation of the procedure both during tunneling to a desired location and during subsequent balloon inflation. An elongated neck of the balloon is secured to the tunneling member. The elongated neck permits the tubular member to be withdrawn slightly from the balloon after inflation to facilitate observation.

Abstract: A flexible, fluid-tight envelope provides access for a hand and surgical instruments through a body tissue incision while maintaining insufflation pressure or a pneumoperitoneum within the body. The envelope is transparent and has an interior volume with opposite proximal and distal ends. A first opening in the envelope at the proximal end adjoins the incision in the body tissue and is secured and sealed to the body tissue. The second opening at the envelope distal end is provided with a closure member that seals closed the second opening on itself or around the forearm of a surgeon or a surgical instrument inserted into the interior volume of the envelope.

Abstract: A needle device which is manufactured from shape memory or pseudo-elastic materials, such as Nickel Titanium alloys, is provided which may be formed and used repeatedly without adverse effects, such as permanent deformation or fatigue failure. The device in accordance with the present disclosure may be provided having an initial shape which a doctor may bend to a desired shape. The device may be easily returned to its initial shape after use by heating the device above a predetermined sterilization temperature. This cycle may be repeated during subsequent uses, substantially extending the life of the instrument, due to the reduced work hardening and enhanced fatigue properties of the Nickel Titanium device.