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: A stent and catheter for implanting or removing a helical-shaped stent within a body passageway; the catheter having an elongate sheath capable of being secured to one end of the stent at a distal region of the sheath and an inner member extending from the sheath, and capable of being secured to 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 as 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: Apparatus and methods for applying fasteners during endoscopic surgery. The apparatus generally comprises a handle portion, a triggering mechanism and a fastener applicator. In one embodiment, the invention forms the fastener around a pair of anvils. Another embodiment uses a two section ramp to move the fasteners from a fastener storage channel to a position at least partially in a fastener driving channel. The various embodiments may be variously combined together in a single device.

Abstract: The present invention accordingly provides a device or apparatus for manipulating matter in a confined or inaccessible space, comprising 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 (preferably of elongate tubular form) 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 said 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 said manipulation temperature, and become(s) relatively straightened on withdrawal into the housing at the said temperature.

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: Apparatus and methods for applying fasteners during endoscopic surgery. The apparatus generally comprises a handle portion, a triggering mechanism and a fastener applicator. One embodiment of the invention forms the fastener around a single focal point on an anvil. Another embodiment vertically stacks the fasteners in a fastener applicator which is readily detachable from the handle portion by virtue of a rotational locking system and which may be replaced with a new fastener applicator having a fresh load of vertically stacked fasteners. A third embodiment of the invention has a fastener applicator having only one actuated part in its application mechanism, and makes use of biased springs controlled by position of the actuated part for the remaining part of the mechanism. A fourth embodiment of the invention deploys a plunger/ratchet assembly and pawl within the handle portion of the apparatus to ensure that the apparatus application mechanism will not reverse in the middle of a triggered application stroke.

Abstract: A device and method for deploying helical fasteners which may be used to attach a prosthesis to tissue, e.g., to attach a mesh patch in a hernia repair procedure. A helical coil fastener which is inhibited from undesirable migration after installation is also provided.

Abstract: An inflatable manipulator for organ manipulation during surgery is disclosed. The system typically includes an inflatable balloon connected to an infusion source where the balloon is either coupled to a relatively rigid platform or fitted with a positioning structure such as a pocket. In open heart surgery, the platform is used to position and stabilize the balloon under the heart. In minimally invasive surgery, the balloon fitted with the pocket and can be rolled into a narrow configuration and inserted through a small incision using an insertion device. The insertion device can then be removed once the manipulator is in position. In use, the balloon of the manipulator is inflated by the infusion source thereby elevating and tilting the organ to the desired position for surgical access. Systems including multiple chamber manipulators each with a separate infusion source are also disclosed, as are combined methods for cooling organs during surgery and for using the manipulators to separate adhesions.

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 balloon device useful for dissecting tissue or retracting tissue for the purpose of providing space for laproscopic surgery comprising a balloon having at least two protuberances in its distal region. The present device is particularly useful in bladder neck suspension and hernia repair procedures.

Abstract: Apparatus for applying fasteners during endoscopic surgery includes a handle portion, a triggering mechanism and a fastener application. The fastener applicator is detachable from the handle portion by virtue of a rotational locking system and may be replaced with a new fastener applicator having a fresh load of vertically stacked fasteners. The fastener may be formed around a single point on an anvil. The fastener applicator having only one actuated part in its applicator mechanism, and makes use of biased springs controlled by the position of the actuated part for the remaining part of the mechanism. Another embodiment of the invention deploys a plunger/ratchet assembly and pawl within the handle portion of the apparatus to ensure that the apparatus applicator mechanism will not reverse in the middle of a triggered application stroke.

Abstract: A balloon apparatus adapted for sequential dissection of an anatomical space and associated methods are provided. The balloon apparatus comprises a tubular member having a lumen, a tunneling member slidably disposed in the lumen of the tubular member, a flattened substantially rectangular balloon sealed about the tubular member, a sleeve which contains the deflated balloon in generally cylindrical rolls about the tunneling member, and a retainer which prevents an inverted substantially heel-shaped portion of the balloon from everting and inflating prior to inflation of the remainder of the balloon. In a preferred method of operation, the balloon apparatus enters an anatomical space whereby the entry point into the anatomical space divides the space into a superior and inferior portions. The tunneling member is advanced into the superior portion of the space and the balloon inflated, thereby dissecting the superior portion of the anatomical space.

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: Medical devices which are currently proposed to use elements made from shape memory alloys may be improved by the use of stress-induced martensite alloy elements instead. The use of stress-induced martensite decreases the temperature sensitivity of the devices, thereby making them easier to install and/or remove.

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. The laparoscope provides direct observation of dissection through the open distal end of the tunneling member. Observation is provided both when the device is used to tunnel between tissue layers to a region of interest within the body of a patient, and during subsequent balloon inflation when the tissue layers are dissected to cause separation of the tissue layers and the creation of an anatomical working space. After the anatomic space has been created, the device and laparoscope are withdraw through the incision.

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. The laparoscope provides direct observation of dissection through the open distal end of the tunneling member. Observation is provided both when the device is used to tunnel between tissue layers to a region of interest within the body of a patient, and during subsequent balloon inflation when the tissue layers are dissected to cause separation of the tissue layers and the creation of an anatomical working space. After the anatomic space has been created, the device and laparoscope are withdraw through the incision.

Abstract: Apparatus and method for applying fasteners during endoscopic surgery includes a handle portion, a triggering mechanism and a fastener application. The fastener applicator is detachable from the handle portion by virtue of a rotational locking system and may be replaced with a new fastener applicator having a fresh load of vertically stacked fasteners. The fastener may be formed around a single point on an anvil. The fastener applicator having only one actuated part in its applicator mechanism, and makes use of biased springs controlled by the position of the actuated part for the remaining part of the mechanism. Another embodiment of the invention deploys a plunger/ratchet assembly and pawl within the handle portion of the apparatus to ensure that the apparatus applicator mechanism will not reverse in the middle of a triggered application stroke.

Abstract: An improved laparoscopic apparatus for tunneling to a desired anatomical location and developing a surgical space is disclosed, including a tunneling member adapted to receive a laparoscope therein and an inflatable balloon secured on the tunneling member. The tunneling member has a passage extending between its open proximal and distal ends. A lip is integrally formed on the distal end to retain a laparoscope inserted into the passage, the lip having a substantially rounded and blunt distal edge. The lip defines a recessed or open center area in the distal opening, enhancing the field of view of the laparoscope therethrough. The balloon is formed from flexible, transparent material, and is rolled and secured to the tunneling member.

Abstract: The present invention relates to an expansible tunneling apparatus suitable for tissue dissection. The apparatus is provided with a cannula-loading shaft at its proximal end such that a cannula chosen from a range of different cannulas may be loaded over the cannula-loading shaft and installed in an anatomic space created by the expansible tunneling apparatus. The apparatus is also provided with an inflatable member such as a balloon to accomplish the dissection and a sleeve covering the balloon which are removed from the apparatus before the cannula is loaded on the cannula-loading shaft.