Abstract: Laparoscopic apparatus and method for insertion into a space or potential space in a body comprising an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is provided and is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A tunneling member is mounted on the distal extremity of the tunneling shaft. A balloon assembly is provided which is removably secured to the tunneling shaft. The balloon assembly includes a balloon wrapped about said tunneling shaft. A sheath is provided which encloses the balloon on the tunneling shaft. The sheath has a slit extending longitudinally thereof permitting the sheath to be removed whereby the balloon can be released and inflated. A tubular member is provided which has a balloon inflation lumen thereon and is coupled to the balloon for inflating said balloon.

Abstract: Method for developing an anatomic space for laparoscopic hernia repair comprising separating a first layer of tissue from a second layer of tissue for creating an anatomic operating space for the performance of a surgical procedure by making an incision through the first layer of tissue. A non-elastomeric deflated balloon is introduced into the incision. The balloon is inflated to cause separation of the first layer of tissue from the second layer of tissue to thereby produce an anatomic operating space. The balloon is then deflated and removed from the incision. The anatomic operating space is inflated with insufflation gas. A surgical procedure in then performed in the anatomic operating space.

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: An instrument and method for retracting or repositioning a distal anatomic structure (organ) having a lumen (cavity) by remote manipulation. The method includes advancing the distal end of a flexible variform intraluminal member in a linear shape through a lumen (i.e., the esophagus) in the body to a distal location (the stomach), and deforming the distal end of the instrument to a rigid articulated (arched or curved) shape which retracts tissue surrounding the lumen. Further axial or rotational manipulation of a handle attached to the member correspondingly further retracts the distal anatomic structure to facilitate an endoscopic surgery.

Abstract: A 360.degree. dissection instrument and method for accomplishing an atraumatic blunt dissection of connective tissues in 360.degree. around the circumference of a saphenous vein and branch veins to facilitate a minimally invasive harvesting of the vein. The 360.degree. pulsable dissector has an elongate body with a distal dissecting surface that is progressively "circumferential" or "wrapped" around an axial vessel-receiving passageway or channel. The dissecting surface includes a longitudinal gap that has a reduced transverse dimension in the proximal direction to funnel branch veins through the gap. The wrapped dissecting surface includes an "active" periphery incorporating a pulsable expansion structure of elastomeric material having and interior pressurizable chamber. An inflation lumen in the dissector body communicates with a pressure source and a pulse-control mechanism.

Abstract: A surgical dissector and method for facilitating fiberoptic viewing when developing a minimally invasive accessway to a surgical objective in the interior of the body. The dissector or guide is used to dissect tissues along an anatomic plane under direct fiberoptic vision. A balloon is provided to further dissect and retract tissue along the dissected accessway to provide an adequate depth of field for fiberoptic viewing through transparent walls of the balloon. The dissection allows a surgeon safely to make additional incisions into the region of the fiberoptic viewing space and to perform surgical procedures under fiberoptic vision by manipulating an accessory instrument on the exterior surface of the inflated balloon that is disposed within the dissected space.

Abstract: Apparatus for creating an anatomic space in tissue in a body including an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A blunt tip is secured to the distal extremity of the tunneling shaft. A balloon assembly is provided. The balloon assembly is removably secured to the tunneling shaft. The balloon assembly includes a deflated collapsed balloon. A sheath encloses the balloon and is carried by the tunneling shaft. The sheath has a weakened region extending longitudinally thereof permitting the sheath to be removed to release the balloon.

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 withdrawn through the incision.

Abstract: An excisional biopsy needle assembly for use in combination with a stereotactic platform for excising tissue from the interior of the body. The biopsy needle includes a rotatable flexible blade that is capable of transforming between a contracted configuration for piercing into the interior of the body and an expanded configuration in which the flexible blade is expanded relative to the shaft of the needle for excising tissue. The needle assembly may be mounted in a stereotactic needle for a breast biopsy procedure that digitally directs the needle tip into a lesion with the flexible blades in a contracted configuration, then expands the flexible blades to the expanded configuration and rotates the blades thus excising tissue in a region having a cross sectional dimension that is large in relation to the cross section of the needle shaft. The excised tissue is extracted from the needle tip through an aspiration channel.

Abstract: An instrument and method for retracting or repositioning a distal anatomic structure (organ) having a lumen (cavity) by remote manipulation. The method includes advancing the distal end of a flexible variform intraluminal member in a linear shape through a lumen (i.e., the esophagus) in the body to a distal location (the stomach), and deforming the distal end of the instrument to a rigid articulated (arched or curved) shape which retracts tissue surrounding the lumen. Further axial or rotational manipulation of a handle attached to the member correspondingly further retracts the distal anatomic structure to facilitate an endoscopic surgery.

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 surgical dissector and method for facilitating fiberoptic viewing when developing a minimally invasive accessway to a surgical objective in the interior of the body. The dissector or guide is used to dissect tissues along an anatomic plane under direct fiberoptic vision. A balloon is provided to further dissect and retract tissue along the dissected accessway to provide an adequate depth of field for fiberoptic viewing through transparent walls of the balloon. The dissection allows a surgeon safely to make additional incisions into the region of the fiberoptic viewing space and to perform surgical procedures under fiberoptic vision by manipulating an accessory instrument on the exterior surface of the inflated balloon that is disposed within the dissected space.

Abstract: A surgical instrument for gripping tissue in an endoscopic workspace. The instrument has an elongate introducer sleeve extending along a primary axis. An articulating jaw assembly is coupled to the distal end of the introducer sleeve with a ball and socket-type joint that provides jaws that open and close with around a secondary axis. Thus, the secondary axis of the jaw assembly is free to articulate and rotate relative to the primary axis of the introducer sleeve. When tissue is gripped by the jaws, lateral retraction forces cause the jaw assembly to align itself with the direction of retracting forces. A trigger within a proximal handle actuates the jaws in any articulated position. The instrument further provides a "flex jaw" feature by which is meant the jaw working faces are somewhat free to rotate relative to the jaw arms. Thus, as the jaw arms close to grip tissue, the jaw working faces rotate to accommodate tissue thickness and density thereby uniformly apply gripping pressure on tissue.

Abstract: An apparatus for creating an anatomic space in tissue in a body includes an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A blunt tip is secured to the distal extremity of the tunneling shaft. A balloon assembly is provided. The balloon assembly is removably secured to the tunneling shaft. The balloon assembly includes a deflated collapsed balloon. A sheath encloses the balloon and is carried by the tunneling shaft. The sheath has a weakened region extending longitudinally thereof permitting the sheath to be removed to release the balloon.

Abstract: A surgical instrument and method for facilitating the resection of an anatomic structure in a minimally invasive procedure. The resection instrument includes an inflatable enveloping sleeve member that has an inflation chamber lying between an outer sleeve and an inner sleeve thus providing an inflatable chamber that surrounds an "organ lumen" extending along the member's longitudinal axis. The enveloping member typically is of non-elastomeric sheet material and in the collapsed state is folded and stored in the instrument's handle by turning both the inner and lumen sleeves "inside-out". The instrument is disposed proximate to the anatomic structure to be resected and the enveloping member is inflated. As the inflation chamber is inflated, the enveloping member deploys distally turning itself "right-side-out" and is capable of circumferentially enveloping the anatomic structure (or portion thereof) thus progressively capturing the structure within the organ lumen.

Abstract: A safety incising instrument for helically incising a pathway through a body wall at a controlled rate without exerting longitudinal forces on the instrument. The instrument incorporates a helix assembly with a helically-protruding edge made of two cooperating elements: a tapered blade element with a sharp helical blade edge and a resilient shield element with a dull helical edge. The blade and shield elements mate along helical interfaces and jointly define the helically-protruding edge. A periphery of the helix is transformable between an incising position in which the sharp blade edge is exposed and a non-incising position in which the sharp blade edge is not exposed. The shield element is made of resilient material and tissue counterforce or drag on the shield causes the helix to transform to the incising position to incise a pathway in the body wall.

Abstract: A method for locating additional cannulae in surgery on a patient having a body with tissue and overlying skin with the use of a guide member having proximal and distal extremities comprising introducing the distal extremity of the guide member through the skin of the body to a first location in the body. The distal extremity of the guide member is advanced in a direction below the skin to a second location remote from the first location. The distal extremity of the guide member is advanced through the skin of the patient at the second location from within the body to a position outside the body so that the distal extremity is exposed outside the body. A cannula is placed over the distal extremity of the guide member and is advanced through the skin of the patient at the second location utilizing the guide member as a guide. The distal extremity of the guide member is removed from the cannula.

Abstract: A surgical instrument for bluntly dissecting connective tissues in a plane around a vein or other anatomic structure in a minimally invasive surgery. An anterograde or retrograde spiral dissector comprises one or more elongate spiral members, each having a blunt distal tip adapted for helical advancement in a plane around the surface of a vein. Anterograde helical advancement of the spiral assembly bluntly dissects small diameter "guide paths" in connective tissues with little resistance to penetration. With the spiral dissector thus helically engaged, the instrument drives itself anterograde upon rotation. The spiral dissector includes a "path-expanding" structure associated with either a distal, medial or proximal region of each spiral member, by which is meant the path-expanding structure is adapted for anterograde or retrograde travel along the dissected "guide paths" to further expand the dimensions of the guide paths thereby to dissect the connective tissues in a 360.degree. plane around the vein.

Abstract: For surgery, an endoscopic retrograde dissector instrument and less invasive method for bluntly dissecting tissue planes overlying and underlying a rectus abdominus muscle to mobilize the muscle in a transverse abdominal mastoplasty (breast reconstruction). The retrograde dissector includes an elongate blunt-tipped guide member that carries a distal inflatable sleeve. The blunt tip of the guide member is advanced distally along a plane in the interior of the body thereby creating a small diameter dissected track. The distal inflatable sleeve is inflated and then pulled in a retrograde movement along the track to dissect a wide tissue plane laterally on each side of the track in a single efficient step. A pulse mechanism rapidly pulsates the inflated sleeve to facilitate the dissection of connective tissues along planes of least resistance to create a relatively blood-free dissected tissue plane.