Abstract: A surgical trocar access sheath having a laterally expandable retention mechanism for percutaneous insertion through a body cavity wall. The expandable retention mechanism is positioned about the distal end of the sheath for retaining the access sheath within the body cavity. The access sheath has an inner elongated member cannula and an outer elongated member tube having a slick surface for ready insertion through a puncture site. The laterally expandable retention mechanism includes a plurality of strips extending and formed longitudinally in the outer tube. The retention mechanism has an expanded state and a retracted state. In the expanded state, the longitudinal strips extend radially from the outer elongated member tube to engage the interior surface of the body cavity wall. The expandable retention mechanism is actuated by sliding an actuating mechanism hub attached to the distal end of the outer elongated member tube against another hub fixedly attached to the inner elongated member cannula.

Abstract: A surgical cutting instrument is disclosed for percutaneously debulking tissue through an access sheath commonly used in minimally invasive laparoscopic or endoscopic surgical procedures. The cutting instrument includes a inner rotary member tube having a cutting edge at the distal end thereof for cutting and slicing tissue. The distal end of the cutting member tube extends from the distal end of a stationary sheath which prevents tissue from wrapping around the inner cutting member tube. The inner cutting member tube includes a hollow passageway for suctioning and aspirating tissue and fluid through the tube and into a collection chamber or out through a vacuum or suction line attached thereto. The instrument further includes an outer safety shield having a rounded distal end for preventing the puncture of a surgical tissue bag or from unintentionally cutting tissue by the attending physician.

Abstract: Echogenic medical devices and methods of fabrication and of use are disclosed. The devices are adapted to be inserted into a patient. The device includes an elongated member including a material having an acoustic impedance different from that of the surrounding medium. The medium includes surrounding biological tissue or fluids surrounding the member when inserted into a passageway of the patient. The acoustic impedance of the elongated member is sufficiently different from the surrounding medium for enhancing an image produced in response to a sonic beam produced from imaging equipment. The elongated member also includes an interface layer of a high density metal of which the deposition on the base material of the member is ion beam assisted. The interface layer includes an outside surface having a plurality of particulate-type, discontinuous curved surfaces of partially spherical indentations formed therein or spheres extending therefrom.

Abstract: A surgical cutting instrument is disclosed for percutaneously debulking tissue through an access sheath commonly used in minimally invasive laparoscopic or endoscopic surgical procedures. The cutting instrument includes a inner rotary member tube having a cutting edge at the distal end thereof for cutting and slicing tissue. The outside surface of the rotary inner cutting member tube and outer sheath annularly close about the distal ends thereof for preventing perforation of the surgical tissue bag in which the tissue is contained. The inner cutting member tube includes a hollow passageway for suctioning and aspirating tissue and fluid through the tube and into a collection chamber or out through a vacuum or suction line attached thereto. Vacuum or suction control ports are included at the proximal end of the inner cutting member tube and stationary sheath for also controlling the amount of vacuum or suction applied to the tissue.

Abstract: An instrument for removing tissue samples from a tissue mass which automatically penetrates, severs, and removes a tissue portion for examination. The instrument is motor powered, preferably by self-contained rechargeable batteries, and employs electrically actuated stops to control the action of penetration into and retraction from the tissue mass. The tissue penetrating means and severing means includes an inner stylet which penetrates the tissue mass and a hollow outer tube or cannula which surrounds the stylet and serves to sever a sample of tissue. In a preferred form the tissue penetrating end of the stylet is notched so that when the stylet penetrates the tissue mass, a portion of the tissue relaxes in the notched area. After tissue penetration by the stylet, the cannula, having a cutting surface at its distal end, penetrates the tissue and cuts off the tissue portion residing in the notched area of the stylet.

Abstract: Echogenic medical devices and methods of fabrication and of use are disclosed. The devices are adapted to be inserted into a patient. The device includes an elongated member including a material having an acoustic impedance different from that of the surrounding medium. The medium includes surrounding biological tissue or fluids surrounding the member when inserted into a passageway of the patient. The acoustic impedance of the elongated member is sufficiently different from the surrounding medium for enhancing an image produced in response to a sonic beam produced from imaging equipment. The elongated member also includes an interface layer of a high density metal of which the deposition on the base material of the member is ion beam assisted. The interface layer includes an outside surface having a plurality of particulate-type, discontinuous curved surfaces of partially spherical indentations formed therein or spheres extending therefrom.

Abstract: A rotational surgical instrument including a working head connected to a rotatable, pencil-like handle. The handle includes a casing with distal and proximal end caps, an elongated outer member extending into the casing, and a actuation link extending from the distal end cap through the casing and elongated member to the working head. An actuating mechanism is positioned distally from the distal end cap about the proximal portion of the elongated member for slidably actuating the working head between and open and closed positions. A compression spring is included in the passageway of the casing around the actuation link between the proximal end cap and the proximal end of the elongated member to return the working head to the nonactuated position. Keyed surfaces are included within the passageway of the casing and attached to the distal end of the casing and the proximal end of the elongated member for preventing rotation of the elongated member with respect to the casing and actuation link.

Abstract: A rotational pressure drive for a medical syringe to obtain, maintain, and release a desired fluid pressure within the syringe. The commercially available medical syringe includes a barrel with a plunger extending therein. Extending laterally and radially about the proximal end of the syringe barrel are several flanges. The rotational pressure drive comprises a hollow cylindrical chamber with a closed end for engaging the proximal end of the syringe plunger, and a hollow passageway extending therethrough to an open end which receives the plunger. Positioned circumferentially and longitudinally along the chamber are pluralities of internal threads with individual starts for engaging the radially extending flanges of the syringe barrel. The extended plunger is inserted into the passageway of the drive to the closed end, whereas the flanges of the syringe barrel are rotationally engaged with the starts of the internal thread pluralities for advancement into the passageway of the drive.

Abstract: Echogenic medical devices and methods of fabrication and of use are disclosed. The devices are adapted to be inserted into a patient. The device includes an elongated member including a material having an acoustic impedance different from that of the surrounding medium. The medium includes surrounding biological tissue or fluids surrounding the member when inserted into a passageway of the patient. The acoustic impedance of the elongated member is sufficiently different from the surrounding medium for enhancing an image produced in response to a sonic beam produced from imaging equipment. The elongated member also includes an interface including the outside surface of the member and a plurality of partially spherical indentations therein. Alternatively, generally spherical particles are attached to the surface of the member for producing the image in response to the sonic beam. Materials such as stainless steel, plastic, and glass are utilized in the manufacture of the medical device.

Abstract: Apparatus and methods for performing fine-needle aspiration biopsies are disclosed. Each method and apparatus includes a needle having an opening which can be occluded during both the penetration and withdrawal stages of the aspiration cycle. After penetration of the target area, the needle is reciprocated a predetermined number of times determined by the desired cytological sample yield. The needle is unoccluded during the reciprocation phase of the cycle. Both manual and automatic apparatus for performing the fine-needle aspiration biopsy procedures in accordance with the disclosed method are disclosed. Numerous sheath configurations for various biopsy applications are illustrated, including those applicable to prostate and breast or other soft tissue biopsies and for use in conjunction with ultrasonic transducers. Alternative needle configurations are disclosed to improve sample yield, reduce coring and minimize needle fouling.

Abstract: A suture guide and, in particular, a urethral sound having interchangeable tips for placing sutures in the severed end of a body duct. The urethral sound includes an attachment mechanism having interconnection parts longitudinally rotatable when interconnected. The sound further includes an elongated member having a distal end portion including one of the interconnection parts. A plurality of interchangeable tips are provided each having a rounded distal end and a proximal end including the second interconnection part. Interchangeable tips are positioned at the distal portion of the elongated member and are longitudinally rotated thereat. Various tips include one or more apertures for placing sutures through, for example, a severed urethral stump created during a radical prostatectomy. Channels are also placed in a number of the tips to provide placement of individual sutures about the distal end of the severed stump as desired by the physician.

Abstract: An instrument for removing tissue samples from a tissue mass which automatically penetrates, severs, and removes a tissue portion for examination. The instrument is motor powered, preferably by self-contained rechargeable batteries, and employs electrically actuated stops to control the action of penetration into and retraction from the tissue mass. The tissue penetrating means and severing means includes an inner stylet which penetrates the tissue mass and a hollow outer tube or cannula which surrounds the stylet and serves to sever a sample of tissue. In a preferred form the tissue penetrating end of the stylet is notched so that when the stylet penetrates the tissue mass, a portion of the tissue relaxes in the notched area. After tissue penetration by the stylet, the cannula, having a cutting surface at its distal end, penetrates the tissue and cuts off the tissue portion residing in the notched area of the stylet.

Abstract: A surgical tissue bag for percutaneously debulking large volumes of tissue contained within the bag. The tissue bag comprises two layers of material, an inner layer of a puncture-resistant material and an outer layer of moisture-proof material for containing cells and fluid therein. The bag material is foldable and flexible for insertion through an access sheath into the surgical site and for forming a gas-tight seal when extended through the access sheath or puncture site. A drawstring is attached to the open end of the bag to close the bag when the tissue is contained therein and pulled through the puncture site in the outer surface of the skin. After the closed open end of the bag is pulled through the puncture site, the closed end is fanned out against the outer layer of the skin, and a morcellator is inserted into the bag for debulking the large volume of tissue. The open end of the bag is continually fanned out to maintain a compact and tight containment of the tissue and fluid remaining in the bag.

Abstract: A needle driver instrument suitable for use with a trocar sheath in operative endoscopic surgical procedures such as laparoscopic and pelviscopic procedures is disclosed for driving a curved suture needle. The needle driver instrument comprises an elongated cylindrical tube member having a channel formed about the distal end thereof for receiving either a curved or a straight suture needle. The channel is transversely formed through the elongated member and has a plurality of surfaces to orient and fix the suture needle in a predetermined orientation. A wedge operable across the channel and through the passageway of the elongated member wedges the needle between at least two of the contact surfaces of the channel to fixedly position the suture needle in the desired orientation. At the proximal end of the device is a handle with a generally U-shaped spring extending therefrom for manual operation of the wedge.

Abstract: Apparatus and methods for performing fine-needle aspiration biopsies are disclosed. Each method and apparatus includes a needle having an opening which can be occluded during both the penetration and withdrawal stages of the aspiration cycle. After penetration of the target area, the needle is reciprocated a predetermined number of times determined by the desired cytological sample yield. The needle is unoccluded during the reciprocation phase of the cycle. Both manual and automatic apparatus for performing the fine-needle aspiration biopsy procedures in accordance with the disclosed method are disclosed. Numerous sheath configurations for various biopsy applications are illustrated, including those applicable to prostate and breast or other soft tissue biopsies and for use in conjunction with ultrasonic transducers. Alternative needle configurations are disclosed to improve sample yield, reduce coring and minimize needle fouling.

Abstract: A device and method for intravaginal, barrier-type prevention of conception and infection by sexually-transmitted diseases based upon a barrier-type device including a flexible cervical dome having a continuous fornical rim defining an opening into the dome and a continuous, annular, vaginal brim which circumscribes and is attached to the cervical dome at the fornical rim. The vaginal brim is reverse-folded from the fornical rim, and has a dimension which continuously increases with circumferential symmetry from an anterior vaginal extension of the brim to a posterior vaginal extension of the brim which is diametrically opposite the anterior vaginal extension. The fornical rim is characterized in having a lip which extends inwardly from the opening toward the centerline of the dome. The brim has a curvature in a direction away from the dome.

Abstract: An endoscopic aspiration instrument suitable for use with a trocar sheath in laparoscopic surgical procedures is disclosed for aspirating fluid from an ovarian cyst without leakage of the fluid into the peritoneal cavity. The endoscopic instrument comprises a elongated suction tube member having a needle guide positioned within the passageway thereof. The suction tube and needle guide are connected at the proximal ends thereof with the use of a three access port connector. The first access port connects to the proximal end of the suction tube. The proximal end of the needle guide tube is extended through the first port and connected to the second port of the T-type connector. An aspiration needle is inserted through a sealing cap positioned over the second access port and into the passageway of the needle guide tube.

Abstract: An indwelling ureteral stent positioning apparatus is provided for allowing single intrusion placement of a stent in the ureter of a patient. The apparatus is pre-assembled and includes a wire guide with floppy tip. The stent is positioned about the wire guide adjacent to the floppy tip of the wire guide, and is adjustably situated on the wire guide to expose a pre-determined length of the floppy tip for insertion into the patient. The stent is a dual open-ended tubular stent having a resilient retentive curved circular or pigtail shape at each end for retention in the kidney and bladder. A positioner is conveyed on the wire stent until the end of the positioned abuts the anatomically distal end of the stent. A pin-vise clamp abuts the external end of the positioner and releasably engages the wire guide to stabilize the apparatus during insertion. When used to position the stent within the ureter, the apparatus is conveyed along the ureter until the floppy tip is within the renal collecting system.

Abstract: A medical procedure involving direction of the operative end of a medical instrument via observation through a remote small caliber fiber optic bundle disposed through a prepositioned needle lumen.

Abstract: A surgical instrument such as a needle is particle-blasted with particles approximately 50 microns in diameter to produce a uniformly roughened surface portion for use with an ultrasound imaging system to provide real-time monitoring of the location of a specific portion of the needle during insertion and guidance inside the patient's body.