Abstract: A method for replacing a deficient native mitral valve includes positioning a support band around the leaflets of a native mitral valve and expanding a prosthetic heart valve within the native mitral valve. After the prosthetic heart valve is expanded, the leaflets of the native mitral valve are captured between the prosthetic heart valve and the support band. The prosthetic heart valve and support band are delivered into the body as separate and independent components. The prosthetic heart valve and support band may be deliverable into the left ventricle via a transapical approach in a minimally invasive procedure.

Abstract: Expandable, percutaneously deployable, prosthetic heart valves and systems for minimally invasive replacement of damaged or diseased native aortic valves comprise an expandable, tubular stent body and a unidirectional valve assembly. Embodiments of the stent body comprise an annulus anchoring section, a sinus section, and an outflow section, with the outflow section flared outward from the sinus section in an expanded configuration. Embodiments of the stent body are self-expanding, comprising, for example nitinol. The valve assembly disposed within the sinus section of the stent body and sutured thereto. Embodiments of the valve assembly comprise three leaflets, each leaflet comprising a curved outer edge sutured to the sinus section of the stent body, and a coapting free edge. Embodiments of the valve leaflets comprise pericardium. Embodiments of the prosthetic heart valve have a contracted configuration dimensioned for percutaneous delivery thereof.

Abstract: An incrementally adjustable wound retractor, which provides access to a body cavity, includes an inner ring having a diameter greater than the desired diameter of the wound incision, an outer ring having an annular axis and a diameter greater than the desired diameter of the wound incision, and a flexible sleeve disposed in a generally cylindrical form between the inner and outer rings. The outer ring includes first and second circular tubes spaced apart axially with each including a lumen having a rigid, noncompliant split hoop placed therein. The outer ring may be rolled over itself and around the annular axis to retract the sleeve with sufficient force to stretch the incision to the desired diameter. A gel cap seal may be coupled to the outer ring outside of the biological body to seal the opening produced by the wound retractor between the body cavity and outside the body cavity.

Abstract: A wound retractor for retracting a surgical incision includes an inner ring, an outer ring and a distensible sleeve coupled to the inner and outer rings. The outer ring includes at least a pair of circular tubes coupled to each other. At least one of the circular tubes includes a lumen and a split that forms open ends. A noncompliant tubular hoop having a split therein is positioned in the lumen. The tubular hoop is oriented with its open ends positioned away from the split of the circular tubes. A core is positioned in the lumen of the tubular hoop. The core has a first end and a second end and is oriented with the ends positioned away from the split in the tubular hoop. The circular tubes may be parallel or may form a helical pattern similar to a Mobius strip.

Abstract: An incrementally adjustable wound retractor, which provides access to a body cavity, includes an inner ring having a diameter greater than the desired diameter of the wound incision, an outer ring having an annular axis and a diameter greater than the desired diameter of the wound incision, and a flexible sleeve disposed in a generally cylindrical form between the inner and outer rings. The outer ring includes first and second circular tubes spaced apart axially with each including a lumen having a rigid, noncompliant split hoop positioned therein. The outer ring may be rolled over itself and around the annular axis to retract the sleeve with sufficient force to stretch the incision to the desired diameter. A gel cap seal may be coupled to the outer ring outside of the biological body to seal the opening produced by the wound retractor between the body cavity and outside the body cavity.

Abstract: A trocar is provided with a cannula and a housing and valve assembly disposed in the housing which forms a housing seal, and instrument seal, and in some cases a zero seal. A gel material is included in the valve and provides the valve with superior flotation properties for maintaining the instrument seal even when the instrument is moved off-axis In order to accommodate movement of the gel material, voids can be formed within the valve housing and even within the gel material.

Abstract: The invention relates to a hand access laparoscopy device having a gelcap, a retainer, a sleeve and a retention ring. The gelcap includes gel that is bonded to a cap. The cap includes an inner cylindrical wall to which the gel in bonded, thereby providing a sealing area between the device and the wound in a body wall. By securing the gel to the inner cylindrical wall, the thickness of the gel and corresponding cap is minimized along with the overall footprint of the device. With the gel thickness reduced and able to be substantially flush, the “doming” phenomenon produced by insufflation of a patient's abdomen is reduced.

Abstract: An incrementally adjustable wound retractor, which provides access to a body cavity, includes an inner ring having a diameter greater than the desired diameter of the wound incision, an outer ring having an annular axis and a diameter greater than the desired diameter of the wound incision, and a flexible sleeve disposed in a generally cylindrical form between the inner and outer rings. The outer ring includes first and second circular tubes spaced apart axially with each including a lumen having a rigid, noncompliant split hoop placed therein. The outer ring may be rolled over itself and around the annular axis to retract the sleeve with sufficient force to stretch the incision to the desired diameter. A gel cap seal may be coupled to the outer ring outside of the biological body to seal the opening produced by the wound retractor between the body cavity and outside the body cavity.

Abstract: The invention is directed to a method for manufacturing a thin-wall, single-piece optical obturator having an integral tip and shaft. The invention includes providing an injection mold defining a mold cavity having a core pin positioned within the mold cavity. The mold includes at least one gate and multiple core support pins between the core pin and the mold cavity walls, with at least one primary core support pin positioned on a side opposite the at least one gate. The method also includes injecting a transparent molten polymeric material having high flow properties into the injection mold such that the polymeric material flows between the surface of the mold cavity and the core pin. The core support pins substantially prevent the core pin from shifting while the polymeric material is injected into the mold. The high-flow nature of the polymeric material allows for complete filling of the mold cavity.

Abstract: A surgical access device, such as a trocar, includes a pendent valve having an elongate structure extending from a proximal end to a septum valve disposed at a distal end. In operation, the elongate structure follows the angle of the instrument to pre-position the septum valve into the path of the instrument where it is not significantly challenged during instrument insertion or manipulation. The pendant valve can be made to float at both the proximal end and the distal end of the elongate structure, to further reduce the vulnerability of the septum valve. Since the valve is less vulnerable to instrument insertion, it can be formed to minimize friction and maximize the functional range of the access device.

Abstract: A surgical obturator comprising an elongate shaft extending along an axis between a proximal end and a distal end, and a bladeless tip disposed at the distal end of the shaft having a conical surface forming proximally into an outer surface, the outer surface extending distally to a blunt point and having a pair of side sections. The side sections extend from the blunt point radially outwardly with progressive positions proximally along the axis. The conical surface facilitates insertion of the obturator with a reduced penetration force and minimizes tenting of the body wall. The conical surface further facilitates separation of different layers of the body wall and provides proper alignment of the tip between the layers. The surgical obturator may be constructed from a disposable or reusable material such as a metal or an autoclavable polymer.

Abstract: The invention relates to a hand access laparoscopy device having a gelcap, a retainer, a sleeve and a retention ring. The gelcap includes gel that is bonded to a cap. The cap includes an inner cylindrical wall to which the gel in bonded, thereby providing a sealing area between the device and the wound in a body wall. By securing the gel to the inner cylindrical wall, the thickness of the gel and corresponding cap is minimized along with the overall footprint of the device. With the gel thickness reduced and able to be substantially flush, the “doming” phenomenon produced by insufflation of a patient's abdomen is reduced.

Abstract: The invention relates to a hand access laparoscopy device having a gelcap, a retainer, a sleeve and a retention ring The gelcap includes gel that is bonded to a cap. The cap includes an inner cylindrical wall to which the gel in bonded, thereby providing a sealing area between the device and the wound in a body wall. By securing the gel to the inner cylindrical wall, the thickness of the gel and corresponding cap is minimized along with the overall footprint of the device. With the gel thickness reduced and able to be substantially flush, the “doming” phenomenon produced by insufflation of a patient's abdomen is reduced.

Abstract: A surgical access device includes a seal housing and a roller disposed in the housing and defining a working channel. The roller may be stationary or moveable within the seal housing to form both a zero seal in the absence of an instrument, and an instrument seal in the presence of an instrument. Rotation of the roller is contemplated and low-friction surfaces are discussed to reduce instrument insertion forces. Multiple rollers, wiper elements, low-friction braid, pivoting elements and idler rollers are contemplated. The rollers will typically be formed of a gel material in order to facilitate the desired compliance, stretchability and elongation desired.

Abstract: An incrementally adjustable wound retractor, which provides access to a body cavity, includes an inner ring having a diameter greater than the desired diameter of the wound incision, an outer ring having an annular axis and a diameter greater than the desired diameter of the wound incision, and a flexible sleeve disposed in a generally cylindrical form between the inner and outer rings. The outer ring includes first and second circular tubes spaced apart axially with each including a lumen having a rigid, noncompliant split hoop positioned therein. The outer ring may be rolled over itself and around the annular axis to retract the sleeve with sufficient force to stretch the incision to the desired diameter. A gel cap seal may be coupled to the outer ring outside of the biological body to seal the opening produced by the wound retractor between the body cavity and outside the body cavity.

Abstract: An insufflating surgical instrument adapted for movement across an abdominal wall to insufflate an abdominal region of a patient is disclosed comprising a shaft having an insufflation channel extending along an axis between a proximal end and a distal end, the insufflation channel being adapted for connection to a source of fluid under pressure at the proximal end, a tip at the distal end of the shaft, and at least one vent hole formed at the tip or the shaft being in connection with the insufflation channel and being adapted to expel the fluid under pressure to insufflate the abdominal region. At least one of the tip and the shaft is formed of a translucent or transparent material such as polycarbonate to facilitate visualization of the abdominal wall and the abdominal region.

Abstract: A wound retractor for retracting a surgical incision includes an inner ring, an outer ring and a distensible sleeve coupled to the inner and outer rings. The outer ring includes at least a pair of circular tubes coupled to each other. At least one of the circular tubes includes a lumen and a split that forms open ends. A noncompliant tubular hoop having a split therein is positioned in the lumen. The tubular hoop is oriented with its open ends positioned away from the split of the circular tubes. A core is positioned in the lumen of the tubular hoop. The core has a first end and a second end and is oriented with the ends positioned away from the split in the tubular hoop. The circular tubes may be parallel or may form a helical pattern similar to a Mobius strip.

Abstract: A surgical obturator adapted to penetrate a body wall includes an elongate shaft having an axis which extends between a proximal end and a distal end. A bladeless tip, disposed at the distal end of the shaft has an outer surface which extends to a blunt point. The outer surface has a pair of side sections separated by an intermediate section. The side sections extend from the blunt point radially outwardly with progressive positions proximally along the axis. These side sections include a distal portion in proximity to the blunt point, and a proximal portion in proximity to the shaft. The distal portion of the side section is twisted radially with respect to the proximal portion of the side section. The outer surface in radial cross section has the general configuration of a geometric shape which rotates in a first direction about the axis with progressive proximal radial cross sections along the axis.

Abstract: An incrementally adjustable wound retractor (100), having a first ring (102) with a diameter greater than the desired diameter of the wound incision. A second ring (104), having an annular axis and a diameter greater than the desired diameter of the wound incision. A flexible sleeve (106), disposed in a generally cylindrical form between the first and second rings (102, 104), the second ring may be rolled over itself and around the annular axis to provide a sleeve with a radical retraction force sufficient to stretch the incision to the desired diameter.

Abstract: A trocar is provided with a cannula and a housing and valve assembly disposed in the housing which forms a housing seal, and instrument seal, and in some cases a zero seal. A gel material is included in the valve and provides the valve with superior flotation properties for maintaining the instrument seal even when the instrument is moved off-axis. In order to accommodate movement of the gel material, voids can be formed within the valve housing and even within the gel material.