Abstract: A reconfigurable suture needle includes an elongated body having a curved proximal section and a curved distal section. A joint interconnects a distal end of the curved proximal section and a proximal end of the curved distal section. The joint enables the curved proximal section and the curved distal section to rotate relative to one another between a first configuration having a higher profile and a second configuration having a lower profile. Each of the curved proximal and distal sections of the elongated body defines about one-quarter of a circle. The elongated body has a semi-circular shape when in the first configuration and a wave shape when in the second configuration. The elongated body is rotated into the smaller profile for passing through a cannula and, after passing through the cannula, rotated back into the higher profile for use as a suturing needle.

Abstract: The subject matter disclosed herein relates to an encoded cinching mechanism for use with an implant delivery sleeve. The delivery sleeve includes: an enclosure having a first portion, an orifice, and a throat disposed between the first portion and the orifice; and a cinching mechanism disposed about the throat, in which the cinching mechanism comprises a plurality of demarcations each of which are indicative of a sized opening of the throat.

Abstract: A tissue expander having an integrated drain includes an outer shell having an opening and one or more drainage holes. An injection port is disposed in the opening of the shell and forms a fluid-tight seal with the shell. The injection port includes a needle guard having a needle guard base with a top surface, and a barrier membrane that overlies the top surface of the needle guard base. The barrier membrane defines an inflation chamber located between the top surface of the needle guard base and a bottom surface of the barrier membrane, and a drainage chamber overlying a top surface of the barrier membrane. The tissue expander includes one or more inflation ports that are in fluid communication with the inflation chamber for inflating and deflating the outer shell with a first fluid. A drainage conduit is in fluid communication with and extends between the drainage chamber and the one or more drainage holes for draining a second fluid from outside the shell.

Abstract: An implantable prosthesis includes a silicone shell having an apex, a base, a radius located between the apex and the base, and a dome extending between the apex and the radius. The silicone shell has an outer surface and an inner surface that surrounds an interior volume of the silicone shell. A silicone gel material is disposed within the interior volume of the silicone shell. A gelling enhancer layer containing a gelling enhancer covers the inner surface of the silicone shell. After the silicone gel material has been thermally cured, the silicone gel material that is located within a zone that is in the vicinity of the gelling enhancer layer has a higher level of cohesiveness than the silicone gel material that is located outside the zone. The gelling enhancer contains crosslinker and/or platinum catalyst, such as a Karstedt catalyst.

Abstract: A composite suture needle configured for passing through a smaller cannula used in minimally invasive surgery includes a curved elongated body made of stainless steel. The curved elongated body has a proximal end and a distal end with a pointed tip. The composite suture needle includes a sheath overlying the curved elongated body. The sheath is curved for conforming to the shape of the curved elongated body. The sheath is made of a material that is more elastic than the curved elongated body. The pointed tip of the curved elongated body extends distally beyond the distal end of the sheath. The curved elongated body is made of stainless steel and the sheath is made of a material, such as nitinol, that is more elastic than the elongated body.

Abstract: A suture package includes a suture housing having a tray with a suture channel, and at least one suture disposed on the suture housing, whereby the suture includes a suture thread disposed within the suture channel of the tray. The package includes a suture straightening assembly provided on the suture housing. The suture straightening assembly defines a suture dispensing path for removing the suture thread from the suture housing. The suture straightening assembly includes a first suture thread straightening section that is configured to apply a first flexing force within a first plane upon an exterior surface of the suture thread as the suture thread is drawn along the suture dispensing path, and a second suture thread straightening section that is configured to apply a second flexing force within a second plane upon the exterior surface of the suture thread as the suture thread is drawn along the suture dispensing path.

Abstract: Novel recessed surgical fastening devices are disclosed. The fastening devices have a compressible member and a fastening element disposed at least partially within the compressible member. The fastening element has at least one tissue engagement member that is extensible through the compressible member to engage tissue when a force is applied to the fastening device.

Abstract: The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to enhance the properties of repaired or adjoined tissue at a target surgical site, especially when sealing an anastomosis between adjacent intestinal sections so as to improve tissue viability, prevent tissue infection, and to prevent leakage. The present invention further relates to an expandable compression device for application to anastomotically joined tubular tissues, comprising: an upper ring-shaped or disk-shaped flange at a distal end of said device connected to a lower ring-shaped inflatable flange at a proximal end of said device via a hollow cylindrical tubular body, with an opening forming an axial passage through said upper flange, lower flange, and tubular body.

Abstract: The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to enhance the properties of repaired or adjoined tissue at a target surgical site. The present invention further relates to hypothermic linear stapling instruments configured to pre-cool the tissues being joined by staples.

Abstract: The present is directed to systems for ex vivo testing performance of a hemostatic or sealing product attached to an animal organ and fully covering a cored channel in said organ, comprising: a pressure sensor positioned proximate to said hemostatic or sealing product in said cored channel; a monitoring or recording device configured to receive pressure readings from said pressure sensor; and a pressurized fluid source connected to said cored channel and configured to supply said pressurized fluid into said cored channel under constant or variable pressure. The present invention is also directed to methods of use for such systems.

Abstract: A reconfigurable suture needle includes an elongated body having a curved proximal section and a curved distal section. A joint interconnects a distal end of the curved proximal section and a proximal end of the curved distal section. The joint enables the curved proximal section and the curved distal section to rotate relative to one another between a first configuration having a higher profile and a second configuration having a lower profile. Each of the curved proximal and distal sections of the elongated body defines about one-quarter of a circle. The elongated body has a semi-circular shape when in the first configuration and a wave shape when in the second configuration. The elongated body is rotated into the smaller profile for passing through a cannula and, after passing through the cannula, rotated back into the higher profile for use as a suturing needle.

Abstract: The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to enhance the properties of repaired or adjoined tissue at a target surgical site, especially when sealing an anastomosis between adjacent intestinal sections to improve tissue viability under hypoxia conditions, prevent tissue inflammation, and to prevent leakage. The present invention further relates to hypothermic circular stapling instruments configured to pre-cool the tissues being joined by staples.

Abstract: A surgical incision drape, comprises a flexible substantially flat areal substrate having an upper side and an opposing tissue-facing side, having a longitudinal axis and a pressure sensitive adhesive disposed on the tissue-facing side; at least one hollow microtubular compartment containing a flowable medical agent, said hollow microtubular compartment positioned to intersect the longitudinal axis and embedded into the substrate or positioned on the substrate.

Abstract: A device for joining two layers of tissue, comprises a substantially flat and flexible scaffold having an upper surface, a lower surface and sidewalls; a plurality of first passages penetrating said scaffold from said upper surface to said lower surface; a plurality of second passages penetrating said scaffold from said upper surface to said lower surface; a substantially flat and flexible top cover releasably attached to said upper surface and covering all of said upper surface; said top cover having a plurality of top cover passages aligned with said first plurality of passages.

Abstract: The present invention is directed to a spray applicator for spraying a tissue treatment medicant onto a tissue that has a container containing the medicant and is positioned at a proximal end of the spray applicator; a spray tip positioned at a distal end of the spray applicator; a cannula connecting the container with the spray tip; an actuatable dispensing mechanism at a proximal end of the applicator to express the medicant from the container through the cannula and through the spray tip toward the tissue; an optional pressurized gas source discharging a gas through the cannula in the vicinity of the spray tip or inside the spray tip; and a distance indicator that provides indicia of the distance between the spray tip and the tissue but does not prevent positioning the spray tip closer to the tissue than a defined distance for the distance indicator.

Abstract: A scaffold for joining two layers of tissue, comprises a substantially flat and flexible body having a top surface, a bottom surface and sidewalls; at least one channel within the body starting at an injection port; a plurality of first passages on the top surface and a plurality of second passages on the bottom surface, said passages in fluid communication with the channel; a plurality of third passages penetrating the body from the top surface to the bottom surface, said plurality of third passages not in fluid communication with the channel.

Abstract: The present invention is directed to circular surgical staplers for anastomotic joining of tissue comprising a stapling head connected to an opposing anvil, said stapling head containing a plurality of deployable staples in concentric arrays; a plurality of resorbable medicant-releasing microneedles, the microneedles comprising elongated rods having a sharp tissue-penetrating distal end and a proximal end; with the microneedles releasably disposed on or within the stapling head or the anvil. The present invention is also directed to methods of use of such stapler devices.

Abstract: A mammary implant and method of making are provided herein. The implant includes an outer shell configured to retain fluid therein, an injection element coupled to the outer shell and adapted to receive therethrough an injection device for injecting fluid into the outer shell, and an injection marker zone made of a material having ultrasonically detectable markers incorporated therein. The markers are a plurality of microcavities that are located relative to the injection element so that, when ultrasonically detected, such detection indicates a location of the injection element.