Abstract: Tissue engineering devices and methods employing scaffolds made of absorbable material for use in the human body for tissue genesis and regenerative and cellular medicine including breast reconstruction and cosmetic and aesthetic procedures and supplementing organ function in vivo.

Abstract: The present invention relates to method for surgically placing an artificial stomach in a patient. The method involves the steps of cutting an opening in the abdominal wall of the patient, dissecting the area around the stomach, placing the artificial stomach in the patient's abdomen, and closing the opening in the abdominal wall.

Abstract: A valved conduit including a bioprosthetic valve, such as a heart valve, and a tubular conduit sealed with a bioresorbable material. The bioprosthetic heart valve includes prosthetic tissue that has been treated such that the tissue may be stored dry for extended periods without degradation of functionality of the valve. The bioprosthetic heart valve may have separate bovine pericardial leaflets or a whole porcine valve. The sealed conduit includes a tubular matrix impregnated with a bioresorbable medium such as gelatin or collagen. The valved conduit is stored dry in packaging in which a desiccant pouch is supplied having a capacity for absorbing moisture within the packaging limited to avoid drying the bioprosthetic tissue out beyond a point where its ability to function in the bioprosthetic heart valve is compromised. The heart valve may be sewn within the sealed conduit or coupled thereto with a snap-fit connection.

Abstract: Embodiments of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such embodiments can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some embodiments can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some embodiments include an elastic outer cover positioned outside the outer layer. Embodiments of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

Abstract: A heart valve repair system includes a delivery sheath and an implant that includes a frame including a braided structure of intertwining strands and having a surface configured to contact an upstream surface of a native heart valve. First and second gripping members are coupled to the frame, each including atrial and ventricular arms. The implant is disposed in the sheath in a delivery state in which the frame defines a wall fully surrounding a central longitudinal axis of the implant. The distal end of the wall defines a distal opening of the frame. The distal end of the wall is disposed proximally to the second end of the ventricular arm of each of the gripping members. The second end of each ventricular arm moves toward the axis of the implant more than the first end moves toward the axis. Other embodiments are also described.

Abstract: Apparatuses, systems, and methods for crimping prosthetic implants onto a delivery apparatus are disclosed. In some examples, a support body for a prosthetic heart valve can comprise a first portion comprising an alignment device configured to couple with a crimping device, and a second portion comprising a support surface that tapers from a wider end disposed adjacent the first portion to a narrower end, where the support surface is configured to receive the prosthetic heart valve thereon and hold one or more leaflets of the prosthetic heart valve in an open position. The support body can further comprise a central channel extending through the first portion and the second portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

Abstract: Vaginal dilator assemblies, devices and kits. Assemblies can include a base, and an adapter. The base can have an inner portion and the adapter can have an outer portion that is complimentary to the inner portion of the base such that the adapter is non-rotatably fitted into the base. Vaginal dilator devices can include a base defining a recess aligned with the longitudinal axis of the base. The recess can have a plurality of step tapered sections. Vaginal dilator kits are also provided that include a plurality of vaginal dilators having different diameters. Each of the plurality of vaginal dilators is configured to be axially aligned and securely fitted into one of the step tapered sections of the recess of the base.

Abstract: Disclosed is a prosthetic heart valve, wherein the prosthetic heart valve comprises: a ring-shaped stent, comprising: a mesh structure which allows the stent to be contracted or expanded in a radial direction; and a leaflet structure, comprising a plurality of leaflets, each leaflet is attached to the stent and has a first portion disposed within the stent and a second portion being wrapped to an outer circumferential side of the proximal end of the stent. With a growth of the heart, the stent can be expanded after the prosthetic heart valve is anchored, to allow the prosthetic heart valve to operate in different states, and under at least one of the different states, each leaflet has an excessive portion freely sagging to a position away from the stent along a direction from the distal end to the proximal end, to allow the stent to form a more functional valve.

Abstract: A voice prosthesis comprising a outer cannula and an inner cannula wherein the outer cannula is generally in the shape of a spool and comprises two flanges connected by a hollow annular stem therebetween, and the inner cannula comprises a proximal flange and a stem configured to fit within a passageway of the stem of the outer cannula. The outer cannula comprises a retaining slot on its outer proximal edge which can be used to rotationally secure an obround inner cannula proximal flange. The inner cannula may also comprise windows for use with retaining nubs disposed on the interior of the outer cannula passageway and an insertion tool having a moveable protrusions.

Abstract: A valve repair device for repairing a native valve of a patient. The valve repair device includes a compressible spacer element, a pair of paddles, and a pair of gripping members. The pair of paddles are coupled to the spacer element. The pair of gripping members are disposed between the pair of paddles. The paddles and the gripping members are configured to attach to leaflets of a heart valve.

Abstract: Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that securely anchor the prosthetic heart valve to the anatomy at the site of the native heart valve. Such structural features can provide robust migration resistance. In addition, the prosthetic heart valves can include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate paravalvular leakage. In particular implementations, the prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved inner catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.

Abstract: Devices, systems, and methods for coupling a prosthetic implant to a fenestrated body are disclosed herein. In some embodiments, a branch stent graft is provided. The branch stent graft can include an engagement portion for engagement with an opening in a fenestrated body, such as a vessel wall or an aortic stent graft. The engagement portion of the branch stent graft can be coupled to the fenestrated body such that the branch stent graft can move, rotate or shift relative to the fenestrated body but such that axial movement of the branch stent graft is restricted and/or prevented.

Abstract: A prosthetic insertion apparatus and related methods of use in delivering filled prosthetic bladders through a skin incision and into a surgical cavity or pocket. The prosthetic insertion apparatus imparts control and retention properties to a surgical professional such the prosthetic bladder can be oriented and manipulated into the surgical cavity without risk of inadvertent dropping of the prosthetic bladder and without imparting damaging stress or torque to the bladder. Suitable materials can be utilized that are selected as having advantageous properties including lubricity, rigidity, easily sterilizable, and high strength.

Abstract: Features for a heart valve device are described. The device may include a frame with anchors configured to secure the device to tissue. The frame may include a flared end or skirt for additional securement of the implanted device. The device may include a seal such as a barrier and/or cuff for preventing leakage. The device may contract for endovascular delivery of the device to the heart and expand for securement within the heart, such as the within the native mitral valve annulus. The device may include a replacement valve. The valve may have leaflets configured to re-direct blood flow along a primary flow axis.

Abstract: Tubes (e.g., catheters, endotracheal or chest tubes and bypass grafts) are provided, comprising a catheter and a plurality of sensors.

Abstract: A system that can be used for suturing implants includes a first automated fixture that can comprise an articulation arm and a target device holder and a second automated fixture configured to operate as a sewing machine to sew material onto the implant. The second automated fixture uses a curved needle to form a stitch without having to release the needle in the process. The second automated fixture can also include a stitch looper that moves in coordination with the curved needle to perform a single-suture or single-thread stitch.

Abstract: Prosthetic heart valves, which are collapsible to a relatively small circumferential size for less invasive delivery into a patient and which then re-expand to operating size at an implant site in the patient, include a collapsible/expandable stent-like supporting structure and various components of flexible, sheet-like material that are attached to the supporting structure. For example, these sheet-like other components may include prosthetic valve leaflets, layers of buffering material, cuff material, etc. Improved structures and techniques are provided for securing such other components to the stent-like supporting structure of the valve.

Abstract: Biodegradable antimicrobial films are provided that are solid at room temperature and substantially liquefy in situ after implantation into a mammal, such as a human patient. Methods of using the films to cover a medical device, such as a breast implant, prior to insertion into a subject are also provided.

Abstract: The present disclosure is directed to Myointegration, the improvement of breast implant apparatus, system and methods for a design that extends the breast implant centrifugally, or in which a separate device is utilized in combination with a breast implant, that has one or more straps originating from the breast implant extension or from the separate device. The one or more straps are looped through the pectoralis major muscle then back into the implant extension or the separate device repeatedly. The straps are eventually attached in some manner to themselves, to the implant extension, or to the separate device. Since the pectoralis major muscle contains neuromuscular spindles that sense length, velocity and acceleration, when the user changes position from supine to vertical, the gravitational force generated by the mass of the breast implant pulls on the strap or straps, which pulls the muscle and stimulates the neuromuscular spindles, thereby generating lift of the implanted breast insert.

Abstract: The invention provides new devices for implantation in a patient having irregular textured surfaces, which devices show significantly improved cellular response compared to conventional smooth and textured implants, indicating that significantly improved biocompatibility would be achieved in vivo. Methods for making such new devices and surface textures are also disclosed.