An implantable soft tissue prosthesis device comprising a silicone elastomer-shell filled with silicone gel or liquid, which among the layers that constitute its shell includes a barrier layer formed of a low permeability silicone, which impedes the bleeding or diffusion of the silicone gel from the inside of the implant to its surroundings through the shell. This barrier layer is given a coloration different to the other layers of the shell, making it visible in the finished product. The coloration of the barrier layer gives the fabricator of the implant as well as to medical personnel, the possibility to identify the presence of the barrier layer and its homogeneity, improving the safety of the device.

Systems and methods for the manufacture of an hourglass shaped stent-graft assembly having an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.

A method for producing an accommodative intraocular lens includes providing first and second components and a support body with an interior space and open to the top, fastening the first component to the support body, generating pressure which is higher in the exterior space than in the interior space such that the first component deforms downward, producing an adhesive surface on the upper side of the first component and/or on the second component, applying a liquid to the first component from above into the latter's downwardly deformed region, the liquid at no time contacting the adhesive surface, fastening the second component to the first component with the adhesive surface, as a result of which the accommodative intraocular lens is formed and the liquid is encapsulated with the first component and the second component in a cavity arranged in the interior of the intraocular lens.

A graft compression system for compressing soft tissue grafts used in connection with reconstructive surgery on the anterior cruciate ligament (ACL). The graft compression system includes a compression chamber having an elongate hollow shaft body having two ends that are threaded to mate with correspondingly threaded collet nuts. Collets are removably inserted into, and engage, the collet nuts fastened to opposing ends of the compression chamber A surgical graft may be inserted into a hollow compression tube having a lumen with a compressible diameter, said compression tube being sized for insertion into the collets and compression chamber. When such collet nuts are tightened by a user of the graft compression system, the inner diameters of the respective collet nuts nested within such collet nuts are decreased, causing the diameter of the lumen of the hollow compression tube to in turn be decreased and compress the surgical graft within.

A catheter device and manufacturing process for manufacturing the catheter device, wherein the catheter device has a halo-shaped coiled portion extending away from a perpendicular stem portion through a swan neck portion. Eyelets on the halo coil portion and swan neck portion facilitate flow out of the bladder through the catheter device vertical to the catheter, rather than perpendicularly as is the case with existing catheters. The catheter device is formed by using a straight catheter tube, heating and cooling it within a formed mold to have the halo coil and swan neck, such that it can be straightened using a pusher and stylet, inserted into the body while straightened, and thereafter return to its coiled shape when the stylet is removed.

A lumen stent preform is provided using a plasma nitriding technology, a preparation method thereof, a method for preparing a lumen stent by using the preform, and a lumen stent obtained according to the method. The preform is manufactured by using pure iron or an iron alloy containing no strong nitrogen compound, has a hardness of 160-250HV0.05/10, and has a microstructure that is a deformed structure having a grain size scale greater than or equal to 9 or a deformed structure after cold machining. Alternatively, the preform is an iron alloy containing a strong nitrogen compound, and has a microstructure that is a deformed structure having a grain size scale greater than or equal to 9 or a deformed structure after cold machining. The lumen stem preform meets the requirements of a conventional stent for radial strength and plasticity, so that plasma nitriding is applicable to commercial preparation of a lumen stent.

A scaffold includes a radiopaque marker connected to a strut. The marker is retained within the strut by a head at one or both ends. The marker is attached to the strut by a process that includes forming a rivet from a radiopaque bead and attaching the rivet to the marker including deforming the rivet to enhance resistance to dislodgement during crimping or balloon expansion. The strut has a thickness of about 100 microns.

Medical implants that include a containment layer surrounding, or surrounded by, a biodegradable medical device provide the benefit that pieces formed during degradation of the medical device are held within a constrained place and thus do not causes injury to a hosts.

A device for disrupting tissue in an eye including a distal portion sized and configured for ab interno insertion into an anterior chamber of the eye having an elongate, flexible shaft of super-elastic memory-shape material. A distal end region is shaped into a curve having a radially inner surface connected to a radially outer surface by two lateral sides. The device has a tissue disruptor proximal of a distal-most end formed on at least one of the inner surface and the outer surface. The distal face of the tissue disruptor is a blunt tissue-engaging surface without any cutting element. Related methods and devices are provided.

Wearable and implantable devices that are used to support human anatomy and are formed using additive manufacturing are provided. Systems and methods for performing additive manufacturing allow for the formulation of a mesh material that has localized stiffness and slack in regions to best serve the needs of the patient. For example, regions of the mesh material can be designed to rigidly support portions of human anatomy, such as injured tissue, while regions of the mesh material adjacent to the injured tissue can be designed to closely mimic movement of the relevant human anatomy. For example, the mesh material can be formed in a manner such that it does not fold in those regions, and therefore is not obtrusive. The present disclosure allows for control of toolpaths when printing fibers used to form the devices. Other devices, as well as systems and methods for creating the same, are also provided.