Abstract: This invention comprises a novel approach for the refixation of a loosened implant to bone, wherein the novel approach comprises providing access to a boundary region between the implant and the bone; removing abnormal interface tissue, wear debris and/or bone cement debris from the boundary region; and inserting bone fixation material into the boundary region so that the bone fixation material engages the implant and the bone and thereby effects refixation of the loosened implant to the bone.

Abstract: An implant injection system that facilitates the introduction of a bone implant material into the cancellous bone portion of a patient's bone to serve as an anchor or to fill a void in the bone. The implant injection system and method provide a quantity of meltable material which is melted in situ so that the melted material can flow and diffuse into, and be anchored to, the cancellous bone portion beneath the cortical bone layer. The flowing of the bone implant material can be accomplished by an electrical resistance heater or other heater located at the distal end of the implant injection system. The implant material may be provided in multiple layers with an inner layer having a lower flowing temperature than the outer layers. There can also be a looped suture that passes though the meltable material, with the free ends of the suture extending outwardly to be tied to soft tissue to affix the soft tissue to the bone.

Abstract: A fused loop of an elongated material, such as a surgical suture, and apparatus for making the loop. Portions of one or more segments to be joined together are fused in a welding process to form a welded joint. The shear area of the fused portion of the joint determines the strength of the joint and is thus preferably relatively large. Various configurations for the welding apparatus facilitate the creation of relatively large fused portions of the joint by maximizing contact between at least one of the welding members of the apparatus and at least one of the segments to be joined.

Abstract: A suture anchor for securing soft tissue to bone may include a threaded body, a head extending along a longitudinal axis, and a plurality of eyelets that extend though the anchor head and that are each configured to receive a suture. The eyelets are offset from one another along an axis that is transverse to the longitudinal axis of the suture anchor. Each eyelet may have a desired shape and cross section. Surgical kits including one or more suture anchors and one or more surgical tools are also described.

Abstract: A soft tissue fixation assembly comprises an anchor element which is installed in a bone or other tissue and a suture joiner element which mates with the anchor element. The suture joiner element includes a suture retaining element that securely retains suture and which is connected to the anchor element. Energy is transmitted through the suture joiner element to cause relative vibratory motion between the respective components and localized collapsing and compressing of the suture joiner element to secure the suture within the suture joiner element and to secure the suture joiner element within the anchor element. The soft tissue segment is thus fixed to the bone via the sutures secured in the bone anchor.

Abstract: A welding apparatus that includes a first member having a first suture-contacting surface, a second member having a second suture-contacting surface, and a device for moving the first member relative to the second member to define a gap between the respective suture-contacting surfaces. The first member is capable of vibrating and delivering mechanical energy at ultrasonic frequencies. The second member is stationary relative to the first member. A fixture element is adapted to receive and maintain two or more segments of a material to be welded in a predetermined alignment in the gap between the first and second surfaces of the first and second members during a welding operation. According to another aspect of the invention, an ultrasonic welding apparatus includes first and second members with patterned first and second suture-contacting surfaces. The patterned surfaces can be complementary or non-complementary and the surface patterns on each member may vary in either a periodic or a non-periodic manner.

Abstract: An implantable access device including a port for receiving and guiding a filament, such as a needle, into an entry region of the device. The port includes a plate for receiving a filament, and at least two walls extending upwardly from the plate. The walls are shaped and positioned to guide the filament moving between opposing first and second ends of the plate through an entry region defined between the walls at the second end of the plate. Preferably, a greatest distance between the walls is at least five times greater than a height of the walls, so that the port provides a large filament strike area, yet has a small overall height. In addition, a greatest distance between the ends of the plate is also preferably at least five times greater than the height of the walls, to further increase the filament strike area without increasing height.

Abstract: A suture anchor for securing soft tissue to bone, including a body and a continuous suture loop. The body extends along a longitudinal axis between opposing first and second ends, and has an external threaded portion extending coaxial with the axis, and a bore extending from the second end towards the first end. The continuous suture loop is secured within the bore of the body so that at least a portion of the loop extends from the second end of the body to form an eyelet.

Abstract: A stapler for ejecting at least one staple of resilient thermoplastic material having a base member and two legs extending from the base member to sharp ends and wherein the legs include overlapping distal portions for engaging body tissue. The stapler includes a pair of jaws movable between open and closed positions, a handle and trigger assembly for controlling operation of the jaws, an elongated tubular structure connecting the handle and trigger assembly to the jaws, an ejector for ejecting at least one staple from one of the jaws against the other of the jaws, and posts for holding normally overlapping distal portions of legs of the staple generally parallel until after the staple is ejected from the stapler.

Abstract: A suture anchor for securing soft tissue to bone, including a body having opposing first and second ends, a longitudinal axis extending between the ends, an external threaded portion extending from the first end, and a bore extending from the second end towards the first end. The body also has a first pair of slots extending laterally outwardly from the bore and extending longitudinally to a predetermined first distance from the second end, and a second pair of slots extending laterally outwardly from the bore and extending longitudinally to a predetermined second distance from the second end. The anchor additionally includes an eyelet receivable within the first and the second pairs of slots of the body and having an opening for receiving a suture, and a spring biasing the eyelet into the bore.

Abstract: A surgical stapler utilizing plastic staples and ultrasonic welding to secure the staples in body tissue. The stapler includes a pair of jaws movable between open and closed positions, a handle and trigger assembly for controlling operation of the jaws, and an elongated tubular structure connecting the handle and trigger assembly to the jaws. The stapler also includes an ejection assembly for ejecting at least one staple from one of the jaws against the other of the jaws. An anvil and a horn are positioned in the other of the jaws and are arranged to receive ends of the ejected staple such that the ends overlap between the anvil and the horn. The horn is for melting and bonding at least a portion of the overlapping ends of the staple upon being energized by a predetermined form of energy, and one of the anvil and the horn is movable from within the bonded staple to allow the jaws to be moved to an open position.

Abstract: A device for closure of a living tissue wound without requiring knots. The device is a resiliently flexible and fusible collar having a C-shaped side profile disposed about a central region extending along a central axis. The collar extends circumferentially between two end portions for containing at least a portion of two tissue edges forming a tissue wound. The collar is biasable into a nominally closed O-shape so that the end portions overlap and tissue edges therein are joined together to close the tissue wound. The overlapping end portions are adapted to be fused together upon application of sufficient energy to the overlapping end portions to maintain the tissue edges in a joined position. The collar has a width greater than a thickness of the collar to increase the area of fusion between the overlapping end portions. In addition, at least one of the end portions of the collar has a sharp edge for tissue penetration so that the collar can be used to close open tissue wounds.

Abstract: A fusible collar for securing sutures without knots and for securing living tissue structures together without sutures is provided. The fusible collar is made of a resilient compressible material and is formed generally in a C-shape which can be compressed into an O-shape, with portions of the collar overlapping around the structures to be secured. Energy is applied to the overlapping portions of the collar to cause localized heating and plastic flow so as to fuse the overlapped portions together. The collar can include one or more energy directors on a contact surface to direct and focus energy to particular regions so as to effect collar-to-suture welding. The invention further provides a kit for securing elongated structures without knots. The kit includes the fusible collar and a tool for compressing the collar around the elongated structures and fusing the collar to itself and/or the elongated structures.

Abstract: This invention is a fused loop (10) of an elongated material such as a surgical suture, and apparatus for making the loop. Portions of one or more segments (12) to be joined together are fused in a welding process to form a welded joint (14). The shear area of the fused portion (20) of the joint (14) determines the strength of the joint (14), and is thus preferably relatively large. Various configurations for the welding apparatus facilitate the creation of relatively large fused portions (20) of the joint (14) by maximizing contact between at least one of the welding members of the apparatus, and at least one of the segments (12) to be joined.

Abstract: An implantable access device including a port for receiving and guiding a filament, such as a needle, into an entry region of the device. The port includes a plate for receiving a filament, and at least two walls extending upwardly from the plate. The walls are shaped and positioned to guide the filament moving between opposing first and second ends of the plate through an entry region defined between the walls at the second end of the plate. Preferably, a greatest distance between the walls is at least five times greater than a height of the walls, so that the port provides a large filament strike area, yet has a small overall height. In addition, a greatest distance between the ends of the plate is also preferably at least five times greater than the height of the walls, to further increase the filament strike area without increasing height.

Abstract: A fused loop of an elongated material, such as a surgical suture, and apparatus for making the loop. Portions of one or more segments to be joined together are fused in a welding process to form a welded joint. The shear area of the fused portion of the joint determines the strength of the joint and is thus preferably relatively large. Various configurations for the welding apparatus facilitate the creation of relatively large fused portions of the joint by maximizing contact between at least one of the welding members of the apparatus and at least one of the segments to be joined.

Abstract: A prosthetic cardiac valve assembly for sutureless implantation in a patient. The assembly includes a generally disk-shaped valve annulus element and one or more generally disk-shaped retainer elements. The elements are adapted for mutual engagement and for engagement with a host tissue region so as to fix a portion of the host tissue between them in a sutureless bond. Ultrasonic or thermal energy is applied to one or more of the elements to bond them together. Either the valve annulus element or the retainer element includes a plurality of projections, and the corresponding element includes a corresponding plurality of apertures for receiving the projections, thus providing for mutual physical engagement. The valve annulus element can include a plurality of valve leaflets which open and close in response to fluid pressure differentials across them. Various insertion devices for the assembly are designed to facilitate insertion of the elements in the heart through a relatively small incision.

Abstract: A soft tissue fixation assembly comprises an anchor element which is installed in a bone or other tissue, and a joiner element which mates with the anchor element to define a tissue capture region between them. A section of soft tissue is held within the tissue capture region, and energy is transmitted into the joiner element to cause relative vibratory motion between the respective components and localized melting of the contacting portions of the respective components to establish a welded joint. The soft tissue segment is thus fixed to the bone without sutures or other fasteners.

Abstract: A single-piece soft tissue fixation device includes an elongated element terminating in a tip at one end and a receptacle at the other end which bond with each other in a welded joint. The device is made of a heat-bondable, biocompatible material that can be ultrasonically or thermally welded. The tip and receptacle of the device can be textured or contoured or otherwise complementarily configured to promote mutual engagement prior to and during bonding. The tip can include a needle or needle-like extension for penetrating tissue. The device may be at least partially resorbable in living tissue.

Abstract: A fused loop of an elongated material, such as a surgical suture, and apparatus for making the loop. Portions of one or more segments to be joined together are fused in a welding process to form a welded joint. The shear area of the fused portion of the joint determines the strength of the joint and is thus preferably relatively large. Various configurations for the welding apparatus facilitate the creation of relatively large fused portions of the joint by maximizing contact between at least one of the welding members of the apparatus and at least one of the segments to be joined.