Abstract: A method for force, displacement, and rate control of shape memory material implant. The rate of implant shape change as well as the force exerted on the surrounding tissue of the implant can be controlled by the surgeon and the extent of movement is controlled in circumstances where the bone element is free to move. The invention allows for the first time the fine control of force when fixating osteoporotic bone and rate of bone transport when working near the spinal cord. This heating profile of the implant provides the surgeon to control the extent of microstructure phase transformation so that the rate, force or extent of tissue movement can be controlled individually or together.

Abstract: Shape memory tissue engagement elements (15) are created using shape memory alloys or shape memory (SM) composite sheets (33, 36) with one or more SM material sheets (20, 32). Arrays of the tissue engagement elements may then be inserted or molded into flexible base materials forming pads for tissue engagement. In certain embodiments, the composite sheets incorporate two SM material layers (20, 32) having differing transition temperatures to allow activation of one layer for tissue engagement and activation of the second layer for tissue release. In exemplary embodiments, insertion of interconnected tissue engagement elements (46) into a base layer (19) with slots (48) provides a completed pad array. In alternative exemplary embodiments, vacuum forming of composite sheets (51) with cutting of corrugated sides (53) to form tissue engagement elements allow production of complete arrays of tissue engagement elements. Overmolding the arrays with a flexible base material (19) provides a completed pad.

Abstract: In one embodiment the present invention is an implant suitable for implantation in bone, comprising a median zone extending along a longitudinal axis between a first end and a second end, the first end having a face extending generally perpendicular to the axis to form an abutment having a width; and a first fixation zone extending from the first end and the abutment, the first fixation zone including a pair of tabs formed of shape-memory material extending from a base portion of the tabs adjacent the abutment such that the abutment extends further from the axis in a radial direction than the base portion of the tabs, wherein the pair of tabs are separable from one another by shape-memory action at body temperature.

Abstract: A fracture fixation system particularly useful for bones of the hand and foot is disclosed. The system uses curved shape-memory alloy (e.g., Nitinol) wires that have a predetermined radius of curvature to accommodate different sized bones. These shape-memory alloy wire forms can be inserted into phalanx, metacarpal or metatarsal bones via a percutaneous technique. The technique uses small skin incisions; a specialized drill guide that has holding K-wires to maintain fixation of the drill guide to the bone so that it does not lose the insertion point; a specialized drill as well as a specialized wire cutter and advancement tool to make sure that the level of the wire is below the level of the outer cortical bone. Shape-memory alloy (e.g., Nitinol) based wires with a pre-bent curve have an advantage over the typical standard K-wire in that they can spring back to their predetermined memory shape when inserted into the intramedullary canal of the bone and heated, i.e., a more aggressive curve.

Abstract: A shape-memory device manufactured from shape memory material includes multiple activation temperatures. The multiple activation temperatures arise from either the heat treatment of the device during manufacturing, or by combining different elements with different activation temperatures. To manufacture a shape-memory device with multiple activation temperatures, it is formed into a first shape. A first portion of the shape-memory device is heated to a first temperature, and a second portion of the shape-memory device is heated to a second temperature. The shape-memory device is then worked into a second shape. Accordingly, the first portion has a first transition temperature, and the second portion has a second transition temperature. In use, the shape-memory device is placed into a desired position. Energy is applied such that the first portion, second portion, or both portions are transformed.

Abstract: A mechanism to connect the supporting portions of orthopaedic implants such as in the head, spine, upper limb and lower limb and thereby prevent loosening and fretting at the implant interface of an orthopaedic implant construct has been developed based on shape memory effect and super-elasticity of shape memory materials such as nickel-titanium (nitinol or NiTi) shape-memory-alloy, without the use of typical threaded fastening technique. Advantages are conferred by making the entire device, not just connecting pieces, out of shape memory alloy and having shape memory effect and super-elasticity. Heating the memory head of the device will compress the connection portion without the use of an auxiliary device (e.g. coupling member) so that the connection portion can be completely clamped down by the memory head.

Abstract: Methods and apparatus described herein may utilize activation of an SMP material to install medical devices with respect to a surgical site. Activation of the SMP material may be performed with the use of a triggering force and/or a constraint applied to the SMP material. Activation using a triggering force and/or a constraint may be used to create varied activation rates in an SMP material and may be combined with temperature or other activation stimuli to create the varied activation rates.

Abstract: A method for augmenting a tissue including introducing into the tissue a first thermoplastic material at a first condition; treating the first thermoplastic material to achieve a second condition that includes an at least partially crystalline skin; and introducing a second material into the tissue whereby the first thermoplastic material and the second material are contained by the at least partially crystalline skin. Also a method of fracture reduction in a tissue including exposing to gamma radiation a mass of polycaprolactone characterized by a first shape; heating the mass of irradiated polycaprolactone above its melting temperature; introducing the heated mass of polycaprolactone into the tissue annulus to deform it from the first shape; allowing the material to return to the first shape.

Abstract: A surgical fastener comprising a clip movable between an open configuration and a closed configuration and a biasing member contacting the clip and biasing the dip to its open configuration when the biasing member is actuated. The biasing member and clip both tend to assume the closed configuration when no external forces are applied to them. A needle may be releasably attached to the clip. Methods for making the fasteners are also disclosed, in which both the clip and the biasing member are set in the closed position.

Abstract: The present invention concerns shape memory materials comprising polyelectrolyte segments. These segments can be used for fixing a permanent shape and/or such segments can also be employed as switching segments responsible for the fixation and release of the temporary shape.

Abstract: An endoscope system includes: an actuator having an SMA wire and driving a moving member for moving a lens; an output control circuit; a detection circuit; and a CPU. The CPU outputs a driving signal to the output control circuit, on a basis of an instruction to move the lens, and on the basis of a position of the moving member corresponding to a resistance value detected by the detection circuit. In response to a moving instruction to move the lens from a far-point position to a near-point position, the CPU outputs the driving signal so that a current for moving the moving member from the far-point position to a position beyond the near-point position is passed through the SMA wire to heat the SMA wire. The CPU then performs preheating control, holding constant current transition control, and reheating control.

Abstract: A medial device including a handle portion, and a deployable member disposed in mechanical cooperation with the handle portion is disclosed. The deployable member includes a distal tip and a bend that is disposed adjacent the distal tip. The deployable member is extendable form the handle portion such that the distal tip extends in a spiral-like configuration in response to extension of the deployable member. The spiral-like configuration includes non-equivalent radii.

Abstract: A medical implant interposable between a first bone and a second bone in order to support the first and second bones substantially joined one to the other, so as to obtain bony fusion of the first and second bones. Also disclosed is a surgical kit comprising an implant and a surgical instrument for bony preparation. Also disclosed is a method for manufacturing a medical implant.

Abstract: Systems and methods are provided for fixation of a fractured bone with an intramedullary bone fixation device. During an implantation procedure, the fixation device may be guided by a removable guidewire which is not coupled to the fixation device. The guidewire and device may be inserted into an intramedullary canal along a pathway which is not parallel to the intramedullary canal. The fixation device may be composite, formed of a support structure and a matrix material. The matrix material may be thermo-chemically activated, transformable from a deformable first thermo-chemical state to a hardened second thermo-chemical state. The fixation device may be radially expandable to deform to the shape of the intramedullary canal, to provide support to the fractured bone.

Abstract: Intervertebral spacers are provided for use in orthopedic treatment of spinals defects. The intervertebral spacer is formed of a shape memory polymer. The spacer can be fabricated into a desired configuration and then deformed into an alternative or deformed configuration. Cooling the deformed spacer effectively freezes the spacer into its deformed conformation. The deformed configuration can be selected to facilitate implantation of the spacer into a prepared disc space between adjacent vertebrae. During operation, the surgeon can heat the spacer to allow it to revert to its original configuration. The spacer in its original conformation is sized to restore and/or maintain the adjacent vertebrae in a desired conformation and disc space height.

Abstract: The present invention relates to a bone fixation device having a fixation member using a shape memory effect to secure bone fractures, including but not limited to, femur, tibia and humerus fractures. The fixation member can be malleable at a room temperature, but become rigid at a body temperature because of the shape memory effect, such as derived from a super-elastic property found in such as a nickel titanium alloy. The fixation member can be formed on one or more of the shaft portion and the two end portions of a nail member for securing bone fractures, such as by providing translational and rotational stabilities. The fixation member is also capable of providing a continuous and controllable compression force over the fractured bone, if needed.

Abstract: A method and system of evaluating the geometry of the nuclear cavity within the annulus. A three-dimensional mold of the nuclear cavity is created. The three-dimensional mold is preferably removed from the nuclear cavity. The three-dimensional mold can be used for qualitative and quantitative analysis of the nuclear cavity.

Abstract: A bone anchoring device, the device including a body having a first end affixable with a bone; and an engagement device engageable with a settable compound brought into contact with the engagement device prior to setting of the settable compound.

Abstract: A laser energy delivery device is provided that is suitable for irradiating a body tissue with relatively long wavelength laser energy in the presence of an aqueous liquid without significant absorption of the laser energy by the liquid. The device includes an elongate hollow sheath that has an open aperture at its distal end portion and closed at its proximal end, a laser energy conduit such as an optical fiber or hollow wave guide, within the sheath, the distal end of the conduit being disposed near the open aperture at the distal end portion of the sheath, and the proximal end of the conduit being adapted for connection to a source of long wavelength laser energy. The sheath also includes an inlet port, spaced from the proximal end of the sheath, and adapted to receive and deliver a biologically compatible gas through the sheath to a body tissue site in contact with the open distal end of the sheath.

Abstract: Controlling the transformation of the microstructure of shape memory material implants. A surgeon can use the inventive energy delivery device to control the rate of implant shape change, the extent of implant shape change, as well as the force exerted on the surrounding tissue. The invention allows for the fine control of force when fixating osteoporotic bone and rate of bone transport. This system models or measures the heating profile of the implant and provides the surgeon a method to control the extent of microstructure phase transformation so that the rate, force or extent of tissue movement can be controlled individually or together.

Abstract: A supplemental spine fixation device and method is used in association with a primary spine fixation device. The supplemental spine fixation device includes a guide and spacer for distracting apart adjacent spinous processes and the device has hook members which hook about the first and second spinous processes. With the spinous processes distracted and the hook members about the spinous processes, the hook members can be rigidly secured to a hub in order to rigidly affix the spinous processes about the spacer. The rigidity between the spinous processes assures that the vertebral bodies will be held rigidly in place in order to promote bone growth and fusion. Further additional freedom of movement between the spacer and hub is accomplished with the spacer being pivotably mounted relative to the hub. The hooks have a tissue distracting lead-in guide for allowing the hooks to be easily urged between spinous processes.

Abstract: A microsurgical laser probe is provided with a distal end portion of an optic fiber that projects from a tubular sleeve of the probe and can be caused to bend relative to the probe sleeve by manual manipulation of a mechanism on a handle of the probe.

Abstract: A mechanism and method for steering a surgical instrument inserted into an endoscope such as a ureteroscope, nephroscope, or cystoscope, and/or for steering the endoscope, utilizes a shape memory structure secured to the surgical instrument or to the endoscope, the shape memory structure having a transformation temperature slightly greater than that of the human body so that bending of the shape memory structure, and therefore of the surgical instrument or endoscope, may be carried out by raising a temperature of irrigation fluid in the working channel. The steering mechanism may be used as a supplement to a tensioned-wire steering mechanism, reducing stress on the endoscope shaft and extending the service life and repair interval of the endoscope. In addition, when the surgical instrument is a glass optical fiber, the steering mechanism may be used to ensure that a tip of the optical fiber is within the field-of-view of fiber optics incorporated into the endoscope.

Abstract: A laser energy delivery device and method are provided for irradiating a body tissue with relatively long wavelength laser energy in the presence of an aqueous liquid without significant absorption of the laser energy by the liquid. The device includes an elongate hollow sheath that is open at its distal end and closed at its proximal end, a laser energy conduit such as an optical fiber or hollow waveguide, within the sheath, the distal end of the conduit being disposed near the open distal end of the sheath, and the proximal end of the conduit being adapted for connection to a source of long wavelength laser energy. The sheath also includes an inlet port, spaced from the proximal end of the sheath, and adapted to receive and deliver a biologically compatible gas through the sheath to a body tissue site in contact with the open distal end of the sheath.

Abstract: Devices and methods for creating a series of percutaneous myocardial revascularization (PMR) channels in the heart. One method includes forming a pattern of channels in the myocardium leading from healthy tissue to hibernating tissue. Suitable channel patterns include lines and arrays. One method includes anchoring a radiopaque marker to a position in the ventricle wall, then using fluoroscopy repeatedly to guide positioning of a cutting tip in the formation of multiple channels. Another method uses radiopaque material injected into each channel formed, as a marker. Yet another method utilizes an anchorable, rotatable cutting probe for channel formation about an anchor member, where the cutting probe can vary in radial distance from the anchor. Still another method utilizes a multiple wire radio frequency burning probe, for formation of multiple channels simultaneously. Still another method utilizes liquid nitrogen to cause localized tissue death.

Abstract: A percutaneous surgical device and method for creating a cavity within tissue during a minimally invasive procedure. A cavitation device includes a shaft interconnected to a flexible cutting element. A flexible cutting element has a first shape suitable for minimally invasive passage into tissue. The flexible cutting element has a means to move toward a second shape suitable for forming a cavity in tissue. When used in bone, the resulting cavity is usually filled with bone cement or suitable bone replacement material that is injectable and hardens in situ. The disclosed cavitation device and methods can be used for the following applications: (1) treatment or prevention of bone fracture, (2) joint fusion, (3) implant fixation, (4) tissue harvesting (especially bone), (5) removal of diseased tissue (hard or soft tissue), and (6) general tissue removal (hard or soft tissue).

Abstract: The present invention relates to devices for moving a two bodies 1, 2 relative to each other. The device of the invention is essentially characterized by the fact that it comprises two parts 11, 12, a projecting portion 14 mounted to co-operate with one of the two parts, a cavity 13 formed in the other part and complementary in shape to the projecting portion 14, the two parts 11, 12 being mounted to move relative to each other in such a manner that the projecting portion 14 penetrates into the cavity 13, the projecting portion 14 forming a closed loop made of an electrically conductive material which completely surrounds a magnetic core 101 which is not completely surrounded by the mechanism 100 for interconnecting the projecting portion 14 and the first part 11. The invention is applicable in particular to a bone prosthesis, a medullary nail for lengthening bones, a rod for correcting and supporting the spinal column.

Abstract: A patella clamp has a first part including a reference surface engageable with the anterior surface of a patella. The first part includes a stop surface spaced from the reference surface. A second clamping part is provided which is moveable with respect to the first clamping part. A cutting element coupled to the first clamping part is moveable with respect to the first part. The cutting element includes a shaft with an adjustable collar mounted on the shaft for movement with respect to the longitudinal axis of the shaft and cutting element. The adjustable collar on the shaft is engageable with a stop surface on the first part for spacing the cutting element a desired distance from the reference surface. A pair of gages are provided for selectively setting the position of the adjustable collar with respect to either the amount of patella bone being removed or the amount of patella bone remaining.

Abstract: The present invention relates to a self-expanding device for sealing a defect in a wall, such as a septal defect. The device of the present invention has a helical shaped periphery formed from an elastic wire and at least one eyelet. The eyelet has a non-circular (“asymmetric”) shape which allows the eyelet to slide along a guiding mandrel. The non-circular shaped eyelet and mandrel prevent rotation of the eyelet relative to the mandrel thereby ensuring a consistent deployed shape. The present invention also incorporates a self-articulating catheter tip which can be bent to a variety of angles to enhance the ease of delivery. The tip is articulated by varying the position of the closure device within the articulated portion of the catheter.

Abstract: A microsurgical laser probe is provided with a distal end portion of an optic fiber that projects from a tubular sleeve of the probe and can be caused to bend relative to the probe sleeve by manual manipulation of a mechanism on a handle of the probe.

Abstract: A method for delivering a plurality of individual surgical fasteners. The method includes the step of providing a surgical fastener delivery device having a drive mechanism with distal and proximal ends, the drive mechanism comprising moving and fixed opposing members, the moving member being moveable proximally and distally with respect to the delivery device, and the fixed member being fixed with respect to the delivery device, the device having the plurality of surgical fasteners located between the moving and the fixed members. The method further involves the step of penetrating tissue and placing a distal end one of the surgical fasteners within tissue, by moving the moving member distally. The method further involves the step of deploying a distal end of one of the surgical fasteners by moving the moving member proximally.

Abstract: A device (10) for fastening a cranial flap (17) to the cranial vault (16), comprising an upper ring (11) and a lower ring (12), connected to each other by a pillar (13), where the upper ring (11) is composed of two sections (18, 19) and may assume a first configuration in which the sections (18, 19) are approached, and a second configuration in which the sections (18, 19) are spread apart.

Abstract: Methods and apparatuses for compressing and holding a bulging or herniated intervertebral disc. A number of fastener embodiments are disclosed, including a resiliently curved fastener, suture, screw, staple, tack and others. The curved fastener is resiliently straightened and loaded into a needle for delivery and deployment. In the intervertebral disc, the deployed fastener resumes the curvature to grip and hold the bulge. Alternatively, the suture is anchored and used to tie down the bulging tissue. The screw, staple or tack can also be used to securely fasten, compress and hold the bulge from impinging upon adjacent nerves or tissues.

Abstract: A mechanism and method for steering a surgical instrument inserted into an endoscope such as a ureteroscope, nephroscope, or cystoscope, and/or for steering the endoscope, utilizes a shape memory structure secured to the surgical instrument or to the endoscope, the shape memory structure having a transformation temperature slightly greater than that of the human body so that bending of the shape memory structure, and therefore of the surgical instrument or endoscope, may be carried out by raising a temperature of irrigation fluid in the working channel. The steering mechanism may be used as a supplement to a tensioned-wire steering mechanism, reducing stress on the endoscope shaft and extending the service life and repair interval of the endoscope. In addition, when the surgical instrument is a glass optical fiber, the steering mechanism may be used to ensure that a tip of the optical fiber is within the field-of-view of fiber optics incorporated into the endoscope.

Abstract: In one embodiment, a spinal fixation assembly includes an elongated member, such as a spinal rod, configured for placement adjacent the spine and a bone engaging fastener, such as a bone screw having a lower portion configured for engaging a vertebra and a head that is at least partially spherical. The assembly further includes a receiver member defining a bore therethrough from a top end to a bottom end, a recess for receiving the head of the bone screwing fastener therein, and a lower opening at said bottom end of the receiver member through which the bone screw extends. The recess is configured to at permit pivoting of the bone screw within the receiver member until the head is fixed within the recess. The receiver member also includes a channel communicating with the bore and having an upper opening at the top end of the receiver member for insertion of the spinal rod into the channel.

Abstract: A device for the irradiation of internal cavities of the body includes a flexible catheter, made of a transparent material, containing a fiber optic of which the section at one end is designed to radially diffuse light coming from a source arranged at the other end. An inflatable balloon fixed to one end of the catheter surrounds the diffusing section of the fiber optic. The balloon is made of an elastomeric material that diffuses the light and is prefabricated by molding based on the shape of the cavity to be treated. The balloon presses against the cavity wall and, with the thickness of its surfaces remaining constant after inflation, the pressure needed for inflation is low and cannot damage the cavity tissues.

Abstract: A focused ultrasound ablation device includes an ultrasound emitting member and a handle shaft having a distal end at which the ultrasound emitting member is disposed. The handle shaft is malleable to permit selective, manual shaping of the handle shaft to access a selected anatomical operative site from a remote location and/or to orient the ultrasound emitting member for contact with anatomical tissue at the selected operative site.

Abstract: The device according to the invention is composed of an axially perforated cylinder having at least one split end so as to form at least two independent sectors. The material of which the cylinder is made is a Ni—Ti alloy with hot, cold or superelastic shape memory. The cylinder is inserted in a hole that passes through the fracture region and is heated with an electric scalpel, causing the independent sectors of the split end to open out and accordingly compact and couple the two fractured segments.

Abstract: Medical devices which are currently proposed to use elements made from shape memory alloys may be improved by the use of stress-induced martensite alloy elements instead. The use of stress-induced martensite decreases the temperature sensitivity of the devices, thereby making them easier to install and/or remove.

Abstract: In one embodiment, a spinal fixation assembly includes an elongated member, such as a spinal rod, configured for placement adjacent the spine and a bone engaging fastener, such as a bone screw having a lower portion configured for engaging a vertebra and a head that is at least partially spherical. The assembly further includes a receiver member defining a bore therethrough from a top end to a bottom end, a recess for receiving the head of the bone screwing fastener therein, and a lower opening at said bottom end of the receiver member through which the bone screw extends. The recess is configured to at permit pivoting of the bone screw within the receiver member until the head is fixed within the recess. The receiver member also includes a channel communicating with the bore and having an upper opening at the top end of the receiver member for insertion of the spinal rod into the channel.

Abstract: A spine distraction implant alleviates pain associated with spinal stenosis and facet arthropathy by expanding the volume in the spine canal and/or neural foramen. The implant provides a spinal extension stop while allowing freedom of spinal flexion.

Abstract: A device for heating and closing heat-retractable clamps for surgical use includes a housing which encloses an electronic power and control circuit, a power cord connected to the circuit, and a heating unit for applying heat to the clamps. The electronic power and control circuit includes a power supply, a controller and a regulating circuit for delivering different predetermined amounts of heat, each corresponding to a clamp of a given size. The heating unit is capable of being sterilized in an autoclave and includes a linking cord, one end of which is capable of being plugged into the housing for the electronic circuit and the other end of which is coupled with a sleeve having a pair of electrodes and a control switch for operating the electrodes.

Abstract: Clips having pseudoelastic properties at body temperature are used to cause hemostatis of blood vessels located along the gastrointestinal tract. Methods for causing the hemostasis of blood vessels and ulcer beds using the clips of the present invention are also disclosed.

Abstract: Method and apparatus for providing a socket of uniform shape within a bone preparatory to receipt of an anchoring member of an implant or augmentable bone. The tool is placed in a cavity in which a diseased bone or bone portion has been removed. A substantially cylindrical-shaped tool is inserted within the cavity. Grip extenders are selectively projected from the tool to secure the tool in place preparatory to its operation. The side walls and tip are expanded, preferably in a reciprocating fashion, compressing adjacent walls of the cavity modifying their length and width and making the sidewalls more uniform to assure precision placement of an augmented bone while providing a more uniform cavity shape and a more enriched site for a transplant, implant and/or bone augmentation. The resulting socket is scanned and a the scan is employed to prepare the augmented bone whereupon the implant may then be interfaced with the augmented bone in a highly precise manner.

Abstract: The invention relates to an osteosynthesis aid for treating upper arm fractures close to the head with an elastically derformable helical wire which is inserted laterally into the medullary space. The helical wire consists e.g. of implant steel wire and is configured as a self-cutting helical spring. The wire is characterized in that it is reversibly deformable in the longitudinal direction by up to 90° over its entire length, for its lateral insertion into the medullary space. The helix becomes elastically braced, forming a three-point brace as it is deformed in the medullary space, and bores itself further into the spongiose bone of the head of humerus. The shape of the osteosynthesis aid advantageously enables the treatment of fractures in oestoporotically altered bone and is also characterized in that the cross-section of the helical spring is triangular, rhomibic or round.

Abstract: The present invention relates to a self-expanding device for sealing a defect in a wall, such as a septal defect. The device of the present invention has a helical shaped periphery formed from an elastic wire and at least one eyelet. The eyelet has a non-circular (“asymmetric”) shape which allows the eyelet to slide along a guiding mandrel. The non-circular shaped eyelet and mandrel prevent rotation of the eyelet relative to the mandrel thereby ensuring a consistent deployed shape. The present invention also incorporates a self-articulating catheter tip which can be bent to a variety of angles to enhance the ease of delivery. The tip is articulated by varying the position of the closure device within the articulated portion of the catheter.

Abstract: In one embodiment, a spinal fixation assembly includes an elongated member, such as a spinal rod, configured for placement adjacent the spine and a bone engaging fastener, such as a bone screw having a lower portion configured for engaging a vertebra and a head that is at least partially spherical. The assembly further includes a receiver member defining a bore therethrough from a top end to a bottom end, a recess for receiving the head of the bone screwing fastener therein, and a lower opening at said bottom end of the receiver member through which the bone screw extends. The recess is configured to at permit pivoting of the bone screw within the receiver member until the head is fixed within the recess. The receiver member also includes a channel communicating with the bore and having an upper opening at the top end of the receiver member for insertion of the spinal rod into the channel.

Abstract: A bone fixation apparatus and method for repairing fractured bones is provided. A first pin is located on the bone adjacent the fracture and a flexible line is led to a second pin located on the other side of the fracture. A third pin is provided spaced from the first pin on the same side of the fracture and the flexible line is extended from the second pin to the third pin. A fourth pin is provided spaced from the second pin on the same side of the fracture and the flexible line is extended from the third pin to the fourth pin. Finally, the flexible line is extended from the fourth pin back to the first pin. The flexible line may be doubled up. A similar arrangement of pins and flexible line is made diametrically on the opposite side of the bone.

Abstract: In one aspect of the present invention, a cardiac lead is provided that includes a connector for coupling to a cardiac stimulator that has a first rotatable member, and a tubular insulating sleeve that has a first end coupled to the connector and a second end. A tip assembly is coupled to the second end. The tip assembly has a second rotatable member. A coiled wire is coupled between the first rotatable member and the second rotatable member. The coiled wire is composed of a shape-memory material and is operable to transmit torque between the first rotatable member and the second rotatable member. Where the lead is provided with a bend, the shape-memory coiled wire retains a straight set, enabling smooth rotation of a fixation corkscrew without precession of the lead tip.

Abstract: The present invention provides a system and a method for closing septal defects and the like. The system includes a closure device having a pair of occluding disks, each disk being formed of a membrane and an elastically deformable frame carried about the periphery of the membrane. The frame, which may be formed of a superelastic material, is capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding the membrane. A central portion of the membrane of each disk is attached to a central portion of the other membrane to define a conjoint disk. The method of the invention involves collapsing the frames of the disks, inserting the closure device into a catheter, and positioning the distal end of the catheter adjacent a septal defect. The first disk is then urged out of the distal end of the catheter to permit its frame to elastically return to a predetermined shape, pulling the membrane taut on one side of the defect.