Abstract: Methods and devices are provided for cutting and removing tissue from a body. In one exemplary embodiment, a surgical device is provided having a suction shaft and a cutting assembly. The suction shaft can have an inner passageway configured to receive tissue. The cutting assembly can include an outer shaft having at least one opening formed in a sidewall thereof configured to receive tissue. The cutting assembly can be configured to mate with the suction shaft, and it can include a cutting element configured to move relative to the opening to cut tissue disposed through the opening. Suction can be applied to cause the cut tissue to flow proximally through the suction shaft and away from the cutting assembly.

Abstract: A tip (41) for use with a lancing device (11). A wall extends upwardly from a base and forms a substantially saddle-shaped distal surface for interfacing with a patient's skin. An opening (43) extends entirely through the tip. The tip (41) is movably received by a pressure sleeve assembly. The pressure sleeve assembly includes a housing (37) and a pressure sleeve movable between first and second positions. A spring (35) is connected between the housing (37) and the pressure sleeve. A lancet (21) is rigidly fixed to the housing (37) and is covered when the pressure sleeve is in the first position and exposed through the substantially saddle-shaped distal surface (42) of the tip (41) when the pressure sleeve is in the second position. The substantially saddleshaped distal surface (42) gathers the patient's skin toward the center of the tip to facilitate expressing blood from a lanced site.

Abstract: A disposable lancing device including: a lancet housed in a housing and urged by a spring member such that a puncture member provided at a distal end of the lancet is adapted to extend out from the housing so as to carry out a puncturing operation; a locking ring disposed within the housing such that the lancet is allowed to displace in an extension direction through the locking ring; a locking protrusion provided to the lancet and adapted to be engaged by the locking ring so as to hold the lancet in a puncture-ready position located deep in the housing with the spring member being compressed; and an operating member adapted to carry out the puncturing operation by rotating the locking ring so as to disengage the locking protrusion from the locking ring and displace the lancet in the extension direction by means of the spring member.

Abstract: A tunneling device for creating a pathway in subcutaneous tissue of a person's body. The tunneling device includes a member having two ends, where each of the ends defines an insertion surface that facilitates the insertion of the ends into the subcutaneous tissue of the person's body. The tunneling device includes an interchangeable handle connectable to each of the ends. The handle defines a grasping surface and an opening. The opening is configured to receive either of the ends. The grasping surface enables a user to securely hold the handle with one hand to forcibly move the member through the subcutaneous tissue of the person's body to create the pathway in the subcutaneous tissue, and pull a cable of an implant device through the created pathway.

Abstract: An intra-bronchial device may be placed and anchored in an air passageway of a patient to collapse a lung portion associated with the air passageway. The device includes an obstructing member that prevents air from being inhaled into the lung portion, and an anchor that anchors the obstruction device within the air passageway. The anchor may piercingly engage the air passageway wall. The anchor may be releasable from the air passageway for removal of the obstructing member. The anchor may be releasable by collapsing a portion of the obstructing member, or by drawing the obstructing member toward the larynx. The obstructing member may be a one-way valve.

Abstract: A multi-method and multi-apparatus for treating obesity. The multi-method includes a method for estimating a volume of an intragastric balloon appropriate for an individual patient, a method for using an enterocutaneous fistula to inspect an intragastric balloon without sedation and endoscopic complications associated with an upper endoscopy, and a method for decreasing ability of the stomach of an individual patient to distend or expand after a meal increasing satiety and helping the individual patient to comply with a weight loss diet. The multi-apparatus includes an intragastric balloon for inflating without installation of a pressurized gas or liquid, an intragastric balloon for minimizing trauma of the intragastric balloon on the gastric mucosa, and an intragastric balloon for administering therapeutic medications.

Abstract: Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

Abstract: A device for delivering an occlusive element includes an elongate pusher member having a lumen extending between distal and proximal ends. An elongate releasing member is slideably disposed within the lumen of the elongate pusher member. A retaining member is disposed on the distal end of the elongate pusher member and includes a finger portion having an aperture sized to receive the distal end of the elongate releasing member. An occlusive element such as a coil is provided and includes a securing member positioned at a proximal end thereof. The securing member is releasably secured to the finger portion of the retaining member. The securing member is secured to the finger portion when the elongate releasing member is disposed in the aperture of the finger portion and unsecured when the elongate releasing member is retracted proximally from the aperture of the finger portion.

Abstract: Tourniquet assemblies are provided including a pressure applicator adapted to be secured around a limb and a tensioning mechanism for applying a working tension to the pressure applicator. The tensioning mechanism may include a platform, a clip and a tensioning member. The tensioning mechanism may be configured to apply the working tension via rotation of the tensioning member, and the clip may be configured to receive, and at least temporarily inhibit rotation of, the tensioning member. A tension indicator may also be provided including a base configured to attach to a tourniquet strap, a platform configured to move relative to the base when subjected to a tourniquet working pressure, and one or more tactile or visual indicators configured to provide a variable tactile or visual indicator based on the tourniquet working pressure.

Abstract: The present invention is directed to a method for sealing a puncture in a wall of a lumen of a body including the steps of deploying a deployment member of a sealing device through an elastic membrane adjacent the wall of the lumen and the puncture, wherein the sealing device includes a sealing element; positioning the sealing element adjacent the wall of the lumen; retracting the deployment member relative to the sealing element to stretch the membrane away from the wall of the lumen; retracting the deployment member relative to the sealing element to allow the elastic nature of the membrane to force the sealing element against the puncture; and retracting the device from the puncture.

Abstract: A puncture closure device operable to seal closed a vessel puncture in a vessel. The puncture closure device includes a delivery member insertable through a tissue tract to the vessel puncture, a sealing material, and an expandable member. The sealing material is deliverable through the delivery member to the vessel puncture and configured to seal closed the vessel puncture from outside the vessel. The expandable member is positionable within the vessel through a vessel access distinct from the vessel puncture and is operable to temporarily seal closed the vessel puncture from within the vessel to restrict passage of the sealing material into the vessel.

Abstract: An apparatus for delivering a closure element into an opening formed in a blood vessel or other body lumen and methods for manufacturing and using same. The apparatus is configured to retain the closure element such that the closure element is disposed substantially within the apparatus. The apparatus also can engage, and position the closure element substantially adjacent to, the blood vessel wall adjacent to the opening. During deployment of the closure element, the apparatus expands the closure element beyond a natural cross-section of the closure element such that the closure element, when deployed, is configured to engage a significant amount of the blood vessel wall and/or tissue. Engaging the blood vessel wall and/or tissue, the closure element is further configured to return to the natural cross-section, thereby drawing the engaged blood vessel wall and/or tissue substantially closed and/or sealed, such that hemostasis within the opening is enhanced.

Abstract: Embodiments are described for creating and closing tissue access ports, such as transapical access ports, which involve placement of an introducer across the subject tissue structure, and deployment of a controllable port closure device assembly configured to remain in place with a ratcheting mechanism, and to hold the tissue surrounding the previous access port location closed against a sealing disc with proximal and distal strut assemblies, after the introducer has been removed.

Abstract: A surgical method of treating tissue within the body of a patient may include: providing an endocutter having a staple holder and a plurality of staples, where a plurality, but less than all, of the staples are arranged in a firing position within the staple holder; engaging tissue of the patient with the staple holder; deploying the plurality of staples in firing position through a buttress and into tissue of the patient; disengaging the end effector from tissue of the patient; moving a plurality of staples into firing position; engaging tissue of the patient with the staple holder; advancing a segment of buttress relative to the staple holder; and repeating the deploying.

Abstract: A barbed suture is disclosed having barbs defined by a variable-angle cut surface. A cutting bed supports the suture during cutting. A cutting device is moved through the suture thread along a selected path. The angle of the cutting device is changed during cutting so that there is a corresponding change in the angle of the cut surface which defines each barb. A cutting arm is articulated to allow change of the angle of the cutting device. The change in the angle of the cutting device is used to control the shape and depth of cut of the barbs.

Abstract: The present disclosure generally provides systems and methods of anchoring surgical wires, catheters, leads, and other medical objects in an effective, efficient, and cost-sensitive manner. In one embodiment, the present disclosure could include a system to secure a medical object. The system could include a body having a first inner arm, a second inner arm, and a first outer arm. The first inner arm and the first outer arm could include a pronged structure. The system could also include a crossbar having a bore to receive a screw. The crossbar could be disposed between opposing surfaces of the first inner arm and the second inner arm and could be coupled to sliding grooves disposed along the opposing surfaces. When the screw is in an engaged position relative to the crossbar, the pronged structure could be configured to secure the medical object.

Abstract: A surgical device includes a first fastener having a planar profile, a second fastener having a concave surface, and a suture that can be manipulated to change a distance between the first and second fasteners. The second fastener has a curvature that substantially matches the curvature of a top surface of a clavicle bone in a direction perpendicular to a long axis of the clavicle bone. A method of treating an acromioclavicular joint injury includes forming axially aligned passages through a patient's clavicle and coracoid process, passing a fastener having a concave surface through the passages, positioning the concave surface of the fastener against a top surface of the patient's clavicle with a long axis of the fastener extending perpendicular to a long axis of the clavicle, positioning a fastener having a planar profile below the patient's coracoid process, and adjusting a suture that couples the fasteners.

Abstract: A fixation device includes a member defining at least two openings, and a suture tied to the member by passing the suture through the at least two openings in the member to form two suture loops through which ends of the suture pass. The two suture loops are interconnected. A method of securing a tissue graft includes providing the fixation member, attaching the suture to a tissue graft, and adjusting the length of the suture between the fixation member and the tissue graft by pulling the suture.

Abstract: Methods and devices for securing soft tissue to a rigid material such as bone are disclosed herein. A bone anchor is described that comprises a base and a top such that suture material may be compressed between surfaces on the base and top to secure the suture to the anchor. Also described is an inserter that can be used to insert the bone anchor into bone and move the anchor top relative to the anchor base to clamp suture material there between. Also described is a soft-tissue and bone piercing anchor and associated inserter. Methods are described that allow use of the bone anchors to provide multiple lengths of suture material to compress a large area of soft tissue against bone.

Abstract: Devices and methods for treating degenerative conditions of the spine or for alleviating pain or discomfort associated with the spinal column are disclosed. In particular, laminoplasty fixation devices and methods are disclosed. Also disclosed, is a vertebral implant comprising a first bone engaging portion configured for securing to a first cut portion of a vertebra and a second bone engaging portion configured for securing to a second cut portion of the vertebra. A body portion is provided for associating the first and second bone engaging portions at a preselected spacing from each other, wherein the implant is adjustable to select said spacing.

Abstract: A novel allograft is provided for insertion into a prepared site between adjacent spinal facets. The allograft or facet dowel is typically comprised of three portions, a partially spherical body defining a spherical segment, a nose portion, and a tail portion, all aligned along a longitudinal axis. In addition, a set of instruments is provided for the excavation of an allograft placement site between the two facets. The set of instruments includes a T-spade drill which will, in conjunction with a normal drill, excavate a site for the emplacement of the allograft. A novel method of using the instruments and the allograft is also provided.

Abstract: A cervical spine spacer includes a spacer body configured to be disposed between adjacent cervical vertebrae in the cervical spine and to maintain a desired spacing between the adjacent cervical vertebrae. The cervical spine spacer also includes a channel passing completely through the spacer body from a first surface of the spacer body to a second surface of the spacer body and a fastener configured to pass through the channel. At least one of the first surface and the second surface is configured to contact one of the adjacent cervical vertebrae and the channel is sized to accommodate the fastener passing through the channel at a plurality of angles.

Abstract: A surgical implant device that controls the relative movement between a first bone or tissue portion and a second bone or tissue portion. The device has a first connector member connected for movement with the first bone or tissue portion and a second connector member connected for movement with the second bone or tissue portion. A biasing member pivotally connects the first connector member to the second connector member and resists the relative rotation between the first connector member and the second connector member.

Abstract: A spine stabilization system including a first anchor, a second anchor and a rod for connecting the first and second anchors together. The first anchor includes an anchor body and a hook. A slot is defined between the hook and a first wall of the anchor body, facing the hook, the slot being configured to receive a bony structure. The first anchor further comprises a flexible member having first and second ends, and an intermediate portion therebetween. The anchor body is provided with an exit passage from which the first and second ends extend, and a loop passage going through the first wall and facing the hook, the intermediate portion extending from the loop passage to form a loop going through the slot and around the bony structure.

Abstract: There is provided a modular polyaxial pedicle screw assembly that includes various components which may be configured in various manners so as to provide different functionalities to the pedicle screw assembly. This advantageously decreases surgery time, reduces repetitive and tedious surgical steps, and allows for streamlining inventory of expensive medical equipment. In one embodiment, a pedicle screw assembly includes a pedicle screw, a rod holding element, a polyaxial insert, a rod, and a set screw. The pedicle screw includes a threaded shaft and a cap. The rod holding element includes a screw hole, an insert bearing area, a chamber, chamber walls, a saddle area, and a threading area. The insert is disposed within the chamber, and the insert defines a bearing surface, an upper surface, side walls and a receiving area.

Abstract: A polyaxial bone screw assembly includes a shank body having an upper head portion with a mating segment and a first partial spherical surface, a retainer structure being mateable with the mating segment of the upper head portion, the retainer structure having a second partial spherical surface such that when mated, the first and second partial spherical surfaces form a spherical ball member, a receiver defining an open channel and having a base with a seating surface partially defining a cavity with a shaped wall, the open channel communicating with the cavity, the cavity communicating with an exterior of the base through an opening sized and shaped to receive the shank upper head portion therethrough, and a bushing sized and shaped to fit within open channel and cavity and lock in recesses on interior of receiver.

Abstract: A receiving part for receiving a rod for coupling the rod to a bone anchoring element, the receiving part including: a receiving part body having a channel for receiving a rod and defining an accommodation space for accommodating a head of a bone anchoring element, the accommodation space having an opening for inserting the head; and a pressure element at least partially in the accommodation space, the pressure element including a first portion having a recess to receive the rod, and a second portion having a flexible portion to clamp the head, wherein the pressure element is moveable along a longitudinal axis of the receiving part body from an inserting position to insert the head, to a pre-locking position to clamp the head in the receiving part by a pre-stress exerted by the pressure element, to a locking position to lock the head in the receiving part.

Abstract: Open implant closure structures include a helically wound guide and advancement flange form having splay control surfaces. Multi-start closures and closures with inner set screws have splay control contours for interlocking with cooperating flange forms of bone anchor receivers. Flange form heights, thicknesses and other geometry, such as splay control ramp angle may be varied.

Abstract: This equipment comprises at least one anchoring assembly including two antagonistic hooks connected to each other through a rod, a first of these hooks having a body crossed by a hole for letting through the rod and being able to be connected to connection means with which the anchoring assembly may be connected to another part of the equipment; said body has an aperture laid out substantially perpendicularly to the axis of said hole, communicating with this hole, and the anchoring assembly has a tightening member which may be engaged into this aperture until it abuts against the rod engaged in the hole, and tightened in order to immobilize this rod in this hole. Said tightening member is directly connected to a part belonging to said connection means, which allows the mounting of the latter on the body of said first hook.

Abstract: Fixation system for bones with a connection support, at least one bone screw that can be inserted into a through hole of the connection support and a sensor and telemetry system, wherein the sensor and telemetry system is arranged on a separate plate, which can be connected with the connection support.

Abstract: A bone plate attachable to a bone for internal fixation. The bone plate has an upper surface and an opposite bone-contacting surface and includes a plurality of threaded through-holes for bone fasteners. The bone plate can include through-holes for passing sutures, and also suture-clearance recesses formed on the bone-contacting surface. Each suture-clearance recess is defined proximate to at least one of the suture holes for providing suturing clearance for a suturing instrument, such as a curved suturing needle.

Abstract: Systems and methods for applying signals, including contralesional electromagnetic signals, to neural populations, are disclosed. A particular method can be directed to treating a patient having a subject neural population in a first (e.g., ipsilesional) hemisphere of the brain, with the subject neural population having, or previously having, a functionality capable of being improved. The method can include directing an application of electromagnetic signals at least proximate to a target neural population at a second (e.g., contralesional) hemisphere of the brain to at least constrain a functionality of the target neural population, which has transcallosal communication with the first hemisphere.

Abstract: An interstitial laser energy treatment apparatus having co-acting movable probe holders which facilitate positioning of a laser probe and thermal probe in different positions relative to a tissue mass such as the tumor to be treated and relative to each other to facilitate treating tissue masses based on the exact position, size and shape of the tissue mass.

Abstract: Provided is a handpiece of a laser treatment device which can restrict a temperature rise of body tissues in a path from an irradiation portion to a target region more effectively than in the related art. The handpiece 10 includes an optical fiber 16 which guides laser light emitted from a pulse light source, and a revolving holder which holds a tip portion 64 of the optical fiber 16 such that the tip portion 64 is tilted with respect to a rotational axis C0 to direct an optical axis C1 of the laser light towards a target point P located on the rotational axis C0 and revolves the tip portion 64 of the optical fiber 16 about the rotational axis C0. Further, a pulse number of the pulse light source per unit time and a number of revolutions of the tip portion 64 of the optical fiber 16 per unit time are determined such that the pulse number of the pulse light source per unit time is not an integral multiple of the number of rotations of the tip portion 64 of the optical fiber 16 per unit time.

Abstract: The present invention is directed to balloon folding configurations and methods for catheter devices having dual lumens in radial proximity to the balloon, such as, but not limited to, self-aligning stent delivery systems for treatment of bifurcated lesions. The configuration designs alters the conventional catheter profile by packing balloon materials in otherwise vacant areas located on both sides of the side branch shaft and/or the parent shaft, such that the device takes on more of a round profile instead of the classical elongated egg-shaped profile.

Abstract: Devices, methods and systems facilitate and enable vessel wall treatment, particularly at the neck of an aneurysm. A tethered cage-like structure functions in conjunction with supplemental therapies such as a vaso-occlusive coil delivering microcatheter system and/or pharmaceutical delivery, among other things, by stabilizing vessel walls and providing tethered cage-like therapeutic support for treating aneurysms, temporarily or on an implantable basis.

Abstract: A generally spherical vascular remodeling device is permanently positionable at a junction of afferent and efferent vessels of a bifurcation having an aneurysm. After positioning the device at the junction to substantially conform the device to the shape of the junction, the device acts as a scaffolding to inhibit herniation of objects out of the aneurysm and permits perfusion to the efferent vessels. Positioning the device may include deployment and mechanical or electrolytic release from a catheter. Embolic material may be inserted in the aneurysm before or after positioning the device. The device may have a first end, a second end substantially opposite to the first end, and a plurality of polymer filaments extending between and coupled at the first end and the second end. Such devices may be football shaped, pumpkin shaped, or twisted. The device may include a plurality of polymer loops forming a generally spherical shape.

Abstract: A system for treating an aneurysm comprises an elongate flexible shaft and an expandable member. An expandable scaffold is disposed over the expandable member and may be expanded from a collapsed configuration to an expanded configuration. A double-walled filling structure is disposed over the scaffold and has an outer wall and an inner wall. The filling structure is adapted to be filled with a hardenable fluid filing medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a substantially tubular lumen to provide a path for blood flow. In the expanded configuration the scaffold engages the inner wall of the filling structure. A tether is releasably coupled with the filling structure and the flexible shaft thereby constraining axial movement of the structures relative to each other.

Abstract: Apparatus, systems, and methods are provided for deploying an implantable device, such as a stent, within a lumen of a body of a patient. The delivery device may include an inner member and an outer sheath surrounding a distal portion of the inner member and configured to retain the implantable device sheathed near the distal end of the outer sheath until deployment. The outer sheath is slidably moveable relative to the inner member such that proximal movement of the outer sheath relative to the inner member deploys the implantable device. A trigger assembly of the delivery device can include an internal connector coupled to the outer sheath, a plurality of triggers, and a floater coupling two of the triggers. The triggers are serially retracted to deploy the stent. A panchor secures the stent against proximal and distal movement relative to the inner member during deployment.

Abstract: An endoprosthesis deployment system includes an axial catheter, an outer sheath extending parallel to the axial catheter, and an inner sheath positioned transversely between the axial catheter and outer sheath, the inner sheath including first and second inner sheath sections extending along the axial catheter, each of said first and said second inner sheath sections mounted for axial movement relative to the other inner sheath section.

Abstract: An embodiment of the invention provides a prosthesis delivery system comprising a delivery catheter having an expandable member and a prosthesis carried over the expandable member. The prosthesis includes a radially expandable scaffold section and at least two anchors extending axially from an end thereof; and means for capturing at least the anchors to prevent the anchors from divaricating from the expandable member as the catheter is advanced through a patient's vasculature.

Abstract: A temporary diameter reduction constraint arrangement for a stent graft is disclosed. The arrangement comprises: primary and secondary release wires extending along the graft; a plurality of loops of thread, each loop engaged with either the primary or secondary wire and engaged around a portion of the graft circumferentially spaced away from its release wire, and drawn tight to reduce the diameter of the graft; an end constraint arrangement comprising four of the plurality of loops of thread arranged into a first and second pairs engaged with respective primary and secondary wires; and an intermediate constraint arrangement comprising a fifth and sixth of the plurality of loops of thread arranged into a third pair, the third pair engaged with the primary release wire, the primary release wire deviating towards the secondary release wire so as to locate the intermediate constraint arrangement substantially in-line with the end constraint arrangement.

Abstract: An endoluminal prosthesis may include a tubular graft extending in a longitudinal direction, where the graft has an inner surface forming a lumen extending a length of the graft. An elongate member may be attached to the graft in a circumferentially and longitudinally extending manner such that the elongate member forms a series of longitudinally spaced apart turns, each turn extending substantially around a circumference of the graft. The elongate member may torsion the graft in at least the circumferential direction and cause the graft to form circumferentially and longitudinally extending folds in the portions of the graft disposed between longitudinally adjacent turns of the elongate member.

Abstract: A stent incorporating flexible, preferably polymeric, connecting elements into the stent wherein these elements connect adjacent, spaced-apart stent elements. Preferably the spaced-apart adjacent stent elements are the result of forming the stent from a helically wound serpentine wire having space provided between adjacent windings. Other stent forms such as multiple, individual spaced-apart ring-shaped or interconnected stent elements may also be used. The connecting elements are typically web-shaped and result from creating slits or apertures in a covering of graft material applied to the stent and then, for example, applying heat to cause the slits or apertures to enlarge. The remaining graft material forms the interconnecting webs between the adjacent stent elements.

Abstract: A composite implantable prosthesis including a scaffold with a plurality of axially spaced apart sections connected by one or more bridges, each bridge including one or more hinges. The material of the bridges is generally distinct from the material of the scaffold.

Abstract: A heart valve prosthesis configured for deployment within a native heart valve. The heart valve prosthesis includes a tubular stent and a prosthetic valve component disposed within and secured to the stent. In addition, one or more elements are coupled to a distal end of the stent to position, anchor, and/or seal the prosthesis within the native heart valve. Each element transforms from a compressed configuration in which the elements distally extend from the distal end of the stent to a deployed configuration in which the elements proximally extend from the distal end of the stent. Each element includes at least one U-shaped or V-shaped support arm that bends radially outward and then towards an outer surface of the stent such that it translates more than ninety degrees from the compressed configuration. Each element may include an outer support arm and an inner support arm.

Abstract: Embodiments of an apparatus for treating a deficient mitral valve include an expandable spacer configured for placement between the native leaflets of the mitral valve, the spacer anchorable to a wall of the ventricle. Methods and apparatus for delivering and implanting the prosthetic are also described.

Abstract: A delivery device for percutaneously deploying a stented prosthetic heart valve, including a delivery sheath, an inner shaft, and a spindle. The inner shaft is slidably disposed within a lumen of the delivery sheath. The spindle is attached to the shaft and includes a hub defining at least one longitudinal slot sized to slidably receive a post of the stented valve. An outer surface of the hub forms a curved proximal segment. The device provides a loaded state in which the delivery sheath retains the stented valve over the inner shaft and coupled to the spindle via the slot. In a deployed state, the distal end of the delivery sheath is withdrawn from the prosthesis to permit the stented valve to release from the slot, sliding along the curved outer surface of the hub.

Abstract: Valve delivery catheter assemblies including components that limit trauma to the expanded prosthetic valve and body channels as the distal tip of the catheter is withdrawn through the expanded valve and thereafter from the body. Catheter assemblies according to the present invention can include a handle assembly, an introducer sheath, and a distal tip assembly. The handle assembly can include a fixed main handle and two or more rotating handles that allow a user to control the distal tip assembly of the catheter. A safety button can be included on the handle assembly to allow for precise and consistent positioning of the prosthetic valve in the body. A valve retaining mechanism can be included to assist in retaining the prosthetic valve prior to deployment.

Abstract: A dual valve prosthesis having first and second prosthetic valve sections is disclosed. The first prosthetic valve section includes a stent structure with a first prosthetic valve secured therein and the second prosthetic valve section includes an annular frame with a second prosthetic valve secured therein. When the dual valve prosthesis is in an expanded configuration, the annular frame extends from the stent structure such that the first and second prosthetic valves are laterally offset from each other. In a method in accordance herewith, the first and second prosthetic valve sections include prosthetic aortic and mitral valves, respectively, and the dual heart valve prosthesis is configured to replace both the native aortic and mitral valves of the heart in a single transcatheter heart valve implantation procedure.