Example implantable tissue anchors, kits that include an implantable tissue anchor, and associated methods are described. An example implantable tissue anchor is moveable between a first, expanded configuration and a second, compressed configuration. The implantable tissue anchor has a first end, a second end, and a main body. The main body defines a first arm, a second arm, a first plurality of recesses on the first arm, a first plurality of barbs on the first arm, a second plurality of recess on the second arm, and a second plurality of barbs on the second arm. The first arm and the second arm define a first closed loop and a first passageway that extends through the main body when the implantable tissue anchor is in the first, expanded configuration.
A61B 17/04 - Surgical instruments, devices or methods for closing wounds or holding wounds closedAccessories for use therewith for suturing woundsHolders or packages for needles or suture materials
There is disclosed, among other things, embodiments of a biopsy needle for taking a full core sample through soft tissue. In the illustrated embodiments, an inner tubular member having a semi - cylindrical distal end is within and slidable with respect to an outer tubular member. A semi - cylindrical channel is in the distal end, as well as a planar end surface. The channel has a set of one or more protrusions or texture, and a complementary set of protrusions or texture are placed on the inside of the outer member so that the sets of protrusions or texture face each other when the distal ends of the members are adjacent each other.
There is shown and described embodiments of a biopsy needle that is simpler to make and use than existing devices. An inner and outer cannula are provided, with the outer cannula having a superelastic finger that lies along the length of the inner cannula in a retracted position and partially covers the lumen of the inner cannula in an extended position. The finger is pointed and in the form of a triangle in a particular embodiment, and does not extend beyond the outer extent of the inner cannula in the extended position.
A method of performing a percutaneous vascular procedure includes sliding a vascular constriction crossing mechanism in a proximal to distal direction over a wire guide having a wire guide tip positioned at a proximal side of a vascular constriction, and rotating a sheath of the vascular constriction crossing mechanism about an axis of rotation relative to another sheath of the vascular constriction crossing mechanism. The method further includes advancing a constriction crossing tip by way of helically engaging the sheaths during the steps of rotating, and guiding an intraluminal treatment device into or past the vascular constriction for performing a vascular procedure within the patient. The vascular constriction crossing mechanism includes a first sheath and a second sheath, and a constriction crossing tip coupled with a distal segment of the first sheath. The vascular constriction crossing mechanism further includes a helical coupling between the first and second sheaths, which is configured to convert a torque on one of the sheaths to an axial force on the other of the sheaths for crossing a vascular constriction with the constriction crossing tip. An anchoring mechanism may be coupled with one of the sheaths and includes a deployed state at which the anchoring mechanism contacts a vascular wall of the patient for resisting displacement of the second sheath within a vascular structure of a patient.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
Disclosed is a deflectable biopsy device (110) that includes a cannula (40) having a preformed bend (46), wherein the shape of the cannula (40) can be temporarily altered with the cannula returning to its original shape afterward. The deflectable biopsy device (110) also includes a sampling member (60) slidably disposed within the cannula (40) and operable therewith to collect a tissue biopsy.
Retrieval tool (10) for retrieving a vascular implant from a patient includes a wire (12) having proximal (14), middle(16) and distal(18) segments. The distal segment may include a guide segment (22) and a coupling segment (24), a tip (20) and at least two turns (26, 28) about a longitudinal axis (A) defined by the middle segment. The wire may further have an increasing stiffness profile in a proximal direction from the tip. A vascular implant retrieval assembly includes a vascular implant, such as a vascular filter, a retrieval tool having a distal segment wound about the vascular implant and a sheath surrounding a middle segment of the retrieval tool.
A61F 2/01 - Filters implantable into blood vessels
A61F 2/84 - Instruments specially adapted for their placement or removal
A61B 17/221 - Calculus gripping devices in the form of loops or baskets
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
9.
LOADING APPARATUS AND SYSTEM FOR EXPANDABLE INTRALUMINAL MEDICAL DEVICES
Medical device loading apparatuses, systems, methods and kits are described. A loading apparatus comprises a main body having a proximal end defining a proximal opening, a distal end defining a distal opening, and a passageway extending between the proximal and distal openings. The passageway defines a proximal chamber having a first inner diameter, a distal chamber having a second inner diameter, and a transition chamber disposed between the proximal and distal chambers. The transition chamber has an inner diameter that transitions from the larger second inner diameter to the smaller first inner diameter. The main body has a separable connection that divides the main body between proximal and distal portions when disrupted. An expandable intraluminal medical device can be loaded into a delivery catheter using the loading apparatus by placing the device into the passageway such that it is in a radially-expanded configuration; pulling the device along an axial path through the loading apparatus such that the device transitions from the radially-expanded configuration to a radially-compressed configuration; and pushing the radially-compressed device along the axial path into the delivery catheter.
The present disclosure provides an aspiration catheter (20) for removing thrombus from a lumen of a hemodialysis catheter (100). One embodiment of the aspiration catheter comprises an elongate flexible shaft having a proximal end and a distal end. The aspiration catheter further comprises an operable device at the distal end of the elongate flexible shaft to be inserted through the lumen of the hemodialysis catheter. The operable device (30) is capable of being extended beyond a distal end of the lumen of the hemodialysis catheter. The operable device is configured to engage and remove thrombus from the lumen of the hemodialysis catheter. The aspiration catheter further comprises a source of negative pressure. The aspiration catheter further comprises a connector adapted to connect the source of negative pressure and the proximal end of the elongate flexible shaft. The elongate flexible shaft is configured to draw debris into the aspiration catheter.
A61B 19/00 - Instruments, implements or accessories for surgery or diagnosis not covered by any of the groups A61B 1/00-A61B 18/00, e.g. for stereotaxis, sterile operation, luxation treatment, wound edge protectors(protective face masks A41D 13/11; surgeons' or patients' gowns or dresses A41D 13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M 1/00)
11.
LOW PROFILE SUPPORT FRAME AND RELATED INTRALUMINAL MEDICAL DEVICES
A low profile support frame (10) for use as an or in an expandable intraluminal medical device includes first (12) and second (14) wire members that define arcuate paths having opposing curves. Connectors (20,22) join the wire members, and barbs can be disposed on the connectors. The support frame has radially compressed and radially expanded configurations. When the support frame is in the radially expanded configuration, substantially no portion of the support frame is disposed on a first transverse axis of the frame opposite one end of the frame and substantially no portion of the frame is disposed on a second transverse axis of the frame opposite the other end of the frame. The support frame can be used as an intraluminal medical device by itself or as a component in a medical device that includes other components, such as a stent, prosthetic valve, occluder, or filter.
An implantable valve prosthesis (10) is provided. The valve prosthesis includes a frame structure having first (14) and second (16) independent frame elements. A graft member (18) is attached to both the first and second frame elements and includes a closure member (20), such as a valve leaflet. The closure member is movable between a first position that allows fluid flow through the prosthesis in a first, antegrade direction and a second position that restricts flow through the prosthesis in a second, retrograde direction.
A catheter (10) having an outer tubular layer (42) defining a lumen (13) and a thin-walled liner (11) on an inner surface of an outer tubular layer is disclosed. In the presently preferred embodiment, the material of the liner is PTFE which has a thickness of ≤ 0.0015 inches. The outer tubular layer is composed of a nylon, polyurethane, or PEBAX material. The flex modulus of this material is under 60,000 psi so that the catheter retains some flexibility. Although the liner by itself is fairly rigid and kinkable, the PTFE liner provides excellent strength in preventing ruptures. The traits change, however, when the outer tubular layer is applied. The combination of the two materials results in a flexible shaft with excellent flow rate capacity.
The present application generally relate to a medical surgical device and specifically a wire guide (10) for percutaneous placement within a body cavity. The wire guide includes a multi-filar coil (20) having an increasing pitch towards the distal end of the wire guide.
Wire guides and methods of using wire guides are presented. The methods include inserting an introducer into a vascular system in a first general direction, inserting a wire guide including an outer flexible coil disposed about a core having a pre-curved distal end into the vascular system through the introducer so that the pre-curved distal end of the core is positioned in a body vessel, and advancing the outer flexible coil over the core so that the outer flexible coil is advanced past the pre-curved distal end in a second direction that is different from the first direction.
A low-profile gastric port device (100) configured to attach to a gastric tube (106, 107) that is cut to a length customized for a specific patient. The port device (100) comprises a first (102) and a second portion (104) connected to each other in a manner aligning the first portion passage (133) and the second portion passage (124) to form a continuous passage. Different embodiments may have a clamshell structure that closes around the tube, or a circumferential clamping structure configured to engage a tube end.
An introducer sheath includes a lubricious inner liner having a passageway extending longitudinally therethrough, a reinforcing member positioned over the inner liner, and an outer jacket positioned longitudinally over the reinforcing member and the inner liner. The outer jacket has a higher durometer proximal portion, a lower durometer distal portion, and a transition zone between the proximal portion and the distal portion. The transition zone has a variable durometer from a junction with the outer jacket proximal portion to a junction with the outer jacket distal portion, to provide a transition between the higher durometer proximal portion and the lower durometer distal portion.
A balloon catheter is provided that may be used to dilate hardened regions of a stenosis on a vessel wall. The balloon catheter is provided with cutting elements that extend along a surface of a balloon. At least one bioactive is present, either on the cutting element, within the interior of the balloon, within the material of the balloon or on an outside surface of the balloon. The bioactive is delivered to the vessel wall upon dilation of the balloon.
A61M 29/00 - Dilators with or without means for introducing media, e.g. remedies
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
19.
INTRODUCER FOR DEPLOYING A STENT GRAFT IN A CURVED LUMEN
An introducer (10) includes release wires (42') that constrain at least one stent (4') whilst the remainder of a stent graft (18) is expanded during deployment. By allowing the constrained stent (4') to expand after an adjacent stent (4), the constrained stent (4') overlaps with the interior of the adjacent stent (4) where the stent graft (18) is deployed within a curved body lumen (70).
A locking mechanism (15) for a catheter includes a main body (20), a tip (30), and a locking arm (50). The locking arm includes a pivotable portion (56) selectively receivable in a contoured outer surface portion of the main body (24). One end of a tubular member is engageable with the distal end of the tip, and the other end is insertable into a body cavity, e.g., for drainage of fluid therefrom. A tension member (14), e.g. suture, extends through the locking mechanism and the tubular member, and is actuable to maneuver the inserted end of the tubular member into a desired configuration, such as a loop or a pigtail (12). An end of the tension member is receivable along the main body contoured surface following actuation, and is lockable therein upon receipt of the locking arm pivotable portion in the contoured surface, thereby locking the tubular member end in the desired configuration.
A vascular occlusion device for occluding a body vessel is disclosed. The device comprises a hub having proximal and distal ends and a plurality of anchoring struts. Each anchoring strut has a first end and a second end. The first ends are connected together at the hub. Each of the second ends extends freely from the first end to engage the body vessel for anchoring the device therein. The device further comprises a central strut attached to the proximal end of the hub. The device further comprises a proximal and distal members and an extracellular matrix material. The proximal and distal members are slidibly disposed about the central strut. The extracellular matrix material is disposed about the central strut between the proximal and distal members.
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
A61B 17/00 - Surgical instruments, devices or methods
22.
INTRODUCER FOR DEPLOYING A STENT GRAFT IN A CURVED LUMEN AND STENT GRAFT THEREFOR
A stent graft (18) for deployment in a curved lumen such as the aortic or thoracic arch (130) comprises a constraining mechanism at its proximal end. A stent (4') provided at the proximal end of the stent graft (18) includes loops of material (11) that co-operate with restraining wires (42) that extend between a central guide wire carrier (24) and a restraining wire cannula (8). The constraining mechanism acts to maintain the proximal stent (4') constrained at three points around its circumference at both the proximal and distal ends of the proximal stent (41). The proximal stent (41) is thus allowed to expand after expansion of the remainder of the stent graft (18) during deployment. In an embodiment, the constraining mechanism acts to constrain two adjacent struts of the proximal stent (4') at three points radially therearound, at the proximal end of the stent (41) and at the distal end of the stent (41). The proximal stent (4') may then overlap with the interior of an adjacent stent at an inner part (31) of a curved vessel.
Certain aspects of the present invention provide devices for occluding vascular vessels. In some preferred forms, these devices are able to move from a first condition to a less compact, second condition in a vascular vessel so as to fully or partially prevent fluid from passing through the vessel. One such device includes a frame and a flexible sheet material. The device also includes an occluding material that is located in an interior region of the frame. The flexible sheet material and frame are associated with one another such that when the device is in the second condition in the vascular vessel, the sheet material is positioned in the vessel lumen so as to block fluid flow through the lumen.
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
A rotationally-symmetric stent graft (10; 30) for deploying in a curved vessel (32) has identical spaced stents (16) along its length, with the stents being further apart in the region of the greatest curvature. The ends of the stents are parallel to each other and to the ends of the graft. The inter-stent spacing (D) may vary along the entire length of the graft or only adjacent one end.
A61F 2/89 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
A61F 2/91 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
A61F 2/82 - Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
Prosthetic valve devices, as well as systems and methods for the delivery thereof, are disclosed. A device (30) includes one or more leaflets (31, 32) disposed within a frameless conduit (33), wherein the conduit is adapted for attachment to walls of a vascular vessel, and the leaflets are adapted for attachment to walls of the conduit. The leaflets are configured to selectively restrict blood flow through the conduit, and the conduit can include wall-engaging adaptations, for example, barbs or an adhesive. The conduit and the leaflets are formed with a flexible material, which may comprise a remodelable material and/or a synthetic polymer.
An introducer assembly (100) including at its distal end a dilator tip (20) and an inner catheter for supporting an implantable medical device (1) for deployment, is provided with a plurality of strut elements (102, 202) extending from the dilator tip (20) to the proximal end of the medical device (1 ). The strut elements (102, 202) act to apply both a pulling and a pushing force against the proximal end of the medical device (1), having the effect of assisting in the correct positioning of the proximal end of the medical device in a patient's lumen, particularly where this is curved such as with the aortic arch. The strut elements (102, 202) form part of the introducer assembly and are removed from the patient following the deployment procedure. The device avoids the need for bare stents at the end of a stent graft.
A catheter tip assembly (50) is provided with a catheter tip (56) and an inner catheter (54). The catheter tip (56) has a tapered proximal end, an elongate center portion, and a tapered distal end. The inner catheter (54) includes a narrow proximal portion, a narrow elongate center portion (66), and a wide distal end (68). The catheter tip (56) is disposed within the wide distal end (68) of the inner catheter (54). One advantage of the catheter tip assembly is that no proximal-facing edge is formed at the transition between the narrow elongate center portion of the inner catheter and the catheter tip, which may help reduce the risk of the catheter tip snagging on a stent during use.
A catheter system a method and a kit for cannulating an occlusion in a body lumen are provided. The catheter system includes an elongate sheath having a proximal portion, a distal portion, a first lumen extending at least partially through the elongate sheath and a second lumen extending at least partially through the sheath. The sheath further includes an opening at the distal portion of the sheath, the opening is connected to the first lumen and positioned proximal to a distal end of the second lumen. The system also includes a stiffening elongate member slidably and removably positionable within the second lumen and distally extendable within the second lumen so that a distal end of the stiffening elongate member is positional distal to the opening. The stiffening member has a first stiffness.
A reinforcement member (10) for a fenestration in a stent graft (30) comprises a composite wire (12) formed from wire strands of at least two types (14, 16, 18). A first type of wire strand comprises a metal alloy with shape memory characteristics and a second type of wire strand comprising a metal with radiopaque characteristics. The first type of wire strand and the second type of wire strand are twisted or braided together to form the composite wire and then formed into the circular ring with at least two turns of the composite wire forming the ring. The reinforcement member can be a circular ring mounted into a fenestration (40) in a wall (32) of a stent graft, or mounted around a stent graft, or it can be a substantially U-shaped edging along the edge of a scalloped fenestration (44).
An introducer sheath. (10) and a method for making the sheath. The sheath includes a f luoropolymer liner (31) having a passageway extending longitudinally therethrough. An inner jacket (35) is positioned longitudinally over the liner, and the inner surface of the inner jacket is bonded to the outer surface of the liner. An outer jacket (44) is positioned longitudinally over the inner jacket, and the inner surface of the outer jacket is bonded to the outer surface of the inner jacket. A reinforcing coil (40) is encapsulated within the inner jacket and the outer jacket.
A stent including a stent wire comprising a plurality of filaments twisted into a bundle having a helix, the stent wire being bent into a pattern having a plurality of substantially straight wire sections separated by a plurality of bends. The pattern of the stent wire is spirally wound about a central axis in the same direction as the helix formed by the plurality of filaments. The each of the filaments in a bend have a cylindrical cross-section where at least one of the plurality of filaments is displaced and spaced from an immediately adjacent filament in the bend.
A61F 2/90 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
A method of forming an introducer sheath having a crease-free tapered distal tip portion. A mandrel is provided having an outer configuration comprising an elongated body and a tapered distal tip portion. A generally tubular inner liner comprising heat shrinkable PTFE, is positioned over the mandrel. The inner liner is heat shrunk to the outer configuration of the mandrel, in a manner that avoids the formation of creases along the inner diameter of the liner. A reinforcing member is positioned over a length of the inner liner, and an outer jacket is positioned over the reinforcing member and the inner liner. The liner, reinforcing member, and outer jacket are heated in a heat shrink enclosure, whereby the outer jacket melts and bonds to an outer surface of the inner liner.
B29C 65/02 - Joining of preformed partsApparatus therefor by heating, with or without pressure
B29C 70/02 - Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts comprising combinations of reinforcements and fillers incorporated in matrix material, forming one or more layers, with or without non-reinforced or non-filled layers
F16L 11/08 - Hoses, i.e. flexible pipes made of rubber or flexible plastics with reinforcements embedded in the wall
The invention provides, in certain aspects, grafting devices deliverable into the body for repairing defects in bodily structure walls. One such grafting device comprises a compliant sheet-form material, and a removable resilient element that is retained in association with the sheet-form material. In some forms, the resilient element is adapted for delivery in its entirety into the body, and thereafter, can be disassociated from the sheet-form material for removal from the body. The sheet- form material may be formed with one or more of a variety of biocompatible materials including some that are naturally derived and some that are non-naturally derived. Illustratively, the sheet-form material may be comprised of a remodelable, angiogenic material, for example, a remodelable extracellular matrix (ECM) material. In additional embodiments, the invention provides methods and apparatuses for delivering these and other inventive grafting device into the body.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A61B 17/00 - Surgical instruments, devices or methods
A haemostatic or check-flow valve (10) for an implant deployment device (12) includes a conformable valve element such as a gel-filled sack (25) inside a valve housing (21). An actuator (29) is provided in the valve housing (21), and is operable to reduce the effective volume of a valve chamber (23) provided within the valve housing (21). Reduction in the effective volume of the valve chamber (23) causes the conformable sack (25) to change shape, thereby to close a bore (27) that extends longitudinally through the sack (25).
A chemo-embolization agent for treating diffuse diseases in a targeted tissue vessel of a patient and a process thereof is presented. This chemo-embolization agent comprises an inner core of a chemotherapy drug having a diameter less than a predetermined size for the opening in the targeted tissue vessel; and an outer sphere of an embolization material encompassing the inner core and having an initial diameter to occlude the initial opening in the targeted tissue vessel. During the treatment of the disease, the outer sphere of embolization material erodes at a predetermined rate, enhancing penetration of the chemo-embolization agent into the opening in the targeted tissue vessel. The inner core of chemotherapy drug disperses into the targeted tissue vessel after becoming exposed by the erosion of the embolization material of the outer sphere.
A prosthesis with a moveable fenestration includes a tubular graft body having a proximal end, a distal end, at least one fenestration disposed in a sidewall of the tubular body between the proximal end and the distal end, a first biocompatible graft material, and a second biocompatible graft material adjacent the perimeter of the at least one fenestration, wherein the second biocompatible material is of greater flexibility than the first biocompatible material such that movement of the fenestration relative to the surface plane of the tubular graft body is permitted.
A stent graft delivery device (30) has a pull wire arrangement with a pull wire (46) fastened to the distal end of a nose cone dilator (45) and extending to a wire pull mechanism (60) for the pull wire associated with a handle (52) of the stent graft delivery device. The pull wire can be pulled by the wire pull mechanism to induce a curve in a guide wire catheter (44) distally of the nose cone dilator such that the proximal end of the delivery device more closely fits the shape of a portion of the vasculature of a patient into which the device is deployed.
An endoluminal prosthesis includes a support structure comprising a curvilinear portion having a first strut and a second strut that meet at an apex. Disposed on the support structure is an anchor (25) with an anchor body and one or more barbs (21) extending outwardly from the anchor body. The anchor body fits at least partially about, and conforms to the first strut, second strut, and the apex.
A multi-section tubular device suitable for use as a stent is provided. The multisection tubular device includes a first tubular section (12) having a first end and a second end. A second tubular section (18) is connected to the first end of the first tubular section and a third tubular section (20) is connected to the second end of the first tubular section. The first tubular section is more flexible than the second and third tubular sections. One advantage is that the coiled first tubular section is highly flexible axially, radially, and torsionally, which makes the multi-section tubular device resistant to kinking or fracturing.
A61F 2/88 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
40.
IMPLANTABLE PROSTHESIS WITH REDUCED DENSITY REGIONS
An implantable woven graft for bridging a defect in a main vessel near one or more branch vessels includes a region of reduced density (111). Reduced density regions (111) are alignable with at least one of the one or more branch vessels, and are suitable for in situ fenestration, for example by perforation. The disclosed examples are particularly suited for bridging abdominal aortic aneurysms.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A coated stent (20) for use in a medical procedure and methods of manufacturing the coated stent (20) are described. A stent component (30) has an expanded state in which an inner diameter (ds) of the stent (30) is less than or equal to an outer diameter (dc2) of a coating (40), thereby causing an inner surface (35) of the stent (30) to engage the outer surface (42) of the coating (40). In one exemplary method of manufacture, the stent (30) is disposed over the coating (40) when the coating (40) is provided with a first, smaller outer diameter (dc1). The coating (40) then is radially expanded to a second, larger outer diameter (dC2), which is greater than or equal to the inner diameter (ds) of the stent (30), to cause the outer surface (42) of the coating (40) to engage the inner surface (35) of the stent (30).
A removable filter for capturing thrombi in a body vessel is disclosed. The filter comprises a plurality of primary struts comprising proximal and distal portions. Each proximal portion has a first end, wherein the first ends are attached together along a longitudinal axis. Each primary strut extends arcuately along the longitudinal axis and linearly radially. The distal portions of the primary struts are configured to expand in the body vessel, engaging the distal hooks with the body vessel. Each distal portion integrally extends from the proximal portion to a plurality of distal hooks. The distal hooks are substantially equal in size relative to each other.
An introducer sheath for deploying a stent to a target site within a body passageway of a patient. The introducer sheath includes a tubular inner liner having a proximal portion, a distal portion, and an outer surface. A first reinforcing element, and a second reinforcing element are positioned along the outer surface of the inner liner. The first reinforcing element comprises a braid the second reinforcing element comprises a coil. The braid is positioned at the proximal portion of the inner liner and extends distally therefrom. The coil is positioned at the distal portion longitudinally adjacent the braid. The braid has a length that may extend about 90% of the length of the sheath. An outer jacket is positioned longitudinally around the reinforcing elements, and is connected to the inner liner between the respective wires of the braid and the coil.
An occluding device is provided for occluding fluid flow through a lumen of a body vessel. The occluding device includes an expandable tubular body having a tubular wall defining a lumen formed therethrough. The tubular wall has a proximal end extending to a distal end along a longitudinal axis of the tubular body. A plurality of longitudinal slits is formed through the tubular wall to define a plurality of flexible strips bound by a proximal non-slit portion and a distal non-slit portion. A plurality of barbs is disposed on the flexible strips. The tubular body is configured to open radially to engage the barbs with the vessel wall defining an expanded state and to collapse along the longitudinal axis to draw the vessel wall radially inward defining a collapsed state. Occluding material is housed within the lumen of the tubular body and the occluding material is configured to move between a collapsed state and an expanded state with the tubular body.
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
45.
DEVICE AND METHOD FOR CLOSURE OF VESSEL ACCESS SITE
A device for closure of an opening formed in a body vessel includes a grasping member and a sheath movable thereover. The grasping member comprises a tubular body having a plurality of grasping fingers extending from a distal end of the tubular body. The fingers radially extend from the tubular body at a first angle, and are collapsible therefrom to a second angle. The fingers have a distal tip configured for grasping an outer wall of the body vessel surrounding the vessel opening when the fingers are at the first angle. The sheath is slidable over the tubular body and at least a portion of the grasping fingers for collapsing the fingers from the first angle to the second angle, thereby causing the collapsed fingers to at least substantially close the opening.
In at least one embodiment of the present invention a balloon catheter is provided. The balloon catheter comprises a shaft having a lumen formed therethrough. Connected to the shaft is an inflatable balloon. The inflatable balloon has a balloon wall defining a balloon interior surface and a balloon exterior surface that is opposite the interior surface. In fluid communication with the balloon wall is the lumen for inflating the balloon to define an inflated state and for collapsing the balloon to define a deflated state. The balloon wall is textured in the deflated state such that the balloon interior surface is spatially registered with the balloon exterior surface. The balloon in the inflated state is tensioned to have a surface roughness substantially less than a surface roughness of the balloon in the deflated state.
Valve devices (10) useful in the treatment of various valve-related disorders and/or conditions are described. A valve device includes a leaflet (14) and a means (12) for biasing the leaflet in an open configuration. A method of making a valve device comprises the steps of determining a desired closing pressure; determining a desired opening pressure, selecting one or more valve leaflets; selecting an appropriate means for biasing the leaflet in an open configuration based on the determined closing and opening pressures; and attaching the one or more valve leaflets to the means for biasing the leaflet in an open configuration.
A hydraulic guidewire advancement system for enhancing access through lesions or occlusions in distal regions of a patient's vasculature includes a catheter comprising a sheath, a guidewire lumen, and a proximal catheter port connected to a hydraulic driver. A hydraulic guidewire is coaxially disposed through the guidewire lumen, the hydraulic guidewire comprising a piston movably disposed in the guidewire lumen, the piston forming a seal with an interior surface of the sheath. The hydraulic driver is configured to generate hydraulic pressure against the piston sufficient to advance or retract the hydraulic guidewire relative to the catheter. The hydraulic driver can apply positive or negative pressure to the piston, so as to repeatedly contact and break through the lesion with the distal end of the hydraulic guidewire.
A deployment assembly (10) for an introducer used for introducing into a patient a stent or other device, the deployment assembly including a housing 30 carrying a sprung loaded (90) actuator (44,50). The actuator includes a toothed wheel (50) carrying a spool (48) around which a retraction strap (44) can be wound. The strap (44) is coupled to a body member (26) of the introducer and through this to the outer sheath (14) thereof. A trigger (16) is provided for operating the actuator (44, 50). When the trigger (16) is pressed, the actuator winds, under the force produced by the spring (90), the strap (44) to thereby retract the outer sheath (14) so as to expose and then deploy the device carried on the introducer. The mechanism is such that a surgeon need not expend his own energy to retract the outer sheath (14) since this force is provided by the spring (90). Furthermore, the spring (90) acts in a plane other than that of the direction of retraction of the sheath (14), which minimises the risk of inadvertent movement of the introducer as the sheath (14) is being retracted.
A method of joining and/or sealing tissues in a surgical procedure or medical treatment, comprising the steps of: (1) applying a matrix protein, a photoactivatable metal-ligand complex and an electron acceptor to a tissue portion; (2) irradiating said tissue portion to photactivate the photoactivatable metal-ligand complex: thereby initiating a cross-linking reaction of the matrix protein to seal said tissue portion or join said tissue portion to an adjacent tissue portion.
A stent graft introducer (1) has a distally opening capsule (5) on a nose cone dilator (3) and a plug device (17; 53) in the capsule. The plug device (17; 53) is movable longitudinally within the capsule (5) to move to a distal end (7) of the capsule (5) to extend from the capsule (5) whereby to provide a smooth transition from the otherwise distal opening (7) of the capsule (5) to enable retraction of the nose cone dilator (3) through a deployed stent graft (35). The capsule (5) includes an in-turned distal end (7) and the plug device (17; 53) has a proximal shoulder (25) whereby to prevent the plug device (17; 53) from being completely withdrawn from the capsule (5). The plug device (17; 53) has a distal linearly tapered surface (27) or a distally facing bullet shaped surface (57). There can be an arrangement (72; 80) to prevent subsequent retraction of the plug device (53; 17).
A catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof. The device includes a wholly external wire guide structure secured to the tubular shaft by a figure-eight polymer sleeve.
A delivery assembly (10) for an implant (30) includes a release mechanism comprising a locking element (52) and a blocking member (56). The locking element (52) includes a latching pin (14) that engages with an eyelet (54) in the implant (30) to attach the implant (30) to a distal end of an inner catheter (36) of the deployment of the delivery assembly (10). The blocking member (56) prevents premature disengagement of the latching pin (14) from the implant (30). Withdrawal of the blocking member (56) allows disengagement of the latching pin (14) once the implant (30) has been correctly positioned within a patient's vasculature. The locking pin (52) and the blocking member (56) extend along the lumen of the inner catheter (36) from a handle (12) at the proximal end thereof, and are arranged such that a guide wire (34) is also able to extend through the lumen of the inner catheter (36). The locking pin (52) and the blocking member (56) preferably have a crescent-shaped transverse cross section. The release mechanism allows an implant (30) to be retrieved either during deployment of the implant (30) to allow the surgeon to correct any mislocation of the implant (30), or in order to remove a previously deployed temporary implant (30) from a patient.
A method of loading a medical device into a delivery system includes providing a two-stage shape memory alloy at a temperature at which at least a portion of the alloy includes austenite. A stress which is sufficient to form R-phase from at least a portion of the austenite is applied to the medical device at the temperature. A delivery configuration of the medical device is obtained, and the medical device is loaded into a restraining member. Preferably, the delivery configuration of the medical device includes stress-induced R-phase.
A61F 2/84 - Instruments specially adapted for their placement or removal
C22F 1/00 - Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
C22F 1/10 - Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of nickel or cobalt or alloys based thereon
The present disclosure describes an implantable branched vessel prosthesis, such as a prosthetic valve, having both a radially expandable annular portion and a laterally extendable branch portion. Methods of delivering the branched vessel prosthesis to a branched body vessel are also provided, as well as delivery systems comprising the branched vessel prosthesis. The branched vessel prostheses are useful, for example, as implantable prosthetic venous valves for treating venous valve insufficiency. The delivery system is configured to deploy independently both the annular portion within a primary vessel and the branch portion within a branch vessel with only one delivery system.
A stent-graft (100) is provided with a tightenable loop element (104) having a first end terminated in a slip knot or self-tightening knot (112) and a second end which is received in and can slide in the knot (112). The knot (112) is tied by a suture to the stent-graft (100) so as to be fixed thereto. The loop (104) is fitted to the stent-graft (100) in a manner as to pass between the inside to the outside of the graft material and in such a manner that controlled curvature of the stent-graft (100) is possible, in particular control of the overlapping of adjacent stents held within the zone of the loop (104). An introducer assembly is also disclosed which includes a control cannula (120) able to the fixed to the stent-graft (100) during the deployment procedure, as well as a mechanism of suture loops (150, 152) at the proximal end of the stent-graft (100) for retaining this in a constricted form during the process of curving the latter during the deployment process.
An apparatus for loading an expandable intraluminal medical device into a delivery device has a flexible main body with first and second rolled ends that enable the main body to alternatively adopt a substantially flat configuration that exposes a portion of the inner surface and a helical configuration that defines an interior chamber adapted to receive said expandable intraluminal medical device. An expandable intraluminal medical device is prepared for loading into a delivery device by placing the device on the main body of the loading apparatus while in the substantially flat configuration and then transforming the main body into the helical configuration. The medical device can then be compressed and forced out of the loading apparatus - and into a delivery device - by applying rotational and translational force to one end of the loading apparatus. Related kits and methods are also described.
An occlusion device (30) includes at least one self-expanding frame (42, 44) and graft material (46). Occlusion occurs by constricting the graft material (46) at a substantially central point or at an end of the device. The constriction is sized such that a guide wire (34) is able to pass therethrough. A valve mechanism (50) includes a screen (52) made from a resilient material and which includes a closable opening (54). The valve mechanism (50) allows a guide wire to pass through the occlusion device (30) whilst an effective physical barrier is maintained after removal of the guide wire (34).
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
59.
CUTTING BALLOON WITH CONNECTOR AND DILATION ELEMENT
A balloon catheter is provided that may be used to dilate hardened regions of a stenosis. The balloon catheter is provided with one or more dilation elements (130, 320) that extend along a surface of a balloon (140, 311). Each dilation element (130, 320) is connected to an outer surface (140, 311) of the balloon by a connector (120, 330). The connector (120, 330) is sufficiently sized and designed to undergo stress-induced plastic deformation incurred during blow molding so that a significant portion of each of the dilation elements (130, 320) does not become absorbed into the wall of the final blow molded balloon (150), thereby maintaining the structural integrity of each of the dilation elements (130, 320).
A stent structure (30) particularly for use in treating cerebral aneurysms is provided with a fibrous coating (34) which reduces the permeability of the underlying stent (32) to an extent that the flow through the stent structure is sufficiently suppressed to allow for resorbtion of an aneurysm while still providing sufficient flow through the stent structure to allow for flow into the perforator vessels. The fibrous coating may have different permeabilities in different zones of the underlying stent (32). The coating could be applied to other devices such as filters and occluders.
A fitting device (104) for fitting a stent-graft (100) into a lumen of a patient includes a catheter (110), a cannula (112) reciprocably carried in the catheter (110) and a pair of gripper claws (106) in the cannula (112). The gripper claws (106) grip onto a stent (102) at the proximal end (128) of the stent-graft (100) which a suture loop (108) is tied to a stent (102) at an intermediate position along the stent graft (100). The stent-graft (100) can be curved by pulling the end-most stent (102) backwards, that is by retracting the cannula (112) into the catheter (110) while the gripper claws (106) grip onto the stent (102). The proximal end of the stent-graft (100) can also be adjusted position-wise by moving the cannula (112) into and out of the catheter (110). Thus, precise positioning and curving of the stent-graft (100) can be achieved.
A coupling device (28) is formed of a double tubing (50) of a substantially non-porous membrane material, typically a conventional graft material, that is of inner and outer layers of membrane material (52, 54). The inner and outer layers (52, 54) are coupled by bridging rings (56, 58) which allow the layers (52, 54) to be spaced from one another in use. Attached to the inner and outer layers (52, 54) are first and second stents (60, 62). The stent (60) is located on the inside of the double tubing, while the stent (62) is located on the outside of the double tubing (50). The device (28) can expand in effect to 'bulge' and thus to fill the gaps to the vessel wall and to the stent-graft sections (24, 26). The device can provide reliable coupling of stent-grafts in vessels of varying diameter or in vessels inflicted with one or more aneurysms.
An introducer assembly for introducing a stent-graft (70) or other device into a vessel of a patient includes a pre-shaped curved cannula (60) made preferably of a shape memory material. The curved cannula can pull the proximal end (74) of the stent-graft (70) against the inner side wall of the vessel thereby to ensure a good leak free connection at this point. The assembly is particularly useful in deploying stent-grafts into the aortic arch.
A stent graft delivery arrangement for a stent graft (50) has a proximal end to be deployed into a patient in use and a distal end to remain outside the patient. The stent graft (50) is a tubular body of a biocompatible graft material with a plurality of self expanding stents (54). The stent graft is releasably retained onto the delivery device (132) towards the proximal end thereof. A curve forming arrangement (56) on the stent graft is arranged to curve a portion of the stent graft towards its proximal end. A pulling arrangement (58) extends along the delivery device. The pulling arrangement releasably engages the curve forming arrangement such that pulling on the pulling arrangement causes the a curve forming arrangement on the stent graft to form a curve in a portion of the stent graft towards the proximal end. The pulling arrangement can be subsequently released leaving the curve forming apparatus in place on the stent graft and the portion of the stent graft towards the proximal end thereof being laterally curved. The curve forming arrangement can comprise a suture thread. A gripping arrangement engages the suture thread between the second position and the third position to prevent re-extension of the suture thread after retraction thereof. The gripping arrangement can be a slip knot (107).
The disclosure relates to frames suitable for prosthetic implantable valves, and methods of treatment with such frames, to regulate blood flow and to be compliant in percutaneous delivery and, upon implantation, configured to conform to the changing shape of the body vessel or vein. The frames include at least one anchoring member attached to a support member at one or more attachments, and a valve member, preferably a monocuspid valve leaflet, attached to the support member. Preferred frames include two anchoring members with the support member in between the anchoring members. The support member preferably has a semielliptical shape and extends diagonally to sealingly contact the wall of the body vessel.
The present invention relates to an introduction catheter set for a collapsible self- expandable implant (1) into a blood vessel of a patient. Without being limited thereto the invention is concerned in particular with the introduction of collapsible self -expandable stents or filters of the type comprising a number of diverging legs to secure correct positioning of the implant when arranged in the blood vessel.
A stent graft (150) adapted to telescopically receive a secondary stent graft having an evertible, elastic socket (130) communicating with an opening in the stent graft. The socket comprises an elastic wall that forms a lumen with a stent at least partially encased within the wall. The socket may be adapted for use with stent grafts for implantantation in an aneurysm.
An implantable device (10) having a composite weave graft is disclosed. The device (10) comprises a graft body (12) forming a lumen (20) defining a longitudinal axis and comprising a proximal end (21) and a distal end (22). The graft body (12) comprises a composite of low dernier yarns and polymeric yarns configured for low profile delivery and radial elongation relative to the longitudinal axis during use. The graft body (12) has a first portion (40) and a second portion (42) extending from the first portion. The first portion (40) comprises at least one expandable stent (43) radially attached thereto for support and the second portion (42) has corrugations (46) for enhanced kink resistance.
A delivery system (20) for cannulating a limb (16) of a bifurcated device (10) includes a bifurcated prosthesis disposed on a delivery device and a snare catheter having a snare opening system (44). A sheath (22) is slidably disposed over at least a portion of the prosthesis and at least a portion of the snare catheter. One end of the snare catheter resides external to the prosthesis in the delivery system and the other end at least partially resides in a limb of the prosthesis. A snare mechanism (42) is disposed within the snare catheter that is capable of forming a loop (46) external to the snare catheter through the opening and snaring a guidewire (60) for placement in a limb of the prosthesis.
A radiopaque alloy based on titanium nickelide and having shape memory and superelastic properties includes, according to one embodiment, at least one radiopaque alloying element selected from the group consisting of gold, platinum, and palladium at a concentration of from about 10 at.% to about 20 at.%, and at least one additional alloying element selected from the group consisting of aluminum, chromium, cobalt, iron, and zirconium, where the additional alloying element has a concentration of from about 0.5 at.% to about 4 at.%. The alloy includes titanium at a concentration of from about 48 at.% to about 52 at.%, and the balance of the alloy is nickel. The radiopaque alloy preferably exhibits superelastic behavior suitable for medical device applications in the human body.
C22C 19/03 - Alloys based on nickel or cobalt based on nickel
C22F 1/10 - Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of nickel or cobalt or alloys based thereon
C22F 1/18 - High-melting or refractory metals or alloys based thereon
Drug coated stents for implantation in a body vessel are provided. A stent can include a plasma treatment on the luminal surface and a protein-adherence deterring layer on at least a portion of the luminal surface. A further embodiment includes a method of manufacturing a drug coated stent. Another further embodiment includes a method of treating a vascular condition with a drug coated stent.
An implantable graft device (10) having treated yarn (22, 23) is disclosed. The device comprises a graft body (12) forming a lumen (13) defining a longitudinal axis (14) and comprising proximal and distal ends (20, 21). The graft body (12) comprises a woven fabric having warp yarns (22) aligned in a first direction and a weft yarn (23) aligned in a second direction. At least one of the weft yarns (23) and the warp yarns (22) has an agent applied thereto defining treated yarns (22, 23) of the graft body (12).
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A deployment handle (112) for an implant deployment device (10) facilitates withdrawal of a sheath (18). The deployment handle (112) includes two separate actuators: a trigger (130) and a sliding actuator (330). The trigger (130) can be used to effect small step-wise movement of a carriage (120) that is connected to a sheath (18) to be withdrawn. The sliding actuator (330) can be used to effect continuous movement of a carriage (120) to withdraw a sheath (18). In order to transmit movement of either the trigger (130) or the sliding actuator (330) to the carriage (120), a flexible rack (380) is used. The flexible rack (380) includes upper teeth (390) and lower teeth (395) for engagement with the trigger (130) and the sliding actuator (330) respectively. The ability of the flexible rack (380) to bend back on itself means that unnecessary elongation of the deployment handle (112) is avoided.
A stent constructed from at least two individual monolithic stent units is provided. The stent includes at least two individual stent units. Each individual stent unit has, as a monolithic structure, a first strut, a second strut, and a third strut. A first apex adjoins the first and second struts, and a second apex adjoining the second and third struts, where the second apex is disposed in a direction generally opposite the first apex. The monolithic stent unit includes an attachment mechanism at the end of at least the first strut. The first strut of each monolithic stent unit is joined at an attachment point to the third strut of an adjacent monolithic stent unit. The attachment mechanism is bent to form an angle relative to the attachment point. A method of manufacturing the same stent also is provided.
A stent member for use in a medical procedure having opposing sets of curved apices, where the curved section of one set of apices has a radius of curvature that is greater than the curved section of the other set of apices.
An inner catheter (36) for use in an endoluminal delivery assembly (10) includes a stiffening element positioned at a transition between a hypotube (36a), a middle tube (36b) and a distal tube (36c) of the inner catheter (36) having different flexibilities. The stiffening element comprises three stiffening wires (42) embedded within the internal wall of the inner catheter (36) at their proximal ends. The stiffening wires (42) extend inwardly and distally to meet at an apex (60).
An introducer for use in the implantation and retrieval of a device in a patient includes a catheter (43) within which a stylet (14) is slidably carried, the stylet (14) being biased to a retracted position by a spring (35) and deployable by depression of an actuator (50). A locking device (40) locks the stylet (14) relative to the catheter (43) such that the locking device (40) must be disengaged prior to operation of the actuator (50). In the preferred embodiment, both the locking device (40) and the actuator (50) must be actuated by movement thereof in a direction substantially perpendicular to the direction of motion of the stylet (14). In an alternative embodiment, it is the catheter (43) which moves relative to the stylet (14).
Medical devices, as well as methods of treatment and manufacturing such devices, are provided for applying vascular therapy locally within the body vessel. The medical devices (10) include an expandable tubular frame (20) and a sleeve (60). The medical devices can be used for local delivery of a therapeutic agent within a body vessel or a tamponade for a lacerated body vessel, while simultaneously allowing perfusion of fluid or blood flow distal of the implanted medical device. The tubular frame of the medical device can have a middle region with a plurality of members (32). The members can expand radially outward away from a longitudinal axis of the tubular frame, which can urge the sleeve to contact the wall of the body vessel. In the expanded configuration, a portion of the device allows fluid flow to continue while the sleeve is against the body vessel wall.
A method of characterizing phase transformations of a shape memory material specimen entails recording data from the specimen during heating and cooling. The temperature of the specimen is changed in a first direction to a first temperature sufficient to define a first inflection and a second inflection in the data being recorded. The temperature of the specimen is changed in a second direction to a second temperature sufficient to define a third inflection in the data. The third inflection is formed by overlapping primary and secondary sub-inflections. The temperature of the specimen is changed in the first direction to a third temperature sufficient to define the first inflection but not sufficient to define the second inflection. The temperature of the specimen is then changed in the second direction to a fourth temperature sufficient to define the secondary sub-inflection in the data being recorded.
G01N 25/48 - Investigating or analysing materials by the use of thermal means by investigating the development of heat, i.e. calorimetry, e.g. by measuring specific heat, by measuring thermal conductivity on solution, sorption, or a chemical reaction not involving combustion or catalytic oxidation
80.
TAPERED LOADING SYSTEM FOR IMPLANTABLE MEDICAL DEVICES.
Loading systems for compressing and loading an implantable medical device into a device chamber of a medical device delivery system are described. The loading systems include an elongate holding chamber within which the intraluminal medical device is disposed. A plunger has one or more attached pushers adapted to axially advance the intraluminal medical device through an intermediate portion of the holding chamber that has a tapered surface, which compresses the intraluminal medical device over a dilator of a medical device delivery system that has been introduced through the distal end of the elongate holding chamber. The elongate holding chamber can be placed within an outer storage container with an appropriate seal to for storage of the intraluminal medical device within the loading system. Methods of preparing an intraluminal medical device for implantation in a patient and kits useful in such methods are also described.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A61F 2/84 - Instruments specially adapted for their placement or removal
81.
STORAGE AND LOADING SYSTEM FOR IMPLANTABLE MEDICAL DEVICES
Storage and loading systems (100) for expandable intraluminal medical devices (112) are described. The systems include a container (110) that defines an opening (156) that tapers from a relatively large first diameter to a relatively small second diameter. A neck region (122) includes structure adapted to engage an outer sheath of a delivery system such that an intraluminal medical device within the chamber of the container can be advanced through the tapered opening to effect compression of the intraluminal medical device and, ultimately, loading of the device into the delivery system. Methods of preparing and intraluminal medical device for implantation in a patient and kits useful in such methods are also described.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
The disclosure relates to medical devices coated with zein admixed with levulinic acid. The medical device may further include a therapeutic agent in contact with zein admixed with levulinic acid. Zein admixed with levulinic acid allows the therapeutic agent to be retained on the device during delivery and also controls the elution rate of the therapeutic agent following implantation. The disclosure further relates to methods of delivering a therapeutic agent on said medical devices as well as their use especially in the form of stents for prevention of restenosis.
The disclosure relates to support frames for prosthetic implantable valves, that may include a proximal annular member longitudinally spaced from a distal annular member and a plurality of longitudinal connecting members extending substantially parallel to a longitudinal axis from the proximal annular member to the distal annular member including a first member opposably positioned across the lumen from a circmferentially adjacent to the first member.
An intraluminal bypass prosthesis (150; 250) is described and includes a first prosthetic module (30; 60; 150a; 250a; 550a), a second prosthetic module (30; 60; 150b; 250b; 550b), and a third prosthetic module (30; 150c; 250c; 550c). The first and second prosthetic modules each have a first end (152a, 152b; 252a, 252b) and second ends (154a, 154b; 254a, 254b), and a fenestration (50; 70; 156a, 156b; 256a, 256b; 556a, 556b) disposed between the first and second ends. The third prosthetic module has a first end that is sealingly engageable within the first module fenestration and a second end that is sealingly engageable within the second module fenestration. The third prosthetic module has a lumen for providing fluid communication between the first and second prosthetic modules. Additional devices, systems, kits, and methods are described.
An implantable endoluminal prosthesis for replacing a damaged aortic valve is provided. In one embodiment, the prosthesis includes a balloon-expandable stent (204), a tubular conduit (206) that extends into the ascending aorta, and a self-expanding stent (208). The tubular conduit extends across the balloon-expandable stent (204). The tubular conduit includes an artificial valve (210). The self-expanding stent (208) extends across the tubular conduit into the ascending aorta. The balloon-expandable stent (204), the tubular conduit (206), and the self-expanding stent (208) are coupled to provide unidirectional flow of fluid into the aorta and further into the coronary arteries. Also described is a method of implanting the endoluminal prosthesis.
A stent introducer (100) has a delivery sheath (60) positioned to restrain a self expandable stent (30). A pull wire (50a; 50b) is connected with the delivery sheath and extends through a pull wire lumen (41a, 41b) to enable remote retraction of the delivery sheath. The distal end of the pull wire lumen is associated with a region of weakness in the structure such that the region of weakness is torn on retraction of the delivery sheath.
The haemostatic valve assembly (10) includes a housing (14) with a chamber (16) therewithin. A flexible valve element (26) is located in the chamber (16) and supported by the housing (14). A source (28) of pressurized fluid can be fed into the chamber (16) through a port (18) in the housing (14). A catheter, dilator, pusher or other elongate insert fed through the haemostatic valve assembly (10) can be sealed by the application of fluid pressure into the chamber (16), which causes the sides of the valve element (26) to press against the insert (24) thereby to provide an effective seal.
A flexible stent graft for deployment in a body vessel at a treatment site includes a tubular body, at least a first portion of which comprises a graft material and a coiled stent comprising a plurality of helical turns with spacings between the turns. The coiled stent is affixed to the graft material of the first portion. The first portion has a first portion diameter and the coiled stent has a helix diameter which is substantially the same as the first portion diameter. The coiled stent comprises a ratio of helical pitch to helix diameter of from about 1 :2 to about 1 :20, where the helical pitch is the spacing between adjacent turns of the coiled stent.
There is disclosed a tri-leaflet valve (100) in which the leaflets (102) extend for substantially the entire length of the valve (100). The valve (100) is provide with a waist (106). An element (16) inserted in the tri-leaflet valve (100) can be sealed by closure of the valve (100), for example by pressurization or twisting. The seal is more effective then prior art seals.
A stent graft delivery device (10) has an indwelling catheter (26) extending from a handle (12) through a pusher lumen and a stent graft lumen outside the guide wire catheter (32) of the delivery device towards the nose cone dilator (16). The indwelling catheter comprises a material able to transmit rotational and longitudinal movement (advancement and withdrawal) from the distal end to the proximal end thereof and a more flexible tip (24). The indwelling catheter facilitates catheterization of a branch artery.
Valve devices, methods of making valve devices, and methods of treating various venous-related conditions, disorders and/or diseases are described. In one embodiment, a valve device includes an expandable support frame and a bioprosthetic valve attached to the support frame. The bioprosthetic valve comprises a leaflet and a contiguous wall portion harvested from a multi-leaflet xenogeneic valve. The contiguous wall portion includes the attachment region where the leaflets attaches to the vessel wall and, in some embodiments, includes the natural margins of attachment between the leaflet and vessel wall.
Medical systems, devices and methods are provided for coupling a wire guide to a previously introduced wire guide in intracorporeal procedures, and generally include a supplemental wire guide and a tracking element. The tracking element defines a first passageway and a second passageway. The first passageway is sized to receive the previously introduced wire guide and the second passageway is sized to receive the supplemental wire guide. The supplemental wire guide is attached to the tracking element in a coupled configuration and detached from the tracking element in a decoupled configuration for independent translation of the supplemental wire guide.
The present invention provides a wire guide (20) suitable for use in a body vessel, such as a peripheral vessel. The wire guide comprises a core member (22) and a first coiled member (40), each having proximal and distal ends. In one embodiment, the core member comprises at least one recessed portion (36), wherein the proximal end of the first coiled member is seated at least partially within the recessed portion to form a substantially flush exterior surface with the core member. The wire guide further preferably comprises a second coiled member (50) having proximal and distal ends, wherein the second coiled member is disposed distal to the first coiled member. The distal end of the first coiled member may be partially intertwined with the proximal end of. the second coiled member. A shaping ribbon (60) may be disposed substantially beneath the second coiled member to achieve a desired curvature at the distal tip of the wire guide.
Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel. Preferably, the catheter balloon assemblies include a stiffening' member (210) within the proximal portion and/or a plurality of lumens lined with a fluorinated hydrocarbon to independently inflate the inner balloon, deliver the therapeutic agent through the outer balloon and house a wire guide (50). The catheter balloon assemblies may provide improved tractability and/or pushability characteristics.
Described are methods, devices, and systems for occluding or ablating vascular vessels. Noninvasive procedures can be used to occlude and obliterate the greater saphenous vein, for example in the treatment of varicose vein condition caused by venous valve insufficiency. Further described is the cooperative use of an angiogenic remodelable material with one or more sclerosing agents to cause closure of a targeted bodily vessel.
A61L 27/36 - Materials for prostheses or for coating prostheses containing ingredients of undetermined constitution or reaction products thereof
A61L 31/14 - Materials characterised by their function or physical properties
A61B 17/00 - Surgical instruments, devices or methods
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
There is disclosed a drug eluting balloon catheter assembly (10) provided with a balloon formed of an inner balloon member (30) of non- compliant material and an outer balloon member (32) of a compliant material and which is provided with holes therein for eluting a drug or other fluid. In use, the outer balloon member (32) is biased by contraction onto the inner balloon member thereby keeping the holes therein normally sealed closed and minimising dead space in the device.
A stent (100) or other implantable medical device is provided with one or more gripping shoulders (106) which are able, when the stent is compressed onto a delivery cannula (24) to frictionally mechanically engage the outer surface of the catheter (24) so as to grip thereon and maintatin the position of the stent (100) relative to the cannula during withdrawal of the covering sheath (32).
A catheter (100) for use in an endoluminal delivery assembly includes a device holding region or element (102) on which there is provided a plurality of flexible fingers (104) extending outwardly therefrom. The fingers act to maintain a device to be deployed in the correct position on the catheter and act to resist deformation of the device during deployment.
A device for occluding septal defects or other bodily passageways including PFOs, includes an occluding body formed from a plurality of flexible outwardly radiating occluding wires connected to one or more biocompatible sheet materials. The occluding wires are joined together at proximal wire ends. Linking members connectively link the occluding body to a flexible, substantially linear anchor formed from at least one tube, coil, or bar. The anchor is configured for placement on one side of bodily passageway, whereby the longitudinal axis of at least one anchor extends across a transverse cross-section of the bodily passageway, anchoring the occluding body in place against the other side of a bodily passageway to close, occlude, or fill at least a lumenal portion of a bodily passageway. The anchor may include one or more grasping member(s) integrally formed or connected to the tube, coil, or bar for releasable attachment to an anchor engaging member, such as a biopsy forceps. In a further aspect, a closure device assembly includes a delivery catheter housing a collapsibly disposed closure device linked to a biopsy forceps. The biopsy forceps may be positioned in a locking catheter, which is configured to prevent inadvertent release of the closure device when held in a compressed state inside the delivery catheter. By positioning the catheter near a bodily passageway, such as a PFO, and disengaging the anchor engaging member from the grasping member, the closure device may be released so as to facilitate stable closure of the bodily passageway.
A stent graft deployment device (10) has a tubular fixed handle (34, 36) to be gripped and held by a user and an elongate release handle (30) extending through the fixed handle so that the release handle can be moved through the fixed handle. The deployment device assembly has a pusher (38) and a sheath (18) to cover a stent graft (64) on the pusher. The pusher is connected to the fixed handle and the sheath is connected to the release handle so that retraction of the release handle through the fixed handle causes the sheath to be retracted from the stent graft on the pusher. The fixed handle includes a grip component (34) that grips the pusher and a rotator component (36) that grips a release clamp (48) on the pusher. The release clamp has trigger wires for the release of the stent graft attached to it. The rotator component has a screw thread (54) with a portion (52) of the release clamp engaged into the screw thread so that rotation of the rotator component causes longitudinal movement of the release clamp on the pusher which pulls the trigger wires.
