Abstract: An introducer apparatus includes an outer sleeve and an inner cannula received within the lumen of the outer sleeve. The outer sleeve has a profile such that at least a portion of the distal end of the outer sleeve tapers in the distal direction at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus. The distal open end of the outer sleeve has a wall thickness not exceeding about 0.003 inch, and is sized such that a first wire guide is receivable therethrough. The inner cannula includes a tapered distal end portion. The inner cannula distal open end is sized such that a second wire guide is receivable therethrough, and the first wire guide is not receivable therethrough. The tapered distal portion of the inner cannula extends distal to the distal open end of the outer sleeve, such that a generally smooth diametrical transition is provided between the outer sleeve tapered portion and the open distal end of the inner cannula.

Abstract: An occluding device for occlusion within a body vessel is disclosed. The device comprises an expandable frame having an occluding portion disposed within a closure area of the frame. An anchoring component is attached to the frame to engage the body vessel. A coupling is attached to the frame for repositioning the device.

Abstract: A package for containing a medical device can have a bottom portion and inner and outer lids releasably sealed to the bottom portion. The bottom portion defines a cavity for receiving a medical device. A flange extends outward from sidewalls of the bottom portion and includes an inner flange portion and an outer flange portion. The inner flange portion can be recessed below the outer flange portion. The sealed inner lid permits sterilization of the cavity. The outer lid provides a moisture-resistant barrier to the package. A corner portion of the outer lid can extend past a corner of the bottom portion. Upon application of a withdrawing force sufficient to break the seals, the inner lid and the outer lid are together capable of being peeled from the bottom portion.

Abstract: In at least one embodiment, a hemostatic valve for use with a splittable introducer (10) is provided. The hemostatic valve (22) comprises a seal (24) molded in a first configuration of polymeric material and having two adjacent end surfaces (34,35). The seal is deformable from the first configuration into a second configuration. In the first configuration, the seal is substantially non-planer with the two adjacent end surfaces exposed. In the second configuration, the two adjacent end surfaces are unexposed so as to form a split extending through the seal.

Abstract: An introducer apparatus includes an outer sleeve and an inner cannula received within the lumen of the outer sleeve. The outer sleeve has a profile such that at least a portion of the distal end of the outer sleeve tapers in the distal direction at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus. The distal open end of the outer sleeve has a wall thickness not exceeding about 0.003 inch, and is sized such that a first wire guide is receivable therethrough. The inner cannula includes a tapered distal end portion. The inner cannula distal open end is sized such that a second wire guide is receivable therethrough, and the first wire guide is not receivable therethrough. The tapered distal portion of the inner cannula extends distal to the distal open end of the outer sleeve, such that a generally smooth diametrical transition is provided between the outer sleeve tapered portion and the open distal end of the inner cannula.

Abstract: 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.

Abstract: An introducer apparatus includes an outer sleeve and an inner cannula received within the lumen of the outer sleeve. The outer sleeve has a profile such that at least a portion of the distal end of the outer sleeve tapers in the distal direction at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus. The distal open end of the outer sleeve has a wall thickness not exceeding about 0.003 inch. The inner cannula includes a tapered distal end portion. The tapered distal portion of the inner cannula extends distal to the distal open end of the outer sleeve, such that a generally smooth diametrical transition is provided between the outer sleeve tapered portion and the open distal end of the inner cannula.

Abstract: 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.

Abstract: A medical introducer apparatus for use in inserting an interventional device into a body vessel of a patient. The apparatus includes a housing having a proximal opening, a distal opening, and a chamber positioned between the proximal and distal openings. A sheath, defining a conduit for the interventional device, extends distally from the housing distal opening. A hemostatic valve system is provided in the housing chamber. The valve system includes a plurality of generally elastomeric valve members axially arranged in the chamber. The valve members each have a generally circular hole extending therethrough, which hole is sized for substantially leak-free passage of the interventional device. The valve members are aligned in the chamber to be sequentially penetrable by the interventional device, such that the hole in one valve member is covered by an adjoining valve member.

Abstract: A device for removing thrombus from a body cavity is disclosed. The device comprises a flexible wire having a proximal end and a distal end. The device further comprises an elongated shaft having a proximal portion and a distal portion. The proximal portion attached to the distal end of the flexible wire and distally extends therefrom to the distal portion. The device further comprises an expandable member formed helically about the elongated shaft. The expandable member is configured to helically close, defining a collapsed state for delivery and retrieval of the device. The expandable member is configured to helically open, defining an expanded state for removing thrombus from the body cavity. The expandable member has at least one member portion helically extending from the elongated shaft at a predetermined angle, defining a proximally faced opening when the member is in the expanded state.

Abstract: A package for containing a medical device can have a bottom portion and inner and outer lids releasably sealed to the bottom portion. The bottom portion defines a cavity for receiving a medical device. A flange extends outward sidewalls of the bottom portion and includes an inner flange portion and an outer flange portion. The inner flange portion can be recessed below the outer flange portion. The sealed inner lid permits passage of sterilization. The outer lid provides a moisture-resistant barrier to the package. A corner portion of the outer lid can extend past a corner of the bottom portion. Upon application of a withdrawing force sufficient to break the seals, the inner lid and the outer lid are together capable of being peeled from the bottom portion.

Abstract: A package for containing a medical device can have a bottom portion and inner and outer lids releasably sealed to the bottom portion. The bottom portion defines a cavity for receiving a medical device. A flange extends outward sidewalls of the bottom portion and includes an inner flange portion and an outer flange portion. The inner flange portion can be recessed below the outer flange portion. The sealed inner lid permits passage of sterilization. The outer lid provides a moisture-resistant barrier to the package. A corner portion of the outer lid can extend past a corner of the bottom portion. Upon application of a withdrawing force sufficient to break the seals, the inner lid and the outer lid are together capable of being peeled from the bottom portion.

Abstract: In at least one embodiment of the present invention, an introducer for use in inserting a medical device into a body vessel of a patient is provided. The introducer comprises a housing having a proximal opening, a distal opening and a chamber extending therebetween. A seal in diaphragm form is disposed in the chamber. The seal is formed of polymeric material having a first phase transition temperature higher than about body temperature and a second phase transition temperature that is less than the first phase transition temperature but is greater than about room temperature. The seal is in a first configuration and has an opening formed therethrough when at about room temperature for advancing the medical device through the seal. The seal self-configures to a second configuration when at a temperature of at least the second phase transition temperature for obstructing the body fluid from flowing through the opening of the seal.

Abstract: In at least one embodiment of the present invention, a device for mixing and dispensing a bone cement mixture is provided. The device comprises an injector housing having a chamber for containing a first and a second bone cement component and a second housing having a chamber for containing a flexible wire mixing element. A plunger actuates within the chamber of the second housing to transfer the wire mixing element to the injector housing for mixing the first and second bone cement components to form the bone cement mixture. The plunger rotates the wire mixing element to mix the bone cement mixture. Thereafter, the wire mixing element is withdrawn from the injector housing and the injector housing is assembled with an injector handle. A plunger coupled to the injector handle advances through the injector chamber to dispense the bone cement mixture from the device.

Abstract: An introducer apparatus includes an outer sleeve and an inner cannula received within the lumen of the outer sleeve. The outer sleeve has a profile such that at least a portion of the distal end of the outer sleeve tapers in the distal direction at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus. The distal open end of the outer sleeve has a wall thickness not exceeding about 0.003 inch. The inner cannula includes a tapered distal end portion. The tapered distal portion of the inner cannula extends distal to the distal open end of the outer sleeve, such that a generally smooth diametrical transition is provided between the outer sleeve tapered portion and the open distal end of the inner cannula.

Abstract: An embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel is disclosed. The device comprises an elongated shaft having a proximal portion and a distal portion extending from the proximal portion. The device further comprises an expandable filter formed helically about the distal portion of the elongated shaft. The expandable filter is configured to helically close defining a collapsed state for delivery and retrievable of the device. The expandable filter is configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel. The expandable filter has at least one filter portion helically extending from the elongated shaft at a predetermined angle defining an opening when the filter is in the expanded state.

Abstract: A flow adapter has a housing, a connector disposed on the distal end of the housing, a valve member disposed within the housing, and a side port disposed on the housing. The housing has a first opening in a proximal end of the housing, a second opening in a distal end of the housing, and a passageway extending between the first and second openings. The first and second openings and the passageway are configured for the passage of an elongate medical device there through. The connector is in communication with the second opening and is configured for attachment to the medical introducer. The side port is fluidly connected to the passageway by one or more conduits extending along a side of the housing and the conduits are configured to direct the flushing fluid to a proximal portion of the passageway adjacent to the first opening.

Abstract: A device for capturing emboli during treatment of a stenotic lesion in a body vessel is disclosed. The device comprises a base having expanded and collapsed states, and proximal and distal portions. The distal portion has a support portion configured to deploy in the body vessel when the base is in the expanded state. The device further comprises a filter portion disposed on the distal portion of the base. The filter portion includes a lip extending to a filter body to a filter end. The filter portion is configured to engage the support portion when deployed to define an opening of the filter portion for capturing emboli. The device further comprises a collector through which the base is slideably disposed for delivery and retrieval of the device.

Abstract: A haemostatic valve device (10) comprises a disk valve (52a) having a valve body with a first surface facing in a first direction, a second surface facing in a second direction opposite the first direction, and an opening (58a) formed in the valve body for providing communication through the disk valve. In some examples, the disk valve comprises a nipple (60b), axially off-set from the opening, extending outwardly and away from at least one of the first and second surfaces. The haemostatic valve device may further comprise a second disk valve (52b) and the nipple (60b) may be removably disposed within, and sealingly engage, an opening (58b) of the second disk valve.

Abstract: An embolic protection device including a core wire and a basket is disclosed. The basket includes struts and a filter portion formed from a cannula. The struts extend from a first end of the basket to the second end of the basket. The filter portion extends from the struts and is formed unitarily therewith. The filter portion extends between a middle portion of the basket and the second end of the basket and includes openings in the cannula configured to allow the passage of blood cells therethrough.