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 openings. 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 a hole in one valve member is covered by an adjoining valve member. A valve opener having a tubular body with a curved portion penetrates the hemostatic valve system to aid in the positioning of the interventional device. The curved portion maintains the valve opener stationary within the valve system.

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: The disclosure provides apparatus and methods a flow adapter for use with a medical introducer. The flow adapter comprises 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 comprises 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 valve member disposed within the housing is configured to prevent the leakage of blood from the adapter. The side port disposed on the housing is configured to be attached to a source of flushing fluid.

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 apparatus and method for making an occlusion device for occluding a body vessel. The apparatus and method include providing a frame and a mandrel. The frame has a hub extending along a longitudinal axis from a proximal end to a distal end. A plurality of arcuate legs are attached to the hub and extend distally. The arcuate legs are flexible and have inner surfaces defining an inner profile in an unconstrained state. The mandrel has an outer surface corresponding to the inner profile of the occlusion device. A base layer of a biocompatible material is disposed on the outer surface of the mandrel. The frame is placed on the outer surface with the base layer between the frame and the mandrel. The frame is attached to the base layer such that the biocompatible material forms a membrane extending along and between the arcuate legs.

Abstract: A catheter assembly is provided with a flexible tubular body having two lumens. A solid slidable member with a sharp distal end is disposed within one of the lumens. The slidable member is capable of sliding within the lumen of the tubular body between an exposed position in which the sharp distal end of the slidable member protrudes from the distal end of the tubular body and a shielded position in which the distal end of the slidable member is within the tubular body. One advantage is that the sharp distal end of the slidable member may be withdrawn into the tubular body in order to shield a patient from unintentional cutting or irritation from the sharp distal end of the slidable member.

Abstract: A catheter assembly is provided with a flexible tubular body having two lumens. A solid slidable member with a sharp distal end is disposed within one of the lumens. The slidable member is capable of sliding within the lumen of the tubular body between an exposed position in which the sharp distal end of the slidable member protrudes from the distal end of the tubular body and a shielded position in which the distal end of the slidable member is within the tubular body. One advantage is that the sharp distal end of the slidable member may be withdrawn into the tubular body in order to shield a patient from unintentional cutting or irritation from the sharp distal end of the slidable member.

Abstract: The present invention is directed to apparatus and methods for gaining percutaneous access to body anatomy, for example an organ or a body lumen. According to one aspect of the invention, an apparatus is provided comprising a needle and an outer sheath. The needle is receivable within the outer sheath and comprises a plurality of outer diameters. A distal portion of the needle has a lesser diameter than a proximal portion of the needle. Other embodiments are also disclosed.

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: 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 expandable and retrievable device for treatment of a stenotic lesion in a body vessel is disclosed. The device comprises a tubular portion including a proximal end and a distal end extending from the proximal end. The tubular portion has a lumen formed therethrough between the proximal and distal ends. The device further comprises an expandable member formed helically about the tubular portion. The expandable member is configured to helically close, defining a collapsed state for delivery of the device. The expandable member is configured to helically open, defining an expanded state for treatment of the stenotic lesion in the body vessel. The expandable member has at least one filter portion that helically extends from the tubular portion at a predetermined angle. This defines a proximally faced opening when the expandable member is in the expanded state.

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 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 catheter assembly is provided with a flexible tubular body having two lumens. A solid slidable member with a sharp distal end is disposed within one of the lumens. The slidable member is capable of sliding within the lumen of the tubular body between an exposed position in which the sharp distal end of the slidable member protrudes from the distal end of the tubular body and a shielded position in which the distal end of the slidable member is within the tubular body. One advantage is that the sharp distal end of the slidable member may be withdrawn into the tubular body in order to shield a patient from unintentional cutting or irritation from the sharp distal end of the slidable member.

Abstract: An apparatus and method for making an occlusion device for occluding a body vessel. The apparatus and method include providing a frame and a mandrel. The frame has a hub extending along a longitudinal axis from a proximal end to a distal end. A plurality of arcuate legs are attached to the hub and extend distally. The arcuate legs are flexible and have inner surfaces defining an inner profile in an unconstrained state. The mandrel has an outer surface corresponding to the inner profile of the occlusion device. A base layer of a biocompatible material is disposed on the outer surface of the mandrel. The frame is placed on the outer surface with the base layer between the frame and the mandrel. The frame is attached to the base layer such that the biocompatible material forms a membrane extending along and between the arcuate legs.

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 openings. 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 a hole in one valve member is covered by an adjoining valve member. A valve opener having a tubular body with a curved portion penetrates the hemostatic valve system to aid in the positioning of the interventional device. The curved portion maintains the valve opener stationary within the valve system.

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: The present invention is directed to apparatus and methods for gaining percutaneous access to body anatomy, for example an organ or a body lumen. According to one aspect of the invention, an apparatus is provided comprising a needle and an outer sheath. The needle is receivable within the outer sheath and comprises a plurality of outer diameters. A distal portion of the needle has a lesser diameter than a proximal portion of the needle. Other embodiments are also disclosed.