Abstract: A collapsible filter element (40) for a transcatheter embolic protection device (1). The filter element (40) comprises a collapsible filter body (41) which is movable between a collapsed stored position for movement through a vascular system and an expanded position for extension across a blood vessel such that blood passing through the blood vessel is delivered through the filter element (40). A proximal inlet portion of the filter body (41) has two inlet openings (50) sized to allow blood and embolic material enter the filter body (41), and a distal outlet portion of the filter body (41) has a plurality of small outlet openings (51) to allow through-passage of blood, but to retain embolic material within the filter body (41). The filter body (41) is of an oriented polymeric material.

Abstract: A catheter 1 suitable for advancement through a body passageway of a patient. The catheter 1 comprises a catheter body 4 which is flexible to provide the necessary trackability for the catheter 1 to advance through a body passageway, and two stainless steel reinforcement wires 5 extending along the catheter body 4 which provide the necessary pushability to advance the catheter 1 through the passageway. The reinforcements 5 are positioned diametrically opposed to one another by approximately 180 degrees on opposite sides of the longitudinal axis of the catheter 1, and the catheter body 4 is relatively soft and twistable. This configuration enables the entire catheter 1 to spontaneously twist during advancement so that the reinforcements 5 orientate themselves along a plane of neutral bending during advancement of the catheter 1. In this way, any resistance to the trackability of the catheter 1 due to the stiff reinforcements 5 is minimized.

Abstract: A collapsible filter element for a transcatheter embolic protection device comprises a collapsible filter body which is movable between a collapsed stored position for movement through a vascular system and an expanded position for extension across a blood vessel such that blood passing through the blood vessel is delivered through the filter element. A proximal inlet portion of the filter body has one or more inlet openings sized to allow blood and embolic material enter the filter body and a distal outlet portion of the filter body has a plurality of outlet openings sized to allow through-passage of blood, but to retain embolic material within the filter body. The filter body is at least partially of laminate construction comprising a membrane coated with a coating which is biocompatible, the thickness of the coating being from 4% to 40% of the thickness of the membrane. The coating may be of hydrophilic material.

Abstract: A device for removing a filter element from a retrieval catheter is provided. The device includes a core member which has a diameter corresponding to a filter element; a handle at a proximal end of the core member; and an engagement portion, formed at a distal end of the core member, for engaging the filter element. Alternatively, the device includes a first member including a core wire, a core wire handle; and an engagement portion, and a second member including a hypotube; and a hypotube handle, wherein the core wire is moveably disposed coaxially inside of the hypotube, such that when a distal end of the core wire handle is pressed against a proximal end of the hypotube handle, the engagement portion of the first member extends beyond a distal end of the hypotube. Alternatively, the device includes a partially cylindrical member, a handle; and at least one blade.

Abstract: An embolic protection device has a collapsible filter element (105) mounted on a carrier such as a guidewire (101). The filter element (105) collapses into the outer end of a catheter (118) for deployment and retrieval through a vascular system of a patient. The filter element (105) has a collapsible filter body with a proximal inlet end and a distal outlet end. The proximal inlet end has inlet openings sized to allow blood and embolic material enter the filter body. The outlet end has outlet openings which allow through passage of blood but retain embolic material within the filter body. After use, the catheter (118) is movable along the guidewire (101) to engage the proximal end of the filter element and close the inlet openings before sliding over the filter element from the proximal end to the distal end to progressively collapse the filter body on the guidewire (101) for retrieval.

Abstract: A catheter tip and a catheter system are provided. The catheter tip includes a shaft which comprises at least two segments at a distal end portion thereof, wherein the at least two segments define a reception space for receiving a filter element; an expandable tip body; and at least two tethers connecting the segments. The catheter system includes a guide catheter; and a retrieval catheter for insertion into the guide catheter, the retrieval catheter having a catheter tip including a shaft which comprises at least two segments at a distal end portion thereof, wherein the at least two segments define a reception space for receiving a filter element; an expandable tip body; and at least two tethers connecting the segments.

Abstract: An embolic filter device and method of manufacturing the same are provided. The method includes reducing a wall thickness of a tube in a central region between a proximal end portion and a distal end portion of the tube; cutting the proximal end portion of the tube to form an annular ring at a proximal end of the proximal end portion; cutting a plurality of slits in the central region; and expanding a portion of the tube between the annular ring and the distal end portion. The device includes a distal annular ring; a mesh connected to the distal annular ring; and a proximal annular ring connected to the mesh by at least two connecting portions.

Abstract: A medical guidewire (1) suitable for advancement through a vasculature comprises a core element (2) extending along the length of the guidewire (1), a first coil (6), and a distal end cap (7). The core element (2) comprises a proximal portion (3), an intermediate portion (4), and a distal portion (5). The distal portion (5) is plastically deformable to facilitate steering of the guidewire (1). The first coil (6) is located radially outwardly of the core element (2). The first coil (6) extends along the distal portion (5) and part of the intermediate portion (4).

Abstract: A removable retrieval tip for use with a catheter, a catheter tip, and a system for retrieval of an embolic filter device are provided. The removable retrieval tip includes a filter reception space for receiving a filter; and an interface portion for interfacing with the catheter. The catheter tip for receiving a removable retrieval tip includes a catheter body having an inside wall and an outside wall; an inflatable balloon disposed on the outside wall of the catheter body; and at least two indentations which are spaced from a distal end of the catheter tip and are formed in the inside wall of the catheter body. The system includes a catheter having a catheter tip at a distal end thereof, and a removable retrieval tip including a cylindrical body and an interface portion provided at a proximal end of the cylindrical body for interfacing with the catheter tip.

Abstract: A medical guidewire (1) suitable for advancement through a vasculature comprises a core element (2), a collar element (3), a distal outer element (4), a proximal outer element (5), and a distal end cap (6). The collar element (3) is fixedly attached to the core element (2) proximally of the distal end of the guidewire (1), and extends radially outwardly from the core element (2). The collar element (3) acts as a stop to limit distal movement of a medical device over the guidewire (1).

Abstract: A guidewire for use with an embolic protection filter and a method of deploying an embolic protection filter are provided. The guidewire includes a core wire; a core wire tip disposed at a distal end of the core wire; and a hypo shaft, coaxially disposed around the core wire, wherein the hypo shaft is moveable proximally and distally along the core wire with the core wire tip limiting a distal movement of the hypo shaft.

Abstract: A medical guidewire assembly comprises a guidewire having a flexible tip. A medical device such as a collaptible filter for use as an embolic protection device is mounted on the guidewire. The filter is advanced through a body lumen with the guidewire tip extending distally. At a first location the filter is advanced relative to the tip to a location which is distally advanced from the first location. Placement of the filter in an optimal distal location is thereby achieved.

Abstract: An embolic protection device has a collapsible filter element (105) mounted on a carrier such as a guidewire (101). The filter element (105) collapses into the outer end of a catheter (118) for deployment and retrieval through a vascular system of a patient. The filter element (105) has a collapsible filter body with a proximal inlet end and a distal outlet end. The proximal inlet end has inlet openings sized to allow blood and embolic material enter the filter body. The outlet end has outlet openings which allow through passage of blood but retain embolic material within the filter body. After use, the catheter (118) is movable along the guidewire (101) to engage the proximal end of the filter element and close the inlet openings before sliding over the filter element from the proximal end to the distal end to progressively collapse the filter body on the guidewire (101) for retrieval.

Abstract: An embolic protection device has a collapsible filter element (105) mounted on a carrier such as a guidewire (101). The filter element (105) collapses into the outer end of a catheter (118) for deployment and retrieval through a vascular system of a patient. The filter element (105) has a collapsible filter body with a proximal inlet end and a distal outlet end. The proximal inlet end has inlet openings sized to allow blood and embolic material enter the filter body. The outlet end has outlet openings which allow through passage of blood but retain embolic material within the filter body. After use, the catheter (118) is movable along the guidewire (101) to engage the proximal end of the filter element and close the inlet openings before sliding over the filter element from the proximal end to the distal end to progressively collapse the filter body on the guidewire (101) for retrieval.

Abstract: A medical guidewire assembly comprises a guidewire having a flexible tip. A medical device such as a collapsible filter for use as an embolic protection device is mounted on the guidewire. The filter is advanced through a body lumen with the guidewire tip extending distally. At a first location the filter is advanced relative to the tip to a location which is distally advanced from the first location. Placement of the filter in an optimal distal location is thereby achieved.

Abstract: A collapsible filter element for a transcatheter embolic protection device comprises a collapsible filter body which is movable between a collapsed stored position for movement through a vascular system and an expanded position for extension across a blood vessel such that blood passing through the blood vessel is delivered through the filter element. A proximal inlet portion of the filter body has one or more inlet openings sized to allow blood and embolic material enter the filter body and a distal outlet portion of the filter body has a plurality of outlet openings sized to allow through-passage of blood, but to retain embolic material within the filter body. The filter body is at least partially of laminate construction comprising a membrane coated with a coating which is biocompatible, the thickness of the coating being from 4% to 40% of the thickness of the membrane. The coating may be of hydrophilic material.

Abstract: A collapsible filter element (40) for a transcatheter embolic protection device (1). The filter element (40) comprises a collapsible filter body (41) which is movable between a collapsed stored position for movement through a vascular system and an expanded position for extension across a blood vessel such that blood passing through the blood vessel is delivered through the filter element (40). A proximal inlet portion of the filter body (41) has two inlet openings (50) sized to allow blood and embolic material enter the filter body (41), and a distal outlet portion of the filter body (41) has a plurality of small outlet openings (51) to allow through-passage of blood, but to retain embolic material within the filter body (41). The filter body (41) is of an oriented polymeric material.

Abstract: A retrieval catheter 1 for retrieval of an embolic protection filter from a vasculature. The catheter 1 comprises a proximal hypotube 3, a radially offset distal shaft 4 and a centering shank 9. A guidewire lumen 13 is provided through the shank 9 in communication with a larger guidewire lumen 7 through the shaft 4 for a continuous guidewire passageway to accommodate passage of a guidewire 21 through the shank 9, the shaft 4 and out through a proximal guidewire opening 6 to facilitate rapid exchange of the catheter 1 over a guidewire 21. The shank 9 is movable between an introduction configuration in which the shank 9 protrudes distally from the shaft 4 to centre the catheter 1 during advancement through a vasculature, and a retrieval configuration in which the shank 9 is located within the guidewire lumen 7 to facilitate retrieval of an embolic protection filter into the shaft 4.

Abstract: An embolic protection system 1 comprises a guidewire 99 for advancing through a vasculature, the guidewire 99 having a distal end and a proximal end; an embolic protection filter 1 having a filter body 41 with a distal end and a proximal end, the filter body 41 providing for a collapsed configuration and an expanded deployed configuration. The embolic protection filter body 41 has a guidewire path for slidably receiving the guidewire 99 to permit movement of the filter 1 relative to the guidewire 99 when the filter 1 is in the collapsed configuration and the expanded deployed configuration. A delivery catheter 2 is advanceable over the guidewire 99 for delivery of the embolic protection filter 1; the delivery catheter 2 having a proximal end and a distal end. The filter 1 is deployed from the distal end of the delivery catheter 2 into the expanded deployed configuration.

Abstract: A retrieval catheter 1 comprises a distal tubular sheath 2 with a reception space 5 into which an embolic protection filter 10 may be retrieved. An elongate connector 10 extends proximally from the sheath 2 to allow a clinician to control movement of the sheath 12. The sheath 2 is backloaded over a procedural catheter such as a balloon catheter 20, for example for post dilatation of a stent 55. The procedure is more efficient and procedure time is reduced because a catheter system is provided which allows a procedural step to be carried out and a filter 50 to be retrieved.