EMBOLIC PROTECTION BASKET APPARATUS

Abstract

The present invention provides an aortic embolic filter mounted on a catheter. A pair of spaced apart hubs are provided, one hub being a catheter hub mounted on the catheter, the other hub being a tip hub spaced distally of the catheter hub. A filter basket is attached to the hubs and positioned distally of the catheter hub. The basket includes multiple supports that each span the two hubs. A filter material/sheet is supported by the supports, the filter material having concave and convex surfaces, first and second edge portions, and an opening that spans most of the distance between the hubs and in between the filter material edge portions. One of the supports is movable relative to the catheter hub. An operator, controller or handle enables the movable support to change length between the hubs to put more or less of a curvature of the filter basket.

Claims

1. An aortic embolic filter apparatus, comprising: a) an elongated catheter having a length, proximal and distal end portions and a catheter lumen with a catheter central, longitudinal axis; b) a pair of spaced apart hubs, at least one said hub being a catheter hub mounted on the catheter, the other hub being a tip hub spaced distally of the catheter hub; c) a filter basket attached to the hubs and positioned distally of the catheter hub; d) the filter basket including multiple supports that each span from the catheter hub to the tip hub; e) a filter material that is supported by the supports, said filter material having concave and convex surfaces, first and second edge portions, and an opening that spans most of the distance between the hubs and in between the filter material first and second edge portions; f) one of the supports being a support that is movable relative to the catheter hub; and g) an operator that enables the movable support to change length between the hubs to put more or less of a curvature of the filter basket.

2. The aortic embolic filter apparatus of claim 1 wherein the supports are curved.

3. The aortic embolic filter apparatus of claim 1 wherein there are at least three fixed supports.

4. The aortic embolic filter apparatus of claim 1 wherein the movable support extends the full length of the catheter.

5. The aortic embolic filter apparatus of claim 1 wherein the apparatus includes a guidewire, each of the hubs having a hub opening and the guidewire extending through the hub openings.

6. The aortic embolic filter apparatus of claim 1 further comprising a control attached to the proximal end portion of the catheter, the control including a controller that moves the movable support.

7. The aortic embolic filter apparatus of claim 6 wherein the controller includes a rotatable knob.

8. The aortic embolic filter apparatus of claim 1 wherein each hub has sockets that are receptive of the supports.

9. The aortic embolic filter apparatus of claim 1 wherein the filter material includes ribs.

10. The aortic embolic filter apparatus of claim 1 wherein at least some of the supports have a generally rectangular cross section.

11. The aortic embolic filter apparatus of claim 1 wherein the movable support has a generally cylindrical cross section.

12. The aortic embolic filter apparatus of claim 1 further comprising a sheath sized and shaped to fit over the filter basket to define a collapsed storage position.

13. The aortic embolic filter apparatus of claim 1 wherein the filter material extends circumferentially about the catheter central longitudinal axis about one hundred eighty degrees.

14. The aortic embolic filter apparatus of claim 1 wherein at least one hub has a hub periphery and a hub opening spaced inwardly of said hub periphery.

15. The aortic embolic filter apparatus of claim 14 wherein the supports attach to the hub in between the hub opening and the hub periphery.

16. The aortic embolic filter apparatus of claim 15 wherein there are multiple sockets in between the hub opening and the hub periphery and the supports attach to the hub at the hub sockets.

17. An aortic embolic filter apparatus, comprising: a) an elongated catheter having a length, proximal and distal end portions and a catheter lumen with a catheter central, longitudinal axis; b) a catheter hub mounted on the catheter; c) a tip hub spaced distally of the catheter hub; d) a filter basket attached to the hubs and positioned distally of the catheter hub and proximally of the tip hub; e) the filter basket including multiple filter supports that each span from the catheter hub to the tip hub; f) a filter material that is supported by the filter supports; g) the filter basket having concave and convex surfaces, first and second edge portions, and a filter basket opening that spans most of the distance between the hubs and in between the filter material first and second edge portions; h) one of the supports being a movable support that is longitudinally movable relative to the catheter hub wherein the movable support slides relative to the catheter hub; and i) an operator that enables the movable support to change length between the hubs to put more or less of a curvature to the filter basket.

18. The aortic embolic filter apparatus of claim 17 wherein the supports have one or more curved sections.

19. The aortic embolic filter apparatus of claim 17 wherein there are three fixed supports.

20. The aortic embolic filter apparatus of claim 17 wherein the movable support extends the full length of the catheter.

21. The aortic embolic filter apparatus of claim 17 wherein the apparatus includes a guidewire, each of the hubs having a hub opening and the guidewire extends through the hub openings and catheter lumen.

22. The aortic embolic filter apparatus of claim 17 further comprising a control attached to the proximal end portion of the catheter, the control including a controller that enables movement of the movable support relative to the catheter hub.

23. The aortic embolic filter apparatus of claim 22 wherein the controller includes a rotatable member and wherein the movable support is wound upon the rotatable member.

24. The aortic embolic filter apparatus of claim 17 wherein each hub has sockets that are receptive of the supports.

25. The aortic embolic filter apparatus of claim 17 wherein the filter material includes transversely placed ribs.

26. The aortic embolic filter apparatus of claim 17 wherein at least some of the supports have a generally cross section that is not circular.

27. The aortic embolic filter apparatus of claim 17 wherein the movable support has a generally rounded cross section.

28. The aortic embolic filter apparatus of claim 17 further comprising a sheath that is sized and shaped to fit over the filter basket to define a collapsed storage position wherein the filter basket is inside the sheath.

29. The aortic embolic filter apparatus of claim 17 wherein the filter material extends circumferentially about the catheter central longitudinal axis less than 360 degrees.

30. The aortic embolic filter apparatus of claim 17 wherein at least one hub has a hub periphery and a hub opening spaced inwardly of said hub periphery.

31. The aortic embolic filter apparatus of claim 30 wherein multiple of the supports attach to the hub in between the hub opening and the hub periphery.

32. The aortic embolic filter apparatus of claim 15 wherein there are multiple sockets next to the hub opening and the supports attach to the hub at the hub sockets.

33. An aortic embolic filter apparatus, comprising: a) an elongated catheter having a length, proximal and distal end portions and a catheter lumen with a catheter central, longitudinal axis; b) a catheter hub mounted on the catheter, the catheter hub having an opening; c) a tip hub spaced distally of the catheter hub the tip hub having an opening; d) a guidewire that occupies the openings of the hubs; e) a filter basket attached to the hubs and positioned distally of the catheter hub and proximally of the tip hub; f) the filter basket including a supporting structure that spans from the catheter hub to the tip hub; g) a filter material that is supported by the supporting structure; h) the filter basket having concave and convex surfaces, first and second edge portions, and a filter basket opening that spans most of the distance between the hubs and in between the filter material first and second edge portions; i) a movable support that affixed to the tip hub and that is longitudinally movable relative to the catheter hub wherein the movable support slides relative to the catheter hub; and j) an operator that enables the movable support to change length between the hubs to thus change the shape of the filter basket.

34. The inventions substantially as shown and described herein.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0068] For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein:

[0069] FIG. 1 is a schematic diagram of a preferred embodiment of the apparatus of the present invention showing deployment in a patient's aorta with sheath, catheter, filter basket and guidewire in operative positions;

[0070] FIG. 2 is a side view of a preferred embodiment of the apparatus of the present invention;

[0071] FIG. 3 is a side view of a preferred embodiment of the apparatus of the present invention;

[0072] FIG. 4 is a side view of the handle/controller of a preferred embodiment of the apparatus of the present invention;

[0073] FIG. 5 is a partial perspective view of a preferred embodiment of the apparatus of the present invention;

[0074] FIG. 6 is a partial perspective view of a preferred embodiment of the apparatus of the present invention and showing an alternate filter basket arrangement;

[0075] FIG. 7 is a partial perspective view of a preferred embodiment of the apparatus of the present invention;

[0076] FIG. 8 is a partial perspective view of a preferred embodiment of the apparatus of the present invention and showing an alternate filter basket arrangement;

[0077] FIG. 9 is a partial perspective view of a preferred embodiment of the apparatus of the present invention;

[0078] FIG. 10 is a partial perspective view of a preferred embodiment of the apparatus of the present invention and showing an alternate filter basket arrangement;

[0079] FIG. 11 is a partial perspective view of a fixed basket support member of a preferred embodiment of the apparatus of the present invention;

[0080] FIG. 12 is a sectional view taken along lines A-A of FIG. 11;

[0081] FIG. 13 is a partial perspective view of a movable basket support member of a preferred embodiment of the apparatus of the present invention;

[0082] FIG. 14 is a sectional view taken along lines B-B of FIG. 13;

[0083] FIG. 15 is a fragmentary perspective view showing a hub of a preferred embodiment of the apparatus of the present invention;

[0084] FIG. 16 is an end view of the hub of FIG. 15;

[0085] FIG. 17 is a side view of the hub of FIG. 15; and

[0086] FIG. 18 is a partial sectional view of a preferred embodiment of the apparatus of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0087] FIG. 1 is a perspective view showing the apparatus 10 of the present invention after placement in a patient's heart 11, and more particularly in annulus 13 of aorta 12. A plurality of arteries 14, 15, 16 are shown discharging blood (indicated by arrows 67) from aorta 12. These arteries 14-16 include the brachiocephalic artery, carotid artery and left subclavian artery.

[0088] Embolic protection basket/catheter apparatus 10 includes catheter shaft 18 or polymeric tube having a catheter lumen 20. A distal end portion of catheter shaft 18 is connected to fitting or catheter hub or sprocket 24. Basket or filter 25 occupies a position in between fitting or catheter hub or sprocket 24 and distally located tip hub, hub, or fitting or tip 31. A plurality of supports spans between the fittings or hubs 24 and 31 (see FIGS. 1 and 5-10). These supports include a plurality of fixed supports 27, 28, 29 and an adjustable or movable support or arm 30. The fixed supports 27, 28, 29 can be seen in more detail in FIGS. 11-12. The movable or adjustable support 30 can be seen in more detail in FIGS. 13-14. Each of the fixed supports 27, 28, 29 can be of the same size and shape as shown in FIGS. 11-12. Each support 27, 28, 29 has ends or end portions 38, 39. End portion 38 has straight section 40 that connects with bend 42. Bend 42 connects with bend 43. End portion 39 has straight section 41 that connects with bend 44. Bend 44 connects with bend 45. Arch section 46 connects with bends 43, 45 as seen in FIG. 11. The cross section A-A of FIG. 11 is shown as FIG. 12. In FIG. 12, each support 27, 28, 29 has flat surfaces 34, 35 and edge surfaces 36, 37.

[0089] FIGS. 13-14 show the movable or adjustable support 30 in more detail. Support 30 has end portions 47, 48. Each end portion 47, 48 can have a straight section 49 or 50 in FIG. 13. Arch section 53 connects with bends 51, 52. Bend 51 connects with straight section 49. Bend 52 connects with straight section 50. Movable support 30 can have a generally cylindrical or circular cross section with outer surface 54 as shown in FIG. 14.

[0090] A sheet or expanse of filter material 26 is attached to the fixed supports 27, 28, 29 as seen in FIGS. 2-3 and 5-10. The configuration of sheet of material 26 can be changed by applying more or less tension to adjustable support 30. The movable or adjustable support 30 is fixedly attached to tip hub or distal tip fitting 31. A slidable connection is provided at fitting or sprocket or catheter hub 24 with adjustable support 30. The basket/catheter apparatus 10 has a basket or filter 25 at the distal end 56, a controller or handle 60 at the proximal end 55, and a flexible polymeric catheter or catheter shaft 18 connecting the two ends. The controller or handle 60 has a flush port 65 on top that allows for flushing the catheter lumen 20 with e.g., saline, heparin, contrast or other media. The controller/handle 60 has a guidewire/pigtail port 64 that allows for the guidewire/pigtail 23, 21 changes. Once the orientation of the filter or basket 25 position is achieved, rotating tension knob 62 on controller or handle 60 body 61 (see FIG. 4) increases the movable/adjustable support arm 30 tension. This increased tension on the movable/adjustable support arm 30 will help in keeping the filter/basket 25 in a curved position (e.g. see FIG. 1) during the procedure. For instance, increasing the tension on the adjustable/movable support arm 30 causes the filter/basket 25 to form an arc or curve that closely matches the aortic arch curve as seen in FIG. 1. A pigtail catheter 21 having lumen 22 can be advanced over the guidewire 23 wherein the guidewire 23 occupies the lumen 22. The pigtail catheter 21 is then placed in the left ventricular outflow tract (LVOT) or wherever desired.

[0091] The basket/catheter apparatus 10 has basket/filter 25 at a distal end portion 56, a controller or handle 60 at the proximal end portion 55, and a flexible polymeric catheter shaft 18 connecting to handle/controller 60 and to catheter hub, sprocket or fitting 24.

[0092] The basket/filter 25 can be constructed out of a plurality of shape-set supports or ribbons (see FIGS. 11-12) 27, 28, 29 (e.g., nitinol) and a movable or adjustable support, arm, or wire 30 (see FIGS. 13-14). The basket/filter 25 can have at least four of the ribbons, wires, arms or supports 27, 28, 29, 30. Three supports or arms 27, 28, 29 are fixed at both ends. One of the supports or arms 30 is fixed only at the distal end to fitting, hub or tip 31, and sliding at its other end relative to sprocket, catheter hub, fitting 24 allowing for basket/filter 25 size adjustments appropriately to the anatomy/procedure. Alternatively, the basket/filter 25 can be milled from e.g., a tube of nitinol and then covered with a sheet of filter material 26, 32 (see FIGS. 2, 3).

[0093] The fixed nitinol supports or arms 27, 28, 29 (see FIGS. 11, 12) are shape-set in the configuration out of preferably 0.002-0.010 inches (0.005-0.025 cm) by 0.010-0.060 inches (0.025-0.152 cm), more preferably, 0.003-0.007 inches (0.008-0.018 cm) by 0.030-0.050 inches (0.076-0.127 cm), and most preferably 0.005 inches by 0.020 inches (0.0127 cm by 0.0508 cm), nitinol support or ribbon (see FIGS. 11-12). The adjustable support or arm 30 (see FIGS. 5-10, 13, 14) is fixed only at the distal end to tip or fitting or hub 31 and is shape-set out of, for example, preferably 0.005-0.040 inch (0.013-0.102 cm) wire, more preferably 0.010-0.030 inch (0.025-0.076 cm) wire, and most preferably 0.020 inch (0.0508 cm) wire. All four supports or arms 27, 28, 29, 30 are fixedly secured at the distal end portion 56 to fitting, hub or tip 31 which can be made out of either polymeric material or metal. The nitinol supports or arms 27, 28, 29, 30 can be secured to the fitting, tip hub or tip 31 at sockets 71, 72, 73, 74 either by e.g., adhesive, welding, soldering or crimping. Each hub or fitting 24, 31 has a through hole in the middle for guidewire 23 of preferably 0.009-0.045 inches (0.023-0.114 cm) in diameter, more preferably 0.014-0.035 inches (0.0356-0.089 cm) in diameter, and most preferably 0.035 inches (0.0889 cm) in diameter to pass through for the initial placement of the basket/filter 25 in the patient's aorta 12.

[0094] A filter material or sheet of filter material 32 is secured to the three fixed filter supporting arms 27, 28, 29 by sewing, adhesives or by heat-sealing to itself. The filter material 32 can be made out of e.g., nylon fabric with thickness of preferably 5-200 μm, more preferably 25-150 μm, and most preferably for example around 84 μm and having mesh opening of preferably 10-200 μm, more preferably 50-175 μm, and most preferably 140 μm. The nitinol arms or supports 27, 28, 29, 30 are assembled with the filter material 32 to form a minimum deployed diameter of for example about 0.75 inches (1.905 cm). At the proximal end of the basket/filter 25, the arms 27, 28, 29, 30 are assembled using a hub, fitting or sprocket 24 with two exceptions: 1) at the catheter hub 24, the through hole 57 is large enough for a pigtail catheter to pass through; and 2) the movable or adjustable supporting arm 30 attaches to a securement hole 58 that is large enough for the arm 30 to slide freely relative to the catheter hub 24.

[0095] The fixed filter supporting arms 27, 28, 29 are secured at the proximal end or catheter hub 24 in similar fashion as at the tip hub 31, and these three arms 27, 28, 29 are terminated at this junction with catheter hub 24. The movable or adjustable supporting arm 30 is passed through the sprocket 24 opening 58 and terminated in the controller or handle 60 of the catheter 18. In FIGS. 15-17, there can be seen hubs 24, 31. Hubs 24, 31 can also be referred to as fittings or sprockets. Hubs 24, 31 can be similarly sized and shaped. Hub 31 is a distal or tip hub to which all supports 27, 28, 29, 30 are attached. In that regard, each hub 31 has sockets 68, 69, 70 that form a connection with end portions 38 of supports 27, 28, 29. Hub 31 has a cylindrical or rounded socket 71 that forms a connection with end portion 47 of movable support 30. Each of the supports 27, 28, 29, 30 is affixed or attached to tip or hub 31 using adhesive, welding soldering or crimping.

[0096] Only supports 27, 28, 29 are rigidly or fixedly attached to hub 24 (using e.g., adhesive, welding, soldering or crimping). Hub 24 has an opening at 58 that is large enough for movable support 30 to slide at opening 58 relative to hub 24. Hub 24 has central opening 57 that enables passage of guidewire 23 and pigtail catheter 21.

[0097] In order to better secure the filter material 32 and to make it collapse easily, small diameter wires 33 can be weaved through the filter material 32 like ribs. The ends of the ribs/wires 33 can be secured to the fixed filter supporting arms 27, 28, 29 using e.g., adhesive, solder or welds. Superelastic nitinol wires can be used for ribs 33, each preferably 0.001-0.010 inches (0.00254-0.0254 cm) in diameter, more preferably 0.002-0.008 inches (0.00508-0.02032 cm) in diameter, and most preferably about 0.003 inches (0.00762 cm) in diameter. The number and spacing of ribs 33 can vary. Typical spacing between the ribs 33 can be preferably 0.050-0.500 inches (0.127-1.270 cm), more preferably 0.100-0.300 inches (0.254-0.762 cm), and most preferably about 0.200 inches (0.508 cm).

[0098] The basket/filter 25 can be secured to a catheter polymeric shaft 18 either by heat fusing or by adhesives. A cross sectional view of the catheter assembly is shown in FIG. 18. The catheter shaft 18 can be e.g., an extruded polymeric tube having a bore or lumen 20. The polymeric shaft 18 could be reinforced with e.g., metal braids, monofilament or yarn to improve column strength and to improve kink resistance. Polymeric material can be used for the shaft 18 and can be e.g., Pebax, Nylon, PVDF (Polyvinylidene Fluoride) or Polyurethane.

[0099] The catheter shaft 18 connects to controller or handle 60 at the proximal end via a connector/strain relief 66. The catheter shaft 18 connects to the catheter hub 24 using UV curable adhesive, Cyanoacrylate adhesive or insert molding. The controller or handle 60 has a slider 63 on top for deploying and collapsing the basket/filter 25. A sheath 17 can be used to deploy the filter/basket 25. Sheath 17 initially holds basket/filter 25 in sheath lumen 19 as seen in FIGS. 2-3. Sheath 17 can be preferably a 5F-16F sheath and most preferably a 7F or 10F sheath. Sheath 17 is placed in the lumen 13 of a patient's aorta 12 over guidewire 23. Catheter 18 and basket/filter 25 are then introduced into the sheath 17 lumen 19 and over guidewire 23. The basket/filter 25 and catheter 21 are then tracked over guidewire 23 to the aortic arch region 59 (see FIG. 1) while viewing position under fluoroscopy.

[0100] Operator or slider 63 on handle or controller 60 body 61 deploys the filter/basket 25 pulling the sheath 17 to release and place the basket/filter 25 to the position in the aortic arch 59 seen in FIG. 1. Orientation of the filter/basket 25 position can be manipulated by rotating the catheter shaft 18 while the movable/adjustable support arm 30 is under minimal tension. Once the desired orientation of the filter/basket 25 is achieved, rotating knob 62 increases the movable support arm 30 tension. This increased tension on the movable support arm 30 keeps the filter/basket 25 in position during the procedure, filtering blood flow from the aorta 12 to the arteries 14, 15, 16 that discharge from the aorta 12 in the direction of arrows 67 (see FIG. 1).

[0101] Increasing the tension of the movable/adjustable support arm 30 enables a surgeon, technician or nurse to shape the filter/basket 25 to form an arc or curved shape that closely matches the aortic arch 59 curve. Pigtail catheter 21 having lumen 22 can be advanced over guidewire 23 (see FIGS. 1, 9-10 and 18). The pigtail catheter 21 can be then placed in the left ventricular outflow tract or other desired locale.

[0102] The present invention includes an aortic embolic filter apparatus 10, comprising: an elongated catheter 18; a pair of spaced apart hubs 24, 31; a filter basket 25 attached to the hubs 24, 31, wherein the filter basket 25 includes multiple supports 27, 28, 29, 30; and, a filter material 26 that is supported by the supports, wherein, one of the supports being a support that is movable 30 relative to the catheter hub 24, and wherein an operator 63 handle or controller 60 body 61 enables the movable support 30 to change length between the hubs 24, 31 to put more or less of a curvature of the filter basket 25.

[0103] In one embodiment, the fixed supports 27, 28, 29 are curved as shown in FIG. 11.

[0104] In one embodiment, there are at least three fixed supports 27, 28, 29 as shown in FIGS. 5-10.

[0105] In one embodiment, the movable support 30 extends the full length of the catheter 18.

[0106] In one embodiment, the apparatus 10 includes a guidewire 23 as shown in FIGS. 1, 7, and 8, and each of the hubs 24, 31 has a hub opening 57 and the guidewire 23 extending through the hub openings 57.

[0107] In one embodiment, the filter apparatus 10 further comprises a controller 60 attached to the proximal end portion 55 of the catheter 18, the controller 60 including an actuator 63 that moves the movable support 30. In another embodiment, the controller 60 includes a rotatable knob 62 as shown in FIG. 4.

[0108] In one embodiment, each hub 24, 31 has sockets 68, 69, 70, 72, 73, 74 that are receptive of the supports 27, 28, 29.

[0109] In one embodiment, the filter material 32 includes ribs 33 as shown in FIGS. 6, 8, and 10.

[0110] In one embodiment, at least some of the supports 27, 28, 29 for the filter material 26, 32 have a generally rectangular cross section as shown in FIG. 12.

[0111] In one embodiment, the movable support 30 has a generally cylindrical cross section as shown in FIG. 14.

[0112] In one embodiment, the filter apparatus 10 further comprises a sheath 19 sized and shaped to fit over the filter basket 25 to define a collapsed storage position as shown in FIGS. 2-3.

[0113] In one embodiment, the filter material 26, 32 extends circumferentially about the catheter 18 central longitudinal axis about one hundred eighty degrees.

[0114] In one embodiment, at least one hub 24, 31 has a hub periphery and a hub opening 57 spaced inwardly of said hub periphery. In this embodiment, the supports 27, 28, 29, 30 attach to the hub 24, 31 in between the hub opening 57 and the hub periphery. Additionally, there may be multiple sockets 68, 69, 70, 72, 73, 74 in between the hub opening 57 and the hub periphery and the fixed supports 27, 28, 29 attach to the hub 24, 31 at the hub sockets 68, 69, 70, 72, 73, 74.

[0115] The present invention also includes an aortic embolic filter apparatus 10, comprising: an elongated catheter 18; a catheter hub 24 mounted on the catheter 18; a tip hub 31 spaced distally of the catheter hub 24; a filter basket 25 attached to the hubs 24, 31 and positioned distally of the catheter hub 24 and proximally of the tip hub 31, the filter basket 25 including multiple filter supports 27, 28, 29, 30 that each span from the catheter hub 24 to the tip hub 31; a filter material 26, 32 that is supported by the filter supports 27, 28, 29, 30, wherein one of the supports is movable 30 relative to the catheter hub 24; and a controller 60 that enables the movable support 30 to change length between the hubs 24, 31 to put more or less of a curvature to the filter basket 25.

[0116] In one embodiment, the fixed supports 27, 28, 29 have one or more curved sections 42, 43, 44, 45, 46 as shown in FIG. 11.

[0117] In one embodiment, there are three fixed supports 27, 28, 29 as shown in FIGS. 5-10.

[0118] In one embodiment, the movable support 30 extends the full length of the catheter 18.

[0119] In one embodiment, the apparatus 10 includes a guidewire 23, each of the hubs 24, 31 having a hub opening 57 and the guidewire 23 extends through the hub openings 57 and catheter lumen 20 as shown in FIGS. 1 and 18.

[0120] In one embodiment, the filter apparatus 10 further comprises a controller 60 attached to the proximal end portion 55 of the catheter 18, the controller 60 including a slider 63 that enables movement of the movable support 30 relative to the catheter hub 24. In this embodiment, the controller may include a rotatable member 62 and wherein the movable support 30 is wound upon the rotatable member 62.

[0121] In one embodiment, each hub 24, 31 has openings or sockets 58, 68, 69, 70, 71, 72, 73, 74 that are receptive of the supports 27, 28, 29, 30 as shown in FIGS. 15 and 16.

[0122] In one embodiment, the filter material 32 includes transversely placed ribs 33 as shown in FIGS. 6, 8, and 10.

[0123] In one embodiment, at least some of the supports 27, 28, 29 have a generally cross section that is not circular as shown in FIG. 12.

[0124] In one embodiment, the movable support 30 has a generally rounded cross section as shown in FIG. 14.

[0125] In one embodiment, the filter apparatus 10 further comprises a sheath 19 that is sized and shaped to fit over the filter basket 25 to define a collapsed storage position wherein the filter basket 25 is inside the sheath 19 as shown in FIGS. 2-3.

[0126] In one embodiment, the filter material 26, 32 extends circumferentially about the catheter 18 central longitudinal axis less than 360 degrees.

[0127] In one embodiment, at least one hub 24, 31 has a hub periphery and a hub opening 57 spaced inwardly of said hub periphery. In this embodiment, multiple of the supports 27, 28, 29, 30 attach to the hub 24, 31 in between the hub opening 57 and the hub periphery as shown in FIGS. 15-16.

[0128] The following is a list of parts and materials suitable for use in the present invention:

PARTS LIST

[0129]

TABLE-US-00002 PART NUMBER DESCRIPTION 10 embolic protection basket apparatus 11 patient's heart 12 patient's aorta 13 aorta annulus/lumen 14 artery 15 artery 16 artery 17 sheath 18 catheter/polymeric shaft 19 sheath lumen 20 catheter lumen 21 pigtail catheter 22 pigtail catheter lumen 23 guidewire 24 sprocket/fitting/catheter hub 25 filter/basket 26 filter material/sheet 27 fixed support/arm 28 fixed support/arm 29 fixed support/arm 30 movable support/arm/wire 31 tip/fitting/tip hub/hub 32 filter material/sheet of material 33 rib/wire 34 surface 35 surface 36 edge 37 edge 38 end portion 39 end portion 40 straight section 41 straight section 42 bend 43 bend 44 bend 45 bend 46 bend/curved section/arch section 47 end portion 48 end portion 49 straight section 50 straight section 51 bend 52 bend 53 bend/curved section/arch section 54 outer surface 55 proximal end portion 56 distal end portion 57 hole/opening 58 hole/opening 59 aortic arch region/aortic arch 60 controller/handle 61 body 62 knob/rotating member 63 slider/sliding member/actuator/operator 64 guidewire/pigtail catheter port 65 flush port 66 connector/strain relief/interface 67 arrow 68 socket 69 socket 70 socket 71 socket 72 socket 73 socket 74 socket

[0130] All measurements disclosed herein are at standard temperature and pressure, at sea level on Earth, unless indicated otherwise. All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise.

[0131] The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.