Patent Publication Number: US-2012035650-A1

Title: Methods, systems, and devices for deploying a filter from a filter device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application is a continuation of U.S. application Ser. No. 11/206,617, filed Aug. 18, 2005, which is a continuation of U.S. application Ser. No. 10/186,255, filed Jun. 28, 2002, now U.S. Pat. No. 6,951,570, which claims priority to U.S. Provisional Patent Application Ser. No. 60/302,417, filed Jul. 2, 2001, U.S. Provisional Patent Application Ser. No. 60/345,333, filed Nov. 9, 2001, U.S. Provisional Patent Application Ser. No. 60/347,500, filed Jan. 11, 2002 and U.S. Provisional Patent Application Ser. No. 60/341,092, filed Dec. 12, 2001, the disclosures of which are herein incorporated by this reference. 
     Additionally, this patent application incorporates by reference the disclosure of co-pending patent applications entitled “Methods, Systems, and Devices for providing Embolic Protection and Removing Embolic Material,” U.S. patent application Ser. No. 10/186,275, “Methods, Systems, and Devices for Deploying an Embolic Protection Filter,” U.S. patent application Ser. No. 10/186,292, and “Methods, Systems, and Devices for Providing Embolic Protection,” U.S. patent application Ser. No. 10/186,304. 
    
    
     BACKGROUND OF THE INVENTION 
     1. The Field of the Invention 
     The present invention relates generally to the field of percutaneous medical filters, and more specifically, to vascular filter devices that are configured for percutaneous insertion into a blood vessel of a patient. 
     2. The Relevant Technology 
     Human blood vessels often become occluded or blocked by plaque, thrombi, other deposits, or material that reduce the blood carrying capacity of the vessel. Should the blockage occur at a critical place in the circulatory system, serious and permanent injury, and even death, can occur. To prevent this, some form of medical intervention is usually performed when significant occlusion is detected. 
     Several procedures are now used to open these stenosed or occluded blood vessels in a patient caused by the deposit of plaque or other material on the walls of the blood vessels. Angioplasty, for example, is a widely known procedure wherein an inflatable balloon is introduced into the occluded region. The balloon is inflated, dilating the occlusion, and thereby increasing the intraluminal diameter. 
     Another procedure is atherectomy. During atherectomy, a catheter is inserted into a narrowed artery to remove the matter occluding or narrowing the artery, i.e., fatty material. The catheter includes a rotating blade or cutter disposed in the tip thereof. Also located at the tip are an aperture and a balloon disposed on the opposite side of the catheter tip from the aperture. As the tip is placed in close proximity to the fatty material, the balloon is inflated to force the aperture into contact with the fatty material. When the blade is rotated, portions of the fatty material are shaved off and retained within the interior lumen of the catheter. This process is repeated until a sufficient amount of fatty material is removed and substantially normal blood flow is resumed. 
     In another procedure, stenosis within arteries and other blood vessels is treated by permanently or temporarily introducing a stent into the stenosed region to open the lumen of the vessel. The stent typically comprises a substantially cylindrical tube or mesh sleeve made from such materials as stainless steel or nitinol. The design of the material permits the diameter of the stent to be radially expanded, while still providing sufficient rigidity such that the stent maintains its shape once it has been enlarged to a desired size. 
     Unfortunately, such percutaneous interventional procedures, i.e., angioplasty, atherectomy, and stenting, often dislodge material from the vessel walls. This dislodged material can enter the bloodstream, and may be large enough to occlude smaller downstream vessels, potentially blocking blood flow to tissue. The resulting ischemia poses a serious threat to the health or life of a patient if the blockage occurs in critical tissue, such as the heart, lungs, kidneys, or brain, resulting in a stroke or infarction. 
     In general, existing devices and technology have a number of disadvantages including high profile, difficulty using multiple parts and components that result in an involved procedure, manufacturing complexity, and complex operation of the device or system. 
     BRIEF SUMMARY OF THE INVENTION 
     Embodiments of the present invention provide systems, methods, and devices for overcoming the above-referenced problems. More specifically, embodiments of the present invention include filter devices that have small, low, or no profiles, few parts and components, and are simple to manufacture and use. Consequently, embodiments of the present invention are able to be easily inserted into a patient, be steerable through the tortuous anatomy of a patient, provide filtering capabilities, have a sufficiently low profile to provide exchange capability so other medical devices can be advanced along the filter device, and be capable of removing the captured material without allowing such material to escape during filter retrieval. 
     According to one aspect of one embodiment of present invention, an illustrative embodiment of the present invention includes a vascular filter device. This device includes a guide member, such as a guidewire or hypo-tube having a lumen that extends from a distal end toward a proximal end thereof. Disposed within the lumen are one or more actuating members and a filter assembly. The one or more actuating members are coupled to an actuating mechanism at the proximal end of the guide member and are configured to deploy the filter assembly during a procedure, such as through movement of one or more actuating members. 
     The filter assembly includes a filter and a plurality of radially spaced-apart struts connected to a peripheral edge of a proximal end of the filter. The struts expand outwardly upon being deployed from the lumen of the guide member to place the peripheral edge of the proximal end of the filter adjacent to the wall of the vessel. 
     The filter includes a plurality of pores or holes that are so sized to capture material that may become detached during the procedure. The proximal end of the filter is configured to be constrained against the blood vessel within which the filter is disposed, while the distal end, in one embodiment, is configured to “float” within the blood flowing through the blood vessel and change shape to collect material and maintain the flow of blood through the vessel. 
     In one embodiment of the present invention, the filter device includes a number of radiopaque bands and/or markers affixed to a variety of positions on the device. These radiopaque bands and/or markers are one example of means for radiopacity, with various other means for radiopacity being known to those skilled in the art. 
     During use of the filter device of the present invention, blood flow will cause the filter to assume a parachute-like configuration such that material is collected within the interior of the filter. To remove the filter and the material, in one embodiment, the actuating member is moved in the proximal direction so that the proximal end of the filter cooperates with the distal end of the lumen through the guide member. Upon positioning the proximal end of the filter, a capture catheter is moved or advanced along the guide member until the catheter substantially encloses the filter. Following positioning of the capture catheter, the catheter and guide member are removed from the patient. 
     According to another embodiment of the present invention, a guide member includes a plurality of struts disposed at the distal end of the guide member. In one configuration, the distal end of the guide member is divided into a plurality of struts, at least two of which are biased to move outwardly. In another configuration, a strut assembly is coupled to the distal end of the guide member, with the strut assembly including one or more struts attached to the filter, while formed at a distal end of a third strut is a coil tip. This third strut is optionally biased toward the center of the lumen of the guide member. Before the filter is deployed, the filter is folded about the distal end of the guide member, folded about one or more of the plurality of struts, and/or is positioned within the lumen of the guide member. 
     To maintain the struts in the closed position, i.e., not extending outwardly from the remaining body of the guide member, a retaining member or mechanism cooperates with the guide member and/or struts and applies a restraining force to one or more of the struts. By moving the guide member relative to the restraining member, or vice versa, the distal ends of two or more of the biased struts are allowed to move outwardly to deploy the filter, i.e., the restraining force is released. 
     In another configuration, the restraining member or mechanism surrounds a tip of the guide member, including the struts and a part of the guide member. This restraining member or mechanism can be attached to the struts and is configured to apply a restraining force to the one or more struts. In one configuration, the restraining member or mechanism is configured to separate into a number of different sections to allow the distal ends of two or more of the biased struts to move outwardly to deploy the filter. In another embodiment, the restraining member or mechanism includes two or more actuating members that are attached to a location just proximal to the proximal end of each strut. The two or more actuating members extend to the distal end of the guide member, pass through apertures in the distal end of the restraining member or mechanism, and terminate within the lumen of the guide member after passing through holes formed in the guide member proximal to the proximal end of each strut. 
     To actuate the filter device, an actuating assembly at the proximal end of the guide member draws the actuating members in the proximal direction. Since one end of the actuating member is located at the proximal end of the restraining member or mechanism, whether forming part of the restraining member or mechanism, attached to the restraining member or mechanism, or attached to the guide member, pulling the actuating member in the proximal direction causes the actuating member to preferentially separate the restraining member or mechanism, thereby releasing the strut. 
     In another configuration, the restraining member or mechanism includes a plurality of apertures formed therein. The restraining member or mechanism has a first portion and a second portion with one or more of the plurality of apertures formed therein. The restraining member or mechanism further includes a securing member that passes through one or more of the plurality apertures to cause the first portion to be releasably connected to the second portion. The securing member passes through an aperture in the guide member and/or a strut assembly to pass into the end of the guide member and extend toward the proximal end. Upon moving the securing member in a proximal direction using one of a variety of different actuating mechanisms, a distal end of the securing member is removed from the apertures and the first and second both portions of the restraining member or mechanism. In this manner, the force applied to the struts to maintain a closed configuration, where the struts are retained or prevented from extending outwardly, is released from the struts, enabling them to deploy the filter. 
     In still another configuration, the restraining member or mechanism includes a securing member that is “sewn” through portions of the restraining member. In a similar manner to the configuration discussed above, the securing member can be removed from cooperating with the restraining member or mechanism to allow the struts to extend outwardly and deploy the filter. 
     In still another configuration, the restraining member or mechanism includes a plurality of channels. These channels are formed on both first and second ends of the filter in an offset configuration. The securing member can pass through one or more of the channels formed in the first side and the second side to maintain the first side in cooperative engagement with the second side. In this manner, the restraining member or mechanism applies a restraining force to the one or more struts and prevents them from extending outwardly. Upon moving the securing member in a proximal direction, a distal end of the securing member is removed from within the channels formed in the first side and second side, thereby releasing the restraining force applied by the restraining member or mechanism against the one or more struts. 
     In still another configuration, the restraining member or mechanism has the form of a sleeve that is adapted with one or more hoops formed therein. The wire forms a channel by maintaining a first set of hoops and second set of hoops in engagement using a securing member. By removing the securing member from engaging within one or more of the hoops, the first side and second side of the restraining member or mechanism can disengage with one another and release the restraining force that was applied to the one or more struts. In this manner, the struts are able to deploy the filter. 
     In yet another configuration, the restraining member or mechanism is combined with the one or more struts of the filter device. In such a configuration, two or more of the struts include tubular members adapted to receive a securing member. As the struts are brought towards each other, the lumens of the tubular members become aligned so that the securing member can pass therethrough to prevent the struts from extending outwardly or otherwise maintain the struts together or in close proximity one to another. 
     In still another configuration, the restraining member or mechanism is combined with the filter of the filter device. In this configuration, the filter includes at least one flap that is adapted to extend through the gap disposed between two struts. The flap(s) can be wrapped around the struts and secured to prevent the struts from extending outwardly. 
     These and other objects and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  illustrates an exemplary filter device according to one embodiment of the present invention. 
         FIG. 2  illustrates an exploded perspective view of an exemplary tip of the filter device of  FIG. 1 . 
         FIG. 3  illustrates a cross-sectional side view of the exemplary tip of the filter device of  FIG. 2 . 
         FIGS. 4A-4I  illustrates various cross-sectional side views of different exemplary configurations or embodiments of the tip of the filter device of  FIG. 2 . 
         FIG. 5  illustrates a cross-sectional side view of the tip of the filter device of  FIG. 2  with exemplary actuating member and filter assembly in a closed position. 
         FIG. 6   a  illustrates a cross-sectional side view of the tip of the filter device of  FIG. 2  with exemplary actuating member and filter assembly in an actuated position. 
         FIG. 6   b  illustrates one or more pores of the filter of the filter device of the present invention. 
         FIG. 7  illustrates a cross-sectional side view of the tip of the filter device of  FIG. 2  with exemplary actuating member and filter assembly in an actuated position and a portion of the filter filled with material. 
         FIG. 8  illustrates a cross-sectional side view of the tip of the filter device of  FIG. 2  with exemplary actuating member and filter assembly in a retracted position. 
         FIG. 9  illustrates a cross-sectional side view of an exemplary actuating assembly of the filter device of  FIG. 2 . 
         FIG. 10  illustrates a perspective view of one exemplary capture catheter adapted for use with the filter device of the present invention. 
         FIG. 11  illustrates a cross-sectional side view of the actuating member and filter assembly in a retracted position with the capture catheter in position surrounding the filter of the filter device of  FIG. 2 . 
         FIG. 12  illustrates a flow diagram of an exemplary method for using the filter device of  FIG. 2 . 
         FIG. 13  illustrates a portion of the vasculature of an individual within which the filter device of  FIG. 2  can be inserted. 
         FIG. 14  illustrates a lesion formed in the interior carotid artery of the individual of  FIG. 13 . 
         FIG. 15  illustrates one embodiment of the filter device of  FIG. 2  deployed in the interior carotid artery distal of the lesion of  FIG. 14 . 
         FIG. 16  illustrates one embodiment of the filter device of  FIG. 2  deployed in the interior carotid artery distal of the lesion of  FIG. 14  and a pre-dilation balloon. 
         FIG. 17  illustrates one embodiment of the filter device of  FIG. 2  deployed in the interior carotid artery distal of the lesion of  FIG. 14  and a stent located about the lesion. 
         FIG. 18  illustrates a partial cross-sectional side view of another embodiment of the filter device of the present invention. 
         FIG. 19  illustrates a cross-sectional side view of another exemplary actuating assembly of the filter device according to the present invention. 
         FIG. 20  illustrates a partial cross-sectional view of yet another embodiment of the filter device of the present invention. 
         FIG. 21  illustrates a side view of a tip of the filter device of  FIG. 20 . 
         FIG. 22  illustrates a side view of the embodiment of  FIG. 20  with the filter deployed. 
         FIG. 23  illustrates a side view of yet another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention. 
         FIG. 24  illustrates a side view of the embodiment of  FIG. 23  with the filter deployed. 
         FIG. 25  illustrates a cross-sectional side view of another exemplary actuating assembly of the filter device according to the present invention. 
         FIG. 26  illustrates a perspective view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention. 
         FIG. 27  illustrates a perspective view of the restraining member of  FIG. 26  before becoming coupled to the filter device according to another aspect of the present invention. 
         FIG. 28  illustrates a perspective view of the restraining member of  FIG. 26  before becoming coupled to the filter device according to another aspect of the present invention. 
         FIG. 29  illustrates a perspective view of another restraining member of the filter device according to another aspect of the present invention. 
         FIG. 30  illustrates a perspective view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention. 
         FIG. 31  illustrates a perspective view of the restraining member of  FIG. 30  before becoming coupled to the filter device according to another aspect of the present invention. 
         FIG. 32  illustrates a side view of the restraining member of  FIG. 30  before becoming coupled to the filter device according to another aspect of the present invention. 
         FIG. 33  illustrates a side view of the restraining member  FIG. 30  part way through restraining the filter device according to another aspect of the present invention. 
         FIG. 34  illustrates a side view of the restraining member  FIG. 30  as it restrains the filter device according to another aspect of the present invention. 
         FIG. 35  illustrates a perspective view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention. 
         FIG. 36  illustrates a perspective view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention. 
         FIG. 37  illustrates a side view of the restraining member of  FIG. 36  before becoming coupled to the filter device according to another aspect of the present invention. 
         FIG. 38  illustrates a side view of the restraining member of  FIG. 36  before becoming coupled to the filter device according to another aspect of the present invention. 
         FIG. 39  illustrates perspective view of the restraining member  FIG. 36  as it restrains the filter device according to another aspect of the present invention. 
         FIG. 40  illustrates a perspective side view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention. 
         FIG. 41  illustrates a perspective side view of the restraining member  FIG. 40  as it restrains the filter device according to another aspect of the present invention. 
         FIG. 42  illustrates a side view of another embodiment of a filter device according to another aspect of the present invention. 
         FIG. 43  illustrates a side view of yet another embodiment of a filter device according to another aspect of the present invention. 
         FIG. 44  illustrates a perspective view of another embodiment of a capture catheter used with the filter device of the present invention. 
         FIG. 45  illustrates a perspective view of yet another embodiment of a capture catheter used with the filter device of the present invention. 
         FIG. 46  illustrates a perspective view of still another embodiment of a capture catheter used with the filter device of the present invention. 
         FIG. 47  illustrates a side view of the capture catheter of  FIG. 46  as it begins to capture the filter device of the present invention. 
         FIG. 48  illustrates a side view of the capture catheter of  FIG. 46  as it captures the filter device of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention generally relates to percutaneous filter devices, systems, and methods of using the same. Embodiments of the present invention can be utilized in association with devices, systems, and methods for inserting a filter device, such as but not limited to a vascular filter device, within any blood vessel of a patient. 
     One or more of the embodiments of the filter devices of the present invention meet criteria for both guidewires and filter devices. For instance, it is preferable that a guidewire is steerable. Consequently, embodiments of the filter device of the present invention can be insertable within any blood vessel of a patient, such as but not limited to, coronary artery, carotid arteries, renal arteries, bypass grafts, superficial femoral artery, the arteries of the upper and lower extremities, or cerebral vasculature, and manipulated and steered by a physician to traverse the tortuous anatomy of the patient to a lesion or occlusion. 
     To assist the physician with the above-recited endeavor, one or more embodiments of the filter device include a shapeable, soft, distal tip. In addition, the filter device is capable of translating rotational movement or force applied to the proximal end thereof substantially equally to the distal end. In other words, with the filter device positioned within a vessel of the patient, as a physician rotates the proximal end of the filter device, the distal end of the filter device rotates substantially having a one-to-one torqueability. 
     Further, the filter device of the present invention is kink resistant and is capable of receiving a variety of different coatings to improve lubricity, have anti-thrombogenic properties, and/or reduce platelet aggregation. These coatings can include, but are not limited to, a hydrophilic coating, a heparinized coating, Teflon, silicone, or other coating known to those skilled in the art in light of the teaching contained herein. 
     With respect to the filter of the filter device of the present invention, in one embodiment, the filter is configured to capture material of a variety of sizes and enable removal of the captured material. Therefore, filter pore sizes and shapes can be selected based upon the size of material to be captured. The material can include but is not limited to, particulates, thrombi, any atherosclerosis or plaque material dislodged during a procedure, or other foreign material that may be introduced in to the vasculature of the patient. 
     Referring now to  FIG. 1 , depicted is one embodiment of a vascular filter device, designated by reference number  10 , of the present invention. As illustrated, filter device  10  includes a guide member  12  having a distal end  14  and a proximal end  16 . Extending between distal end  14  and proximal end  16  of guide member  12  is a lumen  18  within which is disposed an actuating member  40  and a filter assembly  42 . Distal end  14  of guide member  12  includes a tip  15  that is configured for percutaneous insertion into a blood vessel of a patient, while proximal end  16  is configured with or couples to an actuating assembly  20 . 
     In this configuration, filter device  10  is capable of being insertable into any blood vessel of a patient or body and function as a guidewire or exchange wire for other medical components or devices, such as but not limited to catheters, stents, balloons, atherectomy devices, or other components or devices that can be exchanged using a guidewire. Further, filter device  10  can be used to filter particulates, as will be described in more detail hereinafter, thereby acting or providing embolic protection during a procedure. 
     Illustratively, the term “guide member” can refer to a member that is completely solid, such as a guidewire, a member that partially includes a lumen therein, or a member that includes a lumen extending from a proximal end to a distal end thereof, such as a hypo-tube. Consequently, the term “guide member” can include or encompass a guidewire or a hypo-tube that is configured to perform the functions described herein, 
     Guide member  12  can be fabricated from a variety of materials. For example, guide member  12  can be fabricated from Nitinol, steel, metals, metal alloys, composites, plastic, polymer, synthetic materials, or combinations thereof. Further, guide member  12  can be covered with a variety of different coatings, such as but not limited to, coatings to improve lubricity or having anti-thrombogenic properties, reduce platelet aggregation, hydrophilic coatings, a heparinized coating, Teflon, silicone, or combinations thereof. 
     Illustratively, guide member  12  can have an outside diameter of between about 0.010 inches to about 0.035 inches, between about 0.014 inches to about 0.018 inches, or between about 0.010 inches to about 0.018 inches. In one configuration, the outside diameter of guide member  12  is about 0.014 inches. Similarly, the diameter of lumen  18  can range from about 0.004 inches to about 0.029 inches or between about 0.008 inches to about 0.014 inches. In one configuration, the diameter of lumen  18  is about 0.008 inches. 
     As illustrated in  FIGS. 2 and 3 , the exemplary distal end  14  of guide member  12  has a step configuration, with a step portion  22  of guide member  12  having a smaller diameter than other portions of guide member  12 . For ease of explanation, actuating member  40  and filter assembly  42  have been excluded from  FIGS. 2 and 3 . 
     The step portion  22  can have a variety of different configurations so long as it is adapted to couple with other portions of filter device  10 . For instance, step portion  22  can include multiple steps instead of a single step as illustrated in  FIG. 2 . Consequently, distal end  14  of guide member  12  could include a first step portion having a first outer diameter smaller than the outer diameter of the remaining portion of guide member  12  toward proximal end  16  thereof. Further, distal end  14  of guide member  12  could include a second step portion having a smaller outer diameter than the first outer diameter of the first portion. 
     Attached to step portion  22  of guide member  12  is a sheath  24 . Sheath  24  has a lumen  30  that extends between a distal end  26  and a proximal end  28  thereof A portion of distal end  26  is substantially co-planar with distal end  14  of guide member  12  when sheath  24  is connected to guide member  12 . Stated another way, a portion of distal end  14  of guide member  12  and distal end  26  of sheath  24  are contained within a plane that is substantially perpendicular to the longitudinal axis of lumen  18  of guide member  12  when sheath  24  is coupled, connected, or attached to guide member  12 . Although this is the case in one embodiment of the present invention, one skilled in the art can identify various other configurations where this need not be the case. For instance, in an alternate configuration, distal ends  14  and  26  are not co-planar. In another configuration, portions of distal ends  14  and  26  are co-planar. In still another configuration, at least one of distal ends  14  and  26  is angularly orientated relative to the longitudinal axis of lumen  18  or lumen  30 . 
     As illustrated in  FIG. 3 , distal end  26  of sheath  24 , either alone or in combination with distal end  14  of guide member  12  is atraumatic. In this manner, as filter device  10  is inserted within a blood vessel filter device  10  is able to slide along the interior surface of the blood vessel and is prevented from catching upon protrusions, i.e., lesions, occlusions, stenosis, or the like, during a procedure. One skilled in the art can identify a variety of different configurations of distal ends  14  and/or  26  to perform such a desired function. For instance, the curvature of distal end  14  of guide member  12  can be varied as long as the curvature allows filter device  10  to slide along the interior surface of the blood vessel without catching upon protrusions; the curvature can be based upon distal end  14  of guide member  12  and/or the distal end of sheath  24 . 
     Proximal end  28  of sheath  24  is configured to cooperate with a proximal end of step portion  22 . Proximal end  28  of sheath  24  and the proximal end of step portion  22  are substantially parallel one to another upon coupling, connecting, or attaching sheath  24  to step portion  22 . In another configuration, the proximal end of step portion  22  can include one or more raised portions within which one or more complementary recesses formed in proximal end  28  mate, or vice versa. In still another configuration, sheath  24  has a stepped configuration that allows matting with a complementary configured stepped proximal end of step portion  22 , such as when step portion includes multiple steps. Various other configurations are applicable to allow sheath  24  and the remainder of guide member  12  to couple, connect, or be attached one to another. 
     According to another aspect of one embodiment of the present invention, sheath  24  has an outside diameter substantially the same as the outer diameter of guide member  12 , while the diameter of lumen  30  is substantially the same as the outer diameter of step portion  22 . Consequently, when sheath  24  is coupled to guide member  12  at step portion  22 , guide member  12  has substantially the same outer diameter along its length. In other configurations, sheath  24  has a smaller or larger diameter than guide member  12 . 
     As illustrated, sheath  24  is configured to friction fit to step portion  22 . Consequently, the inner diameter of sheath  24  is configured to securely mount to step portion  22  upon slidable engagement of sheath  24  and step portion  22 . In other configurations, sheath  24  can be affixed to step portion  22  with an adhesive, such as but not limited to, any medical grade adhesive, UV curable adhesive, or other adhesive that cause sheath  24  to securely connect to step portion  22 . In still another configuration, sheath  24  can be press fit, soldered, mechanical attached, or coupled to guide member  12  using any other mechanism that causes sheath  24  to be securely connected to step portion  22 . In still other configurations, sheath  24  and step portion  22  have a key configuration where sheath  24  includes at least one key and step portion  22  includes at least one key way to receive the at least one key, or vice versa. 
     In general, sheath  24  can be fabricated from a variety of different materials and have a variety of different configurations. For example, sheath  24  can be fabricated from steel, titanium, platinum, metals, metal alloys, composites, plastics, polymers, synthetic materials, or combinations thereof Further, sheath  24  can include means for radiopacity. Additionally, sheath  24  can be fabricated from (i) a radiopaque substance, (ii) a non-radiopaque substance and coated with a radiopaque substance, or (iii) a non-radiopaque substance doped with a radiopaque substance. The radiopaque substances can include, but not limited to, barium sulphate, bismuth subcarbonate, titanium dioxide, combinations thereof, or other radiopaque substances. In still another configuration, sheath  24  can include one or more markers that have radiopaque characteristics. These markers can be fabricated from a radiopaque material, whether the material is radiopaque, a non-radiopaque material coated with a radiopaque material, or a non-radiopaque materials doped with a radiopaque material. Consequently, sheath  24  can include means for radiopacity, whether such means results from the materials forming sheath  24  or from attaching, coupling, or connecting markers, bands, or other indicators having radiopaque properties or characteristics. 
     Disposed over sheath  24  and optionally a portion of guide member  12  is cover  32 . Cover  32  is configured to seal and secure sheath  24  to guide member  12 . Consequently, cover  32  acts as a means for securing sheath  24  to guide member  12 . In one embodiment, cover  32  is a thin walled plastic heat shrink tubing or silicon tubing. In other configurations, interference fit or compression fit plastics, polymers, synthetic materials, or silicon can be used that need not be heat shrunk. In general, cover  32  can be a medical grade synthetic material. 
     According to another aspect of the present invention, distal end  14  of guide member  12 , distal end  26  of sheath  24 , and/or the distal end of cover  32  can be configured, collectively, to form a bullet nose or have a curved profile. This can be in addition to or alternatively from only distal end  14  of guide member  12  and/or distal end  26  of sheath  24  being curved or being atraumatic. 
     Collectively, distal end  14  of guide member  12 , sheath  24 , and cover  32  form tip  15  of filter device  10 . Although this is one configuration, one skilled in the art can appreciate that tip  15  can be formed solely from or any combination of guide member  12 , sheath  24 , and cover  32 . 
     To provide flexibility to tip  15  of filter device  10 , embodiments of the present invention may include one or more grooves  34  that extend entirely or partially through one or more of distal end  14  of guide member  12 , sheath  24 , and cover  32 , as illustrated in  FIGS. 4A-4I . The flexibility of tip  15  allows a physician or clinician to shape the tip and enable the guide member to be steered during a procedure. Consequently, the tip may maintain a level of resiliency so that a curvature defined by the physician or clinician is maintained during movement of the guide member through the tortuous anatomy of a patient. 
     The term “groove” includes one or more cuts or slits that partially or completely extend through a portion of filter device  10 , optionally including the sleeve and the securing member. Further, the term “groove” includes one or more cuts or slits that partially or completely surrounds a portion of filter device  10 , whether or not such one or more cuts or slits extend completely or partially through one or more of the guide member, the sleeve, or the securing member. 
     Each groove  34  can have a variety of different configurations, such as but not limited to straight, helical, geometric, or combinations thereof. For instance, a single groove  34  can extend around all or a portion of tip  15  and optionally extend into the remainder of filter device  10 . Further, any number of grooves  34  can be included in tip  15  of filter device  10  depending upon the degree of flexibility needed for a procedure. For example, the more grooves  34  included in tip  15  of filter device  10 , the greater the flexibility. Similarly, the depth of each groove  34  can vary depending upon the flexibility desired. For instance, the deeper grooves  34  the greater the flexibility of tip  15  of filter device  10 . Similarly, difference in the configuration of each groove  34  can affect the flexibility of tip  15  of filter device  10 . For instance, the steeper the sides of grooves  34 , the less flexibility of tip  15 . 
     As illustrated in  FIGS. 4A-4I , grooves  34  can be disposed along the longitudinal length of tip  15  of filter device  10  equally, gradually, continuously, periodically, or combinations thereof For instance, as shown in  FIG. 4A , tip  15  includes a single helical groove  34  that has an equal pitch along the length of tip  15 , while  FIG. 4B  depicts a single helical groove  34  that has a gradually increasing pitch along the length of tip  15 . Although not shown, it can be understood that tip  15  can include a single helical groove  34  that has a gradually decreasing pitch along the length of tip  15  from the proximal end to the distal end thereof. 
     As shown in  FIG. 4C , tip  15  can have a plurality of individual grooves  34  disposed along the length of tip  15 . It can be understood that each groove  34  need not encircle tip  15  of guide member  12 ; rather, each groove  34  can partially encircle tip  15  of guide member  12 , as depicted illustratively in  FIG. 4D . 
       FIG. 4E  depicts a configuration of tip  15  where groupings of grooves  34 , whether straight, helical, or geometric, are disposed at different portions of tip  15 . 
       FIG. 4F  depicts a configuration where grooves  34  are large and have shallow sides, i.e., the angle between the axis of the groove that passes through the apex of the groove and the side of the groove is large. In the alternative, each groove  34  can be small and have steep sides, i.e., the angle between the axis of the groove that passes through the apex of the groove and the side of the groove is small. 
       FIG. 4G  illustrates a configuration of tip  15  of filter device  10  where the pitch between adjacent grooves is increasing from the proximal end to the distal end of tip  15  and the depth of each groove  34  varies, i.e., each groove  34  need not extend the entire depth of tip  15  of filter device  10 . 
       FIG. 4H  illustrates a configuration of tip  15  of filter device  10  wherein grooves  34  are straight and extend into lumen  18 , while  FIG. 4I  illustrates a configuration where grooves  34  are helical and extend from the exterior of tip  15  to lumen  18 . 
     The above described configurations of the grooves with tip  15  of filter device  10  are only illustrative and should not be considered as limiting the applicability of other configurations as known by one skilled in the art in light of the teaching contained herein. For instance, grooves  34  can pass through securing member  32 , sleeve  24 , and terminate in guide member  12 , can pass through sleeve  24  and terminate in guide member  12 , be contained solely in guide member  12 , combinations thereof, or the like. 
     Generally, grooves  34  can be formed in tip  15  of filter device  10  using a variety of different techniques, such as but not limited to, micro-machining, grinding, etching, laser cutting, abrasive water jet, electrical discharge machine, or the like. Further, grooves  34  can have a pitch of between about 0.015 inches to about 0.100 inches, from about 0.020 inches to about 0.060 inches, or from about 0.025 inches to about 0.050 inches. 
     Referring now to  FIG. 5 , depicted is a partial cross-sectional view of a lumen  18  of guide member  12 . Disposed within lumen  18  of guide member  12  are an actuating member  40  and a filter assembly  42 . Actuating member  40  forms part of actuating assembly  20  and is adapted to deploy and partially or completely retract filter assembly  42 . Additionally, actuating member  40  provides structural support to filter device  10  and assists with preventing kinking of filter device  10 . 
     The actuating member  40  extends toward a proximal end  16  of filter device  10 . As illustrated, the distal end of actuating member  40  includes a head  44 . Head  44  has a generally cylindrical form and is configured to create a seal between actuating member  40  and the interior walls of lumen  18 . In other embodiments of the present invention, the remainder of actuating member  40  is configured to create a seal between actuating member  40  and the interior walls of lumen  18 . Alternatively, actuating member  40  and head  44  are not configured to create a seal with the interior walls of lumen  18 , rather a separate seal, such as but not limited to, one or more O-rings, quad-rings, V-rings, gaskets, combinations thereof or other structure capable of creating a seals is mounted to head  44  to create a seal between the interior wall of lumen  18  and head  44 . 
     The head  44  of actuating member  40  cooperates or engages with filter assembly  42  and forces filter assembly  42  from the distal end of lumen  18  as actuating member  40  is moved during a procedure. By so doing, a filter  50  of filter assembly  42  is deployed to collect material. Further, head  44  can be moved within lumen  18  by actuating member  40  to retrieve filter assembly  42 , thereby aiding with removal of the collected material subsequent to a procedure or to allow for repositioning of filter  50  of filter assembly  42 . The head  44  and actuating member  40  can have various other configurations so long as actuating member  40  is capable of deploying and retrieving filter assembly  42 . For instance, in another configuration, actuating member  40  can be devoid of head  44  and be formed from a plurality of wires, strands, or members that are braided together, connected to, or formed as part of filter assembly  42 . 
     Actuating member  40  and head  44  can be fabricated from a variety of different materials, such as but not limited to, stainless steel, tungsten, titanium, platinum, Nitinol, other metals, alloys thereof, composites, plastics, polymers, synthetic materials, D or combinations thereof. 
     Referring now to  FIGS. 6   a  and  6   b , depicted is filter assembly  42  in a deployed position following movement of actuating member  40  in the distal direction. As illustrated, filter assembly  42  includes filter  50  and a plurality of radially spaced-apart struts  52  extending from filter  50  to head  44  of actuating member  40 . Filter  50  has a distal end  54  separated from a proximal end  58  by an intermediate portion  56 . A peripheral edge of proximal end  58  is secured to struts  52  to form an opening  60  that allows material to flow into filter  50 , while distal end  54  is closed to prevent material from escaping or exiting from filter  50 . 
     Although in one configuration filter is hemispherical, it can be understood that filter  50  can be a variety of configurations, such as but not limited to, hemispherical, conical, cylindrical, combinations thereof, or any other configuration that allows for material to be collected therein, while the opening of the filter substantially extends to the peripheral surface of the blood vessel within which the filter is disposed. More generally, filter  50  can have any configuration so long as proximal end  58  has an opening that allows material to flow into filter  50  and distal end  54  is closed to prevent material from escaping or exiting from filter  50 . 
     Intermediate portion  56  and distal end  54  are free to float in the blood flow or stream within the blood vessel, while proximal end  58  is in a fixed relationship with actuating member  40  through struts  52 . By allowing intermediate portion  56  and distal end  54  of filter  50  to float, as filter collects material, such as illustrated in  FIG. 7 , the material creates drag on filter  50  so that the shape of filter  50  changes, while maintaining substantially the same volume as when deployed. Consequently, blood can continue to flow through portions of intermediate portion  56  as distal end  54  continues to fill with material, as indicated by arrows A and B in  FIG. 7 . In this manner, material can be collected as blood flow is maintained through filter  50 . 
     Filter  50  can be fabricated from a variety of different materials, such as but not limited to, a woven or braided plastic or metallic mesh, a perforated polymer film, a Nitinol mesh, combinations thereof, or other material that is capable of capturing material within flowing blood, while allowing the blood to flow through the pores or apertures thereof Generally, filter  50  can be fabricated from a variety of materials so long as filter  50  is capable of being packed within lumen  18 , floating in the blood flow or stream passing through the blood vessel within which it is inserted, and is bio-compatible. 
     Filter  50  can have a variety of differently sized pores  51  ranging from about 50 microns to about 200 microns, from about 60 microns to about 180 microns, or from about 75 microns to about 150 microns. For instance, as illustrated in  FIG. 6   b , pores  51  can have a variety of different configurations, such as but not limited to circular, oval, polygonal, combinations thereof or other configurations known to one skilled in the art in light of the teaching contained herein. In one configuration, therefore, filter  50  can includes pores that are differently sized and configured. Consequently, a major or minor axis of each pore can have a variety of different sizes ranging from about 50 microns to about 200 microns, from about 60 microns to about 180 microns, or from about 75 microns to about 150 microns. Generally, the pore size can vary as needed, so long as the pores are sized so that the pores do not compromise blood flow through the filter, i.e., prevent blood flowing through the filter, and collect material that could potentially occlude smaller downstream vessels, potentially blocking blood flow to tissue or result in stroke or infarction. 
     In addition to the above, filter  50  can be coated with a hydrophilic coating, a heparinized coating, Teflon, silicone, combinations thereof, or various other coatings as know or desired by one skilled in the art in light of the teaching contained herein. 
     Referring again to  FIG. 6   a , connecting filter  50  to head  44 , and optionally directly to actuating member  40 , are struts  52 . As illustrated, the distal ends of struts  52  are connected at radially spaced-apart locations about the peripheral edge of proximal end  58  of filter  50 . The struts  52  attach to filter  50  on the exterior of filter  50 , on the interior of filter  50 , along the edge of filter  50 , through filter  50 , or combinations of one or more of the above. The struts  52  can be attached to filter  50  and/or actuating member  40  by medical grade adhesives, such as but not limited to, ultra violet curable adhesives, acrylics, cyanoacrylates, solvent bonding, radio frequency or ultrasonic bonding, or some other manner to securely connect the distal end of one or more struts  52  to filter  50 . Alternatively, struts  52  can be thermally bonded to filter  50  and/or actuating member  40 , such as when struts  52  are fabricated from a material allowing such thermal bonding. In another configuration, struts  52  are woven into filter  50  or are distally formed with hooks or loops that are can be used to attach struts  52  to filter  50 . In still another configuration, struts  52  can be lengthened strands of filter  50  that extend from filter  50  to actuating member  40 . In still another configuration, struts  52  are extensions or strands of actuating member  40 , such as when actuating member  40  is a braided wire, a slit tube, or other member that is capable of performing the functions described herein with respect to actuating member  40 . In still another configuration, struts  52  are extensions of filter  50  that extend to head  44  and connect thereto. 
     As illustrated, each strut  52  is formed from Nitinol, stainless steel, metals, alloys, composites, plastics, polymers, synthetic materials, combinations thereof, or other materials that allow struts to perform one or more of the functions described herein. Each strut  52  can have a generally curved distal portion  62  and may be biased to extend radially outward when filter  52  is to be deployed. In this manner, distal portion  62  is in close proximity to the wall of the blood vessel within which filter device  10  is inserted when deployed. The struts  52  extend the edge of proximal end  58  of filter  50  into contact with the wall of the blood vessel. By so doing, the proximal end  58  of filter  50  can contact a substantial portion of the wall of the blood vessel and accommodate for variations in the profile of the wall. 
     Although, reference is made to the edge of proximal end  58  contacting the blood vessel, other configurations of the present invention locate the edge of proximal end  58  adjacent to, in close proximity to, juxtaposed, or contiguous with the wall of the blood vessel. This can be the case, so long as material can be captured through opening  60  and material is not captured between the outer surface of filter  50  and the wall of the blood vessel within which filter device  10  is inserted. 
     Referring now to  FIG. 8 , depicted is filter  50  in the captured or retrieved position. When actuating member  40  is moved in the proximal direction, opening  60  of filter  50  is drawn toward distal end  14  of guide member  12 . As actuating member  40  is moved in the proximal direction, the interior wall of lumen  18  forces struts  52  inwardly. Simultaneously, distal end  62  of each strut  52  moves inwardly to close opening  60 . This simultaneous motion prevents material trapped within the interior of filter  50  from escaping. Opening  60  can alternatively be substantially completely closed following the initial movement of actuator member  40  in the proximal direction. In still another configuration, opening  60  can be partially closed as actuator member  40  is moved in the proximal direction and gradually becomes substantially completely closed upon a substantial portion of struts  52  being retracted into lumen  18  of filter device  10 . In still another configuration, opening  60  can be substantially completely closed upon a portion of struts  52  being retracted into lumen  18  of filter device  10 . 
     To move actuating member  40  in the proximal direction and/or distal direction filter device  10  includes an actuating assembly  20 . The actuating assembly  20  can be integrated with guide member  12  and/or separate therefrom. With reference to  FIG. 9 , depicted in an illustrative configuration of actuating assembly  20 . 
     Referring now to  FIG. 9 , depicted is an exemplary embodiment of an actuating assembly  20  that can be used to manipulate actuating member  40 . Through operating actuating assembly  20 , filter assembly  42  ( FIG. 5 ) can be deployed and retrieved. 
     As illustrated, actuating assembly  20  includes an actuating element  70  and actuator member  40 . Actuating element  70  includes a distal end  74  that is configured to cooperate with guide member  12 , while a proximal end  76  of actuating element  70  is attached to proximal end  16  of guide member  12 . The distal end  74  has a step configuration and includes indentations  78  that are configured to cooperate with complementary protrusions  80  formed in guide member  12 . As actuating element  70  is moved in the distal direction, indentations  78  and protrusions  80  mate to position actuating element  70  in a desired location relative to proximal end  16  of guide member  12 , thereby positioning filter assembly  42  in a selected position, such as in the retracted position illustrated in  FIG. 9 . 
     As actuating element  70  is continually moved in the distal direction, distal end  74  meets a wall  82  formed in guide member  12  that prevents further movement in the distal direction. Through this configuration, actuating element  70  is prevented from excessive longitudinal displacement in the distal direction. This stopping of the longitudinal displacement of actuating element  70  indicates that filter assembly  42  is deployed. 
     Although reference is made to one manner to indicate the particular location filter assembly  42 , one skilled in the art can identify a variety of different manners. For instance, a plurality of indentations and/or protrusions can be included within actuating element  70  and guide member  12  to control the distance which actuating element  70  and consequently filter assembly  42  is moved. In another configuration, a wall formed in actuating element  70  mates with the distal end of guide member  12  to prevent excessive longitudinal displacement in the distal direction. In still another configuration, a combination of walls in actuating element  70  and guide member  12  can be used. In still another configuration, distal end  76  of actuating element  70  is tapered and cooperates with a taper formed in proximal end  16  of guide member  12 . The complementary tapers control the longitudinal displacement of actuating element  70  relative to proximal end  16  of guide member  12 . In still other configurations, a combination of indentations, protrusions, walls, or tapers can be used. Various other manners are known to control the distance traveled by actuator element  70  while indicating the position of filter assembly  42 . 
     To remove filter device  10  from within the patient, embodiments of the present invention provide a capture catheter  90 , as shown in  FIG. 10 . Capture catheter  90  is adapted to enclose filter  50  to prevent filter from tearing or catching on stents, grafts, other implants, guide members, catheters, sheaths, or other protrusions that may be encountered as filter  50  is removed from the patient. 
     As illustrated in  FIG. 10 , capture catheter  90  has a generally elongate form having a lumen  92  extending from a distal end  94  to a proximal end  96  thereof. Disposed at distal end  94  is at least one radiopaque marker or band  100  that aids a physician or clinician in placing capture catheter  90  in the desired location relative to filter  50 , as illustrated in  FIG. 11 . Through viewing the insertion of capture catheter  90  through a fluoroscope, a physician or clinician can place distal end  94  to surround filter  50 . 
     The lumen  92  of capture catheter  90  is adapted to receive filter  50  and substantially completely enclose filter  50 . The inside diameter of lumen  92  is configured to engage with struts  52  when they are in the open configuration, i.e., filter  50  is in the deployed position, and push struts  52  radially together to close opening  60 . Through this configuration, opening  60  is closed before distal end  94  of capture catheter  90  contacts filter  50  and the engagement of capture catheter  90  with filter  50  does not cause embolic material to escape from within filter  50 . 
     As capture catheter  90  is advanced over filter  50 , it is compressed into lumen  92  of capture catheter  90 . To limit the amount of compression of the embolic material within filter  50 , a section of lumen  92  which or that optionally has greater elasticity than the remainder of capture catheter  90 , the border of this section being represented by dotted lines in  FIG. 10 . By so doing, this portion of capture catheter  90  can expand around filter  50  and any captured embolic material. 
     Capture catheter  90  can have various configurations and be fabricated from a variety of different materials. For example, capture catheter  90  can be fabricated from metals, alloys, plastics, polymers, synthetic materials, composites, or other medical grade materials. Further, capture catheter  90  can be kink resistant, biocompatible, radiopaque, in whole or in part, and capable of being exchanged over guide member  12 . Additionally, the elasticity of capture catheter  90  can be constant along its length, variable along its length, constant along a portion and variable along another portion of capture catheter  90 , or combinations thereof. 
     As illustrated in  FIG. 10 , disposed at proximal end  96  of capture catheter  90  is a locking mechanism  98 . The locking mechanism  98  engages with the proximal end of guide member  12  to securely capture guide member  12  when distal end  94  partially or completely surrounds filter  50  ( FIG. 11 ). In one configuration, locking mechanism  98  is an annular clamp that can be rotated to clamp a proximal end of guide member  12 . In another configuration, locking mechanism  98  can be a rotating hemostatis valve through which is disposed the proximal end of guide member  12 . In still another configuration, locking mechanism  98  can be a locking jaw-set, such as a mechanical collett. Each of these locking mechanisms can be configured in a variety of different manners and fabricated from a variety of different materials as known to those skilled in the art. For instance, the locking mechanism can be fabricated from plastics, polymers, metals, synthetic materials, alloys, or various other materials. 
     According to another aspect of the present invention, filter device  10  is generally used with a fluoroscope that enables a physician to view the insertion of filter device  10  through the tortuous anatomy of a patient. To enable filter device  10  to be visible to the physician, filter device  10  includes radiopaque bands, markers, or other means for radiopacity that provide reference points for the physician. With reference to  FIG. 7 , various locations are illustrated as being radiopaque by reference letter R. As shown, tip  15  of filter device  10  is radiopaque. More specifically, the most distal portion of distal end  14  is radiopaque so that the physician knows the location of tip  15  of filter device  10 . 
     The distal end of actuating member  40  is radiopaque so that the physician knows a (D, A, OA whether filter assembly  42  is in the stored, deployed, or retrieved position, while distal end  54  of filter  50  includes a radiopaque marker that defines the most distal portion of filter device  10 . Similarly, capture catheter  90  can include radiopaque bands, other markers, or means for radiopacity to define the distal end thereof. 
     In addition to the distal ends of guide member  12 , capture catheter  90 , actuating member  40 , and filter  50 , embodiments of the present invention include radiopaque markers or other means for radiopacity at the junction of struts  52  and proximal end  58  of filter  50 . In this manner, a physician can view the location of opening  60  during the procedure and verify that opening  60  is closed before the physician retrieves filter device  10  when the procedure is completed. 
     Although reference is made to placing radiopaque bands or markers at various locations on the components of filter device  10 , one skilled in the art can identify various other locations where radiopaque bands, markers, or other means for radiopacity are appropriate. Further, embodiments of the present invention need not include all discussed radiopaque bands or markers, but rather can include one or more of the described radiopaque bands or markers as desired. 
     Following hereinafter is a discussion of an illustrative manner by which a filter device of one embodiment of present invention is inserted into a carotid artery. Although reference is made to the present invention being inserted into a carotid artery, it can be understood by one skilled in the art that different methods can by used to insert the filter device of the present invention into any blood vessel within a patient. 
     With reference to  FIGS. 12-17 , initially, a small needle is used to gain femoral access, as represented by block  110 . This small hole is subsequently dilated until the hole is large enough to allow the insertion of an introducer of appropriate size as known to one skilled in the art. 
     With reference to  FIG. 13 , it can be understood by one skilled in the art, that a variety of different access sites can be used. For example, the right subclavian artery  210 , left subclavian artery  206 , right brachial artery  218 , left brachial artery  215 , right femoral artery  225 , left femoral artery  220 , right radial artery and left radial arteries  227 ,  228 , or any other artery as known by one skilled in the art can be used to enter a patient&#39;s arterial circulation. Alternatively, as known by one skilled in the art, any other blood vessel selectable by the physician can be chosen as an access site. 
     Referring now to  FIGS. 12-17 , following insertion of the introducer, a guidewire  230  is inserted into the femoral access site and steered, under fluoroscopy, to the desired location in the arterial system, just proximal to the lesion to be treated, as represented by block  112 . In this illustrative example, the following discussion relates to stenting of a lesion in the internal carotid artery, as referenced by arrow D in  FIG. 12  and illustrated in  FIG. 13 . 
     Guidewire  230  and guide catheter  232  are advanced together incrementally until the distal tip of guidewire  230  is placed proximal to the lesion, as represented by block  114  and shown in  FIG. 12 . Upon placing guide catheter  232 , guidewire  230  is removed and filter device  10  is advanced through guide catheter  232 , as represented by block  116  and illustrated in  FIG. 14 . 
     The filter device  10  is carefully advanced through the lesion to a point distal to the lesion and subsequently acts as an exchange guidewire with a filter attached. Alternatively, filter device  10  can function as guide member  230  so that a physician need not exchange filter device  10  for guidewire  230 . In such a configuration, the steps of placing the filter device and accessing the lesion can be performed simultaneously. This particular configuration is useful because it limited the number of exchanges performed by the physician and consequently accelerates the performance of the procedure. 
     Once in position, moving actuating member  40  distally actuates filter device  10  and deploys filter  50 , as represented by block  118  and shown in dotted lines in  FIG. 15 . In this manner, filter assembly  42  is deployed from lumen  18  of guide member  12  and struts  52  expand to secure proximal end  58  of filter against the wall of the vessel, as shown in  FIG. 6   a . Alternatively, when struts  52  are formed from the same material as filter  50 , the flow of blood through the vessel causes proximal end  58  to become secured against the wall of the vessel. Consequently, in either case, the blood flowing through the lesion subsequently flows through filter  50 . 
     Next, a stent is placed over the lesion, as represented by block  120 . This may be preceded by advancing a pre-dilation balloon  234 , such as a relatively long, high-pressure balloon, over filter device  10 , shown in dotted lines, until balloon  234  is within the lesion. Next, balloon  234  is inflated to dilate the lesion, as illustrated in  FIG. 16 , and then deflated and removed from the patient. Then a stent delivery system is advanced over guide member  12  until a stent  236 , shown in dotted lines in  FIG. 17 , is within the lesion. The stent delivery system deploys stent  236 , which then expands to fit the interior of the lesion within the artery. Once stent  236  is thus deployed, the stent delivery system is then removed. 
     To secure stent  236  in place, a post-dilation balloon, having a similar configuration to the pre-dilation balloon, is advanced over filter device  10  until the balloon is within stent  236 . Subsequently, the post-dilation balloon is inflated to a pressure and held at the desired pressure for a period selected by the physician. The maintenance of the balloon at such a pressure for this period causes stent  236  to be imbedded into the inner wall of the vessel. Following imbedding stent  236  into the inner wall of the vessel, the balloon is deflated and removed. 
     To complete the procedure, the devices within the patient and punctured vessel and tissue are closed. With respect to filter device  10 , locking mechanism  20  is activated to cause actuating member  40  to move in the proximal direction. The actuating member  40  draws struts  52  within lumen  18  of guide member  12 , thereby causing proximal end  58  of filter  50  to be retained within lumen  18 , as illustrated in  FIG. 8  and represented by block  122  in  FIG. 12 . In another configuration, activating actuating member  40  causes proximal end  58  of filter  50  to contact distal end  26  of guide member  12 , while remaining external from lumen  18 . In either case, the material captured within filter  50  are enclosed and prevented from escaping during removal of filter device  10 . By locating proximal end  58  of filter  50  within lumen  18  or in contact distal end  26  of guide member  12 , filter device  10  securely encloses the material with a sufficiently low force to prevent escape of any material but not cause material to be extruded through the holes of filter  50 . 
     Once filter  50  is in the retracted position, capture catheter  70  is advanced over guide member  12  until the capture catheter encloses filter device  10 , as illustrated in  FIG. 11 . This capture catheter is optionally locked in place with respect to guide member  12  and the filter system, including filter device  10 . Subsequently, the capture catheter  70  and the filter device  10  are removed from the patient, as represented by block  124 . To complete the procedure, all remaining devices are removed from the patient and the vessel puncture is closed. 
     The previously described embodiment of a filter device of the present invention is only one illustrative embodiment of the filter device. The following discussion provides various other configurations of various alternate embodiments of the filter device, including the guide member, the capture catheter and various elements of components. The following embodiments can be used in a similar manner to filter device  10  in performing the above-discussed method to insert the filter device into a carotid artery or some other body lumen. Further, the applicability of the features and functions discussed with respect to the previously discussed embodiment of the present invention are applicable to the to the following embodiments. 
     Referring now to  FIG. 18  is another configuration or embodiment of the filter assembly and actuating assembly. As depicted in  FIG. 18 , a filter device  310  includes a guide member  312  having a distal end  314  and a lumen  318  extending from distal end  314  toward a proximal end (not shown). In this particular configuration, a sheath and cover are excluded from guide member  312 . In another configuration, however, a sheath and cover can be included in a similar manner to guide member  12 . 
     Disposed within lumen  318  are a filter assembly  342  and an actuator  340 , with associated head  344 . The filter assembly  342  includes a filter  350 , which can be similar to other filters described herein, and a plurality of struts  352  extending from filter  350  to actuator  340  or head  344 . Each strut  152  includes a distal portion  362 , a proximal portion  366 , and an intermediate portion  364  disposed between distal portion  362  and proximal portion  366 . The struts  352  attach to filter  350  on the exterior of filter  350 , on the interior of filter  350 , along the edge of filter  350 , through filter  350 , or combinations of one or more of the proceeding. To provide additional surface area to connect each strut  352  to filter  30 , each strut  352  can be configured so that distal portion  362  has a cross-sectional dimension larger than intermediate portion  364 . Stated another way, distal portion  362  can have a larger surface area than intermediate portion  364 . The large cross-sectional area provided by the cross-sectional dimension of distal portion  312  provides large area for bonding each strut  352  to filter  350 . In this configuration, a strong bond is created between each strut  352  and filter  350 . 
     Similarly, each strut  352  can be configured so that proximal portion  366  has a cross-sectional dimension larger than intermediate portion  364 , while optionally having a similar, larger, or smaller cross-sectional dimension than distal portion  362 . By having a large cross-sectional dimension and hence large surface area, each strut  352  can be securely connected to actuating member  340  or head  342  which can be similar to other actuating members and heads described herein. 
     By varying the cross-sectional dimensions of distal portion  362 , intermediate portion  364 , and/or proximal portion  366 , the degree of bias exerted by each strut  352  to move distal portion  362  toward the wall of a blood vessel can be varied. The biasing force can also be changed through optionally varying the length of each strut  352  and/or changing the curvature of each strut  352 . 
     Although reference is made herein to each strut  352  having the above-referenced configurations, one skilled in the art can appreciate that one or more of struts  352  can be configured as described above. Further, each strut  352  can optionally be configured differently so that each strut  352  can have similar or dissimilar biasing forces compared to others struts  352  of the same filter device. Through varying the biasing forces, the my filter device can be used for a variety of different procedures or blood vessel configurations. 
     Struts  352  can be formed from Nitinol, stainless steel, metals, alloys, composites, plastics, polymers, synthetic materials, or combinations thereof. Each strut  352  can have a generally curved distal portion  362 , proximal portion  366 , and/or intermediate portion  364 . 
     Referring now to  FIG. 19 , illustrated is an alternate embodiment of actuator assembly, designated by reference number  420 . This particular embodiment of actuator  420  is capable of deploying and retrieving a filter assembly with use of a clamp assembly  472 . 
     As illustrated, actuating assembly  420  includes an actuating element  470 , and an actuating member  440 , each of which can be similar to other actuating elements and actuating members described herein. Actuating element  470  includes a distal end  474  that is configured to cooperate with guide member  412 , which can be similar to the other guide members described herein, while a proximal end  476  of actuating element  470  is attached to proximal end of actuating member  440 . The distal end  474  has a step configuration and includes protrusions  478  that are configured to cooperate with complementary indentations  480  formed in guide member  412 . As actuating element  470  is moved in the distal direction, such as by a physician, clinician, or a device operated by the physician, clinician, or technician, protrusions  478  and indentations  480  mate to position actuating element  470  in a desired location relative to proximal end  416  of guide member  412 , thereby positioning filter assembly  442  in a selected position, such as in the retracted position illustrated in  FIG. 8 . 
     As actuating element  470  is continually moved in the distal direction, distal end meets a wall  482  formed in guide member  412  that prevents further movement in the distal direction. Through this configuration, actuating element  470  is prevented from excessive longitudinal displacement in the distal direction. This stopping of the longitudinal displacement of actuating element  470  indicates that filter assembly  442  is deployed. 
     As illustrated, actuator element  470  engages with clamp assembly  472 . The clamp assembly  472  includes two annular clamp sets  484  and  486 . Clamp set  484  couples to actuator element  470 , while clamp set  486  couples to guide member  412 . In this illustrative embodiment, clamp set  484  is capable of being translated along the longitudinal axis of the filter device, while clamp set  486  is fixed. Clamp set  484  can be connected to a threaded screw, hydraulic rams, pneumatic rams, slide systems, linear actuators, combinations thereof, or the like that enables clamp set  484  to move in the proximal and distal directions. For instance, in one embodiment a threaded screw is rotatably attached to clamp set  486 , with clamp set  484  mounted thereto. Upon rotating the threaded screw, clamp set  484  advances along the threaded screw in either the proximal or distal direction to open or retract the filter assembly (not shown) of the filter device. 
     Generally, clamp assembly  472  can include a variety of different clamp sets, whether annular or opposed clamping jaws or clamp set, or the like as known to one skilled in the art. Further, clamp assembly  472  can use pneumatics, hydraulics, electricity, combinations thereof, or the like to move actuator element  470  and/or guide member  412 . 
     Referring now to  FIG. 20 , another illustrative embodiment of the present invention is depicted. As shown, a guide member  512 , which can be similar to the other guide member described herein, has a distal end  514 , a proximal end  516 , and a lumen  518  extending from distal end  514  to proximal end  516 . A tip  515  of guide member  512  includes a plurality of struts  522 , such as three or more struts. Each strut  522  can be biased such that a distal end thereof is biased to move outwardly from the longitudinal axis of guide member  512 . 
     At least one strut, designated by reference numeral  524 , is biased toward the longitudinal axis of guide member  512 , as shown in  FIG. 21 . Disposed upon strut portion  524 , as more clearly seen in  FIG. 20 , is a coil tip  526  that is commonly used with guidewires. This coil tip  526 , either alone or in combination with strut  524 , may be configured to allow a physician or clinician to shape the same before insertion into a body lumen. In this manner, the physician or clinician is able to configure the tip with an appropriately shaped J that enables guide member  512  to be guided through the tortuous anatomy of a patient. The coil tip  526  can be platinum, platinum alloys, radiopaque materials, metals, alloys, plastic, polymer, synthetic material, combinations thereof, or other materials that provide an appropriate radiopaque signature, while capable of being shaped, whether alone or in combination with strut  524 , by a physician or clinician. 
     Attached to the distal ends of two or more of struts  522  is a filter  550 . As shown, filter  550  is disposed within lumen  518  of guide member  512 . In alternate embodiments, filter  550  can surround guide member  512  or partially surround and partially be contained within lumen  518 . Filter  550  can have a variety of different configuration such as those described with respect to the other filters described herein. 
     Filter  550  can be attached to guide member  512  via a variety of different techniques and methods as known to one skilled in the art. For instance, filter  550  can be attached through adhesives, solvent bonding, thermal bonding, mechanical connections, or some other manner that is capable of securely connecting filter  550  to one or more of struts  522 . In another configuration, a distal end of two or more struts  522  can include respective holes (not shown) through which strands of filter  550  can be passed and attached to strut  522  to connect filter  550  to struts  522 . Alternately, the strands can be tied in a knot or folded back upon filter  550  and woven into or affixed to filter  550 . 
     To maintain struts  522  in the closed position, i.e., not extending outwardly from guide member  512 , a catheter  540  surrounds guide member  512 . The catheter can extend completely or partially from the distal end to the proximal end of guide member  512 . Illustratively, the catheter can surround substantially only struts  522 . The catheter  540  acts as a restraining member or mechanism that applies a force against, the struts to prevent the struts from extending outwardly. Catheter  540  can have a lumen (not shown) that has an inside diameter that is sufficiently similar to the outside diameter of guide member  512  that struts  522  are restrained from extending outwardly. Through moving guide member  512  with respect to catheter  540 , or vice versa, the distal ends of two or more of struts  522  are allowed to move outwardly to deploy filter  550 , as illustrated in  FIG. 21  that depicts guide member  512  having two struts  522 . Retracting filter  550  and catheter  540  can be performed in a similar manner to that described with respect to the other filter devices discussed herein, such as but not limited to using a capture catheter. 
     As mentioned above, the catheter can extend completely or partially the length of the guide member. In another configuration, the catheter can be replaced with a sleeve, a band, or other structure that partially extends toward the proximal end of the guide member from the distal end. These sleeves, bands, or other structures can be radiopaque or include one or more radiopaque markers. Furthermore, these sleeves, bands, or other structures can be slidable relative to the guide member using an actuating member that is disposed on the exterior of the guide member, within the lumen of the guide member, or partially within the lumen and partially on the exterior of the guide member. The actuator member can be any of the actuator members described herein. 
     According to an alternate configuration of the present invention, a filter device  610  includes a guide member  612  with a plurality of struts  622  disposed at a distal end  614  thereof These struts  622  can be maintained in the closed position using a sleeve  660 , as illustrated in  FIG. 22 . The sleeve  660  acts as a restraining member or mechanism that applies a force against the struts to prevent the struts from extending outwardly. 
     Sleeve  660  surrounds struts  622 , and a filter  650 , which can be similar to other filters described herein, when filter  650  is located on an exterior surface of guide member  612 . Disposed within sleeve  660  or between sleeve  660  and guide member  612  and/or filter  650  are one or more actuating members or actuating members  654 . These actuating members  654  are attached to guide member  612  at a location just proximal to the proximal end of each struts  622 , identified by letter E, extend distally to the distal end of sleeve  660 , and subsequently extend proximally on the outside of sleeve  660  to terminate at an actuating element  670  of an actuating assembly  620  ( FIG. 25 ) via one or more holes  656  and lumen  618 . Since one end of each actuating member  654  is located at the proximal end of sleeve  660 , whether forming part of sleeve  660 , attached to sleeve  660 , attached to guide member  612 , or combinations it, thereof, pulling actuating member  654  in the proximal direction by actuating element  670  of actuating assembly  620  ( FIG. 25 ) causes actuating member  654  to preferentially separate sleeve  660  into one or more portions, thereby releasing struts  622 , as illustrated in  FIG. 24 . 
     Stated another way, and with reference to  FIG. 25 , one or more of actuating members  654  can cooperate with an actuating assembly  620  and connect to actuating element  670 , such as through soldering, adhesives, or other forms of attachment. The actuating element  670  can be moved in the proximal direction until a stop member  672  formed in a proximal end  616  of actuating element  670  engages with a stop member  674  in guide member  612 . During the movement from a distal end  676  of actuating element  670  cooperating with a surface  678  of guide member  612  to stop member  672  engaging with stop member  674 , actuating member  654  moves in a proximal direction to preferentially separate sleeve  660 . 
     Sleeve  660  can be formed from a variety of different materials, so long as the material is sufficiently strong to secure struts  522 , while being configured to preferentially separate under the action of actuating member or actuating member  654 . For example, sleeve  660  can be fabricated from heat shrink synthetic material, including but not limited to, low-density polyethylene (LDPE), polyethylene terphthalate (PET), Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyethylene (PE), polyurethane (PU) or silicone tubing. 
     Actuating members  654  can be formed from a variety of different materials, so long as the material used is sufficiently strong to allow an actuating mechanism, such as those actuating mechanisms disclosed herein, to move actuating members or actuating member  654  proximally without breaking the same. For example, actuating members  654  can be fabricated from plastics, polymers, metals, composites, alloys, synthetic materials, or combinations thereof. 
     Instead of using actuating members  654 , embodiments of the present invention can employ various other manners to preferentially separate sleeve  660 . For example, sleeve  660  can have dissolvable chemical bonds which dissolve due to a chemical reaction with the fluid in the vessel within which the filter device is disposed, bonds that are broken through applying resistive heating, ultrasonic or radio frequency energy, preferential regions or zones where the material has a weaker strength than other regions or zones of the sleeve, or combinations thereof. 
     Following is a discussion of other methods, devices, and systems for restraining or constraining one or more struts attached to or integrally formed as part of a guide member. The embodiments provide methods, devices, and systems for, applying a restraining force to one or more struts and subsequently releasing the same to allow the struts to expand outwardly. 
     Referring now to  FIG. 26 , depicted is a perspective view of one embodiment of a restraining member or mechanism. The restraining member or mechanism, is in the form of a sleeve  760  and associated securing member  762 , the combination of which is adapted to surround one or more struts  752  of a guide member  712  and apply a restraining force against struts  752  to maintain struts  752  in a closed configuration. The sleeve  760  includes a first side  764  and a second side  766  with first and second sides  764 ,  766  being separated by an intermediate portion  768 . The sleeve  760  surrounds guide member  712  in such a manner that intermediate portion  768  surrounds guide member  712  so that portions of intermediate portion  768  contacts with, are juxtaposed to, are contiguous with, or are adjacent one to another. The securing member  762  passes through such portions of intermediate portion  768  to secure sleeve  760  upon guide member  712 . To further aid with applying a restraining force against struts  752 , first side  764  and second side  766  are folded to attach to respective portions of outside surface of sleeve  760 . 
     The process of forming the restraining member or mechanism of  FIG. 26  is illustrated in  FIGS. 27 and 28 . With reference first to  FIG. 27 , which depicts sleeve  760  in an open position before securing member  762  is coupled thereto, sleeve  760  can be directly formed on guide member  712  or can be formed on a separate tubular member and subsequently attached or coupled to guide member  712 . Sleeve  760  is illustrated as having a generally polygonal configuration, however, one skilled in the art can appreciate that sleeve  760  can have various other configuration so long as it is capable of performing the functions described herein. In this exemplary configuration, sleeve  760  is coupled directly to a guide member  712 . The first side  764  and second side  766  of sleeve  760  are wrapped around at least a portion of guide member  760 , until a portion of intermediate portion  768  is in close proximity another portion of intermediate portion  768 . Alternatively, a first side  764  can be contacting, juxtaposed, contiguous, or adjacent to second side  766 . 
     When the portions of intermediate portion  768  are in close proximity, securing member  762 , or alternatively some other actuating member, is stitched through both sleeve  760  to couple the portions of intermediate portion  768 , as shown in  FIG. 28 . Once securing member  762  is drawn straight, first end  764  and second end  766  are folded to attach to respective outside surfaces of sleeve  760 , as shown in  FIG. 25 . 
     In an alternate configuration, as illustrated in  FIG. 29 , sleeve  760  can include a plurality of apertures  780  on portions of intermediate portion  768  that receive securing member  762  thereby allowing securing member  762  to be passed through apertures  780  rather than stitched through sleeve  760 . In another embodiment, first end  764  of sleeve  760  can be coupled to second end  764  of sleeve  760  without attaching first end  764  or second end  766  to the outside surface of sleeve  760 . Depending upon the particular configuration, a portion of first end  764  can overlap a portion of second end  766 , or vice versa. Alternatively, first end  764  and second end  766  contact each other but do not overlap. Similarly, first end  764  and second end  766  can be adjacent to one another, adjoining one another, contiguous to one another, or juxtaposed to one another. 
     To operate the restraining member or mechanism described in reference to  FIGS. 26-29 , a proximal end (not shown) of securing member  762  extends to a proximal end (not shown) of guide member  712 , either within or without a lumen of the guide member  712 . Disposed upon the end of securing member  762  is an actuating member, such as actuating member  20 , which allows a physician or clinician to move securing member  762  longitudinally to remove securing member  762  from being disposed through at least a portion of sleeve  760 . By so doing, the restraining force applied by sleeve  760  is released, struts  752  extend outwardly, and the filter (not shown) is deployed. 
     Sleeve  760  can be formed from a variety of different materials, so long as the material is sufficiently strong to restrain one or more struts  752 . For example, sleeve  760  can be fabricated from various types of polymer or silicone films, such as but not limited to, heat shrink plastic, polymer, low-density polyethylene (LDPE), polyethylene terphthalate (PET), Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyethylene (PE), polyurethane (PU), or silicone tubing. 
     Securing member  762  can be formed from a variety of different materials, so long as the material used is sufficiently strong to allow the actuating mechanisms disclosed herein to move securing member  762  proximally without breaking securing member  762 . For example, securing member  762  can be fabricated from plastics, polymers, metals, composites, alloys, synthetic materials, combinations thereof, or other material that is capable of performing the function of being disposed through sleeve  760  and capable of being withdrawn therefrom. 
     Referring now to  FIGS. 30-34 , illustrated is another alternate configuration of a restraining member or mechanism. This particular configuration utilizes a hinged configuration with a securing member acting as the pin to maintain the hinged portions of a sleeve in a closed configuration to constrain or restrain a portion of the guide member. 
     As shown in  FIG. 30 , a sleeve  860  includes a plurality of channels  864   a - 864   f  that are adapted to receive a securing member  862 . Both a first side  866  and a second side  868  of sleeve  860  are formed with some of channels  864   a - 864   f,  i.e., channels  864   a,    864   c,  and  864   e  on first side  866  and channels  864   b,    864   d,  and  864   f  on second side  868 . Through passing securing member  862  through channels  864   a - 864   f  in sequential order, so that securing member  862  passes through a channel on first side  866  and subsequently a channel on second side  868 , first side  866  is coupled to second side  868  and sleeve  860  applies a restraining force against the struts (not shown) of a guide member. 
     The process of forming the restraining member or mechanism of  FIG. 30  is illustrated in  FIGS. 31-34 . With reference first to  FIG. 31 , which depicts sleeve  860  in an open position before securing member  862  is coupled thereto, sleeve  860  includes a number of extensions or tongues  870   a - 870   n.  These extensions  870   a - 870   n  are configured to surround a tubular member or tube, such as but not limited to, a guide member  812 , and form channels  864   a - 864   f  within which securing member  862  is located, as will be described hereinafter. 
     To attach sleeve  860  to guide member  812 , sleeve  860  is positioned over the desired portion of guide member  860 . The securing member  862  is placed in close proximity to guide member  860 , as shown in  FIGS. 31 and 32 . The ends of the extensions  870   a - 870   n  are inserted between guide member  860  and securing member  862 , as shown in  FIG. 33 . Alternatively, extensions  870   a - 870   n  can be partially wrapped around guide member  812  and securing member  862  placed into contact with these partially wrapped extensions  870   a - 870   n.    
     After the extensions  870   a - 870   n  are pulled tightly around guide member  812  and securing member  862 , an end of each extension  870   a - 870   n  is folded over securing member  862  to attach to the outer surface of sleeve  860 , as shown in  FIGS. 30 and 34 . In this manner, channels  862   a - 862   n  are formed and sleeve  860  is configured with securing member  862  to releasably restrain the struts (not shown) of guide member  812 . 
     Releasing the restraining force applied by sleeve  860 , alone or in combination with securing member  862 , is achieved through moving or pulling securing member  862  longitudinally with respect to guide member  812 . The securing member  862  is withdrawn from channels  864   a - 864   f  to allow the biasing force of the struts (not shown) to extend the struts outwardly to deploy the filter (not shown). The longitudinal motion of securing member  862  can be initiated through a variety of different mechanisms as described herein, such as but not limited to actuating assembly  20 , or otherwise known to one skilled in the art in light of the teaching contained herein. 
     Referring now to  FIG. 35 , depicted is another embodiment of a restraining member or mechanism of the present invention. The restraining member  960  includes a number of hoops  964   a - 96   n  that are adapted to receive a securing member  962 . In a similar manner to that described with respect to other embodiments of the restraining member or mechanism, securing member  962  is disposed within hoops  964   a - 964   n  so that restraining member  960  applies a retaining force against the struts of a guide member  912 . The securing member  962  can be removed from hoops  964   a - 964   n  to thereby allow the struts to extend outwardly to deploy the filter (not shown). The restraining member  960  may be made from metallic wires, polymer fibers, or other materials that can be manipulated to form hoops through which a securing member is disposed and which can expand outwardly either under the influence of one or more struts or due to a biasing force applied by the configuration and/or material of the restraining member. 
     The restraining member  960  can be attached to guide member  912  and/or one or more of the struts associated therewith through various attachment mechanisms. For instance, restraining member  960  can be attached to guide member and/or one or more of the struts through adhesives, mechanical fasteners, securing loops, or other manner that securely attaches restraining member  960  to the guide member and/or one or more of the struts. Alternatively, restraining member  960  may be attached to securing member  962  and be removed when securing member  962  is moved in a proximal direction. 
     Referring now to  FIGS. 36-39 , depicted is another embodiment of a restraining member or mechanism of the present invention. Instead of a separate restraining member or mechanism that is connected to a guide member, the filter media itself is adapted to function both as a filter and as a restraining member or mechanism. 
     As illustrated, a guide member  1010  includes a plurality of struts  1052  that are adapted to extend outwardly to deploy a filter  1050  that is disposed within a lumen  1018  of guide member  1010 . The filter  1050  includes two flaps  1060  and  1062  that extend between a gap  1064  between two struts  1052 . These flaps  1060  and  1062  are adapted to be pulled around struts  1052  to compress them and secure filter  1050  within lumen  1018 , as illustrated in  FIG. 37 . These flaps  1060  and  1062  can be integral with filter  1050 , two separate members that are bonded or otherwise connected to filter  1050 , or a single member that has an intermediate portion bonded or otherwise connected to filter  1050 , with the ends of the member forming flaps  1060  and  1062 . 
     When flaps  1060  and  1062  have been positioned to securely retain struts  1052 , they are then stitched together at a location  1066  identified in  FIG. 38  with an actuating member  1070 . This actuating member  1070  extends the length of the filter device to cooperate with an actuating assembly, such as but not limited to an actuating assembly described herein and those others known to one skilled in the art in light of the teaching contained herein. 
     Following the coupling of flaps  1060  and  1062  using actuating member  1070 , flaps  1060  and  1062  are folded back around the bundled struts  1052  and filter  1050 , and then attached to filter  1050 , struts  1052 , or other portion of guide member  1012 , as illustrated in  FIG. 39 . When actuating member  1070  is moved in a proximal direction, flaps  1060  and  1062  are released and filter  1050  is deployed as struts  1052  extend outwardly. 
     Although reference is made to two flaps  1060  and  1062 , one skilled in the art can appreciate that the filter can includes one or more flaps. For instance, one flap can be wrapped around struts  1052  and an end of the flap sewn or otherwise releasable connected to filter  1050 . 
     Referring now to  FIG. 40 , depicted is another embodiment of a restraining member or mechanism of the present invention. This particular configuration is depicted as part of a filter assembly  1142  that can be coupled to or attached to a distal end of a guide member. The filter assembly  1142  can includes a strut assembly  1144  and a filter (not shown) coupled to strut assembly  1144 . The strut assembly  1144  has an elongated proximal end  1146  and a distal end  1148  having a plurality of struts  1152 . The length of elongated proximal end  1146  can vary based upon the particular configuration of the guide member. For instance, proximal end  1146  can have any length greater than 1 centimeter. 
     As mentioned above, disposed at distal end  1148  are struts  1152 . Each strut  1152  includes a tubular member  1154  adapted to receive a securing member  1162 . Adjacent tubular members  1154  on adjacent struts  1152  are staggered such that when struts  1152  are brought together securing member  1162  can be disposed through tubular members  1154  to restrain struts  1152  and prevent them from extending outwardly, as illustrated in  FIG. 41 . 
     The securing member  1162  can extend through a lumen  1164  of strut assembly  1144  into a lumen  1118  of guide member  1112  to terminate at an actuating assembly (not shown) at a proximal end  1116  of guide member  1112 . Alternatively, securing member  1162  can extend through lumen  1164  to exit through an aperture  1166 , depicted in dotted lines, in strut assembly  1144  before terminating at an actuating assembly (not shown) at a proximal end of guide member  1112 . In still another configuration, securing member  1162  can pass into lumen  1164  through aperture  1166 , depicted in dotted lines, in strut assembly  1144  before terminating at an actuating assembly (not shown) at a proximal end of guide member  1112 . 
     Each tubular member  1154  coupled to struts  1152  can be fabricated from a metal, a plastic, polymer, a polymer, a synthetic materials, whether or not the material is the same as that forming guide member  1112 . In one embodiment, each tubular member  1154  is a polymer tube, such as a polyimide or polyurethane tube that is fixed to respective struts  1152  with adhesive. In another configuration, each tubular member  1154  is a metallic cut tube that may be attached to respective struts  1152  with and adhesive or solder. In still another configuration, each strut  1152  includes an aperture through which securing member  1162  passes to restrain struts  1152  and prevents the same from extending outwardly. 
     Referring now to  FIG. 42  is another configuration or embodiment of a device according to another aspect of the present invention. As depicted in  FIG. 42 , a filter device  1210  includes a guide member  1212  having a distal end  1214  and a lumen  1218  extending from distal end  1214  toward a proximal end (not shown). In this particular configuration, and for ease of explanation, filter device  1210  is devoid of a restraining member or mechanism, however, in other configurations, filter device  1210  can include a restraining member or mechanism. 
     Disposed at distal end  1214  are a plurality of struts  1252 , coupled to which is a filter  1250 . Although reference is made herein to struts  1252  being integrally formed with guide member  1212 , it can be appreciated that struts  1252  can be part of a strut assembly that is attached to proximal end  1214  of guide member  1212 . For instance, the struts assembly can have a proximal end that terminates substantially with a proximal end of the guide member or at a location distal to the proximal end of the guide member, whether such location is close to the distal end of the guide member or the proximal end of the guide member. 
     Each strut  1252  includes a distal portion  1262 , a proximal portion  1266 , and an intermediate portion  1264  disposed between distal portion  1262  and proximal portion  1266 . The struts  1252  attach to filter  1250  on the exterior of filter  1250 , on the interior of filter  1250 , along the edge of filter  1250 , through filter  1250 , or combinations of one or more of the proceeding. To provide additional surface area to connect each strut  1252  to filter  1250 , each strut  1252  can be configured so that distal portion  1262  has a cross-sectional dimension larger than intermediate portion  1264 . Stated another way, distal portion  1262  can have a larger surface area than intermediate portion  1264 . The large cross-sectional area provided by the cross-sectional dimension of distal portion  1212  provides large area for bonding each strut  1252  to filter  1250 . In this configuration, a strong bond is created between each strut  1252  and filter  1250 . 
     Similarly, each strut  1252  can be configured so that proximal portion  1266  has a cross-sectional dimension larger than intermediate portion  1264 , while optionally having a similar, larger, or smaller cross-sectional dimension than distal portion  1262 . By having a large cross-sectional dimension and hence large surface area, each strut  1252  can apply a greater biasing force to extend strut  1252  outwardly to deploy filter  1250 . 
     By varying the cross-sectional dimensions of distal portion  1262 , intermediate portion  1264 , and/or proximal portion  1266 , the degree of bias exerted by each strut to move distal portion  1262  toward the wall of a blood vessel can be varied. The biasing force can also be changed through optionally varying the length of each strut  1252  and/or changing the curvature of each strut  1252 . 
     Although reference is made herein to each strut  1252  having the above-referenced configurations, one skilled in the art can appreciate that one or more of struts  1252  can be configured as described above. Further, each strut  1252  can optionally be configured differently so that each strut  1252  can have similar or dissimilar biasing forces compared to others struts  1252  of the same filter device. Through varying the biasing forces, the filter device can be used for a variety of different procedures or blood vessel configurations. 
     Struts  1252  can be formed from Nitinol, stainless steel, metals, alloys, composites, plastics, polymers, synthetic materials, or combinations thereof. Each strut  1252  can have a generally curved distal portion  1262 , proximal portion  1266 , and/or intermediate portion  1264 . 
     Disposed with lumen  1218  at distal end  1214  is a core  1260  forming part of an atraumatic tip  1262 . Surrounding at least a portion of core  1260  is a coil  1264  that provides flexibility and radiopaque properties to atraumatic tip  1262 . The core  1260  passes through an aperture  1266  in a distal end of filter  1250 . Alternatively, core  1260  passes through one or more pores formed in filter  1250 . 
     To secure filter  1250  to atraumatic tip  1262 , a securing coil  1270  surrounds a portion of coil  1264  and the distal end of filter  1250 . Although this is one manner to connect filter  1250  to atraumatic tip  1262 , one skilled in the art can identify various other manners to connect filter  1250  to atraumatic tip  1262 . For instance, the distal end of filter  1250  can be bonded to atraumatic tip  1262  using adhesives, mechanical fasteners, crimping, seals, friction fit, press fit, or other manners to connect filter  1250  to atraumatic tip  1262 . In another configuration, filter  1250  is not connected to atraumatic tip  1262  but can slide along a portion of atraumatic tip  1262 . 
     Referring now to  FIG. 43 , another illustrative embodiment of the present invention is depicted. The majority of the features previously discussed with respect to other embodiments of the present invention apply to this exemplary embodiment. 
     A filter assembly  1342  comprises a filter  1350  and a spring member  1364 . Filter  1350  includes a plurality of struts  1352 . These struts  1352  are lengthened strands of filter  1350 . These struts  1352  connect filter  1350  to actuating member  1340  and are unbiased. Alternatively, struts  1352  can be biased to open filter  1350 . 
     Disposed at proximal end  1358  of filter  1350 , is biased spring member  1364 . Biased spring member  1364  has a coil-type configuration and includes a proximal end  1368  that extends into lumen  1318  of guide member  1312  to be attached to actuating member  1340 , such as similar to actuating member  40  discussed herein, and/or a head  1344 . Spring member  1364  is biased to an opened position where spring member  1364  forms opening  1360 . During deployment of filter assembly  1342 , the flow of blood through the blood vessel applies a force to filter  1350 . This force enables filter  1350  to be withdrawn from lumen  1318  and become deployed into the form described herein. Since spring member  1364  is biased to open, spring member  1364  draws the outer peripheral edge of filter  1350  at proximal end  1358  toward the inner wall of the blood vessel. 
     To retract filter  1350 , actuating member  1340  is moved in the proximal direction, causing proximal end  1358  of filter  1350  to be drawn proximally. This causes proximal end  1358  to be drawn toward lumen  1318  and become closed, thereby enabling filter  1350  to be removed through the procedure discussed herein, such as through use of a capture catheter. 
     Various configurations of capture catheter are known to those skilled in the art in light of the teaching contained herein. The capture catheters described herein can be used with any of the embodiments of the filter device or guide member described herein. 
     As illustrated in  FIG. 44  an alternate embodiment of a capture catheter, designated by reference number  1390  is illustrated. As shown, capture catheter  1390  includes a distal portion  1392  and a positioning member  1394  connected or attached to distal portion  1392 . The distal portion  1392  includes a lumen  1400  extending from a distal end  1396  to terminate at an aperture  1402  at a proximal end  1398  thereof. The distal end  1396  optionally includes a radiopaque marker or band  1408 , while lumen  1400  is configured to receive a filter assembly of a filter device in a similar manner to lumen  92  of capture catheter  90 . Alternatively, lumen  1400  can include a stop member  1404 , depicted in dotted lines, with a hole  1406  therethrough. The stop member  1404  allows guide member  1412  to pass through hole  1406 , but prevents a filter assembly disposed at a distal end of guide member  1412  to pass through hole  1406  once capture catheter  1390  has received the filter assembly within lumen  1400 . One skilled in the art can identify various other configurations of stop member. For instance, hole  1406  can be disposed in stop member  1404  at any location. 
     To move capture catheter  1390  along guide member  1412  of the filter device, capture catheter  1390  includes positioning member  1394 . This positioning member  1394  has sufficient stiffness that application of a force at a proximal end  1416  can be transferred to longitudinal motion of distal portion  1392  of capture catheter  1390 . In one configuration, positioning member  1394  is a solid member, while in another configuration positioning member  1394  is hollow or has at least a portion thereof hollow. The positioning member  1394  can be fabricated from a polymer, a plastic, polymer, a synthetic material, a metal, an alloy, combinations thereof, or other material that can be used for medical devices and has the needed stiffness. 
     As illustrated in  FIG. 45  an alternate embodiment of a capture catheter, designated by reference number  1420  is illustrated. As shown, capture catheter  1420  includes a distal end  1422  and a lumen  1424  extending from distal end  1422  to terminate at an aperture  1426  at a location proximal to distal end  1422 . Lumen  1424  is configured to receive a filter assembly of a filter device in a similar manner to lumen  92  of capture catheter  90 , while aperture  1426  is adapted to receive guide member  1412  and prevent passage of filter assembly of the filter device. In this configuration, the length of lumen  1424  is configured to prevent capture catheter  1420  from being advanced further over the filter device or filter assembly of the filter device than is required. Alternatively, lumen  1424  can include a stop member similar to stop member  1404  discussed herein. Furthermore, capture catheter  1420  can optionally include one or more radiopaque markers disposed at and/or between a distal end and a proximal end thereof. 
     Referring now to  FIG. 46 , depicted is another embodiment of a capture catheter in accordance with another aspect of the present invention. As illustrated, capture catheter  1490  is adapted to cooperate with a filter device  1510 . The illustrative filter device  1510  includes a filter assembly  1542  coupled to a distal end  1514  of guide member  1512 . The filter assembly  1542  includes a plurality of struts  1552  and a filter  1550  connected to one or more of the plurality of struts  1552 . As shown, filter assembly  1542  is a separate component that is attached, connected, or coupled to guide member  1512 . In an alternate configuration, however, filter assembly  1542  can be integrally formed with guide member  1512 , such that each of the plurality of struts  1552  is formed from a portion of guide member  1512 . Also forming part of filter assembly  1542  is an atraumatic tip  1560 . This atraumatic tip  1560  can be disposed through filter  1550  of filter assembly  1542 . Alternatively, atraumatic tip  1560  can pass around filter  1550 , as depicted in dotted lines, and be configured from one of the plurality of struts  1552  that elongated. 
     Returning to capture catheter  1490 , the capture catheter  1490  includes a distal portion  1492  and a proximal portion  1494  that communicates with the distal portion  1492 . The proximal portion  1494  is stiffer than the distal portion  1492  and can have a similar configuration to the other capture catheters described herein. For instance, proximal portion  1494  can be capture catheter  90 , can have a similar configuration to distal portion  1392  of capture catheter  1390 , or can be capture catheter  1420 . The distal portion  1492  is flexible and tapers from proximal to proximal portion  1494  to a distal end  1498  of capture catheter  1490 . 
     Disposed at distal end  1498  is a lumen  1500  that receives guide member  1512  of filter device  1510 . Lumen  1500  can be formed from a separate tubular member that is connected, attached, or coupled to the distal end of capture catheter  1490 . Alternatively, lumen  1500  can be formed from the distal portion  1492  of capture catheter  1490 . The lumen  1500  is adapted to slidably receive guide member  1512  of filter device  1510 , but prevent passage of filter assembly  1542 . Stated another way, filter assembly  1542  has an outer diameter greater than the inner diameter of lumen  1500 . Consequently, as capture catheter  1490  is moved in a distal direction, distal end  1498  engages with either a proximal end of filter assembly  1542  or one or more of the extending struts  1552 . As capture catheter  1490  continues to be advanced, distal portion  1492 , due to its flexibility, begins to invert, as depicted in  FIG. 47 . As capture catheter  1490  is continued to be advanced, struts  1552  and filter  1550  are completely enclosed within capture catheter  1490 , as shown in  FIG. 48 . 
     Embodiments of the present invention and the various components or elements thereof can be used interchangeably so that features and functions of one exemplary embodiment of a filter device can be used with other embodiments of the filter device. Illustratively, the restraining members or mechanisms of the described embodiments of the present invention can be used with multiple different configurations of the filter device. Further, exemplary capture catheters can be used interchangeably such that any capture catheter can be used with any of the described filter devices and such other that may be known to those skilled in the art in light of the teaching contained herein. Additionally, methods of using one embodiment of the present invention can be used with other embodiments of the present invention. Therefore, embodiments of the present invention provide filter devices that have small, low, or no profiles, few parts and components, are simple to manufacture and use, are able to be easily inserted into a patient, be steerable through the tortuous anatomy of a patient, provide filtering capabilities, provide exchange capability so other medical devices can be advanced over or along the filter device, and be capable of removing captured material without allowing such material to escape during filter retrieval. 
     The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.