Variable thickness embolic filtering devices and method of manufacturing the same

[0001] The present invention relates generally to filtering devices and systems which can be used when an interventional procedure is being performed in a stenosed or occluded region of a body vessel to capture embolic material that may be created and released into the vessel during the procedure. The present invention is more particularly directed to an embolic filtering device with a strut assembly having varying wall thickness and strut widths. The present invention is particularly useful when an interventional procedure, such as balloon angioplasty, stenting procedures, laser angioplasty or atherectomy, is being performed in a critical body vessel, such as the carotid arteries, where the release of embolic debris into the bloodstream can occlude the flow of oxygenated blood to the brain, resulting in grave consequences to the patient. While the present invention is particularly useful in carotid procedures, the invention can be used in conjunction with any vascular interventional procedure in which an embolic risk is present.

[0002] Numerous procedures have been developed for treating occluded blood vessels to allow blood to flow without obstruction. Such procedures usually involve the percutaneous introduction of the interventional device into the lumen of the artery, usually through a catheter. One widely known and medically accepted procedure is balloon angioplasty in which an inflatable balloon is introduced within the stenosed region of the blood vessel to dilate the occluded vessel. The balloon catheter is initially inserted into the patient's arterial system and is advanced and manipulated into the area of stenosis in the artery. The balloon is inflated to compress the plaque and press the vessel wall radially outward to increase the diameter of the blood vessel, resulting in increased blood flow. The balloon is then deflated to a small profile so that the dilatation catheter can be withdrawn from the patient's vasculature and the blood flow resumed through the dilated artery. As should be appreciated by those skilled in the art, while the above-described procedure is typical, it is not the only method used in angioplasty.

[0003] Another procedure is laser angioplasty which utilizes a laser to ablate the stenosis by super heating and vaporizing the deposited plaque. Atherectomy is yet another method of treating a stenosed blood vessel in which cutting blades are rotated to shave the deposited plaque from the arterial wall. A vacuum catheter is usually used to capture the shaved plaque or thrombus from the blood stream during this procedure.

[0004] In the procedures of the kind referenced above, abrupt reclosure may occur or restenosis of the artery may develop over time, which may require another angioplasty procedure, a surgical bypass operation, or some other method of repairing or strengthening the area. To reduce the likelihood of the occurrence of abrupt reclosure and to strengthen the area, a physician can implant an intravascular prosthesis for maintaining vascular patency, commonly known as a stent, inside the artery across the lesion. The stent can be crimped tightly onto the balloon portion of the catheter and transported in its delivery diameter through the patient's vasculature. At the deployment site, the stent is expanded to a larger diameter, often by inflating the balloon portion of the catheter.

[0005] The above non-surgical interventional procedures, when successful, avoid the necessity of major surgical operations. However, there is one common problem which can become associated with all of these non-surgical procedures, namely, the potential release of embolic debris into the bloodstream that can occlude distal vasculature and cause significant health problems to the patient. For example, during deployment of a stent, it is possible that the metal struts of the stent can cut into the stenosis and shear off pieces of plaque which become embolic debris that can travel downstream and lodge somewhere in the patient's vascular system. Pieces of plaque material can sometimes dislodge from the stenosis during a balloon angioplasty procedure and become released into the bloodstream. Additionally, while complete vaporization of plaque is the intended goal during laser angioplasty, sometimes particles are not fully vaporized and thus enter the bloodstream. Likewise, not all of the emboli created during an atherectomy procedure may be drawn into the vacuum catheter and, as a result, enter the bloodstream as well.

[0006] When any of the above-described procedures are performed in the carotid arteries, the release of emboli into the circulatory system can be extremely dangerous and sometimes fatal to the patient. Debris that is carried by the bloodstream to distal vessels of the brain can cause these cerebral vessels to occlude, resulting in a stroke, and in some cases, death. Therefore, although cerebral percutaneous transluminal angioplasty has been performed in the past, the number of procedures performed has been limited due to the justifiable fear of causing an embolic stroke should embolic debris enter the bloodstream and block vital downstream blood passages.

[0007] Medical devices have been developed to attempt to deal with the problem created when debris or fragments enter the circulatory system following vessel treatment utilizing any one of the above-identified procedures. One approach which has been attempted is the cutting of any debris into minute sizes which pose little chance of becoming occluded in major vessels within the patient's vasculature. However, it is often difficult to control the size of the fragments which are formed, and the potential risk of vessel occlusion still exists, making such a procedure in the carotid arteries a high-risk proposition.

[0008] Other techniques include the use of catheters with a vacuum source which provides temporary suction to remove embolic debris from the bloodstream. However, as mentioned above, there can be complications associated with such systems if the vacuum catheter does not remove all of the embolic material from the bloodstream. Also, a powerful suction could cause trauma to the patient's vasculature.

[0009] Still other techniques which have had some limited success include the placement of a filter or trap downstream from the treatment site to capture embolic debris before it reaches the smaller blood vessels downstream. The placement of a filter in the patient's vasculature during treatment of the vascular lesion can reduce the presence of the embolic debris in the bloodstream. Such embolic filters are usually delivered in a collapsed position through the patient's vasculature and then expanded to trap the embolic debris. Some of these embolic filters are self expanding and utilize a restraining sheath which maintains the expandable filter in a collapsed position until it is ready to be expanded within the patient's vasculature. The physician can retract the proximal end of the restraining sheath to expose the expandable filter, causing the filter to expand at the desired location. Once the procedure is completed, the filter can be collapsed, and the filter (with the trapped embolic debris) can then be removed from the vessel. While a filter can be effective in capturing embolic material, the filter still needs to be collapsed and removed from the vessel. During this step, there is a possibility that trapped embolic debris can backflow through the inlet opening of the filter and enter the bloodstream as the filtering system is being collapsed and removed from the patient. Therefore, it is important that any captured embolic debris remain trapped within this filter so that particles are not released back into the body vessel. Additionally, the recovery apparatus should be relatively flexible to avoid straightening of the body vessel. Recovery devices which are too stiff can cause trauma to the vessel walls as the filter is being collapsed and removed from the vasculature.

[0010] Some prior art expandable filters are attached to the distal end of a guide wire or guide wire-like tubing that allows the filtering device to be placed in the patient's vasculature as the guide wire is steered by the physician. Once the guide wire is in proper position in the vasculature, the embolic filter can be deployed to capture embolic debris. Some embolic filter devices which utilize a guide wire for positioning also utilize the restraining sheath to maintain the expandable filter in a collapsed position. Once the proximal end of the restraining sheath is retracted by the physician, the expandable filter will move into its fully expanded position within the patient's vasculature. The restraining sheath can then be removed from the guide wire allowing the guide wire to be used by the physician to deliver interventional devices, such as a balloon angioplasty dilatation catheter or a stent delivery catheter, into the area of treatment. After the interventional procedure is completed, a recovery sheath can be delivered over the guide wire using over-the-wire techniques to collapse the expanded filter for removal from the patient's vasculature. As mentioned above, the recovery device, i.e., the recovery sheath, should be relatively flexible to track over the guide wire and to avoid straightening the body vessel once it is in place.

[0011] When a combination of an expandable filter and guide wire is utilized, it is important that the expandable filter remains flexible in order to negotiate the often tortuous anatomy through which it is being delivered. An expandable filter which is too stiff could prevent the device from reaching the desired deployment position within the patient's vasculature. As a result, there is a need to increase the flexibility of the expandable filter without compromising its structural integrity once in position within the patient's body vessel. Additionally, a fluoroscope is currently the most widely used instrument to visualize the filter during deployment and as such, requires an expandable filter having sufficient radiopacity to produce an identifiable image.

[0012] Expandable filters can be provided with high flexibility by forming the struts of the filter assembly from relatively thin material. However, the use of thin material often can reduce the radiopacity of the expandable filter, often making it difficult for the physician to visualize the filter during deployment. Conversely, the use of thicker materials, which can promote radiopacity of the expandable filter, usually reduces its flexibility, which may impair the deliverability of the expandable filter within the patient Since some expandable filter assemblies are made from nickel titanium alloys, which provide the self-expansion characteristics to the filter assembly, there may be a need for increasing radiopacity since nickel titanium generally has a low degree of radiopacity. Moreover, the radiopacity of an expandable filtering assembly which utilizes nickel titanium can be greatly reduced if the struts of the filter assembly are formed thinner in order to increase the flexibility of the filter assembly. Therefore, there is a need for a careful balance between achieving high flexibility in the filter assembly while maintaining sufficient radiopacity to allow the device to be visualized using current visualization equipment.

[0013] What has been needed is an expandable filter assembly having high flexibility with sufficient strength and radiopacity to be successfully deployed within a patient's vasculature to collect embolic debris which may be released into the patient's vasculature. The present invention disclosed herein satisfies these and other needs.

[0014] The present invention provides an expandable strut assembly and methods for making the same which can be used to create an embolic filtering device for capturing embolic debris created during the performance of a therapeutic interventional procedure, such as a balloon angioplasty or stenting procedure, in a body vessel. The present invention is particularly useful when an interventional procedure is being performed in critical arteries, such as the carotid arteries, in which vital downstream blood vessels can easily become blocked with embolic debris, including the main blood vessels leading to the brain. The present invention provides the physician with a flexible embolic filtering device which is sufficiently flexible to be steered through tortuous anatomy, but yet possesses sufficient strength to hold open a filtering element against the wall of the body vessel for capturing embolic debris. Moreover, the present invention provides sufficient flexibility without compromising the radiopacity characteristics of the filtering device. As a result, an embolic filtering device made in accordance with the present invention is relatively easy to deploy, has enhanced visibility under flouroscopy, and has good flexibility and conformable to the patient's anatomy.

[0015] An embolic filter assembly of the present invention utilizes an expandable strut assembly made from a self-expanding material, for example, nickel titanium (NiTi) or spring steel, and includes a number of outwardly extending struts capable of expanding from a collapsed position having a first delivery diameter to an expanded or deployed position having a second implanted diameter. A filter element made from an embolic-capturing material can be attached to the expandable strut assembly to move between the collapsed position and the deployed position with expandable struts.

[0016] The struts of the strut assembly can be set to remain in the expanded, deployed position until an external force is placed over the struts to collapse and move the struts to the collapsed position. One way of accomplishing this is through the use of a restraining sheath, for example, which can be placed over the filtering device in a coaxial fashion to contact the strut assembly and move the assembly into the collapsed position. The embolic filtering device can be implanted in the patient's vasculature and remain implanted for a period of time or can be attached to the distal end of an elongated member, such as a guide wire, for temporary placement in the vasculature. A guide wire is used in conjunction with the filtering device when embolic debris is to be filtered during an interventional procedure In this manner, the guide wire and filtering assembly, with the restraining sheath placed over the filter assembly, can be placed into the patient's vasculature. Once the physician properly manipulates the guide wire into the target area, the restraining sheath can be retracted to deploy the strut assembly into the expanded position. This can be easily performed by the physician by simply retracting the proximal end of the restraining sheath (located outside of the patient). Once the restraining sheath is retracted, the self-expanding properties of the strut assembly cause each strut to move in a outward, radial fashion away from the guide wire to contact the wall of the body vessel. As the struts expand radially, so does the filter element which will now be maintained in place to collect any embolic debris that may be released into the bloodstream as the physician performs the interventional procedure. The guide wire is used by the physician to deliver the necessary interventional device into the are of treatment. The deployed filter element captures embolic debris which may be created and released into the body vessel during the procedure.

[0017] The strut assembly which forms part of the filtering assembly includes portions in which the struts flex during delivery and recovery of the device within the patient's vasculature. Also, there are portions of the strut assembly which will remain relatively stable (i.e., largely undeformed or not flexed) during the travel through the sometimes tortuous pathway of the patient's vasculature. For example, as the embolic filtering device is being delivered through the patient's vasculature, it will bend longitudinally in order to cross and navigate the curves of the vasculature. When the strut assembly passes through such curved portions of the vasculature, the flexing portions of the strut assembly will resiliently flex while the stable portions remain largely unflexed or undeformed, even when the filtering assembly as a whole is being delivered through extremely tight turns. Thus, the strut assembly of the embolic filtering assembly can be thought of having both flexing portions and stable portions which cooperate with each other in order to provide a composite assembly having both the necessary flexibility and strength to create an effective embolic filtering device.

[0018] The flexibility of the strut assembly is largely derived from those portion of the struts which actually flex, without substantial assistance from the stable portions of the assembly Those stable portions are usually not subject to sufficient loads to cause bending when the composite device is delivered across curved portions of the anatomy since the flexing portions delivering the flexibility need to negotiate the turns. Accordingly, the stable portions of the strut assembly will remain substantially stiff and will not undergo substantial bending or flexing. As a result, these stable portions provide strength to the strut assembly which will be later needed when the strut assembly is expanded in the body vessel to maintain the filter element in its deployed position in the body vessel. Accordingly, the thickness or width of the stable portions of the strut assembly will not materially impact the overall flexibility or ease of delivering the embolic filtering assembly through the patient's vasculature.

[0019] The flexing portions of the strut assembly, on the other hand, can have reduced strut thickness or strut width to increase the strut assembly's overall ability to flex or bend as it is being delivered through the curved portions of the anatomy. Thus, in order to provide an optimal range of strength, flexibility and radiopacity, the present invention provides a strut assembly having thinner areas which promote flexibility, with greater strut thickness and/or widths in select stable areas to promote greater strength. This use of thicker and/or wider struts provides enhanced visibility by increasing the radiopacity in those select areas. By increasing the amount of material in the stable areas of the strut assembly, overall flexibility should not be impacted by the thicker or wider struts in the stable portions. On the other hand, a thinner and/or narrower strut can be utilized in the flexing portions to achieve the needed overall flexibility for the strut assembly. Again, the stable portions could utilize thicker struts or wider struts for increased radiopacity while the thinner, narrower struts in the flexing portions would create preferential bending points leading to enhanced conformability and flexibility.

[0020] Additionally, in embolic filtering devices which utilize a restraining sheath to deploy the self-expanding filter assembly, the surface area of the strut assembly in contact with the sheath can be decreased thereby reducing the amount of friction created between restraining sheath and strut assembly as the sheath is being retracted over the struts. As a result, it should be easier to retract the restraining sheath once the filter assembly is to be deployed in the patient's vasculature. The combination of these properties lead to an embolic filtering device which can be easy to deploy, is more visible under a fluoroscope, and has increased flexibility and conformability with the patient's anatomy. The present invention is also directed to various methods for making such an expandable strut assembly/filtering device.

[0021] It is to be understood that the present invention is not limited by the embodiments described herein. The present invention can be used in arteries, veins, and other body vessels. Other features and advantages of the present invention will become more apparent from the following detailed description of the invention, when taken in conjunction with the accompanying exemplary drawings.

[0036] Turning now to the drawings, in which like reference numerals represent like or corresponding elements in the drawings, FIGS. 1 and 2 illustrate one particular embodiment of an embolic filtering device 10 incorporating features of the present invention. This embolic filtering device 10 is designed to capture embolic debris which may be created and released into a body vessel during an interventional procedure. The embolic filtering device 10 includes an expandable filter assembly 12 having a self-expanding strut assembly 14 and a filter element 16 attached thereto. In this particular embodiment, the expandable filter assembly 12 is rotatably mounted on the distal end of an elongated tubular shaft, such as a steerable guide wire 18. A restraining or delivery sheath 20 (FIG. 3) extends coaxially along the guide wire 18 in order to maintain the expandable filter assembly 12 in its collapsed position until it is ready to be deployed within the patient's vasculature. The expandable filter assembly 12 is deployed by the physician by simply retracting the restraining sheath 20 proximally to expose the expandable filter assembly. The self-expanding strut assembly 14 thus becomes uncovered and immediately begins to expand within the body vessel (see FIG. 4).

[0037] It should be appreciated that the embolic filtering device 10 depicted herein is just one example of the numerous designs which can be used to create an embolic protection device made in accordance with the present invention. An obturator 22 affixed to the distal end of the filter assembly 12 can be implemented to prevent possible “snowplowing” of the embolic protection device as it is being delivered through the vasculature. The obturator can be made from a soft polymeric material, such as Pebax D 40, and has a smooth surface to help the embolic filtering device travel through the vasculature and cross lesions while preventing the distal end of the restraining sheath 20 from “digging” or “snowplowing” into the wall of the body vessel. Additional details regarding the particular structure and shape of the various elements making up the filter assembly 12 are provided below.

[0038] In FIG. 3, the embolic filtering device 10 is shown as it is being delivered within an artery 24 or other body vessel of the patient. This portion of the artery 24 has an area of treatment 26 in which atherosclerotic plaque 28 has built up against the inside wall 30 of the artery 24. The filter assembly 12 is to be placed distal to, and downstream from, the area of treatment 26 as is shown in FIGS. 3 and 4. The therapeutic interventional procedure may comprise the implantation of a stent (not shown) to increase the diameter of an occluded artery and increase the flow of blood therethrough. It should be appreciated that the embodiments of the embolic filtering device and method for manufacturing and using the same are illustrated and described herein by way of example only and not by way of limitation. Also, while the present invention is described in detail as applied to an artery of the patient, those skilled in the art will appreciate that it can also be used in other body vessels, such as the coronary arteries, carotid arteries, renal arteries, saphenous vein grafts and other peripheral arteries. Additionally, the present invention can be utilized when a physician performs any one of a number of interventional procedures, such as balloon angioplasty, laser angioplasty or atherectomy which generally require an embolic filtering device to capture embolic debris created during the procedure.

[0039] The strut assembly 14 includes self-expanding struts 32 which, upon release from the restraining sheath 20, expand the filter element 16 into its deployed position within the artery (FIG. 4). When the struts 32 are expanded, the filter element 16 may take on a basket shape, or any other shape, that will adequately deploy the filter element 16 against the wall of the artery. Embolic debris created during the interventional procedure and released into the bloodstream are captured within the deployed filter element 16. Although not shown, a balloon angioplasty catheter can be initially introduced within the patient's vasculature in a conventional SELDINGER technique through a guiding catheter (not shown). The guide wire 18 is disposed through the area of treatment and the dilatation catheter can be advanced over the guide wire 18 within the artery 24 until the balloon portion is directly in the area of treatment 26. The balloon of the dilatation catheter can be expanded, expanding the plaque 28 against the inside wall 30 of the artery 24 to expand the artery and reduce the blockage in the vessel at the position of the plaque 28. After the dilatation catheter is removed from the patient's vasculature, a stent (not shown) could be implanted in the area of treatment 26 using over-the-wire techniques to help hold and maintain open this portion of the artery 24 and help prevent restenosis from occurring in the area of treatment. The stent could be delivered to the area of treatment on a stent delivery catheter (not shown) which is advanced from the proximal end of the guide wire to the area of treatment. Any embolic debris created during the interventional procedure will be released into the bloodstream and should enter the filter 16. Once the procedure is completed, the interventional device is removed from the guide wire and the filter assembly 14 is to be collapsed and removed from the artery 24, taking with it any embolic debris trapped within the filter element 16. A recovery sheath (not shown) can be delivered over the guide wire 18 to collapse the filter assembly for removal from the patient's vasculature.

[0040] The ability of the embolic filtering device to negotiate the sometime tortuous anatomy of the patient results from the flexibility associated with the strut assembly 14 which forms part of the filter assembly 12. Referring specifically now to FIGS. 6 and 7, one particular embodiment of a strut assembly 14 is shown which incorporates features of the present invention. It should be appreciated by those skilled in the art that this is just one particular structure incorporating struts which form a basket-like structure that can be used in accordance with the present invention. Many other structural designs could also be implemented to create the strut assembly without departing from the spirit and scope of the present invention.

[0041] The struts 32 which form the strut assembly 14 shown in FIGS. 6 and 7 include flexing portions 36 in which the struts or portions of the struts flex or otherwise resiliently bend both during delivery and recovery of the embolic filtering device. Also, there are stable portions 38 of the strut assembly which remain stable (i.e., largely undeformed or unflexed) during delivery through the vasculature. For example, as the embolic filtering device is being delivered through the patient's vasculature, it will bend longitudinally to cross and navigate the curves of the vasculature. When the strut assembly passes through such curved portions, the flexing portions 36 of the assembly will flex while the remaining portions stay relatively unflexed or stiff, even as the filtering assembly as a whole is bent through extremely tight turns. The flexing portions 36 and stable portions 38 thus cooperate with each other in order to provide the necessary flexibility to bend and be delivered through tight turns. The strength of the strut assembly 14 is achieved by the stable portions 38 once the strut assembly is deployed in the body vessel.

[0042] The flexibility of the strut assembly 14 is largely derived from the flexing portions 36 of the strut, without substantial assistance from the stable portions 38 of the assembly, even though stable portions 38 are subjected to some bending forces when the device is being delivered across curved portions of the anatomy. Accordingly, the stable portions 38 will remain substantially straight and will not undergo substantial bending or flexing. These stable portions 38 do have sufficient strength to provide the structural integrity needed to maintain the filter assembly 12 in its expanded position once placed in the artery. The strong stable portions 38 also provide additional metal to the strut assembly which allows the embolic filtering device 10 to become more visible utilizing equipment, such as a fluoroscope, to determine the location of the device within the patient's anatomy. As can be seen in FIGS. 6 and 7, the stable portions 38 include strut portions which have greater strut depth or thickness than the portion of the struts which are located in the flex portions 36. As can be seen specifically in FIG. 7, the thickness of the strut or the strut depth is the measurement of the strut from the inner surface 40 to the outer surface 42 of the strut. In FIG. 7, arrows T₁ show the greater strut thickness in the stable portions 38 which provides the higher strength and radiopacity than the strut thickness in the flex portions 36 (indicated by arrows T₂). The strut thickness in the flex portions 38 depicted by arrows T₂ is less than the strut thickness in the stable portion 36, thus providing increased flexibility to the strut assembly 14.

[0043] The stable portion 38 may also include struts which have greater strut widths than the struts which are located in the flexing portions 36 of the strut assembly 14. In FIG. 7, arrows W₁ show the wider strut formed in the stable portions 38. Arrows W₂ show the smaller strut widths appearing in the flexing portions 36. The smaller strut width provides greater flexibility, enhancing the ability of the strut assembly 14 to negotiate the tortuous anatomy of the patient. As a result, the flexing portions 36 may include both smaller strut thickness and a smaller strut width to provide this increased flexibility. The flexing portions can be thought of somewhat as mechanical hinges which provide regions of articulation to the strut assembly. Conversely, the stable portions 38 may include struts having greater strut thickness, and strut width to provide additional strength and added mass to increase the level of radiopacity of the strut assembly 14. As is shown in FIG. 6, there are several areas in which flexing portions 36 are located to provide the increased flexibility needed to maneuver in the patient's vasculature. It should be appreciated that the number, size and location of flexing portions 36 and stable portions 38 of the strut assembly 14 will vary depending upon the particular structure utilized to create the strut assembly.

[0044] The current invention provides additional strut thickness and/or width to all or part of the stable portions of the strut assembly. FIGS. 8A-8D depicts a partially fragmented perspective view of a portion of a strut similar to that shown in FIGS. 6 and 7 which shows different ways of increasing the mass of the strut in the stable portion of the strut assembly. In FIG. 8A, it can be seen that all portions of the strut 44 have the same, or a nominal strut depth 46 and a constant strut width 48. In the embodiment shown in FIG. 8A, there are no stable portions or flex portions due to the fact that the nominal thickness 46 and nominal strut width 48 are substantially uniform throughout. Many prior art filtering devices are made with struts having uniform strut thickness and width. Bending occurs on those devices at points along the strut assembly which are most vulnerable to bending forces. In such devices, there are no specifically formed flexible struts which are designed to flex and bend and take the brunt of the bending forces that can be generated during passage of the device through the patient's vasculature. In FIG. 8B, however, the strut pattern 50 has both stable portions 38 and flexing portions 36. The stable portion 38 is made with a material which has greater than nominal depth 52 and greater than nominal width 54 without compromising the flexibility of the struts in the flexing portion 36. When used on the strut assembly, these thicker and wider struts in the stable portions 38 provide additional strength and enhanced radiopacity characteristics to the strut assembly 14. FIG. 8C depicts a further embodiment of stable portions 38 of a strut 56 having varying strut thickness which smoothly transitions from a nominal strut thickness 46 to a greater-than-nominal thickness 52. In the particular embodiment of FIG. 8C, the strut width 58 is substantially the same. However, due to the greater than nominal strut thickness 52 in the stable portions 38, additional strength and increased radiopacity will be provided to the strut assembly. FIG. 8D provides still another embodiment of a strut portion 60 of a strut assembly in which unique stable portions 38 can be found. In this particular embodiment, the stable portion 38 is made from a geometry which includes a “bump” pattern generating a greater-than-nominal strut thickness 52 in a desired area. The bumps 62 formed in the stable portions 38 would be inherent in the material used to create the strut assembly. Also, in the embodiments shown in FIGS. 8C and 8D, when a restraining sheath is utilized to deploy and retrieve the filter assembly, the variable thickness design effectively reduces the surface area of the strut in contact with sheath, thereby reducing frictional forces which can be generated as the restraining sheath moves over the strut assembly. As a result, the restraining sheath should slide off of the strut assembly with less resistance.

[0045] The preparation of a strut assembly in accordance with the present invention can be accomplished in a variety of ways. An initial step would be to select a particular pattern for the struts and identify stable portions and flexing portions. The identification of stable portions can be accomplished using many different techniques. For example, a computer base modeling of a strut pattern can be performed that models the embolic protection device during bending of the strut assembly. Alternatively, a physical model or actual embolic protection device bearing the particular strut pattern could be prepared and subject to bending, so that flexing and stable portions of the strut assembly could be identified through inspection of the physical device. Other approaches for identifying the flexing portions and stable portions would be well-known in the art and are within the scope of the present invention.

[0046] After identification of the stable and flexing portions has occurred, a strut assembly can be prepared having the desired strut pattern, with the variations in the strut thickness and/or strut widths associated with the flexing portions and stable portions. Various techniques could be utilized to manufacture the strut assembly. For example, the strut assembly could be prepared from a tubular member having a nominal thickness with the strut pattern being laser cut or otherwise cut to create a rough pattern. Additional material could then be added to the surface of the cut strut pattern on selected stable portions until the selected stable portions reach the desired greater-than-nominal strut depth or greater-than-nominal width, depending again, on the particular pattern which is to be utilized. Various techniques could be used to add the additional material, including sputter coating, electroplating, or chemical vapor deposition.

[0047] Referring now to FIGS. 9A-9C, a particular strut pattern 66 which forms the strut assembly 14, is depicted two-dimensionally (FIG. 9B) as if the strut assembly 14 were cut longitudinally and “unrolled” to form a flat sheet, showing the combination of flex portions 36 and stable portions 38 which, in combination, create the strut assembly 14. FIG. 9A shows a cross-sectional view of a tubular member 68 which could be utilized and laser cut in order to create the varying strut thicknesses of the strut assembly shown in FIG. 9B. As is shown, the tubular member 68 has different wall thicknesses which correspond to the flexing portions 36 and stable portions 38 of the strut assembly 14. The areas 70 which have larger-than-nominal strut thickness in the tubular member are utilized to create the stable regions 38 of the strut assembly. As can be seen in FIGS. 9A and 9C, the wall thicknesses in the areas forming the stable regions 38 can vary. For example, areas 70 have the same wall thickness T₁. However, the wall thickness T₃ in area 72 forming another stable region has an even greater wall thickness than area 70. This creates an even larger strut thickness in those stable regions of the strut assembly. Area 74, which forms the flexing portions of the strut assembly, has a wall thickness T₂ which is less than T₁ and T₃. Moreover, the width can be increased in those regions as well. In a similar fashion, the strut widths and strut depths in the flexing regions can vary on the strut assembly as well. For example, as can be seen in FIG. 9B, certain strut widths in flexing portions 76 are smaller than the strut widths in the other flexing portions 36. The strut thickness in these areas could also be less-than-nominal strut thickness to provide even increased flexibility. Moreover, the flexing portions can have varying strut thickness, similar to the varying strut thickness of the stable portions 38 depicted in FIG. 8C. The free ends of the struts could be attached to collars 31, as is shown in FIG. 6, which help form the particular shape of the strut assembly disclosed herein. The free ends 78 of the struts could be attached to the collars using well-known bonding techniques known in the art, including welding, brazing, and adhesive bonding. It should be appreciated that numerous variations of strut width and depths in the various stable and flexing portions of the strut assembly can be achieved in accordance with the present invention.

[0048] Due to manufacturing and other considerations, it may be desireable to start with a tubular member having a desired larger than nominal thickness, and then selectively reduce the thickness of desired portions, such as the flexing portions, to create a nominal thickness or even a less-than-nominal thickness. In this particular manner, the tubular member shown in FIG. 9A would have a greater-than-nominal thickness and selected portions of the outer surface would be removed to create the nominal thickness utilized to create the flexing portions of the strut assembly. In the embodiment shown in FIG. 9A, the machining could involve rotating the tubular member along its longitudinal axis, as may be accomplished utilizing a lathe or other rotating device, and pressing a machine tool against the outer surface. Other techniques include chemical etching, laser ablation, grinding, or milling. Once the particular form of the tubular member is selected, the pattern which forms the strut assembly could then be cut into the tubular member. In this manner, the width of the struts in the stable portions could be cut to be larger than the struts in the flexing portions, as is shown in FIG. 9B. Any one of a number of different combinations of stable portions and flexing portions can be utilized, as will be appreciated by those skilled in the art, to create the particular pattern for the strut assembly. Accordingly, a strut assembly will have flexing portions having a nominal thickness and/or nominal strut width, with stable portions having greater than nominal thickness and/or greater than nominal strut widths.

[0049] In addition to the physical machining methods discussed above, the reduction in strut thickness could also be achieved through a variety of other methods, including ablating selected surface areas. The ablation could be formed through various methods, including chemical and/or laser ablation. This step may also be formed as part of the process of cutting the strut pattern into the tubular member. For example, where laser cutting is used to cut the strut pattern, the laser might also be used to thin desired portions of the tubular member. Such thining using a laser might involve changing the focus depth of the laser, changing laser power, or using the laser to tangentially “shave” across the surface of the tubular member thereby removing a layer of material.

[0050] The strut assembly of the present invention can be made in many ways. However, the one particular method of making the strut assembly is to cut a thin-walled tubular member, such as nickel-titanium hypotube, to remove portions of the tubing in the desired pattern for each strut, leaving relatively untouched the portions of the tubing which are to form each strut. The tubing may be cut into the desired pattern by means of a machine-controlled laser. Prior to laser cutting the strut pattern, the tubular member could be formed with varying wall thicknesses which will be used to create the stable and flexing portions of the strut assembly.

[0051] The tubing used to make the strut assembly could possible be made of suitable biocompatible material such as stainless steel. The stainless steel tube may be alloy-type: 316L SS, Special Chemistry per ASTM F138-92 or ASTM F139-92 grade 2. Special Chemistry of type 316L per ASTM F138-92 or ASTM F139-92 Stainless Steel for Surgical Implants in weight percent.

[0052] The strut size is usually very small, so the tubing from which it is made must necessarily also have a small diameter. Typically, the tubing has an outer diameter on the order of about 0.020-0.040 inches in the unexpanded condition. The greater-than-nominal wall thickness of the tubing is usually about 0.076 mm (0.003-0.006 inches). As can be appreciated, the nominal strut depth in the flexing portions will be less. For strut assemblies implanted in body lumens, such as PTA applications, the dimensions of the tubing may be correspondingly larger. While it is preferred that the strut assembly be made from laser cut tubing, those skilled in the art will realize that the strut assembly can be laser cut from a flat sheet and then rolled up in a cylindrical configuration with the longitudinal edges welded to form a cylindrical member.

[0053] Generally, the hypotube is put in a rotatable collet fixture of a machine-controlled apparatus for positioning the tubing relative to a laser. According to machine-encoded instructions, the tubing is then rotated and moved longitudinally relative to the laser which is also machine-controlled. The laser selectively removes the material from the tubing by ablation and a pattern is cut into the tube. The tube is therefore cut into the discrete pattern of the finished struts. The strut assembly can thus be laser cut much like a stent is laser cut. Details on how the tubing can be cut by a laser are found in U.S. Pat. No. 5,759,192 (Saunders) and U.S. Pat. No. 5,780,807 (Saunders), which have been assigned to Advanced Cardiovascular Systems, Inc.

[0054] The process of cutting a pattern for the strut assembly into the tubing generally is automated except for loading and unloading the length of tubing. For example, a pattern can be cut in tubing using a CNC-opposing collet fixture for axial rotation of the length of tubing, in conjunction with CNC X/Y table to move the length of tubing axially relative to a machine-controlled laser as described. The entire space between collets can be patterned using the CO₂ or Nd:YAG laser set-up. The program for control of the apparatus is dependent on the particular configuration used and the pattern to be ablated in the coding.

[0055] A suitable composition of nickel-titanium which can be used to manufacture the strut assembly of the present invention is approximately 55% nickel and 45% titanium (by weight) with trace amounts of other elements making up about 0.5% of the composition. The austenite finish transformation temperature is between about 0° C. and 20° C. in order to achieve superelasticity. The austenite finish temperature is measured by the bend and free recovery tangent method. The upper plateau strength is about a minimum of 60,000 psi with an ultimate tensile strength of a minimum of about 155,000 psi. The permanent set (after applying 8% strain and unloading), is approximately 0.5%. The breaking elongation is a minimum of 10%. It should be appreciated that other compositions of nickel-titanium can be utilized, as can other self-expanding alloys, to obtain the same features of a self-expanding stent made in accordance with the present invention.

[0056] The strut assembly of the present invention can be laser cut from a tube of nickel-titanium (Nitinol) whose transformation temperature is below body temperature. After the strut pattern is cut into the hypotube, the tubing is expanded and heat treated to be stable at the desired final diameter. The heat treatment also controls the transformation temperature of the strut assembly such that it is super elastic at body temperature. The transformation temperature is at or below body temperature so that the stent is superelastic at body temperature. The strut assembly is usually implanted into the target vessel which is smaller than the diameter if the strut assembly in the expanded position so that the struts apply a force to the vessel wall to maintain the filter element in the expanded position. It should be appreciated that the strut assembly can be made from either superelastic, stress-induced martensite NiTi or shape-memory NiTi.

[0057] One way of making the strut assemblies of the present device is to utilize a shape-memory material, such as nickel titanium, which has the struts cut utilizing a machine-controlled laser. A tubular piece of material could be utilized in this process. The strut assembly could be manufactured to remain in its open position while at body temperature and would move to its collapsed position upon application of a low temperature. One suitable method to allow the strut assembly to assume a phase change which would facilitate the strut and filter assembly being mounted into the restraining sheath include chilling the filter assembly in a cooling chamber maintained at a temperature below the martensite finish temperature through the use of liquid nitrogen. Once the strut assembly is placed in its collapsed state, the restraining sheath can be placed over the device to prevent the device from expanding once the temperature is brought up to body temperature. Thereafter, once the device is to be utilized, the restraining sheath is simply retracted to allow the filter assembly/strut assembly to move to its expanded position within the patient's vasculature. If superelastic NiTi is used, the strut assembly/filter assembly can be simply back loaded into the restraining sheath. The strut assembly would be “set” to the expanded position.

[0058] The polymeric material which can be utilized to create the filtering element include, but is not limited to, polyurethane and Gortex, a commercially available material. Other possible suitable materials include ePTFE. The material can be elastic or non-elastic. The wall thickness of the filtering element can be about 0.00050-0.0050 inches. The wall thickness may vary depending on the particular material selected. The material can be made into a cone or similarly sized shape utilizing blow-mold technology. The perfusion openings can be any different shape or size. A laser, a heated rod or other process can be utilized to create to perfusion openings in the filter material. The holes, would of course be properly sized to catch the particular size of embolic debris of interest. Holes can be lazed in a spiral pattern with some similar pattern which will aid in the re-wrapping of the media during closure of the device. Additionally, the filter material can have a “set” put in it much like the “set” used in dilatation balloons to make the filter element re-wrap more easily when placed in the collapsed position.

[0059] The materials which can be utilized for the restraining sheath and recovery sheath can be made from polymeric material such as cross-linked HDPE. These sheaths can alternatively be made from a material such as polyolifin which has sufficient strength to hold the compressed strut assembly and has relatively low frictional characteristics to minimize any friction between the filtering assembly and the sheath. Friction can be further reduced by applying a coat of silicone lubricant, such as Microglide®, to the inside surface of the restraining sheath before the sheaths are placed over the filtering assembly.

[0060] Further modifications and improvements may additionally be made to the device and method disclosed herein without departing from the scope of the present invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.