Abstract:
An embolic protection device provides a filter membrane for removing emboli from a fluid flowing in a vessel of a patient. The filter membrane is mounted on a filter frame having an integrated strain relief mechanism that provides strain relief and kink resistance in the transition between the relatively stiff filter and the flexible distal tip of the guidewire that is used to guide the filter into the treatment area. The strain relief mechanism is one or more cuts through the distal end of the filter frame. The cut pattern, pitch and variation of the pitch from one end to the other provides a way of fine-tuning the strain relief to a wide variety of filter frames, guidewires and flexible distal guidewire tips.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to an embolic protection device for use in percutaneous procedures and, more particularly, to an improved embolic protection device for filtering bodily fluids flowing through a vessel of a patient by providing a strain relief between the filter frame and the distal end of the device to provide easier access of the device distal to the treatment site. 
       BACKGROUND OF THE INVENTION 
       [0002]    Various surgical and intravenous treatments have been developed for treating and/or removing obstructions such as plaque in stenosed regions of vessels of a patient. In balloon angioplasty, a balloon placed on the distal end of a catheter is inflated, usually with a fluid, in order to dilate the stenosed region of the vessel thereby improving fluid flow. In addition a stent may be placed in the stenosed region of the vessel in order to reduce the occurrence and severity of restenosis of the vessel. In an atherectomy or thrombectomy, a rotating blade or other similar cutting device can be used to remove plaque in a stenosed region. Surgery may also be used to remove plaque and improve fluid flow in the vessel. All of these treatments result in the production of small particles of plaque or other materials resulting in emboli that can travel in the direction of fluid flow in the vessel and block smaller vessels downstream of the stenosis resulting in stroke, tissue damage or other problems. 
         [0003]    In order to prevent such an occurrence various embolic protection devices have been suggested that place a filter distal to the stenosed region before and/or during the angioplasty, stenting, atherectomy or other emboli producing procedure. One type of filter is a woven wire mesh filter. Another type of filter is a polymeric material with filter pores placed on or around a filter frame often made of a self-expanding shape-memory metal such as a nickel-titanium alloy known as nitinol. These filter elements are mounted on the distal end of a guidewire or other elongated member which is used to place the filter into the vessel of the body through an external opening in the body containing the vessel. In some systems a guidewire is first inserted into the lumen of the vessel and is directed past a lesion or other area of interest. After insertion of the guidewire a filter element is pushed along the wire past the lesion or other area of interest where it is deployed. For example, U.S. Pat. No. 6,179,859 issued to Bates et al. and entitled “Emboli Filtration System and Method of Use” describes a filter that is restrained in a delivery sheath until it is placed in the vessel. 
         [0004]    In another type of embolic protection system the guidewire and filter element are simultaneously inserted into the lumen of the vessel and the filter element is directed past the lesion or other area of interest where it is deployed. For example, in U.S. Pat. No. 6,468,291 issued to Bates et al. and entitled “Emboli Filtration System Having Integral Strut Arrangement and Methods of Use” such an embolic protection device is disclosed. 
         [0005]    In an embolic protection device filter elements are usually mounted on one or more collars either at the distal end, the proximal end or both. These collars are then either fixed to the guidewire or are allowed to travel between one or more stops placed on the guidewire to allow longitudinal movement of the guidewire in relation to the filter. The proximal and distal collars of the filter basket may be allowed to rotate on the guidewire to provide rotational movement of the guidewire relative to the filter. 
         [0006]    In an embolic protection device, the guidewire and/or the delivery sheath restraining the embolic protection device is pushed through the vessel. Ideally, the performance of the embolic protection device and guidewire system should be the same as a guidewire alone. In many embolic protection devices when the filter is captured within its delivery sheath the device is relatively stiff at the distal end of the filter. The guidewire, however, usually has a very flexible coil tip so as to be atraumatic and maneuverable. The transition between the stiff distal end of the filter and the flexible coil tip of the guidewire is prone to kinking. It would, therefore, be desirable to provide an embolic protection device that could reduce kinking at this transition in order to provide a more maneuverable and useful device. 
         [0007]    It would also be desirable to have an embolic protection device wherein the strain relief could be easily changed or “tuned” in order to accommodate differences between various filters, guidewires and atraumatic guidewire tips. 
         [0008]    The filter frame and filter have a larger diameter than the central guidewire core thereby causing a step transition between the guidewire core and the filter frame at the distal end. This step transition can cause problems within the vessel during implementation of the device. Furthermore, it would be desirable to have an embolic protection device in which there is a smooth transition between the atraumatic distal tip and the filter frame. 
       SUMMARY OF THE INVENTION 
       [0009]    The present invention generally relates to an embolic protection device for capture and removal of emboli from a fluid flowing in a vessel. More particularly, the invention relates to the filter frame, particularly the transition of the distal end of the filter frame to the guidewire or core wire that is used to guide the embolic protection device into place. In the present invention a portion of the distal section or distal collar of the filter frame is cut in various configurations in order to provide an integrated strain relief element in this transition area. 
         [0010]    The strain relief element may also be tapered so as to provide a smooth transition between the guidewire or core wire and the filter frame so as to avoid a problematic step transition. The strain relief element may be covered with a sleeve, such as a polymeric sleeve, to create an atraumatic transition. 
         [0011]    The strain relief element of the present invention can be “tuned” by changing the cut pattern, the pitch of the cut and how the pitch varies to the distal end of the filter frame. Additionally, because the strain relief element is integral to the filter frame there is less chance of the strain relief element breaking away from the embolic protection device and thereby causing a hazard in the patient. 
         [0012]    The strain relief element may be a single spiral cut or double spiral cut pattern or may have an interlocking castellated pattern. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  is an elevational view of a first embodiment of an embolic protection device in accordance with the present invention. 
           [0014]      FIG. 2  is a perspective view of a flexed filter frame and guidewire core of the embolic protection device of  FIG. 1  in accordance with the present invention. 
           [0015]      FIG. 3  is an elevational view of a portion of the filter frame of an embolic protection device having a spiraling integrated strain relief in accordance with the present invention. 
           [0016]      FIG. 4  is an elevational view a portion of an embolic protection device having integrated strain relief with a polymeric sleeve thereon. 
           [0017]      FIG. 5  is an elevational view of the filter frame of an embolic protection device in accordance with the present invention. 
           [0018]      FIG. 6  is an elevational view of the distal end of the filter frame of an embolic protection device in accordance with the present invention. 
           [0019]      FIG. 7  is a cut pattern for a 4-8-4 filter frame having spiraling integrated strain relief in accordance with the present invention. 
           [0020]      FIG. 8  is a cut pattern for a 6-12-6 filter frame having a spiraling slotted integrated strain relief in accordance with the present invention. 
           [0021]      FIG. 9  is a cut pattern for a 4-8-4 filter frame having a spiraling slotted integrated strain relief in accordance with the present invention. 
           [0022]      FIG. 10  a cut pattern for the distal end of a 4-8-4 filter frame having spiraling integrated strain relief in accordance with the present invention. 
           [0023]      FIG. 11  a cut pattern for the distal end of a 4-8-4 filter frame having spiraling integrated strain relief in accordance with the present invention. 
           [0024]      FIG. 12  is a cut pattern for the distal end of a 4-8-4 filter frame having spiraling castellated integrated strain relief in accordance with the present invention. 
           [0025]      FIG. 13  is a partial cross-sectional and elevational view of an embodiment of a filter system with deployment sleeve in accordance with the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    Referring to  FIG. 1 , embolic protection device  100  comprises a guidewire core  102  having a proximal end  104  and a distal end  106 . Guidewire core  102  is of sufficient length to enable the user of the embolic protection device to route the device to a position in the lumen of a vessel where embolic protection is desired, such as distal to an area of plaque for which an angioplasty procedure is to be used to open the vessel. Typical lengths, y, of the guidewire core  102  are between 150 to 200 centimeter for rapid-exchange systems and between 280 and 330 cm over-the-wire systems but other lengths could be used depending on the application. Guidewire core  102  is metal, preferably stainless steel or another type of non-reactive metal or metal alloy with or without a lubricous coating. The types of lubricious coatings that can be applied to guidewire core  102  include Polytetrafluoroethylene (“PTFE”) coatings, silicone coatings and hydrophilic coatings. 
         [0027]    A tubular member  110  may be placed over a portion of guidewire core  102  near its distal end  106 . Tubular member  110  is a polymeric tube or coil wire tube. In a preferred embodiment a coil wire tube from Asahi Intec Co., Ltd. is used. Tubular member  110  has a diameter slightly larger than the diameter of the core guidewire core  102  at the distal end. The tolerance between the guidewire core  102  and the tubular member  110  is preferably approximately 0.001″ but could be 0.0005 or greater. The tubular member  110  can also be coated with a lubricious coating, such as PTFE, internally and/or externally if desired. 
         [0028]    For a tubular member  110  that is a coil wire tube the ends are preferably soldered to prevent the wire from unraveling. Also, the ends of the tubing can be ground down a small amount if necessary to approximately 50% of the original wall thickness. 
         [0029]    Tubular member  110  may also be composed of a polymer polymeric blend or a polymer fabric. This would give the same torque characteristics, but would results in less stiffness of the distal end. Polymers that could be used for tubular member  110  include PEEK™ polymer from Victrex plc, polyamide, polyurethane, nylon PTFE and polyethylene, among others. VICTREX PEEK polymer, is a repeat unit that comprises of oxy-1,4-phenylenocoxy-1,4-phenylene-carbonyl-1,4-phenylene. PEEK is a linear aromatic polymer that is semi-crystalline. 
         [0030]    Tubular member  110  floats freely on the guidewire core  102  and is not attached to the guidewire core at any point along its length. Tubular member  110  is of a length, x, that is between approximately 10 and 40 centimeters for a rapid exchange system that would be between 150 to 200 centimeters in length. Preferably tubular member should have a length between 15 and 35 centimeters for such a rapid exchange system. Tubular member  110  should have a length between approximately 15 and 35 centimeters for an over-the-wire system that would be between approximately 280 and 330 centimeters in length. The important attribute of the present invention is that the tubular member  110  extend not only under the proximal end of filter  120  but that it extends a substantial distance proximal the filter  120 . Preferably tubular member  110  extends at least approximately 15 centimeters along the guidewire core  102  in the proximal direction. Too long of a tubular member will unnecessarily add to the cost of the device without providing significant added benefit. Additionally, a significantly longer tubular member  110  will result in reduced pushability. 
         [0031]    Tubular member  110  may also be significantly shorter at its proximal end or may be left out altogether provided that the longitudinal motion limiter  140  is moved near the proximal end of a shorter tubular member  110  or near the proximal end of the proximal collar  130  of filter frame  128 . If there is no tubular member  110  then the interior diameter of proximal collar  120  and distal collar  134  should be sized so as to float freely on guidewire core  102 . Alternatively, filter frame  128  may be fixed to the guidewire core  102  through any known means such as soldering, brazing, adhesive bonding or other fixation means. Fixation of the filter frame  128  will prevent rotation of the filter frame around guidewire core  128  and obviates the need for longitudinal motion limiter  140 . 
         [0032]    A longitudinal motion limiter  140  is a polymer sleeve or other motion limiting device attached to the core guidewire core  102  to prevent migration of the tubular member  110  toward the proximal end of the guidewire core  102 . Attachment of the polymer sleeve may be by any appropriate bonding means. Alternatively, guidewire core may be tapered at this point to transition to a larger diameter at the proximal end of the distal portion in order to prevent such migration. 
         [0033]    Filter  120  in  FIG. 1  is depicted as having a filter frame  128  having a plurality of proximal struts  122  connected at the proximal end to proximal collar  130  and at the distal end to apposition member  124 . The number of proximal struts is not critical to the invention, but preferably there are at least two proximal struts and more preferably four proximal struts. Apposition member  124  is used to provide proper apposition of the filter  120  against the wall of the vessel. Apposition member  124  is also connected to a plurality of distal struts  126  which are connected to a distal collar  130 . Preferably there are twice as many apposition members  124  as there are proximal struts  122  and an equal number of proximal struts and distal struts. Common strut configurations are 4-8-4 and 6-12-6 although other configurations could be used. Filter frame  128  may be constructed by cutting a single tube of material or may be constructed from a number of different combinations of proximal and distal struts and an apposition member, proximal collar and distal collar which may be interconnected by a number of known means such as welding, brazing or chemical bonding. Filter frame  128  may be made of any number of metal alloys but is preferably made from a “shape memory” metal such as nitinol. 
         [0034]    Filter membrane  129  is attached to filter frame  128  and may be comprised of a polymeric blend or may also be made of a thin film of nitinol or other similar metal exhibiting memory characteristics. If filter membrane  129  is a polymeric membrane it can be bonded to filter frame  128  or can be molded around the filter frame  128  as part of the manufacturing process. Filter membrane  129  contains a plurality of holes which are sized to provide a path for fluid flow but are not large enough to permit emboli to pass. The preferred hole size is 0.00394″ (0.1 mm) and there are preferably approximately 3100 holes per square centimeter. 
         [0035]    The distal end of filter frame  128  ends in a proximal collar  134 . As will be discussed in detail herein proximal collar  134  has an integral strain relief element  136  which can have a variety of configurations. Strain relief element  136  provides a tunable amount of flexibility depending on the pattern cut into the element. An optional sleeve  150  is a tapered polymeric sleeve or a tapered coil that provides an atraumatic transition between the distal end  106  of the guidewire core  102  and the filter  120 . Strain relief element may also be covered by a polymeric sleeve  150  as shown in  FIG. 4 . 
         [0036]    Other types of filter elements can be substituted for the filter  120  of  FIG. 1  of the present invention without departing from the spirit of the present invention. For example, filter  120  could be a wire mesh filter made of a woven wire fabric wherein the interstices between the metal wires provides the proper filtering function or a thin film nitinol mesh. Additionally filter  120  and/or filter membrane  129  could be comprised of woven polymeric threads. Filter  120  may be a self-actuating filter, i.e., one that expands to oppose the vessel wall upon removal from a restraining sheath or other restraining mechanism or the filter may be one that requires actuation such as through mechanical compression or inflation of an actuation balloon. A self-actuating filter is preferred because lack of an actuator results in a lower profile embolic protection device. Additionally, filter  120  could be a mechanically actuated filter requiring one or more wires, rods or other means of mechanical actuation. Other means of filter actuation are also possible. 
         [0037]      FIG. 2  shows a perspective view of a flexed filter frame  128  (the filter membrane is not shown) having an integrated strain relief element  136  and guidewire core  102 . In  FIG. 2  the strain relief element  136  has a double spiral cut pattern. As discussed in greater detail below, the pitch of the spiral cut pattern may be varied in order to change the flexibility of the strain relief element so as to provide the flexibility necessary for a specific application. 
         [0038]      FIG. 3  shows an elevational view of a central portion of the filter frame  128  not mounted on a guidewire core and without a filter membrane mounted thereon. Distal collar  134  has at its distal end the integrated strain relief member  136  which is a spiral cut “corkscrew” pattern. The width of the spiraling “corkscrew” element and the pitch of a spiral may be varied in order to produce variations in flexibility in the distal portion of the filter frame  128  in the transition to the distal tip of the guidewire core  102 . 
         [0039]      FIG. 4  shows an elevational view of the filter frame  128  having a filter membrane  129  mounted thereon. A portion of distal collar  134  of the filter frame and the strain relief element  136  are covered by a polymeric sleeve  150  providing an atraumatic transition between the distal end of the filter frame  128  and the guidewire core  102 . 
         [0040]      FIGS. 5 and 6  depict two elevational views of a filter element  128  in accordance with the present invention. In  FIG. 5  strain relief element  136  is substantially cylindrical and has a double spiral cut pattern while in  FIG. 6  strain relief element  136  is tapered along its length toward the distal end of the filter element and also has a double spiral cut pattern. The double spiral cut pattern is advantageous in that it provides symmetric bending properties while also providing an additional safety factor in that for the strain relief to separate from the filter assembly, multiple attachment sites must fracture. The taper should be between 0.5 degrees and 10 degrees from the longitudinal axis. A tapering distal end will create a smoother transition to guidewire core  102  and will make it easier to install a polymeric sleeve  150  at the distal transition. A tapered design will also provide the filter with the ability to track through calcification or deployed stents without the strain relief element catching on the obstruction, also known as a reduction in the “fish mouthing” of the strain relief. 
         [0041]      FIGS. 7-12  depict various patterns which can be used to create the strain relief element  136  of 4-8-4 filter frame  128 .  FIG. 7  shows a spiral cut pattern having an angle A of approximately 15 degrees where the width of material removed by the double spiral cut (C) is approximately 0.015 inch and the width of material remaining (B) is approximately 0.005 inch. Angle A may be varied to change the characteristics of the strain relief element  136  and should preferable be between 2 and 45 degrees. The ratio of width C to width B should be approximately 3:1, depending on degree of flexibility and rate of transition desired in the strain relief. The width (W) of distal collar  134  and strain relief element  136  together is approximately 0.146 inch although the length may vary depending on the strain relief characteristics desired. 
         [0042]    In  FIG. 8  the cut pattern for a 6-12-6 filter frame  128  is shown. Strain relief element  136  has a plurality of slots  138  made in a spiraling slot pattern with angle A starting at approximately 18 degrees and decreasing to approximately 12 degrees at the distal end at a rate of approximately 0.2 degree every one (1) spiral. Alternatively, angle A may also be kept at a constant 18 degrees. Slots at the distal end have a length E of approximately 0.026 inch and decrease in length as the spacing between spirally adjacent slots increases. Angle D is approximately 2 degrees. The width C of each slot  138  is approximately 0.003 inch. At the distal collar  134  a plurality of rectangular slots  137  are cut around the circumference with each slot having a width of approximately 0.10 inch and a height of 0.015 inch. The slots are an optional feature to ease in the manufacture and handling of the dipped filter membrane and also provide potential device crimping locations for marker bands etc. Width F at the proximal end of the distal collar is approximately 0.005 inch. The width (W) of distal collar  134  and strain relief element  136  together is approximately 0.308 inch although the length may vary. 
         [0043]      FIG. 9  is identical to  FIG. 8  in the strain relief section of the drawing. The difference is in the filter section proximal to the strain relief i.e. a 6-8-6 filter design versus a 4-8-4 filter design. 
         [0044]    An alternative cut pattern for distal strain relief element  136  is shown in  FIG. 10 . In  FIG. 10  the width C of the spiral of material cut from the tube of material is approximately 0.003 inch. Angle A is approximately 10 degrees at the proximal end of the strain relief element and is reduced by about 1 degree every third spiral. At the distal collar  134  a plurality of rectangular slots  137  are cut around the circumference with each slot having a width of approximately 0.010 inch and a height of 0.015 inch. Width F at the proximal end of the distal collar is approximately 0.008 inch. The width (W) of distal collar  134  and strain relief element  136  together is approximately 0.237 inch although the length may vary. 
         [0045]    An alternative cut pattern for distal strain relief element  136  is shown in  FIG. 11 . In  FIG. 11  the width C of the spiral of material cut from the tube of material is approximately 0.001 inch. Angle A is approximately  10  degrees at the proximal end of the strain relief element and is reduced by about 1 degree every third spiral. Width F at the proximal end of the distal collar is approximately 0.006 inch. A distal tip of material of width (T) is left uncut at the distal end of strain relief element  136 . In  FIG. 11  width T is 0.010 inch. This uncut material at the distal tip reduces the possibility of a portion of the spiral fracturing particularly when width C is narrow. The width (W) of distal collar  134  and strain relief element  136  together is approximately 0.241 inch although the length may vary. 
         [0046]    An alternative cut pattern for distal strain relief element  136  is shown in  FIG. 12 . In  FIG. 12  a castellated cut pattern creates a series of interlocking elements. Angle A is approximately 12 degrees at the proximal end of the strain relief element and is reduced by about 0.6 degree every third spiral. Width F at the proximal end of the distal collar is approximately 0.008 inch. A distal tip of material of width (T) is left uncut at the distal end of strain relief element  136 . In  FIG. 12  width T is 0.008 inch. The width (W) of distal collar  134  and strain relief element  136  together is approximately 0.242 inch although the length may vary. 
         [0047]    The filter frame  128  is typically made of a nickel-titanium (Nitinol) alloy cylinder having a thickness of between 0.002 and 0.010 inch. The various patterns for strain relief as well as the struts of the filter frame are cut into the cylinder using a laser. Integration of the strain relief reduces the manufacturing steps of making a separate component for the strain relief and then attaching the strain relief element to the distal collar of the filter frame. The spiral is formed by laser cutting and then is heat set around a mandrel of suitable diameter causing the remaining material to form (within limits) to the outer diameter of the mandrel. This provides the required inner diameter of the distal (or proximal) leg. The shape could be changed to form a gradual taper by using a tapered mandrel. 
         [0048]      FIG. 13  depicts an embodiment of an embolic protection filter system in accordance with the present invention. In  FIG. 13  the embolic protection device  100  is placed within a deployment and delivery system  500  that comprises a distal portion  510  coaxially disposed around the guidewire core  102  and the filter  120  with filter frame  128 , proximal collar  130 , distal collar  134 , strain relief element and tubular member  110 . Narrower proximal portion  508  of delivery system  500  is disposed around guidewire core  102 . In use the deployment and delivery system  500  with an embolic protection device  100  contained therein is placed through an incision in the patient into the lumen of a vessel of the patient. Once the distal end of the embolic protection filter system is placed distally of the region of interest and/or treatment such as a lesion, the filter is uncovered and the filter basket radially expands to oppose the lumen of the vessel of the patient. Upon completion of the procedure at the treatment site, the filter is collapsed using a retrieval catheter (not shown) as is known in the art. The embolic protection filter system is then removed from the vessel of the patient. 
         [0049]    The preceding description has been presented with reference to presently preferred embodiments of the invention. Workers skilled in the art and technology to which this invention pertains will appreciate that alterations and changes in the described structure may be practiced without meaningfully departing from the principal, spirit and scope of this invention. 
         [0050]    Accordingly, the foregoing description should not be read as pertaining only to the precise structures described and illustrated in the accompanying drawings, but rather should be read consistent with and as support to the following claims which are to have their fullest and fair scope.