Abstract:
A multi-purpose vascular device defines a lumen allowing fluid communication there through and has a coil with a side of the coil winds having solid physical connections between the coil winds to prevent the connected coil wind side from expanding following the application of force by an actuating member which causes the connected coil winds to have a predetermined configuration in an unstressed state. The application of longitudinal force causes the unconnected coil winds to expand, resulting in the vascular device assuming a different configuration.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to apparatus and methods for performing surgical procedures that access hollow conduits of mammalian anatomy. More particularly, the invention discloses a multi-function device for navigating tortuous vascular pathways, reaching and then crossing total occlusions in blood vessels. 
       BACKGROUND 
       [0002]    Intracorporal medical devices have been developed and used to navigate and access the tortuous vascular and other hollow conduits of a mammalian body. Some of these devices include guidewires, catheters, intravenous guidewires, stylets, intravenous catheters and related devices like endoscopes and colonoscopes that have a predetermined degree of flexibility and may have straight or pre-formed, shaped ends to guide the device through the anatomical conduit. Of the devices that are employed to reach vascular blockages, each has certain advantages and disadvantages. Many fall short of desired performance before reaching a vascular blockage because of a device prolapse at a vascular bifurcation, an inability to enter a bifurcation or be directed to the site of therapy. Others may reach an occlusion but then require a different device to be introduced before crossing the stenosis. The medical industry has striven to reach a balance between the flexibility required to negotiate around tortuous pathways and the rigidity necessary to stabilize a catheter&#39;s advancement. Many products such as intravenous interventional guidewires provide directability, flexibility or stiffness but fail to do all or a combination at the same time. These products typically have pre-formed flexible distal ends that provide minimal directability but not true directability, flexibility and stiffness combined, which would be the most useful advantage. Additionally, most physicians must use a series of different diameter guidewires to perform one procedure, creating a procedure that costs additional time, money and risks patient safety from vascular injury. 
         [0003]    Accessing occlusions having relatively sharp angles and passage constrictions using conventional guidewires having pre-formed “J” shapes or angled distal ends requires rotating the guidewire while simultaneously moving it proximally and distally. This action can cause damage to the fragile endothelial cell layer lining blood vessels. Additionally, conventional guidewires can lose their ability to be rotated when the flexible distal ends enter vessels of reduced diameter. Rotation of the guidewire following inserting the distal end into a vessel having a reduced diameter produces high frictional forces between the walls of the small vessels and the guidewire. A desirable device would therefore require reduced rotation and increased ability to advance in a forward or distal direction through tortuous anatomies. 
         [0004]    Another undesirable characteristic of conventional guidewires is the inability to support a catheter at the flexible, tapered, distal end. When a catheter is advanced toward a vascular location in and close to a bifurcation, the catheter tends to proceed in a straight line rather than following the guidewire, defined as prolapse. Further, the natural pulsation of the vascular system of a living animal can cause a conventional guidewire to move into or out of the body during the procedure, thereby losing its distal location. 
         [0005]    An additional disadvantage of a general use catheter is that it must be inserted into the body over a guidewire. Therefore, both a catheter and a guidewire must be used to reach a targeted site within the body. A single device that functions as an independent guidewire or both a catheter and a guidewire would save procedural time, reduce patient recovery time and cause less vascular damage to the patient. 
         [0006]    Still another disadvantage related to current practices resides in the catheter itself. Conventional catheters typically have totally open distal ends. Manufacturers have made efforts to design catheters with soft distal ends to minimize the extent of vascular damage when the open end engages the interior wall of blood vessels. This scraping of the endothelial layer results in a triggering of the auto immune system, causing clots to form at the damage site. Also, the distal end of the catheter may become clogged with material removed from the interior wall of the blood vessels. It is apparent that this bolus of material will be expelled from the distal catheter end when another device is inserted through the catheter. An all-in-one device having a soft, closed distal end that opens to allow other devices to be deployed from the distal end and then re-closing when the devices are withdrawn, would resolve this problem. 
         [0007]    Once the occlusion is reached, the objective is to cross the blockage with the guidewire or remove the guidewire and insert yet another device to cut through the occlusion. This is inherently disadvantageous in that additional time is required and a greater risk of vascular damage or perforation of the vessel wall is presented. Conventional devices used to cross the blockage are generally stiffer than conventional guidewires and when inside the catheter and reaching a bifurcation can cause the more flexible catheter to move away from the target site and follow the guide into the opposite branch of the bifurcation. 
         [0008]    Physicians generally have four objectives when using such vascular devices: (1) To reach the occlusion; (2) To reach the occlusion without causing vascular damage; (3) To cross the occlusion once it is reached; and (4) To reach the occlusion and cross it in as little time as possible. A device able to accomplish all four objectives would be extremely advantageous. It is not uncommon for a physician to place a catheter somewhere in a vessel and exchange the first guidewire with one or more secondary guidewires having progressively stiffer distal ends to prevent prolapse of the devices placed over the guidewire(s). Yet another advantage would be having a guidewire stiff enough to be pushed and yet be directed into branched vessels with minimal torquing. Still another advantage would be a multi-function device able to carry a second device that could bore its way through an occlusion. 
         [0009]    Vascular occlusions defined as Chronic Total Occulsions are blockages that can occur anywhere in a patient&#39;s vascular system, including coronary, carotid, renal, iliac, femoral, cerebral, popliteal and other peripheral arteries. 
         [0010]    U.S. Pat. No. 4,676,249 to Arenas discloses a guidewire having a moving internal member to provide stiffness when required, but does not disclose a directable distal end or the ability to cross occlusions. Another U.S. Pat. No. 5,542,434, discloses a longitudinally movable core wire made of a memory metal alloy that stiffens when subjected to thermal energy. This allows the wire to become stiff and yet torquable when desired, but fails when a catheter needs to be slid over the device. Both devices are deficient when they reach an occlusion with heavily calcified plaque in that they do not have the ability to bore through the occlusion. 
         [0011]    Using a conventional guidewire to reach the occlusion requires a catheter to be pushed over the guidewire, the final guidewire removed and then another device to be pushed through the catheter and used to cross the blockage. Such devices are generally known as percutaneous transluminal thrombectomy or artherectomy devices. These devices have various means to cross the occlusion and are singular devices lacking the ability to solely navigate the vasculature. As an example, one such device is disclosed in U.S. Pat. No. 6,945,951 and describes a thrombectomy catheter using high velocity saline through jets that erode away the blockage and cross an occlusion. 
         [0012]    For all these and other reasons there is a clear need for a single device that can vary its distal end, is relatively stiff, has the ability to cross an occlusion and/or a feature that can drill or bore its way through an occlusion. 
       SUMMARY 
       [0013]    In one aspect, the invention is directed to a vascular device including a shaft defining a longitudinal dimension, a lumen allowing fluid communication through the shaft extending along the longitudinal dimension and a proximal section and a distal section. The distal section further defines a weak side and a strong side and an actuating member is attached to the distal section, with the actuating member being capable of transmitting longitudinal force to the distal section. When longitudinal force is applied to the actuating member, the weak side of the distal section increases in size while the strong side maintains substantially the same size, resulting in the distal section deflecting. 
         [0014]    In another aspect, the invention is directed to a vascular device including a shaft defining a lateral dimension, a longitudinal dimension, a proximal section, a distal section having greater flexibility than the proximal section and a lumen allowing access through the shaft extending along the longitudinal dimension. The shaft at least partly defines a coil, and the coil further defines a distal end. An actuating member is attached to the coil, and is capable of transferring longitudinal force to the coil. A side of the coil winds is physically connected, defining a connected side, which maintains the coil winds on the connected side in a constant configuration preventing differential spacing resulting from the application of longitudinal force and causing the connected coil winds to have a predetermined configuration in an unstressed state. When longitudinal force is applied to the actuating member, an unconnected side of the coil winds expands, resulting in the vascular device assuming a stressed configuration having a different shape than the vascular device in the unstressed configuration. 
         [0015]    In a further aspect the invention is directed to a vascular device, including a shaft defining a lateral dimension, a longitudinal dimension, a proximal section, a distal section having greater flexibility than the proximal section and a lumen allowing access through the shaft extending along the longitudinal dimension. The shaft at least partly defines a coil, with the coil further defining a distal end. A flexible cutting shaft extends through the lumen and defines a proximal end and a distal end, with a cutting burr attached to the distal end of the cutting shaft. An actuating member is attached to the coil and is capable of transferring longitudinal force to the coil. A side of the coil winds is physically connected and defines a connected side, which maintains the coil winds on the connected side in a constant configuration preventing differential spacing resulting from the application of longitudinal force and causing the connected coil winds to have a predetermined configuration in an unstressed state. When longitudinal force is applied to the actuating member an unconnected side of the coil winds expands, resulting in the vascular device assuming a stressed configuration having a different shape than the vascular device in the unstressed configuration. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a cross sectional centerline view taken along the longitudinal axis of a vascular device of the present invention having a hollow actuating member. 
           [0017]      FIG. 1A  is a cross sectional centerline view taken along the longitudinal axis of the vascular device of  FIG. 1 , in a deflected configuration, following the application of distal force to the actuating member. 
           [0018]      FIG. 1B  is a cross sectional centerline view taken along the longitudinal axis of the vascular device of  FIG. 1 , in a deflected configuration, following the application of proximal force to the actuating member. 
           [0019]      FIG. 1C  is a lateral cross section view of the guidewire of  FIG. 1  taken through the lines  1 C- 1 C, illustrating the locations of the non-expandable side and expandable side. 
           [0020]      FIG. 2  is a cross sectional centerline view taken along the longitudinal axis of a vascular device of the present invention with a hollow conduit extending the length of the device and having a fibrous polymer or metal actuating member. 
           [0021]      FIG. 2A  is a cross sectional centerline view of the embodiment of the vascular device of  FIG. 2  in a deflected configuration following the application of proximal force. 
           [0022]      FIG. 2B  is a lateral cross section view of the guidewire of  FIG. 2  taken through the lines  2 B- 2 B, illustrating the locations of the non-expandable side and expandable side. 
           [0023]      FIG. 3  is a cross sectional centerline view taken along the longitudinal axis of an alternative embodiment of the vascular device having a hollow actuating member, a handle and a cutting burr. 
           [0024]      FIG. 3A  is a cross sectional centerline view of the embodiment shown in  FIG. 3  in a deflected configuration following the application of distal force. 
           [0025]      FIG. 3B  is a cross sectional centerline view of the embodiment shown in  FIG. 3  in a deflected configuration following the application of proximal force. 
           [0026]      FIG. 3C  is a lateral cross section view of the guidewire of  FIG. 3  taken through the lines  3 C- 3 C, illustrating the locations of the non-expandable side and expandable side. 
           [0027]      FIG. 4  is a cross sectional centerline view taken along the longitudinal axis of an alternative embodiment of the vascular device having a hollow actuating member, a handle and a cutting head which are covered by a sheath. 
           [0028]      FIG. 4A  is a side plan view of an embodiment of the vascular device shown in  FIG. 4 . 
           [0029]      FIG. 4B  is a cross sectional centerline view of the embodiment shown in  FIG. 4  in a deflected configuration following the application of distal force. 
           [0030]      FIG. 4C  is a cross sectional centerline view of the embodiment shown in  FIG. 4  in a deflected configuration following the application of proximal force. 
           [0031]      FIG. 4D  is a lateral cross section view of the guidewire of  FIG. 4  taken through the lines  4 D- 4 D, illustrating the locations of the non-expandable side and expandable side. 
           [0032]      FIG. 5A  shows the vascular device of  FIG. 3  in use following introduction into a patient, approaching an obstruction at the onset of treatment. 
           [0033]      FIG. 5B  shows the vascular device of  FIG. 3  in use during treatment. 
           [0034]      FIG. 5C  shows the vascular device of  FIG. 3  in use following completion of treatment. 
           [0035]      FIG. 5D  shows the vascular device of  FIG. 3  in use with the vascular device contained in a catheter used to aspirate debris from the treatment site. 
           [0036]      FIG. 5E  shows a vascular device similar to that shown in  FIG. 4 , having an angled cutting shaft, in use during treatment. 
       
    
    
     DETAILED DESCRIPTION 
     Nomenclature 
       [0037]      50  Catheter 
         [0038]      400  Vascular Device 
         [0039]      402  Hollow Shaft 
         [0040]      402   a  Proximal Termination of Hollow Shaft 
         [0041]      402   b  Distal Termination of Hollow Shaft 
         [0042]      404  Actuating Member 
         [0043]      406  Coil 
         [0044]      406   a  Open Wound Coil Section 
         [0045]      406   b  Solid Coil Section 
         [0046]      407  Distal Section 
         [0047]      408  Weld 
         [0048]      410  Distal Lumen Opening 
         [0049]      412  Proximal End of Solid Coil Section 
         [0050]      414  First Lumen 
         [0051]      416  Second Lumen 
         [0052]      418  Ribbon 
         [0053]      420  Cutting Head 
         [0054]      422  First Handle 
         [0055]      423  Third Handle 
         [0056]      424  Cutting Shaft 
         [0057]      424   a  Proximal End of Cutting Shaft 
         [0058]      424   b  Distal End of Cutting Shaft 
         [0059]      425  Second Handle 
         [0060]      426  Flattened Section of Coil 
         [0061]      428  Solder 
         [0062]      430  Non-Expandable Side 
         [0063]      432  Expandable Side 
         [0064]      500  Vascular Device 
         [0065]      502  Hollow Shaft 
         [0066]      504  Actuating Member 
         [0067]      505  Sheath 
         [0068]      506  Distal End (of Vascular Device) 
         [0069]      508  Slit 
         [0070]      510  Coil 
         [0071]      510   a  Open Wound Coil Section 
         [0072]      510   b  Solid Coil Section 
         [0073]      512  Weld 
         [0074]      514  First Lumen 
         [0075]      516  Second Lumen 
         [0076]      517  Distal Section 
         [0077]      518  Ribbon 
         [0078]      520  Cutting Head 
         [0079]      524  Cutting Shaft 
         [0080]      524   a  Proximal End of Cutting Shaft 
         [0081]      524   b  Distal End of Cutting Shaft 
         [0082]      526  Flattened Section of Coil 
         [0083]      528  Solder 
         [0084]      530  Non-Expandable Side 
         [0085]      532  Expandable Side 
         [0086]      534  First Handle 
         [0087]      536  Second Handle 
         [0088]      600  Vascular Device 
         [0089]      602  Coating 
         [0090]      604  Actuating Member 
         [0091]      606  First Lumen 
         [0092]      608  Coil 
         [0093]      610  Second Lumen 
         [0094]      612  Ribbon 
         [0095]      614  Open Coil Section 
         [0096]      615  Flattened Section of Coil 
         [0097]      616  Distal Closed Coil Section 
         [0098]      617  Distal Section (of Vascular Device) 
         [0099]      618  Actuating Member Attachment 
         [0100]      620  Distal First Lumen Opening 
         [0101]      622  Non-Expandable Side 
         [0102]      624  Expandable Side 
         [0103]      626  Handle 
         [0104]      628  Proximal Closed Coil Section 
         [0105]      718  Cutting Shaft 
         [0106]      720  Cutting Head 
         [0107]      722  Angle in Cutting Shaft 
         [0108]      1000  Vascular Vessel 
         [0109]      1002  Vascular Obstruction 
         [0110]      1002   a  Attached Obstruction 
         [0111]      1002   b  Obstruction Debris 
         [0112]      1400  Vascular Device 
         [0113]      1410  Central Space 
         [0114]      1412  Distal Section 
         [0115]      1412   a  Loose Wound Section 
         [0116]      1412   b  Tight Wound Section 
         [0117]      1414  Coil 
         [0118]      1415  Proximal Coil Section 
         [0119]      1416  Flattened Section of Coil 
         [0120]      1418  Ribbon 
         [0121]      1420  Hollow Member 
         [0122]      1422  Lumen 
         [0123]      1424  Solder 
         [0124]      1426  Coating 
         [0125]      1428  Distal End of Vascular Device 
         [0126]      1429  Proximal End of Coil 
         [0127]      1430  Actuating Member 
         [0128]      1432  Actuating Member Attachment 
         [0129]      1434  Distal End of Coil 
         [0130]      1436  Distal Lumen Opening 
         [0131]      1438  Non-Expandable Side 
         [0132]      1440  Expandable Side 
         [0133]      1442  Handle 
       Definitions 
       [0134]    “Anatomical Conduit” refers to a naturally occurring vessel or duct within a patient&#39;s body. 
         [0135]    “Distal” means further from the point controlled by the operator (e.g., physician or technician) of a device. 
         [0136]    “Distal Force” means force applied in a distal direction or toward a distal end of the device. 
         [0137]    “ePTFE” means expanded polytetrafluoroethylene. 
         [0138]    “FEP” means fluorinated ethylene-propylene. 
         [0139]    “Handle” means a device used to grip certain components of the invention for the purpose of causing longitudinal movement of additional components. 
         [0140]    “Longitudinal Force” means either distal force or proximal force. 
         [0141]    “Prolapse” refers to an adverse event occurring when a medical device does not follow the desired path at a vascular bifurcation but instead where a relatively stiff device forces a relatively less stiff device straight through the vessel, pulling the less stiff device out of the side branch of the bifurcation. 
         [0142]    “Proximal” means closer to the point controlled by the operator (e.g., physician or technician) of a device. 
         [0143]    “Proximal Force” means force applied in a proximal direction or toward a proximal end of the device. 
         [0144]    “PTFE” means polytetrafluoroethylene. 
       Construction 
       [0145]    The following detailed description is to be read with reference to the drawings in which similar components in different drawings have the same nomenclature. The drawings, which are not necessarily to scale, show illustrative embodiments and are not intended to limit the scope of the invention. 
         [0146]    It should be noted that combinations of materials and components described within this specification may be interchangeable and anyone skilled in the art will understand that a combination of materials or exchange of other materials to accomplish the work of the invention will not depart from the spirit of the invention. It is further understood that the invention is not limited to vascular use and can also be applied to use through an endoscope, gastroenterological procedures, laparoscope, artherectomy procedures, urological procedures or neurological procedures. 
         [0147]    For the purpose of describing the actuation of the embodiments of the invention  600 ,  1400  as described below, a handle  626 ,  1442  is used. The function of the handle  626 ,  1442  is to contact the coated coil  608 ,  1414 , move the actuating member  604 ,  1430  and provide greater control to the operator. Using the handle  626 ,  1442  allows the application of a longitudinal force (distal or proximal) from a proximal end (unnumbered) of the device  600 ,  1400  to the attached actuating member  604  and proximal force to the actuating member  1430 , which causes a sliding motion. As described in detail below, the application of longitudinal force causes a distal section  617 ,  1412  of the vascular device  600 ,  1400  to deflect. In the cases of the embodiments of the invention  400 ,  500  a first handle  422 ,  534 , contacts the hollow shaft  402 ,  502  and is attached to the actuating member  404 ,  504  allowing longitudinal force to be applied to the distal section  407 ,  517 , causing it to deflect. A second handle  425 ,  536  is attached to a cutting head  420 ,  520  which distally extends from a distal lumen opening  410  or a sheath  505  and manually rotated in procedures requiring plaque removal. 
         [0148]      FIG. 1  shows a cross sectional centerline view taken along the longitudinal axis of a vascular device  600  having a first lumen  606  and a second lumen  610 . The vascular device  600  can be used as a guidewire or a catheter or as a combination of the two. The presence of a first lumen  606  and a second lumen  610  allows the device  600  to function as an aspiration device as well as a catheter so that during a medical procedure it can be simultaneously used to deliver other medical devices to a remotely navigated anatomical site and to aspirate fluids. The device  600  can also be used for the delivery of therapeutic fluids through the first lumen  606  to remote anatomical sites following navigation using the device  600  as a guidewire. The device  600  includes a coil  608  defining a proximal open coil section  614  and a distal closed coil section  616 . A proximal closed coil section  628  extends proximally of a distal coil section  617  and is wound in a relatively closed coil configuration similar to the distal closed coil section  616 . In one embodiment, the coil  608  can be made from a radiopaque material such as a platinum-nickel alloy that allows the physician to visualize the position of the coil  608  using radiological means, thereby navigating the vascular device  600  into desired anatomical pathways with minimal forward motion. In a manner similar to the other embodiments of the invention  400 ,  500  the device  600  is capable of deflecting by applying longitudinal force to an actuating member  604  which causes the expandable side  624  of the coil  608  to expand while the non-expandable side  622  is prevented from expanding by being fixedly attached to a ribbon  612  as explained below. The actuating member  604  can be made from a variety of materials having sufficient strength to be able to cause the distal section  617  to deflect and still be flexible enough to move with the coil  608 , including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. An outer polymer coating  602  covers the device  600  to the proximal point of attachment (unnumbered) of the ribbon  612 , leaving the open coil section  614  exposed. The ribbon  612  is attached to the open coil section  614  at a flattened section  615 . Means of attaching the ribbon  612  include but are not limited to adhesives, laser welding, or soldering. When negative pressure is applied to the second lumen  610  the device  600  can be used as an aspiration device to remove fluid or debris through the spaces between the open coil section  614 , from an anatomical location the device  600  has been navigated to. The distal closed coil section  616  is close or tight wound and forms an area  618  for attaching a hollow actuating member  604 . The actuating member  604  can be made from a variety of materials having sufficient strength to be able to cause the distal section  617  to deflect and still be flexible to flex enough to curve with the coil  608 , including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. The first lumen  606  which extends through the center of the actuating member  604  can also be used for aspirating fluids or debris when negative pressure is applied to the first lumen  606 . Likewise, the first lumen  606  can be used for delivery of drugs or therapeutic fluids when positive pressure is applied. A coating  602  such as non-thrombogenic polymers, PTFE, ePTFE, FEP, polyester, polyurethane, polyethylene, silicone or hydrophilic may be applied over the proximal section (unnumbered) of the coil  608  to improve sterility as well as enhancing the outer smoothness of the guidewire  600 , thereby causing less trauma to the patient during introduction, the procedure itself and removal. In one embodiment the coating  602  is applied to the coil  608  by applying a polymer heat shrink tubing such as a PTFE, FEP, or polyester, followed by the application of a proper amount of heat or an appropriate length of time. In additional embodiments the coating  602  is applied by dipping the guidewire  600  into a dispersion polymer such as urethane or silicone, by spraying a polymer such as PTFE, FEP, polyester or silicone or by a co-extrusion process of a polymer such as PTFE, FEP, polyester, urethane or silicone. An additional advantage of a coating  602  is a reduction in adverse reactions due to adhesion of platelets, proteins, cells or other fouling materials, which can cause fibrin clot production. 
         [0149]    When distal force is applied to the actuating member  604  by the operator, as shown in  FIG. 1A , the distal section  617  deflects due to the non-expandable side  622  to which the ribbon  612  is attached being prevented from expanding while allowing the expandable side  624  to expand, resulting in the distal section  617  assuming a deflected configuration as best shown in  FIG. 1A . As shown in  FIG. 1B , if proximal force is applied to the actuating member  604  the distal section  617  is deflected in another direction than when distal force is applied. This is due to the pitch of the open wound coil section  614  having a relatively loose or open pitch to the coil winds (unnumbered), which allows the coil winds (unnumbered) on the expandable side  624 , to be forced into a closer configuration. If the actuating member  604  is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of longitudinal force.  FIG. 1C  shows a lateral cross section of the vascular device  600  taken through the lines  1 C- 1 C and illustrates the locations of the non-expandable side  622  and expandable side  624 . 
         [0150]      FIG. 2  is a cross sectional centerline view taken along the longitudinal axis of a vascular device  1400  of the present invention having a fibrous actuating member  1430  or metal actuating member (not shown) attached  1432  to a distal end  1434  of a coil  1414  enabling the vascular device  1400  to deflect to an alternative shape upon proximal force being applied to the actuating mechanism  1430 . The vascular device  1400  can be used as a guidewire or a catheter or as a combination of the two. The device  1400  includes a coil  1414  defining a distal section  1412 , further defining a loose wound section  1412   a  and a tight wound section  1412   b . A proximal coil section  1415  extends proximally of the distal coil section  1412  and may be wound in a relatively closed coil configuration similar to the tight wound section  1412   b . In one embodiment, the coil  1414  can be made from a radiopaque material such as a platinum-nickel alloy that allows the physician to visualize the position of the coil  1414  using radiological means, thereby navigating the vascular device  1400  into desired anatomical pathways with minimal forward motion. The coil  1414  extends between a distal end  1434  and a proximal end  1429  and defines a central space  1410  inside the coil winds. The coil  1414  defines a flattened section  1416  towards the distal end  1434  which is configured to receive a ribbon  1418  which is affixed to the coil  1414 . The ribbon  1418  is made of a suitable metallic material such as austenitic stainless steel alloy or a tungsten alloy such as tungsten-molybdenum and tungsten-rhenium. In some instances, iridium is added to the alloy to increase strength and radiopaqueness. In another embodiment (not shown) the ribbon  1418  is not used and instead the deflectable distal section  1412  is defined by a series of welds (not shown), gluing (not shown) or mechanical fasteners (not shown) affixed to the coil winds. In an alternative embodiment (not shown), the ribbon  1418  is replaced by the application of a polymer fiber fused to coil  1414 . The fiber (not shown) is entangled into the coil  1414  by means of weaving in and out of the coil winds and looping around the individual coil winds to form a solid attachment after application of an adhesive. The ribbon  1418  (or other means of securing) functions to bind together the portions of the coil  1414  to which it is attached to form a non-expandable side  1438  as best shown in  FIG. 2B . Means of attaching the ribbon  1418  to the flattened section  1416  include but are not limited to adhesives, laser welding, or soldering. Thus, when proximal force is applied to the actuating member  1430  by the operator, the distal section  1412  will deflect due to the non-expandable side  1438  of the coil  1414  to which the ribbon  1418  is attached being prevented from expanding while allowing the expandable side  1440  to expand, resulting in the distal section  1412  deflecting from a straight configuration. If the actuating member  1430  is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of proximal force. It is also observed that along the distal section  1412  the coil  1414  defines a loose wound section  1412   a  where it is wound at a lesser or looser pitch than the remainder of the coil  1414 , imparting a greater degree of flexibility to the distal section  1412 . Attached by solder  1424  or other means to the coil  1414  at the distal end  1428  is a hollow member  1420  which resides inside the central space  1410  and extends the length of the vascular device  1400 . The hollow member  1420  functions to add stiffness and stability to the vascular device  1400 , while also defining a lumen  1422  which can be used for such purposes as drug delivery, aspiration or as a general catheter. The hollow member  1420  can be made from a variety of materials having sufficient strength to be able to cause the distal section  1412  to deflect and still be flexible enough to move with the coil  1414 , including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. The actuating member  1430  can be made of a polymeric material such as Kevlar® or other suitable metallic material such as stainless steel and is attached by solder  1424  or other means to the distal end  1434  of the coil  1414  and routed through the central space  1410  so as to be able to apply proximal force to the distal section  1412 , allowing an operator to precisely deflect the distal section  1412  thereby enhancing the steerability and overall maneuverability of the vascular device  1400 . A coating  1426  such as non-thrombogenic polymers, PTFE, ePTFE, FEP, polyester, polyurethane, polyethylene, silicone or hydrophilic may be applied over the coil  1414  to improve sterility as well as enhancing the outer smoothness of the guidewire  1400 , thereby causing less trauma to the patient during introduction, the procedure itself and removal. In one embodiment the coating  1426  is applied to the coil  1414  by applying a polymer heat shrink tubing such as a PTFE, FEP, or polyester, followed by the application of a proper amount of heat or an appropriate length of time. In additional embodiments the coating  1426  is applied by dipping the guidewire  1400  into a dispersion polymer such as urethane or silicone, by spraying a polymer such as PTFE, FEP, polyester or silicone or by a co-extrusion process of a polymer such as PTFE, FEP, polyester, urethane or silicone. An additional advantage of a coating  1426  is a reduction in adverse reactions due to adhesion of platelets, proteins, cells or other fouling materials, which can cause fibrin clot production. 
         [0151]    As shown in  FIG. 2A , if proximal force is applied to the actuating member  1430  the distal section  1412  is deflected. This is due to the expandable side  1440  being able to expand while the non-expandable side  1438  is prevented from expanding. If the actuating member  1430  is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of longitudinal force.  FIG. 2B  shows a lateral cross section of the vascular device  1400  taken through the lines  2 B- 2 B and illustrates the locations of the non-expandable side  1438  and expandable side  1440 . 
         [0152]      FIG. 3  shows a vascular device  400  which can be used as a guidewire or a catheter or as a combination of the two. A hollow shaft  402  defines a first lumen  414  into which is fitted an actuating member  404  which is itself hollow and defines a second lumen  416 . The hollow shaft  402  is proximally attached to a first handle  422  which, as described above, is used to contact the device  400  as a whole. A third handle  423  is attached to the actuating member  404  which provides longitudinal control over the position of the actuating member  404 . The hollow shaft  402  provides strength and support to the vascular device  400  and defines a proximal termination  402   a , which is mounted within the first handle  422 , and a distal termination  402   b . The hollow shaft  402  and actuating member  404  can be made from a variety of materials having sufficient strength to be able to cause the distal section  407  to deflect and still be flexible enough to move with a coil  406 , including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. The coil  406  defines an open wound section  406   a  which is attached to and extends distally from the distal termination  402   b  of the hollow shaft  402  to the proximal end  412  of a solid coil section  406   b . The open wound section  406   a  is further defined by the attachment of a ribbon  418  which in one embodiment is attached to a flattened section  426  of the coil  406 . Means of attaching the ribbon  418  include but are not limited to adhesives, laser welding, or soldering. In one embodiment, the coil  406  can be made from a radiopaque material such as a platinum-nickel alloy that allows the physician to visualize the position of the coil  406  using radiological means, thereby navigating the vascular device  400  into desired anatomical pathways with minimal forward motion. The vascular device  400  defines a deflectable distal section  407  such that when longitudinal force is applied to the actuating member  404  by the operator, the distal section  407  deflects as a result of preventing the non-expandable side  430 , to which the ribbon  418  is attached, from expanding, while allowing the expandable side  432  to expand, resulting in the distal section  407  assuming a deflected configuration as best shown in  FIGS. 3A and 3B . The ribbon  418  is made of a suitable metallic material such as austenitic stainless steel alloy or a tungsten alloy such as tungsten-molybdenum and tungsten-rhenium. In some instances, iridium is added to the alloy to increase strength and radiopaqueness. In another embodiment (not shown) the ribbon  418  is not used and instead the deflectable distal section  407  is defined by a series of welds (not shown), gluing (not shown) or mechanical fasteners (not shown) affixed to the coil winds. In an alternative embodiment (not shown), the ribbon  418  is replaced by the application of a polymer fiber fused to the open wound coil section  406   a . The fiber (not shown) is entangled into the open wound coil section  406   a  by means of weaving in and out of the coil winds and looping around the individual coil winds to form a solid attachment after application of an adhesive. The solid, distally located section  406   b  of the coil  406  is created by the presence of welds  408  between the individual coil winds (unnumbered) which function to prevent flexing of the solid section  406   b  from the application of longitudinal force. The solid coil section  406   b  terminates at a distal lumen opening  410  which is in fluid communication with the second lumen  416  and can thus be used to either deliver or aspirate substances from the anatomical area accessed by the device  400 . The actuating member  404  extends proximally from the first handle  422  allowing access to the second lumen  416  and distally to the junction between the open wound section  406   a  and solid section  406   b  of the coil  406 , where it is attached by solder  428 . Extending through the second lumen  416  is a rotatably mounted, flexible cutting shaft  424 , defining a proximal end  424   a  and a distal end  424   b  which terminates distally with a cutting burr  420  mounted thereon which is used to remove plaque or clots from a vessel. A second handle  425  is distally attached to the cutting shaft  424  and is manually rotated by the physician as needed, resulting in the cutting burr  420  simultaneously rotating. Flexibility of the cutting shaft  424  is preferably provided by making it of superelastic nitinol, but it is also contemplated to be made of stainless steel, glass-filled polymer or carbon-filled polymer. 
         [0153]    When distal force is applied to the actuating member  404  by the operator, as shown in  FIG. 3A , the distal section  407  deflects due to the non-expandable side  430  to which the ribbon  418  is attached being prevented from expanding while allowing the expandable side  432  to expand, resulting in the distal section  407  assuming a deflected configuration as best shown in  FIG. 3A . As shown in  FIG. 3B , if proximal force is applied to the actuating member  404  the distal section  407  is deflected in the opposite direction as when distal force is applied. This is due to the pitch of the open wound coil section  406   a  having a relatively loose or open pitch to the coil winds (unnumbered), which allows the coil winds (unnumbered) on the expandable side  432 , to be forced into a closer configuration. If the actuating member  404  is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of longitudinal force.  FIG. 3C  shows a lateral cross section of the vascular device  400  taken through the lines  3 C- 3 C and illustrates the locations of the non-expandable side  430  and expandable side  432 . 
         [0154]      FIG. 4  is a cross sectional centerline view taken along the longitudinal axis of an alternative embodiment of the vascular device  500  which is similar to the embodiment of the vascular device  400  shown in  FIGS. 3-3C , with the addition of a covering sheath  505 . The vascular device  500  can be used as a guidewire or a catheter or as a combination of the two. The sheath  505  can be insert molded and surrounds at least the distal section  517  of the vascular device  500 . The sheath  505  functions to make the device  500  more atraumatic, creating a safer device. A distal end  506  of the sheath  505  defines a range of at least one and up to eight slits  508  which are impressed across the center axis of the distal end  506  and which function to enclose a cutting head  520  and thereby protect delicate anatomical structures during introduction. When the cutting head  520  or other medical device (not shown) is deployed the slits  508  will open, becoming flaps (not shown), allowing the physician to perform a medical procedure, such as loosening and ultimately removing plaque from the interior surfaces of artery walls. When the cutting head  520  or other medical device (not shown) is pulled back into the second lumen  516  following completion of the procedure, the flaps  508  may close (not shown) or remain open still enclosing the cutting head  520 , allowing the device  500  to be removed in a manner less likely to cause additional trauma to the patient. 
         [0155]    As shown in  FIG. 4  hollow shaft  502  defines a first lumen  514  into which is fitted an actuating member  504  which is itself hollow and defines a second lumen  516 . The hollow shaft  502  and actuating member  504  are proximally attached to a first handle  534  which is used to contact the device  500  as a whole as well as allowing longitudinal control over the position of the actuating member  504 . The hollow shaft  502  provides strength and support to the vascular device  500  as a whole and defines a proximal termination (unnumbered), which is mounted within the first handle  534 . The hollow shaft  502  and actuating member  504  can be made from a variety of materials having sufficient strength to be able to cause the distal section  517  to deflect and still be flexible enough to move with a coil  510 , including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. The coil  510  defines an open wound section  510   a  which is attached to and extends distally from the distal termination (unnumbered) of the hollow shaft  502  to a proximal end (unnumbered) of a solid coil section  510   b . The open wound section  510   a  is further defined by the attachment of a ribbon  518  which in one embodiment is attached to a flattened section  526  of the coil  510 . Means of attaching the ribbon  518  include but are not limited to adhesives, laser welding, or soldering. In one embodiment, the coil  510  can be made from a radiopaque material such as a platinum-nickel alloy that allows the physician to visualize the position of the coil  510  using radiological means, thereby navigating the vascular device  500  into desired anatomical pathways with minimal forward motion. The vascular device  500  defines a deflectable distal section  517  so that when longitudinal force is applied to the actuating member  504  by the operator, the deflectable distal section  517  deflects, as described in detail below. The ribbon  518  is made of a suitable metallic material such as austenitic stainless steel alloy or a tungsten alloy such as tungsten-molybdenum and tungsten-rhenium. In some instances, iridium is added to the alloy to increase strength and radiopaqueness. In another embodiment (not shown) the ribbon  518  is not used and instead the deflectable distal section  517  is defined by a series of welds (not shown), gluing (not shown) or mechanical fasteners (not shown) affixed to the coil winds. In an alternative embodiment (not shown), the ribbon  518  is replaced by the application of a polymer fiber fused to the open wound coil section  510   a . The fiber (not shown) is entangled into the open wound coil section  510   a  by means of weaving in and out of the coil winds and looping around the individual coil winds to form a solid attachment after application of an adhesive. The solid, distally located section  510   b  of the coil  510  is created in this embodiment by the presence of welds  512  between the individual coil winds (unnumbered) which function to prevent flexing of the solid section  510   b  from the application of longitudinal force. The solid coil section  510   b  terminates at a distal lumen opening (unnumbered) which is in fluid communication with the second lumen  516  and can thus be used to either deliver or aspirate substances from the anatomical area accessed by the device  500 . The actuating member  504  extends proximally from the first handle  534  allowing access to the second lumen  516  and distally to the junction between the open wound section  510   a  and solid section  510   b  of the coil  510 , where it is attached by solder  528 . Extending through the second lumen  516  is a rotatably mounted cutting shaft  524 , defining a proximal end  524   a  and a distal end  524   b  which terminates distally and is mounted with a cutting head  520  and is used to remove plaque or clots from a vessel. A second handle  536  is distally attached to the cutting shaft  524  and is manually rotated by the physician as needed, resulting in rotation of the cutting head  520 . Flexibility of the cutting shaft  524  is preferably provided by making it of superelastic nitinol, but it is also contemplated to be made of stainless steel, glass-filled polymer or carbon-filled polymer. 
         [0156]    When distal force is applied to the actuating member  504  by the operator, as shown in  FIG. 4B , the distal section  517  deflects due to the non-expandable side  530  to which the ribbon  518  is attached being prevented from expanding while allowing the expandable side  532  to expand, resulting in the distal section  517  assuming a deflected configuration as best shown in  FIG. 4B . As shown in  FIG. 4C , if proximal force is applied to the actuating member  504  the distal section  517  is deflected in another direction as when distal force is applied. This is due to the pitch of the open wound coil section  510   a  having a relatively loose or open pitch to the coil winds (unnumbered), which allows the coil winds (unnumbered) on the expandable side  532 , to be forced into a closer configuration. If the actuating member  504  is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of longitudinal force.  FIG. 4D  shows a lateral cross section of the vascular device  500  taken through the lines  4 D- 4 D and illustrates the locations of the non-expandable side  530  and expandable side  532 . 
         [0157]      FIG. 5A  shows the vascular device  400  as shown in more detail in  FIG. 3  in use following introduction into a patient, approaching an obstruction  1002  at the onset of treatment. It is seen that the device  400  has been navigated to the obstruction  1002  in a vessel  1000  which requires opening. Cutting head  420  has been deployed from the second lumen  416  to eventually bore through the obstruction  1002  and it is observed that the distal end (unnumbered this figure) of the device  400  is in the deflected configuration as a result of applying distal force to the actuating member  404  which allows the device to be precisely navigated through a tortuous vascular pathway. 
         [0158]      FIG. 5B  shows the vascular device  400  in use during the beginning of treatment. It is seen that the deployed cutting head  420  is being rotated and contacting the obstruction  1002 . It is further seen that some of the obstruction  1002   b  has been detached from its main body following treatment. 
         [0159]      FIG. 5C  shows the vascular device  400  in use following completion of treatment. It is seen that the obstruction  1002  has been crossed and that some obstruction  1002   a  remains attached to the vessel  1000  wall while other obstruction  1002   b  is detached and has been removed. 
         [0160]      FIG. 5D  shows the vascular device  400  in use following introduction into a patient, approaching an obstruction  1000  at the onset of treatment, with the vascular device  400  contained in a catheter  50  used to aspirate debris from the treatment site. 
         [0161]      FIG. 5E  shows a vascular device  500  similar to that shown in  FIG. 4  with an additional difference being a predetermined angle  722  formed into the cutting shaft  718 . It is seen that the deployed cutting head  720  extends from the slit  508  at the distal end  506  of the sheath  505  and is being rotated and contacting the obstruction  1002 . The angle  722  confers the advantage of allowing the physician to rotate the proximal end (not shown) of the actuating member (not shown) causing the cutting head  720  to move in an elliptical path around the inner walls of the vessel  1000 , cutting and removing obstruction  1002 . This allows the sheath  505  to remain stationary and not rotated by the physician.  500  and held in the center axis of the vessel  1000 . This advantage also reduces the amount of vascular damage caused by required rotating of conventional guidewires or cutting devices by the physician in the process of navigating the device  500  through vascular obstructions. 
         [0162]    The outer diameter of the vascular device  400 ,  500 ,  600 ,  1400  is manufactured to dimensions that are industry standards for certain medical procedures and can range from between approximately 0.006 inch to 0.121 inch which allows passage through a ten French catheter at 0.131 inch outer diameter, as an example. The length of the vascular device  400 ,  500 ,  600 ,  1400  is similarly manufactured to conform to industry standards and may range between approximately 10 centimeters to 300 centimeters as required by the particular medical procedure. 
       Use 
       [0163]    Using the vascular device  400 ,  500 ,  600 ,  1400  of the present invention first requires removal from sterile packaging. Standard surgical techniques are employed to incise the proper blood vessel or bodily duct using an introducer having one or more sealed ports. The introducer can range in diameter from 4 to 24 French depending on the vessel or bodily duct size and location. Most procedures performed for Percutaneous Transluminal Coronary Angioplasty (PTCA) use a 6 to 10 French device passing through the introducer. A 6 to 10 French catheter having an open and blunt distal end can cause vascular damage passing through the vessels. Therefore one embodiment of the invention described herein discloses a rounded, bulleted distal end. The introducer is placed into the vessel lumen and is followed by insertion of a guidewire, catheter or other medical device that can pass transluminally through the vessel to the site of therapy. A rounded distal end will facilitate this task with less vascular damage. 
         [0164]    The vascular device  400 ,  500 ,  600 ,  1400  is then inserted into the introducer and carefully navigated through the patient&#39;s vasculature until the treatment site is reached. 
         [0165]    At that point, either the vascular device  400 ,  500 ,  600 ,  1400  is used to complete the procedure or another device is passed over or through the vascular device  400 ,  500 ,  600 ,  1400 . At the completion of the procedure the vascular device  400 ,  500 ,  600 ,  1400  is disposed of. 
         [0166]    In the embodiments  400 ,  500  as described above, the invention may be employed as a combination guidewire and thrombectomy or atherectomy device to remove calcified plaque or venous thrombosis. When these embodiments of the vascular device  400 ,  500  are used the physician places the distal end  410 ,  506  near the obstruction and a radio opaque contrast material may be injected into the artery through a lumen in the device, after which the physician advances a second handle  425 ,  536  at the proximal end (unnumbered) to deploy the cutting head  420 ,  520  at the distal end  410 ,  506  and slowly advance the device while manually rotating the second handle  425 ,  536 . Aspiration may be used to remove the debris detached and displaced by the cutting head  420 ,  520 . Upon completion of the procedure, the vascular device  400 ,  500  is removed and disposed of. These embodiments allow the physician to navigate a single device to the diseased area and complete the procedure in the shortest time with the least amount of vascular damage. 
         [0167]    While the invention as described above can be used as a combination guidewire/thrombectomy/atherectomy device, it can also be used a catheter. Most transfemoral coronary catheterization employ between a 4 and 10 French catheter. Small arteries will utilize around a 4 French catheter while larger arteries could utilize up to a 10 French catheter. Cited by the Journal of the American Medical Association, upward of three million cardiac catheterizations are performed annually in the United States. A device to reduce procedural time vascular damage would be an economic advantage to the industry. The vascular device  400 ,  500 ,  600 ,  1400  may be applied to a variety of medical devices capable of being introduced into the vasculature or other anatomy of a patient. For example, the vascular device  400 ,  500 ,  600 ,  1400  could be applied to singular guidewires, guidewire/catheter combination (e.g., balloon angioplasty, stent deliver, drug delivery, fluid delivery or fluid removal), as a conduit for atherectomy devices and NUS catheters, laparoscopic and endoscopic devices, spinal or cranial navigation devices, neurostimulation and cardiac resynchronization leads, embolic protection devices, therapeutic devices and other medical devices. When used for drug delivery the invention finds utility by being able to remove fluid causing the surrounding area to lose excess fluid. A drug can then be injected and the affected area will more readily absorb the drug by the osmotic difference in pressure. This allows the drug to remain at the site rather than be carried away by the movement of interstitial fluids. 
         [0168]    The vascular device  600 ,  1400  finds further utility in the implantation of neurostimulation or resynchronization leads which are typically 30 to 60 cm long. Currently these leads must include a large lumen for the insertion of a preformed stylet to steer the lead to the target site. As the industry continues to reduce the diameter of these leads to 4.1 French or less by removing the stylet lumen, a device is needed to steer the leads to the target site and allow the physician to rotate the lead (not shown) at the proximal end to implant the lead. The vascular device  600 ,  1400  accomplishes this by providing an open lumen from the proximal end (unnumbered) to the distal end  620 ,  1436  while allowing the distal end  620 ,  1436  to be manipulatively deflected by the physician and the proximal end of the lead manually rotated. Following implantation of the lead the invention is removed and disposed of.