Patent Publication Number: US-2021186535-A1

Title: Catheter systems, kits, and methods for gaining access to a vessel

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. application Ser. No. 15/444,510, filed Feb. 28, 2017, which claims priority to U.S. Provisional Application No. 62/301,397 filed Feb. 29, 2016, the entire contents of each of which are specifically incorporated herein by reference without disclaimer. 
    
    
     BACKGROUND 
     1. Field of Invention 
     The present invention relates generally to catheter systems, kits, and methods of using the catheter systems and kits useful for gaining access to a vessel by way of the vessel. 
     2. Description of Related Art 
     Access to a patient&#39;s vascular system, e.g., the central venous or arterial system, of a patient can be necessary to carry out many lifesaving medical procedures. For example, the usual method of gaining access to the venous system in the area of the neck is to directly puncture a major vein in the neck with a large gauge needle through which a guide wire is placed. This approach is described as going from the outside (skin) to inside the vein/vessel. The guide wire supports the remainder of the intervention at the site that usually results in the placement of an introducer sheath or the like. A problem can arise however when a major vein is blocked with a clot or fibrous occlusion. Similarly, a problem can also arise when an artery is blocked with a clot or fibrous occlusion. 
     SUMMARY 
     Embodiments of the present disclosure facilitate gaining access to a patient&#39;s vessel by way of the patient&#39;s vasculature (i.e. from the inside out). Some embodiments facilitate gaining access to an occluded vessel, where part of the access path is through the occlusion. The occlusion is first penetrated by a needle wire and then by a larger diameter catheter that then directs a second catheter along a path that is at an angle to the longitudinal axis of the larger diameter catheter (e.g., projection angle). In some embodiments, the occluded vessel is in the upper chest and/or neck (e.g., at a location near the clavicle). 
     One embodiment of the present disclosure is a method for providing access to a central venous system of a patient. Such methods can comprise: applying a radiopaque target having a radiopaque area and a radiolucent area to the skin of the patient so that the radiolucent area defines an exit point on the skin of the patient introducing a catheter and a projection angle catheter into the patient in an area remote from the exit point, wherein the projection angle catheter is configured to extend out a side aperture of a distal tip of the catheter at a projection angle, and a needle wire is configured to extend through the projection angle catheter, wherein the catheter has a aperture at a distal end of the distal tip configured such that the needle wire can extend through the aperture advancing the needle wire through the distal end aperture of the catheter to a desired location in the central venous system; advancing the catheter to position said distal tip in a desired tip location in the central venous system; viewing the catheter and said distal tip under fluoroscopy through the radiolucent area of the radiopaque target; rotating the catheter so that the side aperture and therefore the projection angle plane is aligned with the radiolucent area of the radiopaque target; adjusting the projection angle catheter so that the projection angle is aimed at the radiolucent area of the radiopaque target; and advancing the needle wire through the projection angle catheter, such that the distal end of the needle wire advances at an angle relative to the catheter and penetrates the skin of the patient adjacent the radiolucent area of the radiopaque target thereby providing a distal end of the needle wire exterior to the skin. 
     Another embodiment for providing access to a central venous system of a patient can comprise: introducing a catheter into the patient, wherein the catheter has a projection angle catheter configured to extend out a side aperture of a distal tip of the catheter at a projection angle, and a needle wire configured to extend through the projection angle catheter, wherein the catheter has an aperture at a distal end of the distal tip configured such that the needle wire can extend through the aperture in a direction substantially parallel with a longitudinal axis of the catheter, wherein the projection angle is angled with respect to the longitudinal axis; advancing the needle wire through the distal end aperture of the catheter and into a vessel occlusion; advancing the catheter to position said distal tip in a desired tip location; retracting the needle wire into the catheter and the projection angle catheter; advancing the projection angle catheter so that the catheter extends through the side aperture; and advancing the needle wire through the projection angle catheter and through the skin of the patient, thereby providing a distal end of the needle wire exterior to the skin. 
     Another embodiment of the present disclosure can comprise a catheter system. Such systems can comprise: a first catheter that can comprise a shaft comprising a proximal end and a distal end extending along a longitudinal axis and defining a lumen extending therebetween; a distal tip disposed at the distal end of the shaft and defining a lumen extending along a longitudinal axis and in fluid communication with the shaft lumen and comprising a distal end, wherein the distal tip comprises a side aperture in fluid communication with the shaft lumen and an aperture at the distal end in fluid communication with the shaft lumen; a second catheter having a portion configured to extend through the shaft lumen and the side aperture, the second catheter comprising a proximal end and a distal end and defining a lumen along a longitudinal axis between the proximal end and the distal end, wherein a portion of the second catheter is curved along the longitudinal axis and the curved portion is closer to the distal end than the proximal end, wherein the first catheter and the second catheter are configured such that the distal end of the second catheter passes through the side aperture of the first catheter when advanced through the first catheter; and a needle wire configured to extend through the second catheter lumen and to extend through the distal end exit aperture of the first catheter in a direction substantially parallel with the longitudinal axis of the shaft, the needle wire having a sharp dissection tip, wherein the needle wire is configured such that it can penetrate a muscle tissue without deflection. 
     The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are “coupled” can be unitary with each other. The terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise. The term “substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. In any disclosed embodiment, the term “substantially” can be substituted with “within [a percentage] of” what is specified, where the percentage includes 0.1, 1, 5, and 10 percent. 
     Further, a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described. 
     The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), and “include” (and any form of include, such as “includes” and “including”) are open-ended linking verbs. As a result, an apparatus that “comprises,” “has,” or “includes” one or more elements possesses those one or more elements, but is not limited to possessing only those elements. Likewise, a method that “comprises,” “has,” or “includes” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps. 
     Any embodiment of any of the apparatuses, systems, and methods can consist of or consist essentially of—rather than comprise/include/have—any of the described steps, elements, and/or features. Thus, in any of the claims, the term “consisting of” or “consisting essentially of” can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb. 
     The feature or features of one embodiment can be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments. 
     Some details associated with the embodiments described above and others are described below. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number can be used to indicate a similar feature or a feature with similar functionality, as can non-identical reference numbers. 
         FIGS. 1A and 1B  are schematic views of an embodiment of a catheter system.  FIG. 1A  illustrates a needle wire extending from a distal end, and  FIG. 1B  illustrates the needle wire and a catheter extending from a side aperture. 
         FIG. 1C  is an isolated, magnified, top perspective view of the distal tip of the embodiment shown in  FIGS. 1A and 1B . 
         FIG. 1D  is an isolated, magnified, bottom perspective view of the distal tip of the embodiment shown in  FIG. 1C . 
         FIG. 1E  is a schematic, perspective view of the handle shown in embodiment of  FIG. 1A . 
         FIG. 1F  is a schematic, cross-sectional view of the handle shown in  FIG. 1E . 
         FIG. 2A  is an isolated, magnified, top perspective view of a distal tip of another catheter system embodiment. 
         FIG. 2B  is an isolated, cross-sectional view of the distal tip of the embodiment shown in  FIG. 2A . 
         FIG. 2C  is an isolated, cross-sectional view of the distal tip of the embodiment shown in  FIG. 2A  where the cross-section is taken on a plane that is transverse to that of  FIG. 2B . 
         FIG. 3A  is a cross-sectional, schematic view of a patient with a vessel occlusion involving a vessel in the upper chest region above the level of the superior vena cava (SVC) and the right atrium. A portion of a catheter system embodiment is shown extending through the vessel. 
         FIGS. 3B-3H  are schematic illustrations of a series of process steps of an embodiment of using a catheter system, the illustration showing a vessel with a vessel occlusion and the distal portion of a catheter system embodiment.  FIG. 3A  is similar to  FIG. 3B  yet provides a wider perspective of a catheter system extending through the vessel, proximal an occlusion. 
         FIG. 3I  is a cross-sectional, schematic view of a patient with a vessel occlusion involving a vessel in the upper chest region above the level of the superior vena cava (SVC) and the right atrium, and a portion of a catheter system embodiment extending through the vessel and into an occlusion. 
         FIG. 4  is a schematic of a radiopaque target embodiment aligned with a distal tip embodiment. Some or all of the elements may be viewable with radiographic imaging. 
     
    
    
     DETAILED DESCRIPTION 
       FIGS. 1A to 1D  illustrate one embodiment of a catheter system  12 . In  FIGS. 1A and 1B , system  12  is shown as a schematic view with components of the system in different positions. Catheter system  12  comprises a catheter  20 , a catheter  34  configured to extend at least partially through catheter  20 , and a needle wire  32  configured to extend through catheter  34 . Catheter  20  comprises a shaft  18  having a proximal end  18   a  and a distal end  18   b.  Shaft  18  at proximal end  18   a  is coupled to a handle  28  through an optional resilient member  14  that defines a lumen in communication with the lumen of catheter  20 . Distal tip  22  is disposed at the distal end  18   b  of shaft  18 . 
       FIGS. 1C and 1D  show a magnified top, perspective view and bottom, perspective view of a distal tip  22  of catheter  20 . Distal tip  22  defines a lumen  23  that is in fluid communication with the lumen of shaft  18 . Distal tip  22  comprises a side aperture  21  disposed between a proximal end  22   a  and a distal end  22   b  of the distal tip. Distal tip  22  also comprises an aperture  29  at distal end  22   b.  Both side aperture  21  and aperture  29  are in fluid communication with lumen  23  of distal tip  22 . Distal tip  22  and needle wire  32  are configured such that the distal end of needle wire can extend through lumen  23  and distal end aperture  29  (e.g., a transverse dimension of the aperture and conduit is greater than a maximum transverse dimension of the needle wire). Side aperture  21  and catheter  34  are configured such that catheter  34  can extend through the side aperture (e.g., cross-sectional dimension of the aperture is greater than a maximum transverse, cross-sectional dimension of catheter  34 ) when entering lumen  23  through proximal end  22   a.  In the embodiment shown, the transverse cross-sectional area of lumen  23  is greater at the proximal end  22   a  than the distal end  22   b  since the distal end  22   b  only needs to accommodate needle wire  32 . 
     Distal tip  22  can also comprise side aperture  41  ( FIG. 1C ) and/or side aperture  42  ( FIG. 1D ). Side apertures  41  and/or  42  can be disposed between proximal end  22   a  and distal end  22   b  of distal tip  22  and can be in fluid communication with lumen  23  of distal tip  22 . Distal tip  22  can comprise a radiopaque material that defines at least a portion of side aperture  41  and/or side aperture  42 . Side aperture  41  and/or side aperture  42  can be used as reference guide during the circumferential alignment of catheter  20 . The visibility of side aperture  41  and/or  42  will vary with the axial rotation distal tip  22 . When viewing a real-time radiographic image of distal tip  22 , side apertures  41  and/or  42  will appear widest and/or brightest when the plane of a radiographic detector is aligned with (e.g., in the same plane as) apertures  41  and/or  42 . The aiming and alignment of the distal tip  22  will be described in further detail below. This angle can be used to select the projection angle at which catheter  34  extends from side aperture  21  and/or define the exit path of a needle wire  32  advancing from catheter  34 . When the projection angle of catheter  34  substantially corresponds to the angle of the detector plane, the exit path of needle wire  32  will intersect the desired exit site on the patient. In some embodiments, side aperture  21  can also be defined by a radiopaque material to facilitate the rotational alignment and angle setting process. Distal tip  22  can be coupled to or integral with shaft  18 . 
     Catheter  34  is configured to extend through side aperture  21  at an angle relative to the longitudinal axis Y of catheter  20 . The angle is defined by the section of catheter  34  extending through side aperture  21  and is referred to as the projection angle θ (see  FIG. 3I ). The projection angle θ corresponds to the angle of the exit path  38  of needle wire  32  relative to distal tip  22  (e.g., the angle of the tissue track). Catheter  34  and distal tip  22  can be configured such that the projection angle can be selectively adjusted. For example, catheter  34  can comprise a resilient section  34   b  near distal end  34   a  that is curved along the longitudinal axis of catheter  34  in a preformed shape. When disposed within catheter  20 , curved section  34   b  is held in a less curved configuration by sidewall  52  of catheter  20 . However, by advancing catheter  34  in a distal direction, distal end  34   a  becomes adjacent side aperture  21  and the constraint by sidewall  52  is reduced and the curved section  34   b  adopts a more curved or less constrained configuration. As distal end  34   a  progressively extends through side aperture  21 , the projection angle θ increases. In this manner, catheter  34  moves through a range of projection angles θ as the length of catheter  34  extending from side aperture  21  is increased or decreased. In some embodiments, the length (dimension along longitudinal axis Y) of side aperture  21  can be such that the constraint on catheter  34  is sufficiently reduced and the distal end  34   a  is able to advance at an angle through side aperture  21  and not intersect (e.g., clear or not get hung on) sidewall  52 . 
     In some embodiments, catheter  34  is configured not to rotate (e.g., spin) within the lumen of catheter  20 . This restraint on rotational movement allows for the inner curved surface of curved section  34   b  to remain facing in the direction of side aperture  21 . This can assist in the reliability of the exit of catheter  34  through the side aperture. One mechanism for restraining rotation within the lumen of catheter  20  is to have a channel longitudinally disposed in surface of catheter  34  that receives (e.g., interlocks with) a rigid protrusion that is disposed in handle  28  or on the luminal surface of catheter  20  such that longitudinal movement is not restrained by this mechanism, only rotational movement. 
     In some embodiments, particularly those that are used to penetrate an occlusion, catheter  20  can be configured to be sufficiently push-able (in a proximal-distal direction) and/or torque-able to allow distal tip  22  to be forced into a vessel occlusion (e.g., a thrombus). In some embodiments, catheter system  12  is configured such that the distal tip  22  can penetrate a vessel occlusion without deflection. In some embodiments, an appropriate value of bending stiffness can be between 30-60 (pounds force) times (inches squared) (e.g., about 30, 35, 40, 45, 50, 55, or 60 (pounds force) times (inches squared)). For example, a stainless steel tube with an inside diameter of 0.074 inches and outside diameter of 0.094 inches would be sufficient for this purpose. However it is understood that any variety of materials with various wall thicknesses can be pushed and/or torqued to force distal tip  22  into an occlusion. Other embodiments can comprise a polymeric tube. Such tubes may comprise higher stiffness braided or coiled materials like metals embedded in the polymer. 
     The magnitude of the forces required can also depend on the “sharpness” of the distal tip  22  and the overall diameter. In some embodiments, the tip can be blunted distal end or where the transverse cross-sectional area of the distal end  22   b  is at least 1.5× the area of the aperture  29 . In other embodiments, the tip can have a distal end that tapers toward aperture  29  or where the transverse cross-sectional area of the distal end  22   b  is less than 1.5× the area of the aperture  29 . 
     Needle wire  32  can be configured to penetrate a muscle tissue and/or thrombus at a distal end  32   a  without deflection. For example, needle wire  32  can comprise a trocar-type tip or sharp dissection tip at distal end  32   a.  Such tip can be blunted, flat and angled, conical, or pyrimidal in shape. Needle wire  32  can also have a bending stiffness sufficient to penetrate a tissue without deflection. Suitable needle wire materials can include any medical grade material that can provide the material properties needed to perform the above function, e.g., steel, titanium (e.g., titanium alloy or nitinol), or the like. 
     In some embodiments, the needle wire  32  is made of nitinol with 55-57% nickel and 43-45% titanium. For example, nitinol can comprise the following composition (in wt %): 
     
       
         
           
               
               
               
             
               
                   
                   
               
               
                   
                 Chemical Composition 
                   
               
               
                   
                 (reference ASTM F2063) 
                 wt % 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                   
                 Nickel (nominal) 
                 55.96 
               
               
                   
                 Titanium 
                 43.98 
               
               
                   
                 Carbon 
                 0.025 
               
               
                   
                 Cobalt 
                 0.00033 
               
               
                   
                 Copper 
                 0.00038 
               
               
                   
                 Chromium 
                 0.00024 
               
               
                   
                 Hydrogen 
                 0.0001 
               
               
                   
                 Iron 
                 0.0094 
               
               
                   
                 Niobium 
                 &lt;0.00002 
               
               
                   
                 Oxygen 
                 0.0288 
               
               
                   
                   
               
            
           
         
       
     
     In some embodiments, the diameter of needle wire  32  can be between 0.02 in. to 0.03 in., e.g., 0.020 in., 0.021 in., 0.022 in, 0.023 in., 0.024 in., 0.025 in., 0.026 in., 0.027 in., 0.028 in., 0.029 in., or 0.030 in. 
     In some embodiments, needle wire  32  can be a drawn filled tube wire comprising a radiopaque core. In some embodiments, the outer sheath is nitinol. In some embodiments, the core can be at least located on the distal end and not extending the entire length. 
     Catheter system  12  can further comprise handle  28 . A magnified, isolated, and exterior view of handle  28  is provided in  FIG. 1E  and a cross-sectional view is provided in  FIG. 1F . In embodiment shown, handle  28  is approximately cylindrical with a central axis Y. Handle  28  can be configured to axially rotate distal tip  22  of catheter  20 , catheter  20 , and/or catheter  34 . In some embodiments, handle  28  is configured such that its axial rotation axially rotates catheter  20  and/or catheter  34 . This motion facilitates the rotational alignment of distal tip  22  relative to a radiographic detector as described above. 
     Handle  28  can also be configured to advance catheter  34  through catheter  20  and out of side aperture  21 . In the embodiment shown, rotary knob  16  is configured to turn in a clockwise and/or counter clockwise direction thereby advancing and/or retracting catheter  34 . Handle  28  also comprises a gauge or scale  17  that indicates the projection angle θ of catheter  34 . The position of catheter  34  and the projection angle θ is displayed on gauge or scale  17  in handle  28 . Thus, knob  16  is configured to adjust the projection angle θ of catheter  34  and adjust the reading from the scale  17 . For example, knob  16  can be configured such that its rotation turns a threaded body  19 , whereby the threaded body&#39;s rotation advances or retracts catheter  34  depending upon direction of rotation. Knob  16  can also be configured such that its rotation translates post  60  within companion slot  61 , whereby indicating the projection angle based upon the post&#39;s position relative to scale  17 . 
     Handle  28  can also be configured to advance and/or retract needle wire  32  through catheter  34  and distal tip  22 . For example, handle  28  can comprise a wire clamping and propelling mechanism located within the handle  28  that allows the user to advance the needle wire  32  out of the handle. Wire clamping and propelling mechanism can comprise a J-arm clamp  62  coupled to pommel  25 . Pommel  25  is movable with a reciprocating motion (or piston-like motion), as indicated by motion arrow  27 . Pommel  25  is coupled to J-arm clamp  62  that is configured to wedge against needle wire  32  as the pommel is advanced distally and to release the needle wire upon a return stroke of the pommel. J-arm clamp  62  is configured to remain stationary while the pommel moves during the return stroke. Pommel  25  and handle  28  are configured to support the wire  32  during the stroke so that needle wire  32  does not bend or kink. The stroke is relatively fixed so that a user may count the number of pommel strokes to have an estimate of how much needle wire  32  has been advanced. Retracting needle wire  32  can occur by proximally pulling the wire. 
     Handle  28  can also comprise a releasable locking mechanism  66  configured to fix the axial position of needle wire relative to handle  28  so the withdrawal of the handle also pulls the needle wire. When unlocked, needle wire  32  can move axially relative to handle to facilitate the removal of catheters  20  and catheter  34  from body while the needle wire remains in place. Releasable locking mechanism  66  comprises a toggle switch  67  to alternate the mechanism between a lock and unlock position. 
     Referring to  FIGS. 2A to 2C , another embodiment of the catheter system can comprise a distal tip  122  instead of distal tip  22 . Distal tip  122  in the embodiment shown is the same as distal tip  22  except that a distal portion of sidewall  152  defines a curved ramp  120  configured to guide distal end  34   a  through side aperture  121 . A portion of sidewall  152  opposite and proximal to aperture  121  can also be sloped or ramping. The angle of the slope can align with entrance angle of ramp  120 . Lumen  123  is effectively a gap between the sloping surfaces, ramp  120  and the sloping sidewall  152 . This gap is sized to accommodate needle wire  32 . This gap can further be sized so that it does not accommodate catheter  34 . In some embodiments, distal tip  22  comprises a concave, straight-sided channel or groove in sidewall that gradually increases in depth in a distal to proximal direction, where the surface of channel defines side aperture  21 . This embodiment may be used with a catheter  34  with or without a curved section  34   b.    
     In some embodiments, distal tip  122  comprises a channel that extends from proximal end  122   a  to an intermediate location between proximal end  122   a  and distal end  122   b.  The channel gradually decreases in depth in a proximal-to-distal direction. The base of the channel is curved along its length. Lumen  123  is in fluid communication with the channel. Proximal end  122   a  of distal tip  122  is configured to couple (e.g., mate) with distal end  18   b  of shaft  18 . 
     Distal tip can further comprise a second side aperture  43  opposite the side aperture  21  such that a line transverse to longitudinal axis passes through both apertures  21  and/or  43 . 
       FIGS. 3A to 3I  illustrate one embodiment of the present methods. Such methods can be performed using catheter systems described herein, but it is understood that the present methods can be performed using any suitable catheter system.  FIG. 3A  shows a patient  10  with an occlusion  13  involving a vessel  300  in neck region above the level of the superior vena cava (SVC) and the right atrium near reference numeral  15 . As shown, a distal tip  22  of catheter  20  has approached occlusion  13 .  FIGS. 3B-3H  are schematic illustrations of a series of process steps, the illustration showing vessel  300  with a vessel occlusion  13  and the distal portion of catheter system  12 .  FIG. 3I  illustrates that the radiopaque target  30  placed on the surface of the patient  10  serves to set a desired exit site  40  on the skin of the patient and projection angle θ. 
     A method for gaining access to a vessel (e.g., a vein, central venous vein, right internal jugular, superior vena cava, or other suitable vessel) can comprise applying a radiopaque target  30  defining a radiolucent area  31  to the skin of the patient so that the radiolucent area defines a desired exit site  40  on the skin of the patient ( FIG. 3A ). Catheter system  12  can then be introduced into the patient in an area remote from exit site  40  (e.g., femoral vein) and advanced to a desired site in the vasculature ( FIG. 3B ). In the embodiment shown, the desired site is in the vicinity of occlusion  13 . In some embodiments, an introducer catheter that has a lower stiffness than catheter  20  and/or catheter system  12  is first inserted into the vessel (e.g., femoral vein) and serves as a guide for catheter system  12 . 
     To facilitate locating the occlusion relative to catheter system  12 , a contrast agent can be injected into the vasculature and a radiographic instrument can be used to pin point the occlusion and the relative position of distal tip  22 , which can comprise a radiopaque material. The introducer catheter can also have a radiopaque distal tip so that its location can be ascertained. 
     Once at the staging area, needle wire  32  can be advanced through the distal end aperture  29  of the catheter beyond distal end  22   b  and into occlusion  13  ( FIG. 3C ). In some embodiments, radiographic imaging can be used to determine the depth of penetration into the occlusion. The depth of penetration can depend on the extent of occlusion  13 . Pommel  25  can be reciprocated as described above to advance needle wire  32 . Since needle wire  32  is not curved like catheter  34 , it will advance past side apertures (e.g., aperture  21 ,  401 , and/or  42 ) and through distal end aperture  29 . Needle wire  32  once inserted into the occlusion can define the path of catheter  20  such that when catheter  20  is advanced distally and pushed into the occlusion, it will follow the path of the needle wire. 
     Once in position, catheter  20  is advanced over needle wire  32  and into occlusion  13  as well ( FIG. 3D ). Distal tip  22  can be pushed in to the occlusion by axial (along Y) and/or rotational forces (around Y) applied to handle  28  attached to the proximal end of catheter  20 . In some embodiments, radiographic imaging can be used to determine the depth of penetration into occlusion  13 . The depth of penetration can depend on the extent of occlusion  13 . 
     To facilitate rotational alignment of the distal tip, distal tip  22  can be viewed using a radiographic instrument (such as an x-ray detector, e.g., CT-scanner, fluoroscope, ultrasound detector, or the like) through radiolucent area  31  of radiopaque target  30 . Catheter  20  can be rotated so that side aperture is aligned with or faces radiolucent area  31  ( FIG. 3E ). The angle of the line extending between detector plane and distal tip  22  and to the longitudinal axis of patient or catheter (axis Y) can then be ascertained. Such angle substantially corresponds to the projection angle θ. 
     In some embodiments, the detector can be disposed on a C-arm. The angle of the C-arm relative to the patient can be used to determine the projection angle  74  . Once the desired tip location is achieved, for example, the C-arm cranial angle is observed and it is used to determine the projection angle θ. In general, the C-arm is moved to image the tip  22  through the target  30 . The angular location of distal tip  22  is determined by viewing side apertures  41  and/or  42  through target  30 .  FIG. 4  shows a schematic of the radiographic image. As tip  22  is rotated around its long axis the width and/or opacity of side apertures  41  and/or  42  varies and this changing image feature is used to determine the rotational orientation of distal tip  22 . 
       FIG. 4  is a schematic view of a radiographic image that could be observed by a user. Distal tip  22  has side apertures  41  and/or  42  that can be view through the central aperture  31  of radiopaque target  30 . The opacity of the apertures  41  and/or  42  can vary with the rotation of catheter  20 . In general, apertures  41  and/or  42  will appear widest and/or brightest when one of aperture  41  and  42  is facing the central aperture  31 . A user can advance or retract the tip  22  and rotate the distal tip  22  to optimize the exit path. Once the user has positioned the distal tip at the desired position and rotated it to the desired orientation, the projection angle θ can be ascertained from the C-arm. To set the projection angle θ, knob  16  is turned until the scale  17  corresponds to the desired projection angle. The angular range can vary between about 10 degrees to 90 degrees, e.g., 15 to 60 degrees as indicated on scale  17  or any other range between 10 to 90 degrees. The adjustability of the tip combined with the use of fluoroscopic imaging allows a user to precisely position and aim the distal end of the needle wire. This ability to view and direct the needle wire enhances patient safety. 
     Needle wire  32  can then be retracted from beyond aperture  29  into catheter  20  and into catheter  34  ( FIG. 3F ). So as to not unduly effect the axial movement of catheter  34 , the distal end of the needle wire is retracted so that its distal end is disposed in a non-curved portion of catheter  34  (e.g., not disposed in curved section  34   b ). In some embodiments, the distal end of needle wire  32  is spaced apart from distal end  34   a  of the catheter  34  at least a distance that is not impeding the curvature of catheter curved section  34   b,  e.g., a distance of 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, or more. 
     Catheter  34  can then be advanced a selected distance such that it extends from side aperture at the desired projection angle ( FIG. 3G ). Scale  17  can be used to ascertain the projection angle. Catheter  34  positioned at the desired projection angle is aimed at radiolucent area  31 . Once catheter  34  is in position, needle wire  32  can be advanced through catheter  34  and into tissue, eventually through the skin of the patient adjacent the radiolucent area of the radiopaque target ( FIGS. 3H and 3I ). Distal end  32   a  of needle wire  32  can then be exteriorized to the patient. 
     With the needle wire  32  exteriorized as seen in the figure the access provided to the end of the wire allows additional intervention at the exit wound site as described below. For example, a dilation catheter can be coupled to the exteriorized needle wire and the dilation catheter can be drawn into the exit site by pulling on a proximal end of needle wire  32  thereby forming a dilated tissue track. A guide wire can be inserted into the dilation catheter and a medical device can be advanced over the guide wire along the dilated tissue track and into the vessel. 
     It should be understood that the foregoing device is broadly usable to establish an access point to a patient&#39;s vasculature from the inside out at any desired location. Once the access point has been established, it can be used for any desired medical procedure. For example, pacing leads for pacemakers can be delivered into a vessel after the tissue track has been established, and treatment devices (such as steerable catheters) can be delivered to the vessel through the access point. 
     The above specification and examples provide a complete description of the structure and use of illustrative embodiments. Although certain embodiments have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention. As such, the various illustrative embodiments of the methods and systems are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and embodiments other than the one shown can include some or all of the features of the depicted embodiment. For example, elements can be omitted or combined as a unitary structure, and/or connections can be substituted. Further, where appropriate, aspects of any of the examples described above can be combined with aspects of any of the other examples described to form further examples having comparable or different properties and/or functions, and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above can relate to one embodiment or can relate to several embodiments. 
     The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively.