Abstract:
A guide wire control device and methods of use are described herein. A guide wire is retained by a lock mechanism to a translating assembly within a stationary tubular structure. A rotating actuator controls the translation of the translating assembly and resulting guide wire. The guide wire control device provides improved control of guide wires and angles of a deployment capsule during transcatheter surgical procedures.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of pending U.S. provisional application Ser. No. 62/315,669 filed Mar. 31, 2016 by the present inventor, which is incorporated by reference in its entirety. 
         [0002]    This application is also a continuation-in-part of pending U.S. application Ser. No. 15/005,520 filed Jan. 25, 2016 by the present inventor, which is incorporated by reference in its entirety. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED R&amp;D 
       [0003]    Not related to this application. 
       TECHNICAL FIELD 
       [0004]    This invention relates to guide wire control devices, and more particularly to guide wire control devices for use in procedures involving catheter deployed medical devices. 
       BACKGROUND OF THE INVENTION 
       [0005]    Guide wires are commonly used in the field of medicine. They are used to navigate the torturous pathways of anatomy. Guide wires, also called stylets, can be inserted through an orifice of a body, or surgically inserted. The wire is pushed, turned, and flexed at a proximal end which remains outside the body. The forces applied to the proximal end translate down the wire to a distal end. The distal end can provide various procedure specific functions inside the body. A guide wire can be made from various materials, with metal being most common. Guide wires also come in a wide range of diameters, typically being 0.050 inches or less. Guide wire coatings and finishes can provide additional benefits for a given procedure. A common application for a guide wire is with endovascular procedures. 
         [0006]    The practice of repairing an artery through the use of a stent is well known in the field of medicine. In general and as an example of a typical guide wire application, a guide wire is inserted into an artery using the Seldinger technique. The femoral artery, near the groin, is a common entry point. The guide wire is advanced to a desired location. A delivery catheter with a stent attached is placed around the guide wire through a central lumen and is advanced along the length of the guide wire. Depending on the type of stent, the stent may be deployed by expansion of a balloon or in the case of nitinol stents, by withdrawing a sheath covering the nitinol stent and allowing the nitinol stent to assume its memory shape through self-expansion. A well-known issue with self-expanding nitinol stents is their tendency to “jump” as the sheath on the delivery catheter is retracted, which limits the precision of the stent deployment and can result in malposition of the stent. Once the stent is deployed, the delivery catheter is removed from the body. 
         [0007]    A recent advancement in the treatment of cardiac disease is transcatheter devices to either replace or repair dysfunctional native or prosthetic cardiac valves. These include the aortic, mitral, tricuspid and pulmonary valves. Rather than using an open heart procedure to replace or repair a defective valve in a patient&#39;s heart, a minimally invasive catheter system is used to deliver and deploy an expanding structure (typically a stent-like device) containing a replacement valve. The new prosthetic valve displaces the leaflets of the defective valve and takes over the function of regulating blood flow through the heart and artery. Transcatheter prosthetic valve technology is dominated by two technologies. The first uses a stainless steel (or other similar metal composition) stent that is expanded by an inflatable balloon. The second utilizes a nitinol metallic mesh that is cooled and compacted, and then expands to a desired shape and size when the metal approaches body temperature. 
         [0008]    Transcatheter valve replacement presents marked challenges over other endovascular procedures that utilize a catheter. Unlike typical endovascular procedures which occur in constrained tubular blood vessels where there is limited spatial movement of the devices, transcatheter valve procedures by their nature are performed in the heart with relatively large and spatially complicated chambers that pose significant challenges to guidewire management and device manipulation by the surgeon. First, the prosthetic valve must be located extremely precisely relative to the natural valve prior to the prosthetic valve being expanded in place. The replacement valve needs to be located plus or minus 1-3 mm in depth relative to its target location at the valve annulus. The surgeon may use fluoroscopic and ultrasound imaging to determine optimal depth of the valve prior to deployment. From the proximal end, the surgeon manipulates the guide wire and catheter sheath to achieve the desired deployment location of the prosthetic valve. An improperly deployed valve can lead to perivalvular regurgitation or catastrophic embolization of the device into either the heart or aorta. Secondly, in order to minimize canting of the prosthetic valve, the deployed valve should be positioned ideally in the center and coaxially within the diseased native valve. Again, the surgeon uses forces on the proximal end of the guide wire and catheter to attempt to manipulate the location of the valve relative to the walls of the defective valve. Third, during the procedure the surgeon in addition to maintaining optimal forces on both the catheter sheath and guide wire, has additional responsibilities of managing the operating room, and monitoring fluoroscopic, hemodynamic and other monitors. When the replacement valve is optimally located, the surgeon must maintain optimal pressure on both the guide wire and the catheter to resist translational forces created by the expanding valve. Wherein many endovascular procedures utilize the guide wire only for navigation purposes, in new advanced procedures such as transcatheter aortic valve replacement, the guide wire is often the key element throughout the procedure and requires constant attention. The transcatheter aortic valve replacement guide wire provides navigation of the catheter sheath as well as impacting location of the deployed valve. With guide wires being small in diameter, often coated in low friction materials, and with bodily fluids present, maintaining optimal pressure on the guide wire throughout the valve replacement procedure can be challenging and fatiguing for the surgeon. Although the field of transcatheter mitral and tricuspid valve replacement and repair is less mature than transcatheter aortic valve replacement, the challenges of accurate device deployment may be even greater due to the factors outlined above. 
         [0009]    In these respects, the present invention departs from conventional concepts of the prior art by providing a guide wire control device for use in catheter based medical procedures. The present invention also provides an improved way to achieve optimal valve deployment in transcatheter valve replacement and repair procedures. 
       SUMMARY OF THE INVENTION 
       [0010]    The present invention takes a very different approach to controlling a guide wire during medical procedures in comparison to the prior art. 
         [0011]    The present invention provides a device for controlling a guide wire during a surgical procedure. The proximal end of a guide wire is retained by a releasable lock mechanism to a translational assembly. The translational assembly moves relative to a stationary assembly. The movement of the translational assembly, and resulting guide wire, is controlled by a rotating actuator that gives the user precise control of the resulting movement of the guide wire. 
         [0012]    Control of a guide wire, according to the present invention, provides the advantages of reducing fatigue of the surgeon and better locational accuracy of catheter delivered medical devices. The preferred embodiments for both the apparatus and process is described for use in heart valve repair and replacements, but the present invention is applicable to any medical procedure utilizing a catheter. 
         [0013]    Also described in the present invention are nonlinear shapes in the proximity of the distal end of the guide wire, which depending on wire stiffness and shape can facilitate a change in orientation of the delivery capsule relative to the cardiac or other anatomy. The resulting trajectory and position changes of the delivery capsule provides the ability to more accurately place a prosthetic heart value in optimal locations within the heart. 
         [0014]    Although described for use in heart valve replacement and repairs as part of the best mode of the present invention, optimizing guide wires as described herein is applicable to any guide wire based medical procedure. 
         [0015]    These and other features, aspects, and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    Preferred embodiments of the invention are described below with the reference to the following accompanying drawings: 
           [0017]      FIG. 1  is a front partial section view of a heart with a guide wire inserted through the aortic artery and into the left ventricle of the heart. 
           [0018]      FIG. 2  is the same front partial view as  FIG. 1 , but with a catheter sheath and artificial valve inserted around the guide wire of  FIG. 1  and into the heart. 
           [0019]      FIG. 3  is the same front partial section view of  FIG. 1  and showing a deployed artificial valve. 
           [0020]      FIG. 4  is a perspective view showing a distal end of a prior art sheath, capsule and valve. 
           [0021]      FIG. 5  is a top view of a proximal end of a novel heart valve deployment device according to the present invention. 
           [0022]      FIG. 6  is a perspective view of the deployment device of  FIG. 5 . 
           [0023]      FIG. 7  is a perspective view of the deployment device main body having two threaded sections. 
           [0024]      FIG. 8  is a perspective view of the guide wire control device and having a partial section view of the wire manager showing how the sleeve engages with the cover and actuator. 
           [0025]      FIG. 9  is a rear perspective view of the sleeve of  FIG. 8 . 
           [0026]      FIG. 10  shows one half of the sleeve of  FIG. 9 . 
           [0027]      FIG. 11  is a rear perspective view of the actuator of  FIG. 8 . 
           [0028]      FIG. 12  is a rear perspective view of the spring of  FIG. 8 . 
           [0029]      FIG. 13  is an exploded view of the wire carrier and how it fits into the sleeve. 
           [0030]      FIG. 14  shows one half of the cover and features for engaging with the sleeve of  FIG. 9 . 
           [0031]      FIG. 15  is a partial perspective view of the threaded section of the stationary handle and showing the wire carrier, and tabs, sliding in the wire slot. 
           [0032]      FIG. 16  is a partial perspective view of a prior art delivery capsule connected to the sheath in a linear relationship, and having a linear version of a guide wire. 
           [0033]      FIG. 17  is a partial perspective view of a delivery capsule connected to the sheath in a novel non-linear relationship caused by mechanical forces of a non-linear guide wire. 
           [0034]      FIG. 18  is a partial side distal end view of an offset guide wire alternative embodiment shape. 
           [0035]      FIG. 19  is a partial side distal end view of a reversing offset guide wire alternative embodiment shape. 
           [0036]      FIG. 20  is a partial side distal end view of a double offset guide wire alternative embodiment shape. 
           [0037]      FIG. 21  is a partial side distal end view of a complex shaped guide wire alternative embodiment shape. 
           [0038]      FIG. 22  side a partial perspective distal end view a helical guide wire alternative embodiment shape. 
           [0039]      FIG. 23  side a partial side distal end view the helical guide wire alternative embodiment shape of  FIG. 22 . 
           [0040]      FIG. 24  is a partial perspective section view of the delivery capsule and sheath in a non-linear relationship with respect to each other. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0041]    Many of the fastening, connection, wiring, control, manufacturing and other means and components utilized in this invention are widely known and used in the field of the invention, and their exact nature or type is not necessary for a person of ordinary skill in the art or science to understand the invention; therefore they will not be discussed in detail. Furthermore, the various components shown or described herein for any specific application of this invention can be varied or altered and anticipated by this invention and the practice of a specific application or embodiment of any element may already be widely known or used in the art, or persons skilled in the art or science; therefore, each will not be discussed in significant detail. 
         [0042]    The present invention, as described, is used to control guide wires during medical procedures. Guide wires can be used to navigate tortuous pathways, can be used in advance of a delivery catheter, or used in conjunction with a delivery catheter to perform a desired medical procedure. Although the present invention is primarily described for use within an aortic artery, it should be appreciated that the present invention should not be construed to be limited to any particular body lumen. Other applicable lumens include, but are not limited to, gastrointestinal and urine lumens. Similarly, the present invention is primarily described for use with heart valve replacement procedures, but the present invention should not be construed to be limited to any particular procedure. Other applicable procedures include, but are not limited to, coronary angioplasty, stenting procedures and angiograms. 
         [0043]    Now referring to the figures,  FIGS. 1, 2 and 3  show a partial section view of a heart  10 . The anatomy of heart  10  is well known in the art of medicine and a detailed understanding is not necessary for one to understand and appreciate the present invention; therefore it will not be described in significant detail. Components of heart  10  shown in the accompanying drawings are in the non-limiting context of using the present invention in an aortic valve replacement procedure. 
         [0044]    In replacing an aortic valve and referring to  FIG. 1 , a guide wire  30  is advanced through an aortic artery  12 , through a natural aortic valve  16 , and into a left ventricle  18 . Aortic artery  12  starts in the abdomen. An aortic arch section  14  comes from the back side of the heart and bends towards an ascending aorta section  15  which is just before aortic valve  16 . Blood leaving left ventricle  18  escapes through natural aortic valve  16 . Aortic valve  16  is surrounded by an aortic valve annulus section  17 . It should be appreciated that the lumens of heart  10  are complex in shape and trajectory. 
         [0045]      FIG. 4  shows the distal end of a prior art heart valve replacement delivery system. Although the present invention is not limited to any particular delivery system, one such system is commercially produced by MEDTRONIC® under the tradename COREVALVE®. Guide wire  30  has a guide wire distal end  32  which is shown manufactured with a flexible curl. Guide wire  30  is approximately 0.035 inches in diameter and made from a metallic material which is coated in a low friction material, such as polytetrafluorethylene. Guide wire distal end  32  is more flexible than the rest of guide wire  30  which allows it to more easily navigate tortuous pathways with minimal damage to adjacent tissue. A catheter sheath  40  is advanced over guide wire  30 . Catheter sheath  40  is connected to a capsule  44  which houses a prosthetic valve  42 . In  FIG. 4 , prosthetic valve  42  is shown in a partially deployed state. With advancement of catheter sheath  40 , prosthetic valve  42  is completely encapsulated within capsule  44 . With retraction of catheter sheath  40 , prosthetic valve  42  is deployed. 
         [0046]    The application of the prior art heart valve delivery system of  FIG. 4  is shown in  FIGS. 1, 2 and 3 . In  FIG. 1 , guide wire  30  has been advanced through aorta  12 , has navigated both aortic arch  14  and ascending aorta  15  sections, has penetrated though natural valve  16 , and has guide wire distal end  32  located within left ventricle  18 . The curve of distal end  32  is shown against a wall of left ventricle  18  which can provide some force against guide wire  30 . It should be appreciated at the stage of  FIG. 1 , the surgeon has advanced guide wire  30  by applying forces to the proximal end of guide wire  30 . Imaging and feel ensures guide wire  30  is properly placed in heart  10 . Guide wire  30 , when placed in heart  10 , has some impact to the normal function of heart  10 . Therefore, it is desirable for the surgeon to act quickly and precisely to deploy prosthetic valve  42 . 
         [0047]      FIG. 2  shows catheter sheath  40  advanced over and along guide wire  30 . Because guide wire  30  is used in conjunction with catheter sheath  40  to locate prosthetic valve  42  in its optimal location, it should be appreciated that the surgeon may have to move guide wire  30  in relationship to catheter sheath  40 . Optimal location of prosthetic valve  42  in relationship to natural valve  16  and aortic annulus section  17  may be plus or minus one to three millimeters. Once optimal location of prosthetic valve  42  has been achieved both radially and in depth, the surgeon retracts catheter sheath  40  causing deployment of prosthetic valve  42 . The angled expansion of prosthetic valve  42  can cause a “jump” translation of either catheter sheath  40 , guide wire  30 , or both, during deployment. Translations during deployment can negatively impact deployment of prosthetic valve  42 . To maintain a successful deployment of prosthetic valve  42 , the surgeon must maintain optimal locations and forces of both catheter sheath  40  and guide wire  30 .  FIG. 3  shows prosthetic valve  42  deployed. 
         [0048]      FIGS. 5 and 6  show the overall present invention of a novel heart valve deployment device  50 . Deployment device  50  is comprised of a stationary handle  60 , a sheath manager  80  and a wire manager  90 . Similar to the prior art MEDTRONIC® COREVALVE® deployment device, sheath  40  is connected to sheath manager  80 . Sheath manager  80  rotates around stationary handle  60  causing both sheath manager  80  and a hollow tube  45  within sheath  40  to translate. A sheath slot  66  engages with sheath manager  80  so that only linear translation of sheath  40  occurs. Sheath manager  80  provides the means to control the translation of prosthetic valve  42  within capsule  44 . Novel guide wire manger  90  provides the means to control the translation of guide wire  30  and to facilitate optimal location of valve  42  in the heart. 
         [0049]      FIG. 7  shows stationary handle  60  which is preferably molded from plastic. A grip body  62  is used to provide stability to the overall system. During use, a surgeon&#39;s hand is in contact with grip body  62  to resist rotation and translation of stationary handle  60 . Connected to grip body  62  is a sheath threads  64 . Running through opposite sides of sheath threads  64  is sheath slot  66 . Towards the back end of stationary handle  60  is a wire thread  68  and wire slot  69 . To give approximate sizing but not intended to be limiting, grip body  62  is roughly 5 inches in length and has a major diameter of 1.75 inches. Threads  64  and  68  are approximately 0.050 inches wide, 0.040 inches deep and having approximately 10 threads per inch. 
         [0050]      FIG. 8  shows the details of novel guide wire manager  90 . Guide wire manager  90  is comprised of a cover  95 , a cap  100 , a carrier  98 , a spring  96 , an actuator  94 , and a sleeve  92 . Guide wire manager  90 , and the rotation of cover  95  with respect to stationary handle  60  drives linear translation of guide wire  30 . Shown in  FIGS. 9 and 10 , sleeve  92  has two instances of a tab  92   a . Tab  92   a  engages with wire threads  68 . Tab  92   a  is naturally biased to not engage with wire threads  68 . With spring  96  applying a force to actuator  94  and moving it forward over tab  92   a , tab  92   a  is deflected downward to engage with threads  68 . A user applying a rearward force to a grip  94   a  causes actuator  94  to compress spring  96 , translate rearward, and to allow tab  92   a  to return to its natural non-engaged position relative to wire threads  68 . With tab  92   a  in its natural non-engaged position, guide wire manager  90  may spin freely or be removed from stationary handle  60 . Spring  96  only needs to create enough force to deflect tab  92   a  in the engaged position within wire threads  68 . 
         [0051]    Sleeve  92  includes a flange  92   b  and a flat section  92   d . Flange  92   b  engages with a groove  95   a  of cover  95  to keep sleeve  92  fixed to cover  95 . A flat edge  95   b  of cover  95  engages with flat section  92   d  to force sleeve  92  to rotate with cover  95 . It should be appreciated that with a user holding grip body  62  fixed, and rotating cover  95 , that tab  92   a  rotates around threads  68  causing controlled linear translation of wire manger  90  and guide wire  30 . It should further be appreciated that with a user applying a backward force to grip  94   a , tab  92   a  is allowed to deflect out of threads  68  and guide wire manager  90  and guide wire  30  are free to slide or rotate relative to threads  68 . With wire slot  69  extending through the back end of stationary handle  60 , wire manager  90  and guide wire  30  are able to be quickly decoupled from stationary handle  60  during a procedure. 
         [0052]    As shown in  FIGS. 9 and 10 , sleeve  92  includes a clip section  92   c . As shown in  FIG. 13 , clip section  92   c  engages with a plurality of flanges  98   a  of carrier  98 . Carrier  98  is inserted into clip section  92   c  with flanges  98   a  deflecting and then snapping outward into clip section  92   c . Alternatively, clip section  92   c  can be an attached member to sleeve  92  or carrier  98  can be created by joining two halves. The result is that sleeve  92  is able to rotate freely around carrier  98  so that guide wire  30  only translates linearly. Linear motion is maintained because flanges  98   a  protrude through wire slot  69  of stationary handle  60 . On the rear portion of carrier  98  is carrier threads  98   b . Carrier threads  98   b  engage with cap  100  wherein rotation of cap  100  causes compression of a tube  102  around guide wire  30 . The angle of tube  102  against the corresponding cavity within carrier  98  creates a friction force on guide wire  30 . Preferably tube  102  is made from a rubber material and having a hole diameter of a couple of thousands of an inch larger than guide wire  30 . 
         [0053]    To use the device with respect to guide wire management, the surgeon can freely move guide wire  30  relative to deployment device  50  when cap  100  is not creating a compression on tube  102 . With guide wire  30  in close proximity to the desired location within the patient, guide wire  30  is secured to deployment device  50  by turning cap  100  and creating a frictional force between guide wire  30  and tube  102 . Rotating cover  95  turns sleeve  92  thus causing a screw force between tab  92   a  and wire threads  68 . The screw force creates a linear translation to wire carrier  98 . During the procedure and as needed, the surgeon can rotate cover  95  in either direction causing forward and backward translation of guide wire  30 . At any time the surgeon can apply a rearward force to grip  94   a  and freely move wire manager  90 , or decouple it from stationary handle  60 . 
         [0054]    In comparison to the prior art delivery devices wherein the doctor must use their fingers to try to control and secure guide wire  30 , deployment device  50  of the present invention, and the co-invented guide wire controller of pending U.S. patent application Ser. No. 15/005,520 herein incorporated in its entirety by this reference, provide the means to securely and predictably translate guide wire  30 . In addition to secured control, deployment device  50  and the referenced guide wire controller of the ′520 application provide the means for a doctor, or user, to apply a greater translational force to guide wire  30  than they can accomplish with their fingers. Control and increased force creates opportunities to further improve alignment of capsule  44  within heart  10 , and a more likely optimal location of valve  42  within heart  10 . 
         [0055]    One such improvement is described in  FIGS. 16 and 17 .  FIG. 16  shows a prior art delivery capsule  44  which is linearly aligned with the axis of sleeve  40  creating an angle A′ which is equal to 180 degrees. With guide wire  30  being linear, translation of guide wire  30  does not cause any mechanical forces within. With prior art delivery devices, and wherein the doctor must try to control the guide wire manually by hand, it is desirable to minimize translation forces by reducing any friction between guide wire  30  and sheath  40 .  FIG. 17  shows a novel angled orientation of delivery capsule  44  with respect to sheath  40  caused by mechanical forces of a helical guide wire  900 . An angle “A” exists between sheath  40  and capsule  44 . Angle “A” is caused by a non-linear shape pre-formed into guide wire  900  prior to inserting it through delivery sheath  40 . Because guide wires  30  and  900  are typically made from a rigid material, it has been found that the non-linear shape of helical guide wire  900  can create enough force to make angle “A” not equal to 180 degrees. It has also been found that small changes in translation of helical guide wire  900  can control the amount of change in angle “A”. Deployment device  50  in combination with helical guide wire  900  allow capsule  44  to be angled as needed to be centered and with optimal trajectory to deploy valve  42  within heart  10 . 
         [0056]      FIG. 24  shows more detail on the interaction of guide wire  900  with capsule  44  and sheath  40 . Within sheath  40  is hollow tube  45  that runs the length of sheath  40  and is attached to a valve connector  47  and to sheath manager  80 . Valve connector  47  removably attaches to valve  42 . Hollow tube  45  is connected to sheath manager  80  and pushes or pulls valve  42  within capsule  44  as needed for deployment of valve  42 . Guide wire  30 , or helical guide wire  900 , is located within hollow tube  45 . The nonlinear shape of helical guide wire  900  causes hollow tube  45  to want to bend with respect to sheath  40  creating a radial force between valve connector  47  and capsule  44 , and a change in angle “A”. 
         [0057]    Different wire shapes have been found to create different changes to the orientation of capsule  44  with respect to sheath  40 . As shown in  FIGS. 22 and 24 , helical guide wire  900  has a coil radius  901  and a pitch  902 . Although the present invention should not be construed to be limited to any particular dimension or range, it has been found that coil radius  901  being approximately one-half inch and coil pitch  902  being approximately one inch causes movement of capsule  44 . Optimal dimensions for a given procedure or device are a function or desired translation force, guide wire material and guide wire diameter. As shown in  FIG. 24 , the helical shape of helical guide wire  900  creates both angle “A” being less than, or greater than, 180 degrees, but also creates a rotation “B” wherein angle “A” rotates around the axis of sheath  40 . The translation of guide wire  900  through sheath  40  allows coil radius  901  to control angle “A” and causes coil pitch  902  to control rotation “B”. 
         [0058]    Although helical guide wire  900  has been found to be useful in providing a user control over the angle and rotation of capsule  44  with respect to sheath  40 , the present invention should not be construed to be limited to such a shape. 
         [0059]      FIGS. 18 through 21  show more alternative embodiments of guide wire  30  with any one being optimal for a particular patient&#39;s heart or for a given procedure.  FIG. 18  shows offset guide wire  500  having an offset  501  and an angle  502  relative to the main guide wire axis. Offset  501  may be chosen to be ideally suited for a particular patient&#39;s heart or procedure, and to create a particular angle “A”.  FIG. 19  shows a reversing offset guide wire  600  having an offset  601  and an angle  602  relative to the main guide wire axis and a second angle  603 . Offset  601  may be chosen to be ideally suited for a particular patient&#39;s heart or procedure.  FIG. 20  shows a double offset guide wire  700  having a first angle  702  and a first offset  701  which is connected to a second angle  703  and having a second offset  704 . As a further example,  FIG. 21  shows a complex guide wire  800  having a plurality of bends and offsets that may be made in any direction of three dimensional space. A first offset  801  and a first dimensional angle  802  creates movement of capsule  44  in a first direction and a second movement direction is created by a second and rotated angle  803  and a second rotated offset  804 . It should be appreciated that translation of guide wire  800  can move capsule  44  in different three dimensional planes as needed to optimally place valve  42 . 
         [0060]    While the catheter guide wire control device and related methods described herein constitute preferred embodiments of the invention, it is to be understood that the invention is not limited to these precise form of assemblies, and that changes may be made therein without departing from the scope and spirit of the invention as defined in the appended claims.