Abstract:
A surgical tool for the obliteration of small and medium sized veins in the skin of a patient, through the deployment of a hook member.

Description:
CROSS REFERENCE 
       [0001]    The present case claims the benefit of and is the utility conversion of U.S. Provisional Application 61/668,138 filed Jul. 5, 2012, entitled “Horizontal Phlebectomy—A Novel Device for the Treatment of Small and Medium Sized Veins”. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to vein obliteration technology and more particularly to a surgical instrument operated by a physician for locating, intercepting and obliterating small and medium sized veins in the skin of a patient. 
       BACKGROUND OF THE INVENTION 
       [0003]    The heart pumps blood to supply oxygen and nutrients to all parts of the body. Arteries carry blood from the heart towards the body parts, while veins carry blood from the body parts back to the heart. Veins contain one-way valves to prevent the blood from flowing backwards. If the one-way valve becomes weak, some of the blood can leak backwards through the valve, collect in the vein upstream of the valve, and then become congested as the pressure builds. This congestion will cause the vein to abnormally enlarge. These enlarged veins can be seen on the surface of the skin. Removal of diseased veins can be accomplished in several ways including surgical intervention. 
       SUMMARY OF THE INVENTION 
       [0004]    The present invention relates generally to a tool that can be used conveniently by a physician or other user to intercept and pull a vein to disrupt the vessel. In contrast to prior art devices that simply cut the vein; the present device includes a hook that engages the vein with blunt, non-cutting surfaces. Motion of the tool supplies force to the vein and the tissues surrounding the vein. The tool is manipulated enough to disrupt the vein and create an extensive injury to the vein and the immediate tissue at the site of the intervention. This form of injury prevents the vein from re-cannulizing and therefore results in vein obliteration. The applicants have discovered that this distributed injury results in the more reliable removal of the vein than the previously known vein cutting technique. It is preferred that the tool enter the skin nearly “horizontally” to facilitate vein location and obliteration. The exact angle is a matter of medical judgment by the tool in tended to operate at low entry angles. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]    Throughout the figures of the drawing identical reference numerals indicate identical structure, wherein: 
           [0006]      FIG. 1  shows the device in the hand of a physician user interacting with a patient; 
           [0007]      FIG. 2  shows the interior of the device; 
           [0008]      FIG. 3A  shows a portion of the device in isolation; and, 
           [0009]      FIG. 3B  shows a portion of the device in isolation. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0010]      FIG. 1  shows the device  10  resting in the hands of a physician  12 . The device lies in the hand between the thumb and forefinger. The device has an elongate axis  14  and a set of finger paddle levers typified by lever  16  and lever  17  for activation by the physician&#39;s fingers. The physician squeezes the two lever arms together to activate the device. The energy supplied by translating the motion of the physician&#39;s fingers causes a hook member  18  to emerge from a needle member  20 . 
         [0011]    In use the needle member  20  is forced into the patients skin  24  through a wound  26 . Activation of the hook member  18  and manipulation by the physician  12  allows the hook member  18  to engage and snare a vein  26  located below the skin  24  and tear it by manipulation of the lever  16  and lever  17 . Entry into the skin occurs at a low angle indicated as theta in the figure. Full compression of the finger levers moves the device from a static initial state or position to a competed or deployed position locating the hook member  18  in its fully extended a fixed position a predetermined distance into the tissue. 
         [0012]      FIG. 2  shows a perspective view of the interior of the device  10  and shows one embodiment of a mechanical arrangement for translating the surgeon&#39;s squeezing of the paddle lever arms, rotating them about axis  14  to a translational movement of the hook member  18 . Each finger paddle lever  16  and  17  connects to a sector gear contained within the housing bottom. The sector gear for lever  17  is labeled  26  in the figure. The complimentary sector gear  28  is formed integrally with lever arm  16 . Both finger lever arms share a common axis of rotation  15  or common axle. Both arms are mounted for pivoting around this common axle that is perpendicular to axis  14 . The finger lever arms and associated sector gear segments are biased against each other by a wound torsion spring  40 , shown in  FIG. 3B . The housing or body shown is half of a clamshell construction the forms the body  11  of the device  10 . 
         [0013]      FIG. 3A  shows a portion of the mechanism in isolation to improve clarity of description of the operation. As seen in  FIG. 3A  the spring  40  is anchored in both lever arm  16  and  17  at locations defined by holes. This arrangement causes the lever arms to react against each other to improve the “feel” or sensitivity of the device. It is believed that the haptics of the device will be important to its acceptance and use. As the two gear sectors scissor past each they drive a pinion gear  30  rotating about axis  14 . This pinion gear is coupled to shaft  32  that connects to the tip assembly bushing  38 . The pinion gear  30  and shaft  32  are journaled in bearings not labeled that serve to retain the shaft within the housing or body while still allowing smooth rotation. The pinion gear further serves to keep the levers mechanically mated to each other in synchronous fashion such that pivoting or actuating movement of one lever is dependent on movement of the second lever. In summary, lever motion results in rotation of the shaft  32  and a restoring force supplied by spring  40  returns the levers to the initial position. 
         [0014]    The sector gear tooth count and pitch to pinion diameter pitch and tooth count establish a ratio that is selected to provide the maximum desired amount of rotation that is translated into a translational motion of the hook member  18 . 
         [0015]      FIG. 3B  is a view of a portion of the device  10  illustrating the mechanism to advance the hook member  18 . A worm and peg drive system is provided to rotate the worm section  34  when the shaft  32  rotates. A peg  36  located in the groove of the worm  34  advances or retracts based on this motion. The peg  36  also sits in an anti-rotation groove in bushing  38  to prevent rotation of the hook member  18  as it advances out of the needle member  20 . 
         [0016]    In summary the device  10  has an instrument body  11  that is held in a physician&#39;s hand  12 . His fingers may operate a pair of opposed levers  16  and  17 . 
         [0017]    When pressed the levers rotate a spindle assembly that advance a hook member  18  out of the needle member  20 . As a part of the treatment the device  10  handle may be retracted and or rotated with the hook  18  engaging a vein  26  as shown in  FIG. 1 . 
         [0018]    To permit entry into the skin a needle member  20  will be quite sharp. In use the hypodermic needle member  20  will cover the hook member  18  during entry into the skin  24 . The hook member  18  will emerge from the needle member  20  and surround or hook the vein  26 . Rotation of the handle and retraction of the hook will disrupt the vein  26 . 
         [0019]    The device of the present invention has two mechanisms of action. A translational mode and a rotational mode. They may be used together or separately to effectively remove a vein. 
         [0020]    In general the device includes a handle assembly that can rotate a spindle to advance a hook. 
         [0021]    The physician can also pull on the spindle or push on the spindle with the handle. The spindle can retract into a hypodermic needle that can be manipulated by the handle. 
         [0022]    In use the physician enters the skin at a shallow angle with the spindle retracted into the handle thereby exposing the sharp needle tip. The needle is manipulated to navigate to the vein and the spindle extended to engage the vein. 
         [0023]    With the vein trapped in the hook of the distal tip of the spindle the physician may apply both traction and/or rotation to ensure that a long length of vein is injured. 
         [0024]    Important attributes of the device include the convertibility between sharp and blunt dissection along with two modes of vein disruption. 
         [0025]    It is also anticipated that fluid injection through the needle or the spindle to provide local anesthetic effects may be readily incorporated into the device. 
         [0026]    The device is intended to be a single use tool however reusable versions are contemplated within the scope of the invention. It is proposed to have single tip configuration but a replaceable tip is contemplated within the scope of the invention.