Abstract:
Device and method for puncturing blood vessels while using fluoroscopy. The disclosed device enables improved needle orientation control and avoids direct exposure of the clinician&#39;s hand to X-ray during the puncturing procedure.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention generally relates to a device and a method for needle puncturing of small blood vessels for small vessel angioplasty, such as below the knee (BTK) blood vessels and other small blood vessels (e.g., coronary, pediatric), which are partially or totally occluded. 
       BACKGROUND OF THE INVENTION 
       [0002]    A chronic total occlusion (CTO) is an arterial vessel blockage that prevents blood flow beyond the obstruction. CTO&#39;s typically occur in coronary, peripheral, pediatric, and either small arteries. In the coronary and peripheral arteries, they result from the same underlying cause—atherosclerosis. 
         [0003]    Endovascular therapies tor arteries below the knee have emerged as a promising revascularization technique for patients with critical limb ischemia (CLI). However, when employing standard angioplasty techniques, angioplasty of BTK arteries fails to achieve revascularization in up to 20% of cases. The main cause for failure is the inability to penetrate the plaque&#39;s proximal cap with the guidewire. 
         [0004]    A new technique of approaching the plaque from below—known as the retrograde approach—is often used to pass the guidewire through the plaque from the other direction. This approach has high success rates, but is technically challenging to perform and has its own complications, especially the danger of vessel perforation. 
         [0005]    In order to use the retrograde technique, the clinician must puncture the small target artery with a needle—usually smaller than a 21 gauge needle. The clinician relies on several angiographic images to aim the needle into the artery, and verifies proper needle tip location by observing blood flow exiting from the needle&#39;s proximal end. 
         [0006]    Puncturing small arteries is not easy; it requires proper manipulation of the C-arm and a gentle needle stick to avoid arterial perforation. Once a guidewire is inserted (through a small sheath or directly (sheath-less) through the skin) within the needle into the artery, the needle can be removed. 
         [0007]    Currently, relative short standard needles are used to puncture small blood vessels. Long needles that might potentially extend the user hand from the puncturing site are not used for two reasons: 
         [0008]    1) Long thin needles are too flexible, which prevents accurate and controlled positioning of the needle tip in the direction of the blood vessel; and 
         [0009]    2) Blood is expected to come out from the proximal end of the needle. This is fine for a short needle, but for a long needle the blood may not reach the proximal end due to low blood pressure in the treated vessel and high flow resistance of the long narrow needle lumen. 
         [0010]    Another important disadvantage of the prior art, is that during this needle insertion the clinician&#39;s hand is exposed to direct X-ray radiation which may have deleterious long-term health effects. 
       SUMMARY OF THE INVENTION 
       [0011]    The present invention is directed to a device and a method for needle puncturing of blood vessels for vessel angioplasty. The invention seeks to provide a special needle holder that facilitates needle insertion, and increases the needle puncturing procedure accuracy, while preventing hand exposure to radiation. 
         [0012]    In accordance with an embodiment of the invention, a standard needles is affixed onto a special extended needle holder, e.g., by using a female to male standard luer connection. The needle holder reduces the clinician&#39;hand exposure to x-rays during the needle insertion and provides better control of the needle trajectory and puncture. The device includes a vent for both blood passage to confirm needle tip location in the target artery and for guidewire passage. A standard guidewire may be inserted through the needle into the artery. Afterwards, the needle and needle holder are removed. 
         [0013]    Optionally, a guidewire holding mechanism is provided that reduces procedure time and minimizes blood spillage, by holding the distal portion of the guide wire inside the needle holder. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: 
           [0015]      FIG. 1  is a simplified cross-sectional illustration of a needle holder, in accordance with an embodiment of the present invention. 
           [0016]      FIG. 2  is a simplified cross-sectional illustration of a needle holder with a guidewire holder, in accordance with an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0017]    Reference is now made to  FIG. 1 , which illustrates a needle holder  10 , constructed and operative in accordance with an embodiment of the present invention. 
         [0018]    Needle holder  10  is an elongate stiff member  13  that includes a needle connector  14 , such as but not limited to, a male luer connector, at a distal end  15  thereof. Connector  14  connects to a needle  11 , such as by means of connecting with a female luer connector affixed to the proximal end of the needle  11 . Needle holder  10  may be supplied without the needle  11  and the user connects the holder to the needle. Alternatively, needle holder  10  may be supplied with needle  11  already assembled therewith. Without limitation, needle holder  10  preferably has a length of at least 12 cm, most preferably in the range of 20-25 cm; holder  10  is preferably longer than the needle  11 . The elongate stiff member  13  may be a hollow tube with a lumen  16 , which may be made, without limitation, from a stiff, clear polymeric material, e.g., polycarbonate. Lumen  16  is big enough for easy blood flow therethrough, preferably, but not necessarily, having a diameter of equal to or more than 1.0 mm. 
         [0019]    The long and stiff holder  10  reduces the clinician&#39;s hand exposure to x-rays during insertion of needle  11 , and provides better control of the needle orientation, trajectory, and puncture. 
         [0020]    Needle holder  10  includes a vent  12  at a proximal end thereof for blood flow to verify that the needle tip is property located inside the blood vessel. Vent  12  preferably, but not necessarily, has a standard female luer shape. 
         [0021]    Reference is now made to  FIG. 2 , which illustrates a needle holder  10  and guidewire holder  17 , constructed and operative in accordance with an embodiment of the present invention. 
         [0022]    Guidewire holder  17  may be used to hold the distal portion of a guidewire  25  inside the needle holder lumen before and during blood vessel puncturing. The option to hold the guidewire distal section inside the needle holder lumen may be useful for the operator, because it eliminates the need to look for the guidewire at the operation table, while holding the needle and needle holder steady. It reduces the amount of blood coming out of the needle, and spillage near the patient, by shortening the time needed to insert the guidewire through the needle. 
         [0023]    Guidewire holder  17  includes a guidewire locking element  18 , which may be made of a flexible material, such as but not limited to, silicone. A sliding knob  19  is arranged to slide over guidewire locking element  18 , which forces element  18  through a small hole  41  in elongate stiff member  13  into lumen  16 , thereby pressing the distal end of guidewire  25  against the inner wall of lumen  16  and holding guidewire  25  in place. To release guidewire  25 , the user slides sliding knob  19  to release guidewire locking element  18  from lumen  16 . 
         [0024]    A vent hole  20  may be added to elongate stiff member  13  distal to guidewire holder  17  to allow free blood flow outwards from the needle, even if lumen  16  is blocked by guidewire holder closing element  18 . 
         [0025]    Guidewire locking element  18  and/or other locking elements can be alternatively assembled to vent  12 . 
         [0026]    In accordance with an embodiment of the present invention, the procedure steps are: 
         [0027]    a. Fix needle  11  into connector  14 . 
         [0028]    b. Optionally insert and lock the distal portion of guidewire  25  inside needle holder lumen  16 . 
         [0029]    c. Using x-ray angiography, insert and adjust the needle and needle tip until entering the blood vessel. 
         [0030]    d. Conform needle tip is inside the blood vessel by looking at blood coming up into lumen  16  of elongate stiff member  13 . 
         [0031]    e. Insert guidewire  25  through vent  12  (e.g., female luer) and lumen  16  (if not inserted and locked before), through connector  14  and needle  11 , and into the blood vessel. 
         [0032]    f. Extract needle holder  10  together with needle  11  from the patient, and remove proximally from guidewire  25 . 
         [0033]    g. Continue the angioplasty procedure.