Abstract:
An introducer needle assembly including a compressible section between the rigid needle and the hub. Once the vessel is entered as determined by blood entering the syringe, the compressible section of the introducer needle is occluded by compressing the section with the thumb and a finger. Neither blood for air can pass. Since the compressible section is in a flattened area it is easier to hold the needle while the syringe is unscrewed. The operator then can begin threading a guidewire down the device which is now easier to enter because blood is not coming out of the hub thus obscuring the lumen.

Description:
[0001]    This application claims the benefit of U.S. Provisional Application No. 62/096,628, filed on Dec. 24, 2014, the contents of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This relates to the field of medical devices and more particularly to vascular guidewire introducer devices. 
       BACKGROUND OF THE INVENTION 
       [0003]    Generally, to insert a catheter into a blood vessel, the vessel is identified by aspiration with a long hollow needle in accordance with the well-known Seldinger technique. In its simplest application, a needle, with a syringe attached, is introduced into the patient. When blood enters the syringe, it provides visual indication that the vessel has been found; the syringe is then disconnected from the needle and a thin guidewire is then introduced into the needle and into the interior of the vessel. The introducer needle is then removed from the patient and slid over the guidewire proximal end, leaving the distal end portion of the guidewire that has been inserted into the vessel within the vessel and the opposing end of the guidewire projecting beyond the surface of the skin of the patient. After which, the catheter is directed over the guidewire, either directly or using a dilator or the like. 
         [0004]    During the procedure, when the syringe is removed from the introducer needle, bleeding can occur from the needle and onto the operative field, or air can be aspirated into the vessel if the patient inspires while the needle is not sealed prior to and during introduction of the guidewire into the needle. Blood on the operative field exposes the caregivers to contamination with blood-borne pathogens, and intravascular air can result in vascular occlusion and injury or death. Currently this is controlled by the interventionist by putting their finger tip on the needle hub. 
       SUMMARY OF THE INVENTION 
       [0005]    In at least one aspect, the present invention provides a compressible section between the rigid needle and the hub. Once the vessel is entered as determined by blood entering the syringe, the compressible section of the introducer needle is occluded by compressing the section with the thumb and a finger. Neither blood nor air can pass. Since the compressible section is in a flattened area it is easier to hold the needle while the syringe is unscrewed. The operator then can begin threading a guidewire down the device which is now easier to enter because blood is not coming out of the hub thus obscuring the lumen. Compression is then released while the guidewire is passed with the guidewire now partially occluding blood or air passage. 
         [0006]    In at least one embodiment, the present invention provides an introducer needle assembly including a hollow needle with a needle passage extending from a needle distal end to a needle proximal end. A hub extends from a hub distal end to a hub proximal end with the hub distal end secured to the needle proximal end. The hub includes a needle connector at the hub distal end and a device connector at the hub proximal end with a pair of spaced apart rails interconnecting the needle connector and the device connector with a hollow space defined therebetween. A first passage is defined from the needle connector through a first post extending proximally thereof and the first passage is in communication with the needle passage. A second passage extends from the device connector through a second post extending distally thereof. A compressible member having a tubular body defines a third passage extending between the ends thereof. The compressible member is secured on the first and second posts such that a continuous passage is defined through the second passage, the third passage, the first passage and the needle passage and the third passage has an inner diameter equal to or less than an inner diameter of the first passage. 
         [0007]    In at least one embodiment, the hub of the introducer needle assembly has a generally wide, flat configuration extending in a plane extending between the side rails. 
         [0008]    In at least one embodiment, opposed sides of the tubular body have indentations defined therein with a compression pad defined in the center of each indentation. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings: 
           [0010]      FIG. 1  is a plan view of an introducer needle assembly in accordance with an embodiment of the disclosure. 
           [0011]      FIG. 2  is a perspective view of the hub of the introducer needle assembly of  FIG. 1   
           [0012]      FIG. 3  is a side elevation view of the hub. 
           [0013]      FIG. 4  is a cross-sectional view along the line  4 - 4  in  FIG. 2 . 
           [0014]      FIG. 5  is a perspective view of the compressible member of the introducer needle assembly of  FIG. 1 . 
           [0015]      FIG. 6  is a cross-sectional view along the line  6 - 6  in  FIG. 5 . 
           [0016]      FIG. 7  is a cross-sectional of the hub and compressible member. 
           [0017]      FIG. 8  is a perspective view of another exemplary compressible member in accordance with an embodiment of the disclosure. 
           [0018]      FIG. 9  is a side elevation view of the compressible member of  FIG. 8 . 
           [0019]      FIG. 10  is a cross-sectional view along the line  10 - 10  in  FIG. 8 . 
           [0020]      FIG. 11  is a plan view of an introducer needle assembly including the compressible member of  FIG. 8 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0021]    In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terms “distal” and “proximal” refer, respectively, to directions closer to and away from a patient&#39;s blood vessel. The following describes preferred embodiments of the present invention. However, it should be understood, based on this disclosure, that the invention is not limited by the preferred embodiments described herein. 
         [0022]    Referring to  FIGS. 1-7 , an exemplary embodiment of an introducer needle assembly  10  in accordance with an embodiment of the invention will be described. The introducer needle assembly  10  generally comprises a hollow needle  12 , a hub  20  and a compressible member  50 . The hollow needle  12  extends from a distal end  11  to a proximal end  13  with a passage  14  extending therethrough. The proximal end  13  of the hollow needle  12  is connected with the distal end  21  of the hub  20 . 
         [0023]    Referring to  FIGS. 2-4 , the hub  20  includes a generally rigid body  22  extending from the distal end  21  to a proximal end  23  and includes a pair of side rails  24  extending between a needle connector  28  at the distal end  21  and a device connector  30  at the proximal end  23 . In the illustrated embodiment, a bridge  29  interconnects the needle connector  28  with the side rails  24  and a shoulder  32  interconnects the device connector  30  with the side rails  24 , although other configurations are contemplated. The needle connector  28  may be molded about the proximal end  13  of the hollow needle  12  or may be otherwise secured thereto. The device connector  30  includes a thread  31  or the like for engagement with the threads of a syringe or the like. 
         [0024]    The configuration of the hub body  22  is preferably a generally flat, wide configuration such that the interventionist can easily grasp the hub  20  and prevent it from inadvertently rotating during the procedure, for example, while the syringe is twisted during detachment. Other configurations other than that specifically illustrated may also be utilized. 
         [0025]    A hollow space  25  is defined between the side rails  24  for receipt of the compressible member  50  as will be described hereinafter. A proximal post  34  extends distally from the shoulder  32  and a distal post  36  extends proximally from the bridge  29 . Each of the posts  34 ,  36  may include outwardly extending barbs  33  or the like to secure connection of the compressible member  50 . A passage  40  extends along the central axis CA of the hub  20  from the proximal end  23  to the distal end  21 , with an area of discontinuity  49  between the posts  34  and  36 . As described below, upon assembly, a passage  54  through the compressible member  50  (see  FIGS. 5-7 ) aligns with the passage  40  and eliminates the discontinuity such that a continuous passage extends through the hub  20  from the proximal end  23  to the distal end  21 . 
         [0026]    Referring to  FIGS. 5 and 6 , an exemplary compressible member  50  will be described. The compressible member  50  has an elastic tubular body  52  extending from a distal end  51  to a proximal end  53 . A passage  54  extends through the body  52  from the proximal end  53  to the distal end  51 . The elastic body  52  has an outside diameter COD in a central region between the ends  51 ,  53  and the passage  54  defines an inner diameter MID. The distance between the outside diameter COD of the central region and the inner diameter MID defines a wall thickness in the central region, the area which will be compressed to occlude the passage  54 . An alternative embodiment of the compressible member will be described hereinafter wherein the configuration of the elastic body  52  is such that the thickness to be compressed is reduced while still providing a sufficiently rigid structure and reliable compression area. 
         [0027]    With reference to  FIG. 7 , upon assembly, the proximal end  53  of the compressible member  50  is positioned over the proximal post  34  such that the post  34  is received in the passage  54 . Likewise, the distal end  51  of the compressible member  50  is positioned over the distal post  36  such that the post  36  is received in the passage  54 . The barbs  33  on each of the posts  34 ,  36  engage the compressible member  50  such that the ends  51 ,  53  thereof are retained on the posts  34 ,  36 . Other securement arrangements may alternatively be utilized. With the compressible member  50  secured to the posts  34 ,  36 , the passage  54  aligns with the passage  40  and a continuous passage is defined through the hub  20  from the proximal end  23  to the distal end  21 . As illustrated in  FIG. 3 , each side rail  24  has a narrow central portion  26  with a width W which is less than the outside diameter COD of the central region of the compressible member. As such, the central region of the compressible member  50  will extend above the central portion  26  of the side rails  24 , whereby it may be easily accessed to compress and thereby occlude the passage  54 . 
         [0028]    In use, the introducer needle assembly  10  with a syringe or the like (not shown) attached to the device connector  30  is utilized to access a blood vessel in a manner similar to the prior technique. The distal end  11  of the hollow needle  12  is introduced into the patient. When blood enters the syringe, it provides visual indication that the vessel has been found. At this time the syringe may be removed. Removal of the syringe generally requires two actions, twisting off of the syringe and occlusion of the passage. The exemplary configuration of the hub  20  facilitates the two actions generally happening in a simultaneous, intuitive manner. As the interventionist grabs the side rails  24  of the hub  20 , for example between the interventionist&#39;s thumb and pointer finger, to stabilize the hub  20  such that he syringe may be twisted relative thereto, the thumb and pointer finger naturally extend above and below the compressible member  50 . As a holding force is applied to the hub  20 , the force may naturally be applied to the central region  55  of the compressible member  50  to occlude the passage  54 . With the passage  54  occluded, the syringe may be removed. As indicated, the two actions may naturally occur almost simultaneously. After the syringe is removed, a thin guidewire is then passed through the hub  20 , introduced into the needle and into the interior of the vessel. The interventionist may ease some, if not all, of the compressive force as the guidewire is passed through the passage  54 . With the guidewire properly positioned, the introducer needle assembly  10  may be removed and the catheter inserted over the guidewire. 
         [0029]    With reference to  FIGS. 4, 6 and 7 , the illustrated passage  40  and the passage  54  will be further described. The passages  40  and  54  are preferably configured to assist guidance of a guidewire (not shown) through the hub  20  into the hollow needle  12 . In the illustrated embodiment, a large bore  41  is defined in the device connector  30  such that a large opening is defined at the proximal end  23  of the hub  20  to easily receive the guidewire. The passage  40  includes a tapered bore  42  distally of the large bore  41  which transitions to a narrower bore  43  through the proximal post  34 . A similarly sized bore  44  extends into the distal post  36  and has an inner diameter PID. The inner diameter MID of the compressible member passage  54  is equal to or slightly smaller than the inner diameter PID of the bore  44 . In this way, when the compressible member  50  is secured on the post  36 , the inside surface of the passage  54  will be slightly inside of or aligned with the inside surface of the bore  44 , thereby defining a smooth transition without any interruptions which may catch the guidewire and make passage through the hub  20  more difficult. The inner diameter of the bore  43  is preferably equal to the inner diameter PID, but could be slightly larger or smaller since the guidewire will be moving from the bore  43  to the passage  54  and the chance of catching is reduced. 
         [0030]    The illustrated passage  40  includes another tapered bore  45  distally of the bore  44  which transitions to a bore  46  at about the bridge  29 . The bore  46  has an inner diameter which is approximately equal to the inner diameter of the hollow needle. The bore  47  in the needle connector  28  is slightly larger in diameter than the bore  46 , with the difference corresponding to the thickness of the hollow needle  12  wall. With such a configuration, upon assembly of the needle  12  with the hub  20 , a generally continuous surface is defined between the bore  46  and the inside surface of the needle bore  14 . 
         [0031]    It is noted that inner diameter PID of the bore  44  may be the same as the inner diameter of the bore  46  whereby the tapered bored  45  can be eliminated. By reducing the inner diameter PID of the bore  44 , the inner diameter MID of the compressible member passage  54  will be correspondingly reduced. Such a reduction in diameter is advantageous in that it will reduce the available volume for blood or air passage and will also reduce the diameter which must be occluded; however, an overly narrow passage  54  through the compressible member  50  may make passage of the guidewire therethrough more difficult. The passage inner diameter MID is therefore selected to balance the ease of passing the guidewire through the passage  54  while also being able to reliably occlude the passage. 
         [0032]    The compressible member  50  may be manufactured from various natural and synthetic biocompatible elastomeric materials. As an example, the compressible member  50  may be manufactured from silicone. The materials and the hardness thereof may be selected such that the compressible member  50  has sufficient rigidity that a guidewire may pass through the passage  54  with minimal interference, yet is sufficiently elastic that the member  50  may be compressed and the passage  54  reliably occluded. 
         [0033]    Referring to  FIGS. 8-11 , an introducer needle assembly  10 ′ with an alternative compressible member  50 ′ will be described. The introducer assembly  10 ′ includes a hollow needle  12  and hub  20  the same as in the previously described embodiment. The compressible member  50 ′ is similar to the previous embodiment and includes an elastic, tubular body  52 ′ extending from a distal end  51  to a proximal end  53 . As in the previous embodiment, a passage  54  extends through the body  52  from the proximal end  53  to the distal end  51 . In the present embodiment, opposed sides of the tubular body  52 ′ have indentations  56  defined therein with a compression pad  58  defined in the center of each indentation  56 . The indentations  56  and compression pads  58  define clear alignment points for the interventionist&#39;s fingers. As illustrated in  FIG. 11 , the compression pads  58  extend parallel with the plane of the side rails  24  and are easily accessible within the hollow space  25 . 
         [0034]    Furthermore, the indentations  56  reduce the amount of body material which must be compressed to occlude the passage  54 ; however, the compression pads  58  provide a sufficient thickness about the passage  54 . The opposed compression pads  58  define opposed structures aligned with the passage  54  that can be brought together to occlude the passage  54 . Compressing of the compression pads  58  provides a directed occluding force without any force being wasted on compressing outer portions of the tubular body  52 ′ as such are removed by the indentations  56 . As illustrated in  FIG. 10 , the compressible member  50 ′ maintains a significant central outer diameter COD about the passage  54 . The central outer diameter COD is again preferably larger than the width W of the central portion  26  of the side rails  24  such that the compression pads  58  are easily accessible. 
         [0035]    The indentations  56  and compression pads  58  may be defined by cutting away of the body  52 ′. Alternatively, the body  52 ′ may be manufactured, for example, via molding, with the indentations  56  and compression pads  58  already formed therein. In all other respects, the introducer needle assembly  10 ′ functions similarly to that described above. 
         [0036]    These and other advantages of the present invention will be apparent to those skilled in the art from the foregoing specification. Accordingly, it will be recognized by those skilled in the art that changes or modifications may be made to the above-described embodiments without departing from the broad inventive concepts of the invention. It should therefore be understood that this invention is not limited to the particular embodiments described herein, but is intended to include all changes and modifications that are within the scope and spirit of the invention as defined in the claims.