Patent Publication Number: US-2007123935-A1

Title: Method and apparatus for contemporaneous formation of a body structure opening and homologous pedicle

Description:
FIELD OF THE INVENTION  
      The present invention relates generally to the field of apparatus and methods for creating and sealing of body structure access sites. More specifically, the present invention relates to an improved surgical needle apparatus and method for contemporaneously forming a body structure opening and homologous pedicle for closure thereof. The needle apparatus may be partially useful in accessing fluid- transporting structures such as vascular members.  
     BACKGROUND OF THE PRIOR ART  
      Accessing the vascular system has, for several decades, been performed by one or more techniques of percutaneous entry. Early percutaneous entry involved puncturing of the site with a needle and then following the needle with an external hub and obturator. In this method, the needle punctured both the anterior vascular wall and the posterior vascular wall. The hub and obturator were blunt smooth surfaces that would displace and/or compact the vessel walls as they extended therethrough, as there was no removal of material during the procedure. Once positioned, the hub and obturator were progressively withdrawn until the needle drew blood, indicating proper placement in arterial lumen.  
      In such procedures, resealing of the arterial wall became difficult where the arterial wall had been stretched and/or deformed resulting in tissue necrosis and preventing proper recoil of the tissue.  
      More recently, a single wall cutting needle was introduced that only cuts into the anterior arterial wall, thus not requiring sealing of the posterior arterial wall. However, such needles and devices result in the removal of tissue from the arterial wall, including the vaso vasorum, leaving a hole in the tissue, once again making resealing of the site difficult.  
      The main disadvantage of this method is that resealing of the vessel wall requires external compression at the puncture site for a period of about forty-five minutes to one hour to allow closure by natural clotting. Following this, a patient must generally undergo 3-8 hours of bed rest to allow the seal to strengthen and usually should not return to normal activity for 2-3 days following the procedure. The medical, social and economic impact of this prolonged recovery period is substantial. Over  6  million such procedures occur annually in the United States, having an economic impact in the billions of dollars in terms of time and expense.  
      A number of vascular closure products have been introduced to address this problem. However, all such devices introduce non-homologous substances to the puncture site, such as bovine collagen. Even where most of such products perform under a wide range of conditions, none has been able to completely replace the procedure of manual compression. Specifically, for patients with larger puncture sites or patients taking anti-coagulant medications, compression remains the preferred means for sealing the puncture site. Sealing of a puncture site in a vascular wall, however, ultimately results in the formation of scar tissue that replaces a section of the vaso vasorum in the vessel wall. Accordingly, the puncture site remains a damaged area of the vessel wall subsequent to closure, and can act as a starting point to subsequent medical problems.  
      It would, therefore, be advantageous to provide an improved apparatus and method for overcoming these and additional shortcomings of the prior art.  
      More specifically, it would be advantageous to provide a method and apparatus for accessing a vascular system that minimizes damage to the arterial wall and vaso vasorum, and does not require removal of material therefrom, and further to provide a method and apparatus that does not require introduction of foreign materials to the vascular site for the sealing thereof.  
      It is a further object of the present invention to provide a method and apparatus for accessing a body structure in vivo that minimizes damage to such body structure and enables rapid re-sealment thereof.  
     SUMMARY OF THE INVENTION  
      The present invention provides a surgical needle apparatus and method for contemporaneously creating a body structure access site and a homologous pedicle for sealing and closure thereof.  
      The surgical needle apparatus includes a needle member having a piercing tip at a distal portion thereof. The distal portion is configured to form a first edge extending obliquely to a proximal portion of the needle member. A bore is formed in the distal portion, about which bore the first edge extends defining opposing sides thereof and a pair of longitudinal cutting edges extend rearwardly from the first edge to define a recessed portion of the distal portion of the needle member. The bore is in fluid communication with the lumen of the needle member. The longitudinal cutting edges are configured to extend substantially parallel to an elongate axis defined by the needle member, such longitudinal cutting edges having a raised cutting surface extending radially from the outer surface of the needle member.  
      In operation, the piercing tip and first edge form a first incision in a body structure wall extending substantially perpendicular to the elongate axis of the needle member. The longitudinal cutting surfaces form incisions on opposing sides of the first incision, generally perpendicular thereto, to form an intact homologous pedicle in the body structure wall.  
      It is an object of the present invention to provide an apparatus and method for creating a vascular access site.  
      It is another object of the present invention to provide an apparatus and method for creating a homologous pedicle in an arterial wall for accessing and sealing of the vascular access site. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is a top view of a prior art needle apparatus.  
       FIG. 2  is a top view of a needle apparatus in accordance with the present invention.  
       FIG. 3  is a cross-sectional view of the needle apparatus from  FIG. 2  along cut line  3 - 3 .  
       FIG. 4  is a cross-sectional view of the needle apparatus from  FIG. 2  along cut line  4 - 4 .  
       FIG. 5  is a cross-sectional view of the needle apparatus from  FIG. 2  along cut line  5 - 5 .  
       FIG. 6  is a cross-sectional view of the needle apparatus from  FIG. 2  along cut line  6 - 6 .  
       FIG. 7  is a side view of the needle apparatus of the present invention.  
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
      The objects and advantages enumerated above together with other objects, features, and advances represented by the present invention will now be presented in terms of detailed embodiments described with reference to the attached drawing figures which are intended to be representative of various possible configurations of the invention. Other embodiments and aspects of the invention are recognized as being within the grasp of those having ordinary skill in the art.  
       FIG. 1  shows a needle apparatus  100  from the prior art wherein a needle member  102  has a piercing tip  104  formed at a distal portion  106  thereof. The distal portion  106  is configured such that a top face  108  of the needle apparatus  100  obliquely extends rearwardly from the piercing tip  104  formed in the distal portion  106  thereof. The top face  108  of the needle apparatus  100  further defines a boundary of a bore  110  that is in fluid communication with the inner lumen  112  of the needle member  102 . A proximal end  114  of the top face  108  of the needle apparatus  100  interfaces with the outer surface  116  of the needle member  102 .  
      Top face  108  of needle apparatus  100  is further defined by first and second edges  109 ,  111  that diverge from piercing tip  104  and meet at heel portion  113  of proximal end  114  of top face  108 . First and second edges  109 ,  111  form cutting surfaces to penetrate through, for example, the anterior wall of a vascular member. As distal portion  106  of needle apparatus  100  is pressed into the vascular member, heel portion  113  of first and second edges  109 ,  111  acts to cut and ultimately remove a section of the interior wall of the vascular member to leave an aperture in such vascular member. It is this aperture that induces the post-procedure healing difficulties described above.  
       FIG. 2  shows a surgical needle apparatus  10  having a piercing tip  12  formed at a distal portion  14  of a needle member  16 . In preferred embodiments, needle member  16  is substantially tubular in configuration, though variations of such a configuration are contemplated as being useful in apparatus  10  of the present invention. For example, needle member  16  may be fluted so as to provide for a desired entry characteristic into the vessel wall. The distal portion  14  of the needle member  16  further includes a first edge  17  obliquely extending proximally from the piercing tip  12  to a heel portion  20  of the surgical needle apparatus  10 . A bore  22  is defined in the surgical needle apparatus  10  by opposing edges  17 ,  19 , which diverge from piercing tip  12 . A pair of longitudinal cutting edges  28 ,  30  extend rearwardly from heel portion  20 , and define lateral boundaries of a recessed portion  32  that is coextensive with bore  22 . As illustrated in  FIG. 2 , longitudinal cutting edges  28 ,  30  preferably terminate at end  29 , which has a blunt or unsharpened surface so as not to function as a cutting surface.  
      First and second longitudinal cutting edges  28 ,  30  are generally shown extending parallel to an elongate axis “A” of the needle member  16 . In a preferred aspect of the present invention, the first and second longitudinal cutting edges  28 ,  30  are configured to be raised so as to radially extend outwardly from an outer surface  34  of the needle member  16 . Preferably, first and second longitudinal cutting edges  28 ,  30  extend radially outwardly from outer surface  34  of needle member  16  by between about 0.25 and 2 mm, and more preferably by between about 0.5 and 1 mm.  
      First and second longitudinal cutting edges  28 ,  30  preferably extend longitudinally from heel portion  20  to end  29  for a distance of between about 0.5 and 10 mm, and more preferably between about 1 and 7 mm. Moreover, first and second longitudinal cutting edges  28 ,  30  are preferably spaced apart by between about 0.5 and 5 mm, and more preferably between about 1 and 3 mm, such that recessed portion  32  has a width of between about 1 and 3 mm. While the dimensional specifications identified above provide a preferred construction of the present invention, it is contemplated that various dimensions may be utilized for various needle structures and for various applications that are outside the ranges set forth above. Such dimensional modifications, however, are contemplated as being included in the present invention. For example, first and second longitudinal cutting edges  28 ,  30  may extend in substantially non-parallel directions from heel portion  20 . In some embodiments, first and second cutting edges  28 ,  30  may extend convergently from heel portion  20 , while in other embodiments, first and second cutting edges  28 ,  30  may divergently extend from heel portion  20 .  
      The raised aspect of longitudinal cutting edges  28 ,  30  act. to operably create thin incisions in the body structure wall and extending from opposed end portions of a first incision made by first and second edges  17 ,  19 . In this manner, a homologous pedicle having a width of about 1-3 mm and a length of about 0.5-7 mm is created in the wall of the body structure being accessed by needle apparatus  10 . The pedicle remains connected to the wall of the body structure, and provides a living homologous material that rapidly re-closes the access site once the needle apparatus  10  of the present invention is removed from the body structure.  
      The homologous pedicle has a shape defined by the relative orientation of first and second longitudinal cutting edges  28 ,  30 . Accordingly, where first and second longitudinal cutting edges  28 ,  30  extend in substantially parallel relationship from heel portion  20 , the homologous pedicle is a substantially three-sided flap that remains living and connected to the vessel member. Other configurations for the formed pedicle, however, are created through various relative configurations of first and second longitudinal cutting edges  28 ,  30 .  
       FIGS. 3-6  each provide a cross-sectional view of the needle apparatus  10  at different locations along the axis “A” defined by the elongate dimension of the needle member  16 .  FIG. 3  shows the generally radial cross section near the piercing tip  12  such that the opposing edges  17 ,  19  define terminating ends of the cross section shown at line  3 - 3 .  FIG. 4  shows a cross-section at distal portion  14  illustrating the beveled side profile  18  leading to first and second edges  17 ,  19 .  
       FIG. 5  shows a cross-section of distal portion  14  including the longitudinal cutting edges  28 ,  30 . Longitudinal cutting edges  28 ,  30  extend radially outwardly relative to the outer surface  34  of the needle member  16 , as shown in comparison to the outer surface  34  of the needle member  16  in  FIG. 6 .  
       FIG. 7  shows an embodiment of the surgical needle apparatus  10  of the present invention placed within an arterial lumen  40 . The piercing tip  12  allows percutaneous entry through the outer skin and tissue tract to the arterial wall  42  and creates an access site  44  therethrough. Surgical needle apparatus  10  may also be utilized non- percutaneously, such as during an open surgical procedure, to access a vessel such as arterial lumen  40 . Other body structures, however, may be accessed by surgical needle apparatus  10  of the present invention, with examples of such alternative body structures including the synnovium, dura matter, pericardium, periturneam, and plura. Preferably, surgical needle apparatus  10  may be utilized with a variety of body structures to penetrate a wall thereof with minimal damage.  
      The piercing tip  12  and the first and second edges  17 ,  19  cooperate to create a first incision  46  in, for example, the arterial wall  42 . The first incision  46  extends generally perpendicular to the axis “A” of the needle member  16 . As the needle apparatus  10  is further advanced into the arterial lumen  40 , the raised longitudinal cutting edges  28 ,  30  engage the arterial wall  42  at opposing end portions of the first incision  46  to simultaneously create second and third incisions  50 ,  52  and form a homologous pedicle  48 . The second an third incisions  50 ,  52  preferably form a pair of generally parallel incisions that extend substantially perpendicular to the first incision  46  creating three sides of the homologous pedicle  48  in the arterial wall  42 . The homologous pedicle  48  allows access to the arterial lumen  40  such that when the needle apparatus  10  is later removed from the arterial lumen  40 , the homologous pedicle  48  will substantially return to its original position and orientation to provide a seal over the access site  44  and provide closure to the arterial wall  42 .  
      As shown in the embodiment of  FIG. 7 , the beveled section  18  of the needle apparatus  10  may comprise a first beveled portion  36  and a second beveled portion  38 , with each section  36 ,  38  being at a different oblique angle as it extends proximally with respect to the axis “A” of the needle member  16 . Such an inflection relationship enables the preferred design of needle apparatus  10 .  
      In use, the present invention provides a surgical needle apparatus  10  configured to contemporaneously access a body structure and create a homologous pedicle of the body structure wall. The present invention is further configured to cause minimal damage to the accessed body structure, such as by minimizing stretching of the tissue of the wall and/or minimizing the amount of material removed or otherwise damaged during such use. Instead, a homologous pedicle of body structure wall tissue is created for accessing the body structure which can be used to substantially reseal the body structure wall after completion of a procedure in which access is obtained. By way of example, apparatus  10  of the present invention may be particularly useful in preventing complications such as spinal fluid leak after a spinal tap, fluid/air leak after thoracentesis, blood/fluid/air leak from percutaneous needle lung biopsy, fluid/blood leak from pericardial centesis, fluid leak from arthrocentesis, and fluid leak following pericentesis.  
      Surgical needle apparatus  10  may be utilized in fluid-transporting vessels such as arteries, veins, and lymphatics in either an anti-grade or retrograde orientation. In applications requiring a retrograde insertion of surgical needle apparatus  10  into the fluid-transporting vessel, surgical needle apparatus  10  is preferably inserted into the anterior wall of the vessel in an orientation similar to that illustrated in  FIG. 7 . In particular, a retrograde application of surgical needle apparatus  10  is preferably conducted with first and second cutting edges  28 ,  30  being operably oriented facing substantially away from the vessel. The resultant pedicle  48  is formed such that fluid flow through the vessel contacts the connected portion of pedicle  48  prior to contacting the portion of pedicle  48  disconnected from the wall of the vessel. In such a manner, the extent to which homologous pedicle  48  is displaced from a pre-operative position co-extensive with the wall of the vessel minimized. Such minimization of displacement of pedicle  48  once surgical needle apparatus  10  is removed from the access site assists in the healing process.  
      In like manner to the above, applications requiring an anti-grade insertion of surgical needle apparatus  10  into the fluid-transporting vessel is preferably accomplished by inserting surgical needle apparatus  10  in an orientation such that first and second cutting edges  28 ,  30  are in facing relationship with the fluid-transporting vessel. This “upside-down” orientation of surgical needle apparatus  10  results in the formation of a homologous pedicle  48  having a flow contacting relationship with the fluid similar to that described above. Specifically, fluid flow preferably contacts a portion of pedicle  48  remaining connected to the vessel wall prior to contacting a portion of pedicle  48  disconnected from the vessel wall.  
      The embodiment of the present invention described herein is intended to be illustrative and not limiting as to the scope and spirit of the present invention.