Abstract:
A method for applying a surgical fastener including the steps of providing a fastener applier having an elongated shaft with at least one fastener located within the elongated shaft. The fastener has a pair of bosses extending laterally therefrom. The fastener has an open and closed position. The method further includes the step of inserting the distal end of the shaft into a target location within a body of a patient. Thereafter, the method includes applying at least one fastener within a body of a patient. This step involves the steps of advancing the at least one fastener within the shaft so it is adjacent the distal end, placing the fastener in contact with tissue, and closing the fastener by moving the bosses away from each other as the fastener is advanced distally.

Description:
FIELD OF THE INVENTION  
         [0001]    This invention generally relates to surgical methods, and more particularly, the invention relates to surgical methods for placing fasteners in tissue.  
         BACKGROUND OF THE INVENTION  
         [0002]    In recent years, there have been many advances in endoscopic and laparoscopic surgical procedures. In these procedures, a surgeon makes an incision at the desired location where the surgical procedure is to be performed. Typically, a trocar is then inserted into the incision made by the surgeon. By applying pressure against the proximal end of the trocar, the obturator is forced through the tissue until it enters a target location, such as the abdominal cavity or any other desired hollow viscus of the body. The cannula is inserted through the perforation made by the obturator and the obturator is withdrawn, leaving the cannula as an accessway to the abdominal cavity. If desired, a pressurizing gas such as, for example, carbon dioxide can be pumped through the cannula of the trocar to inflate the abdomen or hollow viscus of the body. Then, any number of surgical instruments such as, for example, a tissue fastening instrument can be inserted through the cannula of the trocar to perform the surgical procedure.  
           [0003]    One such tissue fastening instrument inserted through the cannula during a surgical procedure is the surgical stapler. Surgical staplers are employed by the surgeon during the procedure to sequentially or simultaneously apply one or more surgical fasteners such as, for example, staples or two-part fasteners to body tissue for the purpose of joining segments of body tissue together. An example of a surgical stapler is disclosed in U.S. Pat. No. 5,725,554 issued to Simon et al. A surgical stapler and staple is described for joining together tissue of a patient. The surgical stapler has a long endoscopic arm, a stapling actuation mechanism located at the end of the endoscopic arm, and a handle with a trigger. The staple, which is a rounded M-shape, has a circular cross-section with a flat surface on the lower side. The operation of the trigger causes a linear force to travel through the length of the arm to the stapling actuation mechanism, which forms the staple to fasten tissue. One drawback of the design of this surgical stapler and staple is that the long endoscopic arm has a large cross-section, which requires a larger access port and larger incision to reach the surgical site.  
           [0004]    Another such tissue fastening instrument inserted through the cannula during a surgical procedure is the clip applier. Clip appliers are employed by the surgeon during the procedure to sequentially or simultaneously apply one or more clips to body tissue for the purpose of pinching vessels. An example of a clip applier is disclosed in U.S. Pat. No. 5,843,097 issued to Mayenberger et al. A surgical applicator for U-shaped clips is described comprising a handle, a tubular shaft adjoining the handle, a forceps-type applicator tool at the free end of the tubular shaft, a clip magazine in the tubular shaft, a closing mechanism comprising jaws at the distal end of the tubular shaft, and an advancing mechanism arranged in the tubular shaft. The advancing mechanism pushes a clip into the jaws of the closing mechanism. When the handle is actuated, the jaws of the closing mechanism pinch the clip around the vessel. One drawback of the design of this surgical applicator and its U-shaped clip is that the tubular shaft has a large cross-section, which requires a larger access port and larger incision to reach the surgical site.  
           [0005]    In minimally invasive surgery, in particular, endoscopic or laparoscopic surgery, it has become desirable to provide smaller instruments capable of reaching surgical sites through smaller access ports, yet still providing the ability to deliver relatively large staples and clips therethrough. Smaller incisions cause less damage in accessing the surgical site and the access wounds from such incisions heal faster. The presently known surgical fastening devices such as, for example, clip appliers and surgical staplers all exhibit the drawback of having an instrument shaft with a large cross-section, which is dictated, in general, by the size of the fastener as it is passed therethrough. Having an instrument shaft with a large cross-section requires a larger access port and a larger incision. Therefore, what is needed is a tissue fastening instrument and tissue fastener having a shaft with a reduced cross-section capable of reaching surgical sites through smaller access ports and smaller incisions.  
         SUMMARY OF THE INVENTION  
         [0006]    A method for applying a surgical fastener including the steps of providing a fastener applier having an elongated shaft with at least one fastener located within the elongated shaft. The fastener has a pair of bosses extending laterally therefrom. The fastener has an open and closed position. The method further includes the step of inserting the distal end of the shaft into a target location within a body of a patient. Thereafter, the method includes applying at least one fastener within a body of a patient. This step involves the steps of advancing the at least one fastener within the shaft so it is adjacent the distal end, placing the fastener in contact with tissue, and closing the fastener by moving the bosses away from each other as the fastener is advanced distally. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0007]    The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:  
         [0008]    [0008]FIG. 1 is a perspective view of the fastener device of the present invention.  
         [0009]    [0009]FIG. 2 is section view of the shaft assembly of the present invention illustrating the surface in connection with the shaft.  
         [0010]    [0010]FIG. 3 is a perspective view of the surface in the shaft assembly of the present invention including the first and second channels.  
         [0011]    [0011]FIG. 4 is an end view of the distal end of shaft assembly of the present invention.  
         [0012]    [0012]FIG. 5A is a section view of the fastener of the present invention illustrating the open position.  
         [0013]    [0013]FIG. 5B is a section view of the fastener of the present invention illustrating the closed position.  
         [0014]    [0014]FIG. 6 is a section view of the shaft assembly of the present invention illustrating how the fasteners are assembled into the surface.  
         [0015]    [0015]FIG. 7 is a top perspective view of the shaft assembly showing the pushing mechanism resting against the retaining wall prior to actuating the trigger.  
         [0016]    [0016]FIG. 8 is a top perspective view of the shaft assembly showing the pushing mechanism biased against the distal most fastener after actuating the trigger.  
         [0017]    [0017]FIG. 9 is a cross-section view of the device showing the shaft assembly and pushing mechanism advancing the fastener distally.  
         [0018]    [0018]FIG. 10 is a cross-section view of the device showing the shaft assembly and pushing mechanism advancing the fastener distally into the bend channels.  
         [0019]    [0019]FIG. 11 is a cross-section view of the device showing the shaft assembly, pushing mechanism, and fastener transforming from the open to closed position into tissue during distal movement into the bend channels.  
         [0020]    [0020]FIG. 12 is a cross-section view of the device showing the shaft assembly, pushing mechanism, and fastener transforming from the open to closed position into tissue during further distal movement into the bend channels.  
         [0021]    [0021]FIG. 13 is a cross-section view of the device showing the shaft assembly and the fastener after it has been transformed into the closed position around tissue.  
         [0022]    [0022]FIG. 14 is a section view of an alternate embodiment of the surface of the present invention connected to the shaft.  
         [0023]    [0023]FIG. 15A is a perspective view of an alternate embodiment of the fastener of the present invention illustrating the open position.  
         [0024]    [0024]FIG. 15B is a perspective view of an alternate embodiment of the fastener of the present invention illustrating the closed position.  
         [0025]    [0025]FIG. 15C is an end view of an alternate embodiment of the fastener of the present invention taken along line  15 C- 15 C of FIG. 15A.  
         [0026]    [0026]FIG. 16 is a section view of an alternate embodiment of the shaft assembly of the present invention illustrating how the fasteners are assembled into the surface.  
         [0027]    [0027]FIG. 17 is a cross-section view of an alternate embodiment of the device showing the shaft assembly and pushing mechanism advancing the fastener distally.  
         [0028]    [0028]FIG. 18 is a cross-section view of an alternate embodiment of the device showing the shaft assembly and pushing mechanism further advancing the fastener distally.  
         [0029]    [0029]FIG. 19 is a cross-section view of an alternate embodiment of the device showing the shaft assembly and the fastener after it has been removed out of the shaft and transformed into the closed position around a vessel. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0030]    Reference numerals are used in this description to designate the various components and elements of the instrument of this invention. Identical reference numerals designated in the various drawings refer to the identical element or component of the surgical penetration instrument. As used in this description, “proximal” or “proximally” refers to that portion of the instrument, component, or element which extends toward the user. Conversely, “distal” or “distally” refers to that portion of the instrument, component, or element which extends away from the user.  
         [0031]    Referring to FIG. 1, there is shown fastener device  2 , which includes shaft assembly  20  and housing assembly  10 , of the present invention. Housing assembly  10  includes housing  12  and handle  14 . Housing  12 , which may be made from a suitable, rigid medical grade thermoplastic such as, for example, polypropylene or polycarbonate, is integrally attached to handle  14  forming generally a pistol shape. Housing  12 , which has a cavity therein, comprises feeding mechanism. Feeding mechanisms are well known in the art and one of many suitable materials such as, for example, springs, may be selected for use in feeding mechanism. Housing assembly  10  further includes trigger  16 , which could be comprised of many suitable materials known in the art most of which are rigid thermoplastics such as, for example, polycarbonate. Trigger  16  extends from housing  12  and is pivotally mounted thereto. Attached to the distal end of housing  12  is the proximal end of knob  18 . Knob  18 , which is preferably made of a rigid polymer such as, for example, polycarbonate, is generally conical having a cavity therethrough. Knob  18  permits 360 degree rotation of shaft assembly  20  with respect to housing assembly  10 .  
         [0032]    As illustrated in FIGS. 2, 3, and  4 , shaft assembly  20  comprises shaft  22 , surface  30 , pushing mechanism  40 , and retaining wall  50 . Shaft  22 , which is preferably made of a reinforcing material such as, for example, stainless steel, aluminum or any other material known to those skilled in the art, is generally a tubular structure having a proximal end and a distal end. Shaft  22  has cavity  24  therethrough created by its inner diameter which forms first sidewall  26  and second sidewall  28 . Attached to second sidewall  28  of shaft  22  is surface  30 , as shown in FIG. 4. Surface  30  is generally a semi-tubular structure made from a rigid polymer such as, for example, polycarbonate, or any other material known to those skilled in the art. Surface  30  has first channel  32  and second channel  34  extending generally longitudinal therein. First channel  32  and second channel  34  are integrally molded from surface  30  using manufacturing methods such as, for example, injection molding.  
         [0033]    Referring to FIG. 2, first channel  32  and second channel  34  include first straightaway  37  and second straightaway  39  which extend parallel to the longitudinal axis of shaft  22 . First channel  32  and second channel  34  further includes first bend channel  33  and second bend channel  35 . First bend channel  33  is integrally attached to the distal end of first straightaway  37 . Second bend channel  35  is integrally attached to the distal end of second straightaway  39 . First bend channel  33  and second bend channel  35  fan away from the longitudinal axis at the distal end of surface  30 . Surface  30  further includes first wall  36  and second wall  38 . Attached to first wall  36  and second wall  38  of surface  30  is retaining wall  50  as shown in FIG. 4. Retaining wall  50 , which is generally an elongated rectangular structure made from a rigid polymer such as, for example, polycarbonate, or any other material known to those skilled in the art, extends longitudinally through shaft  22 . Retaining wall  50  includes retaining side  52 . Biased against retaining side  52  of retaining wall  50  is pushing mechanism  40 . Pushing mechanism  40  is generally an elongated structure preferably formed from a single piece of thin, resilient material such as, for example, stainless steel or any other material known to those skilled in the art. Pushing mechanism  40 , which extends longitudinally through shaft  22  and out its proximal end, has a bend at the distal end to form pushing arm  42 . Located at the distal end of pushing arm  42  is pushing wall  44 , which will be described in more detail later.  
         [0034]    Referring to FIG. 5A and FIG. 5B, there is shown fastener  60  of the present invention. Fastener  60 , which is preferably made of a ductile bio-compatible metal such as, for example, titanium or tantalum, includes first boss  62  and second boss  64  extending laterally therefrom. First boss  62  and second boss  64  generally have circular cross-sections and are integrally attached to fastener  60 . Fastener  60  further comprises closed end  66  and open end  68 . Open end  68  is adjacent to distal end  23  of shaft  22  when the fastener  60  is being deployed. Closed end  66  has connecting member  70  therebetween. Connecting member  70 , which is generally curved, comprises first end  71  and second end  73 . First end  71  may be integrally or separately attached to the distal end of first boss  62 . Second end  73  is integrally attached to the distal end of second boss  64 . Closed end  66  includes first elongated leg  72  extending longitudinally therefrom. First elongated leg  72  is generally curved having a distal end and a proximal end. The proximal end of first elongated leg  72  may be integrally or separately attached to the proximal end of first boss  62 . The distal end of first elongated leg  72  includes first tip  80 , which is generally conical and sharp to facilitate fastening tissue. Closed end  66  further comprises second elongated leg  74  extending longitudinally therefrom. Second elongated leg  74  is generally curved having a distal end and a proximal end. The proximal end of second elongated leg  74  is integrally attached to the proximal end of second boss  64 . The distal end of second elongated leg  74  comprises second tip  82 , which is generally conical and sharp to facilitate fastening tissue. Fastener  60  has open position  90  and closed position  92 . Open position  90  of fastener  60  is generally W shaped as shown in FIG. 5A. Closed position  92  of fastener  60  is generally box shaped as shown in FIG. 5B. Open position  90  and closed position  92  will be described in more detail later.  
         [0035]    Referring now to FIG. 6, it can be understood how fastener  60  is assembled into shaft assembly  20 . First boss  62  and second boss  64  are slid into the proximal ends of first straightaway  37  of first channel  32  and second straightaway  39  of second channel  34  respectively such that first boss  62  resides in first channel  32  and second boss  64  resides in second channel  34 . Fastener  60  is then moved distally in surface  30  and stopped prior to coming in contact with first bend channel  33  and second bend channel  35 . A series of fasteners  60  can then be slid into first channel  32  and second channel  34  such that the first tip and second tip of each fastener is positioned against the closed end of the fastener distal to it in the series.  
         [0036]    Shaft assembly  20 , including fastener  60 , is assembled to housing assembly  10  forming fastener device  2  of the present invention. Pushing mechanism  40  which extends longitudinally within and out of the proximal end of shaft  22  is fixedly attached to trigger  16  such that when trigger  16  is actuated pushing mechanism  40  moves distally beyond retaining wall  50 . The distal end of the feeding mechanism would be biased against closed end  66  of the proximal most fastener  60  of a series of fasteners  60 . The distal end of knob  18  which has a cavity therethrough is coupled to the proximal end of shaft assembly  20 .  
         [0037]    FIGS.  7 - 13  show an endoscopic or laparoscopic procedure utilizing fastener device  2  of the present invention. After gaining access to the surgical site through, for example, a trocar, the surgeon inserts fastener device  2  through the access way to the surgical site such that segments of body tissue  101  to be joined are placed against the distal end of shaft assembly  20 . Knob  18  is rotated to allow the surgeon to get the proper orientation of the fastener at the target location. After positioning fastener device  2  at the target location, the surgeon grasping handle  14  of housing assembly  10  actuates trigger  16 . During actuation, pushing mechanism  40 , which is fixedly attached to trigger  16 , is propelled past retaining wall  50  as shown in FIGS. 7 and 8. After propelling past retaining wall  50 , pushing wall  44  of pushing mechanism  40  is biased against the proximal end of first boss  62  and second boss  64  of the distal most fastener  60  in shaft  22 . The surgeon then releases trigger  16 . During the release of trigger  16 , pushing mechanism  40  advances the distal most fastener  60  past first straightaway  37  and second straightaway  39  and into first bend  33  and second bend  35  respectively as shown in FIGS. 10 and 11. Fastener  60  is continually advanced distally through first bend  33  and second bend  35 . During the distal movement through first bend  33  and second bend  35 , fastener  60  begins to be transformed from open position  90  to closed position  92  shown by FIGS. 11 and 12. When the trigger is completely released, fastener  60  is advanced out of the distal end of shaft  22  completely transforming into closed position  92 . As shown in FIG. 13, closed position  92  of fastener  60  fastens segments of body tissue  101  which are placed against the distal end of shaft  22 .  
         [0038]    Referring to FIG. 14- 19 , there is shown an alternate embodiment of the fastener device  102  of the present invention including fastener  160  and surface  130 . As shown in FIGS.  15 A- 15 C, fastener  160 , which is preferably made of a spring-like bio-compatible metal such as, for example, Nitinol, includes first boss  162  and second boss  164  extending laterally therefrom. First boss  162  and second boss  164  generally have elongated rectangular cross-sections are integrally attached to fastener  160 . Fastener  160  further comprises closed end  166  and open end  168 . Open end  168  is adjacent to distal end  123  of shaft  122 . Closed end  166  has connecting member  170  therebetween. Connecting member  170 , which is generally V-shaped, comprises first end  171  and second end  173 . First end  171  is integrally attached to the proximal end of first boss  162 . Second end  173  is integrally attached to the proximal end of second boss  164 . Closed end  166  includes first elongated leg  172  extending longitudinally therefrom. First elongated leg  172  is generally straight having a distal end and a proximal end. The proximal end of first elongated leg  172  is integrally attached to the distal end of first boss  162 . Closed end  166  further comprises second elongated leg  174  extending longitudinally therefrom. Second elongated leg  174  is generally straight having a distal end and a proximal end. The proximal end of second elongated leg  174  is integrally attached to the distal end of second boss  164 . Fastener  160  has open position  190  and closed position  192 . Open position  190  of fastener  160  is generally V-shaped as shown in FIG. 15A. Closed position  192  of fastener  160  is generally U-shaped as shown in FIG. 15B. Fastener  160  begins in closed position  192  and is retained in open position  190  by first boss  162  residing in first channel  132  and second boss  164  residing in second channel  134  of surface  130  as shown in FIG. 14. Surface  130  is generally a semi-tubular structure made from a rigid polymer such as, for example, polycarbonate, or any other material known to those skilled in the art. Surface  30 , as shown in FIG. 16, comprises first channel  132  and second channel  134 . First channel  132  and second channel  134 , which are generally straight, extend longitudinally from the distal end of shaft  122  to the proximal end of shaft  122  running parallel to the longitudinal axis. First channel  132  and second channel  134  are integrally molded from surface  130  using manufacturing methods such as, for example, injection molding. FIGS.  17 - 19  show an endoscopic or laparoscopic procedure utilizing the alternate embodiment of fastener device  2  of the present invention. In the procedure, fastener  160  is retained in open position  190  by first boss  162  residing in first channel  132  and second boss  164  residing in second channel  134 . After pushing mechanism  140  moves fastener  160  out of distal end  123  of shaft  122 , fastener  160  closes around vessel  201  and returns to closed position  192 .  
         [0039]    While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.