Abstract:
A surgical suturing device has a body with a “J”-shaped suturing needle attached. One end of a movable arm is pivotably attached to the body so that the other end of the movable arm may swing into and out of engagement with the tip of the suturing needle. The movable arm is engaged by a rod that slides transversely within the body. The moveable arm swings in response to pressure on a thumb nut that moves the rod. Rod movement is resisted by a compression spring within the body. The device allows a surgeon to suture the fascial layer from within a surgical incision. The surgeon avoids unwanted penetration of tissue by pressing the thumb nut to cause the movable arm to engage and cover at least a portion of the needle tip.

Description:
BACKGROUND  
       [0001]     When suturing a surgical incision, a surgeon generally attempts to close the incision in a manner that minimizes scarring, hernias, and the likelihood of infection. A common technique is to anchor a suture on either side of an incision within the relatively tough fascial layer.  
         [0002]     However, placing a suture through this inner tissue layer without damaging surrounding tissue and organs may be difficult under the best of circumstances and almost impossible where the patient is very obese and/or the incision is very small. A surgeon may have difficulty reaching into the incision and even more difficulty seeing the surrounding tissue beyond his fingers. Additionally, a suture needle that pierces tissue from an outer tissue layer toward the interior of the body may accidentally puncture a blood vessel or an organ.  
         [0003]     A curved or inverted needle can provide a means for penetrating the fascial layer from beneath, thereby reducing the risk of accidental puncture. An inverted needle attached to an elongated shaft can be inserted into a small and/or deep incision without blocking the surgeon&#39;s view, simplifying the task of puncturing the fascial layer from beneath in the optimum location.  
         [0004]     However, an inverted needle presents new difficulties once the suture is placed, since the upwardly-directed point tends to snag tissue while being withdrawn and relocated. Attempts to mitigate this problem usually involve retracting the needle into a hollow shaft or masking the tip of the needle with block of material, either by sliding the needle into the block or the block onto the needle.  
         [0005]     In any case, both a hollow shaft of sufficient diameter to accommodate an internal mechanism and a mask large enough to cover a needle tip spaced any distance from the shaft can obstruct the surgeon&#39;s view and impair his ability to move and place the needle.  
         [0006]     What is needed is a surgical device that provides an inverted suture needle that a surgeon can easily mask and unmask while identifying a desirable location within the body, while moving the needle to that location, while placing a suture, and while subsequently withdrawing the device entirely. The needle and supporting apparatus should minimize the bulk of any material inserted into an incision. Once the suture is placed, the device should allow the surgeon to quickly withdraw the apparatus without concern for tissue damage.  
       SUMMARY  
       [0007]     A preferred embodiment of the present invention provides such a device in the form of an apparatus with a body that fits comfortably in the palm of a surgeon&#39;s hand, a “J” suture needle attached to the body, and a moveable arm attached to the body. In this preferred embodiment the moveable arm pivots about a point within the body and has a lower tip shaped to smoothly cover the point of the needle.  
         [0008]     The needle tip is exposed when the apparatus is in an open position. To set the apparatus in a closed position, the surgeon depresses a thumb nut protruding from one side of the body of the apparatus, causing the lower end of the moveable arm to swing away from the supporting shaft of the needle and to cover the tip of the needle. In the closed position the needle tip is protected and the needle and moveable arm form an elongated.“U” so that the needle may be inserted into and withdrawn from an incision without snagging tissue.  
         [0009]     In a typical procedure, a surgeon threads a loop of suture material through a hole near the needle tip. The surgeon depresses the thumb nut on the apparatus and inserts the closed-position needle tip into an incision, placing the needle tip at a desired location. The surgeon then releases the thumb nut to expose the needle tip. After penetrating the tissue and placing the suture, the surgeon pushes the needle inward again, presses the thumb nut to cover the needle tip, and withdraws the apparatus quickly. The remaining portion of the suture is placed on the opposite side of the incision in the same manner. The smooth, narrow shafts of the needle and moveable arm minimize apparatus bulk within an incision and allow the apparatus to be inserted and withdrawn quickly and safely, speeding surgical procedures.  
         [0010]     All of these features and advantages of the present invention, and more, are illustrated below in the drawings and detailed description that follows. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]      FIG. 1  shows a perspective view of a preferred embodiment of the present invention.  
         [0012]      FIG. 2  shows an elevation view of a preferred embodiment of the present invention in the open position.  
         [0013]      FIG. 3  shows an exploded view of a preferred embodiment of the present invention.  
         [0014]      FIG. 4  shows a cross-sectional view of the body of a preferred embodiment of the present invention.  
         [0015]      FIG. 5  shows a perspective view of a preferred needle tip design.  
         [0016]      FIG. 6A  shows a perspective view of an alternate embodiment of the present invention with finger depressions on opposite sides of the apparatus body.  
         [0017]      FIG. 6B  shows a perspective view of an alternate embodiment of the present invention with finger depressions on the underside of the apparatus body. 
     
    
     DETAILED DESCRIPTION  
       [0018]      FIG. 1  shows a perspective view of a preferred embodiment of the present invention in a closed position. A cylindrical body  100  is machined from a block of TEFLON®. Handles  102 , also TEFLON®, are screwed  104  onto opposite sides of the body  100  to provide gripping surfaces for a surgeon&#39;s fingers. A cover plate  106 , also TEFLON®, may be unscrewed  108  from the top of the body  100  to provide access to the mechanism within.  
         [0019]     A set screw  122  closes an access port to a compression mechanism chamber within the body  100 . The compression mechanism reacts against a TEFLON® thumb nut  120  that is on the opposite side of the body  100  from the set screw  122  and is axially aligned with the set screw  122 .  
         [0020]     The upper end of a needle  130  is mounted within the body  100 . The lower end of the needle  130  has a bend  132  that inverts the pointed tip  133  of the needle  130 . The upper end of a moveable arm  140  is pivotally mounted within the body  100 . When the present invention is in a closed position, the lower end of the moveable arm  140  rests against the needle tip  133  so that the needle tip  133  is at least partially covered by a tip protector  141 . The tip protector  141  is a portion of the moveable arm  140  that has been machined, ground, cut, pressed, or otherwise formed to provide a recess that at least partially covers the needle tip  133 .  
         [0021]     In the elongated “U” of the preferred embodiment shown in  FIG. 1 , the bend  132  is a smooth radius that causes the tip  133  to be parallel to the needle shaft  131  and laterally offset from the shaft  131  a desired distance. However, in alternate embodiments the bend  132  may comprise more than one radius and/or one or more sharp angles, and the tip  133  may angle toward, away from, or to either side of the shaft  131 , with the moveable arm  140  shaped and oriented correspondingly to allow the tip protector  141  to mate smoothly with the tip  133 . Both the needle shaft  131  and the tip protector  141  may also employ any angle, curve, or combination of angles and curves needed to allow the apparatus to reach any potential location for a suture. In this embodiment the needle  130  and moveable arm  140  have circular cross-sections, but any cross-sectional shape may be employed as desired. A hole  135  for suture material is bored radially through the needle a short distance below the base of the tip  133 .  
         [0022]     In this preferred embodiment, the needle  130 , moveable arm  140 , and screws  104 ,  108 ,  122  are made of stainless steel, although other corrosion-resistant materials may be used. Other metal parts are preferentially stainless steel, and non-metal parts are preferentially TEFLON®. In alternate embodiments, non-metal parts may be plastic or ceramic. The present invention may be designed for single or repeated use. Embodiments intended for repeated use must be sterilized between uses, so materials that will tolerate sterilizing agents, solvents, or autoclave temperatures are preferred.  
         [0023]     The body  100  described in this preferred embodiment is drilled, milled, and turned from a single block of TEFLON®, but in other embodiments the body may be assembled, cast, injection-molded, or formed by other techniques well-known in the art. The body  100 , handles  102 , and other parts may be contoured and/or made in other shapes without changing the nature of the invention. The handles  102  may be eliminated entirely. The relative component sizes and shapes as well as the overall size of the apparatus may vary according to surgical needs. The components and interior chambers may be resized or reconfigured to accommodate surgeons with hands of different sizes, left or right-handedness, or disabilities. For example, the component configuration in a left-handed apparatus would mirror the component configuration in a right-handed apparatus.  
         [0024]      FIG. 2  shows an elevation view of the embodiment of  FIG. 1  in the open position. When the thumb nut  120  is released, an internal compression mechanism (not shown) forces the thumb nut  120  out and the moveable arm  140  swings inward toward the needle shaft  131 , exposing the needle tip  133 . When the thumb nut  120  is depressed, the moveable arm  140  moves to the closed position, where the tip protector  141  at least partially covers the needle tip  133 .  
         [0025]      FIG. 3  shows an exploded view of a preferred embodiment of the present invention.  FIG. 4  shows a cross-sectional view of the body  100 . The upper end  336  of a needle  130  (shown in  FIG. 3 ) is inserted into a hole  452  (shown in  FIG. 4 ) that is drilled, cast, or otherwise formed into the underside of the body  100 . The upper end  336  of the needle  130  may be retained in the hole  452  by friction or by a set screw  334  screwed into a tapped hole  454 . The tapped hole  454  is drilled, cast or-otherwise formed into the body  100  and intersects with the hole  452 , holding the upper end  336  of the needle  130 .  
         [0026]     A moveable arm chamber  301  is formed in the upper interior portion of the body  100 . In a preferred embodiment, the moveable arm chamber  301  has at least two substantially parallel sides and is large enough to accommodate a moveable arm holder  341  and two washers  343 . A dowel hole  303  is formed through the moveable arm chamber  301  normal to at least one side of the moveable arm chamber  301 . An oblong or rectangular moveable arm hole  456  communicates between the bottom of the moveable arm chamber  301  and the bottom surface of the body  100 .  
         [0027]     A compression mechanism chamber  323  is drilled, cast, or otherwise formed through the body  100  below the moveable arm chamber  301 . In a preferred embodiment, the compression mechanism chamber  323  is aligned with the long axis of the bottom of the moveable arm chamber  301 . In a preferred embodiment, the compression mechanism chamber  323  has three concentric diameters, the largest portion  457  opening to one side of the body  100  and accepting a set screw  122 , a medium diameter portion  458  disposed within the interior of the body  100  and accepting a plunger sleeve  328 , and the smallest diameter portion  459  opening to the opposite side of the body  100  and accepting a thumb nut  120 : The moveable arm hole  456  passes through and is approximately normal to the medium diameter portion  458 . In alternate embodiments, the compression mechanism chamber  323  could comprise a hole of a single diameter, or have a non-circular cross-section.  
         [0028]     A threaded plunger rod  325  with a moveable arm slot  326  is screwed to a captive nut  327  which is in turn screwed to a plunger sleeve  328 . In alternate embodiments, these plunger components may be assembled with bayonet connectors, bonding, or other techniques well known in the art. The assembled plunger components are inserted into the interior of the compression mechanism chamber  323  and the moveable arm slot  326  is aligned so that a movable arm  140  may be passed upward through the moveable arm hole  456  and the moveable arm slot  326  into a hole (not shown) in the bottom of the moveable arm holder  341 .  
         [0029]     A set screw  344  is screwed into a tapped hole  345  formed in a side of the movable arm holder  341 . The tapped hole  345  is normal to and intersects with the hole holding the movable arm  140 . The set screw  344  presses against a flat surface  346  ground onto a side of the upper end of the movable arm  140 , thereby adjustably locking the movable arm  140  within the movable arm holder  341 .  
         [0030]     With a washer  343  positioned on either side of a dowel hole  347 , the assembled movable arm  140  and movable arm holder  341  are inserted into the movable arm chamber  301  with the moveable arm  140  passing through the movable arm hole  456  and the moveable arm slot  326 , emerging from the bottom surface of the body  100 . The dowel hole  347  in the movable arm holder  341  is aligned with the dowel hole  303  in the body  100 . A dowel  342  is passed through the aligned dowel holes  303 ,  347  so that the movable arm  140  pivots on the dowel  342 .  
         [0031]     The dowel hole  303  in the body  100  is positioned so that the tip protector  141  mates properly with the needle tip  133 . The movable arm  140  and the needle  130  may be shifted axially and rotated to effect a desired alignment.  
         [0032]     The compression member  324  is inserted into the compression mechanism chamber  323  concentrically over the plunger rod  325 . The set screw  122  is screwed in and tightened to hold the assembly in place. The thumb nut  120  is screwed into the plunger sleeve  328  from the opposite end of the compression mechanism chamber  323 . The moveable arm chamber  301  is closed by a cover plate  106  held in place by screws  108 . The handles  102  are attached to the body  100  with screws  104 .  
         [0033]     In alternate embodiments, the handles  102  and the cover plate  106  may be attached by bonding agents, rivets, or other means known in the art. Alternatively, the handles  102  may be cast or otherwise formed as an integral part of the body  100 . As shown in  FIG. 6A , the handles may also be replaced by depressions  602  in the sides of the body  600 .  FIG. 6B  shows an alternate embodiment in which the depressions  604  are positioned on the underside of the body  601 . In each case, the depressions are sized, shaped, and positioned to accept a surgeon&#39;s fingers and provide a comfortable, secure grip on the apparatus. Apart from the use of depressions to provide gripping surfaces, the bodies  600 ,  601  shown in  FIGS. 6A and 6B  may comprise any of the materials, components, and configurations described elsewhere in this specification.  
         [0034]     In a preferred embodiment, the compression member  324  (shown in  FIG. 3 ) is a stainless steel compression spring, but other compression devices well-known in the art may serve the same purpose. In use, the compression member  324  reacts against the set screw  122  to urge the plunger rod  325 , captive nut  327 , plunger sleeve  328 , and thumb nut  120  away from the set screw  122 . Since the moveable arm  140  is captured in the moveable arm slot  326  and pivots on a dowel  342 , the compression member  324  tends to force the moveable arm  140  to the open position. When the thumb nut  120  is depressed, the compression member  324  is compressed and the moveable arm  140  swings to the closed position, covering at least a portion of the needle tip  133  with the tip protector  141 .  
         [0035]      FIG. 5  shows a perspective view of a preferred needle tip design. The needle tip  133  in this embodiment is conical, but any shape useful for surgery may be employed. A hole  135  for suture material is bored radially through the needle a short distance below the base of the tip  133 . In alternate embodiments, additional holes may be bored in any position and orientation desired by a surgeon.  
         [0036]     A tip protector  141  is formed by grinding, milling, or otherwise forming a side of the lower end of the moveable arm  140  to approximately one-half of a full cross-section, leaving a curved or angled bevel  549  at the uppermost end of the tip protector  141 . Further forming operations produce a receiving cavity  548  in the remaining portion of the tip protector  141 . The receiving cavity  548  is sized and shaped to receive enough of the needle tip  133  to prevent the tip  133  from snagging tissue and to approximately align the full cross-sectional center of the tip  133  with the full cross-sectional center of the moveable arm  140 . When the moveable arm  140  swings into the closed position, the aligned needle  130  may then be quickly inserted into and withdrawn from an incision without damage to tissue.  
         [0037]     Utilizing the apparatus to expedite a common surgical technique, the surgeon holds the apparatus with the cover plate  106  against the palm of a hand and hooks a finger around each handle  102 . Alternatively, when utilizing an embodiment equipped with finger depressions rather than handles, the surgeon holds the apparatus with the cover plate  106  against the palm of a hand and positions a finger within each depression. The surgeon inserts the needle  130  and moveable arm  140  into an incision. With the apparatus in a closed position, the surgeon manipulates the apparatus until the needle tip  133  is near the underside of the fascial layer at a location desirable for suture placement.  
         [0038]     The surgeon releases the thumb nut  120 , allowing the moveable arm  140  to swing to the open position. The apparatus is then pulled outward slightly, causing the needle tip  133  and hole  135  to pass through the tissue. The surgeon inserts a loop of suture material though the hole  135  below the needle tip  133 . A free end of the suture material may be grasped with forceps, then the needle tip  133  is pushed back through the tissue. As the needle tip  133  emerges from the tissue, the surgeon presses the thumb nut  120 , thereby covering the needle tip  133  with the tip protector  141 .  
         [0039]     The apparatus is then rotated so that the needle tip  133  is near a desired suture location on the opposite side of the incision. The surgeon releases the thumb nut  120  and passes the needle  130  far enough through tissue to allow the suture material to grasped with forceps. The suture material is cut and the apparatus is inserted into the body far enough to allow the needle tip  133  to be engaged by the tip protector  141 . The thumb nut  120  is then pressed to return the apparatus to the closed position and the apparatus is quickly withdrawn from the incision, which is drawn and tied together with the remaining suture material. The surgeon may repeat this operation as many times as needed.  
         [0040]     In another surgical technique, an embodiment with two holes  135  allows each end of a pre-cut length of suture material to be threaded into a different hole. The apparatus is lowered into an incision, the needle  130  is drawn through tissue, one suture end is removed, and the needle  130  is withdrawn and moved to a new location. The needle  130  is drawn through tissue again and the remaining end of the suture material is removed. The apparatus is closed and withdrawn from the incision and the suture is closed. Again, this procedure may be repeated as many times as necessary.  
         [0041]     The principles, embodiments, and modes of operation of the present invention have been set forth in the foregoing specification. The embodiments disclosed herein should be interpreted as illustrating the present invention and not as restricting it. The foregoing disclosure is not intended to limit the range of equivalent structure available to a person of ordinary skill in the art in any way, but rather to expand the range of equivalent structures in ways not previously contemplated. Numerous variations and changes can be made to the foregoing illustrative embodiments without departing from the scope and spirit of the present invention.