Abstract:
A hand-held, surgical suturing device that can be operated and manipulated with one hand. The device has a suture spool that can be locked The device can rotate in either direction. It is configured to accept at least two different types of needles, a single hook needle and a corkscrew needle useful in different suturing applications. These needles can be supplied in different sizes and shapes. The needle, suture spool and needle carrier are typically supplied in sterile packages and are disposable. A first embodiment has a triangular-shaped squeeze handle that, when squeezed, causes the needle to rotate. A second embodiment has a cylindrical handle for manual stitching where the needle can be released to freely rotate by pressing a control button. In either embodiment, the suture spool can be locked or allowed to rotate freely by activating a releasing rod.

Description:
BACKGROUND 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates generally to suturing devices used in surgery, especially laparoscopic surgery and more particularly to an improved reversible hand-controlled suturing device. 
         [0003]    2. Description of the Prior Art 
         [0004]    Suturing is a necessary part of most surgeries. Surgeons need to be able to continuously suture different types of tissues using a device that can store large amounts of different suturing materials. There are prior art suturing devices that allow both suturing and the storing of suturing material; however, these devices can only be used to suture in one direction. Among these prior art devices are my inventions disclosed in U.S. Pat. Nos. 6,221,085 and 6,315,784. It would be tremendously advantageous to have a hand-powered and controlled surgical suturing device that takes disposable sterile needles of two different types, for left turn and right turn suturing, for storing the suturing material internally, and which is easily manipulated with one hand. 
       SUMMARY OF THE INVENTION 
       [0005]    The present invention relates to a hand-held, surgical suturing device that can be operated and manipulated with one hand. The device can lock the spool in order to prevent the unnecessary release of suture material. The device can also use a suture unit containing a curved needle for either right or left turn suturing. Shape wise, the needle can be either single hook or curved for placement of an interrupted stitch, or a multi-coiled needle that can place continuous stitching in the length related to the number of coils. These needles can be supplied in different sizes and preloaded with different suture material. 
         [0006]    Embodiments of the present invention include an elongated hollow shaft with an internal rotatable drive rod. A smaller locking rod also runs inside the hollow shaft. A removable needle carrier fits onto the distal end of the rotatable drive rod. This needle carrier includes a conical cap part that receives the needle at its apex, and an extended cylindrical part that holds a spool of suturing material. The proximal end of the spool is made with teeth in between which a spool locking rod can be engaged in order to prevent unwanted release of suture material. 
         [0007]    At the proximal end of the elongated hollow shaft, a particular embodiment of the invention includes a triangular shaped arrangement of two handles, one moving and the other stationary. When the surgeon squeezes the handles together, a linear gear arrangement causes the drive rod to turn the suture unit which is attached to the distal end. This, in turn, causes the needle to rotate with the suture material. The surgeon can then tie the knot in the sutures. The linear gear arrangement in the handle includes a control that can reverse the direction of rotation. 
         [0008]    An alternate embodiment of the invention includes a cylindrical handle instead of a triangular squeeze drive. In this embodiment, the surgeon can allow the spool to spin as the locking rod is retracted allowing the release of a desired amount of suture material; then, when the surgeon releases pressure on a locking rod control button, a spring pushes the locking rod toward the distal end of the hollow shaft to engage the spool tooth gear to lock the spool. The surgeon can then tie the stitch. 
     
    
     
       DESCRIPTION OF THE FIGURES 
         [0009]    Attention is now directed to several figures that illustrate features of the present invention. 
           [0010]      FIG. 1  shows an embodiment of the present invention with a squeeze handle. 
           [0011]      FIG. 2  shows an alternate embodiment of the present invention with a cylindrical handle. 
           [0012]      FIG. 3  shows the distal end of various embodiments of the invention including the needle carrier, locking rod and curved needle. 
           [0013]      FIG. 4  shows the distal end of various embodiments of the invention including the needle carrier locking rod and corkscrew needle. 
           [0014]      FIG. 5A  shows a side view of the assembled squeeze-handle embodiment. 
           [0015]      FIG. 5B  shows a sectional view of the assembled squeeze-handle embodiment. 
           [0016]      FIG. 6A  shows a detail view of the triangular-shaped handle. 
           [0017]      FIG. 6B  shows details of the linear gear arrangement. 
           [0018]      FIG. 7A  shows details of the cylindrical-handle embodiment including the mechanism the releases the needle carrier. 
           [0019]      FIG. 7B  shows details of the operation of the locking rod and its associated spring. 
           [0020]      FIG. 8A  shows a side view of the needle carrier. 
           [0021]      FIG. 8B  shows a section of the needle carrier of  FIG. 8A . 
           [0022]      FIGS. 9A-9B  show a right and left handed curved needle. 
           [0023]      FIGS. 10A-10B  show a right and left handed corkscrew needle. 
       
    
    
       [0024]    Several drawings and illustrations have been presented to aid in understanding the present invention. The scope of the present invention is not limited to what is shown in the figures. 
       DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0025]    The present invention relates to an improved, hand-held, hand-controlled, reversible surgical suturing device.  FIG. 1  shows an embodiment of the invention. An elongated hollow shaft  200  attaches to a suture material spool compartment  201  on a distal end of the shaft  200  that, in turn, attaches to a needle carrier  202  that is configured to receive a suturing needle  203   a.  The suturing needle is hollow, and suture can be threaded through the needle from a spool.  FIG. 1  shows a curved suturing needle; however, the needle may also be of a corkscrew configuration or any other configuration. Also the needle  203  may be curved right handed or left handed. 
         [0026]    At the proximal end of the hollow shaft  200 , there is a triangular arrangement of two squeeze handles  204   a  and  204   b.  one fixed and the other able to move inward when squeezed. These squeeze handles drive a rotatable shaft  208  that extends into, and runs the length of, the hollow shaft  200  that causes the needle carrier  202  and the needle  203   a  to rotate when the handles  204   a  and  204   b  are squeezed together. A linear gear arrangement  205  engages a circular drive shaft end gear  207  on the end of the drive shaft  208  that causes the drive shaft  208  to rotate. A control button  206  allows both release of the needle carrier from the shaft  200  by means of a set of internal jaws. The circular gear can engage either one side of the linear gear  205  thus allowing the surgeon to reverse the direction of rotation by changing which side of the linear gear is engaged. 
         [0027]    A locking button  209  moves a locking rod (shown in  FIG. 3 ) that extends inside the hollow shaft  200  in or out of the suture spool to cause the spool to lock and not rotate. This prevents unwanted extra suture from unraveling from the spool. The locking button and rod are spring-biased so that the spool is locked in the default condition. To disassemble the unit for cleaning, the control  206  is released, and the entire needle carrier  202 , suture compartment  201  and needle  203   a  or  203   b  is removed as a disposable suturing unit. A C-clip  210 , or other fastening device, can be removed releasing the hollow shaft  200  from the handle. The hollow shaft  200  can simply be a piece of tubing which can be pulled off. This exposes the drive shaft  208  and the locking rod  400  (shown in  FIG. 3 ). All of the components can be soaked using approved surgical cleaning methods. The instrument can be reassembled by sliding the hollow shaft  200  over the drive shaft  208  and the locking rod  400 . The tip of the hollow shaft  200  can have a cover with a larger hole for the drive shaft  208  and a smaller peripheral hole for the locking rod  400 . The proximal end of the hollow shaft  200  can contain a small slat that engages one or more slots on the handle. The C-clip  210  can then be inserted at the proximal end of the shaft  200  to lock it to the handle. A new pre-sterilized suturing unit with suture, and needle can then be attached to the hollow shaft  200  by releasing the control button  206 , inserting the needle carrier and suture compartment combination  202 ,  201 , and releasing the button  206 . 
         [0028]      FIG. 2  shows an alternate embodiment of the present invention. In this embodiment, the distal and central part of the hollow shaft  200 , the spool compartment  201  and the needle carrier  202  are similar to the embodiment of  FIG. 1 . However, the proximal end of the hollow shaft  200  terminates in a cylindrical handle  300  that can be manipulated manually. A locking rod button  309  is located at the top of the cylindrical handle  300  that engages the locking rod (shown in  FIG. 3 ) causing the suture spool to lock. In this embodiment, the surgeon engages the locking rod button  309  to pull the locking rod down on its spring to take out a desired amount of suture material, and then releases the locking rod button  309 . The spring (shown in  FIG. 7 ) inside the cylindrical handle  300  forces the locking rod back into a locked position allowing suturing. A release control knob  306  can be seen on the bottom of the proximal end of the device. This is used to release the internal jaws and remove the needle carrier  202 .  FIG. 2  shows a corkscrew needle  203   b.  The present invention can accept any type of removable needle. The corkscrew needle  203   b  is more useful with the manual embodiment of  FIG. 2 . 
         [0029]      FIGS. 3-4  show details of the distal end of embodiments of the present invention.  FIG. 3  shows a curved needle  203   a,  while  FIG. 4  shows a corkscrew needle  203   b.  The needle carrier  202  is configured to receive a removable, sterile needle  203   a  (or  203   b  from  FIG. 4 ). The needle  203   a  locks into the needle carrier  202  and is typically supplied with it as a disposable unit. The lower end of the needle carrier  403  is cylindrical and is configured to receive a spool  402  of suturing material. The suturing material can be Silk 2-0, 3-0, chromic 2-0, 3-0, polyester 2-0, 3-0 and nylon 2-0, 3-0. While these are the common suturing materials, any suturing material may be used with the present invention. The sterile suture is also usually supplied with the needle carrier as a single disposable unit. Below the cylindrical portion  403  of the needle carrier is a locking gear  401  having protruding teeth. The locking gear is part of the suture spool  402 . A locking rod  400  that extends the length of the hollow shaft  200  can be moved toward and away from the distal end of the device. When the locking rod  400  is moved toward the distal end, it engages the teeth in the locking gear  401  causing the spool  402  to lock in position and not rotate. When the locking rod is moved away from the distal end of the device, it releases the locking gear  401  allowing the spool  402  to rotate either freely. 
         [0030]      FIGS. 5A-5B  show side views of the embodiment of  FIG. 1 .  FIG. 5A  is a simple side view of the assembled device, while  FIG. 5B  is a sectional view. The elongated hollow shaft  200  terminates in the spool compartment  201  and the needle carrier  202 . At the proximal end, the hollow shaft  200  terminates at the juncture of the two squeeze handles  204   a  and  204   b.  The drive shaft  208 , and locking shaft button  209  can be seen. The jaw release  206  is used to release the spool compartment and needle and allow replacement with a new sterile assembly. 
         [0031]      FIG. 6A  shows details of the triangular-shaped squeeze handle including the left  204   a  fixed handle and right  204   b  handle squeezable members and the linear gear  205 .  FIG. 6B  shows details of the linear gear  205  and shaft end gear  207 . The linear gear  205  includes two tracks, a left track  402  and a right track  403 . The gear  207  only engages one of the left track  402  or the right track  403  at a time. The direction of rotation of the drive shaft  208  when the handles  204   a  and  204   b  are squeezed together and hence the direction of rotation of the suturing needle is determined by whether the left  402  or right  403  track is engaged. 
         [0032]      FIG. 7A  shows details of the embodiment of  FIG. 2 . The top drawing shows a needle carrier clamp  500  located inside the hollow shaft  200  in a relaxed position with no needle carrier. The second drawing shows the clamp  500  extended into an open or receiving position by adjustment of the release control  306 . The clamp jaw  500  receives the end shaft  501  as the needle carrier  202  and suture compartment  201  are loaded. The release control  306  is then relaxed to a locked position causing the clamp jaw  500  to lock down on the end shaft  501  securing the needle carrier  202  to the hollow shaft  200 . In a particular example shown in  FIG. 7A , the release control  306  is 0.0840 inches from its bottom position in a relaxed configuration, 0.0000 inches at the bottom or open position, and 0.0675 inches from the bottom position in the locked configuration. These dimensions and numbers are given to aid in understanding the operation of the clamp jaw  500 . Any distances, dimensions or numbers may be used. 
         [0033]      FIG. 7B  shows the operation of the locking rod  400 . The locking rod button  309  can be moved toward or away from the distal end of the device. A spring  505  engages the locking rod  400  and biases it into the locked position. When the surgeon desires to release the spool to draw out suture, the locking rod button  309  is moved toward the proximal end of the device compressing the spring  505  as shown in the lower drawing of  FIG. 7B . The locking rod  400  disengages from the locking gear  401  on the spool  402  (details shown in  FIGS. 3-4 ). When the surgeon has drawn out enough suture and desires to stitch, the locking rod button  309  is released. The spring  505  pushes the locking rod  400  toward the distal end of the device, and it engages between two teeth in the locking gear  401 . This locks the spool  402 . 
         [0034]      FIG. 8A  is a side view of the needle carrier  202 , while  FIG. 8B  is a sectional view. The end of the needle carrier shaft  501  is configured so that it can be received and clamped into the device by the clamp jaw  500  shown in  FIG. 7A . 
         [0035]      FIGS. 9A-9B  show a left and right-handed configuration of a curved needle. The curved needle is preferred for use with the squeeze embodiment of  FIG. 1 .  FIGS. 10A-10B  show a left and right-handed configuration of a corkscrew needle. The corkscrew needle is preferred for use with the embodiment of  FIG. 2 . However, any needle of any type may be used with either of the embodiments of the present invention. 
         [0036]    In various embodiments of the present invention, components may be made of convenient materials including metal and plastic. The needle carrier may be made of plastic using silicone epoxy to hold the needle. Alternatively, the needle carrier may be made of stainless steel with the needle attachment being silver soldered. 
         [0037]    Several descriptions and drawings have been presented to aid in understanding the present invention. One with skill in the art will realize that numerous changes and variations may be made without departing from the spirit of the invention. Each of these changes and variations is within the scope of the present invention.