Abstract:
A medical instrument used for closing an opening for surgery in which a trocar is used, and a method of securely closing the opening. The instrument includes a hollow tube, into which is inserted an elongated actuating mechanism, having at least two needles that can be positioned in a closed or an open position. By securing a suture on the needles, inserting the instrument into the surgical opening, placing the needles into the open position, withdrawing the instrument through the body tissue, and tying the sutures, a secure closure of the surgical opening can be achieved.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
   This application claims priority to Provisional Application No. 60/361,701 filed on Mar. 6, 2002, the entire contents of which are incorporated by reference. 

   BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The present invention relates to a medical instrument for closing an opening for surgery in which a trocar is used, and a method of securely closing the opening. 
   2. Description of Background Art 
   Conventionally, the closing of openings created by trocars of size No. 10 or larger has posed significant problems in surgery. Typically, conventional devices have one needle. In obese patients in particular, these devices are difficult, tedious, time consuming, and sometimes impossible to use. Also, when these conventional devices are used, many steps are required, which both complicates and increases the cost of the surgical procedure. 
   Specifically, since these conventional devices have only one needle, they require the passage of one suture at a time and the placement of sutures at varying distances from the peritoneal and fascial tissue edges. This often results in a poor or inadequate closure of the surgical opening. Also, since the use of conventional closure devices takes considerable time, the patient is subject to an unnecessary prolongation of anesthesia. 
   SUMMARY AND OBJECT OF THE INVENTION 
   The object of the present invention is to solve these problems, by providing a device that ensures accurate placement of the suture needles, and allows the surgeon to easily and accurately close a trocar site opening in a minimum of time. 
   To overcome the disadvantages of conventional devices and methods for closing an opening in which a trocar is used for surgery, the present invention provides an elongated hollow cylindrical member or tube for receiving an elongated actuating mechanism of approximately the same length as the cylindrical member. The elongated hollow cylindrical member has a proximal end top end, which is open, and a blunt distal end which is closed. Additionally, the hollow cylindrical member has longitudinal slots formed on opposite sides of the shaft of the cylindrical member, the two slots running longitudinally for predetermined distances between a point near the proximal end of the cylindrical member to a second point near the distal end of the cylindrical member. These longitudinal slots, or cuts through the outer surface of the cylindrical member, expose the inside of the cylindrical member to the outside. The longitudinal slots also are the openings through which needles (described below) are deployed during the use of the instrument. 
   The cylindrical member also has a slot on its distal end, but unlike the longitudinal slots, the distal end slot does not cut through to the inside of the cylindrical member. The slots running longitudinally are separate from the slot on the distal end of the cylindrical member. 
   An elongated actuating mechanism having a turnable shaft with a proximal end and a distal end is provided for insertion into the hollow cylindrical member during assembly of the medical instrument of the present invention. On the proximal end of the turnable shaft is a knurled knob for easy rotation of the shaft by hand. The shaft of the elongated actuating mechanism is formed with a screw-threaded portion formed near the distal end thereof. 
   During assembly of the medical instrument of the present invention, the shaft is inserted into the hollow cylindrical member or tube, and slides through an upper cylindrical holding piece which is affixed on the inside of the cylindrical member near the proximal end of the longitudinal slots. As the shaft is inserted further, the screw threaded portion at the distal end of the shaft engages with teeth formed on an arc portion of the distal end of each of two needles rotatably mounted in slots cut into upper edges of a lower cylindrical holding piece which is affixed on the inside of the hollow cylindrical member near the distal ends of the longitudinal slots. The spaces and the distal ends of the needles are aligned to face the slots in the cylindrical member. In other words, the plane of the distal ends of the needles pass through the open longitudinal slots formed on opposite sides of the cylindrical member. As such, the teeth formed on the arc portions of the needles engage the screw-threaded portions of the shaft. 
   The turnable shaft is insertable into the cylindrical member and through the cylindrical holding pieces. When inserted, the shaft is held in place with respect to the cylindrical member by the cylindrical holding pieces, the holding pieces fitting snuggly around the shaft. 
   The tips on the proximal ends of the needles are sharp permitting the needles to easily pass through tissue, whereas the sides along the lengths of the needles are provided with non-cutting surfaces. 
   The needles of the present invention can be manufactured in a variety of lengths to provide for closing openings in tissues of different thicknesses. Short needles are suitable for tissue having little thickness, whereas longer needles are needed to close a tissue having a large thickness, such as in obese patients. Accordingly the needles of the medical instrument of the present invention may be formed with lengths in the range of 2.0 to 20 cm or 0.75 to 8 inches, preferably 2.5 to 7.5 cm or 1 to 3 inches. 
   In an initial or closed position, the needles are arranged lengthwise along the length of the turnable shaft, and facing the longitudinal slots of the hollow tube. The length of the needles is less than the length of the slots, such that when the shaft is turned by means of the knob, the upper ends of the needles radiate outward through the longitudinal slots for a predetermined distance, in the range of 0.5 to 2.0 cm. By means of this turning, as described above, the needles can be positioned in either of two positions: a closed position, wherein the needles are pulled in close to the shaft, and an open position, wherein the proximal ends of the needles project outward for a predetermined distance. 
   An eye is formed near the proximal end of each needle, and each eye has a spring mechanism for easy loading of the suture. Prior to use of the instrument, a length of suture is threaded through the eye of one needle, down around the length of the hollow cylindrical members and through the slot at the distal end of the hollow cylindrical member, and then up the opposite side of the cylindrical member and through the eye of the other needle. Once the suture is threaded as described above, and the needles are turned to a closed position, the instrument is ready for insertion into the patient. 
   According to the present invention, an instrument for closure of surgical openings in which a trocar is used, includes an elongated hollow cylindrical member, an elongated actuating mechanism insertable into the hollow cylindrical member, the actuating mechanism including a turnable shaft, a pair of needles, the distal end of the needles being rotatably mounted on pins in slots in the lower cylindrical holding piece disposed inside the hollow cylindrical member near the distal end. The proximal ends of the needles are provided with eyes capable of being threaded with suture, and the needles can be positioned in either an open position or a closed position by turning the elongated shaft, thereby causing the needles of the instrument to move between the open and closed positions. 
   Further according to the present invention, a method for closing a surgical opening employing a medical instrument having a hollow cylindrical member, an actuating mechanism having a turnable shaft, and a pair of elongated needles which are rotatable, includes the steps of threading a suture through the tips of the needles and through an end slot of the hollow cylindrical member, placing the medical instrument into a closed position, inserting the medical instrument until tips of needles are below an inner most layer of tissue, deploying needles to an open position by turning a knob on a proximal end of the elongated shaft by a predetermined amount, withdrawing the medical instrument until tips of the needles appear above the skin level, removing the suture from the needles, reinserting the medical instrument while still in an open position until the tips of the needles are below the inner most layer of tissue, closing the instrument by turning the knob on the shaft, withdrawing the instrument, retrieving ends of the suture in a subcutaneous tissue; and tying required knots in the suture, thereby closing the surgical opening. 
   Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, and thus are not limitative of the present invention, and wherein: 
     FIG.  1 ( a ) is a sectional side view of the instrument of the present invention in a closed position, and FIG.  1 ( b ) is a side view of the instrument as viewed from the direction of the arrow in FIG.  1 ( a ); 
     FIG.  2 ( a ) is a view of the instrument as viewed from the distal end, FIG.  2 ( b ) shows a cross-sectional view of the distal end of the needles and a lower cylindrical holding piece taken at line II—II of FIG.  1 ( b ), FIG.  2 ( c ) is a side view of the arc portion on the distal end of the needle, and FIG.  2 ( d ) is a side view of the eye of the needle showing the spring mechanism; 
       FIG. 3  is a sectional side view of the instrument of the present invention in an open position, viewed from the same direction as FIG.  1 ( a ); 
       FIG. 4  is a flow chart of the steps of the method of closing a surgical opening with the instrument of the present invention; 
     FIGS.  5 ( a )- 5 ( e ) are pictorial representations of steps S 3 , S 4 , S 5 , S 9 , and S 11  of the method of closing a surgical opening using the instrument of the present invention; 
       FIG. 6  is a sectional side view of a second embodiment of the present invention, similar to FIG.  1 ( b ) above, and shows the niches which replace the slots of the hollow cylindrical member described in the first embodiment; 
     FIG.  7 ( a ) is a side view of the actuating mechanism subassembly of the third embodiment of the present invention prior to insertion into the hollow cylindrical member; FIG.  7 ( b ) is a sectional side view of the actuating mechanism subassembly after insertion into the hollow cylindrical member; and 
     FIG.  8 ( a ) shows a cross-sectional view of the cylindrical member, and FIG.  8 ( b ) shows a bottom face of the lower cylindrical holding piece that fits within the hollow cylindrical member, both FIGS.  8 ( a ) and ( b ) being taken at line III—III of FIG.  7 . 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   The first embodiment will be described with reference to  FIGS. 1-3 . 
   The medical instrument  1  for closing an opening for surgery includes an elongated hollow cylindrical member or tube  2  for receiving an elongated actuating mechanism  3  of approximately the same length as the tube  2 . The elongated hollow cylindrical member or tube  2  has an outer surface  2 ′, a proximal end  2   a  which is open, and a distal end  2   b  which is closed. The hollow cylindrical member  2  has longitudinal slots or cuts  7 ,  8  formed on opposite sides of the tube, the two slots  7 ,  8  running longitudinally for predetermined distances between a point near the proximal end  2   a  to a second point near the distal end  2   b  . These longitudinal slots  7 ,  8  cut through the outer surface  2 ′ of cylindrical member  2 , and expose the inside of the cylindrical member to the outside. The cylindrical member also has a slot  6  on its distal end, but unlike the longitudinal slots  7 ,  8 , the distal end slot  6  doses not cut through the closed distal end  2   b  of the cylinder member  2 . Slot  6  is shown in FIGS.  1 ( b ) and  2 ( a ). The longitudinal slots  7 ,  8  are separate from the end slot  6 . 
   The elongated actuating mechanism having a turnable shaft  9  with a proximal end  9   a  and a distal end  9   b  is provided for insertion into the hollow tube. On the proximal end of the turnable shaft  9  is a knurled knob  10  for easy rotation of the shaft by hand. The shaft of the elongated actuating mechanism is formed with screw-threaded portion  12  formed near the distal end  9   b  thereof. 
   During assembly of the medical instrument of the present invention, shaft  9  is inserted into the hollow tube  2 , and slides through the upper holding piece  18  which is affixed on the inside of the hollow tube  2  near the proximal ends  7   a ,  8   a  of the longitudinal slots  7 ,  8 . As the shaft is inserted further, the screw-threaded portion  12  at the distal end of shaft  9  engages with the distal ends  30   b ,  31   b  of needles  30 ,  31  rotatably mounted in slots  23 ,  24  cut into upper side edges of the lower holding piece  20 , which is affixed on the inside of the hollow tube  2  near the distal  7   b ,  8   b  of the longitudinal slots  7 ,  8 . 
   As shown in FIG.  2 ( c ), teeth  25  are also provided on inward facing arc portions  27  of distal ends  30   b ,  31   b  of the needles, the arc portions  27  having a predetermined length. The spaces  23 ,  24  are aligned to face the open longitudinal slots  7 ,  8  in the tube; in other words, the plane of the arc portions  27  of the distal ends of the needles passes through the longitudinal slots  7 ,  8  formed on opposite sides of the tube  2 . 
   Again, during assembly of the medical instrument of the present invention, turnable shaft  9  is inserted into the tube  2  and through the upper and the lower cylindrical holding pieces  18  and  20 . When inserted, shaft  9  is held in place with respect to the hollow tube by the cylindrical holding pieces  17 ,  18  and  19 ,  20  which fit snuggly around the shaft, and the teeth  25  of the arc portions  27  which engage with the screw threaded portion  12  of the shaft  9 . 
   As described above and shown in FIG.  2 ( b ), the distal ends  30   b ,  31   b  of the needles are rotatably mounted on pins  26  in slots  23 ,  24  cut into upper edges of holding piece  20 . In an initial or closed position, the needles  30 ,  31  are arranged lengthwise along the length of the turnable shaft  9 , and facing the open longitudinal slots  7 ,  8  of the hollow tube  2 . 
   The length of the needles  30 ,  31  is in the range of 2 to 20 cm or 0.75 to 8 inches, preferably 2.5 to 7.5 cm or 1 to 3 inches. The length of the needles is less than the length of the open longitudinal slots, such that when the shaft  9  is turned by means of the knob  10 , the proximal ends  30   a ,  31   a  of the needles radiate outwardly through the longitudinal slots  7 ,  8  for a predetermined distance, in the range of 0.5 to 2.0 cm By means of this turning, the needles  30 ,  31  can be positioned in either of two positions: a closed position (as shown in FIGS.  1  and  2 ), wherein the needles are pulled in close to the shaft  9 , and an open position (as shown in FIG.  3 ), wherein the proximal ends of the needles project outward from shaft  9  for a predetermined distance as describe above. The predetermined distance by which the proximal ends  30   a ,  31   a  of the needles  30 ,  31  can rotate outwardly is limited by the length of arc portions  27  thereon. As shown in FIG.  2 ( c ), a boss  28  is provided at the lower end of the arc portions  27  on the distal ends  30   b ,  31   b  of the needles. When the needles  30 ,  31  are rotated by a predetermined amount, bosses  28  press up against the shaft  9 , and prevents further rotation of the needles. 
   As shown in  FIG. 2  ( d ), eyes  30   e ,  31   e  are formed near the proximal ends  30   a ,  31   a  of each needle  30 ,  31 , and each eye has a spring mechanism  30   s ,  31   s  for easy loading of the suture  40 . Further, cutting tips  30   t ,  31   t  are formed at the tip of each needle. 
   A cylindrical seal member  35  is fitted around shaft  9  to form a tight seal the proximal end  2   b  of the hollow tube  2 , for preventing gas from escaping from the operative surgical area  44 . 
     FIG. 6  shows a second embodiment of the present invention. In the second embodiment, the hollow cylindrical member  2  is provided with elongated niches  33  on the outer surface  2 ′ of the cylindrical member  2 , rather than longitudinal slots  7 ,  8  as described in the previous embodiment. In this second embodiment, the needles  30 ,  31  are rotatably mounted in the niches. When the needles are rotated, the proximal ends thereof project outwardly from the niches  33  to an open position similar to that described above in the previous embodiment. 
   FIGS.  7 ( a ) and ( b ), and FIGS.  8 ( a ) and ( b ) show a third embodiment of the present invention. The third embodiment is similar to the first embodiment except that the actuating mechanism and needles  30 ,  31  are designed as a disposable subassembly  60  to be inserted as a unit into a reusable cylindrical member  2 . Further, if desired, the needles may be pre-threaded with suture. 
   Actuating mechanism includes shaft  9 , turnable knob  10 , sealing member  62 , and lower cylindrical holding piece  20 . Needles  30 ,  31  are mounted and operate in the same manner as the needles in the first embodiment. Once the actuating mechanism and needles  30 ,  31  are inserted into cylindrical member  2 , the configuration of the third embodiment is essentially the same as that of the first embodiment. Sealing member  62 , which is integrally formed by cap  63  and fitting  64 , is then pressed downward against the open end of the hollow cylindrical member  2  thus sealing the open end. At the same time, fitting  64  snuggly fits around shaft  9  stabilizing it within the proximal end of cylindrical member  2 . 
   Cylindrical holding piece  20  surrounding the distal end of shaft  9  is formed with at least one groove  2 D on an outer side thereof. The at least one groove  2 D engages with at least one longitudinal ridge  2 R projecting inwardly from the cylindrical member  2 , and thus ensuring proper orientation of the needles with respect to longitudinal slots  7 ,  8 . 
   In FIG.  7 ( a ), suture  40  is shown forming a loop  45  as it passes through the eyes  30   e ,  31   e  of the needles. In FIG.  2 ( b ), loop  45  of suture  40  is shown pulled downward from eyes  30   e ,  31   e , out through longitudinal slots  7 ,  8  in cylindrical member  2 , and down around the distal end  2   b , where it is held in place in distal end slot  6 . 
   Since the actuating mechanism and needles of the third embodiment described above are disposable, there is no need for these components to be cleansed and sterilized between uses, thus saving time and reducing possibility of contamination. 
   Next, is a description of the method steps involved in using the medical instrument of the present invention. These method steps are shown in  FIGS. 4 and 5 . 
   First, (Step S 1 ), a length of suture  40  is threaded through the eye  30   e  of one needle  30 , around the slot  6  at the distal end of the hollow cylindrical member or tube, and then through the eye  31   e  of the needle  31  on the opposite side of the cylindrical member. Once the suture  40  has been threaded through the needles  30 ,  31  and the distal end slot  6  as described, and the needles  30 ,  31  are placed in a closed position (Step S 2 ), the instrument is ready for insertion (Step S 3 ) into the surgical opening  43 . The proper insertion depth is determined when mark  36  on the hollow cylindrical member is visible by the surgical viewing camera (not shown) and is determined to be inserted below the inner most layer  51  of tissue  50 , and into the operative surgical area  44 . This ensures that the proximal ends of the needles are lower than the inner most layer  51  of tissue  50 , the knob on the shaft is turned (Step S 4 ) to deploy the proximal end of the needles out through longitudinal slots  7 ,  8  to a predetermined distance from the outside of the cylindrical member. The distance of deployment of the needles  30 ,  31  is approximately 0.5 to 2 cm, and when the needles are so deployed, the instrument is in an open position. The instrument is then ready to be withdrawn from the opening  43 . The instrument is withdrawn (Step S 5 ) until the needles  30 ,  31  pierce through the layers of tissue  50  and for the tips  30   t ,  31   t  of the needles to emerge through the outer skin surface  52 , whereby the suture  40  can be easily removed (Step S 6 ) from the needle eyes  30   e ,  31   e . The instrument, while still in its open position, is then reinserted (Step S 7 ) into the opening  43  until the needle tips  30   t ,  31   t  are below the inner most layer  51 . Next, (Step S 8 ) the instrument is closed (needles  30   e ,  31   e  are retracted through longitudinal slots  7 ,  8  into a closed position), and the instrument is withdrawn from the opening  43  (Step S 9 ). After this, the suture ends  41  are retrieved from below the skin level (in the subcutaneous tissue  50 ) (Step S 10 ), and required knots  42  are tied to close the opening  43  (Step S 11 ). The above procedure, results in the opening  43  being fastened at both the inner and outer layers  51 ,  52  of the tissue  50 . 
   In the case of the third embodiment shown in FIGS.  7 ( a ),  7 ( b ),  8 ( a ), and  8 ( b ), the steps required to prepare the instrument are slightly different. With the actuating mechanism and needle subassembly  60 , the suture is pre-threaded through the eyes of needles  30 ,  31  and up along the shaft  9  and through sealing member  62  as shown in FIG.  7 ( a ). The subassembly  60  must first be inserted into cylinder member  2 . Grooves  2 R of holding member  20  engage with ridges  2 R or the cylindrical member  2  causing the needles  30 ,  31  to be properly oriented with respect to longitudinal slots  7 ,  8 . 
   Once the subassembly is inserted into the cylindrical member, loop  45  of suture  40  is then pulled out through one of longitudinal slots  7 ,  8  and down around slot  6  in the distal end  2   b  of the cylindrical member. Further, the upper ends of the suture are pulled out respectively through longitudinal slots  7 ,  8 , causing the instrument to appear as shown in FIG.  7 ( b ). This third embodiment is now ready for use as previously described in method steps S 2 -S 11 . 
   The invention being thus described, it will be obvious that the same may be varied in many ways. For example the instrument may be provided with more than the two needles described in the embodiment above. Further, the materials used to form the components described herein, may be metal, plastic, other suitable material, or combination of materials. Plastic components may be more suited for disposable components of the instruments, whereas metal components may be more suited for reusable components of the instruments. As described above, the needles of the medical instrument of the present invention may be formed with different lengths in order to accommodate the closing of surgical openings in tissues having different thicknesses. Further, the needles may be formed such that different types of suture may be used. 
   These and other variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.