Abstract:
A surgical suturing device has a grasper device that is translatable within an outer lumen where a first end of a needle is grasped with the grasper device. The needle may be resilient to a curved resting state. The grasper device translates proximally relative to the outer lumen such that the needle is translated into the outer lumen, wherein the outer lumen tends to straighten the needle from the curved resting state. The grasper device may be translated distally relative to the outer lumen such that a second end of the needle extends distally from the outer lumen and pierces the tissue. The needle may return to the curved resting state as it exits the outer lumen. When a second end of the needle emerges from the tissue, the second end of the needle may be grasped with the grasper device.

Description:
BACKGROUND 
     Various embodiments are directed to surgical devices and methods of using the same. 
     In endoscopic, laparoscopic, and other noninvasive surgical techniques, internal suturing or other tissue fastening must be performed with instruments small enough to fit through a trocar or endoscope working channel, which can often be quite narrow. For example, the working channel of a typical flexible endoscope has a diameter in the range of about 2.5 to about 4 millimeters. Current staplers and suturing devices cannot be easily redesigned to work through such small openings. In addition, performing procedures by way of the working channel does not easily permit using two instruments positioned at different angles with respect to the wound site in order to “pass and catch” a needle and apply sutures. 
     Various clips, suture fasteners and anchors have been developed such that clinicians may endoscopically close tissue perforations resulting from, for example, ulcers, polypectomy, incisions, etc. One type of suture anchor is known as a “T-tag” fastener. The T-tag is a small metallic pin with a suture attached at the middle. The physician may load the T-tag into the end of a cannulated needle of an applicator that may be inserted through the working channel of an endoscope. The physician may push the needle into the tissue near the perforation and implant the T-tag into the tissue with the attached suture trailing through the working channel and out the proximal end of the endoscope. After two or more T-tags are attached to the tissue near the wound in this manner, the physician may pull the sutures to appose the tissue around the wound. The physician may then fasten the sutures together by applying a plurality of alternating, right and left overhand knots using a knot pushing device or by applying a knotting element or other type of fastener through the working channel of the endoscope. 
    
    
     
       FIGURES 
       The novel features of the various embodiments are set forth with particularity in the appended claims. The various embodiments, however, both as to organization and methods of operation, together with advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings as follows. 
         FIG. 1  is a drawing of one embodiment of an endoscope inserted into the upper gastrointestinal tract of a patient. 
         FIG. 2  illustrates one embodiment of a distal end of the endoscope of  FIG. 1  showing a flexible needle and grasper device extending from a working channel. 
         FIG. 3  illustrates one embodiment of the curved needle of  FIG. 2 . 
         FIG. 4A  illustrates one embodiment of the grasper device of  FIG. 2  grasping the back end of the needle of  FIGS. 2 and 3 . 
         FIG. 4B  illustrates one embodiment of a surgical instrument comprising the grasper device of  FIG. 2 , a shaft assembly and a handle or hand piece. 
         FIGS. 5A-5F  illustrate one embodiment of a process for placing a stitch using the needle and grasper device of  FIG. 2 . 
         FIG. 6  illustrates one embodiment of a double-pointed needle that may be used with the grasper device of  FIG. 2  to place a stitch. 
         FIG. 7  illustrates one embodiment of a grasper device and a portion of a needle having corresponding gripping features. 
         FIG. 8  is a full view of one embodiment of the needle shown in  FIG. 7 . 
         FIGS. 9 and 10  illustrate another embodiment of a needle and grasper device having gripping features. 
         FIG. 11  illustrates one embodiment of a surgical instrument comprising the grasper device of  FIG. 9 , a shaft assembly and a hand piece. 
         FIG. 12  illustrates one embodiment of a distal portion of the surgical instrument of  FIG. 11 . 
         FIG. 13  illustrates one embodiment of a flexible jointed needle. 
     
    
    
     DESCRIPTION 
     Various embodiments are directed to curved, flexible suturing needles as well as devices and methods for manipulating such needles to place sutures during surgical operations. A flexible needle may be made from any resilient, flexible material. In its rest position, the flexible needle may have a curved shape. In use, the needle may be provided to a surgical site through a hollow lumen, such as the working channel of an endoscope, a trocar, an accessory channel, etc. When the flexible needle is within the lumen, it may be held in a straight position. At the surgical site, the flexible needle may be extended through a distally facing end of the lumen where it may encounter and pierce tissue. As the needle exits the lumen and extends through the tissue, it may regain its curved shape. This may cause the needle to curve back on itself and exit the tissue, for example, through the same surface that it entered. A collet, jaws, or other grasper device may then be used to grasp the leading end of the needle, pull the needle through the tissue, and complete the stitch. For subsequent stitches, the needle may be retracted into the lumen to straighten it and then used again, for example, in the manner described above. 
       FIG. 1  illustrates one embodiment of an endoscope  14  (illustrated here as a gastroscope) inserted into the upper gastrointestinal tract of a patient. The endoscope  14  may be used to provide flexible suturing needles, and tools for manipulating the needles, to a surgical site, for example, as described herein. The endoscope  14  has a distal end  16  that may include various optical channels, illumination channels, and working channels. According to various embodiments, the endoscope  14  may be a flexible endoscope and may be introduced via natural orifices and may be combined with trans-organ techniques. In one embodiment, Natural Orifice Translumenal Endoscopic Surgery (NOTES)™ techniques may be employed to introduce instruments into the patient and carry out the various procedures described hereinbelow. A NOTES™ technique is a minimally invasive therapeutic procedure that may be employed to treat diseased tissue or perform other therapeutic operations through a natural opening of the patient without making incisions in the abdomen. A natural opening may be the mouth, anus, and/or vagina. Medical implantable instruments may be introduced into the patient to the target area via the natural opening. In a NOTES™ technique, a clinician inserts a flexible endoscope into one or more natural openings of the patient to view the target area using a camera. During endoscopic surgery, the clinician inserts surgical devices through one or more lumens or working channels of the endoscope  14  to perform various key surgical activities (KSA). These KSAs include forming an anastomosis between organs, repairing ulcers and other wounds, etc. In some embodiments, surgical devices may be provided to surgical sites other than through the working channel of an endoscope including, for example, via one or more accessory channels. Also, although the devices and methods described herein may be used with NOTES™ techniques, it will be appreciated that they may also be used with other surgical techniques including, for example, other endoscopic techniques, laparoscopic techniques, etc. 
       FIG. 2  illustrates one embodiment of the distal end  16  of the endoscope  14  showing a flexible needle  202  and grasper device  204  extending from a working channel  18 . The distal end  16  of the endoscope  14  comprises a distal face  4  defining illumination channels  20 , an optical channel  22 , and the working channel  18 . The illumination channels  20  may comprise one or more optical fibers or other suitable waveguides for directing light from a proximally positioned light source (not shown) to the surgical site. The optical channel  22  may comprise one or more optical fibers or other suitable waveguides for receiving and transmitting an image of the surgical site proximally to a position where the image may be viewed by a clinician operating the endoscope  16 . As described above, the working channel  10  may allow the clinician to introduce one or more surgical tools to the surgical site including, for example, the needle  202  and grasper device  204 . It will be appreciated that the endoscope  14  as illustrated is but one example of an endoscope that may be used in accordance with various embodiments. Endoscopes having alternate configurations of optical channels  22 , illumination channels  20  and/or working channels  18  may also be used. 
       FIG. 3  illustrates one embodiment of the curved needle  202 . The needle  202  may comprise a sharp leading end  206  for piercing tissue and a back end  208 . The back end  208  may define a suture hole  212 , through which suture  210  may be threaded. According to various embodiments, the suture hole  212  may be placed at other positions in the needle  202  including, for example, at about a midpoint between the leading end  206  and the back end  208 . The needle  202  may be made from any suitably resilient material. For example, the needle  202  may be made from nitinal (an alloy of Ni and Ti) or another shape memory alloy. In some embodiments, the needle  202  may be made from a resilient alloy of stainless steel or a suitable synthetic material. The resiliency of the needle  202  may allow it to return to the curved, rest position shown in  FIG. 3  after it has been straightened, for example, to pass through the working channel  18  as described herein. 
       FIG. 4A  illustrates one embodiment of the grasper device  204  grasping the back end  208  of the needle  202 . Some components of the grasper device  204  are also illustrated in  FIG. 2 . The grasper device  204  may comprise a collet  250  positioned within a collet lumen  256 . On its distal-facing end, the collet  250  may comprise a plurality of fingers  252 . The proximal portions of the fingers  252  may merge into a flexible, collet shaft  254  that may extend proximally through the collet lumen  256 . When the collet  250  is extended distally relative to the collet lumen  256 , such that the fingers  252  clear the collet lumen  256 , the fingers  252  may be separated from one another such that there is an opening between them. When the collet  250  is retracted proximally relative to the collet lumen  256 , the collet lumen  256  may exert a force on the collet  250 , causing the fingers  252  to close. In this way, the collet  250  may be used as a grasper to grasp the needle  202 . 
     The collet  250  and collet lumen  256  may be actuated by the clinician to open and close the fingers  252  according to any suitable manner. For example,  FIG. 4B  illustrates one embodiment of a surgical instrument  400  comprising the grasper device  204 , a shaft assembly  402  and a handle or hand piece  404 . The hand piece  404  may be configured to be grasped by the clinician. In at least one embodiment, the hand piece  404  may comprise a pistol grip including a stationary member  406  and movable member, or trigger  408 . In use, the trigger  408  may be moved toward the stationary member  406  as indicated by arrow  410 , for example, in order to operate the grasper device  204  within a surgical site. The collet shaft  254  may extend proximally from the collet fingers  252  to the trigger  408 . When the trigger  408  is moved toward the stationary member  406 , it may cause a distally directed force to be exerted on the collet shaft  254 . This may force the collet  250  in a distal direction relative to the collet lumen  256 , causing the collet fingers  252  to open. The clinician may close the collet fingers  252  by moving the trigger  408  away from the stationary member  406 . This may tend to pull the collet shaft  254  in a proximal direction relative to the collet lumen  256 , which may pull the collet  250  into the collet lumen  256 , causing the fingers  252  to close. 
     The grasper device  204  (e.g., the collet  250  and the collet lumen  256 ) may be slidably coupled within an outer lumen  258 . Referring to  FIG. 4B , the clinician may be able to slide the outer lumen  258  relative to the working channel  18  of the endoscope  14  and relative to grasper device  204 . For example, near the position of the handle  404 , the outer lumen  258  may be coupled to pair of loops  412  or other suitable control mechanism. The clinician may grasp the loops  412  and the handle  404  to change the relative positions of the outer lumen  258  and the grasper device  204 . The clinician may also use the loops  412  to change the relative position of the outer lumen  258  and the working channel  18  of the endoscope  14  (not shown in  FIG. 4B ). In use, when the needle  202  is grasped by the grasper device  204 , the grasper device  204  and the needle  202  may be retracted proximally relative to the outer lumen  258 . This may bring the needle  202  within the walls of the outer lumen  258 , which may force the needle  202  from its curved, rest position into a straight position. In some example embodiments, the outer lumen  258  may be omitted. For example, the walls of the working channel  18  may serve to straighten the needle  202 . Also, for example, an accessory channel provided outside of the working channel  18  may be used to serve the function of the outer lumen  258 . 
       FIGS. 5A-5F  illustrate one embodiment of a process for placing a stitch using the needle  202  and grasper device  204  described above.  FIG. 5A  illustrates one embodiment of the distal end  16  of the endoscope  14  in proximity to tissue  500  having a wound  502  to be sutured. The wound  502  may be, for example, an ulcer, incision or any other opening to be closed. The outer lumen  258  may be extended distally from the working channel  18  to be near or in contact with the tissue  500 . Although the grasper device  204  is not visible in  FIG. 5A , it may be positioned within the outer lumen  258 . Also, for example, the needle  202  may be secured in the grasper device  204 . The walls of the outer lumen  258  may hold the needle  202  in a straight position. When the outer lumen  258  is in position, as shown in  FIG. 5A , the clinician may extend the needle  202  into the tissue  500 , as shown, by extending the grasper device  204  distally relative to the outer lumen  258 . 
       FIGS. 5B and 5C  illustrate one embodiment of the needle  202  being pushed through the tissue  500 . For example, the clinician may continue to extend the grasper device  204 , and therefore the needle  202 , distally within the outer lumen  258 . As the needle  202  exits the outer lumen  258  and enters the tissue  500 , it may tend to bend into its resting, curved shape, as shown. As more of the needle  202  enters the tissue, the curvature may increase, until the needle  202  bends back on itself and begins to exit the tissue  500 , as shown in  FIG. 5C . 
       FIG. 5D  illustrates one embodiment of the needle  202  after it has been released by the grasper device  204 . When the needle  202  is fully extended into the tissue  500 , the grasper device  204  may extend distally from the lumen  258  as shown. The clinician may then cause the grasper device  204  to release the needle  202 . For example, the collet  250  may be extended distally relative to the collet lumen  256  (not shown in  FIG. 5D ) causing the fingers  252  to release, thus releasing the grip on the needle  202 . The needle  202  may remain embedded in the tissue  500  as shown. The suture  210 , as shown in  FIG. 5D , may extend proximally, for example, through the working channel  18 . According to various embodiments, the collet  250  may have a hollow center allowing, the suture  210  to extend proximally through the collet  250 . 
     After the needle  202  is released, the clinician may cause the grasper device  204  to grasp the leading end  206  of the needle  202 , as shown in  FIG. 5E . The grasper device  204  may then be retracted proximally relative to the outer lumen  258 . This may cause the needle  202  to be pulled proximally out of the tissue  500  and into the outer lumen  258 . Accordingly, the suture  210  may form a stitch tending to close the wound  502 .  FIG. 5F  illustrates one embodiment where the needle  202  is retracted into the outer lumen  258  as described. To begin a new stitch, the needle  202  may be pulled proximally out of the working channel  18 . The needle  202  may then be reloaded into the working channel  18  or other access device (e.g., trocar, accessory channel, etc.) with the leading edge  206  facing distally. At that point, a new stitch may be placed, for example, as illustrated in  FIGS. 5A-5F . 
       FIG. 6  illustrates one embodiment of a double-pointed needle  600  that may be used with the grasper device  204  to place a stitch, for example, as described herein. The needle  600  may comprise two leading ends  602 , each defining a point for piercing tissue. A suture hole  604  threaded with suture  210  is shown at approximately the mid-point of the needle  600 . It will be appreciated, however, that the suture hole  604  may be positioned at any point in the needle  600 . The needle  600  may be used to place a stitch in a manner similar to that described above with respect to  FIGS. 5A-5F . It may not be necessary, however, to retract the needle  600  from the proximal end of the endoscope  14  after every stitch to turn it around. Because the needle  600  comprises two leading ends  602 , it may always have one leading end  602  facing distally when it is in within the lumen  258 . Accordingly, after being removed from the tissue  500  in a manner similar to that shown in  FIG. 5F , the needle  600  may be retracted into the lumen  258  far enough to allow the lumen  258  to straighten the needle  600 . Then the needle  600  may be used to place another stitch, this time with the opposite leading end  602  entering the tissue  500  first. 
       FIG. 7  illustrates one embodiment of a grasper device  704  and a portion of a needle  700  having corresponding gripping features.  FIG. 8  is a full view of one embodiment of the needle  700 . The needle  700  may have a leading end  702  and a back end  705 . A suture hole  706  may be optionally placed at the back end  705 , as shown in  FIG. 8 . Also at the back end  705 , the needle  700  may have a collar  708  extending around the needle shaft. The grasper device  704  may have corresponding grooves  756 , formed as a concave feature, in the fingers  752  of its collet  750 . Accordingly, when the grasper device  704  grips the back end  705  of the needle  700 , the grooves  756  may receive the collar  708 . In this way, the grasper device  704  may obtain an improved grip on the needle  700  during the stitching process. In addition to, or instead of, the collar  708 , the needle  700  and/or fingers  752  may include other gripping features including, for example, textured, friction-enhancing surfaces, or features having various other shapes. 
       FIGS. 9 and 10  illustrate a needle  900  and grasper device  904  with another embodiment of a gripping feature. The needle  900  may have a leading end  902  and a back end  905 . A suture hole  906  may be positioned at the back end  905  as shown, or at any other location on the needle  900 . The needle  900  may also have a rounded or ball shaped feature  908  at its back end  905 . The grasper device  904  may have a pair of jaw members  920  defining concave openings  922  configured to receive the ball  908 . When the needle  900  is grasped by the jaw members  920 , the ball  908  and cavities  922  may tend to improve the grip of the jaws  920  on the ball  908 . Also, because of the round shape of the ball  908 , the needle  900  may be free to pivot relative to the jaws  920  even when the jaws  920  are in a closed position. 
     The grasper device  904  illustrated in  FIG. 9  utilizes a set of jaws  920  instead of the collets and collet lumens described above. The jaws  920  may be actuated by the clinician according to any suitable manner. For example,  FIG. 11  illustrates an embodiment of a surgical instrument  1100  comprising the grasper device  904 , a shaft assembly  1102  and a hand piece  1104 . The hand piece  1104  may be configured to be grasped by the clinician and, in at least one embodiment, the hand piece  1104  may comprise a pistol grip including a stationary member  1106  and a movable member, or trigger  1108 . In use the trigger  1108  may be moved toward the stationary member  1106  as indicated by arrow  1107 , for example, in order to operate the grasper device  904  within a surgical site. In various embodiments, referring to  FIG. 12 , the jaw members  920  may be movably coupled to a housing, or clevis  1202  such that they may be moved, or pivoted, between open and closed positions about pivot pin  1204 . In use, the jaw members  920  may be positioned in their closed, or at least partially closed, positions before they are inserted into a surgical site through a trocar or endoscope working channel  18 , for example. Once positioned within the surgical site, the jaw members  920  may then be reopened. According to various embodiments, the shaft  1102  may be positioned within both the working channel  18  and the outer lumen  258 , allowing the grasper device  904  to slide axially within the outer lumen  258 , as described above. 
     In order to move the jaw members  920  between their open and closed positions, the trigger  1108  of the hand piece  1104  may be pivoted relative to the stationary member  1106  such that the trigger  1108  may displace an actuator, or rod  1110  relative to shaft  1102 . In various embodiments, the actuator rod  1110  may be round, or any other suitable shape, and may be either solid or tubular. For example, the actuator rod  1110  may be hollow to allow suture to extend proximally therethrough. In either event, referring to  FIG. 12 , the actuator rod  1110  may be operably engaged with an actuator  1206  such that, when the trigger  1108  is pivoted toward the stationary member  1106  as described above, the actuator rod  1110  and the actuator  1206  may be slid proximally such that the actuator  1206  pulls on jaw links  1208  and  1210 . When the jaw links  1208  and  1210  are pulled proximally, the jaw links  1208  and  1210  may apply a force to the jaws  920  such that they are pivoted about pivot pin  1204  into their closed state. In order to move jaws  920  into their open positions, the trigger  1108  may be moved away from the stationary member  1106  and, correspondingly, the actuator rod  1110  and the actuator  1206  may be moved distally by the trigger  1108 . Similarly, the actuator  1206  may move links  1208  and  1210  distally such that the links  1208  and  1210  apply a force to jaws  920  and rotate them about pivot pin  1204  in the opposite, or open, direction. According to various embodiments, the instrument  1100  may also comprise a rotation knob  1112 . The clinician may rotate the knob  1112  to cause the shaft  1102  and the grasper device  904  to rotate relative to the handle.  FIG. 12  also illustrates the outer lumen  258  and loops  412  described above with respect to  FIG. 4B . It will be appreciated that the outer lumen  258  may be used with the grasper device  904  in the same way that it is described above in use with the grasper device  204 . 
     Various embodiments are described herein with a jaw-based grasper device  904  and a collet-based grasper device  204 ,  704 . It will be appreciated, however, that any of the embodiments described herein may be implemented with any suitable style of grasper device including, for example, a collet-based or a jaw-based grasper device. For example, the needle  700  could alternately be used with a jaw-based grasper device, where the jaws may have grooves for receiving the collar  708  (e.g., similar to the grooves  756  in the collet fingers  752  of the collet  750 ). Also, for example, the needle  900  could alternately be used with a collet-based grasper device where the collet fingers define a cavity corresponding to the shape of the ball  908 . 
       FIG. 13  illustrates one embodiment of a flexible jointed needle  1300 . The needle  1300  may comprise straight sections  1306  connected by curved sections  1304 . Although four curved sections  1304  and four straight sections  1306  are shown, it will be appreciated that any suitable number of curved and straight sections, and hence, any suitable polygonal shape may be used. In some example embodiments, the curved sections  1304  and the straight sections  1306  may be made from the same material (e.g., nitinal, or another resilient material as described above). Also, in other example embodiments, the curved sections  1304  may be made from a resilient material while the straight sections  1306  may be made from another material (e.g., a less expensive material). The needle  1300  may be capable of being substantially straightened, for example, by straightening the curved sections  1304 . Accordingly, the needle  1300  may be used with any of the grasper assemblies  204 ,  704 ,  902  described above. Although the needle  1300  is pictured with two leading edges  1302 , it will be appreciated, that a jointed needle may be provided with a leading edge  1302  and a back end (not shown) for example, similar to the needles  202 ,  700  and  900  described above. 
     In various embodiments, surgical instruments utilizing various embodiments of the needles  202 ,  700 ,  900 ,  1300  and/or grasper assemblies  204 ,  704 ,  904  may be employed in conjunction with a flexible endoscope, such as a GIF-100 model available from Olympus Corporation, for example. In at least one such embodiment, the endoscope, a laparoscope, or a thoracoscope, for example, may be introduced into the patient trans-anally through the colon, the abdomen via an incision or keyhole and a trocar, or trans-orally through the esophagus, for example. These devices may assist the clinician to guide and position the grasper assemblies and/or needles near the tissue treatment region to treat diseased tissue on organs such as the liver, for example. In another embodiment, these devices may be positioned to treat diseased tissue near the gastrointestinal (GI) tract, esophagus, and/or lung, for example. In various embodiments, the endoscope may comprise a flexible shaft where the distal end of the flexible shaft may comprise a light source, a viewing port, and at least one working channel. In at least one such embodiment, the viewing port may transmit an image within its field of view to an optical device such as a charge coupled device (CCD) camera within the endoscope, for example, so that an operator may view the image on a display monitor (not shown). 
     It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician manipulating an end of an instrument extending from the clinician to a surgical site (e.g., through a trocar, through a natural orifice, through an open surgical site, etc.). The term “proximal” refers to the portion closest to the clinician, and the term “distal” refers to the portion located away from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. 
     While several embodiments have been illustrated and described, and while several illustrative embodiments have been described in considerable detail, the embodiments are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. Those of ordinary skill in the art will readily appreciate the different advantages provided by these various embodiments. 
     While several embodiments have been described, it should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the embodiments. For example, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope of the appended claims. 
     The devices disclosed herein may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either case, however, the device may be reconditioned for reuse after at least one use. Reconditioning may include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device may be disassembled, and any number of particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device may utilize a variety of different techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application. 
     Preferably, the embodiments described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that may penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument may then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. 
     Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials do not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
     The embodiments are not to be construed as limited to the particular embodiments disclosed. The embodiments are therefore to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the scope of the claims. Accordingly, it is expressly intended that all such equivalents, variations and changes that fall within the scope of the claims be embraced thereby. 
     In summary, numerous benefits have been described which result from employing the concepts described herein. The foregoing description of the one or more embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or limiting to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more embodiments were chosen and described in order to illustrate principles and practical applications to thereby enable one of ordinary skill in the art to utilize the various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the claims submitted herewith define the overall scope.