Abstract:
Devices and methods are provided which may be used for suturing, including performing a totally transoral surgical procedure, such as a posterior gastropexy procedure. A suture lock and cut assembly is provided to lock and cut one or more sutures in one motion, which motion can be a non-curved, non rotational linear motion. The suture lock and cut assembly with one or more sutures threaded therethrough may be pushed through, for example, a patient&#39;s esophagus and into the stomach by the tip of an endoscope, or alternatively, sized to be fed through the working channel of the endoscope.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS  
       [0001]     This application claims priority to and incorporates by reference the following applications: U.S. Provisional Application 60/571,117 filed May 14, 2004; U.S. provisional Application 60/571,119 filed May 14, 2004; and U.S. Provisional Application 60/571,000 filed May 14, 2004. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention relates to an endoscopic suturing device. More particularly, this invention relates to an endoscopic suturing device which can perform the dual function of locking onto and cutting the suture.  
       BACKGROUND  
       [0003]     Application of sutures in the gastrointestinal tract is required for several different types of medical procedures, for example, for transoral endoscopic valvuloplasty for gastroesophageal reflux disease (GERD), gastroplasty, fundoplication, anterior gastropexy, posterior gastropexy, suturing esophageal perforations, or closure of the esophageal side of the tracheo-esophageal fistula. Traditionally, these procedures are performed by physicians, such as gastroenterologist or surgeons, either by laparoscopy or open surgical techniques. Such procedures are invasive, as laparoscopy requires that small access incision(s) be made in the body of the patient through which a laparoscope and other surgical enabling tools are provided, while open surgical techniques are traditionally invasive and can have complications and cause long patient recovery periods.  
         [0004]     The solution to these problems is to perform these medical procedures through the gastroesophageal tract via the mouth or other naturally occurring orifice. Already available flexible endoscopes, commonly called gastroscopes, can be provided through the gastroesophageal tract and enable illumination and visualization of tissue along the gastroesophageal tract on a video display for diagnostic purposes. These flexible endoscopes also provide an instrumentation means for applying sutures in tissue, such as in the wall of the stomach. What is needed are improved methods of providing a totally transoral surgical procedure, such as a posterior gastropexy procedure, and thereby avoid more-invasive laparoscopic procedures.  
         [0005]     New endoscopic suturing methods performed through the gastroesophageal tract as an alternative to the invasive laparoscopic method of, for example, a posterior gastropexy procedure, are currently being developed. For example, suturing methods under the control of endoscopic ultrasound (EUS) are being evaluated. EUS is a procedure that combines endoscopy and ultrasound. In particular, a Mar. 14, 2003 publication authored by Fritscher-Ravens, Mosse, Mukherjee, Yazaki, Park, Mills, and Swain, entitled, “Transgastric gastropexy and hiatal hernia repair for GERD under EUS control: a porcine model,” (American Society for Gastrointestinal Endoscopy) describes how endoluminal operations for gastroesophageal reflux are currently limited by the inability of the surgeon to visualize and manipulate structures outside the wall of the gut. The publication describes a way to define the EUS anatomy of structures outside the gut that influence reflux, to place stitches in the median arcuate ligament, to perform posterior gastropexy, and to test the feasibility of crural repair, under EUS control, in pigs. More specifically, by using a linear-array EUS, the median arcuate ligament and part of the right crus were identified and punctured with a needle, which served as a carrier for a tag and suture. These were anchored into the muscle. An endoscopic sewing device was used, which allowed stitches to be placed through a 2.8-mm accessory channel to any predetermined depth.  
         [0006]     The publication also describes new methods of knot tying and suture cutting through the 2.8-mm channel of the EUS. More specifically, stitches were placed through the gastric wall into the median arcuate ligament, and one stitch was placed just beyond the wall of the lower esophageal sphincter. The stitches were tied together and locked against the gastric wall, and the surplus length of suture material was then cut and removed. While this publication describes a suitable transgastric gastropexy and hiatal hernia repair procedure, further improvements in methodology and equipment to perform such procedures would be beneficial. For example, the publication describes a process for locking and cutting the suture from inside the stomach. However, the suture requires that a separate suture cutting step, along with its associated cutting instrumentation, be available via the working channel of the endoscope. This may result in multiple passes of instrumentation back and forth through the working channel of the endoscope. What is needed is a way to both lock and cut a suture automatically with a single device and thereby simplify the medical procedure, such as a posterior gastropexy procedure.  
         [0007]     It is therefore an object of the invention to provide improved methods of performing a totally transoral surgical procedure, such as a posterior gastropexy procedure, and thereby avoid more-invasive laparoscopic procedures.  
         [0008]     It is another object of this invention to provide a single mechanism for locking and/or cutting a suture and thereby simplifying medical procedures, such as, but not limited to, a posterior gastropexy procedure.  
       SUMMARY OF THE INVENTION  
       [0009]     Certain embodiments of the present invention are directed to providing improved methods of performing a totally transoral surgical procedure, such as a posterior gastropexy procedure, and thereby avoiding more-invasive laparoscopic procedures. Several embodiments of the present invention provide a device and method for a physician in a medical procedure to automatically lock and cut a suture in one motion and without the need for additional cutting instrumentation, rather than perform separate locking and cutting actions.  
         [0010]     In one embodiment of the invention, a suture lock and cut assembly is provided that forms a hollow body that is slidably connected upon a stem through which one or more sutures is threaded. Depending on the slidable position of the body upon the stem, a locking arm is first engaged to clamp the suture permanently within the stem, and a cutting arm is engaged next to cut any surplus suture, which is then removed from the patient.  
         [0011]     In another embodiment of the invention, a suture lock and cut assembly is provided that forms a hollow body, within which a clamp device is engaged and through which a suture is threaded. Depending upon the slidable position of the clamp device within the body, first, the suture within the clamp device is engaged to clamp the suture permanently, and then a cutting knife is engaged to cut any surplus suture, which is then removed from the patient.  
         [0012]     While the suture lock and cut assembly may be sized to be introduced through an endoscopic instrument, in some applications the suture lock and cut assembly with one or more sutures threaded therethrough can be pushed through, for example, a patient&#39;s esophagus and into the stomach, by the tip of an endoscope, in the event the suture lock and cut assembly is sized to not fit through the working channel of the endoscope. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]     While the novel features of the invention are set forth with particularity in the appended claims, the invention, in all its embodiments, may be more fully understood with reference to the following description and accompanying drawings.  
         [0014]      FIG. 1  illustrates a side view of a suture lock and cut assembly in accordance with a first embodiment of the invention.  
         [0015]      FIG. 2  illustrates a cross-sectional view of the suture lock and cut assembly of the first embodiment of the invention, in the default state, taken along line B-B of  FIG. 1 .  
         [0016]      FIG. 3  illustrates a cross-sectional view of the suture lock and cut assembly of the first embodiment of the invention in the lock state.  
         [0017]      FIG. 4  illustrates a cross-sectional view of the suture lock and cut assembly of the first embodiment of the invention in the cut state.  
         [0018]      FIG. 5  illustrates a cross-sectional view of the suture lock and cut assembly of the first embodiment of the invention in the release state.  
         [0019]      FIG. 6  illustrates a flow diagram of an example method of using the suture lock and cut assembly of the first embodiment of the invention.  
         [0020]      FIG. 7  illustrates a cross-sectional view of a suture lock and cut assembly in accordance with a second embodiment of the invention.  
         [0021]      FIG. 8  illustrates a cross-sectional view of a suture lock and cut assembly in accordance with a third embodiment of the invention in the default state.  
         [0022]      FIG. 9  illustrates a first end view of the suture lock and cut assembly of the third embodiment of the invention.  
         [0023]      FIG. 10  illustrates a second end view of the suture lock and cut assembly of the third embodiment of the invention.  
         [0024]      FIG. 11  illustrates a cross-sectional view of the suture lock and cut assembly of the third embodiment of the invention in the lock state.  
         [0025]      FIG. 12  illustrates a cross-sectional view of the suture lock and cut assembly of the third embodiment of the invention in the cut state.  
         [0026]      FIG. 13  illustrates a cross-sectional view of the suture lock and cut assembly of the third embodiment of the invention in the release state. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0027]      FIG. 1  illustrates a side view of a suture lock and cut assembly  100  in accordance with a first embodiment of the invention. Suture lock and cut assembly  100  includes a body  110  that is installed upon a stem  122 .  FIG. 1  shows suture lock and cut assembly  100  in use and, therefore, it includes a suture  136 , which runs through the center of suture lock and cut assembly  100  and attaches together a first tissue  140  and a second tissue  142 . Suture lock and cut assembly  100  is not limited to a single suture  136  installed therein, a plurality of sutures  136  may be engaged within a single suture lock and cut assembly  100 . Further details of suture lock and cut assembly  100 , in combination with suture  136 , first tissue  140 , and second tissue  142 , are found in reference to  FIGS. 2 through 6 .  
         [0028]      FIG. 2  illustrates a cross-sectional view of suture lock and cut assembly  100  taken along line B-B of  FIG. 1  in accordance with a first embodiment of the invention. Suture lock and cut assembly  100  can include body  110 , which as a first end  112  and a second end  114 . Body  110  is hollow and has openings at both ends; therefore, it includes a cavity  116  along its full length. The geometry of body  110  and cavity  116  is irregular, as shown in  FIG. 2 . More specifically, body  110  and cavity  116  are largest in size nearest second end  114  and tapered to a smaller size nearest first end  112 . Accordingly, cavity  116  includes a clearance surface  118 , which is oriented toward second end  114  and a tapered surface  120 , which is oriented toward first end  112 .  
         [0029]     Inserted through cavity  116  of body  110 , suture lock and cut assembly  100  can further comprise stem  122 , which has a stem base  124 , which, when installed, is oriented toward second end  114  of body  110 . At the end of stem  122 , opposing stem base  124  is a pair of raised structures spaced some distance apart that form a first barb  126  and a second barb  128 . The geometry of cavity  116  nearest first end  112  of body  110  matches the geometry of first barb  126  and second barb  128 . Running within stem  122  along its full length is a channel  130 , as shown in  FIG. 2 .  
         [0030]     Suture lock and cut assembly  100  can further comprise a cantilever-type locking arm  132  and a cantilever-type cutting arm  134 , each of which has one end anchored within stem base  124  and an opposing end that passes through slots within the wall of stem  122  and allows their tips to enter channel  130 , as shown in  FIG. 2 . Suture lock and cut assembly  100  performs the dual functions of automatically clamping and cutting suture  136  within one apparent motion by the user, although it is recognized that the clamping and cutting actions are two separate events that occur as body  110  and stem base  124  are compressed.  
         [0031]     Body  110  and stem  122  are formed of, for example, molded plastic, whereas locking arm  132  and cutting arm  134  are formed of any suitable metal that is hard, tempered, and possesses spring properties, such as alloy steel. Alternatively, locking arm  132  (but not cutting arm  134 ) is formed of plastic, such as a polyetheretherketone (PEEKTM) polymer material. PEEK is a general name for a series of polymers, i.e., rigid thermoplastic, which is commonly mixed with other resins and fillers.  
         [0032]     Upon initial assembly in preparation of use, body  110  and stem  122  are slidably connected as follows. First barb  126  of stem  122  is inserted into cavity  116  of body  110  via the opening at second end  114 ; subsequently, first barb  126  comes into contact with the walls of cavity  116  that form first end  112  of body  110 . Next, sufficient pushing force is applied, which causes the opening at first end  112  of body  110  to expand temporarily, such that first barb  126  passes through the tightly fitted opening. As a result, and in this default state (i.e., undeployed state), the structure of first end  112  of body  110  is slidable along the outer surface of stem  122 , and its slidable range is restricted between first barb  126  and second barb  128 . More specifically, on one extreme, the slidable range is restricted by a flat surface of first barb  126  that provides a hard stop when it is abutted against the outer surface of first end  112  of body  110  and, on the opposite extreme, by the tapered surface of second barb  128  that provides resistance when it is abutted against the matching tapered walls of cavity  116  at first end  112  of body  110 .  
                                           TABLE 1                           Example dimensions of suture lock and cut assembly 100                Example Dimension                            Body 110 outside diameter   0.33   inches           Stem 122 length   0.58   inches           First barb 126 and second barb   0.15   inches           128 outside diameter           Locking arm 132 and cutting arm   0.06-0.20   inches           134 tip-to-tip spacing                      
 
         [0033]     Table 1 provides one non-limiting example of dimensions for the suture lock and cut assembly  100 . Also shown in  FIG. 2  is suture  136 , which is attached to a T-tag  138 , which is threaded through channel  130  of stem  122  and which passes through first tissue  140  and is anchored in second tissue  142 . T-tag  138  is a well-known medical device for anchoring a suture into body tissue. A method of using suture lock and cut assembly  100  in combination with suture  136 , T-tag  138 , first tissue  140 , and second tissue  142  is described in further detail in reference to  FIG. 6 .  
         [0034]     The operation of suture lock and cut assembly  100  for automatically locking and cutting a suture includes a sequential transition from a default state (i.e., undeployed state) to a lock state, a cut state and, finally, a release state (i.e., deployed state).  
         [0035]      FIG. 2  shows suture lock and cut assembly  100  in the default state, which is described as follows. 
        Default state: In the default or undeployed state, body  110  is slidable along the outer surface of stem  122 ; its slidable range restricted between first barb  126  and second barb  128 , as shown in  FIG. 2 . In this state, locking arm  132  and cutting arm  134  are not engaged within cavity  116  of body  110  and, thus, are in their relaxed state. Consequently, their tips are not in physical contact with suture  136  within channel  130  of stem  122 . Thus, suture  136  slides freely along the length of channel  130 .          
         [0037]      FIG. 3  illustrates a cross-sectional view of suture lock and cut assembly  100  in the lock state, which is described as follows. 
        Lock state: The lock state is achieved by the user&#39;s applying sufficient pushing force between body  110  and stem  122  to cause the opening at first end  112  of body  110  to expand temporarily, such that second barb  128  of stem  122  passes through the tightly fitted opening. As a result, the structure of first end  112  of body  110  is slidable along the outer surface of stem  122  and its slidable range is now restricted between second barb  128  and stem base  124 . More specifically, on one extreme, the slidable range is restricted by a flat surface of second barb  128  that provides a hard stop when it is abutted against the outer surface of first end  112  of body  110  and, on the opposite extreme, by the outer surface of stem base  124  of stem  122  that provides a hard stop when it is abutted against the outer surface of second end  114  of body  110 . However, in the lock state, body  110  is positioned such that its first end  112  is abutting second barb  128 , and locking arm  132  and cutting arm  134  are engaged within cavity  116  of body  110  because their outer surfaces ride upon clearance surface  118  of cavity  116  but, importantly, without coming into contact with tapered surface  120 , as shown in  FIG. 3 . Consequently, when locking arm  132  and cutting arm  134  are engaged along clearance surface  118  within cavity  116 , the position of their tips is forced toward the center of channel  130  of stem  122 . In the lock state, locking arm  132  is now in physical contact with suture  136 , which is within channel  130  of stem  122 , and, thus, provides a clamping action upon suture  136 . This is accomplished by locking arm  132  creating a torturous path within stem  122  that prevents suture  136  from sliding freely along channel  130 . However, in the lock state, the cutting tip of cutting arm  134  is not in physical contact with suture  136 , which is within channel  130  of stem  122 .          
         [0039]      FIG. 4  illustrates a cross-sectional view of suture lock and cut assembly  100  in the cut state, which is described as follows. 
        Cut state: The cut state is achieved by the user&#39;s sliding body  110  toward stem base  124 , such that second end  114  is abutting the outer surface of stem base  124 , which causes locking arm  132  and cutting arm  134  to come into contact with tapered surface  120 . Consequently, the position of the tips of locking arm  132  and cutting arm  134 , which ride upon tapered surface  120  within cavity  116 , are forced yet further toward the center of channel  130  of stem  122 . In the cut state, locking arm  132  remains in physical contact with suture  136  within channel  130  of stem  122  and, thus, the clamping action is maintained. However, in the lock state, the cutting tip of cutting arm  134  crosses the path of suture  136 , which is within channel  130  of stem  122 , as shown in  FIG. 4  and thereby cuts suture  136  on the side of locking arm  132  that is farthest away from stem base  124 .          
         [0041]      FIG. 5  illustrates a cross-sectional view of suture lock and cut assembly  100  in the release state, which is described as follows. 
        Release state: In the release state, the user releases pressure upon body  110 , which thereby allows locking arm  132  and cutting arm  134  to disengage from tapered surface  120  and allows body  110  to move away from stem base  124 , as locking arm  132  and cutting arm  134  are now riding only upon clearance surface  118  of body  110 , as shown in  FIG. 5 . In the release state, locking arm  132  remains in physical contact with suture  136 , which is within channel  130  of stem  122 , and, thus, the clamping action is maintained indefinitely. The portion of suture  136  exiting stem  122  at first barb  126  is removed, while the portion of suture  136  exiting stem base  124  remains locked within suture lock and cut assembly  100 .          
         [0043]      FIG. 6  illustrates a flow diagram of an example method  600  of using suture lock and cut assembly  100  in accordance with the invention. More specifically, method  600  provides an example of a posterior gastropexy procedure that uses the suture lock and cut assembly  100  of the present invention. The use of suture lock and cut assembly  100  is not limited to a posterior gastropexy procedure; suture lock and cut assembly  100  may be used in any of various, similar medical procedures. Furthermore, method  600  is not limited to a single suture  136  installed within suture lock and cut assembly  100 , a plurality of sutures  136  may be engaged within a single suture lock and cut assembly  100 .  
         [0044]     At step  610 , a physician passes an EUS endoscope through a patient&#39;s mouth and esophagus and into the stomach. Example EUS endoscopes include endoscope model GF-UC160P-AT8 manufactured by Olympus Europe (Hamburg, Germany) and endoscope model EG-3630U manufactured by Pentax Medical Company (Orangeburg, N.Y.). The working channel of the EUS endoscope is preloaded with a standard EUS needle, such as is manufactured by Wilson-Cook (Winston-Salem, N.C.), that serves as a carrier for a tag and thread, such as T-tag  138  and suture  136 . Suture  136  may run either through the needle or outside the needle, but still inside the working channel of the EUS endoscope; alternatively, suture  136  can run along the outside of the EUS endoscope.  
         [0045]     At step  612 , under the guidance of the EUS endoscope, the physician locates and identifies structures outside of the stomach wall and selects a fixation point, such as the median arcuate ligament.  
         [0046]     At step  614 , under the guidance of the EUS endoscope the physician pushes the EUS needle, which is carrying T-tag  138  and suture  136 , through the stomach wall, which is represented by first tissue  140  in  FIG. 2 .  
         [0047]     At step  616 , under the guidance of the EUS endoscope, the physician deploys and affixes T-tag  138 , with suture  136  attached thereto, to the fixation point, such as to the median arcuate ligament, which is represented by second tissue  142  in  FIG. 2 .  
         [0048]     At step  618 , the physician withdraws the EUS endoscope and associated instrumentation from the patient, but leaves a length of suture  136  still threaded through the patient&#39;s gastroesophageal tract and anchored to second tissue  142  (e.g., median arcuate ligament). The length of suture  136  extends out of the patient&#39;s mouth and is accessible to the physician.  
         [0049]     At step  620 , the physician threads the length of suture  136  that is extending out of the patient&#39;s mouth through channel  130  of stem  122  of suture lock and cut assembly  100 , which is in the default state, as shown in  FIG. 2 . Suture  136  is threaded into the stem base  124  end and out of the first barb  126  end of suture lock and cut assembly  100 .  
         [0050]     At step  622 , the physician threads the length of suture  136  that is extending out of the patient&#39;s mouth through suture lock and cut assembly  100  and into the working channel of a standard endoscope that has a standard vision system (i.e., not an EUS endoscope). The physician aligns the first barb  126  end of stem  122  into the working channel of the endoscope, such that the tip of the endoscope is abutting first end  112  of body  110 . Stem  122  may serve as an alignment aid for aligning body  110  to the tip of the endoscope.  
         [0051]     At step  624 , while holding tension on suture  136  and with the distal end of the endoscope pushing against suture lock and cut assembly  100 , which is external to the working channel of the endoscope, the physician passes the endoscope and suture lock and cut assembly  100  through the patient&#39;s mouth and esophagus and into the stomach. Suture lock and cut assembly  100  is sliding freely along suture  136  in the default state, until stem base  124  of stem  122  is firmly abutted against the inside of the stomach wall, which is represented by first tissue  140  in  FIG. 2 .  
         [0052]     At step  626 , having determined that the desired geometry change between the stomach and the median arcuate ligament (represented by first tissue  140  and second tissue  142 ) is achieved and while continuing to hold tension on suture  136 , the physician applies sufficient pushing force upon the endoscope, whose distal end is abutting body  110 , such that the opening in first end  112  of body  110  slips past second barb  128  of stem  122  in the direction of stem base  124  and thereby engages locking arm  132  and cutting arm  134  within cavity  116  of body  110  by their outer surfaces, which ride, first, upon clearance surface  118 , which causes locking arm  132  to clamp against suture  136 , and second, upon tapered surface  120  of cavity  116 , which causes cutting arm  134  to cut suture  136 , as shown in  FIGS. 3 and 4 .  
         [0053]     At step  628 , having secured suture lock and cut assembly  100  against first tissue  140  and having cut suture  136 , the physician relaxes the pushing force upon the endoscope against body  110 . As a result, suture lock and cut assembly  100  relaxes into the release state, while suture  136  remains firmly clamped, as shown in  FIG. 5 . The physician then withdraws the endoscope and surplus material of suture  136  from the patient. Method  600  ends.  
         [0054]     In an alternative embodiment, method  600  uses a single EUS endoscope device that also has a standard vision system. As a result, only one endoscope device is needed throughout the entirety of method  600 . In this case, the EUS endoscope device with a standard vision system is passed into the patient at step  610 . It is removed at step  618 , and a the same EUS endoscope device with a standard vision system is passed into the patient at step  624 .  
         [0055]      FIG. 7  illustrates a cross-sectional view of a suture lock and cut assembly  700  in accordance with a second embodiment of the invention. Suture lock and cut assembly  700  includes body  110  that is installed upon stem  122 , as described in  FIGS. 1 through 5 . However, suture lock and cut assembly  700  further includes a compression spring  710 , which is anchored at one end around the circumference of body  110  and abutted against a pledget  712  at its opposing end, such that it is sandwiched between stem base  124  and first tissue  140 . Pledget  712  has a center hole through which suture  136  may pass. Like suture lock and cut assembly  100 , suture lock and cut assembly  700  performs the dual functions of automatically clamping and cutting suture  136  within one apparent motion by the user, although it is recognized that the clamping and cutting actions are two separate events that occur as body  110  and stem base  124  are compressed.  
         [0056]     Suture lock and cut assembly  700  operates identically to suture lock and cut assembly  100 , as described in  FIGS. 1 through 6 . However, because pledget  712  presses against first tissue  140  under a force provided by compression spring  710 , suture lock and cut assembly  700  is useful in medical procedures, such as an anastomosis process, where a stoma, or a hole, is to be formed in the wall of an organ. Because compression spring  710  presses on pledget  712 , compression of the tissue is achieved, which is used to create this hole over time.  
         [0057]     The pledget can be coated with, formed from, or contain one or more diagnostic or therapeutic agent. For example, the pledget may comprise a composition selected from the group consisting of medicinal agents, drugs, narcotics, pain killers, hemostatic agents, antibacterial agents, antiseptic agents, diagnostic agents, antiviral agents, blood thinning agents, gene therapy agents, tissue growth or tissue healing agents, radiological agents, radio-isotopes, and combinations thereof.  
         [0058]      FIG. 8  illustrates a cross-sectional view of a suture lock and cut assembly  800  in accordance with a third embodiment of the invention. Suture lock and cut assembly  800  includes a body  810 , which is installed upon a clamp device  820 .  FIG. 8  shows suture lock and cut assembly  800  in use and, therefore, it includes suture  136 , which runs through the center of suture lock and cut assembly  800  and attaches together first tissue  140  and second tissue  142 . Further details of suture lock and cut assembly  800 , in combination with suture  136 , first tissue  140 , and second tissue  142 , are found in reference to  FIGS. 9 through 12 . Also shown in  FIG. 8  is suture  136 , which is attached to T-tag  138 , which is threaded through suture lock and cut assembly  800 , passes through first tissue  140 , and is anchored in second tissue  142 . Suture lock and cut assembly  800  is not limited to a single suture  136  installed therein, a plurality of sutures  136  may be engaged within a single suture lock and cut assembly  800 . Like suture lock and cut assembly  100  and  700 , suture lock and cut assembly  800  performs the dual functions of automatically clamping and cutting suture  136  within one apparent motion by the user, although it is recognized that the clamping and cutting actions are two separate events that occur as body  810  and clamp device  820  are compressed.  
         [0059]     With continuing reference to  FIG. 8 , suture lock and cut assembly  800  includes body  810 , which is a hollow cylindrical shape that has an opening at a body first end  812  that is large enough to accept clamp device  820  therein. Mounted within an enclosed body second end  814  of body  810  is an L-shaped cutting knife  816 , which protrudes into a cavity  818  within body  810 . Clamp device  820  is cylindrically shaped and has a clamp first end  822  that is sized to fit within the opening at body first end  812  of body  810 . Clamp device  820  includes a first side  842  and a second side  844  of clamp device  820  through which suture  136  passes. At the opposite end of clamp device  820  is a clamp base  824  that has an outside diameter that approximates the outside diameter of body  810 . Clamp device  820  includes a clamp first region  826  that is nearest clamp first end  822  and that has an outside diameter of 0.16 inches and a clamp second region  828  that is nearest clamp base  824  and that has an outside diameter of 0.17 inches or slightly larger. Included at clamp first end  822  of body  810  is a guide slot  830  and a channel  832 . A latching mechanism between body  810  and clamp device  820  is formed by a ball  834 , which protrudes from the outer surface of clamp first region  826  and which is fitted within a ball-detent  836 , that is formed in the inner wall of body  810 , as shown in  FIG. 8 .  
         [0060]     Body  810  and clamp device  820  are formed of any suitably strong, rigid, and nontoxic material, such as molded plastic or stainless steel, whereas cutting knife  816  is formed of any suitable metal that is hard, tempered, and possesses spring properties, such as alloy steel.  
         [0061]      FIG. 9  illustrates an end view of suture lock and cut assembly  800  from the body  810  end of suture lock and cut assembly  800 . In this view, it is shown that cutting knife  816  is a wide flat blade which is mounted within an opening of body second end  814  of body  810 . Cutting knife  816  further includes a hole  838 . Suture  136  is allowed to pass through body second end  814  of body  810  via hole  838  in cutting knife  816 .  
         [0062]      FIG. 10  illustrates an end view of suture lock and cut assembly  800  from the clamp device  820  end of suture lock and cut assembly  800 . In this view, it is shown that suture  136  passes through a slot  840  formed between first side  842  and second side  844  of clamp device  820 . When first side  842  and second side  844  of clamp device  820  are in a relaxed state, suture  136  may move freely. Channel  832  allows axial movement but serves to restrain suture  136  from side-to-side movement. By contrast, by squeezing together first side  842  and second side  844  of clamp device  820 , suture  136  may be locked in position.  
         [0063]     The operation of suture lock and cut assembly  800  for automatically locking and cutting a suture includes a sequential transition from a default state (i.e., undeployed state) to a lock state, a cut state and, finally, a release state (i.e., deployed state).  
         [0064]     Again referencing  FIG. 8 , suture lock and cut assembly  800  is shown in the default state, which is described as follows. 
        Default state: In the default or undeployed state, body  810  and clamp device  820  are slidably connected as follows. Clamp first end  822  of clamp device  820  is inserted into cavity  818  of body  810  via the opening at body first end  812 . Subsequently, ball  834  is aligned with a groove (not shown) that allows ball  834  to be engaged within ball-detent  836 , by rotating body  810  relative to clamp device  820 . As a result and in this default state (i.e., undeployed state), the slidable movement of clamp device  820  within body  810  is restricted because ball  834  is locked within ball-detent  836 , which allows only clamp first region  826  to enter into body  810 . In the default state, first side  842  and second side  844  of clamp device  820  are in a relaxed state and suture  136  slides freely within slot  840 , along the length of suture lock and cut assembly  800 . Because the outside diameter of clamp first region  826  of clamp device  820  is slightly smaller than the inside diameter of body  810 , a relaxed state results and, thus, no pressure is applied for squeezing together first side  842  and second side  844  of clamp device  820 .        
 
         [0066]      FIG. 11  illustrates a cross-sectional view of suture lock and cut assembly  800  in the lock state, which is described as follows. 
        Lock state: The lock state is achieved by the user&#39;s applying sufficient pushing force between body  810  and clamp device  820  to cause ball  834  to disengage with ball-detent  836  and slide toward body second end  814  of body  810  and into a clearance area within body  810 . As a result, the structure of body first end  812  of body  810  is slidable along the outer surface of clamp second region  828  of clamp device  820 . However, in the lock state, body first end  812  of body  810  is not abutting clamp base  824 . Because the outside diameter of clamp second region  828  of clamp device  820  is slightly smaller than the inside diameter of body  810 , a lock state results and, thus, no pressure is applied for squeezing together first side  842  and second side  844  of clamp device  820 . In the lock state, first side  842  and second side  844  of clamp device  820  are now in physical contact with suture  136  within slot  840  of clamp device  820  and, thus, provide a clamping action upon suture  136 . This is accomplished by creating a compression zone within clamp base  824  of clamp device  820  that prevents suture  136  from sliding freely along suture lock and cut assembly  800 . Additionally, in the lock state, the cutting tip of cutting knife  816  is beginning to enter guide slot  830  of clamp device  820 , but it is not in physical contact with suture  136 , which is within channel  832  of clamp device  820 .          
         [0068]      FIG. 12  illustrates a cross-sectional view of suture lock and cut assembly  800  in the cut state, which is described as follows. 
        Cut state: The cut state is achieved by the user&#39;s sliding body  810  toward clamp base  824  of clamp device  820 , such that its body first end  812  is abutting the outer surface of clamp base  824 , which causes the cutting tip of cutting knife  816  to ride deeper into guide slot  830 , cross the path of suture  136 , which is within channel  832 , and thereby cut suture  136 . In the cut state, first side  842  and second side  844  of clamp device  820  remain in physical contact with suture  136 , which is within slot  840  of clamp device  820  and, thus, maintains the clamping action upon suture  136 .          
         [0070]      FIG. 13  illustrates a cross-sectional view of suture lock and cut assembly  800  in the release state, which is described as follows.  
         [0071]     Release state: In the release state, the user releases pressure upon body  810  and cutting knife  816  remains engaged within guide slot  830  of clamp device  820 . In the release state, clamp second region  828  of clamp device  820  remains engaged within body  810  and, thus, pressure is maintained for squeezing together first side  842  and second side  844  of clamp device  820  and, thus, the clamping action is maintained indefinitely. The portion of suture  136  exiting body second end  814  of body  810  is removed, while the portion of suture  136  exiting clamp base  824  remains locked within suture lock and cut assembly  800 .  
                                       TABLE 2                           Example dimensions of suture lock and cut assembly 800                Example Dimension                            Body 810 outside diameter   0.28 inches           Body 810 inside diameter   0.16 inches           Body 810 length   0.41 inches           Clamp device 820 length   0.34 inches           Clamp first region 826 outside diameter   0.15 inches           Clamp second region 828 outside diameter   0.17 inches           Length of suture lock and cut assembly   0.49 inches           800 when closed and locked                      
 
         [0072]     Table 2 provides a non-limiting example of dimensions of a suture lock and cut assembly  800 . By substituting the specific lock and cut mechanisms of suture lock and cut assembly  800 , the method of using suture lock and cut assembly  800 , in combination with suture  136 , T-tag  138 , first tissue  140 , and second tissue  142 , is generally the same as described in  FIG. 6 , in reference to suture lock and cut assembly  100 .  
         [0073]     While the present invention has been illustrated by description of various embodiments, it is not the intention of the applicants to restrict or limit the spirit and scope of the appended claims to such detail. Numerous other variations, changes, and substitutions will occur to those skilled in the art without departing from the scope of the invention. Moreover, the structure of each element associated with the present invention can be alternatively described as a means for providing the function performed by the element. It will be understood that the foregoing description is provided by way of example, and that other modifications may occur to those skilled in the art without departing from the scope and spirit of the appended Claims.