Patent Publication Number: US-2021161584-A1

Title: Simplified methods for non-invasive vasectomy

Description:
PRIORITY CLAIMS 
     The instant application is a continuation in part of U.S. patent application Ser. No. 16/700,393 filed Dec. 2, 2019, which, in turn, claims the benefit of U.S. Provisional Application Ser. No. 62/917,325 filed Dec. 3, 2018. The instant application also claims the benefit of U.S. Provisional Application Ser. No. 62/995,188 filed Jan. 16, 2020. The contents of these prior applications are hereby incorporated by reference in their entirety. 
    
    
     TECHNICAL FIELD OF THE PRESENT INVENTION 
     The present invention relates to a simplified method for performing a non-invasive vasectomy. 
     BACKGROUND OF THE PRESENT INVENTION 
     Vasectomy is surgical procedure that typically involves the removal of a portion of the ducts that carry sperm out of the testes (i.e., the vas deferens), thereby stopping the flow of sperm from the testicle to the prostate gland; once the vas deferens is interrupted, the sperm cannot be delivered and the man is rendered sterile. Currently used vasectomy methods, such as the No Scalpel Vasectomy (NSV), require that each vas deferens be dissected from the scrotum to allow the clinician to occlude and divide the vas duct. Therein, the vas deferens is isolated, extracted, or otherwise delivered from the scrotum via one or two openings formed by puncturing the scrotum and then expanding the opening(s). The vas sheath is then retracted from a portion of the vas duct, which is then hemi-dissected and occluded, preferably by means of mucosal cautery in which the distal end of the filament of a battery powered cautery unit is inserted into each duct lumen and energized so as to create a luminal plug of scar tissue. Alternatively, vas occlusion may involve ligation with a suture or surgical clip. In either case, after the vas is divided, a portion of the duct is optionally excised and one end is isolated in the vas sheath to create a barrier to reconnection of the duct. For example, a layer of the vassal sheath may be placed between the two severed ends of the vas in order to cover one end but not the other in a technique referred to as “fascial interpositioning”. Once both ends are sufficiently secured, the duct is then returned to the scrotum, the opening through which the vas was accessed is allowed to close and the procedure is deemed complete. 
     While the procedure appears simple, significant surgical skill is required, and complications may result. Most common of these is the arisal of hematomas caused by slow bleeders at the site of the duct occlusion and division. In non-elastic tissue, a small amount of bleeding is quickly stopped by the tension that develops in the tissue. However, because the scrotum is essentially an elastic balloon-like vessel, the hydrostatic pressure necessary to stop bleeding is not present. Accordingly, even the slightest amount of persistent bleeding can cause a tremendously large hematoma. In a similar manner, rough handling of the tissue can lead to significant swelling. Even the most experienced vasectomy surgeon will occasionally encounter these problems. 
     Other disadvantages inherent in conventional surgical vasectomy, as exemplified by the NSV, include the prolonged surgical duration, which is generally on the order of twenty minutes or more. In addition, conventional vasectomy procedures fail to adequately account for the natural tendency of the cut ends of the vas deferens to grow back together, thereby allowing the flow of sperm to the prostate and resumption of fertility. Means for avoiding this failure have been the subject of debate among those skilled in the art, the question being whether the vas deferens should be clipped, cut, cauterized, ligated, or all of the above. Finally, because sharp instruments are used, performing a vasectomy on HIV+ patients presents a risk to the surgeon. 
     U.S. Pat. Nos. 8,220,464 and 8,561,615, both to Pannell et al. and both incorporated herein by reference in their entirety, represent an attempt to address the afore-noted drawbacks. In particular, Pannell et al., in U.S. Pat. Nos. 8,561,615 and 8,220,464 (hereinafter referred to as “Pannell &#39;615” and “Pannell &#39;464”, respectively), describe devices and minimally invasive methods in which the vas duct is not dissected from the scrotum, but rather occluded percutaneously by radio frequency (RF) energy applied to the site by a bipolar coagulating device. Thereafter, a portion of the occluded duct and surrounding scrotal tissue is removed by means of an integral cutting member that serves to excise and thus permanently divide the duct. 
     However, as noted in co-pending U.S. patent application Ser. No. 17/700,393 filed Dec. 2, 2019 referenced above, which as published to Robert Van Wyk as US 2020/0170831 A1 on Jun. 4, 2020 (hereinafter, “the &#39;393 application” or, alternatively, “Van Wyk &#39;831”), the inclusion of such an integral cutting member increases the complexity of the device and the associated manufacturing process. In addition, when occluding a vas duct by the above Pannell method, the clamp that maintains the position of the duct in the fold and locates the fold in the jaws of the coagulating device must be removed before excising the tissue portion. As removal of the clamp may allow the coagulated tissue to be displaced in the jaws before or during excision of the tissue, it accordingly, it may be necessary for the clinician to exercise extreme care since displacement of the tissue may result in incomplete excision of the uncoagulated central tissue portion. Moreover, given that tissue shrinks and forms a smooth lubricious surface when coagulated, such displacement may readily occur. Thus, a goal the &#39;393 application was to simplify the vasectomy process so as to allow those less skilled to perform the procedure, as well as to overcome existing disadvantages and deficiencies in the existing prior art. 
     In that vein, the &#39;393 application teaches clamps (i.e., “excising clamps”) that serve not only to maintain the location of the duct in a fold of the scrotum, but also to excise the tissue portion when coagulation is complete according to the methods of U.S. Pat. No. 8,561,615. These excising clamps and their associated bipolar coagulating device represent a simplification over the devices of U.S. Pat. No. 8,220,464. However, although minimally invasive, the &#39;393 application nevertheless requires surgical intervention that can prove problematic for the unskilled clinician and moreover, extend the requisite recovery period and/or impose severe limitations on post-surgical activity. Accordingly, it is a goal of the present invention to improve upon the vasectomy techniques of the &#39;393 application by eliminating altogether any active excision step. 
     SUMMARY OF THE PRESENT INVENTION 
     As noted above, the &#39;393 application describes the surgical removal of a portion of the vas duct, generally via a cooperating cutting action between an excising clamp and the coagulating jaws of the electrosurgical handpiece. See, e.g.,  FIGS. 32B and 56  (excise duct portion  27 ) and  FIG. 81 , inset C (tissue portion  30 ). The instant application avoids the need for active removal. In particular, in the methods of the present invention, a vas duct is isolated within a fold of scrotal skin and clamped between the arcuate jaws of a bipolar coagulating device. Using RF energy, the portion of the fold of scrotal tissue and the vas duct positioned therein that is clamped between the jaws is fused by coagulation so as to occlude the duct in two places. Coagulation of the tissue prevents blood flow to the central uncoagulated region. Because of this, tissue in this region will necrose and slough from the body so as to divide the vas duct. Optionally, a clamp may be used to maintain the position of the vas duct in the fold of scrotal skin, the clamp being removed when coagulation is complete. 
     As noted above, the present invention is characterized by substantial advantages not found in conventional methods and devices. For example, by avoiding both dissection and excision, the non-invasive methods of the present invention effectively eliminate bleeding and the associated the risk for the development of massive hematomas and swelling. In addition, the present invention allows for the separation of the vas deferens in such a manner that it is virtually impossible for the ends of the vas deferens to contact each other and rejoin. Also, as compared to vasectomy methods currently available, the inventive procedure utilizes no surgical steps and thereby reduces the opportunity for complications. The inherent simplicity of the disclosed procedures and associated instruments simplifies training and allows clinicians with limited experience to master their use. Moreover, the non-invasive procedures of the present invention avoid exposure to bodily fluids, which, in turn, significantly reduces risks of transmission of blood-borne diseases, such a HIV and Hepatitis, to performing clinicians. 
     These and other objectives can be accomplished by the invention herein disclosed. Further objects and features of the invention will become more fully apparent when the following detailed description is read in conjunction with the accompanying figures and examples. To that end, it is to be understood that both the foregoing summary of the invention and the following detailed description are of a preferred embodiment, and not restrictive of the invention or other alternate embodiments of the invention. In particular, while the invention is described herein with reference to a number of specific embodiments, it will be appreciated that the description is illustrative of the invention and is not constructed as limiting of the invention. In addition, regarding the specific objectives recited above, it will be understood by those skilled in the art that one or more aspects of this invention can meet certain objectives, while one or more other aspects can meet certain other objectives. Each objective may not apply equally, in all its respects, to every aspect of this invention. As such, the objectives herein can be viewed in the alternative with respect to any one aspect of this invention. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       Various aspects and applications of the present invention will become apparent to the skilled artisan upon consideration of the brief description of figures and the detailed description of the present invention and its preferred embodiments that follows: 
         FIG. 1  depicts a first step in a prior art No Scalpel Vasectomy (NSV) procedure in which a vas duct is located in a fold of scrotal tissue. 
         FIG. 2  depicts a subsequent step in the prior art NSV procedure in which the vas duct is isolated in a fold of scrotal tissue using a ringed clamp. 
         FIG. 3  depicts a subsequent step in the prior art NSV procedure in which an opening is formed in the scrotum and a portion of a vas duct in its surrounding sheath is extracted from the scrotum. 
         FIG. 4  depicts a subsequent step in the prior art NSV procedure in which the vas sheath is stripped back from the vas duct in preparation for occlusion. 
         FIG. 5  depicts a subsequent step in the prior art NSV procedure in which a first side of the hemi-dissected vas duct is coagulated using a cautery. 
         FIG. 6  depicts a subsequent step in the prior art NSV procedure in which a second side of the hemi-dissected vas duct is coagulated using a cautery. 
         FIG. 7A  depicts the vas duct after subsequent removal of the portion medial to the dissections in the prior art NSV procedure, with the end of the prostate leg ligated and the suture left untrimmed. 
         FIG. 7B  depicts the site subsequent to  FIG. 7 , wherein the ends of the vas enclosed in the sheath are returned to the scrotum with the leg of the ligating suture extending from the puncture in the scrotum. 
         FIG. 7C  depicts the site subsequently to  FIG. 8 , with the end of the prostate leg of the vas duct secured outside of the vas sheath so as to establish fascial interposition. 
         FIG. 7D  depicts the site at completion of occlusion of the duct via the prior art NSV procedure in which the ends of the duct returned to the scrotum. 
         FIG. 8  is a plan view of a bipolar electrosurgical device of a vasectomy system of the present invention. 
         FIG. 9  is a side elevational view of the objects of  FIG. 16 . 
         FIG. 10  is a perspective view of the objects of  FIG. 16 . 
         FIG. 11A  is an expanded view of the objects of  FIG. 16  at location B. 
         FIG. 11B  is an expanded sectional view of the objects of  FIG. 19A  at location A-A. 
         FIG. 12  is an expanded view of the objects of  FIG. 18  at location A. 
         FIG. 13  is an expanded side elevational view of the distal portion of the bipolar electrosurgical device of  FIG. 16  with the device in an open, unclamped condition. 
         FIG. 14  is a distal perspective view of the objects of  FIG. 21 . 
         FIG. 15  is a proximal perspective view of the objects of  FIG. 21 . 
         FIG. 16  is an expanded view of the objects of  FIG. 22  at location D. 
         FIG. 17  is an expanded view of the objects of  FIG. 23  at location E. 
         FIG. 18  depicts a surgical system including the bipolar electrosurgical device of  FIG. 8  connected to a suitable electrosurgical generator with optional foot pedal connected thereto for activation of the generator. 
         FIG. 19  is a perspective view of yet another alternate embodiment for an excising clamp in accordance with the present invention in a closed (clamped) condition. 
         FIG. 20  is an expanded view of the objects of  FIG. 19  at location A. 
         FIG. 21  is a side elevational view of the objects of  FIG. 19 . 
         FIG. 22  is an expanded view of the objects of  FIG. 2 l    at location C. 
         FIG. 23  is a plan view of the objects of  FIG. 19 . 
         FIG. 24  is an expanded view of the objects of  FIG. 23  at location D. 
         FIG. 25  is a plan view of a portion of a scrotum with a vas duct positioned in a fold thereof. 
         FIG. 26  is a perspective view of the objects of  FIG. 25 . 
         FIG. 27  depicts the scrotum of  FIG. 25  wherein the position of a vas duct is maintained by the clamp of  FIG. 19 . 
         FIG. 28  is an expanded view of the objects of  FIG. 27  at location A. 
         FIG. 29  is a plan view of the scrotum and clamp of  FIG. 27  wherein the jaws of the bipolar handpiece of  FIG. 8  are positioned around the clamp in preparation of sealing the tissue between the jaws by coagulation. 
         FIG. 30  is an expanded view of the objects of  FIG. 29  at location A. 
         FIG. 31  is a perspective view of the objects of  FIG. 29 . 
         FIG. 32  is an expanded view of the objects of  FIG. 31  at location A. 
         FIG. 33  depicts the scrotum and clamp of  FIGS. 27 and 29  after the bipolar handpiece is removed following the completion of sealing of the tissue. 
         FIG. 34  is an expanded view of the objects of  FIG. 33  at location A. 
         FIG. 35  is a perspective depiction of a scrotum wherein the vas duct has been occluded according to methods of the present invention. 
         FIG. 36  is a plan view of the objects of  FIG. 35 . 
         FIG. 37  is an expanded view of the objects of  FIG. 15  at location A. 
         FIG. 38  is a perspective view of an alternate embodiment clamp used in vasectomy methods of the present invention. 
         FIG. 39  is a side elevational view of the objects of  FIG. 38 . 
         FIG. 40  is a perspective view of the clamp of  FIG. 38  in use maintaining the position of a vas duct in a scrotum. 
         FIG. 41  is a plan view of the objects of  FIG. 40 . 
         FIG. 42  is an expanded view of the objects of  FIG. 40  at location B. 
         FIG. 43  is an expanded viewed of the objects of  FIG. 41  at location A. 
         FIG. 44  is a perspective view of the objects of  FIG. 40  with alternate positioning of the clamp. 
         FIG. 45  is a plan view of the objects of  FIG. 44 . 
         FIG. 46  is a perspective view of a tenaculum used in vasectomy methods of the present invention. 
         FIG. 47  is a side elevational view of the tenaculum of  FIG. 46 . 
         FIG. 48  is an expanded view of the tenaculum of  FIG. 46  at location A. 
         FIG. 49  is an expanded view of the tenaculum of  FIG. 47  at location B. 
         FIG. 50  is a perspective view of the distal portion of the tenaculum of  FIG. 46  in use maintaining the position of a vas duct in a fold of scrotal tissue. 
         FIG. 51  is a plan view of the objects of  FIG. 50 . 
         FIG. 52  is a side elevational view of the objects of  FIG. 50 . 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Before the present materials and methods are described, it is to be understood that this invention is not limited to the specific devices, systems, methodologies or protocols herein described, as these may vary in accordance with routine experimentation and optimization. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims. Accordingly, unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present invention belongs. However, in case of conflict, the present specification, including definitions below, will control. 
     All publications mentioned herein are incorporated herein by reference in their entirety. However, nothing herein should be construed as an admission that the invention is not entitled to antedate such disclosure by virtue of prior invention. 
     Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. However, in case of conflict, the present specification, including definitions, will control. Accordingly, in the context of the present invention, the following definitions apply: 
     The words “a”, “an” and “the” as used herein mean “at least one” unless otherwise specifically indicated. Thus, for example, reference to an “opening” is a reference to one or more openings and equivalents thereof known to those skilled in the art, and so forth. 
     As used herein, the noted directional terms relate to a human body in a standing position. For instance, “up” refers to the direction of the head, “down” refers to the direction of the feet. Likewise, herein, the “vertical” direction is parallel to the axis of the body and the “horizontal” direction is parallel to the floor. In a similar fashion, the term “lateral” refers to the direction extending away from the center of the body whereas “medial” refers to a direction extending toward the center of the body. 
     In the context of the present invention, the term “proximal” refers to that end or portion of a device or instrument which is situated closest to the body of the subject when the device is in use. Accordingly, the proximal end of an excising clamp or bipolar electrosurgical device of the present invention includes the handle portions. 
     In the context of the present invention, the term “distal” refers to that end or portion of a device or instrument that is situated farthest away from the body of the subject when the device is in use. Accordingly, the distal end of an excising clamp of the present invention includes the jaw components. 
     In the context of the present invention, the term “arcuate” is used herein to describe shapes forming or resembling an arch. It is used interchangeably with its synonym, arciform. 
     In the context of present invention reference invention, the terms “coagulated” or “cauterized” are interchangably used to describe a treated area of tissue. As used herein, coagulated or cauterized tissue is tissue that through the application of RF energy and pressure has been dessicated and fused to eliminate the flow of blood or other fluids. 
     In the context of the present invention, the term “convex” refers to a surface or boundary that curves outward, as the exterior of a sphere. Conversely, the term “concave” refers to a surface or boundary that curves inward, as to the inner surface of a sphere, or is hollowed or rounded inward like the inside of a bowl. Herein, the area of unclamped scrotal tissue defined by the U-shaped jaws of the bipolar coagulating device and the arcuate area of clamped scrotal tissue contained therein is referred to as convex in shape. 
     In the context of the present invention, the terms “vas”, “duct”, “vas duct” are used interchangeably and refer to the vas deferens, and may include the vas sheath as well. The terms “pure duct” or “pure vas” refer to the duct only. 
     Clamping devices in vasectomy methods of the present invention are used solely to maintain the position of a vas duct in a fold of scrotal skin for subsequent occlusion of the duct. Because a clamping device may contact the jaws of a bipolar handpiece during use, in order to prevent shorting of the bipolar device these clamps are formed of a dielectric material, typically a polymer or ceramic, or are formed of a metallic material and are covered with a dielectric coating. Indeed, clamps having a wide variety of configurations may be used including standard metal ring forceps and tenaculums to which a non-conductive coating has been applied. 
     As noted above, the present invention is characterized by substantial advantages not found in conventional methods and devices. For example, by avoiding direct dissection and resulting bleeding, the present invention is able to eliminate the risk for development of massive hematomas and swelling. In addition, the present invention allows for the separation of the vas deferens in such a manner that it is virtually impossible for the ends of the vas deferens to contact each other and rejoin. Also, the vasectomy procedure of the present invention requires fewer steps than other current vasectomy techniques, thereby reducing opportunities for complications and medical errors. Furthermore, the inherent simplicity of the disclosed procedure and associated instruments simplifies training and allows clinicians with limited experience to master their use. Moreover, the procedures of the present invention avoid exposure to bodily fluids, which, in turn, minimizes risks of transmission of blood-borne diseases, such a HIV and Hepatitis, to performing clinicians. 
     Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, the preferred methods, devices, and materials are depicted in the accompanying figures and described hereinafter. However, the embodiments described herein are merely intended to illustrate the principles of the invention. Those skilled in the art will recognize that variations and modifications may be made to the embodiments without changing the principles of the invention herein disclosed. Accordingly, the accompanying figures, described in detail below that depict aspects of the invention are in no way intended to limit the scope of the present invention. 
     Examples 
     The most common method of vasectomy currently practiced is the “No-Scalpel Vasectomy” (NSV), a procedure in which the vas deferens is delivered from the scrotum via one or two openings formed by puncturing the scrotum and then expanding the opening(s). Critically, vasectomy techniques currently in use are considered to be “No Scalpel” if the openings in the scrotum are not formed by incision using a cutting device, but rather by puncturing the scrotum and then using forceps to expand the opening by stretching the tissue. As many prospective vasectomy patients find the idea of an incision on their scrotum very intimidating, the “no scalpel” name attached to the current NSV methods tends to reduce patient anxiety. In fact, in an effort to even further reduce patient anxiety, many current NSV techniques create a single opening on the mid-line of the scrotum and both vas ducts are occluded through this opening. Nevertheless, the fact remains that conventional NSV requires extraction of the vas duct from the scrotum and thus the formation of an opening of sufficient size to permit surgical access. 
     To that end, steps of a typical prior-art NSV wherein a vas duct is occluded are depicted in  FIGS. 1 through 7D . In  FIG. 1 , a vas duct  20  is located in scrotum  10  using a standard three-finger technique. Thereafter, a local anesthetic is injected at the site. Duct  20  is then isolated in a fold of scrotum  10  using a ringed forceps  4  as shown in  FIG. 2 . The scrotum is then punctured using a dissecting forceps and the opening expanded sufficiently to allow the surgeon to deliver a portion  26  of vas duct  20  as depicted in  FIG. 3 . Dissecting forceps  6  are then used to puncture vas sheath  29  and then strip sheath  29  back to expose duct portion  28  as shown in  FIG. 4 . In  FIGS. 5 and 6 , duct portion  28  is hemi-dissected into abdominal and testicular portions, after which the distal element of an electrocautery  7  is inserted into the lumens of the respective portions and activated so as to form scar tissue in the lumens and thereby occlude them. Thereafter, as shown in  FIG. 7A , a suture  8  is applied to the abdominal leg of the separated duct portion  28 . Next, vas sheath  29  with the testicular portion of separated duct  28  are drawn back into scrotum  10  with suture  8  extending through the opening in sheath  29  and the opening in scrotum  10  as shown in  FIG. 7B . In  FIG. 7C , suture  8  is used to draw duct  28  and sheath  29  out of scrotum  10 , and to draw the abdominal side occluded end of duct  28  out of sheath  29 , whereupon suture  10  is tied around a portion of sheath  28  and duct  29  as depicted in  FIG. 7C . Placing suture  9  in this manner permanently places a wall of sheath  29  between the divided occluded ends of duct  28  so as to provide an additional barrier to reuniting of the divided ends.  FIG. 7D  depicts the site with occluded, divided vas duct  20  returned to scrotum  10  with the duct ends being separated by fascial interpositioning. 
     As discussed elsewhere herein and as the above-referenced figures demonstrate, a typical NSV procedure involves multiple steps and requires extensive surgical skills. Completing the procedure generally requires twenty minutes or more. If the surgeon fails to notice and address any bleeders, hematomas may result. Because the scrotum is a flexible expandable vessel, these hematomas may become massive, resulting in pain and anxiety for the patient. In all cases it is necessary for the patient to restrict activities following the procedure, frequently for a week or more. 
     While the methods of the present invention may also be referred to as “no scalpel”, in that no incision is made in the scrotum, the instant methods in fact transcend the “no scalpel” designation in that no opening(s) are formed in the scrotum and thus the vas is not delivered from the scrotum but rather accessed in situ. Thus, in contrast to existing NSV procedures, only the methods of the present invention may be truly characterized as “non-invasive”. 
     In addition, the non-invasive methods of the present invention enable a clinician to perform a vasectomy in less time and with a decreased likelihood of complications. For example, in the current NSV technique, occluding of the duct, dividing of the duct, and creating the fascial interposition are accomplished in three separate steps. However, using the methods of the present invention, these three tasks may be accomplished in a single step, Thus, as less surgical skill is required, the procedure may be performed by a non-surgeon on the medical staff, for example, a nurse, nurse practitioner, or physician&#39;s assistant. 
     To wit, in the vasectomy methods of the present invention, a vas duct is located in the scrotum and manipulated into a fold of tissue, preferably in a high lateral position. The position of the duct in the fold is maintained using a surgical clamp, the clamp being either positioned just distal to the duct, or aligned with the mid-portion of the duct. Thereafter the jaws of a bipolar coagulating device, such as described in Pannell &#39;464, Pannell &#39;615, or Van Wyk &#39;831, the contents of which are enumerated and incorporated above, are positioned around the clamp and closed onto the tissue so as to compress an arcuate region of tissue surrounding the clamp. Radio Frequency (RF) energy from the bipolar outputs of an electrosurgical generator is applied to the jaws so as to coagulate the tissue compressed between the jaws of the handpiece. This action seals the two vas duct portions clamped between the jaws along with scrotal tissue clamped between the jaws while a small region of tissue scrotal tissue and a third duct portion between the two sealed portions remain uncoagulated. When coagulation is finished the handpiece and clamp are removed from the site to complete the procedure. The vas duct is now occluded in two locations with an uncoagulated portion between the occlusion sites. While the uncoagulated tissue is not actively excised or otherwise removed during the procedure, because the aforementioned coagulation blocks the blood supply to this tissue, it will necrose and slough off naturally over time, thereby dividing the vas duct. 
     A bipolar coagulating device (handpiece)  400  suitable for use in methods of the present invention is depicted in  FIGS. 8 through 12  with the jaws in a first, clamped position. Handpiece  400  is substantially similar to the equivalent electrosurgical device described in Pannell &#39;464, Pannell &#39;615, and Van Wyk &#39;831 and operates by an analogous procedure. To wit, bipolar handpiece  400  has an upper handle assembly  402  with a proximal handle portion  404  and a distal portion  406  wherein is mounted lower jaw  408 . Handpiece  400  has a lower handle assembly  422  with a proximal handle portion  424  and a distal portion  426  wherein is mounted upper jaw  428 . Upper handle assembly  402  and lower handle assembly  422  are rotatably joined by element  401 . Lower handle assembly  422  has located adjacent to its proximal end ratchet element  430  that, in cooperation with downward extending proximal portion  410  of upper handle assembly  402  maintains the clamping force of jaws  408  and  428 , portion  432  of ratchet element  430  limiting the interjaw force that can be applied. Bipolar cable  440  is connected at its proximal end to the bipolar outputs of a suitable electrosurgical generator, and at its distal end, via wires  442  and  444  to upper jaw  428  and lower jaw  408  respectively such that Radio Frequency (RF) energy from the generator is conducted to jaws  408  and  428  so as to coagulate tissue clamped therebetween. In a preferred embodiment, RF energy from the electrosurgical generator is modulated according to an algorithm in the generator for maximal coagulation of tissue between the jaws. 
     As best seen in the close-up views of  FIGS. 10-12 and 14-15 , upper  428  and lower  408  jaws are mirror images, each including a proximal portion that attaches to the distal end of the handpiece and a distal portion that is off-set from the longitudinal axis defined by the handpiece, preferably disposed at an angle of about 45 degrees. The angular offset affords the surgeon better visibility and access to the target surgical site. As best seen in  FIG. 11A , upper jaw  428  has a “U” shape with a central slot  429  of width  480 , with lower jaw  408  having a corresponding shape so that tissue may be clamped between the U-shaped jaw portions of jaws  408  and  428 . 
     Referring now to  FIG. 11B , the U-portions of jaws  408  and  428  preferably have radiused outer circumferential portions  403  and  423  respectively adjacent to their clamping surfaces to prevent cutting of tissue clamped between jaws  408  and  428 . In a preferred embodiment, each offset central slot defined by each “U-shaped” distal portion is approximately 1-3 mm in width. The distal portion of handpiece  400  with handpiece  400  in its second (unclamped) position is depicted in  FIGS. 13 through 17 . Jaws  408  and  428  are ideally formed of a stainless steel or other suitable metallic material. 
       FIG. 18  depicts a bipolar coagulating device  400  connected by cable  440  to the bipolar outputs of electrosurgical generator  13  that is suitable for use in connection with the inventive methods. In the depicted preferred embodiment, generator  13  is activated by foot pedal  15 . While not shown, it is understood that electrosurgical generator may be powered by alternating current, for example, via a conventional wall socket, or alternatively may be powered by direct current, for example, by means of an included rechargeable power source. 
     In  FIGS. 19 through 24 , clamp  700  is formed of elements  740  having proximal portions that form finger holes  742 , and whereon are formed ratchet portions  744 . Elements  740  are pivotably joined by element  746 . Distal to element  746 , distal portions  748  of elements  740  have a distal-most portion  714  of width  716  ( FIG. 24 ) that is less than width  480  of slots  429  and  409  of jaws  428  and  408  respectively (see  FIG. 11A ). Distal-most portions  714  have at their distal ends jaw portions  718  with vertically opposed, planar jaw faces  720 . Distal-most portions  714  have laterally opposed surfaces  715 , and surfaces  722  that are perpendicular to surfaces  715 , and that together define distal opening  750  of clamp  700 . Clamp  700  may be made from a suitable dielectric material or from a metallic material with the distal portions  714  coated with a suitable dielectric coating so as to prevent shorting of bipolar handpiece  400  during use. 
     In a first step of a vasectomy procedure according to methods of the present invention, a first vas duct is isolated in a fold of scrotal skin as depicted in  FIGS. 25 and 26  wherein duct  20  is located in a fold of scrotal skin  10 . A local anesthesia is injected at the site. In  FIGS. 27 and 28 , clamp  700  is applied to the fold of scrotal skin  10  with jaws  718  medial to duct  20  so as to maintain the position of duct  20  in the fold. Thereafter, upper and lower jaws  408  and  428  of handpiece  400  are positioned around distal portions  714  of clamp  700  and handpiece  400  is closed so as to apply compressive force to the tissue between jaws  408  and  428  as shown in  FIGS. 29 through 32 . The clamping force may be maintained by ratchet element  430  of lower handle assembly  422 . Subsequently RF energy from electrosurgical generator  13  ( FIG. 18 ) is supplied to jaws  408  and  428  by wires  442  and  444  and cable  440  so as to coagulate portions of scrotal skin  10  and vas duct  20  that are compressed between jaws  408  and  428 . When coagulation is complete, handpiece  400  is removed leaving clamp  700  in place as shown in  FIGS. 33 and 34 . The clamp is then removed, leaving site  15  as shown in  FIGS. 35 through 37 . Referring to  FIG. 37 , site  15  contains region  17  in which scrotum  10  and duct  20  are sealed by coagulation, and region  19  which remains uncoagulated since it was not compressed between bipolar jaws  408  and  428  of handpiece  400 . Region  19  has no blood supply because it is surrounded by coagulated region  17 . Because region  19  has no blood supply, it will necrose and slough off thereby dividing vas  20 . Tissue adjacent to site  15  will heal and when healing is complete the gap left by the necrosed tissue will blend into the normal contour of scrotum  10 . 
     Because the methods of the present invention require use of a clamp solely for maintaining the location of vas duct  20  in a fold of scrotal tissue  10 , and to aid in positioning the jaws  408  and  428  of handpiece  400 , clamps of various configurations may be used so long as they are formed of a dielectric material or coated with a dielectric material. Nevertheless, certain illustrative clamping devices are depicted and described in Van Wyk &#39;831, the contents of which are incorporated by reference in their entirety. 
     For instance,  FIGS. 38 and 39  depict a ring forceps  300 , an instrument commonly used in no scalpel vasectomy procedures. Ring forceps  300  is so named because of the ring shape of its distal end  302 . Ring forceps  300  is used in the same manner as when doing a no scalpel vasectomy, that is to maintain the position of a vas duct in a fold of scrotal tissue. Forceps  300  is of usual metallic construction but is covered with a dielectric coating so as to not short bipolar jaws  408  and  428  of handpiece  400  when coagulating tissue. In a preferred embodiment, the device  300  is coated with parylene. Device  300  is coated in its entirety. Other embodiments are only partially coated, the coating covering the distal portion that is in proximity to jaws  408  and  428  during use. Other dielectric coatings including, for example, PTFE, may be used. 
     Referring now to  FIGS. 42 and 43 , duct  20  and surrounding tissue of scrotum  10  are maintained in position by capture within the aperture formed at distal end  302  of ring forceps  300 . Jaws  408  and  428  of handpiece  400  are positioned about distal end  302  of ring forceps  300  in the manner previously herein described. Occlusion of the vas duct and sealing of the surrounding tissue proceeds in the same manner after which handpiece  400  and ring forceps are removed from the site. 
     Referring again to  FIG. 37 , the distance to which regions  17  and  19  of site  15  extend medially into the scrotum is determined by the location of jaws of  408  and  428  of handpiece  400  during coagulation of the tissue. This, in turn, is determined by the position of the clamp around which the jaws  408  and  428  are placed. In the examples previously herein described, the clamp is placed medially adjacent to duct  20  so as to maintain the duct position. Jaws  408  and  428  are positioned medially adjacent to the clamp. It is desirable to minimize the medial extent of regions  17  and  19 . This may be accomplished by modifying the location of the clamp that is maintaining the location of duct  20 . For instance, referring now to  FIGS. 44 and 45 , distal end  302  of ring forceps  300  may be placed at the mid-line of duct  20  so as to compress duct  20  and the adjacent tissue of scrotum  10  between the clamping faces of distal end  302  of ring forceps  300 . Because the position of jaws  208  and  228  is determined by the position of distal end  302 , the medial extent of portions  17  and  19  of site  15  is reduced. 
     Further reduction of coagulated region  17  and region  19  that will be necrosed during healing may be realized by the use of an alternate instrument for maintaining the position of duct  20 . Tenaculum  600 , shown in  FIGS. 46 through 49  has sharpened distal portions  644  that are configured to pierce tissue so that the tissue position may be controlled by tenaculum  600 . Aperture  642  formed by distal portions  644  is configured in a manner to make the distal portion  640  depth limiting. That is, when tissue is grasped by tenaculum  600 , the distance at which sharpened portions  644  intersect and penetrate tissue is limited by aperture  642 . Referring now to  FIGS. 50 through 52 , tenaculum  600  maintains the position of duct  20  in a fold of tissue of scrotum  10 , sharpened portions  644  penetrate scrotum  10  and duct  20  in the mid portion of duct  20 . The positioning of jaws  408  and  428  when the location of duct  20  is maintained by tenaculum  600  is much less medial than when using clamp  700  or ring clamp  300 . The medial extent of portions  17  and  19  of site  15  is commensurately reduced. 
     INDUSTRIAL APPLICABILITY 
     As noted previously herein, by eliminating the steps of scrotal dissection and vas duct extraction, the vasectomy methods of the present invention overcome disadvantages and deficiencies of conventional vasectomy methods, providing a rapid, reliable, non-invasive male sterilization procedure that significantly reduces or eliminates negative side effects, including swelling and spontaneous regeneration, and minimizes recovery time and recovery restrictions. The methods of the present invention further avoid exposure to patient bodily fluids, thereby minimizing the potential for transmission of blood-borne diseases such as HIV and Hepatitis. 
     Due to the complications associated with traditional vasectomies but eliminated by the techniques and devices herein disclosed, successful procedures have, in the past, required the utilization of skilled experienced surgeons. However, the vasectomy method of the instant invention minimizes the number of steps and duration of the procedure, thereby allowing the procedure to be quickly completed by clinicians with minimal training. Moreover, given its simplicity, less skilled heath care workers can master the procedure in a relatively short period of time. This will extend the feasibility of male sterilization to areas of the world where doctors, more particularly skilled surgeons, are in short supply. For example, the method of the instant invention may be advantageously used for population control in developing countries. 
     While the invention has been described in detail and with reference to specific embodiments thereof, it is to be understood that the foregoing description is exemplary and explanatory in nature and is intended to illustrate the invention and its preferred embodiments. Through routine experimentation, one skilled in the art will readily recognize that various changes and modifications can be made therein without departing from the spirit and scope of the invention. 
     Other advantages and features will become apparent from the claims filed hereafter, with the scope of such claims to be determined by their reasonable equivalents, as would be understood by those skilled in the art. Thus, the invention is intended to be defined not by the above description, but by the following claims and their equivalents.