Patent Publication Number: US-2022218375-A1

Title: Bipolar coagulating devices and vasectomy kits associated therewith

Description:
PRIORITY 
     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 is also a continuation-in-part of U.S. patent application Ser. No. 17,338,115 filed Jun. 3, 2021, which, in turn, is a continuation-in-part of U.S. patent application Ser. No. 17/150,313 filed Jan. 15, 2021, which, in turn, both claims the benefit of U.S. Provisional Application Ser. No. 62/995,188 filed Jan. 16, 2020 and 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 contents of these prior applications are hereby incorporated by reference in their entirety. 
    
    
     TECHNICAL FIELD OF THE INVENTION 
     The present invention relates to surgical instruments, and more particularly to bipolar surgical instruments and kits for performing vasectomies and methods for performing vasectomies using the instruments and kits. 
     BACKGROUND OF THE INVENTION 
     Vasectomy is a 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 vas sheath may be placed between the two severed ends of the vas duct 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, and the opening through which the vas was accessed is allowed to close, and the procedure is deemed complete. Optionally, a stitch or skin adhesive is used to aid in closure. 
     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. represents an attempt to address the afore-noted drawbacks. Therein, Pannell et al. describe an instrument and method that overcomes some of these disadvantages of conventional vasectomy techniques, more particularly a bipolar coagulating device able to occlude a vas duct in situ, without dissecting the duct from the scrotum. In a preferred embodiment, the coagulating device includes an integral cutting element able to excise a portion of scrotal tissue. In the context of the Pannell method, a vas duct is located in a fold of scrotal skin and maintained in that location by a clamp made of a dielectric material. The arcuate jaws of the bipolar coagulating device are positioned around the clamp so as to compress a similarly arcuate region of tissue between the jaws. The arcuate clamped region contains two portions of the vas duct trapped in the fold of scrotal tissue. After coagulating the arcuate clamped region, the clamp is removed so as to allow an integral cutting element pivotably mounted to the bipolar device to excise the uncoagulated tissue in the center of the arcuate region. Thus, the excised tissue contains the uncoagulated portion of the vas duct between the two coagulated regions sealed in the coagulated tissue fold. 
     The method described by Pannell et al. has significant advantages over other vasectomy methods. For example, because there is no dissection, there can be no bleeders and therefore no hematomas. Additionally, as the procedure has fewer steps, it can be completed in much less time. Finally, extensive surgical skills are not required. However, due to the inclusion of an integral excision element, the Pannell device tends to be complex, particularly if excision of the tissue is to be accomplished electrosurgically, as is the preferred embodiment. Also, when occluding a vas duct by the 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. Removal of the clamp may allow the coagulated tissue to be displaced in the jaws before or during excision of the tissue. 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. Given that tissue shrinks and forms a smooth lubricious surface when coagulated, such displacement may readily occur. 
     The present invention builds and improves upon the teachings of Pannell et al. described in U.S. Pat. Nos. 8,220,464 and 8,561,615, the contents of which are incorporated by reference herein. In particular, the present invention is intended 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 prior art including, but not limited to, a substantial risk for the development of hematomas and swelling, and a need for a highly skilled surgical professional, as well as a long recovery period, accompanied by severe limitations on post-surgical activity. 
     Accordingly, the present invention addresses an ongoing need in the art for vasectomy methods that utilize simplified instruments to occlude and divide a vas duct simply and quickly and with fewer steps and fewer post-surgical complications. To that end, the present invention further addresses the need in the art for expeditious vasectomy methods that prevent hematomas and swelling, that minimize the potential for spontaneous regeneration and undesired resumption of fertility, that negate the need for a highly skilled surgical professional, an extended procedure duration, and a prolonged recovery time. Finally, the present invention addresses the desire in the art for such new methods to avoid the need for sharp instruments so that clinicians may limit their exposure to a patient&#39;s body fluids and thus operate on patients with infectious diseases such as HIV without risk of infection. 
     SUMMARY OF THE INVENTION 
     The present invention addresses the afore-noted needs in the art by providing both novel vasectomy devices and instruments and novel methods for their use. For example, through the use of the excising instruments of the present invention, together with a bipolar coagulating device in methods of the present invention, a vas duct may be quickly and simply occluded, divided, and separated by fascial interposition. For example, in a first embodiment, the present invention provides a novel vasectomy method in which the requisite operations are accomplished in a single step, after the duct is dissected from the scrotum. In a second, alternative embodiment, the present invention allows for these operations to be accomplished in a single step without removing the duct from the scrotum. Further illustrative aspects and embodiments of the present invention in accordance with the foregoing objectives are as follows: 
     It is an objective of the present invention to provide a bipolar vasectomy device and surgical method for vasectomy in which the vas is located in a conventional manner and anesthetized using a local anesthetic. Thereafter, the scrotum is punctured in accordance with standard procedures, for example, using a dissecting forceps, and expanded to allow insertion of either an “excising clamp” or “excising hook” of the present invention, i.e., instruments used to position a vas duct within the coagulating jaws of a bipolar electrosurgical device of the present invention, to maintain that position during coagulation, and thereafter to optionally divide the vas by excision. 
     In the context of a first embodiment, the bipolar vasectomy device and vasectomy method of the present invention involves the capture of the vas using one of the novel excising clamps or hooks of the present invention and the subsequent delivery of the vas out of the scrotum a sufficient distance to allow the arcuate jaws of an improved bipolar coagulating device described in detail herein to be positioned around the hook or clamp. In the context of the present invention, the tissue is secured between the angularly offset, U-shaped cutting jaws of a coagulating device such as exemplified in  FIG. 25  and radio frequency (RF) energy is supplied for a brief period, on the order of 10 to 20 seconds, so as to thermally coagulate portions of the vas between the arcuate jaw portions. When coagulation is complete, the excising clamp or hook is moved downward, upward, or at an angle relative to the U-shaped jaws of the coagulating device so that the portion of the vas captured within an interior surface of the clamp or hook is excised. Excision is accomplished by the cooperative action of the cutting edges on the jaws of the improved coagulating device and the sharp edges on the excising clamp or hook. Sealing of the duct, sealing of the sheath, and dividing of the vas are all accomplished in two simple steps that do not require surgical skill. Thus, the opportunity for hematoma creation is dramatically reduced. 
     In certain optional embodiments, the vas may be delivered from the scrotum by a conventional surgical instrument such as, for instance, a ring clamp or dissecting clamp, and subsequently transferred to a dissecting clamp of the present invention for positioning in the jaws of the bipolar vasectomy device. 
     In other optional embodiments, the portion of the vas captured within the interior region of the clamped, U-shaped jaws of the bipolar vasectomy device may be excised after coagulation by means of an alternative cutting instrument conventional in the surgical arts, examples of which include, but are not limited to, a scalpel, dissecting forceps, scissors or other surgical device. 
     In the context of an alternative embodiment, the bipolar vasectomy device and vasectomy method of the present invention avoids the need for dissecting the vas from the scrotum. In this alternative scenario, after the duct is isolated in a fold of scrotal tissue, an excising clamp of the present invention is applied to the fold medial to the duct so as to maintain the position of the duct. Once again, the arcuate jaws of a bipolar coagulating device in accordance with the present invention are then positioned around the clamp so as to compress an arcuate region of tissue between the jaws. This arcuate region contains a portion of the duct positioned within a portion of the fold of scrotal tissue by the excising clamp. This arcuate region is then coagulated by means of the RF energy supplied to the jaws by an electrosurgical generator. When coagulation is complete, the excising clamp is displaced upward, downward, or angularly relative to the jaws so as to excise the central uncoagulated tissue portion bound by the arcuate coagulated region clamped between the jaws of the coagulating device. Excision is accomplished by interaction between cutting edges formed on the jaws of the coagulating device and cutting edges formed on the jaws of the clamp. Further exemplary details and illustrations of this alternative intra-scrotal procedure may be found in co-pending U.S. patent application Ser. No. 17,338,115 referenced above, the contents of which are incorporated by reference herein in their entirety. 
     In certain optional embodiments, the portion of the vas captured within the interior region of the clamped, U-shaped jaws of the bipolar vasectomy device may excised after coagulation using an alternative conventional cutting instrument conventional in the surgical arts such as mentioned above, examples of which include a scalpel, dissecting forceps, scissors, biopsy punch, or other surgical device. As noted above, the present invention is one aspect relates to the provision of a variety of novel surgical instruments suitable for use in connection with the above-mentioned vasectomy methods and improved bipolar coagulating device, more particularly in the form of novel excising hooks and clamps adapted and suitable for isolating and excising a portion of the vas deferens targeted for removal. 
     In one aspect, the surgical instrument provided by the present invention is an excising hook that resembles a shepherd&#39;s crook, as exemplified in  FIG. 37 . In a preferred embodiment, the excising hook is composed of an elongate shaft having a thickened proximal portion and a narrowed distal end that curves back on itself to form a circular hook. In a preferred embodiment, the circular hook is formed of suitable dielectric material and is sized to slidably fit within the U-shaped jaws of the bipolar coagulating device of the present invention. Likewise, the interior surfaces of the hook are suitably sharpened so as to cooperate with the cutting jaws of the bipolar coagulating device to thereby enable removal of a portion of uncoagulated tissue containing an excised length of the vas duct. 
     In another aspect, the surgical instrument provided by the present invention is an excising clamp in the form of a pair of eyelet forceps, such as exemplified in  FIG. 11 , that includes a proximal handle portion provided with a pair of “finger grips” or “finger holes” that drive a pair of hinged arms that, in turn, define the longitudinal axis of the device, and a ratchet mechanism that enables the hands-free maintenance of the arms, and their respective distal tissue-gripping portions, in a locked configuration. Disposed distally along the respective arms, past a pivoting hinge, the tissue-gripping portions of this novel, excising clamp comprise a pair of mating semi-circles that together circumscribe a small hole or eyelet that, in operation, becomes disposed about the portion of the vas duct being excised. As noted above, the distal end tissue-gripping portions are provided with sharpened interior edges that enable removal of an uncoagulated vas tissue through cooperative action with the cutting jaws of the bipolar coagulating device as described above. 
     In yet a further aspect, the surgical instrument provided by the present invention is an excising clamp in the form of a slidable assembly as illustrated in  FIG. 57 . In a preferred embodiment, the slidable clamp assembly is composed of two pieces, namely an elongate generally U-shaped clamp body and a slidable control ring, assembled into a single unit that is suitable for isolating and excising an uncoagulated portion of a vas duct. In the context of the present invention, the elongate clamp body is made up of a proximal handle portion that, proceeding distally, splits for form a pair of elongate movable pincer arms that take the form of two relatively parallel intermediate portions (upper and lower) that, in turn, terminate in opposed distal portions (upper and lower), each of which is provided a distal-most portion that takes the form of a symmetrically opposed jaw. Each opposed jaw is a mirror image of the other, or has an otherwise form complementary to the other, and includes a sharp distal tip projecting towards an interior surface of the assembly. 
     In a particularly preferred embodiment, the elongate clamp body further includes a pair of proximal stops, a first positioned along the exterior surface of the upper intermediate portion and a second positioned at an equivalent point along the exterior surface of the lower intermediate portion, and a pair of distal stops, a first positioned along the exterior surface of the upper distal portion and a second positioned at an equivalent point along the exterior surface of the lower distal portion, such that the spacing between the upper proximal and distal stops is identical to the spacing between the lower proximal and distal stops. 
     The afore-mentioned slidable control ring is provided with a central opening that allows it to be disposed about the periphery of the elongate body and slide along the spacing between respective proximal and distal stops. When the slidable control ring is positioned adjacent the proximal stops, in a proximal-most position, the opposed upper and lower distal jaws remain in the “open” (unclamped) configuration. However, distal movement of the slidable control ring forces the upper and lower distal portions to deflect inward, moving the respective sharp distal tips toward contact. When the slidable control ring encounters the distal stops, it arrives at a distal-most position in which the distal portions of the opposed distal jaws meet, i.e., are moved into close proximity, or optionally in contact close form a “closed” (clamped) configuration. 
     In a preferred embodiment, both the excising clamp body and slidable control ring are formed of a suitable dielectric material, preferably from a polymeric material by injection molding or other suitable process. 
     In yet another aspect, the surgical instrument provided by the present invention is forceps-like clamp as exemplified in  FIG. 86 . Similar to the eyelet clamp described above, this excising clamp resembles a pair of scissors or forceps, including a proximal handle portion provided with a pair of “finger grips” or “finger holes” that drive a pair of hinged blades that define the longitudinal axis of the device and a ratchet mechanism that enables the hands-free maintenance of the blades, and their respective distal jaw portions, in a locked configuration. Disposed distally along the respective blades, past a pivoting hinge, the jaws of this alternate excising clamp are preferably defined by two relatively parallel, planar, and laterally opposed portions (upper and lower), each of which is provided with a distal-most vertically opposed portion (upper and lower) that is relatively perpendicular to the longitudinal axis of the device. Upper and lower laterally opposed portions comprise symmetrical mirror images; likewise, upper and lower vertically opposed portions are also symmetrically disposed. In the context of the present invention, pivoting the hinged blades brings the upper and lower vertically opposed portions into contact, such that their respective terminal surfaces come into contact to form a sharp cutting edge. In the context of the present invention, the respective terminal surfaces (and corresponding cutting edges) may be planar, mirror-image serrated or complementary serrated. As in previously described embodiments, the sharpened surfaces of the excising clamp cooperate with the cutting jaws of the bipolar coagulating device to thereby enable removal of a portion of uncoagulated tissue containing an excised length of the vas duct. 
     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 minimize or preferably eliminate 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 significantly fewer 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 procedures of the present invention minimize or even avoid exposure to bodily fluids, which, in turn, significantly reduces risks of transmission of blood-born 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. 7  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. 8  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. 9  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. 10  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. 11  is a perspective view of an excising clamp of the present invention. 
         FIG. 12  is a side elevational view of the clamp of  FIG. 11 . 
         FIG. 13  is an expanded view of the clamp of  FIG. 11  at location A. 
         FIG. 14A  is an expanded view of the clamp of  FIG. 12  at location B. 
         FIG. 14B  is an expanded sectional view of the objects of  FIG. 14A  at location A-A. 
         FIG. 15  is an expanded plan view of the distal portion of the clamp of  FIG. 11 . 
         FIG. 16  is a plan view of a bipolar electrosurgical device of a vasectomy system of the present invention. 
         FIG. 17  is a side elevational view of the objects of  FIG. 16 . 
         FIG. 18  is a perspective view of the objects of  FIG. 16 . 
         FIG. 19A  is an expanded view of the objects of  FIG. 16  at location B. 
         FIG. 19B  is an expanded sectional view of the objects of  FIG. 19A  at location A-A. 
         FIG. 20  is an expanded view of the objects of  FIG. 18  at location A. 
         FIG. 21  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. 22  is a distal perspective view of the objects of  FIG. 21 . 
         FIG. 23  is a proximal perspective view of the objects of  FIG. 21 . 
         FIG. 24  is an expanded view of the objects of  FIG. 22  at location D. 
         FIG. 25  is an expanded view of the objects of  FIG. 23  at location E. 
         FIG. 26  depicts a surgical system including the bipolar electrosurgical device of  FIG. 16  connected to a suitable electrosurgical generator with optional foot pedal connected thereto for activation of the generator. 
         FIG. 27A  is a perspective diagrammatic view of an elongate tissue element captured within the excising clamp of  FIG. 11 , and clamped between the jaws of the bipolar electrosurgical device of  FIG. 16  as during use. 
         FIG. 27B  is an expanded view of the objects of  FIG. 27A  at location A. 
         FIG. 27C  is a plan view of the objects of  FIG. 27A . 
         FIG. 27D  is an expanded view of the objects of  FIG. 27C  at location B. 
         FIG. 27E  is an expanded sectional view of the objects of  FIG. 27D  at location B-B. 
         FIG. 27F  depicts the objects of  FIG. 27E , wherein RF energy is applied so as to coagulate tissue between the jaws of the electrosurgical device. 
         FIG. 27G  is a perspective view of the objects of  FIG. 27F , wherein the excising clamp has been moved downward so as to remove a portion of the elongate tissue element. 
         FIG. 27H  is an expanded view of the objects of  FIG. 27G  at location A. 
         FIG. 27I  is a plan view of the objects of  FIG. 27G   
         FIG. 27J  is an expanded view of the objects of  FIG. 27I  at location B. 
         FIG. 27K  is an expanded sectional view of the objects of  FIG. 27J  at location A-A. 
         FIG. 27L  is a sectional view of the elongate tissue element after coagulation and excision as previously described. 
         FIG. 27M  is a perspective view of the elongate tissue element of  FIG. 27L . 
         FIG. 28A  is a diagrammatic plan view of a portion of a scrotum with a vas deferens contained therein. 
         FIG. 28B  is a perspective view of the objects of  FIG. 28A . 
         FIG. 29A  is a plan view of an excising clamp of the present invention capturing the vas deferens of  FIG. 27  inside the scrotum of  FIG. 27 . 
         FIG. 29B  is an expanded view of the objects of  FIG. 29A  at location A. 
         FIG. 30A  depicts the objects of  FIG. 29A  with the vas duct delivered from the scrotum. 
         FIG. 30B  is an expanded view of the objects of  FIG. 30A  at location A. 
         FIG. 31A  depicts the objects of  FIG. 30A  with the captured vas duct clamped between the jaws of the bipolar coagulating device of the vasectomy system of the present invention. 
         FIG. 31B  is an expanded view of the objects of  FIG. 31A  at location A. 
         FIG. 32A  is a perspective view of the coagulated vas duct clamped between the jaws of the bipolar device with an uncoagulated portion of the duct removed by the excising clamp. 
         FIG. 32B  is a side elevational view of the objects of  FIG. 32A . 
         FIG. 33A  is a plan view of the scrotum and coagulated vas duct after removal of the bipolar coagulating device. 
         FIG. 33B  is a perspective view of the objects of  FIG. 33A . 
         FIG. 34  depicts the site after the vas duct is returned to the scrotum. 
         FIG. 35  is a plan view of an excising hook of the present invention. 
         FIG. 36  is a side elevational view of the objects of  FIG. 35 . 
         FIG. 37  is a perspective view of the objects of  FIG. 35 . 
         FIG. 38  is an expanded view of the objects of  FIG. 36  at location A. 
         FIG. 39  is an expanded view of the objects of  FIG. 37  at location B. 
         FIG. 40  is a plan view of a vas duct portion within a portion of scrotum. 
         FIG. 41  is a perspective view of the objects of  FIG. 40 . 
         FIG. 42  is a plan view depicting the vas duct and scrotum portion, wherein the duct portion is captured in the excising hook of  FIG. 35 . 
         FIG. 43  is an expanded view of the distal portion of the objects of  FIG. 42 . 
         FIG. 44  is a side elevational view of the objects of  FIG. 43 . 
         FIG. 45  is a perspective view of the objects of  FIG. 43 . 
         FIG. 46  is a side elevational view of the objects of  FIG. 42 , wherein a portion of the vas duct has been delivered from the scrotum. 
         FIG. 47  is an expanded view of the distal portion of the objects of  FIG. 46 . 
         FIG. 48  is a plan view of the objects of  FIG. 46 . 
         FIG. 49  is an expanded view of the distal portion of the objects of  FIG. 48 . 
         FIG. 50  is a perspective view of the objects of  FIG. 46 . 
         FIG. 51  is an expanded view of the distal portion of the objects of  FIG. 50 . 
         FIG. 52  is a side elevational view of the objects of  FIG. 46 , further wherein the vas duct portion external to the scrotum is clamped between the jaws of a bipolar coagulating device. 
         FIG. 53  is an expanded view of the distal portion of the objects of  FIG. 52 . 
         FIG. 54  is a plan view of the objects of  FIG. 52 . 
         FIG. 55  is an expanded view of the distal portion of the objects of  FIG. 54 . 
         FIG. 56  is a side elevational view of the objects of  FIG. 52 , further wherein an uncoagulated portion of the vas duct has been removed by the excising hook. 
         FIG. 57  is a plan view of an alternate embodiment for an excising clamp body in accordance with the present invention. 
         FIG. 58  is a side elevational view of the objects of  FIG. 57 . 
         FIG. 59  is a perspective view of the objects of  FIG. 57 . 
         FIG. 60  is an expanded view of the objects of  FIG. 58  at location A. 
         FIG. 61  is an expanded view of the objects of  FIG. 59  at location B. 
         FIG. 62  is a perspective view of an excising clamp ring in accordance with the present invention. 
         FIG. 63  is an axial view of the objects of  FIG. 62 . 
         FIG. 64  is a side elevational view of the objects of  FIG. 62 . 
         FIG. 65  is a plan view of an excising clamp in accordance with the present invention, formed of the clamp body of  FIG. 57  and the clamp ring of  FIG. 62  with the clamp in a first, open/unclamped condition. 
         FIG. 66  is a side elevational view of the objects of  FIG. 65 . 
         FIG. 67  is a perspective view of the objects of  FIG. 65 . 
         FIG. 68  is a plan view of the alternate excising clamp of  FIG. 65  in a second closed/clamped condition. 
         FIG. 69  is a side elevational view of the objects of  FIG. 68 . 
         FIG. 70  is a perspective view of the objects of  FIG. 68 . 
         FIG. 71  is an expanded view of the objects of  FIG. 69  at location A. 
         FIG. 72  is a plan view of a portion of a scrotum with a vas duct located in a fold thereof. 
         FIG. 73  is a perspective view of the objects of  FIG. 72 . 
         FIG. 74  is a perspective view of the alternate excising clamp of  FIG. 65  applied to the objects of  FIG. 72  so as to maintain the position of the vas duct in the fold of scrotal tissue. 
         FIG. 75  is an expanded view of the objects of  FIG. 74  at location A. 
         FIG. 76  is a plan view of the scrotum and clamp of  FIG. 75  positioned within the jaws of the electrosurgical device of  FIG. 16 . 
         FIG. 77  is an expanded view of the objects of  FIG. 76  at location A. 
         FIG. 78  is a perspective view of the objects of  FIG. 76 . 
         FIG. 79  is an expanded view of the objects of  FIG. 78  at location B. 
         FIG. 80  is a perspective view of the objects of  FIG. 76  wherein the excising clamp has been displaced downward so as to excise a portion of the vas duct. 
         FIG. 81  is an expanded view of the objects of  FIG. 80  at location B. 
         FIG. 82  is an expanded view of the objects of  FIG. 81  at location C. 
         FIG. 83  is a side elevational view of the objects of  FIG. 82 . 
         FIG. 84  is a plan view of the treatment site containing the occluded divided vas duct contained in a region of coagulated scrotal tissue. 
         FIG. 85  is a perspective view of the objects of  FIG. 84 . 
         FIG. 86  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. 87  is an expanded view of the objects of  FIG. 86  at location A. 
         FIG. 88  is a side elevational view of the objects of  FIG. 86 . 
         FIG. 89  is an expanded view of the objects of  FIG. 88  at location C. 
         FIG. 90  is a plan view of the objects of  FIG. 86 . 
         FIG. 91  is an expanded view of the objects of  FIG. 90  at location D. 
         FIG. 92  is a perspective view of the alternate excising clamp of  FIG. 86  in the open (unclamped) condition. 
         FIG. 93  is a side elevational view of the objects of  FIG. 92 . 
         FIG. 94  is an expanded view of the objects of  FIG. 92  at location A. 
         FIG. 95  is an expanded view of the objects of  FIG. 93  at location B. 
         FIG. 96  is a side elevational view of an excising clamp of the present invention analogous to that depicted in  FIG. 86  in which the jaws of the distal clamping portion (depicted in the closed (clamped) condition) are modified to include mirror-image serrations. 
         FIG. 97  is a perspective view of the alternative excising clamp of  FIG. 96  in which the modified jaws are depicted in the open (unclamped) condition. 
         FIG. 98  is a side elevational view of another excising clamp of the present invention analogous to that depicted in  FIG. 86  in which the jaws of the distal clamping portion (depicted in the closed (clamped) condition) are modified to include complementary serrations. 
         FIG. 99  is a perspective view of the alternate excising clamp of  FIG. 98  in which the modified jaws are depicted in the open (unclamped) condition. 
         FIG. 100  is a side elevational view of the distal portion of yet another excising clamp of the present invention analogous to that depicted in  FIG. 86  in which the jaws of the distal clamping portion (depicted in the closed (clamped) condition) are modified to include complementary cylindrical surfaces. 
         FIG. 101  is a perspective view of the alternate excising clamp of  FIG. 100  in which the modified jaws are depicted in the open (unclamped) condition. 
         FIG. 102  is a side elevational view of yet another excising clamp of the present invention analogous to that depicted in  FIG. 86  in which the jaws of the distal clamping portion (depicted in the closed (clamped) condition) are modified to include complementary beveled surfaces. 
         FIG. 103  is an expanded view of the objects of  FIG. 102  at location D. 
         FIG. 104  is a sectional view of the objects of  FIG. 103  at location A-A. 
         FIG. 105  is a perspective view of the objects of  FIG. 102  with the modified jaws of the clamp in an open (unclamped) condition. 
         FIG. 106  is an expanded view of the objects of  FIG. 105  at location E. 
         FIG. 107  is a perspective view of the clamp of  FIG. 2  positioned on a scrotum when coagulation of the site is completed according to the principles of the present invention. 
         FIG. 108  is an expanded view of the objects of  FIG. 107  at location A. 
         FIG. 109  is a perspective view of yet another excising clamp of the present invention analogous to that depicted in  FIG. 86  in which the distal clamping portion (with jaws depicted in the open (unclamped) condition) is modified to include low included angle edges. 
         FIG. 110  is an expanded view of the objects of  FIG. 107  at location F. 
     
    
    
     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. 
     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. 
     Reference is made herein to “an arcuate sealed area” that contains one or more portions of the vas duct and a portion of its surrounding sheath. This “arcuate” area is exemplary only and not meant to be limiting. The sealed area may have a variety of regular or irregular shapes. Any sealed area formed by bipolar jaws positioned distal to a clamp located on the vas duct within the sheath falls within the scope of this invention. The sealed region may be arcuate, linear, irregularly shaped, or a combination of linear and curvilinear segments. 
     In describing some embodiments of methods of the present invention reference is made to the placement of a clamp on the midline of a vas duct within a vas sheath. It will be understood that such placement is imprecise and the midline of the clamping surface need not be on the exact midline of the duct. So long as a portion of the clamping surface of the clamp is closed upon a middle portion of the vas duct while minimizing contact with the distal region of the sheath, the method falls within the scope of this invention. In other embodiments, a clamp is configured such that the distal clamping surfaces may be positioned distal to the vas duct within the vas sheath. In these embodiments the clamp distal portion and bipolar jaws of the sealing device are configured so as to minimize their effect on nerves located in the sheath distal to the vas duct and therefore fall within the scope of this invention. 
     In the context of present invention reference invention, the terms “coagulated” or “cauterized” are interchangeably 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 desiccated 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 vas tissue defined by the U-shaped jaws of the bipolar coagulating device and the arcuate area of clamped vas tissue contained therein is referred to as convex in shape. 
     In the context of the present invention, the terms “vas” and “vas deferens” are used interchangeably to refer to the coiled biological channel that conveys sperm from the epididymis to the ejaculatory duct and the urethra that is comprised of an inner tubular duct (i.e., the “vas duct”) and an outer muscular sheath (i.e., the “vas sheath”). 
     In the context of the present invention, the terms “duct” and “vas duct” are used interchangeably to refer to the interior channel of vas deferens that serves to as a conveyance for sperm. Likewise, the terms “sheath” and “vas sheath” are used interchangeably to refer to the amorphous muscular sheath that surrounds the vas duct and houses the bulk of the sensory nerves. 
     The instant invention makes reference to certain surgical instruments that are configured for both clamping tissue or capturing a vas duct and for excision as well. Such instruments, often referred to herein as “excising” or “excision” clamps or hooks, are designed for use in conjunction with the bipolar coagulating device of the present invention to facilitate the vasectomy methods of the present invention, namely, to position a vas duct within the jaws of the bipolar coagulating device, to maintain that position during coagulation, and thereafter to optionally divide the vas by excision. 
     In order to prevent shorting of the jaws of the bipolar coagulating device of the present invention, such clamping devices are formed from a dielectric material, typically a polymer or ceramic, or are formed of a metallic material and are covered with a dielectric coating. While specific embodiments are described herein, it should be understood that clamps having a wide variety of configurations may be used, including, for example, standard metal ring forceps and tenaculum 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, in the context of the present invention, nerves in the sealed region and closely adjacent thereto are destroyed or deadened by a process known as RF neurotomy so as to reduce the probability of post procedure pain. In addition, in those embodiments that avoid 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 for 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 reduce exposure to bodily fluids, which, in turn, reduces the 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”) 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). Steps of a typical prior-art NSV wherein a vas duct is occluded are depicted in  FIGS. 1 through 10 . In  FIG. 1 , a vas duct  20  is located in scrotum  10  using a standard technique. Thereafter, a local anesthetic is injected at the site. Duct  20  is then located 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. 7 , 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. 8 . In  FIG. 9 , 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. 9 . 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. 10  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, the NSV procedure has 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. 
     Devices and methods of the present invention enable a clinician to perform an NSV procedure in less time and with a decreased likelihood of complications. To that end, 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 devices and methods of the present invention, these three tasks may be accomplished in a single step. Namely, the vas duct and its surrounding sheath are captured in an excising clamp or excising hook of the present invention and delivered from the scrotum. While remaining contained and isolated in the clamp or hook, the duct and its surrounding sheath are grasped between the jaws of a modified version of a bipolar coagulating device such as described in U.S. Pat. Nos. 8,220,464 and 8,561,615, the contents of which are enumerated and incorporated above, and sealed using RF energy. Thereafter, the duct is divided by excision using one of the novel excising clamps or excising hooks of the present invention or another surgical instrument before releasing the jaws of the coagulating device. In contrast with the conventional art-accepted NSV technique, stripping of the vas sheath, occlusion of the duct by cautery or ligation, and creating fascial interpositioning of the sheath as discrete steps by the surgeon are not required. 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. 
     The inventive method and novel excising clamps and hooks are now described. To that end, a first iteration of an excising clamp  100  of the present invention is depicted in  FIGS. 11 through 15 . Excising clamp  100  has a first element  102  with a proximal handle portion  104  and a distal portion  106 , and a second element  122  with a proximal handle portion  124  and a distal portion  126 , elements  102  and  122  being rotatably affixed by element  101 . First element  102  has formed near its proximal end first ratchet portion  118 . Second element  122  has formed near its proximal end second ratchet portion  138 . Ratchet elements  118  and  138  cooperatively, when engaged, maintain closure and tension of clamp  100  during use. Distal portion  106  of first element  102  has formed at its distal end arcuate first jaw  108 . Distal portion  126  of second element  120  has formed at its distal end arcuate second jaw  128 . When in the closed position, inner surfaces  110  and  130  of jaws  108  and  128  respectively circumscribe eyelet  103  proximal to jaws  108  and  128 . Laterally opposed planar surfaces  115  of lower jaw  108  and  135  of upper jaw  128  intersect with surfaces  110  and  130  respectively to form sharp edges perimetral to opening  103  (see  FIG. 14B ). When viewed in plan view, as in  FIG. 15 , jaws  108  and  128  together with proximally adjacent portions of distal portions  106  and  126  have width  116 . Excising clamp  100  is formed of a suitable dielectric material. In a preferred embodiment, clamp  100  is formed of a polymeric material formed by injection molding. 
     Excising clamp  100  is configured for removal of an uncoagulated tissue portion by cooperative action of clamp  100  and the jaws of a bipolar coagulating device configured for this purpose. The bipolar coagulating device (handpiece)  400  of the present invention depicted in  FIGS. 16 through 20  with the jaws in a first, clamped position is substantially similar to the equivalent electrosurgical device described in U.S. Pat. No. 8,561,615 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 while minimizing thermal damage to adjacent tissue. 
     As best seen in the close-up views of  FIGS. 18-20 and 22-23 , 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. 19A , 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. 19B , the U-portions of jaws  408  and  428  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 . Edge  405  formed by the intersection of surface  407  of jaw  408  with the circumferential surface of slot  409  is sharp so as to allow edge  405  to cut tissue. Edge  425  formed by the intersection of surface  427  of jaw  428  with the circumferential surface of slot  429  is also sharp so as to allow edge  425  to cut tissue. Width  480  of slots  409  and  429  is slightly greater than width  116  of distal portions  106  and  126  of excising clamp  100  (see  FIG. 15 ). In a preferred embodiment, each offset central slot defined by each “U-shaped” distal portion is approximately 1-3 mm in width and is further provided with an interior sharp edge, radiused lateral portions, and a relatively planar exterior surface; when brought into contact, in a closed configuration, the respective upper and lower sharp edges together form the cutting surface of the surgical jaws. The distal portion of handpiece  400  with handpiece  400  in its second (unclamped) position is depicted in  FIGS. 21 through 25 . Jaws  408  and  428  are formed of a stainless steel or other suitable metallic material. 
       FIG. 26  depicts bipolar coagulating device  400  connected by cable  440  to the bipolar outputs of electrosurgical generator  13  for use. 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 a preferred embodiment, generator  13  monitors the impedance of the tissue between jaws  408  and  428  of coagulating device  400  during activation, the impedance increasing as coagulation of the tissue proceeds. When the impedance reaches a preset value indicating that a predetermined level of coagulation has been reached, generator  13  is automatically deactivated or, alternatively, an audible signal is given to indicate to the surgeon that coagulation is complete so that the surgeon may terminate activation. In other embodiments, the surgeon determines when coagulation is complete and physically deactivates the generator by releasing foot pedal  15 . In some preferred embodiments, generator  13  has an algorithm that modulates the power output of generator  13  to achieve effective coagulation without charring the tissue. In other embodiments, the power output of generator  13  is determined by the surgeon. In still other embodiments the generator measures the initial impedance of tissue clamped between jaws  408  and  428 . If the impedance falls within a predetermined acceptable range, the generator may automatically activate after a predetermined time delay and terminate activation when a predetermined impedance value is reached. In these embodiments foot pedal  15  is eliminated. 
     Excising clamp  100  and coagulating device  400  work together to occlude a generally tubular tissue structure by means of coagulation and to subsequently excise a portion of the tissue structure. In use, an elongate tissue structure is captured by clamp  100 , locally coagulated by coagulating device  400 , and thereafter a portion of the tissue is excised by clamp  100 . A preferred method of cooperative use of excising clamp  100  and bipolar coagulating device  400  is hereafter described. 
       FIGS. 27A through 27E  depict an elongate tissue element  70  captured within eyelet  103  of jaws  108  and  128  of clamp  100  (see  FIG. 14A ). As best seen in  FIG. 27E , jaws  108  and  128  with tissue element  70  captured therein are positioned within slots  409  and  429  of jaws  408  and  428  respectively of bipolar coagulating device  400 , with jaws  408  and  428  clamped on tissue element  70  lateral to jaws  108  and  128  of clamp  100 . In  FIG. 27F , generator  13  has been activated causing radio frequency energy indicated by arrows to flow between jaws  408  and  428  of bipolar coagulating device  400 . This energy flow and pressure applied by jaws  408  and  428  causes coagulation of portions  73  of elongate tissue element  70  clamped between jaws  408  and  428  of coagulating device  400 . When RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse the walls of the tubular tissue element  70 , thereby forming a permanent seal. 
     In  FIGS. 27G through 27K , clamp  100  has been displaced downward relative to jaws  408  and  428  of coagulating device  400  so as to excise portion  71  of tissue element  70 . Referring to  FIG. 27K , the intersections of surface  130  with lateral surfaces  135  form cutting edges on excising clamp  100  at eyelet  103 . Similarly, the intersection of surface  407  with the surface of slot  409  of jaw  408  forms cutting edge  405  that surrounds slot  409  of coagulating device  400 . Portion  71  is excised from elongate tissue element  70  by the cooperative cutting action of the previously described cutting edges of clamp  100  and coagulating device  400 . Jaw  428  of coagulating device  400  and jaw  108  of clamp  100  each have cutting edges symmetrically opposed to those of the opposing jaw on their particular device so that excision of portion  71  may alternatively be accomplished by upward relative movement of clamp  100  relative to coagulating device  400 . Because the cutting edges formed on jaws  408  and  428  of coagulating device  400  are planar, and edges of jaws  108  and  128  of excising clamp  100  have a curvilinear profile, a shearing action occurs as a cutting edge of clamp  100  passes by a cutting edge of coagulating device  400 . Portion  71  of elongate tissue element  70  is not coagulated. 
       FIGS. 27L and 27M  depict elongate tissue element  70  at the completion of the procedure previously described. Element  70  has been divided and the ends created sealed by coagulation. Coagulated regions  73  occlude the lumen, and dividing tubular element  70  by excision of portion  71  permanently prevents flow through tubular element  70 . 
     Bipolar tissue sealing and cutting devices are well known in the art. Typical of these is the LigaSure™ Vessel Sealing System by Covidien, Inc (Boulder, Colo.). Therein, a pair of bipolar jaws is used to coagulate tissue clamped between them. When coagulation is complete, a cutting element is distally extended in a groove formed in the jaws to divide the vessel through the middle of the coagulated region. The sealing and excision method and devices of the present invention differ from those of prior art vessel sealing and cutting systems in that a tissue portion is excised to divide the structure, the excised portion being made up of uncoagulated tissue. Also, excision of the uncoagulated tissue portion is accomplished by a second device, one that is particularly adapted to receive, isolate and excise a tubular tissue as opposed to by the coagulating device per se. In the novel methods of the present invention, an excising clamp of the present invention excises an uncoagulated tissue portion through a cooperative cutting action between cutting edges formed on the excising clamp and the jaws of the bipolar coagulating device. In further contrast to prior art seal and cut devices, which tend to be poorly suited for vasectomy applications, the novel methods of the present invention enable delivery of the vas duct from the scrotum so that coagulation and separation of the duct can be directly observed and avoid the unnecessarily complex and inconvenient manipulation and exchanging of devices by the surgeon. 
     Use of devices and methods of the present invention for occluding and dividing by excision a tubular tissue element are hereinafter described as they relate to performing a vasectomy. 
       FIGS. 28A and 28B  diagrammatically depict a vas duct  20  positioned within a fold of scrotum  10 . Vas duct  20  is located in scrotum  10  using the standard “three-finger” technique used for no scalpel vasectomy (NSV) procedures. Thereafter, a local anesthetic is introduced and an opening formed in scrotum  10  using a dissecting forceps, both in the same manner as for a standard NSV. Then, as depicted in  FIGS. 29A and 29B , distal portion of clamp  100  is inserted into scrotum  10  so as to capture duct  20  in eyelet  103  formed by jaws  108  and  128  of clamp  100  (see  FIG. 14A ). In  FIGS. 30A through 31B , excising clamp  100  has delivered vas  20  from scrotum  10  with portion  26  of duct  20  retained within eyelet  103  of clamp  100  in the manner previously described using tubular tissue element  70 . The clinician may, optionally, grasp the vas after forming the opening in the scrotum with the dissecting forceps or another device to position the vas for capture by clamp  100 . Thereafter, jaws  408  and  428  are positioned about jaws  108  and  128  of clamp  100  as depicted in  FIGS. 31A and 31B , portion  26  of duct  20  being clamped between jaws  408  and  428  as previously described and shown in  FIGS. 27A through 27E  using tubular tissue element  70 . Radio Frequency energy is then supplied by electrosurgical generator  130  via cable  440  to jaws  408  and  428  so as to coagulate portions of portion  26  of vas duct  20  clamped between jaws  408  and  428 . When coagulation is complete, clamp  100  is moved downward relative to coagulating device  400  so as to excise duct portion  27  retained within eyelet  103  of clamp  100  as shown in  FIGS. 32A and 32B . Jaws  428  and  408  are then unclamped from vas portion  26  and removed.  FIGS. 33A and 33B  depict scrotum  10  and duct  20  prior to returning the divided duct  20  to scrotum  10 . Coagulated end portions  28  of duct portion  26  occlude the vas duct, and also seal the occluded duct ends within the coagulated ends of the vas sheath so as to provide fascial interposition.  FIG. 34  depicts vas  20  with occluded coagulated ends  28  returned to scrotum  10 . The procedure is repeated on the second vas duct to complete the vasectomy. Occlusion of the two ducts may be accomplished through a single opening or through two openings depending on the surgeon&#39;s preference. Optionally the surgeon may excise duct portion  27  after coagulation using a third conventional cutting instrument such as, for instance, a scalpel, dissecting forceps, scissors, biopsy punch, or other surgical device. 
     In an alternate embodiment, the procedure of the present invention for occluding a vas duct may be modified such that the excising clamp  100  is replaced by an excising hook  200  of the present invention. Referring to  FIGS. 35 through 39 , excising hook  200  has a proximal handle portion  202  and an elongate distal portion  204  with a distal end portion  206 . Distal end portion  206  has parallel planar lateral surfaces  212  spaced distance  214  apart, distance  214  being slightly less than width  480  of slots  409  and  429  of jaws  408  and  428  of bipolar device  400  (see  FIG. 19A ). Distal hook portion  208  has an inner surface perpendicular to lateral surfaces  212  so as to form a sharp edge. Hook  200  is formed of a suitable dielectric material, either polymeric or ceramic. In a preferred embodiment, distal portion  204  is formed of a ceramic material and handle portion  202  is formed of a polymeric material. 
     In this alternative method of the present invention for occluding and dividing a vas duct, excising hook  200  and bipolar coagulating device  400  are used in the same manner as previously described with respect to excising clamp  100  and coagulating device  400  except as subsequently specifically described.  FIGS. 40 and 41  depict vas duct  20  located within a fold of scrotum  10 , duct  20  being positioned therein and the region injected with a local anesthetic using standard NSV methods. An opening is then formed in scrotum  10  proximate to duct  20  using a dissecting forceps in the usual manner. Thereafter, as shown in  FIGS. 42 through 45 , distal portion  206  of excising hook  200  is inserted into scrotum  10  through the opening formed therein and duct  20  is captured in distal hook portion  208 . The clinician may, optionally, grasp the vas after forming the opening in the scrotum with the dissecting forceps or another device to position the vas for capture by hook  200 . Handle  202  of excising hook  200  is then pivoted downward and proximal so as to deliver duct  20  from scrotum  10  as depicted in  FIGS. 46 to 51 . Portion  26  of vas duct  20  remains captured within hook portion  208  of excising hook  200 . Jaws  408  and  428  of coagulating device  400  are then positioned about hook portion  208  of excising hook  200  and clamped onto portion  26  of vas duct  200  as depicted in  FIGS. 52 through 55 . Radio frequency energy supplied to jaws  408  and  428  of coagulating device  400  by electrosurgical generator  13  along with pressure applied by jaws  408  and  428  coagulates portions of duct portion  26  clamped between the jaws in the manner previously described so as to occlude duct portion  26 . After coagulation is complete, excising hook  204  is displaced downward relative to jaws  408  and  428  of coagulating device  400  so as to excise an uncoagulated duct portion  27  from the coagulated portions of duct portion  26  clamped between jaws  408  and  428  to divide duct  20 . Excision is accomplished through cooperative action of the cutting edges formed between surface  210  and lateral surfaces  212  of excising clamp  200 , and the cutting edge  403  of jaw  408  (see  FIG. 27K ). Thereafter jaws  408  and  428  are unclamped from the coagulated portions of duct portion  26  and the occluded portions of duct  20  are returned to scrotum  10 . The second vas duct is then occluded in the same manner to complete the procedure. 
     In NSV methods, including the inventive versions described herein, vas ducts are delivered from the scrotum for occlusion and division. In an alternate embodiment, the modified vasectomy methods of the present invention that utilize the novel devices of the present invention avoid the need for the vas duct to be delivered from the scrotum, but rather allow it to remain positioned within a fold of scrotal skin and occluded and divided in situ, without dissection from the scrotum. In this manner, no openings are formed in the scrotum. Because there is no dissection, hematomas are wholly prevented. Likewise, as no sharp instruments are used, the risk to the clinician when performing a vasectomy on a HIV+ patient is substantially reduced. As with the previously described embodiments, excision is accomplished by an excising clamp of the present invention in cooperation with the jaws of bipolar coagulating device  400 .  FIGS. 57 through 61  depict a body  301  for an alternate embodiment excising clamp of the present invention. Body  301  has a proximal handle portion  302  and upper and lower distally extending portions  304 . Portions  304  have proximal parallel portions  306  whereon are positioned proximal stops  308 , distal parallel portions  312  with distal stop  313  at their distal ends, and angled portions  310  positioned between proximal and distal parallel portions  306  and  312 . Distal portions  314  of thickness  316  have distal-most portions forming opposed jaws  318  with symmetrically opposed faces  320 , and adjacent symmetrically opposed faces  322 . The edges between surfaces  320  and  322  and the laterally opposed faces  315  of distal portions  314  are orthogonal and have minimum edge radii. 
     Referring now to  FIGS. 62 through 64  depicting a control ring  360  for an excising clamp of the present invention, ring  360  has a central opening  362  configured to be slidably received on the proximal parallel portions  306  of distally extending portions  304  of body  300 . 
     Excising clamp body  301  and ring  360  are formed of a suitable dielectric material. In a preferred embodiment body  100  and ring  200  are formed of a polymeric material by injection molding or other suitable process. 
     Excising clamp  300  of the present invention is depicted in its open (unclamped) position in  FIGS. 65 through 67 . Ring  360  is positioned on proximal parallel portions  306  of distally extending portions  304  of body  301 , distal to proximal stops  308 . In an unconstrained condition, stops  308  protrude beyond the upper and lower surfaces of opening  362  in ring  360 , ring  360  being moved distal to stops  308  by deflecting distally extending portions  304  inward. Surfaces  320  of jaws  318  are separated by distance  324  in the unclamped condition depicted. 
     Clamping tissue between opposed surfaces  320  of clamp body  301  is accomplished by moving ring  360  distally over angled portions  310  of clamp body  301  so as to deflect distally extending portions  304  toward each other as depicted in  FIGS. 68 to 71 . Ring  360  is moved distally until it reaches distal parallel portions  312  encountering distal stop  313 . In this closed position, opposed faces  320  are in close proximity to each other, or optionally may be in contact. 
     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. 72 and 73  wherein duct  20  is located in a fold of scrotal skin  10 . In  FIGS. 74 and 75 , clamp  300  is applied to the fold of scrotal skin  10  with jaws  318  medial to duct  20  so as to maintain the position of duct  20  in the fold, and ring  360  is advanced to its distal position so as to close jaws  318  on the tissue. Thereafter, upper and lower jaws  408  and  428  of handpiece  400  are positioned around distal portion  314  of clamp body  301  of clamp  300  and handpiece  400  is closed so as to apply compressive force to the tissue between jaws  408  and  428  as shown in  FIGS. 76 through 79 . The clamping force may be maintained by ratchet element  430  of lower handle assembly  422 . Subsequently RF energy from electrosurgical generator  13  ( FIG. 26 ) 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, clamp  300  is moved relative to jaws  408  and  428  so that the central uncoagulated tissue portion  30  containing scrotal skin  10  and a portion of vas duct  20  is removed as depicted in  FIGS. 80 and 81 . Tissue portion  30  is removed by cooperative cutting action between an edge of clamp  300  and an edge of lower jaw  408 . Specifically, the clamp cutting edge is formed by the intersection of surfaces  320  and  322  with lateral surfaces  315  of the upper distal portion  314  of clamp body  301 . The handpiece jaw cutting edge is edge  411  of lower jaw  404 . As clamp  300  is moved downward relative to coagulating device or “handpiece”  400  as depicted in  FIGS. 80 and 81 , initially tissue trapped between surfaces  320  is cut by the portion of edge  411  of jaw  404  in the distal radius of edge  411  adjacent to surface  320  of clamp body  300 . Thereafter, as downward motion of clamp  300  continues, tissue trapped between the clamp cutting edge formed by the intersection of surface  322  with lateral surfaces  315  of upper distal portion  314  of clamp  300  and the linear portions of edge  411  of lower jaw  404  is cut.  FIGS. 80 and 81  depict handpiece  400  and clamp  300  with the uncoagulated tissue portion  30  after removal of portion  30 . 
     Optionally the surgeon may excise uncoagulated tissue portion  30  after coagulation using a third conventional cutting instrument such as, for instance, a scalpel, dissecting forceps, scissors, biopsy punch, or other surgical device. 
     Referring now to  FIGS. 82 and 83 , tissue portion  30  contains a segment of vas duct  20  comprising the duct and sheath wrapped in a portion of scrotal tissue  10 . By examining removed tissue portion  30  under magnification, the clinician can verify that the procedure was successful through visualization of vas duct segment  20  within removed tissue portion  30 . 
     After coagulation of the site and removal of tissue portion  30 , ratchet  430  is disengaged so as to remove the clamping pressure from jaws  408  and  428  of handpiece  400 . The handpiece  400  is then opened and removed. Thereafter the site is as depicted in  FIGS. 84 and 85 . Region  12  contains coagulated scrotal tissue  10  and coagulated vas duct  20 . Coagulated region  12  surrounds slot  14  wherein uncoagulated portion  30  was previously excised. 
     Vas duct  20  is coagulated along with its surrounding sheath so to provide fascial interposition sealing of duct  20  during healing. 
     In the above described embodiment, excising clamp  300  is moved into a clamped (closed) position by advancing control ring  360  to a distal position, clamp body  301  having a unitary construction with resilient distally extending portions  306 . However, in other embodiments of excising clamps of the present invention, the clamp may be formed of two pivotably joined elements in the manner of clamp  100  ( FIGS. 12 through 15 ). Such an alternate embodiment is depicted in  FIGS. 86 through 95 , wherein excising 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. 91 ) that is slightly less than width  480  of slots  429  and  409  of jaws  428  and  408  respectively (see  FIGS. 19A and 19B ). 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 . The juncture of laterally opposed surfaces  715  and the distal surface joining them with vertically opposed surfaces  720  and surfaces  722  of elements  740  form a cutting edge in the same manner as the corresponding features of clamp  300 . Clamp  700  is used in the same manner as clamp  300  and performs the same functions. 
     In use, clamp  700  maintains the position of duct  20  within fold of scrotal tissue  10  as depicted in  FIGS. 74 and 75 , with closure of clamp  700  being maintained by cooperative action of ratchet features  744  of elements  740 . Thereafter, jaws  408  and  428  of device  400  are positioned around distal portions  714  of clamp  700  in the same manner as depicted with portions  314  of clamp  300  in  FIGS. 76 through 79 . When coagulation is complete, tissue portion  30  ( FIGS. 80 and 81 ) is removed by clamp  700  in the same manner as depicted using clamp  300 . Cutting edges of distal portions  714  in cooperation with cutting edges of jaws  408  and  428  of coagulating device  400  separate tissue portion  30  from the surrounding coagulated tissue trapped between jaws  408  and  428 . 
     While vertically opposed surfaces  720  of distal portions  714  of clamp  700  are depicted as planar, in other alternate embodiments of the present invention serrations may be formed on surface to aid in maintaining the location of jaws  718  when clamping scrotal tissue, and to aid in cutting tissue portion  30  from the surrounding coagulating tissue. For instance, excising clamp  500 , the distal portion of which is depicted in  FIGS. 96 and 97 , is identical in all aspects of form and function to excising clamp  700  except as specifically subsequently herein described. Vertically opposed surfaces  520  of clamp  500  have formed thereon serrations, the serrations on a first surface  520  being a mirror of the serrations on the opposing, second surface  520 . 
     Another embodiment of an excising clamp  600  in accordance with the present invention is depicted in  FIGS. 98 and 99  and is identical in all aspects of form and function to clamp  700  except as specifically subsequently described. Vertically opposed surfaces  620  of clamp  600  have formed thereon serrations, the serrations on a first surface  520  being complementary to the serrations on the opposing, second surface  520 . Another alternate embodiment excising clamp  800  is identical in all aspects to previously described clamp  700  in form and function except that vertically opposed surfaces  820  are configured as complementary cylindrical surfaces. Indeed, the vertically opposed clamping surfaces of excising clamps of the present invention may be optimized for the dual functions of clamping tissue so as to maintain the position of a vas duct in a fold of scrotal skin, and of subsequently excising a tissue portion that is confined within the jaws of a coagulating device. These clamping surfaces may be planar, may have serrations formed thereon, may have a cylindrical surface formed thereon, or may have a combination of these features. Cross-sections of these surfaces may include linear, radial or curvilinear shapes. All fall within the scope of the present invention. 
     In excising clamps of the present invention previously described herein, opposed surfaces  820  of clamp  800  are indicated as perpendicular to lateral surfaces  815 , with surfaces  720  of clamp  700  being perpendicular to lateral surfaces  715 , and surfaces  620  of clamp  600  being perpendicular to lateral surfaces  615 . However, in an alternate embodiment of the present invention, low included angle cutting edges may be formed on the upper opposed clamping surface to aid in tissue dissection. Referring now to  FIGS. 102 through 106  depicting the distal portion of such an alternate excising clamp  900 , upper opposed surface  920  is not planar like lower opposed surface  920 , but rather has formed thereon beveled edges  921  with included angle  919 . Beveled edges  921  extend around the distal radius of upper opposed surface  920  so that a continuous cutting edge is formed. Angle  919  is preferably between 10 and 80 degrees, and more preferably between 20 and 60 degrees. Excising clamp  900  may be used in the same manner as those previously herein described, that is, to maintain the position of the vas duct in a fold of scrotal tissue, to provide a guide for positioning of the jaws of handpiece  400 , and to excise the uncoagulated tissue portion from the site when coagulation is complete. Because low included angle edges  921  are formed on upper opposed surface  920 , clamp  900  may optionally be used to excise the uncoagulated tissue portion from the site when coagulation is complete without cooperative interaction with jaws  408  and  428  of device  400 . That is, jaws  408  and  428  may be unclamped and device  400  may be removed from the site when coagulation is complete. Thereafter, the site is as depicted in  FIGS. 107 and 108  wherein clamp jaws  1018  are positioned on scrotum portion  10 . Uncoagulated tissue portion  19  is surrounded by arcuate coagulated region  12 , the opposing sharp inner edges of jaws  408  and  428  creating a sharp margin  17  between uncoagulated tissue portion  19  and surrounding coagulated region  12 . When clamp  900  is moved downward and proximally edges  921  of upper opposed clamping surface  920  initiate dividing of the tissue along margin  17  so that uncoagulated portion  19  is removed from the site. Thereafter the site is as previously depicted in  FIGS. 84 and 85 . In an alternate embodiment, shown in  FIGS. 109 and 110 , low included angle edges  1023  are formed on a distal portion of surface  1022  of the upper jaw  1014  of clamp  1000  to aid in excising portion  19  from coagulated region  12 . 
     INDUSTRIAL APPLICABILITY 
     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. 
     As noted previously herein, the vasectomy device, kit and method for performing vasectomies of the present invention overcome disadvantages and deficiencies of conventional vasectomy materials and methods by providing a rapid, reliable, less invasive male sterilization procedure that reduces or eliminates negative side effects, including swelling and spontaneous regeneration, and minimizes recovery time and recovery restrictions. It further avoids or minimizes the potential for 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 device and 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 instruments, kit and method of the instant invention may be advantageously used for family planning 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.