Patent Publication Number: US-11648010-B2

Title: Apparatus for irrigating the vas deferens

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 15/512,821 filed Mar. 20, 2017, now allowed, which is a U.S. National Stage Entry of PCT Application Serial No. PCT/US2015/053578 filed Oct. 1, 2015, which claims the benefit of U.S. Provisional Application No. 62/062,059 filed Oct. 9, 2014, which are incorporated by reference. 
    
    
     FIELD 
     This invention relates generally to surgical instruments and, more particularly, to surgical instruments useful in techniques for the anastomosis of the vas deferens, i.e., vasectomy reversal or vasovasostomy. 
     BACKGROUND 
     Vasectomies are performed on millions of men worldwide annually. For example, approximately 500,000 vasectomies are performed each year in the United States alone. Of those men that receive vasectomies, approximately five percent of such men subsequently choose to have their vasectomies reversed. Vasectomies generally involve altering the human male anatomy such that sperm cells are unable to mix with seminal fluid. 
     In a human male, sperm cells are created in the testicles. The sperm cells migrate from the testicles to the epididymis, a long, coiled tube that connects the testicles to the vas deferens. At the time sperm cells enter the epididymis, they are unable to fertilize an egg without assistance. However, the sperm cells mature as they travel through the epididymis and exit the epididymis capable of fertilizing an egg. Mature sperm cells enter the vas deferens from the epididymis and flow through the vas deferens to the seminal vessel. There, the sperm can enter seminal fluid which can then enter a human female and fertilize an egg. 
     To prevent fertilization, or for any other reason, some men choose to have a vasectomy performed. To perform a vasectomy, a surgeon typically creates an opening in the scrotum using either a scalpel or some other suitable means, and exposes the vas deferens. The vas deferens is then cut or separated and the two resulting open portions of the vas deferens are sealed. For example, each side of the separated vas deferens may be sealed using sutures or cauterization. 
     The vas deferens is severed to prevent sperm exiting the epididymis from flowing through the vas deferens and ultimately becoming part of the seminal fluid. In this way, any seminal fluid exiting the human male will lack sperm. If seminal fluid does not contain sperm, fertilization cannot take place using traditional means. Therefore, vasectomies can be effective birth control procedures. However, some men wish to reverse a successful vasectomy and restore normal sperm flow. 
     Generally, two different types of surgeries, or repairs, exist to reverse vasectomies. Whichever surgery is used, the purpose of the surgery is to reestablish the flow of sperm cells from the testicle through the vas deferens. The first repair involves reconnecting the disconnected portions of the vas deferens created by the vasectomy. The second repair is more complicated than the first repair and requires the vas deferens to be reconnected directly to the epididymis instead of the other portion of the vas deferens created by the original vasectomy. Thus, a portion of the vas deferens is bypassed in the second repair. 
     The first repair is generally preferred because of the differences in size and composition between the vas deferens and the epididymis. The vas deferens is relatively tough and about 3 millimeters in diameter. In contrast, the epididymis is relatively fragile and roughly 0.3 millimeters in diameter. Thus, it is generally easier to surgically reconnect two different portions of the vas deferens than to connect the vas deferens to a portion of the epididymis. 
     Although the first repair is generally preferred, sometimes the second repair is required. For a variety of reasons, after a vasectomy is performed, obstructions can occur in either the epididymis or the vas deferens. For example, the sperm that are unable to migrate through the vas deferens can form an obstruction, or sperm plug, in either the epididymis or in the portion of the vas deferens still in fluid communication with the testicles. One indication that sperm have formed a sperm plug is the observation that vasal fluid has small clumps of solid material within the fluid. 
     The second repair, sometimes called epididymal bypass surgery, is much more expensive and complicated than the first repair. The second repair can last about an hour and can require an epidural or a general anesthetic. In contrast, the first repair can require only a local anesthetic and lasts a significantly shorter amount of time. 
     In addition to the greater complexity of the procedure, the second repair is generally less successful than the first repair. Published studies since the 1980&#39;s report sperm return in only 60% to 68% of patients and pregnancy rates in about 25% to 57% of patients. Both ranges are lower than the rates for the first repair. Therefore, if a nonsurgical solution could be found for those patients that had in the past required the second repair, patients could be saved the pain, expense and potential complications associated with the second repair. 
     BRIEF SUMMARY 
     In part, the present application relates to an apparatus for irrigating the vas deferens of a patient in connection with a vasectomy reversal. The apparatus comprises a fluid delivery device having a first portion that connects to the vas deferens. The fluid delivery device connects such that a catheter tip inserts into the vas deferens and is held in stable position relative thereto and such that fluid enters the vas deferens through the catheter tip. In some instances, the apparatus can have a fluid delivery device having a first portion that attaches to the adventitia or surrounding connective tissue of the vas deferens. 
     In some embodiments, the fluid delivery device comprises a catheter assembly, a clamp and a stabilizing bar. The catheter assembly has a first end suitable for connection to a fluid reservoir and terminates at a second end in the catheter tip, which is configured for insertion into the vas deferens. The clamp is configured to clasp around the vas deferens when the catheter tip is positioned within the vas deferens. The clamp and the catheter tip form part of the first portion of the fluid delivery system. The stabilizing bar is connected to the clamp and the catheter assembly such that the clamp and the catheter assembly are held in stable position relative to each other. 
     In certain embodiments, the clamp has a first interactive tip and a second interactive tip. The first interactive tip and the second interactive tip are shaped to clasp around the vas deferens when the catheter tip is positioned within the vas deferens. The first interactive tip and the second interactive tip can interact to secure the catheter tip in the vas deferens during introduction of a fluid from the catheter to the vas deferens. Further, the first interactive tip and the second interactive tip can interact to secure the catheter tip in the vas deferens during breaking up of an obstruction in the vas deferens by the introduction of the fluid. Additionally, at least one of the first interactive tip and the second interactive tip can have a hook portion which attaches to the adventitia of the vas deferens when the first interactive tip and the second interactive tip clasp around the vas deferens. 
     In some embodiments, the clamp further comprises a first arm and a second arm. The first arm can comprise the first interactive tip and the second arm can comprise the second interactive tip. The first arm and the second arm can be connected so that the first interactive tip and the second interactive tip can be pressed towards one another. Additionally, the first arm and the second arm can be connected so as to resiliently bias the first interactive tip and the second interactive tip towards one another. 
     In certain embodiments, the fluid delivery device further comprises a base supporting the catheter assembly. A first end of the stabilizing bar can be connected to the base and a second end of the stabilizing bar can be connected to the clamp. The base can be a closed-end forceps clamp. The forceps clamp can have a handle end and a clamp end with the first end of the stabilizing bar connected to the clamp end. 
     In some embodiments, the fluid delivery device further comprises a fluid reservoir. The fluid reservoir is configured to hold and release a fluid to the catheter assembly. 
     The apparatus can comprise a catheter assembly, itself comprising a catheter tip. The apparatus can further comprise a clamp. The clamp can further comprise a first arm and a second arm wherein the first arm and the second arm each further comprise a first interactive tip and a second interactive tip, respectively. The first and second interactive tips can be shaped so as to be able to clasp around the catheter tip and the vas deferens. Additionally, the apparatus can comprise a stabilization bar. The stabilization bar is connected to the catheter assembly and the clamp to allow the first and second interactive tips of the clamp to close around the catheter tip or the vas deferens. 
     In another embodiment, the apparatus further includes a fluid reservoir. The fluid reservoir is capable of holding and releasing a fluid to the catheter assembly. The catheter assembly is capable of conveying the fluid into the vas deferens. 
     In another embodiment, the apparatus described in the present application is adapted for irrigating the vas deferens in connection with a vasectomy reversal. The apparatus comprises a catheter assembly having a first end suitable for connection to a fluid reservoir and terminating at a second end in a catheter tip suitable for insertion into a vas deferens. The apparatus further comprises a clamp having a first interactive tip and a second interactive tip where the tips interact to secure the catheter tip in the vas deferens during breaking up of the obstruction. The apparatus further comprises a stabilizing bar connected to the clamp and the catheter assembly such that the clamp and catheter are held in stable position relative to each other. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a schematic illustration of one embodiment of the apparatus described in the present application. 
         FIG.  2    is a schematic illustration of another embodiment of the apparatus described in the present application. 
         FIG.  3    is a schematic illustration of an embodiment of the apparatus shown in  FIG.  2    wherein a rotational connection is used for the stabilization bar. 
         FIG.  4    is a schematic illustration of a frontal view of the clamp portion of an embodiment of the current apparatus. 
     
    
    
     DETAILED DESCRIPTION OF AN EMBODIMENT 
     In the description that follows, like parts are marked throughout the specification and drawings with the same reference numerals, respectively. The drawings are not necessarily to scale and the proportions of certain parts have been exaggerated to better illustrate details and features of the invention. Where components of relatively well-known design are employed, their structure and operation will not be described in detail. 
     Referring to  FIG.  1   , one embodiment of a fluid delivery device or apparatus  10  described in the present application is shown. The apparatus comprises a catheter assembly  12 , which is also known as a cannula assembly. Catheter assembly  12  can further comprise several other components. For example, catheter assembly  12  can comprise a catheter tip  14 , or cannula tip. Catheter tip  14  is configured so as to be able to enter a vas deferens  20 . Catheter tip  14  is further configured so as to be able to deliver a fluid  24  into vas deferens, schematically represented by tube  60 . 
     Catheter tip  14  can optionally be attached to a filter  16 . Filter  16  can be positioned such that any fluid flowing through catheter tip  14  is appropriately filtered. In  FIG.  1   , filter  16  is shown interspaced in fluid transmission line  18 . 
     Generally, catheter assembly  12  will comprise catheter tip  14  and a fluid transmission line  18 . In some embodiments, catheter assembly  12  can comprise a single, unitary piece. For example, in some embodiments, catheter assembly  12  can be made of metal. In such an embodiment, catheter assembly  12  can optionally comprise a single metal unit with fluid transmission line  18  and catheter tip  14  being integral so as to form a unitary piece. In other embodiments, catheter tip  14  and fluid transmission line  18  can be two separate pieces joined together. In this case, catheter tip  14  can also be attached to a luer  20 . Typically, luer  20  is adapted to provide a leak free connection between catheter tip  14  and fluid transmission line  18 . Luer  20  can use any suitable connection method to connect to catheter tip  14 . For example, luer  20  can be threaded such that catheter tip  14  can screw into luer  20 . 
     Luer  20  provides a connection between catheter tip  14  and fluid transmission line  18 . Fluid transmission line  18  can be connected to luer  20  by any suitable means or can comprise part of luer  20  itself. Fluid transmission line  18  can also be adapted to connect to a fluid line receiver  22 , as further described below. 
     Fluid transmission line  18  can be any material or shape suitable for allowing fluid  24  to flow from a fluid reservoir  26  to catheter assembly  12 , through catheter tip  14  and into vas deferens  60 . For example, fluid transmission line  18  can be metal or comprise flexible or inflexible plastics or polymers. Fluid transmission line  18  can comprise a single component or can comprise multiple components joined together. For example, the fluid transmission line  18  can be adapted to be detached and reattached to fluid reservoir  26  such that the fluid reservoir  26  can be periodically replaced if desired. 
     Fluid reservoir  26  is connected to fluid transmission line  18  so as to be in fluid flow communication with catheter tip  14 . Fluid  24  flows through catheter assembly  12  and exits through catheter tip  14 . Thus, fluid reservoir  26 , fluid transmission line  18 , catheter assembly  12  and catheter tip  14  can be connected such that fluid  24  can flow into vas deferens  60  and irrigate vas deferens  60  so as to remove obstructions, such as sperm plug. 
     Fluid reservoir  26  can comprise any suitable material and be of any suitable size. Fluid reservoir  26  can comprise flexible or inflexible plastics or polymers and be sized to contain 5 to 1,000 milliliters. In some embodiments, fluid reservoir  26  can comprise a saline bag, as illustrated in  FIG.  1   . Typically, the saline bag will be sized to contain 250 to 1,000 milliliters of fluid. In further embodiments, fluid reservoir comprises a syringe as shown in  FIGS.  2  and  3   . Typically, the syringe will be sized to contain from 5 to 20 milliliters of fluid. For example, fluid reservoir  26  can comprise a syringe sized to hold 10 milliliters of fluid. In such an embodiment, the plunger  28  of the syringe will aid in transmitting fluid  24  from fluid reservoir  26  through fluid transmission line  18 , then through catheter tip  14  and into vas deferens  60 . As a result, vas deferens  60  is irrigated by fluid  24 . Fluid  24  contained in fluid reservoir  26  can be a sterile saline solution. 
     In some embodiments, fluid transmission line  18  can be directly connected to fluid reservoir  26 , such as illustrated in  FIG.  2    when a syringe is used as fluid reservoir  26 . In other embodiments, typically where a saline bag is used as the fluid reservoir, fluid transmission line  18  can use a second fluid transmission line  30 . When second fluid transmission line  30  is used, the two fluid transmission lines  18 ,  30  are generally connected using fluid line receiver  22 . Fluid line receiver  22  functions similarly to luer  20  in that the purpose of fluid line receiver  22  is to provide a leak-free connection between fluid transmission line  18  and second fluid transmission line  30 . Second fluid transmission line  30  is connected to fluid reservoir  26 , and fluid line receiver  22  can control the flow of fluid  24  from fluid reservoir  26  through second fluid transmission line  30  into fluid transmission line  18  using any suitable means. Fluid transmission line  30  can be connected to fluid line receiver  22  using any suitable means. For example, fluid line receiver  22  can be threaded and second fluid transmission line  30  can be adapted to screw onto or into fluid line receiver  22 . 
     Similarly, second fluid transmission line  30  can connect to fluid reservoir  26  using any suitable means. The connection can include a portion of the fluid reservoir  26 . Fluid reservoir  26  is adapted to contain fluid  24  and allow fluid  24  to flow through fluid transmission  18 , through any connections, and through catheter tip  14 . 
     Catheter assembly  12  is connected to a clamp  50  using a stabilization bar  32 . Stabilization bar  32  is configured to stabilize and position clamp  50  such that claim  50  and catheter assembly  12  are held in stable position relative to each other. The exact position and shape of stabilization bar  32  can vary depending on the exact position and shape of clamp  50 . However either is shaped, stabilization bar  32  is positioned or shaped so as to allow clamp  50  to close around catheter tip  14  and vas deferens  60 . 
     In the embodiment illustrated in  FIG.  2   , stabilization bar  32  is comprised of a first member or mount  34  and a second member or bar  36 . Bar  36  is attached to and extends outward from mount  34  such that at a first end (not shown), it is attached to mount  34  and at a second end  38  it is attached to clamp  50  so as to stabilize clamp  50  and hold it in a predetermined position. Bar  36  may be attached to mount  34  by any suitable means which results in bar  36  and clamp  50  being held in a stable position. In some embodiments, bar  36  is attached in an adjustable manner to mount  34 . For example, bar  36  can slidingly engage mount  34  such that second end  38  can be extended out from mount  34 , as illustrated in  FIG.  3   . In  FIG.  3   , the extension of second end  38  is controlled by screw device  39 , which interacts with teeth on bar  36  (not shown). 
     In some embodiments, stabilization bar  32  can be adjustable in shape and orientation. There are a variety of mechanisms that would allow for the adjustment of stabilization bar  32  in shape and orientation. For example, stabilization bar  32  could comprise two members joined by a hinge. In such an embodiment, the hinge would allow the two members comprising stabilization bar  32  to be rotated with respect to one another and thereby adjust the orientation of stabilization bar  32 . For a further example, stabilization bar  32  could comprise two or more members rotatably connected to one another. In such an embodiment, the rotation of the members comprising stabilization bar  32  could lengthen or shorten the total length of stabilization bar  32 , as illustrated in  FIG.  3   . 
     As further illustrated by  FIGS.  1 ,  2  and  3   , stabilization bar  32  can be connected to a base  40 , which can be part of catheter assembly  12 . As illustrated by  FIGS.  2  and  3   , base  40  can have handles  42  for facilitating positioning of fluid delivery device  10 . Base  40  can be of a forceps design as shown. The illustrated forceps design is a closed-end forceps clamp. The forceps base can have first branch  44  and second branch  46  each terminating in a handle  42  at one end and terminating in a tip or clamp end  48  at a second end. Accordingly, the forceps design of base  40  can allow for attachment of the clamp end  48  to the to the tissue surrounding the vas deferens in order to stabilize the apparatus in relation to the vas deferens. Generally, the tissue to which the clamp end  48  is attached will be the vasal sheath or connective tissue immediately surrounding the vas deferens. 
     As stated, stabilization bar  32  can connect catheter assembly  12  to clamp  50 . Clamp  50  can further have any shape suitable to hold catheter tip  14  in place inside vas deferens  60 . By stabilizing clamp  50  relative to catheter assembly  12 , stabilization bar  32  causes the apparatus to be in a stable position relative to the patient being operated upon. 
     In some embodiments, stabilization bar  32  or base  40  can have a small chamber or tube (not shown). The chamber or tube is designed to receive catheter tip  14  therein. Thus, catheter tip  14  connects to stabilization bar  32  and base  40  by being introduced into the chamber or tube. In one process using this design, catheter assembly  12  is attached to syringe  26  prior to being introduced into the chamber. Subsequently, catheter tip  14  of catheter assembly  12  is introduced into the chamber so as to place the fluid  24  of syringe  26  in fluid flow communication with the vas deferens. 
       FIG.  4    provides another view of clamp  50  interacting with catheter tip  14  and vas deferens (not shown). In this view, it is clear that clamp  50  has a first arm  52   a  and a second arm  52   b . First arm  52   a  and second arm  52   b  can further comprise a first interactive tip  54   a  and a second interactive tip  54   b , respectively. First interactive tip  54   a  and second interactive tip  54   b  typically comprise the lower portion of first arm  52   a  and second arm  52   b , respectively. First interactive tip  54   a  and second interactive tip  54   b  are shaped to aid in securing vas deferens  60  around catheter tip  14 . In some embodiments, first interactive tip  54   a  and second interactive tip  54   b  can be roughly hemispherical in shape so as to adapt to the cylindrical shape of vas deferens  60  and catheter tip  14 . In other embodiments, first interactive tip  54   a  and second interactive tip  54   b  can be nearly straight so as to provide greater pressure on some portions of vas deferens  60  around catheter tip  14 . 
     First interactive tip  54   a  and second interactive tip  54   b  are configured to interact with the particular geometry of catheter tip  14  and vas deferens  60 . In the embodiment shown, first interactive tip  54   a  and second interactive tip  54   b  are configured to clamp around a cylindrical shape. Because first interactive tip  54   a  and second interactive tip  54   b  can have a roughly semi-circular in shape, they are able to clamp around vas deferens  60 , hold vas deferens  60  in place around catheter tip  14 , and not damage or impart unnecessary force onto vas deferens  60 . However, first interactive tip  54   a  and second interactive tip  54   b  are not limited to the semi-circular configuration. For example, first interactive tip  54   a  and second interactive tip  54   b  may have serrations for strong interaction with vas deferens  60 . For further example, first interactive tip  54   a  and second interactive tip  54   b  may be triangular in shape such that first interactive  54   a  and second interactive tip  54   b  interact with only a portion of vas deferens  60 . 
     In some embodiments, first interactive tip  54   a  and/or second interactive tip  54   b  are configured to attach to the adventitia  61  or surrounding connective tissue of vas deferens  60 . For example, first interactive tip  54   a  and second interactive tip  54   b  can each have hooks  58  which attach each tip  54   a ,  54   b  to the adventitia. 
     First arm  52   a  and second arm  52   b  of clamp  50  can press toward one another by any suitable mechanism such that first interactive tip  54   a  and second interactive tip  54   b  can clasp catheter tip  14  and vas deferens  60 . For example, first arm  52   a  and second arm  52   b  can be configured so as to resiliently bias first interactive tip  54   a  and second interactive tip  54   b  towards one another. For further example, first arm  52   a  and second arms  52   b  of clamp  50  can be pressed toward one another using a spring  56 . Other suitable means to press first interactive tip  54   a  and second interactive tip  54   b  towards each other may be used, such as a ratcheting connection or screw connection between first arm  52   a  and second arm  52   b.    
     First arm  52   a  and second arm  52   b  can apply sufficient force to vas deferens  60  through first interactive tip  54   a  and second interactive tip  54   b  such that vas deferens  60  remains firmly affixed to catheter tip  14 . In this way, fluid  24  from fluid reservoir  26  enters vas deferens  60  and does not spill out prior to flushing vas deferens  60 . Further, first arm  52   a  and second arm  52   b  can apply sufficient force around vas deferens  60  such that a flow of fluid  24  cannot dislodge catheter tip  14  from vas deferens  60 . 
     Clamp  50  can interact with catheter tip  14  and vas deferens  60  with an appropriate predetermined amount of force. For example, if clamp  50  exerts too much pressure on vas deferens  60  and catheter tip  14 , clamp  50  could collapse catheter tip  14  and thereby prevent fluid from flowing into vas deferens  60 . Additionally, if clamp  50  exerts insufficient pressure on vas deferens  60 , fluid  24  may not be forced to flow into vas deferens  60 . 
     In a method using the presently described apparatus, vas deferens  60  must first be exposed. For example, a surgeon can open the scrotum using a scalpel. Any suitable method may be used to expose vas deferens  60  such that a surgeon can interact with vas deferens  60 . The surgeon can then make a further incision into vas deferens  60  or otherwise interact with vas deferens  60  in order to open vas deferens  60  to fluid communication with catheter tip  14 . If an apparatus in accordance with  FIG.  2  or  3    is used, clamp end  48  of the forceps base  40  can be clamped or attached to the vasal sheath or connective tissue immediately surrounding the vas deferens after the tip has been introduced into the incision. Catheter tip  14  can then be inserted into vas deferens  60  in the desired location. 
     Once catheter  14  is inserted into vas deferens  60 , clamp  50  can be attached by placing first interactive tip  54   a  of first arm  52   a  and second interactive tip  54   b  of second arm  52   b  around vas deferens  60 , which also contain catheter tip  14 . In this way, clamp  50  can secure vas deferens  60  around catheter tip  14 . Next, fluid  24  from fluid reservoir  26  is allowed or caused to flow into vas deferens  60 . Fluid  24  flowing from fluid reservoir  26  can flow through fluid transmission line  18  and any connections and into vas deferens  60 . The flow of fluid  24  into vas deferens  60  irrigates vas deferens  60 . As a result of the irrigation, obstructions in vas deferens  60  can be reduced enough to restore sperm flow through vas deferens  60 . 
     Once obstructions in vas deferens  60  have been removed, the clamp  50  is removed from vas deferens  60  and catheter tip  14  is removed from vas deferens  60 . After catheter tip  14  and any obstruction in vas deferens  60  have been removed, the severed portions of vas deferens  60  are reconnected. In this way, sperm flow from the epididymis to the seminal fluid is restored. Once the seminal fluid contains sperm, fertilization of an egg may occur using traditional means. 
     Although the invention has been described with reference to a specific embodiment, the foregoing description is not intended to be construed in a limiting sense. Various modifications as well as alternative applications will be suggested to persons skilled in the art by the foregoing specification and illustrations. It is therefore contemplated that the appended claims will cover any such modifications, applications or embodiments as followed in the true scope of this invention.