Abstract:
A method of implanting a penile prosthetic includes providing a tool having a barrel with a first groove formed in an exterior surface of the barrel and a second groove formed in the exterior surface of the barrel; capturing opposing lateral edges of a deflated penile implant into the respective the first groove the second groove; placing the barrel of the tool and the deflated penile implant into a corpora cavernosum of a penis; removing the barrel from the corpora cavernosum of the penis and leaving the deflated penile implant in the corpora cavernosum of the penis.

Description:
BACKGROUND 
       [0001]    An implanted penile prosthetic has proven useful in treating erectile dysfunction in men. The penile prosthetic includes two inflatable cylinders implanted in the penis, a pump implanted in the scrotum or other internal space, and a liquid holding reservoir implanted in the abdomen or other internal space. 
         [0002]    In a typical implantation procedure, the penis of the patient is incised in a corporotomy to expose a pair of corpora cavernosa that are aligned axially in a side-by-side orientation within the penis. A cutting implement, such as a curved Mayo scissors, is employed to penetrate the fascia of the penis and form an opening accessing each corpora cavernosum. Subsequently, each corpora cavernosum is dilated (opened) with an appropriate dilation tool to form a recess that is sized to receive one of the two cylinders of the penile prosthetic. Thereafter, a tool (e.g., a “Furlow” introducer) is inserted into each dilated corpora cavernosum to measure a length of the penis distally and proximally to determine a desired length of the cylinders. A cylinder of the appropriately selected length is secured to a suture, and the suture is secured to a needle (sometimes called a “Keith” needle) that is loaded into the Furlow introducer. The Furlow introducer delivers the needle through the dilated corpora cavernosum and out the glans penis. The needle is discarded and the suture is employed to tow the cylinder into place within the dilated corpora cavernosum. 
         [0003]    The above-described procedure has proven effective when implanting penile prostheses. However, surgeons and users would both appreciate improved tools for implanting penile prosthetic cylinders. 
       SUMMARY 
       [0004]    One aspect provides a tool for implanting an inflatable penile prosthetic cylinder. The tool includes a barrel having a solid central portion and two groove formed in an exterior side surface of the barrel. The first groove and the second groove each form a cavity extending into the exterior side surface of the barrel toward the solid central portion, and the cavity has a first gap dimension measured at the exterior side surface that is smaller than a second gap dimension measured inboard relative to the exterior side surface of the barrel. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]    The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. 
           [0006]      FIG. 1A  is an exploded side view of a prior art tool for implanting a cylinder into a penis as illustrated in cross-section in  FIG. 1B . 
           [0007]      FIG. 2  is a perspective view of one embodiment of a tool for implanting an inflatable penile prosthetic cylinder. 
           [0008]      FIG. 3  is a side view and  FIG. 4  is a top view of the tool illustrated in  FIG. 2 . 
           [0009]      FIG. 5  and  FIG. 6  are cross-sectional views of a barrel of the tool illustrated in  FIG. 2 . 
           [0010]      FIG. 7  is a perspective view of a kit of parts including an implantable penile prosthetic system and the tool illustrated in  FIG. 2 . 
           [0011]      FIG. 8  is an end view of a deflated prosthetic cylinder coupled to the tool illustrated in  FIG. 2 . 
           [0012]      FIG. 9  is a cross-sectional view of one embodiment of a tool for implanting an inflatable penile prosthetic cylinder. 
       
    
    
     DETAILED DESCRIPTION 
       [0013]    In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the attached claims. 
         [0014]    The features of the various exemplary embodiments described in this application may be combined with each other (“mixed and matched”), unless specifically noted otherwise. 
         [0015]    End means endmost. A distal end is the furthest endmost location of a distal portion of a thing being described, whereas a proximal end is the nearest endmost location of a proximal portion of the thing being described. The portion next to or adjacent to an end is an end portion. 
         [0016]    The term “hemisphere” in this application means one equatorial half of a sphere. 
         [0017]    An implantable penile prosthetic system includes two cylinders implanted in the penis, a pump implanted in the scrotum or other internal space, and a liquid holding reservoir implanted in the abdomen or other internal space. The surgeon usually implants the reservoir last, after confirming that the tubing attached to the reservoir, pump, and cylinders is not leaking. The reservoir is filled with saline or another liquid at approximately atmospheric pressure. The pump is employed to transfer the liquid from the reservoir to the cylinders, and in so doing, the liquid in the cylinders is pressurized to create an erection. A flow path is provided to depressurize and return the liquid from the cylinders back to the reservoir. 
         [0018]      FIG. 1A  is an exploded side view of a prior art tool  20  for implanting an inflatable cylinder  22  into a penis P illustrated in  FIG. 1B . The inflatable cylinders  22  are fabricated to be pliant and comfortable when deflated and rigid and erect when inflated. The deflated cylinder  22  lacks column strength and will bend and twist and resist being pushed into the penis P. For this reason, a suture or strand is employed to pull the inflatable cylinder into place within the penis P. 
         [0019]    The tool  20  includes a barrel  30 , a needle  32  that is insertable into the barrel  30 , and a plunger  34  that is insertable into the barrel  30  to push the needle  32  out of the barrel  30 . One such needle  32  is a Keith needle. 
         [0020]    The barrel  30  extends between a curved distal end  40  and a handle  41  provided at a proximal end  42 . The barrel  30  has markings  44  applied on an external surface to indicate or measure a depth to which the barrel  30  has been inserted into the corpora cavernosum. The barrel  30  is provided with a slot  46  that is sized to receive the needle  32  and a lumen  48  sized to receive the needle  32  and the plunger  34 . 
         [0021]    The needle  32  is attached to a tow suture  50  that is coupled with the cylinder  22 . The tow suture  50  is generally inserted through an eyelet of the needle  50  and a hole provided at a distal end of the cylinder  22 . 
         [0022]    The plunger  34  is insertable into the lumen  48  at the proximal end  42  of the barrel  30  and operates to push the needle  32  out of the lumen  48 . 
         [0023]      FIG. 1B  is a cross-sectional view of the penis P oriented to access by the surgeon. The surgeon gains access to the corpora cavernosa though small incisions made through the fascia after the penis is reclined toward the abdomen, as illustrated in the cross-sectional view of  FIG. 1B . In the view of  FIG. 1B  the penis P of the patient is reclined against the torso such that the urethra U, surrounded by corpus spongiosum CS tissue, is oriented upward. 
         [0024]    In preparation for the implantation of the penile prosthesis, the groin area of the patient is shaved, cleaned and suitably prepped with a surgical solution prior to draping with a sterile drape as directed by the healthcare provider&#39;s procedures. A retraction device, such as a retractor sold under the trademark Lone Star and available from Lone Star Medical Products of Stafford, Tex., is placed around the penis P. A catheter is inserted into the urethra U from the distal end of the penis P into the bladder. Thereafter, the surgeon forms an incision to access the corpora cavernosa C 1  and C 2  of the penis. 
         [0025]    Suitable examples of incisions include either an infrapubic incision or a transverse scrotal incision. The infrapubic incision is initiated between the umbilicus and the penis (i.e., above the penis), whereas the transverse scrotal incision is made across an upper portion of the patient&#39;s scrotum. 
         [0026]    In the transverse scrotal approach the surgeon forms a 2-3 cm transverse incision through the subcutaneous tissue of the median raphe of the upper scrotum and dissects down through the Darto&#39;s fascia Df and Buck&#39;s fascia Bf to expose the tunicae albuginea TA of the penis P. Thereafter, each corpora cavernosum C 1  and C 2  is exposed in a corporotomy where a small (approximately 1.5 cm) incision is formed to allow the surgeon to access to the corpora cavernosa C 1  and C 2 . 
         [0027]    Each corpora cavernosum C 1 , C 2  is dilated with an appropriate dilation tool to form a recess in the penis P that is sized to receive one of the two cylinders  22 . The barrel  30  of the tool  20  is inserted into each dilated corpora cavernosum C 1 , C 2  to measure the length of the corpora prior to selecting an appropriately sized cylinder  22 . The barrel  30  is removed from the penis P. The suture  50  is inserted through the distal, leading end of the cylinder  22  and the needle  32 . The needle  32  is loaded into the barrel  30  through the slot  46  and the plunger  34  is inserted into the lumen  48  via the proximal end  42  of the barrel  30 . The barrel  30  is inserted into the dilated corpora cavernosum and the plunger  34  is pushed into the lumen  48  to push the needle  32  out of the barrel  30  and through the glans penis. The surgeon captures the needle  32 , disengages the needle  32  from the tow suture  50 , and pulls on the tow suture  50  to draw the cylinder  22  into the dilated corpora cavernosum. The tow suture  50  is disengaged from the cylinder, which is now implanted within the corpora cavernosum C 1  or C 2 . 
         [0028]    Pushing the needle  32  through the glans penis can cause bleeding from the head of the penis, which while harmless, can be alarming to the patient. Surgeons have expressed a desire to avoid the use of the needle  32 . 
         [0029]    As noted above, the suture  50  is inserted through the distal, leading end of the cylinder  22 . The distal end of the cylinder  22  is oftentimes structurally reinforced to accommodate the hole that the suture  50  is passed through. The reinforced end of the cylinder can be felt by some patients who perceive it as a hard and unnatural, undesirable pointed projection. 
         [0030]    Embodiments provide a tool for implanting a prosthetic cylinder of such a system into a penis, where the tool does away with the handling and the use of a Keith needle. The tool is useful for measuring the depth of the corpora cavernosum in selecting a length of an appropriately sized cylinder, and then can be used to push the deflated prosthetic cylinder into the opening formed in the penis. The tool may be fabricated from plastic or metal and can be provided in both disposable and reusable forms. 
         [0031]      FIG. 2  is a perspective view,  FIG. 3  is a side view, and  FIG. 4  is a top view of one embodiment of a tool  100  useful for implanting an inflatable penile prosthetic cylinder. 
         [0032]    The tool  100 , as described below, includes a barrel having a solid central portion and a groove formed in an exterior side surface of the barrel between a first convex curved exterior surface and a second convex curved exterior surface of the barrel. The groove extends to and forms an opening at a distal end of the barrel and forms a cavity extending into the barrel from the exterior side surface toward the solid central portion. The cavity has a first gap dimension measured at the exterior side surface that is smaller than a second gap dimension measured inboard relative to the exterior side surface of the barrel. The cavity is dimensioned and configured to capture an edge portion of an implantable cylinder after the cylinder is wrapped around the barrel. 
         [0033]    In one embodiment, the barrel is provided with one groove (e.g., groove  108 ) forming one cavity, and the edges of the flattened cylinder are captured in the one cavity. 
         [0034]    In one embodiment, the barrel is provided with a second groove (e.g., groove  110 ) formed in a second exterior side of the barrel between the first convex curved exterior surface and the second convex curved exterior surface, and both of the first groove  108  and the second groove  110  each form a cavity extending into the barrel from an exterior side surface of the barrel toward the solid central portion, and each cavity has a first gap dimension measured at the exterior side surface that is smaller than a second gap dimension measured inboard relative to the exterior side surface of the barrel. 
         [0035]    In one embodiment, the tool  100  includes a barrel  102  extending between a proximal end  104  and a distal end  106 , with a pair of grooves  108 ,  110  that extend to the distal end  106  of the barrel  102 . The first groove  108  and the second groove  110  extend all the way to and form an opening  111  in the distal end  106  of the barrel  102 . The grooves  108 ,  110  form cavities longitudinally within the barrel  102 , where each cavity is sized to receive a deflated edge of the prosthetic cylinder and each groove operates to clamp down on a portion of the deflated prosthetic cylinder. 
         [0036]    In one embodiment, the first groove  108  and the second groove  110  extend from the proximal end  104  to the distal end  106  of the barrel  102 . The distal end  106  of the barrel  102  is formed to be a blunt end that is sized to fit into the glans penis when inserting the deflated prosthetic cylinder. One example of a blunt distal end  106  of the barrel  102  is a hemispherical end  112 . The length of the barrel  102  between the proximal end  104  and the distal end  106  is selected based on the length of the penis (distal from the incision or access area formed in the penis) and the length of the prosthetic cylinder. Suitable lengths for the barrel  102  are in a range from 10 cm to 20 cm, with one length of a prosthetic cylinder implant being about 16 cm. 
         [0037]    In one embodiment, a handle  120  is attached to the proximal end  104  of the barrel  102 . The handle  120  allows the surgeon to grasp the barrel  102  and apply pressure in the distal direction when inserting the prosthetic cylinder. One example of the handle  120  includes a push pad  122  (or a pad  122 ) that has a concave curve sized to receive pressure from the surgeon&#39;s thumb when manipulating the tool  100 . 
         [0038]    Embodiments provide demarcations or markings  124  similar to a ruler, where the markings  124  are useful in measuring the depth that the barrel  102  is inserted into the penis. The markings  124  assist in selecting a prosthetic cylinder with an appropriate length for the patient. The markings  124  include printed indicia or indicia engraved into a surface of the barrel. 
         [0039]      FIG. 5  is a cross-sectional view of the barrel  102 . The barrel  102  has a solid central portion  130  surrounding its geometric center C. In one embodiment, the barrel  102  is substantially circular in lateral cross-section. Other shapes for the cross-section of the barrel  102  other than circular are also acceptable. For example, cross-sectional shapes such as an elongated oval or segments of a circle connected by straight lines (edges) are also acceptable. 
         [0040]    The central portion  130  is bounded by a first convex curved exterior surface  132  opposite from a second convex curved exterior surface  134 , and is located between a first exterior side surface  142  and a second exterior side surface  144 . The grooves  108 ,  110  are generally formed in the exterior side surfaces  142 ,  144 , respectively, and extend into the barrel  102  from each exterior side surface toward the solid central portion  130 . The grooves  108 ,  110  extend to the end of the barrel  102  to form a pair of openings in the distal end  106 . Each of the grooves  108 ,  110  forms a cavity  148 ,  150  in one of the exterior side surfaces  142 ,  144 , respectively, between the first  132  and the second  134  curved exterior surfaces. 
         [0041]      FIG. 6  is a cross-sectional view of the cavity  148 . Each of the cavities is formed as a slot that extends a length along the barrel  102 . The cavity  148  is formed in the exterior side surface  142  at a center that is a distance X away from the exterior side surface  142 . The center of the cavity  148  or the slot  148  is located such that a longitudinal axis through its center is parallel to a longitudinal axis through the center C of the barrel  102 . The cavity  148  or the slot  148  is formed with a radius R that is larger than the distance X, which results in a gap G being formed in the exterior side surface  142 . 
         [0042]    In one embodiment, the barrel  102  is substantially circular and has an exterior perimeter formed by the side surfaces  142 ,  144 . Each of the cavities  148 ,  150  is formed as a slot that creates an opening in the exterior perimeter (or side surface  142 ) of the barrel  102 . Each slot, for example slot  148 , has a slot center X that is parallel in the longitudinal sense with the center C of the barrel  102 , and a radius of the slot  148  is larger than the distance that the slot center X is located away from the exterior perimeter  142 . This manner of fabricating the slots  148 ,  150  provides each slot with a gap or an opening into the cavity. 
         [0043]    The cavity  148  is formed to include a gap G at the exterior side surface  142 . The cavity  148  has a first gap distance Gd 1  measured at the exterior side surface  142  that is less than a second gap distance Gd 2  that is measured inboard relative to the exterior side surface  142 . 
         [0044]    The gap G forms a lip  160 . The lip  160  is formed by a remaining portion of the second side surface  142  of the barrel  102  between a first wall  162  and a second wall  164  of the cavity  148 . A distance between the lip  160  and a second wall  164  forms the gap G, or specifically, the gap distance Gd 1 . In one embodiment, the lip  160  is flexible and pre-stressed to provide a clamping force into the direction of the cavity  148 . The lip  160  is flexible, and can be lifted outward in a radial direction to allow a portion of the prosthetic cylinder to be inserted into the cavity  148 . The lip  160  is configured to recover and provide a clamping force that holds the prosthetic cylinder in the cavity  148 . 
         [0045]    The tool  100  is employed to deliver a deflated prosthetic cylinder into a dilated corpora cavernosum. The prosthetic cylinder has a wall thickness of about 0.020 inches, such that the deflated cylinder has a thickness of twice the wall thickness, or about 0.040 inches. The cavities  148 ,  150  are sized to receive the deflated wall thicknesses of the cylinder, and the lip  160  and the gap distance Gd 1  are selected to provide a clamping forced against the walls of the deflated cylinders. The gap distance Gd 1  is thus less than about 0.040 inches. 
         [0046]      FIG. 7  is a schematic view of a kit of parts  200 . The kit of parts includes the tool  100 , an implantable penile prosthetic system  202 , and instructions for use of the tool  100 . The implantable penile prosthetic system  202  includes a pump  210  connectable between a reservoir  212  and prosthetic cylinders  214 . The pump  210  operates to move liquid from the reservoir  212  and into the inflatable cylinders  214 . The inflated cylinders  214 , when implanted, provide the penis with an erection. The inflatable cylinders  214  can be deflated by evacuating the air and the liquid from the cylinders, which collapses the cylinders  214  into a flat, pancake shape. 
         [0047]      FIG. 8  is a cross-sectional view of one of the deflated cylinders  214  secured to the barrel  102 . The view of  FIG. 8  is side-to-side relative to the cylinder  214 . 
         [0048]    The deflated cylinder  214  extends between a first deflated edge that is inserted and retained within the first cavity  150  and a second deflated edge that can be inserted into the cavity  148 . The lip  160  is flexible and can be maneuvered upward and out of the way to allow the edge of the cylinder  214  to be inserted into the cavity  148 . When the lip  160  is released it provides a clamping force directed into the barrel against the edge of the cylinder  214 . With the deflated cylinder  214  secured between the cavities  148 ,  150  the surgeon inserts the barrel  102  into the opened space formed in one of the corpora cavernosum. The deflated cylinder  214  is delivered through the corpora cavernosum up to the glans penis at which point the surgeon slides the barrel  102  away from the inserted cylinder  214 . The deflated cylinder  214  slides out of the cavities  148 ,  150  and is implanted into the penis. 
         [0049]      FIG. 9  is a cross-sectional view of one embodiment of a barrel of a tool that is useful for implanting an inflatable penile prosthetic cylinder into a penis. The barrel  302  includes two cavities  308 ,  310  (or slots  308 ,  310 ) formed by a pair of grooves. In one embodiment, the first groove  308  is located diametrically opposite from the second groove  310 . In one embodiment, the first groove  308  is formed as a circular cavity in the barrel  302 . The circular cavity  308  is formed on a center parallel to a center of the barrel  302 . The center of the cavity is located a center distance away from exterior perimeter of the barrel  302 . The center distance of the circular cavity  308  is less than a radius R of the circular cavity  308 , which results in the circular cavity  308  forming an opening in the exterior surface of the barrel  302 . 
         [0050]    Embodiments provide an improved tool for implanting a prosthetic cylinder of an implantable device useful for treating erectile dysfunction. The tool described in this application obviates the use of a Keith needle and does away with perforating the glans penis when implanting a prosthetic cylinder. 
         [0051]    Although specific embodiments have been illustrated and described, it will be appreciated by those of ordinary skill in the art that a variety of alternate and equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of the kind of medical devices described above. Therefore, it is intended that this invention be limited only by the claims and their equivalents.