Patent Publication Number: US-9402723-B2

Title: Penile prosthesis implantation device

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application is a continuation of U.S. patent application Ser. No. 14/337,926, filed Jul. 22, 2014, which is a continuation of U.S. patent application Ser. No. 14/037,797, filed Sep. 26, 2013, now U.S. Pat. No. 8,864,651, which is a continuation of U.S. patent application Ser. No. 12/644,805, filed Dec. 22, 2009, now U.S. Pat. No. 8,545,391, which is based on and claims the benefit of U.S. provisional patent application Ser. No. 61/140,173, filed Dec. 23, 2008 and U.S. provisional patent application Ser. No. 61/140,350, filed Dec. 23, 2008. The above-referenced applications are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND 
     The present disclosure relates to medical devices used in implant surgery. More specifically, the present disclosure relates to a penile prosthesis implantation device used to assist in the implantation of penile prostheses cylinders in the corpus cavernosae of a patient. In some instances, these cylinders are inflatable, which are connected to a fluid-filled reservoir with a pump and valve assembly. Another type of cylinder is non-inflatable and does not require the pump and valve assembly. 
     The penile implantation operation is an invasive treatment. To reach the corpus cavernosae and implant the cylinders, the surgeon will first make an incision at the base of the penis, such as where it meets the scrotum. The patient is prepared for the cylinders by dilating each corpus cavernosum. 
     Once the patient has been prepared, the surgeon will insert a medical device known as a Furlow insertion tool with a Keith needle into the dilated corpus cavernosum. The Furlow tool is a well known and often used device in the art and is described in U.S. Pat. No. 4,244,370, which was filed in 1978. The Furlow tool is a long slender device having a hollow barrel with a plunger device known as an obturator at the rearward end. The Keith needle is also a well-known article used in many areas of medicine. The Keith needle looks like a heavy sewing needle and is used to pierce tissue. The Keith needle fits within the barrel of the Furlow tool and is ejected from the forward end with the obturator. 
     In order to install the penile prosthesis cylinder in one of the corpus cavernosum, the Keith needle is attached to a suture that is also attached to the cylinder. The Keith needle with a threaded suture is then inserted into the distal opening of the Furlow tool. The Furlow tool is advanced into the corpus cavernosum until the forward end is inside of the crown of the penis, or glans. At this point, the cylinder and part of the suture attached to the cylinder remain outside of the patient&#39;s body. The Furlow tool is used to force the Keith needle out of the barrel and through the glans. The surgeon grasps the Keith needle from outside of the body and pulls it from the penis leaving the suture threaded through the corpus cavernosum. The Furlow tool is withdrawn from the penis. The suture is then pulled to draw the cylinder into the incision and the corpus cavernosum. Once the implant is in place, the suture is removed. This procedure is then performed again on the other corpus cavernosum. 
     Problems with the above-described system include the numerous opportunities for medical personnel, the patient, or an inflatable penile prosthesis to become pierced by the Keith needle. For example, medical personnel must handle the Keith needle while threading the suture through the eye of the Keith needle and during insertion of the needle into the Furlow tool. Additionally, while the Keith needle provides a slight interference fit within the barrel of the Furlow tool, it may also fall out during handling, thereby presenting additional opportunities for medical personnel, the patient or the penile prosthesis to become pierced by the Keith needle. Also, threading the suture through the eye of the Keith needle lengthens surgical time, increasing the chance of infection, and can be a source of frustration for the surgeon when threading the suture is difficult. 
     The discussion above is merely provided for general background information and is not intended to be used as an aid in determining the scope of the claimed subject matter. 
     SUMMARY 
     Embodiments of the invention are generally directed to a penile prosthesis implantation device. One embodiment of the penile prosthesis implantation device comprises a barrel having a bore, an obturator and a needle clamp. The obturator has a longitudinal axis, a first end and a second end. The second end of the obturator is adapted for slidable insertion into the bore of the barrel. The needle clamp is coupled to the second end of the obturator and comprises first and second pinching surfaces that are separated by a gap. 
     Another embodiment of the invention is directed to a needle guard that attaches to the penile prosthesis implantation device that includes a barrel having a bore, an obturator having a first end and a second end, the second end adapted for slidable insertion into the bore and a needle within the bore adjacent the second end of the obturator. The needle guard generally operates to secure a needle within the barrel of the device. One embodiment of the needle guard comprises first, second and third members. The first member is configured to cover an end of the barrel at which the bore is exposed. The second member is configured to engage the first end of the obturator. The third member is coupled to the first and second members of the needle guard. 
     Yet another embodiment of the invention is directed to a kit comprising a penile prosthesis implantation device, a penile prosthesis, a suture and packaging. The device includes a barrel having a bore, an obturator, a needle clamp and a needle. The obturator has a longitudinal axis, a first end and a second end, which is adapted to slide within the bore. The needle clamp is located at the second end of the obturator and comprises first and second pinching surfaces separated by a gap. The needle has a connecting end that is held between the first and second pinching surfaces, and a pointed tip opposite the connecting end. The needle is recessed within the bore adjacent an end of the barrel. The suture has a first end connected to the connecting end of the needle, and a second end connected to the penile prosthesis. The packaging contains the device, the penile prosthesis, and the suture. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a cross-sectional view of a penile prosthesis implantation device in accordance with embodiments of the invention. 
         FIG. 2  is a magnified cross-sectional view of a needle clamp of the device of  FIG. 1 . 
         FIG. 3  is a side cross-sectional view of a needle clamp in a clamping position in accordance with embodiments of the invention. 
         FIGS. 4 and 5  respectively are isometric and cross-sectional views of a penile prosthesis implantation device, formed in accordance with embodiments of the invention, in a retracted position. 
         FIGS. 6 and 7  respectively are isometric and cross-sectional views of a penile prosthesis implantation device, formed in accordance with embodiments of the invention, in an extended position. 
         FIG. 8  is a cross-sectional view of a penile prosthesis implantation device in accordance with embodiments of the invention. 
         FIG. 9  is a magnified view of a needle clamp of the device of  FIG. 8 . 
         FIG. 10  is a cross-sectional view of a needle guard in accordance with embodiments of the invention. 
         FIG. 11  is a top plan view of a needle guard in accordance with embodiments of the invention. 
         FIG. 12  is a cross-sectional view of a needle guard in accordance with embodiments of the invention. 
         FIG. 13  is a schematic diagram of a kit in accordance with embodiments of the invention. 
     
    
    
     DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS 
       FIG. 1  is a cross-sectional view of a penile prosthesis implantation device  100 A in accordance with embodiments of the invention. The device  100 A is configured for the use in the insertion of a penile prosthesis  101 , a tip end  102  of which is shown in  FIG. 1 , into the corpus cavernosa of the penis of a patient for the treatment of impotence, in a similar manner as that described above. One embodiment of the device  100 A comprises a barrel  104 , an obturator  106  and a needle clamp  108 A. The barrel  104  has a bore  110  that is generally axially aligned with a longitudinal axis  112  of the obturator  106 . In accordance with one embodiment, most of the components of the device  100 A are formed of plastic. 
     The needle clamp  108 A is configured to grasp a thread attachment or connecting end  114  of a needle  116 , such as a Keith needle. Embodiments of the needle  116  include various shapes, such as straight, crooked like a lightning bolt as shown in  FIG. 1 , or other desired shape. In one embodiment, the barrel  104  is designed such that the needle  116  fits inside the bore  110  with a light interference with the interior surface  117  of the bore. In one embodiment, friction between the needle  116  and the surface  117  preferably holds the needle  116  within the bore  110  during normal handling of the device  100 A. 
     The needle  116  includes a piercing end  118  used to pierce the glans of the penis. In one embodiment, a suture  120  is coupled to the thread attachment end  114  of the needle  116  and the tip end  102  of the penile prosthesis  101 . In one embodiment, this coupling of the suture  120  to the thread attachment end  114  and the tip end  102  of the penile prosthesis is performed in accordance with the method described in U.S. Pat. No. 7,407,482, which is incorporated herein by reference in its entirety. 
     The needle clamp  108 A is either attached to, or formed integral with, a distal end  122  of the obturator  106 . One embodiment of the clamp  108 A comprises pinching members  123 A and  123 B respectively having opposing pinching surfaces  124 A and  124 B, which are best shown in the magnified cross-sectional view of the needle clamp  108 A provided in  FIG. 2 . The pinching surfaces  124 A and  124 B are separated by gap  126 . 
     In general, the needle clamp  108 A includes a receiving position  128 , in which the needle clamp  108 A is poised to receive the thread attachment end  114  of the needle  116 , as shown in  FIGS. 1 and 2 . In one embodiment, the needle clamp  108 A is positioned in the receiving position  128  in response to the extension of the needle clamp  108 A outside of the barrel  104 , as shown in  FIG. 1 . In one embodiment, the pinching members  123 A and  123 B are biased such that they separate from each other in the radial direction relative to the longitudinal axis  112  when the clamp  108 A is moved to the receiving position  128 . 
     The clamp  108 A also includes a clamping position  130 , which is illustrated in the side cross-sectional view of  FIG. 3 . Note that the sutures  120  and the penile prosthesis  101  ( FIG. 1 ), which may be attached to the needle  116 , are not shown in  FIG. 3  in order to simplify the illustration. When the needle clamp  108 A is moved from the receiving position  128  to the clamping position  130 , the pinching members  123 A and  123 B are biased toward each other in the radial direction relative to the longitudinal axis  112  such that the corresponding pinching surfaces  124 A and  124 B pinch the thread attachment end  114  of the needle  116  and secure the needle  116  to the obturator  106 . 
     In one embodiment, the needle clamp  208 A comprises at least one deflector portion, such as deflector portion  132 A or  132 B, that is axially displaced from the longitudinal axis  112  of the obturator  106 . When the needle clamp  108 A is in the receiving position  128 , the deflector portions  132 A and  132 B are positioned outside of the barrel  104 , as shown in  FIGS. 1 and 2 . The needle clamp  108 A is moved to the clamping position  130  by sliding the obturator  106  relative to the barrel  104  in the axial direction to pull the deflector portions  132 A and  132 B within the bore  110  of the barrel  104 , which in turn drives the pinching members  123 A and  123 B toward each other in the radial direction to move the needle clamp  108 A into the clamping position  130 , as shown in  FIG. 3 . 
     Thus, the engagement of the deflector portions  132 A and  132 B with the interior surface  117  of the barrel  104  biases the first and second pinching surfaces  124 A and  124 B toward each other as the clamping member moves from the receiving position  128  to the clamping position  130 . This movement of the pinching members  123 A and  123 B also causes a reduction in a length of the gap  126  between the pinching surfaces  124 A and  124 B as the clamp  108 A moves from the receiving position  128  to the clamping position  130 . This reduction in the length of the gap  126  causes the thread attachment end  114  of the needle  116  to be pinched by the surfaces  124 A and  124 B thereby securing the needle  116  within the clamp  108 A. 
     While the needle  116  is secured within the clamp  108 A, the needle  116  along with the suture  120  can be held within the bore  110  of the barrel  104  until it is necessary to deploy the needle, such as after the piercing end  118  is passed through the glans of the penis. The needle  116  can be released by moving the obturator  106  in the axial direction to place the clamp  108 A in the receiving position  128 . This allows the needle  116  to be pulled through the glans of the penis, for example. 
     In one embodiment, the barrel  104  includes a stop portion or member  140  that protrudes within the bore  110  and restricts the axial movement of the obturator  106 , as shown in  FIG. 3 . In one embodiment, the barrel  104  comprises first and second ends  142  and  144 . The internal diameter of the bore in the first end  142  is greater than the internal diameter of the bore  110  in the second end  144 . The reduction in the diameter of the bore  110  from the first end  142  to the second end  144  forms the stop  140 . In one embodiment, the deflector portions  132 A and  132 B engage the stop member  140  to prevent further axial movement of the obturator  106  and clamp  108 A along the longitudinal axis  112  in the direction that is toward the second end  144  of the barrel  104 . 
     In operation, the obturator  106  is slid within the barrel  104  through an opening  146  at the first end  142  such that the deflector portions  132 A and  132 B extend beyond the bore  110 . This places the clamp  108 A in the release position  128 , in which the pinching members  123 A and  123 B as well as the corresponding pinching surfaces  124 A and  124 B are separated, as shown in  FIGS. 1 and 2 . The thread attachment end  114  of the needle  116 , which is coupled to the tip end  102  of the penile prosthesis by the suture  120 , is received within the gap  126 . The obturator  106  is then slid within the barrel  104  along the longitudinal axis toward the second end  144  such that the clamp  108 A is retracted within the bore  110  at the first end  142  of the barrel  104 . This causes the deflector portions  132 A and  132 B to engage the interior surface  117  of the barrel  104  and deflect the pinching members  123 A and  123 B radially causing the gap  126  to be reduced and the pinching surfaces  124 A and  124 B to pinch the thread attachment end  114  of the needle  116 . With the needle  116  secured between the pinching surfaces  124 A and  124 B of the clamp  108 A, the obturator  106  pulls the needle  116  and the attached suture  120  within the first end  142  of the barrel  104 , as shown in  FIG. 3 . When the deflector portions  132 A and  132 B engage the stop members  140  of the barrel  104 , the needle is preferably fully received within the bore  110  of the barrel  104 . This is considered the fully retracted position. 
     When the needle is delivered through the glans penis during the implantation of a penile prosthesis, the obturator  106  is slid relative to the barrel  104  from the retracted position to move the clamp  108 A into the release position  128 , which allows the needle to be released and easily pulled through the penis. 
       FIGS. 4-7  illustrate a penile prosthesis implantation device  100 B in accordance with additional embodiments of the present invention. Elements of the device  100 B shown in  FIGS. 4-7  that are identified by the same or similar numbers used to identify elements in  FIGS. 1-3  correspond to the same or similar elements.  FIGS. 4 and 5  respectively are isometric and cross-sectional views of the penile prosthesis implantation device  100 B while in a retracted position, in which the needle  116  is retracted within the bore  110  of the barrel  104 .  FIGS. 6 and 7  respectively are isometric and cross-sectional views of the penile prosthesis implantation device  100  while in an extended position, in which the needle  116  is extended beyond the barrel  104 . 
     As with the device  100 A, the device  100 B is configured for use in the insertion of a penile prosthesis into the corpus cavernosae of the penis of a patient for the treatment of impotence, as described above. One embodiment of the device  100 B comprises a barrel  104 , an obturator  106  and a needle clamp  108 B. The barrel  104  has a bore  110  that is generally axially aligned with a longitudinal axis  112  of the obturator  106 . 
     In one embodiment of the device  100 B, the bore  110  of the barrel  104  comprises a tapered section  110 A at the opening  146 . The tapered section  110 A of the bore  110  has an internal diameter that increases with distance traveled along the longitudinal axis  112  toward the opening  146 . As the device  100  is moved from the retracted position ( FIGS. 4 and 5 ) to the extended position ( FIGS. 6 and 7 ) by moving the clamp  108 B toward the opening  146  of the barrel  104 , the needle clamp  108 B opens to the receiving position  128 , shown in  FIG. 7 . While in the receiving position  128 , the deflector portions  132 A and  132 B are positioned within the tapered section  110 A of the bore  110 . The larger internal diameter in the section  110 A allows the deflector portions  132 A and  132 B to expand slightly within the bore  110  thereby increasing the gap between the pinching members  123 A and  123 B. 
     In one embodiment, the gap between the pinching members  123 A and  123 B allows for an interference fit between the thread attachment end  114  of the needle  116  while the needle clamp  108 B is in the receiving position  128 . The thread attachment end  114  can be secured to the needle clamp  108 B by the interference fit between the pinching members  123 A and  123 B. One advantage to this receiving position  128  is that one may attach the thread attachment end  114  of the needle  116  to the needle clamp  108 B without having to retract the obturator  106 . 
     As the obturator  106  is moved relative to the barrel  104  toward the retracted position, the deflector portions  132 A and  132 B are compressed by the narrowing of the internal diameter of the bore  110  as the needle clamp  108 B is moved from the tapered section  110 A to section  110 B of the bore  110 , which has a narrower internal diameter. The compression of the deflector portions  132 A and  132 B within the section  110 B of the bore  110  drives the pinching members  123 A and  123 B toward each other thereby narrowing the gap between the pinching members  123 A and  123 B and securing the thread attachment end  114  of the needle  116  within the needle clamp  108 B. Accordingly, the needle clamp  108 B moves to this clamping position  130  as the device  100  moves from the extended position to the retracted position. In one embodiment, the needle  116  is fully received within the bore  110  of the barrel  104  when the device  100  is the fully retracted position shown in  FIGS. 4 and 5 . 
     In accordance with another embodiment, the obturator  106  includes a stop member  180  positioned, for example, intermediate a proximal end  210  and the needle clamp  108 B. Additionally, the bore  110  includes a section  110 C having an internal diameter that accommodates the stop member  180 . The section  110 B located at the first end  142  of the barrel  104  and a section  110 D located at the second end  144  of the barrel  104  have internal diameters that are smaller than the internal diameter of the section  110 C of the bore  110 . Additionally, the stop member  180  is sized to prevent it from entering the sections  110 B or  110 D of the bore  110 . As a result, the stop member  180  limits the distance the obturator  106  can be moved relative to the barrel  104  between the fully retracted position shown in  FIG. 5  and the fully extended position shown in  FIG. 7 . In one embodiment, the needle clamp  108 B is positioned within the tapered section  110 A of the bore  110  when the device  100  is positioned in the fully extended position, as shown in  FIG. 7 . 
     One embodiment of the device  100 B includes a protective member  182  that snaps to the shaft  170  of the obturator  106  while the device  100  is in the fully retracted position, as shown in  FIGS. 4 and 5 . The protective member  182  operates to prevent the obturator  106  from moving from the retracted position to the extended position and thereby prevents the needle  116  from being unintentionally extended out of the barrel  104 . Other similar devices for use with the penile prosthesis implantation devices of the present invention are described below. 
       FIG. 8  is a cross-sectional view of a penile prosthesis implantation device  100 C in accordance with additional embodiments of the invention. The elements illustrated in  FIG. 8  and other figures having the same or similar labels as the elements of  FIGS. 1-7  generally correspond to the same or similar elements.  FIG. 9  is a magnified view of the needle clamp  208 C shown in  FIG. 8 . As with the devices  100 A and  100 B, the device  100 C is configured for use in the insertion of a penile prosthesis into the corpus cavernosae of the penis of a patient for the treatment of impotence, as described above. Accordingly, the sutures  120  and the penile prosthesis  101  ( FIG. 1 ) may be attached to the needle  116  held by the device  100 C, but are not shown in order to simplify the illustrations. 
     One embodiment of the device  100 C comprises a barrel  104 , an obturator  106  and a needle clamp  108 C. The barrel  104  has a bore  110  that is generally axially aligned with a longitudinal axis  112  of the obturator  106 . In one embodiment, the barrel  104  comprises separate halves that are secured together using one or more o-rings  184  (shown in  FIG. 8 ), one or more latches, an adhesive, ultrasonic welding, or other suitable technique. 
     The needle clamp  108 C is configured to grasp the connecting end  114  of a needle  116  formed in accordance with the embodiments described above. The needle clamp  108 C is either attached to, or formed integral with, a distal end  122  of the obturator  106 . One embodiment of the clamp  108 C comprises pinching members  186 A and  186 B respectively having opposing pinching surfaces  188 A and  188 B, which are best shown in the magnified cross-sectional view of the needle clamp  108 C provided in  FIG. 9 . The pinching surfaces  188 A and  188 B are separated by a gap, which is configured to receive the thread attachment end  114  of the needle  116 , as shown. The gap between the pinching surfaces  188 A and  188 B is preferably selected to be slightly smaller than the thickness of the end  114  of the needle  116  to provide an interference fit between the pinching surfaces  188 A and  188 B and the end  114  of the needle  116 . Frictional resistance between the pinching surfaces  188 A and  188 B and the end  114  of the needle  116  caused by the interference fit operates to secure the end  114  of the needle  116  in the needle clamp  108 C during normal use of the device  100 C including handling the device  100 C and piercing the glans of the penis with the end  118  of the needle  116  during a penile prosthesis implantation operation. In one embodiment, the end  114  of the needle  116  can be inserted within the gap between the pinching surfaces  188 A and  188 B by hand. 
     In one embodiment, the barrel  104  includes a stop member  140  at the second end  144  of the bore  110 , such as a shoulder portion, that engages a portion of the distal end  122  of the obturator  106  to prevent the distal end  122  of the obturator  106  from being pulled out of the end  144  of the barrel  104 . In accordance with another embodiment, the barrel  104  includes a stop member  190  at the first end  142  of the bore  110 , such as a shoulder portion, that engages a portion of the distal end  122  of the obturator  106  to limit the distance the obturator  106  can travel toward the end  142  of the barrel  104 . 
     One embodiment of the obturator  106  includes one or more bore engaging members  196 , embodiments of which are shown in  FIG. 9 . The one or more bore engaging members  196  are configured to engage the interior wall  117  of the bore  110  and provide frictional resistance between the obturator  106  and the barrel  104 . The frictional resistance between the bore engaging members  196  and the interior wall  117  of the barrel  104  operates to prevent undesired movement of the obturator  106  relative to the barrel  104  during normal handling of the device  100 C. When the needled  116  secured by the clamp  108 C is retracted within the barrel  104 , as illustrated in  FIG. 8 , the frictional resistance prevents the obturator  106  from sliding relative to the barrel  104  and extending the needle  116  outside of the barrel  104 . 
     In one embodiment, the bore engaging member or members  196  include a surface  198  that is radially displaced from the axis  112  a greater distance than other portions of the distal end  122  of the obturator  106 . In one embodiment, a gap  199  is formed between the bore engaging member  196  and the interior portion of the distal end  122  of the obturator  106 . The gap  199  allows the bore engaging member  196  to deflect toward the central axis  112  responsive to contact between the surfaces  198  and the surface  117  of the bore  110 . In one embodiment, the bore engaging members  196  flex toward the axis  112  when installed within the bore  110  of the barrel  104 . The pressure applied to the interior wall  117  of the bore  110  by the surface  198  of the one or more bore engaging members  196  generates the desired frictional resistance between the obturator  106  and the barrel  104 . In one embodiment, the one or more bore engaging members  196  comprises a ring-shaped member that is generally coaxial to the axis  112 . Alternatively, the bore engaging members  196  may comprise a plurality of components that are angularly displaced about the axis  112 . 
     Another embodiment of the invention is directed to a needle guard that is configured to secure the needle  116  within the bore  110  of a prosthesis implantation device, such as the devices  100 A-C described above. While the embodiments of the needle guard will be illustrated as being applied to the device  100 A, it is understood that embodiments of the needle guard  200  may also be used with the devices  100 B and  100 C, or other similar device, in the same or similar manner. 
       FIG. 10  is a cross-sectional view of a needle guard  200  in accordance with embodiments of the invention. It is understood that the end  114  of the needle  116 , installed within the barrel  104 , may be coupled to sutures  120  that are connected to a penile prosthesis  101 , as shown in  FIG. 1 . These elements are not shown in order to simplify the illustration. 
     In one embodiment, the needle guard  200  is formed of plastic. The attachment of the needle guard  200  to the device  100  operates to cover the open end  142  of the barrel  104  to prevent the piercing end  118  of the needle  116  from sticking out. In one embodiment, the needle guard  200  cradles the obturator  106  to prevent it from advancing the needle  116  through the opening in the end  142  of the barrel  104 . 
     One embodiment of the needle guard  200  comprises a first member  202 , a second member  204  and a third member  206 . The first member  202  is configured to cover the opening  208  of the bore  110  at the first end  142 . In one embodiment, the first member comprises a surface  209 , such as a convex surface, that partially extends within the bore  110  of the barrel  104 . The second member  204  engages a first end  210  of the obturator  106  and the third member  206  couples the first and second members of the needle guard  200  together. 
     In one embodiment, the obturator  106  includes a cross member  212  at the first end  210  that extends transversely from the longitudinal axis  112 , and the second member  204  of the needle guard  200  engages the cross member  212 , as shown in  FIG. 10 . In one embodiment, the first and second members  202  and  204  include portions that are inline with the longitudinal axis  112  of the obturator  106 . In one embodiment, the needle guard  200  is partially secured to the device  100  through the application of a compressive force between the first and second members  202  and  204  that is applied to the obturator  106  and the barrel  104 . 
     One embodiment of the needle guard  200  includes a fourth member  214  that is positioned between the cross member  212  and the barrel  104 , as shown in  FIG. 10 . The fourth member is configured to limit movement of the obturator  106  toward the barrel  104  along the longitudinal axis  112 . As a result, one embodiment of the needle guard  200  operates to prevent relative movement between the obturator  106  and the barrel  104 . One embodiment of the fourth member  214  comprises a portion  216  that engages the cross member  212  of the obturator and a portion  218  that engages the barrel  104 . While illustrated as being integral with or coupled to third member  206 , it is understood that the fourth member  214  can be formed as a separate component (i.e., non-integral to the needle guard  200 ) that fits between the barrel  104  and the cross member  212 . 
     In accordance with one embodiment, the fourth member  214  is secured between the cross member  212  and the barrel  104  due to an interference fit there-between. In accordance with another embodiment, the fourth member  214  is configured to snap-fit to the shaft  220  of the obturator  106 , as illustrated in the top plan view of the needle guard  200  shown in  FIG. 11  with the obturator  106  and the barrel  104  illustrated in phantom lines. In one embodiment, the fourth member  214  includes at least two opposing clip members such as clip member pair  222 A and  222 B extending from portion  216 , or clip member pair  224 A and  224 B extending from portion  218 . The gap  226  separating clip member pair  222 A and  222 B or gap  228  separating clip member pair  224 A and  224 B is set such that the shaft  220  of the obturator  106  can be secured between the clip member pairs  222 A and  222 B and/or  224 A and  224 B by an interference-fit. 
       FIG. 12  is a side view of the needle guard  200  in accordance with another embodiment of the invention. This embodiment of the needle guard  200  takes advantage of the stop member  140  (devices  100 A and  100 C) of the barrel  104  which prevents the obturator  106  from being pulled out of the second end  144  of the barrel  104 . The device  100  is secured to the needle guard  200  using the first member  202 , the third member  206  and the fourth member  214 . In one embodiment, the portion  216  includes the clip members  222 A and  222 B (not shown) to provide the desired snap-fit or interference fit to the shaft  220  of the obturator  106 . 
     One embodiment of the invention relates to a kit  230 , embodiments of which are illustrated in the schematic diagram of  FIG. 13 . One embodiment of the kit  230  includes one or more penile implantation devices  100  formed in accordance with one or more of the embodiments described above. In one embodiment, the device  100  holds a needle  116  in the needle clamp  108  formed in accordance with one or more of the embodiments described above. In one embodiment, the needle  116  is threaded with a suture  120  and coupled to a tip end  102  of the penile prosthesis  101 . The obturator  106  is placed in the retracted position, in which the needle  116  is fully received within the barrel  104 . In one embodiment, a needle guard  200 , formed in accordance with one or more embodiments described above, is installed on the device  100 . In one embodiment, the kit contains instructions  232  for using the device  100  to implant the penile prosthesis. In one embodiment, system components  234 , such as pumps, fluid reservoirs and other components used in penile prosthetic systems are also included in the kit  230 . 
     In one embodiment, a device holder  240  is used to attach one or more of the devices  100 , penile prosthesis  101 , and/or sutures  120  together, as illustrated in  FIG. 13 . In one embodiment, the device holder  240  includes at least one device receiving portion  242 , such as a slot or a bore, configured to receive, or attach to, a device  100 . The device  100  is preferably sufficiently held by the portion  242  to allow for normal handling of the device holder  240  while allowing the device  100  to be removed from the portion  242  by hand. In one embodiment, the device holder  240  includes at least one prosthesis receiving portion  244  configured to receive a penile prosthesis  101 , such as a slot or a bore. The penile prosthesis  101  is preferably sufficiently held by the portion  244  to allow for normal handling of the device holder  240  while allowing the penile prosthesis  101  to be removed from the portion  242  by hand. 
     In one embodiment, the device holder is formed using a silicone elastomer. Some advantages of such a material include its elasticity and ability to accommodate the device and prosthesis, its biocompatibility, and its ability to be easily sterilized by common methods. 
     In one embodiment, the device holder  240  includes at least one suture receiving portion  246  configured to receive the suture  120 , such as a slot or a bore. The suture  120  is preferably sufficiently held by the portion  246  to allow for normal handling of the device holder  240  while allowing the suture  120  to be removed from the portion  242  by hand. In one embodiment, the portion  246  is in the form of a bore and the suture  120  is wrapped up and inserted into the bore. When the device  100  and prosthesis  101  are removed from the portions  242  and  244 , the suture  120  can be pulled from the portion  246  without tangling the suture  120 . Additionally, portion  246  is used to hold the suture  120  to prevent it from becoming tangled with the other components of the kit  230  during shipment and handling. 
     In one embodiment, the kit  230  includes packaging  250  that contains one or more of the components of the kit  230  described above. The components of the kit  230  are preferably sterilized in the packaging  250 . The packaging  250  is then sealed. 
     Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.