Abstract:
The invention includes a system and method for reducing the approximation of wound edges of a stricture that affects a cross-sectional area of a lumen in a mammal. The system includes a body defining a passageway for fluid flow. The body is positionable in the lumen. The system also includes a separating device disposed relative to the body. The separating device can adjust the cross-sectional area of the lumen to reduce approximation of the plurality of wound edges of the stricture. Moreover, the separating device facilitates fluid flow through the passageway of the body.

Description:
TECHNICAL FIELD 
   This invention generally relates to strictures and, more specifically, methods and devices to reduce approximation of wound edges of a stricture in a lumen of a body. 
   BACKGROUND INFORMATION 
   Suffering an injury is often painful and upsetting to the injured party. The body typically responds in several fashions, often dependent upon the type and severity of the injury. One such response is the production of scar tissue, whose growth may impede other parts of the body. The scar tissue&#39;s growth can lead to other problems within the body. For example, scar tissue can form around and/or affect a lumen of the body, thereby potentially narrowing the lumen. This narrowing of the lumen, also called a stricture, typically reduces the amount of fluid that can flow through the lumen. 
   An example of a lumen that a stricture can affect is the urethra. The male urethra is generally a tubular passageway extending from the bladder to the end of the penis. As urine travels from the bladder and out of the body, the urine passes through the urethra. A stricture, however, narrows the urethra. This narrowing of the urethra (i.e., lumen) can impede fluid flow (e.g., urine) through the urethra, cause pain during use of the urethra, and/or require medical intervention to expand or stretch the obstruction. 
   A trauma to the urethra or surrounding areas is an example of an event that can cause the formation of a stricture. A trauma can be the result of an external injury, such as a straddle injury (e.g., falling onto a bicycle frame). Pelvic fractures, which can occur as a result of an automobile accident, can also lead to strictures of the urethra. Surgical procedures involving the urethra can cause stricture formation. Other causes of a urethral stricture include an infection, such as gonorrhea, or inflammation of an area of the urethra. 
   To treat a stricture, medical professionals (e.g., doctors, nurses, hospital employees, or people with medical training) often have several options. One option is a procedure called dilation. Dilation is performed in the medical professional&#39;s office and involves stretching of the stricture using progressively larger dilators. Another option, which medical professionals perform in the operating room using an endoscopic instrument, is called internal urethrotomy. Internal urethrotomy involves an internal incision of the stricture through the penis to open the stricture. Thus, the medical professional typically cuts the stricture to remove the narrowing of the urethra. 
   After the surgical incision through the stricture, the stricture&#39;s wound edges heal. If left unattended, the stricture&#39;s wound edges can heal together, likely resulting in a larger stricture than present before the surgical incision. Thus, the surgery&#39;s objective of removing the narrowing of the urethra may be met temporarily, but the healing of the stricture can narrow the urethra even further. 
   The medical professional typically places a catheter into the urethra after the surgical incision is made. The catheter typically keeps the urethra opened after the surgery until the catheter is removed (after a certain period of time). In addition to helping prevent subsequent recurrence of a stricture, patency of the urethra is important for several reasons, such as to aid in the healing of the urethra, for the drainage of urine, and to enable vascular flow through the urethra. One such type of catheter that a medical professional inserts is a Foley catheter. 
   The technique of using a catheter to maintain urethral patency, however, is subject to several drawbacks. First, the catheter that the medical professionals insert to maintain the proper opening of the urethra has a fixed diameter. Thus, because catheters are typically limited to a fixed diameter, wound edges can form up to the diameter of the catheter. Moreover, dilation devices, such as balloons, can hinder or prevent blood or other bodily fluids from flowing through the urethra because the passageway or a large portion of the passageway is typically blocked by the dilation device. Catheters may also suffer from this drawback, as their diameter can limit the amount of fluid that can flow in and out of the urethra when attempting to prevent wound edges from approximating. 
   Although described above with a urethra, a stricture may form around any other type of lumen, such as a person&#39;s esophagus. Further, the problems described above also apply to these other types of lumens. Thus, there is a need to reduce the approximation of wound edges of a stricture while not preventing fluid flow through the lumen. 
   SUMMARY OF THE INVENTION 
   The invention enables fluid flow through a lumen that is narrowed by a stricture while also reducing the approximation of wound edges of the stricture. 
   In one aspect, the invention includes a system for reducing the approximation of wound edges of a stricture that affects a cross-sectional area of a lumen in a mammal. The system, or stricture retracting system, includes a body defining a passageway for fluid flow. The body is positionable in the lumen. The system also includes a separating device disposed relative to the body. The separating device can adjust the cross-sectional area of the lumen to reduce approximation of the plurality of wound edges of the stricture. Moreover, the separating device facilitates fluid flow through the passageway of the body. 
   The separating device can include wings and can be connected to or coupled to the body. Additionally, the system can also include an actuating mechanism that communicates with the separating device. The actuating mechanism can communicate with the separating device for disposing the separating device relative to the body for the adjusting of the cross-sectional area of the lumen. In one embodiment, the actuating mechanism is a spring that is connected to the separating device to dispose the separating device relative to the body. 
   Moreover, the actuating mechanism can include a mechanical device, a pneumatic device, a hydraulic device, or an electronic device. The actuating mechanism can also include a slide cam or a screw cam. Further, the body can include one or more separating device slits for disposing the separating device. The body can also include a control ring that enables adjustment of the cross-sectional area of the lumen. 
   In another aspect, the invention includes a flexible member that is positionable in a lumen and a controller. The controller can adjust the pressure of the flexible member to alter the cross-sectional area of the lumen. This reduction in the cross-sectional area of the lumen reduces approximation of wound edges of the stricture. Moreover, the adjustment of the pressure facilitates fluid flow through the lumen. 
   In one embodiment, the controller includes a valve. The controller can also include an electrical controller connected to the flexible member for adjusting the pressure of the flexible member. Additionally, the flexible member can be hydraulic or pneumatic and can be made from a compliant material or a semi-compliant material. 
   In yet another aspect, a system for reducing approximation of wound edges of a stricture that affects a cross-sectional area of a lumen in a mammal includes means for adjusting the cross-sectional area of the lumen. The adjustment of the cross-sectional area reduces approximation of wound edges of a stricture. Moreover, the system includes means for facilitating fluid flow through the lumen after adjusting the cross-sectional area of the lumen. 
   In another aspect, the invention includes a method for reducing approximation of wound edges of a stricture. The method includes the step of inserting a body defining a passageway into the lumen. The method also includes the step of causing a separating device disposed relative to the body to adjust the cross-sectional area of the lumen for reducing approximation of the wound edges of the stricture. The method additionally includes facilitating fluid flow through the passageway of the body of the lumen. 
   The method can include employing an actuating mechanism to cause the separating device to adjust the cross-sectional area of the lumen. This can include translating a cam device or mechanically rotating a cam device. Further, the amount of cross-sectional area adjustment can also be adjustable. 

   
     BRIEF DESCRIPTION OF DRAWINGS 
     The advantages of the invention described above, together with further advantages, may be better understood by referring to the following description taken in conjunction with the accompanying drawings. The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. 
       FIG. 1  is an embodiment of a schematic view of a male urinary system. 
       FIG. 2A  is an embodiment of a perspective view of a stricture affecting a urethra. 
       FIG. 2B  is an embodiment of a cross-sectional view of a urethra not affected by a stricture. 
       FIG. 2C  is an embodiment of a cross-sectional view of a urethra affected by a stricture. 
       FIG. 2D  is an embodiment of a perspective view of a surgical incision made through the stricture. 
       FIG. 2E  is an embodiment of a cross-sectional view of the urethra affected by the stricture after the surgical incision of  FIG. 2D  is made. 
       FIG. 3  is a block diagram of an embodiment of a stricture retracting system that provides therapeutic expansion of the urethra after the surgical incision through the stricture. 
       FIG. 4  is a flow diagram of an embodiment of a flexible member stricture retractor inserted into the urethra affected by the stricture. 
       FIG. 5  is an embodiment of a cross-sectional view of a flexible member, stricture, and urethra after the flexible member expands. 
       FIG. 6A  is an embodiment of a perspective view of an embodiment of a stricture retracting system. 
       FIG. 6B  is an embodiment of a cross-sectional view of the stricture retracting system of  FIG. 6A . 
       FIG. 7A  is a perspective view of another embodiment of the stricture retracting system of  FIG. 6A  having an actuating mechanism. 
       FIG. 7B  is an embodiment of a cross-sectional view of the stricture retracting system of  FIG. 6A . 
       FIG. 7C  is an embodiment of a cross-sectional view of the stricture retracting system of  FIG. 6A  having a connector. 
       FIG. 8A  is a perspective view of an embodiment of the stricture retracting system of  FIG. 6A  having a cylinder as the actuating mechanism. 
       FIG. 8B  is perspective view of an embodiment of the stricture retracting system of  FIG. 6A  having a spring as the actuating mechanism. 
       FIG. 8C  is a frontal view of the spring of  FIG. 8B  in a rest state. 
       FIG. 8D  is a frontal view of the spring of  FIG. 8B  in a compressed state. 
       FIG. 9  is a perspective view of an embodiment of the stricture retracting system of  FIG. 6A  having a control ring. 
       FIG. 10  is a perspective view of an embodiment of the stricture retracting system of  FIG. 6A  having slits in various positions. 
       FIG. 11  is a perspective view of an embodiment of the stricture retracting system of  FIG. 6A  having a zig-zag slit. 
       FIG. 12  is a block diagram of an embodiment of a stricture retractor delivery system. 
   

   DETAILED DESCRIPTION 
     FIG. 1  shows a male urinary system  100 , which includes a bladder  102  and a urethra  104 . The male urethra  104  is generally a tubular passageway extending from the bladder  102  to the meatus  106  of the penis. As urine travels from the bladder  102  and out of the body, the urine passes through four sections of the urethra  104 , referred to as the prostatic urethra, the membranous urethra, the bulbar urethra, and the pendulous or distal urethra. Surrounding the prostatic urethra and below the bladder  102  is a prostate gland  108 , which, among other functions, produces the fluid in semen. 
     FIG. 2A  shows a perspective view of a portion of the urethra that is affected by a stricture  204 . The affected urethra  202  is narrowed by the stricture  204 . Urine  206  flows through the affected urethra  202 . The stricture  204 , however, decreases the volume of urine  206  that can pass through the affected urethra  202  at any given time because of the narrowing of the affected urethra  202 . Moreover, the stricture  204  can become so large that the stricture  204  substantially blocks urine flow  206  through the affected urethra  202 . 
     FIG. 2B  refers to a cross-sectional view of a urethra not affected by a stricture. The unaffected urethra  104  (i.e., all or a portion of the urethra  104 ) can have an initial, circular cross-sectional area  210 .  FIG. 2C  is a cross-sectional view of the urethra  202  narrowed by the stricture  204 . The cross-sectional area  212  of the affected urethra  202  is less than the initial cross-sectional area  210 . Moreover, the amount of reduction in the cross-sectional area  212  of the affected urethra  202  relative to the initial cross-sectional area  210  varies depending on the stricture  204 . Additionally, the stricture  204  affecting the urethra  202  has an initial cross-sectional area  216 . 
   Referring to  FIG. 2D , to reduce the narrowing of the affected urethra  202  and consequently relieve the pressure applied against the urethra  202 , a medical professional makes a surgical incision  220  through the stricture. The incisions  220  can be made at a location at which the urethra is affected the greatest amount by the stricture  204 . Moreover, in one embodiment the surgical incision  220  is made axially through the stricture  204 . Further, the incision  220  has a depth equal to the depth of the stricture  204 . Although described as being cut axially through the stricture, the incisions  220  may also be any direction and any size in order to relieve some of the effect that the stricture  204  has on the urethra  202 . 
   Referring to  FIG. 2E , once the medical professional cuts the stricture  204 , the cross-sectional area  212  of the affected urethra  202  increases to a pressure-relieved cross-sectional area  250 . Likewise, the initial cross-sectional area of the stricture  204  is reduced to an after-cut cross sectional area  254 . Although shown with a particular cross-sectional area size and shape, the urethra  202 , stricture  204 , and/or cut  220  may have any size and any shaped cross-sectional area. 
   After the stricture  204  has been incised, wound edges  258  of the stricture  204  begin to heal together. Further, the healing of the stricture  204  can result in tougher, less vascular scar tissue (e.g., an epidermal layer). The stricture  204  may consequently contain more tissue mass. Moreover, the stricture  204  can become larger than before the cut  220  and again narrows the urethra  202  (e.g., such as the narrowing shown in  FIG. 2A ). 
   To reduce the approximation of the wound edges  258 , the medical professional can insert a flexible member into the urethra  202 . The medical professional can then adjust the pressure of the flexible member to keep the wound edges  258  apart while facilitating fluid flow through the urethra  202 . 
     FIG. 3  shows an embodiment of a stricture retracting system  300  that provides therapeutic expansion of the urethra  202  after the surgical incision through the stricture  204 . The system  300  includes a flexible member  304 , which can be a balloon dilation device. The flexible member  304  can be constructed of any flexible material, such as a compliant material. Examples of compliant materials include silicone, urethane, and latex. Alternatively, the flexible member  304  can be made of a semi-compliant material, such as ethylene vinyl acetate or polyethene. Further, although described below as having a balloon-like shape and size, the flexible member  304  can have any shape or any size. Additionally, the flexible member  304  can be a pneumatically actuated device. 
   The flexible member  304  can also have an initial pressure that is set for insertion into the patient&#39;s urethra  202 . The initial pressure of the flexible member  304  can also be set to a predetermined amount before delivery to the user of the flexible member  304 . The user can additionally set the initial pressure before its insertion into the urethra  202 . Thus, after the surgical cut  220  of the stricture  204 , the user can insert the flexible member  304  into the urethra  202 , which subsequently increases the pressure of the flexible member  304  to keep the wound edges  258  of the stricture  204  apart. 
   Moreover, the flexible member  304  has a distal end  308  which is inserted into the patient before the rest of the flexible member  304  and a proximal end  312 . Although the flexible member  304  is shown with the portion of its body near the distal end  308  having a larger cross-sectional area than the cross-sectional area of a portion of the flexible member  304  near the proximal end  312 , any portion of the flexible member  304  can be any size. The proximal end  312  of the flexible member  304  can include an opening  316  that can be used to adjust the pressure of the flexible member  304 . The opening  316  can be adjustable so that a medical professional can open and close the opening  316 . Moreover, the amount that the medical professional opens and closes the opening  316  can also be adjustable. For example, the medical professional can open the aperture  316  slightly to decrease the pressure of the flexible member  304  slightly. 
   Further, the flexible member  304  can include a flexible member line  320 . The flexible member line  320  is connected to (e.g., attached to, passing through, or terminating at) the opening  316  so that the flexible member line  320  can adjust the pressure of the flexible member  304 . The flexible member line  320  can be rigid or flexible. Examples of materials that the flexible member line  320  can be made with include thermoplastic, thermoset, metal, and composite materials. In one embodiment, the flexible member line  320  is secured inside the proximal end  312  of the flexible member  304  (e.g., through the opening  316 ). For example, the flexible member line  320  can be secured to the flexible member  304  with a fastening member  324 , such as with tape, glue, a staple, or velcro. Moreover, a user can increase the length of the flexible member line  320  by pulling its proximate end  328  (i.e., the end furthest away from the opening  316  of the flexible member  304 ) in a direction away from the opening  316 . Likewise, a user can also decrease the length of the flexible member line  320  by pushing its proximate end  328  in a direction towards the opening  316 . 
   In yet other embodiments, a medical professional can adjust the shape of the flexible member line  320  for different scenarios. For instance, if a medical professional determines that the size and/or shape of the flexible member line  320  needs to be altered after insertion of the flexible member  304  into the urethra  202 , the medical professional can choose a first flexible member line made from thermoplastic. Thus, when the medical professional determines that the first flexible member line needs adjustment, the medical professional can heat the first flexible member line to shape the flexible member line for its use. Moreover, the medical professional can choose a flexible member line  320  made from, for example, thermoplastic to facilitate recycling of the flexible member line  320 . 
   The medical professional can additionally determine that the flexible member line  320  has to be consistent and stable, such as during exposure to heat. The medical professional can choose a flexible member line  320  made from a thermoset material. In another embodiment, the flexible member  304  enables the changing of the flexible member line  320 . Thus, the medical professional can be able to unfasten the fastening member  324  and change the flexible member line  320  at any time before, during, or after the insertion of the flexible member  304  into the urethra  202 . 
   The flexible member line  320  can also include a controller connector  332 . The controller connector  332  enables the adjustment of pressure to the flexible member  304 . The controller connector  332  can limit the type of devices that can be used to adjust the pressure to a device having a connector that mates with the controller connector  332 . 
   The stricture retracting system  300  can additionally include a controller  336  to adjust the pressure of the flexible member  304 . Examples of the controller  336  include a computer, a valve, and a pump. The controller  336  adjusts the pressure of the flexible member  304  to reduce approximation of at least some of the wound edges  258  of the stricture  204 . Moreover, the controller  336  can also adjust the pressure to facilitate fluid flow through the urethra  202 . 
   The controller  336  includes one or more control panels  340  enabling the medical professional to adjust the output of the controller  336 . Each control panel  340  can include, for example, knobs, buttons, keys, and/or sliders to enable the medical professional to adjust the output of the controller  336 . The control panel  340  can be a touch sensitive display having virtual knobs, buttons, keys and/or sliders. Further, an external computer (e.g., desktop computer or handheld computer) can control the controller  336 . In particular, a software module executing on the computer can control the controller  336 . The computer and/or the controller  336  can additionally be connected to a network, such as the Internet or World Wide Web. The network connection can enable the medical professional to remotely control the controller  336  via another computer. 
   Furthermore, the controller  336  can also include a display screen  344 . The display screen  344  may display the settings of the controller  336  (e.g., number of pounds per square inch that the controller  336  is outputting, time settings, such as the length of time at which to output a predetermined number of pounds per square inch, program execution, etc.). The display screen  344  can be a touch sensitive panel having virtual buttons, knobs and settings. 
   The controller  336  also includes a controller line  348  for the delivery of the controller&#39;s output. For example, the controller  336  can provide air to inflate the flexible member  304 . Like the flexible member line  320 , the controller line  348  can be a rigid or flexible cable. Furthermore, the controller line  348  can be made with one or more of the materials described above for the flexible member line  320  (e.g., thermoplastic or composite materials). The user may also be able to adjust the length of the controller line  348  in a similar fashion as described above for the flexible member line  320  (e.g., by pushing the controller line  348  towards the controller  336  to shorten the line&#39;s length). Additionally, the controller line  348  can be secured to an output port  352  of the controller  336 . Thus, the output port  352  enables a user to change the type of controller line  348  that delivers the output of the controller  336  (e.g., from a flexible controller line to a rigid controller line). 
   The controller line  348  also has a flexible member line connector  356  attached to its proximal end  360 . The flexible member line connector  356  is a connector that mates with the controller connector  332 . Moreover, once the connection is made between the two connectors  332 ,  356 , the connectors may not be easily disconnected. For instance, the medical professional may not be able to disconnect the connectors  332 ,  356  until rotating each connector  332 ,  356  in opposite directions simultaneously. This security measure can prevent the connectors  332 ,  356  from disconnecting accidentally. 
   In one embodiment, the medical professional inflates the flexible member  304  to stretch the narrowed urethra  202  by the desired amount, thereby maintaining wound edge separation of the stricture  204 . To reduce pressure necrosis, which occurs when wound healing is compromised from a reduced vascular flow, the pressure of the flexible member  304  can be reduced to cause the flexible member  304  to deflate. This reduction in pressure can occur periodically or spontaneously. The medical professional can adjust the controller  336  to decrease the pressure of the flexible member  304 , such as via an adjustment of a button on the control panel  340 . Alternatively, the controller  336  cycles the pressure supplied to the flexible member  304 . This cycling can be based on a software program. For example, the controller  336  can execute a program having instructions to apply a first pressure for 3 seconds, a second pressure for 5 seconds, a third pressure for 10 seconds, and then repeat the previous steps. The medical professional may instead adjust the pressure of the flexible member  304  manually, such as by expanding the opening  316  slightly to let out some air of the flexible member  304 . Thus, the cross-sectional area  212  (and therefore diameter) of the flexible member  304  can be adjusted (i.e., increased and/or decreased) at any rate and at any time (e.g., during the implantation of the device and/or during follow-up evaluation of the flexible member  304 ). 
   Furthermore, the display screen  344  can display the amount of pressure that the controller  336  supplies through the controller line  348  to the flexible member. The medical professional may also measure the pressure of the flexible member  304  by applying a pressure gauge or monitor to the flexible member  304 . 
   In addition to preventing the reduction of vascular flow, the flexible member  304  also includes a flexible member drainage line  364 . In  FIG. 3 , the flexible member drainage line  364  is a line (or tube) having a portion placed behind the flexible member  304 . Thus, the flexible member drainage line  364  enables the drainage of fluids during, for example, the implanting of the flexible member  304 . These fluids can be bodily fluids, such as urine and/or blood, that can collect behind, the flexible member  304 . 
   The flexible member drainage line  364  can be made of any material described above. Further, the flexible member drainage line  364  has a drainage port  366  at the proximal end  367  of the flexible member drainage line  364 . The drainage port  366  can empty into another location for removal of the bodily fluids and/or waste. For example, the drainage port  366  may empty into a waste container or may connect to a device used to remove or clean the waste. 
   The flexible member line  320  and the flexible member drainage line  364  can be individually wrapped and/or grouped in a sheath or coating. For example, the sheath or coating can be employed to group the lines  320 ,  364  together so as to facilitate easy retrieval of each line&#39;s contents. Additionally, the flexible member  304  can also be coated to provide additional protection from waste, debris, etc. 
   The flexible member  304  together with each line  320 ,  364  and each corresponding connector or port  332 ,  366  may be referred to below as a flexible member stricture retractor  370 . A grouping of the lines  320 ,  364  in a sheath or coating can also facilitate deploying the flexible member stricture retractor  370  into the patient&#39;s urethra  202 . 
   Although described above as being a pneumatic device, the flexible member  304  can also be a hydraulic device. Examples of the fluid that can be used to inflate/deflate the flexible member  304  include saline, sterile water, radiopacifier, and hydrogel. Moreover, a combination of one or more of these fluids can also be used to fill the flexible member  304 . 
   Referring to  FIG. 4 , a medical professional inserts the flexible member stricture retractor  370  into the urethra  202 . The medical professional can connect the controller  336  to the controller connector  332  and can apply, for example, air (or a liquid) to the flexible member  304 , as shown with arrow  404 . The flexible member  304  increases in size as the controller  336  applies pressure. Moreover, the flexible member drainage line  364  and the drainage port  366  provide a lumen that enables drainage of the bodily fluids, as shown with arrow  408 . 
   Referring to  FIG. 5 , an embodiment of the cross-section of the stricture  204  and the urethra  202  is shown after the flexible member  304  expands to an expanded cross-sectional area  504  (e.g., in response to the controller&#39;s application of pressure). The cross-sectional area of the proximal end  312  of the flexible member  304  is shown as cross-sectional area  508 . In particular, the flexible member  304  has opened up the urethra  202  to a cross-sectional area  512  by expanding the stricture  204  to an expanded cross-sectional area  516 . Due to this expansion, the stricture  204  no longer substantially narrows the urethra  202 . 
   Referring to  FIGS. 6A and 6B , an alternate stricture retracting system  600  for reducing the wound edges  258  from approximating includes components that can be activated to adjust the cross-sectional area  212  of the urethra  202 . The system  600  includes a body  604  that defines a passageway  608 . The body  604  is constructed from a circular channel and has an initial cross-sectional area  612 . The initial cross-sectional area  612  of the body  604  is less than the cross-sectional area  212  of the affected urethra  202 , thereby enabling the insertion of the body  604  into the urethra  202  narrowed by the stricture  204 . The passageway  608  has a cross-sectional area  614 . Although illustrated as circular, the body  604  and/or the passageway  608  can be any shape or size. Moreover, any part of the stricture retracting system  600  (e.g., the body  604 ) can be coated with a coating to provide additional protection to the component(s) of the alternate stricture retracting system  600 . 
   The body  604  can additionally be connected to a suture  616 . The medical professional can leave the body  604  (or the flexible member  304 ) in the urethra  202  for a predetermined period of time (e.g., 1-3 days or 7 days) and then use the suture  616  (or lines  320 ,  364 ) to retrieve the body  604  from the urethra  202 . The suture  616  can have any length needed to enable the retrieval of the body  604 . The medical professional can also determine the length of the suture  616  at the time of insertion into the urethra  202 , such as by cutting the suture  616 . Similarly, the medical professional can connect the suture  616  to the proximal end  618  of the body  604  (e.g., the portion of the body  604  entering the urethra  202  after the other end of the body  604 ). The connection of the suture  616  can occur by, for example, tying the suture  616  onto the body  604  or taping the suture  616  onto the body. Further, the body  604  can have suture holes  620  for attaching the suture  616  to the body  604 . Additionally, the suture  616  can be made from one or more materials, such as nylon. 
   The body  604  also includes a separating device  622  (shown in an unactivated state in  FIG. 6A ) disposed relative to the body  604 . The separating device  622  is employed to adjust the cross-sectional area  212  of the affected urethra  202  to reduce the approximation of the wound edges  258  of the stricture  204 . The separating device  622  can also be coupled to the body  604 . The separating device  622  can be coupled to the body  604  via, for instance, mechanical coupling devices (e.g., screws, nails, tape, velcro, glue) or electrical or magnetic coupling techniques (e.g., via one or more magnets or an electrical circuit). Alternatively, the separating device  622  is connected to the body  604 . This connection can be via a mechanical linkage, such as one or more tie-rod, link, rope, chain, etc. 
   The separating device  622  can additionally include a rib  624 . The rib  624  may or may not be the same material as the separating device  622  and can be made of, for example, a polymer, plastic, or a combination of materials. The rib  624  can also be any size and shape. Further, although illustrated with one rib  624 , the body  604  can include any number of ribs. The rib  624  can protrude from the outside surface of the separating device  622  (or the body  604 ). The rib  624  can help prevent the body  604  from rotating inside the urethra  202  by, for example, “anchoring” the body  604  into the walls of the urethra  202 . Thus, if some type of bodily fluid (e.g., blood) traversing through the urethra  202  provided a torque on the body  604  during the flow of the fluid, the rib  624  can help stabilize the body  604  to facilitate the reduction of wound edge approximation. 
   Alternatively, the rib  624  is located on the inside of the separating device  622 . In this configuration, a medical professional can insert an instrument or item, such as the medical professional&#39;s finger, into the passageway  608  defined by the body  604  to activate the rib  624 . Activation of the rib  624  can occur by pushing, pulling, or exerting some type of force on the rib  624 . The rib  624  can then cause the activation (or deactivation) of the separating device  622  so that the separating device  622  opens or closes. 
   Furthermore, the separating device  622  can also include stress relief holes  628 . The separating device  622  includes stress relief holes  628  to alleviate the stress on the body  604  during activation of the separating device  622 , as described in more detail below. The stress relief holes  628  can be any size and shape, and although shown with two stress relief holes  628  in  FIG. 6A , the body  604  can have any number of stress relief holes  628 . 
   Referring to  FIG. 7A , the body  604  separates the wound edges  258  of the stricture  204  by activating the separating device  622 . The separating device  622  can include a first wing  702  and a second wing  704  that open when activated and close when deactivated. Moreover, the separating device  622  (i.e., the first and/or second wing  702 ,  704 ) can open until reaching any angle or until, for instance, blocked from further movement by the body  604 . For example, each wing  702 ,  704  can open 180 degrees relative to its starting position (e.g., 0 degrees) or any angle between 0 and 180 degrees. Although described above and below with two wings  702 ,  704 , the separating device  622  can have any number of wings  702 ,  704  needed to reduce the approximation of the wound edges  258 . Moreover, although the invention is described below with respect to the first wing  702 , any application can also be applied to the second wing  704  or both wings  702 ,  704 . Also, the wings  702 ,  704  are formed from an “I” cut into the body  604 . 
   The separating device  622  additionally has a height  708 . Furthermore, different stricture retracting systems  600  can have separating devices  622  with different heights  708 . The medical professional can select the height  708  of the separating device  622  before inserting the body  604  into the patient&#39;s urethra  202 . This determination can be based on, for example, the cross-sectional area  216  of the stricture  204 , the cross-sectional area  212  of the urethra  202 , and/or the initial cross-sectional area  210  of the unaffected urethra  104 . Alternatively, the height  708  of the separating device  622  is adjusted during insertion into the patient&#39;s urethra  202 , such as by pushing or pulling on the wings  702 ,  704 . 
   Also referring to  FIG. 7B , the cross-sectional area  212  of the urethra  202  is adjusted by changing the cross-sectional area  712  of the body  604 . As described above, this occurs during the activation of the separating device  622 . Upon activation of the separating device  622 , the separating device  622  opens to a particular angle and increases the initial cross-sectional area  712  of the body  604  to an expanded, circular cross-sectional area  716 . This consequently increases the cross-sectional area  212  of the urethra  202  to reduce the approximation of the wound edges  258 . Moreover, the expanded, circular cross-sectional area  716  of the body  604  is derived from and varies depending on the height  708  of the wings  702 ,  704  of the separating device  622 . Additionally, the pressure applied by the wings  702 ,  704  (i.e., the separating device  622 ) to the wound edges  258  can vary depending on the amount of narrowing of the urethra  202 . Thus, the pressure applied by the separating device  622  can decrease as the urethra  202  “relaxes” and the narrowing of the urethra  202  decreases. 
   Referring again to  FIG. 7A , an actuating mechanism  720  can be used to adjust the separating device  622 . The communication between the actuating mechanism  720  and the separating device  622  is shown with arrow  714 . The actuating mechanism  720  can additionally wirelessly communicate with the separating device  622 . For instance, the actuating mechanism  720  can be a radio frequency (or infrared, microwave, etc.) controller that the medical professional can use to open the separating device  622 . The medical professional can also be able to select an angle at which the medical professional prefers to have the actuating mechanism  720  open and inputs this selection into the actuating mechanism  720 . The actuating mechanism  720  then adjusts the separating device  622  to open the wings  702 ,  704  to the selected angle. 
   The actuating mechanism  720  can mechanically adjust the amount of opening of the separating device  622 . The actuating mechanism  720  can be externally located from the body  604  or located within the body  604 . In one embodiment, the actuating mechanism  720  connects to an actuating mechanism connector  724 . The actuating mechanism connector  724  is an internal component of the body  604  and connected to the separating device  622 . Alternatively, the actuating mechanism connector  724  is a component externally located from the body  604 , yet still connected to the separating device  622 . The actuating mechanism connector  724  can also be a screw. The actuating mechanism  720  can rotate the screw, thereby applying torque to the separating device  622  to open/close the device  622 . The actuating mechanism connector  724  can alternatively be a lever. The actuating mechanism  720  can be used to rotate or push the lever in various directions to change the opening amount of the separating device  622 . 
   Although shown with one actuating mechanism connector  724 , the body  604  can have any number of actuating mechanism connectors  724  connected to any part of the separating device  622 . Moreover, the actuating mechanism connector  724  can be any shape and/or size so long as the connector  724  can adjust the opening of the separating device  622 . 
   The actuating mechanism  720  can be or can communicate with the rib  624 . Further, the rib  624  can be located on one or both wings  702 ,  704 . The use of the rib  624  to manually open the separating device  622  can be useful in determining the range of motion of the wings  702 ,  704 , for instance. 
   Also referring to  FIG. 7C , one end of the actuating mechanism connector  724  can extend from the body  604  into the passageway  608 . Additionally, the actuating mechanism connector  724  can be positioned in any configuration. Further, the medical professional can move the actuating mechanism connector  724  to facilitate connection with the actuating mechanism  720 . For example, the actuating mechanism connector  724  can be moved to position  728 . 
   Referring to  FIG. 8A , the actuating mechanism  720  can be a cylinder  804 . The medical professional can insert the cylinder  804  into the passageway  608  defined by the body  604  to adjust the amount of opening of the separating device  622 . Further, the medical professional can rotate the cylinder  804  to adjust the amount of opening of the separating device  622 . The cylinder  804  can also have a retractable member  808  to connect to the actuating mechanism connector  724 . After at least some of the cylinder  804  is inserted into the passageway  608  defined by the body  604 , the retractable member  808  can extend out of the cylinder  804  and connect to the actuating mechanism connector  724 . In further embodiments, the cylinder  804  is rotated (e.g., by the medical professional, by a magnetic or electrical force, or by an external device such as a controller) to adjust the opening amount of the separating device  622 . Moreover, the cylinder  804  can additionally utilize a cam surface to control the amount of opening of the wings  702 ,  704 . 
   Referring to  FIG. 8B , the actuating mechanism  720  can also be a spring  816  connected to the separating device  622  (e.g., one of the wings  702 ,  704 ). In particular, one end  820  of the spring  816  is secured to the body  604  and the other end of the spring  816  is secured to the separating device  622 . Although illustrated with a particular orientation, the spring  816  can be oriented in any fashion to adjust the opening of the separating device  622 . 
   A spring controller  818  can control the amount of extension of the spring  816 . In one embodiment, the medical professional adjusts the amount of extension of the spring using the spring controller  818  before inserting the body  604  into the urethra  202 . In another embodiment, the medical professional uses the spring controller  818  after inserting the body  604  into the urethra  202  to adjust the spring  816 . Although the spring controller  818  is illustrated as a lever, the spring controller  818  can be any type of device having any shape or size. 
   Also referring to  FIGS. 8C and 8D , when the spring  816  is in a rest or unrestrained state in which no external forces are exerted upon any portion of the spring  816 , the spring  816  becomes an unrestrained spring  820  having an initial length  824 . In one embodiment, the unrestrained spring  820 , when secured to the body  604  and the wing  702 ,  704 , maintains the wing  702 ,  704  in a partly-opened position. The unrestrained spring  820  can alternatively maintain the wing  702 ,  704  in a fully opened position. When inserting the separating device  622  into the urethra  202 , the medical professional may compress the unrestrained spring  820  to a compressed state (i.e., compressed spring  828 ). The compressed spring  828  has a height  832  that is less than the height  824  of the unrestrained spring  820 . The spring  816  can additionally have a spring spread of (i.e., can be stretched or extended) substantially greater than or equal to two times the thickness of the incision cut  220 . 
   Referring to  FIG. 9 , the body  604  can also include a control ring  904 . A medical professional may slide the control ring  904  along the body  604  to adjust the stability of the body  604 . Thus, the control ring  904  can provide additional traction to the body  604  so that the body  604  remains in its desired position while, for instance, bodily fluids rush through the passageway  608 . Therefore, the medical professional may slide the control ring  904  to position  908  to provide additional stability to the body  604  at that location. The medical professional may also slide the control ring  904  to position  912  for increased stability. The control ring  904  can be any thickness and any length. Moreover, the control ring  904  can be made of any material, such as thermoplastic. Although illustrated as a ring, the control ring  904  can be a tube or other structure which is moveable along the body  604 . The control ring  904  can be moved to any position along the body  604 . 
   Referring to  FIG. 10  and instead of the “I” cut that forms the wings  702 ,  704  in the body  604 , the body  604  can have a slit cut into it. The slit can be an axial slit  1004  cut along the axis of the body  604 . In other embodiments, the slit can be an angled slit  1008 . These slits  1004 ,  1008  can provide additional flexibility to the body  604 . Further, upon activation through any of the means described above, the slit  1004 ,  1008  can open, creating wings (e.g., long or unsymmetrical) which can reduce wound edge approximation. 
   Referring to  FIG. 11 , the body  604  can alternatively have any type of slit creating wings of any shape. The medical professional may desire wings having different shapes depending on the patient, the patient&#39;s urethra  202 , the desired flexibility of the stricture retracting system  600 , the ease at which the body  604  can fit inside the urethra  202 , etc. For example, the body  604  can have a zig-zag slit  1104  to facilitate any of the previously mentioned purposes (e.g., increase the body&#39;s flexibility). 
   Referring to  FIG. 12 , the medical professional uses a stricture retractor delivery system  1200  to deploy flexible member stricture retractor  370  or the stricture retracting system  600  (e.g., the body  604 , the separating device  622 , the suture  616 , etc.). The stricture retractor delivery system  1200  can include a sliding member  1204  to exert a deploying force on the proximal end  328 ,  367  (or controller connector  332  or drainage port  366 ) of the lines  320 ,  364 , respectively. Similarly, the sliding member  1204  of the stricture retractor delivery system  1200  can provide a deploying force on the proximal end  618  of the body  604 . 
   Additionally, the proximal end  1206  of the stricture retractor delivery system  1200  can include a handle  1208 . The handle  1208  enables the sliding member  1204  to slide along a body  1212  of the stricture retractor delivery system  1200 . In particular, the handle  1208  can be coupled to the sliding member  1204 . The medical professional uses the handle  1208  to slide the sliding member  1204  along the body  1212  to exert the deploying force. In particular, the medical professional causes the sliding member  1204  to slide towards the distal end  1216  of the stricture retractor delivery system  1200  by pulling an inside handle arm  1220  towards an outside handle arm  1224  (shown by arrow  1228 ). 
   The handle  1208  can also include a spring attached from the proximal end  1232  of the stricture retractor delivery system  1200  to the proximal end  1206  of the sliding member  1204 . The handle  1208  includes the spring so that the movement of the inside handle arm  1220  towards the outside handle arm  1224  compresses the spring. Upon release of the handle arms  1220 ,  1224 , the spring subsequently expands longitudinally to provide an actuation force on the sliding member  1204 . The actuation force produces movement of the sliding member  1204  along line  1236  so that the sliding member  1204  can exert the deploying force on, for example, the proximal end  618  of the body  604 . Any other means can also be used to provide an actuation force on and subsequent movement of the sliding member  1204 . 
   In one embodiment, the device that the stricture retractor delivery system  1200  is deploying (e.g., the flexible member stricture retractor  370  or the alternate stricture retracting system  600 ) fits inside the body  1212  of the stricture retractor delivery system  1200 . In this deployment technique, the sliding member  1204  is pushed (either manually or via pushing the inside handle arm  1220  towards the outside handle arm  1224 ) into the body  1212  so that the sliding member  1204  contacts a part of (e.g., controller connector  332 , drainage port  366 , or proximal end  618 ) the device (e.g., flexible member stricture retractor  370  or alternate stricture retracting system  600 ) to be deployed. 
   Further, the sliding member  1204  can include a deploying mechanism  1240  attached to its distal end  1216  to ensure that the sliding member  1204  provides the deploying force on, for instance, the body  604  and does not extend into the passageway  608  of the body  604  without making contact with the body  604 . The deploying mechanism  1240  can be a circular-shaped member in which a portion contacts the proximal end  618  of the body  604  as a result of the movement of the sliding member  1204  from the actuation force. Alternatively, the deploying mechanism  1304  can be any shaped mechanism, such as square, octagonal, and triangular, so long as the sliding member  1304  provides some sort of deploying force on the body  604  to deploy the body  604  into the patient&#39;s urethra  202 . Although described above as being deployed by the stricture retractor delivery system  1200 , the flexible member stricture retractor  370  and/or the stricture retracting system  600  can be deployed by any delivery device or technique. 
   In another embodiment, the device that the stricture retractor delivery system  1200  is deploying is located beyond the stricture retractor delivery system  1200 , but the actuating of the sliding member  1204  extends the sliding member  1204  beyond the stricture retractor delivery system  1200  so that the sliding member  1204  still provides the deploying force. In this embodiment, the device being deployed can only be up to a particular distance away from the stricture retractor delivery system  1200  so that the sliding member  1204  extends far enough to make contact with and provide the deploying force to the device. 
   Having described certain embodiments of the invention, it will now become apparent to one of skill in the art that other embodiments incorporating the concepts of the invention can be used. Therefore, the invention should not be limited to certain embodiments, but rather should be limited only by the spirit and scope of the following claims.