Patent Publication Number: US-2005131442-A1

Title: Insertion and retrieval system for inflatable devices

Description:
FIELD OF THE INVENTION  
      The present invention is directed to devices for inserting and retrieving articles that are inflatable and deflatable into and from body cavities. In particular, these devices are directed to inserting and retrieving inflatable and deflatable articles that are configured for at least temporarily seating in the urinary r neck, whereupon this seating, block urine flow from the bladder.  
     BACKGROUND OF THE INVENTION  
      There are many treatments for urinary incontinence in both males and females. One such treatment involves use of a balloon that temporarily seats in the bladder, blocking urine flow therefrom, as detailed in commonly owned U.S. Pat. No. 6,293,923 and U.S. patent application Ser. No. 09/594,641, both documents incorporated by reference in their entirety herein.  
      The balloons used in these systems are initially stored in deflated and unexpanded or contracted states. As a result of storage in this state, they may, upon long term storage, become creased and stressed, leading to a damaged balloon, whose inflation is problematic or partial, or not at all. These damaged balloons must be rejected, leading to increased costs with obtaining a new balloon.  
     SUMMARY OF THE INVENTION  
      The present invention improves on the contemporary art by providing systems for insertion and removal of articles, typically balloons, that are of few pieces and easily operable. As such, these systems can be operated by multiple types of medical personnel, and are not limited to highly trained physicians. Moreover, the insertion devices that utilize balloons stored in inflated or expanded states. By storing the balloons in this manner, they are free of stresses and creases, assuring a high degree of structural integrity, reducing the chances of an unusable, and thus rejected balloon. Also, the operator can visually inspect the balloon in both the inflated and deflated states in the insertion device, eliminating the chances that a defective balloon will be deployed.  
      One embodiment of the present invention is directed to a system for deploying and retrieving implantable members, fillable articles (members), such as balloons, typically for treating incontinence, from the bladder. The system includes a urethral module, this deployed in the urethra and bladder with the coupling of a mandrel. The deployed urethral module, with the mandrel removed therefrom, provides a channel to the bladder, for a magazine unit, that deploys the balloon, and a retriever, that retrieves the balloon, and is ultimately removed from the body with the balloon in a deflated or contracted state.  
      Another embodiment of the invention is directed to a magazine unit. This magazine unit includes a body including a chamber configured for receiving an implantable device, typically a balloon, and the body including a passageway extending therethrough. There is a rod slidably received by the passageway in the body, this rod of a length for sliding beyond the body. The rod also includes a channel for fluid passage extending at least substantially therethrough. Also included is a channel member, typically a needle, in fluid communication with the channel, the needle configured for receipt of the implantable device.  
      Another embodiment of the invention is directed to a retrieving device, for retrieving the implanatable devices, typically a balloon. This retrieving device or retriever includes a body including a tubular segment extending therefrom, a capturing member engaged within the tubular segment defining a tip portion of the tubular segment; and a needle including a tip and a bore extending therethrough. The needle is coupled with a force generating member, for example, a spring, so as to be movable between a first position, where the needle tip has not moved beyond the tip portion, and a second position, where the needle tip has moved beyond the tip portion. This spring provides forces to the needle sufficient to pierce an implantable member or device, such as a balloon or other fillable article.  
      There is another embodiment directed to a method for deploying an implantable member or device, such as a balloon or other fillable device, in a body organ, such as the bladder. This method includes providing a magazine unit comprising: a body including a chamber configured for receiving an implantable member or device, the body including a passageway extending therethrough; a rod slidably received by the passageway in the body and of a length for sliding beyond the body, the rod including a channel for fluid passage extending at least substantially therethrough, and a channel member, for example, a needle, in fluid communication with the channel, the needle received in the implantable member. An implantable member in at least a partially expanded state is then provided onto the channel member; and the implantable member is contracted. Upon traveling to the bladder, the implantable member is then expanded (inflated), and once expanded it is released into the bladder, as the needle is retracted whereby a tip on the rod resists the implantable member upon retraction, ultimately releasing the implantable member into the bladder absent body forces.  
      Another embodiment is directed to a method for retrieving an implantable member (article, device, etc.), for example, a balloon or other fillable article from an organ, such as the bladder. This method includes accessing the bladder, for example, by creating a tubular channel thereto; capturing the implantable member, typically with a magnet as the capturing member; piercing the implantable member with a device in fluid communication with a fluid channel or conduit; and contracting (deflating) the implantable member by suctioning the contents of the member through the fluid channel or conduit. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      Attention is now directed to the attached drawings, wherein like reference numeral or characters indicate corresponding or like components. In the drawings:  
       FIG. 1  is an exploded view of the system of the present invention;  
       FIG. 2A  is a cross-sectional view of the urethral module in accordance with an embodiment of the present invention;  
       FIG. 2B  is a perspective view of the urethral module of  FIG. 2A ;  
       FIG. 2C  is a front view of the seal of the urethral module of  FIGS. 2A and 2B ;  
       FIG. 3A  is a cross sectional view of the mandrel in a first position in accordance with an embodiment of the present invention;  
       FIG. 3B  is a perspective view of the mandrel  FIG. 3A ;  
       FIG. 3C  is a cross sectional view of the mandrel in a second position in accordance with an embodiment of the present invention;  
       FIG. 4A  is a perspective view of the magazine unit in a first position in accordance with an embodiment of the present invention;  
       FIG. 4B  is a cross-sectional view of the magazine unit in a second position in accordance with an embodiment of the present invention;  
       FIG. 4C  is a perspective view of the magazine unit in a third position in accordance with an embodiment of the present invention;  
       FIG. 4D  is a cross-sectional view of the magazine unit in a fourth position in accordance with an embodiment of the present invention;  
       FIG. 5A  is a perspective view of the retriever in accordance with an embodiment of the present invention, in a first position;  
       FIG. 5B  is a cross-sectional view of the retriever of  FIG. 5A ;  
       FIG. 5C  is a perspective view of the retriever of  FIG. 5A  in a second position;  
       FIG. 5D  is a cross-sectional view of the retriever of  FIG. 5C ; and  
       FIG. 6  is a cross-sectional view of the mandrel in the urethral module in accordance with the present invention, prior to insertion into the urinary tract;  
       FIGS. 7-9  are partial cross sectional and partial perspective views of instrumentation in accordance with the present invention in operation creating an instrument channel into the bladder;  
       FIGS. 10, 11 ,  12 A,  13  and  14  are perspective views of the magazine unit and urethral module in accordance with the present invention, detailing processes associated with the deployment of an inflatable member or device;  
       FIG. 12B  is a cross-sectional view of  FIG. 12A  taken along line  12 B- 12 B;  
       FIGS. 15 and 16  are partial cross sectional and partial perspective views of instrumentation in accordance with the present invention in operation deploying the implantable member or device into the bladder;  
       FIG. 17  is a cross-sectional view of the deployed implantable member or device seated in the bladder neck;  
       FIGS. 18-20  are partial cross sectional and partial perspective views of instrumentation in accordance with the present invention in operation capturing implantable member or device in the bladder; and  
       FIGS. 21 and 22  are partial cross sectional and partial perspective views of instrumentation in accordance with the present invention in operation associated with the removal of the captured implantable member or device from the bladder.  
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       FIG. 1  shows the system  20  of the present invention with the relation of the components that form it. The system  20  includes a urethral module  30 , having a longitudinal axis LX extending therethrough. The urethral module  30  receives a removable mandrel  32  (having a longitudinal axis LX 1  extending therethrough), for example, in an aligned manner, where the longitudinal axes LX and LX 1  are coaxial, that allows for placement of the urethral module  30  into the urinary tract, for example, here, the female urethra and bladder. With the mandrel  32 , removed and the urethral module  30  in the urinary tract, either of the magazine unit  36  (having a longitudinal axis LX 2  extending therethrough) or the retriever  38  (having a longitudinal axis LX 3  extending therethrough) can be removably received by and placed through the urethral module  30 , for example, in an aligned manner, where the longitudinal axes LX, and LX 2  and LX 3 , respectively, are coaxial, to access the bladder for respectively inserting and inflating (collectively “deploying”), and retrieving an implantable device. The magazine unit  36  and retriever  38  can then be removed with the urethral module  30 , typically as a unit, when the requisite insertions and retrievals of the implantable devices have been completed, as detailed further below.  
       FIGS. 2A and 2B  show the urethral module  30 . This module  30  is typically formed of a body  52  and guide tube  54 . The body  52  includes a receiver portion  55 , with a cylindrical section  56  that defines a port  57 . This cylindrical port  57  is configured to receive corresponding portions of the mandrel  32 , magazine unit  36  and retriever  38 , as detailed below.  
      The body  52  also includes a nose member  58 , typically formed of an underlying nose  58   a , and a nose cone  58   b , for placement thereover. The nose  58   a  and nose cone  58   b  attach to each other by corresponding threads  58   a ′,  58   b ′ in a screw-like manner. This attachment holds the guide tube  54  in place by a clamping arrangement. The tapered shape of the nose cone  58   b  limits travel of the module  30  in the urethra.  
      The body  52  also includes a head  60  that includes a peripheral rim  61 . This rim  61  includes indents  62 , typically on both sides, for enhanced gripping by the fingers of the person performing the requisite procedure, with the urethral module  30 .  
      The guide tube  54  includes an edge  54   a , and is of a diameter large enough to support the corresponding shaft of the mandrel  32 , and rods  132 ,  222  of the magazine unit  36  and the retriever  38 , respectively, and the implantable device, typically in its deflated position. This diameter is of a size to minimize trauma to the urethra upon its insertion.  
      The receiver portion  55  is configured to connect within the body  52  at the rim  61 , in a frictionally tight manner. Similarly, the cylinder section  56  defining the port  57  is of an internal diameter to receive the head  80  of the mandrel  32 , at its preliminary diameter portion  86   a  ( FIGS. 3A-3C ), and the neck portion  134  of the magazine unit  36  (as shown in  FIGS. 4   a - 4   e ) and the distal segment  254  (as shown in  FIGS. 5   a - 5   d ) of the retriever  38  in a stable manner in a frictional engagement tight enough to seal against urine leakage. This cylindrical section  56  also includes an outer surface  56   c  and an edge  56   e.    
      The receiver portion  55  also includes a collar  66 , with rounded  66   a  and straight  66   b  sides. A ledge  70  is formed by inner walls  66   aa  and  66   bb  of the rounded  66   a  and straight  66   b  sides, and the walls  72  surrounding a circular bore  73  (as shown in  FIG. 2A ). The circular bore  73  is at the junction of the collar  66  and cylinder section  56 , as is of a diameter, for example, smaller than the inner diameter of the cylinder section  56 . This wall  72  defines the diameter of the circular bore  73 , and serves as a stop surface for the magazine unit  36  and retriever  38 , limiting their respective travel through the urethral module  30  (as detailed below).  
      The body  52 , and its receiver portion  55  are formed, for example of medical grade polymers. These medical grade polymers may be for example, polyethylene, polypropylene, TEFLON® or the like. The guide tube  54  is typically formed of a thin polymer, for example, TEFLON® or silicon.  
      The ledge  70 , receives a seal  74 , that is dimensioned, for example, to have a perimeter just slightly smaller that the corresponding perimeter of the inner walls  66   aa ,  66   bb  of the collar  66 . This dimensioning allows the seal  74  to seat in the collar  66 , in a frictional engagement (although additional securement with adhesives is also permissible). The seal  74 , shown in detail in  FIG. 2C , protects against massive leakage of urine, but allows for passage of drops  411  ( FIG. 9 ) of urine from the urethral module  30 , when it is properly deployed (as detailed below and shown in  FIG. 9 ).  
      The seal  74  has, for example, cuts  75  that extend through it in a crosshair pattern. These cuts  75  are typically in a circular area  76  on one side of the seal  74 , and divide the seal  74  into panels  78 . This configuration accommodates the shape of the noses of the magazine unit  36  and the retriever  38 , by allowing for penetration of the magazine unit  36  and retriever  38  therethrough, while capturing these instruments to prevent them from moving backwards in the urethral module  30 . The edge  74   a  of the seal  74  is typically flush with the edge  66   e  of the collar  66 . The seal  74  is typically made of a medical grade silicone, or other elastomeric material.  
      The mandrel  32  is shown in  FIGS. 3A-3C .  FIGS. 3A and 3C  show the mandrel  32  in a first position, associated with insertion (in cooperation with the urethral module  30  as detailed below), while  FIG. 3B  shows the mandrel  32  in a second position, associated with its removal from the urethral module  30  (detailed below).  
      The mandrel  32  includes a head  80 , and a shaft  82 , with the shaft  82  capped by a flexible tip  84 . The head  80  includes a first section  86  and a second section  87 . The first section  86  is of a preliminary diameter portion  86   a , that is typically of a smaller diameter than the second section  87 . This preliminary diameter portion  86   a  of the first section  86  is slightly smaller than that of the inner diameter of the cylindrical section  56  of the receiver portion  55 . This configuration allows for the shaft  82  of the mandrel  32  to be aligned in the guide tube  54  of the urethral module  30 .  
      At least a portion, typically the distal edge  87   a , of the second section  87  is of larger diameter then the inner diameter of the cylindrical section  56  of the receiver portion  55 . This dimensioning allows the proximal edge  56   e  ( FIG. 2B ) of the cylindrical section  56 , to serve as a stop surface for the head  80 , limiting travel of the shaft  82  in the urethral module  30  (detailed below). For example, the diameter of the second section  87 , at the distal edge  87   a  can be equal to the outer diameter of the of the cylinder section  56 , of the receiver portion  55 , so that the outer surfaces  56   c ,  80   c , of the cylindrical section  56  and head  80  are flush.  
      The head  80 , and in particular its outer surface  80   c , can also be contoured. This contouring is typically in the form of an indented rounded ring  88 . This indented rounded ring  88  allows for enhanced gripping by the fingers of the person performing the procedure.  
      The shaft  82  is typically of a stiffness necessary to penetrate and move within the urethra and bladder (as detailed below). The shaft  82  is of a diameter less than that of the guide tube  54  of the urethral module  30 , for sliding therethrough. The shaft  82  has a main portion  98  of a hard material, with a central pole  100  extending therefrom. The flexible tip  84  is of an inner dimensioning to be frictionally fit over this pole  100 , this friction fit of a tolerance that allows movement of the tip  84  to slide along the pole  100  in directions parallel to it (to the longitudinal axis LX 1 ).  
      The pole  100  is formed of a tapered portion  110  on a rod  112 . The tapered portion  110  extends beyond the diameter of the rod  112 , forming an edge  110   e . The flexible tip  84  includes a corresponding tapered end  114  joined to a cylindrical section  116 . The cylindrical section  116  includes an inner lip  117 , for contacting the edge  110   e  when the flexible tip  84  moves away from the main portion  98 , such that the flexible tip  84  remains on the pole  100 , and does not fall off of the pole  100  during removal of the mandrel  32  from the guide tube  54  (of the urethral module  30 ), as shown in  FIG. 3C  (illustrative of a second position for the mandrel  32 ).  
      Similar to the tapered portion  110 , the tapered end  114  extends to a diameter beyond that of the cylindrical section  116 , forming an edge surface  114   e  at the junction of the tapered end  114  and the cylindrical section  116  ( FIG. 3A ). This diameter of the tapered end  114  is typically equal to that of the diameter of the guide tube  54 . By providing this flexible tip  84  for moving on the pole  100  of the shaft  82 , it reduces trauma to the urethra by moving to a smaller diameter, upon its removal from the guide tube  54  of the urethral module  30 , as shown in  FIG. 3C . This edge surface  114   e  is of a perimeter thickness, sufficient for abutting the edge  54   a  of the guide tube  54 . The outer diameters of the tapered end  114  and guide tube  54  are typically equal, such that the outer surfaces  114   c ,  54   c  ( FIG. 2B ) of respective tapered end  114  and guide tube  54  are flush. This flushness keeps the edge  54   a  of the guide tube  54 , that can be sharp, from contacting urethral tissue, avoiding damage and trauma to it.  
      Accordingly, when mandrel  32  is removed from the urethral module  30 , ( FIG. 3B ) the abutment of the edge surfaces  114   e  and  54   a  causes the flexible tip  84  to move apart from the main portion  98 . Upon this movement, a portion of this flexible tip  84  has a smaller diameter than the guide tube  54 , allowing the remainder of the flexible tip  84  to be pulled through the guide tube  54  upon removal.  
      The shaft  82 , and in particular, the main portion  98  connects to the head  80  by a threaded rod portion  118 . This threaded rod portion  118  is typically integral with the main portion  98  and is received by a correspondingly threaded section  119  in the head  80 , and as such, allows the shaft to be adjustable, whereby the flexible tip  84  can be adjusted to accommodate for individual guide tubes  54 , and in particular their edges  54   a , such that the outer surfaces  114   c  and  54   c  are flush (as detailed further herein).  
      The pole  100 , and shaft main portion  98  can be separate or integral members. In the case that they are separate members, they can attach to each other by corresponding screw threads or the like. All components of the mandrel  32 , except the flexible tip, are typically made of the medical grade polymers as detailed above. The flexible tip  84  is typically made of an elastomeric material, such as medical grade silicone, and is of a hardness less than that for the pole  100  and shaft main portion  98 .  
       FIGS. 4A-4E  detail the magazine unit  36 .  FIGS. 4A and 4B  show the magazine unit in a first position where the implantable device, member, article, or the like, is stored.  FIG. 4C  shows the magazine unit  36  in a second position, where the implantable device has been deflated or contracted, so as to be ready for deployment.  FIG. 4D  shows the magazine unit in a third position, where the implanatable device is in a proper position for deployment, prior to its expansion or inflation and  FIG. 4E  shows the magazine unit  36  in a fourth position, where the implantable device has been expanded or inflated prior to its release into the body.  
      The magazine unit  36  includes a main body  130  that receives a rod  132 , slideable within this main body  130 , the rod connecting to a head  133 . This slideable arrangement of the rod  132  in the main body  130 , allows for inserting of an implantable member (device), for example, a balloon  134 , or other member or device into the urinary tract, that can block urine flow from the bladder.  
      The balloon  134  is typically a balloon or other fillable article or member, that can be inflated or expanded and deflated or contracted. The balloon  134  can be for example, a balloon or other article or device, as detailed in U.S. Pat. No. 6,293,923, the disclosure of which is incorporated by reference in its entirety herein. This balloon is typically fillable with fluids, such as gases, liquids, gels, etc.  
      Other balloons and other fillable articles, suitable for use herein are typically inflated or filled with fluids, including gases, liquids, gels, etc. These balloons, for example, typically include magnetic or magnetizable materials therein. These balloons are such that when inflated or expanded in the bladder, these balloons can be positioned to seat in the bladder neck, so as to block the flow of urine (as detailed below). Positioning can be either by sinking (should the balloon have a specific density greater than that of urine), so as to fall in the bladder neck, or held in place there by a magnet in an undergarment or the like (should the balloon be of specific density less than that of urine).  
      The main body  130  includes a distal end  130   d  and a proximal end  130   p . The distal end  130   d  includes a nose portion  136  and a neck portion  138  ( FIG. 4A ).  
      The nose portion  136  includes a collar  136   a , typically correspondingly shaped (here for example, outwardly tapered) with respect to the nose  58   a  in the urethral module  30 . This nose portion  136  is received in the nose  58   a , with the collar  136   a  serving to catch the seal  74 , to prevent backward movement of the magazine unit  36  when in the urethral module  30 .  
      Similarly, the neck portion  138  is typically cylindrical in shape and of a diameter slightly less than that of the inner diameter of the cylindrical section  56  of the receiver portion  55 , so as to allow for sliding within the cylindrical section  56 . This dimensioning is such that engagement of the neck portion  138  by the cylindrical section  56  stabilizes the magazine unit and seals the components of the magazine unit  36  against leakage of urine (once its nose portion  136  has moved past the seal  74  in the urethral module  30 ).  
      A magazine section  140  is formed in the main body  130 , intermediate the distal  130   d  and proximal  130   p  ends. This magazine section  140  is proximate to the neck portion  138 , and has a cavity  140   a  dimensioned to accommodate, the balloon  134  in an inflated or expanded state in order to allow its storage and subsequent deployment, as detailed herein ( FIG. 4B ). The magazine section  140  includes openings  141 , typically covered with a transparent, clear or other see-through sheath  141   a , that allows for viewing (and in some cases a visual inspection) of the balloon  134 .  
      The proximal end  130   p  of the main body  130  includes a bore  142 , continuous with the magazine unit cavity  140   a  and the cavity  143  formed by the interiors of the nose  136  and neck  138  portions, through which the rod  132  slides. This proximal end  130   p  also includes a slot  144 , through which a tongue  146  slideably extends through. The tongue  146  includes an opening  148 , with edges  148   a , for engaging distal  158  and proximal  159  notches in the rod  132 . These notches  158 ,  159  are typically paired or in series, and disposed approximately 180 degrees from each other on the rod  132 . There can also be single notches on the rod  132  at these positions.  
      The tongue  146  can be slid within the slot  144  (in the direction of double headed arrow  160 ), such that its edges  148   a  engage one of the respective distal  158  and proximal  159  notches, locking the rod  132  in position. Sliding the tongue  146  in the slot  144 , such that the engagement is broken (also as per arrow  160 ), allows the rod  132  to slide freely in the body  130  of the magazine unit  36 . The notches  158 ,  159  are at positions where the rod  132  can be locked, whereby operations of the magazine unit  36  (detailed below) can be performed with safety.  
      The rod  132  has a shaft  162  and a tip  164  at its distal end. The tip  164  ( FIG. 4B ) receives a channel member, such as a needle  166  (with a bore extending therethrough, allowing for fluid transport therethrough for inflation/deflation of the balloon  134 ), this needle  166  received by the balloon  134 , and in particular in a valve in a magnetic or magnetically attractive portion  167 , typically defining the central core of the balloon  134 .  
      A tube  170  ( FIG. 4C ), attached to the head  133 , extends from the head  133 , through the shaft  162  to a point proximate the tip  164 , this tube  170  receiving the needle  166 , typically by a frictional engagement (with this additional securement with adhesives, and the like also permissible). The tube  170  is of an inner diameter slightly larger then the outer diameter of the needle  166 , so as to receive the needle  166  in a frictional engagement.  
      This arrangement of the needle  166 , tube  170 , and port  172 , at the proximal end of the head  133 , defines a channel or conduit  173 , such that fluid, including air, liquid, gel or the like, can be suctioned from or placed into the balloon  134 , or the like (depending on the particular process). The port  172  is configured for typically receiving a syringe  174  (typically formed of a plunger  174   a  received in a body  174   b ), or any other suction or inflation mechanism(s), detailed additionally below.  
      The tube  170  can be for example, a metal tube, with a polymeric port  172  (to provide friction for receiving the syringe  174 ). Alternately, the needle  166  and tube  170  can be a single or integral member, for example, a single needle having a bore extending therethrough.  
      The head  133  is of a diameter larger than the bore  142 , so as to limit travel of the rod  132 , in the distal direction ( FIGS. 4C-4D ) The head  133  joins to the shaft  162 , in particular a collar  175  on the shaft  162 , by threads  133   a , that engage corresponding threads  175   a  on the collar  175  in a screw-like manner. The head  133  can be separated from the collar  175  (typically by rotating it in the direction indicated by the arrow RR) ( FIG. 4E ). Upon this separation, the head  133  can be pulled proximally (in the direction of arrow PP). As the head  133  is attached to the tube  170 , that receives the needle  166  in a frictional engagement, the needle  166 , upon this proximal pulling, moves proximally into the tip  164 . Continued proximal movement results in the disengagement (release) of the implantable member (device), here for example, the balloon  134 , from the needle  166  without any forces on the body of the patient, who is receiving the implantable member (device).  
      The head  133  can be formed of additional or multiple pieces. These pieces can be joined together by screw type mechanisms or the like.  
      The tube  170 , typically in the shaft  162 , also includes a protruding ring or alternately, rings  177  ( FIG. 4C ) of a diameter larger than that of the tube opening  178  in the shaft  162  or collar  175 . The larger diameter ring(s)  177 , limit travel of the tube  170  and needle  166 , such that they are not pulled out of the rod  132 , when the head  133  is pulled proximately (typically during retraction of the needle  166  upon release of the implantable member, here for example, the balloon  134 ).  
      The shaft  162  includes the notches  158 ,  159 , that receive the portions of the tongue  146 , when locking (as detailed above), typically for safety, is desired. The distal notches  158  are, for example, positioned such that locking is at a position where there is sufficient space for the balloon  134  in the magazine section  140 , such that it can be stored in an expanded state, so as to minimize potential damage from storage. The proximal notches  159  ( FIG. 4D ) are, for example, positioned such that the shaft  162  can extend a sufficient distance through the distal end  130   d  and into the urethra and bladder, so as to properly insert and inflate (deploy) the balloon  134  in the bladder ( FIG. 4E ).  
      The shaft  162  can be, for example, formed in pieces, here three pieces  162   a - 162   c  ( FIGS. 4A-4C ). These pieces  162   a - 162   c  can include series of corresponding threads, each joining together in accordance with a screw mechanism.  
      Turning specifically to  FIG. 4B , the tip  164  includes a tail  190 , typically threaded, so as to be received in the shaft  162  (piece  162   a  that is correspondingly threaded) in a screw-like engagement, a platform  194 , and a neck  196 , extending from the platform  194 . This tip  164  is typically a one-piece integral member formed of the medical grade polymers detailed above. A bore  198  extends through this tip  164 , so as form a passage and support for the needle  166 , that connects to the tube  170 .  
      The platform  194  is of a diameter slightly greater than the bore  142  in the main body  130 , so as to keep the rod  132 , from sliding out of the body  130 . However, it is much less then the diameter of the guide tube  54 . This dimensioning provides room for balloon  134  portions that may move proximally and into the space between the platform  194  and guide tube  54  when the balloon  134  is moved distally for its insertion, so as not to be pinched and damaged upon this distal movement in the guide tube  54  of the urethral module  30  (also shown in  FIGS. 11, 12A  and  12 B).  
      The body  130  and rod  132 , and all components thereof, except where specifically mentioned, are typically formed from several pieces (as detailed above). These pieces, are made of medical grade polymers, as detailed above. The needle  166  and tube  170  and ring  177  are, for example, made of metal, such as surgical grade metals.  
       FIGS. 5A-5D  show the retriever or retriever member  38  in detail.  FIGS. 5A and 5B  show the retriever  38  in a first position, suitable for capture of the implanatable member article in the body (here, for example, the balloon  134  in the bladder  412  as shown in  FIGS. 18-22  and described below).  FIGS. 5C and 5D  show the retriever  38  in a second position, where it punctures the implantable article (e.g., the balloon  134 ) for its deflation or contraction, in order that the implantable article be removed from the body with minimal trauma thereto.  
      The retriever  38  includes a body  220 , with distal  220   d  and proximal  220   p  ends, and a support tube  222  extending distally therefrom. The body  220  receives a rod  224 , that slides therein, the rod  224  having a head  226  at its proximal end ( FIGS. 5A-5B ). The head  226  is similar in construction to the head  133  detailed above. A tube  228  extends from the head  226  and into the rod  224 , where it receives a needle  230  (having a bore extending therethrough). The support tube  222  typically includes a capturing member, here for example a magnet or magnet attracting member  232  (hereinafter, “magnet”), defining its tip  234  (and also the tip of the retriever  38 ). The magnet  232  typically includes a groove  232   g , for receiving the needle  228  and providing a track for it, when it is extended from the tip  234 .  
      The distal end  220   d  of the body  220  includes a nose portion  240 . The nose portion  240  includes a collar  240   a , similar to the collar  136   a  of the magazine unit  36  detailed above, that prevents backward movement of the retriever  38  in the urethral module  30 .  
      The proximal end  220   p  of the body  220  includes a main portion  246  that typically receives a backing member  248 , for example in a screw-like engagement. The main portion  246  is typically open or hollow (defining a chamber  250 ) for accommodating a nose segment  261  of the backing member  248 , a force generating member, typically a spring  252 , and a plate  280  of the rod  224 , all detailed further below. The main portion  246  includes a distal segment  254 , and a proximal segment  256 .  
      The distal segment  254  is similar to the neck portion  138  of the magazine unit  36 , as it is typically cylindrical in shape and of a diameter slightly less than that of the cylindrical portion  56  of the receiver portion  55 , so as to allow for sliding within the cylindrical portion  56 . This dimensioning is such that engagement of the cylindrical portion  56  and the distal segment  254  will also serve to stabilize the retriever  38  upon this engagement, and seals the retriever  38  against leakage of urine (once its nose portion  240  has moved past the seal  74  in the urethral module  30 ).  
      The proximal segment  256 , in particular its outer surface  256   c , can also be contoured, similar to the contour ring  88  of the head  80  of the mandrel  32  (detailed above). This contouring is typically in the form of an indented rounded ring  258 . This indented rounded ring  258  allows for enhanced gripping by the fingers of the person performing the procedure.  
      The backing member  248  includes a disc segment  260 , typically integral with a nose segment  261 , with a continuous bore  264  therethrough. This bore  264  is of a diameter slightly larger than that of the rod  224 , to allow the rod  224  to slide therein. The disc segment  260  includes a slot  266 , through which a tongue  268  slideably extends through. The tongue  268  includes an opening  270  with edges  270   a  for engaging notches  272  (at least one notch but typically two, arranged in a manner similar to notches  158 ,  159  in magazine unit  36  as detailed above) for locking and unlocking the rod  224  when the tongue  268  is slid in the directions of the double headed arrow  274 . The tongue  268 , slot  260 , notches  272  are similar to those for the magazine unit  36  detailed above.  
      The nose segment  261  typically includes threads  276  at one end, for connecting with corresponding threads  277  on the main portion  246  of the body  220 , to hold the backing member  248  in place, allowing the rod  224  to slide proximally and distally, moving the needle  230  (into and out of the support tube  222 ), when the spring  252  is contracted (compressed) and relaxed (by expansion) as detailed below. The other end of the nose segment  261  is of a flat surface  261   c , and is of a diameter larger than the rod  224 , and serves as one confinement for the spring  252 .  
      The rod  224  extends distally beyond the backing member  248 , where it terminates in a plate  280 . The spring  252  extends along this portion of the rod  224  to this plate  280 , that is of a larger diameter then the rod  224 . The plate  280  serves as the other confinement for the spring  252 .  
      The tube  228  connects to the needle  230  proximate this plate  280 , with the needle origin  230   n  concentric and coaxial with the rod  224  and tube  228 . The needle  230  is received by the tube  228 , typically in a friction fit, and can also be joined to the tube  228  by adhesives, other fastening mechanisms or combinations thereof. The needle  230 , tube  228  and port  304  (detailed below) define a channel or conduit  305 , for fluid transport through the retriever  38 . The needle  230  extends distally from this plate  280  and through the support tube  222 , typically at an angle with respect to the longitudinal axis LX 3 , so as to be received by the groove  232   g  in the tip  234 . For example, the needle  230 , in this orientation, will pierce (puncture the outer shell and penetrate into the interior chamber) the balloon  134  at a location off center, to the side of the magnet central core  167 . Alternately, the needle  230  and tube  228  can be a single member, for example, a single needle with a bore extending therethrough.  
      The needle  230  is initially in the support tube  222 , when the spring  252  is in the compressed position ( FIGS. 5A-5B ). This compression is retained, as the tongue  268  engages a notch  272 , creating a locking for safety. When unlocking from this locked position is desired, the tongue  268  is slid in the down direction of the arrow  274 , breaking the contact, allowing the spring  252  to expand, resulting in the needle  230 , in particular the needle tip  230   a , moving out of the support tube, beyond the tip  234  ( FIGS. 5C-5D ). The spring  252  is such it provides a force for propelling the needle  230  to easily penetrate the balloon  134 . The needle  230  has a hollow interior of a bore diameter such that the balloon filling material can rapidly flow through the needle  230 , without regard to its viscosity, allowing the balloon  134  to drain and deflate (contract) rapidly.  
      The rod  224  terminates in the head  226 . The tube  228  within the rod  224  extends to a port  304  in the head  226 . This tube  228  is in communication with the needle  230 , such that fluid, including air, liquid, gel, or the like can be suctioned from or placed into the balloon  134 , or the like, once it has been captured, as detailed below. The port  304  is configured for typically receiving a syringe (similar to the syringe  174  detailed above), or any other suction or inflation mechanism(s), detailed additionally below.  
      The head  226  is of a diameter larger than the bore  264 , so as to limit travel of the rod  224 , in the distal direction. The head  226  may join to the rod  224 , by correspondingly positioned threads  308 ,  309 , that create a screw-like engagement. The head  226  is similar in construction to the head  133  detailed above.  
      The body  220 , rod  224 , head  226 , and all components thereof, except where indicated, can be formed of any number of pieces, with some pieces being combined to be integral pieces. These pieces are made, for example, of the medical grade polymers detailed above. The tube  228  and needle  230  are for example, integral pieces and typically made of surgical grade metals or the like. The magnet or magnetically attractive member  232  is for example made of magnetic metals or magnetically attractive metals. The port  304  is typically of a polymeric material, to provide friction for receiving the syringes or the like.  
       FIGS. 6-20  detail the system  20  in an example operation in the urinary tract of a human female. In these figures reference is made to the urethral module  30 , mandrel  32 , magazine unit  36  and retriever  38 , and components thereof, as detailed above and shown in the previous drawing figures.  
      As shown in  FIG. 6 , the mandrel  32  is placed within the urethral module  30 . There may be an adjustment of the tip  114  with respect to the guide tube  54  of the urethral module  30 , such that they abut in alignment and their outer surfaces  114   c  and  54   c  are flush. This is performed by rotating the head  80  on the threaded rod portion  118  of the shaft  82 .  
      The now combined devices  30 ,  32  are now gripped by the person inserting them, and inserted into the female urethra  404 , in the direction of the arrow  406  ( FIG. 7 ). Insertion continues until movement becomes difficult, typically from resistance by the widening of the nose  58  of the urethral module  30 , as shown in  FIG. 7 .  
      In  FIG. 8 , the mandrel  32  is then removed, by moving it in the direction of arrow  410 , while the urethral module  30  is held in place. In this moving, the tip  84  (in particular the tapered portion  114 ) of the mandrel  32  contacts the edge  54   a  of the guide tube  54  and moves distally, so as to decrease its diameter to lessen trauma, as it subsequently pulled into and through the guide tube  54  of the urethral module  30 .  
      In  FIG. 9 , the urethral module  30  remains in the urethra  404 , and its proper placement can be confirmed as drops of urine  411  can be detected by leaking through the seal  74 . The now deployed urethral module  30  provides a channel therethrough, for instrumentation to access the bladder  412 .  
      In  FIG. 10 , the magazine unit  36  is then made ready for placement into the now deployed urethral module  30 . This process begins as a syringe is then connected to the port  172  of the magazine unit  36  and the fluid, typically air, is suctioned from the balloon  134 , such that it contracts (deflates) ( FIG. 4C ). In  FIG. 11 , the previously locked rod  132  is unlocked as the tongue  146  is moved down, in the direction of the arrow  413 , out of engagement with the distal notch  158 . The rod  132  is now released and this now contracted balloon  134  is pushed distally for its deployment, by pushing the rod  132  distally (in the direction of the arrow  414 ).  
      Pushing (distally) on the rod  132  continues, until the rod  132  cannot be further pushed or the balloon  134  is outside (beyond) he guide tube  54 , as shown in  FIG. 12A . During this proximal movement, the balloon  134  may include portions that sagged over the needle  166  and tip  164 , with this sagging accommodated by the space between the guide tube  54  and the tip  164 , as also shown in  FIG. 12B . Here, the balloon  134  has entered the bladder.  
      In  FIG. 13 , the balloon  134  is now in position for inflation (expansion). The rod  132  is now locked in a safety position, as the tongue  146  is moved up in the direction of the arrow  415  into engagement with a proximal notch  159  ( FIGS. 4A, 4D ). A syringe  174  is now attached to the port  172 , with its plunger  174   a  pushed distally (in the direction of the arrow  416 ), so as to introduce fluid, air, liquid, gel, etc., here, for example, air through the tube  170  and the needle  166  into the balloon  134 , inflating (expanding) it.  
      With the balloon  134  now inflated (expanded), the head  133  is separated (unscrewed) from the collar  175  of the shaft  162  (in the direction of the arrow RR). Once unscrewed, the head  133  is pulled proximally (away from the body), in the direction of arrow  417 . This pulling moves the needle  166  proximately (as per arrow  417 ), retracting it into the tip  164 . This retraction, coupled with resistance from the tip  164  (in particular the neck  196 ), releases the balloon  134  into the bladder  412  (as per the arrow  418 ), absent any forces from the body, as shown in  FIG. 14 .  
      In  FIG. 15 , the magazine unit  36  and the urethral module  30 , typically as a unit, are now pulled back (in the direction of the arrow  419 ), away from the urethra  404 . Here, the balloon  134  floats in the bladder  412 . Pulling continues in the direction of arrow  419  until the magazine unit  36  and urethral module  30  (as a unit) are completely removed from the body, as shown in  FIG. 16 .  
      In  FIG. 17 , the balloon  134  is maintained in the bladder neck  420  for example, by forces from a magnet  430  in a pad  432  in an undergarment or the like, as detailed in U.S. Pat. No. 6,293,923. This positioning of the balloon  134  in the bladder neck  420  blocks the flow of urine from the bladder  412 , until the magnetic force is removed, whereby the balloon  134  will again floats free in the bladder  412 , as also detailed and shown in U.S. Pat. No. 6,293,923.  
      When removal of the balloon  134  from the bladder  412  is desired, the urethral module  30  and mandrel  32  are assembled and inserted into the urethra  404 , as detailed above and shown in  FIGS. 6 and 7 . The mandrel  32  is then removed, with the bladder located, as detailed above and shown in  FIGS. 8 and 9 .  
      In  FIG. 18 , the retriever  38  is now inserted into the urethral module  30 , in the direction of the arrow  468 , until the tip  234 , with the capturing member  232 , has entered the bladder neck  420 . In this position, the rod  224  of the retriever  38  is locked (tongue  268  engages notch  272 ). The magnet  232 , attracts the balloon  134 , so as to be in contact therewith, as shown in  FIG. 19 .  
      With the balloon  134  in contact with the magnet  232  of the tip  234 , the locked rod  224  is released, as the tongue  268  disengages from the notch  272 , as it is moved in the direction of the arrow  470 . This unlocking allows the spring  252  to expand and move the rod  224  distally. Accordingly, the needle  230  moves distally, beyond the tip  234 , such that the needle tip  230   a  punctures the balloon  134 . Fluid (air, water, solution, gel, etc.) from the balloon  134  enters the needle  230 , and coupled with suction from the syringe  174  (previously attached to the port  304 ), the fluid is pulled proximally (in the direction of the arrow  474 , the direction the plunger  174   a  is moved) into the syringe  174 , as shown in  FIG. 20 . Suction continues, as the plunger is pulled proximally (in the direction of the arrow  474 ) until the balloon  134  is deflated, as shown in  FIG. 21 .  
      In  FIG. 22 , the retriever  38  with the now deflated balloon  134 , on it, and the urethral module  30 , as removed as a unit from the urinary tract by pulling in the direction of the arrow  480 . Throughout this process the balloon  134  remains on the magnet  232  of the tip  234  due to the strong magnetic forces.  
      While the system  20  has been described above for a human female, it can be modified to accommodate the human male urinary system as well. Similarly, it can be modified for animals, both male and female, in accordance with the disclosure above.  
      While preferred embodiments of the present invention have been described, so as to enable one of skill in the art to practice the present invention, the preceding description, including instruments, components and combinations thereof, is intended to be exemplary only. It should not be used to limit the scope of the invention, which should be determined by reference to the following claims.