Abstract:
A balloon dissector includes a cannula, an expandable bladder, and a cord. The cannula defines a lumen between proximal and distal ends. The expandable bladder is configured to expand when fluid is injected into the lumen and includes an inner surface, a proximal base, and a retainer. The proximal base is selectively coupleable to the distal end of the cannula in a sealing relationship. The retainer is positioned on the inner surface of the expandable bladder. The cord includes a first end, a second end, and a central portion. The one end of the cord extends from the proximal end of the cannula. The cord extends through the lumen of the cannula and through the retainer of the bladder returning into the lumen. The cord configured to draw the expandable bladder into the lumen after the expandable bladder is expanded.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/865,637, filed Aug. 14, 2013, the entire disclosure of which is incorporated by reference herein. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to medical devices, and particularly to fluid expandable medical devices such as cannulas, catheters, dissectors, retractors, and similar devices including a desufflation mechanism. 
         [0004]    2. Discussion of Related Art 
         [0005]    Tissue dissectors are used for separating tissues in order to create a space between tissue layers and tissue retractors are used to expand a space between organs and/or tissue layers. The space created and/or expanded is used to improve visualization and to increase working space during open surgery and/or minimally invasive surgery. Fluid expandable balloon devices allow a surgeon to take potential spaces within the body and turn them into existing spaces safely, easily, and controllably in order to safely visualize appropriate tissue and/or operate. Such devices allow for selective dissection and/or retraction of tissue, either of hard tissue such as bone or soft tissue planes, to be moved out of the way to improve working space and visualization, which is of particular benefit while operating from within the body, e.g., minimally invasive surgery. These fluid expandable balloon devices also permit working within the body without damaging a great deal of tissue in the path between a skin opening and the working area, by minimizing the external orifice or skin incision. Although such devices have achieved relative levels of success, improvements to such fluid expandable balloon devices would be advantageous. For example, an active means for desufflating a fluid expandable balloon device and removing the bladder from the surgical space. 
       SUMMARY 
       [0006]    In an aspect of the present disclosure, a balloon dissector includes a cannula, an expandable bladder, and a cord. The cannula defines a lumen extending between proximal and distal ends of the cannula. The expandable bladder is configured to expand when a fluid is injected into the lumen. The bladder includes an inner surface, a proximal base, and a retainer. The proximal base is selectively coupled in a sealing relationship to the distal end of the cannula. The retainer is positioned on the inner surface of the bladder. The cord has a first end, a second end, and a central portion. One of the first and second ends extends from the proximal end of the cannula. The central portion extends from the first end to the second end through the lumen and through the retainer of the bladder. The cord is configured to draw a portion of the bladder into the lumen after the bladder is deflated. The central portion of the cord can draw the deflated bladder into the lumen. The first end of the cord can be affixed to the proximal end of the cannula. In embodiments, the first end of the cord is affixed to an inner surface of the cannula. The proximal end of the cannula can include retaining mechanism. The retaining mechanism is configured to slidably receive the second end of the cord therein. The second end of the cord can slidably pass through the clamp. In some embodiments, the distal end of the cannula includes a recess configured to receive an expandable ring. The expandable ring is configured to retain the proximal base of the bladder in a sealing relationship with the proximal end of the cannula. The expandable ring can include a passage to slidably receive the cord. The expandable ring can be integrally formed in the proximal base of the bladder. 
         [0007]    In another aspect of the present disclosure, a method of dissecting tissue layers includes inserting a balloon dissector into a surgical site between two tissue layers, dissecting the tissue layers by expanding a bladder with an inflation fluid, and withdrawing at least a portion of the bladder into a lumen of the cannula by pulling a portion of a cord. The balloon dissector can include a cannula, an expandable bladder, and the cord. Dissecting the tissue layers can include deflating the bladder by pulling an end of the cord, repositioning the cannula, and reinflating the bladder with the inflation fluid. Deflating, repositioning, and reinflating can be repeated until a desired space is formed between the tissue layers. The method may further include selecting the inflation fluid from the group consisting of air, nitrogen, and saline. The method may include removing the bladder from the proximal end of the cannula. The method may include inserting a surgical instrument through the lumen of the cannula. 
         [0008]    In yet another aspect of the present disclosure, an expandable bladder for dissecting and/or retracting tissue is configured for use with an introducer. The expandable bladder includes a proximal base, an inner surface, at least one retainer, and a cord. The introducer can be a cannula as described herein. The proximal base is sized and configured to engage the introducer. The proximal base can engage the introducer in a sealing relationship. The cord has a first end, a second end, and a central portion. The central portion of the cord is slidably received by the at least one retainer. The expandable bladder has an inflated condition having a first volume and a deflated condition having a second volume. In the inflated condition, the expandable bladder has a first volume and in the deflated condition, the expandable bladder has a second volume. The second volume can be smaller than the first volume. The cord is configured to transition the expandable bladder from the inflated condition to the deflated condition. In embodiments, the expandable bladder forms a spherical enclosure and the at least one retainer includes a plurality of retainers around a circumference of the inner surface. In some embodiments, the expandable bladder forms a toroidal enclosure and the at least one retainer includes a central hole through the expandable bladder. In certain embodiments, the expandable bladder forms a triangular enclosure, the at least one retainer includes a connector positioned at each corner of the triangular enclosure, and the proximal base is positioned orthogonal to the triangular-shaped enclosure. 
         [0009]    Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any or all of the other aspects described herein. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    Various aspects of the present disclosure are described hereinbelow with reference to the drawings, wherein: 
           [0011]      FIG. 1  is a partial cutaway of a fluid expandable balloon dissector provided in accordance with the present disclosure including a desufflation cord; 
           [0012]      FIGS. 1A and 1B  are enlargements of the detail areas  1 A and  1 B shown in  FIG. 1 ; 
           [0013]      FIGS. 2-8  are a progression of side views showing the balloon dissector of  FIG. 1  being used to dissect tissue layers; 
           [0014]      FIGS. 9A and 9B  are perspective views of other fluid expandable balloon devices in accordance with the present disclosure; and 
           [0015]      FIG. 10  is a partial cutaway of another fluid expandable balloon dissector provided in accordance with the present disclosure including a vacuum desufflator. 
       
    
    
     DETAILED DESCRIPTION 
       [0016]    Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “clinician” refers to a doctor, a nurse, or any other care provider and may include support personnel. Throughout this description, the term “proximal” will refer to the portion of the device or component thereof that is closest to the clinician and the term “distal” will refer to the portion of the device or component thereof that is furthest from the clinician. 
         [0017]    While the fluid expandable balloon device described in detail below is a fluid expandable balloon dissector, it will be appreciated by a person skilled in the art that the fluid expandable balloon device is adaptable to a fluid expandable retraction device or other similar fluid expandable surgical devices that include fluid expandable balloons. 
         [0018]    Referring now to  FIG. 1 , a fluid expandable balloon dissector  10  is provided in accordance with the present disclosure incorporating a cannula  20  and a bladder  30 . Cannula  20  has a proximal portion  22  near an open proximal end  22   a,  an elongated tubular body  24  extending distally from proximal portion  22 , and a distal portion  26  near an open distal end  26   a  of the elongated tubular body  24 . Elongated tubular body  24  has an outer wall  27  defining a central lumen  28  between proximal end  22   a  and distal end  26   a.    
         [0019]    With additional reference to  FIG. 1A , expandable bladder  30  includes an inner surface  34 . Inner surface  34  can include retainers  34   a  that slidably receive cord  36 . Cord  36  is operatively associated with inner surface  34  such that cord  36  can manipulate the size and/or shape of bladder  30 . As will be appreciated by those skilled in the art, cord  36  may be of any known material or construction, including but not limited to fabric, plastic, latex and elastomeric materials, and may include any number of segments or fibers, including braided constructions. A proximal base  37  of bladder  30  is releasably coupled to proximal portion  26  of cannula  20 . In embodiments, proximal base  37  is releasably coupled to proximal portion  26  by an expandable ring  38  seated in a recess  26   b  formed in proximal portion  26  as shown in  FIG. 1A . Cord  36  can be coupled to an outer surface of expandable ring  38 . Expandable ring  38  can include a passage  38   a  which slidably receives cord  36  therethrough. In some embodiments, expandable ring  38  is integrally formed into proximal base  37  of bladder  30 . 
         [0020]    Referring also to  FIG. 1B , cord  36  has a first end  36   a,  a central portion  36   b,  and a second end  36   c.  First and second ends  36   a,    36   c  extend into proximal portion  22  of cannula  20  and through lumen  28  of elongated tubular body  24 . In embodiments, first and/or second end  36   a,    36   c  are positioned proximal to proximal end  22   a  of cannula  20 . In the embodiment shown, central portion  36   b  of cord  36  extends distally from first end  36   a  through central lumen  28 , into distal portion  26  of cannula  20  through distal end  26   a,  and into bladder  30 . Central portion  36   b  of cord  36  passes through retainer  34   a  in inner surface  34  of bladder  30 . Central portion  36   b  reenters cannula  20  through distal end  26   a  after passing though retainer  34   a.  Central portion  36   b  extends proximally from distal end  26   a  through central lumen  28  to proximal portion  22  of cannula  20  to second end  36   c  of cord  36 . First end  36   a  and/or second end  36   c  can be affixed within lumen  28  in proximal portion  22  of cannula  20 . In embodiments, first and/or second end  36   a,    36   c  is slidably received in a retaining mechanism such as clamp  23  positioned in proximal portion  22  of cannula  20 . Clamp  23  can be positioned at proximal end  22   a  of cannula  20  as shown in  FIG. 1B . As will be appreciated by those skilled in the art, retaining mechanism  23  may comprise a variety of constructions, including loops, hooks, and shoulders. 
         [0021]    With reference to  FIGS. 2-8 , the use of fluid expandable balloon dissector  10  will now be described in detail. Bladder  30  is disposed substantially within central lumen  28  of cannula  20 , proximal base  37  of bladder  30  is coupled in a sealing relationship with distal portion  26  of cannula  20 , and first and second ends  36   a,    36   c  of cord  36  are positioned near proximal end  22   a  as shown in  FIG. 2 . When bladder  30  is at least partially deflated, surgical instrument  10  is slidable through a surgical site  81  in tissue layer  80  of a patient. Surgical site  81  can be a naturally occurring orifice or an incision in a tissue layer. Surgical instrument  10  can be slid through a port of an access device (not shown) or inserted directly through surgical site  81 . 
         [0022]    Referring to  FIG. 3 , inflation fluid (not shown) is introduced into central lumen  28  through inflation port  29 . The inflation fluid can be air, nitrogen, saline, or any other suitable fluid. The inflation fluid can be gas, liquid, or a combination thereof. A valve member  21  in the proximal portion  22  of cannula  20  is closed when the inflation fluid is being introduced into central lumen  28 . As the inflation fluid is introduced into central lumen  28 , pressure increases in central lumen  28  and bladder  30  such that expandable bladder  30  extends distally through distal end  26   a  of cannula  20  and into body cavity  83 . When expandable bladder  30  extends from distal end  26   a,  expandable bladder  30  is positioned near tissue and/or organs to be dissected and/or retracted. As expandable bladder  30  extends, central portion  36   b  of cord  36  cooperates with retainer  34   a  on inner surface  34  to extend expandable bladder  30  from distal end  26   a.    
         [0023]    Referring to  FIG. 4 , as additional inflation fluid is introduced through inflation port  29  to inflate bladder  30 , the tissue and/or organs are dissected and/or retracted. When bladder  30  is inflated, bladder  30  can maintain the tissue and/or organs in a desired position to provide access and/or visibility to underlying tissue and/or organs. 
         [0024]    Referring to  FIG. 5 , bladder  30  is deflated allowing the tissue and/or organs to at least partially return to the position each was in before being dissected and/or retracted. Inflation fluid can be released by opening valve member  21  and/or deflation port  25 . The pressure of the tissue and/or organs acting on bladder  30  to at least partially deflate bladder  30 . Bladder  30  can be repositioned and reinflated after being partially retracted or fully retracted as described below. First and/or second end  36   a,    36   c  can be pulled to partially retract and/or shape bladder  30 . For example, if first end  36  is affixed to proximal end  22   a  and second end  36   c  is slidably received within clamp  23 , second end  36   c  is pulled such that central portion  36   b  of cord  36  engages retainers  34   a  to partially retract bladder  30 . It will be appreciated that the position and number of retainers  34   a  can determine the shape of and retraction of bladder  30  when cord  36  is pulled. 
         [0025]    Referring to  FIG. 6 , first and/or second end  36   a,    36   c  of cord  36  are further pulled to retract bladder  30  into cannula  20 . Continuing the example above, second end  36   c  is pulled such that central portion  36   b  of cord  36  draws retainers  34   a  and bladder  30  through distal end  26   a  and into cannula  20 . Further pulling of second end  36   c  draws bladder  30  through proximal end  22   a  of cannula  20  as shown in  FIG. 7 . As second end  36   c  is pulled, proximal base  37  of bladder  30  is decoupled from distal portion  26  of cannula  20 . In embodiments, proximal base  37  separates from distal portion  26 . It will be appreciated that when proximal base  37  separates from distal portion  26 , bladder  30  will rapidly desuffalate when valve member  21  and/or deflation port  25  are closed. In some embodiments, bladder  30  pulls on proximal base  37  to disengage proximal base  37  from expandable ring  38 . In embodiments where cord  36  passes through passages  38   a  ( FIG. 1A ) in expandable ring  38 , cord  36  disengages expandable ring  38  from distal portion  26  of cannula  20 . 
         [0026]    Referring to  FIG. 8 , bladder  30  can be completely withdrawn from cannula  20  while instrument  10  is inserted within body cavity  83  permitting introduction of additional instruments into body cavity  83  through cannula  20 . In embodiments, proximal portion  22  includes a sealing member to engage the body of additional surgical instruments (not shown). In some embodiments, proximal portion  22  of cannula  20  is releasably coupled to elongated tubular body  24  such that when bladder  30  is withdrawn from instrument  10 , proximal portion  22  is separated from elongated tubular body  24  permitting a second proximal portion (not shown) to be coupled to elongated tubular body  24 . The second proximal portion can be at least one of a seal housing, an obturator, etc. 
         [0027]    In embodiments, retainers  34   a  form a continuous sleeve around inner surface  34  and cord  36  is disposed within the sleeve formed by retainers  34   a.  In some embodiments, a rib (not shown) is formed in inner surface  34  having openings (not shown) and cord  36  laces through the openings. In certain embodiments, cord  36  is affixed to inner surface  34 . 
         [0028]    Referring to  FIGS. 9A and 9B , additional fluid expandable balloon devices  110 ,  210  are provided in accordance with the present disclosure each including a cannula  120 ,  220 , a bladder  130 ,  230 , and a cord  136 ,  236 . Fluid expandable balloon devices  110  and  210  are substantially similar to dissector  10  ( FIG. 1 ) with similar structures labeled with similar identifiers with a “1” or a “2” preceding the previous label respectively. 
         [0029]    Fluid expandable balloon device  110  is triangular dissector including a bladder  130  having retainers  134   a  positioned about the edge of bladder  130 . 
         [0030]    Fluid expandable balloon device  210  is a toroidal retractor including a bladder  230  having a central hole  234   a  through the center of bladder  230 . Cord  236  of fluid expandable balloon device  210  includes a central portion  236   b  within bladder  230  which surrounds central hole  234   a.  When central portion  236   b  is retracted it can engage the inner surface of central hole  234   a  to withdraw bladder  230  within and through a cannula  220  such that central hole  234   a  acts as a retainer. In some embodiments, central portion  236   b  is attached to retainers (not shown) in the inner surface of bladder  230  similar to central portion  36   b  ( FIG. 1 ) of fluid expandable balloon dissector  10  ( FIG. 1 ). 
         [0031]    Referring to  FIG. 10 , another fluid expandable balloon dissector  310  is provided in accordance with the present disclosure including a cannula  320 , a bladder  330 , and a vacuum desufflator  340 . Fluid expandable balloon device  310  is substantially similar to dissector  10  ( FIG. 1 ) with similar structures labeled with similar identifiers with a “3” preceding the previous label. 
         [0032]    Bladder  330  includes a proximal base  337  releasably coupled to a proximal portion  326  of cannula  320 . In embodiments, proximal base  337  is releasably coupled to proximal portion  326  by an expandable ring  338  seated in a recess  326   b  formed in proximal portion  326 . In some embodiments, expandable ring  338  is integrally formed into proximal base  337  of bladder  330 . 
         [0033]    Vacuum desufflator  340  includes a nozzle  342  and a proximal connector  344 . Nozzle  342  is positioned at the distal end of vacuum desufflator  340  and is configured to sealing engage a proximal end  322   a  of cannula  320 . Proximal connector  344  is configured to couple to a vacuum source (not shown), e.g., a vacuum source commonly available in a surgical environment. Vacuum desufflator  340  can include an actuator  346  configured to control the vacuum or suction at nozzle  342 . Actuator  346  can be an analog switch or a binary switch. 
         [0034]    Vacuum desufflator  340  may be used to deflate bladder  330  and/or withdraw bladder through proximal end  322   a  of cannula  320 . Nozzle  342  is positioned over proximal end  322   a  of cannula  320  such that nozzle  342  sealingly engages proximal end  322   a  of cannula  320 . Suction from nozzle  342  deflates bladder  330 . Additional suction from nozzle  342  draws bladder  330  through cannula  320  such that proximal base  337  separates from distal portion  326  of cannula  320  as bladder  330  is drawn to nozzle  342 . Bladder  330  may be drawn through nozzle  342 . In embodiments, bladder  330  seals nozzle  342  such that as nozzle  342  disengages proximal end  322   a  of cannula  320 , bladder  330  is removed from proximal end  322   a.    
         [0035]    While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Any combination of the above embodiments is also envisioned and is within the scope of the claimed invention. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.