Abstract:
An embodiment of the invention includes a quantum fluid flow management apparatus which controls and facilitates delivery of liquid and/or air to the surgical site during a surgical procedure via a trumpet valve, various restriction (crimping) devices, and a network of tubing for selectively passing air or fluid through to the surgical site. The trumpet valve allows for selective control of air or fluid or both or neither. Additionally the flow management apparatus controls the application and suction of fluids from the surgical site which may be used in cooperation with the injection of a fluid such as water to irrigate the surgical site to remove body fluids, debrided material or the like.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of the prior filed U.S. provisional application No. 61/253,068 filed Oct. 20, 2009 which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention is broadly concerned improvements in instruments for endoscopic surgery. 
         [0003]    Modern surgery tends toward minimally invasive techniques whenever possible. Although often more complicated in some ways for the surgeon, minimally invasive techniques result in less trauma to the patient and less scarring because of much smaller incisions thereby promoting faster healing and reducing possibilities for infections. In general, minimally invasive surgeries involve making one or more small incisions at appropriate locations and inserting tubular devices through the incisions to the surgical site. The tubular devices may be referred to as endoscopes, arthroscopes, and the like and typically have optical fiber based optical viewing apparatus and light sources, surgical instruments, lumens for exchanging fluids with the surgical site, or combinations thereof extending therethrough. In some circumstances it is more appropriate to separate the light source and viewing scope from specifically surgical instruments, thus requiring two incisions and endoscopes. This technique is sometimes referred to as triangulation. In other instances, external types of imaging techniques are used for locating endoscopic instruments, such as fluoroscopes, computed tomography, magnetic resonance imaging, or the like. 
         [0004]    Endoscopic instruments are configured in a number of different ways depending on their intended purpose. There are rigid endoscopes and flexible endoscopes. Some are simply tubes through which provide access to a surgical site for instruments which are passed through the scopes or for the exchange of fluids to and from the surgical site. Viewing scopes, including light sources, may be used for viewing a surgical site for diagnostic purposes or to view surgical operations occurring through the same scope or a different scope. Surgical operations may include cutting, shaving, debriding, cauterizing, or the like as well as grasping tissues or parts of organs, such as with forceps. 
       SUMMARY OF THE INVENTION 
       [0005]    The present invention provides improvements in certain areas of minimally invasive surgical techniques and instrumentation. 
         [0006]    An embodiment of the invention includes a quantum fluid flow management apparatus which controls and facilitates delivery of liquid and/or air to the surgical site during a surgical procedure via a trumpet valve, various restriction (crimping) devices, and a network of tubing for selectively passing air or fluid through to the surgical site. The trumpet valve allows for selective control of air or fluid or both or neither. Additionally the flow management apparatus controls the application and suction of fluids from the surgical site which may be used in cooperation with the injection of a fluid such as water to irrigate the surgical site to remove body fluids, debrided material or the like. 
         [0007]    An embodiment of the invention includes an improved trephine which includes a shaped surface with a stopper at the end with an opening at a front, a rear, and a side entry for the passage of surgical instruments including flexible forceps, passage of fluid/air and providing a resealable rear entry for containing any fluid/air within the surgical site. The trephine is adapted for receiving a shaver or other instrument with a rear portal opening having a shaped surface for which the new trephine is adapted for providing a hermetic seal thereabout and the trephine includes a shaped end which is adapted for hermetic sealing the end of the trephine. The trephine also allows for the receipt of standard surgical instruments including the flexible forceps. 
         [0008]    The tip of the trephine may be formed to present a cutting edge providing a cutting instrument when in the receipt of a shaver and the tip disposed within the patient near the surgical site may also be curved or straight for passing the flexible forceps through the ligament head into the femoral head with around a 30° curve. The tip of the end may also be removable for passage of the forceps as needed. The trephine may be telescoping as desired to substantially place the tip below a fluid level. 
         [0009]    An embodiment of the improved trephine is provided with a conically tapered distal tip of the cannula which is then cut at an angle. The tapering allows the cannula to pass more easily through the incision to the surgical site with reduced incidence of injury to intervening tissues. 
         [0010]    An embodiment of the improved trephine is provided with a visual indicator of the direction of the angled cut tip of the cannula. A side port of the trephine is secured to a ring which is rotatable relative to the body of the trephine. Passages are provided within either the ring of the body of the trephine to provide fluid communication between the side port and the main passage of the trephine body. An indicator post projects from the proximal end of the body and shows the rotated position of the body, and thus the angular position of the tip, with respect to the side port. The indicator post may also facilitate rotation of the body and cannula. 
         [0011]    In addition, the trephine may be used as a Boveri device for electro-cauterization of the surgical site as needed by associating an electric charge with the invention presenting a cauterization tip for treatment with the trephine presenting the proper electric connectivity for passing the electrical charge down to the tip of the flexible forceps. 
         [0012]    Another embodiment of the invention includes an improved outflow adapter which is provided for use with other types of endoscopic instruments, such as an arthroscopic shaver, to provide triangular outflow from a surgical site. The outflow adapter includes an adapter body with a proximal end port, a distal end port, and a side or lateral port. A pair of plugs, including a closed plug and an open plug, are provided for insertion into the proximal end port to either close the proximal end or to allow outflow therefrom. The distal end of the outflow adapter is sized to be sealingly received in a proximal end of the endoscopic instrument with which it is used. 
         [0013]    Various objects and advantages of the present invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. 
         [0014]    The drawings constitute a part of this specification, include exemplary embodiments of the present invention, and illustrate various objects and features thereof. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]      FIG. 1  is a view of an embodiment of quantum flow fluid management apparatus according to the present invention. 
           [0016]      FIG. 2  is a view similar to  FIG. 1  and shows the fluid management apparatus of the present invention. 
           [0017]      FIG. 3  is a block diagram illustrating components of the fluid management apparatus of the present invention. 
           [0018]      FIG. 4  is an enlarged photograph of a trumpet valve unit of the fluid management apparatus. 
           [0019]      FIG. 5  is a photographic side view of an embodiment of an improved trephine according to the present invention. 
           [0020]      FIG. 5A  is an enlarged fragmentary side elevational view of a distal end of an embodiment of the improved trephine and illustrates a conical tapering of the distal end. 
           [0021]      FIG. 6  is a photographic perspective view of the improved trephine from a proximal end and illustrates a visual indicator in a non-aligned angular relationship with a side port of the trephine. 
           [0022]      FIG. 7  is an enlarged photographic side view of the embodiment of the improved trephine with a portion broken away to illustrate exemplary details thereof. 
           [0023]      FIG. 8  is an enlarged photographic side view of an embodiment of an outflow adapter according to the present invention along with a pair of stoppers for use with the outflow adapter. 
           [0024]      FIG. 9  is an enlarged photographic perspective view of the outflow adapter and illustrates embodiments of closed and open stoppers for use with the outflow adapter. 
           [0025]      FIG. 10  is an enlarged photographic perspective view of the outflow adapter with the closed stopper inserted into a proximal end thereof. 
           [0026]      FIG. 11  is a view similar to  FIG. 10  and shows the outflow adapter with the open stopper inserted into the proximal end thereof. 
           [0027]      FIG. 12  is a photographic side view of the outflow adapter shown inserted into a proximal end of an elongated endoscopic surgical instrument. 
           [0028]      FIG. 13  is a photographic side view of the outflow adapter shown inserted into the proximal end of a short endoscopic surgical instrument. 
           [0029]      FIG. 14  is a greatly enlarged photographic side view of the outflow adapter shown with the open stopper inserted and shown inserted into the proximal end of an alternative configuration of an endoscopic surgical instrument. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0030]    As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. 
         [0031]    Referring to the drawings in more detail, the reference numeral  1  generally designates an embodiment of a quantum flow or fluid management apparatus according to the present invention. In general, the fluid management apparatus  1  controls the flow of fluids such as water or gases such as air to a surgical site associated with a patient and the removal of fluids or gases from the surgical site, either by release and outflow thereof or by the use of suction. 
         [0032]    Referring to  FIGS. 1-4 , the illustrated fluid management apparatus  1  includes a trumpet valve unit  5  including a main passage  7  ( FIG. 4 ), and a pair of branch passages  9  and  10 . The trumpet valve unit  5  includes valves  11  and  12  which control fluid communication respectively between the branch passages  9  and  10  and the main passage  7 . The valves  11  and  12  are normally closed and are manually opened against spring pressure to provide fluid communication therethrough. As depicted the valve  11  is associated with a fluid or hydraulic source and the valve  12  is associated with a pneumatic source, although the valves may be arranged alternatively as desired. The trumpet valve unit  5  includes a grip member  14  positioned on the tubular member forming the main passage  7  to facilitate grasping the unit  5  and operating the valves  11  and  12  by a surgeon or a surgical assistant during a surgical procedure. 
         [0033]    In the illustrated embodiment of the fluid management apparatus  1 , a fluid source, pump or other fluid delivery means  17  is connected through a main fluid conduit  18  through a removable crimp valve  19  to the main passage  7  of the trumpet valve unit  5 . A Y-branch member  20  is positioned in the main fluid conduit  18  and connects the conduit  18  to the fluid branch passage  9  by way of a branch fluid conduit  21 . The crimp valve  19  is of the ratcheted type and is operable to pinch or crimp the main fluid conduit  18  to control flow therethrough. The crimp valve  19  can be released or removed to enable continuous flow of fluid through the main passage  7 . As illustrated, the fluid source  17  may be paired via a Y-branch fluid supply line  16  to facilitate addition or removal of fluid during the surgical procedure. In addition, the supply line  16  may be coupled to the Y-branch member  20  via easy coupling connectors  38 , with a female and male portions  38   a ,  38   b . Generally, the easy coupling connectors facilitate rapid convenient attachment of the fluid to the fluid management apparatus  1 . 
         [0034]    A suction conduit  24  connects an operating room suction source  25  to the branch passage  10  of the trumpet valve unit  5  through a crimp valve  26 . Alternatively, an air supply connector  32  may be utilized through a connector coupling or as illustrated by a Y-branch member  27  in the conduit  24  with an air conduit  28  connected to it. An air filter  29  can be positioned at an end of the air conduit  28  to filter ambient air  30  entering the air conduit. The air conduit  28  may also have an air crimp valve  31  positioned on it. The crimp valves  19 ,  26 , and  31  can be partially applied through an adjustable ratchet to restrict flow as desired at their respective conduits, partially or fully applied to completely close the conduit. 
         [0035]    The illustrated fluid management apparatus  1  includes a main conduit or patient conduit  33  connected to the main passage  7  and to an endoscopic instrument  34  at the surgical site through a crimp valve  35 . 
         [0036]    The fluid management apparatus  1  enables the surgeon to alternately and repeatedly depress the water valve  11  to inject water or other fluid to the surgical scope  34  at the surgical site or to aspirate the fluid or other matter from the surgical site by selectively pressing the air or suction valve  12 . These operations can be performed to initially clean up the surgical site or to remove tissue, debrided matter, or bodily fluids from the surgical site as the procedure is performed. The configuration of the apparatus  1 , including the trumpet valve  5  and the length of conduits  18 ,  24 , and  33 , enables the surgeon to stretch his or her arms, with one hand on the trumpet valve unit  5 , the other hand on an endoscopic instrument  34 , and eyes on a video monitor (not shown) to achieve a more balanced and comfortable stance to thereby reduce fatigue during surgery. 
         [0037]    Alternatively, two scopes may be interconnected by the fluid management apparatus in a triangulation configuration with one scope attached to the main patient conduit  33  and another scope or other surgical instrument attached to the triangulation scope conduit via an alternative air supply conduit  32  connectably secured at the crimp valve  26 . In this manner one or more surgical instruments may be introduced into the cavity through multiple scopes at different openings with the distal ends of each scope being angularly oriented to the surgical site. By connecting one scope to the air branch passage  10  and one scope to the patient conduit  33  the valves  11  and  12  can be operated simultaneously to provide a steady stream of irrigating fluid to the surgical site which is continuously drawn from the site by the suction source  25 . The crimp valves  19 ,  26 , and  35  can be adjusted by the surgeon to control the flow rate of fluid to the surgical site and the flow of materials drawn therefrom. 
         [0038]    Alternatively, as further described below, one scope may include an electrode and an electrical insulating sheath for passage of an electrical current along the selected scope to the distal scope end for use during electro-surgery. In this arrangement, current passes from the active electrode to the surgical site along the scope, separated from the patient by the insulating sheathing. In this manner, the electrical properties of the electrode may be adjusted for cutting, dessication or coagulation between the electrode and the surgical site of interest. During, prior or at the conclusion of the electro-surgery operation, the fluid management apparatus may be operated to provide suction and irrigation to wash the surgical site and/or wet the tissue to reduce contact impedance. 
         [0039]      FIGS. 5-7  illustrate an embodiment of an improved trephine  40  according to the present invention. The illustrated trephine  40  includes a trephine body  42  formed of a cylindrical section  44  converging in a conical section  46  to a cannulated rod, cannula, or tube  48 , terminating in a tip section  50 . The trephine body  42  includes a lateral or side port  52  having a side port passage  54  which communicates with a main passage  56  of the trephine body  42 . The illustrated cylindrical section  44  is further divided into a rear or proximal section  58 , a center section  60 , and a front or distal section  62 . The proximal section  58 , distal section  62 , and the cannula  48  form a body assembly  64  of the trephine  40 . The center section  60  and the side port  52  form a side port assembly  66 . The body assembly  64  is provided with a radially projecting post  68 , as on the proximal section  58 . 
         [0040]    Referring to  FIG. 5A , the illustrated tip section  50  includes a conically tapered termination  70  which is cut at an angle to form a projection cannula tip  72 . The conical taper of the termination  70  facilitates movement of the tip section  50  through an incision and past tissues and organs with less injury thereto in comparison to a cylindrical termination of the cannula  48 . Because the cannula tip  72  projects outwardly, to further reduce injury, it is important for the surgeon to know its orientation. In the illustrated trephine  40 , the post  68  is aligned with the cannula tip  72  to provide the surgeon with a visual indication of the angular orientation of the cannula tip  72  with respect to the side port  52 . 
         [0041]    The side port assembly  66  is rotatably mounted on the body assembly  64  for relative rotation therebetween.  FIG. 7  illustrates an exemplary configuration of the manner in which the side port assembly  66  is rotatably mounted with respect to the body assembly  64 . In the illustrated trephine  40 , the center  60  of the trephine body  42  is an annular member or ring from which the side port  52  projects. The body assembly  64  includes a cylindrical neck member or neck  76  which extends from the proximal section  58  and is sized to extend through the center  60  to the distal section  62  of the trephine body  42  into which it is secured, as by being press fit or the like. It is foreseen that the neck  76  could alternatively extend from the distal section  62  toward and be secured to the proximal section  58 . It is also foreseen that the neck  76  could be a separate part and be secured to both the proximal section  58  and the distal section  62 . In any case, the proximal section  58 , the neck  76 , and the distal section  62 , along with the cannula  48  form an assembled unit, the body assembly  64 . 
         [0042]    The illustrated neck  76  includes a portion of the main passage  56  which communicates with a cannula passage  78  through the cannula  48 . The side port passage  54  communicates with the main passage  56 . In the illustrated trephine  40 , the neck  76  is provided with an external circumferential groove  80 . A plurality of apertures or holes  82  are formed through the wall of the neck  76  within the groove  80 . The groove  80  and holes  82  cooperate to provide fluid communication between the side port passage  54  and the main passage  56  for any angular relation between the body assembly  64  and the side port assembly  66 . 
         [0043]    The illustrated trephine  40  includes an O-ring  84  positioned in the main passage  56  and may include a second or distal O-ring  86  positioned at a location distally spaced from the O-ring  84 . It is foreseen that the second O-ring  86  could be positioned between the first or proximal O-ring  84  and the side port  52  or, as illustrated, between the side port  52  and the distal body section  62 . The proximal O-ring  84  is preferably formed of an elastomeric material and provides a cushion for an instrument (not shown) extending through the trephine  40  and a fluid seal to prevent fluid flow out the rear of the trephine  40 . 
         [0044]    The distal O-ring  86  provides balance for an instrument extending through the trephine  40  and loosely engages such an instrument such that it does not prevent fluid flow past its area of engagement. Alternatively, it is foreseen that an inner surface of the O-ring  86  could be notched or otherwise shaped to enable fluid flow past it. This allows the trephine  40  to dissipate pressure within the surgical site and reduces tension at the incision or within soft tissue when the instrument is being manipulated in soft tissue. The loose engagement of the distal O-ring  86  and the engagement between the received surgical instrument and the O-ring  84  allows for maneuverability of the received instrument within the trephine  40 , providing a range of access to the surgical site greater than the corresponding diameter of the cannula passage  48 . In this way, the maneuverability of the received instrument resembles plastic deformation in that the angular movement of the instrument associated with the tip section  50  is greater than the angular movement of the body assembly  64 . 
         [0045]    Because of the use of the O-rings  84  and  86  and because of deep engaging surfaces of the body assembly  64  and the side port assembly  66 , the trephine  40  is maintained as a single use instrument eliminating the potential bio-hazards associated with reused surgical instruments. Based upon the illustrated configuration, it is difficult to reliably sterilize the trephine  40  after use within a patient. While the proximal O-ring  84  could be removed for autoclaving and replaced, the distal O-ring  86  is inaccessible. Based upon the illustrated configuration, the instrument must be disposed because small amounts of tissue from the patient and any pathogens associated therewith may enter the interfaces between the components of the assemblies  64  and  66 . For these reasons, the trephine  40  must be disposed after a single use or recycled in a manner that prevents the release of possible biological hazards. 
         [0046]    The trephine  40  may be provided with a means (not shown) of releasably interlocking a surgical instrument extending therethrough to the trephine  40 , such as a so-called j-lock or bayonet mechanism. 
         [0047]    In use of the trephine  40 , an incision is made at an appropriate location, and a guide wire (not shown), such as a nitinol guide wire, is advanced to the surgical site, using radiant imaging, such as fluoroscope, if necessary. The cannula  48  of the trephine  40  is sleeved onto the guide wire, and the tip section  50  is advanced toward the surgical site. The guide wire can then be removed, and a surgical instrument is inserted through the trephine  40  toward the surgical site. If required, the surgical site can be triangulated with a second endoscopic instrument for direct viewing, assistance with the surgical procedure occurring through the trephine  40 , fluid management at the surgical site, or the like. 
         [0048]    As previously discussed, in one embodiment of the trephine  40 , the body assembly  64  may be configured for receiving an electrode with an elongated portion extending through the cannula passage  78 , the elongated portion being coated or otherwise insulated (not shown) for use as an electro-cauterization device connected to the trephine  40 , the elongated portion having a non-insulated tip for selectively cauterizing tissues at the surgical site. 
         [0049]      FIGS. 8-14  illustrate an embodiment of an improved outflow or egress adapter  90  according to the present invention. Generally, the adapter  90  is used with a second endoscopic instrument  92  to prevent or control the outflow of fluids from a surgical site or to enable the insertion of surgical instruments (not shown) through the adapter  90  and endoscope  92 . The illustrated adapter  90  includes a main body section  94  having an axial main passage (not shown) therethrough and having a side port  96  projecting radially therefrom. The side port  96  has an axial passage (not shown) extending therethrough and communicating with the main passage of the main body  94 . The adapter  90  includes a distal end port  98  sized for reception in the second endoscopic instrument  92 . The adapter  90  has a proximal port  100  sized to receive either a closed plug  102  or an open or cannulated plug  104 . The illustrated proximal port  100  has a knurled external surface for positive gripping by the surgeon. The closed plug  102  is inserted into the proximal port  100  to prevent the outflow of fluids from the adapter  90 . A closed plug O-ring  106  is secured to the closed plug  102  to positively seal the closed plug within the proximal port  100 . In contrast, the cannulated plug  104  has an axial passage  108  extending therethrough for receiving surgical instruments or for the controlled outflow of fluids from the adapter  90 . The cannulated plug  104  may be provided with an O-ring  110 , as illustrated in  FIG. 8 .  FIG. 10  shows the outflow adapter  90  with the closed plug  102  inserted in its proximal end port  100 .  FIG. 11  shows the outflow adapter  90  with the cannulated plug  104  inserted in its proximal end port  100 . 
         [0050]    An alternative canulated endoscope instrument  92  is illustrated in  FIGS. 12-13  with a flexile cannula located between a second distal end  112  associated with a helical thread  114  and a second proximal end  116  associated with a flexible gasketed material adapted to receive the distal end port  98  of the outflow adapter  90 , the second proximal end  116  being generally adapted to restrict the flow of fluid. The cannulated endoscopic instrument  92  also is illustrated with an outflow port  118  for selectively releasing fluid from the cannulated endoscopic instrument  92 . Additional access is provided by the side port  96  for suction, irrigation or other surgical devices. 
         [0051]    The outflow adapter  90  may be used during triangulation when a second incision is made at an appropriate location, and a guide wire is inserted therethrough and advanced toward the surgical site. The cannulated endoscopic instrument  92  is telescoped over the guide wire and advanced toward the surgical site. An instrument such as an arthroscopic shaver (not shown) can be inserted through the cannulated endoscopic instrument  92  and used, for example, for a debriding procedure. The shaver is then removed, and the outflow adapter  90  is inserted into the instrument  92  to control the outflow of fluids from the surgical site. 
         [0052]    Alternatively, the outflow adapter  90  may be received by one end of a shaver  120  providing access to the surgical site and controlling the outflow of fluid as illustrated in  FIG. 14 . The closed plug  102  can be used to prevent the outflow of fluids, while the cannulated plug  104  may be used for receiving surgical instruments or for the controlled release of such fluids. The illustrated plugs  102  and  104  are circumferentially ribbed to facilitate gripping by the surgeon to insert the plugs  102  or  104  into the adapter  90  or remove them therefrom. 
         [0053]    It is to be understood that while certain forms of the present invention have been illustrated and described herein, it is not to be limited to the specific forms or arrangement of parts described and shown.