Abstract:
A method and apparatus for injecting saline into an open cavity of a patient&#39;s body, and, alternatively, vacuuming fluids from said cavity, during laparoscopic surgery that provides constant feed and amplified pressure to provide a steady fluid output, in a disposable, single use handheld surgical device.

Description:
TECHNICAL FIELD 
       [0001]    The present novel technology relates to the field of medical device technology, and more particularly, a method and apparatus used during laparoscopic surgery for injecting saline into an open cavity of the patient&#39;s body, and, alternatively, vacuuming fluids from said cavity. 
       BACKGROUND 
       [0002]    Laparoscopic surgery has continuously gained momentum and popularity since it was first introduced in the United States around 1988. Laparoscopic surgery, a minimally invasive surgical technique in which surgeons operate through multiple, small incisions in the abdomen, reduces standard risks, patient discomfort, scarring, and recovery time compared to previously utilized open surgical techniques. 
         [0003]    Due to the intricate process of utilizing specialized instrumentation and a laparoscope camera to perform the operation while watching detailed images on a monitor, a clear surgical field is important. Without a clear surgical field, the surgeon is essentially operating “blind”. Irrigation and aspiration are essential procedures during laparoscopic surgery, especially for maintaining a clear visual field and maintained hemostasis. Therefore, it is crucial that the device used for irrigation and aspiration provide enough hydraulic pressure to clear away debris, blood, blood clots, char, or any other material that may obstruct the surgeon&#39;s vision throughout the procedure, without delay. 
         [0004]    Typically, disposable, single-use battery-powered laparoscopic devices are utilized for irrigation and aspiration. These mechanical pumping systems typically utilize standard alkaline batteries to power a motor, which in turn, activates a pump to drive irrigation fluid through the system for delivery to the operative site. Although these devices provide portable handheld systems with a built-in pump motor and generally adequate fluid pressure, there is currently a need for an aspiration and irrigation device that solves several issues unaddressed by the devices currently in the marketplace. The current solution is expensive and requires multiple disposal methods for proper disposal of the various components, such as metal, chemical, and surgical waste. In addition, an improved method of operating a pump, utilizing standard operating room resources, would be more transferable, efficient, inexpensive, and reliable. The present novel technology addresses this need. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]      FIG. 1  is a front plan view of a vacuum powered saline injection system according to a first embodiment of the present novel technology. 
           [0006]      FIG. 2  is a side plan view of a first embodiment illustrating the gun portion of the vacuum powered saline injection system. 
           [0007]      FIG. 3  is a front perspective view of a second embodiment vacuum powered saline injection system. 
           [0008]      FIG. 4  is a front perspective view of a third embodiment vacuum powered saline injection system. 
           [0009]      FIG. 5  is a front perspective view of a forth embodiment vacuum powered saline injection system. 
           [0010]      FIG. 6  is a front perspective view of a fifth embodiment vacuum powered saline injection system. 
           [0011]      FIG. 7  is a front perspective view of a front perspective view of a sixth embodiment vacuum powered saline injection system. 
           [0012]      FIG. 8  is a front plan view of the first embodiment vacuum powered saline injection system illustrating both the pump portion and the gun portion. 
           [0013]      FIG. 9  is a side plan view of a seventh embodiment illustrating the accumulator portion of a vacuum powered saline injection system in its contracted state. 
           [0014]      FIG. 10  is a side plan view of the seventh embodiment illustrating the accumulator portion of a vacuum powered saline injection system in its expanded state. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0015]    For the purposes of promoting an understanding of the principles of the novel technology and presenting its currently understood best mode of operation, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the novel technology is thereby intended, with such alterations and further modifications in the illustrated device and such further applications of the principles of the novel technology as illustrated therein being contemplated as would normally occur to one skilled in the art to which the novel technology relates. 
         [0016]      FIGS. 1-2  and  FIG. 8  illustrate a first embodiment of the present novel technology, a disposable, single-use handheld surgical device  10  for aspiration, and alternatively, irrigation during surgical procedures such as laparoscopic procedures. The vacuum powered saline injection system  10  generally includes a pump portion  15  and a wand or gun portion  20 , and typically, a plurality of tubing portions  30 , one of which operationally connects the pump  15  and gun portions  20  of the surgical device  10 . 
         [0017]    The pump portion  15  generally includes a housing  12 , which is customarily defined by a base portion  14  and an engageable cover portion (not illustrated in the drawings). Housing  12  is typically made of hard plastic or the like, although any convenient material may be selected. The housing  12  encases a pump motor  55 , which typically includes a spring-biased valve  50  having a pivotable pump  13  connected in fluidic communication with a vacuum inlet  40 , a generally cylindrical lower fluid storage chamber  70  (typically made of plastic or other polymeric material or the like) operationally connected to the spring-biased valve  50  and pivotable pump  13 , a rod  17  extending vertically through the lower chamber  70  and down into the spring-biased valve  50  and pivotable pump  13 , a generally cylindrical upper chamber  60  (typically made of plastic or other polymeric material or the like) in pneumatic communication with the lower chamber  70 , a saline inlet  80  connected to the upper chamber  60 , a generally cylindrical spring-biased accumulator or storage tank  90  (typically made of plastic or other polymeric material or the like) connected in fluidic communication to the upper chamber  60 , and an outlet  95  for connecting the pump portion  15  and the gun portion  20  of the system  10  by way of a tubing component  33 , in fluidic communication with the upper chamber  60  and flexible plastic tubing  30 . 
         [0018]    A vacuum source is connected in fluidic communication with inlet  40 . The vacuum source is likewise connected to the lower chamber  70  through pivotable pump  13 , such that when a partial vacuum is introduced, air pressure differentials are generated and air pressure urges disk member  35  against spring  45 B, moving disk  35  toward pump  13 , likewise pushing rod  17  into receptacle  18  and urging pivotable pump disk  13  to pivot in a first direction. Pivoting pump disk  13  generates a biasing force in spring  45 A, which urges pivoting of disk  13  in a second, opposite direction. Disk  13  pivots in the first direction until port  43  is opened to atmosphere, allowing air into fluidic communication with vacuum source and disk member  35 , reducing the pressure differential and enabling spring  45 A to urge pivoting of disk  13  in the second, opposite direction and spring  45 B to urge disk  35  away from disk  13 . As disk  13  pivots in the second direction, port  43  is closed to atmosphere, air pressure in disk area  13  and around spring  45 B under disk  35  decreases, and the pump circle repeats. 
         [0019]    The side of disk  35  opposite spring  45 B is connected to plunger  61  which is disposed inside upper cylinder  60 . Movement of disk  35  towards disk  13  draws plunger  61  away from cylinder  60 , generating a partial vacuum in cylinder  60  and urging fluid from saline source connected to inlet  80  through check valve  19  and into cylinder  60 . As plunger  61  travels back into cylinder  60 , saline therein is urged through check valve  21  into chamber/storage tank  90 , urging disk  65  to move against spring  45 C, compressing spring  45 C and storing biasing energy therein. When outlet  95  is open, saline is urged from the tank  90 . The vacuum pump motor  55  thus operates to fill tank  90  by urging saline thereinto with a first urging force. Once the tank is full, spring  45 C and the incompressibility of saline generate a second, opposite force urging saline from outlet  95  when outlet is open and an unblocked fluid flow path exists; otherwise, the balance of forces prevent disk  35  from moving and the pump  55  automatically pauses. 
         [0020]    The pump portion  15 , gun portion  20 , and plurality of tubing components  30 , are powered by connection to a standard operating room medical vacuum system, allowing the vacuum powered saline injection system  10  to be utilized in most surgical and/or operating rooms. A first tubing component  31 , has a proximal end  31 A operationally connected to a fluid inlet port within the spring-biased valve  50  and pivotable pump  13 , and a distal end  31 B having a generally elastic, hydrocarbon polymer connector  180  operatively designed to engage a standard operating room medical vacuum system. In other embodiments, the connector  180  is sized and configured to engage non-standard vacuum sources, such as stand-alone vacuum pumps. 
         [0021]    In operation, a flushing agent, such as isotonic saline, may be drawn from the distal end of a second tubing component  32 , having a proximal end  32 A operatively designed to engage a flushing agent from an outside source, and a distal end  32 B in fluidic communication with the upper chamber  60  through a fluid inlet port  80 . A generally T-shaped connector  63  made out of hard plastic, although any convenient material may be selected, is oriented within a first major axis, perpendicular to a generally small upper chamber  60  and in fluidic communication with both the upper chamber  60  and the spring-biased storage chamber  90 , contains a plurality of typically round check valves, a first check valve  19  and a second check valve  21 , to channel the incoming flushing agent between the upper chamber  60  and the spring-biased storage chamber  90 . As the flushing agent enters the system  10  through the fluid inlet port  80 , a first check valve  19  allows the flushing agent to enter the system  10  while a second check valve  21  blocks the flushing agent from passing through the generally T-shaped connector  63  to the spring-biased storage chamber  90 . As the flushing agent enters the system  10 , the spring-biased valve  50  and pivotable pump  13  operationally connected to a vacuum source, continuously cycle, urging a rod  17 , generally connected to a first spring biased disk member  35  and typically extending vertically through the lower chamber  70  down into the spring-biased valve  50 , to engage the spring-bias  45  located within the spring-biased valve  50  to close a first port  43  operationally connected to an atmospheric opening. While a second port  42  operationally connected to a vacuum source is open, the first spring-biased disk member  35  is forced to draw against the biasing force and away from the upper chamber  60 , producing a partial vacuum in the upper chamber  60 , drawing the flushing agent into the upper chamber  60  and down into the lower chamber  70  as the spring-biased disk member  35  is compressed. As the pivotable pump  13  cycles, the spring-biased valve  50  forces a second port  42  operationally connected to a vacuum source to close, opening the first port  43  operationally connected to atmospheric air. The atmospheric air entering the system  10  negates the vacuum force entering the system, allowing the spring-bias  45  to urge a first spring-biased disk  35  positioned in the lower chamber  70 , back towards the upper chamber  60 , drawing the flushing agent back into the upper chamber  60 . As the flushing agent is drawn back into the upper chamber  60  from the lower chamber  70 , the first check valve  19  located within the generally T-shaped connecter  63  moves towards the saline port  80  to block fluid from entering the vacuum powered saline injection system  10  from an outside source, forcing the flushing agent from the upper chamber  60  into the spring-biased storage chamber  90 , containing a second spring-biased disk member  65 . The method of forcing a flushing agent from the lower chamber  70  into a generally smaller upper chamber  60 , while also forcing the flushing agent into the spring-biased storage tank  90  as the system  10  cycles, enables the system  10  to provide constant feed with amplified pressure, and thus, provide a constant, steady fluid output stream through a third tubing component,  33 , having a proximal end  33 A removably connected to the gun portion  20  of the system, and a distal end  33 B in fluidic communication with the spring-biased storage chamber  90  through an inlet  95 . The fluid output of the system  10  is controlled by the user through a multi-position valve  130  located on the gun portion  20  of the system, discussed in more detail herein. The vacuum powered pump further comprises an automatic shutoff feature when the spring-biased storage chamber  90  back pressure is equal to pump pressure forcing the fluid flow to cease through the system, the pivotable spring-biased pump  13  to stop pivoting, and the pump to idly wait until fluid is extracted from the storage chamber  90 . 
         [0022]      FIG. 2  generally illustrates the gun portion  20  of the vacuum powered saline injection system  10 . The gun portion  20  (typically made of hard, electrically non-conducting plastic or the like, although any convenient material may be selected) is generally “L”-shaped, and is more typically ergonomically contoured for comfort and ease of use. The gun portion  20  typically contains a first inlet  140  for receiving a tubing component  33  to place the pump portion  15  in fluidic communication with the gun portion  20  through a tubing inlet  141  located within the pistol-shaped handle  100 , and a second inlet  145  for receiving a vacuum tubing component  147 , located on the underside of the pistol-shaped handle  100 , through a second tubing inlet  146  located within the pistol-shaped handle  100 , in fluidic communication to the storage chamber  90 , as well as the operating room vacuum source. Additionally, a fluid nozzle  110  located on the barrel portion of the gun  150  places the handle  100  and barrel portions of the gun  150 , including the vacuum tubing inlet  146 , as well as the saline tubing inlet  141 , in fluidic communication with the cannula  160 . A multi-position valve  130 , located on the top of the handle between the handle  100  and the barrel  150 , permits a surgeon to quickly and easily manipulate whether the vacuum powered saline injection system  10  is in irrigation, aspiration, or off mode by simply rotating the typically circularly rounded valve  130  to the forward position, center, or back position. The multi-position valve  130  also permits a surgeon to control the flow and rate of a flushing agent, such as isotonic saline solution, or the rate and pressure of the vacuum. Thus, the gun portion&#39;s  20  functionality permits a surgeon to control aspiration or irrigation, as well as utilize a diathermy hook  175  located inside of a generally elongated cannula  160 , without having to use additional tools, reach away from the operating table, and/or physically move to control the function of the system. 
         [0023]    The generally hollow, cylinder-shaped cannula  160  houses a typically L-shaped spring-biased diathermy hook  175  that may be extended from the cannula  160  through an opening located on the distal end of the conduit  160 . The diathermy hook  175  is typically made of surgical stainless steel or metal, although any convenient material may be selected, and is operationally connected to the moveable trigger  170  located on the barrel portion  150  of the gun handle  100 . Actuation of the trigger  170  extends the hook from within the distal end of the cannula  160  in relative relation to the location of the trigger  170 , to aid in clearing unwanted tissue beside linear structures during surgery. 
         [0024]    Additional embodiments follow, wherein the vacuum powered saline injection system  10  operates as described above, however, the valve systems of the vacuum motor and the pump location differ. More specifically, the spring-biased valve  50  and the lower chamber  70  illustrated in  FIG. 1  are replaced by alternative embodiments. 
         [0025]    In an alternate embodiment, as illustrated in  FIG. 3 , a magnetically triggered valve system  200  cycles the saline pump assembly  235  by opening the vacuum chamber  240  to atmosphere when activated. Magnets (not shown), located on both the sliding valve gate (not shown) and the wall of the vacuum chamber  240 , provide attractive and repulsive forces that allow the valve gate (not shown), located on the syringe pump  230 , to move between alternating open and closed positions. In operation, the sliding gate valve (not shown) is initially in closed position sealing the vacuum chamber  240 . As a vacuum is created within the vacuum motor  205 , the atmospheric pressure pushes the syringe pump  230 , compressing the spring bias  226  within the vacuum chamber  240  and the spring bias  225  within the accumulator  236 , drawing a flushing agent such as saline into the attached spring bias syringe pump  230 . As the syringe pump  230  passes the magnet (not shown) affixed to the vacuum chamber wall, the magnet embedded in the sliding valve gate (not shown) is repelled, allowing atmosphere to equalize in the vacuum chamber  240 . The energy stored in the vacuum chamber  240  spring bias  226  pushes the syringe pump  230 , discharging the saline. As the syringe pump  230  returns to the home position with the sliding valve gate (not shown) in closed position, the magnet in the sliding valve gate is attracted to the chamber mounted wall magnet, sealing the vacuum chamber  240  and concluding the stroke cycle. 
         [0026]    In another alternate embodiment, as illustrated in  FIG. 4 , a roller ball valve system  300  contains a lifter  305  that is operationally attached to the motor plunger  360  within the vacuum chamber  315  that actuates a spring-loaded roller ball  320  that opens and closes the atmospheric inlet  307  allowing atmosphere into the vacuum chamber  315 . While engaging a vacuum source, vacuum is applied to the vacuum chamber  315  and atmosphere pushes the motor plunger (not shown) and check valve  310  which drives the lifter  305  and compresses the motor spring  325 . The spring-loaded roller ball  320 , located in a slotted track  308  of the lifter  305  containing an independent spring-loaded push-rod  330 , compresses forcing the roller ball valve  355  to open the vacuum chamber  315  to atmosphere and close the vacuum supply port  335 . Thereafter, the motor spring  325  releases, pushing the motor plunger (not shown) and attached saline chamber accumulator  350  to discharge saline through the attached syringe pump  340  and return to home position wherein the slot on the lifter  308  returns the roller ball assembly  320  to home position, sealing the vacuum chamber  315  and opening the vacuum supply port  335 . A plurality of O-Rings  345  located between the vacuum chamber  315  and vacuum motor plunger  360 , as well as between the saline chamber accumulator  350  and the accumulator  340 , provides a fluid-tight seal when required. 
         [0027]    In another embodiment, as illustrated in  FIG. 5 , the vacuum powered saline injection system  10  valve contains an over-the-center toggle system  400  wherein the pump is driven by the linear motion of the motor plunger  405 , wherein O-rings  460  are located thereon. A motor plunger  405  directly attached to a push-rod lifter  410  located within the vacuum chamber  410  alternatively forces the atmospheric port  445  or the vacuum port  455  to open, and alternately close when the over-the-center spring  450  loaded toggle  415  assembly strikes a valve or gate valve  440  that is spring  465  driven. 
         [0028]    In an additional embodiment, as illustrated in  FIG. 6 , an alternate over-the-center toggle valve system  400  contains an adjacent vacuum redirect valve system  420  wherein the vacuum, entering the system  10  through a vacuum supply line  437  into vacuum ports  427  is redirected to alternating vacuum chambers  425 . Each chamber  425  has a plunger  430  operationally connected to a connecting lever  426  via a plunger push-rod  428  extending from both sides of the connecting lever  426  to the saline pump. The connecting lever  426  drives a second set of push-rods  431  for the over-the-center toggle  432  via a spring bias  436 , to redirect vacuum flow and the pump. 
         [0029]    In an additional embodiment, as illustrated in  FIG. 7 , the vacuum powered saline injection system  10  contains a vacuum connection  550  to an inline vacuum redirect valve  500  wherein the over-the-center toggle valve system  505  is comprised of spring loaded levers  510  driven by a central slotted push-rod  515 / 540  connected to two vacuum chambers  560 . Atmosphere alternately pushes the motor plungers  525  through the use of check valves  565  located between the over-the-center toggle valve center and the saline pump  545  and saline pump syringes  520 , driving the central push-rod  515 / 540  and pumps  530 . As the slotted central push-rod  515 / 540  moves the redirect valve  535  that is held in place by spring loaded levers  510 , the vacuum is applied to each vacuum chamber  560  sequentially. The saline pump syringes  520  are positioned in line with the shown vacuum chambers  560  and are attached to the spring loaded levers  510  by push-rods  540 . 
         [0030]    In an alternative embodiment, as illustrated in  FIGS. 9 and 10 , the system  10  functions as described above regarding the first embodiment  10 , with the exception being that the accumulator  90  has been replaced by an expanding length of hose/tubing  600 . The tubing  600  is typically self-expanding  602  upon application of fluid pressure and increased fluid volume causing a restricting force within the hose  600  and, more typically, self-contracting  601  upon release of the fluid pressure and fluid volume from within the hose  600 . The hose  600  is typically composed of two separate and distinct tubes—an inner tube  605  and an outer tube  610 , both at least partially encased within an expansion restrictor sleeves  645 ,  650 . The inner tube  605  is typically formed from a material that is elastic and has the ability to expand from its relaxed or unexpanded length when a pressurized fluid is introduced into the elastic inner tube  605  and expands radially outwardly or laterally, with respect to its length; the radial expansion of the inner tube  605  is constrained by the maximum diameter of the non-elastic outer tube  610 . The outer tube  610  is typically formed from a relatively non-elastic, relatively soft, bendable, tubular webbing or like material that is typically strong enough to withstand internal pressures of up to  250  pounds per square inch, (psi). 
         [0031]    The hose  600 , in its contracted form  601  as illustrated in  FIG. 9 , results from a lack of force being applied to the inner tube  605 , allowing a flushing agent to enter the storage tank or accumulator  90 . The fluid pressure within the hose  600  is generated by introducing fluid under pressure into one end of the hose  600  and restricting the flow of the fluid out of the other end of the hose  600 , typically controlling fluid passage through the use of washers  660  located on a male coupler  615  and a female coupler  620 , positioned on opposite ends of the flexible tubing  600 . As a pressurized fluid is introduced into the elastic inner tube  605  in its contracted and relaxed state  601 , the elastic inner tube  605  begins to expand laterally and longitudinally and the outer tube  610  begins to unfold and uncompress around the circumference of the elastic inner tube  605 . Consequently, when the inner tube  605  expands to a predetermined degree, the outer tube  610  unfolds, and uncompresses along the entire length of the inner tube  605  until it reaches the same length as the inner tube  605  in the expanded condition  602 . Also, because the inner tube  605  expands both longitudinally and laterally and its expansion is constrained by the non-elastic outer tube  610 , the inner tube  605  fills all of the available space inside the non-elastic outer tube  610  and thus the surface of the unfolded, uncompressed outer tube  601  becomes smooth in the expanded condition  602  (as depicted in  FIG. 10 ), generating an urging force upon the stored fluid within the accumulator  90  for discharge of saline from the system  10 , when the valve  50  is open. 
         [0032]    While the novel technology has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. It is understood that the embodiments have been shown and described in the foregoing specification in satisfaction of the best mode and enablement requirements. It is understood that one of ordinary skill in the art could readily make a nigh-infinite number of insubstantial changes and modifications to the above-described embodiments and that it would be impractical to attempt to describe all such embodiment variations in the present specification. Accordingly, it is understood that all changes and modifications that come within the spirit of the novel technology are desired to be protected.