Abstract:
A liquid containment system in accordance with the present invention includes a flexible plastic or elastomeric bag with several apertures. Surrounding each aperture is a port member such as a silastic ring. The port member functions at least reduce the escape of airborne particules from the bag while permitting the insertion of a surgical instrument into the bag. The port member may be made at least partially of a silicone based material to provide resistance to damage by ultrasonic tools.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     This invention relates to a device and a system for containment of both airborne particles and waste liquid generated during surgical procedures. The device and system of this invention are particularly appropriate for the containment of atomized particles and waste liquid generated during ultrasonic surgical procedures. The invention also pertains to associated methods of use.  
         [0002]     Over the past 30 years, several ultrasonic tools have been invented which can be used to ablate or cut tissue in surgery. Such devices are disclosed by Wuchinich et al. in U.S. Pat. No. 4,223,676 and Idemoto et al. in U.S. Pat. No. 5,188,102.  
         [0003]     In practice, these surgical devices include a blunt tip hollow probe that vibrates at frequencies between 20 kc and 100 kc, with amplitudes up to 300 microns or more. Such devices ablate tissue by either producing cavitation bubbles which implode and disrupt cells, tissue compression and relaxation stresses (sometimes called the jackhammer effect), or by other forces such as micro streaming of bubbles in the tissue matrix. The effect is that the tissue becomes liquefied and separated. The tissue then becomes emulsified with the irrigant solution. The resulting emulsion is then aspirated from the site. Bulk excision of tissue such as a tumor is possible by applying the energy around and under the tumor to separate it from the surrounding structure. The surgeon can then lift the tissue out using common tools such as forceps.  
         [0004]     The probe or tube is excited by a transducer of either the piezoelectric or magnetostrictive type that transforms an alternating electrical signal within the frequencies indicated into a longitudinal or transverse vibration. When the probe is attached to the transducer, the two become a single element with series and parallel resonances. The designer will try to tailor the mechanical and electrical characteristics of these elements to provide the proper frequency of operation. Most of the time, the elements will have a long axis that is straight and has the tip truncated in a plane perpendicular to the long axis. This is done for simplicity and economic considerations. In almost all applications, whether medical or industrial, such an embodiment is practical and useful.  
         [0005]     However, when the devices are used in open field surgery, particularly when the operative sight is on the skin or slightly below, a side effect of the ultrasonic probe interaction with fluids becomes apparent. This is the ability of the ultrasonic vibrating tool to break up fluid and aerosol them such that the particles of fluid may be projected into the operating room atmosphere and either inhaled or otherwise contaminate people or surfaces.  
         [0006]     The ability of ultrasonic probes to atomize fluid is well known. Many patents have been issued for just such hardware, such as U.S. Pat. Nos. 5,516,043, 4,153,201, 4,337,896, 4,541,564, among many others. These devices have application in industry and medicine where it is desired to create fine particles of fluid and transport them to an airstream. In operation, a fluid is introduced to the distal end of the vibrating probe. The frequency of vibration may be from 20 to 200 kHz or higher. The vibrating tip breaks the surface tension of the fluid and projects small amounts of fluid off the surface. The natural phenomenon of fluid to coalesce to a sphere in space creates small particles, which by their low mass and aerodynamic nature are easily suspended in air. Depending upon variables such as frequency of vibration, amplitude and liquid properties, ultrasonic atomizers can produce aerosols with mean diameters from hundreds of microns to below 1 micron in size.  
         [0007]     In the operating room, this atomization has caused concern since the fluids being atomized can contain blood, virus, bacteria or other objectionable constituents. When the probe is in contact with the tissue, no atomization of the liquid occurs from the distal portion of the probe to the work surface. However, the liquid and tissue is also present on the rear faces of asymmetrical probes and the sides of the probes as well. These surfaces project the spray away from the work surface and into the air. In addition, the tissue being ablated by the direct contact with the probe may be aerosolized as well. This phenomenon of aerosoling contaminants is not limited to ultrasonic aspirators alone. Medical lasers can produce smoke when ablating tissue that contains viruses as well. It is well documented that the virus that causes vaginal warts may be present in laser smoke. When the smoke contacts operating room personnel, warts will appear on lips and other mucous membranes. Several inventions have been developed to combat this smoke problem. One such device is the smoke extractor unit. This is a vacuum pump, chemical filter and pickup hose assembly. In practice, the pickup funnel is placed near the operative sight. The air surrounding the site is sucked into the extractor funnel, similar to a vacuum cleaner effect. The smoke and objectionable elements are removed with the chemical filter. The air is then exhausted back into the room.  
         [0008]     Although these devices work reasonably well with laser smoke, they do not provide solutions to all of the issues involved with ultrasonic surgery. For one, the aerosols emitted by the ultrasonic probe are liquid in nature and will contaminate the chemical filter. The liquid will drip out of the filter, causing contamination that must be disinfected and cleansed. Another problem encountered with ultrasonic aspirators not found in lasers is the liquid irrigation fluid waste created.  
         [0009]     In all ultrasonic aspirators, liquid is added to the site to increase the ultrasonic action and to flush the field of debris. If a separate aspiration wand is not used, especially on burn wounds or bedsores, the liquid will run off of the patient and onto the floor. Even in cases where a separate wand is used, the amount of fluid is excessive such that not all of the fluid may be aspirated. This causes contamination that must be cleaned.  
         [0010]     It is therefore desired to find a means to reduce the escape of aerosols into the general operating room atmosphere and to contain the liquid drain off while not impeding the line of sight of the surgeon nor impeding convenient access to the wound.  
       OBJECTS OF THE INVENTION  
       [0011]     An object of the present invention is to provide an improved ultrasonic surgical method for use in debridement of wounds or ablation of tissue in open field procedures.  
         [0012]     Another object of the present invention is to provide a means to contain the aerosols generated by ultrasonic surgical aspirators when used to debride wounds or ablate tissue in open field procedures.  
         [0013]     Another relatively specific object of the present invention is to provide a means to contain and collect contaminated liquid effluent for at least some kinds of ultrasonic ablation or debridement procedures.  
         [0014]     It is a further object of the present invention to provide such a means for aerosol and liquid effluent containment without restricting access to wound site nor impeding the surgeon&#39;s line of sight.  
         [0015]     These and other objects of the invention will be apparent from the drawings and descriptions herein. Although every object of the invention is attained in at least one embodiment of the invention, there is not necessarily any embodiment which attains all of the objects of the invention.  
       SUMMARY OF THE INVENTION  
       [0016]     A liquid containment system in accordance with the present invention includes a flexible plastic or elastomeric bag with several apertures. Surrounding each aperture is a port member such as a silastic ring. The port member is designed to at least reduce the escape of airborne particules from the bag while permitting the insertion of a surgical instrument into the bag. Where the surgical instrument is an ultrasonic tool, it is preferred that the port member is made at least partially of a silicone based material due to the inherent resistance of such materials to damage by ultrasonic tools. However, the invention is not restricted to these materials, since other materials may provide the same benefits.  
         [0017]     The bag, which ideally should be made from a clear or highly translucent material, has an opening which incorporates either an elastic band mounted circumferentially around the opening or a draw string device, either of which can be used to tighten the opening around a limb or torso of the of the patient, and thus inhibit the egress of liquid and airborne particles from the bag via the opening.  
         [0018]     During the preparation of the patient for surgery, the bag is removed from its packaging. The bag may be sterile or unsterile, depending upon the type of surgery to be performed. The open end of the bag is then slid up over the limb to be operated on. In the case of torsos, posteriors or upper thighs, the bag may be shaped in the rough approximation of a body suit.  
         [0019]     The bag or suit must be oversized such that a good deal of play is available in the skin of the bag. This play will allow the opening(s) present in the bag to be positioned over the wound or surgical site. The bag may be adjusted around the patient to facilitate this placement before the drawstring is tightened around the patient to fix the bag in place. In the case where an elastic band is used, the elastic band may be stretched opened and slid around the body to accomplish the same thing.  
         [0020]     The silastic rings may be of different shapes and sizes. They may incorporate flaps or fingers to trap more aerosol particles. They may be raised and have drain ports incorporated. They may have screw tops to seal the openings so that they are leak tight, allowing more than one opening to be located on the bag.  
         [0021]     In any case, one or more drain ports with liquid tight seals will be incorporated in the bag. When the bag is positioned on the patient, the drain port will be positioned at the lowest possible point. This will allow an aspiration tube to be placed on the drain port. When connected to a standard aspiration system with collection bottle attached, the liquid will be drained out of the bag to the collection bottle.  
         [0022]     If the surgical opening is fairly large, the pressure differential from the bag interior to the atmosphere will be low enough not to cause the bag to collapse around the patient. Even with a small amount of collapse, the bag should be sized such that air paths are present to allow full flow through the opening. In cases were it is desired to keep the surgical opening very small, vent flaps may be added to the bag to allow airflow though it to prevent collapse.  
         [0023]     Alternatively, the bag may be supported by rigid members to provide structural support, such as wires or ribs. Such supports may be taped, glued, molded into or otherwise integrated into the assembly. The supports may be used to shape the bag to aid the surgical procedure.  
         [0024]     The flow through the silastic opening causes a vacuum cleaner effect in that the aerosols will be captured and brought back into the bag. Once the atomized fluids contact the wall of the bag, they will coalesce and be removed from the drain port. Even if suction is not used, the raised section of the bag has been shown to reduce the escape of atomized fluids substantially.  
         [0025]     After the procedure is through, the bag is removed from the patient and discarded along with all other contaminated garments and articles.  
         [0026]     In testing, the bag system has proven effective and advantageous for the reasons stated. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0027]      FIG. 1  is a schematic perspective view of a human appendage with an open wound.  
         [0028]      FIG. 2  is a schematic perspective view similar to  FIG. 1 , showing a surgical fluids containment bag in accordance with the present invention in place about the appendage.  
         [0029]      FIG. 3  is a schematic perspective view of a portion of the containment bag of  FIG. 2 , showing a plurality of silastic port members provided at respective access apertures or openings in the bag.  
         [0030]      FIG. 4  is a view similar to  FIG. 2 ,, showing the bag with multiple silastic port members at openings around the bag.  
         [0031]      FIG. 5  is a schematic perspective view of a surgical fluids containment bag for a lower torso.  
         [0032]      FIG. 6  is a schematic perspective view similar to  FIG. 4 , showing a fluid collection system connected to a fluid collection valve on the surgical fluids containment bag.  
         [0033]      FIG. 7  is a schematic perspective view similar to  FIG. 2 , showing the fluids containment bag with positive ventilation.  
         [0034]      FIG. 8  is a schematic perspective view of a surgical fluids containment bag for localized wound access. 
     
    
     DETAILED DESCRIPTION  
       [0035]     As illustrated in  FIG. 1 , an appendage LG of a patient may have a wound or trauma WND which requires a surgical procedure such as ultrasonic ablation or wound debridement. In order to capture airborne particles and liquid effluent generated by the ultrasonic ablation or debridement procedure, a fluids containment bag  10  is placed about the appendage LG. Bag  10  has a mouth or opening  12  provided around a rim (not separately enumerated) with an elastic band or drawstring  14  for closing the mouth or opening  12  about the patient to effectuate a preferably fluid-tight engagement with the patient.  
         [0036]     Fluids containment bag  10  is provided, for instance, at an end opposite opening  12 , with an aperture or opening  16  for the drainage of liquid from the bag. Such liquid may include blood, as well as saline or other liquid that is applied to the surgical site, for example, for cooling and cleaning purposes. Bag  10  is provided at opening  16  with a valve  18  and a connector  20 .  
         [0037]     Bag  10  is made at least partially of optically transmitting material. Preferably the entire bag is made of substantially transparent material for facilitating visual observation of appendage LG and surgical procedures effectuated on wound WND. Alternatively, bag  10  may be partially opaque and provided with one or more windows of transparent or translucent plastic film material.  
         [0038]     As depicted in  FIG. 4 , bag  10  is provided at mutually spaced locations with a plurality of openings  22  defined by respective port members  24  exemplarily taking the form of rigid or semi-rigid rings  26  provided along an inner side with a slotted or pierced web  28 . Web  28  is made of an elastic silicone (silastic) material for facilitating the insertion of a shaft  30  of an ultrasonic instrument  32  and the utilization of the instrument in an ultrasonic tissue ablation or debridement procedure on wound WND. The elastic silicone material of web  28  enables the formation of a seal about instrument shaft  30 . The silicone material is essentially impervious to the ultrasonic vibrations of the instrument  32 . Port members  24  are thus effective to at least inhibit or reduce the escape of airborne particles from bag  10  while permitting penetration into the bag of surgical instrument shaft  30 .  
         [0039]      FIG. 3  depicts three alternative port members  34 ,  36 ,  38  that may be provided on bag  10  in place of or together with port members  24 . Port member  34  comprises a ring  40  and a web  42  of self-sealing silastic material. Web  42  completely covers the respective opening  44  in bag  10 , until the web is pierced during a surgical procedure to enable the passage of a surgical instrument.  
         [0040]     Port member  36  comprises a ring  46  and a silastic web  48  including several flaps  50  separated from one another by slits  52  and connected at respective apices  54  by a button  56 . multiple instruments may be inserted into bag  10  through slits  52 .  
         [0041]     Port member  38  includes a tubular component  58  connected to bag  10  via a ring  60 . Tubular component  58  is optionally provided with a sealing web  62  and a drainage tube  64 . In use, a lower rim (not separately designated) or ring  60  may be placed into contact with a patient&#39;s skin about a surgical site. A distal end portion of a surgical instrument is inserted into tubular component  58  and through web  62  to operate on tissues at the surgical site, at the base of tubular component  58 . In the event that liquid accumulate in tubular component  58 , owing to web  62  and the sealing engagement of ring  60  with the patient&#39;s skin, tube  64  is used to drain the collected liquid into bag  10 .  
         [0042]     A surgical fluids containment bag may take many different forms, depending on the location of the wounds to be treated.  FIG. 5  shows a bag  66  in that has the shape of a pair of shorts with a waist opening  68  and two leg openings  70 , each surrounded at its rim by a respective elastic band or drawstring  72 ,  74 . Bag  66  is provided with multiple surgical access openings  76  defined by respective silastic port members  78 . Bag  66  also has an opening  80  for liquid drainage, provided with a valve  82  and a connector  84 .  
         [0043]     As illustrated in  FIG. 6 , valve  18  (or  82 ) may be connected to a liquid disposal container  86  via connector  20  (or  84 ) and a hose  88 . A suction source or vacuum pump  90  is operatively connected to container  86  for extracting liquid via valve  18  (or  82 ) from a sump formed in bag  10  (or  66 ).  
         [0044]     Typically, port members disclosed herein do not form air-tight seals at the respective surgical access openings in a fluids containment bag. Thus, when the bag is moved, air may be sucked in through the surgical access openings to enable the maintenance of a work space in the containment bag about the surgical site. These considerations apply to port members  24 ,  36 ,  38  and  78 .  
         [0045]     As illustrated in  FIG. 7 , it may be desirable to provide a positive pressure to a fluids containment bag  92 . Accordingly, a source  94  of pressurized gas such as air or carbon dioxide may be coupled to bag  92  via a connector  96  and a valve  98 . Bag  92  is provided a surgical access port  100  including a ring  102  and a silastic sealing element  104  into the form of one or more flaps or a perforated web member. Sealing element  104 , while preventing or inhibiting the escape of airborne particles such as atomized liquid, may permit the leakage of some air, as indicated by an arrow  106 .  
         [0046]     As depicted in  FIG. 8 , a fluids containment device includes a cup-shaped bag  108  provided with a first opening  110  surrounded at its rim (not designated) by a sealing element  112  exemplarily in the form of a ring provided with an adhesive layer (not illustrated) for forming a sealing engagement with the skin of a patient PT about a surgical site SS. Bag  108  is provided with a plurality of second openings or apertures  114  that are effectively closed to airborne particles by respective port members  116 . Port members can take any suitable form, including any described hereinabove. Bag  108  includes a third opening  118  provided with a valve  120  and a connector  122  for enabling the removal of liquid waste material. A portion of bag  108  in a region about opening  118  may be disposed at a location lower than surgical site SS to enable the collection and evacuation of the liquid waste.  
         [0047]     In a method utilizing a fluids containment system as described above, bag  10 ,  66 ,  108  is disposed about a portion of the patient&#39;s body having a target surgical site WND, SS. A rim of first opening  12 ,  68 ,  70 ,  110  is engaged with the patient&#39;s body to close off the opening. This closure may be effectuated in part by the nature of the band, drawstring, or adhesive seal  14 ,  72 ,  74 ,  112  about the opening  12 ,  68 ,  70 ,  110 . A distal end portion of a surgical instrument  32  is inserted through at least an outer portion of port member  24 ,  34 ,  36 ,  38 ,  78 ,  100 ,  116  and thereafter the surgical instrument  32  is operated to effectuate a surgical procedure on tissues of the patient at the surgical site WND, SS. Valve  18 ,  82 ,  98 ,  120  is opened to drain liquid waste material from the bag  10 ,  66 ,  108 .  
         [0048]     In the case of port member  38  ( FIG. 3 ), a rim of tubular element  58  may be placed into engagement with the patient&#39;s body about the surgical site WND or SS so that the distal end portion of surgical instrument shaft  30  is surrounded by the tubular member during the operating of surgical instrument  32 . Fluid may be drained from tubular member  58  through drainage tube  64 .  
         [0049]     Instrument shaft  30  may be subjected to ultrasonic vibrations for purposes of ultrasonically ablating or debriding tissues at surgical site WND or SS. In that case, port members  24 ,  34 ,  36 ,  38 ,  78 ,  100 , and  116  are made at least in part of an ultrasound impervious material such as an eleastic silicone material.  
         [0050]     Where port member  24 ,  36 ,  38 ,  78 ,  100 , or  116  includes at least one flap (e.g., flaps  50 ), the inserting of the distal end portion of the surgical instrument  32  includes moving the flap. The flap may be partially distorted in order to accommodate the passage of instrument shaft  30 .  
         [0051]     As depicted in  FIG. 2 , bag  10  (or any of the surgical containment bags disclosed herein) may be provided with one or more support members  124 ,  126  for maintaining the bag in an at least partially expanded configuration. Support members  124 ,  126  may be circular ribs made of a resilient material, as indicated in the drawing, the ribs being bonded to an inner or outer surface of the bag. Alternatively, support members  124 ,  126  may be parts of a larger interconnected cage or frame structure that is connected to the bag, for instance, by adhesive, heat or ultrasonic welding, etc. Preferably, the support structure is resiliently deformable for enabling transport of the bag in a compact collapsed configuration.  
         [0052]     Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.