Abstract:
A microsurgical irrigation device, comprising a first tube for supplying liquid from a liquid source, the first tube having a first end in communication with the liquid source, and further having a second end; an elastomeric bulb connected to the second end of the first tube, wherein the bulb is in communication with the first tube; a second tube for dispensing liquid expelled from the elastomeric bulb, the second tube having a first end connected to the bulb and further having a second end, wherein the second tube is in communication with the bulb; an inlet, one-way, valve preventing liquid from returning from the bulb into the first tube when the bulb is actuated, and allowing liquid to flow from the first tube into the bulb when the bulb is released; and an outlet, one-way, valve preventing liquid from exiting the bulb until a predetermined amount of pressure is provided by bulb actuation.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of application Ser. No. 08/855,088, filed May 13, 1997 (U.S. Pat. No. 5,921,972), which is a continuation-in-part of application Ser. No. 08/584,336, filed Jan. 21, 1996 (U.S. Pat. No. 5,628,735). 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not applicable. 
     REFERENCE TO A MICROFICHE APPENDIX 
     Not Applicable. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention pertains generally to medical devices. More particularly, the invention relates to devices for removing fluid from a predetermined area during surgery. The apparatus and methods provided by the invention are especially useful for microsurgery and nasal surgery. 
     2. Background Information 
     During surgery, unwanted fluids must be evacuated from the operating field. For large field surgery in the chest, abdomen or pelvis for example, this is often done by using a suction tube placed directly in pooled fluid such as blood. In microsurgery, however, because tissues affected are very small and delicate, use of direct suction even with a very small cannula and very low power can cause significant damage to, and even total destruction of, tissue exposed to the direct suction. 
     In large field surgery, fluid is also removed with sponges mounted on handles such as disclosed in U.S. Pat. No. 1,853 238 to Shields and U.S. Pat. No. 2,294,186 to Kirschbaum. Similar sponge sticks with hollow handles can be attached to a suction source as disclosed in U.S. Pat. Nos. 3,324,855 and 3,394,702 to Heimlich. All those devices are relatively large and designed to be grasped with a hand. They are not suitable for microsurgery where smaller workspace requires smaller tools, and quantities of fluid removed are smaller. Furthermore, to absorb liquids, those devices use gauze or elastomeric synthetic foam sponge for example. Because of their coarseness, these materials can damage delicate tissue typically involved in microsurgery when the materials contact these tissues. Therefore, these devices are not well suited for microsurgery. 
     To remove fluid during microsurgery, a small swab on a stick is often used. Swabs on a stick were disclosed in U.S. Pat. No. 3,179,108 to Block et at. Swabs used for microsurgery typically have an elongated triangular shape and are made of cellulose, for example. These are commonly called eye spears because the triangular shaped swab mounted on a 2″ long shaft resembles a spear. A device sold under the trade name WECK-CEL is typical of those devices. Such a swab is small enough to be handled by the surgeon&#39;s fingers and fit in most areas of the body where microsurgery is performed. However, multiple swabs are needed to remove fluid in a typical microsurgery procedure since each swab quickly saturates and must be replaced. Besides using several swabs, the repeated removing of the saturated swab and replacing it with a dry one takes significant time and diverts the attention of the surgeon from the subject procedure, which is neither safe nor efficient. 
     Microsurgery presents another problem not typical in large field surgeries. Microsurgery is typically done on very small blood vessels, nerves, or other tissue which are delicate and often require a background mat or platform on which to rest these tissues during surgery. Prior art platforms or backgrounds often become basins that catch unwanted fluids, such as blood, which makes such surgery more difficult than if the platforms were clear of unwanted fluids. It is also not desirable to have to intermittently swab the platform during an operation to keep it clear of unwanted fluid. 
     U.S. Patent No. 4,533,352 to Van Beek et at. discloses a flexible silicone rubber platform which incorporates suction in it. One embodiment of Van Beek&#39;s platform has a plurality of ribs and troughs with a hole in each trough connecting to a suction tube. The ribs support the tissue being worked on and the troughs allow fluid to flow in them to the hole where it is sucked away. In another embodiment, the tissues being worked on is supported by a porous pliable material. The porous pliable material has a synthetic coating on its bottom and sides. 
     Drawbacks of both of Van Beek&#39;s platforms include that they rely on gravity to conduct fluid to the suction holes. Therefore, they must be positioned so that fluid can move by gravity (rubber) or by direct suction (porous) to the holes. This significantly limits the positions in which the platforms can be used. Also, Van Beek&#39;s platforms have a rubber or plastic surface on the bottom which may be prone to becoming slippery when in contact with fluid, and which may allow the platform to slide on the tissue on which it is placed. 
     A further drawback of the Van Beek embodiment having a porous member with a synthetic coating on its edges is that the platform is not suited for trimming to fit a desired size or shape. Any trimming would remove a section of the coating on the edge which would allow the platform to “leak”. While it is possible to recoat the edges after trimming, it is not practical to do so. An alternative but expensive solution is to make the platform in a great many predetermined geometrical shapes and sizes. 
     Another prior art platform is the TEBBETTS™ SOFT SUCTION MATT™ manufactured by Applied Medical Technology, Inc. That platform has a nonperforated membrane applied to a polyurethane foam pad which is approximately 1.5 mm thick. A suction tube having a plurality of holes is attached between the membrane and the foam pad. The TEBBETTS device is used with the membrane side down while the tissue being worked on rests on the foam. 
     A drawback of the TEBBETTS device is that it can be used in only limited orientations. Because the polyurethane foam has very poor wicking ability, the device only works by pooling fluids in the foam above the membrane. The polyurethane foam is open-cell and acts as a conduit for fluid to flow to the suction tube. The device can be shaped to allow such pooling, but it does not work well in orientations which do not allow gravity to drain fluid toward the suction tube. 
     Another drawback of the TEBBETTS device is that it slips. There is no mechanism to remove fluid which accumulates between the membrane and the tissue against which it is placed, so the device can slip on the accumulated fluid. 
     A further drawback of the TEBBETTS device is that it has no color. When blood pools in the foam pad, the pad turns red which makes it difficult to distinguish the tissue being worked on from the pad. 
     It is an object of the invention to provide a swab device for use in surgery, particularly microsurgery, to remove excess fluid by continuously and gently wicking fluid away from tissue and into a pad where it is subsequently removed by suction. 
     It is another object of the invention to provide a swab device for use in surgery to remove excess fluid which can be readily trimmed to any desired size and shape. 
     It is another object of the invention to provide a swab device for use in surgery to remove excess fluid which can be used throughout an operation without requiring replacement due to saturation or clogging. 
     It is another object of the invention to provide a swab device for use in surgery to remove excess fluid which will not damage delicate tissue it contacts. 
     SUMMARY OF THE INVENTION 
     The apparatus of the present invention provides a flexible, sterile, trimable device which gently and continuously removes unwanted fluid from an operating field during microsurgery or nasal surgery. The invention basically comprises a mat with a high wicking property, and a flexible tube with one end embedded in the mat. A preferred mat material is rayon felt. The embedded end of the tube has at least one hole through which suction is applied to the mat when the other end of the tube is attached to a suction source. The high wicking property of the mat allows fluid to be gently and efficiently removed from a site without the suction source being in direct contact with the pooling fluid. Suction removes fluid from the mat, thereby preventing it from becoming saturated. 
     The embodiment of the present invention covered by the claims of this application is a swabber. One end of a semi-rigid tube is embedded in the mat and the other end is connected to a flexible tube which is in turn connected to a suction source. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of an embodiment of the present invention as a platform for microsurgery. 
     FIG. 2 is an illustration of a device of FIG. 1 as used in microsurgery. 
     FIG. 3 is a partially exploded view of a device of FIG.  1 . 
     FIG. 4 is a longitudinal sectional view taken along line  4 — 4  of FIG.  1 . 
     FIG. 5 is a cross sectional view taken along line  5 — 5  of FIG.  1 . 
     FIG. 6 is a perspective view of the claimed embodiment of the present invention, namely a swabbing device used for microsurgery. 
     FIG. 7 is a perspective view of the swab end of a device of FIG.  6 . 
     FIG. 8 is a longitudinal sectional view taken along line  8 — 8  of FIG.  6 . 
     FIG. 9 is a view of an alternative embodiment of the swab end. 
     FIG. 10 illustrates an alternative embodiment of the swabbing device having a hand operable bulb suction proximal end. 
     FIG. 11 illustrates an alternative embodiment of the bulb suction proximal end of the device shown in FIG.  10 . 
     FIG. 12 illustrates another alternative embodiment of the bulb suction proximal end of the device shown in FIG.  10 . 
     FIGS. 13-16 illustrate further alternative embodiments of the device shown in FIG.  10 . 
     FIG. 17 illustrates yet another alternative embodiment of the device shown in FIG.  10 . 
     FIG. 18 illustrates a microsurgical irrigation device. 
     FIG. 19 illustrates an microsurgical irrigation device. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring to the drawings, wherein like reference numerals designate like or similar elements throughout, one embodiment of the invention as a platform for microsurgery is illustrated in FIGS. 1 through 5, a second embodiment as a swabber is illustrated in FIGS. 6 through 17. 
     MICROSURGERY PLATFORM 
     Referring to FIG. 1 a microsurgery platform  20  is used to isolate the structure on which microsurgery is to be performed, such as a blood vessel or nerve from surrounding tissue and provide a clean firm surface on which to work. The present invention provides a flexible, sterile microsurgery platform comprised of a wicking mat  22 , a perforated membrane  24  attached to one side of mat  22 , and a flexible tube  26  having a terminal end  30  embedded in mat  22 . Typical sizes of platform  20  range from a 1″ by 2″ rectangle to a 4″ by 6″ rectangle, but platform  20  can be readily trimmed to any size and shape needed. 
     Mat  22  is made of a material which has a high wicking property. A preferred material is rayon felt, such as orange SUNTEX™ from Solar United National Products, Inc., which is approximately 2 mm. thick. Alternatively, polyvinyl alcohol (PVA), polyvinylacetate, cotton, or a combination of the above materials may be used. 
     Blood clotting can be inhibited in the mat by heparinizing it before use. Membrane  24  is thin, flexible and has a plurality of holes  28  perforating it which allow fluid passage through membrane  22  into mat  24 . The holes can be made with a regular pattern and spacing which allows the surgeon, by knowing the distance between the holes, to gage the size of the vessels or other tissue being worked on. Membrane  22  may also be colored, preferably green, to contrast with tissue being worked on. In the preferred embodiment, membrane  22  is made of colored plastic tape adhesively bonded to mat  22 . 
     Tube  26  has a terminal end  30  which is embedded in mat  22  and has one or more holes  32  at or near terminal end  30 . Tube  26  has another end  34  which may have a fitting  36  adapted to connect to a suction device (not shown). 
     In use, fluid either drains through holes  28  in membrane  24  to contact mat  22 , or it contacts mat  22  directly at its exposed surfaces. Mat  22  wicks fluid into it from its surface. Fluid is removed from mat  22  by suction in tube  26  causing fluid to flow from mat  22  through holes  32  into tube  26  where it is carried away. Since fluid in a section of mat  22  in the immediate vicinity of holes  32  has been evacuated, wicking action of mat  22  causes fluid to flow from surrounding areas of mat  22  toward a section where tube  26  is embedded in mat  22 . 
     The advantages of microsurgery platform  20  are that the wicking action of mat  22  conducts fluid to holes in tube  26  so that tube  26  need not be in direct contact with pooling fluid to evacuate it. This provides much greater flexibility in positioning platform  20  compared to other platforms which must be positioned so that fluid will run by gravity to evacuation holes. The construction of platform  20  allows evacuation of fluid from both sides of platform  20 , whereas conventional platforms must pool fluid on the top side to evacuate it. Furthermore, platform  20  does not slip from the position where it is placed as do other platforms made of nonporous materials. Also, mat  22  acts as a buffer for the suction force emanating from tubing  26 . Direct suction, even though very low power, can severely damage very delicate nerves and vessels typically exposed during microsurgery if those tissues come in contact with direct suction. 
     Referring to FIG. 2, microsurgery platform  20  is shown as used to perform microsurgery on vessel  42 . Platform  20  can be trimmed to any size or shape needed. The side of platform  20  with mat  22  exposed is placed against tissue  40 . Wicking action keeps the interface between mat  22  and tissue  40  dry enough that platform  20  tends to stay in place even when used in a vertical orientation as shown in FIG.  2 . The orientation of platform  20  and tube  26  can be in any direction since it does not depend on gravity to function. Also as shown in FIG. 2, platform  20  is flexible enough to easily curve to the natural shape of many tissues. Platform  20  is inserted between the structure on which microsurgery is to be performed, vessel  42  in this illustration, and the underlying tissue  40 . The contrasting color, preferably green, of membrane  24  and vessel  42  give the surgeon a good visual field on which to operate. Membrane  24  also remains clear of excessive fluid during surgery. Fluid from vessel  42  or the surrounding tissue does not accumulate on membrane  24  since fluid on membrane  24  goes through holes  28  and into mat  22  where it is wicked away and subsequently evacuated by tube  26 . 
     Referring to FIG. 3, tube  26  is embedded in mat  22  such that terminal end  30  of tube  26  does not extend to edge  44  of mat  22 , and all holes  32  are inside mat  22 . An adhesive (not shown), such as silicone, is applied at point  52  where tube  26  exits mat  22  to keep tube  26  in place. 
     Referring to FIGS. 4 and 5, when tube  26  is inserted into mat  22 , it forces a portion  50  of mat  22  to bulge out. The thickness  46  of bulging portion  50  of mat  22  is approximately equal to thickness  48  of mat  22  opposite bulging portion  50 . It is preferable but not necessary that holes  32  be oriented as shown in the plane of mat  22 . In the preferred embodiment membrane  24  is attached to mat  22  by an adhesive layer  38 , but it is possible that membrane  24  could be attached to mat  22  by other means such as thermal bonding. 
     SURGICAL SWABBER 
     Referring to FIG. 6, another embodiment of the invention is shown as used as a swabber  120 . A swabber is used to intermittently evacuate fluid from an operating field. Swabber  120  is comprised of a wicking mat  122 , a semi-rigid tubular wand  124  having one end  130  terminate inside mat  122  and another end  128  attached to flexible tube  126 . Tube  126  may have a flexible coupling  138  for attaching to end  128  of wand  124 . The other end  134  of tube  126  has a fitting  136  adapted to connect to a suction device (not shown). Mat  22  is made of a material which has a high wicking property. A preferred material is rayon felt. PVA, polyvinylacetate, cotton or a combination of any of the above materials may be substituted. When cotton is used for mat construction, it is preferably spun formed about the end of the wand  124  and forms a generally rounded or cylindical mat configuration. 
     Swabber  120  is much smaller than a conventional stick sponge and is designed to be gripped with the fingers, not the whole hand. Wand  124  can have various diameters and lengths with typical outer diameter ranging form approximately 1 to 2 mm and lengths ranging from 8 to 12 cm. In the preferred embodiment, mat  122  is approximately 2 mm thick and 5 to 10 mm wide by 10 to 20 mm long. It can be trimmed to any suitable size and shape. 
     Referring to FIGS. 7-8, end  130  of wand  124  is inserted approximately in the center of the thickness of mat  122  causing bulges  140  and  140  of approximately equal thickness in mat  122 . Adhesive  144 , preferably silicone, bonds wand  124  to edge  146  of mat  122 . End  130  of wand  124  has one orifice  132  at end  130  through which suction is applied to mat  122 . The mat  122 ′ may be formed in a rectilinear or curvilinear configuration as shown in FIG.  9 . 
     As with the microsurgery platform described above, mat  122  wicks fluid into it from its surface. Fluid is removed from mat  122  by suction in wand  124  causing fluid to flow from mat  122  through hole  132  into wand  124  where it is carried away. Since fluid in a section of mat  122  in the immediate vicinity of hole  132  has been evacuated, wicking action of mat  122  causes fluid to flow from surrounding areas of mat  122  toward a section where wand  124  is embedded in mat  122 . Therefore, fluid can be evacuated without wand  126  being in direct contact with pooling fluid to evacuate it. Also, mat  122  acts as a buffer for the suction force emanating from wand  124 . Direct suction, even though very low power, can seriously damage very delicate nerves and vessels typically exposed during microsurgery if those tissues come in contact with direct suction. Furthermore, small cannulas typically used for suction often plug with tissue and stop functioning. Mat  122  acts as a filter to prevent such tissue from entering wand  124  thereby preventing blockage of wand  124  or tube  126 . One swabber  120  can eliminate the need for dozens of cotton tipped applicators or similar devices typically used to swab fields during microsurgery. It also reduces the time needed to swab a field since swabber  120  is held in place until the field is sufficiently clear of fluid, compared to repeatedly applying, removing, and changing cotton tipped applicators. 
     FIG. 10 shows an alternative embodiment of the swabber  150  with a wand or shaft  151  having a wicking tip  152  connected at its distal tip and a hand operable, elastomeric suction bulb  153  connected at its proximal tip. The bulb  153  creates suction and serves as a reservoir for removed liquids. A stem  154  extends a predetermined length into the bulb  153  to prevent removed liquid  155  from being returned during multiple depressions of the bulb  153 . FIG. 11 shows an alternative embodiment of the device  160  with a one way valve  161  disposed at an upper portion of the bulb  162 . The valve  161  functions to further avoid return of removed fluids to the distal wicking end of the device  160 . FIG. 12 shows another alternative embodiment of the device  170  with a first one way valve  171  disposed at an upper portion of the bulb  172  and a second one way valve  173  disposed at the distal end of the shaft  174 . The valves  171  and  173  function to further avoid return of removed fluids to the distal wicking end of the device  170 . Referring to FIGS. 13-16, the bulbs and shafts may be configured in a variety of shapes. FIG. 17 shows an alternative embodiment of the device  180  with a bulb  181  which is removable from its shaft  182 , which is disposable. Bulb connector  183  mates with shaft connector  184 . Shaft connector  184  may alternatively be connected to surgical field suction. 
     FIG. 18 illustrates a microsurgical irrigator  190  for squirting or outputting fluids. The irrigator  190  comprises a hand operable, elastomeric bulb  191 , a rigid tube  192 , connected to the distal end of the bulb  191 , a flexible tube  194  connected to the proximal end of the bulb  191 . The tube  192  has a tapered end  193  for precise dispersement of fluids. Alternatively, an IV needle or or the like may be attached to the bulb via a lever lock fitting. The bulb  191  has a one way valve  195  to prevent fluid from traveling proximally during depression of the bulb  191 . Tube  194  has a proximal connector  196  for connection to an IV bag or the like, which is the source of fluid. 
     The descriptions above and the accompanying drawings should be interpreted in the illustrative and not the limited sense. While the invention has been disclosed in connection with the preferred embodiment, or embodiments thereof, it should be understood that there may be other embodiments which fall within the scope of the invention as defined by the following claims. Where a claim is expressed as a means or step for performing a specified function it is intended that such claim be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof, including both structural equivalents and equivalent structures.