Abstract:
An irrigation and aspiration tubing system for use with surgical handpieces and irrigation fluid supplies has a flexible tube with first and second lumens formed integrally along its length, with a first lumen used for transporting irrigation fluid to the handpiece and a second lumen used for aspiration of fluid and emulsified particles from a surgical site. The cross-sectional area of the first lumen is selected to provide a cross-sectional area available for fluid flow in excess of the cross-sectional area of a standard surgical irrigation tubes. The system also includes at least one adaptor to allow the tubing to be attached to known surgical handpieces. Preferably, a second adaptor is also provided allowing attachment to sources of irrigating fluid and aspiration vacuum. One said lumen is formed integral with either the interior or exterior surface of the flexible tube.

Description:
[0001]    This application is a continuation-in-part application of application Ser. No. 11/069,773, filed Mar. 1, 2005, which claims priority from provisional application Ser. No. 60/613,645, filed Sep. 27, 2004 and which also claims priority from provisional application Ser. No. 60/828,599, filed Oct. 6, 2006 all of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    This invention relates generally to surgical instruments and surgical techniques and, more particularly, to eye surgery and to phacoemulsification apparatus and methods for their use. 
         [0003]    A common ophthalmological surgical technique is the removal of a diseased or injured lens from the eye. Earlier techniques used for the removal of the lens typically required a substantial incision to be made in the capsular bag in which the lens is encased. Such incisions were often on the order of 12 mm in length. 
         [0004]    Later techniques focused on removing diseased lenses and inserting replacement artificial lenses through as small an incision as possible. For example, it is now a common technique to take an artificial intraocular lens (IOL), fold it and insert the folded lens through a relatively small incision, allowing the lens to unfold when it is properly positioned within the capsular bag. Techniques and instruments have also been developed to accomplish the removal of the diseased lens through an equally small incision. 
         [0005]    One such technique is known as phacoemulsification. A typical phacoemulsification system includes a handpiece having a tip sized to fit through a small incision. Within the tip a hollow needle is vibrated at ultrasonic frequencies in order to fragment the diseased lens into small enough particles to be aspirated from the eye. Commonly, an irrigation sleeve is mounted around the needle through which irrigating liquids are infused into the eye to flush the lens particles created by the vibrations. Often the needle is hollow and forms a pathway to aspirate the irrigating fluid and lens particles from the eye. In this way both aspiration and irrigation are performed by a single instrument requiring only a single incision. 
         [0006]    It is extremely important to properly infuse liquid during such surgery. Maintaining a sufficient amount of liquid prevents collapse of certain tissues within the eye and attendant injury or damage to delicate eye structures. As an example, endothelial cells can easily be damaged during such collapse and this damage is permanent because these cells do not regenerate. One of the benefits of using as small an incision as possible during such surgery is to minimization any leakage of liquid during and after surgery to prevent tissue collapse. 
         [0007]    Separate flow paths are required for the infusing and aspirating functions to be carried out properly. This requires the use of separate lengths of flexible tubing extending from the handpiece to the flow system control module. Typically these tubing lengths are on the order of 200 to 250 cm. Because the aspiration and irrigation tubes both go from the handpiece to the control module they often become tangled with one another, making manipulation of the handpiece more difficult. 
         [0008]    While this invention is principally described with reference to eye surgery and the use of instruments and techniques for phacoemulsification, instruments requiring separate fluid flow paths, such as for aspiration and irrigation, are known in other surgical arts as well. For example, some instruments used in liposuction (the shaping and removal of adipose tissue by breaking up the tissue and aspirating the tissue particles) also are designed to be used with separate fluid flow lines providing aspiration and irrigation. 
         [0009]    Multichannel tubing is well represented in the prior art. U.S. Pat. Nos. 6,287,290, 6,527,761 and 6,709,401 teach and describe methods, systems and kits for lung volume reduction which utilize catheters having coaxial tubes or tubes with coextensive multiple channels for introduction such expedients as gas for inflating a balloon attached to the catheter, guide channels for the introduction of other catheters and as aspiration channels. 
         [0010]    U.S. Pat. No. 6,143,373 teaches and describes a catheter system and method for injection of a liquid embolic composition and a solidification agent for the injection of a liquid and a solidifying agent to close off aneurysm. The multiple lumens are used for the injection of different liquids into the circulatory system. 
         [0011]    U.S. Pat. No. 6,066,130 teaches and describes a system for delivering laser energy in which, in one embodiment, a liquid and a guide wire are fed through separate channels in a single catheter. 
         [0012]    U.S. Pat. No. 6,013,048 teaches and describes an ultrasonic assisted liposuction system including an instrument used in liposuction, and the irrigation and aspiration functions of the instrument. 
         [0013]    The need thus exists for aspiration/irrigation tubing apparatus and connectors that can be connected to existing surgical handpieces and control consoles without modifying the handpieces. 
         [0014]    A further need exists for such apparatus which allows a surgeon to manipulate the handpiece without kinking the aspiration/irrigation tubing. 
         [0015]    Further, a need exists for such tubing and connectors to be made available in inexpensive and disposable versions. 
         [0016]    While the following describes a preferred embodiment or embodiments of the present invention, it is to be understood that these descriptions are made by way of example only and are not intended to limit the scope of the present invention. It is expected that alterations and further modifications, as well as other and further applications of the principles of the present invention will occur to others skilled in the art to which the invention relates and, while differing from the foregoing, remain within the spirit and scope of the invention as herein described and claimed. Where means-plus-function clauses are used in the claims such language is intended to cover the structures described herein as performing the recited functions and not only structural equivalents but equivalent structures as well. For the purposes of the present disclosure, two structures that perform the same function within an environment described above may be equivalent structures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    These and further objects and characteristics of the present invention will become apparent upon consideration of the following drawings, in which: 
           [0018]      FIG. 1  illustrates a prior art surgical irrigation and aspiration apparatus and its associated tubing; 
           [0019]      FIG. 2  is an enlarged view of both ends of the irrigation tube of  FIG. 1 , showing the connectors that secure the tube to the surgical handpiece and the irrigation solution supply bottle; 
           [0020]      FIG. 3  is an enlarged view of the control module cassette of  FIG. 1 ; 
           [0021]      FIG. 4  is an enlarged view of the cassette of  FIG. 3  showing the tubing ends taped in place; 
           [0022]      FIG. 5  illustrates the use of a prior art handpiece with separate irrigation and aspiration tubes attached thereto; 
           [0023]      FIG. 6  is an lateral elevational view of an adaptor embodying elements of the present invention; 
           [0024]      FIG. 7  is a view along line  7 - 7  of  FIG. 6 ; 
           [0025]      FIG. 8  is a partial sectional view of a second embodiment of an adaptor embodying the present invention; 
           [0026]      FIG. 9  is a partial sectional view of the adaptor of  FIG. 8  attached to a handpiece; 
           [0027]      FIG. 10  is a partial sectional and elevational view showing a third embodiment of an adaptor used to connect coaxial tubing to the control cassette; 
           [0028]      FIG. 11  illustrates a prior art liposuction instrument utilizing separate irrigation and aspiration lines; 
           [0029]      FIG. 12  is an axial cross-sectional view of a double-lumen irrigation/aspiration tube; 
           [0030]      FIG. 13  is a lateral sectional view of the tube of  FIG. 12 ; 
           [0031]      FIG. 14  is a schematic/partial sectional view of a handpiece connector adaptor for use with the tube shown in  FIG. 12 ; 
           [0032]      FIG. 15  is a schematic/partial sectional view of a cassette connector adaptor for use with the tube shown in  FIG. 12 ; 
           [0033]      FIG. 16  is a cross-sectional view of a double-lumen tube with the second lumen formed on the exterior of the tube; 
           [0034]      FIG. 17  is a partial sectional view of a connector adaptor for the tube of  FIG. 16 ; and 
           [0035]      FIG. 18  is a partial sectional view showing the connection of the tube of  FIG. 16  to the connector adaptor of  FIG. 17 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0036]    Referring now to  FIG. 1 , the numeral  10  indicates generally a prior art phacoemulsification apparatus consisting of a handpiece  12 , a flexible, tubular aspiration line  14 , flexible tubular irrigation lines  16  and  16 ′ and a control cassette  18 . Control cassette  18  provides a single control apparatus to connect a supply of irrigation solution to a phacoemulsification handpiece and to complete a path from the handpiece to an aspiration chamber for collecting the aspirated fluid, particles and the like. Electrical line  28  provides electrical power to handpiece  12 . 
         [0037]    Referring now to  FIG. 2 , an enlarged view of prior art irrigation line  16  is shown. Typically, irrigation line  16  has a male end connector  20  which is inserted into an irrigation connector port on handpiece  12  in a liquid-tight friction fit.  FIG. 2  also illustrates a typical irrigation fluid supply connector  22 , used to connect line  16 ′ to a container of sterile irrigating solution, such as a flexible plastic bag or the like. 
         [0038]    Referring now to  FIG. 3 , an enlarged view of prior art control cassette  18  is shown demonstrating the connection to cassette  18  of irrigation line  16  (to the handpiece), aspiration line  14  (from the handpiece) and irrigation line  16 ′ (from the solution supply container). 
         [0039]    Referring now to  FIG. 4 , lines  14 ,  16  and  16 ′ are shown secured to prior art cassette  18  with a length of adhesive tape  30  used to secure lines  14 ,  16  and  16 ′ to cassette  18  in an attempt to keep them from separating from the cassette, tangling or kinking. 
         [0040]    Referring now to  FIG. 5 , a prior art handpiece  32  is shown being hand held by a surgeon  34  with aspiration line  14  and irrigation line  16  attached. Aspiration line  14  and irrigation line  16  are attached at one end to handpiece  32  and at the other end to control cassette  18 . However, in between these attachment points both aspiration line  14  and irrigation line  16  are separate. During surgery, efforts must be made to prevent tubes  14 ,  16  from kinking and tangling.  FIG. 5  shows handpiece  32  as it is held typically during surgery. As can be seen in  FIG. 5 , lines  14 ,  16  are separate and must be moved by the surgeon each time the handpiece  32  is moved. Handpiece  32  shown in  FIG. 5  is typified by the model 8065 817 801 handpiece sold by Alcon. 
         [0041]    In a first preferred embodiment of the present invention, a pair of connecting tubes are disposed one within the other to carry out the aspiration and irrigation functions without the snags and tangles experienced when separate tubes are used. As a part of the invention, adaptors are provided to connect the coaxial tubes to existing handpieces. 
         [0042]    Referring now to  FIG. 6 , the numeral  36  identifies a tubing-and-adaptor apparatus constructed in accordance with the present invention. A tubing assembly  38  has an inner tube  40  disposed within an outer tube  42  with both tubes  40  and  42  manufactured from flexible material such as silicone. Tubes  40 ,  42  will be referred to throughout as “coaxial” even though, strictly speaking, the axes of the tubes are not required to coincide. 
         [0043]    Referring to  FIG. 7  a cross-section of tubes  40 ,  42  is shown, illustrating their relative dimensions. Typically a prior art irrigation tube has an inner diameter of about 3.0 mm and an outer diameter of about 5.0 mm, while a typical prior art aspiration tube has an inner diameter of about 1.0 mm and an outer diameter of about 4.0 mm. 
         [0044]    In a preferred embodiment of the present invention, aspiration tube  40  has the same inner and outer diameters as the prior art tube and thus has a cross-sectional area of about 7.1 mm 2  available for fluid flow. Irrigation tube  42  has an inner diameter of about 7.0 mm and an outer diameter of about 9.0 mm, and a cross-sectional area of about 38.5 mm 2 . When aspiration tube  40  is placed within irrigation tube  42  and the cross-sectional area measured by the inner diameter of irrigation tube  42  is subtracted from the cross-sectional area measured by the outer diameter of aspiration tube  40  there is a cross-sectional area of about 25.9 mm 2  available for irrigation flow, or 18.8 mm 2  more than with a conventional irrigation tube. This creates a flow volume 3.6 times greater than that of a prior art irrigation tube, making possible increased irrigation flow while at the same time keeping the irrigation and aspiration tubes from becoming tangled. 
         [0045]      FIG. 6  shows tubing assembly  38  attached to an adaptor  44  constructed to allow tubing assembly  38  to be attached to a conventional phacoemulsification handpiece. Adaptor  44  has a first, generally horizontal and tapered hollow plug  46  having a first, open end  48  with plug  46  tapering outwardly from end  48  to a break  50  and, thereafter, tapering inwardly to a second open end  52 . Integrally formed with adaptor  44  is a collar  54  within which second end  52  is disposed. A plug channel  56  extends through plug  46  from first end  48  to second end  52 . 
         [0046]    Integral with and depending from plug  46  is a port leg  58  comprising a first, downwardly depending leg segment  60  and a second leg segment  62  extending at substantially a right angle to segment  60  and terminating in a port collar  64 . A port channel  66  begins at and extends through port collar  64 , segment  62  and segment  60  terminating in a connector block  68 . A connector tube  70 , fluid-tightly attached to connector block  68  extends through and past collar  54 . 
         [0047]    As seen in  FIG. 6 , tube assembly  38  is connected to adaptor  44  in the following manner. Inner tube  40  is fluid tightly fit to connecting tube  70  while outer tube  42  is inserted into collar  54  and is frictionally and fluid tightly attached to tapered portion  52  of plug  46 . In this fashion two separate fluid-tight flow paths are created. The first flow path extends from opening  48  and plug  46  through collar  54  and to outer tube  42 . The second flow path begins at port collar  64  and extends through channel  66 , connecting block  68  and straight connecting tube  70  to inner tube  40 . When connected to a suitable handpiece, plug  48  is inserted into the port on the handpiece through which the irrigating solution is directed while port  58  forms an attachment point for a plug on the handpiece through which aspiration occurs. 
         [0048]    Referring now to  FIG. 8 , the numeral  74  identifies a second adaptor or connector having a plug assembly  76  having a first cylindrical section  78  preferably formed as a right cylindrical section and a second or formed integrally with a second plug section  80  larger in diameter than section  78  and having a tapered inner wall  82  formed therewithin. 
         [0049]    As seen in  FIG. 8 , outer tube  42  fits liquid tightly about the outer diameter of first section  78  and abuts against second section  80 . Inner tube  40  is attached to a straight tube section  84  which protrudes from plug assembly  76 . The configured plug assembly  76  forms a pair of flow channels, the first of which is a relatively large cylindrical flow channel  86  having a first right cylindrical cross section  88  and a second flow section with a frustoconical cross section  90 , which tapers outwardly toward an opening  92  through plug section  80 . The second flow path is defined by a tube  84  which is inserted, fluid tightly into inner tube  40 . 
         [0050]    Referring now to  FIG. 9 , the numeral  94  identifies a handpiece constructed to receive the connector and tube assembly shown in  74 . Handpiece  94  has a first end  96  terminating in a hollow nipple  98  tapered outwardly from end  100  to body  102  of handpiece  94 . Handpiece  94  also has a central cannula or channel  104  extending from end  96  toward tip  106 . As seen in  FIG. 9 , adaptor and tube assembly  74  is attachable to end piece  94  by inserting the free end of straight tube  84  into cannula  104  while, at the same time, securing plug  86  to tapered end  96  in a fluid-tight fit. Thus, as seen in  FIG. 9 , a path for aspirating liquids is formed by tip  106 , cannula  104 , and inner tube  40  while a flow path from infusing liquid is formed by outer tube  42 , end  96  and the channel formed through end  96 . 
         [0051]    Referring now to  FIG. 10 , the numeral  108  illustrates a preferred method for connecting tube  42  to a control cassette  110 . A cassette adaptor  112  similar in construction to adaptor  74  has an irrigation inlet port  114  and an aspiration outlet port  116 . A first extension tube  118  has a plug  120  at one end sized to fit irrigation outlet port  122  on cassette  110 . Tube  118  is also sized to allow a fluid-tight fit to irrigation port  114 . In similar fashion, a second extension tube  124  has a plug  126  at one end sized to fit aspiration inlet port  128  on cassette  110 . Tube  126  is also sized to allow a fluid-tight fit to aspiration port  116 . One extension tube found to be useful in making the foregoing connections is the Nipro Extension Tube No. EX5-60AC which may be cut and the male connector ends used to make the connections to the cassette. 
         [0052]    Referring now to  FIG. 11 , the numeral  128  identifies a prior art surgical handpiece used in liposuction, having a body  130  and a hollow, ultrasonically-vibrating cannula  132 . An aspiration line  134  draws fluid and tissue particles through hollow cannula  132 , while irrigating solution is supplied via irrigation tube  136  through an irrigation channel formed in cannula  132 . Electrical power is supplied to the vibrating motor in body  130  via electrical line  138 . 
         [0053]    Applying the principles of the present invention to handpiece  128 , an adaptor (not shown) is designed to fit liquid-tightly at one end to aspiration port  140  and irrigation port  142  and at another end to coaxial tubes such as those shown in  FIGS. 6 and 7  and as described herein. 
         [0054]    Referring now to  FIG. 12 , the numeral  142  identifies a double-lumen tube having an outer wall  144  and an inner wall  146  integral with and extending axially along an interior surface  148  of tube  142 . Inner wall  146  has a first, exterior surface  150  and a second, interior surface  152 . First surface  150  and a first portion  154  of interior surface  148  define a first, or irrigation lumen  156 , while second surface  152  and a second portion  158  of interior surface  148  define a second, or aspiration lumen  160 . 
         [0055]    Tube  142  is preferably connected to a phacoemulsification handpiece or a control cassette such that first lumen  156  and second lumen  160  become part of two separate flow paths. A preferred method of making such a connection is to provide adaptors that will connect with tube  142  and are also configured to connect with selected handpieces, control cassettes or other flow components. One such connection system is shown in  FIGS. 13 through 15 . 
         [0056]    Referring now to  FIG. 13 , an end of tube  142  configured to connect to an adaptor is shown in lateral cross-section. End  162  is intended to be attached to an adaptor for connection to either a phacoemulsification handpiece or a control cassette as described below. To do so, inner wall  146  is cut or foreshortened to form a setback  164  extending from end  162  to inner wall end  166 . 
         [0057]    Referring now to  FIG. 14  a preferred handpiece adaptor  168  is shown having a port collar  170  communicating with a port channel  172  which, in turn, connects with a connection block  174  to form a flow path for aspiration of emulsified lens fragments. A collector tube  176  is fluid-tightly attached to block  174  and extends past a plug  178  into tube  142 . Tube  142  is held liquid-tightly to adaptor  168  at a shoulder  180  of plug  178 . 
         [0058]    As seen in  FIG. 14 , collector tube  176  has a first, straight segment  182 , a second, angled segment  184  and a third straight segment  186  sized and shaped to fit liquid-tightly into second lumen  160 . Setback  164  is selected to allow a sufficient portion of third segment  182  to extend into second lumen  160  to form a liquid-tight fit. 
         [0059]    First lumen  156  communicates with a hollow plug  188  having an open end  190  communicating with a plug channel  192  to form an irrigation flow path. 
         [0060]    Referring now to  FIG. 15 , a preferred cassette adaptor  194  is shown having a plug assembly  196  having a first cylindrical section  198  preferably formed as a right cylindrical section and a second or formed integrally with a second plug section  200  larger in diameter than section  198  and having a tapered inner wall  202  formed therewithin. 
         [0061]    As seen in  FIG. 15 , tube  142  fits liquid tightly about the outer diameter of first section  198  and abuts against second section  200 . A connector tube  204  has a first, straight section  206  that extends through plug  200  and into tube  142 . A second, angled section  208  is formed integrally with first section first section  206  and terminates in a third, straight section  210 , which is sized and shaped to fit liquid-tightly into second lumen  160 . The configured plug assembly  196  forms a pair of flow channels, the first of which is a relatively large cylindrical flow channel  212  having a first right cylindrical cross section  214  and a second flow section with a frustoconical cross section  216 , which tapers outwardly toward an opening  218  through plug section  200 . The second flow channel is formed by lumen  160  and tube  204 . 
         [0062]    Referring now to  FIG. 16  the numeral  220  identifies a double-lumen tube having a first cylindrical lumen  222  with an outer wall  224  and a first flow channel  226 . A second lumen  228  is formed integrally and coextensively with first lumen  222  such that lumen  228  is not within first flow channel  226 . Second lumen  228  has an outer wall  230  which, with a segment  232  of outer wall  224  forms a second flow channel  234 . 
         [0063]    Referring now to  FIG. 17 , the numeral  236  identifies a sectional view of a connector adaptor to connect to tube  220 . Connector  236  has an inlet end  238  formed as part of a solid body  240 . A first flow passage  242  begins at end  238  and extends through body  240 , and a second flow passage  244  extends through body  240 . 
         [0064]    A first nipple  246  is formed on end  238  and serves as the connector for passage  242 , and a second nipple  248  is formed on end  238  and serves as the connector for passage  244 . 
         [0065]    Referring now to  FIG. 18 , tube  220  is shown connected to connector  236 , with first lumen  222  frictionally and liquid-tightly fit to first nipple  246  and second lumen  228  frictionally and liquid-tightly fit to second nipple  248 . When so connected, first flow channel  226  communicates with first flow passage  242  and second flow channel  234  communicates with second flow passage  244 . 
         [0066]    It is anticipated that a separately-configured adaptor will be supplied to fit each existing surgical handpiece and will be supplied with selected lengths of tubing constructed in accordance with the invention variations described herein. tubing.