Abstract:
An irrigation and aspiration tubing system for use with surgical handpieces and irrigation fluid supplies has a first flexible irrigation tube for transporting irrigation fluid to the handpiece and a second flexible aspiration tube disposed within the first tube. The inner diameter of the first tube 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. The system finds particular utility with phacoemulsification instruments used for opththalmic surgery.

Description:
This invention relates to surgical instruments and surgical techniques used in eye surgery and more particularly, to phacoemulsification apparatus and methods for their use. This application claims priority from provisional application Ser. No. 60/613,645, filed Sep. 27, 2004. 
    
    
     BACKGROUND OF THE INVENTION 
     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. 
     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. 
     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. 
     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. 
     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. 
     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 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. 
     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 solidifiying agent to close off aneurysm. The multiple lumens are used for the injection of different liquids into the circulatory system. 
     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. 
     While these references describe catheter systems having multiple lumens, such systems are designed for insertion into the pulmonary or circulatory systems. None are used for the delivery of irrigating solution to an ophthalmological surgical handpiece while simultaneously providing a path for the aspiration of fluid from the handpiece. None teach or suggest the construction of aspiration/irrigation tubing apparatus connectable to existing handpieces and fluid control consoles as well as to handpieces and consoles specifically designed to accept such apparatus. 
     The need thus exists for aspiration/irrigation tubing apparatus and connectors that can be connected to existing surgical handpieces and control consoles without modifying them. 
     A further need exists for such apparatus which allows a surgeon to manipulate the handpiece without kinking the aspiration/irrigation tubing. 
     Further, a need exists for such tubing and connectors to be made available in inexpensive and disposable versions. 
     While the following describes a preferred embodiment or embodiments of the present invention, it is to be understood that this description is made by way of example only and is 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 
       These and further objects and characteristics of the present invention will become apparent upon consideration of the following drawings, in which: 
         FIG. 1  illustrates a prior art irrigation and aspiration apparatus and its associated tubing; 
         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 handpiece and the irrigation solution supply bottle; 
         FIG. 3  is an enlarged view of the control module cassette of  FIG. 1 ; 
         FIG. 4  is an enlarged view of the cassette of  FIG. 3  showing the tubing ends taped in place; 
         FIG. 5  illustrates the use of a prior art handpiece with separate irrigation and aspiration tubes attached thereto; 
         FIG. 6  is an lateral elevational view of an adaptor embodying elements of the present invention; 
         FIG. 7  is a view along line  7 - 7  of  FIG. 6 ; 
         FIG. 8  is a partial sectional view of a second embodiment of an adaptor embodying the present invention; and 
         FIG. 9  is a partial sectional view of the adaptor of  FIG. 8  attached to a handpiece. 
     
    
    
     DETAILED DESCRIPTION OF INVENTION 
     Referring now to  FIG. 1 , the numeral  10  indicates generally a prior art phacoemulsification apparatus consisting of a handpiece  12 , an irrigation line  14 , an aspiration line  16  and a control cassette  18 . Control cassette  18  provides a single control apparatus to connect a supply of irrigating to a phacoemulsification handpiece, to complete a path from the handpiece to an aspiration chamber for collecting the aspirated fluid, particles and the like, and an electrical connector for the handpiece. 
     Referring now to  FIG. 2 , an enlarged view of prior art irrigation line  14  is shown. Typically, irrigation tube  16  has a male end connector  20  which is inserted into an irrigation connector port on handpiece  12  in a friction fit.  FIG. 2  also illustrates a typical irrigation fluid supply connector  22 , used to connect line  14  to a container of sterile irrigating solution, such as a flexible plastic bag or the like. 
     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), irrigation line  16 ′ (from the solution supply container), and an electrical line  28  (which powers the handpiece). 
     Referring now to  FIG. 4 , lines  26 ,  14  and  16  are shown attached to prior art cassette  18  with a length of adhesive tape  30  used to secure lines  14 ,  16  and  26  to cassette  18  in an attempt to keep them from separating from the cassette and/or tangling. 
     Referring now to  FIG. 5 , a prior art handpiece  32  is shown being hand held by a surgeon  34  with aspiration line  16  and irrigation line  14  attached. Aspiration line  16  and irrigation line  14  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  16  and irrigation line  14  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. 
     In a 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. 
     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. 
     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. 
     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. 
       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 . 
     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 . 
     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. 
     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. 
     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 . 
     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 .