Abstract:
An ophthalmic irrigator-aspirator has a handpiece with aspiration and irrigation openings through its distal end; and a narrow aspiration tip projecting distally. A flexible sleeve has an annular hub for watertight connection to the handpiece. The sleeve surrounds the full extent of the tip. An intermediate portion of the sleeve forms a channel for an irrigation fluid along the exterior of the tip to a port in the sleeve. The distal end of the sleeve is sized for a watertight connection over the distal portion of the tip. Such distal end of the sleeve has an aspiration port in communication with the tip aspiration port. The sleeve proximate, intermediate, and distal portions are integral with each other and are formed of a resilient material that allows the sleeve to be manually stretched onto the handpiece and tip.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of Provisional Application No. 61/759560, filed Feb. 1, 2013, and Provisional Application No. 61/710610, filed Oct. 5, 2012, the disclosures of which are hereby expressly incorporated by reference herein. 
       BACKGROUND 
       [0002]    The present invention pertains to an improved irrigator-aspirator tip component of the type inserted into the lens capsule of an eye, such as for removing cortical material, washing, cleaning and/or polishing. 
       SUMMARY 
       [0003]    This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. 
         [0004]    In accordance with the present invention, a unitary, one-piece sleeve is provided for an ophthalmic irrigator-aspirator instrument of the type having a handpiece with an aspiration opening through the distal end thereof and one or more irrigation openings adjacent to the aspiration opening. The instrument includes an elongated, narrow tip projecting from the handpiece distal end, such tip having an internal bore communicating with the handpiece aspiration opening and an aspiration port at or adjacent to a distal end of the tip. The novel sleeve has a proximate annular hub portion constructed and arranged to be manually connected to a distal end portion of the handpiece in a watertight fit, with the sleeve surrounding the full extent of the tip and the aspiration and irrigation openings of the handpiece. An intermediate portion of the sleeve forms a channel for an irrigation fluid between the exterior of the tip and the interior portion of the sleeve. The channel is in communication with the handpiece irrigation opening and an irrigation port adjacent to the distal end of the sleeve, for conveying the irrigation fluid through the channel and ejecting it from the irrigation port of the sleeve. The distal end portion of the sleeve is sized for manual connection over the distal portion of the tip in a watertight fit at a location between the sleeve irrigation port and the aspiration port of the tip. Such distal end portion of the sleeve has an aspiration port located to be in communication with the tip aspiration port. The sleeve proximate, intermediate, and distal portions are integral with each other and are formed of a resilient material that allows the sleeve to be manually stretched onto the handpiece and tip. 
         [0005]    The sleeve is intended to be a single use item for an ophthalmic procedure, but the tip is protected by the sleeve during use and can be reused. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0006]    The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein: 
           [0007]      FIG. 1  is a top front perspective of an intraocular irrigator-aspirator tip component in accordance with the present invention with parts shown in exploded relationship; 
           [0008]      FIG. 2  is a corresponding perspective thereof on a somewhat larger scale showing some parts assembled; 
           [0009]      FIG. 3  is a vertical axial section thereof with the parts shown in the positions of  FIG. 2 ; 
           [0010]      FIG. 4  is a section corresponding to  FIG. 3  but on a larger scale and with parts fully assembled; 
           [0011]      FIG. 4A  is a further enlarged, fragmentary, vertical section of the intraocular irrigator-aspirator tip component of  FIGS. 1-4 ; 
           [0012]      FIG. 5  is a top front perspective of a second embodiment of an intraocular irrigator-aspirator tip component in accordance with the present invention with parts shown in exploded relationship; 
           [0013]      FIG. 6  is a corresponding perspective thereof on a somewhat larger scale showing some parts assembled; 
           [0014]      FIG. 7  is a vertical axial section thereof with the parts shown in the positions of  FIG. 6 ; 
           [0015]      FIG. 8  is a section corresponding to  FIG. 3  but on a larger scale and with parts fully assembled; 
           [0016]      FIG. 8A  is a further enlarged, fragmentary, vertical section of the intraocular irrigator-aspirator tip component of  FIGS. 5-8 ; 
           [0017]      FIG. 9  is a top front perspective of a modified form of an intraocular irrigator-aspirator tip component in accordance with the present invention with parts shown in exploded relationship; 
           [0018]      FIG. 10  is a fragmentary, enlarged, top plan thereof with the parts assembled; 
           [0019]      FIG. 11  is a vertical axial section thereof with the parts shown in the positions of  FIG. 10 ; 
           [0020]      FIG. 12  is a top front perspective of another modified form of an intraocular irrigator-aspirator tip component in accordance with the present invention with parts shown in exploded relationship; 
           [0021]      FIG. 13  is a corresponding perspective thereof on a somewhat larger scale showing some parts assembled; 
           [0022]      FIG. 14  is a vertical axial section thereof with the parts shown in the positions of  FIG. 13 ; 
           [0023]      FIG. 15  is a section corresponding to  FIG. 14  but on a larger scale and with parts fully assembled; and 
           [0024]      FIG. 15A  is a further enlarged, fragmentary, vertical section of the intraocular irrigator-aspirator tip component of  FIGS. 12-15 . 
       
    
    
     DETAILED DESCRIPTION 
       [0025]    With reference to  FIG. 1 , an irrigation-aspiration handpiece  10  has a distal portion  12  adapted to receive a separate tip  14  which typically is surgical grade stainless steel or titanium. In a representative embodiment, tip  14  is reusable and has an externally threaded proximate stem  16  for reception in the internally threaded bore  18  that opens at the distal end of the handpiece.  FIGS. 2-4  show the tip  14  after it has been joined to the handpiece  10 . In  FIG. 3  it can be seen that the tip  14  has an internal bore  17  that communicates with the central longitudinal bore  18  of the handpiece  10 . At the proximate end, the handpiece is connected to a low pressure or vacuum source, such that aspiration is achieved through the distal end port  20  of the tip  16  as controlled by the user (typically a surgeon). In addition, the handpiece has an annular channel  22  for discharge of an irrigation liquid, such as to compensate for material aspirated through the tip  14 . 
         [0026]    In accordance with the present invention, a one-piece or unitary sleeve  24  of a soft, resilient material, such as silicone rubber, is provided for fitting tightly over the tip  14  and the distal end portion of the handpiece  10  to which the tip has been joined. 
         [0027]    With reference to  FIG. 4 , the resilient sleeve  24  has a distal hub portion  26  with a wall diameter somewhat greater than the remainder of the sleeve for increased rigidity adjacent to a lip  28  in the area where the sleeve would typically be grasped by the surgeon or technician assembling the apparatus. At the proximate end, on the internal face  30 , the sleeve is tapered for ease in fitting the sleeve on and over the distal tip portion of the handpiece. The handpiece can be formed with an external thread  32  or a series of ribs to achieve a watertight fit of the sleeve on the handpiece. 
         [0028]    The diameter of an intermediate portion of the sleeve  24  gradually decreases along the length of the tip  14 , being sized to form an annular channel  34  which is in communication with the handpiece irrigation channel  22 . Moving still farther in a distal direction, the wall thickness of the sleeve lessens to increase the overall flexibility of the sleeve in the area where it will protrude through a corneal incision. 
         [0029]    The details of the distal-most portion of the sleeve  24  and inner tip  14  are best seen in  FIG. 4A . In this embodiment, the distal end of the tip  14  has the end port  20 . The sleeve  24  has a distal end portion  36  that projects beyond the end port  20 , with an internal aspiration cavity  38  in communication therewith. In the embodiment shown, the end portion  36  of the sleeve has an annular shoulder  40  to butt against the distal end of the tip  14  when the sleeve is inserted fully over the tip. An external aspiration port  42  is formed in the distal sleeve part  36 . In the illustrated embodiment, port  42  extends obliquely, which is preferred, but it can be positioned at any desired location around the sleeve portion  36 . The wall thickness at the distal portion  36  is greater than the thickness where the sleeve fits over the tip  14 , for a somewhat less flexible but still soft tip that can be manipulated by the surgeon to a desired location. The fit of the sleeve around the distal end of the tip is very snug and watertight. 
         [0030]    Still referring to  FIG. 4A , one or more ports  44  are provided for expulsion of irrigation liquid close to the aspiration port but nevertheless spaced proximate therefrom. Typically, during an intraocular procedure both ports will be positioned inside the cornea and usually inside the lens capsule. The distal part  36  of the sleeve is unsupported and should have sufficient rigidity that it does not collapse so as to block aspiration. Nevertheless, the part of the sleeve  24  proximate to the irrigation port  44  will be fitted through a small corneal slit, and should be sufficiently flexible to conform to the shape of the slit without unduly stretching or tearing the cornea. Whereas the tip  14  itself is very rigid and can have sharp edges that could tear delicate eye tissue with which they come into engagement, the sleeve is soft enough that the risk of tearing, cutting, or abrasion of eye tissue is reduced significantly. In addition, the sleeve protects the tip  14  from being damaged, such as by contact with other instruments during surgery. The sleeve can be a single-use item, allowing the aspiration tip to be used multiple times. 
         [0031]      FIGS. 5 to 8A  correspond, respectively, to  FIGS. 1 to 4A , but for a second representative embodiment of the present invention. The handpiece  10  is the same, including the distal portion  12 , central aspiration bore  18 , and annular irrigation channel  22 . The separate tip  14 ′ has the same threaded stem  16  for joining to the handpiece, but the distal end portion of the tip  14 ′ and the distal end portion of the sleeve  24 ′ are a little different. 
         [0032]    As best seen in  FIG. 8A , the distal end of the tip  14 ′ is closed, and the aspiration port  20 ′ opens through the side, very close to the distal end. The distal end portion  36 ′ of the resilient sleeve tightly embraces the closed end of the tip  14 ′ and the end portion on both sides of the port  20 ′ in a watertight fit. The sleeve  24 ′ has an aspiration port  42 ′ located to register with the tip port  20 ′ when the parts are assembled. Port  42 ′ can be smaller than port  20 ′ so that the hard and potentially sharp metal inner tip will not come in contact with delicate eye tissue during use. 
         [0033]    For both illustrated embodiments it is important that the sleeve  24 / 24 ′ be fully inserted on the tip  14 / 14 ′, and for both embodiments it is important that the sleeve be correctly aligned or registered with the tip.  FIGS. 9-11  illustrate modifications that can be used with both embodiments to assist in obtaining the correct relative orientation. 
         [0034]    The tip  14 / 14 ′ is “clocked” to the handpiece  10 ′ so that the relative orientation will be the same each time one of the aspiration tips is connected. For example, in  FIG. 9  the bend of the tip toward its distal end would always be oriented vertically upward. A registration mark (arrow  50 ) is formed on the exterior of the handpiece for reference, preferably on an enlarged extension  52 . Extension  52  has a flat annular face  54  from which the distal portion  12 ′ extends. Such portion  12 ′ has a pair of longitudinally spaced, circumferential ribs  32 ′ adjacent to the distal end of the handpiece. The sleeve  24 ″ also has a registration mark (arrow  54 ) formed thereon. During assembly, the surgeon or technical assistant can manually pull the sleeve over the aspirator tip  14 / 14 ′ while keeping the registration marks in alignment, thereby assuring the correct relative orientation. 
         [0035]    In addition, the construction of the modified sleeve  24 ″ and handpiece  10 ′ help assure that the sleeve will be fully stretched over the tip and handpiece to the desired degree, and no more. The proximate end of the sleeve will abut against the face  54  of the handpiece extension  52 , and, as seen in  FIG. 11 , an internal rib  56  of the sleeve  24 ″ is snugly received between the handpiece ribs  32 ′ when the desired fit is achieved. 
         [0036]      FIGS. 12 to 15A  correspond, respectively, to  FIGS. 1 to 4A , but for a third representative embodiment of the present invention. The handpiece  10 ′ is the same as previously described except for the distal portion  12 ′″. For example, the handpiece of the third embodiment still has the central aspiration bore  18  (see  FIGS. 14 and 15 ) and annular irrigation channel  22 , and the bore and channel open through the distal end of the distal portion  12 ′″. The outer periphery of the distal portion  12 ′″ is configured for connection to a composite rigid tip component  60 . Tip component  60  has an internally threaded hub or base  62  for joining to the handpiece, such as by mating threads (external on the handpiece distal portion  12 ′″ and internal in the hub or base  62 ).  FIGS. 13 ,  14 , and  15  show the hub or base  62  connected to the handpiece. 
         [0037]    The hub or base  62  can be formed of a rigid plastic material. The composite tip  60  includes a rigid (preferably surgical grade stainless steel or titanium) cannula  64  projecting distally from the hub or base  62 . The cannula is fixed in the base, such as by overmolding during manufacturing. As seen in  FIG. 15 , the bore  66  of the cannula communicates with the aspiration bore  18  of the handpiece and can terminate at or near a distal port  68 . 
         [0038]    As best seen in  FIGS. 13 and 14 , the hub or base  62  includes a distal protrusion or stem  70 . As seen in  FIGS. 14 and 15 , stem  70  has longitudinal passages  72  that communicate with the annular irrigation channel  20  of the handpiece. 
         [0039]    This embodiment includes a thin-walled resilient sleeve  24 ′″ similar to the sleeves previously described. The proximate end portion (hub)  74  of sleeve  24 ′″ can be fitted tightly over the stem  70  of the composite tip component  60 . As best seen in  FIG. 15 , an interior rib  76  at the proximate end of the sleeve can be received in a groove  78  at the proximate end of the stem for a reliable connection of the sleeve to the stem. For registration purposes, the outer periphery of the stem can be a shape other than cylindrical and the proximate portion of the sleeve shaped the same. In the illustrated embodiment the stem and sleeve are approximately triangular in transverse cross section so the sleeve will be oriented correctly as it is slid on the stem prior to use of the IA instrument. 
         [0040]    As best seen in  FIG. 15A , the distal end of the rigid cannula opens through an end port  88 . The distal end portion of the resilient sleeve  24 ′″ tightly embraces the tip of the cannula in a watertight fit. The sleeve  24 ′″ has an aspiration port  80  in fluid communication with the bore of the cannula, and a nearby irrigation port  82  that communicates with the annular passage for irrigation liquid that flows from the handpiece. 
         [0041]    Although this embodiment shows an end port for the cannula, the cannula and sleeve can be modified similar to the embodiment of  FIGS. 6 to 8A  for a side port application. Either way, it is intended that this embodiment of a composite tip and one-piece or unitary resilient sleeve be sold preassembled as a single use item for quick and reliable connection to a reusable handpiece. Both aspiration and irrigation are supported, and sterility is assured because the tip and sleeve are discarded after one use. 
         [0042]    While illustrative embodiments have been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention.