Patent Application
20160374854
The present invention relates generally to instruments used in eye surgery and, more particularly to an irrigation/aspiration (I/A) assembly or apparatus used to remove particles from the capsular bag after removal of a lens, with the apparatus including an integrated aspiration cannula and outer aspiration tip.
When the human eye becomes aged, diseased, or injured it may be necessary to remove the natural lens of the eye. Such removal is common for cataract surgery, in which a lens that has become clouded is removed. The removal of the natural lens of the eye will result in the loss or alteration of focused vision of a patient. Therefore, an artificial lens will be necessary to restore the vision of the patient. Some eyes have an oblong, irregularly shaped cornea that causes astigmatism, or blurred vision due to a refractive error in the eye.
The lens of the eye is held within a capsular bag positioned behind the iris in the anterior chamber of the eye. When the lens becomes damaged or diseased, a common surgical technique is to remove the lens and replace it with an artificial intraocular lens (IOL). Removal of the lens is commonly carried out by physical dismemberment of the lens and phacoemulsification, that is, using a needle to which vibrational energy is transmitted by a phacoemulsification hand piece.
During phacoemulsification, the lens is broken into fragments and the fragments are emulsified and then removed from the capsular bag by aspirating the fragments through a cannula formed as part of the phacoemulsification needle. After the lens has been removed, the capsular bag must be cleaned in order to prepare it for the insertion of an IOL. In particular, epithelial and cortical tissue fragments must be removed from the floor and perimeter of the capsular bag. Typically, an irrigation aspiration (I/A) tip is coupled to a hand piece, which may be the phacoemulsification hand piece, for removal of the fragments. The hand piece will typically have an irrigation and aspiration mode specifically for this task.
Complete removal of the cortex is important for several reasons. If the cortex is not completely removed it may cause post-operative inflammation and an increase in intraocular pressure. Incomplete removal of the cortex may also cause decentration or tilting of the IOL which, in turn, would cause a postoperative refractive error or induced astigmatism. This is especially important if the IOL is a multi-focal or toric type. Incomplete removal of the cortex may also result in the formation of after (secondary) cataract which would impair vision and require laser capsulotomy.
The present invention is directed to an irrigation aspiration (I/A) apparatus or assembly which has been specifically configured to promote safe and efficient irrigation and aspiration of the capsular bag attendant to eye surgery such as implantation of an intraocular lens.
In accordance with present invention, an improved irrigation aspiration (I/A) apparatus or assembly includes an aspiration cannula, and an outer aspiration tip secured to the aspiration cannula to provide an integrated assembly for performing irrigation and aspiration attendant to eye surgery. Notably, the aspiration tip has been configured to include a ball-shaped, generally spherical distal body portion, which may comprise relatively soft or cushiony material for compatibility with the capsular tissue.
The ball-like, bulbous or rounded shape of the tip of the body portion presents a softer surface with no angles to lessen the possibility of injury to the capsule. The tip can be used to polish the anterior capsule to remove fine cortical residue as well as any remaining viscoelastic material present after implanting the lens. To aspirate the viscoelastic material, the tip is introduced beneath the IOL accomplishing aspiration without stressing the capsular bag or the ciliary zonules or the lens itself. Use of an outer sleeve or cover made from thermoplastic material over a metallic hollow cannula results in an I/A instrument that presents a smooth tip surface for polishing the cortex and also allows the tip to have a port formed therethrough which communicates with the hollow passageway in the metallic cannula. The tip port can be placed at any desired location on the tip and the tip passageway is then extended to meet the cannula passageway at an angle.
In accordance with one aspect of the present invention, the irrigation aspiration (I/A) apparatus comprises a cannula in the form of metallic, hollow aspiration cannula having a proximal end and a distal end, with the cannula defining an interior passage extending from the proximal end to the distal end thereof.
The apparatus further comprises an outer, aspiration tip positioned on at least the distal end of the aspiration cannula. The aspiration tip includes a generally spherical body portion defining an aspiration port in fluid communication with the interior passage defined by the aspiration cannula, and a mounting sleeve portion extending from the body portion. The mounting portion surrounds the distal end of the aspiration cannula in substantially fluid-tight relationship therewith. The aspiration port defined by the body portion of the aspiration tip may be chamfered.
The aspiration cannula defines an annular retention step at an outer surface spaced from the distal end thereof. In turn, the sleeve portion of the outer aspiration tip defines an internal, annular abutment surface in engagement with the annular retention step for maintaining the aspiration tip in position on the distal end of the aspirating cannula.
In one illustrated embodiment, the aspiration port defined by the body portion of the aspiration tip is coaxially aligned with the interior passage defined by the aspiration cannula. In alternative embodiments, the aspiration port defined by the body portion of the aspiration tip is disposed at an acute angle to the longitudinal axis of the interior passage defined by the aspiration cannula. In one embodiment, the aspiration port defined by the body portion of the aspiration tip is disposed at an acute angle of about 45 degrees to the axis of the interior passage defined by the aspiration cannula.
In accordance with another aspect of the present invention, the aspiration port defined by the body portion of the aspiration tip is disposed at an obtuse angle to the axis of the interior passage defined by said aspiration cannula.
In another aspect of the present I/A apparatus, the aspiration cannula defines an annular retention groove extending proximally of the annular retention step, with the mounting sleeve portion of the aspiration tip defining an annular retention collar disposed within the annular retention groove defined by said aspiration cannula.
In another aspect of the I/A apparatus, the mounting portion of the aspiration tip extends proximally of the annular retention step of the aspiration cannula, and comprises a retention sheath fitted to the exterior of the aspiration cannula. In accordance with illustrated embodiments, the retention sheath preferably has a length that is at least five times the effective diameter of the generally spherical body portion of the aspiration tip, and more preferably about six times the effective diameter of the generally spherical body portion of the aspiration tip.
It is contemplated that the body portion of said aspiration tip may be configured to define a roughened surface. The outer aspiration tip of the assembly may comprise relatively soft material, compared to the metallic material from which the cannula is formed, with the aspiration tip being integrated and joined to the cannula such as by overmolding, swaging, crimping, or otherwise shaping the aspiration tip to the aspiration cannula so that the annular abutment surface of the aspiration tip engages the annular retention step defined by the aspiration cannula.
It has been determined that the aspiration cannula configured in accordance with the present invention can have straight or curved configurations to allow for selectable maneuverability in use.
In another aspect of the present invention, a method of making an irrigation and aspiration apparatus is disclosed. The method has the step of providing a hollow aspiration cannula having a proximal end and a distal end, the aspiration cannula defining an interior passage extending from its proximal end to its distal end. The method has the step of forming an annular retention step at an outer surface of the aspiration cannula spaced from the distal end thereof. The method has the further step of mounting an aspiration tip on at least the distal end of the aspiration cannula, the aspiration tip including a generally spherical body portion defining an aspiration port in fluid communication with the interior passage defined by the aspiration cannula, and the aspiration tip including a mounting sleeve portion extending from the body portion. The mounting portion surrounds the distal end of the aspiration cannula in substantially fluid-tight relationship therewith, and the sleeve portion of the aspiration tip defining an internal, annular abutment surface in engagement with the annular retention step for maintaining the aspiration tip in position on the distal end of the aspiration cannula.
Other features and advantages of the present invention will become readily apparently from the following detailed description, the accompanying drawings, and the appended claims.
While the following describes presently preferred 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.
Reference will hereinafter be made to the accompanying drawings which illustrate aspects of the invention, where like reference numerals used in the various figures denote like structural elements, and wherein:
While the present invention is susceptible of embodiment in various forms, there are shown in the drawings and hereinafter described presently preferred embodiments of the invention, with the understanding that the present disclosure is to be considered an exemplification of the invention, and is not intended to limit the invention to the specific embodiments illustrated.
In accordance with present invention, an improved I/A apparatus or assembly includes an aspiration cannula, and an outer aspiration tip secured to the aspiration cannula to provide an integrated assembly for performing irrigation and aspiration attendant to eye surgery. Notably, the aspiration tip has been configured to include a ball-shaped, generally spherical distal body portion, which may comprise relatively soft or cushiony material for compatibility with the capsular tissue.
Use of an outer aspiration tip in the form of a sleeve or cover made from thermoplastic material, over a metallic hollow cannula, results in an I/A apparatus that presents a smooth tip surface for polishing the cortex and also allows the body portion to have a aspiration port formed therethrough which communicates with the hollow passageway in the metallic cannula. The aspiration port can be placed at any desired location on the tip and the tip passageway is then extended to meet the cannula passageway, either in alignment with the cannula passageway, or at an angle thereto.
In accordance with the present invention, numeral 10 identifies a miniaturized surgical instrument as described in U.S. Pat. No. 6,491,670, hereby incorporated by reference. As illustrated in
The I/A apparatus further comprises an outer, aspiration tip 20 positioned on at least the distal end of the aspiration cannula 12. The aspiration tip includes a generally spherical body portion 24 defining an aspiration port 26 in fluid communication with the interior passage 18 defined by the aspiration cannula, and a mounting sleeve portion 28 (
The present I/A apparatus 10 can be configured to promote efficient manufacture, and highly effective and convenient use. In certain embodiments, the aspiration tip 20 of the assembly is configured for overmolding for secure fitment to the associated cannula 12, but can be otherwise affixed such as by crimping, squeezing, swaging, or other manipulation. In certain embodiments, the aspiration tip 20 is provided with an extended mounting sleeve portion, such that the tip 20 can be fitted to the associated cannula 12 in a condom-like fashion, with the mounting sleeve extending proximally from the distal body portion of the aspiration tip 20 to cover a substantial portion of the cannula 12 (e.g., as shown in the various embodiments illustrated in
The specific configuration of the body portion of the aspiration tip can be varied while keeping with the principles disclosed herein. The aspiration port defined by the body portion can be aligned with (i.e., coaxial) the axis of the interior passage defined by the hollow cannula of the assembly, but need not be configured in this manner. Similarly, the aspiration port can disposed at an acute or obtuse angle to the axis of the interior passage. The material from which the outer aspiration tip is formed can be selected to exhibit a desired degree of softness or tackiness, such a by formation from any of a variety of suitable polymers including silicone-based polymers. A material exhibiting a Shore hardness of 76-82 is preferably employed. It is within the purview of the invention that the body portion of the aspiration tip be subjected to selected surface-finishing, such as roughening by media-blasting or other processes, to create a desired degree of tackiness for the body portion.
In accordance with the first illustrated embodiment of the present invention, as further illustrated in
In this first illustrated embodiment of the I/A apparatus 10, the aspiration port 26 defined by the body portion 24 of the aspiration tip 20 is disposed at an acute angle of about 45 degrees relative to the axis or central axis of the interior passage 18 defined by the aspiration cannula 12. The angle at aspiration port 26 meets the axis of the interior passage 18 defined by cannula 12 is selected to provide the I/A apparatus 10 with a desired and desirable degree of maneuverability in order to allow the tip 20 to be used to aspirate particles from the eye without removing and reorienting the I/A apparatus 10.
With reference now to
With specific reference to
As in the previous embodiments, in the embodiment of the aspiration tip 120 shown in
As noted, it is contemplated that the body portion 124 of aspiration tip may be configured to define a roughened surface, or otherwise be selected or configured to present suitable tacky surface. This is illustrated in
The specific configuration and disposition of the aspiration port of the aspiration tip of the present I/A apparatus can be varied while keeping with the principles disclosed herein. In the embodiment illustrated in
In alternative embodiments, the aspiration port 126 defined by the body portion 124 of the aspiration tip can be configured such that it is disposed at an acute angle to the axis of the interior passage defined by the aspiration cannula. In the embodiment illustrated in
The inventor has found that embodiments of the I/A apparatus disclosed herein may be advantageously utilized for very soft or so-called “soupy” lenses.
From the foregoing, it will be observed that numerous modifications and variations can be effected without departing from the true spirit and scope of the present invention. It is to be understood that no limitations with respect to the specific embodiment disclosed herein are intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.
This application claims priority for U.S. Provisional Patent Applications No. 62/185,051, filed Jun. 26, 2015, and No. 62/187,297, filed Jul. 1, 2015, the contents of both of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62185051 | Jun 2015 | US | |
| 62187297 | Jul 2015 | US |
