The present invention relates to phacoemulsification surgical systems and more particularly, to aspiration path resistive elements in phacoemulsification surgical systems.
Typical surgical instruments suitable for phacoemulsification procedures on cataractous lenses include an ultrasonically driven phacoemulsification hand piece with a cutting needle and an irrigation sleeve, and a control console. The hand piece is attached to the control console by an electric cable and flexible tubing. The flexible tubing supplies irrigation fluid to the surgical site and carries aspiration fluid from the surgical site to a waste or discard reservoir.
During a phacoemulsification procedure, the tip of the cutting needle and the end of the irrigation sleeve are inserted into the anterior segment of the eye through a small incision in the eye's outer tissue. The surgeon brings the tip of the cutting needle into contact with the lens of the eye, so that the vibrating tip fragments the lens. The resulting fragments are aspirated out of the eye through the interior bore of the cutting needle, along with irrigation fluid provided to the eye during the procedure.
Throughout the procedure, irrigating fluid is infused into the eye, passing between the irrigation sleeve and the cutting needle and exiting into the eye at the tip of the irrigation sleeve and/or from one or more ports or openings formed into the irrigation sleeve near its end. This irrigating fluid is critical, as it prevents the collapse of the eye during the removal of the emulsified lens, protects the eye tissue from the heat generated by the vibrating of the ultrasonic cutting needle, and suspends the fragments of the emulsified lens for aspiration from the eye.
During the surgical procedure, the console controls irrigation flow rates and aspiration flow rates to maintain a proper intra-ocular chamber balance in an effort to maintain a relatively consistent fluid pressure at the surgical site in the eye.
Aspiration flow rates of fluid from the eye are typically regulated by an aspiration pump that creates a vacuum in the aspiration line. The aspiration flow and/or vacuum are set to achieve the desired working effect for the lens removal. While a consistent fluid pressure in the eye is desirable during the phacoemulsification procedure, common occurrences or complications create fluctuations or abrupt changes in fluid flow and pressure at the eye. One known cause for these is occlusions or flow obstructions that block the needle tip. This common, and sometimes desirable occurrence, results in a sharp increase in vacuum in the aspirating line. When the occlusion is removed, the resulting high demand for fluid from the eye to relieve the vacuum can cause a sudden shallowing of the anterior chamber, as the aspiration flow momentarily sharply increases over the irrigation flow.
The degree of shallowing in the eye is a function of vacuum level within the aspiration path when the occlusion breaks, as well as resistive and compliance characteristics of the fluid path. Increased resistance in the aspiration path reduces the flow rate associated with occlusion break and thereby lessens the pressure drop from the irrigating source to the eye and the resulting shallowing of the anterior chamber.
The problem of occlusion surge has been addressed in the past in a number of ways including adding a reduced cross-section orifice. While such a reduced area reduces the effects of occlusion surge, reduction of aspiration path cross-section can also increase the potential for clogging during the procedure. Other methods have been used or proposed that involve torturous paths, with corners, angles, and fluid restrictors that are also subject to clogging. Some prior solutions involve a resistive element at or near the pump. However, the effectiveness of these solutions is limited due to the relatively large tubing compliance between the resistive element and the eye. Another attempted solution has been the use of increased lengths of flexible aspiration tubing in an attempt to increase overall tubing resistance. This solution of adding flexible tubing length has the undesirable effect of adding additional compliance to the aspiration path. The additional compliance increases the demand for fluid from the eye during occlusion break, sometimes entirely offsetting the benefits obtained by the longer tubing length.
According to one exemplary aspect, this disclosure is directed to an aspiration system for a phacoemulsification surgical system. The system includes a pump configured to create a low pressure differential sufficient to draw aspiration fluid from a phacoemulsification surgical site. It also includes flexible tubing configured to convey the aspiration fluid from the hand piece to the pump. The flexible tubing is structurally configured to allow a user to manipulate the hand piece during a surgical procedure. It also includes a non-compliant, resistive element associated with the hand piece and disposed between the surgical site and the flexible tubing. The resistive element comprises a fluid pathway having substantially consistent nominal inner diameter and being configured to convey the aspiration fluid to the flexible tubing, the resistive element being formed in a compact orientation that provides a nonlinear fluid pathway length that is significantly greater than the axial length of the resistive element. The resistive element is structurally configured to provide occlusion surge resistance due to pressure changes resulting from occlusions in the aspiration path at the hand piece needle.
In some aspects, the resistive element is disposed within the hand piece. In other aspects, the resistive element is disposed outside but adjacent the hand piece. In some aspects, the resistive element is in one of a coil shape, a serpentine shape, and a spiral shape.
In some aspects, the resistive element has an inner diameter substantially matching the inner diameter of the flexible tubing, such that the aspiration line between the distal end of the resistive element and a cassette has a substantially uniform inner diameter.
In another exemplary aspect, the present disclosure is directed to a resistive element associated with a hand piece having a needle and disposed between a surgical site and flexible tubing in a phacoemulsification surgical system. The resistive element comprises a rigid body forming a nonlinear fluid pathway configured to convey aspiration fluid and emulsified tissue from a surgical site. The rigid body is formed of a material that remains substantially noncompliant when subjected to vacuum pressure applied by a pump of the phacoemulsification surgical system. The fluid pathway has a substantially consistent nominal inner diameter and is structurally configured to provide occlusion surge resistance due to pressure changes resulting from occlusions at the hand piece needle. The resistive element also includes an output port configured to connect with a flexible tube and arranged to pass the aspiration fluid and emulsified tissue through the output port and an input port configured to receive the aspiration fluid and emulsified tissue through the output port.
In another exemplary aspect, the present disclosure is directed to a method of reducing occlusion surge in a phacoemulsification surgical system. The method includes directing an aspiration fluid through an aspiration system of the phacoemulsification surgical system. It also includes aspirating fluid from the surgical site through a phacoemulsification needle and directing the aspirated fluid and emulsified tissue through a rigid, resistive element associated with the hand piece. The resistive element forms a fluid path having substantially consistent nominal inner diameter and is configured to convey the aspiration fluid to the flexible tubing. The resistive element is formed in a compact orientation that provides a nonlinear fluid pathway length that is significantly greater than the axial length of the resistive element and is structurally configured to provide occlusion surge resistance due to pressure changes resulting from occlusions in the aspiration path at the hand piece needle. The method also includes directing the aspiration fluid from the resistive element to flexible tubing.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the invention as claimed. The following description, as well as the practice of the invention, sets forth and suggests additional advantages and purposes of the invention.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description serve to explain the principles of the invention.
Reference is now made in detail to several exemplary embodiments, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts.
The system of the present disclosure includes a resistive element in the aspiration path that helps reduce occlusion surge during a surgical procedure on the eye. The resistive element is associated with the hand piece and, in the exemplary embodiments described, includes a rigid, noncompliant, uniform cross-section aspiration fluid passageway. Because of its rigid nature, the fluid passageway maintains its shape when subjected to fluctuating vacuum pressures. This adds to the overall fluid passageway length of the aspiration system without adding to the overall occlusion surge. This additional passageway length of the aspiration system increases the overall tubing resistance, further reducing the potential occlusion surge. Substantial path length increases can be achieved in a relatively small amount of space via the use of coiled, spiraled, or serpentine shaped flow paths. Effectiveness of the added resistance is compounded by being close to the eye with minimal compliance between the resistive element and the eye. Flow passages in the system disclosed herein can have a larger inner cross-sectional area than would be required for a short, narrowing orifice to obtain the same level of resistance.
In addition, in some embodiments, an end of the flexible aspiration tubing is associated with the cutting needle of the hand piece 118 and aspirated through a hollow bore in the cutting needle.
The irrigation line 310 extends between the sterile solution reservoir 112 and the hand piece 118, which carries fluid to the surgical site (labeled in
The aspiration system 304 includes a fluid path 313 (
In this embodiment as shown in
In this embodiment, the resistive element 328 reduces the level of occlusion surge in multiple ways. For example, the additional fluid pathway length due to the resistive element increases the overall tubing resistance, resulting in a dampened, or lower occlusion surge. Particularly, the aspiration line 322 between the tip 326 and the pump 316 provides a level of overall tubing resistance. As the length of the aspiration line 322 between the tip 326 and the pump 316 increases, so does the overall tubing resistance. Because the resistive element 328 adds additional length to the fluid pathway of the aspiration line 322, the overall tubing resistance is increased.
In addition, the resistive element 328 is formed of a rigid or noncompliant material. As such, as the vacuum increases, the resistive element does not deform. Deformation or compliance of the flexible tube can more than offset the benefits obtained by increasing the length of the fluid pathway. Accordingly, known systems that propose increasing the length of the flexible tube to increase tubing resistance may provide only limited benefits, and in some instances, because of the additional compliant tubing, may not provide any benefit in reducing occlusion surge. However, as disclosed in the embodiments herein, use of a rigid, noncompliant path length that increases the overall tubing resistance in the aspiration line 322 can provide the benefits of increasing the overall tubing resistance without the detriment arising from providing additional compliant tubing. As such, the rigid nature of the path length reduces or eliminates occlusion surge on the path length.
As shown in
In order to achieve the maximum benefit of the rigid resistive element while still making the hand piece convenient for the surgeon, the resistive element is configured to increase the length of the fluid pathway, without overly increasing the length of the hand piece, to avoid inconveniencing a surgeon using the hand piece. To accomplish this, the rigid resistive element is structurally arranged in a compact manner. In the example shown in
In the examples disclosed herein, the resistive element 328 includes a consistent, nominal inner diameter. Accordingly, the benefits of reducing occlusion surge can be obtained while limiting the chance of creating additional blockages in the resistive element and the aspiration line. Orifices, flow barriers, and mechanical restrictors of conventional systems can form dead zones with no or little flow and other areas of potential clogging. However, a consistent nominal diameter results in smooth fluid flow through the aspiration system, in some embodiments achieving laminar flow, providing smooth passage of tissue in the passageways. In the system disclosed herein, flow passages can have a larger inner cross-sectional area than would be required for a short, narrowing orifice to obtain the same level of resistance.
In some embodiments, the resistive element is formed of a rigid tube having a nominal diameter less than 0.100 inch. In some embodiments, the nominal diameter is within the range of 0.055-0.070 inch, with some aspects having a nominal diameter of about 0.062. In other embodiments, the nominal diameter is in the range of about 0.040-0.050 inch. Other dimensions, both larger and smaller, are contemplated.
In the embodiment disclosed in
Referring now to
Referring now to
The resistive element may be formed of any rigid noncompliant material, including, for example, metals and rigid polymer materials. In some examples, the resistive element is formed through an extrusion process, a molding process, or a machining process.
In use, the systems disclosed herein may operate to reduce occlusion surge during phacoemulsification procedures by employing the resistive element 328 to reduce the level of occlusion surge. It does this by linearly increasing the fluid pathway distance between the surgical site and all, or at least a large majority, of the compliant flexible tubing necessary for manipulation of the hand piece, while maintaining a nominal diameter through the resistive element. The system operates by directing fluids through the irrigation system 302 and the aspiration system 304 of the phacoemulsification surgical console 100. The irrigation system 302 directs fluid to the surgical site, and the aspiration system 304 removes fluid and tissue from the surgical site. During aspiration, fluid is directed through a needle of the hand piece 118 and into the hand piece. The fluid is then directed through the resistive element 328. The resistive element is associated with the hand piece in the manner described above to reduce the occlusion surge by reducing the effects of aspiration line compliance found in the aspiration system, by extending the length of the fluid passageway to increase the overall tube resistance, and by having a relatively consistent, nominal diameter to avoid clogging. For example, the resistive element is formed of a rigid, noncompliant material. The configuration of the resistive element lengthens the overall fluid pathway of the aspiration system, while only slightly or not adding additional length to the hand piece or the area adjacent to it.
In some instances, the resistive element is attached to one end of the flexible tube and to the end of the hand piece such as at the aspiration connector 404. In some embodiments, a relatively small length of flexible tube may connect the resistive element and the hand piece.
It should be appreciated that although several different embodiments are shown, any of the features of one embodiment may be used on any of the other embodiments shown. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
This application claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 61/424,094 titled “Aspiration Path Resistive Element”, filed on Dec. 17, 2010, whose inventors are Gary P. Sorensen and Susan Goodman Zurcher.
Number | Date | Country | |
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61424094 | Dec 2010 | US |