The present invention pertains generally to systems and methods for fragmenting a crystalline lens in preparation for a lens removal surgery. More particularly, the present invention pertains to systems and methods which use a pulsed laser beam to fragment a crystalline lens. The present invention is particularly, but not exclusively, useful as a system and method for creating lens fragments that are geometrically shaped (configured), and are appropriately dimensioned to facilitate their removal from the capsular bag of an eye during cataract surgery.
A removal of the crystalline lens from its capsular bag inside an eye (i.e. a lensectomy) must necessarily be accomplished with minimum trauma to the eye. An important consideration in this regard is the preparation of the lens for such a removal. Heretofore, a common method that has been used to prepare a lens for removal has been to first emulsify the lens using ultrasonic techniques. The emulsified lens is then aspirated from the capsular bag. Lens preparation by ultrasonic emulsification, however, can be relatively labor intensive, and can introduce excessive energy into the eye, which causes unnecessary trauma. With this in mind, the use of lasers for the purpose of preparing a crystalline lens for a lensectomy poses an effective alternative for such a procedure.
It is well known that laser systems can be effectively used for various ophthalmic procedures. Like all surgical procedures, however, each laser procedure has its own particular challenge. In the case of a lens removal, the challenge is essentially two-fold. For one, the lens fragments that are created during a laser procedure must be appropriately dimensioned for subsequent aspiration using conventional surgical implements (e.g. well known phaco-needles). For another, the lens fragments must be geometrically shaped or configured to facilitate their removal from the lens capsule. On this point, it is particularly desirable that the configuration or shape of lens fragments be such as to not block or impede the removal of other lens fragments. Stated differently, it is desirable if the lens fragments can be shaped to actually promote or induce the removal of other lens fragments during their aspiration.
In light of the above, it is an object of the present invention to provide a system and method for performing a fragmentation wherein lens fragments are created and configured by a laser unit to facilitate the removal of the lens fragments during a subsequent aspiration. Another object of the present invention is to provide a system and method for employing a laser unit to perform a fragmentation procedure which reduces labor-intensive requirements, and which minimizes trauma to the eye during the procedure. Yet another object of the present invention is to provide a system and method for employing a laser unit to perform a cataract surgery procedure which is easy to implement, is simple to use and is comparatively cost effective.
In accordance with the present invention, a system and method are provided for fragmenting the crystalline lens of an eye in preparation for a lens removal. In particular, this fragmentation is performed within an operational volume that is defined inside the lens. More specifically, the operational volume is defined with data that is collected by an imaging unit, such as a well-known Optical Coherence Tomography (OCT) device.
In preparation for a procedure, a reference axis is established using data that is obtained by the imaging unit and is based on the crystalline lens. Next, various pluralities (i.e. sets) of parallel planes are defined relative to the reference axis. In accordance with the present invention each plurality of parallel planes is characterized by a particular inclination angle “φ” relative to the reference axis, and a particular azimuthal angle “θ” relative to the reference axis. Also, an intersection angle, “ψ”, can be established between different pluralities (sets) of planes.
Once the different pluralities of parallel planes have been defined and oriented, a pulsed laser beam is used to cut tissue in selected planes. Preferably, the laser beam is configured to fragment the lens by performing Laser Induced Optical Breakdown (LIOB) on tissue in the lens.
For a first embodiment of the present invention, three different pluralities (i.e. sets) of parallel planes are identified in the operational volume. In this case, a first plurality and a second plurality of the planes intersect each other at an angle “ψ”. The third plurality then intersects both the first and second pluralities. In their relationship with the reference axis, a normal to each plurality (i.e. plane set) is coplanar with the reference axis and it is inclined at an angle “φ” relative to the reference axis. Preferably, the respective inclination angles “φ1”, “φ2” and “φ3” are each in a range between approximately 20° and 60°. Also, in addition to its unique inclination angle “φ”, the normal to each plurality of parallel planes is also oriented at a unique azimuthal angle “θ” relative to the reference axis.
As envisioned for the present invention, along with the basic three sets of parallel planes mentioned above, a fourth plurality of parallel planes can be defined to intersect at least one other plurality of parallel planes. Further, a fifth plurality of parallel planes can be defined to also intersect at least one other plurality of parallel planes. Thus, the inclusion of additional sets of parallel planes can be continued at selected locations in the operational volume, as desired.
A second embodiment of the present invention is actually a more specific configuration for the first embodiment. In this second embodiment, however, only three sets (pluralities) of parallel planes are specifically required. In detail, each plane in the first plurality is inclined at a tilt angle “φ1” relative to the reference axis. Similarly, each plane in the second plurality is inclined at a tilt angle “φ2” relative to the reference axis, and each plane in the third plurality is inclined at a tilt angle “φ3” relative to the reference axis. More specifically, the three inclination angles (φ1, φ2 and φ3), and their respective azimuthal angles (θ1, θ2 and θ3) are selected to create symmetrical fragments with rectangular shaped sides.
A preferred result for the configuration of this second embodiment is a cube having square sides. To do this, φ1=45° with θ1=0°; φ2=45° with θ2=120°; and φ3=45° with θ3=240°. A beneficial consequence of this arrangement is that the fragment cubes are all aligned with a respective diagonal that is parallel to the reference axis. The diagonal in this case is a line that extends through the cube, between opposite corners of the cube.
For a third embodiment of the present invention, at least four sets (pluralities) of parallel planes are involved. In this case, rather than a cube, an octahedron is the result. For purposes of discussion, these four sets of planes are based on points in the operational volume that can be identified using Cartesian coordinates (n, m, p). Respectively, for each coordinate; n=0→n, m=0→m, and p=0→p.
In order to set up this third embodiment, five points are identified relative to the reference axis, beginning with a start point (i.e. a first point) at the coordinates (n, m, p). A second point at (n+1, m, p), a third point at (n, m+1, p), a fourth point at (n+1, m+1, p) and a fifth point at (n+0.5, m+0.5, and p±Δ) are then identified. Based on these points, a first plurality of parallel planes can be established from the first, second and fifth points. A second plurality of parallel planes can be defined from the second, third and fifth points. A third plurality of parallel planes can be defined from the third, fourth and fifth points. And, a fourth plurality of parallel planes can be defined from the fourth, first and fifth points. As will be appreciated, this results in an octahedron having an upper section (p=+Δ) and a lower section (p=−Δ). The resultant upper and lower sections are separated from each other by a base plane that is collectively defined by the first, second, third and fourth points. Within this structure, the upper section may be separated from the lower section, at the base plane, by a distance equal to a predetermined value of “p” to, in effect, establish an elongated, extended, or stretched, octahedron.
For all of the embodiments disclosed above, tissue cutting can be accomplished by disrupting tissue along lines that are established at the intersections of a cutting plane and a selected plurality of the parallel planes. Preferably, the cutting plane will be oriented perpendicular to the reference axis, and the disruption (cutting) of tissue is accomplished using a pulsed laser beam to disrupt the tissue by causing Laser Induced Optical Breakdown (LIOB) of the tissue. In more detail, LIOB is accomplished sequentially as successive cutting planes are advanced in an anterior direction.
From a system perspective, the present invention includes an imaging unit (e.g. OCT device) for collecting data that can be used to define the reference axis based on the lens. The imaging unit may also collect data that can be used to establish the operational volume in the crystalline lens. Also included in the system is a computer that is connected to receive input from the imaging unit. With this connection, in addition to the reference axis and the operational volume, the computer uses operator input to define the various pluralities of parallel planes, as well as their orientations in inclination angle “φ” and azimuth angle “θ” relative to the reference axis. Additionally, the system of the present invention will include a laser unit that is controlled by the computer to generate a pulsed laser beam for cutting tissue by Laser Induced Optical Breakdown (LIOB) of the tissue on selected planes in the first, second and third pluralities to create fragments of the crystalline lens.
The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:
Referring initially to
As best appreciated with reference to
In
Still referring to
A preferred embodiment of the present invention is shown in
Another embodiment for generating lens fragments in accordance with the system 10 of the present invention is presented in
In an operation of the system 10, the imaging unit 20 provides input to the computer 22 for defining the reference axis 34 relative to the eye 18, and for establishing the operational volume 26 in the crystalline lens 16. Also, the input 24 that is provided to the computer 22 by the system operator (not shown) will include operational parameters, such as φ, θ, ψ, s, h and d, for defining various sets of parallel planes (e.g. set 36). Using this information, the laser unit 12 is controlled by the computer 22 to generate a pulsed femtosecond laser beam for use in cutting tissue in the operational volume 26. Specifically, this cutting is caused by a Laser Induced Optical Breakdown (LIOB) of the tissue along selected intersection lines 50.
In detail, the LIOB of tissue is accomplished in a cutting plane along intersection lines 50. Preferably, the cutting plane is perpendicular to the reference axis 34. Further, as envisioned for the present invention, the LIOB of tissue will be accomplished sequentially as successive cutting planes are advanced through the operational volume 26 in an anterior direction.
Referring back to
Structurally, as shown in
Insofar as the external inputs 24 are concerned, they are primarily geometric and operational parameters provided by the user to operate the laser unit 12 for fragmentation of the crystalline lens 16. Specifically, the inputs 24 will include details for configuring the laser beam to perform LIOB, and it will include the geometric parameters (e.g. φ, θ, ψ, h and d) that are necessary for defining the fragments 42 (e.g. cube and octahedral) that are to be removed from the eye 18.
In overview, the computer 22 is operationally pre-programmed with a computer program product having program sections that will result in defining fragments 42 that are created between different pluralities of parallel planes. For example, the input 24 can provide parameters for defining a first plurality of parallel planes; a second plurality of parallel planes, wherein the first and second pluralities intersect each other at an angle “ψ”; and for defining a third plurality of parallel planes, wherein the third plurality intersects both the first and second pluralities to create fragments 42. The alignment of fragments 42 in the operational volume 26 can be further refined with greater specificity by defining their orientation in the operational volume 26. This is done by selecting a normal to one of the sets of planes which is coplanar with the reference axis 34, and is inclined at an angle “φ” relative to the reference axis 34. A computer program section can then manipulate the tilt angle “φ”, and the azimuth angle “θ”, to simultaneously orient all of the fragments 42 as specifically desired by the user.
For a preferred embodiment of the present invention, the fragments 42 are created as “cubes”. In this case, the computer 22 includes program sections which will establish that each first, second and third pluralities will be respectively inclined at a tilt angle “φ1”, “φ2”, and “φ3” relative to the reference axis 34. Further, for this embodiment, “φ1”, “φ2” and “φ3” will all be 45°, and each side of the fragment 42 will be square. As envisioned for the present invention, this arrangement results in each fragment 42 (i.e. “cube”) being oriented with an internal diagonal aligned parallel to the reference axis 34.
For specific instances wherein it is desired to have fragments 42 formed as octahedrons, a program section for the computer 22 can be included that will first locate a start point on the reference axis 34. The program section will then be used to identify five points in the operational volume 26 having respective Cartesian coordinates (n, m, p) relative to a start point. Specifically, computer 22 can be programmed to have n=0→n, m=0→m, and p=0→p.
Using Cartesian coordinates, a program section for the computer 22 can be programmed to define octahedral shaped fragments 42. In detail, an upper section 72 and a lower section 74 for the octahedron are defined with a first point at (n, m, p), a second point at (n+1, m, p), a third point at (n, m+1, p), a fourth point at (n+1, m+1, p) and a fifth point at (n+0.5, m+0.5, and p±Δ). Several pluralities of parallel planes can then be defined using these points. Specifically, a first plurality of parallel planes is defined using the first, second and fifth points; a second plurality of parallel planes is defined by the second, third and fifth points; a third plurality of parallel planes is defined by the third, fourth and fifth points; and a fourth plurality of parallel planes is defined by the fourth, first and fifth points. The result here is an octahedron having an upper section 72 (p=+Δ) and a lower section (p=−Δ).
For an octahedral shaped fragment 42, the upper section 72 and the lower section 74 are separated by a base plane 76 that is defined by the first, second, third and fourth points. As a variation of this embodiment, the upper section 72 and the lower section 74 can be separated from each other at the base plane 76 by a distance “d”. With this in mind, two configurations are possible. For one, the separation distance “d” may be zero. If so, the incision of tissue can be made directly on the base plane 76. In another instance, the separation distance “d” may be greater than zero. In this case, the incision of tissue can occur on a cutting plane that is parallel to the base plane 76, wherein the cutting plane is intermediate the upper section 72 and the lower section 74.
It will be further appreciated by the skilled artisan that for any of the above embodiments of the present invention, there can be any number of different sets of parallel planes. In each case, a program section of the computer 22 can be employed to establish the particular set of planes as a part of the methodology for the present invention. In the event interstitials are formed during an operation of the present invention, it is envisioned that they will be dimensioned during fragmentation of the crystalline lens 16 to be sufficiently diminutive for appropriate removal with the fragments 42. For an operation of the present invention, the laser unit 12 will be controlled by the computer 22 to disrupt tissue along lines established by the intersections of a cutting plane and a selected plurality of the parallel planes. As specifically intended for the present invention, the disrupting of tissue in the operational volume 26 will be accomplished using a pulsed laser beam to cause Laser Induced Optical Breakdown (LIOB) of the tissue.
While the particular System and Method for Configuring Fragmentation Segments of a Crystalline Lens for a Lensectomy as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.
This application is a continuation-in-part of application Ser. No. 13/795,641 filed Mar. 12, 2013, which is currently pending and which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/724,729, filed Nov. 9, 2012. The entire contents of application Ser. Nos. 13/795,641 and 61/724,729 are hereby incorporated by reference herein.
Number | Date | Country | |
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61724729 | Nov 2012 | US |
Number | Date | Country | |
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Parent | 13795641 | Mar 2013 | US |
Child | 13837112 | US |