Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F9/00825—Methods or devices for eye surgery using laser for photodisruption
  • A61F9/00836—Flap cutting
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F9/00825—Methods or devices for eye surgery using laser for photodisruption
  • A61F9/0084—Laser features or special beam parameters therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
  • A61F2009/00872—Cornea

Definitions

• the present invention pertains generally to laser surgery procedures. More particularly, the present invention relates to methods and devices for performing intra-material photoablation wherein the energy density of the focused laser beam is selected in accordance with characteristics of the material to be ablated.
• the present invention is particularly, but not exclusively, useful as a method and device for precise photoablation at the interface between materials that have different laser induced optical breakdown thresholds.
• ultra short pulsed laser systems have become widely available for commercial applications.
• One application of such ultra short pulsed lasers involves intra-material ablation.
• the local electrical field strength at the focal point of the laser (usually measured in J/cm 2 or equivalent units) must be equal to or greater than the binding energy of the material's valence electrons to their atoms.
• LIOB laser induced optical breakdown
• a microplasma gas bubbles and Shockwaves are generated.
• the geometry and intensity distribution of a laser beam should be understood.
• the shape of the laser focus can be assumed to be hyperbolic, and the intensity distribution can be assumed to be Gaussian.
• the laser focus has a minimum radius (the beam waist) and has a length (or focal depth).
• the boundary of the laser beam is usually defined by the position where the intensity of the beam has decreased to 1/e 2 of the intensity in the center of the beam.
• the location where LIOB occurs within the laser focus can be simply determined by the position where the necessary energy density is reached. Therefore, the position of LIOB within a material could be changed not only by moving the position of the laser focus, but also by altering the beam energy.
• the intensity needed for LIOB scales with the size of the laser focus.
• this relationship is based on the assumption that the whole energy of the laser pulse is instantaneously deposited within the material.
• the intensity (and, thus, the energy) of the laser beam also has a distribution along the z-axis that is determined by the pulse length and shape of the laser pulse and can be described by a sech 2 -curve.
• LIOB occurs only when the intensity of the laser pulse reaches the threshold intensity needed for LIOB. If the threshold for LIOB changes along the z-axis (e.g., at the interface between two materials), then the position of LIOB changes significantly. For instance, a laser may induce LIOB at its focal point in one material but have no effect when another material is used. Therefore, appropriate settings for beam geometry and beam energy can be used to control the position of LIOB at the interface of two materials having different ablation thresholds. If the ablation thresholds for the materials are known, or can be identified, the energy level can be calculated to provide LIOB in only one of the materials.
• the focal point may be initially positioned in the targeted material with the appropriate energy level to avoid any unintentional ablation.
• detecting means may be used to detect whether LIOB has occurred and, if so, in which material. Such detection may be through analysis of the size of the bubble resulting from LIOB or through spectral analysis of the plasma resulting from LIOB.
• corneal tissue While intra-material photoablation may be performed on various materials, its use on corneal tissue or biological tissue is of particular interest. With regard to corneal tissue, it is noted that several surgical procedures exist for modifying its structure. To understand these procedures, the operation and anatomy of the cornea should be understood.
• the cornea refracts incoming light and focuses the light on or near the retina.
• the curvature of the cornea determines where the incoming light will be focused. If the curvature of the cornea is too steep or too flat, it may be modified by photoablating certain corneal tissue.
• the structurally distinct corneal tissues include, in order from the anterior to the posterior of the eye, the epithelium, Bowman's membrane, the stroma, Descemet's membrane, and the endothelium. Of these, the stroma is the most extensive, being generally around four hundred microns thick. Consequently, the stroma provides the most opportunity for correction via photoablation. Additionally, the healing response of the stroma is typically quicker than the other corneal layers.
• LASIK laser-assisted in situ keratomileusis
• LASEK laser epithelial keratomileusis
• stromal tissue is ablated after being exposed by temporarily removing the overlying tissues.
• Other ophthalmic procedures rely on subsurface photoablation, i.e., the photoablation of stromal tissue without first exposing the tissue through the removal of overlying tissue. Because the subsurface photoablative procedures provide clear benefits over the prior art's reliance on the removal of overlying tissues, further efforts have been made to utilize intracomeal photoablative techniques.
• an intracomeal technique has been discovered that allows precise separation of corneal tissues along their interface using an ultra short (femto-second) pulsed laser.
• Another object of the present invention is to provide a method and device for separating two distinct materials having different ablation energy thresholds.
• a surgical method and device for creating a corneal flap that allows for the accurate positioning of the corneal flap at a predetermined location on the cornea.
• Still another object of the present invention is to provide a method for intra-material photoablation along an interface that is easy to perform and is comparatively cost effective.
• a device for performing photoablation along an interface between materials includes a source for creating a laser beam having a energy density less than the non-targeted material's energy ablation threshold and greater than or equal to the targeted material's energy ablation threshold.
• the device further includes a means for directing the laser beam to the interface to photoablate a portion of the targeted material adjacent the interface.
• a means for scanning the laser beam along the interface provides for photoablation of further portions of targeted material adjacent the interface.
• the energy ablation thresholds of the two materials are identified. Specifically, the materials, which may be corneal or biological tissues, must be identified as having different energy thresholds for ablation. After the ablation thresholds are identified, an ultra short pulsed laser beam is created by selecting a beam geometry, beam energy and pulse duration.
• This desired maximum energy density is less than the ablation threshold of the non-targeted material but greater than or equal to the ablation threshold of the targeted material.
• the beam is employed to photoablate the targeted material adjacent the interface. Despite the use of the laser beam at the interface, the non-targeted material is unharmed.
• the interface can be found by employing means such as a confocal microscope or an optical coherence tomograph.
• the laser beam may be directed thereto to photoablate the targeted material.
• the laser beam is focused to a focal point where the beam reaches its maximum beam energy density.
• the focused beam has a minimum beam energy density that is defined herein to be equal to the threshold of the targeted material. The minimum beam energy is created either at, or spaced from, the focal point.
• the focal point is preferably located in the non-targeted material. In this way, the method avoids or minimizes inadvertent photoablation of targeted material when the laser beam is generated.
• the focal point is located in the non-targeted portion by setting the appropriate distance between the focal point and the laser source.
• the focal point may be located in the non-targeted portion by more generally situating the focal point in the cornea and then generating the laser beam.
• a sensing means is used to sense whether any targeted material is photoablated. If no targeted material is photoablated, then the focal point can be identified as being in the non- targeted material. If targeted material is photoablated, then the focal point is resituated away from the non-interface boundary of the targeted material. Then the beam is generated and the sensing means is used to determine if any targeted material is photoablated. These steps may be repeated until the focal point is identified as being in the non-targeted material.
• the focal point is located in the non-targeted material and the laser beam is generated, the response of the targeted material is detected. For instance, a photoablative result can be confirmed by the size of the bubble, or the spectral analysis of the plasma, created by photoablation. If no targeted material is photoablated, then either the focal point is moved toward the targeted material, or the beam energy is increased (though not to the threshold of the non-targeted material). It is noted that either of these steps will effectively advance the minimum beam energy density toward the interface. After one of, or a combination of, the steps is taken, the laser beam is again generated and the detecting means detects whether any targeted material has been photoablated. If not, the minimum beam energy density is again advanced toward the interface. Preferably, these steps are repeated until the portion of targeted material adjacent the interface and nearest the focal point is photoablated.
• the laser beam is scanned to another location. Then the previous steps are repeated to photoablate a further portion of the targeted material.
• the laser beam is utilized in this manner to form a periphery for a flap.
• a flap is formed by incising the cornea between the anterior surface of the cornea and the periphery.
• the targeted and non-targeted materials can then be separated along the periphery by mechanically peeling the non-targeted material and the targeted material from one another.
• the method may be used to photoablate non-corneal tissue and non-biological tissue.
• a wavefront detector or other means may be utilized rather than, or in addition to, a confocal microscope or an optical coherence tomography.
• Fig. 1 is a plan view of an embodiment of the ultra short pulsed laser system of the present invention
• Fig. 2 is perspective view of an eye
• Fig. 3 is a cross sectional view, not to scale, of a portion of the cornea of the eye as seen along line 3-3 in Fig. 2 showing the anatomical layers of the cornea;
• Fig. 4 is a schematic view, not to scale, of a section of the cornea seen in Fig. 3, showing the shape of the laser beam used to ablate a portion of the targeted material with the targeted material positioned downstream of the interface;
• Fig. 5 is a schematic view of a section through the cornea, as in Fig. 4, showing the shape of the laser beam used to ablate a portion of the targeted material with the targeted material positioned upstream of the interface;
• Fig. 6 is a schematic view of the cornea, as in Fig. 5, with the focal point of the laser beam moved to the interface;
• Fig. 7 is a schematic view of the cornea, as in Fig. 5, with the energy level of the laser beam increased to move the position of the minimum beam energy density to the interface;
• Fig. 8 is a perspective view of a corneal flap created in part using the method of the present invention.
• Fig. 9 is a logic flow chart of the sequential steps to be accomplished in accordance with the methods of the present invention.
• Fig. 10 is a logic flow chart of additional steps that may be accomplished in accordance with the methods of the present invention.
• a laser system 20 for conducting a intracorneal laser procedure on an eye 22.
• the eye 22 is aligned to receive an ultra short pulsed laser beam 24 from the laser system 20.
• the pulsed laser beam 24 having selected parameters is generated by a laser source 26.
• the laser system 20 includes a focusing unit 28 for focusing the beam 24 to its focal point 30.
• a scanning unit 32 for directing the beam 24.
• the laser system 20 includes a scanning unit 32 for directing the laser beam 24.
• a telescope 34 for collimating the beam 24 after it is directed by the scanner 32.
• the system 20 Downstream of the telescope 34 is a reflector 36 that redirects the laser beam 24 toward the eye 22 through the focusing unit 28. While not directly involved with the generation and control of the laser beam 24, several sensors are also provided in the laser system 20. Specifically, the system 20 includes a sensor 38, preferably a confocal microscope or an optical coherence tomograph, for finding the interface 40 at which photoablation is desired. The system 20 further includes a sensor 42 for detecting whether and where photoablation has occurred. The system 20 may include an additional sensor or sensors 44 for identifying photoablation thresholds as discussed below.
• photoablation can be performed to provide intracomeal tissue modification to effect a refractive change in the cornea, to create a flap suitable for a LASIK or LASEK type procedure, to create a passageway or drainage channel in the eye 22, or to effect any other type of surgical procedure, in whole or in part, known in the pertinent art that requires the removal of ocular tissue.
• Fig. 2 shows the anatomical structure of the human eye 22 including the cornea 46, the pupil 48, the iris 50, and the sclera 52.
• the cornea 46 includes five anatomically definable layers of tissue. Going in a direction from anterior 54 to posterior 56 in Fig. 3, the tissue layers of the cornea 46 are: the epithelium 58, Bowman's membrane 60, the stroma 62, Descemet's membrane 64 and the endothelium 66. These corneal layers have distinct photoablation thresholds.
• the stroma 62 may have a base LIOB threshold of 1
• Bowman's membrane 60 may have a relative LIOB threshold of 2
• the epithelium 58 may have a threshold of 0.5.
• the interfaces 40 are of general importance for the present invention. Specifically, the removal or destruction of the portion of one tissue adjacent an interface 40 can be achieved without damage to the other layer of tissue adjacent the interface 40. In addition, due to the natural delineation between layers of tissue at the interface 40, very precise photoablation can be achieved.
• a laser beam 24 is shown being generally directed to an interface 40 between a targeted material 68 and a non-targeted material 70.
• the laser beam 24 is focused such that its focal point 30 is positioned in the non-targeted material 70.
• the maximum beam energy density reached at the focal point 30 is insufficient to photoablate the non-targeted material 70 due to the proper selection of beam parameters such as intensity, geometry and pulse duration.
• Equidistantly spaced from the focal point 30 are beam positions 72 at which a minimum beam energy density is reached.
• the non-targeted material 70 is positioned upstream of the interface 40.
• the laser beam 24 does not pass through the targeted material 68 before reaching its focal point 30.
• the targeted material 68 is positioned upstream of the interface 40 such that the laser beam 24 passes therethrough before reaching its focal point 30.
• Both of Figs. 4 and 5 depict a preferred starting point for the photoablation procedure in which the focal point 30 is positioned in the non- targeted material 70 such that photoablation does not occur in the targeted material 68.
• Fig. 6 the laser beam 24 of Fig. 5 is shown after advancement of the focal point 30 (and the position 72 of minimum beam energy density) toward the interface 40.
• Fig. 6 shows that the minimum beam energy density contacts the targeted material 68 and causes a portion 74 of the targeted material 68 to be photoablated.
• Fig. 7 shows the laser beam 24 of Fig. 5 after advancement of the position 72 of minimum beam energy density due to an increase in intensity of the beam 24.
• the minimum beam energy density contacts the targeted material 68 and causes a portion 74 of the targeted material 68 to be photoablated.
• the performance of the methods of the present invention begins by estimating the depth "d" at which the focal point 30 will be positioned in the eye 22 (action block 76). Specifically, the interface 40 between the targeted material 68 and non-targeted material 70 is found. Then the depth necessary to place the focal point 30 in the non-targeted material 70 near the interface 40 is estimated. In Fig. 6, the estimated distance 78 is shown establishing the focal point 30 in the non-targeted material 70.
• the beam parameters such as the intensity or energy level "E” and the treatment duration " ⁇ " are set (action blocks 80 and 82). It is assumed that the ablation energy thresholds of the targeted material 68 and non-targeted material 70 are known before these steps are taken. Of course, the thresholds may be estimated if they are not previously identified.
• the system 20 is activated to generate the pulsed laser beam 24 (action block 84).
• inquiry block 86 i.e. whether the non-targeted material 70 (i.e., "Mi") is upstream from the interface 40, specific steps are taken depending on whether the sensor 42 identifies any photoablated targeted material 68 in response to the laser beam 24.
• photoablation of material such as corneal or biological tissue causes formation of a bubble or plasma that can be sensed by the sensor 42.
• inquiry block 88 is reached. If no targeted material 68 is photoablated, then the position 72 of the minimum beam energy density is advanced (action block 90). As shown in Figs. 6 and 7, such advance may be performed by moving the focal point 30 toward the interface 40 or by increasing the energy level of the laser beam 24. After the advance of the position 72 of the minimum beam energy density, the system 20 is again activated at action block 84 to generate the pulsed laser beam 24. In this way, the position 72 of the minimum beam energy density is advanced toward the targeted material 68 until photoablation occurs.
• inquiry block 94 requires, if photoablation does not occur, that the position 72 of the minimum beam energy density be advanced toward the targeted material 68 (action block 96) before the beam 24 is again activated (action block 84). If photoablation does occur, then it is determined whether the treatment duration has expired (inquiry block 98).
• the method is restarted at the scanning step of action block 92. If it has expired, then it is determined whether the photoablation pattern of the targeted material 68 is complete (inquiry block 100). If the entire pattern is completed, then the procedure is completed and the actions are stopped. If not, the procedure is begun again at action block 82.
• inquiry block 87 asks whether any targeted material 68 is photoablated in response to the activation of the laser beam 24. If targeted material 68 is photoablated, then the position 72 of the minimum beam energy density is advanced (action block 89). Such an advance may be performed by moving the focal point 30 toward or into the non-targeted material 70 or by decreasing the energy level of the laser beam 24. After advancing the position 72 of the minimum beam energy density, the laser beam 24 is again activated at action block 84 to generate the pulsed laser beam 24.
• the position 72 of the minimum beam energy density is advanced toward the non-targeted material 70 until photoablation does not occur in response to the activation of the laser beam 24.
• This loop ensures that photoablation will occur only in the portion 74 of the targeted material 68 that is adjacent the interface 40.
• the method is restarted at the scanning step of action block 91. If it has expired, then it is determined whether the photoablation pattern of the targeted material 68 is complete (inquiry block 100). If the entire pattern is completed, then the procedure is completed and the actions are stopped. If not, the procedure is begun again at action block 82. As shown in Fig. 10, additional steps may be included when the non- targeted material 70 is upstream of the interface 40. Specifically, the method may include a loop to ensure that the focal point 30 is not positioned too deep within the cornea 46 such that the targeted material 68 is photoablated at a location deeper than the interface 40.
• the position 72 of the minimum beam energy density is withdrawn toward the interface 40 (action block 102). If, after such withdrawal, photoablation still occurs (as noted at inquiry block 104), then the position 72 is withdrawn again. Once photoablation does not occur, the minimum beam energy density is known to be at the interface or slightly within the non-targeted material 70. Therefore, the position 72 of the minimum beam energy density is advanced toward the targeted material 68 (action block 106). If photoablation does not occur in response to this advance (as noted at inquiry block 108), the position 72 is advanced again. Upon sensing that photoablation occurs, execution of the scanning process begins at action block 92 and the method returns to the process set forth in Fig. 9.
• a corneal flap 110 prepared in accordance with the present invention is shown.
• the flap 110 is prepared by first photoablating a periphery 112 for the flap 110. Because the periphery 112 is formed along the interface 40 between two corneal tissues as discussed above, it is much more precise than a periphery cut through a tissue. With the periphery 112 established, an incision can be made extending from the anterior surface 114 of the cornea 46 to the periphery 112 to establish an edge 116 for the flap 110. Once the edge 116 is created, the flap 110 can be peeled from the remainder of the cornea 46 to expose the surface of the underlying tissue 118.
• the underlying tissue 118 can be photoablated using an excimer laser (not shown). After photoablation with the excimer laser, the flap 110 can be repositioned over the underlying tissue 118 and allowed to heal. The result is a reshaped cornea 46.

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• 2004
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