`Neev
`
`US006482199B1
`US 6,482,199 B1
`NOV. 19, 2002
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`(54) METHOD AND APPARATUS FOR HIGH
`PRECISION VARIABLE RATE MATERIAL,
`REMOVAL AND MODIFICATION
`
`(76) Inventor: Joseph Neev, 20321 Lake Forest Dr.,
`Suite D7, Lake Forest, CA (US) 92630
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 82 days.
`
`(21) Appl. No.: 09/632,199
`
`(22) Filed:
`
`Aug. 2, 2000
`
`Related US. Application Data
`
`(63) Continuation of application No. 09/054,834, ?led on Apr. 3,
`1998, now Pat. No. 6,156,030.
`(60) Provisional application No. 60/050,416, ?led on Jun. 4,
`1997.
`
`(51) Int. Cl.7 .............................................. .. A61B 18/18
`(52) us. C1. .............. ..
`606/10; 606/13; 606/2
`(58) Field of Search ........................ .. 606/2, 4—6, 9—13,
`606/27—28, 32, 34, 41; 505/474, 412; 427/596,
`58; 65/61; 219/1216, 121.61, 200, 209,
`220; 443/29, 215; 216/65, 67, 94
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3/1990 Bille etal. ................... .. 606/5
`4,907,586 A
`5/1994 Feld et al. .................. .. 606/11
`5,312,396 A
`8/1994 Vassiliadis et al. ..
`433/215
`5,342,198 A
`5,411,502 A * 5/1995 Zair ....................... .. 606/10
`
`5,613,965 A * 3/1997 Muller . . . . . .
`. . . . . .. 606/5
`5,720,894 A * 2/1998 Neev et al. ................. .. 216/65
`
`OTHER PUBLICATIONS
`
`Raimund Hibst, and Ulrich Keller, “Experimental Studies of
`the Application of the Er:YAG Laser on Dental Hard Sub
`stances: II, Light Microscopic and SEM Investigations”.
`Lasers in Surgery and Medicine. 9:345—351 (1989).
`
`Raimund Hibst, and Ulrich Keller, “Experimental Studies of
`the Application of the Er:YAG Laser on Dental Hard Sub
`stances: I. Measurement of the Ablation Rate”, Lasers in
`Surgery and Medicine 9:338—344 (1989).
`Ulrich Keller, and Raimund Hibst, “Experimental Studies of
`the Application of the Er:YAG Laser on Dental Hard Sub
`stances: II. Light Microscopic and SEM Investigations”,
`Lasers in Surgery and Medicine 9:345—351 (1989).
`J. T. Walsh, Jr., T.J. Flotte, R.R. Anderston and TE Deutsch,
`“Pulsed CO2 Laser Tissue Ablation: Effect of Tissue Type
`and Pulse Duration on Tehrmal Damage”, Lasers in Surgery
`and Medicine 8:108—118 (1988).
`J. T. Walsh, Jr., T. J. Flotte, and T. F. Deutsch, “Er:YAG
`Laser Ablation of Tissue: Effect of Pulse Duration and
`Tissue Type on Thermal Damage”, Lasers in Surgery and
`Medicine 9:314—326 (1989).
`J. T. Walsh, Jr., and T. F. Deutsch, “Er: YAG Laser Ablation
`of Tissue: Measurement of Ablation Rates”, Lasers in Sur
`gery and Medicine 9:327—337 (1989).
`J. Neev, K. Pham, J. P. Lee, J. M. White, “Dentin Ablation
`With Three Infrared Lasers”, Beckman Laser Institute and
`Medical Clinic Irvine, supported by grants: Navy Grant
`#N00014—90—0—0029 DOE #DE—FG0391ER61227, Aug. 9,
`1994, 15 pages.
`
`(List continued on next page.)
`
`Primary Examiner—Michael Pef?ey
`Assistant Examiner—Pete J Vrettakos
`(74) Attorney, Agent, or Firm—Price and Gess
`(57)
`ABSTRACT
`
`Amethod and apparatus is disclosed for fast precise material
`processing and modi?cation Which minimizes collateral
`damage. Utilizing optimized, pulsed electromagnetic energy
`parameters leads to an interaction regime Which minimizes
`residual energy deposition. Advantageously, removal of
`cumulative pulse train residual energy is further maximized
`through the rapid progression of the ablation front Which
`move faster than the thermal energy diffusion front, thus
`ensuring substantial removal of residual energy to further
`minimize collateral thermal damage.
`
`16 Claims, 38 Drawing Sheets
`
`1. 0
`
`24
`
`\23
`
`20
`
`27\
`
`I
`
`Depth (Fm) ——-—>
`
`2 3
`_/
`
`Power
`Densitv
`(J/Cm3)
`
`22
`
`/
`
`Alcon Research, Ltd.
`Exhibit 1001 - Page 1
`
`
`
`US 6,482,199 B1
`Page 2
`
`OTHER PUBLICATIONS
`
`J. Neev, A. StabholtZ, L.L. LiaW, M. Torabinejac, J. T.
`Fujishige, P.D. Ho, and M. W. Berns, “Scanning Electron
`Microscopy and Thermal Characteristics of Dentin Ablation
`by a Sh0rt—Pulse XeCI EXcirner Laser”, Lasers in Surgery
`and Medicine 13:353—362 (1993).
`J. Neev, D. V. Raney, W. E. Whalen, J.T. Fujishige, P.D. Ho,
`J. V. McGrann, and M.W. Berns. “Selectivity and Ef?ciency
`in the Ablation of Hard Dental Tissues With ArF Pulsed
`EXcirner Laser”, Beckrnan Laser Institute and Medical
`Clinic, (University of California, Irvine) 22 pages.
`J. Neev, D.V. Raney, W. E. Whalen, J.T. Fujishige, P.D. Ho,
`J .V. McGrann and M.W. Berns, “Dentin Ablation With TWo
`
`EXcirner Lasers: A Comparative Study of Physical Charac
`teristics”, Lasers in the Life Sciences, 5(1—2), 1992, pp.
`129—153.
`J. Neev, D. V. Raney, W. E. Whalen, J.T. Fujishige, P. D. Ho,
`J. V. McGrann, and M. W. Berns, Reprinted from “Proceed
`ings of Laser—Tissue Interaction II”, SPIE—The International
`Society for Optical Engineering, Jan. 21—23, 1991, pp.
`162—172.
`J. T. Walsh, and D. Ashley Hill, “Erbiurn Laser Ablation of
`Bone: Effect of Water Content” SPIE vol. 1427 Laser—Tis
`sue Interaction II;(1991), pp. 27—33.
`
`* cited by eXarniner
`
`Alcon Research, Ltd.
`Exhibit 1001 - Page 2
`
`
`
`U.S. Patent
`
`Nov. 19, 2002
`
`Sheet 1 0f38
`
`US 6,482,199 B1
`
`Power Densitv (J/CmJ)
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`
`
`
`
`
`Depth (pm) ————-P
`
`Fig. 1
`
`Alcon Research, Ltd.
`Exhibit 1001 - Page 3
`
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`U.S. Patent
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`Nov. 19, 2002
`
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`US 6,482,199 B1
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`US 6,482,199 B1
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`Nov. 19, 2002
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`US 6,482,199 B1
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`US 6,482,199 B1
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`Alcon Research, Ltd.
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`Nov. 19, 2002
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`Alcon Research, Ltd.
`Exhibit 1001 - Page 30
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`Alcon Research, Ltd.
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`US 6,482,199 B1
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`1
`METHOD AND APPARATUS FOR HIGH
`PRECISION VARIABLE RATE MATERIAL,
`REMOVAL AND MODIFICATION
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`This application is a continuation of allowed application
`Ser. No. 09/054,834, filed Apr. 3, 1998, now US. Pat. No.
`6,156,030 which claimed the benefit of the filing date of US.
`Provisional Application No. 60/050,416, filed Jun. 4, 1997,
`the disclosures of both are incorporated fully herein by
`reference.
`
`FIELD OF THE INVENTION
`
`The present invention is generally related to the field of
`pulsed electromagnetic energy source systems suitable for
`material and biological tissue modification processing and
`removal and is more particularly related to a material
`removal and modification method and apparatus in which
`pulsed electromagnetic sources of high ablation-to-
`deposition depth ratios are operable at pulse repetition rates
`ranging up to approximately several hundreds of thousands
`of pulses per second so as to efficiently and precisely remove
`substantial material volumes while substantially eliminating
`collateral damage.
`
`BACKGROUND OF THE INVENTION
`
`The past three decades have brought increased interest in
`the use of lasers in material processing applications. Early
`procedures for material processing and cutting involved
`optical drilling using continuous wave or relatively long
`pulse (e.g., 50 to 350 us) lasers such as C02, ruby and
`ND:YAG (Neodymium doped Yittrium Aluminum Garnet).
`These systems, however, required relatively high radiant
`exposure and resulted in significant alterations to surround-
`ing tissue. As a consequence,
`lasers could become an
`effective cutting tool only in areas which did not require high
`degree of precision or control.
`Optical drilling with ER:YAG (Erbium doped YAG)
`lasers yielded encouraging results in the late 1980s, and has
`demonstrated its capability to perform as an efficient drill
`while incurring only relatively low levels of collateral
`damage to surrounding tissue, provided that no more than
`one to three pulses per second were applied to the target
`material. The success of ER:YAG systems, operating in the
`microsecond pulse duration regime and minimizing thermal
`damage has also been observed in several areas of applica-
`tions in material processing and medicine, and can be
`attributed to the high absorption coefficient of these mate-
`rials at
`the particular wavelengths characteristic of the
`Er:YAG system (2900 nm), when used in combination with
`the relatively short pulse durations and at low pulse repeti-
`tion rates.
`
`Laser systems adapted to hard tissue processing, such as
`dentin and enamel removal in dental applications are dis-
`closed in: 1. Hibst R, Kelly U. Experimental studies of the
`application of the Er:YAG laser on dental hard substances:
`I. Measurement of the Ablation Rate. Laser Surgery and
`Medicine 1989, 9:352—7; and, 2. Keller U, Hibst R. Experi-
`mental studies of the application of the Er:YAG laser on
`dental hard substances:
`II. Light microscopy and SEM
`investigations. Lasers in Surgery and Medicine 1989;
`9:345—351.)
`Both pulsed CO2 and Er:YAG are disclosed in: Walsh, J.
`T., Flotte, T. J., Anderson, R. R., Deutsch, T. F., “Pulsed CO2
`
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`2
`Laser Tissue Ablation: Effect of Tissue Type and Pulse
`Duration on Thermal Damage,” Lasers in Surgery and
`Medicine, Vol. 8, pp. 108—118, 1988; Walsh, J. T., Flotte, T.
`J ., Deutsch, T. F., “Er:YAG Laser Ablation of Tissue: Effect
`of Pulse Duration and Tissue Type on Thermal Damage,”
`Lasers in Surgery and Medicine, Vol. 9, No. 4, pp. 314,
`1989; and Walsh, J. T., Deutsch, T. F., “Er:YAG Laser
`Ablation of Tissue: Measurement of Ablation Rates,” Lasers
`in Surgery and Medicine, Vol. 9 No. 4, pp. 327, 1989.
`A Ho:YSGG laser system is disclosed in Joseph Neev,
`Kevin Pham, Jon P. Lee, Joel M. White, “Dentin Ablation
`with Three Infrared Lasers,” Lasers in Surgery and
`Medicine, 18:121—128 (1996).
`The laser systems disclosed (Er:YSGG, HO:YSGG, and
`Pulsed CO2) all operate in the IR region of the electromag-
`netic spectrum and are pulsed in two different regimes: about
`250 microsecond pulse durations for the ER:YSGG and
`HO:YSGG lasers, and about 150 microsecond pulse dura-
`tions for the CO2 system.
`While the disclosed removal rate is in the range of
`approximately tens of micrometers per pulse, the disclosed
`laser systems exhibit wavelength dependent absorption and
`result in high removal rates by operating at pulse energies in
`excess of 30 millijoules per pulse and often on the order of
`a few hundreds of yJ per pulse. Enhancing material removal
`by increasing laser power is, however, accompanied by
`increased photothermal and photomechanical effects which
`causes collateral damage in adjacent material. In addition,
`increasing power leads to plasma de coupling of the beam,
`e.g., incident laser energy is wasted in heating the ambient
`in front of the target. High intensity pulses additionally
`cause very loud acoustic snaps, when the laser pulse inter-
`acts with tissue. These snaps or pops include a large high
`frequency component which is very objectionable to a user
`or, in the case of a medical application, to a patient. In
`addition to the psychological impact of such noise, these
`high frequency snaps are able to cause hearing loss in
`clinicians when repeated over a period of time.
`US. Pat. No. 5,342,198, to Vassiliadis, et al. discloses an
`ER:YAG IR laser system suitable for the removal of dentin
`in dental applications. The laser produces a pulsed output
`having a beam with a pulse duration in the range of several
`tens of picoseconds to about several milliseconds. Although
`disclosed as being efficient in the removal of dentin and
`dental enamel, the mechanism by which material removal is
`effected is not understood. Significantly, however, the only
`laser systems disclosed as suitable for the process are those
`which operate at wavelengths (1.5 to 3.5 microns) that have
`proven to be generally effective for enamel
`interaction.
`Thus, the absorption characteristics of the material target are
`of primary concern to the removal rate. In addition, high
`energy levels are required to remove enamel and dentin,
`leading to the problem of thermal damage and acoustic
`n01se.
`
`Additional possibilities for the application of lasers to the
`field of dentistry in particular, and to hard tissue ablation in
`general, have been proposed by the use of excimer lasers
`that emit high intensity pulses of ultraviolet (UV) light.
`Several such pulsed UV excimer laser systems, typically
`with pulse durations in the approximately 1 to 125 nano-
`second range are disclosed in:
`1. Neev J, Stabholz A., Liaw L. L, Torabinejad M,
`Fujishige J. T., Ho P. H, Berns M. W., “Scanning
`Electron Microscopy and Thermal characteristics of
`Dentin ablated by a short-pulse XeCl Laser”, Lasers in
`Surgery and Medicine;
`
`Alcon Research, Ltd.
`Exhibit 1001 - Page 41
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`Alcon Research, Ltd.
`Exhibit 1001 - Page 41
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`US 6,482,199 B1
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`3
`2. Neev J, Liaw L, Raney D, Fujishige J, Ho P, Berns M.
`Selectivity and efficiency in the ablation of hard Dental
`tissue with ArF pulsed excimer lasers. Lasers Surgery
`and Medicine 1991; 11:499—510;
`3. Neev J, Raney D, Whalen W, Fujishige J, Ho P,
`McGrann J, Berns M. Ablation of hard dental tissue
`with 193 nm pulsed laser radiation: A photophysical
`study. Spie proceedings, January 1991; and
`4. Neev J, Raney D, Whalen W, Fujishige J, Ho P,
`McGrann J, Berns M. Dentin ablation with two excimer
`lasers: A comparative study of physical characteristics.
`Lasers Life Sci 1992; 4(3):1—25. Both the short wave-
`lengths and nanosecond range pulse durations used by
`excimer lasers contribute to define a different regime of
`laser-tissue-interaction. Short wavelength ultraviolet
`photons are energetic enough to directly break chemi-
`cal bonds in organic molecules. As a consequence, UV
`excimer lasers can often vaporize a material target with
`minimal thermal energy transfer to adjacent tissue. The
`resultant gas (the vaporization product) is ejected away
`from the target surface, leaving the target relatively free
`from melt, recast, or other evidence of thermal damage.
`Another important characteristic of UV excimer lasers is
`that materials which are transparent to light in the visible or
`near infra-red portions of the electromagnetic spectrum
`often begin to exhibit strong absorption in the UV region of
`the spectrum.
`It
`is well established that
`the stronger a
`materials absorption at a particular wavelength, the shal-
`lower the penetration achieved by a laser pulse having that
`wavelength. Thus,
`in many types of materials, a pulse
`typically only penetrates to a depth in the range of from
`about 10 to about 100 micrometers. By simply counting
`pulses, great precision can be achieved in defining removal
`depths. In addition, organic tissue is strongly absorbent in
`the UV wavelengths (193 nm for ArF, for example) therefore
`allowing the laser-tissue interaction region to be controlled
`with great precision.
`Notwithstanding the relatively damage free material
`removal characteristics of UV excimer lasers, these systems
`suffer from several disadvantages which limit their applica-
`bility to biological tissue processing. The reports of damage
`free tissue removal result from evaluations performed on
`single pulses, or on pulses with a very low repetition rate
`(typically about 1 to 10 Hertz). Because of the low volu-
`metric removal per pulse of excimer systems (material
`removed per unit time is poor), efficient material removal
`can only be accomplished by high pulse repetition rates.
`However, when the pulse repetition rate exceeds about 3 to
`5 Hertz, considerable thermal and mechanical collateral
`damage is observed. While UV photons are sufficiently
`energetic to directly break chemical bonds, they are also
`sufficiently energetic to promote mutagenic effects in tissue
`irradiated at UV wavelengths, raising concerns about the
`long term safety and health of a system operator. The
`scattered light produced by excimer lasers also presents a
`significant threat to the clinician and/or the patient. Even low
`intensity scattered radiation, with wavelengths below 300
`nanometers, is able to interact with the ambient environment
`to produce atomic oxygen and other free radicals. These can,
`in turn, react with the lens and cornea of the eye, producing
`cataracts, and produce burns on the skin equivalent to sun
`burns. As a consequence, excimer laser systems have been
`found to be most suitable for inorganic material processing
`applications, such as thin coating patterning or dielectric or
`semiconductor material etching.
`In addition, the operational parameters of excimer laser
`systems are such that material removal remains a wave-
`
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`length and beam energy dependent process (although
`weakly dependent on wavelength). Even when pulsed in the
`tens of nanoseconds pulse duration regime, excimer lasers
`are configured to deliver energy in the range of from about
`10 to about 1000 millijoules per pulse. At
`the higher
`energies, excimer lasers suffer from the same problems
`caused by plasma decoupling and pulse to pulse interaction
`as IR lasers. Additionally, as pulse energy increases, so too
`does the intensity of the associated acoustic snap.
`Neev et al. (University of California Case No. 95—313-1)
`US. patent application Ser. No. 08/584,522 described a
`Selective material removal processing Ultra Short Pulse
`Lasers (USPL) system in combination with a feedback
`system and with higher pulse repetition rates. This invention
`is directed to a system for efficient biological tissue removal
`using ultra short pulses. Such pulse durations are shorter
`than the characteristics electron-phonon energy transfer
`time,
`thus minimizing collateral
`thermal damage. The
`method also requires that plasma is formed and decayed so
`that a thin layer portion of the material is removed. The
`plasma formation step is then repeated at a pulse repetition
`rate greater than 10 pulses per second until a sufficient depth
`of material has been removed with little transfer of thermal
`
`or mechanical energy into the remaining material due to the
`shortness of the pulse duration. The preferred wavelength
`for that invention is in the range of 200—2500 nm. The laser
`specified in that patent application is a Chirped Pulse
`Amplifier (CPA) Solid-state laser.
`the laser system is
`That patent further specified that
`comprised of a feedback means for analyzing material
`characteristics in response to interaction between the laser
`pulses. The envisioned feedback means comprises a spec-
`trograph to evaluate the plasma formed by each pulse. The
`feedback means is operatively coupled to the laser. The laser
`operatively responds to the control signal such that the laser
`ceases operation upon receipt of the control signal. The
`feedback means also comprises an optical tomograph which
`optically evaluates the amount of target material removed by
`each pulse.
`This invention should work well in many applications.
`Unfortunately, the equipment for the ultrashort pulse dura-
`tion is very expensive (currently, over $100,000 and often
`two or three times that amount) and still requires many
`components and careful maintenance. The systems are also
`very large and delicate and require large volume for storage
`and expert maintenance at this stage of the technology. Also
`the interaction is not very selective nor highly sensitive to
`the targeted material type but rather ablate most materials.
`This, in turn, effects some risk of over ablating or removal
`of unintended structures. The highly interactive nature of the
`ultrashort pulse process possess additional problems to
`attempts to deliver the ultrashort pulse beam to the target.
`Most optical fibers as well as mirror and lenses could easily
`be damaged if ablation threshold is exceeded (either through
`narrowing of the beam spot size, an increase in pulse energy,
`or compression of the pulse duration). Thus ultrashort pulses
`are hard to deliver through most conventional delivery
`systems.
`An additional problem is that ultrashort pulse lasers are
`currently achieved principally in the near IR region of the
`electromagnetic spectrum. This is a highly transparent
`region for most biotissue material. Consequently, some
`portion of the radiation propagates linearly into the material
`and is not confined to the surface. This additional energy
`propagating into the target may then encounter more absorb-
`ing structures (for example the blood vessels in the retina)
`and will then result in a secondary—unintended—ablative
`
`Alcon Research, Ltd.
`Exhibit 1001 - Page 42
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`Alcon Research, Ltd.
`Exhibit 1001 - Page 42
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`US 6,482,199 B1
`
`5
`interaction, posing risk to the patients or to the material
`being processed.
`US. Pat. No. 4,907,586 issued to Bille and Brown for
`“METHOD FOR RESHAPING THE EYE”, disclosed a
`method for modifying tissue with a quasi-continuous laser
`beam to change the optical properties of the eye which
`comprises controllably setting the volumetric power density
`of the beam and selecting a desired wavelength for the beam.
`Tissue modification is accomplished by focusing the beam at
`a preselected start point in the tissue and moving the beam’s
`focal point in a predetermined manner relative to the start
`point throughout a specified volume of the tissue or along a
`specified path in the tissue.
`More particularly, the method describes a sequence of
`uninterrupted emissions of at
`least one thousand pulses
`lasting for at least one second. The pulses were specified
`lasting approximately one picosecond (1 ps) in duration and
`of less than 30 micro joules (30 MJ).
`The invention disclosed in US. Pat. No. 4,907,586 should
`work well for reshaping the eye, but is confined to the region
`of 1 ps and thus also involves the generation of ultrashort
`pulses and their relative low thermal and mechanical depo-
`sition of energy during the single pulse interaction. This
`device thus requires the use of expensive ultrashort pulses
`with all
`the specified limitations mentioned above.
`In
`addition, this invention is limited to relatively low energies
`of 30 yJ, which require a very tightly focused beam to affect
`tissue ablation. The invention will thus not work well for
`
`larger areas or for high volume removal rates, which are
`required in many applications, e.g., dentistry, surgery, etc.
`This invention is also limited with regards to its ability to
`deliver pulses through optical fibers, hollow waveguides or
`conventional optics since the very shorted pulses of 1 ps are
`also very reactive and will interact with most material used
`as deliver media. Consequently, specialty optics has to be
`used and conventional lenses and mirrors as well as optical
`fiber and conventional hollow waveguides cannot be used.
`In the present invention, the inventor has recognized that
`a much wider range of pulse durations of up to approxi-
`mately several hundred microseconds will allow the thermal
`diffusion to remain confined to within a distance of only a
`few micrometer of the ablated crater. Thus,
`the present
`invention is concerned with pulses up to several millisec-
`onds long. With a combination of short pulse to pulse
`separation and with new requirement on both the number
`and the rate of the incident sequential pulses, the present
`invention allows large volume removal or volume process-
`ing with substantially little damage to surrounding regions
`of the target.
`The present invention thus allows the use of pulse laser
`systems that are substantially less expensive and in many
`instances safer and more efficient than those described by
`other inventions, while achieving unprecedented volume
`removal rate, high precision, high efficiency and minimal
`thermal or mechanical collateral damage.
`SUMMARY OF THE INVENTION
`
`The present invention specifically addresses and allevi-
`ates the above mentioned deficiencies associated with the
`
`prior art. More particularly, the present invention comprises
`a method for ablating a material. The method for ablat