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EP0836834A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Non-synchronous laser-assisted myocardial revascularization

Assignee: Artivion Inc
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Filing: 1997-10-15
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Granted: —
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Expires: 2017-10-15
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Abstract

Abstract A method of selecting laser parameters for performing laser-assisted myocardial revascularization to avoid inducing undesired cardiac arrhythmia without synchronization of delivery of laser energy and the patient's cardiac cycle, the method comprising the steps of minimizing the power level of laser energy used, thereby decreasing the overall trauma to the heart, selecting a pulse frequency as great as possible while avoiding adverse summation effects, selecting a pulse width as wide as possible to prevent excessively high peak powers per pulse and not so wide as to cause undesired thermal damage, selecting an energy flux rate, shaping the front end of each pulse of laser energy to provide efficient, non-explosive TMR channeling, and correcting the selected power level, pulse width, pulse frequency and energy flux rate for mechanical events, including method of access to the heart, position of selected portions of myocardium in the heart, temporal duration of the procedure, natural movement of the heart, specific heart geometry, pre-existing heart arrhythmia and other factors causing a predisposition to heart arrhythmia. A method for performing laser-assisted transmyocardial revascularization (TMR) and percutaneous transluminal myocardial revascularization (PTMR) using such laser energy with parameters selected to avoid inducing undesired cardiac arrhythmia, the method comprising the steps of generating laser energy having a predetermined non-square wave shape, a predetermined wavelength, a predetermined energy flux and a predetermined power level, and delivering the laser energy in a plurality of pulses, the plurality of pulses having a predetermined pulse frequency and a predetermined pulse width, to selected portions of myocardium to form TMR and PTMR channels without synchronizing delivery of the laser beam with the cardiac cycle.

Inventors

  • 👤 Douglas Murphy-Chutorian
  • 👤 Richard L. Mueller
  • 👤 Mark Roush
  • 👤 Stuart D. Harman
  • 👤 Jeffrey J. Giba
  • 👤 Fred G. Kinley

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 15:02
CPC Classifications
A; A61; A61B; A61B18/00; A61B18/18; A61B18/20; A61B18/22; A61B18/24; A61B17/00; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B2017/00247; A61B2017/00681; A61B2017/00694; A61B2017/00703; A61B2018/00315; A61B2018/00345; A61B2018/00351; A61B2018/00392

Claims Analysis

Total Claims: 23
Claim 1
Independent Claim 133 words
A method of setting up an apparatus for performing transmyocardial revascularization (TMR) or percutaneous transluminal myocardial revascularization (PTMR) with laser energy having parameters selected to avoid cardiac arrhythmia, the method comprising the following steps, in combination: determining a wavelength of the laser energy from a laser selected to perform transmyocardial revascularization; using the wavelength determination to select parameters for the laser energy to produce a non-square wave shape; and generating the laser energy at the determined wavelength with the selected parameters to produce the non-square wave shape; whereby the apparatus is adapted to deliver the generated laser energy in one or more pulses to selected portions of heart tissue to perform transmyocardial revascularization or PTMR in myocardium without inducing cardiac arrhythmia and without synchronizing delivery of the laser energy to a cardiac cycle.
Claim 2
Dependent Claim 19 words
The method of Claim 1 wherein the selected parameters are power level, energy flux, pulse width, and pulse frequency.
Claim 3
Dependent Claim 83 words
The method of Claim 2 wherein the laser energy has a wavelength of between about 1.8 and about 2.2 microns, an energy flux of about 1.78 J/square millimeter and a power level of at least about 6 watts, the laser energy being delivered with a pulse frequency of at least about 5 Hertz and a pulse width of between about 150 and about 350 millisecond, the laser energy as delivered causing about 5 millimeters or less lateral necrosis surrounding a transmyocardial treatment site.
Claim 4
Dependent Claim 15 words
The method of Claim 3 wherein the laser energy is generated by a Holmium:YAG laser.
Claim 5
Dependent Claim 77 words
The method of Claim 2 wherein the laser energy has a wavelength of about 0.308 microns, a power level of about 2 watts and an energy flux of between about 2 and about 8 J/square millimeter, and is delivered with a pulse frequency of between about 5 and about 25 Hertz and a pulse width of about between about 10 and about 200 microseconds, and causes about 5 microns lateral necrosis surrounding the TMR channel produced thereby.
Claim 6
Dependent Claim 16 words
The method of Claim 5 wherein the laser energy is generated by a Xe:Cl excimer laser.
Claim 7
Dependent Claim 64 words
The method of. Claim 2 wherein the laser energy has a wavelength of about 10.6 microns, an energy flux of about 51 J/square millimeter and a power level at least about 800 watts, is delivered in a single pulse about of 0.03 seconds and can be gated, and causes between about 0.05 to about 0.2 millimeters lateral necrosis surrounding a TMR channel produced thereby.
Claim 8
Dependent Claim 16 words
The method of claim 7 wherein the laser energy is generated by a CO 2 laser.
Claim 9
Dependent Claim 64 words
The method of Claim 2 wherein the laser energy has a wavelength of between about 0.488 and about 0.514 microns, an energy flux of between about 1.3 and about 12.74 J/square millimeter and a power level at least between about 1 and about 10 watts, is delivered in a single pulse, and causes approximately 4 millimeters lateral necrosis surrounding a TMR channel produced thereby.
Claim 10
Dependent Claim 15 words
The method of Claim 9 wherein the laser energy is generated by an Argon laser.
Claim 11
Dependent Claim 78 words
The method of Claim 2 wherein the laser energy has a wavelength of about 1.06 microns, an energy flux of between about 9.5 and about 13 J/square centimeter and a power level at least between about 2 and about 100 watts, is delivered with a pulse frequency of between about 1 and about 10 Hertz and a pulse width of about 10 nanoseconds, and causes at least about 15 millimeters lateral necrosis surrounding a TMR channel produced thereby.
Claim 12
Dependent Claim 15 words
The method of Claim 11 wherein the laser energy is generated by an Nd:YAG laser.
Claim 13
Dependent Claim 67 words
The method of Claim 2 wherein the laser energy has a wavelength of about 2.94 microns, an energy flux of between about 50 and about 500 J/square millimeter, is delivered with a pulse frequency of between about 1 and about 15 Hertz and a pulse width of between about 1 and about 250 microseconds, and causes about 0.1 millimeters lateral necrosis surrounding a TMR channel produced thereby.
Claim 14
Dependent Claim 15 words
The method of Claim 13 wherein the laser energy is generated by an Er:YAG laser.
Claim 15
Independent Claim 26 words
An apparatus for performing transmyocardial revascularization (TMR) or percutaneous transluminal myocardial revascularization (PTMR) as set up by the method of any one of the preceding claims.
Claim 16
Dependent Claim 14 words
An apparatus according to claim 15 comprising a catheter apparatus and laser delivery means.
Claim 17
Independent Claim 96 words
An apparatus for percutaneous transluminal myocardial revascularization of a patient's myocardium for relieving angina and avoiding cardiac arrhythmia, the apparatus comprising a guidable elongated flexible lasing apparatus encompassing an optical fiber and insertable into a patient's vasculature, the distal end of the lasing apparatus being guidable to an area within the patient's heart, and directable to an area within the heart to be revascularized; and a Holmium:YAG laser source operating at around 5 Hz with a laser pulse width between 100-250 milliseconds, and approximately 0.7-0.9 Joules/mm 2 emitted from the distal end of the lasing apparatus.
Claim 18
Dependent Claim 28 words
The apparatus of claim 17 wherein the lasing apparatus includes an optical fiber that is between 600-1100 microns in diameter and the average laser power is 3.5 watts.
Claim 19
Independent Claim 114 words
An apparatus for percutaneous transluminal myocardial revascularization of a patient for relief from angina while avoiding cardiac arrhythmia during the procedure, the apparatus comprising: a guidable elongated flexible lasing apparatus encompassing an optical fiber insertable into the patient's vasculature, the optical fiber having a diameter between 600 and 1100 microns, the distal end of the lasing apparatus being guidable to an area within the patient's heart, and directable to an area within the heart to be revascularised; and a Holmium:YAG laser source arranged to provide a single pulse of laser energy with a laser pulse width between 100-250 milliseconds and approximately 1.8 Joules/mm 2 emitted from the optical fiber's end of the lasing apparatus.
Claim 20
Independent Claim 142 words
An apparatus for percutaneous transluminal myocardial revascularization of a patient's heart for relieving angina and avoiding cardiac arrhythmia, the apparatus comprising a) a guidable elongated flexible lasing apparatus encompassing an optical fiber with a distal end and insertable into a patient's vasculature, the distal end of the lasing apparatus being guidable to an area within the patient's heart, and directable at an area within the heart to be revascularised; b) means for controlling a distance the lasing apparatus may be advanced into heart tissue; c) a Holmium:YAG laser source operating at around 5 Hz with a laser pulse width between 100-250 milliseconds; d) means for selecting a laser power level emitted from the distal end dependent upon a controlled distance of the distal end of the laser apparatus; e) means for selecting a number of laser pulses based upon the controlled distance.
Claim 21
Dependent Claim 33 words
An apparatus according to claim 20 wherein the apparatus further includes an ultrasound device for determining a position of the distal end with respect to a ventricle wall prior to each laser pulse.
Claim 22
Independent Claim 162 words
An apparatus for percutaneous transluminal myocardial revascularization of a patient's heart for relieving angina and avoiding cardiac arrhythmia, the apparatus comprising: a) a guidable elongated flexible lasing apparatus encompassing an optical fiber with optical distal end and insertable into the patient's vasculature,the distal end of the lasing apparatus being guidable to an area within the patient's heart, and the distal end of the lasing apparatus being directable to an area within the heart to be revascularized; b) means for controlling a distance the distal end may be advanced into heart tissue; c) an excimer laser source operating at around 15 Hz with a laser pulse width where the distal end can emit radiation of at least about 50 mJ/mm 2 , d) means for selecting a laser power level emitted from the distal end of the lasing apparatus dependent upon a controlled distance of the laser apparatus; and e) means for selecting a number of laser pulses based upon the controlled distance.
Claim 23
Independent Claim 150 words
A method of selecting laser parameters for performing laser-assisted percutaneous transluminal revascularization (PTMR) to avoid cardiac arrhythmia and without synchronization of delivery of laser energy to a patient's cardiac cycle, the method comprising the following steps, in combination: selecting a minimum power level of laser energy to be used, the minimum power level being sufficient to ablate heart tissue; setting a pulse frequency as great as possible and selected to avoid summation effects; setting a pulse width as long as possible and selected to prevent excessively high peak power without causing undesired levels of thermal damage during PTMR; shaping a front end of each pulse of laser energy to provide non-linear pulses to avoid cardiac arrhythmia during PTMR; and correcting the selected power level, pulse width, pulse frequency, and shaping for limiting the depth of a formed channel to no more than half the wall thickness of a patient's myocardium.

References Cited (Backward Citations)

US4658817A Cited
US5125926A Cited
US5380316A Cited
US5389096A Cited
WO1996035469A1 Cited

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