Apparatus and method for reducing laser beam attentuation in a liquid medium
11712298 · 2023-08-01
Assignee
Inventors
Cpc classification
A61B17/22004
HUMAN NECESSITIES
A61B17/22
HUMAN NECESSITIES
A61B2018/20554
HUMAN NECESSITIES
A61B2017/22007
HUMAN NECESSITIES
A61B2017/00176
HUMAN NECESSITIES
A61B18/22
HUMAN NECESSITIES
A61B2018/263
HUMAN NECESSITIES
A61B18/26
HUMAN NECESSITIES
International classification
A61B17/22
HUMAN NECESSITIES
A61B18/22
HUMAN NECESSITIES
Abstract
A method of treating a mobile target tissue with a laser beam includes: providing a laser device for generating a laser beam and providing an optical fiber having a delivery end for guiding the laser beam to the target tissue; a controller causes the laser device to generate one or more laser pulses substantially along the same longitudinal axis. The controller causes the laser device to provide one or more laser pulses. The one or more pulses are selected to allow a vapor bubble formed by the one or more pulse to expand an amount sufficient to displace a substantial portion of the liquid medium from the space between the delivery end of the fiber and the target tissue. The one or more pulses are delivered to the target tissue through the vapor bubble after the vapor bubble has reached its maximum extent and has begun to collapse to reduce retropulsion of the mobile target tissue.
Claims
1. A method for treating a target tissue with a laser beam, said target tissue being mobile and immersed in a liquid medium within a body lumen, the method comprising: providing a Thulium laser device for generating a laser beam; providing an optical fiber having a delivery end for guiding the laser beam to the target tissue; providing a controller for causing the laser device to generate one or more laser pulses; the controller causing the laser device to provide the one or more laser pulses, the one or more laser pulses being configured by the controller to have an energy sufficient to form a chain of multiple bubbles in the liquid medium from the delivery end of the fiber to the target tissue along a longitudinal axis; the one or more pulses being selected to allow the chain of multiple bubbles to expand an amount sufficient to displace a substantial portion of the liquid medium along the longitudinal axis from the space between the delivery end of the fiber and the target tissue, the one or more pulses being delivered to the target tissue through the chain of multiple bubbles until the chain of multiple bubbles has reached its maximum extent and has begun to collapse; and, whereby the collapsing chain of bubbles causes the target tissue to remain substantially stationary as the one or more laser pulses are being delivered, thus reducing retropulsion of the target tissue.
2. The method of claim 1, wherein the one or more laser pulses is more than one train of pulses, further comprising the step of the controller of selecting a repetition rate for delivery of the more than one laser pulses.
3. The method of claim 1, further comprising: the controller: selecting the total energy of one or more pulses to be delivered to the target tissue, and measuring the distance from the delivery end of the fiber to the target tissue.
4. The method of claim 3, further including the step of measuring any change in the distance from the delivery end of the fiber to the target tissue, and, in the event of any change being measured, the controller modifying the energy of the one or more laser pulses to adjust the energy delivered.
5. The method of claim 3, further comprising the steps of: measuring actual energy irradiated by the laser device; comparing the actual measured energy to a total energy selected by the controller; and, if the comparison demonstrates variance of the actual measured energy from the selected total energy, the controller adjusting the energy for any following pulses to achieve the selected energy delivered to the target tissue.
6. The method of claim 5, wherein the step of the controller adjusting the energy is accomplished by a closed loop feedback circuit operatively connected to the controller.
7. The method of claim 3, wherein the step of measuring the actual energy delivered by the laser is performed by a photodetector along the longitudinal axis.
8. The method of claim 1, wherein the target tissue is a tissue, an organ or a formed stone within a human body.
9. The method of claim 1, further comprising the step of selecting and mounting on the laser device an optical fiber type to be used in irradiating the target tissue.
10. The method of claim 9, wherein the type of optical fiber includes at least one of the parameters of: fiber diameter, fiber material, fiber numerical aperture and shape of the distal delivery end.
11. A method of treating a target tissue with a laser beam, said target tissue being immersed in a liquid medium within a body lumen, the method comprising: providing a Thulium laser device for generating a laser beam; providing an optical fiber having a delivery end for guiding the laser beam to the target tissue; providing a controller for causing the laser device to generate one or more laser pulses; the controller causing the laser device to provide the one or more laser pulses, the one or more laser pulses being configured by the controller to have an energy sufficient to form a chain of multiple bubbles in the liquid medium from the delivery end of the fiber to the target tissue along a longitudinal axis; the one or more pulses being selected to allow the chain of multiple bubbles to expand an amount sufficient to displace a substantial portion of the liquid medium along the longitudinal axis from the space between the delivery end of the fiber and the target tissue, the one or more pulses being delivered to the target tissue through the chain of multiple bubbles until the chain of multiple bubbles has reached its maximum extent and has begun to collapse; selecting through the controller, the total energy of the one or more pulses to be delivered to the target tissue, and measuring the distance from the delivery end of the fiber to the target tissue; and, in the event of any change in the distance from the delivery end of the fiber to the target tissue being measured, the controller causing the modifying of the energy of the one or more pulses to adjust the energy delivered to the target tissue to the total energy selected.
12. The method of claim 11, wherein the one or more laser pulses is more than one train of pulses, further comprising the step of the controller of selecting a repetition rate for delivery of the more than one laser pulses.
13. The method of claim 11, further comprising the steps of: measuring actual energy irradiated by the laser device; comparing the actual measured energy to a total energy selected by the controller; and, if the comparison demonstrates variance of the actual measured energy from the selected total energy, the controller adjusting the energy for any following pulses to achieve the selected energy delivered to the target tissue.
14. The method of claim 13, wherein the step of the controller adjusting the energy is accomplished by a closed loop feedback circuit operatively connected to the controller.
15. The method of claim 11, wherein the target tissue is a tissue, an organ or a formed stone within a human body.
16. The method of claim 15, wherein the step of measuring the actual energy delivered by the laser is performed by a photodetector along the longitudinal axis.
17. A medical laser system for treating a target tissue portion with a laser beam, said tissue portion being immersed in a liquid medium within a body lumen, said system comprising: a Thulium laser device for generating a laser beam; an optical fiber having a delivery end for guiding the laser beam to the target tissue portion; a controller for controlling the laser device to sequentially generate one or more laser pulses, wherein one or more laser pulses being configured by the controller to have an energy sufficient to form a chain of multiple bubbles in the liquid medium from the delivery end of the fiber to the target tissue along a longitudinal axis; the one or more pulses being selected to allow the chain of bubbles to expand an amount sufficient to displace a substantial portion of the liquid medium along the longitudinal axis from the space between the delivery end of the fiber and the target tissue portion, wherein the controller controls the initiation of laser pulses so that they are delivered to the tissue through the chain of multiple bubbles until the vapor bubbles has reached its maximum extent and has begun to collapse, further comprising the controller being configured to select the total energy of the one or more pulses to be delivered to the target tissue, and measure the distance from the delivery end of the fiber to the target tissue; and, in the event of any change in the distance from the delivery end of the fiber to the target tissue being measured, the controller being configured to cause modification of the energy of the one or more pulses to adjust the energy delivered to the target tissue to the total energy selected.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE PRESENT INVENTION
(10) According to one aspect of the present invention, after the firing of a first initiation pulse, a second treatment pulse is fired only after a bubble is generated by the first initiation pulse and only after the bubble has reached its maximal size.
(11) Referring now to
(12) It should be mentioned that the real optimization point is also, among other things, dependent upon the total pulse energy, the pulse repetition rate, the fiber type and the fiber tip-to-target tissue distance. According to this aspect of the invention, after time T2, the bubble begins to shrink until it totally collapses at time T3. During the time after T2 when the bubble starts to collapse, a target tissue may experience an attractive force moving it, if feasible (for example if the target was a kidney stone floating in body fluid), towards the energy delivery end of a fiber or a light guide. This same attractive force may further reduce the distance a laser beam travels through the medium until it reaches the target tissue and therefore energy attenuation may be reduced.
(13) Turning now to
(14) This process is schematically shown on the
(15) Analyzing the above figures from top to bottom it can be observed that the energy level delivered to the target is different for each phase of the pulse, as follows: In the first row, the pulse is just beginning, its energy is still low as can be seen in the middle graph. The bubble created is still small as well. In the second row down, the energy of the pulse is at its highest. Therefore, the middle graph also shows higher energy level. The bubble is also much larger, though still not at its maximum due to the time required for its expansion. Within the bubble there is no energy loss, as can be seen by the flat section of the graph. In the last row, the pulse energy is already declining, however the bubble size is at its maximum, and therefore the energy delivered to the target is still significant.
(16) Based on the above explanation, the right column of the graph shows the theoretical energy delivered to the target, taking the bubble effect into consideration (the solid line), and without taking it into consideration (dashed line). It can be seen that the actual energy delivered is higher because of the creation and the presence of the bubble.
(17) It is clearly seen that the bubble formation, to a certain extent, improves the pulse propagation through the liquid environment. A main aspect of the present invention is to optimize the process to get as much power on the target tissue or stone as possible.
(18) One potential way of accomplishing this goal is a special pulse modulation, in which the pulse energy is delivered to a target in two different parts separated by a certain interval of time. An added value is due to the fact that inertial movement of the liquid surrounding the opening bubble (during the mentioned interval of time) occurs without additional energy loss. By varying the ratio of two parts' energies into which the pulse is divided, and the time interval between them, the optimal energy delivery conditions can be obtained.
(19) One of the challenges during a laser treatment is to keep the target tissue in place once it absorbs the optical energy. In certain cases, the target tissue may have a degree of freedom to move in a direction which pushes it away from the tip of the fiber. This may happen, for example, when the target is a stone in the urinary track to be treated, as mentioned above. The optical energy absorbed by the stone may be transformed, at least partially, into kinetic energy which pushes the stone in a direction away from the tip of the fiber. This phenomenon is known to those skilled in the art as retropulsion. In the context of this invention, retropulsion means that the distance the laser light beam must travel from the tip of the fiber to the target tissue may increase. Increased laser light beam traveling distance may mean increased energy loss due to absorption and scattering in the surrounding media. Therefore, according to another aspect of the invention, a treatment energy pulse may be fired during a period the bubble is collapsing to reduce retropulsion of a target tissue and at the same time improve target stone ablation.
(20) In general, in laser systems the pulse energy produced by a laser depends on multiple factors. Among these factors are laser efficiency, which may vary between one cavity to another, and may vary as a function of the working temperature or as a function of the pumping energy. Each factor may also vary in time. These variances may well affect the timing and extent of bubble formation vis a vis the initiation and the treatment pulses. In order to overcome the resulting pulse energy fluctuations, a closed loop control system described herein may implemented as another aspect of the invention. The closed loop control system may be required in order to assure that energy level of each bubble initiation pulse is within a specific predefined range of energies, so that bubble size and expansion rate can be predicted.
(21) Therefore, according to this aspect of the present invention, a system is configured to measure the pulse energy, compare the measured pulse energy to a predefined energy level and to feedback in a closed feedback loop the pumping energy source to compensate on the fly for incorrectly-energized pulses to assure that the level of each bubble initiating pulse is within a predefined range of values.
(22) Referring now to
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(24) In stage 400, a user selects the pulse repetition rate. It should be mentioned that in this context the pulse repetition rate, from the standpoint of the user, is the repetition rate between a pair of pulses. Each pair of pulses contains an initiation pulse and a treatment pulse. In stage 500, according to
(25) According to another embodiment of the present invention, as shown in
(26) It may be mentioned here that E.sup.i may be a single pulse which is configured to initiate a single bubble in the liquid media between the tip of the fiber and the target tissue. According to another embodiment, E.sup.i may be a sequence of two or more pulses. A second Ei pulse may cross the first bubble and generate a second bubble once it exits the first bubble and hits again a liquid media. Multiple E.sup.i pulses may create, in this way, a chain of multiple bubbles. Therefore, according to this aspect of the invention, the distance between the tip of a fiber and a target tissue may be spanned with more than one bubble in order to reduce the absorption level of the liquid media. The time sequence for practicing multiple E.sup.i pulses, according to another aspect of the invention, should be optimized in such a way that a next E.sup.i pulse is fired while the bubble initiated by a previous E.sup.i pulse still exists and has not yet been totally collapsed.
(27) In stage 700, the treatment laser fires a pair of pulses at the target tissue. The system may be configured to measure actual values of each pulse. In stage 800 and in stage 900, the system is configured to compare the measured values to the predefined values on stage 600. Should the measured parameters deviate from the predefined parameter, the system automatically corrects such deviation in stage 1000 and a new set of working parameters are sent to the programmable controller which then causes to be initiated the next pair of pulses in stage 700. In this way, the system maintains the actual working values within the predefined range. It should be understood that during stage 800, the system may be configured to measure different parameters which may be related to actual laser pulse energy.
(28) For example, according to one embodiment, the system may use a photodetector which is configured to measure optical energy output of E.sub.i, E.sub.p or the total pulse energy. According to another embodiment, for example, the system may be configured to measure current or voltage pulses which are sent to the laser pumping energy source. Therefore, the feedback loop may be configured to feedback, based on each measured parameter, whether this is a measured optical value, a measured current or voltage value or any other measured parameter which is related to a pulse energy.
(29) Referring now to
(30) Referring now to
(31) Referring now to
(32) Turning now to
(33) The time of bubble expansion and collapse is believed to be substantially determined by the laws of hydrodynamics. When the duration of a high energy pulse becomes longer than the bubble “lifetime”, the pulse rest energy was found to create a new bubble. This new bubble is separated from the first, collapsing, bubble. Theoretical consideration (in the limit of sufficiently long, comparing the bubble life and pulses) predicts that the bubble will be expanded in time as about
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(35) Due to the proportionality between the pulse energy and its duration, the same dependence on energy should be found for the bubble size, about
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(37) The curve shown in
(38) While the use of Holmium and Thulium laser sources have been generally discussed above, other combinations of two types of laser cavities have been described as potentially being effective in the provision of pulses to create bubbles in accordance with the present invention. One such arrangement is described in co-pending U.S. provisional application Ser. No. 62/482,335, filed Apr. 6, 2017 and assigned to the same assignee as the assignee of the present invention. The entirety of the disclosure of that application is incorporated by reference herein.
(39) In the above-cited provisional, it is disclosed that while use of a Holmium laser is probably the “gold standard” for the treatment of Benign Prostatic Hyperplasia (BPH), due, among other reasons, to the peak power of a Ho laser source which is 20 times higher than that of a Tm laser, there are as well potential undesirable aspects, including unwanted tissue coagulation and tissue charring.
(40) Given that the Tm wavelength is absorbed in tissue more effectively than a Ho laser, the same or substantially the same results as for a Ho laser may be achieved by providing a pulse duration of 1 ms, which was found to decrease the risk of tissue charring. And, to keep the average power balance the same, it is necessary to increase by the same factor the value of the repetition rate as follows: 20 W=0.5 Kw×1 mS×40 Hz. Thus, the foregoing was found to be a most efficacious treatment regime for tissue applications. The ability to control pulse shape, which is intrinsic to IPG fiber lasers, makes it possible to implement the so-called “Moses” features disclosed in the US patent and US provisional patent application cited above, resulting in improved treatments which take place in a liquid environment in the human body.
(41) As mentioned, one main disadvantage of a Tm fiber laser is that it possesses low peak power (0.5-1.0 Kw for Tm versus 10 Kw for A Ho laser). This results in different laser/tissue interactions. The main two fundamental reasons for the low peak power are:
(42) 1. The LED pumping limitations.
(43) 2. Small fiber cross section for the Tm fiber laser.
(44) A main disadvantage of a Ho solid state laser is its low efficiency, which is a result of the need for a multistage pumping process (Cr>Tm>Ho). There are energy losses at each stage, resulting in an overall efficiency of less than 4%, versus 15-20% for a Tm fiber laser.
(45) According to an embodiment of the invention for producing a high peak power Holmium laser cavity and for increasing its efficiency, there is provided a CTH pumped solid state Holmium laser cavity as shown in
(46) As seen in the
(47) According to another embodiment of the invention for producing a high peak power Holmium laser cavity and for utilizing the multiple pulses technology described in the relevant incorporated references, there is provided a direct Thulium pumped solid state Holmium laser cavity as shown in
(48) Referring now to
(49) Thus, it can be seen that use of one of the setups shown in any of
EXAMPLE
(50)
(51) The test of the experimental setup of
(52) The bath 1102 with a window 1104, which is transparent to the Holmium wavelength, is filled with water and placed in front of power meter. The fiber 1108 under the test can be precisely moved to control the distance 1111 between the fiber tip and the window glass surface 1110. The measured power value simulates the amount of energy actually delivered to the target (the inner glass surface) for a given distance and laser setting. This way pulses of different modulation parameters can be compared with each other.
(53) The different sets of modulation parameters were found, depending on the average distance, which a surgeon keeps during the operation. Three distances were used for determining the optimal parameters: 3 mm, 2 mm and 1 mm.
(54) To make sure that the features of the present invention are reliable and stable, the power delivered to the target was measured as a function of a distance to the fiber tip for a given set of modulation parameters, for a given lasing regime and for a given fiber.
(55) In the Table 1 below are presented all fibers and laser regimes for which the power-distance dependence was measured.
(56) TABLE-US-00001 TABLE 1 List of fibers and measured lasing regimes J/Hz 5 10 15 20 30 40 60 70 80 0.2 2, 1 2, 1 2, 1 3, 2, 4, 1 0.3 2, 1 2, 1 2, 1 3, 2, 4, 1 0.4 2, 1 2, 1 2, 1 3, 2, 4, 1 0.5 2 2, 1 2, 1 2, 1 3, 2, 4, 1 0.6 2 2, 1 2, 1 2, 1 3, 2, 4, 1 0.8 2, 1 2, 1 2, 1 2, 1 3, 2, 4 1 3, 2, 1 3, 2, 1 3, 2, 1 3, 2, 4, 1 5 3, 2 3, 2, 5 3, 2 1.2 3, 2, 1 1.5 3 3, 2, 1 3 2 3, 2, 4, 1 5 3, 4 3, 5 3 3, 2, 4 3.5 3 3, 4 3 4 3, 4 3 5 3, 4 3 6 3, 4 3, 4 1- SL2000/F/L 2- SL2000 3- SL365 4- SL550 5- Expeeda
(57)
(58) The percentage scale on the graphs is referring to the laser setting. For example (
(59) The window used in this experiment did not allow the measurement at a very close distance. It is more important for thin fibers, because the cavitation bubbles become more destructive. That's why the range of distances to a target was limited to few tenths of mm.
(60) In some graphs “Added value” is the difference between the B-Pulse and the regular modes.
(61) All the power vs. distance graphs that have been collected show that this dependence has so-called “cigar” shape.
(62) This means that there is no significant difference between regular and B-pulse at the distance range edges. When the fiber tip is very close to the target the role of the bubble becomes minor, and therefore the energy delivered to the target is the same. When the distance exceeds approximately 3-3.5 mm the amount of energy delivered to the target becomes insignificant even for the strongest (5-6 J) pulses. This means that, again, there is no difference between B-pulse and regular pulses, as the delivered energy is negligible.
(63) The most difference (always in favor of B-pulse) occurs at that distance where modulation parameters are optimized. It means that, once the preferable working distance is determined, the optimization can be done for that point. It should be noticed that decreasing the distance for which the optimization is done results in decreased advantage of B-pulse over the regular pulses (the “cigar” shape becomes thinner).
(64) As the so-called Moses effect or feature (increase in an energy delivery to a target) is caused by the formation of a bubble, it is seen that the effect strongly depends on the fiber size, which determines the power density. That is the reason each fiber type requires special optimization of the laser pulse modulation parameters.