Laser Emission Modulation for Soft Tissue Treatment

Description

1 / 21 Laser Emission Modulation for Soft Tissue Treatment RELATED ORDERS

[0001] This application claims priority over U.S. Provisional Application Serial No. 63 / 440,149, entitled LASER EMISSION MODULATION FOR TREATMENT OF SOFT TISSUE, filed January 20, 2023, the contents of which are incorporated herein by reference in their entirety. BACKGROUND Technical field

[0002] The technical field refers, in general, to laser treatment of soft tissue and, more specifically, to pulsed energy modulation in soft tissue treatment. Discussion of background

[0003] In addition to being used for the treatment of hard tissue (e.g., kidney stones, bladder stones), laser energy is also widely used to treat various soft tissue pathologies (e.g., BPH, bladder tumors, etc.) through ablation, cutting, vaporization, and coagulation of the tissue.

[0004] Until recently, the relevant laser sources (e.g., laser Ho:YAG lasers were extremely limited in their ability to modulate laser emission, i.e., alter pulse shape, energy, peak pulse power, and these types of lasers have limited pulse frequencies (pulse repetition rate). However, the advent of new diode-pumped laser sources (e.g., thulium fiber laser (Tm), Tm:YAG laser) offers the possibility of modulating the laser across a wider range of output values. There is a need to optimize soft tissue treatment through laser emission modulation. SUMMARY

[0005] Aspects and modalities refer to methods and systems of laser emission modulation for soft tissue treatment using pulsed laser energy. Petition 870260077988, dated 05 / 08 / 2026, page 7 / 31 2 / 21

[0006] According to an exemplary embodiment, a laser system for soft tissue treatment is provided that includes a laser configured to emit pulsed laser energy with a wavelength in the range of 1.85 to 2.2 microns (pm), inclusive, and a controller configured to control the laser so that each pulse of emitted pulse energy comprises two subpulses, one subpulse of the two subpulses being configured for ablation and incision (ablative subpulse) of a target soft tissue, and the other subpulse of the two subpulses being configured to coagulate the target soft tissue (hemostatic subpulse).

[0007] According to another exemplary embodiment, a method is provided for the treatment of soft tissue that includes generating pulsed laser energy with a wavelength in the range of 1.85 to 2.2 microns (pm), inclusive, emitting each pulse of the emitted pulse energy as two subpulses, one subpulse among the two subpulses being configured for ablation and incision (ablative subpulse) of a target soft tissue, and the other subpulse among the two subpulses being configured to coagulate the target soft tissue (hemostatic subpulse), and directing the pulsed laser energy to the target soft tissue. In one example, the target soft tissue is the hyperplastic tissue of the prostate.

[0008] In one example, the ablative subpulse is followed by the hemostatic subpulse. In a further example, the ablative subpulse and the hemostatic subpulse are separated by a subpulse interval, and the subpulse interval is in the range of 0 to 5 milliseconds (ms), inclusive.

[0009] In one example, the hemostatic subpulse is followed by the ablative subpulse. In a further example, the hemostatic subpulse and the ablative subpulse are separated by a subpulse interval, and the subpulse interval is in the range of 0 to 100 ms, inclusive.

[0010] In one example, the ablative subpulse has a peak power in the range of 400 to 20000 Watts (W), inclusive. In another example, the ablative subpulse has a peak power in the range of 600 to 1500 W, inclusive. In one example, the energy of the ablative subpulse is in the range of 1 to 10 Joules (J), inclusive. In a Petition 870260077988, dated 05 / 08 / 2026, page 8 / 31 3 / 21 For example, the duration of the ablative subpulse is in the range of 0.05 to 10 milliseconds (ms), inclusive. In a further example, the duration of the ablative subpulse is in the range of 1 to 10 ms, inclusive.

[0011] In one example, the target soft tissue has a tissue coagulation threshold and a tissue ablation threshold, and the hemostatic subpulse has a peak power and energy that is greater than the tissue coagulation threshold and less than the tissue ablation threshold.

[0012] In one example, the target soft tissue has a tissue coagulation threshold and a tissue ablation threshold, and the hemostatic subpulse has a peak power and energy that meets or exceeds the tissue coagulation threshold and meets or is less than the tissue ablation threshold multiplied by a factor of 1.5.

[0013] In one example, the hemostatic subpulse has a peak power in the range of 10 to 250 W, inclusive. In a further example, the hemostatic subpulse has a peak power in the range of 50 to 150 W, inclusive. In one example, the hemostatic subpulse energy is in the range of 0.5 to 10 J, inclusive. In one example, the hemostatic subpulse duration is in the range of 2 to 1000 ms, inclusive. In a further example, the duration of the hemostatic subpulse configured to coagulate is in the range of 10 to 100 ms, inclusive.

[0014] In one example, the ablative subpulse is configured to generate a water-induced laser bubble surrounding the target soft tissue with sufficient pressure to induce mechanical tissue incision in the target soft tissue.

[0015] In one example, the laser is a thulium fiber laser, a thulium solid-state laser, or a holmium solid-state laser.

[0016] According to another exemplary embodiment, a laser system for soft tissue treatment is provided that includes a laser configured to emit pulsed laser energy with a wavelength in the range of 1.85 to 2.2 microns (pm), inclusive, and a controller configured to control the laser so that the pulsed laser energy is emitted as a sequence of pulse groups, wherein each pulse group includes two subpulses, and the first subpulse Petition 870260077988, dated 05 / 08 / 2026, page 9 / 31 4 / 21 has a peak power in the range of 10 to 250 Watts (W), inclusive, and a duration of 0.5 to 100 milliseconds (ms), inclusive, a second subpulse has a peak power in the range of 400 to 20000 W, inclusive, and a duration of 0.01 to 5 ms, inclusive, and the pulse groups are separated in time by a group interval that is in the range of 3 to 250 ms, inclusive.

[0017] According to another exemplary embodiment, a method is provided for treating a target soft tissue by controlling laser irradiation to prevent soft tissue carbonization that includes generating pulsed laser energy with a wavelength in the range of 1.85 to 2.2 microns (pm), inclusive, emitting the pulsed laser energy as a sequence of pulse groups, wherein each pulse group includes two subpulses, such that the first subpulse has a peak power in the range of 10 to 250 Watts (W), inclusive, and a duration of 0.5 to 100 milliseconds (ms), inclusive, a second subpulse has a peak power in the range of 400 to 20000 W, inclusive, and a duration of 0.01 to 5 ms, inclusive, and the pulse groups are separated in time by a group interval that is in the range of 3 to 250 ms, inclusive, and directing the pulsed laser energy to the target soft tissue.

[0018] In one example, the group interval is in the range of 3 to 8 ms, inclusive.

[0019] In one example, the subpulses of the pulse group are separated in time by a subpulse interval of one duration to prevent fluid penetration into an area of ​​target soft tissue that has been exposed to pulsed laser energy. In another example, the subpulse interval is in the range of 0 to 30 ms, inclusive. In another example, the subpulse interval is in the range of 0 to 10 ms, inclusive. In another example, the subpulse interval is in the range of 0 to 3 ms, inclusive.

[0020] In one example, the peak power of the second subpulse is in the range of 600 to 1500 W, inclusive.

[0021] In one example, the peak power of the first subpulse is in the range of 50 to 250 W, inclusive. In a further example, the peak power of the first subpulse is in the range of 100 to 250 W, inclusive. Petition 870260077988, dated 05 / 08 / 2026, page 10 / 31 5 / 21

[0022] In one example, the second subpulse is configured to extirpate a layer of carbonization to prevent carbonization of a target soft tissue being treated by pulsed laser energy. In another example, the second subpulse is configured to prevent carbonization by ablating any carbonized tissue layer accumulated in the target soft tissue.

[0023] In one example, the laser is a thulium fiber laser, a thulium solid-state laser, or a holmium solid-state laser.

[0024] According to another exemplary embodiment, a laser system for soft tissue treatment is provided that includes a laser configured to emit pulsed laser energy with a wavelength in the range of 1.85 to 2.2 microns (pm), inclusive, and a controller configured to control the laser so that the pulsed laser energy is emitted as a sequence of pulses, wherein each Nth pulse in the sequence has a peak power in the range of 400 to 20000 W, inclusive, and has a duration of 0.05 to 5 ms, inclusive, and the other pulses in the sequence have a peak power in the range of 10 to 250 W, inclusive, and have a duration of 0.5 to 100 milliseconds (ms), inclusive.

[0025] According to another exemplary embodiment, a method is provided for the treatment of soft tissue that includes generating pulsed laser energy with a wavelength in the range of 1.85 to 2.2 microns (pm), inclusive, emitting the pulsed laser energy as a sequence of pulses such that each N-th pulse in the sequence has a peak power in the range of 400 to 20000 W, inclusive, and a duration of 0.05 to 5 ms, inclusive, and the other pulses in the sequence have a peak power in the range of 10 to 250 W, inclusive, and a duration of 0.5 to 100 milliseconds (ms), inclusive, and directing the pulsed laser energy to a target soft tissue.

[0026] In one example, N is from 2 to 10.

[0027] In one example, the Nth pulse is configured to remove a layer of carbonization to prevent carbonization of a target soft tissue treated by pulsed laser energy. In another example, the Nth pulse is Petition 870260077988, dated 05 / 08 / 2026, page 11 / 31 6 / 21 configured to prevent carbonization by ablating any carbonized tissue layer accumulated in the target soft tissue.

[0028] In one example, the Nth pulse has a peak power in the range of 600 to 1500 W, inclusive.

[0029] In one example, the energy of the Nth pulse is in the range of 0.5 to 5 Joules (J), inclusive.

[0030] In one example, the other pulses in the sequence have a duration of 2 to 100 ms, inclusive.

[0031] In one example, the peak power of the other pulses in the sequence is in the range of 50 to 250 W, inclusive.

[0032] In one example, the laser is a thulium fiber laser, a thulium solid-state laser, or a holmium solid-state laser.

[0033] According to another exemplary embodiment, a laser system for soft tissue treatment is provided that includes a laser configured to emit laser energy with a wavelength in the range of 1.85 to 2.2 microns (pm), inclusive, and a controller configured to control the laser so that laser energy power is emitted as continuous-wave (CW) laser power with modulation providing overlapping pulses of laser energy.

[0034] According to another exemplary embodiment, a method is provided for the treatment of soft tissue that includes generating laser energy with a wavelength in the range of 1.85 to 2.2 microns (pm), inclusive, emitting the laser energy such that a power of the laser energy is emitted as continuous wave (CW) laser power with modulation providing overlapping pulses of laser energy and directing the laser energy to a target soft tissue.

[0035] In one example, the CW laser power is in the range of 10 to 250 Watts (W), inclusive, and the overlapping pulses each have a peak power in the range of 500 to 20000 W, inclusive, and an average power of the overlapping pulses is in the range of 1 to 30% of the CW laser power. In another example, the Petition 870260077988, dated 05 / 08 / 2026, page 12 / 31 7 / 21 The peak power of each overlapping pulse is in the range of 600 to 1500 W, inclusive. In another example, the energy of each overlapping pulse is in the range of 0.5 to 5 Joules (J), inclusive. In another example, the duration of each overlapping pulse is in the range of 0.05 to 5 milliseconds (ms), inclusive. In another example, the CW laser power is in the range of 50 to 250 W, inclusive.

[0036] In one example, each overlapping laser energy pulse is configured to extirpate a layer of carbonization to prevent carbonization of a target soft tissue being treated by the laser energy. In another example, each overlapping laser energy pulse is configured to prevent carbonization by ablating any carbonized tissue layer accumulated in the target soft tissue.

[0037] In one example, the overlapping pulses are separated in time by a pulse interval that is in the range of 5 to 200 ms, inclusive.

[0038] In one example, the overlapping pulses have a repetition rate in the range of 5 to 200 Hertz (Hz) inclusive. In a further example, the overlapping pulses have a repetition rate in the range of 5 to 50 Hz inclusive.

[0039] In one example, the laser is a thulium fiber laser, a thulium solid-state laser, or a holmium solid-state laser.

[0040] Further, other aspects, modalities and advantages of these example aspects and modalities are discussed in detail below. Furthermore, it should be understood that both the foregoing information and the detailed description below are merely illustrative examples of various aspects and modalities, and are intended to provide an overview or framework for understanding the nature and character of the claimed modalities and aspects. The modalities disclosed herein may be combined with other modalities, and references to a modality, an example, some modalities, some examples, an alternative modality, several modalities, a (1) modality, at least one (1) modality, this and other modalities, certain modalities or the like are not necessarily mutually exclusive and are intended to indicate that a specific feature, structure or characteristic described may be Petition 870260077988, dated 05 / 08 / 2026, p. 13 / 31 8 / 21 included in at least one modality. Here, the appearances of such terms do not all necessarily refer to the same modality. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Several aspects of at least one embodiment are discussed below with reference to the accompanying figures, which are not intended to be drawn to scale. The figures are included to provide an illustration and further understanding of the various aspects and embodiments, and are incorporated into and constitute a part of this descriptive report, but are not intended to be a definition of the limits of any particular embodiment. The drawings, together with the remainder of the descriptive report, serve to explain principles and operations of the embodiments and aspects described and claimed. In the figures, each identical or nearly identical component that is illustrated in multiple figures is represented by a similar numeral. For clarity, not all components can be identified in all figures. In the figures: Figure 1 is a graph showing an example of an optimized pulse sequence for soft tissue cutting according to one or more aspects of the invention; Figure 2 is a graph showing another example of a pulse sequence optimized for soft tissue cutting according to one or more aspects of the invention; Figure 3A is a graph showing yet another example of a pulse sequence optimized for soft tissue cutting according to one or more aspects of the invention; Figure 3B is a graph showing yet another example of a pulse sequence optimized for soft tissue cutting according to one or more aspects of the invention; Figure 4 is a graph showing yet another example of a pulse sequence optimized for soft tissue cutting according to one or more aspects of the invention; Petition 870260077988, dated 05 / 08 / 2026, page 14 / 31 9 / 21 Figure 5 is a graph showing yet another example of a pulse sequence optimized for soft tissue cutting according to one or more aspects of the invention; and Figure 6 is a block diagram of a laser system for treating soft tissue according to one or more aspects of the invention. DETAILED DESCRIPTION

[0042] According to one or more modalities, specific laser emission modulation systems and methods are considered below for specific soft tissue treatment purposes. As used herein, the term soft tissue refers to tissues that connect, support, or surround other structures and organs of the body (human or animal), as well as mucous membranes, soft tissue tumors, which may be positioned in anatomical locations of the body (e.g., bladder, prostate, kidney). One or more aspects of this disclosure may be used for diode-pumped holmium-doped crystal or fiber lasers with output wavelengths in the range between 1.85 and 2.2 pm, inclusive. According to certain modalities, the methods and systems disclosed herein may be implemented or otherwise provided by a thulium fiber laser, a thulium solid-state laser, or a holmium solid-state laser.

[0043] As mentioned earlier, laser energy can be used to treat a variety of urological conditions ranging from lithotripsy to soft tissue surgeries (e.g., removal of benign prostatic hyperplasia (BPH) such as enucleation or vaporization by ablation). The application of laser energy can be optimized through modulation of the laser output, as shown in PCT application no. PCT / US2019 / 042491, which is published as WO 2020 / 033121 and is owned by the Applicant and incorporated herein by reference in its entirety.

[0044] According to one or more embodiments, systems and methods for optimizing laser output are disclosed herein for the purposes of: Petition 870260077988, dated 05 / 08 / 2026, p. 15 / 31 10 / 21 • Maximize ablation efficiency during soft tissue cutting / incision / excision, • Optimize hemostasis, • Improve certain specific surgical procedures, for example, prostate enucleation using laser pulses for separation of hyperplastic tissue from the prostate capsule, and • Reduce side effects such as tissue charring, scar formation, loss of viable biopsy material, etc.

[0045] In addition, according to certain embodiments, another objective is to provide a laser system comprising a laser source and a control unit that provides the means for modulating the output of the laser source in accordance with the pulsed modulation modes described herein.

[0046] According to some embodiments, yet another objective is to provide specific ideal pulse shapes for diode-pumped laser systems, such as Thulium Fiber Laser (TFL) and Tm:YAG (thulium solid-state laser) based laser systems, as well as holmium solid-state lasers, which can be used in one or more embodiments of this development.

[0047] It should be considered that, although the primary teachings of this invention are aimed at laser energy applications in urology, the applications of these teachings to other medical fields are also within the scope of this disclosure. Maximizing the efficiency of soft tissue cutting / incision / excision / nucleation, optimizing hemostasis and reducing carbonization.

[0048] Successful cutting / incision / excision / nucleation of soft tissue with directed energy (e.g., laser energy) requires the fulfillment of three conditions: 1) efficient ablation that provides a sufficiently deep cut per unit of energy expended; 2) minimal (ideally, absence of) charred tissue on the laser cut surface (charring); and 3) creation of an ideally deep and uniform coagulation margin, in order to ensure good hemostasis (i.e., preventing and mitigating bleeding, interruption of blood flow). Petition 870260077988, dated 05 / 08 / 2026, page 16 / 31 11 / 21

[0049] Conventional approaches to soft tissue treatment show that treatment with low pulsed peak power (or continuous wave (CW)) results in sufficient depth of cut and good hemostasis, but creates unacceptable levels of charring. Conventional approaches to soft tissue treatment using high pulsed peak power result in minimized charring, but ablation efficiency is reduced and often leads to non-uniform hemostasis that is insufficient to mitigate bleeding. Therefore, according to at least one modality, the goal of pulse shape optimization is to combine the benefits of both modes. In certain modalities, a coagulative laser mode power is primarily adjusted for hemostasis without dehydration, and an ablative laser mode power is optimized to provide efficient ablation.

[0050] The target soft tissue treated by certain methods and systems disclosed herein is associated with benign prostatic hyperplasia (BPH). According to certain modalities, the target soft tissue treated by the methods and systems disclosed herein is hyperplastic prostate tissue. A BPH enucleation process involves the removal of the prostate adenoma within the prostatic capsule. A conventional Ho:YAG laser configured to perform Ho Laser Enucleation Procedure (HoLEP) produces a high peak power (up to 20 kilowatts (kW)) in a short pulse to a thermomechanical separation mechanism. The process involves separating the adenoma tissue from the prostate gland capsule. This separation can be described as cutting or incising tissue precisely in a plane of connection between the capsule and the adenoma.This mechanism is a combination of creating a mechanical force on the tissue through a laser-induced vaporization bubble that creates high mechanical pressure in the tissue and, simultaneously, performs laser ablation and coagulation through a laser pulse propagated through this bubble, which has a primarily thermal effect. Disadvantages of this Ho:YAG treatment include uncontrolled hemostasis and the significant occurrence of bleeding. In contrast, a laser... Petition 870260077988, dated 05 / 08 / 2026, page 17 / 31 The 12 / 21 Thulium Fiber Enucleation Procedure (TFLEP) instrument, configured for this procedure, produces excellent hemostasis but not as good separation of adenoma tissue within the prostatic capsule. Furthermore, tissue charring compromises the visibility of the separation plane.

[0051] One or more modalities disclosed herein overcome the problems presented by diode-pumped TFL or Tm:YAG lasers by combining two subpulses: an ablative subpulse with high peak power followed by a coagulative (hemostatic) subpulse with low peak power. According to at least one modality, one subpulse among the two subpulses is configured for ablation and incision (called the ablative subpulse or ablation subpulse) of a target soft tissue, and the other subpulse among the two subpulses is configured to coagulate the target soft tissue (called the hemostatic subpulse).

[0052] A non-limiting example of such a subpulse combination is shown in Figure 1. In this modality, the ablative subpulse is followed by the hemostatic subpulse (or the ablative subpulse is directed to the target soft tissue before the hemostatic subpulse). In at least one modality, the ablative subpulse and the hemostatic subpulse are separated by a subpulse interval, and the subpulse interval is in the range of 0 to 5 milliseconds (ms) (inclusive). In the non-limiting example shown in Figure 1, the ablative subpulse and the hemostatic subpulse have a subpulse interval of 0, meaning they are joined.

[0053] In an alternative embodiment, the hemostatic subpulse may precede the ablative subpulse (i.e., the hemostatic subpulse is followed by the ablative subpulse), a non-limiting example of which is shown in Figure 2. In at least one embodiment, the hemostatic subpulse and the ablative subpulse are separated by a subpulse interval, and the subpulse interval is in the range of 0 to 100 ms (inclusive). In the non-limiting example shown in Figure 2, the hemostatic subpulse and the ablative subpulse have a subpulse interval of 0, meaning they are joined. Petition 870260077988, dated 05 / 08 / 2026, page 18 / 31 13 / 21

[0054] In both scenarios provided above, the following laser operating parameters can be applied, which were achieved by the Applicant after conducting preclinical and clinical trials: • The peak power of the ablative subpulse can be in the range of 400 to 20000 W, inclusive, preferably in the range of 600 to 1500 W, inclusive. • The energy of the ablative subpulse can be in the range of 1 to 10 J, inclusive. • The pulse duration of the ablative subpulse can be in the range of 0.05 to 10 ms, inclusive, preferably in the range of 1 to 10 ms, inclusive. • The peak power of the hemostatic subpulse can be in the range of 10 to 250 W, inclusive, preferably in the range of 50 to 150 W, inclusive. • The energy of the hemostatic subpulse can be in the range of 0.5 to 10 J, inclusive. • The pulse duration of the hemostatic subpulse can be in the range of 2 to 1000 ms, inclusive, preferably in the range of 10 to 100 ms, inclusive.

[0055] According to at least one modality and several aspects of the revelation, the target soft tissue (being treated by pulsed laser energy) has a tissue coagulation limit and a tissue ablation limit, and the hemostatic subpulse has a peak power and energy that is greater than the tissue coagulation limit and less than the tissue ablation limit. In another modality, the hemostatic subpulse has a peak energy and power such that these values ​​meet or exceed the tissue coagulation limit but meet or are less than the tissue ablation limit multiplied by a factor of 1.5. For example, if for a given set of surgical conditions (e.g., fiber diameter, cutting speed, tissue-to-fiber gap) the tissue coagulation limit is 50 W and the tissue ablation limit is 100 W, then the peak power of the hemostatic subpulse may be in the range of 50 to 150 W.

[0056] The experiments performed by the Applicant showed that the thermomechanical effect generated by such a pulse as described above can be similar to or better than Petition 870260077988, dated 05 / 08 / 2026, p. 19 / 31 14 / 21 that of a conventional Ho:YAG laser due to the superior thermal ablation effect of the TFL or Tm:YAG laser-induced vaporization bubble. The mechanical effect of this laser-induced bubble can be optimized by taking advantage of the effect of a laser-induced bubble oscillation that occurs between the fiber tip and the tissue, a phenomenon discovered by the Applicant. This oscillation produces tissue separation using multiple oscillations of positive and negative pressures, which contrasts with a cycle of positive and negative pressures (as in a Ho:YAG procedure). Although the phenomenon can be observed for both types of subpulses, the amplitude of the positive and negative mechanical pressures is much greater for the ablative subpulse and can be used for better separation of adenoma tissue from the capsule.According to at least one modality, the subpulse ablation is configured to generate a water-induced laser bubble surrounding the target soft tissue with sufficient pressure to induce mechanical tissue incision in the target soft tissue. In another modality, the subpulse ablation is additionally configured to apply positive pressure and at least two instances of negative pressure to the target soft tissue.

[0057] According to other embodiments, a cleaning pulse concept can be implemented for purposes of reducing or otherwise preventing carbon buildup (carbonized tissue layer, i.e., carbonization) during tissue vaporization, cutting, incision, excision, and enucleation. The rationale is that a high-peak-power cleaning pulse will periodically eliminate any accumulated carbon. In at least one embodiment, this can be achieved by adding a high-peak-power post-subpulse cleaning pulse to each regular pulse. For example, in one embodiment, a second subpulse (as described in more detail below and also referred to here as a cleaning pulse) is configured to remove a carbonization layer to prevent carbonization of a target soft tissue to be treated by pulsed laser energy, and in another embodiment, the second subpulse is configured to prevent carbonization by ablating any accumulated carbonized tissue layer. Petition 870260077988, dated 05 / 08 / 2026, p. 20 / 31 15 / 21 in the target soft tissue. A charred tissue layer, or carbonization layer, is formed on the surface of the laser crater or cut during a tissue ablation procedure. After tissue ablation and water vaporization (e.g., tissue temperature of 100 to 300 °C), the dried tissue continues to be heated, and when the temperature reaches approximately 150 °C, a thermal chemical reaction (pyrolysis) occurs, and tissue proteins release carbon atoms. This process is completed at temperatures in the range of 250 to 300 °C with the formation of a charred tissue layer with a typical thickness of 50 to 500 microns (µm) on the laser cut surface. The charred layer enhances the surgeon's ability to recognize tissue types and conditions of the treatment area and slows the healing process. The thickness of such a layer increases at lower powers and with increasing pulse width or dwell time in the tissue.However, lower power and a longer pulse width produce higher ablation efficiencies and a better coagulation margin. Treatment with a short pulse and high peak power produces a lower hemostatic effect, but results in better ablation of the thin layer of dry charred tissue due to better matching of the thermal relaxation time of the layer and the high absorption coefficient of dry charred tissue versus non-dry charred tissue.

[0058] According to certain embodiments, a controller is configured to control the laser so that pulsed laser energy is emitted as a sequence of pulse groups, wherein each pulse group includes two subpulses. Two non-limiting examples of such a configuration are shown in Figures 3A and 3B. According to certain embodiments, the peak power of the post-cleaning subpulse (second subpulse) may be in the range of 400 to 20000 W, inclusive, preferably in the range of 600 to 1500 W, inclusive, and has a duration of 0.01 to 5 ms, inclusive. In certain embodiments, a peak power of the regular portion of the pulse (first subpulse) may be in the range of 10 to 250 W, inclusive, preferably in the range of 50 to 250 W, inclusive, or in the range of 100 to 250 W, inclusive, and have a Petition 870260077988, dated 05 / 08 / 2026, page 21 / 31 16 / 21 duration of 0.5 to 100 ms. In some modes, the pulse groups are separated in time by a group interval (as shown in Figures 3A and 3B) that is in the range of 3 to 250 ms (inclusive), which corresponds to a pulse group repetition rate in the range of 3 to 300 Hz. In other modes, the group interval is in the range of 3 to 8 ms (inclusive), which corresponds to a repetition rate of 10 to 50 Hz.

[0059] Water can penetrate the laser crater between pulses, and additional laser energy is required to vaporize this water. This specific phenomenon is the reason for significant drops in tissue ablation efficiency and reduced cutting depths. To prevent this from happening, according to at least one modality, the subpulses of the pulse group are separated in time by a subpulse interval of a duration to prevent fluid penetration into an area of ​​target soft tissue that has been exposed to pulsed laser energy. In other words, the subpulse interval must be shorter than the time it takes to fill a laser crater (created in the soft tissue by the laser energy) with water (fluid) between subpulses. The duration of the subpulse interval varies depending on the ablation depth.According to some modes, the subpulse interval is in the range of 0 to 30 ms (inclusive), in other modes, the subpulse interval is in the range of 0 to 10 ms (inclusive), and in other modes, the subpulse interval is in the range of 0 to 3 ms (inclusive). The non-limiting example shown in Figure 3B shows a subpulse interval with a value of zero, which means that the first and second subpulses are joined.

[0060] According to at least one embodiment, the objective of reducing charring through a pulse cleaning technique is achieved by employing an amplitude-modulated (AM) sequence, wherein every Nth pulse (where N=2 - 10, i.e., N is a positive integer from 2 to 10) in the sequence is a high peak power pulse (cleaning pulse), while the pulses in the rest of the sequence have a low peak power (ablative pulses). For example, in one embodiment, a controller is configured to... Petition 870260077988, dated 05 / 08 / 2026, page 22 / 31 17 / 21 Control the laser so that pulsed laser energy is emitted as a sequence of pulses, where each Nth pulse in the sequence is configured as a cleaning pulse. The Nth pulse is configured to extirpate a layer of carbonization to prevent carbonization of a target soft tissue treated by pulsed laser energy, and, in a further embodiment, the Nth pulse is configured to prevent carbonization by ablating any accumulated carbonized tissue in the target soft tissue, in a manner similar to that described above.

[0061] A non-limiting example of such a sequence is shown in Figure 4, where N=4, so that every 4th pulse is a cleaning pulse. In a manner similar to that described above, the peak power of the cleaning pulse (i.e., every Nth pulse in the sequence) can be in the range of 400 to 20000 W inclusive, preferably in the range of 600 to 1500 W inclusive, and has a duration in the range of 0.01 to 5 ms (inclusive). In certain embodiments, the Nth pulse has an energy in the range of 0.5 to 5 J inclusive. In certain modes, the peak power of the regular pulse (the other pulses in sequence) may be in the range of 10 to 250 W, inclusive, preferably in the range of 50 to 250 W, inclusive, and have a duration in the range of 0.5 to 100 ms, inclusive, in some modes, have a duration of 2 to 100 ms (inclusive) and, in another mode, have a duration in the range of 10 to 100 ms, inclusive.According to some modalities, a pulse repetition rate can be in the range of 2 to 1000 Hz (inclusive). In some modalities, the pulse sequence may include groups of pulses that are separated by a group interval. For example, in Figure 4, there are 4 subpulses in each pulse group.

[0062] In yet another embodiment, a continuous wave (CW) mode is used and superimposed (superimposed, superimposed) with a sequence of cleaning pulses. According to at least one embodiment, a controller is configured to control the laser so that a power of laser energy is emitted as continuous wave laser power with modulation providing superimposed pulses of laser energy. Petition 870260077988, dated 05 / 08 / 2026, pp. 23 / 31 18 / 21

[0063] A non-limiting example of such a pulse sequence is shown in Figure 5. In this configuration, the CW base power (a baseline laser emission) can be in the range of 10 to 250 W, inclusive, preferably in the range of 50 to 250 W, inclusive, and is modulated to provide overlapping pulses of laser energy that function as a cleaning pulse. In some modes, the overlapping pulses each have a peak power in the range of 500 to 20000 W, inclusive, with some modes in the range of 500 to 1500 W, inclusive, and in another mode in the range of 600 to 1500 W, inclusive. According to at least one mode, an average power of the overlapping pulses is in the range of 1 to 30% of the CW laser power. For example, if the CW laser power is 100 W, the average power of the overlapping pulses may be in the range of 1 to 30 W. In certain modes, the cleaning pulse (i.e., the overlapping pulse) has a duration in the range of 0.05 to 5 ms, inclusive.According to at least one modality, the energy of the overlapping pulses is in the range of 0.5 to 5 J, inclusive. In some modalities, the repetition rate of the cleaning pulse (overlapping pulse) is in the range of 5 to 200 Hz, inclusive, preferably in the range of 5 to 50 Hz, inclusive. In some modalities, the overlapping pulses are separated in time by a pulse interval that is in the range of 0.3 to 10 ms, inclusive, and in other modalities, the pulse interval is in the range of 5 to 200 ms, inclusive. The CW pulse operating mode described herein was considered by the Applicant to be the most efficient regime for ablation, cutting, and incision of deep tissue.In one embodiment, each overlapping laser energy pulse is configured to remove a layer of carbonization to prevent carbonization of a target soft tissue being treated by the laser energy, and, in a further embodiment, each overlapping laser energy pulse is configured to prevent carbonization by ablating any accumulated carbonized tissue in the target soft tissue, in a manner similar to that described above. Petition 870260077988, dated 05 / 08 / 2026, pages 24 / 31 19 / 21 Laser system

[0064] Figure 6 is a block diagram showing a non-limiting example of a laser system configured to generate the laser pulse modes described above. It should be considered that another configuration may be used to implement the aforementioned pulse modes.

[0065] The laser system 100 comprises a power supply 103, a laser driver 125 which may include an optional energy storage device 120, a pump 115, a laser module 130 and a controller 150, also referred to in the present invention as a control module. The laser energy from the laser module 130 is directed to the target soft tissue 160. The laser system 100 may also include a beam application system or module 145 and an optical coupler 140.

[0066] Pump 115 is configured with one or more diode lasers that energize laser 130. Power supply 103 provides power to the system and to the optional energy storage device 125 (e.g., capacitor and / or electrical inductor) which can be configured to store a sufficient amount of energy needed to form a laser pulse. The laser driver 125 of pump 115 forms an electrical pulse of specified characteristics in response to a control signal from the control module 150. The electrical pulses are received by one or more diodes of pump 115 which form an optical pulse necessary to pump the laser medium into laser module 130. The output of laser module 130 is coupled to a beam application system 145, and in some cases this coupling occurs via the optical coupler 140.

[0067] One or more components of the laser system 100 are controlled by the controller 150, which is programmed with control signals that are used to control the laser driver 125, the power supply 103 and / or the laser module 130. For example, the control signal from the controller 150 can be used to directly modulate the pump current of the driver 125 used to pump diodes 115, as will be recognized by those skilled in the art, to provide the Petition 870260077988, dated 05 / 08 / 2026, pages 25 / 31 20 / 21 pulse energy, the desired power and time structure. In some embodiments, a single charge-discharge cycle of the 120 energy storage device can be used to modulate the diode current.

[0068] The aspects disclosed herein in accordance with the present invention are not limited, in their application, to the construction details and component arrangement presented in the following description or illustrated in the accompanying drawings. These aspects may take on other embodiments and be practiced, or performed, in various ways. Examples of specific implementations are provided herein for illustrative purposes only and are not intended to be limiting. In particular, acts, components, elements, and features discussed in connection with any one or more embodiments are not intended to be excluded from a similar role in any other embodiments.

[0069] Furthermore, the phraseology and terminology used herein are for descriptive purposes only and should not be considered limiting. Any references to examples, embodiments, components, elements, or acts of the systems and methods referred to herein in the singular may also encompass embodiments that include a plurality, and any references in the plural to any embodiment, component, element, or act herein may also encompass embodiments that include only a singularity. References in the singular or plural form are not intended to limit the systems or methods disclosed herein, their components, acts, or elements. The use in the present invention of including, comprising, having, containing, involving, and variations thereof is intended to encompass the items listed below and equivalents thereof, as well as additional items.References to or may be interpreted as inclusive, so that any terms described using or may indicate any one, more than one, or all of the terms described. Furthermore, in the case of inconsistent uses of terms between this document and documents incorporated herein by reference, the term usage in the incorporated reference is complementary to that in this document; for irreconcilable inconsistencies, the term usage in this document prevails. Additionally, headings or... Petition 870260077988, dated 05 / 08 / 2026, pp. 26 / 31 21 / 21 captions may be used in the descriptive report for the convenience of a reader, which should not affect the scope of the present invention.

[0070] Having therefore described various aspects of at least one example, it should be considered that various alterations, modifications, and improvements will readily occur for those skilled in the art. For example, the examples disclosed herein may also be used in other contexts. Such alterations, modifications, and improvements are intended to form part of this disclosure and are intended to be within the scope of the examples discussed herein. Consequently, the preceding description and drawings are merely examples. Petition 870260077988, dated 05 / 08 / 2026, pp. 27 / 31

Claims

1 / 3 CLAIMS 1. Laser system for soft tissue treatment characterized by comprising: a laser configured to emit pulsed laser energy having a wavelength in the range of 1.85 to 2.2 microns (pm), inclusive; and a controller configured to control the laser so that each pulse of emitted pulse energy comprises two subpulses, wherein: one subpulse among the two subpulses is configured for ablation and incision (ablative subpulse) of a target soft tissue, and the other subpulse among the two subpulses is configured to coagulate the target soft tissue (hemostatic subpulse).

2. Laser system, according to claim 1, characterized in that the ablative subpulse is followed by the hemostatic subpulse.

3. Laser system, according to claim 2, characterized in that the ablative subpulse and the hemostatic subpulse are separated by a subpulse interval, and the subpulse interval is in the range of 0 to 5 milliseconds (ms), inclusive.

4. Laser system, according to claim 1, characterized in that the hemostatic subpulse is followed by the ablative subpulse.

5. Laser system, according to claim 4, characterized in that the hemostatic subpulse and the ablative subpulse are separated by a subpulse interval, and the subpulse interval is in the range of 0 to 100 ms, inclusive.

6. Laser system, according to claim 1, characterized in that the ablative subpulse has a peak power in the range of 400 to 20000 Watts (W), inclusive, optionally in that the ablative subpulse has a peak power in the range of 600 to 1500 W, inclusive.

7. Laser system, according to claim 1, Petition 870250061747, dated 07 / 18 / 2025, page 59 / 76 2 / 3 characterized by an ablative subpulse energy being in the range of 1 to 10 Joules (J), inclusive.

8. Laser system, according to claim 1, characterized in that the duration of the ablative subpulse is in the range of 0.05 to 10 milliseconds (ms), inclusive, optionally in that the duration of the ablative subpulse is in the range of 1 to 10 ms, inclusive.

9. Laser system, according to claim 1, characterized in that the target soft tissue has a tissue coagulation threshold and a tissue ablation threshold, and the hemostatic subpulse has a peak power and energy that is greater than the tissue coagulation threshold and less than the tissue ablation threshold.

10. Laser system, according to claim 1, characterized in that the target soft tissue has a tissue coagulation limit and a tissue ablation limit, and the hemostatic subpulse has a peak power and energy that satisfies or exceeds the tissue coagulation limit and satisfies or is less than the tissue ablation limit multiplied by a factor of 1.

5.

11. Laser system, according to claim 1, characterized in that the hemostatic subpulse has a peak power in the range of 10 to 250 W, inclusive, optionally in that the hemostatic subpulse has a peak power in the range of 50 to 150 W, inclusive.

12. Laser system, according to claim 1, characterized in that the hemostatic subpulse energy is in the range of 0.5 to 10 J, inclusive.

13. Laser system, according to claim 1, characterized in that the duration of the hemostatic subpulse is in the range of 2 to 1000 ms, inclusive, optionally in which the duration of the hemostatic subpulse configured to coagulate is in the range of 10 to 100 ms, inclusive. Petition 870250061747, dated 07 / 18 / 2025, pp. 60 / 76 3 / 3 14. Laser system, according to claim 1, characterized in that the ablative subpulse is configured to generate a laser-induced bubble in water surrounding the target soft tissue with sufficient pressure to induce mechanical tissue incision in the target soft tissue.

15. Laser system according to claim 1, characterized in that the laser is a thulium fiber laser, a thulium solid-state laser, or a holmium solid-state laser. Petition 870250061747, dated 07 / 18 / 2025, pp. 61 / 76

Images