Energy profile adjusting waveguide and laser-based medical device having the same

Abstract

Energy profile adjusting waveguides and laser-based medical devices having such waveguides. In the medical device, the optical fiber or waveguide includes a refracting or deflecting optical element or both on its interior side that redirects the laser energy propagating along the optical fiber or waveguide so that the laser energy exits the optical element laterally through a sidewall to provide the laser energy to a location within the body that is lateral to the general direction of propagation of the laser energy in the optical fiber or waveguide. Optionally, some of the laser beams propagating in the optical fiber or waveguide exit laterally therefrom to intersect or overlap at a focal point or focal region where the laser-based medical procedure is performed.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to and the benefit of US63 / 192239, filed May 24, 2021, the entirety of which is incorporated herein by reference.

[0002]

[0002] Some embodiments relate to the field of medical devices. [Background technology]

[0003] A waveguide is a structure that guides waves, such as electromagnetic and sound waves, with minimal energy loss. For example, a hollow conductive metal pipe can be used to carry high frequency radio waves. Dielectric waveguides can be used at high radio frequencies. Transparent dielectric waveguides and optical fibers can act as waveguides for light. In acoustics, air ducts and horns can be used as waveguides for sound (e.g., in musical instruments and loudspeakers). Specially shaped metal rods can conduct ultrasonic waves in ultrasonic machining. Summary of the Invention

[0004]

[0004] Some embodiments provide an energy profile adjusting waveguide and a laser-based medical device having the waveguide. For example, according to some embodiments, the medical device has an optical fiber or waveguide that includes a refractive optical element and / or a deflecting optical element on its inner side, which redirects the laser energy propagating through the optical fiber or waveguide to exit laterally through a sidewall to provide the laser energy to a location within the body (e.g., rather than directing the entire propagating laser energy to exit in a forward direction through a tip or cap at the distal end of the optical fiber or waveguide), the location within the body being located laterally of the general direction of propagation of the laser energy in the optical fiber or waveguide. Optionally, some of the laser beam propagating through the optical fiber or waveguide exits laterally therefrom to cross or overlap a focal point or focal area where a laser-based medical procedure is performed.

[0005]

[0005] Some embodiments may provide other and / or additional benefits and / or advantages. [Brief description of the drawings]

[0006] [Figure 1] FIG. 1 is a schematic diagram of a portion of a waveguide in accordance with some demonstrative embodiments, particularly for propagating light or laser-based energy for medical treatment purposes. [Diagram 2] FIG. 2 is a schematic diagram of another portion of a waveguide according to some demonstrative embodiments. [Diagram 3] FIG. 3 is a schematic diagram of a portion of a waveguide in accordance with some demonstrative embodiments, particularly for propagating light or laser-based energy for medical treatment purposes. [Figure 4] FIG. 4 is a schematic diagram of a portion of a waveguide according to some demonstrative embodiments, illustrating a schematic optical view. [Diagram 5]FIG. 5 is a schematic diagram of a portion of a waveguide in accordance with some demonstrative embodiments, illustrating areas having various light-based energy profiles. [Figure 6] FIG. 6 is a schematic diagram of a portion of a waveguide in accordance with some demonstrative embodiments. [Figure 7] FIG. 7 is a schematic diagram of a portion of a waveguide in accordance with some demonstrative embodiments. [Figure 8] FIG. 8 is a schematic diagram of a portion of a waveguide in accordance with some demonstrative embodiments. [Figure 9A] 9A and 9B are schematic diagrams of a portion of a waveguide according to some demonstrative embodiments illustrating changes in energy profile due to controlled changes in a controlled liquid or gas or fluid environment. [Figure 9B] 9A and 9B are schematic diagrams of a portion of a waveguide according to some demonstrative embodiments illustrating changes in energy profile due to controlled changes in a controlled liquid or gas or fluid environment. [Figure 10] FIG. 10 illustrates an isometric view of a portion of a waveguide with directional radiation of energy, according to some demonstrative embodiments. [Figure 11] 11-15 generally illustrate cross-sectional views of several waveguides in accordance with some demonstrative embodiments. [Figure 12] 11-15 generally illustrate cross-sectional views of several waveguides in accordance with some demonstrative embodiments. [Figure 13] 11-15 generally illustrate cross-sectional views of several waveguides in accordance with some demonstrative embodiments. [Figure 14] 11-15 generally illustrate cross-sectional views of several waveguides in accordance with some demonstrative embodiments. [Figure 15] 11-15 generally illustrate cross-sectional views of several waveguides in accordance with some demonstrative embodiments. [Figure 16]16 and 17 are schematic illustrations of cross-sectional views of additional waveguides in accordance with some demonstrative embodiments, illustrating the integration of two or more features into one device. [Figure 17] 16 and 17 are schematic illustrations of cross-sectional views of additional waveguides in accordance with some demonstrative embodiments, illustrating the integration of two or more features into one device. [Figure 18A] 18A and 18B are schematic diagrams of a portion of a waveguide or optical fiber encapsulated (or surrounded) in an inflatable balloon, according to some demonstrative embodiments. [Figure 18B] 18A and 18B are schematic diagrams of a portion of a waveguide or optical fiber encapsulated (or surrounded) in an inflatable balloon, according to some demonstrative embodiments. [Figure 19A] FIG. 19A is a schematic diagram of a medical device, according to some demonstrative embodiments. [Figure 19B] FIG. 19B is a schematic diagram of a medical device, according to some demonstrative embodiments. [Figure 19C] FIG. 19C is a schematic diagram of a medical device, according to some demonstrative embodiments. [Figure 19D] FIG. 19D is a schematic diagram of a medical device, according to some demonstrative embodiments. [Figure 20A] FIG. 20A is a schematic diagram of a medical device, according to some demonstrative embodiments. [Figure 20B] FIG. 20B is a schematic diagram of a medical device, according to some demonstrative embodiments. [Figure 20C] FIG. 20C is a schematic diagram of a medical device, according to some demonstrative embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007]

[0026] It should be clear that the figures are not necessarily to scale, and some components and elements in the figures are intentionally or exaggeratedly smaller or larger or shorter or longer than in reality in order to more clearly show and demonstrate certain structural and / or functional features of some embodiments.

[0008]

[0027] Some embodiments provide an energy profile adjusting waveguide, or a waveguide capable of adjusting or modifying its energy profile or its energy output characteristics according to a specific or predefined energy profile modification scheme or according to a specific predefined configuration. Some embodiments include laser-based devices, particularly medical laser-based devices, that include or incorporate or use such waveguides. Some embodiments allow modification of the profile of the energy output of the optical fiber, which can be used in the treatment of several medical conditions, such as various internal pathologies, with light or light energy.

[0009]

[0028] 19A and similarly FIG. 20A, which diagrammatically illustrate a medical device 100A according to some demonstrative embodiments. The device 100A can be, for example, a catheter configured to perform light-based or laser-based treatment of a particular target area within the body. For example, the device 100A can be inserted into the patient's body, typically while the patient is sedated or anesthetized, or during surgery or other medical procedure (e.g., endoscopy, anoscopy, arthroscopy, bronchoscopy, colonoscopy, cystoscopy, esophagoscopy, gastroscopy, laparoscopy, pharyngoscopy, neuroendoscopy, rectoscopy, sigmoidoscopy, thoracoscopy), and can be guided in a flexible or semi-flexible manner toward the target area (e.g., a tumor or lesion) or can be brought directly to the target area (e.g., directly if the target area is physically accessible). Device 100A can then generate and output energy, specifically light-based energy or optical energy or laser-based energy, and according to some embodiments, the level and direction of the energy can be controllable and / or variable to ensure that the energy specifically treats (or only or selectively treats) the target region and / or to ensure that the energy does not treat (or at all treats or minimizes or minimizes the impact of) other region(s) outside the target region (e.g., regions adjacent to, next to, or surrounding the target region, or regions proximate to the target region).

[0010]

[0029] Device 100A includes a laser / light source 105, which generates a laser or light beam or beam. For demonstration purposes, four such beams 121-124 are shown. The laser or light beam enters a waveguide 103 or optical fiber or fiber optic, which is typically implemented as a thin, long, generally hollow, flexible tube or pipe, typically having a length between 30 and 500 centimeters, or between 10 and 500 centimeters (e.g. for treatment of prostate conditions the device may be about 20 or 200 centimeters long), or between 10 and 1000 centimeters, or between 10 and 2000 centimeters (e.g. for performing certain medical conditions, particularly those using Magnetic Resonance Imaging (MRI), 10 meter or 15 meter or even 20 meter devices may be used), and which is typically cylindrical or generally cylindrical and has a circular or generally circular cross section, with a diameter typically in the range of 0.5 to 10 millimeters, or in the range of 0.2 to 10 millimeters, or in the range of 0.1 to 10 millimeters.

[0011]

[0030] For purposes of demonstration, item 103 will be referred to herein as a “waveguide,” although it may also be referred to as an “optical fiber” or “fiber optic.” In some embodiments, waveguide 103 is enclosed in an encapsulation or jacket or other outer shell or sleeve or protective layer, and typically has a central core surrounded by a cladding layer or cladding, although these are not shown in FIG. 19A to avoid cluttering the drawing.

[0012]

[0031] In some embodiments, the waveguide 103 (or a catheter using the same) terminates in a tip / cap zone 101, which may be dome-shaped or tapered (e.g., for penetrating body tissue). The tip or cap zone is small compared to the overall length of the waveguide, e.g., the tip / cap zone may be less than 1% of the overall length of the waveguide, and the non-cap / non-tip zone 102 may be at least 99% of the length of the waveguide. In some embodiments, particularly where the overall length of the medical device is relatively short (e.g., less than 30 centimeters, or less than 20 centimeters, or less than 15 centimeters), the tip / cap zone 101 may be less than 5% of the overall length of the waveguide, or less than 3% of the overall length of the waveguide, or less than 2% of the overall length of the waveguide, or about 0.5 to 5% of the overall length of the waveguide, with the remainder being the non-cap / non-tip zone 102. The waveguide tip / cap zone 101 differs from the non-tip / non-cap zone 102 in at least one characteristic, e.g., shape, such as the tip / cap zone being tapered or hemispherical in shape, whereas the waveguide non-tip / non-cap zone is generally cylindrical in shape, and / or width or thickness, such as the tip / cap zone (or at least a portion or region thereof) being thinner or less thicker or narrower than the waveguide non-tip / non-cap zone.

[0013]

[0032] According to some embodiments, a first side or region or area of ​​the waveguide 103 includes a first set of optical elements and a second, different side or region or area of ​​the waveguide 103 includes a second set of optical elements, which may be generally similar or the same as those on the first side, or different from those on the first side. For purposes of demonstration, some parts of the description and / or some parts of the drawings may show or describe two such regions or segments of the same waveguide, but some embodiments may use only one region or segment of a waveguide, or three or more such regions or segments of a waveguide, and similarly, some embodiments may have such regions or segments on only one side thereof, or on two opposing sides, or on two non-opposing sides, or on three (or more) sides.

[0014]

[0033] For purposes of illustration, in this drawing, a first side of the waveguide 103 is the top side, which includes two optical elements 111, 112, and in this drawing, a second side of the waveguide 103 is the bottom side, which includes another two optical elements 113, 114. For example, each of the optical elements 111-114 may be an inwardly or inwardly directed wedge or optical hurdle or tooth or optical redirector element (e.g., mirroring element, mirror, micromirror, flat mirror, planar mirror, non-planar mirror, non-planar reflective element, curved mirror, convex mirror, concave mirror, diffuser or optical diffuser or optical diffuser, reflective element, refractive element, prism, lens, microlens, etc.) capable of deflecting and / or refracting an incoming light ray or beam (or a portion thereof) towards a particular direction (or directions). Optionally, each of the optical elements 111-114 may have particular structural and / or optical properties or functions, which may be configured by forming such elements from a particular material, or by coating such elements (or portions thereof) with a particular coating, and / or by setting or changing or configuring or adjusting the refractive index of an external coating or sleeve or medium or encapsulating element, and / or by constructing or forming such elements to have a particular three-dimensional shape and / or volume and / or dimensions and / or contour and / or gradient structure, and / or by setting the position of one or more such elements and / or the distance between them and / or the number of such elements.

[0015]

[0034] For example, due to the position, location, size, tilt, structure, distance, material of construction, and / or coating of each of the optical elements 111-114 (or its external medium or sleeve or encapsulation element), one or more of the incoming light rays 121-124 may be refracted or deflected, in particular away from the long axis of the waveguide 103, or away from the longitudinal dimension or axis of the waveguide 103, or toward a point or region located laterally of the longitudinal dimension of the waveguide 103 and not toward a point or region located in front of (or beyond) the tip / cap zone 101 of the waveguide 103.

[0016]

[0035] For example, incoming light ray (in-waveguide light ray) 121 is deflected or refracted by the surface of optical element 111 and / or due to one or more properties of optical element 111 (e.g., its size, length, tilt, position, coating, etc.) and exits laterally from waveguide 103 (and medical device 100A) as outgoing light ray 131. Additionally, incoming light ray (in-waveguide light ray) 122 is deflected or refracted by the surface of optical element 112 and / or due to one or more properties of optical element 112 (e.g., its size, length, tilt, position, coating, etc.) and exits laterally from waveguide 103 (and medical device 100A) as outgoing light ray 132.

[0017]

[0036] The outgoing rays 131 and 132 intersect or meet or collide or overlap at a focal point 141 (which may be a single focal point, particularly when illustrating the intersection of two rays, or in some embodiments demonstrating an area where multiple rays intersect, may be a focal area or zone or region, typically shaped as a rectangle or square or diamond or quadrilateral or other polygon, or a circle or ellipse), which is at a distance Ddis1 from the waveguide 103 (or from the outside of the envelope or capsule or catheter in which the waveguide 103 is enclosed). Thus, the focal point 141, or similarly the focal area or zone and its adjacent areas or regions, are high energy areas or regions, and are shown in the drawings with an H for High. The areas or regions that continue from the outer envelope of the waveguide 103 to the focal point 141 where the outgoing rays 131 and 132 have not yet intersected are low energy or medium energy regions. After meeting or intersecting or overlapping at the high energy focal point 141, the outgoing rays 131, 132 spread out so that they travel through further intermediate energy regions and then through low energy and / or very low energy zones.

[0018]

[0037] Similarly, incoming light ray (in-waveguide ray) 123 is deflected or refracted by the surface of optical element 113 and exits laterally from waveguide 103 (and medical device 100A) as outgoing ray 133. Furthermore, incoming light ray (in-waveguide ray) 124 is deflected or refracted by the surface of optical element 114 and exits laterally from waveguide 103 (and medical device 100A) as outgoing ray 134. Outgoing rays 133 and 134 intersect or meet or overlap at or near focal point 142, which is a distance Ddis2 from waveguide 103 (or from outside the envelope or capsule or catheter in which waveguide 103 is enclosed). Thus, the focal region or areas at or near focal point 141 and adjacent areas or regions are high energy areas or regions, designated in the drawings as H, for high. Areas or regions leading from the outer envelope of waveguide 103 to focal point 142 that have not yet been intersected by outgoing rays 133 and 134 are low or intermediate energy regions.

[0019]

[0038] After meeting or intersecting or colliding or overlapping at the high energy focal point 142, the outgoing rays 133, 134 spread out so that they pass through further intermediate energy regions and then through low energy and / or very low energy zones. As explained, each of the high energy focal points (141, 142) need not necessarily be a single point, but can be a high energy focal zone or high energy focal area or focal region, through which many such rays intersect at many intersection or overlap points next to or adjacent to each other.

[0020]

[0039] It should be noted that such high energy focal point(s) or focal area(s) or focal zone(s) or focal region(s) may be at other suitable locations or spatial locations relative to the waveguide, for example, they may be near and outside the tip zone or cap zone, or they may be near and outside several different areas of the waveguide. For example, in some embodiments, such a focus or focal zone or area of ​​K1 may be located on a first side of the waveguide, such a focus or focal zone or area of ​​K2 may be located on a second, different side of the waveguide (e.g., a generally opposing or non-opposing side), and such a focus or focal zone or area of ​​K3 may be near and outside the tip or cap zone of the waveguide, where K1, K2 and K3 are predetermined values, each of which may be 0 or 1 or 2 or 3, and may be integers typically less than 10 or typically less than 100, each of which may be different from each other, or two (or more) of them may have the same value.

[0021]

[0040] It should be noted that the two distances Dis1 and Dis2 can be the same as each other, and in other embodiments, they can be different from each other to provide two different distances (perpendicular to the outer envelope of the waveguide 103) at which the high energy profile occurs. In some embodiments, the waveguide 103 can optionally include optical elements, such as optical elements 111, 112, on only one side instead of two sides, such that energy or light rays or beams are emitted from only one side of the waveguide 103 with one focus of high energy on that side.

[0022]

[0041] The distances Dis1 and Dis2 can be configured or determined based on characteristics of each of the optical elements 111, 112 and 113, 114, including the type of each optical element (e.g., wedge, inward teeth, inward ridge, prism, lens, flat mirror, curved mirror, etc.), the tilt or curvature of each optical element, the spatial shape of each optical element, the depth to which each optical element penetrates or blocks the core of the waveguide 103, the amount of light ray or beam that each optical element can redirect, the surface area of ​​the optical element, the surface area of ​​a particular surface of the optical element facing the direction from which the light ray or beam is coming in, the material(s) forming the optical element, the material(s) forming one or more sleeves or encapsulation layer(s) or medium(s) that surround and / or encapsulate the waveguide or optical fiber (e.g., These may include, for example, the thickness of the optical element, which may have a particular refractive index that can be optionally set or configured to achieve particular optical properties, the coating of each optical element, the number of optical elements in each segment or region of the waveguide (e.g., 2 optical elements arranged in series on the same side, or 3 optical elements arranged in series on the same side, or N optical elements arranged in series on the same side), the longitudinal distance spacing between two consecutive optical elements on the same side (e.g., the distance between optical element 111 and optical element 112), and / or other structural parameters that may be preconfigured or set, and / or the wavelength of the incoming light or laser beam (e.g., which may affect the location or distance of the respective focal points or focal areas due to changes in energy absorption by the tissue of the associated body organ).

[0023]

[0042] 19B and 20B, which diagrammatically illustrate a medical device 100B according to some demonstrative embodiments. Device 100B may be generally similar to device 100A of FIG. 19A, except that device 100B further includes a solution sleeve 165 that surrounds or encapsulates waveguide 103 (or at least a portion thereof). Solution sleeve 165 may be a thin, elongated container or conduit or repository that may store solution 166 or other material (e.g., liquid, gas, fluid). For example, the two or more repositories 161, 162 can store two or more ingredients (e.g., water in repository 161 and sugar in repository 162), and the solution controller / modifier unit 153 operates to obtain (e.g., pump or suck) the two ingredients from the repositories 161, 162 according to a specific ratio (e.g., 100:3 water to sugar), mix them, and provide the mixed solution to the solution sleeve 165 via the liquid / solution inlet unit 151.

[0024]

[0043] The solution 166 is a different medium through which the outgoing light rays (light rays 131-134 shown in FIG. 19A) travel or pass, and so changes the deflection or refraction of the outgoing light rays, and the solution also changes the distance (Dis1 or Dis2) of the high energy focal points (141 and / or 142) from the waveguide 103.

[0025]

[0044] Optionally, using a controlled component such as a liquid / solution outlet unit 152 (e.g., using a valve or pump or suction unit), the solution 166, or portions thereof, can be selectively and controllably removed from the solution sleeve 165 and disposed of or discarded to a collection repository 163, and optionally a new, replacement or modified solution can be prepared and injected or introduced into the solution sleeve 165 by the solution controller / modifier unit 153, thereby allowing a user of device 100B to change the distance or position of the high energy focal points (141 and / or 142).

[0026]

[0045] Such controlled and user-selected changes can be made prior to insertion of the medical device 100B into a patient's body and / or can be made in real time or near real time, during surgery or while a medical procedure is in progress or while at least a portion of the device 100B is in vivo or while the waveguide 103 or a portion thereof is in vivo, thereby enabling real time or near real time changes or adjustments of the spatial location or distance of the high energy foci or focal zones or focal areas, and also enabling movement or relative movement of such high energy foci or focal zones or focal areas to gradually cover or reach multiple target regions or areas of interest for a medical procedure.

[0027]

[0046] In some embodiments, optionally, repositories 161, 162, and 163 may be implemented as a closed loop, and in some embodiments, two or more repositories may be implemented as one common repository associated with a closed loop mechanism that allows fluid to be transported from the repository and then returned to the same repository. Optionally, heat exchange units may be used and / or cooling units may be used to ensure, for example, that the transported fluid is at a particular temperature or within a particular temperature range.

[0028]

[0047] 19C and 20C, which diagrammatically illustrate a medical device 100C according to some demonstrative embodiments. Device 100C can be generally similar to device 100A of FIG. 19A, but device 100C further includes a balloon 170 that surrounds or encapsulates waveguide 103 or at least one or more regions of waveguide 103. In demonstrative embodiments, balloon 170 can include one or more inflatable zones and one or more non-inflatable zones.

[0029]

[0048] For example, zone 171 (located near optical elements 111, 112) is inflatable and formed of a stretchable material that can expand and expand its size or volume in response to the injection or pumping of air or gas, and similarly, zone 172 (located near optical elements 113, 114) is inflatable and formed of a stretchable material that can expand and expand its size or volume in response to the injection or pumping of air or gas. In contrast, other zones or regions of balloon 170, such as zones 173 and 174, are non-inflatable, which can be formed of a non-stretchable material and do not expand or expand their size or volume.

[0030]

[0049] In some embodiments, the inflated state of balloon zone 171 is not necessarily the same size or shape as the inflated state of balloon zone 172, e.g., balloon zone 171 may be inflated to P1 times its original thickness and balloon zone 172 may be inflated to P2 times its original thickness, where P1 and P2 are different values. In some embodiments, balloon zones 171 and 172 are not necessarily symmetrical to one another, and the zones may be located in different regions along the longitudinal dimension of waveguide 103.

[0031]

[0050] Inlet unit 175 allows an operator of device 100C to insert, inject, introduce or pump air or gas into balloon 170 to inflate balloon 170, allowing the operator to control, in a controlled or selective manner, the level of inflation and therefore the thickness of the inflated balloon zone(s). Similarly, outlet unit 176 allows an operator of device 100C to remove, pump or aspirate air or gas from balloon 170 to deflate part or all of balloon 170, allowing the operator to control, in a controlled or selective manner, the level of deflation and therefore the remaining thickness of the previously inflated balloon zone(s).

[0032]

[0051] The expansion and contraction actions may similarly change the size of the medium through which the outgoing light rays (131-134) pass before they intersect or touch, thus changing, increasing or decreasing the distance (Dis1 or Dis2) from the waveguide 103 to the associated high energy focal point (141 or 142). Such controlled and user-selected changes may be made in real-time or near real-time, during surgery or while a medical procedure is in progress, or while at least a portion of the device 100C is in vivo, or while the waveguide 103 or a portion thereof is in vivo.

[0033]

[0052] Some embodiments may combine features and / or functions from two or more figures or implementations described above or shown or illustrated herein. For example, an embodiment of a medical device may include all three features shown in Figures 19A, 19B, and 19C, namely, optical elements 111-114, solution sleeve 165, and balloon 170. Similarly, features from other embodiments or figures described or illustrated herein, such as, for example, features described herein that use curved optical elements or other types of optical elements, may be combined in one implementation or medical device.

[0034]

[0053] It should be noted that Figures 19A, 19B, and 19C illustrate some but not all of the components of the device(s) depicted therein to avoid cluttering the figures and to maintain clarity of the figures, For example, such device(s) may include a power source, a cooling unit for cooling one or more of the device units, a sleeve or capsule or other encapsulation layer(s), and / or other suitable components.

[0035]

[0054] 19D, which diagrammatically illustrates a medical device 100C according to some demonstrative embodiments. Device 100D may be generally similar to device 100B of FIG. 19B, but in some embodiments, device 100D may include internal optical elements located within the optical fiber such that they prevent the entirety of the laser beam or laser energy entering the proximal end of the optical fiber from exiting through the distal end or tip or cap of the optical fiber, and / or such that all of the laser beam entering the optical fiber is blocked and / or redirected and / or refracted and / or deflected and / or otherwise guided or deflected while propagating through the optical fiber or waveguide, such that all of the light beam or laser energy or light energy exits through a side panel or cap of the optical fiber. 19D demonstrates that the optical elements may be configured and / or arranged and / or positioned to exit laterally from a side wall or a side wall of the optical fiber, to prevent any laser beam or laser energy or light energy from exiting the optical fiber in a forward or general direction of propagation, and / or to redirect all of the laser or light energy entering the optical fiber so that all of the energy exits through (or from) one or more side panels of the optical fiber or generally perpendicular to (or obliquely or at an angle to) the side panels of the optical fiber, rather than exiting from a tip or cap at the distal end of the optical fiber. Although FIG. 19D illustrates and demonstrates such a configuration of optical elements in connection with a sleeve or chamber that may contain a solution or gas or liquid or fluid, such features of FIG. 19D may likewise be combined with other features described above and / or herein, and / or shown in any other figure(s), such as balloon chambers, inflatable sleeve segments, and the like.

[0036]

[0055] According to some embodiments, medical laser-based procedures or treatments may use laser energy generated by a laser source. For example, a probe waveguide or fiber is positioned near a portion of body tissue that is scheduled to be treated with laser energy. Once the waveguide or fiber is properly positioned, the laser energy is delivered through the waveguide or fiber to the treatment location or target area or region that is the intended target of treatment. In some medical procedures, the laser energy should be directed laterally from the tip to the target region.

[0037]

[0056] Applicants recognize that some "side fire" laser-based procedures using optical fiber-based radial emitting laser catheters may also be used in discectomy, laparoscopy, arthroscopy, benign prostatic hyperplasia, angioplasty, and related or other surgical procedures.

[0038]

[0057] A "side-fire" or radial laser-based fiber catheter can include a fiber optic element disposed within a cap. The fiber optic element has a tip cut and is highly polished at an oblique angle or into a conical shape, followed by an air gap or other medium or medium with a particular refractive index. When the laser energy is "fired" or emitted, the laser output beam is reflected by total internal reflection due to the difference in refractive index between (i) the fiber core and (ii) the cladding all the way to the tip of the fiber. At the tip, a polished surface or cone or other optical element or structure causes the laser beam(s) to be deflected or reflected away from the primary axis of propagation, typically by total internal reflection or lensing at an angle to the primary axis of propagation. In some implementations, the tip includes a protective cap, which itself can serve optical purposes.

[0039]

[0058] Applicant recognizes that laser energy emitted from a fiber follows the laws of point source propagation, which ultimately results in an exponential decay of energy with distance from the energy source. Applicant further recognizes that the thermal and absorption profiles that follow the energy generally exhibit an exponential decay profile in the radial direction from the energy source. Due to the inherent exponential decay, the temperature of the source is forced to be higher than the temperature of any point at some radial distance from the source. The strength or intensity of the decay is primarily a function of the absorption coefficient of the material in or through which the light propagates.

[0040]

[0059] Applicant has recognized that in surgical procedures (e.g., in interstitial procedures) or medical procedures, it is necessary not to vaporize or char or burn nearby or surrounding tissue or body regions that are near or adjacent to the target area to be treated, but not actually within the target area, with the laser energy. For example, such unwanted vaporization may cause an increase in interstitial pressure, which may cause medical complications or adverse outcomes. Similarly, unwanted charring may cause the absorption coefficient to change, which may initiate a cascade effect that may cause damage to the patient and to the medical device itself. Additionally, Applicant has recognized that limitations or restrictions associated with the temperature of the energy source, due to the exponential decay of energy, may lead to limitations or restrictions on the effective distance between the tip or edge of the laser-based device and the target area to be treated.

[0041]

[0060] Some embodiments provide an apparatus or medical device that redistributes energy, particularly optical or laser-based energy, in a manner that allows for better tailoring of the energy (and its intensity level) to the needs of a particular treatment and / or to the size or area or volume of the target region that is planned for treatment or expected to be affected, and further allows for changing and adjusting the directionality and / or depth of penetration of the laser-based energy.

[0042]

[0061] For example, an apparatus or medical device may include an optical unit, with two or more optical elements within each optical unit, and the number of optical units may be configured or set to achieve a particular implementation goal or to facilitate a particular type of medical procedure. Each optical element redirects a portion of the laser beam or light beam outward (or away) from the axis of propagation at a lateral angle. The beams then meet or meet at a distance from the center of the fiber, creating a focal point of energy there, and then continue propagating and spreading in the original direction. The distance from the center of the fiber to the focal point can be adjusted or changed or configured, and the portion of energy from each optical element can be adjusted or changed or configured. These redistributions and adjustments allow for leveling of the energy and temperature distribution of the laser beam in the direction of radiation.

[0043]

[0062] In some embodiments, more than one laser source is used, and more than one wavelength is used. Each wavelength is characterized by a different absorption coefficient for a particular medium or propagation medium. For example, different absorption effects can be used to match different energy emission profiles, because the focus may be different for each wavelength and depending on the specific penetration depth. This structure and method allows versatile control over the radiation energy and temperature profile to better match the specific area or dimension or volume of the target region that is planned to be treated. For example, two (or more) different types of laser beams or light beams or light energy or laser-based energy having two (or more) different wavelengths may propagate through the same waveguide and optical fiber, and the two (or more) beams may exit the waveguide and optical fiber laterally relative to the general direction of propagation (or laterally to the long axis or length of the waveguide and optical fiber), and optionally such two different types of laser beams or light beams may be redirected or affected such that they exit laterally at different locations and / or each of them may perform a medical procedure at a different in-vivo location and / or at a different distance from the external encapsulation of the optical fiber and / or at a different energy level.

[0044]

[0063] For example, a first set of laser beams having a first wavelength λ1 can be redirected by a first optical element (or by a first set of optical elements) in the waveguide or optical fiber to exit the optical fiber and overlap at a first specific focal point (or focal region) located a first distance from the encapsulating sleeve of the optical fiber to provide a first level of energy E1 thereat, and a second, different set of laser beams having a second, different wavelength λ2 can be redirected by a second optical element (or by a second set of optical elements) in the waveguide or optical fiber to exit the optical fiber and overlap at a second, different specific focal point (or focal region) located a second distance from the encapsulating sleeve of the optical fiber to provide a second level of energy E1 thereat, and in some embodiments, for example, D1 and D2 are different and / or E1 and E2 are different. In some embodiments, the first wavelength λ1 is associated with a first level of absorption in human tissue or has a first absorption coefficient (A1), and the second wavelength λ2 is associated with a second, different level of absorption in human tissue or has a second, different absorption coefficient (A2).

[0045]

[0064] In another example, a first set of laser beams having a first wavelength λ1 can be split by a specific optical element (or by a specific set of optical elements) in the waveguide or optical fiber, exit the optical fiber and overlap at a first specific focal point (or focal region) located a first distance D1 from the encapsulating sleeve of the optical fiber, where a first level of energy E1 can be provided, and a second set of different laser beams having a second different wavelength λ2 can be split by the same specific optical element (or by the same specific set of optical elements) in the waveguide or optical fiber, exit the optical fiber and overlap at a second different specific focal point (or focal region) located a second distance D2 from the encapsulating sleeve of the optical fiber, where a second level of energy E2 can be provided, in some embodiments, e.g., D1 and D2 are different and / or E1 and E2 are different. In some embodiments, the first wavelength λ1 is associated with a first level of absorption by human tissue or has a first absorption coefficient (A1), and the second wavelength λ2 is associated with a second, different level of absorption by human tissue or has a second, different absorption coefficient (A2).

[0046]

[0065] In some embodiments, the fiber is embedded inside a structure such as a catheter or guide wire or tube or pipe or probe, and the liquid medium(s) surrounding the waveguide or a capsule around the liquid medium(s). According to some embodiments, the liquid medium can include a particular solution or a mixture or combination of two or more solutions or liquids, and for some solutions, such as water with glucose or ethanol, the refractive index changes with the concentration of the solute. For example, for a solution where water is the solvent and glucose is the solute, the refractive index increases as the concentration of glucose increases. A light ray crossing the interface of two materials is refracted at an angle that depends on the difference between the refractive index of the materials at the intersection. Changing the refractive index of one of the materials (e.g., the liquid medium surrounding the waveguide) will change the direction of the light ray. In some embodiments designed or configured for the light ray to cross a distance from the waveguide, this change in refractive index increases or decreases the lateral distance from the waveguide to the focal point.

[0047]

[0066] In some embodiments, another property or feature of the redistribution can be based on an apparatus or medical device that allows angular control over the laser-based energy emission. For example, the angular envelope can be segmented into two or more sections. Each segment has different optical elements with different emission profiles. Each segment can have different angular sizes and different energy densities. The emission segments are distributed along the longitudinal axis with a desired length that can vary for each segment. The separation into segments and different power levels is useful when the desired heating volume (or volume or area of ​​the target region where the treatment is planned to be performed) is of asymmetric structure and / or when the probe is not exactly located in the center of the volume (or region) to be treated (this can be due to spatial or physical constraints that can prevent or limit or restrict the ability of the tip of the medical device to reach or probe beyond a certain point, or due to spatial obstructions, or due to misalignments that can occur during insertion or manipulation of the medical device).

[0048]

[0067] In some embodiments, the directionality of the emitted laser-based energy is important when there are areas adjacent to the volume (region of interest) that are planned to be treated that should not be treated or exposed to the laser-based energy. For example, in certain treatments of the brain, there may be functionally important areas (fornix, speech centers, etc.) adjacent (or in close proximity or adjacent to) the cancer that is planned to be treated, and in the treatment of prostate cancer, it is typically preferable to avoid treatment near the anal area.

[0049]

[0068] An exemplary embodiment has one optical element with two angular segments, segment A has an angle of 90 degrees and segment B has an angle of 180 degrees. Segment A emits 90% of the source's energy and segment B emits 10% of the source's energy. The density of the radiated energy is controlled by the energy source and by the structure of the optical element, and the total power is a function of the power of the energy source, the shape of the optical element, and the total angular size. These are only non-limiting examples, and some embodiments may provide a different number of such segments, which may be located on the same side or different (opposing or not) sides, and may output different percentage amounts of the source's energy.

[0050]

[0069] In some embodiments, the ability of an optical element to control the power and / or direction of laser-based or light-based energy may be a function of the relative area that the optical element covers of the total cross-section of the waveguide or optical fiber core.

[0051]

[0070] In some embodiments, the inwardly or internally directed wedges (or other suitable optical elements) can be constructed as a continuous or successive spiral shape or spiral structure, with specific optical parameters distributed continuously across the spiral structure depending on the radial position.

[0052]

[0071] For purposes of illustration, some of the figures may show simplified or partial actual ray tracing so as not to obscure or crowd the figures with multiple rays, beams or light paths.

[0053]

[0072] For clarity and to avoid overcrowding in the drawings, some of the drawings may show a cross-section of a portion of a component (e.g., a waveguide or fiber optic or optical fiber) rather than the entirety. In such illustrations of a particular component, it will be understood that similar structures may exist in other portions or regions not shown in the drawing (e.g., continuing the same as the pattern shown, or having complementary or inverted or mirror structures). Additionally or alternatively, an actual waveguide or optical fiber, or a medical device incorporating such, may include a series of the component(s) shown in the drawings, in a repeating sequence or as a continuous chain.

[0054]

[0073] In some embodiments, the waveguide or optical fiber can be configured as a long cylindrical or generally cylindrical article, similar to a long thin tube or pipe, and can be flexible or resilient or bendable or collapsible. In some embodiments, optionally, a non-circular cross-section (e.g., an oval or elliptical cross-section, an oval cross-section) and / or an asymmetric cross-section can be used for the entire medical device and / or its sleeve or encasing element, and / or the waveguide itself and / or the optical fiber itself. It can transport and / or propagate and / or guide and / or direct laser-based energy or laser beam(s) or light or light-based energy or light energy or light beam(s). It typically has a circular or generally circular cross-section, and can have a non-circular and / or asymmetric cross-section as described above, typically having a central core surrounded by a cladding or cladding (concentric or generally concentric). In some embodiments, the refractive index of the surrounding cladding is slightly lower than that of the core (e.g., 0.5 or 1 or 1.5 or 2 percent). In some embodiments, the waveguide or optical fiber can be coated with a protective coating and / or cushioning layer and / or can be coated with (or include) a rigid-flexible coating or layer, or a flexible or resilient coating or jacket or layer, and can optionally have one or more external marking(s) or other visual indicator(s) that aid in the use of the medical device, particularly where the medical device is configured to radiate energy asymmetrically, or to radiate a first level of energy from a first particular side and a second level (different) of energy from a second particular side (different).

[0055]

[0074] Applicant recognizes that in some embodiments, a non-circular (e.g., oval, elliptical, or oval cross-section) and / or asymmetric cross-section may provide one or more functional advantages, for example, it may provide the user of the optical fiber (or medical device) with enhanced mechanical control over bending and / or bending and / or moving the medical device in vivo, and / or it may provide the user of the medical device with better indication as to which side of the optical fiber is pointing towards the interior portion of the body (e.g., this may also be useful when the optical fiber emits laser-based energy laterally according to an asymmetric or non-equivalent energy distribution or energy emission scheme). In some embodiments, the non-circular cross-section may include, for example, at least one straight line (or surface) and at least one arc or curve or semicircular line or partially circular surface (or curved surface), for example, the cross-section may be comprised of a straight line and an arc that encompasses less than 360 degrees (e.g., 330 or 300 or 270 or 180 degrees). Other suitable structures or cross sections may also be used.

[0056]

[0075] Referring to FIG. 1, this diagram illustrates a schematic of a portion of a waveguide 1 according to some demonstrative embodiments, particularly with respect to propagating light or laser-based energy for medical treatment purposes. The diagram shows a longitudinal cross section, with only half of the optical fiber shown for clarity and to avoid overcrowding the drawing. Although one optical component 4 is included for demonstration purposes, several or many such (or similar) optical components can be used in series. A light or laser beam propagates through the waveguide 1 from left to right through the core 2 surrounded by the cladding 3. For example, a light ray 6 (e.g., a light ray, light beam, laser beam) comes from an energy source (e.g., a laser emitter, laser transmitter, laser generator, light source, light energy source).

[0057]

[0076] The internal structure of the waveguide 1 includes inwardly directed protrusions or pins or wedges or teeth, defined in the drawings as faces (or surfaces) 7 and 8. The light ray 6 reaches the surface 7, which is at an angle α with respect to the main propagation direction of the light ray 6 (or with respect to the longest dimension of the waveguide 1). Between the surfaces 7 and 8 there is a gap with a refractive index value lower than that of the core 2, forming an inwardly directed wedge or wedge-like or tooth-like structure or protrusion (or a crater, when the waveguide 1 is viewed from the outside). Based on geometric calculations, the angle of incidence of the light ray 6 on the surface 7 is (90 degrees - α) with respect to the normal 11. As long as the value of (90 degrees - α) exceeds the critical angle, the total internal reflection reflects the light ray back at the same angle, according to Snell's law. The ray is ultimately redirected at an angle θ with respect to its initial propagation direction, where θ is 2×α (eg, this empirical calculation is for rays parallel to the axis of propagation).

[0058]

[0077] If the material outside the optical fiber has a different refractive index than the cladding 3, then when the light rays reach surface 14, they will be redirected again according to Snell's Law. For purposes of demonstration and to avoid cluttering the drawing, the rays shown are generally parallel to the long axis of the waveguide, however, these are merely non-limiting examples and in some embodiments, non-parallel rays, or rays that are not completely parallel to the long axis of the waveguide, can be treated and used similarly, in which case, for example, rather than having a single focal point outside the waveguide, there may be a focal region or zone outside the waveguide (e.g., the quadrilateral or diamond shaped area shown in FIG. 8 as four numerals 12).

[0059]

[0078] Referring to Figure 2, this figure illustrates generally similar to the portion of the waveguide 1 shown in Figure 1, in accordance with some demonstrative embodiments. In Figure 2, light ray 6 reaches surface 7 at an angle less than the critical angle (90 degrees - α) with respect to normal 11, where it is refracted according to Snell's Law and continues to propagate towards surface 8, where specular reflection redirects it at an angle θ with respect to its original axis. The angle θ is the sum of (i) the angle γ between surface 8 and the initial propagation direction, and (ii) the angle of incidence δ of light ray 6 on surface 8.

[0060]

[0079] Referring to FIG. 3, this diagram shows a schematic of a portion of a waveguide 1 according to some demonstrative embodiments, particularly with respect to propagating light or laser-based energy for medical treatment purposes. It includes two non-identical optical elements 4 and 5, e.g., two non-identical inwardly facing wedges, which have different penetration depths and / or different angles relative to the general direction of propagation. The two optical elements may be embedded or recessed into a "jacket" such as a coating layer or coating member or encapsulation layer or capsule 13. For demonstration purposes, in a non-limiting example, capsule or cladding materials of the same or similar refractive index may be used, although in some embodiments capsule or cladding materials of different values ​​of refractive index may be used. The waveguide has a core 2 and a cladding (or cladding) 3.

[0061]

[0080] As demonstrated, two light rays (6 and 6a) originate from a laser source on the left and propagate to the right. Light ray 6 hits face 7 of first optical element 4 (first inward wedge) where it experiences total internal reflection and is redirected at an angle (2×α) with respect to the long axis of the waveguide, and hits outer surface 15 of capsule 13 where it is redirected again at an angle θ, which is the sum of all reflections and refractions upon reaching the medium outside the waveguide. Light ray 6a avoids first optical element 4 and continues to propagate through the long axis of the waveguide until it hits second optical element 5 and its surface 9 where it is reflected and redirected at an angle (2×β) with respect to the initial axis of propagation, and subsequently refracted at a total angle Φ with respect to the original axis. In some embodiments, the light rays reaching the surface 15 go into a material with a lower refractive index than the capsule, so that the light rays are refracted and increase in angle with respect to the normal to the surface 15. The waveguide is constructed or configured such that Φ>θ, so that the light rays intersect at a point 12 outside the waveguide. The location and distance of the point 12 from the waveguide can be controlled or defined by parameters of the waveguide and the two optical elements, for example based on their absolute dimensions, or based on their relative dimensions, or based on the ratio of the inward depth of the first optical element 4 to the inward depth of the second optical element 5, or based on the ratio of the inward depth of the first optical element 4 to the diameter of the circular cross section of the waveguide, or based on the ratio of the inward depth of the second optical element 5 to the diameter of the circular cross section of the waveguide. The light rays (6 and 6a) continue to spread out after (beyond) the focal point 12.

[0062]

[0081] Thus, a high energy focal area (or laser-based high energy focal point, or optical high energy focal point) is created or generated around point 12. This area or spatial region has a high energy density or concentration due to the integration of the light intersecting there or in its immediate vicinity. The amount of overlap and / or the magnitude of the energy coming from each optical element (4 and 5) can be controlled or configured based on the specific characteristics of the optical unit, for example by forming two specific optical elements (4 and 5) with a specific depth, inclination, three-dimensional shape, longitudinal distance between them, or values ​​of other parameters. This energy redistribution makes it possible to change the temperature profile in the medium(s) through which the light beam propagates from a simple exponential decay of energy to a flat radiation profile.

[0063]

[0082] Referring to FIG. 4, this figure shows a schematic optical view of a portion of a waveguide 1 according to some demonstrative embodiments. It represents a schematic optical diagram of an optical unit that may be similar to the optical unit described with reference to FIG. 3 above. An incoming light ray 6 (or a first part of the incoming light ray) is partially reflected out of the waveguide at an angle θ by a first optical element 4. Another incoming light ray 6a (or a second part of the incoming light ray) is emitted out of a second optical element 5 at an angle Φ. These angles are the total product of all internal reflections (contained by the capsule itself). The optical element 5 is at a longitudinal distance L from the optical element 4. The angle Φ is set to be larger than the angle θ, so that the rays (6 and 6a) intersect at a point 12 that is at a perpendicular distance (d) from the main propagation axis. The distance (d) depends on the value of the angle and the distance between the two optical elements. In some embodiments, the distance (d) is determined according to the empirical formula: d = L sinθ sinΦ / sin(Φ-θ) It can be calculated or estimated or estimated using:

[0064]

[0083] Thus, in some embodiments, the values ​​of the geometric parameters can be controlled or configured or set to adapt the energy profile to the volume of the target area that requires treatment with light or laser-based or optical energy. In some embodiments, each medical device or each optical unit thereof can have different values ​​of distance (d) depending on the desired value required in the volume.

[0065]

[0084] Referring to FIG. 5, this diagram illustrates a portion of a waveguide 1 according to some demonstrative embodiments, showing areas with various light-based energy profiles. It shows an energy profile diagram of the impact of an optical unit on an adjacent medium(s). For demonstration purposes, only two light rays and only the upper side of the waveguide are shown. The light rays are emitted outward from optical elements 4 and 5 at angles θ and Φ, respectively. To clarify the energy impact, and therefore the thermal impact, the area adjacent (or close to) the waveguide 1 is divided into two sections, shown in the drawing as a generally rectangular area, and each such section is marked M for Medium or H for High.

[0066]

[0085] For example, in areas 101 and 102, a medium energy level is emitted from both optical elements. The intersection of the light rays at point 12 in area 103 increases the energy at a distance d from the waveguide to a high energy level. Further on, in areas 104 and 105, the energy drops again to a medium level. The result is a medium energy level at a far distance, denoted d1, away from (but not near) the waveguide. Having the maximum energy level away from the waveguide helps protect the waveguide itself (e.g., by preventing cascading effective thermal effects on the waveguide surface), helps extend the mechanical and thermal resilience of the waveguide itself, and / or helps extend the reach of the effective energy to a larger or further treatment volume or target area.

[0067]

[0086] Referring to Figure 6, this figure illustrates diagrammatically a portion of a waveguide 1 according to some demonstrative embodiments. It shows a cross section of a portion of a waveguide having a core 2 and a cladding 3. The optical unit is composed of two continuous and non-identical optical elements (4 and 5), each of which covers or surrounds a full angular envelope. The waveguide is internal or inside a capsule 13.

[0068]

[0087] Referring to FIG. 7, this diagram illustrates a schematic of a portion of a waveguide 1 according to some demonstrative embodiments. In this example, the optical unit has two optical elements (4 and 5), where optical element 5 is a mirror with specular reflection rather than total internal reflection. Light rays 6 and 6a propagate from left to right. Light ray 6 reflects from optical element 4 at an angle θ. Light ray 6a reflects from optical element 5 at an angle Φ. Light rays 6 and 6a meet at point 12 and then diverge beyond. Area 19 is located between the two optical elements (4 and 5). Area 19 may be part of core 2, or may be a void, or may be made of a different material (different from the material of core 2) with a different refractive index.

[0069]

[0088] Referring to FIG. 8, this figure illustrates a schematic of a portion of a waveguide 1 according to some demonstrative embodiments. This is a symmetrical view of a cross section of some embodiments using one or more optical elements with curved surfaces. On the left side, a portion of the waveguide 1 is shown with its core 2 and cladding 3. It ends with a curved surface 7, which has a portion (indicated as 7a) with a different angle of incidence associated with the axial light ray. On the right side, a different second optical element 5 with a reflective surface 9 is shown. The rays 6 and 6a propagate from left to right towards the optical element 4. The ray 6a hits the portion 7a of the curved surface of the optical element 4 at an angle greater than the critical angle (set by the interface between the material of the core 2 and the material of the area 19). Exceeding the critical angle results in the reflection of the ray 6a at the surface 7a at an angle that depends on the particular local curvature and that varies along the surface. The ray 6 propagates from left to right and hits the portion 7, which is a different portion of the curved surface of the optical element 4. The light ray 6 strikes the curved surface at an angle less than the critical angle, so that the light ray 6 travels to area 19 with minimal or no refraction (depending on the particular local curvature of the curved portion 7 of the optical element 4). Upon reaching the curved surface 9 of the second optical element 5, some of the light is specularly reflected at an angle relative to the direction of propagation, depending on the particular curvature. The curvatures of surfaces 7, 7a, and 9 are set such that the light reflected from the surfaces intersects at particular points 12 away from the waveguide with some or all possible combinations of various reflections and refractions at the surfaces, although for illustrative purposes, eight such intersections are shown to represent some of the possibilities.

[0070]

[0089] 9A and 9B, which diagrammatically illustrate a portion of a waveguide 1 according to some demonstrative embodiments, showing changes to the energy profile due to a controlled change in the controlled liquid or gas or fluid environment. Applicant recognizes that some liquids or gases or fluids or solutions may change their refractive index, and / or their optical properties and / or the manner in which they permit a laser beam or light or laser-based energy to pass therethrough, in response to a change in the internal solution, and / or in response to a change or increase or decrease in the concentration of the solution, and / or in response to a change or increase or decrease in the ratio of materials or components of the solution or mixture of materials. For example, a solution or mixture of water and glucose (or ethanol) may change its refractive index in response to the concentration of glucose (or ethanol) in such solution or mixture. According to some embodiments, the waveguide may be placed in a controlled (or configurable or alterable) liquid or gas or fluid or solution environment, such as in a catheter, in a liquid or gas or fluid or solution surrounding the waveguide in the catheter (which may also provide cooling). Thus, controlling or altering the concentration of solvent in the liquid or gas or fluid or solution may change the optical path of the light beam redirected from the waveguide.

[0071]

[0090] In some embodiments, for example, an external or ex vivo control unit can be controllably and / or selectively operated by an operator of the medical device to dynamically change or increase or decrease the concentration of a solution being pumped or inserted or injected into a sleeve chamber or sleeve storage layer, or into a fluid storage chamber or fluid retention chamber that is part of the encapsulating sleeve of the optical fiber, or into a fluid retention canal or fluid retention groove that encloses at least one segment of the optical fiber, or into a corresponding chamber or groove or canal that may be an integral part of the catheter or medical device containing the optical fiber, or into a fluid retention chamber or groove or canal or sleeve that is located near or adjacent to the outside of the optical fiber and / or in direct contact with the optical fiber and / or immediately adjacent to the optical fiber and / or attached directly to the optical fiber and / or attached directly within the catheter that also receives the optical fiber.

[0072]

[0091] It should be noted that in some embodiments the fluid retaining chambers or channels or canals or sleeves are implemented with non-expandable channels or canals or chambers or sleeves, which cannot be expanded by air or gas entering therein and / or which do not increase or change their volume in response to air or gas entering therein and / or which have a fixed volume and / or fixed dimensions, such that the dimensions or volume or contour of a medical device having such channels or canals or chambers or sleeves remains constant and does not change, and only the contents of such channels or canals or chambers or sleeves can be altered, thereby altering the optical properties of such contents, but not the volume or dimensions of the channels or canals or chambers or sleeves or medical devices. In other embodiments, optionally, the fluid-retaining chamber or groove or canal or sleeve is implemented with an inflatable groove or canal or chamber or sleeve, allowing the size, volume, dimensions or contours to be altered by an operator by pumping or inserting or injecting into such fluid-retaining chamber or groove or canal or sleeve to change the fluid or gas or liquid entering therein, and / or by performing inflation and / or deflation actions to effect such change.

[0073]

[0092] In some embodiments, the control unit allows an operator to change the concentration of a solution, inject or insert or pump a solution into such fluid-holding chamber or sleeve or canal, pump the contents (or some of the contents) out of such fluid-holding chamber or sleeve or canal, add only solids or only liquids to a solution already inserted (e.g., to change the concentration of the solution), replace a first liquid or solution previously introduced into the fluid-holding chamber or sleeve or canal with a second, different fluid or solution having different optical properties, and / or any combination of these changes.

[0074]

[0093] As shown in FIG. 9A, the waveguide 1 is located inside or within the catheter. A liquid 20 (and in some embodiments a gas, a mixture of gases, a fluid, a mixture of fluids, a solution) is in the volume between the capsule 13 and the catheter 22. The general direction of the light beam in the medium is a result of the optical elements and refraction at two interfaces (21 and 22) where the light beam passes from one material to the other. A changeable refractive index of the liquid can change the general direction of the light beam. The advantage of such redirection of the light beam is the ability to change the position of the focal point (12) of the light beam and / or its distance (d) from the waveguide by changing the solution or its concentration.

[0075]

[0094] In FIG. 9A, the refractive index of the liquid (or gas or fluid or solution) is similar to that of the surrounding capsule, and therefore the intersection of the light rays occurs at focal point 12, a distance d from the waveguide. FIG. 9B shows the change in position and / or distance of focal point 12 when the refractive index of the liquid or solution or gas or fluid is changed (e.g., by changing the concentration of the solvent in the solution). For example, the refractive index of the surrounding liquid (or gas or fluid or solution) is reduced, which changes the light rays to intersect at point 12 located at a shorter distance (d1) from the waveguide. For example, controlling to reduce the refractive index of the surrounding liquid (or gas or fluid or solution) will cause focal point 12 to occur closer to the waveguide, and similarly, controlling to increase the refractive index of the surrounding liquid (or gas or fluid or solution) will cause focal point 12 to occur farther away from the waveguide.

[0076]

[0095] Referring to Figure 10, this figure illustrates an isometric view of a portion of a waveguide with directional radiation of energy, according to some demonstrative embodiments. It includes a plurality of inwardly facing wedges that are open or positioned or arranged at specific locations or longitudinal intervals along the longitudinal axis to provide non-uniform radiation of energy. For example, a waveguide 1 (or optical fiber) having a core 2 and a cladding 3 can have six optical elements (shown at 30, 31, 32, 33, 34, and 35) embedded therein.

[0077]

[0096] The set of six optical elements is divided into two segments in an angular envelope, with optical elements 30, 32, 34 in segment A and optical elements 31, 33, 35 in segment B. In this example, segment A directs energy radiation towards the top of the drawing and segment B directs energy radiation towards the bottom of the drawing. The direction of the energy radiation, the angular envelope, and the relative power of the energy radiation are a result of (or depend on) the structure of the optical elements, their depths, their shapes, their lengths, the lengths between them, their tilt angles, and / or other configurable parameters.

[0078]

[0097] In a demonstrative example, segment B has optical elements with a smaller power density than the optical elements of segment A, and the power density values ​​of each optical element of the same segment are similar to each other (e.g., P30=P32=P34>P31=P33=P35). The power density is controlled or configurable or depends on the amount of energy deflected from core 2. Inward wedges form optical elements that penetrate into the fiber core, adding a portion of the fiber core that deflects the light beam. Inward wedges can be configured such that the depth at which they penetrate increases as they cover more area within the optical fiber, and the same amount of energy is emitted from the core.

[0079]

[0098] 11-15, which diagrammatically illustrate cross-sectional views of several waveguides in accordance with several demonstrative embodiments, showing control of the directional emission of energy in the fiber axis at various segments to provide different power densities, allowing control of the direction, angular velocity, and relative power between segments.

[0080]

[0099] FIG. 11 shows a cross-sectional view of an optical element 4 with one segment 30 facing upwards. The optical element 4 is shown with a core and cladding 3. In this example, the segment has an angle γ of 90 degrees. The angle γ can vary as needed, for example, between 10 degrees and 180 degrees. Areas not within the optical element 4 are optical fibers themselves, and they can include one or more segments with different optical properties or functions. In the example shown, the optical element deflects about one-quarter of the total laser-based or light-based energy (e.g., to the side or away from the length of the optical fiber).

[0081]

[0100] 12 shows a cross-sectional view of two parallel optical elements: an upper optical element 4 (facing upwards and corresponding to upper segment 30) and a lower optical element 2 (facing downwards and corresponding to lower segment 32). In this case, each of the two optical elements covers 90 degrees and they have similar power densities.

[0082]

[0101] FIG. 13 shows a cross-sectional view of an optical element with one segment 30 facing upwards, which is generally similar in shape to the optical element shown in FIG. 11, but the optical element shown in FIG. 13 has a reduced area and therefore provides a lower power density compared to that provided by the optical element of FIG. 11. The reduced area optical element of FIG. 13 therefore deflects a smaller portion of the incident energy of the propagating light beam. For example, due to its construction, the optical element of FIG. 13 deflects only those light beams that reach (or propagate near) the outer rim of the core, while light beams propagating at (or near) the center of the core avoid the deflection area of ​​the optical element and continue to propagate beyond the optical element.

[0083]

[0102] 14 shows a cross-sectional view of an optical element having segments 30 that provide increased power density. The optical element provides a higher power density by deflecting a larger portion of the incoming light beam, even if the angular proportions of the segments are similar (e.g., 90 degrees). The orientation of the deflected area is primarily a function of the angle of the surfaces in the optical element and therefore remains the same.

[0084]

[0103] 15 shows a cross-sectional view of an optical element having a segment covering 180 degrees or half of the total area of ​​the cross section of the optical fiber, therefore half or approximately half of the propagating energy is deflected by the optical element.

[0085]

[0104] 16-17 and 18A-18B, which diagrammatically illustrate cross-sectional views of several waveguides in accordance with several demonstrative embodiments, which show the integration of two or more of the above features into one device.

[0086]

[0105] In FIG. 16, the waveguide 1 has one continuous spiral or spiral-like optical element with different internal sections or different inward facing regions or different inward facing wedges that combine or provide some or all of the divisions of the angular envelope. The continuous spiral has different segments and the orientation of the optical elements is configured or changed to meet the focusing requirements. The various segments characterize the direction and power density of the emitted light. For example, segments 40, 42, 44 provide a higher average power density than the average power density of the emission from segments 41, 43, 45. This configuration or structure directs more laser-based or optical energy in the upward direction relative to the downward direction. The weight or ratio of the relative power emitted can be adjustable or configurable for various directions and / or can be different within the same segment area (if desired to achieve a specific implementation goal). The direction of the emitted light beams is also controlled by the orientation and / or size and / or shape and / or tilt of the optical elements of each segment and / or the faces or surfaces used to construct each segment or each element (e.g., each wedge). As a non-limiting example, segment 44 directs diagonal radiated energy to the right (northeast) while adjacent segment 42 on the same side directs radiated energy to the left (northwest), and the emitted light beams from these elements (42 and 44) ​​intersect at point 12a above the waveguide. Similarly, segment 45 directs diagonal radiated energy to the right (southeast) while adjacent segment 43 on the same side directs radiated energy to the left (southwest), and the emitted light beams from these elements (45 and 43) intersect at point 12a below the waveguide. In an illustrative example, the combined power density at focal point 12 (or near focal point 12, or at all foci located above the waveguide) is 70% of the total power originally propagated through the waveguide, and the combined power density at focal point 12a (or near focal point 12a, or at all foci located below the waveguide) is 30% of the total power originally propagated through the waveguide.

[0087]

[0106] In Fig. 17, an optical unit is shown that can be used to achieve energy directionality, for example, parallel to the extension of the energy focus. For example, such a structure can direct a first specific percentage of the energy downwards and another different specific percentage of the energy upwards, and can create two different focuses, one on each side of the waveguide, at distances d and d1 (respectively) from the waveguide. The waveguide has two optical elements: a first optical element 4 (e.g., with three faces 7, 7a, 7b) and a second optical element 5 (e.g., with two faces 9 and 9a). Optical element 5 is reflective, for example, by coating with a reflective material or by other suitable means. Light rays 6, 6a, 6b, and 6c propagate through the waveguide from left to right. The rays 6 and 6c are reflected by the optical element 4, while the rays 6a and 6b are refracted at the surface 7a and propagate towards the second optical element 5 where they are redirected. The rays 6 are directed towards the surface 7a and are redirected downwards through total internal reflection. The rays 6a and 6b pass through the surface 7a and the area 19 and reach the optical element 5. The rays 6a are reflected at the surface 9 and are redirected upwards. The rays 6b are reflected at the surface 9a and are redirected downwards. The rays 6c reach the surface 7b and are redirected upwards through total internal reflection. The rays 6a and 6c intersect at the upper focal point 12 located at a distance d above the waveguide. The rays 6 and 6b intersect at the lower focal point 12a located at a distance d1 below the waveguide. The area of ​​surface 7 is larger than the area of ​​surface 7b (e.g., 2 or 2.5 or 3 times larger). The ratio of the cross-sectional areas (or surfaces 7 and 7a) is configured or set such that the redirected energy maintains a desired ratio of the energy radiated in the two (or more) directions, e.g., in this case, 70% to 30% for surfaces 7-7b and 9-9a (excluding the shadows of areas 7 and 7b, respectively).

[0088]

[0107] 18A and 18B, which illustrate a portion of a waveguide or optical fiber encapsulated (or surrounded) in an inflatable balloon, according to some embodiments. For example, the tip of the catheter may be constructed from a stretchable or elastic or expandable material that can be expanded or contracted by applying (or removing) an appropriate pressure, thereby selectively increasing (or decreasing) the volume of the inflatable balloon surrounding (or near) the tip of the catheter, particularly in the emission zone of the optical fiber. The balloon may be, for example, a compliant or elastomeric balloon (e.g., made of polyurethane or silicone), or a non-compliant or high pressure balloon (e.g., made of polyester or nylon), or a semi-compliant or medium pressure balloon that is inflated by volume (not pressure).

[0089]

[0108] The balloon may cover only the azimuth or a portion of the catheter. The advantage of increasing the volume of the balloon around the tip of the catheter may be, in some embodiments, enhanced cooling of the optical fiber area and reduced energy concentration in the tissue adjacent to the tip of the catheter itself, which may help prevent overheating of the tissue and / or protect the optical fiber itself from being damaged by overheating and / or allow the encapsulated medium to move away, which may change the direction of the radiated energy and / or the distance (from the outer jacket of the waveguide) at which the high energy focus occurs.

[0090]

[0109] In FIG. 18A, the balloon is shown in an uninflated or idle or deflated state. In FIG. 18B, the balloon is shown in an inflated state. For example, as shown in FIG. 18A, the optical fiber 1 is inserted into a catheter 40. Area 41 of the catheter is an area that is made of an expandable material, creating a balloon-like region within the catheter. A light emitting zone 42 of the optical fiber is disposed or adapted to be located near or behind (e.g., not at or within) the tip 45 of the catheter and / or adjacent to area 41, which is the balloon area of ​​the catheter 40. The space or gap or pocket or channel between the catheter 40 and the optical fiber is filled with a fluid (e.g., saline), which enters at area 43 and exits at area 44, and can be used to cool or inflate (or deflate) the balloon. As long as the fluid pressure within the balloon is low, the balloon will remain in a deflated state, and the distance (r) between the optical fiber and the catheter will be similar or the same in this area compared to other areas along the catheter. The maximum outer diameter of the catheter is indicated as w.

[0091]

[0110] In FIG. 18B, fluid is pressurized and flows inside the balloon via path 43 and out of the balloon via path 44, causing the balloon to expand due to the pressure drop between the incoming and outgoing flow. In this demonstrative example, the balloon is non-compliant and reaches its full predetermined size when the gap between the optical fiber and the catheter at area 41 of the catheter increases from r to r1 (i.e., r1>r). The maximum diameter of the catheter increases from w to w1 (i.e., w1>w). This effectively increases the gap between the optical fiber and the tissue, with the fluid acting as a buffer between the optical fiber and the tissue in the area of ​​the optical fiber's energy emission. This increase causes the emitted energy to be spread over an effectively larger area by a factor of about r1 / r, thereby reducing the density of the emitted energy at initial contact with the tissue by the same (or similar) factor, and therefore reducing the risk of hot spots or burns at the contact area. Compression of the tissue around the balloon also increases the effective radius of the applied energy.

[0092]

[0111] Some embodiments may include a medical device or catheter or medical probing device or medical device having an optical fiber or waveguide or optical unit therein capable of directing, propagating and emitting laser-based energy or light-based energy or light energy. The optical unit includes two (or more) optical elements in a waveguide. For example, a proximal element A emits a first portion of energy (energy portion I) at an angle θ relative to the original direction of propagation. A distal element (or subsequent element or second element or successive element) B emits a second portion of energy (energy portion II) at another angle Φ relative to the original direction of propagation. The angles θ and Φ are configured or set such that the light rays intersect at a certain distance (d) from the axis of the waveguide and diverge from that point onward. Each optical unit may have more than two optical elements, which may intersect at one focal point or multiple focal points (external to the waveguide). Each waveguide may include more than one optical unit. In some embodiments, successive light units (or light units connected in series) may emit different portions of the total light beam that entered the core of the waveguide.

[0093]

[0112] In some embodiments, the optical unit has two or more optical elements, each of which redirects a portion of the total energy of the waveguide at a specific different tilt angle with respect to the original propagation direction. The angular envelope of the waveguide or optical fiber is partitioned into two or more different segments, each such segment providing a different energy radiation profile.

[0094]

[0113] In some embodiments, the optical unit (or a portion thereof) is disposed in a liquid or solution or fluid (e.g., contained or held in a groove or canal, such as a sleeve, or chamber, or a canal or groove for containing a fluid that encloses, surrounds, covers or encloses the optical unit or at least one segment of the optical fiber or waveguide), and the refractive index of such liquid or solution or fluid can be altered, configured or controlled, thereby affecting distance (d) by changing the properties of the liquid or solution in real time or near real time (e.g., by changing or replacing the fluid, or by changing the concentration or clarity or transparency or translucency of the brightness level or contrast level of the fluid, or by adding a solvent to the solution, or otherwise).

[0095]

[0114] In some embodiments the optical element can be, for example, an inwardly facing wedge or tip or a reflective element or a refractive element, or an inwardly facing protrusion or rib or prism, or an inwardly facing sloped optical obstruction, or an object having one or more inwardly facing curved and / or flat surfaces, or other types of prisms or lenses or curved mirrors or convex mirrors or concave mirrors or flat mirrors.

[0096]

[0115] Some embodiments provide a medical device, comprising an optical fiber configured to be at least partially inserted into a human body, the optical fiber having a flexible proximal end that remains outside the human body and a distal end that can be controllably moved within the human body by one or more actions by an operator of the medical device, the one or more actions being selected from the group including pushing, pulling, bending, turning, redirecting, and bending. The optical fiber is configured to receive at the proximal end one or more laser beams generated by a laser beam generator operatively associated with the optical fiber. At least one region or segment of the optical fiber includes at least one optical element on an interior side of the optical fiber, the optical element being selected from the group including (i) a refracting optical element for refracting one or more laser beams propagating within the optical fiber, (ii) a deflecting optical element for deflecting one or more laser beams propagating within the optical fiber, and (iii) an optical element for deflecting one or more laser beams propagating within the optical fiber and for refracting one or more laser beams propagating within the optical fiber. At least one optical element disposed on the interior side of the optical fiber deflects and / or refracts one or more laser beams propagating through the optical fiber according to a particular laser energy distribution and emission scheme and directs at least one laser beam to exit the optical fiber laterally relative to a longitudinal axis of the optical fiber, through a sidewall of the optical fiber, to provide laser energy to an in vivo location located laterally of the optical fiber.

[0097]

[0116] In some embodiments, at least one optical element located on the interior side of the optical fiber is configured such that two or more laser beams are directed to exit transversely to a longitudinal axis of the optical fiber and to intersect and overlap at a particular distance transversely to the longitudinal axis of the optical fiber.

[0098]

[0117] In some embodiments, the at least one optical element located on the interior side of the optical fiber is configured to direct one or more laser beams to exit the side of the optical fiber in a first direction and to direct one or more other laser beams to exit the side of the optical fiber in a second, different direction.

[0099]

[0118] In some embodiments, the at least one optical element includes (I) a first optical element disposed at a first location on an interior side of the optical fiber and configured to direct one or more laser beams to exit the side of the optical fiber in a first direction, and (II) a second optical element disposed at a second, different location on the interior side of the optical fiber and configured to direct one or more laser beams to exit the side of the optical fiber in a second, different direction.

[0100]

[0119] In some embodiments, the at least one optical element includes: (I) a first optical element disposed at a first location on an interior side of the optical fiber and configured to direct two or more laser beams to exit laterally of the optical fiber in a first direction to intersect and overlap at a first intersection region located a first distance from the optical fiber; and (II) a second optical element disposed at a second, different location on the interior side of the optical fiber and configured to direct two or more laser beams to exit laterally of the optical fiber in a second, different direction to intersect and overlap at a second, different intersection region located a second, different distance from the optical fiber.

[0101]

[0120] In some embodiments, the at least one optical element includes: (I) a first optical element disposed at a first location on an interior side of the optical fiber and configured to (i) direct two or more laser beams to exit laterally from the optical fiber in a first direction to intersect and overlap at a first intersection region located a first distance from the optical fiber, and (ii) output N percent of the laser energy that entered the optical fiber through the proximal end laterally in the first direction; and (II) a second optical element disposed at a second, different location on the interior side of the optical fiber and configured to (i) direct two or more laser beams to exit laterally from the optical fiber in a second, different direction to intersect and overlap at a second, different intersection region located a second, different distance from the optical fiber, and (ii) output M percent of the laser energy that entered the optical fiber through the proximal end laterally in the second direction, where N is less than 100 and M is less than 100. In some embodiments, N is different from M. In some embodiments, N is not necessarily different from M.

[0102]

[0121] In some embodiments, the distal end of the optical fiber includes a cap or tip element, laser energy E enters the optical fiber through a proximal end, at least one optical element on the interior side of the optical fiber is configured to redirect N1 percent of the laser energy to exit the optical fiber laterally, and N2 percent of the laser energy is transmitted by the optical fiber to exit the optical fiber distal end through the cap or tip element in a forward direction rather than laterally. In some embodiments, N1 is less than 100 and N2 is less than 100. In some embodiments, optionally, N1 is different from N2.

[0103]

[0122] In some embodiments, the distal end of the optical fiber includes a cap or tip element, laser energy E enters the optical fiber through a proximal end, and the at least one optical element includes a first optical element and a second optical element disposed at two different locations within the optical fiber. The first optical element within the optical fiber is configured to redirect N1 percent of the laser energy to exit the side of the optical fiber in a first lateral direction. The second optical element within the optical fiber is configured to redirect N2 percent of the laser energy to exit the side of the optical fiber in a second, different lateral direction. Additionally, N3 percent of the laser energy is transmitted by the optical fiber to exit the distal end of the optical fiber via the cap or tip element in a forward direction rather than a lateral direction of the optical fiber. In some embodiments, N1 is less than 100, N2 is less than 100, and N3 is less than 100. In some embodiments, N1 is different from N2.

[0104]

[0123] In some embodiments, at least one optical element includes at least an inward wedge or inward protrusion that redirects at least some of the laser beam entering the optical fiber so that it exits the side of the optical fiber rather than passing through the distal end of the optical fiber.

[0105]

[0124] In some embodiments, the at least one optical element includes at least (I) a first inwardly angled wedge that redirects a first portion of the laser energy entering the optical fiber to exit laterally from the optical fiber in a first lateral direction of the optical fiber without passing through a distal end of the optical fiber, and (II) a second inwardly angled wedge that redirects a second, different portion of the laser energy entering the optical fiber to exit laterally from the optical fiber in a second, different lateral direction of the optical fiber without passing through the distal end of the optical fiber.

[0106]

[0125] In some embodiments, at least one optical element includes at least an inwardly directed generally spiral or generally helical extending protrusion that spirals within the optical fiber as an internal spiral protrusion or internal helical protrusion to provide at least one of (i) a continuum for modifying the optical properties of laser energy propagating within the optical fiber, and (ii) a continuum for guiding a laser beam propagating within the optical fiber to redirect at least some of the laser beams entering the optical fiber so as to exit laterally of the optical fiber without passing through a distal end of the optical fiber.

[0107]

[0126] In some embodiments, the at least one optical element includes only one optical element or two or more optical elements disposed on an interior side of the optical fiber and redirecting laser energy to asymmetrically exit the optical fiber laterally: A first portion of the laser energy that enters the optical fiber through the proximal end exits the optical fiber laterally in a first lateral direction and not through the optical fiber distal end; A second, different portion of the laser energy that enters the optical fiber through the proximal end exits the optical fiber laterally in a second, different lateral direction that is asymmetric to the first lateral direction and not through the optical fiber distal end.

[0108]

[0127] In some embodiments, the at least one optical element is located on an interior side of the optical fiber and redirects a first portion of the laser energy that enters the optical fiber through the proximal end to exit the side of the optical fiber to enable a medical procedure via the laser energy through a sidewall of the optical fiber and not through the distal end of the optical fiber. The at least one optical element also redirects a second portion of the laser energy that enters the optical fiber through the proximal end to exit the optical fiber in a forward direction through the distal end of the optical fiber.

[0109]

[0128] In some embodiments, the medical device further comprises an encapsulating sleeve encapsulating at least one segment of optical fiber, the segment of optical fiber intended for insertion into the human body. The encapsulating sleeve comprises a non-inflatable fluid-containing canal configured to receive an inflow of fluid to effect a change in focus where two or more laser beams intersect and overlap after exiting laterally through a wall of the optical fiber and through the fluid-containing canal. The fluid comprises one or more of a gas, a liquid, a solution, a saline solution, a water-sugar solution, and a water-salt solution.

[0110]

[0129] In some embodiments, the medical device further includes a control unit that is connected ex vivo to the optical fiber and selectively or temporarily changes the focal point where two or more laser beams intersect and overlap after exiting laterally through the wall of the optical fiber and through the non-inflatable fluid-holding canal in a manner that selectively or temporarily pumps a particular fluid into or out of the non-inflatable fluid-holding canal.

[0111]

[0130] In some embodiments, the medical device further includes a control unit that is connected to the optical fiber ex vivo to selectively or temporarily pump certain materials into or out of the non-inflatable fluid-holding canal, thereby changing the concentration of a solution held within the non-inflatable fluid-holding canal and selectively or temporarily altering the focal point where two or more laser beams intersect and overlap after exiting laterally through the wall of the optical fiber and through the non-inflatable fluid-holding canal.

[0112]

[0131] In some embodiments, the optical fiber further comprises an encapsulating sleeve encapsulating at least one segment of optical fiber, the segment of optical fiber intended for insertion into the human body, wherein the encapsulating sleeve comprises an inflatable balloon chamber that is controllably inflatable in vivo by receiving an inflow of fluid, the inflow of fluid causing the inflatable balloon chamber to expand, thereby changing the distance between (i) an inner wall of the optical fiber and (ii) a target area in the body where a medical procedure is to be performed, which in turn changes the power density of laser-based energy reaching the target area in the body, wherein the fluid comprises one or more of a gas, a liquid, a solution, a saline solution, a water-sugar solution, and a water-salt solution.

[0113]

[0132] In some embodiments, the at least one optical element includes at least: (a) a first curved optical element that (a1) redirects a first portion of laser energy entering the optical fiber to exit the optical fiber in a first lateral direction of the optical fiber without passing through a distal end of the optical fiber, and (a2) allows a second portion of the laser energy entering the optical fiber to continue propagating unaltered toward a second, different, curved optical element disposed further along the optical fiber; and (b) the second, different, curved optical element that redirects a first portion of the laser energy entering the optical fiber to exit the optical fiber in a first lateral direction of the optical fiber without passing through a distal end of the optical fiber, and (a2) allows a second portion of the laser energy entering the optical fiber to continue propagating unaltered toward a second, different, curved optical element disposed further along the optical fiber. and a second different curved optical element further disposed along the optical fiber for receiving the second portion of laser energy and redirecting the second portion of laser energy to exit the side of the optical fiber in a second different lateral direction of the optical fiber without passing through a distal end of the optical fiber, wherein the first portion of laser energy exiting the side of the optical fiber by the first curved optical element and the second portion of laser energy exiting the side of the optical fiber by the second curved optical element collide and overlap at a region of interest within the living body that is a region of focal points rather than a single focal point.

[0114]

[0133] In some embodiments, the optical fiber has a non-circular or asymmetric cross-section, which (i) improves mechanical control of bending movements performed by the medical device operator, and (ii) enables the medical device operator to efficiently understand the spatial orientation of the optical fiber in vivo.

[0115]

[0134] In some embodiments, the optical fiber has an oval or oval cross-section.

[0116]

[0135] In some embodiments, the optical fiber has a cross section that includes a straight line and an arc of less than 300 degrees (or an arc of less than 330 degrees, or an arc of less than 270 degrees).

[0117]

[0136] In some embodiments, by incorporating the at least one optical element within the optical fiber, the optical fiber is configured to emit directional, laterally directed, non-forward directed laser energy that is emitted laterally through a sidewall of the optical fiber rather than through a cap or tip located at a distal end of the optical fiber, according to a weighted energy emission scheme that defines: (i) N1 percent of the laser energy that entered the optical fiber through the proximal end is emitted laterally through a first location on the sidewall of the optical fiber in a first lateral, non-forward direction; (ii) N2 percent of the laser energy that entered the optical fiber through the proximal end is emitted laterally through a second location on the sidewall of the optical fiber in a second lateral, non-forward direction; and (iii) N3 percent of the laser energy that entered the optical fiber through the proximal end is emitted in a forward direction of the optical fiber through a cap or tip at the distal end of the optical fiber. In some embodiments, N1 is different from N2 and different from N3, and N2 is different from N1 and different from N3, and N3 is different from N1 and different from N2.

[0118]

[0137] In some embodiments, the optical fiber is configured to emit directional, laterally directed, non-forward directed laser energy by incorporating at least one optical element therein for performing a medical procedure at a body location that is lateral to the longest dimension of the optical fiber but not forward to the longest dimension of the optical fiber, and for providing laser energy to said body location that is lateral to the longest dimension of the optical fiber according to a predetermined or dynamically alterable energy distribution scheme.

[0119]

[0138] In some embodiments, the optical fiber is configured to receive, at a proximal end of the optical fiber, from the laser beam generator in operative association with the optical fiber, (I) a first set of laser beams having a first wavelength λ1 and a first absorption coefficient A1 indicative of a level of absorption by human body tissue, the first set of laser beams having the first wavelength λ1 being redirected within the optical fiber by a first set of optical elements such that the first set of laser beams having the first wavelength λ1 are emitted from the side of the optical fiber and overlap at a first specific focal point or focal region at a first distance D1 from an outer layer of the optical fiber, and the first set of laser beams having the first wavelength λ1 are redirected within the optical fiber by a first set of optical elements such that the first set of laser beams having the first wavelength λ1 are emitted from the side of the optical fiber and overlap at a first specific focal point or focal region at a first distance D1 from an outer layer of the optical fiber, and (II) configured to receive a second set of different laser beams having a second different wavelength λ2 and a second different absorption coefficient A2 indicative of a level of absorption by human body tissue, the second set of laser beams having the second wavelength λ2 being redirected within the optical fiber by a second set of optical elements such that the second set of laser beams having the second wavelength λ2 are emitted from the side of the optical fiber and overlap at a second different specific focal point or focal area at a second different distance D2 from an outer layer of the optical fiber, the second set of laser beams having the second wavelength λ2 providing a second different level of energy E2 at said second specific focal point or focal area at said distance D2.

[0120]

[0139] In some embodiments, the optical fiber is configured to receive, at a proximal end of the optical fiber, from said laser beam generator in operative association with said optical fiber, (I) a first set of laser beams having a first wavelength λ1 and having a first absorption coefficient A1 indicative of a level of absorption by human body tissue, wherein the first set of laser beams having the first wavelength λ1 are redirected within the optical fiber by a specific optical element such that the first set of laser beams having the first wavelength λ1 are emitted from the side of the optical fiber and overlap at a first specific focal point or focal region located at a first distance D1 from an outer layer of the optical fiber, and the first set of laser beams having the first wavelength λ1 have a first level of absorption at said first specific focal point or focal region located at said distance D1. and (II) configured to receive a second set of different laser beams having a second different wavelength λ2 and a second different absorption coefficient A2 indicative of a level of absorption by human body tissue, the second set of laser beams having the second wavelength λ2 being redirected in the optical fiber by the same specific optical element such that the second set of laser beams having the second wavelength λ2 are emitted from the side of the optical fiber and overlap at a second different specific focal point or focal area at a second different distance D2 from an outer layer of the optical fiber, the second set of laser beams having the second wavelength λ2 providing a second different level of energy E2 at the second specific focal point or focal area at the distance D2.

[0121]

[0140] In some embodiments, the medical device is configured to perform an in vivo laser-based medical procedure by emitting laser energy transverse to the general direction of propagation of the laser energy within the optical fiber.

[0122]

[0141] In some embodiments, the entirety of the laser beam that enters the optical fiber through the proximal end propagates within the optical fiber and then is emitted laterally through a lateral panel of the optical fiber, and none of the laser beam that enters the optical fiber through the proximal end exits the optical fiber through a cap or tip located at the distal end of the optical fiber.

[0123]

[0142] Some embodiments include a medical device including an optical fiber configured to be at least partially inserted into a human body. The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controllably moved within the human body by one or more actions of an operator of the medical device, the one or more actions being selected from the group including pushing, pulling, bending, turning, redirecting, and bending. The optical fiber is configured to receive at said proximal end one or more laser beams generated by a laser beam generator in operative association with said optical fiber. At least one region of the optical fiber includes at least one optical element on an interior side of said optical fiber that causes at least a portion of said one or more laser beams to exit the optical fiber optically laterally through a sidewall and that causes laser energy to radiate in a directional manner laterally or perpendicular to a longest dimension of said optical fiber rather than through a cap or tip located at a distal end of said optical fiber. The medical device is configured to perform a laser-based medical procedure in vivo by emitting laser energy transversely to a general direction of propagation of the laser energy in an optical fiber. The medical device includes an encapsulating sleeve that encapsulates at least one segment of an optical fiber, the segment of the optical fiber being intended for insertion into the human body. The encapsulating sleeve includes an inflatable balloon chamber at the segment that can be controllably inflated in vivo by receiving an inflow of fluid, the inflow of fluid inflating the inflatable balloon chamber, thereby changing the distance between (i) an inner wall of the optical fiber and (ii) a target area in the body where the medical procedure is to be performed, thereby changing the power density of the laser-based energy delivered to the target area in the body. The fluid includes one or more of a gas, a liquid, a solution, a saline solution, a water-sugar solution, and a water-salt solution.

[0124]

[0143] Some embodiments include a medical device including an optical fiber configured to be at least partially inserted into a human body. The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controllably moved within the human body by one or more actions of an operator of the medical device, the one or more actions being selected from the group including pushing, pulling, bending, turning, redirecting, and bending. The optical fiber is configured to receive at said proximal end one or more laser beams generated by a laser beam generator in operative association with said optical fiber. At least one region of the optical fiber includes at least one optical element on an interior side of said optical fiber that causes at least a portion of said one or more laser beams to exit the optical fiber optically laterally through a sidewall and that causes laser energy to radiate in a directional manner laterally or perpendicular to a longest dimension of said optical fiber rather than through a cap or tip located at a distal end of said optical fiber. The medical device is configured to perform an in vivo laser-based medical procedure by emitting laser energy transversely to a general direction of propagation of laser energy in an optical fiber. The medical device includes an encapsulating sleeve that encapsulates at least one segment of an optical fiber, the segment of the optical fiber intended for insertion into the human body. The encapsulating sleeve includes a non-inflatable fluid-containing canal that is configured to receive an inflow of fluid to alter a focal point where two or more laser beams intersect and overlap after exiting laterally through a sidewall of the optical fiber and through the fluid-containing canal, where the fluid includes one or more of a gas, a liquid, a solution, a saline solution, a water-sugar solution, and a water-salt solution.

[0125]

[0144] Some embodiments include a method of operating a medical device, the method comprising providing and / or manufacturing and / or producing an optical fiber configured to be at least partially inserted into a human body, the optical fiber having a proximal end that is flexible and remains outside the human body and a distal end that is controllably movable within the human body by one or more actions of an operator of the medical device, the one or more actions being selected from the group including pushing, pulling, bending, turning, redirecting, and bending, and the method comprising providing one or more laser beams generated by a laser beam generator operatively associated with the optical fiber into the proximal end of the optical fiber, deflecting and / or bending the one or more laser beams propagating through the optical fiber according to a specific laser energy distribution and emission scheme via at least one optical element located on an interior side of the optical fiber, and directing at least one laser beam to exit the optical fiber through a sidewall of the optical fiber transverse to a longitudinal axis of the optical fiber to provide laser energy to a location in the body located transverse to the optical fiber.

[0126]

[0145] As used herein, the terms "plurality" or "a plurality" include, for example, "multiple" or "two or more." For example, "a plurality of items" includes two or more items.

[0127]

[0146] The terms "one embodiment," "embodiment," "exemplary embodiment," "various embodiments," "some embodiments," and / or similar terms may indicate that the embodiment(s) so described may optionally include a particular feature, structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, repeated use of the phrase "in one embodiment" may, but does not necessarily, refer to the same embodiment. Similarly, repeated use of the phrase "in some embodiments" may, but does not necessarily refer to the same set or group of embodiments.

[0128]

[0147] The use of ordinal adjectives such as "first," "second," "third," "fourth," etc., used herein to describe items or objects, unless otherwise specified, is intended merely to indicate that reference is being made to various instances of such items or objects, and is not intended to imply that the items or objects so described should be in a particular given order in time or space or in ranking or any other manner of ordering.

[0129]

[0148] Any feature, operation, component, and / or feature described herein with reference to one or more embodiments may be combined or used in combination with one or more other features, operations, components, and / or features described herein with reference to one or more other embodiments. Some embodiments may include any possible combination, rearrangement, assembly, reassembly, or other use of some or all of the modules, functions, or components described herein, even if the modules, functions, or components described herein are described in different locations or different sections in the preceding description, or even if they are described in different figures or across multiple figures.

[0130]

[0149] While certain features of several illustrative embodiments have been illustrated and described herein, various modifications, substitutions, alterations, and equivalents will occur to those skilled in the art, and it is therefore intended that the claims cover all such modifications, substitutions, alterations, and equivalents.

Claims

1. A medical device, Optical fibers configured to be inserted, at least partially, into the human body. Includes, The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controlled to move inside the human body by one or more actions of a medical device operator, wherein the one or more actions are selected from the group including pushing, pulling, bending, rotating, changing direction, and bending. The optical fiber is configured to receive one or more laser beams generated by a laser beam generator operationally related to the optical fiber at its proximal end. At least one region of the optical fiber includes at least one optical element on the interior side of the optical fiber, the at least one optical element being selected from the group including (i) a refraction optical element that refracts one or more laser beams propagating within the optical fiber, (ii) a deflection optical element that deflects one or more laser beams propagating within the optical fiber, and (iii) an optical element that deflects one or more laser beams propagating within the optical fiber and refracts one or more other laser beams propagating within the optical fiber. The at least one optical element disposed on the interior side of the optical fiber deflects and / or refracts one or more laser beams propagating through the optical fiber according to a specific laser energy distribution and radiation scheme, directing at least one laser beam so that it exits the optical fiber through the side wall of the optical fiber, perpendicular to the long axis of the optical fiber, and providing laser energy to an in vivo location located perpendicular to the optical fiber. The at least one optical element is (I) A first optical element positioned at a first location inside the optical fiber, which directs two or more laser beams to exit laterally from the optical fiber in a first direction, and which is configured to intersect and superimpose them in a first intersection region located at a first distance from the optical fiber; (II) A second optical element positioned on the inside of the optical fiber at a second position different from the first position, which directs two or more laser beams so that they exit the optical fiber laterally in a second direction different from the first direction, and which is positioned at a second distance different from the first distance from the optical fiber, and which is configured to intersect and superimpose the second intersecting region different from the first intersecting region. including, Medical devices.

2. A medical device, Optical fibers configured to be inserted, at least partially, into the human body. Includes, The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controlled to move inside the human body by one or more actions of a medical device operator, wherein the one or more actions are selected from the group including pushing, pulling, bending, rotating, changing direction, and bending. The optical fiber is configured to receive one or more laser beams generated by a laser beam generator operationally related to the optical fiber at its proximal end. At least one region of the optical fiber includes at least one optical element on the interior side of the optical fiber, the at least one optical element being selected from the group including (i) a refraction optical element that refracts one or more laser beams propagating within the optical fiber, (ii) a deflection optical element that deflects one or more laser beams propagating within the optical fiber, and (iii) an optical element that deflects one or more laser beams propagating within the optical fiber and refracts one or more other laser beams propagating within the optical fiber. The at least one optical element disposed on the interior side of the optical fiber deflects and / or refracts one or more laser beams propagating through the optical fiber according to a specific laser energy distribution and radiation scheme, directing at least one laser beam so that it exits the optical fiber through the side wall of the optical fiber, perpendicular to the long axis of the optical fiber, and providing laser energy to an in vivo location located perpendicular to the optical fiber. The at least one optical element is (I) The first optical element, It is positioned at a first location on the inside of the optical fiber, Two or more laser beams are directed to exit laterally from the optical fiber in a first direction, and are made to intersect and superimpose in a first intersection region located at a first distance from the optical fiber, and N percent of the total laser energy that entered the optical fiber through the proximal end is output laterally in the first direction. A first light element configured as follows, (II) The second optical element, It is positioned at a second location on the inside of the optical fiber, different from the first location, Two or more laser beams are directed to exit laterally from the optical fiber in a second direction different from the first direction, and are intersected and superimposed in a second intersection region different from the first intersection region, which is located at a second distance different from the first distance from the optical fiber, and M percent of the total laser energy that entered the optical fiber through the proximal end is output laterally in the second direction. A second optical element configured as follows: Includes, N is less than 100, M is less than 100, N is different from M. Medical devices.

3. A medical device, Optical fibers configured to be inserted, at least partially, into the human body. Includes, The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controlled to move inside the human body by one or more actions of a medical device operator, wherein the one or more actions are selected from the group including pushing, pulling, bending, rotating, changing direction, and bending. The optical fiber is configured to receive one or more laser beams generated by a laser beam generator operationally related to the optical fiber at its proximal end. At least one region of the optical fiber includes at least one optical element on the interior side of the optical fiber, the at least one optical element being selected from the group including (i) a refraction optical element that refracts one or more laser beams propagating within the optical fiber, (ii) a deflection optical element that deflects one or more laser beams propagating within the optical fiber, and (iii) an optical element that deflects one or more laser beams propagating within the optical fiber and refracts one or more other laser beams propagating within the optical fiber. The at least one optical element disposed on the interior side of the optical fiber deflects and / or refracts one or more laser beams propagating through the optical fiber according to a specific laser energy distribution and radiation scheme, directing at least one laser beam so that it exits the optical fiber through the side wall of the optical fiber, perpendicular to the long axis of the optical fiber, and providing laser energy to an in vivo location located perpendicular to the optical fiber. The aforementioned at least one optical element is at least, (I) A first inwardly inclined wedge that changes the direction of a first portion of the laser energy entering the optical fiber so that it exits laterally from the optical fiber in a first lateral direction which is the radial direction of the optical fiber, without passing through the distal end of the optical fiber, (II) A second inwardly inclined wedge that changes the direction of a second different portion of the laser energy entering the optical fiber so that it exits the optical fiber laterally in a second lateral direction which is the radial direction of the optical fiber and different from the first lateral direction, without passing through the distal end of the optical fiber. including, Medical devices.

4. A medical device, Optical fibers configured to be inserted, at least partially, into the human body. Includes, The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controlled to move inside the human body by one or more actions of a medical device operator, wherein the one or more actions are selected from the group including pushing, pulling, bending, rotating, changing direction, and bending. The optical fiber is configured to receive one or more laser beams generated by a laser beam generator operationally related to the optical fiber at its proximal end. At least one region of the optical fiber includes at least one optical element on the interior side of the optical fiber, the at least one optical element being selected from the group including (i) a refraction optical element that refracts one or more laser beams propagating within the optical fiber, (ii) a deflection optical element that deflects one or more laser beams propagating within the optical fiber, and (iii) an optical element that deflects one or more laser beams propagating within the optical fiber and refracts one or more other laser beams propagating within the optical fiber. The at least one optical element disposed on the interior side of the optical fiber deflects and / or refracts one or more laser beams propagating through the optical fiber according to a specific laser energy distribution and radiation scheme, directing at least one laser beam so that it exits the optical fiber through the side wall of the optical fiber, perpendicular to the long axis of the optical fiber, and providing laser energy to an in vivo location located perpendicular to the optical fiber. The aforementioned at least one optical element includes two or more optical elements, The two or more optical elements are arranged inside the optical fiber and are configured to change the direction of the laser energy so that it exits asymmetrically and laterally from the optical fiber. The first portion of the laser energy entering the optical fiber through the proximal end exits the optical fiber laterally, in a first lateral direction which is the radial direction of the optical fiber, rather than through the distal end of the optical fiber. A second distinct portion of the laser energy entering the optical fiber through the proximal end exits the optical fiber laterally, not through the distal end of the optical fiber, in a second transverse direction which is the radial direction of the optical fiber and is different from the first transverse direction. Medical devices.

5. A medical device, Optical fibers configured to be inserted, at least partially, into the human body. Includes, The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controlled to move inside the human body by one or more actions of a medical device operator, wherein the one or more actions are selected from the group including pushing, pulling, bending, rotating, changing direction, and bending. The optical fiber is configured to receive one or more laser beams generated by a laser beam generator operationally related to the optical fiber at its proximal end. At least one region of the optical fiber includes at least one optical element on the interior side of the optical fiber, the at least one optical element being selected from the group including (i) a refraction optical element that refracts one or more laser beams propagating within the optical fiber, (ii) a deflection optical element that deflects one or more laser beams propagating within the optical fiber, and (iii) an optical element that deflects one or more laser beams propagating within the optical fiber and refracts one or more other laser beams propagating within the optical fiber. The at least one optical element disposed on the inside of the optical fiber deflects and / or refracts one or more laser beams propagating through the optical fiber according to a specific laser energy distribution and radiation scheme, directing at least one laser beam so that it exits the optical fiber through the side wall of the optical fiber, perpendicular to the long axis of the optical fiber, and providing laser energy to an in vivo location located perpendicular to the optical fiber, and the medical device, Encapsulation sleeve for enclosing at least one segment of the optical fiber It further includes, The segment of the optical fiber is intended to be inserted into the human body. The aforementioned sealing sleeve includes a non-expandable fluid-holding canal, The canal is configured to receive fluid inflow, and the fluid inflow alters the focus where two or more laser beams cross and superimpose after passing laterally through the wall of the optical fiber and through the fluid-holding canal. The fluid includes one or more of the following: gas, liquid, solution, physiological saline, solution of water and sugar, and solution of water and salt. Medical devices.

6. A medical device according to claim 5, Control unit connected to the optical fiber outside the body The control unit further includes, A specific fluid is selectively or temporarily pumped into or from the non-expandable fluid-holding canal. Selectively or temporarily altering the focal point where two or more laser beams cross and superimpose after passing through the wall of the optical fiber and through the non-expandable fluid-holding canal. Medical devices.

7. A medical device according to claim 5, Control unit connected to the optical fiber outside the body The control unit further includes, A specific material is selectively or temporarily pumped into or from the non-expandable fluid-holding canal, thereby changing the concentration of the solution held in the non-expandable fluid-holding canal. Selectively or temporarily altering the focal point where two or more laser beams cross and superimpose after passing through the wall of the optical fiber and through the non-expandable fluid-holding canal. Medical devices.

8. A medical device, Optical fibers configured to be inserted, at least partially, into the human body. Includes, The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controlled to move inside the human body by one or more actions of a medical device operator, wherein the one or more actions are selected from the group including pushing, pulling, bending, rotating, changing direction, and bending. The optical fiber is configured to receive one or more laser beams generated by a laser beam generator operationally related to the optical fiber at its proximal end. At least one region of the optical fiber includes at least one optical element on the interior side of the optical fiber, the at least one optical element being selected from the group including (i) a refraction optical element that refracts one or more laser beams propagating within the optical fiber, (ii) a deflection optical element that deflects one or more laser beams propagating within the optical fiber, and (iii) an optical element that deflects one or more laser beams propagating within the optical fiber and refracts one or more other laser beams propagating within the optical fiber. The at least one optical element disposed on the interior side of the optical fiber deflects and / or refracts one or more laser beams propagating through the optical fiber according to a specific laser energy distribution and radiation scheme, directing at least one laser beam so that it exits the optical fiber through the side wall of the optical fiber, perpendicular to the long axis of the optical fiber, and providing laser energy to an in vivo location located perpendicular to the optical fiber. The aforementioned at least one optical element is at least, (a) A first curved optical element, wherein (a1) the orientation of a first portion of the laser energy entering the optical fiber is changed so that it exits the optical fiber laterally in a first lateral direction relative to the optical fiber without passing through the distal end of the optical fiber, and (a2) the second portion of the laser energy entering the optical fiber is allowed to continue propagating without change toward a second different curved optical element further arranged along the optical fiber, (b) The second different curved optical element further arranged along the optical fiber, receiving the second portion of the laser energy and changing the orientation of the second portion of the laser energy so that it exits laterally from the optical fiber in a second different lateral direction relative to the optical fiber without passing through the distal end of the optical fiber. Includes, The first portion of the laser energy exiting laterally from the optical fiber by the first curved optical element and the second portion of the laser energy exiting laterally from the optical fiber by the second different curved optical element collide and superimpose in a target region within the biological body that is a focal region rather than a single focal point. Medical devices.

9. A medical device, Optical fibers configured to be inserted, at least partially, into the human body. Includes, The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controlled to move inside the human body by one or more actions of a medical device operator, wherein the one or more actions are selected from the group including pushing, pulling, bending, rotating, changing direction, and bending. The optical fiber is configured to receive one or more laser beams generated by a laser beam generator operationally related to the optical fiber at its proximal end. At least one region of the optical fiber includes at least one optical element on the interior side of the optical fiber, the at least one optical element being selected from the group including (i) a refraction optical element that refracts one or more laser beams propagating within the optical fiber, (ii) a deflection optical element that deflects one or more laser beams propagating within the optical fiber, and (iii) an optical element that deflects one or more laser beams propagating within the optical fiber and refracts one or more other laser beams propagating within the optical fiber. The at least one optical element disposed on the interior side of the optical fiber deflects and / or refracts one or more laser beams propagating through the optical fiber according to a specific laser energy distribution and radiation scheme, directing at least one laser beam so that it exits the optical fiber through the side wall of the optical fiber, perpendicular to the long axis of the optical fiber, and providing laser energy to an in vivo location located perpendicular to the optical fiber. The optical fiber, at its proximal end, is connected to the laser beam generator in operation with the optical fiber, (I) A first set of laser beams having a first wavelength λ1, The first wavelength λ1 has a first absorption coefficient A1 that indicates the level of absorption by human body tissues. The first set of laser beams having the first wavelength λ1 is directed by the first set of optical elements in the optical fiber, so that the first set of laser beams having the first wavelength λ1 are emitted laterally from the optical fiber and overlap at a first specific focal point or focal region located at a first distance D1 from the outer layer of the optical fiber. The first set of laser beams having the first wavelength λ1 provides a first level of energy E1 at the first specific focal point or focal region at the first distance D1. The first set of laser beams and, (II) A second set of different laser beams having a second different wavelength λ2, The second different wavelength λ2 has a second different absorption coefficient A2 that indicates the level of absorption by human body tissues. The second set of different laser beams having the second different wavelength λ2 are directed by the second set of optical elements in the optical fiber, so that the second set of different laser beams having the second different wavelength λ2 are emitted laterally from the optical fiber and overlap at a second specific focal point or focal region located at a second distance D2 different from the first distance D1 from the outer layer of the optical fiber. The second set of different laser beams having the second different wavelength λ2 provides a second different level of energy E2 at the second different specific focal point or focal region at the second distance D2. The second set of different laser beams and Configured to receive, Medical devices.

10. A medical device, Optical fibers configured to be inserted, at least partially, into the human body. Includes, The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controlled to move inside the human body by one or more actions of a medical device operator, wherein the one or more actions are selected from the group including pushing, pulling, bending, rotating, changing direction, and bending. The optical fiber is configured to receive one or more laser beams generated by a laser beam generator operationally related to the optical fiber at its proximal end. At least one region of the optical fiber includes at least one optical element on the interior side of the optical fiber, the at least one optical element being selected from the group including (i) a refraction optical element that refracts one or more laser beams propagating within the optical fiber, (ii) a deflection optical element that deflects one or more laser beams propagating within the optical fiber, and (iii) an optical element that deflects one or more laser beams propagating within the optical fiber and refracts one or more other laser beams propagating within the optical fiber. The at least one optical element disposed on the interior side of the optical fiber deflects and / or refracts one or more laser beams propagating through the optical fiber according to a specific laser energy distribution and radiation scheme, directing at least one laser beam so that it exits the optical fiber through the side wall of the optical fiber, perpendicular to the long axis of the optical fiber, and providing laser energy to an in vivo location located perpendicular to the optical fiber. The optical fiber, at its proximal end, is connected to the laser beam generator in operation with the optical fiber, (I) A first set of laser beams having a first wavelength λ1, The first wavelength λ1 has a first absorption coefficient A1 that indicates the level of absorption by human body tissues. The first set of laser beams having the first wavelength λ1 is directed by a specific optical element in the optical fiber, such that the first set of laser beams having the first wavelength λ1 are radiated laterally from the optical fiber and overlap at a first specific focal point or focal region located at a first distance D1 from the outer layer of the optical fiber. The first set of laser beams having the first wavelength λ1 provides a first level of energy E1 at the first specific focal point or focal region at the first distance D1. The first set of laser beams and, (II) A second set of different laser beams having a second different wavelength λ2, The second different wavelength λ2 has a second different absorption coefficient A2 that indicates the level of absorption by human body tissues. The second set of different laser beams having the second different wavelength λ2 are redirected in the optical fiber by the same specific optical element so that the second set of different laser beams having the second different wavelength λ2 are emitted laterally from the optical fiber and overlap at a second specific focal point or focal region located at a second distance D2 different from the first distance D1 from the outer layer of the optical fiber. The second set of different laser beams having the second different wavelength λ2 provides a second different level of energy E2 at the second different specific focal point or focal region at the second distance D2. The second set of different laser beams and Configured to receive, Medical devices.

11. It is a medical device, Optical fibers configured to be inserted, at least partially, into the human body. Includes, The optical fiber is flexible and has a proximal end that remains outside the human body and a distal end that can be controlled to move inside the human body by one or more actions of a medical device operator, the one or more actions being selected from the group including pushing, pulling, bending, rotating, changing direction, and bending. The optical fiber is configured to receive one or more laser beams generated by a laser beam generator that is associated with the operation of the optical fiber at its proximal end. At least one region of the optical fiber includes at least one optical element on the interior side of the optical fiber, the at least one optical element causing at least a portion of the one or more laser beams to exit the optical fiber laterally through the sidewall of the optical fiber and to produce directional radiation of laser energy laterally or perpendicularly to the main propagation direction of the one or more laser beams, instead of passing through a cap or tip located at the distal end of the optical fiber. The medical device is configured to perform laser-based medical procedures in vivo by radiating laser energy perpendicular to the overall propagation direction of the laser energy within the optical fiber. The medical device includes an encapsulation sleeve that encloses at least one segment of the optical fiber. The segment of the optical fiber is intended to be inserted into the human body. The aforementioned sealing sleeve includes a non-expandable fluid-holding canal, The canal is configured to receive fluid inflow, and the fluid inflow alters the focus where two or more laser beams cross and superimpose after passing laterally through the wall of the optical fiber and through the fluid-holding canal. The fluid includes one or more of the following: gas, liquid, solution, physiological saline, solution of water and sugar, and solution of water and salt. Medical devices.

12. A medical device according to claim 3 or 4, The at least one optical element located on the inner side of the optical fiber is configured such that two or more laser beams are directed outwards transversely to the long axis of the optical fiber and intersect and superimpose at a specific distance transverse to the long axis of the optical fiber. Medical devices.

13. A medical device according to any one of claims 5 to 7, The at least one optical element located on the inner side of the optical fiber is configured such that one or more laser beams are directed and exit laterally from the optical fiber in a first direction, and one or more other laser beams are directed and exit laterally from the optical fiber in a second direction different from the first direction. Medical devices.

14. A medical device according to any one of claims 5 to 7, The at least one optical element is (I) A first optical element positioned at a first location inside the optical fiber and configured to direct one or more laser beams so that they exit the optical fiber laterally in a first direction, (II) A second optical element positioned on the inside of the optical fiber at a second position different from the first position, and configured to direct one or more laser beams out of the optical fiber laterally in a second direction different from the first direction. including, Medical devices.

15. A medical device according to any one of claims 1 to 10, The distal end of the optical fiber includes a cap element or a tip element. The laser energy E enters the optical fiber through the proximal end. The at least one optical element located on the inside of the optical fiber is configured to change the direction of N1 percent of the laser energy so that it exits laterally relative to the optical fiber. N2 percent of the laser energy is transmitted through the optical fiber and exits from the optical fiber at the distal end via the cap element or tip element in a forward direction rather than a lateral direction relative to the optical fiber. N1 is less than 100, N2 is less than 100, N1 is different from N2. Medical devices.

16. A medical device according to any one of claims 1 to 10, The distal end of the optical fiber includes a cap element or a tip element. The laser energy E enters the optical fiber through the proximal end. The at least one optical element includes a first optical element and a second optical element arranged at two different positions within the optical fiber. The first optical element within the optical fiber is configured to change the direction of N1 percent of the laser energy so that it exits laterally relative to the optical fiber, in a first lateral direction. The second optical element within the optical fiber is configured to change the direction of N2 percent of the laser energy so that it exits laterally to the optical fiber in a second, different lateral direction. N3 percent of the laser energy is transmitted through the optical fiber and exits from the optical fiber at the distal end via the cap element or the tip element in a forward direction rather than a lateral direction relative to the optical fiber. N1 is less than 100, N2 is less than 100, N3 is less than 100. N1 is different from N2. Medical devices.

17. A medical device according to any one of claims 1, 2, and 4 to 10, The at least one optical element includes at least an inward-facing wedge or projection that changes the orientation of at least some of the laser beams entering the optical fiber so that they exit laterally from the optical fiber without passing through the distal end of the optical fiber. Medical devices.

18. A medical device according to any one of claims 1 to 10, The at least one optical element is located inside the optical fiber and redirects a first portion of the laser energy entering the optical fiber through the proximal end so that it exits the optical fiber laterally, and enables medical treatment via the laser energy through the side wall of the optical fiber without passing through the distal end of the optical fiber. The at least one optical element also redirects the second portion of the laser energy entering the optical fiber through the proximal end so that it exits the optical fiber in the forward direction through the distal end of the optical fiber. Medical devices.

19. A medical device according to any one of claims 1 to 4 and 8 to 10, Encapsulation sleeve for enclosing at least one segment of the optical fiber It further includes, The segment of the optical fiber is intended to be inserted into the human body. The aforementioned sealing sleeve includes an inflatable balloon chamber in the segment, The inflatable balloon chamber is controllable inflatable within a living body upon receiving a fluid inflow, and the inflow of the fluid inflates the inflatable balloon chamber, thereby changing (i) the distance between the inner wall of the optical fiber and (ii) the target area in the living body where a medical procedure is performed, and consequently changing the power density of the laser-based energy reaching the target area in the living body. The fluid includes one or more of the following: gas, liquid, solution, physiological saline, solution of water and sugar, and solution of water and salt. Medical devices.

20. A medical device according to any one of claims 1 to 10, The optical fiber has a non-circular or asymmetrical cross-section, which (i) improves the mechanical control of bending movements performed by the operator of the medical device, and (ii) enables the operator of the medical device to efficiently understand the spatial orientation of the optical fiber within the body. Medical devices.

21. A medical device according to claim 17, The optical fiber has an oval or oval cross-section. Medical devices.

22. A medical device according to claim 17, The optical fiber has a cross-section that includes straight lines and arcs of less than 300 degrees. Medical devices.

23. A medical device according to any one of claims 1 to 10, The optical fiber is configured to emit directional, transverse, non-forward laser energy by incorporating the at least one optical element into the optical fiber. The laser energy is radiated laterally through the side wall of the optical fiber without passing through the cap or tip located at the distal end of the optical fiber. The radiation is defined as a weighted energy radiation scheme, which defines that (i) N1 percent of the laser energy that enters the optical fiber through the proximal end is radiated laterally in a first lateral non-forward direction through a first position on the sidewall of the optical fiber; (ii) N2 percent of the laser energy that enters the optical fiber through the proximal end is radiated laterally in a second lateral non-forward direction through a second position on the sidewall of the optical fiber; and (iii) N3 percent of the laser energy that enters the optical fiber through the proximal end is radiated in the forward direction relative to the optical fiber through the cap or tip of the distal end of the optical fiber. N1 is different from N2 and different from N3. N2 is different from N1 and different from N3. N3 is different from N1 and also different from N2. Medical devices.

24. A medical device according to any one of claims 1 to 10, The optical fiber is configured to emit directional, transverse, non-forward laser energy by incorporating the at least one optical element into the optical fiber. The radiation is provided to the body position located laterally to the main propagation direction of the one or more laser beams, rather than forward, during a medical procedure, and the radiation is provided to the body position located laterally to the main propagation direction of the one or more laser beams, according to a predetermined or dynamically modifiable energy distribution scheme. Medical devices.

25. A medical device according to any one of claims 1 to 10, The medical device is configured to perform laser-based medical procedures in vivo by radiating laser energy perpendicular to the overall propagation direction of the laser energy within the optical fiber. Medical devices.

26. A medical device according to any one of claims 1 to 10, The entire laser beam that enters the optical fiber through its proximal end propagates within the optical fiber and is then radiated laterally through the lateral panel of the optical fiber. Of the laser beam that enters the optical fiber through its proximal end, none exits the optical fiber through the cap or tip located at the distal end of the optical fiber. Medical devices.

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