Devices and methods for the repair of selected blood vessels or parts thereof, and for the rapid healing of damaged body cavity walls.

Abstract

To provide a device that can more effectively treat aneurysms, or other malformations such as malformations of arteries, veins, or dura mater within blood vessels. [Solution] The device includes a catheter having a catheter body 120, a light-emitting element 130 located at the distal end of the catheter body, and a fluid conduit connectable to a fluid source. The fluid conduit is configured to discharge fluid from the fluid source through the conduit and out from the distal end of the catheter body. A spacing member 150 is located at the distal end of the catheter body and can move between a flattened shape and an expanded shape. In the expanded shape, the spacing member is positioned around the light-emitting element. The spacing member transmits and / or semi-transmits at least partially the light emitted from the light-emitting element. The device is configured to be at least partially inserted into a body lumen, to discharge fluid into the body lumen, and to emit light from the light-emitting element to illuminate the inner wall of the body lumen.

Description

Technical Field

[0001] Cross - reference to Related Applications

[0001] This application claims the priority and benefit of U.S. Provisional Patent Application No. 62 / 508,690, filed on May 19, 2017, entitled "Devices and Methods for Repair of a Selected Blood Vessel or Part Thereof and Rapid Healing of Injured Internal Body Cavity Walls", and is a continuation of U.S. Patent Application No. 15 / 976,199, filed on May 10, 2018, entitled "Devices and Methods for Repair of a Selected Blood Vessel or Part Thereof and Rapid Healing of Injured Internal Body Cavity Walls", which claims the priority of U.S. Provisional Patent Application No. 62 / 508,690, filed on May 19, 2017, entitled "Devices and Methods for Repair of a Selected Blood Vessel or Part Thereof and Rapid Healing of Injured Internal Body Cavity Walls". The entire disclosure of each of these is incorporated herein by reference.

[0002] Technical Field

[0002] The present disclosure generally relates to systems, devices, and methods for therapeutic intervention in blood vessels and other body lumens or cavities.

Background Art

[0003] Background

[0003] The embodiments described herein generally relate to adjusting blood flow to a selected blood vessel or a part thereof (e.g., reducing the flow rate or completely stopping the flow).

[0004]

[0004] Photothrombotic occlusion has been proposed as a method for inducing permanent coagulation in arteries. This method involves intravenous or topical introduction of a photosensitizer, such as sodium fluorescein, erythrosine B, or rose bengal dye, which is absorbed onto the endothelial lumen surface of the artery. The photochemical reaction is initiated by light of a wavelength sufficient to excite the molecules of the photosensitizer (e.g., 510 nm to 580 nm, or higher, e.g., 830 nm). This was thought to initiate a type 2 photochemical reaction, in which the excitation energy is transferred to molecular oxygen, i.e., a metastable and highly reactive species. Subsequently, singlet oxygen was thought to initiate direct peroxidation of unsaturated fatty acids and proteins on the lumen surface, causing structural damage, which then stimulates platelet adhesion, followed by platelet aggregation and vascular occlusion.

[0005]

[0005] An alternative, more recent mechanistic explanation of the observed photothrombus formation process is that when blood components such as pluripotent stem cells and hematopoietic stem cells, as well as vascular wall components such as mesenchymal stem cells, vascular stem cells, and endothelial precursor cells or progenitor cells, and differentiated cells such as fibroblasts and collagen are exposed to the effects of low levels of laser light, thereby locally and / or remotely recruiting the cells and initiating cell differentiation, activation, and proliferation to produce the photothrombus effect.

[0006]

[0006] The technique used to treat an aneurysm involves deploying a permeable mesh-like tube of biocompatible material across the neck of the aneurysm to reduce blood flow to the aneurysm and to activate platelets that pass through the device into the aneurysm, thereby promoting blood clotting within the aneurysm.

[0007]

[0007] One proposed method for treating aneurysms and other vascular malformations combines a photothrombosis technique with a mesh-like tube technique. In this technique, the tip of an optical fiber is deployed into the aneurysm within the blood vessel, and prior to or following this, a mesh-like tube is introduced across the neck of the aneurysm. The tip delivers light energy into the aneurysm, initiating or accelerating blood coagulation within the aneurysm. A light energy absorber and / or permeable agent may also be introduced into the aneurysm before the optical fiber is used to deliver light energy.

[0008]

[0008] One drawback of the proposed technique is that it is difficult to control the energy density of light to the blood vessel walls in the area being treated (i.e., the energy per unit area of ​​the blood vessel wall) to be kept relatively uniform, that is, within a range of energy density values ​​that is high enough to have a therapeutic effect but low enough not to damage the blood vessel walls. [Overview of the project] [Problems that the invention aims to solve]

[0009]

[0009] Therefore, there is a need for a device that can more effectively treat aneurysms or other malformations such as arteriovenous or dura mater malformations within blood vessels, which can block blood flow to tumors, occlude varicose veins and spider veins, and treat other areas and indications by creating a stable thrombus in the target area. [Means for solving the problem]

[0010] overview

[0010] In some embodiments, the device includes a catheter having a catheter body with a distal end and a proximal end. A light-emitting element is located at the distal end of the catheter body and configured to emit light. A fluid conduit is located within the catheter body, extending from the proximal end to the distal end of the catheter body, having an inlet at the proximal end of the catheter body that can be connected to a fluid source, and an outlet at the distal end, configured to discharge fluid from the fluid source through the conduit to the distal end. A spacing member is located at the distal end of the catheter body and is reconfigurable from a flattened shape to an expanded shape. In the expanded shape, the spacing member is located around the light-emitting element and holds the light-emitting element approximately centered within the spacing member with respect to at least one axis of the spacing member. The spacing member allows light emitted from the light-emitting element to be at least partially transmitted and / or semi-transparent. The device is configured such that the distal end of the catheter body is at least partially inserted into a body lumen having an inner wall, a spacing member is positioned in an expanded shape within the body lumen, fluid is discharged into the body lumen, and light is emitted from a light-emitting element to irradiate the inner wall of the body lumen. [Brief explanation of the drawing]

[0011] Brief explanation of the drawing [Figure 1]

[0011] This is a schematic block diagram of the system according to the embodiment. [Figure 2A]

[0012] Figure 1 is a schematic diagram of the light scatterer in the system shown. [Figure 2B]

[0012] This is a schematic diagram of the light scatterer in the system shown in Figure 1. [Figure 2C]

[0012] This is a schematic diagram of the light scatterer in the system shown in Figure 1. [Figure 3A]

[0013] Figure 1 is a schematic diagram of the inner body for the fluid and optical conduits of the system. [Figure 3B]

[0013] This is a schematic diagram of the inner body for the fluid conduit and optical conduit of the system shown in Figure 1. [Figure 3C]

[0013] Schematic diagram of the inner body for fluid conduits and optical conduits of the system of FIG. 1. [Figure 3D]

[0013] Schematic diagram of the inner body for fluid conduits and optical conduits of the system of FIG. 1. [Figure 4A]

[0014] Schematic diagram of the spacing member of the system of FIG. 1. [Figure 4B]

[0014] Schematic diagram of the spacing member of the system of FIG. 1. [Figure 4C]

[0014] Schematic diagram of the spacing member of the system of FIG. 1. [Figure 4D]

[0014] Schematic diagram of the spacing member of the system of FIG. 1. [Figure 4E]

[0014] Schematic diagram of the spacing member of the system of FIG. 1. [Figure 4F] 【001F】Schematic diagram of the spacing member of the system of FIG. 1. [Figure 4G]

[0014] Schematic diagram of the spacing member of the system of FIG. 1. [Figure 5A]

[0015] Schematic diagram of the imaging device of the system of FIG. 1. [Figure 5B]

[0015] Schematic diagram of the imaging device of the system of FIG. 1. [Figure 6]

[0016] Schematic diagram of the mesh tube that can be used with the system of FIG. 1. [Figure 7A]

[0017] Schematic diagram of the occlusion device that can be used with the system of FIG. 1. [Figure 7B]

[0017] Schematic diagram of the occlusion device that can be used with the system of FIG. 1. [Figure 8]

[0018] Schematic diagram of the introducer that can be used with the system of FIG. 1. [Figure 9]

[0019] Flowchart showing the method according to the embodiment. [Figure 10]

[0020] Schematic diagram of a kit including elements of the system for use in the method according to the embodiment. [Figure 11A]

[0021] This is a schematic diagram of an apparatus and method for treating intravascular aneurysms according to an embodiment. [Figure 11B]

[0021] This is a schematic diagram of an apparatus and method for treating intravascular aneurysms according to an embodiment. [Figure 11C]

[0021] This is a schematic diagram of an apparatus and method for treating intravascular aneurysms according to an embodiment. [Figure 11D]

[0021] This is a schematic diagram of an apparatus and method for treating intravascular aneurysms according to an embodiment. [Figure 11E]

[0021] This is a schematic diagram of an apparatus and method for treating intravascular aneurysms according to an embodiment. [Figure 12A]

[0022] This is a schematic diagram of an apparatus and method for treating an aneurysm at a branch of a blood vessel, according to an embodiment. [Figure 12B]

[0022] This is a schematic diagram of an apparatus and method for treating an aneurysm at a branch of a blood vessel, according to an embodiment. [Figure 12C]

[0022] This is a schematic diagram of an apparatus and method for treating an aneurysm at a branch of a blood vessel, according to an embodiment. [Figure 12D]

[0022] This is a schematic diagram of an apparatus and method for treating an aneurysm at a branch of a blood vessel, according to an embodiment. [Figure 12E]

[0022] This is a schematic diagram of an apparatus and method for treating an aneurysm at a branch of a blood vessel, according to an embodiment. [Figure 13]

[0023] This is a schematic diagram of an apparatus and method for treating spindle-shaped aneurysms in blood vessels, according to an embodiment. [Figure 14]

[0024] This is a schematic diagram of an embodiment of a device and method for occluding blood vessels. [Figure 15]

[0025] This is a schematic diagram of an apparatus and method for performing embolization on intravascular malformations, according to an embodiment. [Figure 16]

[0026] This is a schematic diagram of an embodiment of a device and method for treating spongiform malformations. [Figure 17A]

[0027] This is a schematic diagram of an apparatus and method for treating a joint, such as the knee joint capsule. [Figure 17B]

[0028] Figure 17A is an enlarged side view of the equipment. [Figure 17C]

[0028] This is an end view of the device shown in Figure 17B. [Figure 17D]

[0029] This is a side view of an alternative embodiment of a device suitable for use in a method for treating joints, as shown in Figure 17A. [Figure 17E]

[0029] This is an end view of an alternative embodiment of an instrument suitable for use in a method for treating joints as shown in Figure 17A. [Figure 17F]

[0030] This is a side view of yet another alternative embodiment of an instrument suitable for use in a method for treating joints, as shown in Figure 17A. [Figure 17G]

[0030] This is an end view of yet another alternative embodiment of an instrument suitable for use in a method for treating a joint as shown in Figure 17A. [Figure 17H]

[0031] This is an end view of an alternative embodiment of a device suitable for use in a method for treating joints, as shown in Figure 17A. [Modes for carrying out the invention]

[0012] Detailed explanation

[0032] Systems and methods are disclosed that are suitable for effectively treating blood vessels, including cerebral, coronary, and peripheral blood vessels, in relation to aneurysms or other malformations (e.g., arteriovenous or dura mater malformations), and for occluding blood vessels to block the blood flow to tumors and to treat varicose veins and spider veins to remove them from circulation. The systems and methods may also be used to treat ulcers in internal body cavity walls such as gastric ulcers, parenchymal tumors such as brain tumors, liver tumors and nonvascular lesions of other soft tissues of the body, bleeding vascular structures, arteries or veins (not by intravascular access), hemorrhagic bleeding, esophageal varices, spider angiomas, joint bleeding, amyloid generative diseases, lymphangiomas, cartilage damage, arthritis such as rheumatoid arthritis, synovial arthritis and traumatic joint injury, bone repair, kidney tumors and inflammatory disorders such as fibrosis, bronchopulmonary hemorrhage of the lungs, myocardial injury, carotid artery disease, neurodegenerative disorders and megasplenomegaly.

[0013]

[0033] The disclosed system includes a catheter device which may include a catheter body having a distal end and a proximal end, and a light-emitting element positioned at the distal end of the catheter body and configured to emit light. A fluid conduit is positioned within the catheter body and extends from the proximal end to the distal end of the catheter body. The fluid conduit has an inlet at the proximal end of the catheter body which can be connected to a fluid source, and an outlet at the distal end which fluid from the fluid source is discharged from the distal end through the conduit. A spacing member is positioned at the distal end of the catheter body and is reconfigurable from a flattened shape to an expanded shape. In the expanded shape, the spacing member is positioned around the light-emitting element and holds the element substantially centered within the spacing member with respect to at least one axis of the spacing member. The spacing member transmits and / or semi-transmits light emitted from the light-emitting element at least partially. The device is configured such that the distal end of the catheter body is at least partially inserted into a body lumen having an inner wall, a spacing member is positioned in an expanded shape within the body lumen, fluid is discharged into the body lumen, and light is emitted from a light-emitting element to irradiate the inner wall of the body lumen.

[0014]

[0034] In some embodiments, the method includes positioning the distal end of a catheter within a patient's blood vessel, adjacent to the area of ​​the vessel wall to be treated. The distal end of the catheter is positioned at the center or proximal end of the treatment area. The catheter is provided with a light-emitting element configured to emit light, an outlet of a fluid conduit connected to a fluid source, and a spacing member reconfigurable from a flattened shape to an expanded shape at the distal end of the catheter. The spacing member may be porous, allowing at least partially and / or semi-transparent light emitted from the light-emitting element to be released from the outlet. Once positioned at the treatment site, the spacing member can be moved to an expanded shape. When in the expanded shape, the spacing member may be positioned around the light-emitting element such that the light-emitting element is kept approximately centered within the spacing member with respect to at least one axis of the spacing member. The method further includes positioning the spacing member approximately centered within the lumen of the blood vessel. Fluid is released into the blood vessel from the outlet of the fluid conduit, diluting the blood within the vessel with the fluid. Light is emitted from the light-emitting element through the diluted blood in the lumen of the blood vessel and onto the area of ​​the blood vessel wall that is being treated.

[0015]

[0035] As schematically shown in Figure 1, the treatment system 100 includes a catheter 110 which can be operably coupled to other devices or systems including a light source LS, a fluid source FS, and an image display ID. The catheter 110 may be used in conjunction with other devices including a mesh tube MT, an occlusion device OD, and an introducer (not shown in Figure 1), and compositions such as photochemical substances PA.

[0016]

[0036] The catheter 110 may have an extended catheter body 120 with a proximal and distal end, suitable for insertion into a body lumen or body cavity BL, such as a blood vessel, adjacent to a treatment area TR of the body lumen or body cavity BL. The catheter body 120 defines an internal working channel 124, and other components of the catheter 110 may be positioned in and movable through the internal working channel 124. Therefore, in some embodiments, the catheter body 120 may be inserted into the patient's body, for example, by being advanced through the patient's vascular structure on a guidewire until its distal end is positioned adjacent to the treatment area TR. The guidewire is then removed, and the other components of the catheter 110 may be advanced through the working channel 124 until the distal end of the other components is positioned in the treatment area TR in an appropriate working relationship with the distal end of the catheter body 120. In other embodiments, some or all of the other components of the catheter 110 may be positioned within and / or coupled to the catheter body 120 before the catheter 110 is inserted into the patient's body and its distal end is delivered to the treatment area TR.

[0017]

[0037] The catheter 110 includes a light-emitting element 130 located at the distal end of the catheter body 120 when the catheter 110 is configured for use. The light-emitting element 130 may be located within the catheter body 120, for example, within the working channel 124, and may be optically coupled to a light source LS by an optical conduit 132 extending from the proximal end to the distal end of the catheter body 120.

[0018]

[0038] The catheter 110 also includes a fluid conduit 140 located within the catheter body 120 and extending from an inlet 144 at the proximal end of the catheter body 120 to an outlet 142 at the distal end of the catheter body 120. The fluid conduit 140 may be connected to a fluid source FS at the inlet 144.

[0019]

[0039] The catheter 110 may also include a spacing member 150 located at the distal end of the catheter body 120. Depending on the implementation example of the spacing member 150, the spacing member 150 may be attached to the distal end of the catheter body 120 and actuated by a fluid passing through the fluid conduit 140. In some embodiments, the spacing member 150 may be coupled to or integrally formed with another component of the catheter 110. For example, the spacing member 150 may be integrally formed with or coupled to an inner body 148 which functions as a spacing member actuator 152 located within the catheter body 120 (as described, for example, with reference to Figure 3D). The spacing member actuator 152 extends from the proximal end to the distal end of the catheter body 120 and may be used to move the spacing member 150 between a compressed shape and an expanded shape.

[0020]

[0040] The catheter 110 may also include an imager 160 coupled to the distal end of the catheter body 120. The imager 160 may be located within the catheter body 120 and optically coupled to an image display ID by an imaging conduit 162 extending from the proximal to the distal end of the catheter body 120.

[0021]

[0041] Each component of the treatment system 100 can be implemented in various ways. In applications where the catheter 110 is used to access a treatment area TR in a body lumen BL intravascularly, the catheter 110 may be implemented as a conventional intravascular catheter, including its structure and materials, the ability to maneuver or not maneuver or change the orientation of its distal end, and whether or not it can be advanced on a guidewire, including user control and attachment at the proximal end. In some embodiments, a guidewire (not shown) may be located within the working channel 124 of the catheter body 120. In other embodiments, for example, where the catheter body 120 may be relatively large, the catheter body 120 may include a separate, dedicated guidewire lumen from the working channel 124. The proximal portion of the catheter body 120 is stiffer than the distal portion, providing sufficient rigidity for the user to push the catheter body 120 along the guidewire and through the lumen, e.g., through a vascular structure. A softer distal portion may facilitate navigation of the catheter body 120 through, for example, a winding vascular structure. The catheter body 120 can be introduced into a body lumen BL, such as a blood vessel, via angiotomy (cut down) or other percutaneous technique to access the vascular lumen. In some applications, the catheter 110 may be used and implemented to directly access the therapeutic area TR rather than through the subject's vascular structure. For example, when the catheter 110 is used to directly access the therapeutic area TR through soft tissue, it may be implemented as a relatively rigid needle inserted through a trocar.

[0022]

[0042] The light-emitting element 130 can be implemented in any known and suitable structure to emit light of a desired wavelength and intensity from the distal end of the catheter 110 to the therapeutic area TR of the body lumen BL. In some embodiments, the light-emitting element 130 may simply be the end of an optical fiber, and the optical fiber may function as an optical conduit 132 for propagating light from a light source LS that can be coupled to the proximal end of the catheter 110. The light source LS may be any suitable light source of a desired wavelength and intensity, and may be a coherent light source such as a laser (pulsed or continuous wave) or an incoherent light source (such as xenon or halogen light and a suitable band-pass filter). In other embodiments, the light-emitting element 130 may be a relatively compact light source located at the distal end of the catheter 110, such as a light-emitting diode (LED) or laser diode, and power is supplied to the distal end of the catheter 110 by a conductor extending from the proximal end of the catheter 110 through the catheter body 120 to the light source. In alternative embodiments, the LED or laser diode may be located at the proximal end of the catheter 110.

[0023]

[0043] To produce a desired light distribution in the treatment area TR, i.e., a distribution different from that produced by the light source LS, in some embodiments, a light scatterer 136 (see, for example, Figure 2A) is operably associated with the light source LS to scatter light from the light source LS across the entire treatment area TR. In some embodiments, for example, as schematically shown in Figure 2A, the light scatterer 136 may be mounted as a convex end cap at the distal tip, i.e., distal end, of an optical fiber, such as an optical fiber. The end cap may contain light scattering particles, such as those shown as a circular region 138 in Figure 2A. Such particles may be, for example, titanium dioxide. Other light scattering materials (with a high refractive index of about 2.5) or refractive structures such as diffraction gratings may be used.

[0024]

[0044] As schematically shown in Figure 2B, the light-emitting element 130 extends from the distal end of the catheter body 120, and the end cap and light-scattering particles diffuse and distribute the light emitted from the distal tip of the optical fiber 132 around the tip and the sides of the end cap, illuminating the treatment area (TR), in this example, the surface of the aneurysm. The light distribution pattern can be adjusted to match the shape of the treatment area TR in order to create a relatively uniform energy density on the surface of the treatment area TR and to avoid areas of excessively high energy density, i.e., "hot spots". For example, in the embodiment shown in Figure 2B, the distribution is nearly spherical, relating to the nearly spherical shape of the vascular aneurysm, which is the treatment area TR. In other embodiments, such as those shown in Figure 2C, the light-scattering element 136 may be implemented as a cylindrical tip that scatters light only radially and not axially, rather than as a convex end cap, thus producing a light distribution that is better associated with cylindrical treatment areas TRs, such as the walls of body lumens like blood vessels.

[0025]

[0045] In other embodiments, which are described in more detail below with reference to Figure 4E, the light scatterer 136 is spaced apart from the light-emitting element 130 and is instead coupled to or forms part of another structure, such as a spacing member 150.

[0026]

[0046] The fluid conduit 140 can be implemented as any known and preferred structure that carries a fluid, such as saline solution, through the catheter 110 and releases it at the distal end of the catheter body 120. The fluid may result in dilution, visualization, and / or cooling. For example, as schematically shown in Figures 3A and 3B, the fluid conduit 140 may be an annular conduit defined between the catheter body 120 and an inner body 148. The inner body 148 may provide a lumen or passage within which other structures, such as an optical conduit 132, can pass through the catheter body 120. In the embodiments shown in Figures 3A and 3B, the inner body 148 may be a braided reinforcement or cover for the optical fiber 132, protecting the delicate optical fiber and providing a more rigid, combined structure that can deliver the optical fiber and attached scattering element 136 distally through the catheter body 120. The inner body 148 also supports the light scatterer 136 at the distal end of the inner body 148. In this embodiment, the fluid conduit 140 is a substantially annular space around the inner body 148, remaining within the working channel 124 of the catheter body 120. In other embodiments, the fluid conduit 140 may be arranged alongside, rather than concentrically, other structures such as the optical conduit 132. As schematically shown in Figure 3A, the outlet 142 may simply be configured as an opening at the annular distal end of the fluid conduit 140. In other embodiments, other geometric shapes or structures may be used, for example, to direct the flow of the diluent fluid laterally with respect to the axis of the catheter body 120, to narrow the flow and reduce the flow rate, or to accelerate the flow velocity.

[0027]

[0047] The inner body 148 in Figures 3A and 3B is shown in more detail in Figure 3C. The inner body 148 has a distal portion 148A and a proximal portion 148B of different structures. The proximal portion 148B may be formed as a solid tubular structure, for example as a hypotube, which occupies most of the length of the inner body 148, for example, 1 m, while the distal portion 148A may be formed as a braid or coil occupying a small portion of the length of the inner body 148, for example, about 25 cm. As described above, the inner body 148 includes a central lumen that can receive an optical conduit, for example an optical fiber 132, and a distal tip to which a light scatterer 136 may be attached. This structure provides a relatively rigid structure, thereby allowing the inner body 148 to be pushed distally through the working channel 124 of the catheter body 120, while the flexible distal portion 148A can be easily navigated into and through the winding body lumen BL. This embodiment is shown in Figures 4D-4G and is suitable for use with a catheter in which the spacing member 150 is internally coupled to the catheter body 110, as described below. In an alternative embodiment shown in Figure 3D, as described in more detail below with reference to Figure 4C, the spacing member 150 may be integrally formed with the distal end 148A of the inner body 148 or may be attached in other ways.

[0028]

[0048] The spacing member 150 can be implemented in various structures and materials to provide a desired function. The primary function of the spacing member 150 is to maintain a minimum distance between the light-emitting element 130 and the treatment area TR, i.e., to prevent the light-emitting element 130 from being positioned too close to the treatment area TR, so that the light energy density of the light-emitting element 130 does not exceed an acceptable upper limit. It may be even more desirable for the spacing member 150 to maintain a relatively uniform distance between the light-emitting element 130 and the treatment area TR, for example, to keep the light-emitting element 130 relatively central within the body lumen BL. These related functions may be achieved in different ways. For example, in some embodiments, the light-emitting element 130 and the spacing member 150 may be fixed to each other, and both may be moved through the working channel 124 of the catheter body 120 to a desired operating position, as shown in Figure 4C. In other embodiments, such as those shown in Figures 4D and 4E, the spacing member 150 may be fixed to the catheter body 120, and the light-emitting element 130 may be movable relative to both.

[0029]

[0049] As schematically shown in Figure 4A, when the spacing member 150 has a shape or geometric shape that is substantially symmetrical around the longitudinal axis LA of the catheter body 120, and the light-emitting element 130 is positioned substantially near the longitudinal axis LA, the light-emitting element 130 is positioned substantially in the center within the spacing member 150. When the catheter 110 is positioned in the body lumen BL, and the spacing member 150 has an expanded shape in which the diameter of the spacing member 150 is close to the diameter of the body lumen BL, the light-emitting element 130 is positioned substantially in the center within the body lumen BL. Therefore, when the light emitted by the light-emitting element 130 is distributed relatively uniformly at an angle around the longitudinal axis LA, the light energy density in the treatment area TR is relatively uniform in the circumferential direction; in other words, the light energy density in the treatment area TR is between the upper and lower limits of the desired energy density. Although schematically shown as an elliptical shape in Figure 4A, the spacing member 150 can be configured to take any other desired shape depending, for example, on the shape of the body lumen and / or the treatment area. As schematically shown in Figure 4B, if the body lumen is shaped like a sac, such as an aneurysm, rather than a tube, such as a blood vessel, then an elliptical or spherical shape may be more appropriate in order to optimally center the light-emitting element 130 within the body lumen BL.

[0030]

[0050] Another function of the spacing member 150 is to allow the diluent fluid DF to pass through the spacing member 150 into the body lumen BL. For example, as will be described in more detail below, it may be desirable for the spacing member 150 to be filled with the diluent fluid DF, for example, to replace blood or other body fluids BF, and / or to cause or assist in the reconstruction of the spacing member 150 from a compressed shape to an expanded shape. It may also be desirable for the diluent fluid to dilute and / or replace blood or other body fluids between the spacing member 150 and the treatment area TR and / or body lumen BL. It may also be desirable to use the fluid to expand or otherwise alter the geometric shape or form of the treatment area TR and / or body lumen BL. Therefore, the side walls of the spacing member 150 may be porous or otherwise permeable to the diluent fluid. In some embodiments, the proximal end of the spacing member 150 may surround all or part of the outlet 142 of the fluid conduit 140, as schematically shown in Figure 4B, in which case the diluting fluid may enter the interior of the spacing member 150 and the fluid may be discharged from the spacing member 150 (for example, through the porous or permeable walls of the spacing member 150). In other embodiments, the outlet 142 of the fluid conduit 140 may be located outside the spacing member 150, and it may be desirable to allow the fluid to enter the spacing member 150.

[0031]

[0051] Another function of the spacing member 150 may be to mechanically expand or otherwise change the geometric shape or form of the treatment area TR and / or body lumen BL, i.e., by interlocking the spacing member 150 with the surface of the treatment area TR and / or body lumen BL.

[0032]

[0052] Figures 4C-4E schematically show several possible structures of the spacing member 150. In the embodiment shown in Figure 4C, the spacing member 150 can take the form of a wire cage formed of multiple wires or struts 155, with multiple apertures 157 formed between the wires or struts, through which the diluting fluid discharged from the fluid outlet 142 can pass. The spacing member 150 may be formed of braided wire or laser-cut tubing, or of other known structures. The spacing member 150 may be self-expanding, for example, formed of a shape-memory material such as nitinol, and set or loaded to be in an expanded shape, but can be held in a flattened shape by being placed, for example, within the fluid conduit 140 (or working channel 124) of the catheter body 120. Alternatively, the spacing member 150 may be loaded to be in a flattened shape, and force may be applied to move it towards an expanded shape.

[0033]

[0053] In the embodiment shown in Figure 4D, the spacing member 150 is formed of an elastomer material and is therefore essentially a balloon. However, the balloon is not a sealed balloon, but includes a perforation 157 to allow the diluent fluid to pass through, and is therefore called a “leak-proof” balloon. The proximal end of the spacing member 150 is positioned near the fluid outlet 142, so that the diluent fluid released from the fluid outlet 142 can enter the spacing member 150 and exit through the perforation 157. The diluent fluid may be used to flush the inside of the balloon and expel all air through an air vent channel or tube (not shown) before the light-emitting element 136 is inserted distally through the working channel 124 (not shown) of the catheter body 120 to its position within the spacing member 150. The diluent fluid may also be used to inflate the balloon, i.e., to move the spacing member 150 from a flattened shape configuration (not shown) to the expanded shape shown in Figure 4D. When the balloon expands, the perforation 157 expands, thus increasing the flow area for the diluent fluid to flow out of the balloon. Therefore, the size of the balloon can be controlled by controlling the flow rate and pressure of the diluent fluid flowing out of the fluid outlet 142. After the treatment procedure, the diluent fluid may be drawn out of the elastic balloon, allowing the spacing member 150 to move into a collapsed shape, and in that configuration, it can be drawn out of the patient's body.

[0034]

[0054] In the embodiment shown in Figure 4E, the spacing member 150 is also formed of an elastomer material and is therefore substantially a balloon. However, in this embodiment, the balloon is sealed, i.e., does not involve perforation as in the previous embodiment. Fluid can be introduced into the body lumen BL via a port (not shown) through the catheter body 120. As in the previous embodiment, the inside of the balloon may be flushed to remove air and then expanded, i.e., the spacing member 150 may be moved from a flattened shape (not shown) to an expanded shape shown in Figure 4E by introducing a diluent fluid from the fluid outlet 142. Thus, the size of the balloon can be controlled by controlling the amount of diluent fluid exiting the fluid outlet 142. In this embodiment, the spacing member 150 also provides some or all of the light scattering function and includes an inner or outer layer of light scattering material 135 (shown on the inner surface in Figure 4E) on the inner or outer surface of the spacing member 150. Figure 4E also schematically shows the light scatterer 136 at the tip of the light conduit 132, although in some embodiments the layer 135 of material of the spacing member 150 may be the sole light scatterer. In some embodiments, light scattering may be brought about by light scattering particles mixed or suspended in a diluent fluid. In some embodiments, the spacing member 150 may at least partially transmit and / or semi-transmit light emitted from the light-emitting element 130.

[0035]

[0055] The embodiments shown in Figures 4F and 4G are similar to the embodiment shown in Figure 4E, except that the spacing member 150 includes a fluid port 158 ​​at its distal end, and the light scatterer 136 includes a valve extension 137 at its distal tip. The valve extension 137, together with the fluid port 158, can selectively form and prevent fluid flow between the body lumen BL and the interior of the spacing member 150. For example, the valve extension acts as a closure member, and the fluid port 158 ​​of the spacing member 150 provides a distal closure surface so that when the valve extension 137 is moved distally, the space between the surface of the port 158 ​​and the surface of the valve extension 137 is sealed. Therefore, as shown in Figure 4F, when the valve extension 137 is positioned at the fluid port 158 ​​to isolate the interior of the elastic spacing member 150 with respect to the fluid, the fluid released from the fluid outlet 142 can expand the spacing member 150 to the desired configuration. Subsequently, the valve extension 137 is pulled out proximal to the body, and as shown in Figure 4G, it is released from its connection with the fluid port 158, allowing a fluid flow to form between the inside of the spacing member 150 and the body lumen BL. The fluid released from the fluid outlet 142 can then be discharged into the body lumen BL via the fluid port 158.

[0036]

[0056] The imaging device 160 may be implemented in any known and suitable structure for acquiring images of the treatment area TR or other parts of the body lumen BL. Various imaging techniques may be used, including light (wavelengths including visible, near-infrared, and / or other parts of the spectrum), ultrasound, and optical coherence tomography (OCT). As schematically shown in Figures 5A and 5B, the imaging device 160, which is an optical imaging device in this example, may include an imaging conduit 162, such as an optical fiber. The imaging device 160 may provide a measurement of the light energy density irradiated onto the treatment area TR by the light-emitting element 130 for a given time, and the total energy irradiated. In other embodiments, the imaging device 160 may be configured to acquire image information from the treatment area TR, for example, to assist in positioning the distal end of the treatment system 100 relative to the treatment area TR, and to evaluate the state of the treatment area TR before, during, and after treatment.

[0037]

[0057] The light irradiated onto the treatment area TR, i.e., the light irradiated via the light-emitting element 130 and optionally via the light scatterer 136, may have one or more wavelengths in the range of 400 nm to 1,000 nm. A convenient and suitable wavelength is 532 nm, which can be produced by readily available and inexpensive lasers and laser diodes. The power of the light irradiated onto the treatment area TR may be in the range of 1 mW to 500 mW, preferably in the range of 100 mW to 200 mW. The power density of the light irradiated onto the treatment area TR is 1 mW / cm². 2 ~5W / cm 2 Within the range of 50 to 500 mW / cm², preferably 50 to 500 mW / cm². 2 Within the range of 175-200 mW / cm², more preferably 175-200 mW / cm². 2 It can be within the range.

[0038]

[0058] Although the mechanism is not well understood, it is thought that the application of light of the aforementioned wavelengths and intensities may activate and / or accelerate hematopoiesis, thereby differentiating stem cells into blood and vascular cells, which may then be involved in the rapid transformation of new thrombi into scar tissue and the healing of the therapeutic area (TR).

[0039]

[0059] Mesh tubes MT can be used in conjunction with catheter 110 in the treatment of certain indications and anatomical configurations. Mesh tubes MT can have various structures, geometric shapes, sizes, etc., suitable for the desired treatment. Examples of suitable mesh tubes are described in U.S. Patent No. 7,942,925 by Yodfat et al., “Implantable Intraluminal Device and Method of Using Same in Treating Aneurysms,” the entire disclosure of which is incorporated herein by reference. One preferred embodiment of mesh tubes MT is schematically shown in Figure 6, with mesh tubes MT positioned in an expanded shape within a body lumen BL. Mesh tubes MT comprise multiple filaments of elastic or inelastic biocompatible material, metal, or plastic, which extend in an intertwined helical manner to form a braided tube. Therefore, the filaments MT1 of the first group extend helically in one direction, and the filaments MT2 of the second group extend helically in the opposite direction, and the two groups of filaments are woven together such that filament MT1 is above filament MT2 at some points as shown in P1, and below filament MT2 at other points as shown in P2. Thus, filaments MT1 and MT2 define a braided tube having multiple windows W. The inscribed diameter and length of each window W are given by W, respectively, under the insertion conditions of the mesh tube MT (e.g., expanded shape). d and W LThese properties depend, among several factors, particularly: the number of filaments; the cross-section of the filaments; and the insertion angle "α" at the intersection of the two groups of filaments MT1 and MT2. The mesh tube MT can be positioned across the neck of a vascular aneurysm, along a straight section of the vessel, or at or near a branch of the vessel, and can function to divert a portion of the blood flow through the vessel away from the aneurysm. The mesh tube MT can also be used to reduce blood flow to a selected portion of the vessel where blood clotting is promoted. In some embodiments, the mesh tube MT is detached from the catheter 110 and deployed within the vessel. In some cases, the blood moving through the mesh tube MT into the aneurysm has a longer residence time in the aneurysm, so that platelets activated during passage into the aneurysm can initiate thrombus formation, and the platelets are then "jailed" or trapped within the aneurysm. Photoactivation of stem cells significantly accelerates thrombotic changes in scar tissue and the healing of disease conditions.

[0040]

[0060] Figures 7A and 7B illustrate the use of an occlusion device OD, which can be used in conjunction with the catheter 110 to treat several indications and anatomical structures. As schematically shown in Figure 7A, the occlusion device OD is positioned within a body lumen BL, such as a blood vessel, and can be moved into an expanded shape, thereby occluding the body lumen BL by contacting its inner wall, i.e., reducing or preventing the flow of fluid, such as blood, through the body lumen BL. In this embodiment, the catheter 110 is shown with its distal end positioned within the aneurysm A upstream of the occlusion device OD. In this configuration, the catheter 110 releases fluid into the aneurysm A, diluting the blood within the aneurysm to a desired dilution ratio, as the body lumen BL is occluded by the occlusion device OD and the fluid is not carried away through the body lumen BL along with the blood. In the embodiment of Figure 7A, since the distal tip of the catheter 110 is maneuverable, the light-emitting element can be positioned at a desired location within the aneurysm A without the need for a spacing device. The occlusion device OD may be positioned in a flattened shape to be delivered to a desired location within the body lumen BL before treatment of aneurysm A, and to be withdrawn after treatment is complete, and may be expanded to an expanded shape by inflating the balloon with fluid in a manner well known to those skilled in the art to occlude the body lumen BL. A suitable balloon occlusion device includes, for example, the HyperForm Occlusion Balloon offered by Medtronic.

[0041]

[0061] In another embodiment shown in Figure 7B, the occlusion device OD may be an extended balloon that extends to the neck of the aneurysm A and "retains" the distal end of the catheter 110. That is, the proximal portion of the occlusion device OD can contact the wall of the body lumen BL and trap a portion of the distal end of the catheter 110, thereby preventing movement of the catheter 110 in addition to occluding the lumen as in the previous embodiment. A suitable extended balloon occlusion device includes, for example, the HyperGlide Occlusion Balloon provided by Medtronic.

[0042]

[0062] Figure 8 shows an embodiment of introducer IN that can be used in conjunction with catheter 110 when treating several indications and anatomical structures. The introducer IN has a cylindrical body B as a whole, and is provided with a tapered distal portion DP, a proximal end PE, a central lumen extending through body B, and a slot SL communicating with the central lumen. The introducer IN can facilitate the introduction of the inner body 148 into catheter 110. For example, an incision or angiotomy may be performed on the patient's skin at the site where catheter 110 is introduced into the patient's body. The catheter 110 is then inserted into the patient's body through a standard introducer sheath. The proximal tip of catheter 110 is then fitted with a standard hemostatic valve. The tip of the tapered distal portion DP can be inserted into the hemostatic valve, allowing the introducer IN to be pushed into the hemostatic valve. When the distal end of introducer IN is in the desired position, the distal end of the inner body 148 can be inserted into the lumen of introducer IN at its proximal end PE, and pushed through the lumen and from the distal tip of introducer IN into a desired portion of the patient's anatomical structure, such as a body lumen BL. Alternatively, the distal end of the inner body 148 can be pre-loaded into the lumen of introducer IN.

[0043]

[0063] Figure 9 schematically illustrates a method for treating a therapeutic area (TR) of a body lumen, particularly a portion of the luminal wall of a blood vessel. In step 202, an optional photochemical can be administered to the person being treated (e.g., the patient). For example, a light-energy absorber or a biochemical thrombosing agent may also be delivered into a selected portion of the vessel to be treated, including the malformed neck and the entire thickness. In some cases, a photochemical such as erythromycin B or rose bengal may be injected into the therapeutic area of ​​the vessel before irradiation to enhance light absorption by the vessel wall and accelerate the photochemical reaction. The active substance can be administered intravenously (IV) (i.e., systemically) or locally to the vessel to be treated (i.e., an aneurysm or malformation) either by catheter 110 or via a separate microcatheter. Subsequently, a translucent or transparent optical field is formed before light energy is applied.

[0044]

[0064] In step 204, a catheter (e.g., catheter 110) can be inserted into the patient's blood vessel, and the distal end of the catheter can be positioned next to or near the area of ​​the blood vessel wall to be treated. In some embodiments, a guidewire is inserted into the blood vessel and positioned near the treatment area before the catheter is inserted into the blood vessel. The catheter can then be inserted over the guidewire (e.g., the lumen of the catheter may be attached over the guidewire) and moved along the guidewire to the desired location in the treatment area.

[0045]

[0065] In step 206, the spacing member of the catheter 110 (e.g., spacing member 150) and the light-emitting element 130 (e.g., light-emitting element 130 comprising a light scatterer 136) can be moved so as to extend from the distal end of the lumen of the catheter 110, and the spacing member can be made into an extended shape around the light-emitting element. The spacing member prevents contact between the light-emitting element and the blood vessel wall and ensures the centering of the light-emitting element within the blood vessel, thereby achieving a uniform distribution of the photon energy flux to the surrounding blood vessel wall. In step 208, the spacing member can be positioned approximately in the center within the blood vessel being treated.

[0046]

[0066] In step 210, fluid can be released into the blood vessel from the outlet of the fluid conduit of catheter 110 to dilute the blood within the blood vessel. For example, saline solution can be injected to create a clear or translucent optical field within the treatment area of ​​the blood vessel. In step 212, light energy can be applied from the light-emitting element of the catheter through the diluted blood to the wall of the blood vessel. The light energy can initiate and / or accelerate blood coagulation within the treatment area, during which the spacing member can prevent the resulting embolus from moving downstream through the blood vessel. In some cases, the spacing member can be detached from the delivery system and permanently retained at the treatment site for protection. After treatment, the catheter can be removed from the blood vessel.

[0047]

[0067] Figure 10 is a schematic diagram of a kit according to an embodiment. As described above, the treatment system 100 can be provided as a kit (KIT) containing one or more components that perform various functions for treating the treatment area TR. In some embodiments, the KIT can be a single-use set of disposable components. In some embodiments, the KIT can include a catheter 110 placed in a kit package, such as a sterile package used to protect the catheter 110 from contamination during transport and storage. In some embodiments, the kit package can include an outer casing and one or more sterile inner components to contain and protect one or more components of the KIT. The catheter 110 can include, for example, a catheter body 120 having a working channel 124, a light-emitting element 130, and a fluid conduit 140, as described above. The KIT can also optionally include one or more of the following components that can be used in conjunction with the catheter 110: an occlusion device OD, a light source LS, a fluid source FS, a photochemical substance PA, a mesh tube MT, an introducer IN, a spacing member 150, an imaging device 160, and / or instructions for use IFU. In some embodiments, the KIT may include, for example, multiple types of spacing members (e.g., 150) so that a user (e.g., a physician) can select the spacing member 150 appropriate for a particular treatment. In some embodiments, the KIT may include, for example, multiple types of light-emitting elements (e.g., 130) so that a user (e.g., a physician) can select the light-emitting element 130 (e.g., various types of light scatterers 136, etc.) appropriate for a particular treatment. Each component of the KIT may be placed in one or more sterile kit packages.

[0048]

[0068] Figures 11A–11E illustrate various methods for using treatment systems, such as those described above, to treat aneurysms located laterally off-center from the lateral wall of a blood vessel. Embodiments and specific components of the treatment systems illustrated and described with reference to Figures 11A–11E may be configured in the same or similar manner as the corresponding components of system 100 described above, and may include the same or similar characteristics. The illustrated systems and components can be used, for example, to treat aneurysms with light energy, as described above.

[0049]

[0069] In the treatment method shown in Figure 11A, the treatment system includes a catheter 210 with its distal end positioned within an aneurysm A located laterally off-center from the side wall of a vessel BV. The catheter 210 may include any of the features described above, details of which are omitted in Figure 11A for brevity. For example, a spacing member 250 positioned at the distal end of the catheter body 224 may be implemented with any of the above options, including a porous balloon, a non-porous balloon, a wire cage, etc. The spacing member 250 can be moved between a flattened shape (not shown) during delivery to the treatment site and an expanded shape (shown in Figure 11A) during the treatment procedure using any of the above techniques. The spacing member 250 can be used to maintain a minimum distance between the light-emitting element 230 and the wall of the aneurysm A being treated. With the light-emitting element 230 and the spacing member 250 positioned within the aneurysm A, the light-emitting element 230 can operate to emit the desired light energy to treat the aneurysm. Optionally, a fluid (e.g., saline solution) may be introduced into the treatment area as described above.

[0050]

[0070] In the method shown in Figure 11B, the catheter 210 is used in conjunction with a mesh tube 246. The mesh tube 246 can be formed and constructed in the same or similar manner as the mesh tube MT described with reference to Figure 6. The mesh tube 246 can be positioned outside the aneurysm A within the vessel BV, extending across (i.e., straddling) the opening of the aneurysm A. The mesh tube 246 can be deployed in a contracted or flattened shape and moved into an expanded shape within the vessel BV. In this embodiment, the catheter 210 is inserted between the wall of the vessel BV and the mesh tube 246 before the mesh tube 246 is expanded. The mesh tube 246 is then expanded so that it holds or traps the catheter 210 in contact with the wall of the vessel BV during treatment with the light-emitting element 230. A fluid (e.g., saline solution) is introduced into the treatment area to form a clear or translucent optical field, and then light energy is applied via the light-emitting element 230 to irradiate the blood vessel wall of the treatment target, initiating or accelerating blood coagulation within the aneurysm. The mesh tube 246 can prevent the resulting embolus from moving into the blood vessel. The mesh tube 246 can also serve to divert a portion of the blood flow through the blood vessel BV away from the aneurysm A.

[0051]

[0071] The technique shown in Figure 11C is similar to that shown in Figure 11B, except that the catheter 210 is used in conjunction with a mesh tube 246', which can be formed and constructed in the same or similar manner as the mesh tube MT described with reference to Figure 6. The mesh tube 246' can be positioned outside the aneurysm A within the vessel BV, extending across (i.e., straddling) the opening of the aneurysm A. In this technique, the mesh tube 246' is expanded at the treatment site, and then the catheter 210 is inserted through the lumen defined by the mesh tube 246' and exiting the side wall of the mesh tube 246' into the aneurysm. The mesh tube 246' can serve to divert a portion of the blood flow through the vessel BV away from the aneurysm A. The mesh tube 246' can also help maintain the position of the catheter 210 relative to the aneurysm A during treatment with the light-emitting element 230. As described above, fluid is injected into the treatment area, and light energy is applied via the light-emitting element 230.

[0052]

[0072] In the method shown in Figure 11D, the catheter 210 is used in conjunction with the occlusion device 254. The occlusion device 254 can be formed and constructed in the same or similar manner as the occlusion device OD described with reference to Figures 7A and 7B. For example, the occlusion device 254 can be an expandable balloon that can be moved between a flattened shape for delivery to the treatment site in the vessel BV and an expanded shape as shown in Figure 11D. The occlusion device 254 is positioned in the vessel BV in its flattened shape and can be deployed into the vessel outside the aneurysm A, extending across (i.e., straddling) the opening of the aneurysm A. The catheter 210 is inserted between the wall of the vessel BV and the occlusion device 254, and then the occlusion device 254 is moved to its expanded shape so that the occlusion device 254 holds or traps the catheter 210 in contact with the wall of the vessel BV. A fluid (e.g., saline solution) is introduced into the treatment area to form a clear or translucent optical field, and then light energy is applied via the light-emitting element 230 to irradiate the blood vessel wall of the treatment target, initiating or accelerating blood coagulation within aneurysm A. During phototherapy, the occlusion device 254 prevents the resulting embolus from moving into the blood vessel BV. The occlusion device 254 also blocks blood flow within the vessel during treatment of aneurysm A.

[0053]

[0073] In the method shown in Figure 11E, the catheter 210' has a maneuverable distal end portion and can therefore be used without the spacing member 250. The distal end portion of the catheter 210' is positioned within the aneurysm A as described in Figure 11A, and the light-emitting element 230 is positioned approximately in the center of the aneurysm A by steering control of the distal end portion. In this figure, the catheter 210' is used in conjunction with the occlusion device 254'. The occlusion device 254' can be formed and configured in the same or similar manner as the occlusion device OD described with reference to Figures 7A and 7B. For example, the occlusion device 254' can be an expandable balloon that can be moved between a flattened shape for delivery to the treatment site within the blood vessel BV and an expanded shape as shown in Figure 11E.

[0054]

[0074] In this technique, the occlusion device 254' is deployed in a collapsed shape downstream of aneurysm A within the vessel BV to block the flow of blood through the vessel BV, and then expanded to fix the occlusion device 254 distal to aneurysm A within the vessel. The catheter 210' is inserted between the expansion conduit of the occlusion device 254' and the wall of the vessel BV, and its distal end is steered so that the light-emitting element 230 is positioned approximately in the center of aneurysm A. A fluid (e.g., saline solution) is introduced into the treatment area to form a clear or translucent optical field, and then light energy is applied via the light-emitting element 230 to irradiate the vessel wall of the treatment target, initiating or accelerating blood coagulation within aneurysm A. During phototherapy, the occlusion device 254 also prevents the resulting embolus from moving downstream into the vessel BV.

[0055]

[0075] Figures 12A–12E illustrate various methods for using treatment systems, such as those described above, to treat aneurysms located at branching points within blood vessels. The embodiments and specific components of the treatment systems illustrated and described with reference to Figures 12A–12E are configured in the same or similar manner as the corresponding components of system 100 described above, and may include the same or similar characteristics. The illustrated systems and components can, as described above, be used, for example, to treat aneurysms using light energy.

[0056]

[0076] In the treatment method shown in Figure 12A, the treatment system includes a catheter 310, the distal end of which is positioned within aneurysm A located at branch BF of vessel BV. The catheter 310 may include any of the features described above, details of which are omitted in Figure 12A for brevity.

[0057]

[0077] For example, the spacing member 350 located at the distal end of the catheter body 324 may be implemented as one of the above options, including a porous balloon, a non-porous balloon, or a wire cage. The spacing member 350 can be moved between a flattened shape (not shown) for delivery to the treatment site and an expanded shape (shown in Figure 12A) during treatment using one of the above techniques. The spacing member 350 can be used to maintain a minimum distance between the light-emitting element 330 and the wall of the aneurysm A being treated.

[0058]

[0078] The catheter 310 is inserted into the blood vessel BV, and the distal end of the catheter 310, including the spacing member 350 and the light-emitting element 330, is positioned within the aneurysm A. The spacing member 350 is moved into an expanded shape, and fluid is injected to form a clear or translucent optical field. Light energy is then applied via the light-emitting element 330 to initiate and / or accelerate blood coagulation in the treatment area. The spacing member 350 can help prevent the resulting embolus from moving downstream into the blood vessel.

[0059]

[0079] In the technique shown in Figure 12B, catheter 310 is used in conjunction with mesh tubes 346 and 347 to further protect the embolus from moving into the blood vessel during treatment. Mesh tubes 346 and 347 can also serve as scaffolds for vascular remodeling after photon therapy and as filters to prevent the embolus from moving into the blood vessel. Mesh tubes 346 and 347 can be formed and constructed in the same or similar manner as mesh tube MT described with reference to Figure 6. Mesh tube 346 includes a first portion that can be positioned outside aneurysm A within blood vessel BV and a second portion that extends into branch B1 of blood vessel BV. Similarly, mesh tube 347 includes a first portion that can engage with mesh tube 346 and be positioned outside aneurysm A within blood vessel BV and a second portion that extends into branch B2 of blood vessel BV. Mesh tubes 346 and 347 are delivered in a flattened shape and can be moved into an expanded shape at the treatment site. In this embodiment, mesh tubes 346 and 347 work together to form an extended space between them within the blood vessel BV, which terminates at the opening of the aneurysm. The distal end portion of the catheter 310 is inserted between the blood vessel wall and the extended space formed by the mesh tubes 346 and 347, and can be efficiently "retained" between the blood vessel wall and the mesh tubes. The spacing member 350 and the light-emitting element 330 are inserted into the aneurysm A, and the spacing member 350 is then expanded within the aneurysm A, and fluid is injected to form a clear or translucent optical field. Light energy is then applied via the light-emitting element 330 to initiate and / or accelerate blood coagulation in the treatment area. The mesh tubes and spacing member 350 can also help prevent the resulting embolus from moving downstream into the blood vessel.

[0060]

[0080] The technique shown in Figure 12C is similar to that shown in Figure 12B, except that in this figure, catheter 310 is used in conjunction with mesh tubes 346' and 347', which can be formed and constructed in the same or similar manner as mesh tube MT described with reference to Figure 6. Mesh tube 346' includes a first portion that can be positioned outside aneurysm A within vessel BV and a second portion that can extend into branch B1 of vessel BV. Similarly, mesh tube 347' includes a first portion that can be positioned outside aneurysm A within vessel BV and a second portion that can extend into branch B2 of vessel BV. In this embodiment, mesh tubes 346' and 347' abut each other within vessel BV, so that together they form a substantially Y-shape (referred to as the “double-barrel technique”). In this embodiment, the catheter 310 is inserted and its distal end positioned within aneurysm A before the mesh tubes 346' and 347' are inserted into the vessel BV. After positioning the catheter 310, the mesh tubes 346' and 347' are positioned and expanded within the vessel BV and branches B1 and B2 so that they can hold or trap the catheter 310 in the space formed between the mesh tubes 346' and 347' and the arterial wall. The mesh tubes 346' and 347' can serve to divert a portion of the blood flow through the vessel BV away from aneurysm A. The mesh tubes 346' and 347' can also help maintain the position of the catheter 310 relative to the aneurysm during treatment with the light-emitting element 330.

[0061]

[0081] In the method shown in Figure 12D, the catheter 310 is used in conjunction with a single mesh tube 346” which can be formed and configured in the same or similar manner as the mesh tube MT described with reference to Figure 6. In this embodiment, the mesh tube 346” includes a first portion extending into branch B1 of blood vessel BV and a second portion extending into branch B2. The catheter 310 is inserted into the aneurysm, and the mesh tube 346” is then opened to an expanded position, substantially trapping the catheter 310 between the arterial wall and the mesh tube 346” with its distal tip inside the aneurysm A, as shown in Figure 12D. The mesh tube 346” can also help maintain the position of the catheter 310 relative to the aneurysm A during treatment with the light-emitting element 330.

[0062]

[0082] In the method shown in Figure 12E, the catheter 310 is used in conjunction with a single mesh tube 346''' which can be formed and configured in the same or similar manner as the mesh tube MT described with reference to Figure 6. The mesh tube 346''' is substantially Y-shaped and includes a central portion positioned outside the opening of aneurysm A within the vessel BV, and two branch portions extending into branches B1 and B2 of vessel BV. In this embodiment, after the catheter 310 is inserted into aneurysm A, the mesh tube 346''' is moved to an open position, substantially "retaining" or trapping the catheter 310 between the arterial wall and the mesh tube 346''', as shown in Figure 12E. The mesh tube 346''' can also help maintain the position of the catheter 310 relative to the aneurysm during treatment with the light-emitting element 330.

[0063]

[0083] Figure 13 shows the use of a treatment system like the one described above for treating a fusiform aneurysm FA located in the wall of a vessel BV near a branch BF. The embodiments and specific components of the treatment system illustrated and described with reference to Figure 13 are configured in the same or similar manner as the corresponding components of system 100 described above and may include the same or similar characteristics. The illustrated system and components can be used, for example, to treat a fusiform aneurysm FA using light energy, as described above.

[0064]

[0084] As shown in Figure 13, the treatment system includes a catheter 410, with its distal end positioned within a spindle-shaped aneurysm FA located on the side wall of a blood vessel BV. The catheter 410 may include any of the features described above, details of which are omitted in Figure 13 for brevity.

[0065]

[0085] The spacing member 450 can be implemented in any of the above-described options and may include a porous balloon, a non-porous balloon, a wire cage, etc. The spacing member 450 can be moved between a flattened shape (not shown) and an expanded shape (shown in Figure 13) using any of the above-described techniques. The spacing member 450 can be used to maintain a minimum distance between the light-emitting element 430 and the wall of the spindle-shaped aneurysm FA to be treated. With the light-emitting element 430 and the spacing member 450 positioned within the spindle-shaped aneurysm FA, the light-emitting element 430 can operate to emit a desired light intensity to treat the aneurysm.

[0066]

[0086] In this embodiment, the catheter 410 includes an occlusion device 454 coupled to the catheter body 420. The occlusion device 454 can be formed and constructed in the same or similar manner as the occlusion device OD described with reference to Figures 7A and 7B. For example, the occlusion device 454 can be an inflatable balloon that can move between a flattened shape for delivery to a treatment site in the blood vessel BV and an expanded shape as shown in Figure 13. In this embodiment, the occlusion device 454 is positioned in front of a spindle-shaped aneurysm FA in the blood vessel BV to obstruct or block the flow of blood through the blood vessel BV.

[0067]

[0087] The catheter 410 can also be used in conjunction with a mesh tube 446, which can be formed and constructed in the same or similar manner as the mesh tube MT described with reference to Figure 6, as shown, for example, in Figure 13. In this embodiment, the mesh tube 446 is shown in an elongated shape, positioned across a spindle-shaped aneurysm FA within a blood vessel BV, with arterial "landing zones" at both ends of the aneurysm FA. The catheter 410 is inserted through the lumen formed by the mesh tube 446 and remains positioned within the lumen of the mesh tube 446 during treatment of the spindle-shaped aneurysm FA using the light-emitting element 430.

[0068]

[0088] Figure 14 shows the use of catheter 410 to treat the wall of a blood vessel BV (for example, to treat a varicose vein), and shows catheter 410 positioned in a blood vessel BV, for example, using an occlusion device 454 to occlude blood flow in the blood vessel BV during treatment with a light-emitting device 430.

[0069]

[0089] Figure 15 shows a catheter 410 positioned within a vascular BV to treat a malformation M within the vascular BV. In Figure 15, the branch BF at the exit of the malformation M represents one of the possible exits from the malformation M. In this example, the catheter 410, including an occlusion device 454 coupled to the catheter body 420, is positioned within the vascular BV and directly reaches the malformation. The spacing member 450 is moved to the open position, initiating the flow of fluid through the channel. Irradiation of the malformation M is initiated by light emitted from the light-emitting element 430, performing embolization of the malformation within the vascular BV. Light penetration into the narrow and weak artery of the malformation M can initiate thrombus formation, followed by the transformation of the thrombus into scar tissue, thereby removing the malformation M from circulation.

[0070]

[0090] Figure 16 shows components of a treatment system, such as the one described above, used to treat vascular malformations with low blood flow in the subject's body, such as cavernous malformations. The embodiments and specific components of the treatment system illustrated and described with reference to Figure 16 may be configured in the same or similar manner as the corresponding components of system 100 described above, and may include the same or similar characteristics. Using the illustrated system and components, embolization of the malformation is performed, for example, using light energy, as described above.

[0071]

[0091] As shown in Figure 16, the treatment system includes a catheter 510, with its distal end positioned within the cavernous region CV. The catheter 510 may include any of the features described above, details of which are omitted in Figure 16 for brevity. In some embodiments, the catheter 510 may be a blunt needle inserted across the trocar to the lesion.

[0072]

[0092] For example, the spacing member 550 is positioned at the distal end of the catheter body 520, passing through the working channel 524. The spacing member 550 shown in Figure 16 is configured the same as or similar to the spacing member 150 illustrated and described with reference to Figure 4C. More specifically, the spacing member 550 includes a plurality of wires or struts that form a number of apertures between which the diluent fluid discharged by the catheter 410 can pass. The spacing member 550 may be used to maintain a minimum distance between the light-emitting element 530 and the wall of the treatment area. Any of the other forms of spacing members described above may be used.

[0073]

[0093] In this treatment method, the catheter 510 is inserted directly (e.g., percutaneously) into the cavernous malformation through the patient's skin and intervening tissues, rather than into an artery or vein. For example, the catheter 510 may be introduced into the patient's body via a delivery sheath inserted into the body through an opening in the skin and / or a bony structure such as the skull of the patient's body. In this embodiment, the working channel 524 of the catheter body 520 can be used to introduce or inject fluid from a fluid source (not shown) into the treatment area, i.e., into the cavernous region CV. A separate suction device 564 can be used to aspirate (e.g., remove) excess fluid and / or other substances from the treatment area. In some embodiments, the catheter 510 may include a suction channel integrated with the catheter body 524. Examples of such embodiments are described below with reference to Figures 17A-17H.

[0074]

[0094] Figures 17A-17C show components of a treatment system used, for example, to treat spongiform malformations or joints, such as the knee joint capsule KC (Figure 17A). Embodiments and specific components of the treatment system illustrated and described with reference to Figures 17A-17C may be configured in the same or similar manner as the corresponding components of system 100 described above, and may include the same or similar characteristics as those of system 100 described above. The illustrated system and components can be used, for example, to treat a treatment area within the knee joint capsule KC using light energy, as described above.

[0075]

[0095] As in the earlier embodiment shown in Figure 16, and as shown in Figures 17A-17C, the treatment system is introduced directly (e.g., percutaneously) into the patient's joint (e.g., knee joint capsule). The treatment system includes a catheter 610 (e.g., a blunt needle), with the distal end portion of the catheter 610 positioned within the knee joint capsule KC. The catheter 610 includes a catheter body 620 that forms a lumen 624 in which an inner body 648 is movably positioned. The lumen 624 can also be used to introduce a fluid (e.g., saline solution) from a fluid source (not shown) into the treatment area. In this embodiment, the inner body 648 forms a lumen 633 (see Figure 17C) that can receive an optical fiber (not shown) coupled to a light-emitting element 630. The light-scattering element can be incorporated into the light-emitting element 630 and attached to the inner body 648. The light-emitting element 630 (and optical fiber) can be coupled to a light source (not shown). Since the fluids within the body's joints are transparent or translucent, diluting such fluids with a transparent fluid such as saline solution is not necessary to allow light irradiation to reach the soft tissue to be treated. Furthermore, if a sufficiently transparent light-scattering material, such as diamond dust, is used, cooling is not necessary.

[0076]

[0096] Figures 17D and 17E show another embodiment of a catheter that can provide fluid flushing and aspiration functions and can be used, for example, to treat a joint, such as the knee joint capsule KC, as shown in Figure 17A. The catheter 710 includes a catheter body 720 that forms a lumen 724 in which an inner body 748 is movably positioned. The inner body 748 forms a lumen 733 (see Figure 17E) that can receive an optical fiber (not shown) coupled to a light-emitting element 730. Although not shown, a light-scattering element may also be attached to or integrated with the light-emitting element 730. The light-emitting element 730 (and optical fiber) can be coupled to a light source (not shown).

[0077]

[0097] In this embodiment, the lumen 724 of the catheter body 720 can also be used to introduce or deliver a fluid, such as saline solution, from a fluid source (not shown) into the treatment area, e.g., a spongiform malformation or knee joint capsule KC. The fluid can flow out of the lumen 724 through a distal opening or outlet 742. As previously stated, the fluid can provide dilution, visualization, and / or cooling within the treatment area. The catheter body 720 also forms a separate suction lumen 766 positioned parallel to the lumen 724. The suction lumen 766 can be used, for example, to aspirate (e.g., remove) excess fluid from the treatment area, either continuously during treatment or when phototherapy is completed.

[0078]

[0098] Figures 17F and 17G show another alternative embodiment of a catheter that can provide fluid flushing and suction functions and can be used, for example, to treat joints, such as knee joint capsule KC or cavernous malformations, as shown in Figures 17A and 16, respectively. The catheter 810 includes a catheter body 820 that forms a lumen 824 in which an inner body 848 is movably positioned. The inner body 848 forms a lumen 833 (see Figure 17G) that receives an optical fiber (not shown) coupled to a light-emitting element 830. Although not shown, a light-scattering element may also be attached to or integrated with the light-emitting element 830. The light-emitting element 830 (and optical fiber) can be coupled to a light source (not shown).

[0079]

[0099] In this embodiment, the lumen 824 of the catheter body 820 can also be used to introduce or deliver fluid from a fluid source (not shown) into the treatment area, e.g., a spongiform malformation or the knee joint capsule KC. The fluid can flow out of the lumen 824 through a distal opening or outlet 842. The catheter body 820 also forms a suction lumen 866 that can be used to aspirate the treatment area (e.g., to remove fluid and / or other material from the treatment area). In this embodiment, the lumen 824 (used for introducing fluid) and the suction lumen 866 are coaxial. Alternatively, the lumen 824 can be used for aspiration, and the lumen 866 can be used to deliver fluid into the treatment area.

[0080]

[0100] In an alternative embodiment shown in Figure 17H, the catheter 810' may include a catheter body 820' that forms a lumen 824' which can be used for both delivering fluid into the treatment area and aspirating the treatment area. For example, the catheter body 824' can be connected to a fluid source to deliver fluid into the treatment area. The fluid flow into the lumen 824' can then be terminated, and the catheter body 820' can be connected to a device to perform aspiration through the lumen 824'. Alternatively, the lumen 824' can be connected to a valve that switches between a fluid infusion source and an aspirator source.

Claims

1. A catheter having a catheter body with a distal end and a proximal end, A light-emitting element is positioned at the distal end of the catheter body and configured to emit light, A fluid conduit disposed within the catheter body and extending from the proximal end to the distal end of the catheter body, having an inlet at the proximal end of the catheter body that can be connected to a fluid source, and an outlet at the distal end, configured to discharge fluid from the fluid source through the fluid conduit from the distal end, A spacing member disposed at the distal end of the catheter body, which is reconfigurable from a flattened shape to an expanded shape, wherein in the expanded shape, the spacing member is positioned around the light-emitting element, holding the light-emitting element substantially centered within the spacing member with respect to at least one axis of the spacing member, and the spacing member transmits and / or semi-transmits the light emitted from the light-emitting element at least partially. Apparatus including, The apparatus is configured such that the distal end of the catheter body is at least partially inserted into a body lumen having an inner wall, the spacing member is positioned in the body lumen in the expanded shape, the fluid is discharged into the body lumen, and the light is emitted from the light-emitting element and irradiated onto the inner wall of the body lumen.

2. The apparatus according to claim 1, further comprising an optical conduit extending through the catheter body from the proximal end to the distal end of the catheter body, wherein the optical conduit has a proximal end that can be optically coupled to a light source and a distal end that can be optically coupled to the light-emitting element, and is configured to transmit light from the light source to the light-emitting element.

3. The apparatus according to claim 2, further comprising a light source that can be coupled to the proximal end of the optical conduit and configured to produce light of wavelengths in the visible portion of the spectrum.

4. The apparatus according to claim 3, wherein the light source is configured to generate light having a power between 1 mW and 500 mW.

5. The apparatus according to claim 2, further comprising a light source that can be coupled to the proximal end of the optical conduit and configured to produce light with wavelengths between 400 nm and 1,000 nm.

6. The apparatus according to claim 1, wherein the spacing member is porous and capable of releasing the fluid from the fluid conduit.

7. The apparatus according to claim 6, wherein the spacing member includes a wire mesh.

8. The apparatus according to claim 6, wherein the spacing member includes a balloon.

9. The apparatus according to claim 1, further comprising an imaging device positioned at the distal end of the catheter and configured to image a portion of a body lumen in which the distal end of the catheter is positioned, wherein the imaging device is connectable to a display on which an image of the body lumen can be displayed.

10. The apparatus according to claim 1, wherein the light-emitting element includes a light-scattering body configured to scatter light from the light-emitting element more uniformly across the spacing-holding member.

11. The distal end of the catheter is positioned within the blood vessel of the subject, adjacent to the area of ​​the blood vessel wall to be treated, and the distal end has, A light-emitting element configured to emit light, The outlet of the fluid conduit connected to the fluid source of the fluid, A spacing member that can be reconfigured from a flattened shape to an expanded shape, wherein in the expanded shape, the spacing member is positioned around the light-emitting element, holding the light-emitting element substantially centered within the spacing member with respect to at least one axis of the spacing member, and the spacing member is porous, allowing at least partially and / or semi-transmitting the light emitted from the light-emitting element and releasing the fluid from the outlet, To be provided, to be arranged, Reconfiguring the spacing member to the expanded shape, The spacing member is positioned approximately in the center within the lumen of the blood vessel, The fluid is released from the outlet of the fluid conduit into the blood vessel, thereby diluting the blood within the blood vessel with the fluid. The light-emitting element emits light from the light-emitting element through the diluted blood in the lumen to the area of ​​the wall of the blood vessel to be treated, Methods that include...

12. The method according to claim 11, wherein emitting the aforementioned light includes emitting light of wavelengths in the visible portion of the spectrum.

13. The method according to claim 12, wherein emitting the light comprises emitting light with sufficient power and duration to deliver to the region of the wall of the blood vessel an amount of light energy sufficient to mobilize cells and endothelialize the region of the wall of the blood vessel.

14. The method according to claim 12, wherein the emission of light is to emit light such that it is necessary to locally and / or remotely mobilize stem cells and to deliver to the region of the wall of the blood vessel a photothrombotic effect in the region of the wall of the blood vessel a photothrombotic effect in the region of the wall of the blood vessel a photothrombotic effect in the region of the wall of the blood vessel, the

15. The method according to claim 12, wherein emitting the light comprises emitting light with sufficient power and duration to deliver to the diluted blood in the blood vessel an amount of light energy sufficient to gradually increase at least one of endothelial progenitor cells or other hematopoietic cells in the diluted blood.

16. The method according to claim 11, wherein emitting the light includes emitting light with a wavelength between 400 nm and 1,000 nm.

17. The method according to claim 11, wherein releasing the fluid includes diluting the blood in the blood vessel such that the ratio of blood to fluid is between 2:1 and 1:

2.

18. The method according to claim 16, wherein the fluid is saline solution.

19. To stop emitting light from the aforementioned light-emitting element, After ceasing to emit the aforementioned light, ceasing to release the aforementioned fluid from the outlet of the fluid conduit, The method according to claim 11, further comprising:

20. Before reconfiguring the spacing member, administer a photochemical substance to the subject. The method according to claim 11, further comprising:

21. The method according to claim 20, wherein the administration includes systemically administering the photochemical substance to the subject.

22. The method according to claim 20, wherein the administration includes administering the photochemical substance into the lumen of the blood vessel near the distal end of the catheter.

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