Blood vessel endoluminal treatment device

Abstract

To provide a method and device for safe and efficient low power density endoluminal treatment of venous insufficiency.SOLUTION: One device emits pulsed or continuous energy radially through an optical fiber end with a conical tip for 360° radial emission. In some embodiments, a conical reflective surface is disposed distally to and faces the emitting tip. This is for enhancing radial emission efficiency by reflecting out arbitrarily directed or remnant forwardly transmitted energy in radial directions. Other devices include flat emitting faces sealed within protective and radiation-transparent covers. Laser radiation is transmitted at a wavelength and power to allow substantially entire absorption within the blood vessel wall to sufficiently damage the intravascular endothelium and achieve blood vessel closure. Because the energy is substantially entirely absorbed within the blood vessel wall, the need for a local anesthetic along a treatment area of the blood vessel may be substantially avoided.SELECTED DRAWING: Figure 1a

Description

[Technical Field]

[0001] The present invention relates to intravascular laser treatment, and more particularly to the treatment of vascular pathologies such as venous insufficiency with laser energy using fiber optics. [Background technology]

[0002] The venous system of the human lower extremity is essentially composed of the superficial venous system and the deep venous system, both of which are connected by perforating veins. The superficial venous system includes the great and small saphenous veins, while the deep venous system includes the anterior and posterior tibial veins, which converge near the knee to form the popliteal vein. When the popliteal vein joins the small saphenous vein, it becomes the femoral vein.

[0003] The venous system includes valves whose function is to achieve unidirectional blood flow back to the heart. Venous valves are bicuspid, with each apex forming a blood reservoir. Bicuspid venous valves press their free faces against each other under retrograde blood pressure. When properly treated, backward blood flow is prevented and only forward flow to the heart is permitted. If the cusp valves cannot properly seal under the backward pressure gradient, backward blood flow occurs and the bicuspid valve becomes ineffective. Retrograde blood flow increases pressure in the venous segments of the lower extremities, causing the veins to dilate and leading to further valve dysfunction.

[0004] Valve dysfunction, commonly referred to as venous insufficiency, is a chronic condition that can lead to skin discoloration, varicose veins, pain, swelling, and ulceration. Varicose veins are dilated, twisted, and lose their progressive elasticity in the vein walls. Due to the dilation of blood vessels, the valves cannot close completely, and the veins lose their function of returning blood to the heart. This leads to blood accumulation inside the vessels, which can further dilate and twist the veins. Varicose veins are usually blue or purple in color and may protrude above the skin surface, creating a characteristically unattractive, twisted shape. Varicose veins commonly form in the superficial veins of the legs and are subject to high pressure when standing. Other types of varicose veins include venous lakes, reticular veins, and telangiectasia.

[0005] There are several treatments available to eradicate these types of valvular symptoms. Some such treatments work to relieve only some symptoms but do not eliminate the varicose veins or prevent them from re-forming. These treatments include elevating the legs by using footrests while lying down or sitting, compression stockings, and exercises.

[0006] Varicose veins are often treated by eliminating the venous insufficiency. In these treatments, blood that would have flowed through the removed vein is forced to flow through the remaining healthy vein. Various methods are used to eliminate the problematic venous insufficiency, including surgery, sclerotherapy, electrocautery, and laser treatment.

[0007] Sclerotherapy uses a sharp needle to inject a solution directly into the vein. This solution irritates the lining of the vein, causing it to expand and clot. The vein will develop scar tissue and become completely discolored in appearance. Some physicians treat both varicose and spider veins with sclerotherapy. Today, commonly used sclerosing agents include hypertonic saline or Sotradecol™ (sodium tetradecyl sulfate). The sclerosing agent acts on the inner lining of the vein wall, causing them to close and block blood flow. Sclerotherapy can cause various complications. People with allergies can sometimes suffer severe allergic reactions. If the needle is not inserted properly, the sclerosing agent can burn the skin or permanently mark or stain it. Furthermore, sclerotherapy can occasionally lead to blood clots or clot migration. Studies have shown that larger varicose veins treated with sclerotherapy are more likely to recur; therefore, sclerotherapy treatment is generally limited to veins below a certain size.

[0008] Vein stripping is a surgical technique used to treat varicose veins under general or local anesthesia. Problematic veins are stripped from the body by passing a flexible device through the vein and removing it through an incision near the groin. Similarly, tributaries of these veins are stripped with such devices or removed through a series of small incisions (e.g., by outpatient phlebectomy). Any connections to deeper veins are then untangled.

[0009] One drawback of stripping procedures is that they can cause scarring at the incision site and occasionally lead to blood clots. Another drawback is that vein stripping can be painful, consume surgical time, and require a long repair period. Yet another drawback is that they can damage collateral branches of the stripped vein, which can lead to bleeding and therefore hematomas, or other complications such as blood loss, pain, infection, nerve damage, and swelling. Yet another drawback is that the damage done to the treatment area can cause the patient to experience hours of pain and discomfort and may require days of surgical visits. Another drawback of vein stripping procedures is that they can have other negative side effects associated with performing such surgical procedures under anesthesia, including nausea, vomiting, and the risk of wound infection.

[0010] Another well-known method for treating venous insufficiency is through the use of radiofrequency ("RF"). For example, an RF method is described in U.S. Patent No. 5,999,499. An electrode is introduced through a catheter inside a vein, the electrode is placed in contact with the vein wall, and RF energy is applied through the electrode to selectively heat the vein wall. RF energy is applied in a directional direction through the electrode and into the portion of the vein wall that contacts the electrode, causing localized heating and fibrosis of the venous tissue. One disadvantage of the RF method is that it requires maintaining contact between the RF electrode and the vein wall, and therefore essentially transfers energy to the vein wall only through such contact points. Yet another disadvantage of the RF method is that it is more time-consuming and therefore more stressful for the patient than other desirable methods. Yet another disadvantage of the RF method is that RF catheters and electrodes are likely to be relatively complex and more expensive to manufacture than other desirable methods.

[0011] Another minimally invasive prior art treatment for varicose veins is endoluminal laser ablation ("ELA"). In a typical prior art ELA procedure, an optical fiber is introduced through an introducer sheath into the vein to be treated. The fiber optic line has a flat emission surface at its distal end. One example of a prior art ELA procedure includes the following steps: first, a guidewire is inserted into the vein to be treated, preferably with the aid of an introducer needle. Second, an introducer sheath is introduced over the guidewire and advanced to the treatment site. The guidewire is then removed, leaving the introducer sheath. An optical fiber (coupled to a laser source) is then inserted through the introducer sheath and positioned so that the flat emission surface at the distal tip of the fiber and the sheath are in the same position. A tumescent anesthetic is then applied to the tissue surrounding the vein to be treated. Prior to firing the laser, the sheath is retracted from the flat emission surface a sufficient distance to prevent the sheath from being damaged by the emitted laser energy. The laser is then ablated so that the laser energy is emitted through the flat emission surface and into the blood and / or vein wall directly in front of the emission surface. While the laser energy is being emitted, the laser fiber and introducer sheath are retracted together to close off the desired length of the treated vein. The laser energy is absorbed by the blood and / or vein wall tissue, thereby thermally damaging it and causing fibrosis of the vein.

[0012] Patent Document 2 discloses an example of a prior art device and method for subcutaneous laser treatment with minimal insertion into the treatment area. Common vascular abnormalities, such as capillary disorders, spider nevi, hemangiomas, and varicose veins, can be selectively removed. A needle is inserted into the vascular structure, and the targeted abnormality is subjected to a burst of laser radiation. The device allows for the orientation and positioning of a laser-delivering optical fiber during treatment. An extension piece maintains the optical fiber in a fixed position relative to and at a fixed distance from the grip, allowing the user to know the length of the fiber inserted into the vein.

[0013] U.S. Patent No. 5,999,623 describes another ELA technique in which percutaneous access to a venous lumen is obtained using an angiocatheter through which a fiber optic line is introduced. The fiber optic line has an exposed, uncoated tip that defines a flat radiation emission surface. The patent teaches manually compressing the vein with a hand or a pressure bandage or similar device so that the vein wall is in contact with the flat emission surface of the fiber tip. Laser energy is delivered in high-energy bursts into the portion of the vein wall that is in contact with the exposed fiber tip. The wavelength of the laser energy is about 532 nm to about 1064 nm, and the duration of each burst is about 0.2 seconds to about 10 seconds. Each burst delivers about 5 watts to about 20 watts of energy into the vein wall. The ELA techniques of this patent and other prior art teach the delivery of sufficient energy to ensure full-thickness damage to the vein wall, ultimately resulting in fibrosis of the vein wall and occlusion of the great saphenous vein.

[0014] Consistent with this patent, the prior art teaches the application of relatively high energy levels (e.g., ≥80 J / cm) to improve the treatment success of ELA on incompetent saphenous veins. Timperman et al. teach that intravenous laser treatment of saphenous veins is successful, particularly when doses greater than 80 J / cm are delivered. Timperman et al. collected data regarding the length of the treated vein and the total energy delivered on 111 treated veins. The wavelength of the applied laser energy was 810 nm or 940 nm. Of the 111 treated veins, 85 remained closed during the follow-up period (77.5%). Among this group of successfully treated veins, the average energy delivered was 63.4 J / cm. No treatment failures were found in patients receiving doses of 80 J / cm or greater (see Non-Patent Document 1).

[0015] One drawback associated with this and other prior art ELA treatments is that laser radiation is applied only through a very small, flat exit surface at the exposed fiber tip. As a result, only a very small, localized portion of the blood and / or vein wall located in front of the flat exit surface receives the emitted laser energy at any one time. A further drawback of such prior art ELA devices and methods is that laser radiation is directed only in a forward direction out of the flat exit surface of the fiber. Thus, substantially no radiation is emitted radially or laterally from the fiber tip; therefore, the laser radiation is delivered in a relatively localized direction. A further drawback is that relatively high levels of delivered energy into the vein can produce significantly elevated temperatures, thereby causing corresponding levels of pain in the surrounding tissue. Relatively high levels of delivered energy can also cause corresponding levels of thermal damage in the surrounding tissue. More intense thermal damage increases the chance of post-procedure pain, bruising, and possible paresthesia. Paresthesia is an abnormal and / or uncomfortable sensation resulting from nerve damage. Yet another drawback is that the relatively high energy levels of laser radiation delivered and / or localized concentrations can result in venous perforation. As a result, such prior art ELA procedures can require relatively high levels of anesthesia, such as tumescent anesthesia, for longer periods of time, which can be more stressful for both the patient and the physician than would otherwise be desirable.

[0016] A further drawback of prior art ELA treatments is that they use tumescent techniques, which involve substantial amounts of tumescent anesthesia. For example, a typical prior art ELA treatment uses at least about 100 ml to about 300 ml or more of tumescent anesthesia, depending on the length of the vein being treated. The tumescent anesthesia is injected into the tissue along the length of the vein. In some cases, the tumescent anesthesia is injected into the perivenous space defined by a band-like sheath surrounding one or more veins. In other cases, the tumescent anesthesia is injected into the leg tissue surrounding the vein. The tumescent anesthesia typically consists essentially of diluted concentrations of lidocaine and epinephrine in saline. One drawback of such tumescent techniques is that the anesthesia can cause adverse patient reactions, such as convulsions. Yet another drawback of the tumescent technique is that the patient can experience an uncomfortable increase in blood pressure due to the use of epinephrine. A further disadvantage of the swelling technique is that it requires the injection of a substantial amount of liquid anesthetic along the length of the vein, which, adding a significant amount to the time required for the entire ELA procedure, can result in adverse post-treatment surface effects such as black or blue markings, and other adverse effects associated with such large amounts of anesthetic.

[0017] The cold saline tumescent injectate used in the tumescent anesthesia or tumescent techniques of prior art ELA procedures creates a heat sink around the vein, which can inflict significantly higher levels of thermal damage to surrounding tissue than desired. The more severe the thermal damage, the greater the chance of postprocedure pain, bruising, and paresthesia. For example, the significant amount of tumescent anesthesia typically used in prior art ELA procedures will prevent the patient from sensing any thermal excitation in the nerves, thus potentially preventing the patient from alerting the physician to stop or adjust the procedure to prevent unwanted thermal damage. Both the tibial nerve (TN) and its common peroneal nerve (CPN) branches are exposed to the possibility of such damage. The CPN is very superficial in the lateral leg just below the knee. Furthermore, thermal damage to this nerve can result in foot drop. Similarly, the TN is exposed to the possibility of thermal damage during a diagnosis high in the popliteal fossa. Depending on its extent, thermal damage to the TN can lead to muscle dysfunction in the calf and foot muscles. The sural nerve (SUN) and saphenous nerve (SAN) are also susceptible to thermal damage during ELA of the small saphenous vein (SSV) or the GSV below the knee. The SUN runs very close to the SSV, especially distally to the ankle. The SAN runs very close to the GSV below the knee, also distally to the ankle. Significant doses of anesthesia, such as tumescent anesthesia, can unwittingly lead to thermal damage to such nerves.

[0018] Patent Document 4 relates to the application of markings on an optical fiber to determine the fiber's position relative to an introducer sheath. However, this and other related inventions lack information on determining the pullback speed of the laser fiber during laser firing. Slow, uncontrolled pullback of the laser fiber or catheter can cause overheating and vessel perforation, and even the best surgeons may have difficulty pulling back the fiber at exactly the right speed while maintaining the appropriate vessel wall heating temperature. On the other hand, excessive pullback speed may result in insufficient emitted energy for adequate vessel occlusion.

[0019] U.S. Patent Application Publication No. 2009 / 0129994 is assigned to the assignee of the present invention and is hereby incorporated by reference in its entirety. This patent discloses a system and method for controllably delivering radiation in percutaneous radiation therapy. A laser is coupled to an optical fiber inserted into a predetermined location under the skin or within a duct lumen. Radiation is then simultaneously delivered to the treatment site while the fiber is retracted toward the entrance. The fiber is manually retracted at a predetermined rate, and radiation is administered at a constant power or energy level. To maintain a constant desired energy density, the retraction speed is measured and sent to a control mechanism. The control mechanism modifies the delivery power, pulse length, or pulse rate to ensure that the vein or tissue receives a consistent dose of energy. While this is a significant improvement over the prior art, radiation is emitted primarily longitudinally through a flat emission surface located at the fiber tip. [Prior art documents] [Patent documents]

[0020] [Patent Document 1] US Patent Application Publication No. 2006 / 0069471 [Patent Document 2] U.S. Patent No. 6,200,332 [Patent Document 3] U.S. Patent No. 6,398,777 [Patent Document 4] U.S. Patent No. 6,986,766 [Patent Document 5] US Patent Application Publication No. 2004 / 0199151 [Non-patent literature]

[0021] [Non-Patent Document 1] P. Timperman, M. Sichlau, R. Ryu, “Greater Energy Delivery Improves Treatment Success Of Endovenous Laser Treatment Of Incompetent Saphenous Venis”, Journal of Vascular and Interventional Radiology, Vol. 15, Issue 10, pp. 1061-1063, 2004 Summary of the Invention [Problem to be solved by the invention]

[0022] SUMMARY OF THE INVENTION It is therefore an object of the present invention to overcome one or more of the above-mentioned drawbacks and / or disadvantages of the prior art. [Means for solving the problem]

[0023] In certain embodiments, improved methods and apparatus are provided for safe and effective endocavitary laser ablation ("ELA") that may be performed at relatively low power densities.

[0024] In one embodiment, an intravascular treatment device comprises a flexible waveguide defining an elongated axis, a proximal end optically connectable to a radiation source, and a distal end receivable within a blood vessel, the distal end including a radiation emission surface through which radiation is emitted from the radiation source laterally relative to the elongated axis of the waveguide onto an angularly extending portion of the surrounding vessel wall.

[0025] In some embodiments, the device includes one (or more) emission surfaces that emit laser energy radially and substantially circumferentially into the peripheral walls of the blood vessel and any blood, saline, and / or other fluids located therebetween. In some embodiments, the device emits pulsed or continuous laser energy radially through the distal end of an optical fiber having a substantially cone-shaped emission surface for 360° radial emission. Some embodiments of the device further include a substantially cone-shaped reflective surface facing and axially spaced relative to the cone emission surface to enhance radial emission efficiency by radially and / or circumferentially reflecting remaining or forwardly transmitted energy.

[0026] In one embodiment, a plurality of grooves, depressions or other means are spaced apart axially along the fiber to cause radiation to be partially emitted radially out of the fiber and partially transmitted into one or more subsequent grooves. In one embodiment, the power density is maintained at a relatively low level, preferably about 10 W / cm. 2 In other preferred embodiments, the emitting portion of the fiber is defined to be within a length of about 1 cm to about 100 cm, depending on the length of the vein being treated.

[0027] In some embodiments, the method of intraluminal treatment comprises the steps of: (i) introducing a waveguide defining an elongated axis into a blood vessel; (ii) the transmission of radiation through a waveguide; and (iii) projecting radiation laterally about the elongated axis of the waveguide onto an angularly extending portion of the surrounding vessel wall.

[0028] In some such embodiments, the emitting step includes emitting radiation laterally onto a region of the surrounding vessel wall extending over an angle of at least about 90°. In some embodiments, the emitting step includes emitting radiation onto a region of the surrounding vessel wall extending over an angle in the range of about 90° to about 360°. Some embodiments further include emitting radiation substantially radially about the elongated axis of the waveguide onto the surrounding vessel wall in a substantially annular pattern. Some embodiments further include reflecting the forward-emitted radiation laterally about the elongated axis of the waveguide onto the surrounding vessel wall in a substantially annular pattern. Some embodiments further include transmitting radiation at a wavelength in the range of about 980 nm to about 1900 nm and at a power of less than about 10 W.

[0029] In some embodiments, the method of intraluminal treatment comprises the steps of: (i) introducing an energy application device into a blood vessel, the energy application device defining an elongated axis; (ii) maintenance of the vessel at approximately the same size before and after introduction of the energy application device into the vessel; (iii) application of energy from the energy application device into the surrounding wall of the blood vessel laterally about the elongated axis of the device, with substantially no pre-forming, flattening, compression, or movement of the blood vessel wall due to the energy application device; and (iv) Thermal damage to blood vessels.

[0030] In some embodiments, the method of intraluminal treatment comprises the steps of: (i) introducing an energy application device into a blood vessel, the energy application device defining an elongated axis; (ii) application of energy from the energy application device into the surrounding wall of the blood vessel without substantial pre-forming, flattening, compression or movement of the blood vessel wall for the energy application device; (iii) substantial absorption of the applied energy within the vessel wall and induction of sufficient damage to the vascular endothelium such that the vessel is closed; and (iv) Substantial prevention of transmission of the applied energy through the vessel wall and into the tissue surrounding the vessel at levels that would cause thermal damage to the tissue.

[0031] In certain embodiments, the method further comprises applying energy in the form of laser radiation at at least one substantially predetermined wavelength and at least one substantially predetermined energy transfer rate that results in the applied radiation being substantially absorbed within the vessel wall to sufficiently damage the vascular endothelium and close the vessel, and further substantially preventing transmission of the applied radiation through the vessel wall and into surrounding tissue at levels that would cause thermal tissue damage.

[0032] In some embodiments, the method of intraluminal treatment comprises the steps of: (i) Introduction of an energy application device into a blood vessel; (ii) the delivery of a predetermined energy per length of the vessel from the energy application device into the treatment region of the vessel, the energy being high enough to cause occlusion of the vessel on average, but low enough to substantially avoid the need for an anesthetic agent along the treatment region; and (iii) Thermal injury and vascular closure.

[0033] In some embodiments, a method for intraluminal treatment of varicose veins comprises the steps of: (i) Introduction of an energy application device into a varicose vein; (ii) delivery of a predetermined amount of energy from the energy application device into the treatment area of the vein, averaging approximately 30 J / cm of energy per cm of vein length; and (iii) Thermal damage and venous closure.

[0034] In some embodiments, the device includes a cap rigidly secured to the distal end of the fiber. In some such embodiments, the distal end of the fiber includes a flat emission surface, and the cap surrounds the emission surface. In other embodiments, the distal end of the fiber includes a radial emission surface, such as a conical surface, and a reflective surface, and the cap surrounds both the emission and reflective surfaces. In some embodiments, the cap is made of quartz or other radiation-transparent material fused, bonded, or rigidly secured to the fiber core to protect the core and its emission surface and for transmission of emitted and reflected radiation therethrough. In other embodiments, to provide a relatively long and flexible emission zone, the cap is made of a relatively flexible, transparent material, such as the polymers Teflon® PFA or Teflon® AF. For wavelengths with relatively low absorption, the cap can be made of an opaque material, since all or part of the emitted energy is converted to heat. In some embodiments, the cap and / or fiber include means for controlling the temperature within the vein, means for adjusting the power input and / or means for adjusting the pullback speed of the fiber. [Effects of the Invention]

[0035] One advantage of the subject devices and methods is that they may provide relatively fast, safe, effective and / or reliable treatment compared to the conventional treatments discussed above.

[0036] Another advantage of the preferred embodiment is that it allows for a substantially uniform and essentially even application of radiation to the vein wall at a relatively low power density, thereby reducing the risk of perforation of the vein wall and therefore reducing pain during and after the procedure compared to conventional treatments.

[0037] Another advantage of certain preferred embodiments is that venous insufficiency can be safely and effectively treated while avoiding the need for administration of general or local tumescent anesthesia. In certain such embodiments, the need for anesthesia along the treated portion of the blood vessel is also substantially avoided. In other embodiments, no general or local anesthesia is required at all, much less tumescent anesthesia.

[0038] A further advantage of certain embodiments is that they provide an intravascular treatment device and method by delivering radiation at multiple regularly spaced delivery points as well as extended diffuse radiation.

[0039] The above and other objects, features and advantages of the present invention and / or its generally preferred embodiments disclosed herein will become more readily apparent from the following detailed description read in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0040] [Figure 1a] FIG. 1 is a perspective view of a first embodiment of an optical fiber including a substantially cone-shaped emission surface on the optical fiber tip, a substantially cone-shaped reflective surface facing and axially spaced relative to the emission surface, and a cap surrounding the emission and reflective surfaces to provide efficient 360° radial emission of laser energy. [Figure 1b] 1a is a partial side-top view of the optical fiber of FIG. 1a with an enlarged detail of its distal portion. [Figure 2a] FIG. 10 is a partial perspective view of another embodiment in which an optical fiber is received within a blood vessel. [Figure 2b] 2b is a partial side top view of the optical fiber of FIG. 2a. [Figure 2c] FIG. 2b is a top view of the distal end of the optical fiber of FIG. 2a with blood vessels removed for clarity. [Figure 3] FIG. 10 is a roughly schematic illustration of the placement of the optical fiber of FIG. 1 or 2 within the vein to be treated. [Figure 4] 1 is a schematic diagram of a preferred embodiment of an apparatus including a laser radiation source, an optical fiber, a temperature sensor, a power control module, and a pullback actuator controlled by a pullback speed controller. [Figure 5] FIG. 10 is a partial perspective view of another embodiment of an optical fiber including a protective quartz cap, a core at the distal end of the optical fiber having a surface groove, a reflective surface, and a guide wire attached to the distal end of the fiber and extending distally therefrom, and an enlarged detail of the attachment of the guide wire to the cap. [Figure 6] FIG. 10 is a partial perspective view of another embodiment of an optical fiber comprising an optical fiber set with a guidewire attached to the distal end of a quartz protective cap. [Figure 7a] FIG. 10 is a partial perspective view of another embodiment of an optical fiber, in which the fiber optic tip defines a reflective cone. [Figure 7b] 7b is a partial cross-sectional view of the fiber optic tip of FIG. 7a. [Figure 8a] 1 is a partial perspective cross-sectional view of another embodiment of an optical fiber including a fiber optic tip having a reflective gap; [Figure 8b] 8a is a cross-sectional view of the fiber optic tip and its enlarged detail. [Figure 9] FIG. 10 is a partial cross-sectional view of another embodiment of an optical fiber including an outer sleeve slidably mounted over the fiber and / or cap defining an internal reflective surface to prevent through transmission of laser radiation and to control the length of the fiber launch section. [Figure 10] 1 is a partial cross-sectional view of another embodiment of an optical fiber including a substantially flat exit face sealed within a radiation-transparent protective cap; [Figure 11] 1 is a partial cross-sectional view of another embodiment of an optical fiber including a substantially flat exit face sealed within a radiation-transparent protective sleeve; DETAILED DESCRIPTION OF THE INVENTION

[0041] The following is described in connection with the drawings accompanying the preferred embodiments, in which like reference numerals are used to designate like elements throughout the various views. As further described below, the preferred embodiments provide improved methods and apparatus for safe and efficient low-power-density intraluminal treatment of venous insufficiency. Some preferred embodiments also provide for pulsed or continuous radial delivery of energy from optical fibers. For circular delivery, a cone or near-cone distal end of the fiber is used against a fixed, cone-shaped reflective surface in the distal end region of the cap. For extended radial delivery, suitable multiple or spaced-apart fiber distal end longitudinally arranged delivery channels may be used.

[0042] Another feature of certain preferred embodiments is the possibility of achieving an extended emission zone. This can be achieved by appropriately positioning a set of opposing cone shapes using a combination of different variables, such as the cut angle of the cone surfaces, the spacing between the cones, the refractive index of the cap material, and the composition of the gaseous constituents remaining in the space. Additionally, a series of graded lenses, such as multi-graded lenses, axially positioned relative to one another, may be used. Furthermore, tapered cone tips may also be used to appropriately shape the radiation pattern in spaced regions. These variables can be adjusted to vary the width of the circular cross-section being treated, as well as the distribution of power density across the length of the spacing. For example, if desired, a substantially uniform power density can be achieved across the entire irradiated cross-section.

[0043] As shown in FIGS. 1a and 1b, a first embodiment of an optical fiber set is generally designated by the reference numeral 100. The optical fiber 100 is comprised of a cladding 146, a core 140, and a quartz cap 106. The fiber optic tip preferably defines a substantially conical-shaped exit surface 110 for achieving 360° radial launch. A preferred substantially conical-shaped reflective surface 112 faces the exit surface 110, axially relative to the exit surface for efficiency enhancement and zone-design distribution of radial launch. As shown, the exit and reflective surface portions are hermetically sealed within the quartz cap 106, which rigidly secures the fiber end and defines a boundary for air or other gas at the exit surface to achieve radial / annular launch. Thus, due to the angle of the exit surface 110 and the difference in refractive index at the interface between the exit surface 110 and the air or other gas provided within the sealed cap 106, the laser radiation is emitted radially (i.e., transverse to the elongated axis of the fiber or laterally with respect to the elongated axis of the fiber) and annularly directly onto the surrounding vessel wall. Preferably, the exit surface 110 is oriented at an acute angle with respect to the elongated fiber axis, which is arranged for substantially total internal reflection of the emitted radiation laterally with respect to the elongated axis of the fiber. In one embodiment, the radiation is emitted laterally and annularly onto the surrounding vessel wall, with the annular beam of radiation expanding over an arc (i.e., beam spread), the arc being defined by the numerical aperture of the fiber. In one embodiment, the annular beam is defined by an angle within a range of about 30° to about 40°. Additionally, the approximate center of the beam is preferably oriented at an angle within the range of about 70° to about 90° with respect to the axis of the elongated fiber.

[0044] One advantage of such novel configurations is that substantially all radiation is emitted radially, thus significantly facilitating radial emission compared to the prior art described above. Laterally or radially emitted annular beams may define a substantially smaller volume than axially or forwardly directed cone-shaped beams, such as those emitted by flat, bare-tip fibers. Laterally emitted beams may therefore deliver radiation more directly and efficiently into the vessel wall. Furthermore, the emission characteristics, as well as the distribution of power density along the length of such annular portion, can be varied and tailored to the length of the annular region of a blood vessel, or other hollow anatomical structure, being treated. For example, in another embodiment, a multi-grooved distal fiber end defining a linear distribution of axially arranged grooves may irradiate an extended linear arc sector of the venous wall, thereby enabling the use of effective, relatively low power density treatments. In a preferred embodiment, a fiber having a distal end engraved with many linearly distributed grooves oscillates or rotates back and forth (e.g., approximately one full revolution) during irradiation to achieve 360° radial stimulation of the vessel wall. Alternatively, the grooves can be offset relative to the fiber to provide a generally circular pattern with either a pullback or rotational motion.

[0045] 2a, 2b, and 2c, another embodiment of an optical fiber is indicated generally by the reference numeral 200. The optical fiber 200 includes a standard portion 202 extending along most of its length from a proximal end that is optically connected to a laser source to a distal end 204 that emits laser radiation. To achieve radial laser emission along an emission zone, the emission portion 204 includes regularly spaced grooves, preferably spaced about 1 mm to several mm apart. Each groove 208 results in some radiation 218 being partially emitted radially outward from the fiber, and the remaining radiation 216 being partially transmitted to the subsequent groove 208.

[0046] The fiber optic tip 210 may be substantially conical in shape to achieve 360° radial launch, and may have a preferably conical reflective surface 212 that, as previously described, reflects all remaining or designed forward-transmitted energy outward in a 360° radial direction, thereby enhancing the efficiency and distribution of the 360° radial launch.

[0047] The emission section 204 of the fiber 200 is covered by a protective cap 206. In one preferred embodiment, if the wavelength used is highly absorbed by the target tissue 214, the protective cap 206 is made of quartz or other radiation-transparent or substantially radiation-transparent material (i.e., a material that allows radiation to be transmitted or substantially transmitted). Polymers such as Teflon® AF or Teflon® PFA are examples, which provide a relatively long and flexible emission zone. In another preferred embodiment, if the wavelength used is poorly absorbed by the target tissue 214, the protective cap 206 is made of an opaque radiation-transmitting material (i.e., a material that absorbs the emitted radiation) to convert substantially all or a portion of the emitted radiation into heat that thermally damages the vein wall. In this case, destruction of the vein can be achieved by thermal means instead of direct laser radiation.

[0048] Turning to FIG. 3 , another embodiment of an optical fiber, generally designated by the reference numeral 320, is shown positioned at a predetermined location within vein 314. It can be seen from this figure that the relatively long launch zone of optical fiber 320 allows for location-specific treatment of a wide portion of the vein (e.g., the vein may be ablated segment by segment). The length of the fiber launch portion can be any desired length, including, but not limited to, lengths ranging from about 1 cm to about 100 cm, from about 1 cm to about 75 cm, or from about 1 cm to about 50 cm. In the particular case where the length of the launch portion matches the entire length of the vein portion to be treated, a controlled pullback may no longer be necessary, resulting in a shorter and simpler treatment. In one such embodiment, the entire length of the affected area may be treated at once by pulling back the fiber to disrupt the vein wall. In other embodiments, the grooves are spaced far enough apart (e.g., about 1 / 2 cm to about 2 cm apart, and in one embodiment, about 1 cm apart) that the fiber remains substantially in place and does not pull back, and the grooves extend along a sufficient length of the fiber to treat the entire vessel, or along a desired portion thereof. In other embodiments, the vessel is ablated segment by segment by treating successive, elongated vessel segments. In one such embodiment, the fiber is held in place within a first portion of the vessel and the laser is fired to treat the first portion. The laser is then turned off, the fiber is pulled back, and the fiber is placed in a second portion of the vessel. The fiber is then held in place in the second portion of the vessel while the laser is fired to treat the second portion. These steps are then repeated to treat any additional vessel segments required. In other embodiments, the laser is not turned off during fiber pullback or movement from one vein segment to another.In other embodiments, the fiber is held stationary while firing the laser in one portion of the vessel, and the fiber is pulled back while firing the laser in another portion of the vessel.

[0049] As shown in FIG. 4, another embodiment of an ELA system comprises a laser radiation source 424, an optical fiber 420, a temperature sensor 426, a power control module 428, and a pullback actuator 430 driven by a pullback speed controller 432. During laser firing, the power control module 428 receives temperature values from the temperature sensor 426, preferably a thermocouple, located near the target tissue. In one embodiment, the temperature sensor is mounted on the fiber or its cap closest to its firing / reflecting surface. The power control module 428 processes the information received from the temperature sensor 426 and provides feedback to both the laser power source 424 and the pullback speed controller 432. In one embodiment, the power control module 428 calculates the ideal or desired power density and pullback speed and sends this information to the laser power controller 428 and the pullback speed controller 432, respectively. The pullback speed controller 432 controls the pullback actuator 430 to retract the fiber through the blood vessel, and the laser radiation source 424 positions the laser power according to control signals received from the control module 428. One advantage of these embodiments is that the power density and / or optical fiber pullback speed can be adjusted throughout an intraluminal treatment procedure, for example, to ensure vein closure while substantially preventing localized hot spots that might otherwise result in perforation of the vein wall or overheating of the vein and / or surrounding tissue that might otherwise cause pain or discomfort to the patient. In another embodiment, the pullback is manual, and the power control module 428 suggests to the physician, and indicates on a display, the ideal or desired power density and pullback speed values, allowing for more efficient and effective manual pullback.Such a system and / or its components for monitoring temperature and adjusting pullback speed and other system variables may be manufactured and may follow the teachings of commonly assigned U.S. patent application Ser. No. 11 / 900,248, filed Sep. 11, 2007, entitled "Vein Treatment Device And Method," and U.S. patent application Ser. No. 11 / 443,143, filed May 30, 2006, entitled "Power Regulated Medical Underskin Irradiation," both of which are expressly incorporated herein by reference in their entireties as part of this disclosure.

[0050] In one preferred embodiment, a low power density is applied, e.g., about 10 W / cm, while a sufficiently high total energy can be applied to the vein within a reasonably short time to ensure collagen denaturation, shrinkage, and elimination of the vein. 2 This can be facilitated by an extended injection zone (or section) and 360° radial irradiation so that during pullback, the area primarily irradiated by the proximal side of the injection zone continues to receive irradiation from the central and distal sides of the injection zone.

[0051] Turning to FIG. 5, another embodiment of an optical fiber is generally designated by the reference numeral 500. The optical fiber 500 primarily comprises a standard portion 202, the length of which extends from a proximal end optically connected to a laser source to a distal end 204 from which laser radiation is emitted. The emission portion 504 includes regularly or otherwise spaced grooves, each of which provides radial laser emission along an emission zone. The fiber optic tip 510 defines a standard critical angle at the distal end, but preferably defines a conical shape as shown to achieve 360° radial emission. Additionally, to enhance the efficiency and effectiveness of the radial emission, the fiber optic tip 510 preferably includes a conical reflective surface 512 axially disposed opposite the emission surface, thereby reflecting any designed or residual forwardly transmitted energy outward in a radial direction.

[0052] Guidewire 534 is attached to quartz cap 506 by a mechanical guidewire attachment / detachment mechanism 536. Because of its illustrated configuration, guidewire 534 remains attached to the optical fiber during insertion of the treatment set into blood vessel 514. At the attachment site, guidewire 534 is appropriately shaped at 538 so that attachment mechanism 536 prevents detachment while pushing inward, but allows detachment while pulling back, thus permitting its withdrawal before or at the beginning of treatment. In another embodiment, the guidewire is attached with a medically safe adhesive, such as wax or cyanoacrylate. As those skilled in the art will recognize in the appropriate techniques based on the teachings herein, the guidewire may be attached in any of a number of different ways, including any of a number of different adhesives or other attachment mechanisms now or later known. The guidewire can be detached by softening the adhesive or breaking down the adhesive bond. This can be done by means of laser radiation at the appropriate location of the treatment set within the vessel. Once detached, the guidewire 534 is removed, leaving the capped optical fiber 500 in place and ready to deliver the laser. While the laser is being delivered, the optical fiber is retracted back towards the insertion site, causing the blood vessel 514 to shrink, preferably closing off the vessel.

[0053] In another preferred embodiment, as depicted in FIG. 6 , fiber optic set 600 includes an optical fiber, a quartz cap 606, and a guidewire 634. Radial laser injection is achieved through a plurality of surface grooves 608 having a reflective surface 610 formed on the distal end portion of the fiber optic core. In this case, guidewire 634 is preferably attached to the distal end of cap 606. Thus, fiber optic set 600 can be easily introduced and advanced through blood vessel 614 to the desired location in one step without having to move guidewire 634. Once in the proper position, the physician initiates laser injection while retracting fiber optic set 600 toward the insertion site, thereby shrinking and preferably closing blood vessel 614.

[0054] 7a and 7b, another embodiment of an optical fiber is generally designated by the reference numeral 700. The optical fiber 700 achieves radial launch by a reflector cone 742 disposed at the fiber tip 700. In this embodiment, the reflector cone 742 is defined by a substantially cone-shaped concave surface. Thus, radiation transmitted through the fiber core 740 is launched radially over 360° upon reaching the fiber tip. Preferably, the substantially cone-shaped concave surface of the cone 742 forms an acute angle with respect to the fiber elongation axis within a range of about 30° to about 50°. As described in the other embodiments above, one advantage of this novel cone-shaped concave surface is that it can achieve efficient 360° radial launch onto the surrounding vessel wall.

[0055] 8a and 8b, another embodiment of an optical fiber is generally designated by the reference numeral 800. Optical fiber 800 achieves radial launch by a cone-shaped reflective gap formed at the fiber tip. As can be seen, gap 844 is defined by a substantially cone-shaped convex surface formed at the distal end of fiber core 840 and a substantially cone-shaped concave surface that is substantially transparent to the launched radiation and axially spaced from the launch surface to form gap 844 therebetween. In this embodiment, as a result of the difference in refractive properties between the air or other gas in gap 844 and fiber core 840, radiation transmitted through fiber core 840 is launched radially upon reaching the fiber tip. Thus, radiation is launched radially (i.e., laterally with respect to the elongated axis of the fiber) in an annular or circumferential pattern onto the nearby surrounding vessel wall. This different tip shape leads to efficient 360° radial launch. As can be seen, a relatively thin wall is formed between the outer perimeter of gap 844 and the outer surface of fiber 800 to seal the gap within the fiber tip, thus maintaining the core-gas interface required in the gap for annular radial laser emission. As described in other embodiments herein, this novel shape facilitates efficient radial emission onto the surrounding vessel wall. As can be seen, to facilitate tip movement through the vessel, the distal tip of fiber 800 is defined by a bulbous portion of enlarged diameter, or substantially hemispherical in shape in the illustrated embodiment. While the bulbous portion is hemispherical in shape, those of ordinary skill in the art will recognize that it may have any of many different bulbous or similar shapes, and / or shapes now known or later to become known, in accordance with the teachings herein.

[0056] In another embodiment, shown in FIG. 9 , the cap 906 of the fiber 900 is partially covered by a sleeve 946 of radiation-reflective material. As indicated by the arrow in FIG. 9 , the sleeve 946 is axially repositionable with respect to the cap 906 and fiber 900 to control the axial length of the fiber's emission section. As can be seen, the sleeve 946 can be positioned to completely cover a desired number, some portion, or all of the distal emission section of the radially emitting grooves 908. Thus, one advantage of the embodiment of FIG. 9 is that it allows the physician to adjust the length of the emission section or fiber section. In one embodiment, the length of the emission section is positioned according to the length of the vessel 914 or portion thereof so that such portion can be ablated and treated segment by segment. In another embodiment, a substantially fully extended emission section delivers laser light progressively to a treatment site in one or more veins, while the extended emission section is pulled back through the vein while emitting the laser light. If the vein segment is shorter than the length of the delivery fiber, a sleeve may be used to cover the delivery segment located outside the vein during laser delivery. The sleeve is preferably made of a reflective material of a type known to those skilled in the art for such a function. Even with a perfectly reflective surface, the reflected light will travel back through the fiber, and some portion of the radiation will be captured, some scattered, and some absorbed. Thus, some amount of the delivered energy in the channel covered by the sleeve will be lost as heat. Nevertheless, because the required power density is low, any buildup of such heat can be kept within an acceptable minimum during ELA treatment.

[0057] Turning to FIG. 10, another embodiment of an optical fiber is generally designated by the reference numeral 1100. Optical fiber 1100 is substantially similar to optical fiber 100 described above with reference to FIGS. 1a and 1b, and therefore, like reference numerals, preceded by the reference numeral "11" instead of the reference numeral "1," are used to designate like elements. A primary difference between optical fiber 1100 and optical fiber 100 is that the optical fiber tip is defined by a substantially flat exit face 1110 that is sealed within a protective cap 1106. Cap 1106 is made from a material that is substantially transparent to the emitted radiation, allowing the radiation to pass through and travel into the vessel wall. In one embodiment, cap 1106 is made from quartz and is adhesively bonded to the fiber core as described above. However, if desired, the cap may be made from any of a number of different materials now or later known and may be rigidly secured to the distal end of the fiber in any of a number of different ways. As can be seen, the protective cap 1106 extends distally relative to the fiber's flat exit face 1110, and further has a rounded distal end 1107 to facilitate movement of the capped fiber through tortuous blood vessels. The distal end 1107 of the cap 1106 extends an axial distance distal to the fiber's flat exit face 1110, preferably within the range of about two to about six fiber core diameters, and more preferably within the range of about three to about five fiber core diameters. In the illustrated embodiment, the distal end 1107 of the cap 1106 extends an axial distance distal to the fiber's flat exit face 1110 at about four fiber core diameters. As can be seen, the protective cap 1106 defines a sealed space 1109 extending between the flat exit face 1110 and the cap's distal end 1107. This allows the transmitted radiation to pass through the walls of the space and the cap, but prevents any contact between the flat exit surface and the vessel wall, and can protect the exit surface of the fiber.In comparison to optical fiber 100 described above, optical fiber 1100 does not define a substantially cone-shaped exit surface or a substantially cone-shaped reflecting surface, and thus optical fiber 1100 emits a substantially cone-shaped beam in a forward, or axial, direction of the fiber.

[0058] Turning to FIG. 11 , another embodiment of an optical fiber is generally designated by the reference numeral 1200. Optical fiber 1200 is substantially similar to optical fiber 1100 described above with reference to FIG. 10 , and therefore like reference numerals, preceded by the reference numeral “12” instead of the reference numeral “11,” are used to designate like elements. A primary difference between optical fiber 1200 and optical fiber 1100 is that fiber 1200 includes an open protective sleeve 1206 rather than a closed protective cap. Protective sleeve 1206 is made from a material that is substantially transparent to the emitted radiation, allowing the radiation to pass through and proceed into the vessel wall. In one embodiment, protective sleeve 1206 is made from quartz and is adhesively bonded to the fiber core in a manner substantially similar to the protective cap described above. However, if desired, the protective sleeve may be made from any of a number of different materials now or later known and may be securely secured to the distal end of the fiber by any of a number of different methods. As can be seen, the protective sleeve 1206 extends distally relative to the fiber's flat exit face 1210 and defines a distal end 1207 that is rounded or bent inward toward the central bore 1209. The distal end 1207 is bent inward to facilitate movement of the fiber tip through the blood vessel. The protective sleeve 1207 extends an axial distance distal to the fiber's flat exit face 1210 that is preferably within the range of about 2 to about 6 fiber core diameters, and more preferably within the range of about 3 to about 5 fiber core diameters. In the illustrated embodiment, the protective sleeve 1207 extends an axial distance distal to the fiber's flat exit face 1210 that is about 4 fiber core diameters. Compared to the optical fiber 100 described above, the optical fiber 1200 does not define a substantially conical exit surface or a substantially conical reflective surface. Thus, the optical fiber 1200 emits a substantially cone-shaped beam in a forward, or on-axis direction of the fiber.

[0059] In one preferred embodiment of the procedure, a fiber optic or other waveguide is first introduced into the vein to be treated. If necessary, a local infiltration anesthetic, such as 0.5% diluted lidocaine (preferably without epinephrine), may be introduced at the access site. In one embodiment, approximately ½ ml of such a local anesthetic is used at the access site. An introducer needle is inserted through the access site and into the vein to gain access to the vein. A guidewire may then be passed through the introducer needle and introduced into the vein. An introducer sheath may then be introduced over the guidewire into the vein. The introducer sheath may take any of many different introducer sheath shapes now known or later known, including short introducer sheaths (e.g., defined as less than about 11 cm in length, or within the range of about 6 cm to about 11 cm) that provide access to a relatively short portion of the vein proximal to the access site, or longer introducer sheaths that may extend beyond the length of the vein to be treated. The guidewire is then removed through the sheath. The optical fiber is then introduced through the introducer sheath until the fiber's ejection tip is positioned approximately 1 to 1 / 2 cm, or other desired distance, downstream from the saphenous-femoral junction ("SFJ"). The fiber tip is positioned at the appropriate starting location downstream from the SFJ under ultrasound guidance and / or by transmission of a red or other prominent aiming beam through the fiber to visually monitor the starting location of the fiber tip through the skin.

[0060] One advantage of the preferred embodiment is that the cap or other distal portion of the fiber tip is rounded, thus facilitating easier insertion through tortuous veins and eliminating the need for an introducer sheath and guidewire in many, if not all, cases. In the preferred embodiment, the fiber has an outer diameter ranging from about 1235 μm to about 1365 μm, the cap has an outer diameter ranging from about 1800 μm to about 2000 μm, and the rounded distal portion of the cap is defined by a radius ranging from about 900 μm to about 1000 μm. Thus, while the use of an introducer sheath and guidewire is described above, such a step may be omitted. Alternatively, if an introducer sheath is used, it may be removed from the vein before the laser is fired and pulled back on the fiber. For example, if a long introducer sheath is used, the introducer sheath may be pulled back and out of the vein before the laser is fired and pulled back on the fiber. Similarly, if a peelable introducer sheath is used, the sheath can be peeled back and removed from the vein before the laser is fired and pulled back on the fiber. If a relatively short introducer sheath is used, the sheath can be removed from the vein or can be left in place at the access site during the laser firing and pull back.

[0061] With the fiber tip at a starting position just downstream of the SFJ or other desired starting position, the laser is activated to emit laser energy into the blood vessel. With a radially emitting fiber, the laser energy is preferably directed radially and circumferentially onto the circumferential wall of the blood vessel. Meanwhile, with a flat-tip fiber, the laser energy is emitted in a substantially conical, axially directed beam. As the radiation is emitted, the fiber is pulled back in a substantially predetermined increment based on the wavelength and power used to damage or kill a portion of the vascular endothelium sufficiently to achieve vessel occlusion. Preferably, the energy per unit length delivered to the blood vessel is high enough to occlude the vein, yet low enough to substantially avoid the need for anesthesia along the length of the vessel being treated. In preferred embodiments, the energy delivered per unit length to the treatment region of the blood vessel is, on average, less than 80 J / cm, preferably less than about 50 J / cm, more preferably less than about 40 J / cm, more preferably less than about 30 J / cm, more preferably less than about 20 J / cm, and even more preferably less than about 10 J / cm. In certain embodiments, the energy delivered per unit length to the treatment region of the blood vessel is, on average, in the range of about 3 J / cm to about 15 J / cm, preferably in the range of about 5 J / cm to about 10 J / cm. In these embodiments, as further described below, the wavelength of radiation is preferably relatively strongly absorbed by water and relatively poorly absorbed by hemoglobin or oxyhemoglobin (e.g., ≧about 1064 nm). One advantage of such predetermined energy levels and / or wavelengths is that (i) the energy may be substantially totally absorbed within the vessel wall, (ii) the vascular endothelium is sufficiently damaged so that occlusion of the vessel is achieved, and (iii) any significant radiation penetration into the tissue surrounding the vessel is substantially prevented, thereby substantially avoiding the need for anesthesia along the treated portion of the vessel.

[0062] In a preferred embodiment, energy such as laser radiation may be delivered in a continuous or pulsed manner. It has been discovered that delivering energy in a pulsed manner may allow for the delivery of higher average levels of energy per length to a treatment region of a blood vessel, substantially without the application of anesthesia to the treatment region, compared to delivering laser energy in a continuous manner (i.e., a greater amount of pulsed energy may be absorbed within the vessel, compared to energy in a continuous manner, while substantially preventing any significant energy penetration through the vessel wall that would otherwise thermally damage surrounding tissue). Furthermore, all general procedures and other factors being equal in a pulsed manner, the greater the percentage of the duty cycle that is "off" as opposed to "on," the higher the average energy delivered per unit length to a treatment region of a blood vessel, substantially without the need for the administration of anesthesia along such treatment region. In some such embodiments, the "off" period is greater than about 1 / 2 of the duty cycle, and preferably the "off" period is about 1 / 2 to about 2 / 3 of the duty cycle. Pulsing can significantly increase the rate of radiation destruction within the vessel wall tissue compared to delivery in a continuous mode, thus resulting in a lower depth of penetration (e.g., average J / cm delivered by an intravascular energy delivery device) per given energy delivery rate than without pulsing (e.g., continuous mode). Thus, one advantage of delivering energy in a pulsed mode is that it allows for a higher energy delivery rate, and therefore, a higher energy dose can be delivered to the vascular endothelium without the need for anesthesia along the treated portion of the vessel. The term "pulsed mode" is used herein to refer to any of a number of different methods now known or later known for delivering energy to a vessel in a duty cycle (i.e., a repetitive cycle, a segment in which energy delivery is active, and another segment in which energy delivery is inactive). This includes, but is not limited to, pulsing, repeatedly switching the energy source on and off, such as with a shutter, and interrupting the energy beam.

[0063] In one preferred embodiment, the wavelength of the radiation is about 1470 nm ± about 30 nm. In other preferred embodiments, the wavelength of the radiation is about 1950 nm ± about 30 nm. Other embodiments use radiation at about 810 nm, about 940 nm, about 1064 nm, about 1320 nm, about 2100 nm, about 3000 nm, and about 10,000 nm, each ± about 30 nm. One advantage of wavelengths that are significantly more highly absorbed in water than in hemoglobin or oxyhemoglobin is that such wavelengths are not strongly absorbed in blood but are strongly absorbed in vascular tissue. Thus, such wavelengths tend to penetrate substantially through the blood interposed between the fiber emission surface and the vessel wall and are then strongly absorbed in the vessel wall. Such wavelengths emitted at less than a given energy delivery rate are substantially totally absorbed in the vessel wall tissue and damage or kill a sufficient depth of the vascular endothelium to promote vascular closure. Preferably, such damage to the vascular endothelium is at an average level of at least about one-third the thickness of the vascular endothelium, or an average of about one-third to about two-thirds the thickness of the vascular endothelium. As a result, such wavelengths can be more readily absorbed at a given relatively low energy delivery rate (e.g., an average delivery to the vascular treatment site of less than about 50 J / cm, preferably less than about 40 J / cm, more preferably less than about 30 J / cm, more preferably less than about 20 J / cm, and even more preferably less than about 10 J / cm). Such low energy delivery rates are nonetheless sufficient to damage or kill a sufficient depth of the vascular endothelium to promote vascular closure. Furthermore, such radiation is substantially totally absorbed within the vessel wall, thereby substantially preventing any heating of tissue near or adjacent to the vessel wall, and thus allowing the procedure to be performed substantially without anesthesia of the portion of the vessel being treated (e.g., non-tumescent local anesthesia may be applied only at the access site or at one or a few discrete locations, within the physician's discretion or at the patient's request on an individual basis).Such wavelengths are preferably about 1064 nm or greater, including, but not limited to, about 1320 nm, about 1470 nm, about 1950 nm, about 2100 nm, about 3000 nm, and about 10000 nm, each ± about 50 nm.

[0064] In one embodiment, the wavelength of the radiation is about 1470 nm ± about 30 nm, and the power is less than about 10 W, preferably less than about 8 W, more preferably less than about 5 W, and most preferably in the range of about 1 W to about 3 W. In one embodiment, the laser is emitted in a continuous mode (although a pulsed mode may be used if desired), and the laser is pulled back at a rate in the range of about 1 sec / cm to about 20 sec / cm, more preferably in the range of about 3 sec / cm to about 15 sec / cm, and most preferably in the range of about 5 sec / cm to about 10 sec / cm. In one exemplary embodiment, a GSV approximately 10 cm in length was closed by applying approximately 1470 nm radiation substantially radially at a power level of about 2 W and a pullback rate of about 5 sec / cm. In this particular example, local infiltration anesthesia was applied only at the access site and was not applied or otherwise required throughout the remainder of the procedure.

[0065] In another exemplary embodiment, a number of different veins (GSVs) were occluded using a flat-tip fiber sealed in a quartz cap (see FIG. 10). The radiation was approximately 1470 nm, and the energy delivered to the vessel per unit length averaged approximately 10 J / cm (i.e., approximately 1 W at a pullback rate of approximately 10 sec / cm). In each of these cases, no local tumescence or general anesthesia was used. Rather, local infiltration anesthesia (½% lidocaine without epinephrine) was applied only at the patient's request or physician discretion. In some cases, the patient did not use anesthesia. In other cases, a small amount was applied at the access site. In other cases, a small amount was applied near the access site and the SFJ. One reason for applying such a small amount of local anesthesia in the area near the SFJ may be that the diameter of the vein in this area is typically largest, and therefore the pullback rate and the average energy delivered to the vessel per unit length in this area will be higher than in more distal treatment areas.

[0066] In another exemplary embodiment, a flat-tip fiber sealed in a quartz cap (see FIG. 10) was used to close a number of different varicose veins (GSVs). The wavelength of the applied radiation was approximately 1470 nm. The first protocol delivered radiation at a rate ranging from approximately 20 J / cm to approximately 30 J / cm. However, some patients received lower energy delivery rates (ranging from approximately 10 J / cm to approximately 20 J / cm), so that the energy per unit length averaged from approximately 10 J / cm to approximately 30 J / cm (averaging approximately 22 J / cm). The first protocol, also in a continuous mode, delivered radiation at a power level of approximately 3 W. However, some patients received approximately 3 W pulsed at a 50% duty cycle (approximately 1 / 2 second on, approximately 1 / 2 second off). The vein diameters ranged from approximately 3 mm to approximately 22 mm (average vein diameter was approximately 8.2 mm). All procedures were performed without the use of any tumescent or general anesthesia, and without any vein preformation or other compression. Some patients received no anesthesia at all, while others received a relatively small amount of local infiltration anesthesia (1 / 2% lidocaine without epinephrine). In the 31 patients treated, the average amount of local anesthesia used throughout the entire procedure was approximately 28 ml, with seven patients receiving less than 10 ml. As a general rule, the lower the energy delivery rate, the less anesthesia volume needed or otherwise desired. Furthermore, as a general rule, pulsed delivery of laser radiation is associated with a lower amount of anesthesia than continuous delivery. In all cases, anesthesia was applied locally as deemed necessary by the physician or as requested by the patient. 24-hour postoperative results demonstrated that over 90% of treated veins were closed with excellent vein wall thickness. Furthermore, there was little postoperative ecchymosis or reported pain. Only approximately 5 to 10% of patients reported some bruising, primarily at the venous access site. Additionally, reported postoperative discomfort was minimal, with a minority of patients reporting the use of over-the-counter pain medications (e.g., aspirin, acetaminophen, etc.).

[0067] Thus, a significant advantage of the preferred embodiment is that neither local tumescent nor general anesthesia is required. As noted above, in many cases, only a small amount of local infiltration anesthesia may be applied at the venous access site, if any is needed at all. If the patient experiences any discomfort during the procedure, the physician may apply a small amount of local infiltration anesthesia (e.g., lidocaine, preferably without epinephrine) to the local area or region of discomfort. In any case, about one vial (about 50 ml) or less of local infiltration anesthesia (e.g., 0.5% lidocaine without epinephrine) is needed on hand during the procedure. Furthermore, depending on the length of the vein being treated and / or the patient's sensitivity to any discomfort perceived or encountered, only a small amount, if any, of such a vial may be needed.

[0068] Some embodiments of the present disclosure involve administering sufficient anesthesia adjacent to the femoral nerve to anesthetize the treatment area, providing a sensory block but not a motor block. One such procedure includes the following steps: Using ultrasound guidance, locate the branch of the femoral nerve between the SFJ and the femoral artery. Under ultrasound guidance, inject a predetermined amount of local anesthetic (e.g., about 1 / 2% lidocaine) above the nerve at a location adjacent to but not touching the nerve (outside the blood vessel or any sheath surrounding the blood vessel being treated). The predetermined amount of local anesthetic is sufficient to cause a sensory block but insufficient to cause a motor block. In a currently preferred embodiment, the predetermined amount is in the range of about 10 to about 30 cc of about 1 / 2% lidocaine, and most preferably in the range of about 15 to about 25 cc of about 1 / 2% lidocaine. The amount of anesthesia may be varied by dilution (e.g., the concentration of lidocaine in saline or other solvent). Generally, the higher the concentration of lidocaine, the lower the volume injected, and vice versa. Generally, no additional anesthesia is required during the procedure. However, if desired, a small amount of local anesthesia, such as a topical anesthetic or a few cc's of diluted lidocaine, may be applied at the access site. The procedure is then performed as described above. For example, a needle is introduced into the vein, a short introducer sheath is introduced through the needle into the vein, a capped fiber is introduced through the introducer sheath to the SFJ, the laser is fired, and the fiber is withdrawn at a rate of about 20 J / cm to about 30 J / cm, or by other methods as described herein.

[0069] Other embodiments of the present disclosure include the use of intravenous infusion into the vessel to be treated to locally anesthetize the treatment area. One such procedure involves introducing a small amount of lidocaine (e.g., several ccs of diluted lidocaine) at the access site to anesthetize the skin at the access site, if desired. A needle is introduced through the access site and into the vessel to be treated. A short introducer sheath is introduced through the needle into the vessel. A sheathed fiber is introduced through the short introducer sheath, and the tip of the sheathed fiber is positioned at a starting location downstream from the SFJ. The sheathed fiber may be a typical "liquid-cooled" fiber, containing one or more ports proximal to the fiber tip to allow for the introduction of fluid between the sheath and the fiber and, in the case of a dilute anesthetic solution, to allow for the instillation or other incorporation of fluid into the vessel proximal to the fiber tip. Instillation of a dilute anesthetic solution (e.g., dilute lidocaine) into the vessel begins at the SFJ or a starting location downstream from the SFJ. After the lidocaine has taken effect, the laser is fired and the fiber is pulled back at the desired rate (e.g., at a rate of about 20 J / cm to about 30 J / cm, or otherwise as disclosed herein. A port for diluted anesthetic is located proximal to the fiber tip, so that the anesthetic is applied to the portion of the vessel just prior to laser firing, so that the portion of the vessel where the laser is fired is anesthetized prior to laser firing.

[0070] Other embodiments of the present disclosure relate to anesthesia of the local treatment area by application of a non-tumescent local anesthetic prior to introduction of the fiber into the vessel. In one such embodiment, a small amount of diluted anesthetic (e.g., about 1% diluted lidocaine) is injected at the access site, a central point in the vessel (e.g., Hunter's Crossing or adjacent points), and at or adjacent to the SFJ. The amount of local anesthetic injected at each location is no more than about 3 to about 5 ml, with a total volume administered of no more than about 9 to about 15 ml.

[0071] Other embodiments may use any of a number of other commonly known or later-known methods and treatments for patient relaxation and / or for producing analgesia, anesthesia, and / or decreased sensitivity to painful stimuli. Such methods or treatments include, but are not limited to, electrical stimulation, electroanesthesia, nerve stimulation, neuromodulation, and other physical or verbal methods for producing analgesia, anesthesia, and / or decreased sensitivity to painful stimuli. Other such methods include, for example, transcutaneous or percutaneous nerve stimulation, deep stimulation, posterior spinal cord stimulation, and transcranial electrical stimulation-based current analgesia. The foregoing references to anesthesia and analgesia are not intended to imply that any anesthesia or analgesia is required in connection with the disclosed intraluminal treatment devices and methods. Rather, many preferred embodiments do not use anesthetics or analgesics at all, or most use small amounts of local anesthetics or analgesics at access sites or other discrete locations to manage any pain perceived or experienced by the patient.

[0072] Thus, a significant advantage of the devices and procedures disclosed herein is that the aforementioned drawbacks associated with tumescent techniques may be avoided, including the potential toxicity and / or adverse patient reactions associated with such anesthesia, a higher incidence of thermal damage to surrounding tissue, and post-operative pain and bruising associated with the relatively high energy levels used in tumescent technique procedures. Another advantage of the currently preferred embodiments over prior art tumescent technique procedures is that the vessel remains approximately the same size before and after introduction of the energy application device into the vessel, and further, energy is applied into the surrounding wall of the vessel substantially without prior formation, flattening, compression, or movement of the vessel wall, which aids the energy application device.

[0073] As discussed above, the cap or other structure at the fiber's emission end provides a rounded, relatively large-diameter distal region for the fiber tip, thereby facilitating ease of insertion into and pullback through the vein. Another advantage of such an enlarged fiber tip structure, compared to prior art bare-tip fibers, is that it displaces a greater amount or portion of the vein lumen. Yet another advantage of certain preferred embodiments is that laser radiation is emitted radially and annularly from the fiber into an annular region around the vein wall, thereby providing more direct and effective radiation delivery into the vein wall compared to prior art ELA methods and devices. Yet another advantage of certain preferred embodiments is that the fiber optic tip provides a significantly larger emission surface area, and also allows radiation to be emitted laterally / radially, compared to prior art bare-tip or other flat-exiting end-face fibers. As a result, the laser radiation is delivered directly into a significantly larger area of the surrounding vein wall tissue and can therefore be delivered at a significantly lower power density compared to prior art ELA procedures, thereby facilitating treatment without substantial localized hot spots that may cause vein wall perforation, overheating of the surrounding tissue, and associated pain and / or discomfort to the patient. Thus, a further advantage of the currently preferred embodiment is that significantly lower power levels may be used compared to prior art ELA procedures.

[0074] A further advantage of certain preferred embodiments is that the laser wavelength used is highly absorbed in water and therefore in vessel wall tissue. As a result, the laser radiation is delivered directly to and absorbed in the annular portion around the vessel wall or to a sufficient depth in the vascular endothelium to kill or damage the absorbing endothelium and subsequently achieve vessel closure. The term vessel closure or similar terms is used herein to refer to the closure or narrowing of a vessel, which accompanies treatment of a vessel and is significant in substantially preventing blood flow through the vessel. Yet another advantage of certain preferred embodiments is that because the laser radiation is delivered directly and effectively to and absorbed in the vessel wall, any significant absorption of radiation by surrounding tissue and resulting thermal damage is substantially avoided. As a result, the preferred embodiments not only require less power input than prior art ELA procedures, but also require less anesthetic, and further allow for the elimination, if any, of local tumescent anesthesia and its various drawbacks and disadvantages.

[0075] If desired, a saline flush, such as a chilled saline flush, may be used to cool and / or freeze the vein prior to laser injection and fiber pullback. In some such embodiments, the saline flush is ice-cold (e.g., about 30°F to about 40°F, and more preferably about 32°F to about 35°F) to facilitate freezing the vein prior to treatment. In one embodiment, the ice-cold saline flush is introduced into the vein through the introducer sheath before the fiber is inserted. In another embodiment, the ice-cold saline flush is introduced through the introducer sheath after fiber insertion and / or while the introducer sheath is retracted before the laser is injected. In another embodiment, the ice-cold saline flush is introduced through the sheath surrounding the fiber while the laser is injected and the fiber is being pulled back. In a final embodiment, the ice-cold saline flush is introduced through one or more ports located proximal to the fiber's injection tip (e.g., at the base of the quartz cap). One such embodiment uses a conventional liquid-cooled fiber sheath construction.

[0076] In some embodiments, ultrasonic energy is applied to the fiber or other waveguide to promote smooth pullback through the vein and / or pullback at a substantially constant or other desired rate. In one embodiment, an ultrasonic transducer or vibrator is attached to the proximal end of the fiber to impart ultrasonic vibrations to the injection tip or region of the fiber during laser injection and pullback. In another embodiment, an ultrasonic transducer or vibrator is attached to the cap or other area adjacent to the injection tip or region of the fiber to impart ultrasonic vibrations thereto during laser injection and pullback through the vein.

[0077] In certain embodiments of the present disclosure, the fiber is a fluoropolymer-capped medical fiber or other fiber based medical laser or light energy delivery device with a fluoropolymer exit surface. One advantage of a fluoropolymer exit surface is that it is less likely to pierce the vessel wall or any clotted blood within the vessel, making it easier to pull back through the vessel than other devices.

[0078] In another preferred embodiment, the fiber optic set incorporates three or more shape-memory extension arms. During insertion of the treatment set, the extension arms are in full contact with the protective coating. Once in the proper position, the extension arms are activated by an internal or external energy source, extending their distal ends until they contact the interior surface of the blood vessel. As a result, the fiber optic set is substantially centered within the target tissue, further promoting substantially uniform heating of the interior surface and further preventing contact with or perforation of the vein wall. The substantially uniform heating of the surface should result in more uniform contraction, effectively shrinking the blood vessel and closing the desired location.

[0079] In a currently preferred embodiment, wavelengths are selected that provide reasonably high absorption in the target tissue, such as about 1470 nm ± about 30 nm and / or about 1950 nm ± about 30 nm. These wavelengths are merely exemplary, and any of numerous other wavelengths now known or later discovered, as recognized by those of ordinary skill in the relevant field, may similarly be used. These include, but are not limited to, about 810 nm, 940 nm, 980 nm, 1064 nm, 1320 nm, 2100 nm, 3000 nm, and 10000 nm, each ± 30 nm. One advantage of the 1470 nm and 1950 nm wavelengths is that they are highly absorbed in water and therefore highly absorbed in the target tissue of the blood vessel wall. The absorption of 1470 nm and 1950 nm in the tissue of the blood vessel wall is approximately one to three orders of magnitude higher than 980 nm, and significantly higher than most other commercially available wavelengths.

[0080] The protective radiolucent cap of the currently preferred embodiment may be fabricated and assembled in accordance with the teachings of commonly assigned U.S. patent application Ser. No. 11 / 592,598, filed Nov. 3, 2006, entitled "Side Fire Optical Fiber For High Power Applications," which is expressly incorporated by reference in its entirety as part of this disclosure. The fiber and other elements of the device may be the same as or similar to the devices, elements, or various aspects thereof, disclosed in commonly assigned U.S. Provisional Patent Application Ser. No. 61 / 067,537, filed Feb. 28, 2008, under express mailing number EB429577158US, entitled "Rapid Insertion Device And Method For Improved Vascular Laser Treatment," which is expressly incorporated by reference in its entirety as part of this disclosure.

[0081] As noted above, in certain preferred embodiments, vascular closure is achieved by thermally damaging or killing an average of at least about one-third of the vascular endothelium's thickness, or an average of about one-third to about two-thirds of the vascular endothelium's depth. As further noted above, wavelengths that are strongly absorbed in water and to which a given energy transfer rate is applied are substantially totally absorbed at a depth of at least about one-third or about one-third to about two-thirds, and the thickness of the vascular endothelium prevents the transmission of any significant levels of radiation into surrounding tissue. This avoids the need for anesthetic agents along the treated vessel. Vascular closure may be promoted by mechanisms other than radiation to damage the vascular endothelium. For example, U.S. Patent No. 6,402,745 (the "'745 Patent") discloses an intravenous whip electrode for phlebectomy, which is expressly incorporated by reference in its entirety as part of this disclosure. Some embodiments of the '745 Patent do not deliver electrical energy to the vascular endothelium, whereas other embodiments do. According to one embodiment of the present disclosure, an intravenous device includes a rotating whip or other device for abrading or abrading the vascular endothelium, as disclosed. As a disclosed example, the abrasive or abrasive action of the '745 patent's whip or other device is combined with an integrated vascular energy application device that delivers sufficient energy to the vascular endothelium to damage at least about one-third to about two-thirds of the endothelium to effect vascular closure. In one such embodiment, the energy application device is an optical waveguide that delivers radiation wavelengths that are strongly absorbed by water (i.e., about 1064 nm or greater). In one such embodiment, the radiation is pulsed, allowing for a relatively high energy delivery rate substantially free of any anesthetic agent along the treated segment(s) of the vessel. The abrasive or abrasive action of the whip or similar device, even at a lower energy delivery rate to the vessel wall, is sufficient to damage the vessel wall and cause closure without the use of an anesthetic agent along the treated segment(s) of the vessel wall.

[0082] While various preferred embodiments have been described with reference to the accompanying drawings, it should be understood that the present invention is not limited to these exact embodiments, and that various changes and modifications may be made therein by those skilled in the art without departing from the scope or spirit of the present invention as defined in the appended claims. For example, the radiation can be emitted in a pulsed or continuous manner and can include one or more laser wavelengths. Furthermore, radiation can be provided by means other than a laser, including, but not limited to, LEDs and superluminescent LEDs. Furthermore, the optical fiber may be formed from any of many different optical fibers or waveguides now known or later known. It is understood that the core, cladding, jacket, end cap, protective sleeve, exit surface, reflective surface, and / or gradient lens may also be any of many different now known or later known. For example, while many of the exposed fibers are capped herein, uncapped fibers, including exposed tipped fibers, may also be used. Furthermore, the exit surface may have any of many different shapes or configurations now known or later known. For example, while certain embodiments utilize a substantially conical exit surface, other arcuate exit surfaces (i.e., curved surface profiles) or non-arcuate surface profiles, such as one or more planar and / or angled exit surfaces, may be used as well. Furthermore, intravenous treatment methods may utilize any of a number of different devices, with or without anesthetic agents, including, but not limited to, no sheath or catheter, or any of a number of different types of sheaths or catheters. This may also include, but is not limited to, short, long, and / or peel-away introducer sheaths, with or without a guidewire. This may also include, but is not limited to, guidewires that can be attached to a fiber or waveguide, detachable from a fiber or waveguide, and / or that cannot be attached to a fiber or waveguide at all.Furthermore, any of many different forms of energy and energy application devices now known or later known may similarly be used to treat blood vessels in accordance with various aspects of the invention disclosed herein. For example, energy application devices may take the form of (i) a waveguide or fiber optics for delivering laser energy as described above, (ii) a microwave catheter or device for delivering microwave energy, (iii) an RF catheter or device for delivering RF energy, (iv) an electrical catheter or device for delivering electrical energy, and (v) an ultrasound catheter or device for delivering ultrasound energy. Accordingly, this detailed description of the currently preferred embodiments should be taken as illustrative and not limiting in spirit.

[0083] (Appendix 1) a flexible waveguide defining an elongated axis, a proximal end optically connectable to a radiation source, and a distal end receivable within a blood vessel and including a radiation emission surface through which radiation is emitted from the radiation source laterally relative to the elongated axis of the waveguide onto an angularly extending portion of a surrounding vessel wall; An intravascular treatment device characterized by:

[0084] (Appendix 2) the exit surface is angled with respect to the elongated axis of the waveguide; 2. The device of claim 1.

[0085] (Appendix 3) the exit surface is oriented at an acute angle with respect to the elongated axis of the waveguide; 3. The device of claim 2.

[0086] (Appendix 4) the exit surface is an arcuate surface profile; 4. The device of claim 3.

[0087] (Appendix 5) The arcuate projection surface extends over an angle of at least about 90°. 5. The device of claim 4.

[0088] (Appendix 6) the arcuate projection surface extends over an angle in the range of about 90° to about 360°; 5. The device of claim 4.

[0089] (Appendix 7) the exit surface defining a distal tip of the waveguide; 5. The device of claim 4.

[0090] (Appendix 8) the exit surface is substantially cone-shaped; 8. The device of claim 7.

[0091] (Appendix 9) the exit surface is either substantially convex or substantially concave; 9. The device of claim 8.

[0092] (Appendix 10) a reflective surface facing and spaced distally relative to the exit surface for reflecting forwardly directed radiation laterally about the elongated axis of the waveguide; 2. The device of claim 1.

[0093] (Appendix 11) the emission surface emits radiation substantially radially about the elongated axis of the waveguide, and the reflective surface reflects radiation substantially radially about the elongated axis of the waveguide; 11. The device of claim 10.

[0094] (Appendix 12) the reflective surface defines an arcuate surface profile oriented at an acute angle with respect to the elongated axis of the waveguide; 11. The device of claim 10.

[0095] (Appendix 13) the reflective surface is substantially cone-shaped; 13. The device of claim 12.

[0096] (Appendix 14) the reflective surface is either substantially convex or substantially concave; 14. The device of claim 13.

[0097] (Appendix 15) a coating rigidly secured and sealed to the waveguide, surrounding the emission surface therein and defining a gas-waveguide interface that refracts emitted radiation laterally about the elongated axis of the waveguide onto the surrounding vessel wall; 2. The device of claim 1.

[0098] (Appendix 16) the covering is a cap that is substantially transparent to the emitted radiation; 16. The device of claim 15.

[0099] (Appendix 17) a radiation reflecting surface facing the emission surface in a spaced-apart relation to the emission surface and enclosed within the jacket for reflecting forwardly directed radiation laterally about the elongated axis of the waveguide; 16. The device of claim 15.

[0100] (Appendix 18) a lateral radiation-emitting distal region defined by a plurality of radiation-emitting surfaces axially spaced apart from one another along a distal region of the waveguide; 2. The device of claim 1.

[0101] (Appendix 19) a first radiation emitting surface formed at the distal tip of the waveguide, and a plurality of second radiation emitting surfaces located proximal to the first radiation emitting surface and axially spaced apart from one another; 19. The device of claim 18.

[0102] (Appendix 20) the first radiation exit surface is substantially cone-shaped; each said second radiation exit surface defining an arcuate surface profile angled with respect to said elongated axis of said waveguide; each second radiation-emitting surface laterally emitting a portion of the radiation transmitted through the waveguide onto an arcuate portion of the vascular wall circumferentially, laterally about the elongated axis of the waveguide, and any downstream second radiation-emitting surface and first radiation-emitting surface enabling lateral emission of the remaining transmitted radiation through the waveguide; 20. The device of claim 19.

[0103] (Appendix 21) an axially extending jacket surrounding the lateral radiation-emitting distal region and forming a gas boundary at each of the plurality of radiation-emitting surfaces sealing against the exterior of the waveguide, the jacket cooperating with the plurality of radiation-emitting surfaces having an arcuate surface profile angled to deflect radiation laterally about the elongated axis of the waveguide; 19. The device of claim 18.

[0104] (Appendix 22) the coating is substantially transparent to emitted radiation and is sufficiently flexible to allow the waveguide to bend over a tortuous path through the blood vessel. 22. The device of claim 21.

[0105] (Appendix 23) a sleeve slidably mounted over the waveguide; defining an internal radiation reflecting surface for laterally reflecting internally emitted radiation and adjusting the axial length of said laterally radiation emitting distal region; 19. The device of claim 18.

[0106] (Appendix 24) A radiation source; a temperature sensor thermally coupled to the distal region of the waveguide for monitoring temperature within the blood vessel and transmitting a signal indicative thereof; a control module in electrical communication with the temperature sensor for adjusting the power output of the radiation source therein. 2. The device of claim 1.

[0107] (Appendix 25) a pullback actuator movably coupled to the waveguide for adjusting a pullback speed of the waveguide; the control module is electrically coupled to the pullback actuator to adjust the pullback speed of the waveguide based on a temperature at the distal region of the waveguide. 25. The device of claim 24.

[0108] (Appendix 26) a guidewire detachably coupled to the waveguide and including a distal portion extending distally beyond the distal tip of the waveguide for guiding the waveguide through the blood vessel. 2. The device of claim 1.

[0109] (Appendix 27) the guidewire is mechanically connected to the waveguide and cannot be detached from the waveguide by pushing distally on the guidewire, but can be detached from the waveguide by pulling proximally on the guidewire; 27. The device of claim 26.

[0110] (Appendix 28) a guidewire rigidly secured to the tip of the waveguide and extending distally therefrom; 2. The device of claim 1.

[0111] (Appendix 29) the waveguide includes a cladding surrounding the radiation-emitting surface; the jacket is sealed about the waveguide and defines a gas boundary surface that cooperates with an angle of the exit surface to refract exit radiation laterally about the elongated axis of the waveguide; the guidewire is rigidly secured to the sheath and extends distally therefrom; 29. The device of claim 28.

[0112] (Appendix 30) the radiation exit surface angled inward from the distal tip toward the elongated axis of the waveguide; 2. The device of claim 1.

[0113] (Appendix 31) the radiation exit surface defines a substantially concave shape that is substantially conical; 31. The device of claim 30.

[0114] (Appendix 32) the distal tip of the waveguide defines an enlarged width compared to a portion of the waveguide extending proximally therefrom; 31. The device of claim 30.

[0115] (Appendix 33) the distal tip is rounded to facilitate insertion of the waveguide through the blood vessel; 33. The apparatus of claim 32.

[0116] (Appendix 34) a distal region of the waveguide defining an enclosed space sealed with respect to the exterior of the waveguide and forming a gas boundary at the radiation exit surface for refracting exit radiation laterally with respect to the elongated axis of the waveguide; 2. The device of claim 1.

[0117] (Appendix 35) the radiation exit surface is substantially cone-shaped; 35. The apparatus of claim 34.

[0118] (Appendix 36) The waveguide is an optical fiber. 2. The device of claim 1.

[0119] (Appendix 37) further comprising at least one laser source providing at least one laser radiation at about 1470 nm and about 1950 nm ± about 30 nm at a power of about 10 W or less; the proximal end of the waveguide is optically coupled to the at least one laser source; the exit surface of the waveguide emits radiation laterally relative to the elongated axis of the waveguide in an axially extending annular pattern onto the surrounding vessel wall. 2. The intracavitary laser ablation device of claim 1.

[0120] (Appendix 38) further comprising an electrical pullback device propellably coupled to the waveguide and configured to pull the waveguide back through the vessel while delivering laser radiation at an average energy transfer rate to the vessel wall of less than about 30 J / cm. 2. The device of claim 1.

[0121] (Appendix 39) a flexible waveguide defining an elongated axis, a proximal end optically connectable to a radiation source, and a distal end receivable within a blood vessel and including means for emitting radiation from the radiation source laterally relative to the elongated axis of the waveguide onto an angularly extending portion of a surrounding vessel wall; An intravascular treatment device characterized by:

[0122] (Appendix 40) the emission means includes a radiation emission surface angled with respect to the elongated axis of the waveguide; 40. The apparatus of claim 39.

[0123] (Appendix 41) the exit surface is one of a substantially convex shape and a substantially concave shape; 40. The apparatus of claim 39.

[0124] (Appendix 42) the exit surface is substantially cone-shaped; 42. The device of claim 41 .

[0125] (Appendix 43) further comprising means for reflecting forwardly directed radiation laterally about the elongated axis of the waveguide; 41. The apparatus of claim 40.

[0126] (Appendix 44) the reflecting means includes a reflecting surface facing the emitting means at a relatively distal spaced distance; 44. The device of claim 43.

[0127] (Appendix 45) and means for defining a gas boundary surface surrounding the emission means for deflecting emitted radiation laterally with respect to the elongated axis of the waveguide. 40. The apparatus of claim 39.

[0128] (Appendix 46) means for emitting diffuse radiation laterally with respect to the elongated axis of the waveguide along an axially extending region of the waveguide; 40. The apparatus of claim 39.

[0129] (Appendix 47) the diffuse radiation emitting means includes a plurality of radiation emitting surfaces located proximally about said emitting means and axially spaced apart from one another; 47. The device of claim 46.

[0130] (Appendix 48) further comprising means for adjusting the length of the diffuse radiation emitting means; 47. The device of claim 46.

[0131] (Appendix 49) the adjustment means includes a sleeve slidably mounted on the waveguide; 49. The apparatus of claim 48.

[0132] (Appendix 50) and means for retracting the waveguide through the blood vessel while laser radiation is being delivered at an average energy transfer rate to the blood vessel wall of less than about 30 J / cm. 39. The apparatus of claim 38. [Explanation of symbols]

[0133] 100 optical fiber 106 Quartz Cap 110 Injection surface 112 Reflective Surface 140 cores 146 Cladding 200 optical fiber 202 Standard part 204 Distal End 206 Protective Cap 208 Groove 210 Fiber Optic Tip 212 Reflective Surface 214 Target tissue 216 remaining radiation 218 Radiation 314 veins 320 Optical Fiber 420 Optical Fiber 424 Laser Radiation Source 426 Temperature Sensor 428 Power Control Module 430 Pullback Actuator 432 Pullback Speed Controller 500 optical fiber 502 Standard part 504 Injection part 506 Quartz Cap 510 Fiber Optic Tip 512 reflective surface 514 Blood vessels 534 Guidewire 536 Guidewire attachment / detachment mechanism 600 Fiber Optic Set 606 Quartz Cap 608 Groove 610 reflective surface 614 Blood vessels 634 Guidewire 700 optical fiber 740 fiber core 742 Reflective Cone 800 optical fiber 840 fiber core 844 Gap 900 Fiber 906 Cap 908 Groove 914 Vascular 946 Sleeve 1100 Optical Fiber 1106 Protective Cap 1107 Distal end 1109 Sealed Space 1110 Injection surface 1200 Optical Fiber 1206 Protective Sleeve 1207 Distal End 1209 Central hole 1210 Injection surface

Claims

1. A flexible waveguide defining a longitudinal axis, one end optically connected to a radiation source that emits radiation that constricts a blood vessel, and another end receivable within the blood vessel and including at least one radiation-emitting surface of the flexible waveguide; a jacket secured to and sealing the flexible waveguide; the at least one radiation emitting surface is configured to emit radiation laterally and circumferentially about the longitudinal axis to a surrounding vessel wall; the coating surrounds the at least one radiation-emitting surface; the radiation source emits at least one laser radiation of 1470 nm±30 nm and 1950 nm±30 nm; An intravascular treatment device characterized by:

2. The method of claim 1, wherein one of the radiation exit surfaces is oriented at an acute angle relative to a longitudinal axis of the flexible waveguide. The intravascular treatment device according to claim 1 .

3. The method of claim 2, wherein one of the radiation exit surfaces defines the other end of the flexible waveguide.

3. The intravascular treatment device according to claim 1 or 2.

4. The radiation emission surface defining the other end of the flexible waveguide is conical in shape and emits radiation radially and annularly. The intravascular treatment device according to claim 3 .

5. The radiation extends over an arc defined by the numerical aperture of the flexible waveguide. The intravascular treatment device according to claim 4 .

6. The flexible waveguide further comprises a reflecting surface spaced apart from the radiation emitting surface for reflecting forwardly directed radiation laterally about the flexible waveguide. The intravascular treatment device according to any one of claims 1 to 5.

7. The reflective surface reflects the radiation laterally and annularly. The intravascular treatment device according to claim 6 .

8. The reflective surface is substantially convex. The intravascular treatment device according to claim 6 or 7.

9. The coating is fixed to and sealed by melting the flexible waveguide. The intravascular treatment device according to any one of claims 1 to 8.

10. The coating is a cap that transmits the radiation from the radiation-emitting surface. The intravascular treatment device according to any one of claims 1 to 9.

11. A temperature sensor thermally coupled to a distal region of the flexible waveguide for monitoring temperature within the blood vessel and transmitting a signal indicative thereof. a control module in electrical communication with the temperature sensor for adjusting the power output of the radiation source therein; The intravascular treatment device according to any one of claims 1 to 10.

12. The flexible waveguide is an optical fiber. The intravascular treatment device according to any one of claims 1 to 11.

13. The radiation source emits radiation at a power of 10 W or less, the one end of the flexible waveguide is optically coupled to the radiation source; the radiation emitting surface of the flexible waveguide emits radiation onto the surrounding vessel wall in an annular manner; The intravascular treatment device according to any one of claims 1 to 12.

14. Further comprising an electrical pullback device propellably coupled to the flexible waveguide and configured to pull the flexible waveguide back through the blood vessel while transmitting laser radiation at an average energy transfer rate to the blood vessel wall of less than 30 J / cm. The intravascular treatment device according to any one of claims 1 to 13.

15. The method of claim 1, further comprising: a distal radiation emission region defined by a plurality of emission surfaces configured to emit radiation laterally and circumferentially about the longitudinal axis toward a surrounding vessel wall. The intravascular treatment device according to any one of claims 1 to 14.

16. The plurality of emission surfaces are axially spaced apart. The intravascular treatment device according to claim 15.

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