Endovascular 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 therapy, and more particularly to the treatment of vascular pathologies such as venous insufficiency with laser energy using an optical fiber.

Background Art

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

[0003] The venous system includes valves that function to achieve a unidirectional blood flow back to the heart. The venous valves are bicuspid, with each tip forming a reservoir for blood. The bicuspid venous valves press their free surfaces against each other under retrograde blood pressure. When properly treated, backward blood flow is prevented and only forward flow to the heart is possible. If the valve cannot be properly sealed under the pressure gradient at which the valve tips recede, backward blood flow occurs and the bicuspid valve becomes ineffective. When retrograde blood flow occurs, the pressure in the venous portion of the lower limb increases, causing the veins to dilate and leading to further valve insufficiency.

[0004] Valvular insufficiency, commonly referred to as venous insufficiency, is a chronic condition that can lead to skin discoloration, varicose veins, pain, swelling, and ulceration. In varicose veins, the veins are dilated, twisted, and have lost progressive elasticity in the vein walls. Due to the dilation of the blood vessels, the valves cannot close completely, and the veins lose their function of returning blood to the heart. This leads to the accumulation of blood inside the blood vessels, which can then further dilate and twist the veins. Varicose veins usually have a blue or purple color and will probably protrude in a twisted shape, likely with an unappealing appearance on the surface of the skin. Varicose veins commonly form in the veins on the surface of the legs and are subjected to high pressure when standing. Other types of varicose veins include venous lakes, reticular veins, and telangiectasias.

[0005] There are several available treatments to eradicate these types of valve symptoms. Some of these treatments act only to relieve certain symptoms and do not remove varicose veins or prevent them from forming again. These treatments include elevating the legs by lying down or using a footrest when sitting, elastic stockings, and exercise.

[0006] Varicose veins are often treated by removing venous insufficiency. In these treatments, the blood that was flowing through the removed vein is forced to flow through the remaining healthy veins. Various methods are used to remove venous insufficiency that has problems, including surgery, sclerotherapy, electrocautery, and laser treatment.

[0007] In sclerotherapy, a fine needle is used to inject a solution directly into the vein. This solution irritates the inside of the vein, causes swelling on the inside, and causes blood to clot. The vein will become scar tissue and will likely be completely discolored visually. Some doctors treat both varicose veins and spider veins with sclerotherapy. Today, commonly used sclerosing agents include hypertonic saline or Sotradecol (trademark) (sodium tetradecyl sulfate). The sclerosing agent acts on the inner side of the vein wall, causing their closure and obstruction of blood flow. Sclerotherapy can cause various complications. People with allergies sometimes suffer severe allergic reactions. If the needle is not inserted properly, the sclerosing agent can burn the skin or leave permanent marks or stains on the skin. Additionally, sclerotherapy can sometimes lead to blood clots or the migration of blood clots. According to some research, larger varicose veins may be more likely to recur when treated with sclerotherapy, and therefore, the treatment of sclerotherapy is generally limited to veins below a certain size.

[0008] Vein stripping is a surgical procedure in which the treatment of varicose veins under general or local anesthesia is used. The problematic vein is removed from the body by passing a flexible device through the vein and removing it through an incision near the groin. Similarly, those that are tributaries of these veins are also stripped using such a device or removed through a series of small incisions (for example, by outpatient phlebectomy). The vein that is connected to deeper veins is then loosened.

[0009] One drawback of the stripping technique is that it may cause scarring at the incision site and sometimes form blood clots. Another drawback is that vein stripping is painful, time-consuming during surgery, and may require a long recovery period. Yet another drawback of the vein stripping technique is that it may damage collateral branches of the stripped vein, leading to bleeding and thus hematoma formation, or other complications such as blood loss, pain, infection, nerve damage, and swelling. Still another drawback of vein stripping is that due to the damage done to the treatment area, the patient may experience pain and discomfort for hours or may have to visit the surgeon for days otherwise. Another drawback of the vein stripping technique is that it may include other negative side effects associated with the treatment of such a surgical technique under anesthesia, including the risk of nausea, vomiting, and wound infection.

[0010] Another well-known treatment for venous insufficiency is through the use of radiofrequency (“RF”). For example, the RF method is described in Patent Document 1. An electrode is introduced through a catheter inside the vein, arranged so that the electrode contacts the vein wall, and RF energy is applied through the electrode to selectively heat the vein wall. The RF energy is applied into the portion of the vein wall in contact with the electrode in the directional direction to cause localization of heating and fibrosis of the vein tissue. One drawback of the RF method is that it is necessary to maintain contact between the RF electrode and the vein wall, and thus energy is essentially transmitted to the vein wall only through such contact points. Another drawback of the RF method is that it is more time-consuming and thus more stressful for the patient than other desirable methods. Still another drawback of the RF method is that the RF catheter and electrode are relatively complex and likely to be more expensive than other desirable ones for manufacturing.

[0011] Another minimally invasive prior art treatment for an extended tortuous vein aneurysm is endovenous laser ablation (“ELA”). In a typical prior art ELA procedure, an optical fiber is guided through an introducer sheath into the vein being treated. The optical fiber line has a flat emitting surface at its distal end. One example of a prior art ELA procedure includes the following steps: First, a guide wire is inserted into the vein to be treated, preferably with the assistance of an introducer needle. Second, the introducer sheath is guided over the guide wire and advanced to the treatment site. Thereafter, the guide wire is removed leaving the introducer sheath. The optical fiber (connected to a laser source) is then inserted through the introducer sheath and positioned such that the flat emitting surface at the distal tip of the fiber and the sheath are in the same position. Tumescent anesthesia is then applied to the tissue surrounding the vein to be treated. Prior to firing the laser, the sheath is retracted a sufficient distance from the flat emitting surface so as not to damage it with the emitted laser energy. The laser is then fired such that laser energy is emitted through the flat emitting surface into the blood and / or the vein wall immediately in front of the emitting surface. While the laser energy is being emitted, the laser fiber and the introducer sheath are both retracted to occlude the vein to be treated to the desired length. The laser energy is absorbed by the blood and / or the vein wall tissue and thus thermally damages it, causing fibrosis of the vein.

[0012] Patent Document 2 discloses an example of a prior art device and a method of subcutaneous laser treatment with minimal insertions into the treatment area. Common vascular abnormalities such as capillary malformation, port-wine stain, hemangioma and extended tortuous vein aneurysm can be selectively removed. A needle is inserted into the vascular structure and the target abnormality is subjected to the emission of laser radiation. The device enables the adaptation and positioning of the laser delivery optical fiber during treatment. An extension member maintains the optical fiber at a position fixed relative to and at a fixed distance from the gripping portion so as to inform the user of the length of the fiber inserted into the vein.

[0013] Patent Document 3 describes another ELA technique in which percutaneous access into the vein lumen is obtained using a vascular catheter through which an optical fiber line is introduced and passed. The optical fiber line has an exposed, uncoated tip that defines a flat radiation emitting surface. In this patent, it is taught to manually compress the vein by hand or something like a compression bandage so that the vein wall comes to a position in contact with the flat emitting surface of the fiber tip. Laser energy is transmitted in a high energy jet into the portion of the vein wall that contacts the exposed fiber tip. The wavelength of the laser energy is from about 532 nm to about 1064 nm, and the duration of each jet is from about 0.2 seconds to about 10 seconds. For each jet, energy from about 5 watts to about 20 watts is transmitted into the vein wall. The ELA techniques of this patent and other prior arts teach that ultimately, sufficient energy transfer is ensured to cause damage to the entire thickness of the vein wall, resulting in fibrosis of the vein wall and closure of the great saphenous vein.

[0014] To improve the treatment success of ELA for incompetent saphenous veins, in line with this patent, the prior art teaches the application of a relatively high energy level (e.g., ≥ 80 J / cm). Timperman et al. teach that laser treatment within the vein of the saphenous vein is successful, especially when an amount greater than 80 J / cm is delivered. Timperman et al. collected data considered to be the length of the treated vein and data on the total energy delivered over 111 treated veins. The wavelength of the applied laser energy was 810 nm or 940 nm. Of the 111 treated veins, 85 remained closed (77.5%) during the follow-up period. Among this group of successfully treated veins, the average energy delivered was 63.4 J / cm. No treatment failures were found in patients who received an amount of 80 J / cm or more (see Non-Patent Document 1).

[0015] One drawback associated with this and other prior art ELA treatments is that in the exposed fiber tip, laser radiation is applied only through a very small flat emission surface. As a result, substantially only very small, localized portions of blood and / or the vein wall located in front of the flat emission surface receive the emitted laser energy at any one time. A further drawback of such prior art ELA devices and methods is that the laser radiation is directed only in the forward direction outside the flat emission surface of the fiber. Thus, substantially the radiation is not emitted radially or laterally from the fiber tip, and thus the laser radiation is transmitted in a relatively local direction. A further drawback is that a relatively high level of the transmitted energy into the vein creates a significantly elevated temperature, which can thereby cause a corresponding level of pain to the surrounding tissue. A relatively high level of the transmitted energy can also cause a corresponding level of thermal damage in the surrounding tissue. The more intense the thermal damage, the greater the likelihood of post-treatment pain, bruising, and paresthesia. Paresthesia is an abnormal and / or unpleasant sensation and results from nerve damage. Yet another further drawback is that such a relatively high level of energy of the laser radiation, when it reaches a transmitted and / or localized concentration, can cause perforation of the vein. As a result, such prior art ELA techniques may require a relatively high level of anesthesia, such as tumescent anesthesia, for a longer period of time, and can be more stressful for both the patient and the physician than other desirable ones.

[0016] Further disadvantages of prior art ELA treatments are that they utilize inflation techniques associated with a significant amount 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 cavity defined by a band-like sheath surrounding one or more veins. In other cases, the tumescent anesthesia is injected into the tissue of the leg surrounding the vein. Tumescent anesthesia typically and essentially consists of a diluted concentration of lidocaine and epinephrine in saline. One disadvantage of such inflation techniques is that the anesthesia can cause an adverse reaction in patients such as seizures. Yet another disadvantage of the inflation technique is that the patient may experience an uncomfortable increase in blood pressure due to the use of epinephrine. Moreover, a further disadvantage of the inflation technique is that a significant amount of liquid anesthesia needs to be injected along the length of the vein, which can add a significant amount of time to the overall ELA procedure and can cause adverse post-treatment surface effects such as black or blue marks, and other adverse effects associated with such large amounts of anesthetic.

[0017] The cold saline infiltration solution used in the infiltration technique of tumescent anesthesia or prior art ELA techniques creates a heat sink around the vein, but it can cause a significantly higher level of thermal damage to the surrounding tissue than desired. The more severe the thermal damage, the greater the chance of post-treatment pain, bruising, and the potential for paresthesia. For example, a significant amount of the infiltration anesthesia typically used in prior art ELA techniques would prevent the patient from feeling any thermal excitation of the nerves. Therefore, it would not alert the physician to stop or adjust the procedure to prevent unwanted thermal damage to the patient. The tibial nerve (TN) and its common peroneal nerve (CPN) branch are both at risk 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 at risk of thermal damage during a high popliteal diagnosis. Depending on its extent, thermal damage to the TN can lead to muscle dysfunction of the calf and foot muscles. The sural nerve (SUN) and saphenous nerve (SAN) are also similarly at risk of thermal damage during the performance of ELA of the small saphenous vein (SSV) or GSV below the knee. The SUN runs very close to the SSV, particularly distally at the ankle. The SAN runs very close to the GSV below the knee and additionally runs distally towards the ankle. A significant amount of anesthesia such as infiltration anesthesia can inadvertently lead to thermal damage of such nerves.

[0018] Patent Document 4 relates to the application of markings on an optical fiber to determine the position of the fiber relative to an introducer sheath. However, this and other related inventions lack information regarding the determination of the pull-back speed of the laser fiber during laser emission. A slow, uncontrolled pull-back of the laser fiber or catheter can cause overheating and perforation of the blood vessel, and even the best surgeons may have difficulty pulling back the fiber at exactly the right speed while maintaining the appropriate blood vessel wall heating temperature. On the other hand, an excessive pull-back speed may result in insufficiently radiated energy for proper blood vessel occlusion.

[0019] Patent Document 5 has been assigned to the assignee of the present invention and is hereby incorporated by reference in its entirety as part of this disclosure. The patent discloses a system and method for controllably emitting radiation in percutaneous radiation therapy. The laser is coupled to an optical fiber inserted into a predetermined location under the skin or within the lumen of a conduit. Then, while the fiber is being retracted towards the entrance, radiation is simultaneously transmitted to the treatment site. The fiber is manually retracted at a predetermined rate, and the radiation is controlled at a constant power or energy level. To maintain a certain desired energy density, the retraction speed is measured and sent to a control mechanism. The control mechanism modifies the emission power, pulse length, or pulse rate to ensure that the vein or tissue receives a consistent amount of energy. This is a significant improvement over the prior art, but the radiation is emitted mainly in the longitudinal direction through a flat emission surface located at the fiber tip.

Prior Art Documents

Patent Documents

[0020]

Patent Document 1

Patent Document 2

[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”, Jurnal of Vascular and Interventional Radiology, Vol. 15, Issue 10, pp. 1061 - 1063, 2004 [Summary of the Invention] [Problems to be Solved by the Invention]

[0022] Accordingly, an object of the present invention is to overcome one or more of the above-mentioned drawbacks and / or disadvantages of the prior art. [Means for Solving the Problems]

[0023] In one embodiment, there is provided an improved method and apparatus for safe and efficient endoluminal laser ablation (“ELA”) that may be carried out at a relatively low power density.

[0024] In one embodiment, the intravascular treatment device comprises a flexible waveguide defining an extended shaft, a proximal end optically connectable to a radiation source, and a distal end receivable within a blood vessel. The distal end includes a radiation emitting surface from which radiation is emitted laterally with respect to the extended shaft of the waveguide onto a portion extending at an angle to the surrounding vessel wall.

[0025] In one embodiment, the device includes one (or more) emission surfaces that emit laser energy radially and substantially peripherally into the surrounding wall of the blood vessel and any blood, saline, and / or other liquids located therebetween. In one embodiment, the device emits pulsed or continuous laser energy radially through the end of an optical fiber having a substantially conical emission surface for 360° radial emission. In one embodiment of the device, a substantially conical reflective surface is further included that is axially spaced and facing the conical emission surface to increase the radial emission efficiency by reflecting the remaining or forward-transmitted energy radially and / or peripherally.

[0026] In one embodiment, a plurality of grooves, depressions, or other means are axially spaced along the fiber to provide radiation that is partially emitted radially outward from 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 or less. In other generally preferred embodiments, the radiating 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] The method of intravascular treatment in one embodiment comprises the following steps: (i) introducing a waveguide defining an extended shaft into the blood vessel; (ii) transmitting radiation through the waveguide; and (iii) Emit radiation laterally with respect to the extended axis of the waveguide on a portion extending with an angle to the surrounding vessel wall.

[0028] In certain such embodiments, the emitting step includes emitting radiation laterally onto a region of the surrounding vessel wall that extends over an angle of at least about 90°. In certain embodiments, the emitting step includes emitting radiation onto a region of the surrounding vessel wall that extends over an angle within the range of about 90° to about 360°. Certain embodiments further include the step of emitting radiation substantially radially with respect to the extended axis of the waveguide in a substantially circular pattern onto the surrounding vessel wall. Certain embodiments further include the step of reflecting the laterally and forwardly emitted radiation with respect to the extended axis of the waveguide in a substantially circular pattern onto the surrounding vessel wall. Certain embodiments further include the step of transmitting radiation at a wavelength within the range of about 980 nm to about 1900 nm and at a power of less than about 10 W.

[0029] A method of endovascular treatment in certain embodiments comprises the following steps: (i) Introduction of an energy application device defining an extended axis into a blood vessel; (ii) Maintenance of the blood vessel at approximately the same size before and after introduction of the energy application device into the blood vessel; (iii) Application of energy from the energy application device laterally with respect to the extended axis of the device into the surrounding wall of the blood vessel, with substantially no pre-forming, flattening, compressing, or movement of the vessel wall for the energy application device; and (iv) Thermal damage to the blood vessel.

[0030] A method of endovascular treatment in certain embodiments comprises the following steps: (i) Introduction of an energy application device defining an extended axis into a blood vessel; (ii) Application of energy from the energy application device into the surrounding wall of the blood vessel, with substantially no pre-forming, flattening, compressing, or movement of the vessel wall for the energy application device; (iii) Substantial absorption of the energy applied within the vessel wall and induction of sufficient damage to the vascular endothelium such that the blood vessel is occluded; and (iv) Substantially preventing the transmission of the applied energy through the vessel wall and into the tissue surrounding the vessel at a level that would cause thermal damage to the tissue.

[0031] In certain embodiments, the method further comprises an energy application step in the formation of laser radiation at at least one substantially predetermined wavelength and at at least one substantially predetermined energy transfer rate. The predetermined energy transfer rate results in radiation being applied that is substantially absorbed within the vessel wall to cause sufficient damage to the vascular endothelium to occlude the blood vessel, and further substantially prevents the transmission of the applied radiation through the vessel wall and into the surrounding tissue at a level that would cause thermal damage to the tissue.

[0032] A method of endovascular treatment in certain embodiments comprises the following steps: (i) Introduction of an energy application device into the blood vessel; (ii) Transfer of a predetermined amount of energy per unit length of the blood vessel from the energy application device into the treatment region of the blood vessel, which is on average high enough to occlude the blood vessel but low enough to substantially avoid the need for anesthetic along the treatment region; and (iii) Thermal damage and occlusion of the blood vessel.

[0033] A method of endovascular treatment of dilated tortuous veins in certain embodiments comprises the following steps: (i) Introduction of an energy application device into the dilated tortuous vein; (ii) Transfer of a predetermined amount of energy per unit length of the vein from the energy application device into the treatment region of the vein, which is on average about 30 J / cm; and (iii) Thermal damage and occlusion of the vein.

[0034] In one embodiment, the device includes a cap that is rigidly fixed 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 radially emitting surface, such as a conical surface, and a reflective surface, and the cap surrounds both the emitting and reflective surfaces. In one embodiment, the cap is made of quartz or another radiation-transmissive material that is melted, bonded, or rigidly fixed to the fiber core for protecting the core and its emission surface and for transmitting the radiation emitted and reflected therethrough. In other embodiments, the cap is made of a relatively flexible, transmissive material, such as the polymer Teflon® PFA or Teflon® AF, to provide a relatively long, flexible emission zone. For wavelengths that are relatively low and absorbed, it is also possible to make the cap of an opaque material because all or part of the energy emitted is converted to heat. In one embodiment, the cap and / or the fiber includes 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.

Advantages of the Invention

[0035] One advantage of the apparatus and method of the present subject matter is that it is possible to provide a relatively fast, safe, effective, and / or certain treatment as compared to the conventional treatments described above.

[0036] Another advantage of the generally preferred embodiment is that it is possible to apply radiation to the vein wall in a substantially uniform and essentially even manner at a relatively low power density, thereby reducing the risk of perforating the vein wall and thus reducing pain during and after the procedure as compared to conventional treatments.

[0037] Another advantage of one generally preferred embodiment is that it can safely and effectively treat venous insufficiency while avoiding the need for general or local infiltration anesthesia. In some 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, let alone infiltration anesthesia.

[0038] A further advantage of some embodiments is to provide intravascular treatment devices and methods by emitting radiation at a number of regularly spaced emission sites, similar to extended diffused 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 reading the following detailed description in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0040]

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DETAILED DESCRIPTION OF THE INVENTION

[0041] The following is described in connection with the drawings accompanying generally preferred embodiments, in which like reference numerals are used throughout the various drawings to indicate like elements. As further described below, generally preferred embodiments of the endovascular treatment of venous insufficiency with safety and low power density provide improved methods and devices. In one generally preferred embodiment, a radially directed emission of pulsed or continuous energy from an optical fiber is provided. For circular irradiation, the distal end of a cone or a cone-like fiber is used opposite a conical reflective surface fixed in the distal end region of a cap. For extended radial irradiation, appropriately multiple or spaced-apart longitudinally disposed emission grooves in the fiber ends can be used.

[0042] Another feature of certain generally preferred embodiments is the ability to achieve an extended emission zone. This can be accomplished by appropriate placement of a set of opposing conical shapes using different combinations of variables. Different variables include, for example, the cut angle of the conical surface, the spacing between the cones, the refractive index of the cap material, and the composition of the gaseous constituents left in the space. Additionally, a series of lenses axially disposed relative to each other and graded, such as a series of graded lenses, may be used. Further, finely cut conical tips can also be used to appropriately enable the formation of a radiation pattern in the spaced regions. Since the width of the circular cross-section to be treated varies as well as the distribution of power density across the length of the spacing, these variables can be adjusted. For example, if desired, it is also possible to traverse the entire irradiated cross-section to achieve a substantially uniform power density.

[0043] As shown in FIGS. 1a and 1b, a first embodiment of an optical fiber set is generally indicated by reference numeral 100. The optical fiber 100 is composed of a cladding 146, a core 140, and a quartz cap 106. The optical fiber tip preferably defines a substantially conical injection surface 110 for achieving 360° radial injection. A preferred substantially conical reflective surface 112 is axially relatively arranged and faces the injection surface 110 for promoting efficiency and the designed distribution within the zone of radial injection. As shown, the injection and reflective surface portions are firmly fixed at the end of the fiber and are hermetically sealed within the quartz cap 106 that defines the boundary line of air or other gas at the injection surface to achieve radial / annular injection. Thus, due to the angle of the injection surface 110 and the difference in refractive index of the boundary surface of the air or other gas supplied within the injection surface 110 and the sealed cap 106, the laser radiation is directly emitted radially from the fiber onto the surrounding blood vessel wall (i.e., across the extended axis of the fiber or laterally with respect to the extended axis of the fiber) and annularly. Preferably, the injection surface 110 is oriented at an acute angle with respect to the extended axis of the fiber arranged for total internal reflection of the substantially lateral injection radiation. In certain embodiments, the radiation is emitted laterally and annularly onto the surrounding blood vessel wall, and the annular beam of the radiation expands over an arc (i.e., the spread of the beam), and the arc is defined by the numerical aperture of the fiber. In certain embodiments, the annular beam is defined by an angle within the range of about 30° to about 40°. Further, the center of the approximate beam is preferably oriented at an angle within the range of about 70° to about 90° with respect to the extended axis of the fiber.

[0044] One advantage of such a novel shape is that substantially all of the radiation is emitted radially. Therefore, compared to the prior art described above, it significantly promotes radial emission. Lateral or radially emitted annular beams can define a substantially smaller volume than, for example, axially or forward-directed conical beams that are emitted by fibers of a flat and exposed chip. Therefore, laterally emitted beams can transmit radiation more directly and efficiently into the vessel wall. Further, the emission characteristics can vary and be adjusted, similar to the power density distribution along the length of such an annular portion, the length of the annular region of the blood vessel, or other hollow anatomical structures being treated. For example, in another embodiment, the distal end of the fiber, which defines a linear distribution of axially disposed grooves, irradiates an extended linear arc sector of the vein wall and is thus expected to be used for treatment with an effective and relatively low power density. In a preferred embodiment, the fiber having a distal end with a plurality of linearly distributed grooves oscillates or rotates back and forth (e.g., about one revolution) during irradiation to achieve a 360° radial stimulation of the vessel wall. Alternatively, it is also possible to offset the grooves with respect to the fiber to provide a schematic annular pattern having either a pull-back or rotational movement.

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

[0046] The optical fiber tip 210 may be defined in a substantially conical shape to achieve 360° radial emission. Conversely, preferably, there may be a conical reflective surface 212. As described above, the conical reflective surface 212 reflects all remaining or designed energy transmitted forward in a 360° radial direction outward, thereby enhancing the efficiency and distribution of 360° radial emission.

[0047] The emission portion 204 of the fiber 200 is covered by a protective cap 206. In one preferred embodiment, when highly absorbed by the target tissue 214 at the wavelength used, the protective cap 206 is made of quartz or other material through which radiation passes or substantially passes through (i.e., a material that allows the transmission of radiation or a substantially passable portion). Examples include polymers such as Teflon® AF or Teflon® PFA, which provide a relatively long and flexible emission zone. In another preferred embodiment, when the wavelength used is poorly absorbed by the target tissue 214, the protective cap 206 is made of an opaque radiation-absorbing material (i.e., a material that absorbs the emitted radiation) to convert substantially all or a portion of the radial emitted radiation into heat for thermally damaging the vein wall. In this case, vein destruction can be achieved by thermal means instead of direct laser radiation.

[0048] Referring to FIG. 3, another embodiment of the optical fiber is generally indicated by reference numeral 320 and is shown disposed at a predetermined location within vein 314. It can be recognized from this figure that the relatively long emission zone of the optical fiber 320 enables treatment at each position of the broad portion of the vein (for example, the vein may be excised segment by segment). The length of the emission portion of the fiber can be any desired length, including but not limited to lengths within the range of about 1 cm to about 100 cm, within the range of about 1 cm to about 75 cm, or within the range of about 1 cm to about 50 cm. In the particular case where the length of the emission portion matches the overall length of the portion of the vein being treated, an adjusted 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 in one pass by pulling back the fiber such that the vein wall breaks. In other embodiments, sufficient spacing is provided in the groove (for example, spaced apart within the range of about 1 / 2 cm to about 2 cm, and in one embodiment about 1 cm apart), and the groove is extended along the full length of the fiber or along the desired portion thereof to treat the entire blood vessel such that the fiber is maintained substantially in the correct position and there is no pullback. In other embodiments, the blood vessel is excised segment by segment by treating successive extended portions of the blood vessel. In one such embodiment, the fiber is maintained in the correct position within the first portion of the blood vessel and is fired to treat the first portion with a laser. Then the laser is turned off, the fiber is pulled back, and disposed in the second portion of the blood vessel. Then the fiber is maintained in the correct position of the second portion of the blood vessel while being fired to treat the second portion with a laser. And these steps are repeated to treat all further portions of the blood vessel as required. In other embodiments, the laser is not turned off during the pullback of the fiber or the movement from one segment of a vein to another.In other embodiments, the fiber remains stationary while the laser is being emitted at a certain portion of the blood vessel, and the fiber is pulled back while the laser is being emitted at other portions of the blood vessel.

[0049] As shown in FIG. 4, another embodiment of the ELA system consists of 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. While the laser is being emitted, the power control module 428 receives temperature values from the temperature sensor 426, preferably a thermocouple, which is located near the target tissue. In one embodiment, the temperature sensor is attached to the fiber or on a cap closest to its emission / reflection surface. The power control module 428 processes the information received from the temperature sensor 428 and supplies 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 the control signal received from the control module 428. One advantage of these embodiments is the ability to adjust the power density and / or the pullback speed of the optical fiber over the intravascular treatment procedure. This procedure substantially prevents localized hot spots that might otherwise cause perforation of the vein wall, or substantially prevents overheating of the vein and / or surrounding tissue that might otherwise cause pain and discomfort to the patient, while ensuring vein closure. In another embodiment, the pullback is manual, and the power control module 428 suggests to the physician and displays the values of the ideal or desired power density and pullback speed, enabling a more efficient and effective manual pullback.The system and / or its components for monitoring temperature and adjusting pullback speed and other system variables may be manufactured and may be in accordance with the teachings of U.S. Patent Application No. 11 / 900,248, filed September 11, 2007, entitled "Vein Treatment Device And Method", and U.S. Patent Application No. 11 / 443,143, filed May 30, 2006, entitled "Power Regulated Medical Underskin Irradiation", which are commonly assigned. This reference is hereby incorporated by reference in its entirety as part of the present disclosure.

[0050] In one generally preferred embodiment, a sufficiently high overall energy can be applied to the vein within a suitably short time to ensure collagen denaturation, shrinkage and removal of the vein, while a low power density is applied, for example about 10 W / cm 2 or less. This can be facilitated by an extended injection zone (or section) and 360° radial irradiation such that during pullback, the region first irradiated by the proximal side of the injection zone continues to receive irradiation from the center and distal side of the injection zone.

[0051] Referring to FIG. 5, another embodiment of the optical fiber is generally indicated by reference numeral 500. The optical fiber 500 includes a standard portion 202 that extends primarily from a proximal end whose length is optically connected to a laser source to a distal end 204 that emits laser radiation. The injection portion 504 has grooves that are each regularly or otherwise spaced to effect radial laser injection along an injection zone. The optical fiber tip 510 defines a distal end at a standard significant angle, but preferably defines the conical shape shown to achieve 360° radial injection. Further, preferably, to enhance the efficiency and effectiveness of the radial injection, the optical fiber tip 510 includes a conical reflective surface 512 that is axially disposed with respect to the injection surface and faces opposite. This is by reflecting any designed or remaining forward-transmitted energy outward in the radial direction.

[0052] The guide wire 534 is attached to the quartz cap 506 by a mechanical guide wire attachment / detachment mechanism 536. While the treatment set is inserted into the blood vessel 514, due to its illustrated shape, the guide wire 534 remains attached to the optical fiber. The attachment mechanism 536 prevents detachment while pushing inward, but detachment is possible while pulling backward, and in this way, at the attachment location, the guide wire 534 is appropriately shaped at 538 so that it can be withdrawn before or at the beginning of the treatment. In another embodiment, the guide wire is attached by a medically safe adhesive, such as wax or cyanoacrylate. In appropriate techniques based on the teachings herein, it will be recognized by those of ordinary skill with general techniques that the guide wire may be attached in many arbitrary different ways. This includes many arbitrary different adhesives or other attachment mechanisms that are currently known or later become known. The guide wire can be detached by softening the adhesive or decomposing the adhesive bond. This can be done at the appropriate position of the intravascular treatment set by means of laser radiation. When detached, the guide wire 534 is removed, leaving the capped optical fiber 500 in the appropriate position and ready to emit a laser. While the laser is being emitted, the optical fiber is retracted in the direction towards the insertion site, and the blood vessel 514 shrinks, preferably closing the blood vessel.

[0053] In another preferred embodiment, as depicted in FIG. 6, the optical fiber set 600 includes an optical fiber, a quartz cap 606, and a guide wire 634. Radial laser emission is achieved through a plurality of surface grooves 608 having a reflective surface 610 formed at a distal end portion of the optical fiber core. In this case, the guide wire 634 is preferably attached to the distal end of the cap 606. Therefore, without the need to move the guide wire 634, the optical fiber set 600 can be easily introduced and advanced through the blood vessel 614 to a desired position in one step. Once in place, while retracting the optical fiber set 600 toward the insertion site, the physician initiates laser emission, thereby causing the blood vessel 614 to constrict and preferably close.

[0054] In FIGS. 7a and 7b, another embodiment of the optical fiber is generally indicated by reference numeral 700. The optical fiber 700 achieves radial emission by means of a reflective cone 742 disposed in the optical fiber tip 700. In this embodiment, the reflective cone 742 is defined by a concave surface that is a substantially conical shape. Accordingly, the radiation transmitted through the fiber core 740 is emitted radially at more than 360° when it reaches the fiber tip. Preferably, the concave surface that is the substantially conical shape of the cone 742 is an acute angle within the range of about 30° to about 50° with respect to the axis along which the fiber is stretched. As described in the other embodiments above, one advantage of this novel concave surface that is conical in shape is that it can achieve an efficient 360° radial emission onto the surrounding vessel wall.

[0055] In FIGS. 8a and 8b, another embodiment of the optical fiber is generally indicated by reference numeral 800. The optical fiber 800 achieves radial emission by means of a conical reflective gap formed in the optical fiber chip. As can be seen, a convex surface, which is a substantially conical surface formed at the distal end of the fiber core 840, and a concave surface, which is a substantially conical surface axially spaced from the injection surface so as to be substantially transparent to the emitted radiation and form a gap 844 therebetween, define the gap 844. In this embodiment, as a result of the difference in refractive characteristics between the air or other gas in the gap 844 and the fiber core 840, the radiation transmitted through the fiber core 840 is emitted radially when it reaches the fiber chip. Thus, the radiation is emitted radially (i.e., laterally with respect to the extended axis of the fiber) in an annular or circumferential pattern onto the adjacent surrounding vessel wall. This different chip shape leads to efficient 360° radial emission. As can be seen, a relatively thin wall is formed to seal the gap within the fiber chip between the outer periphery of the gap 844 and the outer surface of the fiber 800. In this way, the core-gas interface, which is essential in the gap for annular radial laser emission, is maintained. As described in other embodiments herein, this novel shape leads to efficient radial emission onto the surrounding vessel wall. As can be seen, the distal tip of the fiber 800 is defined by an enlarged diameter or a rounded, bulbous portion that is substantially hemispherical in the illustrated embodiment, to facilitate movement of the chip through the blood vessel. The rounded, bulbous portion is hemispherical in shape, but many different rounded, bulbous, or such shapes of suitable techniques based on the teachings herein will be recognized by those of ordinary skill in the art with general technology, and / or as may be known now or later become known.

[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 arrows in FIG. 9, the sleeve 946 can be axially repositioned with respect to the cap 906 and the fiber 900 to control the length of the axial portion of the fiber's injection portion. As can be seen, the sleeve 946 can be arranged to completely cover the desired number of radially emitting grooves 908, some portions, or all of the distal injection portion. Thus, one advantage of the embodiment of FIG. 9 is that the physician can adjust the length of the injection portion or the portion of the fiber. In one embodiment, the length of the injection portion is positioned according to the length of the vasculature 914 or a portion thereof, such that such portions are excised and treated segment by segment. In another embodiment, with a substantially fully extended injection portion, while progressively injecting laser into one or more treatment sites of a vein, the extended injection portion is withdrawn through the vein while the laser is being emitted. If the vein portion is shorter than the length of the injection fiber, the sleeve may be used to cover the injection portion located outside the vein while the laser is being emitted. The sleeve is preferably made of a type of reflective material known to those skilled in the art having a general technology in a suitable field that performs such a function. Even with a complete reflective surface, the reflected light will pass through the fiber and go back and forth, and some portion of the radiation will be captured, some scattered, and some further absorbed. Thus, some amount of the emitted energy in the grooves covered by the sleeve will be lost as heat. Nevertheless, since the required power density is low, such heat, no matter how much it accumulates, can be maintained within an acceptable minimum value during ELA treatment.

[0057] Referring to FIG. 10, another embodiment of the optical fiber is generally indicated by reference numeral 1100. The optical fiber 1100 is substantially similar to the optical fiber 100 with respect to FIGS. 1a and 1b described above, and accordingly, similar reference numerals preceded by the numeral "11" instead of the numeral "1" are used to indicate similar elements. The first difference between the optical fiber 1100 and the optical fiber 100 is that the optical fiber tip is defined by a substantially flat emission surface 1110 that is encapsulated within a protective cap 1106. The cap 1106 is made of a material that is substantially transparent to the emitted radiation in order to allow the radiation to pass through and proceed into the vessel wall. In one embodiment, the cap 1106 is made of quartz and adhered to the fiber core as described above. However, if desired, the cap may be made of any of a number of different materials known now or later known, and may be firmly fixed to the distal end of the fiber in any of a number of different ways. As can be seen, the protective cap 1106 extends relatively distally with respect to the flat emission surface 1110 of the fiber, and further, the distal end 1107 is rounded to facilitate movement of the capped fiber through the curved blood vessel. The distal end 1107 of the cap 1106 extends axially distally with respect to the flat emission surface 1110 of the fiber, preferably within a range of about two to about six times the diameter of the fiber core, more preferably within a range of about three to about five times the diameter of the fiber core. In the illustrated embodiment, the distal end 1107 of the cap 1106 extends axially distally with respect to the flat emission surface 1110 of the fiber at a distance of about four times the diameter of the fiber core. As can be seen, the protective cap 1106 defines a sealed space 1109 that extends between the flat emission surface 1110 and the distal end 1107 of the cap. This allows the transmitted radiation to pass through the space and the walls of the cap, but prevents any contact between the flat emission surface and the vessel wall and protects the emission surface of the fiber.Compared with the above-described optical fiber 100, the optical fiber 1100 does not define a substantially conical-shaped emission surface or a substantially conical-shaped reflection surface. Thus, the optical fiber 1100 emits a substantially conical-shaped beam forward or in a direction on the axis of the fiber.

[0058] Referring to FIG. 11, another embodiment of the optical fiber is generally indicated by reference numeral 1200. The optical fiber 1200 is substantially similar to the optical fiber 1100 with respect to FIG. 10 described above, and thus similar reference numerals preceded by the numeral "12" instead of the numeral "11" are used to indicate similar elements. The first difference between the optical fiber 1200 and the optical fiber 1100 is that the fiber 1200 includes an open protective sleeve 1206 rather than a closed protective cap. The protective sleeve 1206 is made of a material that is substantially transparent to the emitted radiation to allow the radiation to pass through and proceed into the vessel wall. In one embodiment, the protective sleeve 1206 is made of quartz and is adhered to the fiber core in substantially the same manner as the protective cap described above. However, if desired, the protective sleeve may be made of any number of different materials known now or later known, and may be firmly fixed to the distal end of the fiber by any number of different methods. As can be seen, the protective sleeve 1206 extends distally with respect to the flat emission surface 1210 of the fiber and defines a distal end 1207 that is rounded or bent inwardly toward the central hole 1209. The distal end 1207 is bent inwardly to facilitate the movement of the fiber tip through the blood vessel. The protective sleeve 1207 extends distally with respect to the flat emission surface 1210 of the fiber, preferably within a range of about two to about six times the diameter of the fiber core, more preferably within a range of about three to about five times the diameter of the fiber core. In the illustrated embodiment, the protective sleeve 1207 extends distally with respect to the flat emission surface 1210 of the fiber and reaches an axial distance at about four times the diameter of the fiber core. Compared with the optical fiber 100 described above, the optical fiber 1200 does not define a substantially conical emission surface or a substantially conical reflection surface. Thus, the optical fiber 1200 emits a substantially conical beam forward or in the axial direction of the fiber.

[0059] In one generally preferred surgical embodiment, an optical fiber or other waveguide is first introduced into the vein to be treated. If desired, a local infiltration anesthetic such as lidocaine diluted to 0.5% (preferably without epinephrine) may be introduced at the access site. In one embodiment, about 1 / 2 ml of such local anesthetic is used at the access site. The introducer needle passes through the access site and is inserted into the vein to obtain contact with the vein. Thereafter, a guidewire may be passed through the introducer needle and introduced into the vein. Then, an introducer sheath may be introduced over the guidewire within the vein. The introducer sheath may be of any of a number of different introducer sheath configurations known now or later known. This includes short introducer sheaths (e.g., less than about 11 cm in length, or defined within the range of about 6 cm to about 11 cm) that provide access to a relatively short portion of the vein proximate the access site, or longer introducer sheaths that may extend above the length of the vein to be treated. The guidewire is then removed by passing it through the sheath. Then, the fiber injection tip is positioned until it is about 1 to 1 / 2 cm downstream of the saphenofemoral junction (“SFJ”), or other desired distance, and the optical fiber is introduced through the introducer sheath. The fiber tip is positioned at an appropriate start position downstream of the SFJ under ultrasonic guidance and / or by transmission of a red or other prominent aiming beam through the fiber to visually monitor the start position of the fiber tip through the skin.

[0060] One advantage of a generally preferred embodiment is that the cap or other distal portion of the fiber tip is rounded, thus facilitating insertion when passing through a curved vein and eliminating the need for an introducer sheath and guide wire in many cases, if not all. In a generally preferred embodiment, the fiber has an outer diameter in the range of about 1235 μm to about 1365 μm, the cap has an outer diameter in the range of about 1800 μm to about 2000 μm, and the rounded distal portion of the cap is defined by a radius in the range of about 900 μm to about 1000 μm. Thus, while the use of an introducer sheath and guide wire has been described above, such steps may be omitted. Alternatively, if an introducer sheath is used, it may be removed from the vein before the laser is emitted and pulled back with the fiber. For example, if a long introducer sheath is used, the introducer sheath may be withdrawn and removed outside the vein before the laser is emitted and pulled back with the fiber. Similarly, if a peel-away introducer sheath is used, the sheath may be peeled away and removed from the vein before the laser is emitted and pulled back with the fiber. If a relatively short introducer sheath is used, the sheath may be removed from the vein or may be left in place at the access site during laser emission and pullback.

[0061] A laser is activated such that a fiber tip is present at a start position immediately downstream of the SFJ or at other desired start positions, and laser energy is emitted into the blood vessel. In a radially emitting fiber, the laser energy is preferably directed radially and circumferentially onto the wall surrounding the blood vessel. On the other hand, in a fiber with a flat tip, the laser energy is emitted in a beam directed axially of a substantially cone. When radiation is emitted, the fiber is retracted at a substantial predetermined rate based on the wavelength and power used to damage or kill a sufficient portion of the vascular endothelium to achieve closure of the vasculature. Preferably, the energy per unit length delivered to the blood vessel is high enough to close the vein, but low enough to substantially avoid the need for anesthesia along the length of the vasculature being treated. In a generally preferred embodiment, the energy per unit length delivered to the treatment area 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 one embodiment, the energy per unit length delivered to the treatment area 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. As will be further described in these embodiments, the wavelength of the 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 a predetermined energy level and / or wavelength is that (i) the energy may be substantially entirely absorbed within the vessel wall, (ii) sufficient damage is imparted to the vascular endothelium such that closure of the vasculature can be achieved, and further (iii) any significant transmission of radiation into the tissue surrounding the blood vessel is substantially prevented, thereby substantially avoiding the need for anesthesia along the treated portion of the vasculature.

[0062] Even in generally preferred embodiments, energy such as laser radiation may be supplied in a continuous mode or in a pulsed mode. It has been found that energy transfer in a pulsed mode may allow for transfer of a higher average level of energy per length to the treatment area of a blood vessel, without the application of anesthesia to the treatment area, as compared to laser energy transfer in a continuous mode (i.e., substantially preventing any significant energy penetration through the blood vessel wall that would otherwise thermally damage the surrounding tissue, while more of the pulsed energy may be absorbed within the blood vessel as compared to continuous mode energy). Further, in all cases where the general techniques and other elements in the pulsed mode are equal, the greater the ratio of the duty cycle being “off” as opposed to “on,” the higher the average energy per unit length injected into the treatment area of the blood vessel will be, such that substantially no administration of anesthesia along such a treatment area will be required. In certain such embodiments, “off” is greater than about 1 / 2 of the duty cycle, preferably “off” is from about 1 / 2 to about 2 / 3 of the duty cycle. Pulses are capable of significantly increasing the rate of ablation within the blood vessel wall tissue as compared to continuous mode injection, and thus result in a lower depth of penetration per energy injection rate (e.g., average J / cm injected by an intravascular energy injection device) than without pulses (e.g., continuous mode). Thus, one advantage of pulsed mode injection energy is that it allows for a higher energy injection rate, such that there is no problem injecting a higher amount of energy into the vascular endothelium without the use of anesthesia along the treated portion of the blood vessel. Here, the “pulsed mode” is used at intervals that mean any of a number of different methods now known or later known for receiving energy injected into the blood vessel by the duty cycle (i.e., repeating periods, segments where energy injection is active, and another segment where energy injection is inactive). This includes, but is not limited to, pulses, repeated switching of the energy source on and off, such as using a shutter, and interruption of the energy beam.

[0063] In one generally 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. In other embodiments, radiation of about 810 nm, about 940 nm, about 1064 nm, about 1320 nm, about 2100 nm, about 3000 nm and about 10000 nm, each ± about 30 nm, is used. One advantage of wavelengths that are absorbed significantly more highly 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 pass substantially through the blood intervening between the exit surface of the fiber and the vessel wall and are then strongly absorbed into the vessel wall. Such wavelengths emitted at an energy emission rate inferior to a given energy emission rate are absorbed substantially entirely within the vessel wall tissue and, in order to promote vessel closure, damage or kill a sufficient depth of the vascular endothelium. Preferably, such damage to the vascular endothelium is at least about 1 / 3 of the thickness of the vascular endothelium at the average level, or about 1 / 3 to about 2 / 3 of the thickness of the vascular endothelium on average. As a result, such wavelengths can be more easily absorbed at a relatively low given energy emission rate (for example, the average emission to the treatment site of the blood vessel is 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). Despite the low energy emission rate, it is sufficient to damage or kill a sufficient depth of the vascular endothelium to promote vessel closure. Furthermore, since such radiation is absorbed substantially entirely within the vessel wall, it substantially prevents any heating of the tissue near or adjacent to the vessel wall, so that it is possible to perform the treatment substantially without anesthesia of the part of the blood vessel to be treated (for example, a non-swelling local anesthesia may be applied only at the access site or only at one or several scattered locations within the discretion of the doctor or at the patient's request based on individual criteria).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 certain embodiments, the wavelength of the radiation is about 1470 nm ± about 30 nm, 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 retracted 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 of approximately 10 cm in length was closed by substantially radially applying radiation of approximately 1470 nm at a power level of about 2 W and a pullback rate of about 5 sec / cm. In particular in this example, local infiltration anesthesia was applied only at the access site and not at all during the remainder of the procedure, nor was it otherwise required.

[0065] In other exemplary embodiments, a flat tip fiber sealed within a quartz cap (see FIG. 10) was used to occlude a number of different great saphenous veins (GSV). The radiation was at approximately 1470 nm and the energy delivered to the vessel per unit length was on average approximately 10 J / cm (i.e., approximately 1 W at a pullback rate of approximately 10 sec / cm). In each of these cases, local tumescence or general anesthesia was not used. Rather, local infiltration anesthesia (1 / 2% lidocaine without epinephrine) was applied only at the discretion of the patient or physician. 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 at the access site and in the vicinity of the SFJ. One reason for applying such a small amount of local anesthesia in the region near the SFJ is that the diameter of the vein in this region is typically the largest, and thus the pullback rate and the average energy delivered to the vessel per unit length in this region may be higher than in the more distal treatment regions.

[0066] In other exemplary embodiments, flat tip fibers encapsulated within a quartz cap were used (see Figure 10) to close a number of different varicose veins (GSV). The wavelength of the applied radiation was approximately 1470 nm. The first protocol was the emission of radiation at a rate within the range of about 20 J / cm to about 30 J / cm. However, some patients received a lower energy emission rate (within the range of about 10 J / cm to about 20 J / cm), so the energy per unit length was on average within the range of about 10 J / cm to about 30 J / cm (the average was about 22 J / cm). The first protocol in continuous mode was also the emission of radiation at a power level of about 3 W. However, some patients received about 3 W pulsed at a 50% duty cycle (about 1 / 2 second on, about 1 / 2 second off). The diameter of the veins was within the range of about 3 mm to about 22 mm (the average vein diameter was about 8.2 mm). All procedures were performed without the use of tumescent anesthesia or general anesthesia, and without any pre-formation of the vein 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 over the entire procedure was about 28 ml, and 7 patients received less than 10 ml. As a general matter, it is thought that the lower the energy transfer rate, the less anesthesia is required or otherwise desired. Further, as a general matter, pulsed delivery of laser radiation was associated with a lower amount of anesthesia than continuous mode delivery. In all cases, anesthesia was applied locally when deemed necessary by the physician or requested by the patient. Results at 24 hours post-surgery demonstrated that over 90% of the treated veins were closed with excellent vein wall thickness. Further, there was little post-operative patchy bleeding and reported pain. Some purpura was reported in only about 5 to 10% of the patients, mainly at the vein access sites. Also, reported post-operative discomfort was minimal, and a small number of patients reported the use of OTC pain relievers (e.g., aspirin, acetaminophen, etc.).

[0067] Accordingly, a significant advantage of the generally preferred embodiments is that neither local infiltration anesthesia nor general anesthesia is required. As noted above, in many cases, if any is needed at all, only a small amount of local infiltration anesthesia may be applied at the venous access site. If the patient experiences any discomfort during the procedure, the physician may apply a small amount of local infiltration anesthesia (e.g., preferably without epinephrine lidocaine) to the local or area of discomfort. In any case, less than about 1 vial (about 50 ml) of local infiltration anesthesia (e.g., 0.5% lidocaine without epinephrine) is required at hand during the procedure. Further, depending on the length of the vein being treated and / or the patient's sensitivity to any sensation or discomfort encountered, only a small amount of such vial may be needed if any.

[0068] Certain embodiments of the present disclosure involve administering sufficient anesthesia in the vicinity of the femoral nerve to effect a sensory block rather than a motor block of the thigh movement for anesthetizing a treatment area. One such procedure includes the following steps. Locate the branch of the femoral nerve between the SFJ and the femoral artery by ultrasound guidance. Above the nerve at a neighboring location that does not touch the nerve (outside the blood vessel or any sheath surrounding the blood vessel being treated) under ultrasound guidance, inject a predetermined amount of local anesthetic (e.g., about 1 / 2% lidocaine). The predetermined amount of local anesthetic is sufficient to cause a sensory block but insufficient to cause a motor block. In a generally 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 the dilution rate (e.g., the concentration of lidocaine in saline or other solvent). Generally, when the concentration of lidocaine is higher, the amount injected is lower, and vice versa. Generally, no further application of anesthesia during the procedure is necessary. However, if desired, a small amount of local anesthetic such as topical anesthetic or a few cc of diluted lidocaine may be applied at the access site. Thereafter, the procedure is 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 fiber capped to the SFJ is introduced through the introducer sheath, the laser is emitted, and the fiber is withdrawn at a rate of about 20 J / cm to about 30 J / cm, or by another method as otherwise described herein.

[0069] Other embodiments of the present disclosure include the use of intravenous infusion into the blood vessel to be treated for locally anesthetizing the treatment area. One such procedure includes introducing a small amount of lidocaine (e.g., a few cc 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 blood vessel to be treated. A short introducer sheath is introduced through the needle in the blood vessel. A sheath fiber is introduced through the short introducer sheath, and the tip of the sheath fiber is positioned at a start position downstream of the SFJ. The sheath fiber may be a typical "cooled liquid" fiber that allows introduction of liquid between the sheath and the fiber and further allows dripping or other dispensing of liquid into the blood vessel proximal to the fiber tip (in the case of a diluted anesthetic solution), including one or more inlets and outlets proximal to the fiber tip. The dripping of the diluted anesthetic solution (e.g., diluted lidocaine) into the blood vessel begins at the SFJ or a start position downstream of the SFJ. After the effect of lidocaine takes place, the laser is emitted and the fiber is retracted at the desired rate (e.g., at a rate from about 20 J / cm to about 30 J / cm or otherwise in the methods disclosed herein). The inlets and outlets for the diluted anesthetic are located proximal to the fiber tip, so that the anesthetic is applied to the portion of the blood vessel just prior to laser emission so that the portion of the blood vessel where the laser is emitted is anesthetized prior to laser emission.

[0070] Other embodiments of the present disclosure relate to anesthesia of a local treatment area by application of a non-swelling local anesthetic prior to introduction of the fiber into the blood vessel. In certain such embodiments, a small amount of diluted anesthetic (e.g., lidocaine diluted to about 1%) is injected at the access site, at a central point of the blood vessel (e.g., "Hunter's Crossing" or an adjacent point), and at or near the SFJ. The amount of local anesthetic injected at each location is slightly from about 3 to about 5 ml, and the total amount administered is about 9 to about 15 ml or less.

[0071] In other embodiments, any number of other generally known or later-known methods and treatments for relaxing the patient and / or creating a reduced sensitivity to analgesia, anesthesia, and / or pain stimuli may be used. Such methods or treatments include, but are not limited to, electrical stimulation, electroanesthesia, nerve stimulation, neuromodulation, and other physical or verbal methods for creating a reduced sensitivity to analgesia, anesthesia, and / or pain stimuli. Other such methods include, for example, analgesia by current based on transcutaneous or percutaneous nerve stimulation, deep stimulation, posterior spinal cord stimulation, and transcranial electrical stimulation. The foregoing descriptions of anesthesia and analgesia are not intended to imply that any anesthesia and analgesia are required in connection with the disclosed intracavitary treatment devices and methods. Rather, many preferred embodiments use no anesthetic or analgesic agents at all. Or, in most cases, a small amount of a local anesthetic or analgesic agent is used at the access site or at other discrete locations for treating any pain that the patient perceives or experiences.

[0072] Accordingly, an important advantage of the devices and procedures disclosed herein is that the above-described disadvantages associated with tumescent techniques may be avoided. This includes the potential toxicity and / or adverse patient reactions associated with such anesthesia, a higher incidence of thermal damage to surrounding tissues, and ecchymosis resulting from the relatively high energy levels used in post-operative pain and tumescent technique procedures. Another advantage of the generally preferred embodiments over prior art tumescent technique procedures is that the blood vessels are maintained at substantially the same size before and after introduction of the energy application device into the blood vessel, and there is substantially no pre-formation, flattening, compression, and displacement of the blood vessel wall to assist the energy application device, and energy is applied into the surrounding wall of the blood vessel.

[0073] As described above, other structures at the injection end of the cap or fiber are rounded, providing a distal region with a relatively large diameter with respect to the fiber tip, thus facilitating insertion therein and pullback through the vein. Compared to the exposed tip fibers of the prior art, another advantage of such an enlarged fiber tip structure is that it displaces a larger amount or portion of the vein lumen. Further, another advantage of a generally preferred embodiment is that laser radiation is emitted radially and circumferentially from the fiber into the annular region around the vein wall, thus transmitting the radiation more directly and effectively into the vein wall compared to the prior art ELA methods and devices. Further, another advantage of a generally preferred embodiment is that the optical fiber tip has a significantly larger injection surface area compared to the prior art exposed tip or other flat injection end face fibers, and further that the radiation is emitted laterally / radially. As a result, the laser radiation is transmitted directly into a significantly wider area of the surrounding vein wall tissue, so that it can be transmitted at a significantly lower power density compared to prior art ELA procedures, thereby facilitating treatment without substantial local 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 generally preferred embodiment is that a significantly lower power level can be used compared to prior art ELA treatments.

[0074] A further advantage of a generally preferred embodiment is that the laser wavelength used is highly absorbed in water and thus highly absorbed in the vascular wall tissue. As a result, the laser radiation is directly transmitted and absorbed to a sufficient depth in the circumferential portion around the vascular wall or the vascular endothelium so as to kill or damage the absorbing endothelium and then achieve vascular occlusion. The term "vascular occlusion" or words similar thereto are used herein to mean the closure or narrowing of a blood vessel, which is important in treating the blood vessel and substantially preventing blood flow through the blood vessel. Further, another advantage of a generally preferred embodiment is that since the laser radiation is directly and effectively transmitted to and absorbed by the vascular wall, any significant amount of absorption of the radiation by the surrounding tissue and the resulting thermal damage are substantially avoided. As a result, the generally preferred embodiment not only requires less power input than prior art ELA treatments, but also requires less anesthetic, and further, if any, enables the elimination of local infiltration anesthesia and its various drawbacks and disadvantages.

[0075] If desired, prior to laser emission and fiber retraction, a saline flush, such as a cooled saline flush, may be used to cool and / or freeze the vein. In certain such embodiments, the saline flush is chilled (e.g., from about 30°F to about 40°F, and more preferably from about 32°F to about 35°F) to promote freezing of the vein prior to treatment. In one embodiment, the chilled saline flush is introduced into the vein through the introducer sheath prior to insertion of the fiber. In another embodiment, the chilled saline flush is introduced through the introducer sheath after insertion of the fiber and / or while the introducer sheath is retracted, prior to laser emission. In another embodiment, the chilled saline flush is introduced through the sheath surrounding the fiber while the laser is being emitted and the fiber is being retracted. In a final embodiment, the chilled saline flush is introduced through one or more access ports located proximal to the emission tip of the fiber (e.g., at the base of a quartz cap). In one such embodiment, a cooled fiber sheath structure of normal liquid is used.

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

[0077] In certain embodiments of the present disclosure, the fiber is a medical fiber capped with a fluoropolymer, or other fibers based on a medical laser or light energy delivery device having an injection surface of a fluoropolymer. One advantage of the injection surface of the fluoropolymer is that it is difficult to pierce any coagulated blood in the blood vessel wall or within the vasculature, and thus it may be easier to perform a pullback through the blood vessel than with other devices.

[0078] In another preferred embodiment, the optical fiber set is added with three or more shape memory extension arms. While the treatment set is being inserted, the extension arms are in complete contact with the protective coating. When in the appropriate position, the extension arms are actuated by an internal / external energy source and extend their distal ends until they contact the inner surface of the blood vessel. As a result, the optical fiber set is positioned substantially centrally within the target tissue, further promoting substantially uniform heating of the inner surface and further preventing contact or perforation of the vein wall. Substantially uniform surface heating should result in more uniform constriction and effectively closing the desired location by shrinking the blood vessel.

[0079] In generally preferred embodiments, wavelengths are selected that provide moderately 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 many other wavelengths, currently known or later to be known, recognized by those of ordinary skill in the appropriate art may be used as well. This includes, but is 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 thus 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 about one to three orders of magnitude higher than 980 nm and significantly higher than most other commercially available wavelengths.

[0080] The protective radiation-transmissive cap of the generally preferred embodiment may be manufactured and combined in accordance with the teachings of U.S. Patent Application No. 11 / 592,598, entitled "Side Fire Optical Fiber For High Power Applications", filed Nov. 3, 2006, which is commonly assigned to the fibers. This reference is hereby expressly incorporated in its entirety as part of the present disclosure. The fibers and other elements of the device may be the same as or similar to the devices, elements or various aspects thereof disclosed in U.S. Provisional Patent Application No. 61 / 067,537, entitled "Rapid Insertion Device And Method For Improved Vascular Laser Treatment", filed Feb. 28, 2008, under Express Mail No. EB429577158US, which is commonly assigned. This reference is hereby expressly incorporated in its entirety as part of the present disclosure.

[0081] As described above, in one preferred embodiment, vascular occlusion is achieved by thermal injury or ablation of at least about 1 / 3 of the thickness of the vascular endothelium on average, or by thermal injury or ablation to a depth of the vascular endothelium within the range of about 1 / 3 to about 2 / 3 of its thickness on average. Further as described above, the wavelength that is strongly absorbed in water and to which a predetermined energy transfer rate is applied is substantially entirely absorbed at a depth within at least about 1 / 3 or in the range of about 1 / 3 to about 2 / 3, and the thickness of the vascular endothelium prevents some significant level of transmission of radiation into the surrounding tissue. Thereby, the need for an anesthetic agent along the vessel being treated is avoided. Mechanisms other than radiation may promote vascular occlusion and damage the vascular endothelium. For example, U.S. Patent No. 6,402,745 (“the ‘745 patent”) shows an intravascular whip electrode for vein ablation, and this reference is hereby expressly incorporated in its entirety as part of the present disclosure. In some embodiments of the ‘745 patent, electrical energy is not transmitted to the vascular endothelium, whereas in other embodiments it is. According to one embodiment of the present disclosure, the intravascular device includes a rotating whip or other device for ablation or abrasion of the vascular endothelium, as disclosed. As an example disclosed, the ablation or abrasion operation with the whip or other device of the ‘745 patent is combined, and an integrated vascular energy application device that transmits sufficient energy to the vascular endothelium damages at least about 1 / 3 to about 2 / 3 of the depth of the endothelium and achieves vascular occlusion. In some such embodiments, the energy application device is an optical waveguide that transmits a radiation wavelength that is strongly absorbed in water (i.e., about 1064 nm or greater). In some such embodiments, the radiation is pulsed, allowing for a relatively high energy transfer rate with substantially no anesthetic agent along the (multiple) segments of the vessel being treated. The ablation or abrasion operation with the whip or similar device damages the vessel wall sufficiently even at a lower energy transfer rate to the vessel wall and closes without the use of an anesthetic agent along the (multiple) segments of the vessel wall being treated

[0082] Although various preferred embodiments have been described with reference to the accompanying drawings, the present invention is not limited to these embodiments, and it should be construed that various changes and modifications that do not depart from the scope or spirit of the invention as defined in the appended claims by those skilled in the art of this field are also encompassed herein. For example, the radiation can be emitted in a pulsed or continuous mode and can also include one or more laser wavelengths. Further, radiation can be supplied by means other than lasers, including but not limited to LEDs and superluminescent LEDs. Further, the optical fiber may be formed from any of a number of different optical fibers or waveguides, currently known or later known. That is, it defines that the core, cladding, coating, end cap, protective sleeve, injection surface, reflective surface, and / or gradient lens may be any of a number of different ones, currently known or later known. For example, although many of the exposed fibers were capped here, fiber without a cap including exposed chipped fibers may also be used. Further, the injection surface may have many different shapes or profiles, currently known or later known. For example, in one embodiment, an injection surface having a substantially conical shape was used, but other injection surfaces having an arcuate surface profile (i.e., a curved surface profile), or non-arcuate surface profiles such as injection surfaces with one or more planes and / or angles may equally be used. Further, the method of treatment in a vein may use many different optional devices, with or without an anesthetic. This includes, but is not limited to, not using a sheath or catheter, or using any of a number of different types of sheaths or catheters. Further, this includes not using a guidewire or using a guidewire, including but not limited to short, long, and / or peelable introducer sheaths. Further, this includes guidewires that can be attached to, detached from, and / or not attached to the fiber or waveguide at all, including but not limited to those that can be attached to or detached from the fiber or waveguide.Furthermore, in accordance with various aspects of the invention disclosed herein, many different forms of currently known or later-known energy and energy application devices may similarly be used to treat blood vessels. For example, the energy application device may be in the form of (i) a waveguide or optical fiber that emits laser energy as described above, (ii) a microwave catheter or device that emits microwave energy, (iii) an RF catheter or device that emits RF energy, (iv) an electrical catheter or device that emits electrical energy, and (v) an ultrasonic catheter or device that emits ultrasonic energy. Accordingly, this detailed description of generally preferred embodiments should be incorporated by way of illustration and not by way of limitation.

[0083] (Appendix 1) A flexible waveguide defining an elongated shaft, a proximal end optically connectable to a radiation source, and a distal end including a radiation emitting surface through which radiation is emitted laterally from the radiation source about the elongated shaft of the waveguide onto a portion receivable within a blood vessel and extending at an angle to the surrounding vessel wall. An intravascular treatment device, characterized in that.

[0084] (Appendix 2) The emitting surface is angled about the elongated shaft of the waveguide. The device according to Appendix 1, characterized in that.

[0085] (Appendix 3) The emitting surface is directed at an acute angle about the elongated shaft of the waveguide. The device according to Appendix 2, characterized in that.

[0086] (Appendix 4) The emitting surface has an arcuate surface profile. The device according to Appendix 3, characterized in that.

[0087] (Appendix 5) The arcuate emission surface extends over an angle of at least about 90°. The device according to appendix 4, characterized by this.

[0088] (Appendix 6) The arcuate emission surface extends over an angle within the range of about 90° to about 360°. The device according to appendix 4, characterized by this.

[0089] (Appendix 7) The emission surface defines the distal tip of the waveguide. The device according to appendix 4, characterized by this.

[0090] (Appendix 8) The emission surface is substantially conical in shape. The device according to appendix 7, characterized by this.

[0091] (Appendix 9) The emission surface is either substantially convex or substantially concave. The device according to appendix 8, characterized by this.

[0092] (Appendix 10) Further comprising a reflective surface spaced distally and facing the emission surface in order to laterally reflect the forward-directed radiation about the extended axis of the waveguide. The device according to appendix 1, characterized by this.

[0093] (Appendix 11) The emission surface emits radiation substantially radially about the extended axis of the waveguide, and the reflective surface reflects radiation substantially radially about the extended axis of the waveguide. The device according to appendix 10, characterized by this.

[0094] (Appendix 12) The reflective surface defines an arcuate surface profile that is angularly directed at an acute angle about the extended axis of the waveguide. The device according to appended claim 10, characterized in that...

[0095] (Appended claim 13) The reflection surface is substantially conical in shape. The device according to appended claim 12, characterized in that...

[0096] (Appended claim 14) The reflection surface is either substantially convex or substantially concave. The device according to appended claim 13, characterized in that...

[0097] (Appended claim 15) Further comprising a coating that is firmly fixed and sealed to the waveguide, enclosing the injection surface therein, and defining an interface between the waveguide and a gas that refracts the lateral emitted radiation with respect to the extended axis of the waveguide onto the surrounding vessel wall. The device according to appended claim 1, characterized in that...

[0098] (Appended claim 16) The coating is a cap that is substantially transparent to the emitted radiation. The device according to appended claim 15, characterized in that...

[0099] (Appended claim 17) Further comprising a radiation reflection surface that is spaced distally relative to the injection surface and faces it at a distance, for reflecting the forward-directed radiation laterally with respect to the extended axis of the waveguide and is enclosed within the coating. The device according to appended claim 15, characterized in that...

[0100] (Appended claim 18) Further comprising a lateral radiation emission distal region defined by a plurality of radiation emission surfaces that are axially spaced apart from each other along the distal region of the waveguide. The device according to appended claim 1, characterized in that...

[0101] (Appended claim 19) A first radiation emission surface formed at the distal tip of the waveguide, and a plurality of second radiation emission surfaces located proximally with respect to the first radiation emission surface and axially spaced from each other. The apparatus according to appended claim 18, characterized in that.

[0102] (Appended claim 20) The first radiation emission surface is substantially conical in shape. Each of the second radiation emission surfaces defines an arcuate surface profile angled with respect to the extended axis of the waveguide. Each of the second radiation emission surfaces laterally emits a portion of the radiation transmitted through the waveguide onto an arcuate portion around the vessel wall, laterally with respect to the extended axis of the waveguide, enabling lateral emission of the remaining transmitted radiation passing through the waveguide by any downstream second radiation emission surface and the first radiation emission surface. The apparatus according to appended claim 19, characterized in that.

[0103] (Appended claim 21) Further comprising an axially extending covering that forms a gas interface at each of the plurality of radiation emission surfaces that surround the lateral radiation emission distal region and seal outside the waveguide, and cooperate with the plurality of radiation emission surfaces having an arcuate surface profile angled to deflect radiation laterally with respect to the extended axis of the waveguide. The apparatus according to appended claim 18, characterized in that.

[0104] (Appended claim 22) The covering is substantially transparent to the emitted radiation and is sufficiently flexible to allow it to bend along a path passing through the vessel meandering in the waveguide. The apparatus according to appended claim 21, characterized in that.

[0105] (Appended claim 23) Further comprising a sleeve mounted so as to be able to slide on the waveguide. Defining an internal radiation reflection surface for lateral reflection of the injected radiation into the interior and for adjustment of the length of the axis of the lateral radiation emission distal region The device according to appendix 18, characterized in that

[0106] (Appendix 24) A radiation source, A temperature sensor thermally connected to the distal region of the waveguide for monitoring the temperature in the blood vessel and transmitting a signal indicated thereby, Further comprising a control module electrically connected to the temperature sensor for adjusting the power output of the radiation source there The device according to appendix 1, characterized in that

[0107] (Appendix 25) Further comprising a pull-back actuator movably connected to the waveguide for adjusting the pull-back speed of the waveguide, The control module is electrically connected to the pull-back actuator for adjusting the pull-back speed of the waveguide based on the temperature in the distal region of the waveguide, The device according to appendix 24, characterized in that

[0108] (Appendix 26) Further comprising a guide wire removably connected 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, The device according to appendix 1, characterized in that

[0109] (Appendix 27) The guide wire is mechanically connected to the waveguide and is non-detachable from the waveguide by pushing distally on the guide wire, but is detachable from the waveguide by pulling proximally on the guide wire, The device according to appendix 26, characterized in that

[0110] (Appendix 28) Further comprising a guide wire firmly fixed to the tip of the waveguide and extending distally therefrom. The apparatus according to Appendix 1, characterized in that.

[0111] (Appendix 29) The waveguide includes a coating surrounding the radiation emission surface. The coating is sealed with respect to the waveguide and defines a gas interface that cooperates with the angle of the emission surface to refract the laterally emitted radiation with respect to the extended axis of the waveguide. The guide wire is firmly fixed to the coating and extends distally therefrom. The apparatus according to Appendix 28, characterized in that.

[0112] (Appendix 30) The radiation emission surface is angled inward from the distal tip toward the extended axis of the waveguide. The apparatus according to Appendix 1, characterized in that.

[0113] (Appendix 31) The radiation emission surface defines a substantially concave shape that is substantially conical. The apparatus according to Appendix 30, characterized in that.

[0114] (Appendix 32) The distal tip of the waveguide defines a widened width compared to the portion of the waveguide extending proximally therefrom. The apparatus according to Appendix 30, characterized in that.

[0115] (Appendix 33) The distal tip is rounded to facilitate insertion of the waveguide through the blood vessel. The apparatus according to Appendix 32, characterized in that.

[0116] (Appendix 34) The distal region of the waveguide is sealed about the outside of the waveguide and defines an enclosed space that forms a gas interface at the radiation-emitting surface for refracting laterally emitted radiation about the extended axis of the waveguide. The apparatus according to claim 1, characterized in that.

[0117] (Appendix 35) The radiation-emitting surface is substantially conical in shape. The apparatus according to claim 34, characterized in that.

[0118] (Appendix 36) The waveguide is an optical fiber. The apparatus according to claim 1, characterized in that.

[0119] (Appendix 37) Further comprising at least one laser source for supplying 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 emission surface of the waveguide emits radiation laterally about the extended axis of the waveguide in an annular pattern extending axially onto the surrounding vessel wall. The intracavitary laser resection apparatus according to claim 1, characterized in that.

[0120] (Appendix 38) Further comprising an electric pull-back device that is movably coupled to the waveguide and is configured to be pulled back through the blood vessel while transmitting laser radiation at an energy transfer rate to the vessel wall of less than about 30 J / cm on average. The apparatus according to claim 1, characterized in that.

[0121] (Appendix 39) An elongated shaft, a proximal end optically connectable to a radiation source, and a distal end including means for receiving radiation from the radiation source and ejecting the radiation laterally with respect to the elongated shaft of the waveguide onto a portion that is receivable within a blood vessel and extends at an angle to the surrounding blood vessel wall, defining a flexible waveguide. An intravascular treatment device, characterized in that.

[0122] (Appendix 40) The ejection means includes a radiation ejection surface angled with respect to the elongated shaft of the waveguide. The device according to Appendix 39, characterized in that.

[0123] (Appendix 41) The ejection surface is one of a substantially convex shape and a substantially concave shape. The device according to Appendix 39, characterized in that.

[0124] (Appendix 42) The ejection surface is substantially conical in shape. The device according to Appendix 41, characterized in that.

[0125] (Appendix 43) The device further comprises means for reflecting forward-directed radiation laterally with respect to the elongated shaft of the waveguide. The device according to Appendix 40, characterized in that.

[0126] (Appendix 44) The reflection means includes a reflection surface spaced distally and facing the ejection means relatively. The device according to Appendix 43, characterized in that.

[0127] (Appendix 45) The device further comprises means for surrounding the ejection means and forming a gas interface for deflecting the ejected radiation laterally with respect to the elongated shaft of the waveguide. The device according to Appendix 39, characterized in that.

[0128] (Appendix 46) Further comprising means for emitting laterally diffused radiation along an axis of the waveguide in a region extending axially of the waveguide, with respect to the extended axis of the waveguide. The apparatus according to appended claim 39, characterized in that.

[0129] (Appended claim 47) The diffused radiation emitting means includes a plurality of radiation emitting surfaces that are located proximal to the emitting means and are axially spaced from each other. The apparatus according to appended claim 46, characterized in that.

[0130] (Appended claim 48) Further comprising means for adjusting the length of the diffused radiation emitting means. The apparatus according to appended claim 46, characterized in that.

[0131] (Appended claim 49) The adjusting means includes a sleeve that is mounted so as to be slidable on the waveguide. The apparatus according to appended claim 48, characterized in that.

[0132] (Appended claim 50) Further comprising means for retracting the waveguide through the blood vessel while laser radiation is being transmitted, at an energy transfer rate to the blood vessel wall of less than about 30 J / cm on average. The apparatus according to appended claim 38, characterized in that.

Explanation of reference numerals

[0133] 100 Optical fiber 106 Quartz cap 110 Emitting surface 112 Reflecting surface 140 Core 146 Cladding 200 Optical fiber 202 Standard portion 204 Distal end 206 Protective cap 208 Groove 210 Optical fiber chip 212 Reflective surface 214 Target tissue 216 Remaining radiation 218 Radiation 314 Vein 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 Optical fiber chip 512 Reflective surface 514 Blood vessel 534 Guide wire 536 Guide wire attachment / detachment mechanism 600 Optical fiber set 606 Quartz cap 608 Groove 610 Reflective surface 614 Blood vessel 634 Guide wire 700 Optical fiber 740 Fiber core 742 Reflective cone 800 Optical fiber 840 Fiber core 844 Gap 900 Fiber 906 Cap 908 Groove 914 Vessel 946 Sleeve 1100 Optical fiber 1106 Protective cap 1107 Distal end 1109 Sealing space 1110 Ejection surface 1200 Optical fiber 1206 Protection sleeve 1207 Distal end 1209 Central hole 1210 Ejection surface

Claims

【Claim 1】 A flexible waveguide including one end optically connectable to a radiation source that emits radiation for constricting blood vessels, and the other end receivable within the blood vessel; A coating formed of quartz, dissolved and fixed to the flexible waveguide to protect the flexible waveguide and the radiation emission surface of the flexible waveguide and transmit the radiation; and The flexible waveguide includes a reflective gap formed at a tip of the flexible waveguide, the reflective gap being formed by a convex surface which is a conical surface formed at the other end of the flexible waveguide, and a concave surface which is transparent to the radiation, is a conical surface, and is arranged axially spaced from the other end. A blood vessel lumen treatment device characterized by the above.

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