JPH05506601A - High-energy pulsed laser light guide and transmission system - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] High-energy pulsed laser light guide and transmission system Gisara Tateno The present invention relates to a system for transmitting a high-energy laser through an optical waveguide, and particularly to a system for transmitting a high-energy laser using an optical waveguide. The field of application is related to laser-based angioplasty, and such systems are It is related to the method of id.

Sumidan of Oitsui Atherosclerosis using laser energy to create obstructions in blood vessels The technique to remove blackheads is being promoted as an alternative to coronary artery bypass surgery. Research is currently underway. This procedure, known as angioplasty, essentially involves: Insert a fiber optic waveguide into a blood vessel, bring the end of the waveguide close to an obstacle, and pass the waveguide through. This method transmits laser energy to the plaque. At this time, it moves within the blood vessels. A waveguide that provides an illumination source and a blood A waveguide is used in conjunction with a laser waveguide to transmit images from inside the tube to the surgeon. Sometimes.

Many previous experiments and tests in this field have used argon ions, Nd:Y Using continuous wave laser energy such as AG or carbon dioxide lasers Ta. In these types of lasers, the energy of the light produced is relatively small. Become something. Using these types of lasers, the temperature is high enough to destroy the plaque. The obstruction is removed by continuing to heat the plaque with a constant laser power until the I do.

It is known that continuous wave laser energy is sufficient for obstacle removal. However, this does not mean that there are no drawbacks. The most obvious example is the removal of obstacles. This can lead to uncontrolled heat loss and thermal damage to the blood vessel wall in contact with the obstruction.

To avoid such thermal damage and properly control tissue removal, ultraviolet region (4 The use of high-energy laser energy with a wavelength in the range (0-400 nm) is being considered. It is. For example, international application PCT/US102000 (June 20, 1985) Please refer to the following publication. of lasers to produce this high level of energy. One example is known as an excimer laser, which is an aluminum laser with a wavelength of 193 nm. Gon chloride, krypton chloride (222 nm), krypton fluoride (248 nm) ), xenon chloride (308 nm), xenon fluoride (351 nm), etc. A laser is used as a medium. The light produced by this type of laser is generally It lasts for 8 to 10 ns and has a high energy level (e.g. around 200 mJ). It's like a short burst or pulse.

The mechanism of destruction when such energy is used has not been completely elucidated. However, a single pulse of excimer laser can cause thermal damage to the surrounding tissue. However, it has been observed that it produces an “ablative” effect that destroys the target tissue. Ta. Such results can be theorized using one or two of two phenomena. came. That is, by injecting high-energy pulses over a short period of time, substances can be vaporized quickly. Minimize heat transfer to adjacent tissues that are not irradiated. Furthermore, photons of ultraviolet light absorbed by tissues break down intermolecular bonds. There are two phenomena: the tissue can be removed photochemically rather than thermally. Ru.

High peak energies such as those generated by excimer lasers or other pulsed lasers Ghee gives good results when it comes to removing atherosclerotic plaque However, in reality, energy with such characteristics also poses serious problems. It is growing. When coupling a large diameter laser beam into a small diameter fiber, it is common to The artificial end face of the fiber is rubbed and polished to an optical grade flat surface. Ru. At this time, any residual impurities from the polishing compound left on the surface, as well as small scraps, should be removed. The latch absorbs the laser energy. And such small defects can cause laser Absorption of energy causes local expansion at the fiber surface. That is, high energy Excimer laser pulses create shear stresses that destroy the integrity of the fiber surface. It makes me feel the same. Continuously injecting laser energy causes deep penetration inside the fiber. This results in the creation of a crater. Therefore, using continuous wave laser energy Traditional systems designed to cannot supply energy.

The problem with supplying such high-energy laser pulses is that small-diameter optical fibers This is an urgent problem in the field of coronary angioplasty, which requires the use of . For example, the internal diameter of a coronary artery is typically 2 mm or less. Therefore, vascular shape The overall outer diameter of the construction system must be less than or equal to 2 mm. If this system If it consists of three optical fibers arranged next to each other, then It will be appreciated that the cross-sectional area of each fiber must be kept very small.

The critical parameter for optical fiber breakdown is the energy density at the fiber end. Ru. In order to transmit laser energy continuously, the energy density is It is necessary to keep the damage below the destruction threshold. Therefore, the energy density is kept below the value during this time. However, with small cross-sectional area fibers such as those used in angioplasty, It can only transmit as much energy as it does. That is, such limited With a small amount of energy, it is possible to efficiently (remove) obstructive tissue and plaque without causing thermal damage. I can't leave.

Even with very high energy densities, small beams from small diameter fibers can cause interference. It is not always possible to obtain a sufficiently large target area for efficient removal of the harm. this place In some cases, only part of the obstacle is removed and the obstacle cannot be removed completely. Dew. A fiber-guided waveguide is used to inject laser energy into atherosclerotic arteries. An additional problem when attempting to remove hardened plaque is perforation of blood vessels. There is. This occurs because the waveguide comes into contact with and penetrates the blood vessel. Also, this Perforations such as Therefore, it may be caused. Such perforation problems can occur in laser sources and waveguides. Regardless, the glass fiber of the waveguide is inherently stiff and the laser energy This is due to the fact that it cannot be adequately controlled.

Also, in relation to the stiffness of the glass fiber, the position of the fiber within the blood vessel should be Another issue is whether it can be controlled in a direction that spreads in both directions. Fiber optical waveguide in blood vessels In conventional systems, fibers are routed from the center of the blood vessel in a direction that spreads out in all directions. It is impossible to control.

In an effort to develop an angioplasty system, U.S. Patent No. 4.747 , 405. Known catheters include a central guide edge diaphragm, a guide within its lumen. line, one optical fiber located on the side of the catheter for emitting laser energy. Ibato exists. Additionally, catheters have rounded tips that make them difficult to insert into blood vessels. I'm sleeping. The disclosed method consists of one optical fiber and a guide wire. A particular problem is that large fragments of the book can leak into the bloodstream, causing damage to blood vessels. This may cause blockage. Therefore, with known catheters, A special cavity is provided to remove spilled debris.

Currently, wired laser catheters are guided inside arteries using inflexible guide wires. has been done. In the laser angioplasty process, the doctor first inserts a guide wire into the blood that requires treatment. Insert the catheter into the tube. Next, insert the catheter along the guide line and treat the blood vessel. Inject the necessary laser light. Plaques often form in uneven locations within blood vessels Therefore, the direction of the guide wire, i.e. the course of the catheter within the blood vessel, can be changed during the procedure. It is sometimes desirable to However, with a guide wire that is not flexible, the direction of the guide wire is difficult to change.

Laser angioplasty systems that treat incomplete occlusions are designed to The fibers are arranged in a circular pattern and have a fiber east covered by a protective coating. small caliber The tail (e.g. 1.0 to 1.7mm 0.D (outer diameter)) is located at the center guide edge. It has an active optical fiber ring extending from the diaphragm to the outer protective coating. Aku Place the fiber ring in front of the inserted catheter! any closure Blockages can also be removed.

The fiber count of these small diameter catheters is higher than that of larger diameter catheters (e.g. diameter (1.8 mm or more). light in large diameter catheters Increasing the number of fibers reduces the flexibility of the catheter, making it more usable. It becomes difficult. However, the aorta requires a large diameter catheter.

Attempts to guide catheters with ultrasonic transducers have been made in US Pat. 76.177.4, 821, 731.4, 862, 893, M, A, Mar rIntraluminal Ultrasound by Tinelli et al. Guidance of Transverse La5er Coronar y Atherectomy J.

Vertical plate Therefore, the purpose of the present invention is to transmit high-energy pulsed laser light using a guiding wavepath. The objective is to provide a new system for

A further object of the invention is to remove atherosclerotic plaque, To provide a transmission system particularly suitable for transmitting ultraviolet laser energy into living organisms. Is Rukoto. In this respect, the object of the invention is particularly to use in such transmission systems The objective is to provide a highly efficient waveguide.

Yet another object of the invention is to avoid puncturing or damaging blood vessels using the system. The objective is to provide a transmission system that minimizes the possibility of

A further object of the present invention is to facilitate the insertion of optical waveguides into blood vessels using the system. The objective is to provide a system with a guide for

Another object of the invention is to orient optical waveguides in all directions from the center in a blood vessel using the system. It is an object of the present invention to provide a control device for once moving the vehicle.

Another object of the invention is to solve the above-mentioned problems that arise when using inflexible guide wires. The goal is to solve the following problems. In this regard, one form of the transmission system in the present invention is , relates to a guide system that easily guides an optical fiber in a blood vessel.

In one embodiment, the guide system is controlled by the operator at the end proximal to the operator. It includes a guide wire whose distal end can be deformed by a controlled mechanism. like this The mechanism has a wire coil around a central core. Where the coil is (preferably the end) ), the diameter or width of the wire in the coil on one side of the guide wire is the same as the wire on the other side. The line is formed non-uniformly so that it is smaller than the diameter of the The central core It is fixed to the wire coil at the end of one section. At the proximal end of the guide wire, there is a It is possible to apply stress to the core by It is equipped with a deformable handle that allows you to apply a lot of force. Do not apply force unevenly. With this, the coil, ie the end of the guide wire, can be deformed.

In other embodiments, the above-described mechanism for deforming the guide wire may be applied to an optical fiber as a core. ・Used with catheter. Ultrasound to facilitate guidance of this catheter A wave system is also used. In such embodiments, wire coils with non-uniform regions are placed around the fiber optic bundle. Ultrasonic sensors provide information to operators Therefore, it is installed at the end of the system. As a further example of this embodiment, X-ray A radiopaque band, which acts as an opaque marker, is used in conjunction with an ultrasonic sensor. Ru.

In other embodiments of the invention, the flexibility of large diameter catheters can be enhanced with specially designed catheters. It is enhanced using tails and guide lines. The catheter is centered to hold the guide wire. It has a cavity. A concentric cavity exists around the guide edge diaphragm, and the concentric cavity contains the catheter. A plurality of optical fibers are carried at the ends of the fibers for transmitting laser energy. ischemia (to increase the effective removal area of the catheter, is expanding, making it possible to increase the effective outer diameter of the active optical fiber ring. Wear. However, it is possible to reduce the number of optical fibers required to meet the requirements of optical fiber ring. , the distal end of the guide edge constriction is similarly flared to increase the flexibility of the catheter. . The guide wire is also flared at its distal end to match the expanded portion of the guide edge diaphragm.

Using such a configuration centers the catheter relative to the obstruction. The distal end of the catheter can be positioned along the occluded blood vessel and the catheter can be inserted. By advancing the lever, the obstruction can be moved in an outward radial direction.

Another feature of the invention is that when the catheter is bent, the bending stress is uniform throughout the fiber. The point is that the optical fibers are disposed within the catheter so that they are dispersed. one for this The method consists of arranging fibers in rows or layers, with each row or false one next to the other. The other way is to twist it in the opposite direction to the counterfeit.

In addition, by using an optical fiber with a diameter of about 50 microns, it is possible to avoid transmission loss (, It is known that flexibility can be increased.

In yet another embodiment of the invention, the off-center guide edge aperture is shaped like the tip of a fountain pen. It has a catheter tip. The optical fiber is also arranged to match the tip shape. It is.

In other embodiments of the invention, the outer catheter is pressed against the vessel wall and the inner catheter A balloon is used to pass the balloon into the blood vessel and remove any obstructions within the blood vessel.

Ward 10 warm explanation Figure 1 shows high-energy excimer laser beam generation using a funnel-shaped energy coupler. FIG. 2 is a side sectional view of the transmission system.

FIG. 2 is a side sectional view of the energy coupler of the second embodiment.

FIG. 3A is a partial side sectional view of the energy coupler of the third embodiment.

FIG. 3B is a partially enlarged view of FIG. 3A showing the operating principle of this embodiment.

FIG. 4 is a perspective view of the energy coupler in the present invention.

Figure 5 is a perspective view of the guide wire and sleeve used to control the movement of the waveguide. Ru.

FIG. 6 is a perspective view of another embodiment having multiple lumens and multiple fibers; FIG. FIG. 6 is a cross-sectional view of the distal end of No. 6 catheter.

FIG. 8 is an enlarged side cross-sectional view of the catheter of FIG. 6.

FIG. 9 is a cross-sectional view of the deformable guide wire according to the present invention.

FIG. 10 is a diagram showing the embodiment of FIG. 9 when not deformed.

FIG. 11 is a diagram showing the embodiment of FIG. 9 during deformation.

FIG. 12 is a diagram showing another embodiment of FIG. 9.

Section 13 is a diagram showing another embodiment of the present invention.

14A is a diagram illustrating a control mechanism for the deformable guide wire of FIG. 9. FIG.

FIG. 14B is a diagram showing the control mechanism of the deformable guide wire of FIG. 15. FIG. 2 is a cross-sectional view of a deformable fiber optic catheter according to the present invention.

Figure 16 shows a cross-section of a deformable fiber optic catheter with an ultrasonic sensor at its distal end. It is a diagram.

FIG. 17 is a cross-sectional view of the catheter of FIG. 16.

Figure 18 shows the positioning of a catheter with an ultrasound system in an occluded blood vessel. FIG.

Figures 19A and 19B show images from an intravascular catheter with an ultrasound system. FIG.

Figure 20 shows a catheter in which the optical fibers are twisted in opposite directions in different layers. FIG.

FIG. 21 is a diagram showing a state when a conventional catheter is bent.

FIG. 22 is a cross-sectional view of a catheter in which optical fibers are arranged in parallel.

FIG. 23 is a diagram showing a state when the catheter according to the present invention is bent.

FIG. 24 is a cross-sectional view of a catheter with optical fibers twisted together. FIG. Cross-section of a catheter with a flared tip to hold a specially designed guide wire It is a diagram.

FIG. 26 is a side view of a "carrot-shaped" guide wire.

FIG. 27 is a cross-sectional view of a non-centered guide wire catheter according to the present invention. .

28 and 29 are side views of the catheter of FIG. 27.

FIG. 30 is a diagram showing the catheter of FIG. 27 positioned within an occluded duct; .

FIG. 31 shows another implementation of a catheter having multiple fibers and capable of large area removal. It is a perspective view of an example.

Figure 32 shows a balloon-containing catheter for positioning a fiber optic waveguide within a blood vessel. FIG.

FIG. 33 is a perspective view of another embodiment of a multi-lumen catheter.

FIG. 34 is a perspective view of yet another embodiment of a multi-lumen catheter.

FIG. 35 is a perspective view of another embodiment.

FIG. 36 is a perspective view of yet another embodiment of a multi-lumen catheter.

FIG. 37 is a perspective view of yet another embodiment of a fiber optic catheter. and, FIG. 38 is a graph diagram showing the pulse configuration.

A mode to go to during the day In the following specification, angiogenic The system uses a high-energy pulsed laser such as an excimer laser. A laser injection system will be described with reference to.

Figure 1 shows an example of a transmission system for high-energy pulsed laser light in detail. It is. This transmission system consists of two basic elements, one is an optical fiber 12, and the other is an energy combiner 30. high energy pulsed ultraviolet Fibers that are particularly suitable for use in transmitting laser light have a cladding (outer side of the fiber). A multimode fiber with a relatively large core, i.e., operating area, compared to the area of the surface (surface). It's a bar. Here, the core is pure synthetic fused silica, i.e., amorphous silicon oxide. It is made from The proportion of metal impurities contained in this material is 30 parts per million. It is preferable that the Energy transmission efficiency can be obtained. Note that “metal impurities” include metals and This includes both itself and the oxide of the metal.

Despite this low proportion of metal impurities, photons can be detected by defects in the silica fiber. absorbed linearly or nonlinearly. The defect here is that silica Various things can be mentioned, such as oxygen vacancies and non-bonded silicon atoms found in glass. . These reduce the transmission of ultraviolet radiation. Fiber with such defects So, even if the laser light intensity (energy) transmitted to one end is increased, the output at the other end will be does not necessarily increase proportionately. Rather, increasing the intensity level This reduces the threshold level for severe damage to silicon glass, thereby improving the transmission system. This will destroy the system.

According to one aspect of the invention, a fiber made of synthetic silica is coated with high-energy ultraviolet radiation. When transmitting light, we use a substance that repairs the defects inherent in silica. Transmission efficiency is increased by mixing a small amount with silica.

In order to create so-called "wet" silica, it is desirable to mix it with OH groups. Yes. Defects in silica that affect ultraviolet light transmission are oxygen vacancy centers and unbonded silica atoms. It is thought to be caused by children. When OH groups are mixed with silica, oxygen vacancies are removed. and bonds to silicon to form a double bond of SiO□. 5/1,000,000 ( Pure silica, which has an OH group of about 5 ppM), has an OH group of about 1200 ppM. It shows an absorption coefficient that is 2 to 3 times larger than that of silica. J, H, 5 tathes et al, “Physical Review B”, V.

1.29.12.1984. See pp. 70-79. According to other studies, As a result of the fiber drawing process, the silica fiber with low OH content has a light absorption band. It has been reported that this occurs. K15er et al, “J, Opt , SOC, Al11. -, 63°1973, p, 1141 and “J, See Opt, Sac, Aa+, 63.1974. p. 1765.

Obviously, increasing the content of OH groups in silica increases the two types of absorption mentioned above. It can reduce the yield. Therefore, in the present invention, this consideration is It is applied to the transmission of ultraviolet laser pulses to improve the efficiency of energy transmission. here , the silica that makes the fiber contains about 200 to 2000 ppM OH groups. The most desirable content is 120 OppM.

In another embodiment of the invention, the silica used to make the fiber of the transmission system is Add fluorine. Fluorine-doped silica has even lower attenuation than high-OH silica Show rate. This is because fluorine shifts the absorption band width in the 5iOt structure and lowers the wavelength. This is to enable the transmission of many photons. 100 microns to 1500 microns For multimode fibers with diameters in the ron range, between 0.25 and 2.0 wt% It is desirable to contain fluorine, and the most desirable content is 1.0 wt%.

A further feature of the present invention is that both OH groups and fluorine can be mixed into silica. can. When these two substances are used together, the content of OH groups ranges from 200 to In the range of 2000 ppM, the fluorine should be between 0.5 and 3 wt%.

In the present invention, fibers are defined as fibers having a diameter of 100 to 2000 microns. A dense bundle of small diameter fibers, referring to a single fiber or multiple fibers. The material is flexible throughout, allowing the delivery system to pass through the body cavity. This is a desirable property because it allows for the necessary twisting and tight bending.

This property makes it possible to use a relatively large diameter beam with uniform intensity, such as in angioplasty. This is particularly desirable when larger diameter waveguides are required for transmission in be. Note that this entire structure is made of a material that is not damaged by ultraviolet light. It may be protected by covering it with a flexible covering 28. i.e., for example, the junction of two arteries Light loss occurs at sharp bends in the fiber. On this occasion , this loss of light can cause coating materials such as silicone and nylon to melt. It's possible that it will go wrong. However, materials that are resistant to UV light (e.g., UV-resistant treated acrylate compound or Teflon (registered trademark)) may be sharp (bent). It is a preferable material for a coating because it can suppress losses at positions.

In a preferred configuration of the invention, the protective coating is not provided as a separate component surrounding the fiber. rather, it is part of the fiber itself. As mentioned above, all fibers are and a cladding for surrounding the core and confining the transmitted optical energy within the core. Ru. The cross-sectional area of the fiber is typically 80:20 to provide adequate flexibility. A core to cladding ratio is used. Generally, the core and cladding are made of glass. However, the cladding can be appropriately modified (e.g., mixed) to obtain a smaller refractive index. In such conventional structures, where the core and cladding are Includes a third enclosing layer.

In one aspect of the invention, the traditional glass cladding is removed and directly coated with organic material. One suitable material in this case is ultraviolet resistant acrylate. It has a lower refractive index than silica, so the laser energy It functions to keep the energy inside the core. It also has the ability to protect silica glass. , and does not require a third counterfeit. Therefore, the overall size of the fiber can be reduced. In a transmission system with a given outer diameter, the total cross-sectional area of the core can be increased. I can do it.

Further details regarding suitable coating techniques can be found in U.S. Pat. No. 4,511.209. Please refer to the following.

Coating reduces the fiber coating to about 10% of the fiber diameter. The diameter of the fiber is reduced to 50 microns by approximately uniformly around the fiber. It can be reduced to a certain extent. Such fibers have a diameter of 100 microns. It has approximately 16 times more flexibility than conventional fiber. Therefore, many of the Fiber catheters are flexible and transmit 50 micron light with low transmission loss. Fiber can be used.

Silica fibers with this structure can be used in commercial excimer lasers with 10 to 40 pulses. Therefore, it is possible to tolerate an input energy level of about 30mJ/MM” generated by Ru. At energy densities above this level, conventional polishing surfaces with flat polished surfaces The input end of the driver will be damaged and destroyed if the laser is transmitted directly to that input end. It will be done. Unfortunately, this density level is required to remove calcified plaque. This transmission system is close to the lowest density level required for angioplasty procedures. In this case, the permissible range will not be obtained. Therefore, higher level The energy coupler 38 is connected to the fiber to transmit the energy of the fiber into the fiber. Provided at the input end of the See Figure 1. In this example, the energy coupler is a fiber The fiber section has a larger cross-sectional area than the main portion of the fiber. this big The cross-sectional area gradually tapers down to the normal diameter of the fiber, creating a funnel-shaped input region. has been completed.

This shape of the fiber end is used to generate fiber by pulling out the wrinkle force. It can be created by appropriately designing the die.

When fiber drawing is interrupted, a spherical mass remains at one end of the fiber. child By cutting out and polishing the chunk, a funnel-shaped input area is created.

In operation, the cross-sectional area of the funnel-shaped coupler is widened to reduce the human power energy density inside the fiber. to a predetermined level. That is, the area of the input end is sufficient to remove tissue. Transfer a large amount of energy into the fiber without damaging the fiber input end Make it as big as possible. When bonded in this way, the tapered section of the fiber The energy density increases as the cross-sectional area of As a result, such more energy can be transferred into the fiber than without FIG. 2 is a diagram showing an energy coupler of a second embodiment. this In the example, the optical fiber has a uniform diameter along its length and is terminated with a flat polished surface. There is. The end of the fiber is placed within a ring 32 made of a suitable material such as brass or the like. It is stored. Aluminum with an annular ring 34 protruding from the inner wall The case 33 is engaged with the gold ring 32. Located at the end of the annular ring and gold ring. The Teflon O-ring 35 is provided to prevent water from passing between the case and the gold ring. It is. A second O-ring 36 is located above the annular ring and is made of Z-cut quartz. Which glass plate 38 is supported? With this configuration, the gold ring 32, a liquid-tight cavity 40 is formed between the case 33 and the glass plate 38. . The glass plate 38 is connected to a third O-ring 42 located at the top of the case. It is fixed by a bling 44. A liquid-tight cavity provides a buffer to the input end of the fiber. Because it is filled with a liquid that acts as a fiber, it has a relatively high energy density. The energy can be transmitted without damage. The liquid inside the cavity is distilled and io clear water with a refractive index matching that of the fiber 12. Oil may also be used.

3A and 3B are diagrams showing a third embodiment of the energy combiner. This fruit In the embodiment, a fused hemispherical lens 46 is used as the input end of the fiber. here, In order to make high-purity silica lenses that do not contain impurities or cracks, we The lens is created by melting the fiber's own material with a black torch. or, This lens 46 is an individual polished lens connected to the flat end of the fiber. It may be. Note that the fiber 12 has a tapered structure as shown in FIG. Alternatively, the structure may have a constant diameter in the length direction.

A second lens, preferably a plano-convex lens 47, directs the input beam from the laser to a focal point 4. 8. Input lens 46 on the fiber is coaxial with lens 47 When viewed from lens 47, it is located at a distance greater than the focal length of lens 47. Ru. Therefore, the focused laser energy appears to be emitted from a point source. , lens 46 converts this focused energy into a parallel beam of light and sends it into the fiber. Transmit.

The input end of the fiber with lens 46 and focusing lens 47 is housed in chamber 49. being admired. This chamber is provided with a vacuum boat 50 for removing air. ing. The presence of air between lenses 46 and 47 results in a high density at focal point 48. The energy causes the decomposition of nitrogen and oxygen gases that contaminate the lens 46. It's for a reason. Also, by keeping it in a vacuum state, it will adhere to the lens 46 and heat shield. removes dirt and other particles that act like a nick and deform the spherical shape of the lens. You can also On the other hand, the interior of this chamber 49 is adapted to the refractive index of the silica fiber. It is also possible to fill it with a liquid such as water or oil. Increase the refractive index of the liquid When the pulse is transmitted from the liquid conduction medium to the fiber, the dielectric Because the shock can be suppressed compared to when air is the transmission medium. It is.

In a preferred embodiment, a curved lens is used as the lens in contact with the input end of the fiber. However, it is also possible to couple energy into the fiber using a flat manual surface. be. However, care must be taken to ensure that this surface is free of scratches and other defects. No. This is done by heating the fiber end with a microtorch and gradually breaking down the fiber material. Melting can be done by letting it out, and defects caused by polishing can be removed. Wear.

Energy couplers of the type shown in Figure 3A combine energy within the fiber. It has the function of amplifying. Here, the amplification factor is determined by the laser beam diameter at the lens 47 and the beam diameter at the lens 47. equal to the ratio of the fiber diameter. Also, this ratio is made by two lenses It is also related to the expansion rate. In FIG. 3B, length FB is the focal length of lens 47. , and length FA is the distance between lens 47 and focal point 48. Then these two The magnification of the lens is defined as FB/FA. Here, this magnification is the laser energy The distance between the lenses 46 and 47 ( That is, AB=FB+FA) is determined by the following equation.

(FB/FA)=(D,,/Dr) where DL is the laser beam diameter, D7 is the fiber diameter.

Although the laser and coupler are shown as separate elements in the drawing, the energy coupling The combiner can be incorporated into the laser structure to form an integrated system of laser and combiner. Both are possible.

In this way, the lightly doped synthetic silica and the energy transmitted through the fiber are Used in conjunction with an energy combiner that can increase the energy level The laser beam is high enough to remove the obstruction and damage the fiber. It is now possible to safely transmit data through optical fiber waveguides without giving any damage.

To further increase the peak energy that can be transmitted through the system, commercial All you need to do is slightly increase the length of the relatively short pulse width common to ximer lasers, etc. . For example, 10 to 3000 nanoseconds, preferably 30 to 1000 nanoseconds, or 1 Pulse widths in the range of 00 to 300 nanoseconds can be compared to shorter pulses. transmitting higher peak energies in the same transmission system. , and the pulse width is short enough to perform the desired removal process.

One example of a circuit that lengthens the output pulse of a laser is the Jet Propulsio n Laboratory's Dr. J, Laudenslager and T, Ta This is a magnetic switch developed by Dr. Cala. At this time, lengthen or The stretched pulse does not necessarily have to be a single continuous pulse. Rather, shorter It is possible to substantially obtain a pulse of the desired length with a continuous pulse train of long length. can. By lengthening the pulse and increasing the energy, the energy in the fiber is The level will be at least sufficient for the laser beam to clear the obstruction. actual In this case, the beam expands as it exits the fiber, but still has enough energy to remove tissue. energy density. Make the taper thicker (or larger) at the end of the fiber. Increase the laser beam diameter by connecting to a fiber with a larger diameter. When using a small-diameter, flexible fiber that can be easily passed through a tube, Also, a larger tissue area can be removed and blood flow within the blood vessels is better. It becomes possible to do so.

Coupling a virtually pure silica fiber transmission system with a high-energy pulsed laser Another method of combining may be using an energy combiner as shown in FIG.

The pure silica fiber 102 is approximately 30 cm long and tapers with one taper. It is. Fiber 102 has an input end 104 of approximately 15 mm diameter. fiber At the narrow end 106 of 102 there is a modular connector 106 that connects the optical waveguide 1. It is connected to the connector 108 at the end of 10.

Laser energy source 112 supplies energy at connector 106 in the preferred embodiment. The laser energy is applied in a tapered manner so that the energy density is 50 to 100 mJ/mm. The signal is transmitted to the fiber 102 that has been removed.

(Margin below) Guide systems for better control of optical fibers in laser angioplasty can be used. According to FIG. 5, the guide system now includes guide lines 70 and a sleeve 72.

Sleeve 72 is preferably 1 cm to 200 cm long and has a distal end. It has an annular tip 74. The tip 74 is made of stainless steel and is glued to the sleeve. or even if it is joined or formed integrally with the sleeve 72. Good, the diameter of the tip should be between 1.2mm and 2.5mm depending on the size of the blood vessel. be able to. The annular tip 74 can be used as a dilator to dilate blood vessels and as an optical fiber. The rounded ends of the fibers 12 serve as a measure to minimize trauma to the blood vessel.

There are at least two cavities 76 and 78 in the sleeve 72. The first cavity 76 is The ID wire 70 is inserted, and the diameter is from 0.305mm to 0.964mm. The diameter of the first lumen varies depending on the diameter of the guide wire 70, which is preferably in the range of You can get it.

The second sleeve cavity 78 receives the optical fiber or, in the case of a fiber bundle, the bundle. It has become so. The diameter of the second cavity also varies depending on the diameter of the optical fiber 12 used. You can get it. The distal end of the optical fiber 12 may be terminated by any suitable technique known to those skilled in the art. It is joined to the second cavity.

To use the guide system, guide the blood vessel with an insertion catheter (not shown). Pass the ID wire 70 through. This guide wire 7o extends to the position of a complete obstruction within the blood vessel. Or in the case of an incomplete obstacle, it is inserted to the other side of the obstacle.

The sleeve 72 is then guided such that the guide wire passes through the first cavity 76 of the sleeve. Pass it through the cable 7o. The sleeve 72 and the optical fiber joined to this sleeve 12 along the guide line 7o, the sleeve 72 and the end of the optical fiber 72 are removed. Insert until it touches the obstacle to be removed.

The combination of the guide wire 70 and the sleeve 72 allows the optical fiber 1 2 can be properly positioned within the blood vessel, and the optical fiber during fiber positioning can be Avoid the edge of the bar or the laser beam during ablation penetrating the blood vessel. Wear.

On the other hand, guide! Before inserting the I70 into the blood vessel, the guide wire 70 is first inserted into the blood vessel. It is also possible to pass it through the first cavity 76 of the tube 72 . In this way, the fiber 12 When positioned at a location adjacent to a fault, the fault removal process is performed as described above.

In a preferred embodiment, second lumen 78 is offset in sleeve 72. . With this configuration, the optical fiber 12 can be rotated when it is inside the blood vessel. When rotated, the sleeve 72 also rotates, changing the radial position of the optical fiber within the blood vessel. be able to. Therefore, by rotating the optical fiber during laser processing, the Obstacles in large blood vessels can be removed.

When the laser treatment is completed, the sleeve 72 and the optical fiber 12 are pulled out and the guide A line 70 is left in the blood vessel. Next, pass the guide catheter around the guide wire 7o. An angiographic contrast agent can be injected to confirm the results of the laser treatment. I think about the result If this is not possible, use different laser parameters or fibers if possible. Repeat all processes.

6 to 8 illustrate an arterial laser angioplasty procedure operating according to the operating principle described above. Catheter 80 represents a further preferred embodiment of the catheter in the It is composed of multiple compartments and has a central cavity 82 for a guide wire 84. Ga The id wire is inserted through a suitable coupling device 86 located at the base of the catheter. . Surrounding the central cavity 82 are a plurality of outer cavities 88 located annularly. this Each of the cavities 88 includes one or more substantially pure synthetic silica fibers 90. is accommodated.

In the illustrated embodiment, there are three outer cavities 88, each containing two fibers 90. One is accommodated. Here, fiber 90, guide wire 84 . catheter diameter Depending on the relative size, the number of cavities and fibers accommodated per cavity can be varied. You can understand that it is possible. Furthermore, placing the guide wire in an uneven position within the catheter You can also

FIG. 8 is an enlarged cross-sectional side view of the distal end of the catheter. Here, the laser energy Each fiber 90 carrying energy has a larger diameter at its end face 91. The short end of the fiber 92 is coupled to the short end of the fiber 92. For example, fiber 90 is connected to a catheter. fiber 92 has a diameter of 200 microns through the fiber 80 and the short end fiber 92 has a diameter of 300 microns. It has a diameter of Kron. Alternatively, use a short 2o○ fiber with a diameter of 100 microns. It may also be one in which micron diameter fibers are connected at the ends. end fiber 92 The length of each is approximately 3 mm and is made from the same silica material as fiber 90. It will be done.

A fiber with a larger diameter at the end causes the laser beam to expand as it exits the fiber. As a result, a wider area can be irradiated and a wider removal area can be obtained. Furthermore , by arranging multiple fibers symmetrically around a guide wire, it is possible to cover a large area. This results in a uniform energy distribution.

This fiber 92 is positioned at the end of the catheter with a suitable epoxy 94. It will be done. A gold mark ring 96 is placed around the distal end of the catheter for X-ray and vascular inspection. The position of the fiber end can be easily seen during contrast processing.

Each outer cavity 88 contains a fiber, except at the distal end of the catheter where epoxy 94 is present. A free space exists between the bar 90 and the vaginal wall. For this free space, see Figure 22. Please refer. If desired, use this free space to remove salt water or other imaging agents from obstructions. It can be used to send to. Such solvents can be placed in a suitable boat 9 at the base. 8 into the catheter and radiates from a cavity 100 in the distal side wall of the catheter. (See Figure 8).

In some cases, the cavity is partially or completely occluded to keep it open. It may be necessary to remove large areas of the tube. The size of the cavity produced When the diameter is 2 mm or more, the efficiency of removal treatment in large peripheral tubes is improved. energy – When the transmission system is used to remove defects without tube expansion, low pressure Long-term blockage of large vessels with blood flow can be reduced.

Laser angioplasty system for treating incomplete occlusions around the guide limbal diaphragm A system with fiber bundles located concentrically and covered by a protective coating. Including. Small diameter catheters (e.g. 1.0mm to 1.7mm O, D) , with a ring of active fiber optics extending from the central guide edge diaphragm to the outer protective coating. do. This effective fiber optic ring prevents occlusion in front of the catheter during insertion. Substance is removed.

Conventional guide wire catheter systems guide the inside of the canal with a guide wire that does not deform. has been coded. However, plaques are often generated in uneven locations within the canal. The direction of the guide wire, i.e. the bath of the catheter within the tube, can be changed during the procedure. is often desirable. With guide lines that do not deform, it is not possible to change the direction of the guide line. It can be difficult to do so. For this reason, deformable guide wires, especially It is advantageous to have a deformable guide line that can be operated from the base close to the controller. be.

9 to 14 are diagrams illustrating such a deformable guide line 206. guy Guide wire 206 includes a core 208 that exists substantially throughout guide wire 206. . The wire coil 210 can be used where flexibility or deformability is required, especially at the end. is located around the core along the guide line.

The coil has three parts, the first part 21 OA, the middle part 210B, and the third part 210C. The outer diameter of the coil 210 is 0.305 and 0.305. Between 964mm and is preferably about 0.457 mm. The first and second parts 210A and 210B It is preferable to use a radiopaque line. First part 21O of the wire coil Preferably, A is approximately 2-3 cm long. This side of the first part 210A At the end of the joint 214, a process such as soldering or brazing may be performed. , a wire coil 210 is mechanically joined to the core 208.

Is the wire in the middle portion 210B of the wire coil mechanically deformable or Rui has a non-uniform cross-sectional area. As shown in FIGS. 9 and 10, the core 20 By flattening the line 208A on one side of 8, when the line is straight, the core A space is created between each width of the wire coil on the opposite side 208B.

On the other hand, as shown in Fig. 12, the diameter D2 of the wire on one side of the core is It can also be made smaller by etching. Or by coating process. The diameter D1 of the wire on one side of the core can be increased by selectively attaching a substance to the core. Can also be done.

At the front end of the third portion 210C, a process such as soldering or brazing is applied. Thus, the wire coil 210 is secured to the intermediate sheath 216 at the joint 218. intermediate coating 216 is a non-expandable tube that holds and protects the core 208; The guide wire is stretched from the guide wire 210 to the proximal end on the front side of the guide wire. Suitable as an intermediate coating Preferably, it is a hypodermic tube made of a material with some flexibility.

The end of the guide wire has a rounded tip to minimize trauma to the blood vessel during use. An end 212 is provided. As shown in FIG. 9, a rounded tip 212 is provided at the distal end of the core 208. can also be attached. At this time, as shown in FIG. need not extend to the rounded tip 212. In this case, the second part to be deformed Simply fix the core 208 to the wire coil 210 at the end of the wire coil 210B. be. If the core 208 does not extend to the rounded tip 212, the coil 210 Rounded tip 212 and core 208 to avoid stretching and/or spreading. It is preferable to fill the gap with a substitute substance 213. As this substitute substance 213, carbon Use thin wire or ribbon for maximum flexibility at the tip of the tater It is preferable.

The core 208 is manufactured from a high tensile strength material, preferably a single piece of stainless steel. be done. The core 208 is within the second section 210B and third section 21OC of the coil, and It is free to move within the intermediate coating 216. As mentioned above and as shown in Figure 9 uni, at the joint 214 between the first part 21OA and the second part 210B of the wire coil. , the core 208 is attached to a wire coil 210. Also, the proximal odor In other words, the core 208 is attached to a deformable handle 220. See Figure 14A I want to be

A deformation handle 220 is provided to stress the core 208 and is Two portions 210B can be deformed. This means that the second portion 210B is It is the only part of the coating where there is space between the coils and the length can be changed. It's for a reason. See FIGS. 11 and 12. This modified handle 220 has a finger grip. 222 and a thumb ring 224. The core 208 of the guide wire is secured to the bin 226. and connected to the finger grip 222. The covering 216 is attached to the deformable handle 220. The finger grip 222 and the thumb ring are fixed to the fixed part as shown by the arrow in FIG. 14A. When the groups 224 move together, stress is applied to the core 208.

And, due to the non-uniformity of the second portion 210B of the wire, the coil, i.e. the entire guide The wire is deformed in the second portion 210B of the guide wire.

Choosing a core material with high torque will reduce the deformation halves connected to the core 208. The entire guide wire can be rotated by rotating the handle. times like this The ability to roll allows the user to deform the guide wire in any radial direction. Can be done.

The idea of using non-uniform wires to deform guide wires is a good idea for energy transfer. It can also be applied to systems or catheter systems. As shown in Figure 15. The configuration of wire coil and intermediate coating can be applied to optical fibers or optical fiber bundles. You can also. In the embodiment shown in FIG. 15, the wire coil 228 is A and a second portion 228B. The first part is the second part in the embodiment of FIG. Similar to 210B, it has a non-uniform cross-sectional area. A first portion 228A of the wire coil is provided. The line is mechanically deformable or has a non-uniform cross-sectional area. It is something. As shown in Figure 15, by deforming the line on one side to be flat, the A space is created between each width of the wire coil on the opposite side 208B. Meanwhile, on one side of the core The wire diameter can also be reduced by electropolishing or chemical etching. be Alternatively, a coating process may be used to selectively deposit the material on one side of the core. It is also possible to increase the diameter of the wire.

The intermediate coating 230 is wired through the joint by soldering, brazing, or other processing. It is fixed to the proximal end of the coil 228 on the near side. The optical fiber core 234 is a wire coil extending from the distal end of 228 to the proximal end and finally to the laser energy source 227. There is. See Figure 14B. At the end, apply epoxy 236 or other suitable method. Thus, the optical fiber core 234 is secured to the end of the wire coil 228. optical fiber The end of Bacoa 234 is of course exposed, and the laser energy can be passed through the catheter. The light can be emitted forward.

A deformable handle is connected to the proximal end of the intermediate coating or optical fiber core 234.

See Figure 14B. This modified handle is substantially the same as the modified handle shown in FIG. 14A. They are the same. Therefore, we will not repeat the detailed explanation of the transformation handle here. I won't return it. By moving the deformation handle appropriately, the wire coil and hence the optical fiber core can be 234 can be deformed and guided inside the blood vessel.

FIGS. 16-18 illustrate the use of ultrasonic waves to facilitate catheter guidance during the removal process. A catheter essentially similar to the system shown in FIG. 15 except that it includes a wave system. FIG. 1 is a diagram showing a system. Core 238 includes a plurality of small optical fiber elements 240 . center an optical fiber 242 and a signal from an ultrasound sensor located at the distal end of the catheter. or for transmitting signals to ultrasonic sensors! ! 244. small Optical fiber 240 is approximately 50 to 100 microns in diameter, with a large central optical fiber. The diameter of the fibers 242 is approximately 150 to 200 microns. The actual size of the line is Varies depending on each application. Also, make sure that the diameters of the central optical fiber and the outer fibers are the same. You can also make it the same. In one embodiment, the central optical fiber 242 is 100 microns. The surrounding fiber is 80 microns. The outer diameter of the catheter is 1.0 Preferably, it is between mm and 2.0 mm.

At the end of the catheter, four ultrasonic sensors 246 are mounted symmetrically around the optical fiber. will be placed in These ultrasonic sensors are fixed with epoxy 248, and each The gaps between the sensors 246 are also filled with epoxy 248. These ultrasonic sensors are thin It consists of a thin film ultrasonic emitter and a detector, and The device is arranged to emit and detect signals in a radial direction. These ultrasonic waves The sensor is of a similar type to that used for high resolution lumen sequential imaging. but However, here, a low-resolution system is used to detect the affected area in the blood vessel, that is, the occluded area 2. The details of 41 are not shown and the vessel wall 239 is merely depicted.

Each ultrasonic sensor 246 is oriented radially with respect to the catheter and the sensor transmits a signal to the operator indicating the distance between the pipe wall and the pipe wall. In this way, the operation The operator can easily see if the catheter is too close to the vessel wall.

The purpose of this ultrasonic sensor is to confirm the position of the wall so that the laser transmits during the removal process. The purpose is to prevent the light transmitting fiber from inadvertently touching the pipe wall.

Because the ultrasound system has a low resolution, the operator must identify the outer circle and cap representing the tube wall. You will see an image with an inner circle representing Theter. Figure 19A and See 19B. Figure 19A shows the image when the catheter is centered in the tube. Figure 19B shows an image when the catheter is in contact with the tube. It is.

A marker band 247 is fixed to the distal end of the catheter. this marker band 247 is preferably made of a radiopaque material such as gold and is External X-ray or other detection to facilitate guiding the catheter up to internal obstructions Can be detected by the system. Therefore, first, an external detection system and a radiopaque Guide the catheter to the obstruction using a sexual marker. Then, during the removal process, Control is performed using the ultrasonic sensor described above. Note that a radiopaque marker band is used. However, the deformable coil itself is made of radiopaque material. The catheter is deformable, making it easy to carry the catheter up to the obstacle that needs to be removed. Can be easily guided. On the other hand, during the removal process, the tip of the catheter is selectively deformed. This makes it possible to remove defects with a diameter larger than the diameter of the catheter. Ru.

To increase the strength and torque of the catheter core 238, the optical fibers in each row are placed next to each other. Twisted to fit in the opposite direction to the direction in which the caries are wrapped. Ru. The catheter shown in FIGS. 16-18 has a rigid fiber optic core 238. However, the idea of aligning the fibers in opposite directions or having a guide wire cavity in the center It can also be applied to catheters. Figure 20 shows the inside of the catheter visible. 16 to 1 except that it includes a central guide edge stop 282. It is the same as No. 8 catheter. In the present invention, three layers of optical fiber are twisted together. An example is shown below. Preferred embodiments use 5 layers or 6N. light fu The fiber first eyebrow 280 is oriented in a first direction (e.g. For example, it is wound counterclockwise). The second layer of optical fiber 284 are wound in opposite directions over the layers of the optical fiber, and the third layer of optical fiber is wrapped in opposite directions over the layers of the second layer. It is wrapped on top in the same direction as the first layer 280. And outside of plasticity A side coating 288 covers the third layer 286.

As shown in Figures 21 to 24, coaxial and flat This provides favorable properties compared to conventional fibers. Figure 21 shows coaxial and parallel fibers. FIG. 4 is a diagram briefly showing the results when a catheter having a diameter of 180 degrees is bent. one Sample fiber 290 is bent outside the bend, and one sample fiber 292 is bent outside the bend. It is shown inside the section. The outer fiber 290 is stretched by stress and the inner fiber 290 is Fiber 292 is crimped. As shown in Figure 21, both fibers are connected to the catheter. It is pressed towards the center of the tell. Such a force applied to the fiber To deal with non-uniform forces, such coaxial fibers are typically A small gap 293 is provided between the cladding tube 294 and the fiber 296 so that the cladding tube 294 and the fiber 296 are separated. child The gap is not an effective use of catheter space.

In contrast to the configurations shown in FIGS. 21 and 22, FIGS. FIG. 2 is a simplified diagram of twisted optical fibers. As shown in Figure 23, In a straight fiber, the tension and pressure created by bending the fiber is Evenly distributed. Therefore, the catheter does not become flat as shown in Figure 21. . Furthermore, when the fibers are twisted according to the present invention, as shown in FIG. There is no need for a gap between the fiber 297 and the outer coating 299. Therefore , the overall catheter diameter can be made smaller. twist the fibers Another advantage is that twisted catheters are easier to accommodate than coaxial fibers. One advantage is that the catheter can be twisted more easily because of the force transfer. Ru. For example, when twisting the catheter in FIG. 20 clockwise, the third 7128 The diameter of the second layer 284 becomes smaller and the length becomes longer, and conversely the diameter of the second layer 284 becomes larger. The length becomes shorter. If the catheter is twisted counterclockwise, the second layer 28 The diameter of 4 becomes smaller and the length becomes longer, and conversely, the diameter of 1st M2B5 becomes larger. The length becomes shorter.

Figure 20 shows an example in which the fibers are alternately wound in opposite directions; inside the catheter so that the fibers absorb bending pressure substantially uniformly when Fibers can also be placed. This will cause each flap to bend when bending the catheter. This is done by arranging the fibers so that the amount of bend in the fibers is substantially equal. .

When performing angioplasty in large diameter vessels, large It is preferred to use a catheter with a caliber. Conventional large tube with guide wire cavity in the center In caliber catheters, there are multiple optical fibers between the outer sheath and the central guide edge diaphragm. Exists. This large number of fibers reduces the flexibility of the catheter. Put it away.

By increasing the outer diameter of the outer sheath at the distal end of the catheter and the center guide edge diaphragm, the Increases the outer diameter of the catheter's effective removal area without reducing catheter flexibility. I can listen. To increase the outer covering and guide wire lumen size, All you need to do is increase the diameter of the ring of effective fiber light, and make the other fibers thicker. There is no need to Therefore, the flexibility of the catheter is not reduced. end of catheter By increasing the diameter of the central guide edge diaphragm, the possibility of causing ischemia is also reduced. do.

25 and 26 are diagrams showing such a catheter system.

In FIG. 25, the distal diameter of catheter 250 has widened. Outer covering 25 The diameter of 2 also widens at the distal end. At the center of the catheter 250 is a guide edge diaphragm 254. , and its diameter likewise widens at the distal end. The guide edge diaphragm 254 and the outer covering In between is a cavity 256 for one or more optical fibers.

The lumen 256 includes a radiopaque material to facilitate guiding the catheter within the body lumen. A sex marker band 251 is provided. This marker band 251 is made of gold. , an external system such as an X-ray system. Guide edge diaphragm 254 A polyethylene block is used to hold the enlarged dilation site 253 of the catheter. A shing 255 is provided.

In a preferred embodiment, the inner diameter of the expanded portion 253 of the guide edge diaphragm is approximately 1.041 mm. Ru. The expanded portion of the optical fiber cavity is ring-shaped, with an outer diameter of approximately 2.157 mm, approximately It has an inner diameter of 1.421 mm. Approximately 360 50 micron diameter fibers are inserted into the cavity 25. 6. The overall diameter of the catheter expansion section is approximately 2.411 mm.

As shown in Figure 25, the front surface of the catheter is inclined at 25 degrees with respect to the axial direction of the catheter. I'm there.

The guide wire 258 shown in FIG. 26 is for use with the catheter of FIG. This is called a "carrot-shaped" guide line. The main part of the guide wire is the proximal end of the guide wire. It is equipped with a stainless steel shaft 260 extending from the shaft, and has a diameter of 0.457 mm. is preferred. The distal end of shaft 260 has a smaller diameter (e.g. 0.203 mm). A shaft 262 having a length of about 19 cm is fixed. Second shaft 262 The 4 cm portion at the tip tapers to a diameter of approximately 0.051 mm. second shaft At the end of the foot 262 is a flat piece of uniform stainless steel approximately 0.051 mm wide. 266 are in contact.

The second shaft 262 is covered with a stainless wire coil 264. First step The first 13cm of the wire coil 264 in contact with the stainless steel shaft is the entire coil diameter. so that it has a diameter of 0.457 mm, that is, the same diameter as the first stainless steel shaft. It is in contact with and covers the second shaft 262. In addition, the end with a length of 13 cm is The coil diameter has expanded to approximately 0.99mm. In this extension, radiopaque A solid (e.g. gold) marker 267 is fixed to the coil and an external X-ray system The end of the guide wire 258 can be easily detected using the system. Wire coil extension is approximately 2 cm, and the position where the second shaft is fixed to the stainless steel piece 266 The coil diameter is gradually tapered to about 0.457 mm. guy At the end of the wire, a platinum wire coil 268 covering a piece of stainless steel 266 is soldered. It is joined to the stainless steel wire coil 264 at the joint 270. platinum wire carp The end of the wire 268 is soldered to the tip of the stainless steel piece 266. beyond the guide line The ends are rounded to minimize trauma to the tube being inserted. wire coil 264 The expansion site is sized to match that of the central guide wire lumen 254 of FIG. Please note that.

Because both catheter 250 and guide wire 258 are flared at their distal ends. , the catheter 250 and the guide lip 258 both have a distal end of the catheter 250 connected to the tube. The distal end of catheter 250 is aligned with the axis of the target tube so that it is centered Mechanically move the occlusion outward so that the occlusion is on the catheter 250. Acts to be located in a ring of effective fiber optics.

27 to 29 show a catheter having optical fibers 302 located non-uniformly through which the wire is passed. 300 is shown. The catheter 302 includes a plurality of optical fibers 30 The outer cover surrounding 2 rN! 304, and the end has a point 308 like a fountain pen. A guide edge diaphragm 306 is provided. This tip 308 extends from the tip to the outside of the catheter. It includes a wall 310 that tapers to a side sheath 304. This tip 308 may be integrally formed with the outer covering 304.

As shown in FIG. 28, the optical fibers themselves have different lengths, The fiber closer to the guide wire 306 is longer than the fiber farther from the guide wire. Ru. Since the optical fibers have different lengths, the obstruction 312 314 on only one side. That is, as shown in FIG. The optical fiber can be passed through the edge of the fiber to the end of the obstacle, and the length can be smoothly shortened. 302 matches the shape of the obstacle.

The following systems use a small diameter delivery system to create a large diameter hole in a blood vessel. It is a system that can be used for FIG. 31 shows a blood vessel 114 and an obstacle 11 therein. 6 is shown. Catheter 118 includes a concentrically located inflatable balloon 12. There are multiple optical fibers 120 located uniformly around 2. optical fiber 12 Guide wire 124 with a diameter of 0.305 mm or more, where 0 is 50 to 400 microns are located concentrically in the central cavity within balloon 122. If desired, the catheter A metal (gold) marker 126 is placed near the distal end of the cathedral, and the catheter is It is also possible to confirm the location of the terminal 118.

As a processing operation, first, the guide line 124 reaches the end of the obstacle 116 to be removed. A guide wire is inserted into the cavity or blood vessel 114 until the guide wire is inserted into the cavity or blood vessel 114. Next, the catheter 11 Insert the catheter along the guide wire 124 until the distal end of the catheter touches the obstruction 116. entered. and transmit a first high energy laser pulse through fiber 120. and remove the inside of the obstacle 116. Next, the balloon 122 is held at a predetermined pressure. and extrude the fiber 12o to a larger diameter. Here, the high An energy pulsed laser is transmitted to remove the outer periphery of the obstacle 116. Must If necessary, the balloon 122 can be further inflated to create a fiber array 1 with a larger diameter. You can also get 20.

FIG. 32 shows another preferred embodiment of the present invention. Catheter 128 There are three balloons 130, which are evenly distributed at the distal end of the catheter 128. be done. A first cavity 132 is located concentrically with the balloon 130. This first cavity 13 2 holds an optical fiber device 133. If desired, next to the first cavity 132 A second lumen may also be provided for holding a guide wire. Also, lighting and flashing A cavity is provided in the center of each of these balloons 130 to hold a device for such purposes. Good too.

The processing operation is to first selectively inflate or deflate three balloons, Locate the central lumen of the catheter. In one mode of operation, around the catheter The balloon is rotated sequentially and continuously as if rotating the fiber in a circle along the to inflate. When all the balloons are inflated, the fiber will be in the center.

Other embodiments include using two, four, or other numbers of balloons instead of three. Can also be done.

Like the embodiment shown in FIG. 31, the embodiment shown in FIG. A catheter can be provided at the distal end of the catheter.

FIG. 33 is a diagram showing another preferred embodiment of the present invention. In this example, the guide A balloon 152 is present at the end of line 150. On the guide line 150 adjacent to the balloon 152 A marker 154 is provided at. The guide wire 150 is located at the center of the catheter 160. It is held by the guide edge diaphragm 164 of. The catheter 160 further includes a guide edge restriction 16 It has a plurality of fibers 162 arranged in an annular manner around 4. Gold coins if desired. A marker 166, such as a needle, is provided at the distal end of the catheter 160 to facilitate inspection of the catheter. It can also make it easier to get out.

As a processing operation, first, a guide wire 150 having a balloon 152 at one end is inserted into a blood vessel. and position it ahead of the obstacle 158. Next, the balloon 152 is inflated and the guide Line 150 is located in the center of the vessel. Center the guide line 150 like this This reduces the possibility that the catheter 160 will come into contact with the blood vessel wall 156 during the removal process. can. The pawl 168 prevents the catheter 160 from coming into contact with the balloon 152 and causing it to burst. It is provided on the guide line 150 so as to be similar to the guide line 150.

The fibers 162 in catheter 162 range from approximately 50 microns to 300 microns. It is preferable that The guide edge diaphragm 164 has a diameter of 0.355 mm to 0.9 mm. Large enough to allow standard guide wires up to 64mm to move freely It is.

FIG. 34 is a diagram showing another preferred embodiment of the present invention, in which an obstruction 1 is placed inside a blood vessel 170. 72 is a diagram. Catheter 174 has a gasket attached to the interior wall of the catheter. It has an ID wire and a flushing cavity 178. The width of the optical fiber lumen 176 is The guide wire and flushing tube passes through the center of the catheter from the guide wire and flushing lumen 178. This is the length to the opposite side in the diametrical direction when viewed from the plug cavity 178. substantially pure silica A plurality of optical fibers 180 made from The guide wire 182 is retained within the guide wire and flushing cavity 178. Balloon 184 is It is joined to one point on the outer surface of the tether 174.

As a processing operation, first, a first removal process is performed without inflating the balloon 184. . While advancing and rotating the optical fiber 180 around the guide wire 182, Transmitting a high-energy pulsed laser such as a laser through an optical fiber 180 By doing so, efficient removal processing can be performed. By rotating the fiber, the catheter A circular area of the size of the outer diameter of the tile can be removed.

Next, inflate the outer balloon to increase the diameter of the fiber. Perform the second removal process by advancing or rotating the catheter while keeping the A circular area having a diameter larger than the circular area removed during processing is removed. Note that this second In the process, a predetermined size is set so that the second circular area is in contact with the removed first circular area. Inflate the balloon.

Excimer lasers can remove obstacles in the forward direction, and can connect obstacles and optical fibers. There is no need to introduce a solvent such as a laser-transparent saline solution in between. Also, optical fiber A laser transmitted through a fiber can remove obstacles in the blood. Therefore, removal No procedure is required to stop blood flow around the catheter during the procedure.

The tip of the catheter has a rounded conical end to minimize trauma to the vessel wall. Should. The optical fiber 180 has a diameter from 50 microns to 400 microns. A highly flexible fiber array with dimensions of The outer diameter of the fiber tip is increased.

The fiber is fixed to the end of the catheter by epoxy and polished to a rounded end. It becomes.

The guide wire used when inserting the catheter is generally It is preferable that the size is 0.305 mm or more.

If desired, a marker 186, such as a gold band, can also be provided at the distal end of the catheter. , can also facilitate monitoring of the catheter by X-ray or fluoroscopy.

FIG. 35 shows a catheter 174 essentially identical to catheter 174 of FIG. 34, described above. ° is shown. The catheter 174 in FIG. 34 and the catheter 174° in FIG. The difference is that blood flows around the balloon 184° in Figure 35 even during use. The balloon catheter, which is not located at the center of the present invention, has an indentation of 188° so that the Unlike other balloon catheters used in interference x-rays and cardiology, It acts in a certain way. The non-central balloon catheter of the present invention is suitable for use in percutaneous angioplasty. Expansion devices such as those used in surgery (PTA) and percutaneous transluminal angioplasty (PTCA) isn't it. Literally dilate the target blood vessel or push the catheter against the blood vessel wall. It is not intended to be used for Nor is it intended to stop blood flow and inject salt-containing laxatives. Rather, fiber optic A positioning device for placing the high-energy laser at the appropriate position within the blood vessel. It functions as a station. In this respect, it does not press strongly against the blood vessel wall. Therefore, the catheter can be moved and/or rotated even when the balloon is inflated. This enables position-variable angiogenesis.

FIG. 36 shows another embodiment of the invention, in which a blood vessel 190 and an obstruction therein are shown. Object 192 is shown. Catheter 195 allows the catheter to be easily moved within a blood vessel. Smooth, rounded edges that appear to be coated with a waterproofing agent for movement and rotation It has 196.

There is a guide edge diaphragm 198 in the center of the catheter 194, and the guide wire 2° It is movably held in the edge diaphragm. There are obstacles around the center guide edge diaphragm 198. Optical fiber used to transmit high-energy pulsed laser to remove 192 The fibers 202 are arranged in a ring. Balloon 204 is attached to the outer surface of catheter 194. is attached.

As a processing operation, first the guide wire 200 is moved into the blood vessel 19 until it is adjacent to the obstacle 192. Insert within 0. The catheter 194 is then inserted into the obstruction 19. Insert the balloon 204 along the guide line 200 without inflating it until it is adjacent to the guide line 200. . Here, the laser energy transmitted through the optical fiber 202 is used to Harmful substances 192 are removed in a circular manner. The size of this circle is essentially the outer diameter of catheter 194. exactly equal. Next, the balloon is inflated to increase the diameter of the optical fiber 202.

Here, the catheter is moved and rotated to remove the obstruction 192 again using the optical fiber. , the obstacle 192 can make a larger hole. more if necessary The balloon 204 is inflated and the process is repeated.

As a result of the embodiment shown in FIG. Can be removed uniformly. Also, if large pieces of the obstruction 192 flow into the blood, blood vessels occlusion is more likely to occur, but this possibility can also be significantly reduced.

As the obstruction 192 is broken into small pieces, a special cavity is provided to remove the debris. There is no need to provide it on the tether. In the system shown in Figure 36, the section diameter is typically It will be 10g or less.

FIG. 37 shows a system that is a further improvement on the catheter system shown in FIG. ing. Outer catheter 316 holds a means for inflating balloon 318. It has an outer cavity or passageway (not shown). Inner catheter 320 includes multiple optical fibers. The outer catheter 316 has a bar 322 that can be moved in the axial direction of the outer catheter 316. inside Catheter 320 also has a central lumen for a guide wire 324.

In use, outer catheter 316 and inner catheter 320 are connected to a guide wire. 324 to the obstruction 326 into the blood vessel. Reach the location of obstacle 326 Then, balloon 318 is inflated to position outer catheter 316 within blood vessel 328. Ru. The inner catheter 320 is then moved into position and the obstruction removed.

Figure 38 shows the transmission of a high-energy pulsed laser through a nearly pure silica fiber. It concerns the means of sending. Is Figure 38 a short pulse train shifted in the time direction? This shows a pulse of High-energy long pulse I consists of multiple short pulses A-H It is a superimposed structure that can reduce thermal propagation within the tissue. That is, for tissue removal. In some cases, undesirable heat transfer to adjacent tissue due to thermal propagation of the tissue during the removal process high energy pulse width can be increased without causing damage to the . The estimated time required for the high-energy laser pulse to travel from the ablated tissue is approximately It is 1 millisecond.

U.S. Patent No. 4,677.636 relates to such laser pulses. , and we refer to that subject here.

Those skilled in the art will appreciate that the present invention can be understood by others without departing from its spirit and essential characteristics. It can be understood that fushi can be given in the form of . Therefore, all embodiments disclosed herein are All descriptions are for illustrative purposes only and are not intended to be limiting. The scope of the invention is , as indicated by the appended claims rather than the foregoing description, and which Modifications within the same meaning and scope are also included within the scope of the present invention.

FIG/9A FIG/9B IG 27 applying stress to the core to compress the deformable first side more strongly than the second side; and a control handle for deforming the deformable region. As one example of the core This includes the optical fiber that transmits the laser. In other embodiments of the invention, the catheter Optical fibers are A bar is placed within the catheter. One technique for this is to connect the fibers in rows or are arranged in layers, and adjacent rows or layers are aligned in opposite directions. It is a method. Also, using an optical fiber with a diameter of about 50 microns causes transmission loss. It is also possible to increase flexibility without causing any damage.

Claims (41)

[Claims] 1. A deformable guide wire for a catheter, the guide wire comprising: a proximal end to a distal end of the guide wire; a core extending up to The hollow means comprises a deformable region having a first side and a second side, the The first side surface is opposite the second side surface with respect to the axial plane of the hollow means. the first side of the deformable region is located at the deformable region; The core has a higher compressive force than the second side surface of the deformable region. fixed to said hollow means at an end; connecting said core and said hollow means to stress said core with respect to said hollow means; the first side of the deformable region and the second side of the deformable region; control means for deforming the deformable region by compressing it from the side; A deformable guide wire comprising: 2. A deformable catheter having a distal end and a proximal end, the proximal end of the catheter a core extending from the base to the distal end; a hollow means for receiving the core; said hollow means comprising a deformable region having a first side and a second side; the first side is located opposite the second side with respect to the axial plane of the hollow means; the first side has a stronger compressive force than the second side, and the core is fixed to the hollow means at an end of the deformable region; connecting said core and said hollow means to stress said core with respect to said hollow means; the first side of the deformable region and the second side of the deformable region; A control means that compresses from the side and deforms the deformable area. A deformable catheter comprising: 3. The core comprises multiple optical fibers produced from nearly pure synthetic silica. The deformable catheter according to claim 2, characterized in that: 4. Particularly, the part of the hollow means comprising the deformable region comprises a wire coil. 3. The deformable catheter of claim 2, wherein the deformable catheter has the following characteristics: 5. The diameter of the wire of the wire coil on the first side is greater than the diameter of the wire on the second side. 5. The deformable catheter according to claim 4, wherein the deformable catheter has a small diameter. 6. The wires of the wire coil are such that the distance between the wires on the first side is equal to the line on the second side. according to claim 4, characterized in that it has a non-uniform cross-section greater than the distance between Deformable catheter as described. 7. The control means includes: a first part fixed to the core; a second part fixed to the hollow means; the first region and the second region to control stress on the region and on the core. means for manipulating the relative position of the 3. The deformable catheter of claim 2, comprising: 8. The first part is a finger grip and the second part is a thumb ring. The deformable catheter according to claim 7, characterized in that: 9. The core has a central optical fiber in its center and covers the central optical fiber. characterized by having multiple optical fibers smaller than the central optical fiber so that 3. The deformable catheter of claim 2. 10. The optical fibers are arranged in rows, each row having a direction opposite to that of the adjacent row. 10. The deformable catheter of claim 9, wherein the catheter is mated. 11. The core has a plurality of optical fibers having a diameter of approximately 50 microns. 3. The deformable catheter of claim 2. 12. The core has a plurality of optical fibers all having approximately the same diameter. 3. The deformable catheter of claim 2. 13. The core ensures that the bending stress is almost uniform between the fibers when the catheter is bent. A claim characterized by comprising a plurality of optical fibers arranged so as to be distributed in 3. The deformable catheter according to claim 2. 14. The optical fibers are arranged in rows, each row being arranged in a direction opposite to that of an adjacent row. 14. The deformable catheter of claim 13, wherein the deformable catheter is mated. 15. A deformable catheter having a proximal end and a distal end, the distal end of the catheter an optical fiber core extending from the base to the proximal end, and a deformable fiber that covers the core and has a deformable provided at the distal end of the catheter with said hollow means having a region extending from said catheter; an ultrasonic sensor for measuring the radial distance to the vessel wall in which the catheter is used; a control means provided at the proximal end of the catheter for deforming the catheter; A deformable catheter comprising: 16. The optical fiber core is a plurality of fibers produced from nearly pure silica 16. The deformable catheter of claim 15, comprising: 17. A catheter system for laser angioplasty, the catheter system comprising: an outer covering; a cavity for holding a plurality of optical fibers within the sheath; and within the optical fiber cavity; The end of the fiber is oriented in a forward direction to emit laser energy. a plurality of optical fibers each having a diameter of approximately 50 microns; A catheter system comprising: 18. characterized in that the optical fiber is produced from substantially pure silica. 18. The catheter system of claim 17. 19. A catheter system for laser angioplasty, the catheter system comprising: an outer covering; an optical fiber cavity within the sheath; a plurality of optical fibers located within the lumen, the optical fibers being connected to the catheter. arranged so that the bending stress is almost evenly distributed between the fibers when the fiber is bent. A catheter system characterized by: 20. The optical fiber is characterized in that it is produced from almost pure silica. 20. The catheter system of claim 19. 21. A method of deforming a guide wire for a catheter, the first side being a first side. a guide wire having a region where the compressive force is stronger than the side surface of the second side; Pass the guide wire into the cavity, and Applying a compressive force to the region, compressing a first side of the region more strongly than the second side. A method characterized by deforming the guide line by contracting it. 22. A method for guiding a catheter, the first side having a higher pressure than the second side. Equipped with a guide wire having a region with strong contractile force, pass a catheter into the cavity, and Optionally, a compressive force is selectively applied to the region to bring the first side of the region into the A method characterized by deforming the guide wire by compressing it more strongly than the second side. 23. Radiopaque placed at the end of the catheter by an external viewing device The method further includes the step of detecting a marker of the catheter to monitor the position of the distal end of the catheter. 23. A method according to claim 22, characterized in that: 24. The distance from the cavity wall to the distal end of the catheter is 23. The method according to claim 22, characterized in that the measurement is carried out by an ultrasonic sensor. 25. a catheter having an outer sheathing having an outer diameter; a central guide wire lumen located in the number of optical fibers and an outer diameter of said outer jacket that is approximately constant except at the end where the diameter widens. and the central diameter is approximately constant except at the distal end, where the diameter widens as the outer sheath expands. diameter of the id ray cavity, and located within the guide wire lumen and having a substantially constant diameter except for a distal end where the diameter widens. guide line and A catheter system comprising: 26. The guide line is a main shaft extending from the proximal end to the distal end of the guide wire and having a first diameter; a second shaft fixed to the distal end of the shaft and having a second diameter smaller than the first diameter; Futo and a wire coil covering a second shaft, the diameter of the wire coil at each end being approximately approximately equal to the first diameter, and the diameter at the central portion of the wire coil is less than the first diameter. 26. The catheter system of claim 25, wherein the catheter system is also large. 27. a catheter having an outer sheath and a central guide disposed within the outer sheath a wire lumen; a plurality of optical fibers positioned between the central guide wire lumen and the outer sheath; At the distal end of the catheter, a direct means for increasing the diameter; a guide wire having an enlarged end that mates with the augmentation means of the catheter; A catheter system comprising: 28. The guide line is a main shaft extending from the proximal end to the distal end of the guide wire and having a first diameter; a second shaft fixed to the distal end of the shaft and having a second diameter smaller than the first diameter; Futo and a wire coil covering a second shaft, the diameter of the wire coil at each end being approximately approximately equal to the first diameter, and the diameter at the central portion of the wire coil is less than the first diameter. 28. The catheter system of claim 27, wherein the catheter system is also large. 29. an outer jacket having a guide wire lumen and a lumen for an optical fiber therein; It is placed biased toward the edge of the sheath, and the tip is placed forward so that it lies beyond part of the outer sheath. the guide wire lumen extending beyond the distal end of the sheath; a guide wire slidably disposed within the guide wire lumen; and a guide wire positioned within the optical fiber lumen. 1. A catheter system comprising: a plurality of optical fibers that are connected to each other. 30. The tip of the guide wire has a wall that gradually tapers from the distal end to the outer coating. 30. The catheter system of claim 29, comprising: 31. The end surface of the outer sheath is parallel to a plane perpendicular to the axial direction of the outer sheath. 30. The catheter system of claim 29, wherein there is no. 32. The distal end of the outer sheath is in an outer sheath portion adjacent to the tip of the guide wire. 32. The catheter of claim 31, further extending distally. system. 33. The optical fiber adjacent to the guide wire lumen is connected to the optical fiber on the opposite side of the optical fiber lumen. 30. The catheter of claim 29, wherein the catheter extends distally beyond the fiber. -tel system. 34. The optical fiber has a length that matches the distal end face of the nearest outer jacket. 30. The catheter system of claim 29, comprising: 35. Claim 2, wherein the optical fiber has a diameter of approximately 50 microns. 9. The catheter system according to 9. 36. When bending the catheter, the bending stress is distributed almost uniformly between the optical fibers. 30. The optical fiber according to claim 29, wherein the optical fibers are arranged so as to disperse. Deformable catheter. 37. The optical fibers are arranged in rows, each row being wound in the opposite direction to the adjacent row. 37. The deformable catheter of claim 36, wherein the deformable catheter is taut. 38. Variant according to claim 36, characterized in that the optical fiber is braided. Possible catheter. 39. an outer covering; an inflatable balloon secured to an outer surface of a distal end of the outer covering; and an inflatable balloon; means for selectively expanding or contracting within the outer covering; an inner catheter movably positioned within the outer sheath and the inner cover; a plurality of optical fibers held within the tether; and a plurality of optical fibers connected to the proximal ends of the plurality of optical fibers. A laser catheter characterized in that it is equipped with a high-energy pulsed laser source connected to Tell. 40. The optical fiber is characterized in that it is produced from almost pure synthetic silica The laser catheter according to claim 39. 41. A method using a catheter, in which an outer catheter and an inner catheter are Insert both into the tube to the specified position, Inflate the balloon fixed to the outer catheter to move the outer catheter into the canal. Install it in the specified position, further inserting an inner catheter into the canal while leaving the outer catheter in place; transmitting laser energy through an optical fiber in the internal catheter to A method characterized by removing an obstruction within a pipe.