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    • 专利摘要:
    treatment device fiber optic method of asymmetric emission of off-axis radiation and treatment methods for excavation or ablation of cavities in human or animal tissue. an improved device and method for safe, accurate and efficient surgical procedures is disclosed. the disclosed device is an optical fiber assembly with an asymmetrical distal end configuration comprising a folded-tip fiber with a fused glove as an integral part of it, placed at the distal end (outlet) of the fiber and with a rotating connector on the proximal side ( Entrance). the fiber tip and the tissue contact surface located at the distal end of the tip can be constructed with different configurations, such as a convex tip to improve focusing characteristics, a concave tip to achieve divergent irradiation or an expanded beam tip to achieve an effect similar to that obtained by electrosurgical tools. a tightening ensures and intensifies the ability to twist and turn it easily. in another preferred mode, torsion maneuvers are enhanced through a special configuration. both special aspects (folded tip and rotating connector) allow for improved and improved treatment of diverse pathologies, making it possible to reach efficiently and easily and treat specific tissues. the orientation capacity, the torsion capacity and the rotation of the optical fiber lead to an improved, more precise effect on the fabrics. Because of this, easier, faster and more accurate and effective treatments can be performed by your own means. for example, it can be inserted into a cystoscope to perform high-powered ablation of prostatic tissue for treatment of bph, or targeted at one of the prostatic lobes that can be dug from the inside to relieve pressure on the urethra while maintaining the integrity of urethra. other uses may be the removal of tumors, hyperplastic tissue or other unwanted tissue from the body. the disclosed fiber optic array can be used with laser sources of various lengths from where, including dual laser sources, but also higher energy led devices or very bright light sources can be used to generate the radiation to be transmitted also. Due to this new design, the fiber described is easy to put in place, it is also easy to keep in contact with fabric and highly durable. the feeling for the doctor is greatly improved as well. this results in more effective power transfer to tissue and, therefore, procedures are more reliable and procedure times are cut by up to 30%.
    公开号:BR112012005015B1
    申请号:R112012005015-0
    申请日:2010-04-13
    公开日:2021-03-30
    发明作者:Wolfgang Neuberger
    申请人:Biolitec Unternehmensbeteiligungs Ii Ag；
    IPC主号:
    专利说明:

    DESCRIPTIVE REPORT Fundamentals of the Invention 1. Domestic Priority
    [001] This Order claims the benefit and priority of US Provisional Order 61 / 245,484, filed on September 24, 2009, and US Provisional Order 61 / 293,464, filed on January 8, 2010, each entitled “Twister Fiber Optic Systems and their Use in Medical Applications ”, by Wolfgang Neuberger, and US 12 / 714,155, filed on February 26, 2010, by Wolfgang Neuberger, also entitled“ Twister Fiber Optic Systems and their Use in Medical Applications ”, each of which is incorporated herein by reference. 2. Field of the invention
    [002] The present invention relates to laser systems for medical treatments and, in particular, laser surgical procedures. More particularly, it refers to fiber optic systems and methods used to treat various surgical procedures, including benign prostatic hyperplasia. 3. Information Disclosure Statement
    [003] Many important medical conditions suffered by many patients require treatments that consist of removing abnormal soft tissue from the body. Unwanted tissue can include tumors and atheroma plaques, excess fat in cosmetic treatments or parts of prostate tissue. In urology, for example, prostate disorders, such as cancer or benign prostatic hyperplasia (BPH), require that this tissue be partially or totally removed.
    [004] Tissue removal can be performed using different methods. Regardless of the method used, the main objective of this type of treatment is the removal of all unwanted tissue, while preventing damage to the surrounding tissue. In recent years, laser energy has been used to achieve this goal.
    [005] Based on the laser energy applied to the fabric, numerous approaches have been proposed. Laser techniques are generally preferred due to their special ability to release high amounts of energy in small areas, thereby improving the precision and accuracy of the treatment and decreasing the undesirable effects on the surrounding tissue.
    [006] Prostate cancer affects more than 232,000 men in the US each year. It is a growth of malignant tumor that consists of cells of the prostate gland. The tumor usually grows slowly and remains confined to the gland for many years. During this time, the tumor produces little or no symptoms or external signs (abnormalities on physical examination). As the cancer progresses, however, it can spread beyond the prostate to the surrounding tissues. Cancer can also metastasize to other areas of the body, such as bones, lungs and liver. When detected before metastasis, laser surgery employing side-burning fibers is currently a preferred treatment among surgeons and patients. It causes little blood loss and allows for a shorter recovery time.
    [007] Benign prostatic hyperplasia (BPH) or "enlarged prostate" refers to non-cancerous (benign) growth of the prostate gland. Although BPH is the most common prostate problem in men over 50 years of age, benign prostate growth begins with microscopic nodules around the age of 25, but rarely produces symptoms before a man reaches 40. It is estimated that 6.3 million men in the United States have BPH and the disease is responsible for 6.4 million medical visits and more than 400,000 hospitalizations per year.
    [008] The exact cause of BPH is unknown, but it is generally thought to involve hormonal changes associated with the aging process. Testosterone probably plays a role in BPH, since it is produced continuously throughout a man's life and is a precursor to dihydrotestosterone (DHT), which induces the rapid growth of the prostate gland during puberty and early adulthood. . When fully developed, the prostate gland is approximately the size of a walnut and remains that size until a man reaches the early forties. At this point, the prostate begins a second period of growth that, for many men, often leads to BPH later in life.
    [009] In contrast to the global enlargement of the gland during early adulthood, benign prostate growth occurs only in the central area of the gland called the transition zone, which surrounds the urethra. When this area of the prostate grows, the gland presses against the urethra, leading to difficult or painful urination. Finally, the bladder itself weakens and loses its ability to empty itself.
    [0010] BPH obstructive symptoms, such as intermittent flow or hesitation before urinating, can drastically reduce the volume of urine being eliminated from the body. If left untreated, acute urinary retention can lead to other serious complications, such as bladder stones, urinary tract infections, incontinence and, in rare cases, bladder and kidney damage. These complications are more prevalent in older men who are also taking anti-arrhythmic drugs or anti-hypertensive drugs (non-diuretics). In addition to the physical problems associated with BPH, many men also suffer from anxiety and a reduced quality of life.
    [0011] Mild symptoms of BPH are most often treated with medications such as alpha-blockers and anti-androgens. Men who suffer from moderate to severe symptoms of BPH typically must undergo surgery. There are numerous different laser techniques in which light is used to eliminate excess tissue from the prostate either by ablation (vaporization), thermal coagulation or a combination of these mechanisms. The clinical effects observed are due to the absorption of light (by the target tissue and / or surrounding fluids) and subsequent heat transfer, the extent of which depends largely on the power and wavelength of the laser beam.
    [0012] Many types of laser surgery are able to provide an almost immediate improvement in urinary flow. Laser surgery for BPH may have other potential benefits, such as reduced blood loss, as well as shorter treatment times, faster patient recovery and a lower risk of post-treatment incontinence, depending on wavelength and technique used. However, many patients still need catheterization for 1 to 2 weeks after treatment, after undergoing some forms of laser surgery.
    [0013] An important factor that determines the success of laser surgery in urology is the precision with which the surgeon is able to eliminate unwanted prostate tissue to achieve adequate tissue ablation without damaging the surrounding healthy tissue. Accuracy is defined not only in mechanical terms, but also in the confinement of the treatment beam, whether or not significant tissue decantation occurs before ablation and other concerns. To achieve some success, the inventors have worked over the years to develop optical fiber configurations that can improve the efficiency, accuracy and thus the safety of the procedure. The fibers must also be able to withstand the high laser energy emitted by new laser source technologies. In the treatment of BPH, laser beams oriented at a certain angle with respect to the axis of the main fiber are preferred, for more effective tissue ablation. US Patent 5,292,320, by Brown et al., Discloses a side firing outlet end having multiple side firing surfaces within the fiber core. The fiber core has a plurality of grooves, as well as an inclined end surface to reflect laser energy sideways. This approach helped efficiency, but it was a complex structure to do, and if you weren't careful the tip could be fragile. In addition, since the core is glued to the end cap, under high power laser operations, for example, 50 W or greater, this output end generally fails.
    [0014] US Patent 5,509,917 by Cecchetti et al. discloses a side beam laser tip having a transparent quartz cap around the outlet end of the optical fiber therein. The cap is shown to have several focusing means for the laser radiation reflected from the surface of the sloping end of the optical core. This laser tip is generally complex to manufacture and the connection to the underlying fiber can also be variable and difficult to produce repeatedly.
    [0015] In US Patent 5,366,456, Rink et al. represent a laser scalpel in which the transmitted radiation is distributed at an angle to the incident radiation source and the tool. The device has a firing tip that has an insert with a highly polished mirror surface located at a specific angle in relation to the longitudinal central axis of the optical fiber. Thus, the incident laser radiation is reflected to the side and distributed at approximately a right angle to the fiber. The firing tip can be mounted on the tip of a cannula, the entire apparatus being rotatable around the central axis of the fiber. Brekke et al. in US Patent Publication 2006/0285798 claim a folded side-burn laser to redirect light laterally in relation to an axis of the apparatus. Various aspects of fiber construction and use are complex and potentially difficult to reproduce uniformly from case to case. In US Patent 5,428,699, Pon discloses an optical fiber to laterally direct a laser beam similar to Brown and Cecchetti where thick coatings are used to decrease the electromagnetic radiation scattered from the internal reflecting structure and thereby improving the efficiency of the probe. lateral steering. All three patents mentioned above claim that the radiation beam is emitted laterally in relation to the main axis of the probe, in a non-contact way. They improve some of the features of the prior art, although many of the deficiencies of the side firing systems remain, including how to maintain non-uniform contact and avoid “soot” on the active emitting surface.
    [0016] US Patent 5,553,177 by Herring et al. represents a light guidance device consisting of a section of light guidance material that has been bent at an angle of about 90 degrees to the light transmission axis with a small radius of curvature. The output is radiated asymmetrically from the fiber axis. The folded section is treated to obtain a homogeneous refractive index in the core of the light guide. The problems here are the difficulty of forming a small acute angle, often a fragile structure, especially in smaller fibers. In US Patent 5,416,878, Bruce represents a side-burning laser fiber in which the outlet end ends on a flat face having a precise edge around its circumference. It has a curvature near the emission face of the fiber that results in a laser beam directed at a certain angle to the longitudinal axis of the main body of the optical fiber. Here, the difficulty of rotational movements by the surgeon represents a major drawback. In addition, despite some improvements in the formation of shallower curvature, the tip is still somewhat prone to accidental breakage. Another disadvantage is that both inventions have a flat surface end, limiting the fiber's light focusing characteristics, which becomes important, for example, if vapor bubbles appear in front of the fiber, a situation common to high powers. In addition, the flat surface can damage or puncture the target tissue as well.
    [0017] US Patent 6,699,239 by Stiller et al. discloses a laser instrument for vaporizing biological tissue and stabilizing the application lid during tissue removal. The laser instrument includes an optical waveguide with a light guide part that emits light and an application cap attached to the optical waveguide that transmits light. The laser instrument can be inserted into an endoscope and extended or retracted to position the application cover for vaporization and removal of biological tissue. This invention has some characteristics that represent important drawbacks. For example, the fiber tip is fused to the receiving sleeve, but the optical waveguide is mechanically joined to the application guide by means of a connection between the coating and the receiving sleeve. This makes the device potentially vulnerable to deterioration when high temperatures are present and, if high energy is applied, the end cap may come off while inside the body, which poses a danger to the patient and a complication for the surgeon. In addition, the end cap is made up of two parts, mainly a fiber positioned within a curved glass end. Therefore, in a liquid medium, such as inside the urethra, laser radiation is transmitted through the material of the end cap, i.e., from the outer area of the curved part of the probe and emerging from multiple locations. This can represent a difficulty for the surgeon, as it is difficult to point the radiation in a precise direction, thus, healthy tissue will also be damaged. This fact also causes a reduction in power density. Finally, due to the optical coupling between the fiber and the cover, losses of light and reflection can decrease the treatment efficiency.
    [0018] As can be seen from the aforementioned patents, the previous inventions have several disadvantages, such as those related to the difficulty of maneuvering, focusing possibilities and energy limitations. The prior art is also limited in that the treatment is not always as effective as desired, as it takes time. As new technologies emerge, doctors strive to achieve shorter procedure times to satisfy their patients while being able to treat more patients on a daily basis.
    [0019] There is, therefore, a need for a laser treatment system that improves the state of the art, providing a better, more robust fiber tool to enhance removal speed, ease of handling / work, while maintaining the benefits of laser cut. The present invention addresses these needs. Objectives and Brief Summary of the Invention
    [0020] It is an object of the present invention to provide a device and method for improved surgical procedures, such as urological treatments and tissue ablation.
    [0021] It is also an objective of the present invention to provide a device and method for faster, more accurate, safer and more reliable treatment to achieve effective laser radiation, while preserving the surrounding tissue.
    [0022] It is another object of the present invention to provide a device and method for improved laser surgical procedures, enhanced by fiber orientation capability, free rotation and special asymmetric distal end configurations.
    [0023] It is yet another objective of the present invention to more easily treat benign prostatic hyperplasia by means of high-powered vaporization of prostatic tissue, as well as lobe excavation.
    [0024] It is yet another object of the present invention to provide a surgical device and method for the removal of tumor or hyperplastic tissue or other unwanted tissue in the body in an improved, effective manner.
    [0025] Briefly, an improved device and method for safe, accurate and efficient surgical procedures are disclosed. The disclosed device is an optical fiber assembly with an asymmetric distal end configuration comprising a folded-tip fiber with a fused glove as an integral part of it placed at the distal end (outlet) of the fiber and with a rotating connector on the proximal side ( Entrance). The fiber tip and fabric contact surface located at the distal tip of the tip can be constructed with different configurations, such a convex tip, to improve focusing characteristics, concave tip to achieve divergent irradiation or an expanded beam tip to achieve an effect similar to that obtained by electrosurgical tools. A tightening ensures and intensifies the ability to twist and turn it easily. In another preferred embodiment, the torsional maneuvers are intensified by means of a special configuration. Both special features (curved tip and rotating connector) allow for improved and intensified treatment of diverse pathologies, making it possible to reach and treat specific tissues efficiently and easily. The ability to orient, twist and rotate the optical fiber leads to a more accurate and effective effect on the tissues. Because of this, easier, faster and more accurate and effective treatments can be performed by it. For example, a cystoscope can be inserted to perform high-powered ablation of prostatic tissue for BPH treatments, or targeted at one of the prostatic lobes that can be dug from the inside to relieve pressure on the urethra at the same time. maintains the integrity of the urethra. Other uses may be the removal of tumor tissue, hyperplastic or other undesirable tissue in the body. The disclosed fiber optic array can be used with laser sources of different wavelengths, including dual laser sources, but also high power LED devices or very bright light sources can be used to generate the radiation to be transmitted as well. Due to this new design, the fiber described is easy to put in place, it is also easy to keep in contact with the fabric and highly durable. The feeling for the doctor is greatly improved as well. This results in more efficient energy transfer to the tissue and, therefore, procedures are more reliable and procedure times are shortened by up to 30%.
    [0026] The above objectives and other objectives, characteristics and advantages of the present invention will become evident from the following description read in conjunction with the attached drawings. Brief Description of the Figures
    [0027] FIGS. 1a and 1b represent a preferred embodiment of the present invention in which the fiber optic assembly comprises a folded tip, a cast cap, a rotating connector and a grip.
    [0028] FIG. 1c outlines a preferred embodiment of the present invention showing the tip of the optical fiber and its angular notation.
    [0029] FIG. 1d represents an image of a tissue treated with the device disclosed in the present invention.
    [0030] FIGS. 2a and 2b show a preferred embodiment of the present invention in which the optical fiber comprises a rounded concave tip.
    [0031] FIG. 2c outlines a preferred embodiment of the present invention in which the optical fiber comprises a rounded concave gap as its concave tip.
    [0032] FIG. 2d shows a preferred embodiment of the present invention in which the optical fiber comprises a rounded convex tip.
    [0033] FIGS. 3a and 3b represent a preferred embodiment of the present invention in which the optical fiber comprises a covered tip.
    [0034] FIG. 4 shows a preferred embodiment of the present invention in which the optical fiber comprises an expanded beam tip.
    [0035] FIGS. 5a and 5b show a preferred embodiment of the present invention in which the design of the optical fiber assembly allows for improved torsion capacity.
    [0036] FIGS. 6a, 6b, 6c, 6d and 6e represent a preferred embodiment of the present invention combining 3 fibers in a bundle that can be folded and unfolded.
    [0037] FIGS. 7a and 7b show a preferred embodiment of the present invention with 7 fibers in a bundle configuration.
    [0038] FIGS. 8a and 8b outline another embodiment of the present invention in which the fiber is inclined with respect to the fabric surface.
    [0039] FIG. 9 represents another embodiment of the present invention with an enlarged area distal end. Detailed Description of Preferred Modalities
    [0040] According to the prior art, medical laser fibers are generally configured externally concentric to the main fiber axis, for example, bare fibers, ball-point fibers, conical fibers or fibers with lateral emission.
    [0041] When used for surgical procedures, these fibers have obvious deficiencies. The maneuverability of the fiber may be inadequate, leading to poor results and decreased efficiency. In addition, when these types of fibers inadvertently come into contact with the fabric during non-contact procedures, burnt fibers and breakage can occur, as well as unwanted tissue damage. In addition, the state-of-the-art optical fibers lack simple, effective and precise maneuvering and rotation characteristics, which can make it difficult for the clinician to maneuver with confidence and, therefore, represent a disadvantage when treating many pathologies such as benign prostatic hyperplasia ( BPH). Because of this, tissue excavation and orientation can be difficult and slow, leading to longer stressful procedures and generally slower recovery for patients.
    [0042] The present invention discloses an improved device and method for safe and effective surgical light procedures. The device disclosed in the present invention is an optical fiber assembly with an off-axis configuration consisting of a folded-tip fiber with a fused glove as an integral part of it, placed at its distal end (outlet) and with a rotating connector on the proximal side (inlet). The shape of the fiber can be described as an axially extending portion defining an elongated axis, a tip portion extending axially located at the distal end of the fiber and oriented at an obtuse angle to the elongated axis and a contact surface with the fabric , located at the distal end of the tip part. A tightening ensures and intensifies the ability to twist and turn it easily.
    [0043] Numerous advantages arise when performing surgical procedures with the disclosed invention. First, the procedure is made faster and more efficient. Since the fiber can be kept in contact with the fabric, the energy loss due to fiber degradation is practically zero. Also, scattered light from the fiber tip is substantially non-existent, as light only comes out of the fiber tip. In turn, the durability of the fiber is considerably longer because of the structure, overcoming issues of premature failure with state-of-the-art fibers. Finally, at preferred wavelengths, bleeding is not observed during the procedure, resulting in an excellent field of view and visibility of the treated area and the fiber tip.
    [0044] The device described in the present invention can be inserted, for example, in a cystoscope to perform high-powered ablation of prostatic tissue for BPH treatments. In addition, it can be oriented towards one of the prostatic lobes, to excavate tissue from the inside, in order to immediately relieve pressure on the urethra, while maintaining the integrity of the urethra as much as possible. In addition, several other benefits are obtained. For example, with their familiar perception, the surgeon can more easily hold the fiber tip at the apex and in critical areas, such as sphincter and verumontanum. The procedure can be easily and effectively performed with commercially available cystoscopes.
    [0045] Other uses may be the removal of tumor, hyperplastic or other unwanted tissues in other areas within the body.
    [0046] FIGS. 1a and 1b schematically represent a preferred embodiment in which the twisting optical fiber assembly 100 comprises an optical fiber, composed of jacketed fiber 102 and casing / core 104, molten sleeve / cap 106, rotary connector 108 and grip 110. The distal end of the Optical fiber is made up of folded-end fiber coating / core 104 and cast glove 106 designed as an integral part thereof. The glove extends annularly around the tip part. The axially extending coating / core 104 defines the emission face and the emission face of the coating / core and the distal part of the sleeve 106 defines the fabric contact surface. The fused glove 106 would typically be about 15 cm long. The coating / core fiber 104 could be in a size range from about 50/10 μm to about 1800/1700 μm for the coating and core diameters, respectively. The cast glove 106 is made of quartz and acts as a reinforcement, allowing the fiber to withstand high energies and the common handling for most electrosurgical tools. The rotary connector 108 is placed at the proximal (inlet) end of the optical fiber assembly 100, allowing free rotation and the twisting ability of the optical fiber. The 110 grip ensures and intensifies the ability to twist and turn it easily. This allows the surgeon to make smoother, more precise circular movements. The grip can be positioned in different locations along the optical fiber and designed in different ways, according to the treatment requirements and the doctor's preferences. Both special features (folded tip and rotating connector), allow improved and intensified treatment of various pathologies, making it possible to reach and treat specific tissues effectively and easily internally.
    [0047] FIG. 1c outlines a preferred embodiment of the present invention showing the fiber optic tip and its angular rotation. The tip portion extending axially defines an axial length, L, within the range of about 2 mm to about 5 mm. It is important to note that different combinations of radius and angles can be used to develop this fiber. The exact values of radius and angles will be chosen according to the treatment to be performed, considering accessibility, tissue characteristics, size of the instrument, etc. In a preferred embodiment, the tip portion extending axially located at the distal end of the fiber is oriented at an angle Φ, from about 20 ° to about 40 ° with respect to the elongated axis.
    [0048] FIG. 1d represents an image of a tissue treated with the device disclosed in the present invention. It can be seen that the enhanced optical fiber orientation, twisting and rotation capabilities help to achieve an improved effect on the tissues. Because of this, easier, faster and more accurate and effective treatments can be performed using the device and method disclosed in the present invention.
    [0049] FIGS. 2a, 2b, 2c and 2d show preferred embodiments of the present invention in which the fiber tip is rounded at a lens shaped outlet end in order to focus the transmitted radiation according to the specific treatment effect. The twisting optical fiber assembly 200 comprises an optical fiber, composed of the coating 202 and core 204, cast cover 206, rotating connector 208 and clamp 210. The distal end of the optical fiber is composed of the folded-tip fiber 204 and projected cast sleeve 206 as an integral part of it. The emission tip 212 can be either convex, as in FIGS. 2a and 2b, when the radiation is desired to converge. The emission tip 212 may have a concave gap 214 of a specific refractive index, as shown in Fig. 2c, to alter the focusing characteristics and, as a consequence, achieve different radiation patterns. Alternatively, if the radiation is desired to diverge to a given focal point, FIG. 2d shows a modality in which the emission tip 212 has a concave shape to achieve this effect.
    [0050] As shown in FIGs. 3a and 3b, in another embodiment, the twisting optical fiber assembly 300 includes a covered reinforced emission tip. The optical fiber assembly 300 comprises an optical fiber 302 and sheath / core 304, fused sleeve / cap 306, rotary connector 308 and clamp 310. The distal end of the optical fiber is made up of folded-tip fiber 304 and fused sleeve 306 designed as an integral part of it. The molten sleeve / cap 306 would typically be about 15 mm in length. From the cast glove / cap 306, the emission tip 312 protrudes, thus protecting the fiber from damage during treatment. When high laser power is emitted, vapor bubbles are usually formed. This special tip configuration keeps them in place leading to the formation of shock waves and intensifying tissue removal. In addition, the rounded, protruding rounded cap allows for an enhanced blind tip configuration, preventing damage or scratching of tissues in forward movements and also reducing the chance of bleeding when the power is turned off.
    [0051] In another preferred embodiment, the end of the fiber has an expanded beam tip, as shown in FIG. 4. This is achieved by projecting the fiber tip with the inclined part 416 and the perpendicular part 418. The optical properties of the inclined part 416 cause radiation to be emitted on a perpendicular axis and the perpendicular part 418 emits in a forward direction. As a consequence, laser radiation is emitted in a broader beam, imitating the effects of electrosurgical tools.
    [0052] The scanning method used by urologists can be improved through another modality in which the fiber is shaped as in FIGs. 5a and 5b. The cast cap portion is curved, so that the tip of the fiber is on the same axis as the fiber assembly. Thus, the torsion capacity is substantially improved, as well as the visibility by the instrument. As in previous embodiments, the tip can be designed to emit radiation at numerous angles with respect to the main axis.
    [0053] FIGS. 6a, 6b, 6c, 6d and 6e outline another preferred embodiment of the present invention. A variant of the present invention is designed by combining three or more fibers in an intimate contact arrangement in a bundle as shown in FIG. 6th. FIGs. 6b and 6c represent laser radiation beams 620. As a consequence of this radiation pattern, it can be seen that with each laser movement forward, performed by the doctor, a large groove is produced, considerably decreasing the procedure time and intensifying the effectiveness treatment. Additionally, the twisting fiber assembly has the ability to fold and unfold, thus varying the total diameter. FIGs. 6a, 6b, 6c and show a partially unfolded beam, whereas in FIGs. 6d and 6e the fiber bundle is folded and completely unfolded, respectively. In the modality shown, when the bundle is fully unfolded, the angle between the fibers is about 120 °, since it is composed of three fibers. This feature helps with insertion into instruments or channels, such as a cystoscope normally used in urological procedures. In addition, different unfolding properties could allow the modification of radiation patterns. For example, the fiber assembly may unfold partially, fully, or remain folded.
    [0054] In another preferred embodiment, numerous small diameter fibers can be grouped together in an intimate contact arrangement, each folded and reinforced, carrying a reduced amount of energy. In this way, although they fit in a round configuration while on the instrument, they warp outward to cover a larger area in “grid” mode when implanted beyond the end of the instrument in operation. In addition, since fibers of much smaller diameter are used, laser radiation is distributed in a considerably smaller localized size. As a consequence, higher power density is achieved at the distal ends of the fiber. As an example, FIGs. 7a and 7b show a preferred embodiment of the present invention in which the 7 fibers 702 are arranged in a bundle 700, each having a core diameter (D1) of 100 μm and used to transmit and radiate at a P1 power of 30 W important advantage can be appreciated when comparing the power density δi at the distal end of each fiber 702 in the bundle 700 of this modality with the power density δ2 at the distal end of the normally used fiber of 550 μm (D2) transmitting to a P2 power of i80 W. So,
    [0055]

    [0056] This result demonstrates that this modality offers in addition to 5 times more energy density, while using a laser power source 6 times lower (30W x i80W). As a consequence, the treatment is made both more effective and effective, using a laser device of lower power.
    [0057] In another example, 7 fibers with a core diameter of 200 μm are laid out. In this example, the calculation, as in the previous example, yields a power density 1.26 times higher. Again, a higher power density is achieved with highly flexible fibers.
    [0058] In yet another example with the same fiber configuration, the same power density is obtained using a very low energy source. For example, the same power density obtained with 180 W using 550 μm core fibers can be achieved by applying only 6 W to 100 μm core fibers.
    [0059] The outlet ends of the fiber can be fused together or fused in a quartz glass device that would serve as a spacer at the same time. The connector ends can be arranged in a line configuration. With this special design, small diameter fibers can be bent to form a smaller radius, with much lower tension on the fiber surfaces. This results in easier insertion into smaller instruments, due to their flexibility, as well as reduced mechanical stresses. In addition, the output beams can form a scattered pattern, resulting in a wider ablation zone, thus removing tissue more evenly and faster.
    [0060] The radiation pattern formed by the output beam will depend on the arrangement of the beam. The fiber tips can come out with all pointing in the same direction for a more concentrated and focused irradiation, deforming outwards radially forming a conical bundle or any combination of these according to the desired effect.
    [0061] In another preferred embodiment the fiber is designed to use it at an angle to the fabric surface, as shown in FIG. 8th. The radiation pattern 820, as outlined in FIG. 8b, causes a wider shallow groove in the fabric. This is useful, when thin superficial pieces of tissue need to be removed without damaging the underlying tissue.
    [0062] In another preferred embodiment of the present invention, as shown in FIG. 9, the fiber 900 is slightly deformed at the glass tip 912, such that at the outlet end of the distal tip the core and the cross section of the fiber are expanded compared to these dimensions at the proximal end of the fiber, resulting in a volume enlarged at the distal end of the 900 fiber. The tissue contact surface defines a thickness that is sufficient to allow it to wear out during the ablation of the tissue without impeding the passage of laser energy from the fiber through it and into the tissue. In a preferred embodiment, the thickness is within the range of about 1 mm to about 4 mm. As the emission surface is now larger, this wear surface configuration results in a lower power density of emitted radiation which, in turn, significantly decreases the thermal load, thereby improving mechanical, thermal and energy stability. . In addition, this special design increases fiber durability and service life.
    [0063] FIG. 10 represents another preferred embodiment consisting of many small collapsed fused fibers 1002, allowing for tighter curves and a minimal proportion of exhaust bundles. This can be achieved, for example, with a 550, 715 or 900 μm end cap with a specially fused and reinforced distal end where 30 to 40 very small diameter fibers, optimized for the packaging fraction, have been folded, cast and combined with the main fiber. This makes light transmission more efficient and therefore minimum energy levels need to be applied. In addition, this configuration expands the contact with the tissue, also making the treatment more efficient. The greater efficiency, in turn, enhances the precision and safety of the procedure, as well as the durability of the fiber. In another version of this modality, the distal tip is allowed to be enlarged compared to the cross-sectional dimensions of the main fiber, thus creating a wider groove in the fabric.
    [0064] Despite the fact that the coating is shown in the drawings of the previous modality ending at the proximal end of the molten lid, it can be designed to reach the distal end of the fiber.
    [0065] In another embodiment of the present invention, the sweeping movement can be carried out by means of a motor. As a consequence, accurate periodic scanning movements can be achieved, thereby decreasing the physician's stress considerably and enhancing patient safety. In addition, a motor within the grip, or otherwise placed along the proximal side of the fiber, can provide vibration or a combination of different types of movements. The doctor can choose the desired movement pattern according to the specific treatment, experience and personal preferences.
    [0066] The disclosed set of twisting optical fibers can be used with laser sources of different wavelengths. In a preferred embodiment, wavelengths of 980nm, 1470nm, 1950nm or combinations of these wavelengths in suitable proportions can be used, with total combined power levels of 200 W or even more. For example, better and more efficient results were obtained using a twisting fiber assembly having a distal end off-axis with a 980nm laser source compared to the side fiber. In another example, the use of a twisting fiber bundle, as disclosed, with a laser source combining wavelengths of 1,470 and 980nm results in a powerful, safe and easy BPH procedure. In both cases, due to the improved efficiency, lower energy levels were sufficient to obtain the desired results, thus decreasing the risk of damage to healthy tissue and increasing the durability of the fiber.
    [0067] In other preferred embodiments, diode lasers, fiber lasers and also higher power LED devices or very bright light sources can be used to generate the radiation to be transmitted as well.
    [0068] In a preferred embodiment, the twisting optical fiber assembly can be inserted into a cystoscope to perform high-powered vaporization of prostatic tissue for BPH treatments. In addition, it can be oriented towards one of the lobes and said lobe tissue can be excavated from the inside to relieve pressure on the urethra, while maintaining the integrity of the urethra as much as possible intact.
    [0069] In another preferred embodiment, the disclosed optical fiber can be used to remove tumor, hyperplastic or other unwanted tissue in the body.
    [0070] The device proposed in this invention, including all preferred modalities, achieves the best results operating in contact mode and moving the contact surface with tissue in a sweeping movement through the tissue and ablating the contacted tissue.
    [0071] The present invention is further illustrated by the following examples, but is not limited in this way. Example 1
    [0072] According to the BPH technique disclosed in the present invention, a procedure was performed on a 30g prostate. A set of twisting fibers, such as the one described in Fig. 1, was used together with a dual laser source (1470 + 980 nm) and a commercially available cystoscope. The power of the laser used was 100W at the beginning of the treatment, increasing in value up to 120W after 6 to 7 minutes. The total procedure time was approximately 11 minutes and the total energy distributed was 80 kJ. Example 2
    [0073] Based on the BPH technique disclosed in the present invention, another procedure was performed on a 45g prostate. A twisting fiber assembly, such as that described in FIG. 1, it was used together with a dual laser source (1470nm + 980nm) and a commercially available cystoscope. The laser power used was 100W at the beginning of the treatment, increasing the value to 130W after 6 to 7 minutes. The total procedure time was approximately 15 minutes and the total energy distributed was 110kJ.
    [0074] In both of the previous examples, an ablation rate of approximately 2g / minute was easily obtained, which represents an important improvement over the prior art techniques. Considering the information in the first example, it is estimated that 22g of 30g were removed in the procedure, while in the second it is estimated that 30g of 45g was removed in the procedure.
    [0075] The procedure can be easily and effectively performed simply with cystoscopes commercially available for BPH or endoscopes for other applications. A better alternative would be to use an orientation insert at the tip of the instrument. It was also concluded from the experiment that the twisting fiber is easier to handle than a bare fiber. Softer, smoother rotations even by 360 ° are possible and sweeping movements are also more easily achieved smoothly and effectively, due to both the free rotation junction on the proximal side of the fiber set as well as the folded off-axis structure at the end distal.
    [0076] The asymmetric fiber assembly of the present invention may also include a means for vibrating the gloved distal fiber end in a desired pre-selected movement and speed to achieve enhanced ablation, cupping action during a treatment.
    [0077] Having described the preferred embodiments of the invention with reference to the accompanying drawings, it should be understood that the invention is not limited to the precise modalities and that those skilled in the art can make changes and modifications without departing from the scope or spirit of the invention as defined in the appended Claims.
    权利要求:
    Claims (24)
    [0001]
    1. Medical Fiber Optic Treatment Device, (100), for Off-Axis Radiation Emission, comprising: an optical fiber (100), including a bent-tipped part located at a distal end and oriented at an angle to a longitudinal axis of the optical fiber (100); and a glove fused (106) to the folded end part of the optical fiber (100), characterized in that the glove (106) is folded and reinforces the folded end part.
    [0002]
    2. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to Claim 1, characterized in that it comprises two or more optical fibers with bent tip parts which, when extended beyond one introducer, can be reorganized into one or more configurations.
    [0003]
    3. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to Claim 2, comprising three to seven fibers with folded parts, characterized in that a glove (106) is fused at each one of the folded parts of said three to seven optical fibers.
    [0004]
    4. Medical Optical Fiber Treatment Device, (100), for Off-Axis Radiation Emission, according to Claim 2 or 3, characterized in that said multiple fibers are implanted either in a circular shape or in a “ grid".
    [0005]
    5. Optical Fiber Medical Treatment Device (100) with Off-Axis Radiation Emission according to Claim 3, characterized in that the device optionally comprises at least seven optical fibers with small core diameters to aid flexibility and with bent-tipped parts, wherein said fibers are employed in an intimate contact arrangement and in which the sleeve (106) is fused to each of the bent-tipped parts of the at least seven optical fibers.
    [0006]
    6. Optical Fiber Medical Treatment Device (100), for Off-Axis Radiation Emission, according to any one of Claims 1 to 5, characterized in that it further comprises generating means for providing a sweeping motion.
    [0007]
    7. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to any one of Claims 1 to 5, characterized in that it further comprises means for vibrating the distal end of a fiber in a pre-motion - selected, planned, essentially automatic.
    [0008]
    8. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to any one of Claims 1 to 5, characterized in that it further comprises at a distal end of the optical fiber (100) a core (104) and the cross section which are expanded in comparison to these dimensions at a proximal end of the optical fiber (100).
    [0009]
    9. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to any one of Claims 1 to 8, characterized in that the part of the bent tip located at the distal end of the optical fiber ( 100) is oriented at an acute angle in relation to the elongated axis of the optical fiber (100) and the device further comprises a fabric contact surface located at the distal end of the folded tip part, the fabric contact surface being configured to be placed in contact with the fabric to be treated, in which the folded tip part of the optical fiber (100) transmits laser energy from the optical fiber (100) through the fabric contact surface.
    [0010]
    10. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to Claim 9, characterized in that the fabric contact surface is a wear surface that is configured to be placed on contact with the tissue at a treatment site, to transmit laser energy from the optical fiber (100) through the tissue contact surface and to the tissue at the treatment site.
    [0011]
    11. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to Claim 9 or 10, characterized in that the acute angle is within the range of 20 ° to 40 °.
    [0012]
    12. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to Claim 9 or 10, characterized in that the folded tip part optionally further defines an axial length within the range of 2 mm to 5 mm.
    [0013]
    13. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to any one of Claims 9 to 12, characterized in that a sleeve (106) extends annularly around the part of bent point and forms at least a part of the fabric contact surface.
    [0014]
    14. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to Claim 13, characterized in that the optical fiber (100) defines an emission face and the sleeve (106) extends annularly around and is flush with the emission face and the emission face of the optical fiber (100) and the sleeve (106) define the fabric contact surface.
    [0015]
    15. Optical Fiber Medical Treatment Device (100) for Off-Axis Radiation Emission according to Claim 13 or 14, characterized in that the optical fiber (100) includes an axially extending core (104) defining the emission face and the emission face of the core and the distal part of the glove (106) define the tissue contact surface.
    [0016]
    16. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to any one of Claims 13 to 15, characterized in that the distal part of the glove (106) that defines the surface of contact with tissue is curvilinear.
    [0017]
    17. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to any one of Claims 13 to 15, characterized in that the emission face that defines the tissue contact surface is curvilinear and is flush with the distal part of the glove (106).
    [0018]
    18. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to any one of Claims 13 to 17, characterized in that the sleeve (106) extends annularly and axially throughout the entire bent tip part of the optical fiber (100) and a part of the optical fiber (100) proximal to the tip part.
    [0019]
    19. Optical Fiber Medical Treatment Device, (100), Off-Axis Radiation Emission, according to any one of Claims 13 to 18, characterized in that the optical fiber (100) includes a core and a coating ( 104) and the sleeve (106) and the outer part of the liner (104) are made of the same material.
    [0020]
    20. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to any one of Claims 13 to 19, characterized in that the outer part of the coating (104) is made of glass, the glove (106) is made of glass and the glove (106) is thermally fused to the liner (104) across the interface between the glove (106) and the liner (104).
    [0021]
    21. Optical Fiber Medical Treatment Device (100) for Off-Axis Radiation Emission according to Claim 13, characterized in that the sleeve (106) forms a cap that surrounds the distal end of the optical fiber (100 ), the distal end of the cover (106) forms the fabric contact surface, the distal end of the optical fiber (100) defines an emission face that transmits laser energy through it and the fabric contact surface of the cover (106) ) to transmit laser energy to the fabric in contact with the fabric contact surface.
    [0022]
    22. Optical Fiber Medical Treatment Device (100), with Off-Axis Radiation Emission, according to Claim 21, characterized in that the fabric contact surface of the cover (106) defines a thickness within the range of 1 mm to 4 mm.
    [0023]
    23. Optical Fiber Medical Treatment Device (100) for Off-Axis Radiation Emission according to any one of Claims 21 to 22, characterized in that the optical fiber (100) includes a core and a coating ( 104), and the lid (106) and the outer part of the liner (104) are made of the same material.
    [0024]
    24. Optical Fiber Medical Treatment Device, (100), for Off-Axis Radiation Emission, according to any one of Claims 21 to 23, characterized in that the outer part of the coating (104) is made of glass, the glove (106) is made of glass and the glove (106) is thermally fused to the liner (104) across the interface between the glove (106) and the liner (104).
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    同族专利:
    公开号 | 公开日
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    RU2547181C2|2015-04-10|
    CA2775431C|2015-12-08|
    EP2480285B1|2015-09-23|
    BR112012005015B8|2021-06-22|
    IL218603D0|2012-05-31|
    AU2010298670B2|2014-09-04|
    ES2557679T3|2016-01-27|
    MX2012003460A|2012-12-17|
    RU2012110927A|2013-10-27|
    US8721631B2|2014-05-13|
    KR20120120112A|2012-11-01|
    JP2013505771A|2013-02-21|
    CA2775431A1|2011-03-31|
    EP2480285A4|2013-08-14|
    BR112012005015A2|2017-02-21|
    HUE026087T2|2016-05-30|
    EP2480285A1|2012-08-01|
    WO2011037651A1|2011-03-31|
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    US20110160713A1|2011-06-30|
    CN102740928A|2012-10-17|
    AU2010298670A1|2012-04-12|
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    法律状态:
    2017-03-01| B15I| Others concerning applications: loss of priority|
    2017-12-12| B25A| Requested transfer of rights approved|Owner name: BIOLITEC PHARMA IP AND INVESTMENT LTD (MY) |
    2017-12-26| B25A| Requested transfer of rights approved|Owner name: BIOLITEC UNTERNEHMENSBETEILIGUNGS II AG (AT) |
    2019-01-15| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-24| B12F| Appeal: other appeals|
    2020-10-06| B06G| Technical and formal requirements: other requirements [chapter 6.7 patent gazette]|
    2020-12-15| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2021-03-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-03-30| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 30/03/2021, OBSERVADAS AS CONDICOES LEGAIS. |
    2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/04/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |
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