Laser device for vascular and in vivo surgery and method of use thereof

Abstract

A laser atherectomy device includes a sensor-equipped light transmission conduit for monitoring physical properties of a laser application site. An integrated control unit utilizing data from the sensors is provided to optimally adjust laser energy parameters and safely and efficiently ablate vascular occlusions.

Description

Technical Field

[0001] The apparatus and methods of the present invention generally relate to in vivo surgery and the treatment of obstructed body cavities. In particular, the present invention relates to an improved laser system for optimally generating and delivering laser energy via a catheter for removing obstructive material from blood vessels and other body cavities. Background Technology

[0002] The laser systems, devices, and methods of the present invention are applicable to various in vivo surgeries, including but not limited to cutting, rupturing, coagulating, and vaporizing any body tissue (including but not limited to soft tissues, including tendons, ligaments, fascia, skin, fibrous tissue, fat, and synovium; as well as muscles, nerves, and blood vessels (not connective tissue) and hard tissues / bones and connective tissues), involving reaching the target tissue through body channels, including but not limited to blood vessels, ureters, esophagus, stomach and duodenum (esophago-gastroduodenoscopy), small intestine (colonoscopy), large intestine / colon (colonoscopy, sigmoidoscopy), or cutting body tissue (laparoscopic surgery).

[0003] Although the laser systems, devices, and methods for removing obstructive substances from blood vessels and other body cavities are described in more detail below, it should be understood that these laser systems, devices, and methods are only some of the many possible applications of the present invention. The laser systems, devices, and methods of the present invention are applicable to a variety of types of in vivo surgeries as described above, including but not limited to general surgery, cardiology, orthopedic surgery, urological surgery, and gastrointestinal surgery.

[0004] Cardiovascular disease is typically caused by the buildup of atherosclerotic material on the inner walls of blood vessels, particularly the coronary arteries and other vascular systems. This includes coronary artery disease (CAD), where plaque buildup occurs in the heart arteries, and peripheral artery disease (PAD)—the narrowing of the peripheral arteries serving the legs, stomach, arms, and head, leading to a condition called atherosclerosis. Atherosclerosis and other deposits in blood vessels can restrict blood flow and may cause localized ischemia, which in acute cases can lead to a myocardial infarction or heart attack.

[0005] Atherosclerotic deposits can exhibit a wide range of characteristics; some deposits are relatively soft, while others are fibrous and / or calcified. In cases where the deposits are fibrous and / or calcified, they are often referred to as plaques. Atherosclerosis is a natural consequence of aging, but it can be exacerbated by factors such as diet, high blood pressure, genetics, and vascular damage.

[0006] Atherosclerosis can be treated in various ways, including medication, bypass surgery, and various catheter-based methods that rely on widening or removing atherosclerotic material or other substances obstructing the blood vessel. Catheter-based interventional procedures include angioplasty, endovascular ablation, laser ablation, and stent implantation. In most cases, the catheter used for these procedures is introduced via a guidewire, which is placed on the lesion before catheter placement. However, initially placing the guidewire in a tortuous area of ​​the vascular system can be difficult, or even impossible. Furthermore, if the lesion is complete or nearly complete—that is, if the lesion obstructs the lumen to the point that the guidewire cannot travel across it—guidewire placement also becomes very difficult.

[0007] Vascular blockage can be caused by a variety of substances, including hard bone deposits such as calcium deposits, soft blood clots, or fatty deposits. Multiple types of blockages can exist in the same blood vessel. Currently, different tools are used to remove different types of blockages. Surgeons may need to remove one type of catheter and replace it with another to successfully treat different types of blockages. This prolongs treatment time, significantly increases costs, and increases patient risk. This invention provides a more optimized and complete solution to this problem, comprising a method for analyzing the type of obstructive material present and then adjusting the function of the blockage removal device accordingly.

[0008] In the prior art, rotary abrasion systems are known to use diamond drills / rotary files to grind hardened calcified blockages into very small particles. While there is some discussion suggesting that the particle size produced by ablating plaques into microparticles with a 20 mm diamond drill / rotary file is smaller than that of a red blood cell (8 mm) (approximately 5 mm), it is also known that larger debris particles are generated during the process of breaking up the blockage. These larger particles can block capillaries and cause serious side effects. However, even blockage particles as small as blood cells may pose a potential risk if they are present in the bloodstream. The potential risk is even greater if these particles accumulate in vital body tissues, leading to malfunctions of important organs. Even smaller particles (such as tattoo ink particles, less than 1 mm) pose a greater risk. (9)The visible accumulation of tattoo particles is well-known. It is also well-known that the accumulation of tattoo particles (in tattoos) is permanent or at least long-term. Because tattoo ink is inserted into the skin, it primarily resides in the dermis. Therefore, the effects of ink particles on other tissues and organs are localized. On the other hand, since particles generated during the disruption of obstructions can be transported to vital organs via the bloodstream, proper management of these particles becomes important. Some rotational atherectomy catheters have built-in active aspiration devices to remove debris from the bloodstream and drain it through the catheter. However, these aspiration (debris removal) devices are not optimally designed to remove all or most of these debris particles. This invention proposes a more optimized and complete solution to this problem.

[0009] Existing technological solutions for removing calcification plaques are typically equipped with a forward-shaping rotary drill. If such a drill is pushed against the vessel wall during surgery, some of these prior art designs pose a risk of accidental perforation of the vessel wall. One aspect of the present invention provides a method for limiting this risk of vessel wall perforation and minimizing the adverse effects of the surgery on any adjacent tissues. Summary of the Invention

[0010] One aspect of the present invention provides an apparatus for laser ablation of biological tissue, comprising a hollow guidewire having one or more openings distally for aspiration, designed to aspirate and remove debris or embolic material from a blood vessel. The guidewire is formed into a hollow tube designed to aspirate debris generated by laser energy applied to the obstructing material, and the guidewire also has multiple openings distally for aspiration.

[0011] Another aspect of the invention provides a light delivery conduit for laser ablation of biological tissue, configured to deliver light energy from a source to an obstruction in a blood vessel. The light energy is emitted from the distal end of the light guide. The light energy disrupts / affects / removes the obstruction in the blood vessel or soft tissue through vaporization, coagulation, cavitation, or other physical mechanisms such as photoacoustic waves, photochemical reactions, or the interaction of light with the target tissue.

[0012] Another aspect of the invention provides a laser plaque resection device comprising a light delivery conduit equipped with sensors for monitoring the physical characteristics of the laser application site. An integrated control unit utilizing data from the sensors is provided to optimally adjust laser energy parameters and provide safe and effective ablation of vascular obstructions.

[0013] Another aspect of the invention provides a sterile package containing a rotary cutting treatment catheter, allowing a portion of the catheter to be conveniently pulled out of the package for intravenous injection while the remainder of the catheter is stored in a sterile internal storage compartment; - this package housing includes two reels capable of independently rotating and releasing the catheter wound on each reel. Attached Figure Description

[0014] In the following figures, the same parts in the various views have the same reference numerals. The figures are now provided for illustration and not limitation of the invention, wherein: Figure 1 and Figure 2 This is a diagram showing the distal end of the optical transmission conduit and various components of the present invention; Figure 3 This is a diagram illustrating the system of the present invention; Figure 4 This is a diagram showing the distal end of another embodiment of the light transmission conduit; Figure 5 and Figure 5A This is a cross-sectional view showing the combination of a sterile packaging-dispensing device for laser conduits; Figure 6A and 6B This is a diagram showing an inflatable balloon for use as a light delivery conduit; Figure 7 This is a diagram illustrating the motion sensor activation system of the present invention; Figure 8A and Figure 8B This is a diagram illustrating the application of an improved inflatable bladder incorporating a retractable blade; Figure 9A , 9B The 9C further demonstrates the improved combination of inflatable balloons. Figure 8A and 8B A perspective view of the application of the extendable blade; Figure 10 and 10A This is a diagram illustrating a laser surgical apparatus according to yet another embodiment of the present invention; Figure 11 and Figure 11A A diagram illustrating a laser surgical system according to yet another embodiment of the present invention; and Figure 12 This is a diagram illustrating a laser surgical apparatus according to yet another embodiment of the present invention. Detailed Implementation

[0015] This invention contemplates the use of energy sources known to a person of ordinary skill in the medical field to break up, coagulate, or vaporize various unwanted substances from body cavities. In a preferred embodiment, the energy is laser energy having a wavelength highly absorbable in aqueous media. In this regard, the invention contemplates the use of a variety of lasers, including but not limited to solid-state lasers, diode lasers, gas lasers, semiconductor lasers, or broadband light sources. In the method of this invention, light energy disrupts / affects / removes obstructions in blood vessels or soft tissue in an ideal manner. This includes vaporization, coagulation, cavitation, or photoacoustic, photochemical, or other photophysical mechanisms through which light interacts with the target tissue. The light energy is emitted from the distal end of a light guide.

[0016] In a suitable laser system, the energy and pulse frequency of each pulse can be varied. Typically, high-frequency pulses and high energy produce rapid fragmentation, but also lead to increased temperature in the treated area and significant particle movement. Lower pulse frequencies and lower energy are more precise, but result in longer overall treatment times. The device of this invention can use high-frequency pulses and high energy because the active aspiration / suction force removing debris from the bloodstream restricts particle movement. According to the method of this invention, the overall efficiency of treatment is improved by combining aspiration with a laser delivery system. Furthermore, the laser catheter of this invention is equipped with a temperature sensor to monitor the temperature level at the treatment site. The control unit of the laser system uses this temperature sensor to optimize the adjustment of laser energy parameters (e.g., the frequency or repetition frequency of the laser pulses) to prevent overheating and thermal damage to surrounding healthy tissue.

[0017] When the energy emitted by a laser catheter comes into contact with unwanted body material within the patient's vascular system, it separates and cuts the material in a roughly concentric manner. This technique is also known as core extraction. And if the body material being cut is essentially solid, then the material appears as a cylindrical core. Although Figure 1 A generally concentric configuration of laser emitters is shown, but those skilled in the art will understand that many other ways and configurations exist for arranging multiple laser guide emitters. Therefore, the following discussion... Figure 1 The system / arrangement described herein is not intended to represent the only way in which laser guide tubes can be configured and constructed, and all such configurations and constructions are considered to be within the scope of this disclosure to the knowledge of those skilled in the art.

[0018] In this invention, an optical transmission or laser conduit 10 is provided to transmit light energy from a source (laser, solid-state laser, diode laser, gas laser, or broadband semiconductor laser) to a location in the body via a blood vessel (vein or artery or other bodily channel). At this location, the light energy can disrupt / affect / remove blockages in the blood vessel or soft tissue through vaporization, solidification, cavitation, photoacoustic waves, photochemical or other physical mechanisms that interact with the target tissue. This light is emitted from the distal end of the optical conduit. The optical conduit of this invention is formed to have dimensions, thickness, mechanical properties, and other characteristics suitable for and convenient use by the method of this invention.

[0019] A "laser conduit emitter" refers to the end of an optical fiber or optical component that directs a laser beam from the distal end of a conduit toward a desired target, typically tissue. An optical fiber (or active laser fiber) is a flexible, transparent optical fiber made of a light-transmitting material, such as glass (silicon dioxide) or plastic, used as a waveguide or "light tube" to transmit light between its two ends.

[0020] A "coupler" or "fiber optic coupler" is a fiber optic device with one or more input fibers and one or more output fibers. A fiber optic coupler is typically a specialized fiber optic device with one or more input fibers used to distribute optical signals to two or more output fibers. Optical energy is passively split into multiple output signals (fibers), each containing light with the same characteristics as the original signal, but with a reduced amplitude.

[0021] One aspect of the invention provides a combination of a laser emitter and a distally located mechanically cutting tip, used in conjunction with a suction system. The laser conduit transmits laser energy through an optical fiber in a flexible tubular conduit inserted into a body cavity (e.g., a blood vessel) to remove obstructions within the cavity.

[0022] Now for reference Figure 1 and Figure 2 The image shows the distal end 12 of a laser catheter 10 for ablation according to an embodiment of the invention. The laser catheter extends between its distal end 12 and proximal end 14 and forms a central channel 16 that receives a guidewire 18 inserted into a body cavity (e.g., a vascular system) prior to catheter introduction. The channel 16 can also be used to remove / drain obstructive debris from an area near the distal end of the catheter. The guidewire 18 facilitates the advancement and placement of the laser catheter into selected portions of the body cavity for laser ablation of tissue.

[0023] The working (distal) end 12 of the laser conduit is equipped with multiple laser emitters 20, which emit energy and ablate target tissue. The opposite (proximal) end 14 of the laser conduit is connected to a fiber optic coupler 22, which is connected to a laser system or power supply 115 (see [link to laser conduit]). Figure 3The laser conduit 10 is formed with an outer sheath or sleeve that can resist forces applied by the user, such as torque, tension, and compression.

[0024] In one embodiment of the invention, the distal end 12 of the catheter may be formed as an outer band having a plurality of optical fibers serving as a laser emitter 20. The inner band forms a central channel or tube 16, which receives a guidewire 18 and / or provides a potential catheter or channel for connection to the aspiration system discussed in more detail below, for moving the material cut or ablated by the laser emitter to a location.

[0025] The cutting device in this embodiment is a laser ablation device that includes a laser emitter 20 embedded in a catheter. The energy emitted by the laser emitter 20 cuts, separates, and / or ablates soft tissue, plaque buildup, calcium deposits, and other types of undesirable lesions or body material within the patient's vascular system in a pattern substantially similar to the cross-sectional configuration of the laser emitter.

[0026] The light source 26 is an array of optical fibers 20 powered by a laser. The device of the present invention also includes a laser energy / power supply 115 (see [link to device]) that is in electrical communication with the light source. Figure 3 The device is adapted to supply power to the light source. The laser energy / power supply 115 can be DC and / or AC. The device may optionally be adapted to include an autonomous power source (e.g., a battery, etc.). The laser energy source 115 communicates electrically with the light source 26 via any conventional means, including cables. The device also includes a controller or control unit 112 (see...). Figure 3 It controls the amount (including duration) of light applied to the treated area.

[0027] Reference Figure 3 A control unit 112 is provided to adjust the laser energy / power supply 115 based on the type and characteristics of the target obstruction (hard, soft, blood, etc.) and / or the characteristics of the catheter (length, diameter, temperature, etc.) to obtain the optimal laser output level and different characteristics (e.g., wavelength, pulse duration, pulse shape, repetition rate, etc.). The operator can adjust the characteristics of the control unit 112. Regarding the basic aspects of the invention, adjustments can be made based on sensors 32 and 34 installed within the catheter (see...). Figure 1 These characteristics can be adjusted manually or automatically based on the received signals and data.

[0028] like Figure 3As shown, the control unit 112 houses a programmable logic controller 114 or microchip and a laser power supply 115, which provide power and control the operation of the various units of the system of the present invention. The control unit 112 preferably includes a base arranged such that the control unit can be stably supported on a work surface or body surface during material removal operations. The control unit 112 is also preferably combined with a control system for actuating, adjusting, and providing system information regarding laser power characteristics, axial translation, suction, and infusion, displaying readings from sensors located at remote instruments, etc. The control unit may include, but is not limited to, a laser power control unit, a vacuum control unit, a guidewire control unit, and a suction / infusion control unit. The control unit 112 also controls a block that provides information about operating conditions and feedback from the material removal site to the operator. Using a computer or microchip 114, the control unit 112 continuously updates outputs to the operator, including operating parameters such as: laser parameters delivered to the treatment site, temperature of the material being removed, advance rate, inhalation rate and / or volume, and infusion rate and / or volume. The control unit 112 may also provide adjustable controls to allow the operator to control the operating parameters of the material removal operation.

[0029] A control unit 112 is provided to adjust the laser power supply 115 for optimal output level based on the type and characteristics of the target obstruction (hard, soft, blood, etc.) and / or the characteristics of the catheter (length, diameter, temperature, etc.). The characteristics of the control unit 112 can be adjusted by the operator or automatically based on input from sensors 116. Various characteristics / parameters of the operating site are controlled based on information provided by sensors at the distal end of the catheter. Such characteristics can be adjusted manually or automatically based on signals and data received from sensors 16 installed within the laser catheter.

[0030] Sensors 32, 34, and 116 can transmit and receive various types of signals (optical, electromagnetic, acoustic, and capacitance measurement signals), which will change parameters according to the composition of the obstruction, thereby allowing control unit 112 to calculate and generate appropriate signals to control the operation of laser source 115.

[0031] Detectors / sensors 32, 34 located at the distal end 12 of the catheter (see Figure 1) are capable of identifying (determining) the physical and chemical composition of the obstruction. A computer or microchip 114 associated with the control unit 112 receives and analyzes the information / data acquired by the sensors and generates signals to adjust the power supply parameters to optimize the disruption of the obstruction in the blood vessel and / or produce other desired effects on the target soft tissue.

[0032] According to one embodiment of the invention, sensors 32, 34, and 116 are capable of detecting levels of hardness / calcification, water / moisture content, etc., within the blockage material. Optimal levels of laser radiation can be achieved for each treatment area as the tool / laser passes through the various zones / parts / regions of the blockage. For example, lower levels of radiation and / or higher repetition rates can be provided to destroy calcined blockages with higher intensity. Conversely, higher levels of radiation and / or lower repetition rates will be generated and directed towards areas with softer blockage material. The laser power source is also capable of generating different wavelengths or pulse durations, which can be optimized for optimal effect on the target tissue. The generated beam controllably destroys the blockage when absorbed by the target blockage / tissue at a predetermined depth.

[0033] Sensors 32, 34, and 116 can transmit and receive various types of signals (optical, electromagnetic, acoustic, and capacitance measurement signals). These signals will change parameters according to the composition or other physical characteristics of the obstruction and / or the surrounding tissue and / or the physical characteristics of the catheter itself, so as to allow the control unit 112 to calculate and generate appropriate signals to control the operation of the catheter.

[0034] Sensors 32, 34, and 116, located distal to the catheter, can identify (determine) the physical and chemical properties of the obstruction. A computer or microchip 114 associated with the control unit 112 receives and analyzes the information / data acquired by the sensors 116 and generates signals to adjust the parameters of the laser power supply 115 to optimize the destruction of the obstruction in the blood vessel and / or to produce other desired effects on the target tissue. For example, the control unit 112 analyzes the information / data acquired by the sensors 32, 34, and 116 and generates signals to adjust the parameters of the laser power supply 115 to optimize catheter operation. This also includes applying different physical mechanisms of action to destroy the obstruction.

[0035] Sensors 32, 34, and 116 can detect levels of hardness / calcification, water / moisture content, etc., within the blockage material. As the catheter passes through various regions of the blockage, optimal irradiation can be achieved for each treatment area. For example, a higher level of irradiation can be provided to destroy calcined blockages with higher intensity. Conversely, a lower intensity beam will be generated for areas with softer blockage material.

[0036] The laser used in this laser conduit is accompanied by automatic target feedback, such as thermal feedback, to precisely control the dosage of laser irradiation. This is necessary to prevent damage to surrounding tissues. The output of a non-contact thermal detector 136 [to be shown] can be used to adjust the output of the laser power supply 115 to maintain selected characteristics, including the temperature at the treatment site.

[0037] The absorption of laser energy by obstructive substances can lead to an increase in the temperature of surrounding tissues. In this invention, this can occur controllably without causing irreversible thermal damage to the tissues surrounding the artery. The laser control unit 112 adjusts the energy to maintain a predetermined target temperature at the site / point. In one embodiment of the invention, to maximize patient safety, an optional continuous or pulsed cooling device can be provided to deliver coolant to the surgical site via a hollow guidewire during or after laser surgery.

[0038] To further control destructive obstructions, the condition of the entire arterial body and / or the tissue surrounding the surgical site is monitored by a detection device or detector 117 [to be shown], which is adapted to detect irradiation reflected from such tissue. One of the basic functions of detector 117 is to control the effect of energy or light source on the tissue surrounding the site. In each case, the physician sets specific irradiation characteristics to produce the desired effect. If the condition at the surgical site becomes unfavorable, for example, if the temperature exceeds a predetermined limit, detector 138 generates a signal directed to control unit 112, which in turn generates a correction signal to the system's power supply unit or control device.

[0039] The control unit 112 may be equipped with a computer or microchip 114, which can receive and analyze the information obtained by the detector 136 and generate control signals to adjust the parameters of the laser power supply 115 to optimize the destruction of blockages in blood vessels or other desired effects on target soft tissue.

[0040] In this invention, in order to effectively control the destruction of the obstruction, the condition of the entire arterial body and / or the tissues surrounding the surgical site is monitored by a detector 117, which is adapted to detect radiation reflected from these tissues.

[0041] Specifically, the imaging detector 117 can be programmed to detect when laser radiation is accidentally exposed and thus reflects off the blood vessel wall. Since one of the basic functions of the detector 117 is to control the impact of surgery on the surrounding tissues, when laser energy is detected to be in contact with the blood vessel wall, the control unit stops delivering laser energy to the treatment site to avoid damaging healthy blood vessel wall tissue. In each case, the physician sets specific features to produce the desired effect.

[0042] The computer or microchip 114 of the control unit 112 receives and analyzes the information obtained by the detector 117 and generates control signals to adjust the parameters of the power supply 115 to optimize the destruction of blockages in blood vessels and other desired effects on target soft tissue.

[0043] In an alternative embodiment, a control signal excites a special (cooling) device (see above) to directly or indirectly reduce / regulate the temperature at that location. A similar signal is generated when a pre-arranged level of the energy density, power density, or other characteristics of an operating laser is obtained. This is necessary to rule out the possibility of damage to adjacent tissue. Detector 117 can be made using a variety of optoelectronic elements, photoresistors, photodiodes, and other devices known in the art.

[0044] In an alternative embodiment, a control signal generated by thermal detector 117 activates a cooling device (see above) to directly or indirectly reduce / regulate the temperature of the site. This is necessary to eliminate the possibility of damage to adjacent tissues. Detector 117 and sensors 32, 34, 116 can be made using various photoelectric elements, photoresistors, photodiodes, and similar devices. Overheating can also occur along the length of the catheter, especially when the catheter is bent at an acute angle; therefore, installing temperature sensors along the length of the catheter can improve the safety of the device.

[0045] As described above, the material of the obstruction and other factors can cause an increase in temperature in the surrounding tissue. In this invention, the temperature increase is controllable and does not cause irreversible thermal damage to the tissue surrounding the artery. The control unit 112 adjusts the energy to maintain a pre-selected target temperature at the site. In one embodiment of the invention, to maximize patient safety, an optional continuous or pulsed cooling device can be provided to be used during or after the procedure via an infusion pump 153 through a hollow guidewire 18 (see...). Figure 1 The coolant from the infusion material reservoir 155 is delivered to the surgical site.

[0046] The guidewire 18 used in this invention (see Figure 1 and 2 The laser conduit 10 is formed as a hollow tube, which, through the use of techniques known in the art, facilitates the laser conduit 10 (e.g., via a tortuous vascular system) reaching the treatment site. The laser conduit 10 travels along a guidewire 18, wherein at least a portion of the conduit is operatively connected to the guidewire.

[0047] The hollow guidewire provides further benefits and allows the central aperture of the aspiration core to remain open for coolant delivery. An important aspect of guidewire 18 is that its hollow tube or central channel 16 serves as a conduit for aspirating obstructive debris. For example... Figure 2As shown, the guidewire 18 includes multiple openings / ports 19 along its distal end. Using this hollow guidewire allows clinicians to more effectively capture obstruction debris 38 compared to using only the guidewire working channel formed in its central portion. This is because the openings / ports 19 allow for the capture / collection of debris 38 precisely at the site where it is generated during the procedure and before it is dispersed. The hollow guidewire 18 can be made of metal, plastic, graphite, or any other material that meets guidewire requirements and cannot be displaced by fluid containing debris containing obstruction or emboli.

[0048] Multiple ports 19 facilitate direct flow from the sides and front of the inhalation catheter. Embodiments with side openings 19 are preferred when the device of the invention is used to remove material from the body cavity wall, as these side openings provide easy access to the target material and avoid the need to bend the tip.

[0049] If needed, the hollow / tubular guidewire 18 of the present invention can also deliver fluid / drug / coolant to a target location. A cut / opening / port 19 formed along at least a portion of the length of the tubular guidewire allows leakage of liquid / fluid / drug from the guidewire's orifice into the vascular system channel. The location where liquid / drug / coolant exits from the tubular guidewire 18 can be controlled by controlling the depth and position of the opening / port 19. Furthermore, an elastic / polymer sheath can be inserted into the lumen or orifice of the tubular guidewire, and / or also inserted externally, to seal and prevent liquid / fluid / drug from flowing out or exiting the guidewire lumen. Controlling the length of the guidewire 18 on this sheath allows control over the exit point of liquid / drug / coolant from the guidewire. Additionally, the outer sheath provides better engagement / sealing between the guidewire and the vascular system interior, ensuring proper positioning of the catheter within the lumen wall.

[0050] In the method of the present invention, the clinician relies on guidewire 18 to advance a laser catheter or other device to treat damage within the patient's vascular system and to maintain the position of the catheter within the lumen wall.

[0051] Regarding the suction aspect of this invention, vacuum pump 170 (see...) Figure 3 A low-pressure zone is created at the proximal end of the hollow guidewire in the optical catheter to aspirate debris, blockages, or emboli from the blood vessel. Figure 3The schematic diagram illustrates a system according to an embodiment of the invention, which can be connected to a catheter channel to remove ablated or cored body material from a subject's vascular system using different embodiments of catheter 110. In embodiments of the invention, a vacuum pump 170 located proximally to the system generates a low-pressure zone, resulting in a constant suction pressure within the catheter lumen to remove cut and / or ablated body material from the subject's vascular system. Clearly, the vacuum pump 170 located proximally to the system also generates suction pressure within the hollow interior space of the guidewire to remove cut and / or ablated body material directly from the operating site within the vascular system.

[0052] Figure 3 A system according to one embodiment of the invention is schematically depicted, configured for various embodiments using catheters to remove developed body material from a subject's vascular system. A vacuum pump 170 positioned proximally generates a low-pressure zone, resulting in suction pressure to remove cut and / or ablated body material directly from the surgical site of the vascular system.

[0053] In another embodiment, a vacuum pump 170 is interconnected with a pulse modulator 171, the actuation of which generates one or more pressure differentials in the aspiration system. Therefore, in this embodiment, instead of generating a constant aspiration pressure within the catheter lumen to expel cut and / or ablated body material from the subject's vascular system, the aspiration system of the present invention applies alternating pressures to generate intraluminal aspiration pressure pulses. Utilizing a series of constant and / or varying pressure pulses may be advantageous for aspirating body material.

[0054] Inhaled fluid and / or particles from the area near the distal end of the catheter accumulate and are stored in a disposable debris reservoir 176. A filter may also be located upstream of the system to filter debris and inhaled body material and to provide the user with visual feedback related to the type, quantity, and flow rate of material removed from the patient. The debris reservoir 176 may be in fluid communication with a vacuum pump 170 and may include one or more known devices for collecting and filtering material removed from the patient. The debris reservoir 176 may have transparent sidewalls for providing the user with visual feedback regarding flow rate, contents, color, etc. Those skilled in the art will understand that various types of collection containers can be used. Depending on the specific application, the collection container and / or filter may also include one or more custom filter features with various pore sizes, capacities, etc.

[0055] The distal end of the light guide used as a suction catheter can be made of a variety of flexible or rigid materials or a combination of both.

[0056] To improve the laser conduit's resistance to kinking or collapse under vacuum pressure while maintaining flexibility, the exterior can be made of braided or woven fibers from materials such as metal or plastic. The distal laser conduit can have coatings on its interior or exterior for various purposes, such as preventing corrosion from bodily fluids or isolating high energy emitted towards its distal region. It can be any size that facilitates its intended use. Additional structures in the distal region can help prevent blockage of the suction conduit. For example, filters, screens, meshes, protective shields, or other barriers can be placed in the distal region of the suction conduit.

[0057] While the laser catheter 10 for use in percutaneous nephrolithotomy has been discussed above, it should be noted that the application of the laser catheter to various types of intraoperative procedures (as defined above) also constitutes part of this invention. For example, in ureteroscopy for the treatment and removal of stones in the kidneys and ureters, the catheter 10 can be used in combination with a suitable flexible endoscope. During the procedure, the physician inserts an endoscope with the laser catheter through the patient's bladder and ureter into the kidney. The use of the laser catheter 10 is particularly suitable for the removal of larger stones, which are broken up by passing through the endoscope. The catheter 10 is also suitable for ureteroscopy to remove polyps, tumors, or abnormal tissue from the urethra. A further application of the laser catheter of this invention is in percutaneous nephrolithotomy or percutaneous nephrolithotomy, where a small tube is used to reach and break up the stone. After this step, the stone is vacuumed and removed from the system using the suction / aspiration device of this invention.

[0058] like Figure 4 As shown, in another embodiment of the invention, the distal end 12 of the laser conduit is formed with a convex region 54, which may be made of an elastic material. This feature leads to the following advantages of the invention.

[0059] An open convex (funnel-shaped) cavity is formed to accumulate and capture debris from blockages in front of the hollow light guide channel used for aspiration of debris.

[0060] The convex region 54 focuses the light energy emitted from the distal end 12 of the optical / laser conduit 10 to be optimally focused on the longitudinal axis AA of the conduit and near the distal end. The light energy is projected along the longitudinal axis AA of the conduit to optimally destroy obstructions. This minimizes the risk of adverse damage to the walls of body cavities (e.g., vascular systems) and other adjacent tissues caused by laser radiation.

[0061] The elastic convex region 54 forms a suction cup that facilitates engagement between the distal end of the catheter and the blockage, thereby preventing debris spread and facilitating debris capture.

[0062] The convex region 54 of the laser catheter can be used in various types of intraoperative procedures (as described above). For example, it can be used in ureteroscopy, a procedure to treat and remove stones in the kidneys and ureters. The convex region 54 can be used in conjunction with a flexible endoscope that passes through the patient's bladder and ureter for better access to the kidneys. The use of the convex region 54, combined with a laser, facilitates the removal of larger stones, where the laser passes through the endoscope to break up the stones. Another example is the use of the convex region 54 in ureteroscopy to remove polyps, tumors, or abnormal tissue from the urethra. Similar to the methods described above, the convex region 54 can be used in percutaneous nephrolithotomy or percutaneous nephrolithotomy, combined with a tubule to reach the stones and break them up with a laser or high-frequency sonic wave.

[0063] In this invention, the laser acts to selectively absorb laser energy within the obstruction. The absorption and effect on the obstruction depend on laser radiation parameters, including but not limited to laser radiation wavelength, pulse duration, repetition rate, energy in the pulse, and / or the energy flux (laser radiation density) delivered to a square area unit of the target material or surface.

[0064] Regarding alternative embodiments, Figure 4 An alternative method is provided for delivering laser energy to the obstruction site using a diode laser, which is located and integrated into the center of the conduit at the end facing the obstruction. In this design, the laser energy is generated precisely at the end of the conduit, thus eliminating the need for optical fibers to transmit energy as in other embodiments of the invention. In this design, the power line is integrated into the conduit. Using a laser diode allows for cheaper and more reliable delivery of laser energy to the obstruction.

[0065] Throughout the advancement and removal of catheters / guidewires, users often find it difficult to maintain sufficient control over them. Traditional dispensers typically do not allow the catheter / guidewire to remain fluidly / electrically connected throughout the process. Therefore, there has long felt an unresolved need to provide a catheter dispenser that allows for safer handling and operation by enabling users to increase their control over the guidewire and catheter.

[0066] Now for reference Figure 5 and 5A The illustration shows a combination 200 of a sterile packaging-dispensing device for laser catheters of the present invention, wherein the catheter is wound on a reel dispenser rotatably arranged inside the packaging. This combination is configured to safely store and dispense elongated medical devices, such as laser catheters, during procedures such as surgery.

[0067] like Figure 5 and 5AAs shown, the packaging 210 of the present invention is in the form of a bag defined by at least a first wall 212 and a second wall 214, which are spaced apart from each other to define a receiving cavity 244 therebetween. Extensions 215 and 217 extend outward from the central region of the inner surface of the respective walls. The purpose of the extensions will be discussed later in this application. In one embodiment of the invention, each wall 212, 214 may comprise a layer of transparent, impermeable polymer. The two walls are sealed together at their edges to enclose the dispensing device, wherein a conduit is arranged within the receiving cavity. A suspension device (not shown) in the form of an opening may be provided, passing through the two walls near the sealed edges. In an alternative embodiment, for the purpose of facilitating sterilization, at least one wall is formed as a layer of semi-permeable polymer after the dispensing device has been placed inside the packaging.

[0068] Various methods of manufacturing the walls of packaging are within the scope of this invention. For example, in one embodiment, the walls of the packaging may be thermoformed on a mold from a soft thermoplastic such as styrene or polystyrene. In another embodiment, the walls may be injection molded. In yet another embodiment, the walls may be cast onto a mold using a fast-curing plastic or resin. Other manufacturing methods will be apparent to those skilled in the art who will benefit from this disclosure.

[0069] As previously described, the distal end of the laser conduit is equipped with multiple laser emitters that emit energy and ablate target tissue. The proximal end of the laser conduit is connected to an optical fiber coupler and a power source. For the purposes of this application, a portion of the laser conduit associated with the distal end is further referred to herein as distal branch 218, while a portion of the laser conduit associated with the proximal end is referred to herein as proximal branch 216. An inner band forms a central channel or tube that receives a guidewire and / or provides a potential conduit or channel for connection to a suction system for transferring material cut or ablated by the laser emitters.

[0070] like Figure 5 and 5A As further shown, assembly 200 includes a package 210 defined by a first wall 212 and a second wall 214, the first wall 212 and the second wall 214 forming therebetween an internal space 211 for receiving a dispensing device 230. (Reference) Figure 5A , Figure 5AA preferred embodiment of the invention is shown. A dispensing device 230, providing independent dispensing of the distal branch 216 and proximal branch 218 of a laser conduit, comprises at least a first reel 232 and a second reel 234 interconnected by a shaft 250. Each reel consists of a flange 240 having a generally cylindrical base 242 with a hollow interior 244 extending outward from the base. In their independent rotational movement, the reels 232, 234 are supported on one side by packaging wall extensions 215, 217 and rotatably supported on the other side by pins 235, 237. The shaft 250 is provided with an independently rotatable first portion 252 and a second portion 254. A cavity 256 is formed in the central region of the shaft at the interface between the first and second portions. The inner ends of the proximal branch 216 and the distal branch 218 of the laser conduit are spirally arranged on the base 242 of the corresponding spools 232 and 234, so that a reliable optical connection between the branches is maintained when placed in the cavity 256 to ensure the continuity of the conduit.

[0071] Any known device for connecting the laser conduit to the rotating base 242 of spools 232 and 234 can be used, including any additional devices that may be necessary to allow the rotating device to rotate while preventing the conduits 12 from getting tangled or misaligned. The dispensing device of the present invention can be configured to have a variety of sizes as needed. For example, spools of different sizes can be used to accommodate conduits of different lengths. Any suitable material can be used for the features of the spool dispenser. Preferably, the features of the spool dispenser are made of an impermeable material, most preferably a plastic material. The conduits are wound on the corresponding spools of the dispensing device 230 and configured to have different lengths as needed.

[0072] The packaging combination of this invention allows laser catheters or other slender medical devices to be efficiently packaged in a compact, coiled configuration to ensure stability and protection, as well as to allow for the independent distribution of the individual branches of the catheter to suit the needs of the physician during the procedure.

[0073] A method for dispensing a laser catheter according to an embodiment of the present invention includes opening the package through an opening provided at the top of one of the walls to expose the distal end of the catheter, thereby facilitating the introduction of the distal region into the patient.

[0074] By pulling the distal branch 216 of the catheter, the first spool 323 of the device 230 rotates relative to the walls 212, 214 of the packaging, thereby advancing the distal region of the catheter and the transmitter toward the patient. In this operation, the user preferably holds the packaging with one hand while pulling the distal branch 216 of the catheter, causing the first spool 232 to rotate.

[0075] In this way, the distal branch 216, which is wound around the base 242 of the first reel 232, advances from the reel and leaves the device 230 and the package, and then enters the object.

[0076] On the other hand, to distribute the proximal branch 218 of the laser guide tube, the packaging is opened through a hole located at the bottom portion of one of the walls to expose the proximal end of the guide tube outside the packaging. By pulling the proximal branch 216 of the guide tube, the second reel 234 rotates relative to the walls 212, 214 of the packaging, thereby allowing the proximal region of the guide tube to move towards the power supply base of the laser device. Therefore, the proximal branch 218 winds around the base 242 of the second reel 234, advances from the base, and extends out of the device 230 and the packaging for connection to fiber optic couplers and power supplies, etc.

[0077] Now for reference Figure 6A and 6B This illustrates another embodiment of the invention. A laser catheter 300 extends between its distal and proximal ends and forms a central channel 310 that receives a guidewire inserted into a body cavity (e.g., a vascular system) prior to catheter introduction. The channel 310 can also be used to remove / drain obstruction debris from an area near the distal end of the catheter. The guidewire facilitates the advancement and placement of the laser catheter into selected portions of the body cavity for laser ablation of tissue.

[0078] The distal end 320 of the catheter may be formed with one or more optical fibers 322 serving as laser emitters. The energy emitted by the laser emitter cuts, separates, and / or ablates scar tissue, plaque buildup, calcium deposits, and other types of unwanted lesions or body material within the vascular system of the target, in a pattern substantially similar to the cross-sectional configuration of the laser emitter.

[0079] like Figure 6A As shown, the distal end 320 of the laser catheter is inserted into the blood vessel 330 and located immediately adjacent to the obstruction 334 of the blocked blood vessel. The catheter is provided to deliver laser energy to the obstruction to break it into smaller pieces, thereby completely removing the obstruction and / or creating an opening that promotes free blood flow.

[0080] As previously described, in one embodiment for laser energy delivery, the conduit is formed with one or more optical fibers 322, which connect the distal end 320 to a laser energy source. Alternatively, the conduit may be completely or partially filled with a liquid that can act as a medium to transfer laser energy from the source to the surgical site where the obstruction is located.

[0081] like Figure 6A As shown, as required for the best results desired in the clinical purpose of laser therapy, the distal end of the fiber 322, which serves as the laser emitter positioned close to the obstruction, is arranged and shaped so that the laser energy is optimally aimed at the obstruction to break it into fragments of a predetermined size. Figure 6A and 6B The laser beam effectively and optimally covers the entire target area of ​​the obstruction 334.

[0082] In the illustrated embodiment, the catheter 300 is formed such that, after fiber placement, a hollow central channel 310 is formed along the longitudinal axis passing through the central region and along the inner wall of the catheter. The channel 310 serves as a passage for inserting a guidewire. During the procedure, the guidewire can be first inserted into the blood vessel and then pushed through the vascular system to the site of obstruction. The thin and flexible guidewire can easily traverse the complex vascular system. The hollow catheter can then be inserted onto the guidewire.

[0083] The hollow channel 310 in the conduit can also be used to remove debris generated during the application of laser energy to the blockage. To facilitate debris removal, a negative pressure is generated within the hollow opening of the conduit.

[0084] As an optional feature, a sharp blade 340 can be mounted in the distal region inside the hollow channel 310. This blade design and positioning facilitates further dismantling of debris initially generated during the laser-based blockage removal procedure. Due to suction, the initially generated debris is forcefully guided onto the blade for further dismantling into smaller fragments, which can be easily vacuumed into the debris removal area via the conduit. The blade 340 is oriented to not interfere with the use of the guidewire positioned within the conduit.

[0085] To facilitate insertion of the laser catheter 300 into the blood vessel, the outer diameter of the laser catheter 300 should be kept as small as possible (see...). Figure 6A This allows for simple and safe delivery of the catheter through the patient's vascular system to the site of obstruction removal. However, the outer diameter of the target obstruction can be larger than the initial diameter of the catheter. Figure 6A and 6B The illustration shows an alternative design for the distal region of the catheter, which is formed with an expandable device 350, allowing the invention to optimally increase the outer diameter of the catheter and ultimately increase the area of ​​the obstruction targeted by the laser energy for destruction. While multiple expandable arrangements are within the scope of the invention, one preferred embodiment is... Figure 6B As shown in the image. Figure 6BThe distal end 320 of the catheter near the obstruction is shown to have an inflatable or balloon-shaped lumen 352 that expands when pressurized gas is delivered by increasing the pressure of the gas within the lumen. Many possible arrangements are possible and will be apparent to those skilled in the art. In one embodiment of the invention, pressurized gas is delivered via a specially designed tube that connects the lumen or balloon 352 to such a gas source located proximal to the catheter. In another embodiment, the lumen 352 is divided into two or more chambers by walls or barriers 354. Each chamber contains chemicals that are inert when separated but expandable when combined. When the walls 354 are broken and the chemicals come into contact with each other, a large volume of gas is generated, causing the lumen or balloon 352 to expand and significantly increase its volume. In use, the barriers 354 separating these chemicals are remotely broken to bind the chemicals together and create additional volume of pressurized gas to expand the balloon chamber to the required size. There are currently many technically feasible methods for disrupting or puncturing the barrier 354 between two chemical substances, including, but not limited to, inducing an electric current into the barrier wall to generate heat capable of disrupting the barrier. Another method is to deliver an electric current via a wire contained in a conduit, where the current disrupts the barrier. Alternatively, the current delivered via a wire contained in a conduit can raise the temperature of a gas already pre-stored in the balloon cavity, thereby causing the gas volume to expand to the desired conditions, etc.

[0086] exist Figure 6A and 6B In one embodiment, one or more sensors 360 designed to analyze the physical properties of the obstruction and surrounding area may be integrated at the proximal end of the catheter obstruction. Signals from such sensors are transmitted to a laser system control unit, which optimizes the control and management of laser system parameters based on such sensor inputs, including but not limited to temperature, obstruction density (soft, hard, etc.), and an imaging sensor that can decipher the tissue type located in the laser energy path to prevent laser energy from being applied to the vessel wall.

[0087] exist Figure 6BIn some embodiments, the lumen 352 expands radially in the direction from the central channel 310 toward the inner wall of the blood vessel 330. In embodiments 8A, 8B, 9A, 9B, and 9C, in addition to the radially expanding lumen 352, an expandable extension 370 is provided to expand longitudinally along the longitudinal axis of the catheter 300 in the direction of the obstruction 354. A cutting device in the form of a blade 380 is disposed at the distal end of the extension 370. When the extension 370 expands, the cutting device is released and moves toward the obstruction. The expandable extension 370 extends along the periphery of the lumen 352, and at least one or more blades 380 are disposed at the outer end of the extension. The blades 380 may be disposed at any portion of the distal region of the catheter facing the obstruction 334 to separate from or mix with the fibers 322. However, in the illustrated embodiment, the blades 380 are spaced apart from the fibers 322 near the outer surface of the lumen 350.

[0088] Using guidewire 382 or any other control device, a physician can selectively activate, with one or more blades engaging, cutting, and destroying a predetermined area of ​​the obstruction via expandable extension 370. Extension 370 can be integrally formed with or separate from the main lumen 352 so that it can be activated / expanded together with or separately from the main lumen.

[0089] The extension 370 is shown to have an independent barrier / wall 372, which can be independently punctured when expanded using a mixture of various chemicals in a manner similar to that described above. Figure 9A and 9B In one embodiment, the blades 380 are separated from each other. On the other hand, Figure 9C An integral blade 385 in the form of a ring with an outer sharp edge 386 is shown. When the expandable extension 370 is activated, the integral blade 385 is extended and the circular outer sharp edge engages the entire periphery of the blockage. As previously described, the channel 310 is used to remove / drain blockage debris from the area near the distal end of the conduit.

[0090] Referring now to Figure 7, which illustrates a further subsystem 400, forming part of a portable laser ablation device and integrating certain functional elements, such as wheels, into a mobile design with any conventional motion arrangement 410. The main components of the laser energy generation system, such as laser crystals / laser emitters 412, 414, are... Figure 7 As shown in the diagram, the laser system may have multiple laser generating elements for generating, amplifying, and / or adjusting laser irradiation parameters, such as wavelength, pulse duration, polarization, etc., to meet the requirements for optimal clinical efficacy in the treated tissue (soft tissue, hard tissue, or organ tissue).

[0091] To stably generate the desired laser parameters, the laser crystal and / or laser generating elements 412, 414 need to be within certain predetermined ranges of physical parameters, including but not limited to temperature and humidity. To achieve this, the laser crystal / laser emitter elements 412, 414 are equipped with sensors 418, 419 to record the temperature, humidity levels, or other physical characteristics of the laser crystal / laser emitter elements. Furthermore, heating and / or cooling elements 420, 422 are provided to regulate the temperature of the laser crystal / laser emitter elements 412, 414 by heating or cooling them. Signals from sensors 418, 419 are provided to a control unit 428, which controls the operation of the heating and / or cooling elements 420, 422 by applying a computer program. In one embodiment, the heating / cooling elements 420, 422 may be constructed as a water / air circulation loop, including a piping system 425 and a pump 426. An open-profile air cooling system can also be used, and such a cooling system is preferred due to its simplicity and reliability. Alternatively, cooling elements 420, 422 may include directly electronically powered heating / cooling devices. Battery 430 is provided to supply the power required to operate the laser system discussed above.

[0092] Minimum preparation time for laser devices is extremely important during surgical procedures. This is because laser interventions may be required at any time during surgery, often deviating from the initial surgical plan. Preparation time can include or depend on multiple laser functions, including but not limited to warm-up time, calibration time, etc. The laser device may be located in the operating room or sometimes in a separate storage room. Optimal management and control of the heating / cooling elements 420, 422 can play a crucial role in minimizing laser device preparation time. During inactivity (storage), the heating / cooling elements can be programmed to maintain the laser crystal temperature (and other specifications) within an optimal range to prevent any damage to these crystals due to condensation from air moisture. Maintaining the laser crystal temperature within a set range is also important for rapid preheating during actual surgical procedures. Figure 7In this embodiment, the laser system 400 includes a motion sensor 440 configured to activate a preparation protocol to a surgical-operation-grade laser crystal preheating mode. Therefore, once the laser is moved and the motion sensor is activated, the system begins preparation for surgery. This allows the laser system of the present invention to be ready for surgical operation even when it is merely being moved from the storage room to the operating room. In addition to the warm-up steps, other preparation steps can be activated by the motion sensor and a control unit, which includes self-calibration, etc. The control unit can be equipped with remote control functionality via Wi-Fi, the Internet, radio waves, or other remote or wireless communication methods. This allows the operator to remotely control the device, including immediately initiating the preparation mode when surgery may be required. Remote control also allows monitoring of laser system parameters, including battery level, to schedule battery charging if necessary.

[0093] Now for reference Figure 10 and 10A An embodiment illustrates a laser assembly comprising a handheld device 740 and a laser device 700. The laser device 700 is formed of a tubular body 702, which has a hollow interior and consists of a proximal portion 704 and a distal portion 706. The proximal portion 704 is generally longer than the distal portion 706. A laser transmission fiber 708 passes through the central region of the hollow interior 710 of the tubular body 702. The fiber 708 can be a single fiber or a bundle of multiple fibers arranged together. The hollow space between the fiber 708 and the inner wall of the body is used to remove debris generated during surgical procedures. To hold the fiber 708 in its central orientation, a plurality of retaining elements 712 are installed along the length of the hollow interior 710. Each element 712 forms a central opening region 714 and multiple rays 716 extending outward from the central opening region 714. In the assembled position, the fiber 708 is supported by and passes through the central opening region 714 of each distributed element 712. The rays 716 extending to the inner wall of the body 702 stabilize the distribution of the scattering elements and the position of the optical fibers within the hollow interior 710. Segments 719 within the hollow interior, separated by the rays, define multiple longitudinal channels for draining debris from the surgical site and for delivering various fluids to facilitate surgery. The proximal portion 704 is typically made of a rigid material, while the material used in the manufacture / production of the distal portion 706 is elastic and capable of bending or deforming. Figure 10A As further shown, the hollow catheter 720 extends along its longitudinal axis outside the body 702 between its closed end 721 and open end 725. A flexible element or cord 722 is positioned within the hollow interior space and attached to the closed inner end 721 of the catheter. The relatively free end of the cord extends from the open end 725 of the catheter and can be manipulated and pulled by the surgeon during the procedure. To simplify cord manipulation, such as... Figure 10As shown, the free end of the cord 722 extends to a handheld device 740, which is typically in the surgeon's hand during the procedure. An elastic member 726, such as a spring, is positioned at the distal portion 706 opposite the catheter 720. In use, by pulling the cord 722, the surgeon can remotely manipulate and / or bend the elastic distal portion 706 and the fiber optic cable 708 to position them internally at an optimal angle, thereby aiming the distal portion in the desired direction within the patient's body cavity. When manipulation of the corresponding portions of the elastic distal portion 706 and the fiber optic cable 708 is no longer necessary, the surgeon releases the cord 722 at the handheld device 740, and the spring 726 returns the elastic distal portion to its original orientation.

[0094] Now for reference Figure 11 This illustration shows a laser surgical system 500 according to another embodiment of the invention. A connecting device 510 extends between a proximal end 512 and a distal end 514, with the proximal end connected to a laser source 516. In one embodiment, a pump 518 may be disposed at the proximal end 512 to generate a vacuum. In another embodiment, the vacuum pump 518 is connected to a handheld surgical device 520. A control mechanism may be added to the system to adjust the vacuum intensity. The handheld surgical device 520, including a controller and a disposable light guide or laser surgical instrument 525, is disposed at the distal end 514 of the connecting device. The connecting device 510 may be formed as a hollow articulated arm or may be in the form of a flexible fiber optic delivery guide. In an embodiment where the articulated arm is a light transmission system, light is guided from the laser source 516 to the application point at the laser surgical instrument 525. In another embodiment, the connecting device combines an energy transmission device including a flexible fiber optic cable with a suction-generating pump 518 to improve the efficiency of removing material from a body cavity through a hollow space within the arm. In the latter embodiment, the hollow interior of the connecting device may include a suction conduit and a high-energy conduit. Handheld devices similar to those described in this invention are known in the art and are not part of this invention. The handheld device 520 externally houses a disposable laser surgical instrument or energy delivery conduit 525, wherein the distal end of the disposable laser surgical instrument or energy delivery conduit 525 has a light transmission tip 526. A guide 530 facilitates delivery of the disposable laser surgical instrument 525 to the treatment site.

[0095] like Figure 11As shown, the flexible, disposable funnel-shaped guide 530 includes a generally truncated cone or pyramidal hollow body 532 defined by a peripheral wall 534 extending between a larger input region 536 with a larger cross-section and a narrower exit region 538 with a smaller cross-section. The exit region 538 is typically sharp, with a small opening 539 to accommodate the passage of a light-transmitting tip. The wall 534 is centered on a longitudinal axis extending through the guide 530. A resection section / portion 540 extends longitudinally within the peripheral wall 534 between the input and output regions. In use, when a laser surgical instrument or energy delivery conduit 525 is inserted into the hollow body 532, the peripheral wall 534 expands / spreads at the resection portion 540, allowing the light-transmitting tip 526 to pass through the interior of the guide and extend outward from the opening 539 of the output region. The guide can be made of inexpensive, flexible yet sufficiently strong materials to ensure tissue penetration and simplify the sterilization process. Various plastics can be used for this purpose, making the guide 530 disposable to suit the needs of each patient.

[0096] When used under a physician's guidance, the guide 530 is inserted through the patient's muscles, ligaments, bone tissue, etc., so that the outlet end 538 is positioned near the treatment site 550. The laser surgical instrument or energy delivery conduit 525 is then inserted and / or pushed through the hollow body 532 defined by the wall 534, causing the wall to expand at the incision portion 540, allowing the light transmission tip 526 to pass through the output opening to be positioned at the treatment site 550. The engagement between the light transmission tip 526 and the output opening 539 stabilizes the position of the surgical instrument at the treatment site. If the tip contacts tissue, the laser surgical instrument including the light transmission tip 526 can vaporize the tissue; or if the tip is spaced apart from the tissue, the laser surgical instrument can coagulate the tissue. When the pump 516 is positioned at the proximal end 512 of the articulated arm, debris generated during the procedure is discharged from the treatment site through the open area between the arm wall and the fiber optic guide.

[0097] exist Figure 11A In this embodiment, the laser surgical instrument 525 takes the form of the tubular laser device 700 previously discussed. The surgeon's maneuverable distal portion 706 operates on a spring 722 extending to the handheld device 520.

[0098] Now for reference Figure 12 This illustrates a modified version of the guide 630, wherein the guide 630 is used in conjunction with an endoscope or observation instrument 615 and a laser surgical tool or energy delivery rod / catheter 625, wherein its distal end is formed with a light transmission tip 626. According to the above... Figure 10Similarly, the guide 630 body is configured as a truncated cone or pyramid, defined by an outer wall extending between a top input region 636 with a larger cross-section and a narrow outlet region 638 with a smaller cross-section. A hollow chamber 632 is formed within the body. A first orifice 619 and a second orifice 621 are formed in the top region of the input region, wherein the first orifice 619 is adapted to receive and guide the movement of the energy transmission rod. A handle 660 is formed with a suction conduit 662 extending outward from the top input region. The suction conduit is connected at its proximal end to a pump that generates a vacuum, and its distal end coincides with the second orifice 621. The suction caused by the vacuum pump through the conduit 662 connected to the hollow chamber facilitates the removal of debris generated from the treatment site 650 during the procedure through the chamber and the conduit. Additional structures provided at the conduit 662 can help prevent blockage of the drainage system. For example, filters, screens, meshes, protective materials, or other barriers can be molded to or otherwise attached to the conduit 662 or any other suitable area. The exit end 638 is substantially sharp and has a small opening 639 formed to allow the passage of the light transmission tip 626. A cut-off portion similar to the previously discussed portion 540 may extend longitudinally within the outer wall.

[0099] The movement of the light transmission tip within the body cavity is detected by the observation instrument 615. An example of such an observation instrument is an endoscope, which includes a fiber optic illumination source and a fiber optic lens for observation, allowing the physician to view the surgical area 650.

[0100] In use, when the laser transmission rod 625 with light transmission tip 626 is inserted into the hollow interior through the first hole 619 of the input area, the light transmission tip passes through the guide interior 632 to extend outward from the opening 639 of the output area for placement near the surgical site 615. If the tip comes into contact with tissue 650, the light transmission tip 626 can vaporize the tissue, or if the tip is separated from the tissue, the light transmission tip 626 can coagulate the tissue. By moving the handle 629, which forms part of the rod, the physician can remotely manipulate the laser transmission rod within the hole 619 to position the light transmission tip 626 at an optimal angle, thereby aiming the tip in the direction described within the patient's body cavity.

Claims

1. A laser surgical guidance system for guiding laser surgical instruments, comprising: A guiding device is formed by a wall shaped like a truncated cone defining a hollow body extending between an input region and an output region, the cross-section of which is larger than that of the output region. The output region has an output opening, a cut portion extending longitudinally to the wall of the hollow body between the input and output regions, a top wall extending to the input region and having at least first and second holes, a chamber formed within the hollow body, the first hole guiding a laser surgical instrument having a light transmission tip, a handle connected to the second hole and extending outward from the top wall, and a suction conduit connected through the second hole to the chamber and through the handle. The proximal end of the suction conduit is connected to a vacuum device that generates a vacuum at its distal end and is located within the chamber. In use, when the laser surgical instrument is inserted into the chamber through the first hole, the light transmission tip through the output opening is positioned at the treatment site. The vacuum causes debris generated at the treatment site to be expelled through the output opening, the chamber, and the suction conduit.

2. The laser surgical guidance system according to claim 1, characterized in that, It also includes multiple auxiliary devices, which are installed at the suction conduit to prevent blockage of the discharge system.

3. The laser surgical guidance system according to claim 2, characterized in that, The plurality of additional devices are selected from the group consisting of filters, screens, meshes, protective devices and other barriers associated with the conduit.

4. The surgical guidance system according to claim 1, characterized in that, It also includes observation instruments located in the output area.

5. The laser surgical guidance system according to claim 4, characterized in that, The laser surgical instrument is a laser transmission rod. By manipulating the laser transmission rod within the output opening, the light transmission tip is positioned at the optimal angle within the patient's body cavity, while the light transmission tip is observed through the observation instrument.

6. The surgical guidance system according to claim 1, characterized in that, The top wall and the input area are integrated.

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